0001104659-24-011653 | S-1/A | XBRL Viewer

Print Document View Excel Document

Leases - Summary (Details)	3 Months Ended		9 Months Ended		12 Months Ended
Leases - Summary (Details)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($) lease	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Leases
Number of finance leases \| lease	0		0		0
Number of operating leases \| lease	1		1		1
Lessee, Operating Lease, Existence of Option to Extend [true false]			true		true
Renewal term	5 years		5 years		5 years
Operating lease expense \| $	$ 89,000	$ 90,000	$ 267,000	$ 271,000	$ 355,000	$ 180,000
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities \| $			$ 235,000	$ 132,000	$ 175,000	$ 131,000	$ 184,000
Weighted-average remaining lease term (years)	1 year 6 months		1 year 6 months		2 years 3 months
Weighted-average discount rate	11.80%		11.80%		11.80%

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Dec. 31, 2022	Sep. 30, 2023
Commitments and Contingencies
Future purchase commitments		$ 238.2	$ 230.1
Corium Agreement [Member]
Commitments and Contingencies
Quarterly minimum volume amount of product to be ordered	$ 5.6
Additional fee payable as a percentage of transfer price for units ordered	(25.00%)
Percentage of additional fee as penalty percent		25.00%
Reminder 2023		$ 5.3	7.0
2023		7.0
2024 and Each Year Thereafter		$ 22.5
2024 and Each Year Thereafter			$ 22.5

Summary of Significant Accounting Policies - Income Taxes (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Uncertainty in tax positions
Uncertain tax positions	$ 0	$ 0

Equity Incentive Plans - Restricted Stock (Details) - Unvested restricted stock units - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Shares
Restricted stock outstanding at beginning of year (in shares)	8,325	3,988
Granted (in shares)	4,690	7,433
Vested (in shares)	(6,554)	(3,096)
Restricted stock outstanding at end of year (in shares)	6,461	8,325	3,988
Weighted Average Grant Date Fair Value
Granted (in dollars per share)	$ 1.05	$ 67.27
Vested (in dollars per share)	$ 76.30	$ 112.73
Aggregate Intrinsic Value
Intrinsic value of vested shares	$ 2	$ 163	$ 458
Executive officers
Shares
Granted (in shares)		1,774
Vesting period		1 year
Directors
Shares
Granted (in shares)	4,690	5,659
Directors \| Minimum
Shares
Vesting period	1 year	1 year
Directors \| Maximum
Shares
Vesting period		3 years

Restatement of Previously Issued Financial Statements - Impact on Balance Sheet - Other (Details) - $ / shares	Sep. 30, 2023	Apr. 10, 2023	Apr. 09, 2023	Dec. 31, 2022	Jan. 07, 2022	Jan. 06, 2022	Dec. 31, 2021	Jan. 06, 2020
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Preferred stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Preferred stock, authorized (in shares)	10,000,000			10,000,000			10,000,000
Preferred stock, issued (in shares)	4,850			4,850			0
Preferred stock, outstanding (in shares)	0			0			0
Common stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Common stock, authorized (in shares)	300,000,000			300,000,000	300,000,000	150,000,000	300,000,000	300,000,000
Common stock, issued (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901
Common stock, outstanding (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Organization and Description of Business (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Nature of Operations
Accumulated deficit	$ 418,699	$ 408,702	$ 383,290
Cash, cash equivalents and marketable securities	2,900	5,200
Working capital deficit	$ 7,500	$ 2,000

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Statements of Cash Flows - USD ($)	9 Months Ended		12 Months Ended
Statements of Cash Flows - USD ($)	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash flows from operating activities:
Net loss	$ (9,995,000)	$ (21,481,000)	$ (25,412,000)	$ (71,067,000)	$ (51,853,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve				5,323,000
Depreciation	77,000	1,255,000	1,280,000	2,064,000	105,000
Amortization	209,000	188,000	254,000	159,000	171,000
Loss on disposition of assets		11,122,000	11,122,000
Loss on disposition of assets			11,122,000
Noncash stock-based compensation	1,418,000	1,969,000	2,493,000	3,338,000	2,818,000
Noncash amortization of deferred financing costs	838,000	1,635,000	1,969,000	1,661,000	1,341,000
Unrealized gain on warrants	(6,890,000)	(22,171,000)	(25,520,000)	(3,827,000)
Changes in operating assets and liabilities:
Accounts receivable	(144,000)	(2,178,000)	(1,844,000)	(668,000)	(865,000)
Inventory	(1,079,000)	(831,000)	(366,000)	(6,289,000)
Prepaid expenses and other assets	2,480,000	(1,551,000)	880,000	(967,000)	(2,485,000)
Accounts payable and accrued expenses	3,572,000	(2,213,000)	(628,000)	5,202,000	3,641,000
Lease liability	(235,000)	(132,000)	(175,000)	(131,000)	(184,000)
Net cash used in operating activities	(9,749,000)	(34,388,000)	(35,947,000)	(65,202,000)	(47,311,000)
Cash flows from investing activities:
Purchases of marketable securities					(54,837,000)
Sales and maturities of marketable securities				39,729,000	14,500,000
Acquisition of property and equipment		(133,000)	(133,000)	(269,000)	(353,000)
Net cash used in investing activities		(133,000)	(133,000)	39,460,000	(40,690,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs	6,509,000	21,971,000	21,936,000	21,081,000	48,434,000
Proceeds from issuance of long-term debt					20,000,000
Repayments of long-term debt	(675,000)	(17,150,000)	(17,375,000)
Repayments of note payable	(184,000)
Debt financing costs paid					(1,059,000)
Proceeds from exercise of stock options				75,000	610,000
Net cash provided by financing activities	7,375,000	21,523,000	22,183,000	30,422,000	67,985,000
Net decrease in cash and cash equivalents	(2,374,000)	(12,998,000)	(13,897,000)	4,680,000	(20,016,000)
Cash and cash equivalents, beginning of period	5,246,000	19,143,000	19,143,000	14,463,000	34,479,000
Cash and cash equivalents, end of period	2,873,000	6,145,000	5,246,000	19,143,000	14,463,000
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt				1,080,000	3,570,000
Warrants issued in connection with preferred stock offering		2,101,000
Operating right-of-use assets obtained in exchange for new operating lease liabilities				969,000
Supplemental cash flow information
Interest paid	276,000	1,078,000	1,162,000	2,383,000	$ 2,099,000
Series A Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		897,000
Series B Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		887,000
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129,000	4,128,000
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 1,725,000	$ 12,573,000	$ 13,494,000	$ 9,266,000

Equity Incentive Plans

12 Months Ended

Dec. 31, 2022

Equity Incentive Plans

Equity Incentive Plans

11. Equity Incentive Plans

Stock options

The Company had granted stock options under an amended and restated 1997 Equity Incentive Plan (the “1997 Plan”) and a 2008 Equity Incentive Plan (the “2008 Plan”). The plans provided for the granting of incentive and non-statutory options and stock awards to consultants, directors, officers and employees. Such options are exercisable for a period of ten years and generally vest over a four-year period. In conjunction with the adoption of the 2008 Plan in April 2008, no additional grants were made from the 1997 Plan and issued options from the 1997 Plan remain outstanding. In 2014, the Board approved the 2014 Incentive Compensation Plan (the “2014 Plan”). The 2014 Plan is the successor to the Company’s 2008 Plan and 1997 Plan. In conjunction with the adoption of the 2014 Plan in 2014, no additional grants were made from the 2008 Plan and options from the 1997 Plan and the 2008 Plan remain outstanding. In June 2018, the 2014 Plan was amended and restated, and the Amended and Restated 2014 Incentive Compensation Plan is now referred to as the Amended 2014 Plan. As of December 31, 2022, there were 314,398 shares available for future grant under the Amended 2014 Plan.

Through December 31, 2022, the Company granted options to certain employees and non-employees to purchase shares of common stock at exercise prices ranging from $0.20 to $430.00 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2022, 2021 and 2020 based on the fair market value of the options and shares granted at the grant date. Stock-based compensation expense was as follows:


	Year Ended
	December 31,
	2022		2021		2020
Cost of goods sold	$	133	$	271	$	14
Research and development		372		490		651
Selling and marketing		155		148		108
General and administrative		1,833		2,429		2,045
Total	$	2,493	$	3,338	$	2,818

The following assumptions were used to compute employee stock-based compensation under the Black-Scholes option pricing model:


	2022		2021		2020
Risk‑free interest rate	1.71% - 4.22	%	.66% - 1.51	%	.40% - 1.68	%
Expective volatility	107% ‑ 118	%	105% ‑ 106	%	65% ‑ 106	%
Expected dividend yield	0	%	0	%	0	%
Expected life (in years)	6.25		6.25		6.25

Risk-free interest rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants.

Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends.

Expected volatility. The expected volatility assumption was based on volatilities of a peer group of similar companies whose share prices are publicly available until August 2020. The peer group was developed based on comparable companies in the biotechnology and pharmaceutical industries. In August 2020, the Company transitioned to its own expected volatility based on sufficient historical data.

Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historic exercise behavior, management determined the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period.

Forfeitures. The Company has elected to record forfeitures as they occur.

As of December 31, 2022, the unrecorded deferred stock-based compensation balance related to stock options was approximately $3.3 million and will be recognized over an estimated weighted-average amortization period of 2.8 years. The weighted average grant date fair value of options granted during the year ended December 31, 2022 was $3.29.

The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2022, 2021 and 2020:


			Weighted
		Weighted	Average
		Average	Remaining
		Exercise	Contractual	Aggregate
	Options	Price	Life (Years)	Intrinsic Value
Options outstanding at December 31, 2020	212,946	125.29	6.3
Options granted	64,528	105.00
Options exercised	(3,159)	23.80
Options cancelled/forfeited	(15,170)	264.46
Options outstanding at December 31, 2021	259,145	113.33	6.1
Options granted	187,454	3.97
Options exercised	—	—
Options cancelled/forfeited	(48,781)	97.44
Options outstanding at December 31, 2022	397,818	63.75	7.7	$	6
Options exercisable at December 31, 2022	182,667	113.54	5.7	$	—
Vested and expected to vest at December 31, 2022	397,818			$	6

Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 31, 2022, of $0.23 per share, and the exercise price, multiplied by the number of options.

Restricted Stock Units

During the year ended December 31, 2021, the Company granted a total of 1,774 RSUs to certain employees of the Company. These RSUs vested on the one-year anniversary of the grant date. During the year ended December 31, 2021, the Company granted a total of 5,659 RSUs to directors of the Company. These RSUs vest ratably over one and three years.

During the year ended December 31, 2022, the Company granted a total of 4,690 RSUs to directors of the Company. These RSUs vest ratably over one year.

As of December 31, 2022, the unrecorded deferred stock-based compensation balance related to RSUs was approximately $68,000 and will be recognized over an estimated weighted-average amortization period of 0.7 years. The following table shows the Company's restricted stock unit activity during the years ended December 31, 2022, and 2021:


		Weighted Average	Aggregate
	Shares	Grant Date Fair Value	Intrinsic Value
Restricted stock units outstanding at December 31, 2020	3,988		$	458
Granted	7,433	67.27
Vested	(3,096)	112.73
Restricted stock units outstanding at December 31, 2021	8,325	—	$	163
Granted	4,690	1.05
Vested	(6,554)	76.30
Restricted stock units outstanding at December 31, 2022	6,461		$	2

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Accrued Liabilities
Gross to net accruals	$ 3,933	$ 2,332	$ 670
Accrued compensation	2,721	833	2,086
Accrued professional fees and other	1,684	743	807
Total accrued liabilities	$ 8,338	$ 3,908	$ 3,563

Equity Incentive Plans - Stock Option Activity (Details) - Common stock options - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Options
Options outstanding at beginning of year (in shares)	259,145	212,946
Options granted (in shares)	187,454	64,528
Options exercised (in shares)		(3,159)
Options cancelled/forfeited (in shares)	(48,781)	(15,170)
Options outstanding at end of year (in shares)	397,818	259,145	212,946
Options exercisable at end of year (in shares)	182,667
Vested and expected to vest at end of year (in shares)	397,818
Weighted Average Exercise Price
Options outstanding at beginning of year (in dollars per share)	$ 113.33	$ 125.29
Options granted (in dollars per share)	3.97	105.00
Options exercised (in dollars per share)		23.80
Options cancelled/forfeited (in dollars per share)	97.44	264.46
Options outstanding at end of year (in dollars per share)	63.75	$ 113.33	$ 125.29
Options exercisable at end of year (in dollars per share)	$ 113.54
Weighted Average Remaining Contractual Life (Years)
Options outstanding	7 years 8 months 12 days	6 years 1 month 6 days	6 years 3 months 18 days
Options exercisable	5 years 8 months 12 days
Aggregate Intrinsic Value
Options outstanding at the end of the year (in dollars)	$ 6
Vested and expected to vest at end of year	$ 6
Estimated stock price (in dollars per share)	$ 0.23

Restatement of Previously Issued Financial Statements - Impact on Statement of Cash Flows (Details) - USD ($)	3 Months Ended	6 Months Ended	9 Months Ended		12 Months Ended
	Mar. 31, 2022	Jun. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash flows from operating activities:
Net loss			$ (9,995,000)	$ (21,481,000)	$ (25,412,000)	$ (71,067,000)	$ (51,853,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve						5,323,000
Depreciation			77,000	1,255,000	1,280,000	2,064,000	105,000
Amortization			209,000	188,000	254,000	159,000	171,000
Noncash stock-based compensation			1,418,000	1,969,000	2,493,000	3,338,000	2,818,000
Noncash amortization of deferred financing costs			838,000	1,635,000	1,969,000	1,661,000	1,341,000
Unrealized gain on warrants			(6,890,000)	(22,171,000)	(25,520,000)	(3,827,000)
Changes in operating assets and liabilities:
Accounts receivable			(144,000)	(2,178,000)	(1,844,000)	(668,000)	(865,000)
Inventory			(1,079,000)	(831,000)	(366,000)	(6,289,000)
Prepaid expenses and other assets			2,480,000	(1,551,000)	880,000	(967,000)	(2,485,000)
Accounts payable and accrued expenses			3,572,000	(2,213,000)	(628,000)	5,202,000	3,641,000
Lease liability			(235,000)	(132,000)	(175,000)	(131,000)	(184,000)
Net cash used in operating activities			(9,749,000)	(34,388,000)	(35,947,000)	(65,202,000)	(47,311,000)
Cash flows from investing activities:
Purchases of marketable securities							(54,837,000)
Sales and maturities of marketable securities						39,729,000	14,500,000
Acquisition of property and equipment				(133,000)	(133,000)	(269,000)	(353,000)
Net cash provided by investing activities				(133,000)	(133,000)	39,460,000	(40,690,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs			6,509,000	21,971,000	21,936,000	21,081,000	48,434,000
Proceeds from exercise of stock options						75,000	610,000
Net cash provided by financing activities			7,375,000	21,523,000	22,183,000	30,422,000	67,985,000
Net (decrease) increase in cash and cash equivalents			(2,374,000)	(12,998,000)	(13,897,000)	4,680,000	(20,016,000)
Cash and cash equivalents, beginning of period	$ 19,143,000	$ 19,143,000	5,246,000	19,143,000	19,143,000	14,463,000	34,479,000
Cash and cash equivalents, end of period			2,873,000	6,145,000	5,246,000	19,143,000	14,463,000
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt						1,080,000	3,570,000
Operating right-of-use assets obtained in exchange for new operating lease liabilities						969,000
Supplemental cash flow information
Interest paid			276,000	1,078,000	1,162,000	2,383,000	2,099,000
As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from operating activities:
Net loss	(11,769,000)	(23,988,000)		(43,652,000)		(74,894,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve						5,323,000
Depreciation	527,000	1,057,000		1,255,000		2,064,000
Amortization	61,000	124,000		188,000		159,000
Noncash stock-based compensation	764,000	1,433,000		1,969,000		3,338,000
Noncash amortization of deferred financing costs	419,000	797,000		1,635,000		1,661,000
Changes in operating assets and liabilities:
Accounts receivable	(132,000)	(554,000)		(2,178,000)		(668,000)
Inventory	(1,727,000)	(1,374,000)		(831,000)		(6,289,000)
Prepaid expenses and other assets	707,000	1,267,000		(1,551,000)		(967,000)
Accounts payable and accrued expenses	1,095,000	3,643,000		(2,213,000)		5,202,000
Lease liability	(21,000)	(90,000)		(132,000)		(131,000)
Net cash used in operating activities	(14,751,000)	(17,685,000)		(34,388,000)		(65,202,000)
Cash flows from investing activities:
Sales and maturities of marketable securities						39,729,000
Acquisition of property and equipment	(126,000)	(133,000)		(133,000)		(269,000)
Net cash provided by investing activities	(126,000)	(133,000)		(133,000)		39,460,000
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs				21,971,000		21,081,000
Proceeds from exercise of stock options						75,000
Net cash provided by financing activities	(523,000)	11,702,000		21,523,000		30,422,000
Net (decrease) increase in cash and cash equivalents	(15,400,000)	(6,116,000)		(12,998,000)		4,680,000
Cash and cash equivalents, beginning of period	19,143,000	19,143,000		19,143,000	19,143,000	14,463,000
Cash and cash equivalents, end of period	3,743,000	13,027,000		6,145,000		19,143,000	$ 14,463,000
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt						1,080,000
Operating right-of-use assets obtained in exchange for new operating lease liabilities						969,000
Supplemental cash flow information
Interest paid	452,000	898,000		1,078,000		2,383,000
Error Correction, Adjustment \| Error Correction, Accounting for Warrants
Cash flows from operating activities:
Net loss	1,384,000	8,435,000		22,171,000		3,827,000
Adjustments to reconcile net loss to net cash used in operating activities:
Unrealized gain on warrants	(1,384,000)	(8,435,000)		(22,171,000)		(3,827,000)
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs				4,129,000	4,128,000
Public offering \| As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs	4,129,000	4,129,000		4,129,000
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs			$ 1,725,000	12,573,000	$ 13,494,000	9,266,000
At-the-market sales \| As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 348,000	$ 12,573,000		$ 12,573,000		$ 9,266,000

Income Taxes

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Income Taxes

Income Taxes

9. Income Taxes

Sale of New Jersey Net Operating Losses

The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program; however, in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. The Company received final approval in March 2022 for $4.7 million of additional cash benefit that was received in April 2022.

12. Income Taxes

On March 27, 2020 the US government enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which includes numerous modifications to income tax provisions, including a limitation on business interest expense and net operating loss provisions and the acceleration of alternative minimum tax credits. Given the Company’s history of losses, the CARES Act did not have a material impact on its tax provision.

As of December 31, 2022, the Company had available net operating loss carryforwards (“NOLs”) of approximately $390.6 million for federal and $79.9 million for state income tax reporting purposes. Under the TCJA, the federal NOLs generated after 2017, approximately $201.7 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $188.9 million, are available to offset future federal taxable income, if any, through 2037. The Company also has research and development tax credit carryforwards of approximately $6.4 million and $0.9 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2042 and state income taxes, if any, through 2037.

The Internal Revenue Code of 1986, as amended (the “Code”) provides for a limitation on the annual use of NOLs and other tax attributes (such as research and development tax credit carryforwards) following certain ownership changes, as defined by the Code that could significantly limit the Company’s ability to utilize these carryforwards. At this time, the Company has not completed a study to assess whether an ownership change under Section 382 of the Code has occurred, or whether there have been multiple ownership changes since the Company’s formation, due to the costs and complexities associated with such a study. The Company is likely to have experienced various ownership changes, as defined by the Code, as a result of past financings. Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes. Therefore, the Company may not be able to take full advantage of these carryforwards for federal and state income tax purposes. The Company does not have any significant unrecognized tax benefits.

As of December 31, 2022, the Company has not accrued interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2019 through December 31, 2021 are still subject to examination by major tax jurisdictions. However, the Internal Revenue Service (“IRS”) and state tax jurisdictions can audit the NOLs generated in prior years in the years that those NOLs are utilized.

For all years through December 31, 2022, the Company generated research credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment in known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance.

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below:


	December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	87,216	$	81,102
Research credit carryforward		7,071		7,943
Stock options and other		2,297		2,114
Total gross deferred tax assets		96,584		91,159
Valuation allowance for deferred tax assets		(96,584)		(91,159)
Net deferred tax assets	$	—	$	—

The net change in the valuation allowance for the years ended December 31, 2022 and 2021 was an increase of $5.4 million and an increase of $14.4 million, respectively.

A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows:


	December 31,
	2022		2021 (Restated)		2020
Federal income tax at statutory rate	21.0	%	21.0	%	21.0	%
State income tax benefit, net of federal benefit	0.1	%	0.2	%	1.0	%
Unrealized gain on warrants	18.8	%	1.1	%	—	%
Research and development tax credits	0.1	%	0.2	%	0.7	%
Other	(5.6)	%	(2.2)	%	(2.0)	%
Increase to valuation allowance	(18.5)	%	(20.3)	%	(20.7)	%
Effective income tax rate	15.9	%	0.0	%	0.0	%

Sale of New Jersey Net Operating Losses

The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program, however in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. In March 2022, the Company completed the sale of NOLs totaling approximately $44.3 million and research and development credits totaling approximately $1.0 million for net proceeds of approximately $4.7 million. Such proceeds are reflected as a tax benefit for year ended December 31, 2022.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-14

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 21
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-21

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 270
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482526/740-270-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-2

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Fair Value Measurements (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Fair Value Measurements

Schedule of financial instruments measured at fair value by level within the fair value hierarchy

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
September 30, 2023
Assets:
Cash and cash equivalents	$	2,873	$	—	$	—
Total assets at fair value	$	2,873	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,566
Total assets at fair value	$	—	$	—	$	5,566


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3 (Restated)
December 31, 2021
Assets:
Cash and cash equivalents	$	19,143	$	—	$	—
Total assets at fair value	$	19,143	$	—	$	—

Liabilities:
Warrant Liability (Restated)	$	—	$	—	$	5,356
Total assets at fair value	$	—	$	—	$	5,356

Schedule of rollforward of the fair value of Level 3 warrants


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(10,983)
Ending Balance September 30, 2023	$	5,566


Beginning balance at December 31, 2020	$	—
Warrants issued		9,183
Change in fair value		(3,827)
Ending balance at December 31, 2021 (Restated)		5,356
Warrants issued		26,098
Change in fair value		(25,520)
Ending balance at December 31, 2022	$	5,934

Summary of Significant Accounting Policies - Warrants (Details) - shares	May 31, 2023	Dec. 31, 2022	Jul. 31, 2022	Jul. 06, 2022	Apr. 30, 2022	Mar. 31, 2022	Oct. 31, 2021	Feb. 28, 2021	Feb. 26, 2021	Feb. 29, 2020	Feb. 10, 2020
Warrants
Common stock that can be purchased with warrants (in shares)					4,243
Common stock that can be purchased with warrants (in shares)						24,856	6,660
As Previously Reported
Warrants
Common stock that can be purchased with warrants (in shares)					212,188
Common stock that can be purchased with warrants (in shares)						1,242,813	333,333
Public offering
Warrants
Common stock that can be purchased with warrants (in shares)	3,792,572		1,093,333
Common stock that can be purchased with warrants (in shares)							6,660
Public offering \| As Previously Reported
Warrants
Common stock that can be purchased with warrants (in shares)			54,666,665
Common stock that can be purchased with warrants (in shares)			38,296,664	7,518,334			333,333
Common stock warrants \| Public offering
Warrants
Common stock that can be purchased with warrants (in shares)			533,333
Warrants
Warrants
Common stock that can be purchased with warrants (in shares)						225
Warrants \| Public offering \| As Previously Reported
Warrants
Common stock that can be purchased with warrants (in shares)			15,036,668
Perceptive Credit Agreement \| Warrants
Warrants
Common stock that can be purchased with warrants (in shares)	225		225				225
Perceptive Credit Agreement \| Warrants \| As Previously Reported
Warrants
Common stock that can be purchased with warrants (in shares)			11,250			11,250	11,250
Perceptive Credit Agreement \| Perceptive Warrants
Warrants
Common stock that can be purchased with warrants (in shares)								225		700
Common stock that can be purchased with warrants (in shares)									225		700
Perceptive Credit Agreement \| Perceptive Warrants \| As Previously Reported
Warrants
Common stock that can be purchased with warrants (in shares)										35,000
Common stock that can be purchased with warrants (in shares)		35,000					35,000	11,250

Credit Agreement and Guaranty

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Credit Agreement and Guaranty

Credit Agreement and Guaranty

7. Credit Agreement and Guaranty

On February 10, 2020, the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP (“Perceptive”) for a senior secured term loan credit facility of up to $35.0 million (the “Perceptive Credit Agreement”). A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA. The other tranches of debt under the Perceptive Credit Agreement are no longer available to the Company. On January 7, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 8, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 25, 2022, the Company entered into a fifth amendment to the Perceptive Credit Agreement, as amended (the “Fifth Amendment”). Pursuant to the Fifth Amendment, Perceptive agreed to release its security interest in certain assets being transferred from the Company to Corium in connection with an amendment to the Company’s Manufacturing and Commercialization Agreement with Corium and waive the Company’s obligations to comply with certain financial covenants through the end of 2022. In exchange, the Company agreed to prepay $7.0 million of outstanding principal under the Perceptive Credit Agreement using the proceeds of recent sales under the Company’s ATM program with H.C. Wainwright & Co., LLC (see Note 8). Such payment was made on July 25, 2022. On March 21, 2023, the Company and Perceptive entered into a sixth amendment to the Perceptive Credit Agreement (the “Sixth Amendment”). The Sixth Amendment waived the Company’s obligations to (1) comply with certain financial covenants relating to minimum revenue requirements and minimum liquidity through June 30, 2023, and (2) file financial statements along with its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 that are not subject to any “going concern” qualification. On October 30, 2023, the Company and Perceptive entered into a seventh amendment to the Perceptive Credit Agreement (the “Seventh Amendment”). The Seventh Amendment: (1) amends the Company’s obligations to comply with certain financial covenants relating to minimum revenue requirements, (2) amends and waives the Company’s obligations to comply with certain financial covenants relating to minimum liquidity through December 31, 2023, and (3) requires the Company to make principal payments on its outstanding loan balance of $150,000 per month beginning on December 1, 2023.

The facility will mature on February 10, 2024 (“Maturity Date”). Pursuant to the Perceptive Credit Agreement, beginning August 31, 2022, the Company began making monthly principal payments in an amount equal to $75,000. Beginning on December 1, 2023 and pursuant to the Seventh Amendment, the Company will begin making monthly payments of $150,000 until the Maturity Date, at which time all remaining principal amount outstanding is due.

Borrowings under the Perceptive Credit Agreement will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus 10.25%, provided that LIBOR shall not be less than 1.5%. The rate of interest in effect as of September 30, 2023 was 15.58%. Upon the occurrence and during the continuance of any event of default under the Perceptive Credit Agreement, the interest rate automatically increases by 3.0% per annum.

The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of 2.0%.

All of the Company’s obligations under the Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, as amended by the Seventh Amendment, the Company must (i) at all times for the period from June 30, 2023 to October 31, 2023 maintain a minimum cash balance of $0.5 million for the period from November 1, 2023 to December 31, 2023 maintain a minimum cash balance of $1.0 million, and after December 31, 2023 to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending September 30, 2023, report net revenues for the trailing 12-month period that are not less than $5.0 million. Pursuant to the Seventh Amendment, the Company has received a waiver of certain financial covenants through December 31, 2023.

In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 700 shares of the Company’s common stock (together, the “2020 Perceptive Warrants”). The first warrant is exercisable for 350 shares of common stock at an exercise price of $7,480 per share. The second warrant is exercisable for 350 shares of common stock at an exercise price of $9,340 per share. The 2020 Perceptive Warrants expire on February 10, 2027. In connection with the Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 225 shares of the Company’s common stock (the “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $5,740 per share. The 2021 Perceptive Warrant expires on February 26, 2028. In connection with the Sixth Amendment, the Company amended the Perceptive Warrants to reset the exercise price to $10.50 per warrant. In connection with the Seventh Amendment, the Company further amended the Perceptive Warrants to reset the exercise price to $1.82 per warrant. The Perceptive Warrants contain anti-dilution provisions and other warrant holder protections and are not exercisable to the extent that Perceptive would beneficially own more than 19.99% of the Company’s common stock because of the exercise.

As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 8), the antidilution provision of the Perceptive Warrants was triggered, resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $9,340 per share were reduced to $7,080 per share, warrants to purchase 350 shares of common stock that had an exercise price of $7,480 per share were reduced to $5,760 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $5,740 per share were reduced to $4,540 per share.

As a result of the registered direct offering completed in March 2022 (see Note 8), the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an adjusted exercise price of $7,080 per share were reduced to $5,276 per share, warrants to purchase 350 shares of common stock that had an adjusted exercise price of $5,760 per share were reduced to $4,330.50 per share, and warrants to purchase 225 shares of common stock that had an adjusted exercise price of $4,540 per share were reduced to $3,456.50 per share.

As a result of the public offering of the Company’s common stock completed in July 2022 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $5,276 per share were reduced to $745 per share, warrants to purchase 350 shares of common stock that had an exercise price of $4,330.50 per share were reduced to $618.50 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $3,456.50 per share were reduced to $501.50 per share.

As a result of the public offering of the Company’s common stock completed in May 2023 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $745 per share were reduced to $3.69 per share, warrants to purchase 350 shares of common stock that had an exercise price of $618.50

per share were reduced to $3.69 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $501.50 per share were reduced to $3.69 per share.

The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and the Perceptive Warrants. The relative fair value of the Perceptive Warrants of approximately $3.6 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in the preparation of the option pricing model for valuing the Perceptive Warrants issued include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 7-year life), (iii) strike prices of $7,480 and $9,340 for the common stock warrants, (iv) fair value of common stock ($8,020) and (v) expected life (7 years). The fair value of the 2021 Perceptive Warrants of approximately $1.1 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the 2021 Perceptive Warrants issued include (i) volatility (103.5%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 7-year life), (iii) strike price of $5,740 for the common stock warrant, (iv) fair value of common stock ($5,740) and (v) expected life (7 years). The fair value of the warrants as well as the debt issue costs incurred in connection with the entry into the Perceptive Credit Agreement, including a facility fee of 1% of the total amount of loans available under the facility, are presented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet as detailed below (in thousands).


	September 30,		December 31,
	2023		2022
Notes payable	$	1,950	$	2,625
Debt issuance costs		(63)		(209)
Warrant discount		(298)		(990)
Total debt	$	1,589	$	1,426
Less, current portion		1,589		1,426
Long-term debt, less current portion	$	—	$	—

The fair value of the warrants and the debt issue costs are being amortized utilizing the effective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $252,000 and $838,000 for the three months ended September 30, 2023 and 2022, respectively. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $838,000 and $1,635,000 for the nine months ended September 30, 2023 and 2022, respectively.

9. Credit Agreement and Guaranty

On February 10, 2020 (the “Closing Date”), the Company entered into a Credit Agreement and Guaranty with Perceptive for a senior secured term loan credit facility of up to $35.0 million, (the “Perceptive Credit Agreement”). A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA. Another $15.0 million tranche was to be available to the Company based on the achievement of a revenue milestone by December 31, 2021, which was not achieved. The other tranches of debt under the Amended Perceptive Credit Agreement are no longer available to the Company. On January 7, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 8, 2022, the Company prepaid $5.0 million of the outstanding debt, and Perceptive waived the prepayment premium. On July 25, 2022, the Company entered into a fifth amendment to the Amended Perceptive Credit Agreement, as amended (the “Fifth Amendment”). Pursuant to the Fifth Amendment, Perceptive agreed to release its security interest in certain assets being transferred from the Company to Corium in connection with an amendment to the Company’s Manufacturing and Commercialization Agreement with Corium and waive the Company’s obligations to comply with certain financial covenants through the end of 2022. In exchange, the Company agreed to prepay $7.0 million of outstanding principal under the Amended Perceptive Credit Agreement using the proceeds of recent sales under the Company’s ATM program with H.C. Wainwright & Co., LLC. Such payment was made on July 25, 2022.

The facility will mature on February 10, 2024 (“Maturity Date”). Pursuant to the Fifth Amendment, beginning August 31, 2022, the Company began making monthly principal payments in an amount equal to $75,000, continuing until February 10, 2024, at which time all remaining principal amount outstanding is due.

Borrowings under the Fifth Amendment will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus 10.25%, provided that LIBOR shall not be less than 1.5%. The rate of interest in effect as of July 25, 2022 was 11.97% and at December 31, 2022 was 14.38%. Upon the occurrence and during the continuance of any event of default under the Fifth Amendment, the interest rate automatically increases by 3.0% per annum.

The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of 4.0% if such prepayment occurs after February 10, 2022 and on or prior to February 10, 2023; and 2.0% if such prepayment occurs after February 10, 2023 and prior to the Maturity Date.

All of the Company’s obligations under the Fifth Amendment are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Amended Perceptive Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Amended Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the Amended Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Amended Perceptive Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending December 31, 2022, report revenues for the trailing 12-month period that exceed the amounts set forth in the Fifth Amendment which range from $62.6 million for the fiscal quarter ending March 31, 2023 to $87.1 million for the fiscal quarter ending December 31, 2023. Pursuant to the Waiver and Sixth Amendment to the Perceptive Credit Agreement (the “Sixth Amendment”), the Company has received a waiver of certain financial covenants through the second quarter of 2023. In the event the Company does not pay off the remainder of the outstanding principal under the facility, the Company will need to negotiate for a waiver of its obligations to comply with the covenants relating to revenue for Twirla in the second quarter of 2023.

In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 35,000 shares of the Company’s common stock (together, the “2020 Perceptive Warrants”). The first

warrant is exercisable for 17,500 shares of common stock at an exercise price of $149.60 per share. The second warrant is exercisable for 17,500 shares of common stock at an exercise price of $186.80 per share. The 2020 Perceptive Warrants expire on February 10, 2027. In connection with the Amended Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 11,250 shares of the Company’s common stock (the “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $114.80 per share. The 2021 Perceptive Warrant expires on February 26, 2028. The Perceptive Warrants contain anti-dilution provisions that expired on December 31, 2022 and other warrant holder protections and are not exercisable to the extent that Perceptive would beneficially own more than 19.99% of the Company’s common stock as a result of the exercise. In connection with the Sixth Amendment, we amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants.

As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 10), the antidilution provision of the Perceptive Warrants was triggered, resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 17,500 shares of common stock that had an exercise price of $186.80 per share were reduced to $141.60 per share, warrants to purchase 17,500 shares of common stock that had an exercise price of $149.60 per share were reduced to $115.20 per share, and warrants to purchase 11,250 shares of common stock that had an exercise price of $114.80 per share were reduced to $90.80 per share.

As a result of the registered direct offering completed in March 2022 (see Note 10), the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 17,500 shares of common stock that had an adjusted exercise price of $141.60 per share were reduced to $105.52 per share, warrants to purchase 17,500 shares of common stock that had an adjusted exercise price of $115.20 per share were reduced to $86.61 per share, and warrants to purchase 11,250 shares of common stock that had an adjusted exercise price of $90.80 per share were reduced to $69.13 per share.

As a result of the public offering of the Company’s common stock completed in July 2022 (see Note 10), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 17,500 shares of common stock that had an exercise price of $105.52 per share were reduced to $14.90 per share, warrants to purchase 17,500 shares of common stock that had an exercise price of $86.61 per share were reduced to $12.37 per share, and warrants to purchase 11,250 shares of common stock that had an exercise price of $69.13 per share were reduced to $10.03 per share.

The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and the Perceptive Warrants. The relative fair value of the Perceptive Warrants of approximately $3.6 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in the preparing the option pricing model for valuing the Perceptive Warrants issued include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 7-year life), (iii) strike prices of $149.60 and $186.80 for the common stock warrants, (iv) fair value of common stock ($160.40) and (v) expected life (7 years). The fair value of the 2021 Perceptive Warrants of approximately $1.1 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the 2021 Perceptive Warrants issued include (i) volatility (103.5%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 7-year life), (iii) strike price of $114.80 for the common stock warrant, (iv) fair value of common stock ($114.80) and (v) expected life (7 years). The fair value of the warrants as well as the debt issue costs incurred in connection with the entry into the Perceptive Credit Agreement, including a facility fee of 1% of the total amount of loans available under the facility, are presented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet as detailed below (in thousands).


	December 31,		December 31,
	2022		2021
Notes payable	$	2,625	$	20,000
Debt issuance costs		(209)		(550)

Warrant discount		(990)		(2,617)
Total debt	$	1,426	$	16,833
Less, current portion		1,426		16,833
Long-term debt, less current portion	$	—	$	—

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//470/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1C
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1C

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1E
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1E

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1I
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

Statements of Changes in Stockholders' Deficit (Parenthetical)		12 Months Ended
	Apr. 10, 2023	Dec. 31, 2022	Dec. 31, 2021
Statements of Changes in Stockholders' Deficit
Stockholders' Equity Note, Stock Split, Conversion Ratio	0.02	0.025	0.025

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Interest expense [Member]
Deferred Financing Costs
Amortization of deferred financing costs	$ 44,000	$ 146,000	$ 146,000	$ 284,000	$ 342,000	$ 277,000	$ 231,000

Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions	1 Months Ended			12 Months Ended
	Apr. 30, 2022	Jan. 31, 2021	Jan. 31, 2018	Dec. 31, 2022	Mar. 31, 2022
Sale of New Jersey Net Operating Losses
Additional cash benefit received	$ 4.7
New Jersey
Sale of New Jersey Net Operating Losses
Net proceeds from sale of NOL and tax credit				$ 4.7
Sale of unused NOLs \| New Jersey
Sale of New Jersey Net Operating Losses
Maximum lifetime benefit under the Program		$ 20.0	$ 15.0
Sale of unused NOLs \| New Jersey \| Minimum
Sale of New Jersey Net Operating Losses
Allowable sale of unused tax benefits as a percentage of total value			80.00%
Net Operating Losses \| New Jersey
Sale of New Jersey Net Operating Losses
NOLs					$ 44.3
Research and Development. \| New Jersey
Sale of New Jersey Net Operating Losses
NOLs					$ 1.0

Stockholders Equity (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Stockholders' Deficit

Schedule of allocation of stock-based compensation expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Cost of goods sold	$	12	$	29	$	69	$	104
Research and development		94		90		261		284
Selling and marketing		10		40		73		120
General and administrative		323		377		1,015		1,461
Total	$	439	$	536	$	1,418	$	1,969


	Year Ended
	December 31,
	2022		2021		2020
Cost of goods sold	$	133	$	271	$	14
Research and development		372		490		651
Selling and marketing		155		148		108
General and administrative		1,833		2,429		2,045
Total	$	2,493	$	3,338	$	2,818

Leases - Maturity of lease liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Operating Leases
2023	$ 98
2024	397	$ 391
2025	101	397
2025		101
Total	596	889
Less: Interest	(47)	(104)
Present value of lease liability	$ 549	$ 785

Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Summary of Significant Accounting Policies
Advertising costs	$ 0.0	$ 0.9	$ 0.0	$ 6.1	$ 8.2	$ 13.8	$ 5.5

Subsequent Events (Details) - Subsequent event - Series C Preferred Stock [Member]	Jan. 25, 2023 Vote $ / shares
Subsequent Event [Line Items]
Preferred Stock, Dividends Per Share, Declared \| $ / shares	$ 0.001
Preferred Stock, Votes Per Whole Share \| Vote	1,000,000

Income Taxes (Details) - USD ($) $ in Millions	12 Months Ended
Income Taxes (Details) - USD ($) $ in Millions	Dec. 31, 2022	Dec. 31, 2018
Federal \| Net Operating Losses
Income Taxes
Net operating loss carryforwards	$ 390.6	$ 188.9
Indefinite net operating loss carryforward	201.7
Federal \| Research and Development.
Income Taxes
Tax credit carryforwards	6.4
State \| Net Operating Losses
Income Taxes
Net operating loss carryforwards	79.9
State \| Research and Development.
Income Taxes
Tax credit carryforwards	$ 0.9

Summary of Significant Accounting Policies - Segment Information (Details)	12 Months Ended
	Dec. 31, 2022 segment
Segment Information
Number of operating segments	1
Number of reporting segments	1

Fair Value Measurements

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Fair Value Measurements

Fair Value Measurements

3. Fair Value Measurements

ASC 820, Fair Value Measurements and Disclosures, describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value.

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:

●

Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities.

●

Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities.

●

Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company has no Level 3 assets. Level 3 liabilities consist of warrant liability.

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
September 30, 2023
Assets:
Cash and cash equivalents	$	2,873	$	—	$	—
Total assets at fair value	$	2,873	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,566
Total assets at fair value	$	—	$	—	$	5,566


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934

The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of September 30, 2023 include (i) volatility 86.06% - 123.42%, (ii) risk-free interest rate 4.62% - 5.46%, (iii) strike price for the common warrants of $3.69, $45.00 and $1,700.00, (iv) fair value of common stock $2.40 and (v) expected life 1.15 - 4.65 years. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2022 include (i) volatility 136.8% - 137.4%, (ii) risk-free interest rate 4.2% - 4.7%, (iii)

strike price for the common warrants $45.00 and $1,700, (iv) strike price for the preferred warrants of $520.00, (v) fair value of common stock $11.50 and (vi) expected life 0.7 - 4.5 years.

The following is a roll forward of the fair value of Level 3 warrants:


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(10,983)
Ending Balance September 30, 2023	$	5,566

There were no transfers between Level 1, 2 or 3 during the nine months ended September 30, 2023 or 2022.

4. Fair Value Measurements

●

Level 1—Quoted prices in active markets for identical assets and liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities.

●

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities.

●

Level 3—Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company’s level 3 liabilities consist of warrant liability. The Company has no level 3 assets.

The following tables set forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2022 and 2021:


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3 (Restated)
December 31, 2021
Assets:
Cash and cash equivalents	$	19,143	$	—	$	—
Total assets at fair value	$	19,143	$	—	$	—

Liabilities:
Warrant Liability (Restated)	$	—	$	—	$	5,356
Total assets at fair value	$	—	$	—	$	5,356

The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2022 include (i) volatility 136.8% - 137.4%, (ii) risk-free interest rate 4.2%, (iii) strike price for the common warrants $0.90, (iv) strike price for the preferred warrants (10.40), (v) fair value of common stock $0.23, and (vi) expected life 4.3 – 4.5 years. The significant assumptions used in preparing the option pricing model for valuing

the Company’s warrants as of December 31, 2021 include (i) volatility 136.4%, (ii) risk-free interest rate 1.1%, (iii) strike price for the common warrants $34.08, (iv) fair value of common stock $31.63, and (v) expected life 4.98 years.

The following is a roll forward of the fair value of Level 3 warrants:


Beginning balance at December 31, 2020	$	—
Warrants issued		9,183
Change in fair value		(3,827)
Ending balance at December 31, 2021 (Restated)		5,356
Warrants issued		26,098
Change in fair value		(25,520)
Ending balance at December 31, 2022	$	5,934

There were no transfers between Level 1, 2 or 3 during 2022 or 2021.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Stockholders Equity

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Stockholders' Deficit

Stockholders Equity

8. Stockholders’ Deficit

On January 7, 2022, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of common stock authorized for issuance from 150,000,000 shares to 300,000,000 shares.

Reverse Stock Split

On April 10, 2023, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment, or the Certificate of Amendment, to the Company’s Amended and Restated Certificate of Incorporation, which became effective on April 10, 2023. The Certificate of Amendment implemented a 1-for-50 reverse stock split of the Company’s common stock. On the effective date of April 10, 2023, the number of the Company’s issued and outstanding shares of common stock was decreased from 46,605,134 to 932,101, and the par value remained unchanged. No fractional shares were issued as a result of the reverse stock split. Stockholders who would otherwise have been entitled to receive a fractional share received a cash payment in lieu thereof. The reverse stock split affected all shares of the Company’s common stock outstanding immediately prior to the effective date of the reverse stock split, as well as the number of shares of common stock available for issuance under the Company’s equity incentive plans. In addition, the reverse stock split effected a reduction in the number of shares of common stock issuable upon the exercise of stock options, restricted stock units, or warrants outstanding.

Shelf Registration Statement

On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices, and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Public Offerings

In October 2021, the Company completed a public offering of 13,333 shares of its common stock and warrants to purchase 6,660 shares of its common stock at a combined price of $1,700 per share of common stock and one-half of a warrant to purchase one share of common stock. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $21.1 million.

In July 2022, the Company completed a best efforts public offering (the “2022 Offering”) in which the Company raised net proceeds of $22.0 million through the sale of 382,966 shares of common stock and 150,366 pre-funded warrants (“Series B pre-funded warrants”) to purchase 150,366 shares of common stock at a combined price of $45.00 per share of common stock and warrants. Both the sales of shares of common stock and pre-funded warrants were accompanied by Series A-1 and Series A-2 warrants (together the “Series A warrants”) to purchase shares of common stock. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants expired unexercised in August 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the 2022 Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the 2022 Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 26,666 shares of common stock with an exercise price of $56.25 per share.

In May 2023, the Company completed a best efforts public offering of an aggregate of 95,000 shares of common stock and 1,801,286 pre-funded warrants in lieu of shares of common stock and warrants to purchase a total of 3,792,572 shares of common stock at combined public offering price of $3.9551 per share. Proceeds from the public offering, net of underwriting discounts, commissions, and offering expenses were approximately $6.5 million. Through September 30, 2023 at total of 1,115,286 pre-funded warrants have been exercised and 686,000 pre-funded warrants remain available for exercise as of September 30, 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 94,814 shares of commons stock with an exercise price of $4.9439 per share.

The Company has accounted for the warrants as liabilities, while the pre-funded warrants are classified as a component of permanent equity within additional paid-in capital because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The Company also determined that the pre-funded warrants should be included in the determination of basic earnings per share in accordance with ASC 260, Earnings per Share.

ATM Sales Agreement

In March 2021, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the year ended December 31, 2021, the Company issued and sold 3,457 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $9.3 million.

On January 10, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering an at-the-market offering program (the “2022 ATM”) the Company entered into for the sale of up to $50.0 million of shares of its common stock. The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the three months ended March 31, 2022, the Company issued and sold 512 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $0.3 million. On April 26, 2022, the Company terminated the 2022 ATM.

On April 27, 2022, the Company entered into a new at-the-market offering program (the “April 2022 ATM Agreement”) with H.C. Wainwright LLC and Co. (the “Sales Agent”) under which the Company is authorized to sell up to an aggregate of $12.8 million in gross proceeds through the sale of shares of common stock from time to time. The Company agreed to pay a commission of up to 3.0% of the gross proceeds of any common stock sold under the April 2022 ATM Agreement. Through September 30, 2022, the Company issued and sold a total of 173,750 shares of common stock under the April 2022 ATM Agreement, representing the entire capacity of the April 2022 ATM, resulting in net proceeds of approximately $12.2 million. On August 22, 2022, the Company increased the April 2022 ATM (“August 2022 ATM”). As increased, the Company was eligible to offer and sell, from time to time through the Sales Agent, shares of its common stock having an aggregate offering price of up to $75.0 million. During the year ended December 31, 2022, the Company issued and sold 78,852 shares of common stock under the August 2022 ATM resulting in net proceeds of approximately $0.9 million. During the nine months ended September 30, 2023, the Company issued and sold 207,883 shares for net proceeds of approximately $1.7 million. On April 12, 2023, the Company filed a prospectus supplement to its registration statement on Form S-3 for the August 2022 ATM verifying that it is now eligible to sell up to $4.5 million worth of shares through its ATM.

Registered Direct Offering

On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 12,125 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 12,125 shares of common stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $400.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 12,125 shares of common stock. The Series A Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire one and one-half years following the initial exercise date. Proceeds from the 2022 Preferred Stock Offering, net of the placement agent’s fees and offering expenses were approximately $4.1 million. A portion of the placement agent’s fees included warrants to purchase 606 shares of the common stock of the Company at a strike price of $500.00 per share. The warrants become exercisable six months following the date of issuance and will expire 5 years following the commencement of sales in the 2022 Preferred Stock Offering.

On March 15, 2022, 2,425 shares of the Series A Preferred Stock were converted into 6,025 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 6,025 shares of the Company’s common stock.

On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day anniversary of the Closing Date. Pursuant to the Letter Agreement, the Company issued to Armistice a new common stock purchase warrant (“New Warrant”), on the same terms and conditions as the Series A Warrants, provided that such New Warrant shall be exercisable into 4,243 warrant shares. The Series A Warrants have an exercise price of $520.00 per share and will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The New Warrant is exercisable 6 months after the date of the Letter Agreement.

Stock-Based Compensation Expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Cost of goods sold	$	12	$	29	$	69	$	104
Research and development		94		90		261		284
Selling and marketing		10		40		73		120
General and administrative		323		377		1,015		1,461
Total	$	439	$	536	$	1,418	$	1,969

10. Stockholders’ Equity

The Company’s Certificate of Incorporation, as amended, among other things: (i) authorizes 300,000,000 shares of common stock; (ii) authorizes 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series; (iii) provides that the Board be divided into three classes with staggered three-year terms, with one class of directors to be elected at each annual meeting of the Company’s stockholders; (iv) provides that directors may only be removed with cause and only upon the affirmative vote of holders of at least 75% of the voting power of all then-outstanding shares of capital stock of the Company entitled to vote generally in the election of directors; (v) provides that only the Board, the chairman of the Board or the chief executive officer may call a special meeting of stockholders; and (vi) requires that any action instituted against the Company’s officers or directors in connection with their service to the Company be brought in the State of Delaware.

Shelf Registration Statement

On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Public Offerings

In October 2021, the Company completed a public offering of 666,666 shares of its common stock and warrants to purchase 333,333 shares of its common stock at a combined price of $34.00 per share of common stock and one-half of a warrant to purchase one share of common stock. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $21.1 million.

In July 2022, the Company completed a public offering of (1) 19,148,332 shares of its common stock and warrants to purchase 38,296,664 shares of its common stock at a combined price of $0.90 per share of common stock and warrants and (2) 7,518,334 pre-funded warrants to purchase 7,518,334 shares of its common stock and warrants to purchase 15,036,668 shares of its common stock at a combined price of $0.8999 per share of common stock and pre-funded warrant. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $22.0 million.

ATM Sales Agreements

In March 2021, the Company entered into a common stock sales agreement (the “2021 ATM Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the 2021 ATM Agreement. During the year ended December 31, 2021, the Company issued and sold 172,879 shares of common stock under the 2021 ATM Agreement resulting in net proceeds to the Company of approximately $9.3 million.

On January 10, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering an at-the-market offering program (the “January 2022 ATM”) the Company entered into for the sale of up to $50.0 million of shares of its common stock. The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the January 2022 ATM. During the nine months ended September 30, 2022, the Company issued and sold 25,623 shares of common stock under the January 2022 ATM resulting in net proceeds to the Company of approximately $0.3 million. On April 26, 2022, the Company terminated the January 2022 ATM.

On April 27, 2022, the Company entered into a new at-the-market offering program (“April 2022 ATM”) with H.C. Wainwright LLC and Co. (the “Sales Agent”), under which the Company may, from time to time in its sole discretion, issue and sell through or to the Sales Agent, acting as the Company’s agent, up to $12,841,000 of shares of the Company’s common stock (the “Placement Shares”). The Company agreed to pay the Sales Agent a commission of up to 3.0% of the gross sales proceeds of any Placement Shares sold under the April 2022 ATM. Through September 30, 2022, the Company issued and sold a total of 8,687,502 shares of common stock under the April 2022 ATM Agreement, representing the entire capacity of the April 2022 ATM, resulting in net proceeds of approximately $12.2 million.

On August 22, 2022, the Company increased the April 2022 ATM (“August 2022 ATM”). As increased, the Company may now offer and sell, from time to time through the Sales Agent, shares of the Company’s common stock having an aggregate offering price of up to$75.0 million. During the year ended December 31, 2022, the Company issued and sold 3,942,648 shares of common stock under the August 2022 ATM resulting in net proceeds to the Company of approximately $0.9 million.

Registered Direct Offering

On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 606,250 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 606,250 shares of common Stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $8.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 606,250 shares of common stock. The Series A Warrants have an exercise price of $10.40 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $10.40 per share, will become exercisable six months following the date of issuance, and will expire one and one-half years following the initial exercise date. Proceeds from the 2022 Preferred Stock Offering, net of the placement agent’s fees and offering expenses were approximately $4.1 million. A portion of the placement agent’s fees included warrants to purchase 30,313 shares of the common stock of the Company at a strike price of $10.00 per share. The warrants become exercisable six months following the date of issuance and will expire 5 years following the commencement of sales in the 2022 Preferred Stock Offering.

On March 15, 2022, 2,425 shares of the Series A Preferred Stock were converted into 303,125 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 303,125 shares of the Company’s common stock.

On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day anniversary of the Closing Date. Pursuant to the Letter Agreement, the Company issued to Armistice a new common stock purchase warrant (“New Warrant”), on the same terms and conditions as the Series A Warrants, provided that such New Warrant shall be exercisable into 212,188 warrant shares. The Series A Warrants have an exercise price of $10.40 per share, and will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The New Warrant is exercisable 6 months after the date of the Letter Agreement.

On July 6, 2022, the Company completed a best efforts public offering (the “Offering”) in which the Company raised net proceeds of $22.0 million through the sale of 19,148,332 shares of common stock and 7,518,334 pre-funded warrants (“Series B pre-funded warrants”) to purchase 7,518,334 shares of common stock. Both the sales of shares of common stock and pre-funded warrants were accompanied by Series A-1 and Series A-2 warrants (together the “Series A warrants”) to purchase shares of common stock. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance. H.C. Wainwright acted as the exclusive placement agent in connection with the Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 1,333,333 shares of commons stock with an exercise price of $1.125 per share.

Common Stock Warrants

In connection with the Perceptive Credit Agreement (see Note 9), the Company issued warrants to Perceptive to purchase 35,000 shares of its common stock. These warrants contain antidilution provisions that were triggered upon the Company’s public offering that was completed in October 2021. As a result of the offering, warrants to purchase 17,500 shares of common stock that had an exercise price of $186.80 per share were reduced to $141.60 per share, warrants to purchase 17,500 shares of common stock that had an exercise price of $149.60 per share were reduced to $115.20 per share, and warrants to purchase 11,250 shares of common stock that had an exercise price of $114.80 per share were reduced to $90.80 per share. These repricing’s resulted in an immaterial increase to additional paid-in-capital. In connection with the Sixth Amendment, we amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants.

As a result of the registered direct offering completed in March 2022, the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 17,500 shares of common stock that had an adjusted exercise price of $141.60 per share were reduced to $105.52 per share, warrants to purchase 17,500 shares of common stock that had an adjusted exercise price of $115.20 per share were reduced to $86.61 per share, and warrants to purchase 11,250 shares of common stock that had an adjusted exercise price of $90.80 per share were reduced to $69.13 per share.

As a result of the public offering of the Company’s common stock completed in July 2022, the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 17,500 shares of common stock that had an exercise price of $105.52 per share were reduced to $14.90 per share, warrants to purchase 17,500 shares of common stock that had an exercise price of $86.61 per share were reduced to $12.37 per share, and warrants to purchase 11,250 shares of common stock that had an exercise price of $69.13 per share were reduced to $10.03 per share.

All Perceptive Warrants are accounted for in equity, whereas all warrants associated with our various financings are accounted for as liabilities. In accordance with ASC Topic 815-40, Derivatives and Hedging, Contracts in Entity’s Own Equity, these liabilities are measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

Organization and Description of Business

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Organization and Description of Business

Organization and Description of Business

1. Organization and Description of Business

Nature of Operations

Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla^®, and more recently commercializing Twirla. The Company is headquartered in Princeton, New Jersey.

The Company’s sole approved product, Twirla, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA, in February 2020 and was commercially launched in early December 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has generated minimal product revenue to date and is subject to a number of risks similar to those of other early stage commercial companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the need to obtain additional capital necessary to fund the development of its products, reliance on a consistent supply chain both for Twirla and in general, macroeconomic factors such as inflation, competition from larger companies, and compliance with FDA and other government regulations. If the Company does not continue to successfully commercialize Twirla, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of September 30, 2023, the Company had an accumulated deficit of approximately $418.7 million. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company:

●

maintains a sales and marketing infrastructure and contract manufacturing arrangement to support the continued commercialization of Twirla in the United States;

●

continues to commercialize Twirla and seek increased uptake of Twirla in the United States;

●	continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla;

●	maintains, leverages, and expands the Company’s intellectual property portfolio; and

●	maintains operational, financial, and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts.

The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 8), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding.

Going Concern

As of September 30, 2023, the Company had cash and cash equivalents of $2.9 million and a $7.5 million working capital deficit. The Company’s current liquidity is sufficient to fund operations into December 2023. The Company closely monitors its cash and cash equivalents and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities.

The Company has generated losses since inception, used substantial cash in operations, has a working capital deficit as of September 30, 2023, and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing,

management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which this Quarterly Report on Form 10-Q is filed.

The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives, or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities.

The unaudited financial statements as of September 30, 2023 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully commercialize Twirla. The unaudited financial statements as of September 30, 2023 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements.

Basis of Presentation

The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for Quarterly Reports on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the SEC on March 23, 2023.

In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the operating results for the full fiscal year or any future period.

The accompanying unaudited financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. If the Company encounters unforeseen factors that impact the Company’s current business plan or its ability to generate revenue from the commercialization of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.

1. Organization and Description of Business

Nature of Operations

Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla ^®, and more recently commercializing Twirla. The Company is headquartered in Princeton, New Jersey.

The Company’s sole approved product, Twirla, also known prior to its approval as AG200-15, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA, in February 2020 and was commercially launched in early December 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has generated minimal product revenue to date and is subject to a number of risks similar to those of other early stage commercial companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the potential need to obtain additional capital necessary to fund the development of its products, reliance on a consistent supply chain both for Twirla and in general, macroeconomic factors such as inflation, competition from larger companies, and compliance with FDA and other government regulations. If the Company does not successfully commercialize Twirla, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of December 31, 2022, the Company had an accumulated deficit of approximately $408 million.

The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company:

●

maintains a sales and marketing infrastructure to support the continued commercialization of Twirla in the United States;

●

continues to commercialize Twirla and seek increased uptake of Twirla in the United States;

●

continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla;

●

maintains, leverages and expands the Company’s intellectual property portfolio; and

●

maintains operational, financial and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts.

The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 10), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding.

Going Concern

As of December 31, 2022, the Company had cash and cash equivalents of $5.2 million and a $2.0 million working capital deficit. The Company’s current liquidity is sufficient to fund operations only into the second quarter of 2023. The Company closely monitors its cash and cash equivalents and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities.

The Company has generated losses since inception, used substantial cash in operations, has a working capital deficit at December 31, 2022 and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which the Company’s Annual Report on Form 10-K is filed.

The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities.

The audited financial statements as of December 31, 2022 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully launch Twirla. The audited financial statements as of December 31, 2022 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements.

Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			$ 5,326	$ 1,040	$ 1,040
Allowances for current period sales					10,325
Payments & credits					(6,039)
Accounts Receivable, Ending Balance					5,326
Provision for revenue reserve	$ 8,500	$ 3,200	19,300	6,100
Reserve for variable consideration	$ 7,400		7,400
Customer credits, discounts And allowances
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			2,994	371	371
Allowances for current period sales					5,891
Payments & credits					(3,268)
Accounts Receivable, Ending Balance					2,994
Rebates and co-pay assistance
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			$ 2,332	$ 669	669
Allowances for current period sales					4,434
Payments & credits					(2,771)
Accounts Receivable, Ending Balance					$ 2,332

Credit Agreement and Guaranty

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Credit Agreement and Guaranty

Credit Agreement and Guaranty

7. Credit Agreement and Guaranty

The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of 2.0%.

per share were reduced to $3.69 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $501.50 per share were reduced to $3.69 per share.


	September 30,		December 31,
	2023		2022
Notes payable	$	1,950	$	2,625
Debt issuance costs		(63)		(209)
Warrant discount		(298)		(990)
Total debt	$	1,589	$	1,426
Less, current portion		1,589		1,426
Long-term debt, less current portion	$	—	$	—

9. Credit Agreement and Guaranty

The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and the Perceptive Warrants. The relative fair value of the Perceptive Warrants of approximately $3.6 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in the preparing the option pricing model for valuing the Perceptive Warrants issued include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 7-year life), (iii) strike prices of $149.60 and $186.80 for the common stock warrants, (iv) fair value of common stock ($160.40) and (v) expected life (7 years). The fair value of the 2021 Perceptive Warrants of approximately $1.1 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the 2021 Perceptive Warrants issued include (i) volatility (103.5%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 7-year life), (iii) strike price of $114.80 for the common stock warrant, (iv) fair value of common stock ($114.80) and (v) expected life (7 years). The fair value of the warrants as well as the debt issue costs incurred in connection with the entry into the Perceptive Credit Agreement, including a facility fee of 1% of the total amount of loans available under the facility, are presented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet as detailed below (in thousands).


	December 31,		December 31,
	2022		2021
Notes payable	$	2,625	$	20,000
Debt issuance costs		(209)		(550)

Warrant discount		(990)		(2,617)
Total debt	$	1,426	$	16,833
Less, current portion		1,426		16,833
Long-term debt, less current portion	$	—	$	—

- Definition

+ References

+ Details

Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Apr. 10, 2023	Apr. 09, 2023	Dec. 31, 2022	Jan. 07, 2022	Jan. 06, 2022	Dec. 31, 2021	Jan. 06, 2020
Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Preferred stock, authorized (in shares)	10,000,000			10,000,000			10,000,000
Preferred stock, issued (in shares)	4,850			4,850			0
Preferred stock, outstanding (in shares)	0			0			0
Common stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Common stock, authorized (in shares)	300,000,000			300,000,000	300,000,000	150,000,000	300,000,000	300,000,000
Common stock, issued (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901
Common stock, outstanding (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Interest expense [Member]
Deferred Financing Costs
Amortization of deferred financing costs	$ 44,000	$ 146,000	$ 146,000	$ 284,000	$ 342,000	$ 277,000	$ 231,000

Quarterly Financial Information - Statements of Changes in Stockholders' Equity (Details)				1 Months Ended				3 Months Ended						6 Months Ended	9 Months Ended		12 Months Ended
	Apr. 10, 2023	Jul. 06, 2022 shares	Apr. 04, 2022 shares	May 31, 2023 shares	Jul. 31, 2022 USD ($) shares	Oct. 31, 2021 shares	Mar. 31, 2021 shares	Sep. 30, 2023 USD ($) shares	Jun. 30, 2023 USD ($) shares	Mar. 31, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Jun. 30, 2022 USD ($) shares	Mar. 31, 2022 USD ($) shares	Jun. 30, 2022 USD ($) shares	Sep. 30, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Dec. 31, 2022 USD ($) shares	Dec. 31, 2021 USD ($) shares	Dec. 31, 2020 USD ($) shares
Increase (decrease) in stockholders' equity
Balance					$ 2,369,000			$ (12,121,000)	$ (9,433,000)	$ (5,545,000)	$ 2,369,000	$ (5,358,000)	$ 3,915,000	$ 3,915,000	$ (5,545,000)	$ 3,915,000	$ 3,915,000	$ 49,328,000	$ 45,745,000
Share-based compensation - stock options and RSUs								439,000	$ 482,000	498,000	536,000	669,000	764,000				2,492,000	3,338,000	2,818,000
Fractional shares retired as a result of reverse split \| shares									13,000
Issuance of common stock								70,000
Issuance of common stock upon exercise of options																		75,000	610,000
Unrealized net gain on marketable securities																		(3,000)	3,000
Net loss								(799,000)	$ (3,809,000)	(5,389,000)	(5,930,000)	(5,168,000)	(10,385,000)		(9,995,000)	(21,481,000)	(25,412,000)	(71,067,000)	(51,853,000)
Balance								$ (12,411,000)	$ (12,121,000)	$ (9,433,000)	$ (3,025,000)	$ 2,369,000	(5,358,000)	$ 2,369,000	$ (12,411,000)	$ (3,025,000)	$ (5,545,000)	$ 3,915,000	$ 49,328,000
Reverse stock split conversion ratio	0.02																0.025	0.025
Preferred Stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares												2,425
Vesting of RSUs													$ (2,425)
Balance (in shares) \| shares													2,425
Common stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares					247,202			1,640,805	932,101	859,402	247,202	67,308	60,698	60,698	859,402	60,698	60,698	2,189,100	1,745,264
Fractional shares retired as a result of reverse split \| shares																	(11)
Issuance of common stock (in shares) \| shares								29,842			533,333
Issuance of common stock upon exercise of options (in shares) \| shares																		3,160	12,586
Conversion of convertible preferred stock (in shares) \| shares			6,025
Vesting of RSUs (in shares) \| shares								10	76			82	35				6,555	3,096
Balance (in shares) \| shares								2,277,657	1,640,805	932,101	780,535	247,202	67,308	247,202	2,277,657	780,535	859,402	60,698	2,189,100
Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance					$ 401,212,000			$ 405,779,000	$ 404,658,000	$ 403,157,000	$ 401,212,000	$ 388,317,000	$ 387,205,000	$ 387,205,000	$ 403,157,000	$ 387,205,000	$ 387,205,000	$ 361,548,000	$ 306,115,000
Share-based compensation - stock options and RSUs								439,000	$ 482,000	498,000	536,000	669,000	764,000				2,492,000	3,338,000	2,818,000
Fractional shares retired as a result of reverse split \| shares									13,000
Issuance of common stock								70,000
Issuance of common stock upon exercise of options																		75,000	610,000
Balance								406,288,000	$ 405,779,000	404,658,000	401,748,000	401,212,000	388,317,000	401,212,000	406,288,000	401,748,000	403,157,000	387,205,000	361,548,000
Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																		3,000
Unrealized net gain on marketable securities																		(3,000)	3,000
Balance																			3,000
Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance					$ (398,843,000)			(417,900,000)	(414,091,000)	(408,702,000)	(398,843,000)	(393,675,000)	(383,290,000)	(383,290,000)	(408,702,000)	(383,290,000)	(383,290,000)	(312,223,000)	(260,370,000)
Net loss								(799,000)	(3,809,000)	(5,389,000)	(5,930,000)	(5,168,000)	(10,385,000)				(25,412,000)	(71,067,000)	(51,853,000)
Balance								$ (418,699,000)	$ (417,900,000)	(414,091,000)	(404,773,000)	$ (398,843,000)	$ (393,675,000)	(398,843,000)	$ (418,699,000)	(404,773,000)	$ (408,702,000)	(383,290,000)	(312,223,000)
Series A Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares																	(2,425)
Series A Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares													6,063				303,125
Series B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares												(2,425)					(2,425)
Series B Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares												6,062					303,125
Series A and B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Issuance of common stock upon exercise of options (in shares) \| shares													4,850
Conversion of convertible preferred stock (in shares) \| shares																	4,850
Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 3,000	$ 11,898,000	$ 48,435,000
Issuance of common stock (in shares) \| shares				3,792,572	150,366
Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 3,000
Issuance of common stock (in shares) \| shares				95,000	382,966	13,333			95,000								26,666,666	666,666	431,250
Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 11,898,000	$ 48,435,000
At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock									$ 652,000	$ 1,003,000		$ 12,226,000	$ 348,000				$ 13,457,000	$ 9,266,000
At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 1,000
Issuance of common stock (in shares) \| shares							172,879		105,342	72,699		173,750	512				12,655,773	3,457
At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock									$ 652,000	$ 1,003,000		$ 12,226,000	$ 348,000				$ 13,456,000	$ 9,266,000
As Previously Reported
Increase (decrease) in stockholders' equity
Balance													$ 3,915,000	$ 3,915,000		$ 3,915,000	$ 3,915,000	49,328,000
Share-based compensation - stock options and RSUs																		3,338,000
Issuance of common stock upon exercise of options																		75,000
Unrealized net gain on marketable securities																		(3,000)
Net loss																		(71,067,000)
Balance																		$ 3,915,000	$ 49,328,000
As Previously Reported \| Common stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares													3,034,901	3,034,901		3,034,901	3,034,901	2,189,100
Issuance of common stock upon exercise of options (in shares) \| shares																		3,160
Conversion of convertible preferred stock (in shares) \| shares			303,125
Vesting of RSUs (in shares) \| shares																		3,096
Balance (in shares) \| shares																		3,034,901	2,189,100
As Previously Reported \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance													$ 387,205,000	$ 387,205,000		$ 387,205,000	$ 387,205,000	$ 361,548,000
Share-based compensation - stock options and RSUs																		3,338,000
Issuance of common stock upon exercise of options																		75,000
Balance																		387,205,000	$ 361,548,000
As Previously Reported \| Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																		3,000
Unrealized net gain on marketable securities																		(3,000)
Balance																			3,000
As Previously Reported \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance													(383,290,000)	(383,290,000)		(383,290,000)	(383,290,000)	(312,223,000)
Net loss																		(71,067,000)
Balance																		(383,290,000)	(312,223,000)
As Previously Reported \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 11,898,000
Issuance of common stock (in shares) \| shares		7,518,334			7,518,334
As Previously Reported \| Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares		19,148,332			19,148,332	666,666												666,666
As Previously Reported \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 11,898,000
As Previously Reported \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 9,266,000
As Previously Reported \| At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares																		172,879
As Previously Reported \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 9,266,000
As Restated
Increase (decrease) in stockholders' equity
Balance					$ 2,369,000						2,369,000	(5,358,000)	3,915,000	3,915,000		3,915,000	$ 3,915,000
Share-based compensation - stock options and RSUs											536,000	669,000	764,000
Net loss											(5,930,000)	(5,168,000)	(10,385,000)	(15,553,000)		(21,481,000)
Balance											(3,025,000)	$ 2,369,000	$ (5,358,000)	$ 2,369,000		$ (3,025,000)		$ 3,915,000
As Restated \| Preferred Stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares												2,425
Balance (in shares) \| shares													2,425
As Restated \| Common stock
Increase (decrease) in stockholders' equity
Balance					$ 1,000						$ 1,000
Balance (in shares) \| shares					12,360,157						12,360,157	3,365,422	3,034,901	3,034,901		3,034,901	3,034,901
Fractional shares retired as a result of reverse split \| shares												(10)
Vesting of RSUs (in shares) \| shares												4,118	1,773
Balance											$ 4,000	$ 1,000		$ 1,000		$ 4,000
Balance (in shares) \| shares											39,026,823	12,360,157	3,365,422	12,360,157		39,026,823		3,034,901
As Restated \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance					$ 401,211,000						$ 401,211,000	$ 388,317,000	$ 387,205,000	$ 387,205,000		$ 387,205,000	$ 387,205,000
Share-based compensation - stock options and RSUs											536,000	669,000	764,000
Balance											401,744,000	401,211,000	388,317,000	401,211,000		401,744,000		$ 387,205,000
As Restated \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance					(398,843,000)						(398,843,000)	(393,675,000)	(383,290,000)	(383,290,000)		(383,290,000)	(383,290,000)
Net loss											(5,930,000)	(5,168,000)	(10,385,000)
Balance											(404,773,000)	(398,843,000)	$ (393,675,000)	(398,843,000)		(404,773,000)		(383,290,000)
As Restated \| Series A Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares													(2,425)
As Restated \| Series A Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares													303,125
As Restated \| Series B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock												$ (2,425)
As Restated \| Series B Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares												303,125
As Restated \| Series A and B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares													4,850
As Restated \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock												$ 12,226,000	$ 348,000
As Restated \| At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock											$ 3,000	$ 1,000
Issuance of common stock (in shares) \| shares											26,666,666	8,687,502	25,623
As Restated \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock											$ (3,000)	$ 12,225,000	$ 348,000
Error Correction, Accounting for Warrants \| As Previously Reported
Increase (decrease) in stockholders' equity
Balance					3,419,000						3,419,000	2,743,000	9,271,000	9,271,000		9,271,000	$ 9,271,000	49,328,000
Share-based compensation - stock options and RSUs											536,000	669,000	764,000					3,338,000
Issuance of common stock												12,226,000
Issuance of common stock upon exercise of options																		75,000
Registered direct financing costs, inclusive of warrants													(721,000)
Unrealized net gain on marketable securities																		(3,000)
Net loss											(19,666,000)	(12,219,000)	(11,769,000)	(23,988,000)		(43,652,000)		(74,894,000)
Balance											6,260,000	3,419,000	2,743,000	$ 3,419,000		$ 6,260,000		$ 9,271,000	$ 49,328,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Preferred Stock
Increase (decrease) in stockholders' equity
Balance												$ 887,000
Balance (in shares) \| shares												2,425
Registered direct financing costs, inclusive of warrants													(965,000)
Warrants issued in connection with registered direct offering													(2,101,000)
Balance													$ 887,000
Balance (in shares) \| shares													2,425
Error Correction, Accounting for Warrants \| As Previously Reported \| Common stock
Increase (decrease) in stockholders' equity
Balance					$ 1,000						$ 1,000
Balance (in shares) \| shares					12,360,157						12,360,157	3,365,422	3,034,901	3,034,901		3,034,901	3,034,901	2,189,100
Fractional shares retired as a result of reverse split \| shares												(10)
Issuance of common stock												$ 1,000
Issuance of common stock (in shares) \| shares												8,687,502
Issuance of common stock upon exercise of options (in shares) \| shares																		3,160
Vesting of RSUs (in shares) \| shares												4,118	1,773					3,096
Balance											$ 4,000	$ 1,000		$ 1,000		$ 4,000
Balance (in shares) \| shares											39,026,823	12,360,157	3,365,422	12,360,157		39,026,823		3,034,901	2,189,100
Error Correction, Accounting for Warrants \| As Previously Reported \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance					$ 414,523,000						$ 414,523,000	$ 400,742,000	$ 396,388,000	$ 396,388,000		$ 396,388,000	$ 396,388,000	$ 361,548,000
Share-based compensation - stock options and RSUs											536,000	669,000	764,000					3,338,000
Issuance of common stock												12,225,000
Issuance of common stock upon exercise of options																		75,000
Registered direct financing costs, inclusive of warrants													244,000
Warrants issued in connection with registered direct offering													2,101,000
Balance											437,027,000	414,523,000	400,742,000	414,523,000		437,027,000		396,388,000	$ 361,548,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																		3,000
Unrealized net gain on marketable securities																		(3,000)
Balance																			3,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance					(411,105,000)						(411,105,000)	(398,886,000)	(387,117,000)	(387,117,000)		(387,117,000)	(387,117,000)	(312,223,000)
Net loss											(19,666,000)	(12,219,000)	(11,769,000)					(74,894,000)
Balance											(430,771,000)	(411,105,000)	(398,886,000)	(411,105,000)		(430,771,000)		(387,117,000)	$ (312,223,000)
Error Correction, Accounting for Warrants \| As Previously Reported \| Series A Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													$ (897,000)
Conversion of convertible preferred stock (in shares) \| shares													(2,425)
Error Correction, Accounting for Warrants \| As Previously Reported \| Series A Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares													303,125
Error Correction, Accounting for Warrants \| As Previously Reported \| Series A Convertible Preferred Stock \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													$ 897,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Series B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock												$ (887,000)
Conversion of convertible preferred stock (in shares) \| shares												(2,425)
Error Correction, Accounting for Warrants \| As Previously Reported \| Series B Convertible Preferred Stock \| Common stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock (in shares) \| shares												303,125
Error Correction, Accounting for Warrants \| As Previously Reported \| Series B Convertible Preferred Stock \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock												$ 887,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Series A and B Convertible Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													4,850,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Series A and B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													$ 4,850,000
Conversion of convertible preferred stock (in shares) \| shares													4,850
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 21,081,000
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares																		666,666
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ 21,081,000
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock											21,971,000		$ 348,000					$ 9,266,000
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock											$ 3,000
Issuance of common stock (in shares) \| shares											26,666,666		25,623					172,879
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock											$ 21,968,000		$ 348,000					$ 9,266,000
Error Correction, Accounting for Warrants \| Error Correction, Adjustment
Increase (decrease) in stockholders' equity
Balance					(1,050,000)						(1,050,000)	(8,101,000)	$ (5,356,000)	$ (5,356,000)		$ (5,356,000)	$ (5,356,000)
Balance (in shares) \| shares													(5,356,000)	(5,356,000)		(5,356,000)	(5,356,000)
Registered direct financing costs, inclusive of warrants													$ 721,000
Net loss											13,736,000	7,051,000	1,384,000	$ 8,435,000		$ 22,171,000		3,827,000
Balance											(9,285,000)	(1,050,000)	(8,101,000)	(1,050,000)		(9,285,000)		$ (5,356,000)
Balance (in shares) \| shares																		(5,356,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Preferred Stock
Increase (decrease) in stockholders' equity
Balance												(887,000)
Registered direct financing costs, inclusive of warrants													965,000
Warrants issued in connection with registered direct offering													2,101,000
Balance													(887,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance					(13,312,000)						(13,312,000)	(12,425,000)	$ (9,183,000)	$ (9,183,000)		$ (9,183,000)	$ (9,183,000)
Balance (in shares) \| shares													(9,183,000)	(9,183,000)		(9,183,000)	(9,183,000)
Registered direct financing costs, inclusive of warrants													$ (244,000)
Warrants issued in connection with registered direct offering													(2,101,000)
Balance											(35,283,000)	(13,312,000)	(12,425,000)	$ (13,312,000)		$ (35,283,000)		$ (9,183,000)
Balance (in shares) \| shares																		(9,183,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance					$ 12,262,000						12,262,000	5,211,000	$ 3,827,000	$ 3,827,000		$ 3,827,000	$ 3,827,000
Balance (in shares) \| shares													3,827,000	3,827,000		3,827,000	3,827,000
Net loss											13,736,000	7,051,000	$ 1,384,000					$ 3,827,000
Balance											25,998,000	12,262,000	5,211,000	$ 12,262,000		$ 25,998,000		$ 3,827,000
Balance (in shares) \| shares																		3,827,000
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series A Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													897,000
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series A Convertible Preferred Stock \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													(897,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock												887,000
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series B Convertible Preferred Stock \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock												$ (887,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series A and B Convertible Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													(4,850,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Series A and B Convertible Preferred Stock \| Preferred Stock
Increase (decrease) in stockholders' equity
Conversion of convertible preferred stock													$ (4,850,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ (9,183,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																		$ (9,183,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock											(21,971,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock											$ (21,971,000)

Summary of Significant Accounting Policies

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2022 included in its Annual Report on Form 10-K filed with the SEC on March 23, 2023.

Use of Estimates

and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, costs of product revenues, inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates.

Risks and Uncertainties

While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed, or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations.

It should be noted that the possibility of continued public health threats could adversely affect the Company’s ongoing or planned business operations. For example, the coronavirus (“COVID-19”) pandemic previously resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The most significant impacts to the Company’s business were encountered by sales representatives promoting Twirla in the field, as some offices limited opportunities for face-to-face interactions with healthcare providers. Re-implementation of COVID-19 restrictions, if necessary in the future, may disrupt the Company’s business and/or could adversely affect the Company’s commercialization plans and results. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom the Company engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. Another shutdown necessitating work in a completely remote environment could result in delays to its business activities and commercialization plan. The Company will continue to closely monitor events as they develop, and plan for alternative and mitigating measures that can be implemented if needed.

Cash and Cash Equivalents

The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations.

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of September 30, 2023 and December 31, 2022.

Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists.

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents (see Note 3) and the Company’s warrant liability (see Note 3) are carried at fair value. The warrant liability is measured at fair value in accordance with ASC 815.

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of September 30, 2023 and December 31, 2022, inventory reserves approximated $1.4 million and $0.6 million, respectively.

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe the carrying values of any long-lived assets are impaired as of September 30, 2023.

Research and Development Expenses

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees, and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received.

Advertising Costs

The Company has elected to expense advertising costs when incurred. Advertising costs totaled zero and $0.9 million for the three months ended September 30, 2023 and 2022, respectively, and totaled zero and $6.1 million for the nine months ended September 30, 2023 and 2022, respectively.

Deferred Financing Costs

Costs directly attributable to the Company’s senior secured term loan (see Note 7) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $44,000 and $146,000 for the three months ended September 30, 2023 and 2022, respectively and was approximately $146,000 and $284,000 for the nine months ended September 30, 2023 and 2022, respectively.

Concentrations of Credit Risk

Financial instruments, which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high

credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has no financial instruments with off balance sheet risk of accounting loss.

Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.7 million, $1.3 million, $1.1 million, $1.1 million, and $1.1 million, respectively, which represented 93% of total revenues in the three months ended September 30, 2023. In the nine months ended September 30, 2023, the Company had sales to five customers that individually accounted for more than 10% of its total revenue. These customers had sales of $3.2 million, $3.2 million, $3.2 million, $3.0 million and $2.1 million, respectively, which represented 92% of total revenue for the nine months ended September 30, 2023. Accounts receivable related to these five customers comprised 36%, 26%, 18%, 15%, and 0%, of the Company’s total accounts receivable, respectively, as of September 30, 2023. In the three months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $0.7 million, $0.6 million, and $0.6 million, respectively, which represented 30% of total revenues in the three months ended September 30, 2022. In the nine months ended September 30, 2022, the Company had sales to three customers that individually accounted for more than 10% of its total revenue. These customers had sales of $1.9 million, $1.8 million and $1.7 million, respectively, which represented 33% of total revenue for the nine months ended September 30, 2022.

Revenue Recognition

The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy.

The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.

Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following:

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these

provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period.

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data continues to become available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet.

Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the WAC. Prompt pay discount estimates are recorded as contra trade accounts receivable on the balance sheet.

The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of September 30, 2023 was made based on industry standard data and trend analysis. Estimated product returns are recorded as other current liabilities in accrued expenses on the balance sheet.

Chargebacks – Certain covered entities and government entities will be able to purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the balance sheet.

Rebates – The Company will be subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities in accrued expenses on the balance sheet.

Co-payment assistance – The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities in accrued expenses on the balance sheet.

Provisions for the revenue reserves described above totaled $8.5 million and $3.2 million for the three months ended September 30, 2023 and 2022, respectively, and $19.3 million and $6.1 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, reserves on the balance sheet associated with variable consideration were $7.4 million.

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase 700 shares of its common stock to the lender, Perceptive Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase 225 shares of the Company’s common stock (collectively, the “Perceptive Warrants”). The Perceptive Warrants qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. In March 2023, in connection with the Waiver and Sixth Amendment to the Perceptive Credit Agreement, the Company amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants. In October 2023, in connection with the Seventh Amendment to the Perceptive Credit Agreement, the Company reset the strike price of the Perceptive Warrants. See Notes 7 and 8 for additional information.

In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statements of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information.

In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase 24,856 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 7 and 8 for additional information.

In connection with a letter agreement and waiver entered into with an investor on April 2022, the Company issued warrants to purchase 4,243 shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. See Note 8 for additional information.

In connection with a public offering completed in July 2022, the Company issued warrants to purchase 1,093,333 shares of its common stock, of which 533,333 warrants expired unexercised in July 2023. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants.

In connection with a public offering completed in May 2023, the Company issued warrants to purchase 3,792,572 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants.

Income Taxes

are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of September 30, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to no less than the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive, and therefore, basic and diluted net loss per share were the same for all periods presented.

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, respectively, because to do so would be anti-dilutive (in common equivalent shares):


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its consolidated financial statements or disclosures.

The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

3. Summary of Significant Accounting Polices

Basis of Presentation

The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented.

Use of Estimates

The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, costs of product revenues, the accounting for

common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates.

Risks and Uncertainties

It should be noted that current public health threats could adversely affect the Company’s ongoing or planned business operations. In particular, the ongoing COVID-19 pandemic has resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The effect of these orders, government imposed quarantines and measures the Company has taken, such as implementing work-at-home policies, may negatively impact productivity, disrupt the Company’s business and could delay the Company’s commercialization timeline. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom it engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. It is unknown how long these conditions will last and what the complete effect will be on the Company. While to date we have been able to continue to execute our overall business plan, some of our business activities have been slowed and taken longer to complete and we continue to adjust to the challenges of operating in a largely remote setting with our employees. We have only recently launched our commercial activities for Twirla and begun engaging with healthcare providers to promote Twirla. We expect that, as we broaden our sales detailing activities, in some instances our sales force may encounter challenges engaging with healthcare providers during this on-going pandemic. Although many areas of the United States have begun to re-open access to offices and other commercial facilities, there continue to be areas where restrictions remain in place, which may have the potential to affect our ability to conduct our business. Further, new variants, including those which are more easily transmissible or resistant to existing vaccines, may lead to new shutdowns or business disruptions in the future. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed.

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2022 and 2021, respectively.

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents and Warrant liability are carried at fair value (see Note 3).

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf-life date. As of December 31, 2022 inventory reserves approximated $0.6 million.

Property and Equipment

Property and equipment, consisting of office equipment, computer equipment and manufacturing equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy.

In the third quarter of 2022, the Company transferred manufacturing equipment with a book value of $11.1 million to Corium in exchange for relief from minimum material purchase requirements. The Company recorded a loss of $11.1 million for the year ended December 31, 2022 on this disposition.

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2022.

Research and Development Expense

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

Advertising Costs

The Company has elected to expense advertising costs when incurred. Advertising costs totaled $8.2 million, $13.8 million and $5.5 for the years ended December 31, 2022 and 2021 and 2020, respectively.

Deferred Financing Costs

Costs directly attributable to the Company’s term loan (see Note 9) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $342,000, $277,000 and $231,000 for the years ended December 31, 2022, 2021 and 2020, respectively.

Concentrations of Credit Risk

Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents and marketable securities. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company has not recognized any losses from credit risks on such accounts. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has no financial instruments with off balance sheet risk of accounting loss.

Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2022, the Company had sales to four customers that individually accounted for more than 10% of its total revenue. These customers had sales of $2.9 million, $2.7 million, $2.6 million and $1.2 million, respectively, which represented 86% of total revenues in the aggregate. In 2021, the Company had sales to three customers that individually accounted for more than 10% of our total revenue. These customers had sales of $1.3 million, $1.3 million, and $1.2 million, respectively, which represented 93% of total revenues in the aggregate. Accounts receivable related to the four comprised 28%, 29%, 25% and 15%, respectively.

Revenue Recognition

Twirla is sold to customers at the wholesale acquisition cost (WAC). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following:

●

Distribution services fees

●

Prompt pay and other discounts

●

Product returns

●

Chargebacks

●

Rebates

●

Co-payment assistance

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of December 31, 2022 was made based on industry standard data and trend analysis. Estimated product returns are recorded as contra trade accounts receivable on the balance sheet.

Chargebacks – Certain government entities and covered entities will be able to purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the balance sheet.

Co-payment assistance - The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities in accrued expenses on the balance sheet.

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 35,000 shares of its common stock to the lender, Perceptive Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase 11,250 shares of the Company’s common stock (collectively, the “Perceptive Warrants”). The Perceptive Warrants qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. The Perceptive Warrants were subject to repricing in the event of an offering of securities at a price lower than the existing strike price before December 31, 2022. In connection with the Sixth Amendment, we amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants. See Notes 9 and 10 for additional information.

In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 333,333 shares of its common stock. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 9 and 10 for additional information.

In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase 1,242,813 shares of its common stock. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 9 and 10 for additional information.

In connection with a letter agreement and waiver entered into with an investor on April 2022, the Company issued warrants to purchase 212,188 shares of common stock. See Note 10 for additional information.

In connection with a public offering completed in July 2022, the Company issued warrants to purchase 54,666,665 shares of its common stock. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants.

Income Taxes

The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes. Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2022 that qualify for either recognition or disclosure in the financial statements under this guidance.

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting segment, which is the business of commercializing its transdermal patch for use in contraception.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2022, 2021 and 2020, respectively, because to do so would be anti-dilutive (in common equivalent shares):


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. ASU 2016-13 was adopted by the Company on January 1, 2020 and had no current impact on the Company as the Company did not have any financial instruments covered by the topic on the date of adoption. Subsequent to the adoption date, the allowance for credit losses is immaterial.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). This guidance simplifies the accounting for income taxes by, among other things, reducing complexity in the interim-period accounting for year-to-date loss limitations and changes in tax laws. The adoption of this standard did not have a material impact on its financial statements.

In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848), an expansion of ASU 2020-04: Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2021-01”). This guidance permits entities to elect certain optional expedients and exceptions when accounting for derivative contracts and certain hedging relationships affected by changes in the interest rates used for discounting cash flows, for computing variation margin settlements, and for calculating price alignment interest) in connection with reference rate reform activities under way in global financial markets (the “discounting transition”). The guidance was effective immediately and did not have an impact on our consolidated financial statements.

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements.

Summary of Significant Accounting Policies (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Summary of sales allowances and related accruals

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Prepaid Expenses

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Prepaid Expenses

Prepaid Expenses and Other Current Assets

4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Prepaid insurance	$	697	$	628
Other		562		775
Total prepaid expenses and other current assets	$	1,259	$	1,403

Prepaid Expenses

5. Prepaid Expenses

Prepaid expenses consist of the following:


	December 31,
	2022		2021
Prepaid insurance	$	628	$	775
Other		775		1,508
Total prepaid expenses and other current assets	$	1,403	$	2,283

Summary of Significant Accounting Policies - Income Taxes (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Uncertainty in tax positions
Uncertain tax positions	$ 0	$ 0

Accrued Liabilities

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Accrued Liabilities

Accrued Liabilities

5. Accrued Liabilities

Accrued liabilities consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Gross to net accruals	$	3,933	$	2,332
Accrued compensation		2,721		833
Accrued professional fees and other		1,684		743
Total accrued liabilities	$	8,338	$	3,908

7. Accrued Liabilities

Accrued liabilities consist of the following:


	December 31,
	2022		2021
Gross to net accruals	$	2,332	$	670
Accrued compensation		833		2,086
Accrued professional fees and other		743		807
Total accrued liabilities	$	3,908	$	3,563

Fair Value Measurements (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Fair Value Measurements

Schedule of financial instruments measured at fair value by level within the fair value hierarchy

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
September 30, 2023
Assets:
Cash and cash equivalents	$	2,873	$	—	$	—
Total assets at fair value	$	2,873	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,566
Total assets at fair value	$	—	$	—	$	5,566


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3 (Restated)
December 31, 2021
Assets:
Cash and cash equivalents	$	19,143	$	—	$	—
Total assets at fair value	$	19,143	$	—	$	—

Liabilities:
Warrant Liability (Restated)	$	—	$	—	$	5,356
Total assets at fair value	$	—	$	—	$	5,356

Schedule of rollforward of the fair value of Level 3 warrants


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(10,983)
Ending Balance September 30, 2023	$	5,566


Beginning balance at December 31, 2020	$	—
Warrants issued		9,183
Change in fair value		(3,827)
Ending balance at December 31, 2021 (Restated)		5,356
Warrants issued		26,098
Change in fair value		(25,520)
Ending balance at December 31, 2022	$	5,934

Stockholders Equity

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Stockholders' Deficit

Stockholders Equity

8. Stockholders’ Deficit

Reverse Stock Split

Shelf Registration Statement

Public Offerings

ATM Sales Agreement

Registered Direct Offering

Stock-Based Compensation Expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Cost of goods sold	$	12	$	29	$	69	$	104
Research and development		94		90		261		284
Selling and marketing		10		40		73		120
General and administrative		323		377		1,015		1,461
Total	$	439	$	536	$	1,418	$	1,969

10. Stockholders’ Equity

Shelf Registration Statement

On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering.

Public Offerings

ATM Sales Agreements

Registered Direct Offering

On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 606,250 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 606,250 shares of common Stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $8.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 606,250 shares of common stock. The Series A Warrants have an exercise price of $10.40 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $10.40 per share, will become exercisable six months following the date of issuance, and will expire one and one-half years following the initial exercise date. Proceeds from the 2022 Preferred Stock Offering, net of the placement agent’s fees and offering expenses were approximately $4.1 million. A portion of the placement agent’s fees included warrants to purchase 30,313 shares of the common stock of the Company at a strike price of $10.00 per share. The warrants become exercisable six months following the date of issuance and will expire 5 years following the commencement of sales in the 2022 Preferred Stock Offering.

On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day anniversary of the Closing Date. Pursuant to the Letter Agreement, the Company issued to Armistice a new common stock purchase warrant (“New Warrant”), on the same terms and conditions as the Series A Warrants, provided that such New Warrant shall be exercisable into 212,188 warrant shares. The Series A Warrants have an exercise price of $10.40 per share, and will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The New Warrant is exercisable 6 months after the date of the Letter Agreement.

Common Stock Warrants

- Definition

The entire disclosure for equity.

+ References

+ Details

Summary of Significant Accounting Policies (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Summary of sales allowances and related accruals

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Summary of Significant Accounting Policies
Inventory reserve	$ 1.4	$ 0.6

Credit Agreement and Guaranty (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Credit Agreement and Guaranty

Schedule of carrying amount of term loan


	September 30,		December 31,
	2023		2022
Notes payable	$	1,950	$	2,625
Debt issuance costs		(63)		(209)
Warrant discount		(298)		(990)
Total debt	$	1,589	$	1,426
Less, current portion		1,589		1,426
Long-term debt, less current portion	$	—	$	—


	December 31,		December 31,
	2022		2021
Notes payable	$	2,625	$	20,000
Debt issuance costs		(209)		(550)

Warrant discount		(990)		(2,617)
Total debt	$	1,426	$	16,833
Less, current portion		1,426		16,833
Long-term debt, less current portion	$	—	$	—

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 69B
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481568/470-20-55-69B

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 69E
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481568/470-20-55-69E

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 3
-Subparagraph (SX 210.12-04(a))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-3

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482925/835-30-45-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 45
-Paragraph 1A
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482925/835-30-45-1A

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-3

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.22)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480566/210-10-S99-1

Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 835
-SubTopic 30
-Section 55
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482949/835-30-55-8

Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 942
-SubTopic 470
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480848/942-470-50-3

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-8

Reference 11: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-6

Reference 12: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-7

+ Details

Accrued Liabilities

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Accrued Liabilities

Accrued Liabilities

5. Accrued Liabilities

Accrued liabilities consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Gross to net accruals	$	3,933	$	2,332
Accrued compensation		2,721		833
Accrued professional fees and other		1,684		743
Total accrued liabilities	$	8,338	$	3,908

7. Accrued Liabilities

Accrued liabilities consist of the following:


	December 31,
	2022		2021
Gross to net accruals	$	2,332	$	670
Accrued compensation		833		2,086
Accrued professional fees and other		743		807
Total accrued liabilities	$	3,908	$	3,563

Organization and Description of Business (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Nature of Operations
Accumulated deficit	$ 418,699	$ 408,702	$ 383,290
Cash, cash equivalents and marketable securities	2,900	5,200
Working capital deficit	$ 7,500	$ 2,000

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Commitments and Contingencies

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Commitments and Contingencies

Commitments and Contingencies

10. Commitments and Contingencies

The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, total $230.1 million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2023 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment.

In April 2020, the Company entered into a manufacturing and commercialization agreement with Corium (the “Corium Agreement”). Under the Corium Agreement, the Company has a requirement to order quarterly minimum volumes of approximately $5.6 million of product. In the event that the Company does not order the minimum volume, the Company is required to pay an additional fee equal to twenty-five percent (25%) per unit of the transfer price for all units ordered in that quarter. The Company did not meet the minimum volume order in the first or second quarter of 2022, and has, therefore, paid the additional 25% per unit fee as a penalty for all units ordered during the period. Based on then-current demand expectations for Twirla, the Company did not expect to meet the minimum volume order for the balance of 2022 and would be subject to the additional fee on future purchases. On July 25, 2022 the Company and Corium entered into Amendment No. 1 to the Corium Agreement (the “Amendment”) that is designed to restructure the contract minimums applicable to the purchase of manufactured Twirla and other services provided by Corium, transfer equipment ownership to Corium to support the manufacture of Twirla, and extend the term of the Corium Agreement. Pursuant to the Amendment, the parties agreed to adjust the process for the Company providing Corium certain binding and non-binding forecasts required under the Corium Agreement. Additionally, Corium will not enforce the original quantity minimums in the Corium Agreement, which are waived and replaced by new minimums that are based on Corium’s revenue for product purchased by the Company, expiring raw materials, and other services billed by Corium to support batch production and release. The guaranteed minimum revenue requirement for 2023 is $7.0 million, and is $22.5 million for 2024 and each year thereafter. In the event that the Company does not meet the guaranteed minimum revenue requirements in any given year, the Company will be required to make additional payments to Corium for the shortfall. The Company agreed to make certain monthly supplemental payments to Corium through December 2023, which payments are eligible to be retroactively reduced based upon product orders placed by the Company during 2023 meeting certain designated thresholds. In connection with the supplemental payments, Corium will retain the proceeds for the sale of certain raw materials to which the Company would otherwise have economic right to offset such supplemental payments. Further, the Company agreed to reimburse Corium for any unused raw materials in the event the Company’s actual product requirements are lower than initially forecasted. Pursuant to the Amendment, the term of the Corium Agreement was extended to December 31, 2033. Pursuant to the Amendment, the parties agreed to transfer ownership of certain manufacturing equipment used in the manufacture of Twirla from the Company to Corium under a Bill of Sale dated July 25, 2022.

The Company records a provision for contingent losses when it is both probable that a liability has been incurred, and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could

have an adverse effect on the Company's operations or its financial position. As of September 30, 2023, the Company has not recorded a provision for any contingent losses.

13. Commitments and Contingencies

The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, total $238.2 million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2023 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment.

In April 2020, the Company entered into a manufacturing and commercialization agreement with Corium, (the “Corium Agreement”). Under the Corium Agreement, the Company has a requirement to order quarterly minimum volumes of approximately $5.6 million of product. In the event that the Company does not order the minimum volume, the Company is required to pay an additional fee equal to twenty-five percent (25%) per unit of the transfer price for all units ordered in that quarter. The Company did not meet the minimum volume order in the first or second quarter of 2022, and has, therefore, paid the additional 25% per unit fee as a penalty for all units ordered during the period. Based on current demand expectations for Twirla, the Company did not expect to meet the minimum volume order for the balance of 2022 and would be subject to the additional fee on future purchases. On July 25, 2022 the Company and Corium entered into Amendment No. 1 to the Corium Agreement (the “Amendment”) that is designed to restructure the contract minimums applicable to the purchase of manufactured Twirla and other services provided by Corium, transfer equipment ownership to Corium to support the manufacture of Twirla and extend the term of the Corium Agreement. Pursuant to the Amendment, the parties agreed to adjust the process for the Company providing Corium certain binding and non-binding forecasts required under the Corium Agreement. Additionally, Corium will not enforce the original quantity minimums in the Corium Agreement, which are waived and replaced by new minimums that are based on Corium’s revenue for product purchased by the Company, expiring raw materials, and other services billed by Corium to support batch production and release. The guaranteed minimum revenue requirement for 2022 is $5.3 million, for 2023 is $7.0 million, and is $22.5 million for 2024 and each year thereafter. In the event that the Company does not meet the guaranteed minimum revenue requirements in any given year, the Company will be required to make additional payments to Corium for the shortfall. The Company agreed to make certain monthly supplemental payments to Corium through December 2023, which payments are eligible to be retroactively reduced based upon product orders placed by the Company during 2022 and 2023 meeting certain designated thresholds. In connection with the supplemental payments, Corium will retain the proceeds for the sale of certain raw materials to which the Company would otherwise have economic right to offset such supplemental payments. Further, the Company agreed to reimburse Corium for any unused raw materials in the event the Company’s actual product requirements are lower than initially forecasted. Pursuant to the Amendment, the term of the Corium Agreement was extended to December 31, 2033. Pursuant to the Amendment, the parties agreed to transfer ownership of certain manufacturing equipment used in the manufacture of Twirla from the Company to Corium under a Bill of Sale dated July 25, 2022.

The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of December 31, 2022, the Company has not recorded a provision for any contingent losses.

Summary of Significant Accounting Policies

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Use of Estimates

Risks and Uncertainties

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Fair Value of Financial Instruments

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Long-Lived Assets

Research and Development Expenses

Advertising Costs

Deferred Financing Costs

Concentrations of Credit Risk

credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has no financial instruments with off balance sheet risk of accounting loss.

Revenue Recognition

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Income Taxes

Stock-Based Compensation

Net Loss Per Share


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611

Recent Accounting Pronouncements

The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

3. Summary of Significant Accounting Polices

Basis of Presentation

Use of Estimates

Risks and Uncertainties

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2022 and 2021, respectively.

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents and Warrant liability are carried at fair value (see Note 3).

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf-life date. As of December 31, 2022 inventory reserves approximated $0.6 million.

Property and Equipment

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2022.

Research and Development Expense

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

Advertising Costs

Deferred Financing Costs

Concentrations of Credit Risk

Revenue Recognition

●

Distribution services fees

●

Prompt pay and other discounts

●

Product returns

●

Chargebacks

●

Rebates

●

Co-payment assistance

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of December 31, 2022 was made based on industry standard data and trend analysis. Estimated product returns are recorded as contra trade accounts receivable on the balance sheet.

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Income Taxes

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

Segment Information

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures.

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements.

Income Taxes - Reconciliation of U.S. statutory income tax rate to effective tax rate (Details)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate
Federal income tax at statutory rate (as a percent)	21.00%	21.00%	21.00%
State income tax benefit, net of federal benefit (as a percent)	0.10%	0.20%	1.00%
Unrealized gain on warrants	18.80%	1.10%
Research and development tax credits (as a percent)	0.10%	0.20%	0.70%
Other (as a percent)	(5.60%)	(2.20%)	(2.00%)
Increase to valuation allowance (as a percent)	(18.50%)	(20.30%)	(20.70%)
Effective income tax rate (as a percent)	15.90%	0.00%	0.00%

Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			$ 5,326	$ 1,040	$ 1,040
Allowances for current period sales					10,325
Payments & credits					(6,039)
Accounts Receivable, Ending Balance					5,326
Provision for revenue reserve	$ 8,500	$ 3,200	19,300	6,100
Reserve for variable consideration	$ 7,400		7,400
Customer credits, discounts And allowances
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			2,994	371	371
Allowances for current period sales					5,891
Payments & credits					(3,268)
Accounts Receivable, Ending Balance					2,994
Rebates and co-pay assistance
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Accounts Receivable, Beginning Balance			$ 2,332	$ 669	669
Allowances for current period sales					4,434
Payments & credits					(2,771)
Accounts Receivable, Ending Balance					$ 2,332

Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Equity Incentive Plans
Total stock-based compensation expense	$ 1,418	$ 1,969	$ 2,493	$ 3,338	$ 2,818
Common stock options
Equity Incentive Plans
Total stock-based compensation expense			$ 2,493	$ 3,338	$ 2,818
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model
Expected dividend yield (as a percent)			0.00%	0.00%	0.00%
Expected life (in years)			6 years 3 months	6 years 3 months	6 years 3 months
Unrecorded deferred stock-based compensation
Unrecorded deferred stock-based compensation balance related to stock options			$ 3,300
Weighted-average amortization period over which cost is expected to be recognized			2 years 9 months 18 days
Weighted average grant date fair value of options granted (in dollars per share)			$ 3.29
Common stock options \| Cost of goods sold
Equity Incentive Plans
Total stock-based compensation expense			$ 133	$ 271	$ 14
Common stock options \| Research and development
Equity Incentive Plans
Total stock-based compensation expense			372	490	651
Common stock options \| Selling and marketing
Equity Incentive Plans
Total stock-based compensation expense			155	148	108
Common stock options \| General and administrative
Equity Incentive Plans
Total stock-based compensation expense			$ 1,833	$ 2,429	$ 2,045
Common stock options \| Minimum
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model
Risk-free interest rate (as a percent)			1.71%	66.00%	0.40%
Expected volatility (as a percent)			107.00%	105.00%	65.00%
Common stock options \| Maximum
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model
Risk-free interest rate (as a percent)			4.22%	1.51%	1.68%
Expected volatility (as a percent)			118.00%	106.00%	106.00%
Unvested restricted stock units
Unrecorded deferred stock-based compensation
Unrecorded deferred stock-based compensation balance related to stock options			$ 68,000,000
Weighted-average amortization period over which cost is expected to be recognized			8 months 12 days

Restatement of Previously Issued Financial Statements (Tables)

12 Months Ended

Dec. 31, 2022

Restatement of Previously Issued Financial Statements

Schedule of impact of the restatement on the balance sheets, operations and comprehensive loss, equity and cash flow statements for the affected periods

The following tables represent the restated balance sheet, restated statements of operations and comprehensive loss, statements of changes in stockholders’ equity and statement of cash flows for the year ended December 31, 2021. These tables also present a reconciliation from the prior period as previously reported to the restated amounts. The amounts as previously reported for fiscal year 2021 was derived from the Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed on March 30, 2022.

Balance Sheet


	December 31, 2021
	As Previously
	Reported		Adjustment		As Restated
Assets
Current assets:
Cash and cash equivalents	$	19,143	$	—	$	19,143
Accounts receivable, net		1,533		—		1,533
Inventory, net		966		—		966
Prepaid expenses and other current assets		2,283		—		2,283
Total current assets		23,925		—		23,925
Property and equipment, net		12,447		—		12,447
Right of use asset		949		—		949
Other non-current assets		2,012		—		2,012
Total assets	$	39,333	$	—	$	39,333

Liabilities and stockholders’ equity
Current liabilities:
Long-term debt, current portion	$	16,833		—	$	16,833
Accounts payable		8,707		—		8,707
Accrued expenses		3,563		—		3,563
Lease liability, current portion		175		—		175
Total current liabilities		29,278		—		29,278

Lease liabilities, long-term		784		—		784
Warrant liability		—		5,356		5,356
Total liabilities		30,062		5,356		35,418
Commitments and contingencies (Note 13)
Stockholders’ equity
Preferred stock, $.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2022 and no shares issued and outstanding at December 31, 2021		—		—		—
Common stock, $.0001 par value, 300,000,000 shares authorized, 42,970,134 and 3,034,901 issued and outstanding at December 31, 2022 and December 31, 2021, respectively *		—		—		—
Additional paid-in capital *		396,388		(9,183)		387,205
Accumulated deficit		(387,117)		3,827		(383,290)
Total stockholders’ equity		9,271		(5,356)		3,915
Total liabilities and stockholders’ equity	$	39,333	$	—	$	39,333

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Operations and Comprehensive Loss


	Year Ended December 31, 2021
	As Previously Reported		Adjustment		As Restated

Revenues, net	$	4,101	$	—	$	4,101
Cost of product revenues		10,718		—		10,718
Gross profit (loss)		(6,617)		—		(6,617)

Operating expenses:
Research and development	$	6,246	$	—	$	6,246
Selling and marketing		43,444		—		43,444
General and administrative		14,698		—		14,698
Loss on disposition of assets		—		—		—
Total operating expenses		64,388		—		64,388
Loss from operations		(71,005)		—		(71,005)

Other income (expense)
Interest income		25		—		25
Interest expense		(3,914)		—		(3,914)
Unrealized gain on warrant liability		—		3,827		3,827
Total other income (expense), net		(3,889)		3,827		(62)
Loss before benefit from income taxes		(74,894)		3,827		(71,067)
Benefit from income taxes		—		—		—
Net loss	$	(74,894)	$	3,827	$	(71,067)

Net loss per share (basic and diluted)*	$	(30.86)	$	1.58	$	(29.28)

Weighted-average common shares (basic and diluted)		2,426,821		2,426,821		2,426,821

Comprehensive loss:
Net loss	$	(74,894)	$	3,827	$	(71,067)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		(3)		—		(3)
Comprehensive loss	$	(74,897)	$	3,827	$	(71,070)

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Changes in Stockholders’ Equity


	Common Stock			Additional		Accumulated				Net
	Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance December 31, 2020	2,189,100	$	—	$	361,548	$	3	$	(312,223)	$	49,328
Share-based compensation - stock options and RSUs	—		—		3,338		—		—		3,338
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	172,879		—		9,266		—		—		9,266
Issuance of common stock in public offering, net of expenses	666,666		—		21,081		—		—		21,081
Issuance of common stock upon exercise of stock options	3,160		—		75		—		—		75
Vesting of RSUs	3,096		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		1,080		—		—		1,080
Unrealized net gain on marketable securities	—		—		—		(3)		—		(3)
Net loss	—		—		—		—		(74,894)		(74,894)
Balance December 31, 2021	3,034,901	$	—	$	396,388	$	—	$	(387,117)	$	9,271

Adjustment
Balance December 31, 2020	—		—		—		—		—		—
Share-based compensation - stock options and RSUs	—		—		—		—		—		—
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	—		—		—		—		—		—
Issuance of common stock in public offering, net of expenses	—		—		(9,183)		—		—		(9,183)
Issuance of common stock upon exercise of stock options	—		—		—		—		—		—
Vesting of RSUs	—		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		—		—		—		—
Unrealized net gain on marketable securities	—		—		—		—		—		—
Net loss	—		—		—		—		3,827		3,827
Total adjustment December 31, 2021	—	$	—	$	(9,183)	$	—	$	3,827	$	(5,356)

As Restated
Balance December 31, 2020	2,189,100	$	—	$	361,548	$	3	$	(312,223)	$	49,328
Share-based compensation - stock options and RSUs	—		—		3,338		—		—		3,338
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	172,879		—		9,266		—		—		9,266
Issuance of common stock in public offering, net of expenses	666,666		—		11,898		—		—		11,898
Issuance of common stock upon exercise of stock options	3,160		—		75		—		—		75
Vesting of RSUs	3,096		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		1,080		—		—		1,080
Unrealized net gain on marketable securities	—		—		—		(3)		—		(3)
Net loss	—		—		—		—		(71,067)		(71,067)
Balance December 31, 2021 (Restated)	3,034,901	$	—	$	387,205	$	—	$	(383,290)	$	3,915

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Cash Flows


	Year Ended
	December 31, 2021
	As Previously Reported		Adjustment		As Restated
Cash flows from operating activities:
Net loss	$	(74,894)	$	3,827	$	(71,067)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve		5,323		—		5,323
Depreciation		2,064		—		2,064
Amortization		159		—		159
Noncash stock-based compensation		3,338		—		3,338
Noncash amortization of deferred financing costs		1,661		—		1,661
Unrealized gain on warrants		—		(3,827)		(3,827)
Changes in operating assets and liabilities:
Accounts receivable		(668)		—		(668)
Inventory		(6,289)		—		(6,289)
Prepaid expenses and other assets		(967)		—		(967)
Accounts payable and accrued expenses		5,202		—		5,202
Lease liability		(131)		—		(131)
Net cash used in operating activities		(65,202)		—		(65,202)

Cash flows from investing activities:
Purchases of marketable securities		—		—		—
Sales and maturities of marketable securities		39,729		—		39,729
Acquisition of property and equipment		(269)		—		(269)
Net cash provided by investing activities		39,460		—		39,460

Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		—		—		—
Proceeds from issuance of common stock in public offering, net of offering costs		21,081		—		21,081
Proceeds from At-the-Market sales of common stock, net of offering costs		9,266		—		9,266
Proceeds from exercise of stock options		75		—		75
Net cash provided by financing activities		30,422		—		30,422

Net (decrease) increase in cash and cash equivalents		4,680		—		4,680
Cash and cash equivalents, beginning of period		14,463		—		14,463
Cash and cash equivalents, end of period	$	19,143	$	—	$	19,143

Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt	$	1,080	$	—	$	1,080
Operating right-of-use assets obtained in exchange for new operating lease liabilities		969		—		969
Supplemental cash flow information
Interest paid	$	2,383	$	—	$	2,383

Fair Value Measurements

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Fair Value Measurements

Fair Value Measurements

3. Fair Value Measurements

●

Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities.

●

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2023 and December 31, 2022 (in thousands):


	Level 1		Level 2		Level 3
September 30, 2023
Assets:
Cash and cash equivalents	$	2,873	$	—	$	—
Total assets at fair value	$	2,873	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,566
Total assets at fair value	$	—	$	—	$	5,566


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934

strike price for the common warrants $45.00 and $1,700, (iv) strike price for the preferred warrants of $520.00, (v) fair value of common stock $11.50 and (vi) expected life 0.7 - 4.5 years.

The following is a roll forward of the fair value of Level 3 warrants:


Beginning balance at December 31, 2022	$	5,934
Warrants issued		10,615
Change in fair value		(10,983)
Ending Balance September 30, 2023	$	5,566

There were no transfers between Level 1, 2 or 3 during the nine months ended September 30, 2023 or 2022.

4. Fair Value Measurements

●

Level 1—Quoted prices in active markets for identical assets and liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities.

●

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities.

●

Level 3—Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company’s level 3 liabilities consist of warrant liability. The Company has no level 3 assets.

The following tables set forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2022 and 2021:


	Level 1		Level 2		Level 3
December 31, 2022
Assets:
Cash and cash equivalents	$	5,246	$	—	$	—
Total assets at fair value	$	5,246	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,934
Total assets at fair value	$	—	$	—	$	5,934


	Level 1		Level 2		Level 3 (Restated)
December 31, 2021
Assets:
Cash and cash equivalents	$	19,143	$	—	$	—
Total assets at fair value	$	19,143	$	—	$	—

Liabilities:
Warrant Liability (Restated)	$	—	$	—	$	5,356
Total assets at fair value	$	—	$	—	$	5,356

The following is a roll forward of the fair value of Level 3 warrants:


Beginning balance at December 31, 2020	$	—
Warrants issued		9,183
Change in fair value		(3,827)
Ending balance at December 31, 2021 (Restated)		5,356
Warrants issued		26,098
Change in fair value		(25,520)
Ending balance at December 31, 2022	$	5,934

There were no transfers between Level 1, 2 or 3 during 2022 or 2021.

- Definition

+ References + Details

Summary of Significant Accounting Policies (Policies)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Basis of Presentation

Basis of Presentation

Use of Estimates

Use of Estimates

Risks and Uncertainties

Risks and Uncertainties

Cash and Cash Equivalents

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2022 and 2021, respectively.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents and Warrant liability are carried at fair value (see Note 3).

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf-life date. As of December 31, 2022 inventory reserves approximated $0.6 million.

Property and Equipment

Property and Equipment

Long-Lived Assets

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2022.

Research and Development Expense

Research and Development Expenses

Research and Development Expense

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

Advertising Costs

Advertising Costs

Deferred Financing Costs

Deferred Financing Costs

Concentrations of Credit Risk

Concentrations of Credit Risk

credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has no financial instruments with off balance sheet risk of accounting loss.

Concentrations of Credit Risk

Revenue Recognition

Revenue Recognition

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Revenue Recognition

●

Distribution services fees

●

Prompt pay and other discounts

●

Product returns

●

Chargebacks

●

Rebates

●

Co-payment assistance

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of December 31, 2022 was made based on industry standard data and trend analysis. Estimated product returns are recorded as contra trade accounts receivable on the balance sheet.

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Warrants

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Income Taxes

Income Taxes

Stock-Based Compensation

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

Segment Information

Segment Information

Net Loss Per Share

Net Loss Per Share


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Recent Accounting Pronouncements

Recent Accounting Pronouncements

The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures.

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements.

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended						9 Months Ended		12 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Statements of Operations and Comprehensive Loss
Revenues, net	$ 6,662			$ 3,002			$ 15,979	$ 6,888	$ 10,884	$ 4,101	$ 749
Cost of product revenues	2,477			1,425			6,787	5,183	6,836	10,718	282
Gross profit	4,185			1,577			9,192	1,705	4,048	(6,617)	467
Operating expenses:
Research and development	705			788			2,171	2,901	3,253	6,246	13,500
Selling and marketing	4,800			5,560			14,040	23,523	30,369	43,444	23,285
General and administrative	2,680			2,815			8,813	9,837	11,860	14,698	12,735
Loss on disposition of assets				11,122				11,122	11,122
Loss on disposition of assets									11,122
Total operating expenses	8,185			20,285			25,024	47,383	56,604	64,388	49,520
Loss from operations	(4,000)			(18,708)			(15,832)	(45,678)	(52,556)	(71,005)	(49,053)
Other income (expense)
Interest income	13			46			61	50	80	25	309
Interest expense	(341)			(1,004)			(1,114)	(2,699)	(3,131)	(3,914)	(3,109)
Unrealized gain on warrant liability	3,529			13,736			6,890	22,171	25,520	3,827
Total other income, net	3,201			12,778			5,837	19,522	22,469	(62)	(2,800)
Loss before benefit from income taxes	(799)			(5,930)			(9,995)	(26,156)	(30,087)	(71,067)	(51,853)
Benefit from income taxes								4,675	4,675
Net loss and comprehensive loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	$ (5,168)	$ (10,385)	$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Net loss per share (basic) (in dollars per share)	$ (0.27)			$ (8.01)			$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Net loss per share (diluted) (in dollars per share)	$ (0.27)			$ (8.01)			$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Weighted-average common shares (basic) (in shares)	2,950,136			739,957			1,884,793	299,970	21,610,947	2,426,821	2,117,077
Weighted-average common shares (diluted) (in shares)	2,950,136			739,957			1,884,793	299,970	21,610,947	2,426,821	2,117,077
Other comprehensive income:
Unrealized (loss) gain on marketable securities										$ (3)	$ 3
Comprehensive loss									$ (25,412)	$ (71,070)	$ (51,850)

Leases - Summary (Details)	3 Months Ended		9 Months Ended		12 Months Ended
Leases - Summary (Details)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($) lease	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($) lease	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Leases
Number of finance leases \| lease	0		0		0
Number of operating leases \| lease	1		1		1
Lessee, Operating Lease, Existence of Option to Extend [true false]			true		true
Renewal term	5 years		5 years		5 years
Operating lease expense \| $	$ 89,000	$ 90,000	$ 267,000	$ 271,000	$ 355,000	$ 180,000
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities \| $			$ 235,000	$ 132,000	$ 175,000	$ 131,000	$ 184,000
Weighted-average remaining lease term (years)	1 year 6 months		1 year 6 months		2 years 3 months
Weighted-average discount rate	11.80%		11.80%		11.80%

Statements of Changes in Stockholders' Deficit - USD ($)	Preferred Stock Series A Convertible Preferred Stock	Preferred Stock Series B Convertible Preferred Stock	Preferred Stock Series A and B Convertible Preferred Stock	Preferred Stock	Common stock Public offering	Common stock At-the-market sales	Common stock Series A Convertible Preferred Stock	Common stock Series B Convertible Preferred Stock	Common stock	Additional Paid-in Capital. Public offering	Additional Paid-in Capital. At-the-market sales	Additional Paid-in Capital.	Accumulated Other Comprehensive Income	Accumulated Deficit	Public offering	At-the-market sales	Total
Balance at Dec. 31, 2019												$ 306,115,000		$ (260,370,000)			$ 45,745,000
Balance (in shares) at Dec. 31, 2019									1,745,264
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												2,818,000					2,818,000
Issuance of common stock										$ 48,435,000					$ 48,435,000
Issuance of common stock (in shares)					431,250
Issuance of common stock upon exercise of options												610,000					610,000
Issuance of common stock upon exercise of options (in shares)									12,586
Warrants issued in connection with long-term debt												3,570,000					3,570,000
Net loss														(51,853,000)			(51,853,000)
Balance at Dec. 31, 2020												361,548,000	$ 3,000	(312,223,000)			49,328,000
Balance (in shares) at Dec. 31, 2020									2,189,100
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												3,338,000					3,338,000
Issuance of common stock										$ 11,898,000	$ 9,266,000				11,898,000	$ 9,266,000
Issuance of common stock (in shares)					666,666	3,457
Issuance of common stock upon exercise of options												75,000					75,000
Issuance of common stock upon exercise of options (in shares)									3,160
Vesting of RSUs (in shares)									3,096
Warrants issued in connection with long-term debt												1,080,000					1,080,000
Net loss														(71,067,000)			(71,067,000)
Balance at Dec. 31, 2021												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021									60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												764,000					764,000
Issuance of common stock											348,000					348,000
Issuance of common stock (in shares)						512
Issuance of common stock upon exercise of options (in shares)			4,850
Conversion of convertible preferred stock (in shares)							6,063
Vesting of RSUs				$ (2,425)
Vesting of RSUs (in shares)									35
Net loss														(10,385,000)			(10,385,000)
Balance at Mar. 31, 2022												388,317,000		(393,675,000)			(5,358,000)
Balance (in shares) at Mar. 31, 2022				2,425					67,308
Balance at Dec. 31, 2021												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021									60,698
Balance at Jun. 30, 2022												401,212,000		(398,843,000)			2,369,000
Balance (in shares) at Jun. 30, 2022									247,202
Balance at Dec. 31, 2021												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021									60,698
Increase (decrease) in stockholders' equity
Net loss																	(21,481,000)
Balance at Sep. 30, 2022												401,748,000		(404,773,000)			(3,025,000)
Balance (in shares) at Sep. 30, 2022									780,535
Balance at Dec. 31, 2021												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021									60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												2,492,000					2,492,000
Fractional shares retired as a result of reverse split									(11)
Issuance of common stock					$ 3,000	$ 1,000					13,456,000				$ 3,000	13,457,000
Issuance of common stock (in shares)					26,666,666	12,655,773
Conversion of convertible preferred stock (in shares)	(2,425)	(2,425)	4,850				303,125	303,125
Vesting of RSUs (in shares)									6,555
Net loss														(25,412,000)			(25,412,000)
Balance at Dec. 31, 2022												403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022									859,402
Balance at Mar. 31, 2022												388,317,000		(393,675,000)			(5,358,000)
Balance (in shares) at Mar. 31, 2022				2,425					67,308
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												669,000					669,000
Issuance of common stock											12,226,000					12,226,000
Issuance of common stock (in shares)						173,750
Conversion of convertible preferred stock (in shares)		(2,425)						6,062
Vesting of RSUs (in shares)									82
Net loss														(5,168,000)			(5,168,000)
Balance at Jun. 30, 2022												401,212,000		(398,843,000)			2,369,000
Balance (in shares) at Jun. 30, 2022									247,202
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												536,000					536,000
Issuance of common stock (in shares)									533,333
Net loss														(5,930,000)			(5,930,000)
Balance at Sep. 30, 2022												401,748,000		(404,773,000)			(3,025,000)
Balance (in shares) at Sep. 30, 2022									780,535
Balance at Dec. 31, 2022												403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022									859,402
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												498,000					498,000
Issuance of common stock											1,003,000					1,003,000
Issuance of common stock (in shares)						72,699
Net loss														(5,389,000)			(5,389,000)
Balance at Mar. 31, 2023												404,658,000		(414,091,000)			(9,433,000)
Balance (in shares) at Mar. 31, 2023									932,101
Balance at Dec. 31, 2022												403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022									859,402
Increase (decrease) in stockholders' equity
Net loss																	(9,995,000)
Balance at Sep. 30, 2023												406,288,000		(418,699,000)			(12,411,000)
Balance (in shares) at Sep. 30, 2023									2,277,657
Balance at Mar. 31, 2023												404,658,000		(414,091,000)			(9,433,000)
Balance (in shares) at Mar. 31, 2023									932,101
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												$ 482,000					$ 482,000
Fractional shares retired as a result of reverse split												13,000					13,000
Issuance of common stock											$ 652,000					$ 652,000
Issuance of common stock (in shares)					95,000	105,342
Exercise of pre-funded warrants (in shares)									508,286
Vesting of RSUs (in shares)									76
Net loss														(3,809,000)			$ (3,809,000)
Balance at Jun. 30, 2023												$ 405,779,000		(417,900,000)			(12,121,000)
Balance (in shares) at Jun. 30, 2023									1,640,805
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs												439,000					439,000
Issuance of common stock												70,000					70,000
Issuance of common stock (in shares)									29,842
Exercise of pre-funded warrants (in shares)									607,000
Vesting of RSUs (in shares)									10
Net loss														(799,000)			(799,000)
Balance at Sep. 30, 2023												$ 406,288,000		$ (418,699,000)			$ (12,411,000)
Balance (in shares) at Sep. 30, 2023									2,277,657

Equity Incentive Plans (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Equity Incentive Plans

Schedule of stock-based compensation expense

Stock-based compensation expense was allocated as follows (in thousands):


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Cost of goods sold	$	12	$	29	$	69	$	104
Research and development		94		90		261		284
Selling and marketing		10		40		73		120
General and administrative		323		377		1,015		1,461
Total	$	439	$	536	$	1,418	$	1,969


	Year Ended
	December 31,
	2022		2021		2020
Cost of goods sold	$	133	$	271	$	14
Research and development		372		490		651
Selling and marketing		155		148		108
General and administrative		1,833		2,429		2,045
Total	$	2,493	$	3,338	$	2,818

Schedule of assumptions used to compute employee stock-based compensation


	2022		2021		2020
Risk‑free interest rate	1.71% - 4.22	%	.66% - 1.51	%	.40% - 1.68	%
Expective volatility	107% ‑ 118	%	105% ‑ 106	%	65% ‑ 106	%
Expected dividend yield	0	%	0	%	0	%
Expected life (in years)	6.25		6.25		6.25

Summary of options outstanding, vested and exercisable


			Weighted
		Weighted	Average
		Average	Remaining
		Exercise	Contractual	Aggregate
	Options	Price	Life (Years)	Intrinsic Value
Options outstanding at December 31, 2020	212,946	125.29	6.3
Options granted	64,528	105.00
Options exercised	(3,159)	23.80
Options cancelled/forfeited	(15,170)	264.46
Options outstanding at December 31, 2021	259,145	113.33	6.1
Options granted	187,454	3.97
Options exercised	—	—
Options cancelled/forfeited	(48,781)	97.44
Options outstanding at December 31, 2022	397,818	63.75	7.7	$	6
Options exercisable at December 31, 2022	182,667	113.54	5.7	$	—
Vested and expected to vest at December 31, 2022	397,818			$	6

Schedule of restricted stock activity


		Weighted Average	Aggregate
	Shares	Grant Date Fair Value	Intrinsic Value
Restricted stock units outstanding at December 31, 2020	3,988		$	458
Granted	7,433	67.27
Vested	(3,096)	112.73
Restricted stock units outstanding at December 31, 2021	8,325	—	$	163
Granted	4,690	1.05
Vested	(6,554)	76.30
Restricted stock units outstanding at December 31, 2022	6,461		$	2

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property and Equipment

Schedule of components of property and equipment



	December 31,				Estimated
	2022		2021		Life
Office equipment	$	132	$	7	5 years
Computer equipment		121		113	3 Years
Manufacturing equipment		—		14,477	7 years
		253		14,597
Less: accumulated depreciation		(76)		(2,150)
Property and equipment	$	177	$	12,447

Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer	Dec. 31, 2022 USD ($) customer	Dec. 31, 2021 USD ($) customer	Dec. 31, 2020 USD ($)
Concentration of risk, financial assets
Financial instruments with off-balance sheet risk of accounting loss, assets					$ 0
Concentration risk, financial liabilities
Financial instruments with off-balance sheet risk of accounting loss, liabilities	$ 0		$ 0		0
Total revenue	6,662,000	$ 3,002,000	15,979,000	$ 6,888,000	$ 10,884,000	$ 4,101,000	$ 749,000
Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer		3
Customer Concentration Risk \| Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer				3
Customer Concentration Risk \| Sales Revenue
Concentration risk, financial liabilities
Number of major customers \| customer					4	3
Customer Concentration Risk \| Sales Revenue \| Customer One
Concentration risk, financial liabilities
Total revenue	1,700,000	$ 700,000	3,200,000	$ 1,900,000	$ 2,900,000	$ 1,300,000
Customer Concentration Risk \| Sales Revenue \| Customer Two
Concentration risk, financial liabilities
Total revenue	1,300,000	600,000	3,200,000	1,800,000	2,700,000	1,300,000
Customer Concentration Risk \| Sales Revenue \| Customer Three
Concentration risk, financial liabilities
Total revenue	1,100,000	$ 600,000	3,200,000	$ 1,700,000	$ 2,600,000	$ 1,200,000
Concentration risk, percentage					93.00%
Customer Concentration Risk \| Sales Revenue \| Customer Four
Concentration risk, financial liabilities
Total revenue	1,100,000		3,000,000.0		$ 1,200,000
Concentration risk, percentage					86.00%
Customer Concentration Risk \| Sales Revenue \| Customer Five
Concentration risk, financial liabilities
Total revenue	$ 1,100,000		$ 2,100,000
Customer Concentration Risk \| Sales Revenue \| Three Customers
Concentration risk, financial liabilities
Concentration risk, percentage		30.00%		33.00%
Customer Concentration Risk \| Sales Revenue \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer	5		5
Total revenue			$ 92
Concentration risk, percentage	93.00%
Customer Concentration Risk \| Accounts Receivable
Concentration risk, financial liabilities
Number of major customers \| customer					4
Customer Concentration Risk \| Accounts Receivable \| Customer One
Concentration risk, financial liabilities
Concentration risk, percentage			36.00%		28.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two
Concentration risk, financial liabilities
Concentration risk, percentage			26.00%		29.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Three
Concentration risk, financial liabilities
Concentration risk, percentage			18.00%		25.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Four
Concentration risk, financial liabilities
Concentration risk, percentage			15.00%		15.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Five
Concentration risk, financial liabilities
Concentration risk, percentage			0.00%
Customer Concentration Risk \| Accounts Receivable \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer				5

Credit Agreement and Guaranty - Narrative 1 (Details) - USD ($)						1 Months Ended	2 Months Ended	3 Months Ended		4 Months Ended	9 Months Ended		12 Months Ended
	Oct. 31, 2023	Jul. 25, 2022	Jul. 08, 2022	Jan. 07, 2022	Feb. 10, 2020	Feb. 10, 2024	Dec. 31, 2023	Dec. 31, 2023	Sep. 30, 2023	Oct. 31, 2023	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2020
Credit Agreement and Guaranty
Amount borrowed														$ 20,000,000
Repayments of debt											$ 675,000	$ 17,150,000	$ 17,375,000
Interest rate (as a percent)									15.58%		15.58%
Percentage of annual interest rate					3.00%
Perceptive Credit Agreement
Credit Agreement and Guaranty
Repayments of debt			$ 5,000,000.0	$ 5,000,000.0
Prepayment of outstanding principal		$ 7,000,000.0
Principal payments on its outstanding	$ 150,000									$ 150,000
Monthly principal payments		75,000
Periodic Payment Principal	$ 150,000
Variable interest rate margin (as a percent)					10.25%
Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2024
Credit Agreement and Guaranty
Prepayment premium percentage					2.00%
Minimum cash covenants						$ 3,000,000.0	$ 1,000,000.0			$ 500,000
Revenue generated under debt									$ 5,000,000.0
Perceptive Credit Agreement \| Minimum London Interbank Offered Rate (LIBOR) [Member]
Credit Agreement and Guaranty
Interest rate for the base rate					1.50%
Perceptive Credit Agreement \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Maximum borrowing capacity					$ 35,000,000.0
Perceptive Credit Agreement, Tranche One \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					5,000,000.0
Perceptive Credit Agreement, Tranche Two \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					$ 15,000,000.0
As Previously Reported
Credit Agreement and Guaranty
Interest rate (as a percent)													14.38%
Percentage of annual interest rate					3.00%
As Previously Reported \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Outstanding line of credit													$ 0
Repayments of debt			$ 5,000,000.0	$ 5,000,000.0
Prepayment of outstanding principal		7,000,000.0
Monthly principal payments		$ 75,000
Minimum cash covenants					$ 3,000,000.0
Revenue generated under debt								$ 87,100,000					$ 62,600,000
As Previously Reported \| Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2022
Credit Agreement and Guaranty
Prepayment premium percentage					4.00%
As Previously Reported \| Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2023
Credit Agreement and Guaranty
Prepayment premium percentage					2.00%
As Previously Reported \| Perceptive Credit Agreement \| LIBOR London Interbank Offered Rate [Member]
Credit Agreement and Guaranty
Variable interest rate margin (as a percent)					10.25%
Interest rate for the base rate					1.50%
As Previously Reported \| Perceptive Credit Agreement \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Maximum borrowing capacity					$ 35,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche One \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					5,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche Two \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					15,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche Three \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					$ 15,000,000.0

Prepaid Expenses (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Prepaid Expenses

Schedule of prepaid expenses


	December 31,
	2022		2021
Prepaid insurance	$	628	$	775
Other		775		1,508
Total prepaid expenses and other current assets	$	1,403	$	2,283

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Prepaid insurance	$	697	$	628
Other		562		775
Total prepaid expenses and other current assets	$	1,259	$	1,403

Stockholders Equity - Stock-Based Compensation Expense (Details) - Common stock options - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 439	$ 536	$ 1,418	$ 1,969
Cost of goods sold
Stock-Based Compensation Expense
Total stock-based compensation expense	12	29	69	104
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	94	90	261	284
Selling and marketing
Stock-Based Compensation Expense
Total stock-based compensation expense	10	40	73	120
General and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 323	$ 377	$ 1,015	$ 1,461

Prepaid Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Prepaid Expenses
Prepaid insurance	$ 697	$ 628	$ 775
Other	562	775	1,508
Total prepaid expenses and other current assets	$ 1,259	$ 1,403	$ 2,283

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Level 1
Assets:
Cash and cash equivalents	$ 2,873	$ 5,246	$ 19,143
Total assets at fair value	2,873	5,246	19,143
Level 3
Liabilities:
Warrant Liability	5,566	5,934	5,356
Total liabilities at fair value	$ 5,566	$ 5,934	$ 5,356

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)(4)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)(1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (c)(2)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 10: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480524/946-210-50-6

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-04(9)(e))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479617/946-210-S99-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5C
-Subparagraph (SX 210.12-13C(Column H)(Footnote 7))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5C

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-04(9)(b))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479617/946-210-S99-1

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-04(9)(d))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479617/946-210-S99-1

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5
-Subparagraph (SX 210.12-13(Column G)(Footnote 8))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5C
-Subparagraph (SX 210.12-13C(Column H))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5C

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5
-Subparagraph (SX 210.12-13(Column G))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5A
-Subparagraph (SX 210.12-13A(Column E))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5A

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5B
-Subparagraph (SX 210.12-13B(Column E))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5B

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 320
-Name Accounting Standards Codification
-Section S99
-Paragraph 5B
-Subparagraph (SX 210.12-13B(Column E)(Footnote 4))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480032/946-320-S99-5B

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483466/210-20-50-3

Reference 22: http://www.xbrl.org/2003/role/exampleRef
-Topic 210
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 22
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483444/210-20-55-22

Reference 23: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
-SubTopic 20
-Name Accounting Standards Codification
-Section 55
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483444/210-20-55-10

Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482907/825-10-50-10

+ Details

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Credit Agreement and Guaranty
Notes payable	$ 1,950,000		$ 1,950,000		$ 2,625,000	$ 20,000,000
Debt issuance costs	(63,000)		(63,000)		(209,000)	(550,000)
Warrant discount	(298,000)		(298,000)		(990,000)	(2,617,000)
Total debt	1,589,000		1,589,000		1,426,000	16,833,000
Less, current portion	1,589,000		1,589,000		1,426,000	16,833,000
Amortization and debt issue costs	$ 252,000	$ 838,000	$ 838,000	$ 1,635,000	$ 1,969,000	$ 1,661,000	$ 1,341,000

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Prepaid Expenses

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Prepaid Expenses

Prepaid Expenses and Other Current Assets

4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Prepaid insurance	$	697	$	628
Other		562		775
Total prepaid expenses and other current assets	$	1,259	$	1,403

Prepaid Expenses

5. Prepaid Expenses

Prepaid expenses consist of the following:


	December 31,
	2022		2021
Prepaid insurance	$	628	$	775
Other		775		1,508
Total prepaid expenses and other current assets	$	1,403	$	2,283

Document and Entity Information	9 Months Ended
Document and Entity Information	Sep. 30, 2023
Document and Entity Information
Document Type	S-1/A
Entity Registrant Name	Agile Therapeutics, Inc.
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Central Index Key	0001261249
Amendment Flag	false

Credit Agreement and Guaranty - Narrative 2 (Details)		9 Months Ended
Credit Agreement and Guaranty - Narrative 2 (Details)	Feb. 10, 2020 USD ($) Y item $ / shares shares	Sep. 30, 2023 Y USD ($) $ / shares	May 31, 2023 $ / shares shares	Dec. 31, 2022 Y USD ($) shares	Jul. 31, 2022 $ / shares shares	Mar. 31, 2022 $ / shares shares	Mar. 22, 2022 shares	Dec. 31, 2021 Y USD ($)	Oct. 31, 2021 $ / shares shares	Sep. 30, 2021 $ / shares	Feb. 28, 2021 shares	Feb. 26, 2021 $ / shares shares	Feb. 10, 2021 $ / shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						24,856			6,660
Proceeds from Warrant Exercises	$ 20,000,000.0
Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input				4.2				1.1
Risk free interest rate \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input		5.46		4.7
Risk free interest rate \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input		4.62		4.2
Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y								4.98
Expected life \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y		4.65		4.5
Expected life \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y		1.15		0.70
Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input		2.40		11.50				31.63
Common stock warrants \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input		3.69		0.90				34.08
Common stock warrants \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input		1,700.00		1,700
Common stock warrants \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input		45.00		45.00
Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	3,600,000
Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Beneficial ownership percentage		19.99%
Fair value of warrants	$ 1,100,000
Two Thousand Twenty One Perceptive Warrants Sixth Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares		$ 10.50
Two Thousand Twenty One Perceptive Warrants Seventh Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares		$ 1.82
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	70.0
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	1.47
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input	9,340
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input	7,480
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	8,020
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	103.5
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	1.15
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	5,740
Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						225
Perceptive Credit Agreement \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Number of warrants issued \| item	2
Common stock that can be purchased with warrants (in shares) \| shares	700											225
Exercise price of warrants (in dollars per share) \| $ / shares												$ 5,740
Facility fee percentage	1.00%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares	350		350		350	350			350
Exercise price of warrants (in dollars per share) \| $ / shares	$ 7,480		$ 3.69		$ 745	$ 5,276			$ 7,080				$ 7,480
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares	350		350		350	350			350
Exercise price of warrants (in dollars per share) \| $ / shares	$ 9,340		$ 3.69		$ 618.50	$ 4,330.50			$ 5,760				9,340
Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares			225		225				225
Exercise price of warrants (in dollars per share) \| $ / shares			$ 3.69		$ 501.50	$ 3,456.50			$ 4,540			5,740
As Previously Reported
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						1,242,813			333,333
Proceeds from Warrant Exercises	$ 20,000,000.0
As Previously Reported \| Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	3,600,000
As Previously Reported \| Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	$ 1,100,000
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	0.700
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	0.0147
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	186.80
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	149.60
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	160.40
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	1.035
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	0.0115
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	114.80
As Previously Reported \| Perceptive Credit Agreement \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Number of warrants issued \| item	2
Common stock that can be purchased with warrants (in shares) \| shares				35,000					35,000		11,250
Exercise price of warrants (in dollars per share) \| $ / shares												114.80
Beneficial ownership percentage	19.99%
Facility fee percentage	1.00%
As Previously Reported \| Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares				17,500	17,500	17,500	17,500		17,500
Exercise price of warrants (in dollars per share) \| $ / shares	$ 149.60				$ 14.90	$ 105.52			$ 141.60	$ 186.80			186.80
As Previously Reported \| Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares				17,500	17,500	17,500			17,500
Exercise price of warrants (in dollars per share) \| $ / shares	$ 186.80				$ 12.37	$ 86.61			$ 115.20	149.60			$ 149.60
As Previously Reported \| Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares					11,250	11,250			11,250
Exercise price of warrants (in dollars per share) \| $ / shares					$ 10.03	$ 69.13			$ 90.80	$ 114.80		$ 114.80

Statements of Cash Flows - USD ($)	9 Months Ended		12 Months Ended
Statements of Cash Flows - USD ($)	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash flows from operating activities:
Net loss	$ (9,995,000)	$ (21,481,000)	$ (25,412,000)	$ (71,067,000)	$ (51,853,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve				5,323,000
Depreciation	77,000	1,255,000	1,280,000	2,064,000	105,000
Amortization	209,000	188,000	254,000	159,000	171,000
Loss on disposition of assets		11,122,000	11,122,000
Loss on disposition of assets			11,122,000
Noncash stock-based compensation	1,418,000	1,969,000	2,493,000	3,338,000	2,818,000
Noncash amortization of deferred financing costs	838,000	1,635,000	1,969,000	1,661,000	1,341,000
Unrealized gain on warrants	(6,890,000)	(22,171,000)	(25,520,000)	(3,827,000)
Changes in operating assets and liabilities:
Accounts receivable	(144,000)	(2,178,000)	(1,844,000)	(668,000)	(865,000)
Inventory	(1,079,000)	(831,000)	(366,000)	(6,289,000)
Prepaid expenses and other assets	2,480,000	(1,551,000)	880,000	(967,000)	(2,485,000)
Accounts payable and accrued expenses	3,572,000	(2,213,000)	(628,000)	5,202,000	3,641,000
Lease liability	(235,000)	(132,000)	(175,000)	(131,000)	(184,000)
Net cash used in operating activities	(9,749,000)	(34,388,000)	(35,947,000)	(65,202,000)	(47,311,000)
Cash flows from investing activities:
Purchases of marketable securities					(54,837,000)
Sales and maturities of marketable securities				39,729,000	14,500,000
Acquisition of property and equipment		(133,000)	(133,000)	(269,000)	(353,000)
Net cash used in investing activities		(133,000)	(133,000)	39,460,000	(40,690,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs	6,509,000	21,971,000	21,936,000	21,081,000	48,434,000
Proceeds from issuance of long-term debt					20,000,000
Repayments of long-term debt	(675,000)	(17,150,000)	(17,375,000)
Repayments of note payable	(184,000)
Debt financing costs paid					(1,059,000)
Proceeds from exercise of stock options				75,000	610,000
Net cash provided by financing activities	7,375,000	21,523,000	22,183,000	30,422,000	67,985,000
Net decrease in cash and cash equivalents	(2,374,000)	(12,998,000)	(13,897,000)	4,680,000	(20,016,000)
Cash and cash equivalents, beginning of period	5,246,000	19,143,000	19,143,000	14,463,000	34,479,000
Cash and cash equivalents, end of period	2,873,000	6,145,000	5,246,000	19,143,000	14,463,000
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt				1,080,000	3,570,000
Warrants issued in connection with preferred stock offering		2,101,000
Operating right-of-use assets obtained in exchange for new operating lease liabilities				969,000
Supplemental cash flow information
Interest paid	276,000	1,078,000	1,162,000	2,383,000	$ 2,099,000
Series A Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		897,000
Series B Convertible Preferred Stock
Supplemental disclosure of noncash financing activities
Conversion of Series preferred stock into common stock		887,000
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129,000	4,128,000
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 1,725,000	$ 12,573,000	$ 13,494,000	$ 9,266,000

Prepaid Expenses (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Prepaid Expenses

Schedule of prepaid expenses


	December 31,
	2022		2021
Prepaid insurance	$	628	$	775
Other		775		1,508
Total prepaid expenses and other current assets	$	1,403	$	2,283

Schedule of prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Prepaid insurance	$	697	$	628
Other		562		775
Total prepaid expenses and other current assets	$	1,259	$	1,403

Leases (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Leases

Maturity of lease liabilities

Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands):


2023	$	98
2024		397
2025		101
Total	$	596
Less: Interest		(47)
Present value of lease liability	$	549

Future minimum lease payments under non-cancellable leases as of December 31, 2022 were as follows:


2023	$	391
2024		397
2025		101
Total	$	889
Less: Interest		(104)
Present value of lease liability	$	785

Stockholders Equity - Amended and Restated Certificate of Incorporation (Details)		12 Months Ended
	Apr. 10, 2023 shares	Dec. 31, 2022 class shares	Dec. 31, 2021 shares	Sep. 30, 2023 shares	Apr. 09, 2023 shares	Jan. 07, 2022 shares	Jan. 06, 2022 shares	Jan. 06, 2020 shares
Stockholders' Equity
Common stock, authorized (in shares)		300,000,000	300,000,000	300,000,000		300,000,000	150,000,000	300,000,000
Reverse stock split conversion ratio	0.02	0.025	0.025
Common stock, issued (in shares)	932,101	42,970,134	3,034,901	2,277,657	46,605,134
Common Stock, Shares, Outstanding	932,101	42,970,134	3,034,901	2,277,657	46,605,134
Board of Directors, number of classes \| class		3
Term of Board member		3 years
Number of classes elected at each annual meeting \| class		1
Minimum
Stockholders' Equity
Affirmative vote of all then-outstanding shares of capital stock for removal of directors (as a percent)		75.00%

Stockholders Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions								1 Months Ended				3 Months Ended						5 Months Ended		9 Months Ended		12 Months Ended
	Aug. 22, 2022	Apr. 27, 2022	Apr. 25, 2022	Apr. 04, 2022	Mar. 15, 2022	Mar. 14, 2022	Jan. 10, 2022	May 31, 2023	Jul. 31, 2022	Oct. 31, 2021	Mar. 31, 2021	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Apr. 12, 2023	Oct. 02, 2020
Sale of stock
Common stock that can be purchased with warrants (in shares)										6,660							24,856
Stock stated value												$ 0.0001						$ 0.0001		$ 0.0001		$ 0.0001	$ 0.0001
Maximum
Sale of stock
Proceeds from issuance of common stock in public offering, net of offering costs	$ 75.0
Common stock
Sale of stock
Issuance of common stock (in shares)												29,842			533,333
Stock Issued During Period, Shares, Warrants Exercised												607,000	508,286
Conversion of stock shares converted					6,025
Conversion of convertible preferred stock (in shares)				6,025
Series B Warrants
Sale of stock
Issuance of common stock (in shares)				2,425
Warrants and rights outstanding, term						5 years
2020 Shelf Registration Statement
Sale of stock
Aggregate amount of securities issuable																										$ 200.0
2022 Preferred Stock Offering
Sale of stock
Common stock that can be purchased with warrants (in shares)						606
Proceeds from issuance of common stock in public offering, net of offering costs						$ 4.1
Exercise price of warrants (in dollars per share)						$ 500.00
Conversion price						$ 400.00
Preferred Stock, convertible, shares issuable						12,125
Exercisable term						6 months
Stock stated value						$ 1,000
Duration From Offering To Anniversary Of Closing			180 days
2022 Preferred Stock Offering \| Series A Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)			4,243			12,125
Exercise price of warrants (in dollars per share)						$ 520.00
Exercisable term						6 months
Warrants and rights outstanding, term						5 years
Warrant Exercisable Term			5 years
2022 Preferred Stock Offering \| Series B Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)						12,125
Exercisable term						6 months
Warrants and rights outstanding, term						1 year 6 months
At-the-market sales \| Common stock
Sale of stock
Issuance of common stock (in shares)											172,879		105,342	72,699		173,750	512					12,655,773	3,457
Proceeds from issuance of common stock in public offering, net of offering costs																						$ 9.3	$ 9.3
At-the-market sales \| Common stock \| Maximum
Sale of stock
Commission percentage		3.00%									3.00%
Authorized value for shares issuance		$ 12.8									$ 50.0
Public offering
Sale of stock
Issuance of common stock (in shares)								3,792,572	150,366
Common stock that can be purchased with warrants (in shares)										6,660
Share price (in dollars per share)								$ 3.9551	$ 45.00
Proceeds from issuance of common stock in public offering, net of offering costs									$ 22.0
Public offering \| Common stock
Sale of stock
Issuance of common stock (in shares)								95,000	382,966	13,333			95,000									26,666,666	666,666	431,250
Common stock that can be purchased with one-half of warrant (in shares)										1
Share price (in dollars per share)										$ 1,700
Proceeds from issuance of common stock in public offering, net of offering costs								$ 6.5		$ 21.1
Public offering \| Series A-1 warrants
Sale of stock
Warrant Exercisable Term									5 years
Public offering \| Pre-funded warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)								1,801,286
Stock Issued During Period, Shares, Warrants Exercised																		1,115,286
Class of Warrant or Right, Exercisable												686,000						686,000		686,000
Public offering \| Series B Pre-funded Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)									150,366
2022 ATM
Sale of stock
Issuance of common stock (in shares)																			173,750	207,883	8,687,502	78,852
Proceeds from issuance of common stock in public offering, net of offering costs																			$ 12.2	$ 1.7	$ 12.2	$ 0.9
Eligible Amount Authorized To Sell																									$ 4.5
2022 ATM \| Common stock
Sale of stock
Issuance of common stock (in shares)																	512				25,623
Proceeds from issuance of common stock in public offering, net of offering costs																	$ 0.3				$ 0.3
2022 ATM \| Common stock \| Maximum
Sale of stock
Commission percentage							3.00%
Authorized value for shares issuance							$ 50.0
2022 ATM \| New Warrant [Member]
Sale of stock
Warrant Exercisable Term			6 months
H.C. Wainwright & Co., LLC, Sales Agent [Member]
Sale of stock
Common stock that can be purchased with warrants (in shares)								94,814	26,666
Commission percentage		3.00%						7.00%	7.00%
Exercise price of warrants (in dollars per share)								$ 4.9439	$ 56.25
H.C. Wainwright & Co., LLC, Sales Agent [Member] \| Common stock
Sale of stock
Issuance of common stock (in shares)		12,841,000
Series A Preferred Stock
Sale of stock
Conversion of stock shares converted					2,425
Series A Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)						2,425
Exercise price of warrants (in dollars per share)			$ 520.00
Series B Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)						2,425
Exercise price of warrants (in dollars per share)						$ 520.00

Quarterly Financial Information - Statements of Cash Flows (Details) - USD ($)	3 Months Ended		6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2022	Mar. 31, 2022	Jun. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash flows from operating activities:
Net loss				$ (9,995,000)	$ (21,481,000)	$ (25,412,000)	$ (71,067,000)	$ (51,853,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve							5,323,000
Depreciation				77,000	1,255,000	1,280,000	2,064,000	105,000
Amortization				209,000	188,000	254,000	159,000	171,000
Loss on disposition of assets						11,122,000
Noncash stock-based compensation				1,418,000	1,969,000	2,493,000	3,338,000	2,818,000
Noncash amortization of deferred financing costs				838,000	1,635,000	1,969,000	1,661,000	1,341,000
Unrealized gain on warrants				(6,890,000)	(22,171,000)	(25,520,000)	(3,827,000)
Changes in operating assets and liabilities:
Accounts receivable				(144,000)	(2,178,000)	(1,844,000)	(668,000)	(865,000)
Inventory				(1,079,000)	(831,000)	(366,000)	(6,289,000)
Prepaid expenses and other assets				2,480,000	(1,551,000)	880,000	(967,000)	(2,485,000)
Accounts payable and accrued expenses				3,572,000	(2,213,000)	(628,000)	5,202,000	3,641,000
Lease liability				(235,000)	(132,000)	(175,000)	(131,000)	(184,000)
Net cash used in operating activities				(9,749,000)	(34,388,000)	(35,947,000)	(65,202,000)	(47,311,000)
Cash flows from investing activities:
Purchases of marketable securities								(54,837,000)
Sales and maturities of marketable securities							39,729,000	14,500,000
Acquisition of property and equipment					(133,000)	(133,000)	(269,000)	(353,000)
Net cash provided by investing activities					(133,000)	(133,000)	39,460,000	(40,690,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs				6,509,000	21,971,000	21,936,000	21,081,000	48,434,000
Proceeds from Issuance of Long-term Debt								20,000,000
Repayments of long-term debt				(675,000)	(17,150,000)	(17,375,000)
Debt financing costs paid								(1,059,000)
Proceeds from exercise of stock options							75,000	610,000
Net cash provided by financing activities				7,375,000	21,523,000	22,183,000	30,422,000	67,985,000
Net (decrease) increase in cash and cash equivalents				(2,374,000)	(12,998,000)	(13,897,000)	4,680,000	(20,016,000)
Cash and cash equivalents, beginning of period		$ 19,143,000	$ 19,143,000	5,246,000	19,143,000	19,143,000	14,463,000	34,479,000
Cash and cash equivalents, end of period	$ 6,145,000			2,873,000	6,145,000	5,246,000	19,143,000	14,463,000
Supplemental cash flow information
Interest paid				276,000	1,078,000	1,162,000	2,383,000	2,099,000
As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from operating activities:
Net loss		(11,769,000)	(23,988,000)		(43,652,000)		(74,894,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve							5,323,000
Depreciation		527,000	1,057,000		1,255,000		2,064,000
Amortization		61,000	124,000		188,000		159,000
Loss on disposition of assets	11,122,000				11,122,000
Noncash stock-based compensation		764,000	1,433,000		1,969,000		3,338,000
Noncash amortization of deferred financing costs		419,000	797,000		1,635,000		1,661,000
Changes in operating assets and liabilities:
Accounts receivable		(132,000)	(554,000)		(2,178,000)		(668,000)
Income taxes receivable		(4,675,000)
Inventory		(1,727,000)	(1,374,000)		(831,000)		(6,289,000)
Prepaid expenses and other assets		707,000	1,267,000		(1,551,000)		(967,000)
Accounts payable and accrued expenses		1,095,000	3,643,000		(2,213,000)		5,202,000
Lease liability		(21,000)	(90,000)		(132,000)		(131,000)
Net cash used in operating activities		(14,751,000)	(17,685,000)		(34,388,000)		(65,202,000)
Cash flows from investing activities:
Sales and maturities of marketable securities							39,729,000
Acquisition of property and equipment		(126,000)	(133,000)		(133,000)		(269,000)
Net cash provided by investing activities		(126,000)	(133,000)		(133,000)		39,460,000
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs					21,971,000		21,081,000
Repayments of long-term debt		(5,000,000)	(5,000,000)		(17,150,000)
Proceeds from exercise of stock options							75,000
Net cash provided by financing activities		(523,000)	11,702,000		21,523,000		30,422,000
Net (decrease) increase in cash and cash equivalents		(15,400,000)	(6,116,000)		(12,998,000)		4,680,000
Cash and cash equivalents, beginning of period	13,027,000	19,143,000	19,143,000		19,143,000	19,143,000	14,463,000
Cash and cash equivalents, end of period	6,145,000	3,743,000	13,027,000		6,145,000		19,143,000	$ 14,463,000
Supplemental cash flow information
Interest paid		452,000	898,000		1,078,000		2,383,000
Error Correction, Adjustment \| Error Correction, Accounting for Warrants
Cash flows from operating activities:
Net loss		1,384,000	8,435,000		22,171,000		3,827,000
Adjustments to reconcile net loss to net cash used in operating activities:
Unrealized gain on warrants		(1,384,000)	(8,435,000)		(22,171,000)		(3,827,000)
As Restated
Cash flows from operating activities:
Net loss		(10,385,000)	(15,553,000)		(21,481,000)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		527,000	1,057,000		1,255,000
Amortization		61,000	124,000		188,000
Loss on disposition of assets	11,122,000				11,122,000
Noncash stock-based compensation		764,000	1,433,000		1,969,000
Noncash amortization of deferred financing costs		419,000	797,000		1,635,000
Unrealized gain on warrants		(1,384,000)	(8,435,000)		(22,171,000)
Changes in operating assets and liabilities:
Accounts receivable		(132,000)	(554,000)		(2,178,000)
Income taxes receivable		(4,675,000)
Inventory		(1,727,000)	(1,374,000)		(831,000)
Prepaid expenses and other assets		707,000	1,267,000		(1,551,000)
Accounts payable and accrued expenses		1,095,000	3,643,000		(2,213,000)
Lease liability		(21,000)	(90,000)		(132,000)
Net cash used in operating activities		(14,751,000)	(17,685,000)		(34,388,000)
Cash flows from investing activities:
Acquisition of property and equipment		(126,000)	(133,000)		(133,000)
Net cash provided by investing activities		(126,000)	(133,000)		(133,000)
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs					21,971,000
Repayments of long-term debt		(5,000,000)	(5,000,000)		(17,150,000)
Net cash provided by financing activities		(523,000)	11,702,000		21,523,000
Net (decrease) increase in cash and cash equivalents		(15,400,000)	(6,116,000)		(12,998,000)
Cash and cash equivalents, beginning of period	13,027,000	19,143,000	19,143,000		19,143,000	19,143,000
Cash and cash equivalents, end of period	$ 6,145,000	3,743,000	13,027,000		6,145,000		19,143,000
Supplemental cash flow information
Interest paid		452,000	898,000		1,078,000
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs					4,129,000	4,128,000
Public offering \| As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129,000	4,129,000		4,129,000
Public offering \| As Restated
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129,000	4,129,000		4,129,000
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs				$ 1,725,000	12,573,000	$ 13,494,000	9,266,000
At-the-market sales \| As Previously Reported \| Error Correction, Accounting for Warrants
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs		348,000	12,573,000		12,573,000		$ 9,266,000
At-the-market sales \| As Restated
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs		$ 348,000	$ 12,573,000		$ 12,573,000

Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 2,873			$ 5,246				$ 19,143
Accounts receivable, net	3,521			3,377				1,533
Inventory, net	2,411			1,332				966
Prepaid expenses and other current assets	1,259			1,403				2,283
Total current assets	10,064			11,358				23,925
Property and equipment, net	101			177				12,447
Right of use asset	486			695				949
Other non-current assets	238			2,012				2,012
Total assets	10,889			14,242				39,333
Current liabilities:
Long-term debt, current portion	1,589			1,426				16,833
Notes payable, current portion	379
Accounts payable	6,879			7,734				8,707
Accrued expenses	8,338			3,908				3,563
Lease liability, current portion	353			319				175
Total current liabilities	17,538			13,387				29,278
Lease liabilities, long-term	196			466				784
Warrant liability	5,566			5,934				5,356
Total liabilities	23,300			19,787				35,418
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively				4
Additional paid-in capital	406,288			403,157				387,205
Accumulated deficit	(418,699)			(408,702)				(383,290)
Total stockholders' deficit	(12,411)	$ (12,121)	$ (9,433)	(5,545)	$ (3,025)	$ 2,369	$ (5,358)	3,915	$ 49,328	$ 45,745
Total liabilities and stockholders' deficit	$ 10,889			$ 14,242				$ 39,333

Property and Equipment

12 Months Ended

Dec. 31, 2022

Property and Equipment

Property and Equipment

6. Property and Equipment

Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Property and equipment consist of the following:



	December 31,				Estimated
	2022		2021		Life
Office equipment	$	132	$	7	5 years
Computer equipment		121		113	3 Years
Manufacturing equipment		—		14,477	7 years
		253		14,597
Less: accumulated depreciation		(76)		(2,150)
Property and equipment	$	177	$	12,447

Upon successful completion of the validation of the commercial manufacturing process for Twirla by the Company’s contract manufacturer, Corium, and the announcement of the commercial launch of Twirla in December 2020, manufacturing equipment with a cost of $14.3 million was placed into service and started being depreciated.

In accordance with Amendment No. 1 to the Corium Agreement (the “Amendment”), the Company transferred all of its manufacturing equipment to Corium during the third quarter of 2022.

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Dec. 31, 2022	Sep. 30, 2023
Commitments and Contingencies
Future purchase commitments		$ 238.2	$ 230.1
Corium Agreement [Member]
Commitments and Contingencies
Quarterly minimum volume amount of product to be ordered	$ 5.6
Additional fee payable as a percentage of transfer price for units ordered	(25.00%)
Percentage of additional fee as penalty percent		25.00%
Reminder 2023		$ 5.3	7.0
2023		7.0
2024 and Each Year Thereafter		$ 22.5
2024 and Each Year Thereafter			$ 22.5

Equity Incentive Plans - Stock Options Summary (Details) - Common stock options	12 Months Ended
	Dec. 31, 2022 $ / shares shares
Minimum
Equity Incentive Plans
Exercise prices of options granted through the end of the year (in dollars per share)	$ 0.20
Maximum
Equity Incentive Plans
Exercise prices of options granted through the end of the year (in dollars per share)	$ 430.00
1997 Plan and 2008 Plan
Equity Incentive Plans
Expiration period	10 years
Vesting period	4 years
2014 Incentive Compensation Plan
Equity Incentive Plans
Shares available for grant \| shares	314,398

Organization and Description of Business

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Organization and Description of Business

Organization and Description of Business

1. Organization and Description of Business

Nature of Operations

●

maintains a sales and marketing infrastructure and contract manufacturing arrangement to support the continued commercialization of Twirla in the United States;

●

continues to commercialize Twirla and seek increased uptake of Twirla in the United States;

●	continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla;

●	maintains, leverages, and expands the Company’s intellectual property portfolio; and

●	maintains operational, financial, and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts.

Going Concern

Basis of Presentation

1. Organization and Description of Business

Nature of Operations

Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla ^®, and more recently commercializing Twirla. The Company is headquartered in Princeton, New Jersey.

The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company:

●

maintains a sales and marketing infrastructure to support the continued commercialization of Twirla in the United States;

●

continues to commercialize Twirla and seek increased uptake of Twirla in the United States;

●

continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla;

●

maintains, leverages and expands the Company’s intellectual property portfolio; and

●

maintains operational, financial and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts.

Going Concern

The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities.

Stockholders Equity - Amended and Restated Certificate of Incorporation (Details)		12 Months Ended
	Apr. 10, 2023 shares	Dec. 31, 2022 class shares	Dec. 31, 2021 shares	Sep. 30, 2023 shares	Apr. 09, 2023 shares	Jan. 07, 2022 shares	Jan. 06, 2022 shares	Jan. 06, 2020 shares
Stockholders' Equity
Common stock, authorized (in shares)		300,000,000	300,000,000	300,000,000		300,000,000	150,000,000	300,000,000
Reverse stock split conversion ratio	0.02	0.025	0.025
Common stock, issued (in shares)	932,101	42,970,134	3,034,901	2,277,657	46,605,134
Common Stock, Shares, Outstanding	932,101	42,970,134	3,034,901	2,277,657	46,605,134
Board of Directors, number of classes \| class		3
Term of Board member		3 years
Number of classes elected at each annual meeting \| class		1
Minimum
Stockholders' Equity
Affirmative vote of all then-outstanding shares of capital stock for removal of directors (as a percent)		75.00%

Stockholders Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions									1 Months Ended				3 Months Ended						5 Months Ended		9 Months Ended		12 Months Ended
	Aug. 22, 2022	Jul. 06, 2022	Apr. 27, 2022	Apr. 25, 2022	Apr. 04, 2022	Mar. 15, 2022	Mar. 14, 2022	Jan. 10, 2022	May 31, 2023	Jul. 31, 2022	Oct. 31, 2021	Mar. 31, 2021	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Apr. 12, 2023	Oct. 02, 2020
Sale of stock
Common stock that can be purchased with warrants (in shares)											6,660							24,856
Stock stated value													$ 0.0001						$ 0.0001		$ 0.0001		$ 0.0001	$ 0.0001
As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)											333,333							1,242,813
Maximum
Sale of stock
Proceeds from issuance of common stock in public offering, net of offering costs	$ 75.0
Common stock
Sale of stock
Issuance of common stock (in shares)													29,842			533,333
Stock Issued During Period, Shares, Warrants Exercised													607,000	508,286
Conversion of stock shares converted						6,025
Conversion of convertible preferred stock (in shares)					6,025
Common stock \| As Previously Reported
Sale of stock
Conversion of convertible preferred stock (in shares)					303,125
Series A-1 warrants \| As Previously Reported
Sale of stock
Warrant Exercisable Term		5 years
Series A-2 warrants \| As Previously Reported
Sale of stock
Exercisable term		13 months
Series B Warrants
Sale of stock
Issuance of common stock (in shares)					2,425
Warrants and rights outstanding, term							5 years
Series B Warrants \| As Previously Reported
Sale of stock
Conversion of stock shares converted						303,125
2020 Shelf Registration Statement
Sale of stock
Aggregate amount of securities issuable																											$ 200.0
2022 Preferred Stock Offering
Sale of stock
Common stock that can be purchased with warrants (in shares)							606
Proceeds from issuance of common stock in public offering, net of offering costs							$ 4.1
Exercise price of warrants (in dollars per share)							$ 500.00
Conversion price							$ 400.00
Preferred Stock, convertible, shares issuable							12,125
Exercisable term							6 months
Stock stated value							$ 1,000
Duration From Offering To Anniversary Of Closing				180 days
2022 Preferred Stock Offering \| As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)							30,313
Proceeds from issuance of common stock in public offering, net of offering costs							$ 4.1
Exercise price of warrants (in dollars per share)							$ 10.00
Conversion price							$ 8.00
Preferred Stock, convertible, shares issuable							606,250
Exercisable term							6 months
Stock stated value							$ 1,000
Warrants and rights outstanding, term							5 years
Duration From Offering To Anniversary Of Closing				180 days
2022 Preferred Stock Offering \| Series A Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)				4,243			12,125
Exercise price of warrants (in dollars per share)							$ 520.00
Exercisable term							6 months
Warrants and rights outstanding, term							5 years
Warrant Exercisable Term				5 years
2022 Preferred Stock Offering \| Series A Warrants \| As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)				212,188			606,250
Exercise price of warrants (in dollars per share)				$ 10.40			$ 10.40
Exercisable term							6 months
Warrants and rights outstanding, term							5 years
Warrant Exercisable Term				5 years
2022 Preferred Stock Offering \| Series B Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)							12,125
Exercisable term							6 months
Warrants and rights outstanding, term							1 year 6 months
2022 Preferred Stock Offering \| Series B Warrants \| As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)							606,250
Exercise price of warrants (in dollars per share)							$ 10.40
Exercisable term							6 months
Warrants and rights outstanding, term							1 year 6 months
At-the-market sales \| Common stock
Sale of stock
Issuance of common stock (in shares)												172,879		105,342	72,699		173,750	512					12,655,773	3,457
Proceeds from issuance of common stock in public offering, net of offering costs																							$ 9.3	$ 9.3
At-the-market sales \| Common stock \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)																								172,879
At-the-market sales \| Common stock \| Maximum
Sale of stock
Commission percentage			3.00%									3.00%
Authorized value for shares issuance			$ 12.8									$ 50.0
Public offering
Sale of stock
Issuance of common stock (in shares)									3,792,572	150,366
Common stock that can be purchased with warrants (in shares)											6,660
Share price (in dollars per share)									$ 3.9551	$ 45.00
Proceeds from issuance of common stock in public offering, net of offering costs										$ 22.0
Public offering \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)		7,518,334								7,518,334
Common stock that can be purchased with warrants (in shares)		7,518,334								38,296,664	333,333
Share price (in dollars per share)										$ 0.90
Proceeds from issuance of common stock in public offering, net of offering costs		$ 22.0
Public offering \| Common stock
Sale of stock
Issuance of common stock (in shares)									95,000	382,966	13,333			95,000									26,666,666	666,666	431,250
Common stock that can be purchased with one-half of warrant (in shares)											1
Share price (in dollars per share)											$ 1,700
Proceeds from issuance of common stock in public offering, net of offering costs									$ 6.5		$ 21.1
Public offering \| Common stock \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)		19,148,332								19,148,332	666,666													666,666
Common stock that can be purchased with one-half of warrant (in shares)											1
Share price (in dollars per share)										$ 0.8999	$ 34.00
Proceeds from issuance of common stock in public offering, net of offering costs										$ 22.0	$ 21.1
Public offering \| Series A-1 warrants
Sale of stock
Warrant Exercisable Term										5 years
Public offering \| Pre-funded warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)									1,801,286
Stock Issued During Period, Shares, Warrants Exercised																			1,115,286
Class of Warrant or Right, Exercisable													686,000						686,000		686,000
Public offering \| Pre-funded warrants \| As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)										7,518,334
Public offering \| Series B Pre-funded Warrants
Sale of stock
Common stock that can be purchased with warrants (in shares)										150,366
2022 ATM
Sale of stock
Issuance of common stock (in shares)																				173,750	207,883	8,687,502	78,852
Proceeds from issuance of common stock in public offering, net of offering costs																				$ 12.2	$ 1.7	$ 12.2	$ 0.9
Eligible Amount Authorized To Sell																										$ 4.5
2022 ATM \| Common stock
Sale of stock
Issuance of common stock (in shares)																		512				25,623
Proceeds from issuance of common stock in public offering, net of offering costs																		$ 0.3				$ 0.3
2022 ATM \| Common stock \| Maximum
Sale of stock
Commission percentage								3.00%
Authorized value for shares issuance								$ 50.0
2022 ATM \| New Warrant [Member]
Sale of stock
Warrant Exercisable Term				6 months
2022 ATM \| New Warrant [Member] \| As Previously Reported
Sale of stock
Warrant Exercisable Term				6 months
H.C. Wainwright & Co., LLC, Sales Agent [Member]
Sale of stock
Common stock that can be purchased with warrants (in shares)									94,814	26,666
Commission percentage			3.00%						7.00%	7.00%
Exercise price of warrants (in dollars per share)									$ 4.9439	$ 56.25
H.C. Wainwright & Co., LLC, Sales Agent [Member] \| As Previously Reported
Sale of stock
Common stock that can be purchased with warrants (in shares)		1,333,333
Commission percentage		7.00%
Exercise price of warrants (in dollars per share)		$ 1.125
H.C. Wainwright & Co., LLC, Sales Agent [Member] \| Common stock
Sale of stock
Issuance of common stock (in shares)			12,841,000
Series A Preferred Stock
Sale of stock
Conversion of stock shares converted						2,425
Series A Preferred Stock \| As Previously Reported
Sale of stock
Conversion of stock shares converted						2,425
Series A Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)							2,425
Exercise price of warrants (in dollars per share)				$ 520.00
Series A Preferred Stock \| 2022 Preferred Stock Offering \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)							2,425
Series B Preferred Stock \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)					2,425
Series B Preferred Stock \| 2022 Preferred Stock Offering
Sale of stock
Issuance of common stock (in shares)							2,425
Exercise price of warrants (in dollars per share)							$ 520.00
Series B Preferred Stock \| 2022 Preferred Stock Offering \| As Previously Reported
Sale of stock
Issuance of common stock (in shares)							2,425

Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions	1 Months Ended			12 Months Ended
	Apr. 30, 2022	Jan. 31, 2021	Jan. 31, 2018	Dec. 31, 2022	Mar. 31, 2022
Sale of New Jersey Net Operating Losses
Additional cash benefit received	$ 4.7
New Jersey
Sale of New Jersey Net Operating Losses
Net proceeds from sale of NOL and tax credit				$ 4.7
Sale of unused NOLs \| New Jersey
Sale of New Jersey Net Operating Losses
Maximum lifetime benefit under the Program		$ 20.0	$ 15.0
Sale of unused NOLs \| New Jersey \| Minimum
Sale of New Jersey Net Operating Losses
Allowable sale of unused tax benefits as a percentage of total value			80.00%
Net Operating Losses \| New Jersey
Sale of New Jersey Net Operating Losses
NOLs					$ 44.3
Research and Development. \| New Jersey
Sale of New Jersey Net Operating Losses
NOLs					$ 1.0

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended						9 Months Ended		12 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Statements of Operations and Comprehensive Loss
Revenues, net	$ 6,662			$ 3,002			$ 15,979	$ 6,888	$ 10,884	$ 4,101	$ 749
Cost of product revenues	2,477			1,425			6,787	5,183	6,836	10,718	282
Gross profit	4,185			1,577			9,192	1,705	4,048	(6,617)	467
Operating expenses:
Research and development	705			788			2,171	2,901	3,253	6,246	13,500
Selling and marketing	4,800			5,560			14,040	23,523	30,369	43,444	23,285
General and administrative	2,680			2,815			8,813	9,837	11,860	14,698	12,735
Loss on disposition of assets				11,122				11,122	11,122
Loss on disposition of assets									11,122
Total operating expenses	8,185			20,285			25,024	47,383	56,604	64,388	49,520
Loss from operations	(4,000)			(18,708)			(15,832)	(45,678)	(52,556)	(71,005)	(49,053)
Other income (expense)
Interest income	13			46			61	50	80	25	309
Interest expense	(341)			(1,004)			(1,114)	(2,699)	(3,131)	(3,914)	(3,109)
Unrealized gain on warrant liability	3,529			13,736			6,890	22,171	25,520	3,827
Total other income, net	3,201			12,778			5,837	19,522	22,469	(62)	(2,800)
Loss before benefit from income taxes	(799)			(5,930)			(9,995)	(26,156)	(30,087)	(71,067)	(51,853)
Benefit from income taxes								4,675	4,675
Net loss and comprehensive loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	$ (5,168)	$ (10,385)	$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Net loss per share (basic) (in dollars per share)	$ (0.27)			$ (8.01)			$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Net loss per share (diluted) (in dollars per share)	$ (0.27)			$ (8.01)			$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Weighted-average common shares (basic) (in shares)	2,950,136			739,957			1,884,793	299,970	21,610,947	2,426,821	2,117,077
Weighted-average common shares (diluted) (in shares)	2,950,136			739,957			1,884,793	299,970	21,610,947	2,426,821	2,117,077
Other comprehensive income:
Unrealized (loss) gain on marketable securities										$ (3)	$ 3
Comprehensive loss									$ (25,412)	$ (71,070)	$ (51,850)

Credit Agreement and Guaranty - Narrative 1 (Details) - USD ($)						1 Months Ended	2 Months Ended	3 Months Ended		4 Months Ended	9 Months Ended		12 Months Ended
	Oct. 31, 2023	Jul. 25, 2022	Jul. 08, 2022	Jan. 07, 2022	Feb. 10, 2020	Feb. 10, 2024	Dec. 31, 2023	Dec. 31, 2023	Sep. 30, 2023	Oct. 31, 2023	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2020
Credit Agreement and Guaranty
Amount borrowed														$ 20,000,000
Repayments of debt											$ 675,000	$ 17,150,000	$ 17,375,000
Interest rate (as a percent)									15.58%		15.58%
Percentage of annual interest rate					3.00%
Perceptive Credit Agreement
Credit Agreement and Guaranty
Repayments of debt			$ 5,000,000.0	$ 5,000,000.0
Principal payments on its outstanding	$ 150,000									$ 150,000
Prepayment of outstanding principal		$ 7,000,000.0
Monthly principal payments		75,000
Periodic Payment Principal	$ 150,000
Variable interest rate margin (as a percent)					10.25%
Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2024
Credit Agreement and Guaranty
Prepayment premium percentage					2.00%
Minimum cash covenants						$ 3,000,000.0	$ 1,000,000.0			$ 500,000
Revenue generated under debt									$ 5,000,000.0
Perceptive Credit Agreement \| Minimum London Interbank Offered Rate (LIBOR) [Member]
Credit Agreement and Guaranty
Interest rate for the base rate					1.50%
Perceptive Credit Agreement \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Maximum borrowing capacity					$ 35,000,000.0
Perceptive Credit Agreement, Tranche One \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					5,000,000.0
Perceptive Credit Agreement, Tranche Two \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					$ 15,000,000.0
As Previously Reported
Credit Agreement and Guaranty
Interest rate (as a percent)													14.38%
Percentage of annual interest rate					3.00%
As Previously Reported \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Outstanding line of credit													$ 0
Repayments of debt			$ 5,000,000.0	$ 5,000,000.0
Prepayment of outstanding principal		7,000,000.0
Monthly principal payments		$ 75,000
Minimum cash covenants					$ 3,000,000.0
Revenue generated under debt								$ 87,100,000					$ 62,600,000
As Previously Reported \| Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2022
Credit Agreement and Guaranty
Prepayment premium percentage					4.00%
As Previously Reported \| Perceptive Credit Agreement \| Prepayment Occur on or Before February, 10, 2023
Credit Agreement and Guaranty
Prepayment premium percentage					2.00%
As Previously Reported \| Perceptive Credit Agreement \| LIBOR London Interbank Offered Rate [Member]
Credit Agreement and Guaranty
Variable interest rate margin (as a percent)					10.25%
Interest rate for the base rate					1.50%
As Previously Reported \| Perceptive Credit Agreement \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Maximum borrowing capacity					$ 35,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche One \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					5,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche Two \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					15,000,000.0
As Previously Reported \| Perceptive Credit Agreement, Tranche Three \| Senior secured delayed draw term loan facility
Credit Agreement and Guaranty
Amount borrowed					$ 15,000,000.0

Leases

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Leases

Leases

6. Leases

The Company has no finance leases and one operating lease for its corporate headquarters in Princeton, NJ. The current lease commenced on December 1, 2021 and terminates on March 31, 2025. The lease provides the Company with an option to extend the lease for an additional five years. Under the terms of the lease, the Company pays base annual rent subject to a fixed dollar amount increase each year, a fixed monthly charge for electricity, and other normal operating expenses such as taxes, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The lease does not require variable lease payments, residual value guarantees, or restrictive covenants.

The lease does not provide an implicit rate, therefore the Company used its incremental borrowing rate as the discount rate when measuring the operating lease liability. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease.

Operating lease expense was $89,000 and $90,000 for the three months ended September 30, 2023 and 2022, respectively. Operating lease expense was $267,000 and $271,000 for the nine months ended September 30, 2023 and 2022, respectively. Operating cash flows used for operating leases during the nine months ended September 30, 2023

and 2022 were approximately $235,000 and $132,000 respectively. As of September 30, 2023, the weighted average remaining lease term was 1.50 years, and the weighted average discount rate was 11.8%.

Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands):


2023	$	98
2024		397
2025		101
Total	$	596
Less: Interest		(47)
Present value of lease liability	$	549

8. Leases

In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The Company adopted ASU No. 2016-02 on January 1, 2019 for leases that existed on that date. The Company has elected to apply the provisions of ASC 842 modified retrospectively at January 1, 2019 through a cumulative-effect adjustment. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods.

Operating lease expense was $355,000 and $180,000 for the years ended December 31, 2022 and 2021, respectively. Operating cash flows used for operating leases during the years ended December 31, 2022 and 2021 were $175,000 and $131,000 respectively. As of December 31, 2022, the weighted-average remaining lease term was 2.25 years and the weighted average discount rate was 11.8%.

Future minimum lease payments under non-cancellable leases as of December 31, 2022 were as follows:


2023	$	391
2024		397
2025		101
Total	$	889
Less: Interest		(104)
Present value of lease liability	$	785

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Level 1
Assets:
Cash and cash equivalents	$ 2,873	$ 5,246	$ 19,143
Total assets at fair value	2,873	5,246	19,143
Level 3
Liabilities:
Warrant Liability	5,566	5,934	5,356
Total liabilities at fair value	$ 5,566	$ 5,934	$ 5,356

- Definition

+ References

+ Details

Commitments and Contingencies

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Commitments and Contingencies

Commitments and Contingencies

10. Commitments and Contingencies

have an adverse effect on the Company's operations or its financial position. As of September 30, 2023, the Company has not recorded a provision for any contingent losses.

13. Commitments and Contingencies

The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, total $238.2 million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2023 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment.

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,662,624	42,611	56,905,528	647,053	251,972
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,484,077	36,691	56,501,249	379,583	35,000
Unvested restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	135,037	142	6,461	8,325	3,995
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	43,510	5,778	397,818	259,145	212,977

Subsequent Events

12 Months Ended

Dec. 31, 2022

Subsequent Events

Subsequent Events

15. Subsequent Events

On January 25, 2023, the Board declared a dividend of one one-thousandth (1/1,000th) of a share of Series C Preferred Stock for each outstanding share of Company’s common stock to stockholders of record as of February 6, 2023. At a special meeting of stockholders held on March 9, 2023 (“Special Meeting”), the holders of Series C Preferred Stock had 1,000,000 votes per whole share of Series C Preferred Stock and were entitled to vote with the Company’s common stock, together as a single class, on the proposals to implement a reverse stock split (“Reverse Stock Split Proposal”) and adjournment of the Special Meeting, if necessary, but were not otherwise entitled to vote on any other proposals to be presented to the stockholders.

All shares of Series C Preferred Stock that were not present in person or by proxy at the Special Meeting as of immediately prior to the opening of the polls at the Special Meeting were automatically redeemed (the “Initial Redemption”). The outstanding shares of Series C Preferred Stock that were not redeemed pursuant to the Initial Redemption were redeemed automatically upon the approval by the Company’s stockholders of the Reverse Stock Split Proposal.

On March 9, 2023, we conducted the Special Meeting where the vote on the Reverse Stock Split Proposal was approved. We have been notified by Nasdaq that we have until June 30, 2023 to effectuate the reverse stock split and regain compliance.

On March 21, 2023, the Company and Perceptive entered into the Sixth Amendment. The Sixth Amendment waived the Company’s obligations to (1) comply with certain financial covenants relating to minimum revenue requirements and minimum liquidity through June 30, 2023, and (2) file financial statements along with its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 that are not subject to any “going concern” qualification. In connection with the Sixth Amendment to the Perceptive Agreement, we amended and restated the Perceptive Warrants to reset the strike price of the Perceptive Warrants.

Restatement of Previously Issued Financial Statements - Impact on Statement of Operations and Comprehensive Loss (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues, net	$ 6,662			$ 3,002				$ 15,979	$ 6,888	$ 10,884	$ 4,101	$ 749
Cost of product revenues	2,477			1,425				6,787	5,183	6,836	10,718	282
Gross profit	4,185			1,577				9,192	1,705	4,048	(6,617)	467
Operating expenses:
Research and development	705			788				2,171	2,901	3,253	6,246	13,500
Selling and marketing	4,800			5,560				14,040	23,523	30,369	43,444	23,285
General and administrative	2,680			2,815				8,813	9,837	11,860	14,698	12,735
Loss on disposition of assets				11,122					11,122	11,122
Loss on disposition of assets										11,122
Total operating expenses	8,185			20,285				25,024	47,383	56,604	64,388	49,520
Loss from operations	(4,000)			(18,708)				(15,832)	(45,678)	(52,556)	(71,005)	(49,053)
Other income (expense)
Interest income	13			46				61	50	80	25	309
Interest expense	(341)			(1,004)				(1,114)	(2,699)	(3,131)	(3,914)	(3,109)
Unrealized gain on warrant liability	3,529			13,736				6,890	22,171	25,520	3,827
Total other income (expense), net	3,201			12,778				5,837	19,522	22,469	(62)	(2,800)
Loss before benefit from income taxes	(799)			(5,930)				(9,995)	(26,156)	(30,087)	(71,067)	(51,853)
Benefit from income taxes									4,675	4,675
Net loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	$ (5,168)	$ (10,385)		$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Net loss per share (basic) (in dollars per share)	$ (0.27)			$ (8.01)				$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Net loss per share (diluted) (in dollars per share)	$ (0.27)			$ (8.01)				$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Weighted-average common shares (basic) (in shares)	2,950,136			739,957				1,884,793	299,970	21,610,947	2,426,821	2,117,077
Weighted-average common shares (diluted) (in shares)	2,950,136			739,957				1,884,793	299,970	21,610,947	2,426,821	2,117,077
Comprehensive loss:
Net loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	(5,168)	(10,385)		$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)	3
Comprehensive loss										$ (25,412)	(71,070)	$ (51,850)
As Previously Reported
Other income (expense)
Net loss											(71,067)
Comprehensive loss:
Net loss											(71,067)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)
Error Correction, Accounting for Warrants \| As Previously Reported
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues, net				3,002	2,126	1,761	$ 3,887		6,888		4,101
Cost of product revenues				1,425	2,231	1,527	3,758		5,183		10,718
Gross profit				1,577	(105)	234	129		1,705		(6,617)
Operating expenses:
Research and development				788	856	1,257	2,113		2,901		6,246
Selling and marketing				5,560	7,411	10,553	17,964		23,523		43,444
General and administrative				2,815	3,026	3,997	7,023		9,837		14,698
Loss on disposition of assets				11,122					11,122
Total operating expenses				20,285	11,293	15,807	27,100		47,383		64,388
Loss from operations				(18,708)	(11,398)	(15,573)	(26,971)		(45,678)		(71,005)
Other income (expense)
Interest income				46	2	1	3		50		25
Interest expense				(1,004)	(823)	(872)	(1,695)		(2,699)		(3,914)
Total other income (expense), net				(958)	(821)	(871)	(1,692)		(2,649)		(3,889)
Loss before benefit from income taxes				(19,666)	(12,219)	(16,444)	(28,663)		(48,327)		(74,894)
Benefit from income taxes						4,675	4,675		4,675
Net loss				$ (19,666)	$ (12,219)	$ (11,769)	$ (23,988)		$ (43,652)		$ (74,894)
Net loss per share (basic) (in dollars per share)				$ (0.53)	$ (2.71)	$ (3.78)	$ (6.29)		$ (2.91)		$ (30.86)
Net loss per share (diluted) (in dollars per share)				$ (0.53)	$ (2.71)	$ (3.78)	$ (6.29)		$ (2.91)		$ (30.86)
Weighted-average common shares (basic) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Weighted-average common shares (diluted) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Comprehensive loss:
Net loss				$ (19,666)	$ (12,219)	$ (11,769)	$ (23,988)		$ (43,652)		$ (74,894)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)
Comprehensive loss				(19,666)	(12,219)	(11,769)	(23,988)		(43,652)		(74,897)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment
Other income (expense)
Unrealized gain on warrant liability				13,736	7,051	1,384	8,435		22,171		3,827
Total other income (expense), net				13,736	7,051	1,384	8,435		22,171		3,827
Loss before benefit from income taxes				13,736	7,051	1,384	8,435		22,171		3,827
Net loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827
Net loss per share (basic) (in dollars per share)				$ 0.37	$ 1.56	$ 0.44	$ 2.21		$ 1.48		$ 1.58
Net loss per share (diluted) (in dollars per share)				$ 0.37	$ 1.56	$ 0.44	$ 2.21		$ 1.48		$ 1.58
Weighted-average common shares (basic) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Weighted-average common shares (diluted) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Comprehensive loss:
Net loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827
Other comprehensive income:
Comprehensive loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827

Quarterly Financial Information - Balance Sheets - Other (Details) - $ / shares	Sep. 30, 2023	Apr. 10, 2023	Apr. 09, 2023	Dec. 31, 2022	Jan. 07, 2022	Jan. 06, 2022	Dec. 31, 2021	Jan. 06, 2020
Quarterly Financial Information
Preferred stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Preferred stock, authorized (in shares)	10,000,000			10,000,000			10,000,000
Preferred stock, issued (in shares)	4,850			4,850			0
Preferred stock, outstanding (in shares)	0			0			0
Common stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Common stock, authorized (in shares)	300,000,000			300,000,000	300,000,000	150,000,000	300,000,000	300,000,000
Common stock, issued (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901
Common stock, outstanding (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901

Leases (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Leases

Maturity of lease liabilities

Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands):


2023	$	98
2024		397
2025		101
Total	$	596
Less: Interest		(47)
Present value of lease liability	$	549

Future minimum lease payments under non-cancellable leases as of December 31, 2022 were as follows:


2023	$	391
2024		397
2025		101
Total	$	889
Less: Interest		(104)
Present value of lease liability	$	785

Accrued Liabilities (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Accrued Liabilities

Schedule of accrued liabilities

Accrued liabilities consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Gross to net accruals	$	3,933	$	2,332
Accrued compensation		2,721		833
Accrued professional fees and other		1,684		743
Total accrued liabilities	$	8,338	$	3,908


	December 31,
	2022		2021
Gross to net accruals	$	2,332	$	670
Accrued compensation		833		2,086
Accrued professional fees and other		743		807
Total accrued liabilities	$	3,908	$	3,563

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,662,624	42,611	56,905,528	647,053	251,972
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	4,484,077	36,691	56,501,249	379,583	35,000
Unvested restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	135,037	142	6,461	8,325	3,995
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	43,510	5,778	397,818	259,145	212,977

Income Taxes

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Income Taxes

Income Taxes

9. Income Taxes

Sale of New Jersey Net Operating Losses

12. Income Taxes

The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below:


	December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	87,216	$	81,102
Research credit carryforward		7,071		7,943
Stock options and other		2,297		2,114
Total gross deferred tax assets		96,584		91,159
Valuation allowance for deferred tax assets		(96,584)		(91,159)
Net deferred tax assets	$	—	$	—

The net change in the valuation allowance for the years ended December 31, 2022 and 2021 was an increase of $5.4 million and an increase of $14.4 million, respectively.

A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows:


	December 31,
	2022		2021 (Restated)		2020
Federal income tax at statutory rate	21.0	%	21.0	%	21.0	%
State income tax benefit, net of federal benefit	0.1	%	0.2	%	1.0	%
Unrealized gain on warrants	18.8	%	1.1	%	—	%
Research and development tax credits	0.1	%	0.2	%	0.7	%
Other	(5.6)	%	(2.2)	%	(2.0)	%
Increase to valuation allowance	(18.5)	%	(20.3)	%	(20.7)	%
Effective income tax rate	15.9	%	0.0	%	0.0	%

Sale of New Jersey Net Operating Losses

The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program, however in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. In March 2022, the Company completed the sale of NOLs totaling approximately $44.3 million and research and development credits totaling approximately $1.0 million for net proceeds of approximately $4.7 million. Such proceeds are reflected as a tax benefit for year ended December 31, 2022.

- Definition

+ References

+ Details

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Credit Agreement and Guaranty
Notes payable	$ 1,950,000		$ 1,950,000		$ 2,625,000	$ 20,000,000
Debt issuance costs	(63,000)		(63,000)		(209,000)	(550,000)
Warrant discount	(298,000)		(298,000)		(990,000)	(2,617,000)
Total debt	1,589,000		1,589,000		1,426,000	16,833,000
Less, current portion	1,589,000		1,589,000		1,426,000	16,833,000
Amortization and debt issue costs	$ 252,000	$ 838,000	$ 838,000	$ 1,635,000	$ 1,969,000	$ 1,661,000	$ 1,341,000

- Definition

Amount, after deduction of unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Credit Agreement and Guaranty - Narrative 2 (Details)		9 Months Ended
Credit Agreement and Guaranty - Narrative 2 (Details)	Feb. 10, 2020 USD ($) Y item $ / shares shares	Sep. 30, 2023 Y USD ($) $ / shares	May 31, 2023 $ / shares shares	Dec. 31, 2022 Y USD ($) shares	Jul. 31, 2022 $ / shares shares	Mar. 31, 2022 $ / shares shares	Mar. 22, 2022 shares	Dec. 31, 2021 Y USD ($)	Oct. 31, 2021 $ / shares shares	Sep. 30, 2021 $ / shares	Feb. 28, 2021 shares	Feb. 26, 2021 $ / shares shares	Feb. 10, 2021 $ / shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						24,856			6,660
Proceeds from Warrant Exercises	$ 20,000,000.0
Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input				4.2				1.1
Risk free interest rate \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input		5.46		4.7
Risk free interest rate \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input		4.62		4.2
Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y								4.98
Expected life \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y		4.65		4.5
Expected life \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y		1.15		0.70
Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input		2.40		11.50				31.63
Common stock warrants \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input		3.69		0.90				34.08
Common stock warrants \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input		1,700.00		1,700
Common stock warrants \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input		45.00		45.00
Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	3,600,000
Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Beneficial ownership percentage		19.99%
Fair value of warrants	$ 1,100,000
Two Thousand Twenty One Perceptive Warrants Sixth Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares		$ 10.50
Two Thousand Twenty One Perceptive Warrants Seventh Amendment [Member]
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares		$ 1.82
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	70.0
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	1.47
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input	9,340
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input	7,480
Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	8,020
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	103.5
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	1.15
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	5,740
Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						225
Perceptive Credit Agreement \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Number of warrants issued \| item	2
Common stock that can be purchased with warrants (in shares) \| shares	700											225
Exercise price of warrants (in dollars per share) \| $ / shares												$ 5,740
Facility fee percentage	1.00%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares	350		350		350	350			350
Exercise price of warrants (in dollars per share) \| $ / shares	$ 7,480		$ 3.69		$ 745	$ 5,276			$ 7,080				$ 7,480
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares	350		350		350	350			350
Exercise price of warrants (in dollars per share) \| $ / shares	$ 9,340		$ 3.69		$ 618.50	$ 4,330.50			$ 5,760				9,340
Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares			225		225				225
Exercise price of warrants (in dollars per share) \| $ / shares			$ 3.69		$ 501.50	$ 3,456.50			$ 4,540			5,740
As Previously Reported
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares						1,242,813			333,333
Proceeds from Warrant Exercises	$ 20,000,000.0
As Previously Reported \| Two Thousand Twenty Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	3,600,000
As Previously Reported \| Two Thousand Twenty One Perceptive Warrants [Member]
Credit Agreement and Guaranty
Fair value of warrants	$ 1,100,000
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	0.700
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	0.0147
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Maximum
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	186.80
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Strike price \| Option pricing model \| Minimum
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	149.60
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty Perceptive Warrants [Member] \| Fair value \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares	160.40
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Volatility \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input	1.035
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Risk free interest rate \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	0.0115
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Warrants \| Two Thousand Twenty One Perceptive Warrants [Member] \| Strike price \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| item	114.80
As Previously Reported \| Perceptive Credit Agreement \| Two Thousand Twenty One Perceptive Warrants [Member] \| Expected life \| Option pricing model
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y	7
As Previously Reported \| Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Number of warrants issued \| item	2
Common stock that can be purchased with warrants (in shares) \| shares				35,000					35,000		11,250
Exercise price of warrants (in dollars per share) \| $ / shares												114.80
Beneficial ownership percentage	19.99%
Facility fee percentage	1.00%
As Previously Reported \| Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares				17,500	17,500	17,500	17,500		17,500
Exercise price of warrants (in dollars per share) \| $ / shares	$ 149.60				$ 14.90	$ 105.52			$ 141.60	$ 186.80			186.80
As Previously Reported \| Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares				17,500	17,500	17,500			17,500
Exercise price of warrants (in dollars per share) \| $ / shares	$ 186.80				$ 12.37	$ 86.61			$ 115.20	149.60			$ 149.60
As Previously Reported \| Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Common stock that can be purchased with warrants (in shares) \| shares					11,250	11,250			11,250
Exercise price of warrants (in dollars per share) \| $ / shares					$ 10.03	$ 69.13			$ 90.80	$ 114.80		$ 114.80

Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Summary of Significant Accounting Policies
Advertising costs	$ 0.0	$ 0.9	$ 0.0	$ 6.1	$ 8.2	$ 13.8	$ 5.5

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model	Sep. 30, 2023 Y USD ($)	Dec. 31, 2022 Y USD ($)	Dec. 31, 2021 Y USD ($)
Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input			136.4
Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		4.2	1.1
Fair value
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	2.40	11.50	31.63
Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y			4.98
Preferred Warrants [Member] \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		520.00
Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.69	0.90	34.08
Maximum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	123.42	137.4
Maximum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	5.46	4.7
Maximum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	4.65	4.5
Maximum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1,700.00	1,700
Minimum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	86.06	136.8
Minimum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	4.62	4.2
Minimum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	1.15	0.70
Minimum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	45.00	45.00

Statements of Changes in Stockholders' Deficit - USD ($)	As Previously Reported Common stock Public offering	As Previously Reported Common stock At-the-market sales	As Previously Reported Common stock	As Previously Reported Additional Paid-in Capital. Public offering	As Previously Reported Additional Paid-in Capital. At-the-market sales	As Previously Reported Additional Paid-in Capital.	As Previously Reported Accumulated Other Comprehensive Income	As Previously Reported Accumulated Deficit	As Previously Reported Public offering	As Previously Reported At-the-market sales	As Previously Reported	Preferred Stock Series A Convertible Preferred Stock	Preferred Stock Series B Convertible Preferred Stock	Preferred Stock Series A and B Convertible Preferred Stock	Preferred Stock	Common stock Public offering	Common stock At-the-market sales	Common stock Series A Convertible Preferred Stock	Common stock Series B Convertible Preferred Stock	Common stock	Additional Paid-in Capital. Public offering	Additional Paid-in Capital. At-the-market sales	Additional Paid-in Capital.	Accumulated Other Comprehensive Income	Accumulated Deficit	Public offering	At-the-market sales	Total
Balance at Dec. 31, 2019																							$ 306,115,000		$ (260,370,000)			$ 45,745,000
Balance (in shares) at Dec. 31, 2019																				1,745,264
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							2,818,000					2,818,000
Issuance of common stock																					$ 48,435,000					$ 48,435,000
Issuance of common stock (in shares)																431,250
Issuance of common stock upon exercise of options																							610,000					610,000
Issuance of common stock upon exercise of options (in shares)																				12,586
Warrants issued in connection with long-term debt																							3,570,000					3,570,000
Net loss																									(51,853,000)			(51,853,000)
Balance at Dec. 31, 2020						$ 361,548,000	$ 3,000	$ (312,223,000)			$ 49,328,000												361,548,000	$ 3,000	(312,223,000)			49,328,000
Balance (in shares) at Dec. 31, 2020			2,189,100																	2,189,100
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs						3,338,000					3,338,000												3,338,000					3,338,000
Issuance of common stock				$ 11,898,000	$ 9,266,000				$ 11,898,000	$ 9,266,000											$ 11,898,000	$ 9,266,000				11,898,000	$ 9,266,000
Issuance of common stock (in shares)	666,666	172,879														666,666	3,457
Issuance of common stock upon exercise of options						75,000					75,000												75,000					75,000
Issuance of common stock upon exercise of options (in shares)			3,160																	3,160
Vesting of RSUs (in shares)			3,096																	3,096
Warrants issued in connection with long-term debt						1,080,000					1,080,000												1,080,000					1,080,000
Net loss								(71,067,000)			(71,067,000)														(71,067,000)			(71,067,000)
Balance at Dec. 31, 2021						387,205,000		(383,290,000)			3,915,000												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021			3,034,901																	60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							764,000					764,000
Issuance of common stock																						348,000					348,000
Issuance of common stock (in shares)																	512
Issuance of common stock upon exercise of options (in shares)														4,850
Conversion of convertible preferred stock (in shares)																		6,063
Vesting of RSUs															$ (2,425)
Vesting of RSUs (in shares)																				35
Net loss																									(10,385,000)			(10,385,000)
Balance at Mar. 31, 2022																							388,317,000		(393,675,000)			(5,358,000)
Balance (in shares) at Mar. 31, 2022															2,425					67,308
Balance at Dec. 31, 2021						387,205,000		(383,290,000)			3,915,000												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021			3,034,901																	60,698
Balance at Jun. 30, 2022																							401,212,000		(398,843,000)			2,369,000
Balance (in shares) at Jun. 30, 2022																				247,202
Balance at Dec. 31, 2021						387,205,000		(383,290,000)			3,915,000												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021			3,034,901																	60,698
Increase (decrease) in stockholders' equity
Net loss																												(21,481,000)
Balance at Sep. 30, 2022																							401,748,000		(404,773,000)			(3,025,000)
Balance (in shares) at Sep. 30, 2022																				780,535
Balance at Dec. 31, 2021						$ 387,205,000		$ (383,290,000)			$ 3,915,000												387,205,000		(383,290,000)			3,915,000
Balance (in shares) at Dec. 31, 2021			3,034,901																	60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							2,492,000					2,492,000
Fractional shares retired as a result of reverse split																				(11)
Issuance of common stock																$ 3,000	$ 1,000					13,456,000				$ 3,000	13,457,000
Issuance of common stock (in shares)																26,666,666	12,655,773
Conversion of convertible preferred stock (in shares)												(2,425)	(2,425)	4,850				303,125	303,125
Vesting of RSUs (in shares)																				6,555
Net loss																									(25,412,000)			(25,412,000)
Balance at Dec. 31, 2022																							403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022																				859,402
Balance at Mar. 31, 2022																							388,317,000		(393,675,000)			(5,358,000)
Balance (in shares) at Mar. 31, 2022															2,425					67,308
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							669,000					669,000
Issuance of common stock																						12,226,000					12,226,000
Issuance of common stock (in shares)																	173,750
Conversion of convertible preferred stock (in shares)													(2,425)						6,062
Vesting of RSUs (in shares)																				82
Net loss																									(5,168,000)			(5,168,000)
Balance at Jun. 30, 2022																							401,212,000		(398,843,000)			2,369,000
Balance (in shares) at Jun. 30, 2022																				247,202
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							536,000					536,000
Issuance of common stock (in shares)																				533,333
Net loss																									(5,930,000)			(5,930,000)
Balance at Sep. 30, 2022																							401,748,000		(404,773,000)			(3,025,000)
Balance (in shares) at Sep. 30, 2022																				780,535
Balance at Dec. 31, 2022																							403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022																				859,402
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							498,000					498,000
Issuance of common stock																						1,003,000					1,003,000
Issuance of common stock (in shares)																	72,699
Net loss																									(5,389,000)			(5,389,000)
Balance at Mar. 31, 2023																							404,658,000		(414,091,000)			(9,433,000)
Balance (in shares) at Mar. 31, 2023																				932,101
Balance at Dec. 31, 2022																							403,157,000		(408,702,000)			(5,545,000)
Balance (in shares) at Dec. 31, 2022																				859,402
Increase (decrease) in stockholders' equity
Net loss																												(9,995,000)
Balance at Sep. 30, 2023																							406,288,000		(418,699,000)			(12,411,000)
Balance (in shares) at Sep. 30, 2023																				2,277,657
Balance at Mar. 31, 2023																							404,658,000		(414,091,000)			(9,433,000)
Balance (in shares) at Mar. 31, 2023																				932,101
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							$ 482,000					$ 482,000
Fractional shares retired as a result of reverse split																							13,000					13,000
Issuance of common stock																						$ 652,000					$ 652,000
Issuance of common stock (in shares)																95,000	105,342
Exercise of pre-funded warrants (in shares)																				508,286
Vesting of RSUs (in shares)																				76
Net loss																									(3,809,000)			$ (3,809,000)
Balance at Jun. 30, 2023																							$ 405,779,000		(417,900,000)			(12,121,000)
Balance (in shares) at Jun. 30, 2023																				1,640,805
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs																							439,000					439,000
Issuance of common stock																							70,000					70,000
Issuance of common stock (in shares)																				29,842
Exercise of pre-funded warrants (in shares)																				607,000
Vesting of RSUs (in shares)																				10
Net loss																									(799,000)			(799,000)
Balance at Sep. 30, 2023																							$ 406,288,000		$ (418,699,000)			$ (12,411,000)
Balance (in shares) at Sep. 30, 2023																				2,277,657

Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Transfers between fair value levels	$ 0	$ 0
Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	5,934	$ 5,356	$ 5,356	$ 0
Warrants issued	10,615		26,098	9,183
Change in fair value	(10,983)		(25,520)	(3,827)
Ending balance	$ 5,566		$ 5,934	$ 5,356

Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Property and Equipment
Property and equipment, gross		$ 253	$ 14,597
Less: accumulated depreciation		(76)	(2,150)
Property and equipment, net	$ 101	177	12,447
Office equipment
Property and Equipment
Property and equipment, gross		$ 132	$ 7
Estimated Life (in years)		5 years	5 years
Computer equipment
Property and Equipment
Property and equipment, gross		$ 121	$ 113
Estimated Life (in years)		3 years	3 years
Manufacturing equipment
Property and Equipment
Property and equipment, gross		$ 14,300	$ 14,477
Estimated Life (in years)		7 years	7 years

Accrued Liabilities (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Accrued Liabilities

Schedule of accrued liabilities

Accrued liabilities consist of the following (in thousands):


	September 30,		December 31,
	2023		2022
Gross to net accruals	$	3,933	$	2,332
Accrued compensation		2,721		833
Accrued professional fees and other		1,684		743
Total accrued liabilities	$	8,338	$	3,908


	December 31,
	2022		2021
Gross to net accruals	$	2,332	$	670
Accrued compensation		833		2,086
Accrued professional fees and other		743		807
Total accrued liabilities	$	3,908	$	3,563

Leases - Maturity of lease liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Operating Leases
2023	$ 98
2024	397	$ 391
2025	101	397
2025		101
Total	596	889
Less: Interest	(47)	(104)
Present value of lease liability	$ 549	$ 785

Credit Agreement and Guaranty (Tables)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Credit Agreement and Guaranty

Schedule of carrying amount of term loan


	September 30,		December 31,
	2023		2022
Notes payable	$	1,950	$	2,625
Debt issuance costs		(63)		(209)
Warrant discount		(298)		(990)
Total debt	$	1,589	$	1,426
Less, current portion		1,589		1,426
Long-term debt, less current portion	$	—	$	—


	December 31,		December 31,
	2022		2021
Notes payable	$	2,625	$	20,000
Debt issuance costs		(209)		(550)

Warrant discount		(990)		(2,617)
Total debt	$	1,426	$	16,833
Less, current portion		1,426		16,833
Long-term debt, less current portion	$	—	$	—

- Definition

+ References

+ Details

Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Transfers between fair value levels	$ 0	$ 0
Warrants
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Beginning balance	5,934	$ 5,356	$ 5,356	$ 0
Warrants issued	10,615		26,098	9,183
Change in fair value	(10,983)		(25,520)	(3,827)
Ending balance	$ 5,566		$ 5,934	$ 5,356

Restatement of Previously Issued Financial Statements - Impact on Balance Sheet (Details) $ in Thousands		12 Months Ended
	Apr. 10, 2023	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2022 USD ($)	Jun. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
Current assets:
Cash and cash equivalents		$ 5,246	$ 19,143	$ 2,873
Accounts receivable, net		3,377	1,533	3,521
Inventory, net		1,332	966	2,411
Prepaid expenses and other current assets		1,403	2,283	1,259
Total current assets		11,358	23,925	10,064
Property and equipment, net		177	12,447	101
Right of use asset		695	949	486
Other non-current assets		2,012	2,012	238
Total assets		14,242	39,333	10,889
Current liabilities:
Long-term debt, current portion		1,426	16,833	1,589
Accounts payable		7,734	8,707	6,879
Accrued expenses		3,908	3,563	8,338
Lease liability, current portion		319	175	353
Total current liabilities		13,387	29,278	17,538
Lease liabilities, long-term		466	784	196
Warrant liability		5,934	5,356	5,566
Total liabilities		19,787	35,418	23,300
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively		4
Additional paid-in capital		403,157	387,205	406,288
Accumulated deficit		(408,702)	(383,290)	(418,699)
Total stockholders' equity		(5,545)	3,915	(12,411)	$ (12,121)	$ (9,433)	$ (3,025)	$ 2,369	$ (5,358)	$ 49,328	$ 45,745
Total liabilities and stockholders' equity		$ 14,242	$ 39,333	$ 10,889
Reverse stock split conversion ratio	0.02	0.025	0.025
As Previously Reported
Stockholders' deficit
Total stockholders' equity			$ 3,915							49,328
Error Correction, Accounting for Warrants \| As Previously Reported
Current assets:
Cash and cash equivalents			19,143				6,145	13,027	3,743
Accounts receivable, net			1,533				3,711	2,087	1,665
Inventory, net			966				1,797	2,340	2,693
Prepaid expenses and other current assets			2,283				3,834	1,016	1,576
Total current assets			23,925				15,487	18,470	14,352
Property and equipment, net			12,447				203	11,524	12,047
Right of use asset			949				761	825	888
Other non-current assets			2,012				2,012	2,012	2,012
Total assets			39,333				18,463	32,831	29,299
Current liabilities:
Long-term debt, current portion			16,833				1,318	12,630	12,252
Accounts payable			8,707				4,906	12,036	9,537
Accrued expenses			3,563				5,152	3,877	3,828
Lease liability, current portion			175				277	239	231
Total current liabilities			29,278				11,653	28,782	25,848
Lease liabilities, long-term			784				550	630	708
Total liabilities			30,062				12,203	29,412	26,556
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022									887
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively							4	1
Additional paid-in capital			396,388				437,027	414,523	400,742
Accumulated deficit			(387,117)				(430,771)	(411,105)	(398,886)
Total stockholders' equity			9,271				6,260	3,419	2,743	$ 49,328
Total liabilities and stockholders' equity			39,333				18,463	32,831	29,299
Error Correction, Accounting for Warrants \| Error Correction, Adjustment
Current liabilities:
Warrant liability			5,356				9,285	1,050	8,101
Total liabilities			5,356				9,285	1,050	8,101
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022									(887)
Additional paid-in capital			(9,183)				(35,283)	(13,312)	(12,425)
Accumulated deficit			3,827				25,998	12,262	5,211
Total stockholders' equity			$ (5,356)				$ (9,285)	$ (1,050)	$ (8,101)

Quarterly Financial Information (Tables)

12 Months Ended

Dec. 31, 2022

Quarterly Financial Information

Summary of quarterly financial information

Balance Sheets


	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously						As Previously						As Previously
	Reported		Adjustment		As Restated		Reported		Adjustment		As Restated		Reported		Adjustment		As Restated
Assets
Current assets:
Cash and cash equivalents	$	3,743	$	—	$	3,743	$	13,027	$	—	$	13,027	$	6,145	$	—	$	6,145
Accounts receivable, net		1,665		—		1,665		2,087		—		2,087		3,711		—		3,711
Income taxes receivable		4,675		—		4,675		—		—		—		—		—		—
Inventory, net		2,693		—		2,693		2,340		—		2,340		1,797		—		1,797
Prepaid expenses and other current assets		1,576		—		1,576		1,016		—		1,016		3,834		—		3,834
Total current assets		14,352		—		14,352		18,470		—		18,470		15,487		—		15,487
Property and equipment, net		12,047		—		12,047		11,524		—		11,524		203		—		203
Right of use asset		888		—		888		825		—		825		761		—		761
Other non-current assets		2,012		—		2,012		2,012		—		2,012		2,012		—		2,012
Total assets	$	29,299	$	—	$	29,299	$	32,831	$	—	$	32,831	$	18,463	$	—	$	18,463

Liabilities and stockholders’ equity
Current liabilities:
Long-term debt, current portion	$	12,252		—	$	12,252	$	12,630		—	$	12,630	$	1,318		—	$	1,318
Accounts payable		9,537		—		9,537		12,036		—		12,036		4,906		—		4,906
Accrued expenses		3,828		—		3,828		3,877		—		3,877		5,152		—		5,152
Lease liability, current portion		231		—		231		239		—		239		277		—		277
Total current liabilities		25,848		—		25,848		28,782		—		28,782		11,653		—		11,653

Lease liabilities, long-term		708		—		708		630		—		630		550		—		550
Warrant liability		—		8,101		8,101		—		1,050		1,050		—		9,285		9,285
Total liabilities		26,556		8,101		34,657		29,412		1,050		30,462		12,203		9,285		21,488
Commitments and contingencies (Note 13)
Stockholders’ equity
Preferred stock, $.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2022 and no shares issued and outstanding at December 31, 2021		887		(887)		—		—		—		—		—		—		—
Common stock, $.0001 par value, 300,000,000 shares authorized, 42,970,134 and 3,034,901 issued and outstanding at December 31, 2022 and December 31, 2021, respectively *		—		—		—		1		—		1		4		—		4
Additional paid-in capital *		400,742		(12,425)		388,317		414,523		(13,312)		401,211		437,027		(35,283)		401,744
Accumulated deficit		(398,886)		5,211		(393,675)		(411,105)		12,262		(398,843)		(430,771)		25,998		(404,773)
Total stockholders’ equity		2,743		(8,101)		(5,358)		3,419		(1,050)		2,369		6,260		(9,285)		(3,025)
Total liabilities and stockholders’ equity	$	29,299	$	—	$	29,299	$	32,831	$	—	$	32,831	$	18,463	$	—	$	18,463

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Quarterly and Year to Date Statements of Operations and Comprehensive Loss


	Three Months Ended						Three Months Ended						Three Months Ended
	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated

Revenues, net	$	1,761	$	—	$	1,761	$	2,126	$	—	$	2,126	$	3,002	$	—	$	3,002
Cost of product revenues		1,527		—		1,527		2,231		—		2,231		1,425		—		1,425
Gross profit (loss)		234		—		234		(105)		—		(105)		1,577		—		1,577

Operating expenses:
Research and development	$	1,257	$	—	$	1,257	$	856	$	—	$	856	$	788	$	—	$	788
Selling and marketing		10,553		—		10,553		7,411		—		7,411		5,560		—		5,560
General and administrative		3,997		—		3,997		3,026		—		3,026		2,815		—		2,815
Loss on disposition of assets		—		—		—		—		—		—		11,122		—		11,122
Total operating expenses		15,807		—		15,807		11,293		—		11,293		20,285		—		20,285
Loss from operations		(15,573)		—		(15,573)		(11,398)		—		(11,398)		(18,708)		—		(18,708)

Other income (expense)
Interest income		1		—		1		2		—		2		46		—		46
Interest expense		(872)		—		(872)		(823)		—		(823)		(1,004)		—		(1,004)
Unrealized gain on warrant liability		—		1,384		1,384		—		7,051		7,051		—		13,736		13,736
Total other income (expense), net		(871)		1,384		513		(821)		7,051		6,230		(958)		13,736		12,778
Loss before benefit from income taxes		(16,444)		1,384		(15,060)		(12,219)		7,051		(5,168)		(19,666)		13,736		(5,930)
Benefit from income taxes		4,675		—		4,675		—		—		—		—		—		—
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)

Net loss per share (basic and diluted)	$	(3.78)	$	0.44	$	(3.33)	$	(2.71)	$	1.56	$	(1.15)	$	(0.53)	$	0.37	$	(0.16)

Weighted-average common shares (basic and diluted)		3,115,211		3,115,211		3,115,211		4,510,219		4,510,219		4,510,219		36,997,836		36,997,836		36,997,836

Comprehensive loss:
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		—		—		—		—		—		—		—		—		—
Comprehensive loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)


	Six Months Ended						Nine Months Ended
	June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated

Revenues, net	$	3,887	$	—	$	3,887	$	6,888	$	—	$	6,888
Cost of product revenues		3,758		—		3,758		5,183		—		5,183
Gross profit (loss)		129		—		129		1,705		—		1,705

Operating expenses:
Research and development	$	2,113	$	—	$	2,113	$	2,901	$	—	$	2,901
Selling and marketing		17,964		—		17,964		23,523		—		23,523
General and administrative		7,023		—		7,023		9,837		—		9,837
Loss on disposition of assets		—		—		—		11,122		—		11,122
Total operating expenses		27,100		—		27,100		47,383		—		47,383
Loss from operations		(26,971)		—		(26,971)		(45,678)		—		(45,678)

Other income (expense)
Interest income		3		—		3		50		—		50
Interest expense		(1,695)		—		(1,695)		(2,699)		—		(2,699)
Unrealized gain on warrant liability		—		8,435		8,435		—		22,171		22,171
Total other income (expense), net		(1,692)		8,435		6,743		(2,649)		22,171		19,522
Loss before benefit from income taxes		(28,663)		8,435		(20,228)		(48,327)		22,171		(26,156)
Benefit from income taxes		4,675		—		4,675		4,675		—		4,675
Net loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)

Net loss per share (basic and diluted)	$	(6.29)	$	2.21	$	(4.08)	$	(2.91)	$	1.48	$	(1.43)

Weighted-average common shares (basic and diluted)		3,816,569		3,816,569		3,816,569		14,998,534		14,998,534		14,998,534

Comprehensive loss:
Net loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		—		—		—		—		—		—
Comprehensive loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance December 31, 2021	—	$	—	3,034,901	$	—	$	396,388	$	—	$	(387,117)	$	9,271
Share-based compensation - stock options and RSUs	—		—	—		—		764		—		—		764
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	25,623		—		348		—		—		348
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	4,850		4,850	—		—		—		—		—		4,850
Registered direct financing costs, inclusive of warrants	—		(965)	—		—		244		—		—		(721)
Conversion of series A convertible preferred stock	(2,425)		(897)	303,125		—		897		—		—		—
Vesting of RSUs	—		—	1,773		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		(2,101)	—		—		2,101		—		—		—
Net loss	—		—	—		—		—		—		(11,769)		(11,769)
Balance March 31, 2022	2,425	$	887	3,365,422	$	—	$	400,742	$	—	$	(398,886)	$	2,743

Adjustment
Balance December 31, 2021	—		—	—		—		(9,183)		—		3,827		(5,356)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	—		—		—		—		—		—
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	—		(4,850)	—		—		—		—		—		(4,850)
Registered direct financing costs, inclusive of warrants	—		965	—		—		(244)		—		—		721
Conversion of series A convertible preferred stock	—		897	—		—		(897)		—		—		—
Vesting of RSUs	—		—	—		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		2,101	—		—		(2,101)		—		—		—
Net loss	—		—	—		—		—		—		1,384		1,384
Total Adjustment March 31, 2022	—	$	(887)	—	$	—	$	(12,425)	$	—	$	5,211	$	(8,101)

As Restated
Balance December 31, 2021	—	$	—	3,034,901	$	—	$	387,205	$	—	$	(383,290)	$	3,915
Share-based compensation - stock options and RSUs	—		—	—		—		764		—		—		764
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	25,623		—		348		—		—		348
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	4,850		—	—		—		—		—		—		—
Registered direct financing costs, inclusive of warrants	—		—	—		—		—		—		—		—
Conversion of series A convertible preferred stock	(2,425)		—	303,125		—		—		—		—		—
Vesting of RSUs	—		—	1,773		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		—	—		—		—		—		—		—
Net loss	—		—	—		—		—		—		(10,385)		(10,385)
Balance March 31, 2022	2,425	$	—	3,365,422	$	—	$	388,317	$	—	$	(393,675)	$	(5,358)

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance March 31, 2022	2,425	$	887	3,365,422	$	—	$	400,742	$	—	$	(398,886)	$	2,743
Share-based compensation - stock options and RSUs	—		—	—		—		669		—		—		669
Fractional shares retired as a result of reverse split	—		—	(10)		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	8,687,502		1		12,225		—		—		12,226
Conversion of series B convertible preferred stock	(2,425)		(887)	303,125		—		887		—		—		—
Vesting of RSUs	—		—	4,118		—		—		—		—		—
Net loss	—		—	—		—		—		—		(12,219)		(12,219)
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	414,523	$	—	$	(411,105)	$	3,419

Adjustment
Balance March 31, 2022	—		(887)	—		—		(12,425)		—		5,211		(8,101)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Fractional shares retired as a result of reverse split	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	—		—		—		—		—		—
Conversion of series B convertible preferred stock	—		887	—		—		(887)		—		—		—
Vesting of RSUs	—		—	—		—		—		—		—		—
Net loss	—		—	—		—		—		—		7,051		7,051
Balance June 30, 2022	—	$	—	—	$	—	$	(13,312)	$	—	$	12,262	$	(1,050)

As Restated
Balance March 31, 2022	2,425	$	—	3,365,422	$	—	$	388,317	$	—	$	(393,675)	$	(5,358)
Share-based compensation - stock options and RSUs	—		—	—		—		669		—		—		669
Fractional shares retired as a result of reverse split	—		—	(10)		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	8,687,502		1		12,225		—		—		12,226
Conversion of series B convertible preferred stock	(2,425)		—	303,125		—		—		—		—		—
Vesting of RSUs	—		—	4,118		—		—		—		—		—
Net loss	—		—	—		—		—		—		(5,168)		(5,168)
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	401,211	$	—	$	(398,843)	$	2,369

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	414,523	$	—	$	(411,105)	$	3,419
Share-based compensation - stock options and RSUs	—		—	—		—		536		—		—		536
Issuance of common stock pursuant to a public offering, net of expenses	—		—	26,666,666		3		21,968		—		—		21,971
Net loss	—		—	—		—		—		—		(19,666)		(19,666)

Balance September 30, 2022	—		—	39,026,823	$	4	$	437,027	$	—	$	(430,771)	$	6,260

Adjustment
Balance June 30, 2022	—		—	—		—		(13,312)		—		12,262		(1,050)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to a public offering, net of expenses	—		—	—		—		(21,971)		—		—		(21,971)
Net loss	—		—	—		—		—		—		13,736		13,736
Balance September 30, 2022	—		—	—	$	—	$	(35,283)	$	—	$	25,998	$	(9,285)

As Restated
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	401,211	$	—	$	(398,843)	$	2,369
Share-based compensation - stock options and RSUs	—		—	—		—		536		—		—		536
Issuance of common stock pursuant to a public offering, net of expenses	—		—	26,666,666		3		(3)		—		—		—
Net loss	—		—	—		—		—		—		(5,930)		(5,930)
Balance September 30, 2022	—		—	39,026,823	$	4	$	401,744	$	—	$	(404,773)	$	(3,025)

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statements of Cash Flows


	Three Months Ended						Six Months Ended						Nine Months Ended
	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated
Cash flows from operating activities:
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve		—		—		—		—		—		—		—		—		—
Depreciation		527		—		527		1,057		—		1,057		1,255		—		1,255
Amortization		61		—		61		124		—		124		188		—		188
Loss on disposition of assets		—		—		—				—		—		11,122		—		11,122
Noncash stock-based compensation		764		—		764		1,433		—		1,433		1,969		—		1,969
Noncash amortization of deferred financing costs		419		—		419		797		—		797		1,635		—		1,635
Unrealized gain on warrants		—		(1,384)		(1,384)		—		(8,435)		(8,435)				(22,171)		(22,171)
Changes in operating assets and liabilities:						—
Accounts receivable		(132)		—		(132)		(554)		—		(554)		(2,178)		—		(2,178)
Income taxes receivable		(4,675)				(4,675)		—				—						—
Inventory		(1,727)		—		(1,727)		(1,374)		—		(1,374)		(831)		—		(831)
Prepaid expenses and other assets		707		—		707		1,267		—		1,267		(1,551)		—		(1,551)
Accounts payable and accrued expenses		1,095		—		1,095		3,643		—		3,643		(2,213)		—		(2,213)
Lease liability		(21)		—		(21)		(90)		—		(90)		(132)		—		(132)
Net cash used in operating activities		(14,751)		—		(14,751)		(17,685)		—		(17,685)		(34,388)		—		(34,388)

Cash flows from investing activities:
Purchases of marketable securities		—		—		—		—		—		—		—		—		—
Sales and maturities of marketable securities		—		—		—		—		—		—		—		—		—
Acquisition of property and equipment		(126)		—		(126)		(133)		—		(133)		(133)		—		(133)
Net cash (used in) provided by investing activities		(126)		—		(126)		(133)		—		(133)		(133)		—		(133)

Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129		—		4,129		4,129		—		4,129		4,129		—		4,129
Proceeds from issuance of common stock in public offering, net of offering costs		—		—		—				—		—		21,971		—		21,971
Proceeds from At-the-Market sales of common stock, net of offering costs		348		—		348		12,573		—		12,573		12,573		—		12,573
Proceeds from issuance of long-term debt		—		—		—		—		—		—		—		—		—
Repayments of long-term debt		(5,000)		—		(5,000)		(5,000)		—		(5,000)		(17,150)		—		(17,150)
Debt financing costs paid		—		—		—		—		—		—		—		—		—
Proceeds from exercise of stock options		—		—		—		—		—		—		—		—		—
Net cash provided by financing activities		(523)		—		(523)		11,702		—		11,702		21,523		—		21,523

Net (decrease) increase in cash and cash equivalents		(15,400)		—		(15,400)		(6,116)		—		(6,116)		(12,998)		—		(12,998)
Cash and cash equivalents, beginning of period		19,143		—		19,143		19,143		—		19,143		19,143		—		19,143
Cash and cash equivalents, end of period	$	3,743	$	—	$	3,743	$	13,027	$	—	$	13,027	$	6,145	$	—	$	6,145

Supplemental cash flow information
Interest paid	$	452	$	—	$	452	$	898	$	—	$	898	$	1,078	$	—	$	1,078

Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Sep. 30, 2022	Dec. 31, 2022
Loss on disposition of assets			$ (11,122)
Loss on disposition of assets	$ 11,122	$ 11,122	11,122
Corium Agreement [Member]
Minimum material purchase requirements	$ 11,100
Loss on disposition of assets			$ (11,100)

Quarterly Financial Information

12 Months Ended

Dec. 31, 2022

Quarterly Financial Information

Quarterly Financial Information

14. Quarterly Financial Information (Unaudited)

As further described in Note 2, the previously reported financial information for the three months ended March 31, 2022, the three and six months ended June 30, 2022 and the three and nine months ended September 30, 2022, have been restated. Relevant restated financial information for each relevant period is included in the Company’s Annual Report on Form 10-K in the tables that follow. As part of the restatement, the Company recorded adjustments to correct the misstatements in the impacted periods. Descriptions of the restatement can be found in Note 2. The unaudited interim financial statements reflect all adjustments which are, in the opinion of management, necessary for a fair statement of the results for the interim periods presented. Restated amounts are computed independently each quarter; therefore, the sum of the quarterly amounts may not equal the total amount for the respective year due to rounding.

Balance Sheets


	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously						As Previously						As Previously
	Reported		Adjustment		As Restated		Reported		Adjustment		As Restated		Reported		Adjustment		As Restated
Assets
Current assets:
Cash and cash equivalents	$	3,743	$	—	$	3,743	$	13,027	$	—	$	13,027	$	6,145	$	—	$	6,145
Accounts receivable, net		1,665		—		1,665		2,087		—		2,087		3,711		—		3,711
Income taxes receivable		4,675		—		4,675		—		—		—		—		—		—
Inventory, net		2,693		—		2,693		2,340		—		2,340		1,797		—		1,797
Prepaid expenses and other current assets		1,576		—		1,576		1,016		—		1,016		3,834		—		3,834
Total current assets		14,352		—		14,352		18,470		—		18,470		15,487		—		15,487
Property and equipment, net		12,047		—		12,047		11,524		—		11,524		203		—		203
Right of use asset		888		—		888		825		—		825		761		—		761
Other non-current assets		2,012		—		2,012		2,012		—		2,012		2,012		—		2,012
Total assets	$	29,299	$	—	$	29,299	$	32,831	$	—	$	32,831	$	18,463	$	—	$	18,463

Liabilities and stockholders’ equity
Current liabilities:
Long-term debt, current portion	$	12,252		—	$	12,252	$	12,630		—	$	12,630	$	1,318		—	$	1,318
Accounts payable		9,537		—		9,537		12,036		—		12,036		4,906		—		4,906
Accrued expenses		3,828		—		3,828		3,877		—		3,877		5,152		—		5,152
Lease liability, current portion		231		—		231		239		—		239		277		—		277
Total current liabilities		25,848		—		25,848		28,782		—		28,782		11,653		—		11,653

Lease liabilities, long-term		708		—		708		630		—		630		550		—		550
Warrant liability		—		8,101		8,101		—		1,050		1,050		—		9,285		9,285
Total liabilities		26,556		8,101		34,657		29,412		1,050		30,462		12,203		9,285		21,488
Commitments and contingencies (Note 13)
Stockholders’ equity
Preferred stock, $.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2022 and no shares issued and outstanding at December 31, 2021		887		(887)		—		—		—		—		—		—		—
Common stock, $.0001 par value, 300,000,000 shares authorized, 42,970,134 and 3,034,901 issued and outstanding at December 31, 2022 and December 31, 2021, respectively *		—		—		—		1		—		1		4		—		4
Additional paid-in capital *		400,742		(12,425)		388,317		414,523		(13,312)		401,211		437,027		(35,283)		401,744
Accumulated deficit		(398,886)		5,211		(393,675)		(411,105)		12,262		(398,843)		(430,771)		25,998		(404,773)
Total stockholders’ equity		2,743		(8,101)		(5,358)		3,419		(1,050)		2,369		6,260		(9,285)		(3,025)
Total liabilities and stockholders’ equity	$	29,299	$	—	$	29,299	$	32,831	$	—	$	32,831	$	18,463	$	—	$	18,463

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Quarterly and Year to Date Statements of Operations and Comprehensive Loss


	Three Months Ended						Three Months Ended						Three Months Ended
	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated

Revenues, net	$	1,761	$	—	$	1,761	$	2,126	$	—	$	2,126	$	3,002	$	—	$	3,002
Cost of product revenues		1,527		—		1,527		2,231		—		2,231		1,425		—		1,425
Gross profit (loss)		234		—		234		(105)		—		(105)		1,577		—		1,577

Operating expenses:
Research and development	$	1,257	$	—	$	1,257	$	856	$	—	$	856	$	788	$	—	$	788
Selling and marketing		10,553		—		10,553		7,411		—		7,411		5,560		—		5,560
General and administrative		3,997		—		3,997		3,026		—		3,026		2,815		—		2,815
Loss on disposition of assets		—		—		—		—		—		—		11,122		—		11,122
Total operating expenses		15,807		—		15,807		11,293		—		11,293		20,285		—		20,285
Loss from operations		(15,573)		—		(15,573)		(11,398)		—		(11,398)		(18,708)		—		(18,708)

Other income (expense)
Interest income		1		—		1		2		—		2		46		—		46
Interest expense		(872)		—		(872)		(823)		—		(823)		(1,004)		—		(1,004)
Unrealized gain on warrant liability		—		1,384		1,384		—		7,051		7,051		—		13,736		13,736
Total other income (expense), net		(871)		1,384		513		(821)		7,051		6,230		(958)		13,736		12,778
Loss before benefit from income taxes		(16,444)		1,384		(15,060)		(12,219)		7,051		(5,168)		(19,666)		13,736		(5,930)
Benefit from income taxes		4,675		—		4,675		—		—		—		—		—		—
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)

Net loss per share (basic and diluted)	$	(3.78)	$	0.44	$	(3.33)	$	(2.71)	$	1.56	$	(1.15)	$	(0.53)	$	0.37	$	(0.16)

Weighted-average common shares (basic and diluted)		3,115,211		3,115,211		3,115,211		4,510,219		4,510,219		4,510,219		36,997,836		36,997,836		36,997,836

Comprehensive loss:
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		—		—		—		—		—		—		—		—		—
Comprehensive loss	$	(11,769)	$	1,384	$	(10,385)	$	(12,219)	$	7,051	$	(5,168)	$	(19,666)	$	13,736	$	(5,930)


	Six Months Ended						Nine Months Ended
	June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated

Revenues, net	$	3,887	$	—	$	3,887	$	6,888	$	—	$	6,888
Cost of product revenues		3,758		—		3,758		5,183		—		5,183
Gross profit (loss)		129		—		129		1,705		—		1,705

Operating expenses:
Research and development	$	2,113	$	—	$	2,113	$	2,901	$	—	$	2,901
Selling and marketing		17,964		—		17,964		23,523		—		23,523
General and administrative		7,023		—		7,023		9,837		—		9,837
Loss on disposition of assets		—		—		—		11,122		—		11,122
Total operating expenses		27,100		—		27,100		47,383		—		47,383
Loss from operations		(26,971)		—		(26,971)		(45,678)		—		(45,678)

Other income (expense)
Interest income		3		—		3		50		—		50
Interest expense		(1,695)		—		(1,695)		(2,699)		—		(2,699)
Unrealized gain on warrant liability		—		8,435		8,435		—		22,171		22,171
Total other income (expense), net		(1,692)		8,435		6,743		(2,649)		22,171		19,522
Loss before benefit from income taxes		(28,663)		8,435		(20,228)		(48,327)		22,171		(26,156)
Benefit from income taxes		4,675		—		4,675		4,675		—		4,675
Net loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)

Net loss per share (basic and diluted)	$	(6.29)	$	2.21	$	(4.08)	$	(2.91)	$	1.48	$	(1.43)

Weighted-average common shares (basic and diluted)		3,816,569		3,816,569		3,816,569		14,998,534		14,998,534		14,998,534

Comprehensive loss:
Net loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		—		—		—		—		—		—
Comprehensive loss	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance December 31, 2021	—	$	—	3,034,901	$	—	$	396,388	$	—	$	(387,117)	$	9,271
Share-based compensation - stock options and RSUs	—		—	—		—		764		—		—		764
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	25,623		—		348		—		—		348
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	4,850		4,850	—		—		—		—		—		4,850
Registered direct financing costs, inclusive of warrants	—		(965)	—		—		244		—		—		(721)
Conversion of series A convertible preferred stock	(2,425)		(897)	303,125		—		897		—		—		—
Vesting of RSUs	—		—	1,773		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		(2,101)	—		—		2,101		—		—		—
Net loss	—		—	—		—		—		—		(11,769)		(11,769)
Balance March 31, 2022	2,425	$	887	3,365,422	$	—	$	400,742	$	—	$	(398,886)	$	2,743

Adjustment
Balance December 31, 2021	—		—	—		—		(9,183)		—		3,827		(5,356)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	—		—		—		—		—		—
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	—		(4,850)	—		—		—		—		—		(4,850)
Registered direct financing costs, inclusive of warrants	—		965	—		—		(244)		—		—		721
Conversion of series A convertible preferred stock	—		897	—		—		(897)		—		—		—
Vesting of RSUs	—		—	—		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		2,101	—		—		(2,101)		—		—		—
Net loss	—		—	—		—		—		—		1,384		1,384
Total Adjustment March 31, 2022	—	$	(887)	—	$	—	$	(12,425)	$	—	$	5,211	$	(8,101)

As Restated
Balance December 31, 2021	—	$	—	3,034,901	$	—	$	387,205	$	—	$	(383,290)	$	3,915
Share-based compensation - stock options and RSUs	—		—	—		—		764		—		—		764
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	25,623		—		348		—		—		348
Issuance of series A and B convertible preferred stock in a registered direct offering (Note 8)	4,850		—	—		—		—		—		—		—
Registered direct financing costs, inclusive of warrants	—		—	—		—		—		—		—		—
Conversion of series A convertible preferred stock	(2,425)		—	303,125		—		—		—		—		—
Vesting of RSUs	—		—	1,773		—		—		—		—		—
Warrants issued in connection with registered direct offering	—		—	—		—		—		—		—		—
Net loss	—		—	—		—		—		—		(10,385)		(10,385)
Balance March 31, 2022	2,425	$	—	3,365,422	$	—	$	388,317	$	—	$	(393,675)	$	(5,358)

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance March 31, 2022	2,425	$	887	3,365,422	$	—	$	400,742	$	—	$	(398,886)	$	2,743
Share-based compensation - stock options and RSUs	—		—	—		—		669		—		—		669
Fractional shares retired as a result of reverse split	—		—	(10)		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	8,687,502		1		12,225		—		—		12,226
Conversion of series B convertible preferred stock	(2,425)		(887)	303,125		—		887		—		—		—
Vesting of RSUs	—		—	4,118		—		—		—		—		—
Net loss	—		—	—		—		—		—		(12,219)		(12,219)
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	414,523	$	—	$	(411,105)	$	3,419

Adjustment
Balance March 31, 2022	—		(887)	—		—		(12,425)		—		5,211		(8,101)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Fractional shares retired as a result of reverse split	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	—		—		—		—		—		—
Conversion of series B convertible preferred stock	—		887	—		—		(887)		—		—		—
Vesting of RSUs	—		—	—		—		—		—		—		—
Net loss	—		—	—		—		—		—		7,051		7,051
Balance June 30, 2022	—	$	—	—	$	—	$	(13,312)	$	—	$	12,262	$	(1,050)

As Restated
Balance March 31, 2022	2,425	$	—	3,365,422	$	—	$	388,317	$	—	$	(393,675)	$	(5,358)
Share-based compensation - stock options and RSUs	—		—	—		—		669		—		—		669
Fractional shares retired as a result of reverse split	—		—	(10)		—		—		—		—		—
Issuance of common stock pursuant to at-the market stock sales, net of expenses	—		—	8,687,502		1		12,225		—		—		12,226
Conversion of series B convertible preferred stock	(2,425)		—	303,125		—		—		—		—		—
Vesting of RSUs	—		—	4,118		—		—		—		—		—
Net loss	—		—	—		—		—		—		(5,168)		(5,168)
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	401,211	$	—	$	(398,843)	$	2,369

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statements of Changes in Stockholders’ Equity (Unaudited)


	Preferred Stock			Common Stock			Additional		Accumulated				Total
	Number of			Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares	Amount		Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	414,523	$	—	$	(411,105)	$	3,419
Share-based compensation - stock options and RSUs	—		—	—		—		536		—		—		536
Issuance of common stock pursuant to a public offering, net of expenses	—		—	26,666,666		3		21,968		—		—		21,971
Net loss	—		—	—		—		—		—		(19,666)		(19,666)

Balance September 30, 2022	—		—	39,026,823	$	4	$	437,027	$	—	$	(430,771)	$	6,260

Adjustment
Balance June 30, 2022	—		—	—		—		(13,312)		—		12,262		(1,050)
Share-based compensation - stock options and RSUs	—		—	—		—		—		—		—		—
Issuance of common stock pursuant to a public offering, net of expenses	—		—	—		—		(21,971)		—		—		(21,971)
Net loss	—		—	—		—		—		—		13,736		13,736
Balance September 30, 2022	—		—	—	$	—	$	(35,283)	$	—	$	25,998	$	(9,285)

As Restated
Balance June 30, 2022	—	$	—	12,360,157	$	1	$	401,211	$	—	$	(398,843)	$	2,369
Share-based compensation - stock options and RSUs	—		—	—		—		536		—		—		536
Issuance of common stock pursuant to a public offering, net of expenses	—		—	26,666,666		3		(3)		—		—		—
Net loss	—		—	—		—		—		—		(5,930)		(5,930)
Balance September 30, 2022	—		—	39,026,823	$	4	$	401,744	$	—	$	(404,773)	$	(3,025)

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statements of Cash Flows


	Three Months Ended						Six Months Ended						Nine Months Ended
	March 31, 2022 (unaudited)						June 30, 2022 (unaudited)						September 30, 2022 (unaudited)
	As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated		As Previously Reported		Adjustment		As Restated
Cash flows from operating activities:
Net loss	$	(11,769)	$	1,384	$	(10,385)	$	(23,988)	$	8,435	$	(15,553)	$	(43,652)	$	22,171	$	(21,481)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve		—		—		—		—		—		—		—		—		—
Depreciation		527		—		527		1,057		—		1,057		1,255		—		1,255
Amortization		61		—		61		124		—		124		188		—		188
Loss on disposition of assets		—		—		—				—		—		11,122		—		11,122
Noncash stock-based compensation		764		—		764		1,433		—		1,433		1,969		—		1,969
Noncash amortization of deferred financing costs		419		—		419		797		—		797		1,635		—		1,635
Unrealized gain on warrants		—		(1,384)		(1,384)		—		(8,435)		(8,435)				(22,171)		(22,171)
Changes in operating assets and liabilities:						—
Accounts receivable		(132)		—		(132)		(554)		—		(554)		(2,178)		—		(2,178)
Income taxes receivable		(4,675)				(4,675)		—				—						—
Inventory		(1,727)		—		(1,727)		(1,374)		—		(1,374)		(831)		—		(831)
Prepaid expenses and other assets		707		—		707		1,267		—		1,267		(1,551)		—		(1,551)
Accounts payable and accrued expenses		1,095		—		1,095		3,643		—		3,643		(2,213)		—		(2,213)
Lease liability		(21)		—		(21)		(90)		—		(90)		(132)		—		(132)
Net cash used in operating activities		(14,751)		—		(14,751)		(17,685)		—		(17,685)		(34,388)		—		(34,388)

Cash flows from investing activities:
Purchases of marketable securities		—		—		—		—		—		—		—		—		—
Sales and maturities of marketable securities		—		—		—		—		—		—		—		—		—
Acquisition of property and equipment		(126)		—		(126)		(133)		—		(133)		(133)		—		(133)
Net cash (used in) provided by investing activities		(126)		—		(126)		(133)		—		(133)		(133)		—		(133)

Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,129		—		4,129		4,129		—		4,129		4,129		—		4,129
Proceeds from issuance of common stock in public offering, net of offering costs		—		—		—				—		—		21,971		—		21,971
Proceeds from At-the-Market sales of common stock, net of offering costs		348		—		348		12,573		—		12,573		12,573		—		12,573
Proceeds from issuance of long-term debt		—		—		—		—		—		—		—		—		—
Repayments of long-term debt		(5,000)		—		(5,000)		(5,000)		—		(5,000)		(17,150)		—		(17,150)
Debt financing costs paid		—		—		—		—		—		—		—		—		—
Proceeds from exercise of stock options		—		—		—		—		—		—		—		—		—
Net cash provided by financing activities		(523)		—		(523)		11,702		—		11,702		21,523		—		21,523

Net (decrease) increase in cash and cash equivalents		(15,400)		—		(15,400)		(6,116)		—		(6,116)		(12,998)		—		(12,998)
Cash and cash equivalents, beginning of period		19,143		—		19,143		19,143		—		19,143		19,143		—		19,143
Cash and cash equivalents, end of period	$	3,743	$	—	$	3,743	$	13,027	$	—	$	13,027	$	6,145	$	—	$	6,145

Supplemental cash flow information
Interest paid	$	452	$	—	$	452	$	898	$	—	$	898	$	1,078	$	—	$	1,078

Quarterly Financial Information - Statements of Operations and Comprehensive Loss (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						6 Months Ended	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues, net	$ 6,662			$ 3,002				$ 15,979	$ 6,888	$ 10,884	$ 4,101	$ 749
Cost of product revenues	2,477			1,425				6,787	5,183	6,836	10,718	282
Gross profit	4,185			1,577				9,192	1,705	4,048	(6,617)	467
Operating expenses:
Research and development	705			788				2,171	2,901	3,253	6,246	13,500
Selling and marketing	4,800			5,560				14,040	23,523	30,369	43,444	23,285
General and administrative	2,680			2,815				8,813	9,837	11,860	14,698	12,735
Loss on disposition of assets				11,122					11,122	11,122
Loss on disposition of assets										11,122
Total operating expenses	8,185			20,285				25,024	47,383	56,604	64,388	49,520
Loss from operations	(4,000)			(18,708)				(15,832)	(45,678)	(52,556)	(71,005)	(49,053)
Other income (expense)
Interest income	13			46				61	50	80	25	309
Interest expense	(341)			(1,004)				(1,114)	(2,699)	(3,131)	(3,914)	(3,109)
Unrealized gain on warrant liability	3,529			13,736				6,890	22,171	25,520	3,827
Total other income (expense), net	3,201			12,778				5,837	19,522	22,469	(62)	(2,800)
Loss before benefit from income taxes	(799)			(5,930)				(9,995)	(26,156)	(30,087)	(71,067)	(51,853)
Benefit from income taxes									4,675	4,675
Net loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	$ (5,168)	$ (10,385)		$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Net loss per share (basic) (in dollars per share)	$ (0.27)			$ (8.01)				$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Net loss per share (diluted) (in dollars per share)	$ (0.27)			$ (8.01)				$ (5.30)	$ (71.61)	$ (1.18)	$ (29.28)	$ (24.40)
Weighted-average common shares (basic) (in shares)	2,950,136			739,957				1,884,793	299,970	21,610,947	2,426,821	2,117,077
Weighted-average common shares (diluted) (in shares)	2,950,136			739,957				1,884,793	299,970	21,610,947	2,426,821	2,117,077
Comprehensive loss:
Net loss	$ (799)	$ (3,809)	$ (5,389)	$ (5,930)	(5,168)	(10,385)		$ (9,995)	$ (21,481)	$ (25,412)	$ (71,067)	$ (51,853)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)	3
Comprehensive loss										$ (25,412)	(71,070)	$ (51,850)
As Previously Reported
Other income (expense)
Net loss											(71,067)
Comprehensive loss:
Net loss											(71,067)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)
As Restated
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues, net				3,002	2,126	1,761	$ 3,887		6,888
Cost of product revenues				1,425	2,231	1,527	3,758		5,183
Gross profit				1,577	(105)	234	129		1,705
Operating expenses:
Research and development				788	856	1,257	2,113		2,901
Selling and marketing				5,560	7,411	10,553	17,964		23,523
General and administrative				2,815	3,026	3,997	7,023		9,837
Loss on disposition of assets				11,122					11,122
Total operating expenses				20,285	11,293	15,807	27,100		47,383
Loss from operations				(18,708)	(11,398)	(15,573)	(26,971)		(45,678)
Other income (expense)
Interest income				46	2	1	3		50
Interest expense				(1,004)	(823)	(872)	(1,695)		(2,699)
Unrealized gain on warrant liability				13,736	7,051	1,384	8,435		22,171
Total other income (expense), net				12,778	6,230	513	6,743		19,522
Loss before benefit from income taxes				(5,930)	(5,168)	(15,060)	(20,228)		(26,156)
Benefit from income taxes						4,675	4,675		4,675
Net loss				$ (5,930)	$ (5,168)	$ (10,385)	$ (15,553)		$ (21,481)
Net loss per share (basic) (in dollars per share)				$ (0.16)	$ (1.15)	$ (3.33)	$ (4.08)		$ (1.43)
Net loss per share (diluted) (in dollars per share)				$ (0.16)	$ (1.15)	$ (3.33)	$ (4.08)		$ (1.43)
Weighted-average common shares (basic) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534
Weighted-average common shares (diluted) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534
Comprehensive loss:
Net loss				$ (5,930)	$ (5,168)	$ (10,385)	$ (15,553)		$ (21,481)
Other comprehensive income:
Comprehensive loss				(5,930)	(5,168)	(10,385)	(15,553)		(21,481)
Error Correction, Accounting for Warrants \| As Previously Reported
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues, net				3,002	2,126	1,761	3,887		6,888		4,101
Cost of product revenues				1,425	2,231	1,527	3,758		5,183		10,718
Gross profit				1,577	(105)	234	129		1,705		(6,617)
Operating expenses:
Research and development				788	856	1,257	2,113		2,901		6,246
Selling and marketing				5,560	7,411	10,553	17,964		23,523		43,444
General and administrative				2,815	3,026	3,997	7,023		9,837		14,698
Loss on disposition of assets				11,122					11,122
Total operating expenses				20,285	11,293	15,807	27,100		47,383		64,388
Loss from operations				(18,708)	(11,398)	(15,573)	(26,971)		(45,678)		(71,005)
Other income (expense)
Interest income				46	2	1	3		50		25
Interest expense				(1,004)	(823)	(872)	(1,695)		(2,699)		(3,914)
Total other income (expense), net				(958)	(821)	(871)	(1,692)		(2,649)		(3,889)
Loss before benefit from income taxes				(19,666)	(12,219)	(16,444)	(28,663)		(48,327)		(74,894)
Benefit from income taxes						4,675	4,675		4,675
Net loss				$ (19,666)	$ (12,219)	$ (11,769)	$ (23,988)		$ (43,652)		$ (74,894)
Net loss per share (basic) (in dollars per share)				$ (0.53)	$ (2.71)	$ (3.78)	$ (6.29)		$ (2.91)		$ (30.86)
Net loss per share (diluted) (in dollars per share)				$ (0.53)	$ (2.71)	$ (3.78)	$ (6.29)		$ (2.91)		$ (30.86)
Weighted-average common shares (basic) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Weighted-average common shares (diluted) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Comprehensive loss:
Net loss				$ (19,666)	$ (12,219)	$ (11,769)	$ (23,988)		$ (43,652)		$ (74,894)
Other comprehensive income:
Unrealized (loss) gain on marketable securities											(3)
Comprehensive loss				(19,666)	(12,219)	(11,769)	(23,988)		(43,652)		(74,897)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment
Other income (expense)
Unrealized gain on warrant liability				13,736	7,051	1,384	8,435		22,171		3,827
Total other income (expense), net				13,736	7,051	1,384	8,435		22,171		3,827
Loss before benefit from income taxes				13,736	7,051	1,384	8,435		22,171		3,827
Net loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827
Net loss per share (basic) (in dollars per share)				$ 0.37	$ 1.56	$ 0.44	$ 2.21		$ 1.48		$ 1.58
Net loss per share (diluted) (in dollars per share)				$ 0.37	$ 1.56	$ 0.44	$ 2.21		$ 1.48		$ 1.58
Weighted-average common shares (basic) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Weighted-average common shares (diluted) (in shares)				36,997,836	4,510,219	3,115,211	3,816,569		14,998,534		2,426,821
Comprehensive loss:
Net loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827
Other comprehensive income:
Comprehensive loss				$ 13,736	$ 7,051	$ 1,384	$ 8,435		$ 22,171		$ 3,827

Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Apr. 10, 2023	Apr. 09, 2023	Dec. 31, 2022	Jan. 07, 2022	Jan. 06, 2022	Dec. 31, 2021	Jan. 06, 2020
Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Preferred stock, authorized (in shares)	10,000,000			10,000,000			10,000,000
Preferred stock, issued (in shares)	4,850			4,850			0
Preferred stock, outstanding (in shares)	0			0			0
Common stock, par value (in dollars per share)	$ 0.0001			$ 0.0001			$ 0.0001
Common stock, authorized (in shares)	300,000,000			300,000,000	300,000,000	150,000,000	300,000,000	300,000,000
Common stock, issued (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901
Common stock, outstanding (in shares)	2,277,657	932,101	46,605,134	42,970,134			3,034,901

Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Summary of Significant Accounting Policies
Inventory reserve	$ 1.4	$ 0.6

Quarterly Financial Information - Balance Sheets (Details) $ in Thousands		12 Months Ended
	Apr. 10, 2023	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Sep. 30, 2023 USD ($)	Jun. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2022 USD ($)	Jun. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
Current assets:
Cash and cash equivalents		$ 5,246	$ 19,143	$ 2,873
Accounts receivable, net		3,377	1,533	3,521
Inventory, net		1,332	966	2,411
Prepaid expenses and other current assets		1,403	2,283	1,259
Total current assets		11,358	23,925	10,064
Property and equipment, net		177	12,447	101
Right of use asset		695	949	486
Other non-current assets		2,012	2,012	238
Total assets		14,242	39,333	10,889
Current liabilities:
Long-term debt, current portion		1,426	16,833	1,589
Accounts payable		7,734	8,707	6,879
Accrued expenses		3,908	3,563	8,338
Lease liability, current portion		319	175	353
Total current liabilities		13,387	29,278	17,538
Lease liabilities, long-term		466	784	196
Warrant liability		5,934	5,356	5,566
Total liabilities		19,787	35,418	23,300
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively		4
Additional paid-in capital		403,157	387,205	406,288
Accumulated deficit		(408,702)	(383,290)	(418,699)
Total stockholders' equity		(5,545)	3,915	(12,411)	$ (12,121)	$ (9,433)	$ (3,025)	$ 2,369	$ (5,358)	$ 49,328	$ 45,745
Total liabilities and stockholders' equity		$ 14,242	$ 39,333	$ 10,889
Reverse stock split conversion ratio	0.02	0.025	0.025
As Previously Reported
Stockholders' deficit
Total stockholders' equity			$ 3,915							49,328
As Previously Reported \| Error Correction, Accounting for Warrants
Current assets:
Cash and cash equivalents			19,143				6,145	13,027	3,743
Accounts receivable, net			1,533				3,711	2,087	1,665
Income taxes receivable									4,675
Inventory, net			966				1,797	2,340	2,693
Prepaid expenses and other current assets			2,283				3,834	1,016	1,576
Total current assets			23,925				15,487	18,470	14,352
Property and equipment, net			12,447				203	11,524	12,047
Right of use asset			949				761	825	888
Other non-current assets			2,012				2,012	2,012	2,012
Total assets			39,333				18,463	32,831	29,299
Current liabilities:
Long-term debt, current portion			16,833				1,318	12,630	12,252
Accounts payable			8,707				4,906	12,036	9,537
Accrued expenses			3,563				5,152	3,877	3,828
Lease liability, current portion			175				277	239	231
Total current liabilities			29,278				11,653	28,782	25,848
Lease liabilities, long-term			784				550	630	708
Total liabilities			30,062				12,203	29,412	26,556
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022									887
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively							4	1
Additional paid-in capital			396,388				437,027	414,523	400,742
Accumulated deficit			(387,117)				(430,771)	(411,105)	(398,886)
Total stockholders' equity			9,271				6,260	3,419	2,743	$ 49,328
Total liabilities and stockholders' equity			39,333				18,463	32,831	29,299
Error Correction, Adjustment \| Error Correction, Accounting for Warrants
Current liabilities:
Warrant liability			5,356				9,285	1,050	8,101
Total liabilities			5,356				9,285	1,050	8,101
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022									(887)
Additional paid-in capital			(9,183)				(35,283)	(13,312)	(12,425)
Accumulated deficit			3,827				25,998	12,262	5,211
Total stockholders' equity			(5,356)				(9,285)	(1,050)	(8,101)
As Restated
Current assets:
Cash and cash equivalents							6,145	13,027	3,743
Accounts receivable, net							3,711	2,087	1,665
Income taxes receivable									4,675
Inventory, net							1,797	2,340	2,693
Prepaid expenses and other current assets							3,834	1,016	1,576
Total current assets							15,487	18,470	14,352
Property and equipment, net							203	11,524	12,047
Right of use asset							761	825	888
Other non-current assets							2,012	2,012	2,012
Total assets							18,463	32,831	29,299
Current liabilities:
Long-term debt, current portion							1,318	12,630	12,252
Accounts payable							4,906	12,036	9,537
Accrued expenses							5,152	3,877	3,828
Lease liability, current portion							277	239	231
Total current liabilities							11,653	28,782	25,848
Lease liabilities, long-term							550	630	708
Warrant liability							9,285	1,050	8,101
Total liabilities							21,488	30,462	34,657
Stockholders' deficit
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively							4	1
Additional paid-in capital							401,744	401,211	388,317
Accumulated deficit							(404,773)	(398,843)	(393,675)
Total stockholders' equity			$ 3,915				(3,025)	2,369	(5,358)
Total liabilities and stockholders' equity							$ 18,463	$ 32,831	$ 29,299

Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer	Sep. 30, 2023 USD ($) customer	Sep. 30, 2022 USD ($) customer	Dec. 31, 2022 USD ($) customer	Dec. 31, 2021 USD ($) customer	Dec. 31, 2020 USD ($)
Concentration of risk, financial assets
Financial instruments with off-balance sheet risk of accounting loss, assets					$ 0
Concentration risk, financial liabilities
Financial instruments with off-balance sheet risk of accounting loss, liabilities	$ 0		$ 0		0
Total revenue	6,662,000	$ 3,002,000	15,979,000	$ 6,888,000	$ 10,884,000	$ 4,101,000	$ 749,000
Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer		3
Customer Concentration Risk \| Three Customers
Concentration risk, financial liabilities
Number of major customers \| customer				3
Customer Concentration Risk \| Sales Revenue
Concentration risk, financial liabilities
Number of major customers \| customer					4	3
Customer Concentration Risk \| Sales Revenue \| Customer One
Concentration risk, financial liabilities
Total revenue	1,700,000	$ 700,000	3,200,000	$ 1,900,000	$ 2,900,000	$ 1,300,000
Customer Concentration Risk \| Sales Revenue \| Customer Two
Concentration risk, financial liabilities
Total revenue	1,300,000	600,000	3,200,000	1,800,000	2,700,000	1,300,000
Customer Concentration Risk \| Sales Revenue \| Customer Three
Concentration risk, financial liabilities
Total revenue	1,100,000	$ 600,000	3,200,000	$ 1,700,000	$ 2,600,000	$ 1,200,000
Concentration risk, percentage					93.00%
Customer Concentration Risk \| Sales Revenue \| Customer Four
Concentration risk, financial liabilities
Total revenue	1,100,000		3,000,000.0		$ 1,200,000
Concentration risk, percentage					86.00%
Customer Concentration Risk \| Sales Revenue \| Customer Five
Concentration risk, financial liabilities
Total revenue	$ 1,100,000		$ 2,100,000
Customer Concentration Risk \| Sales Revenue \| Three Customers
Concentration risk, financial liabilities
Concentration risk, percentage		30.00%		33.00%
Customer Concentration Risk \| Sales Revenue \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer	5		5
Total revenue			$ 92
Concentration risk, percentage	93.00%
Customer Concentration Risk \| Accounts Receivable
Concentration risk, financial liabilities
Number of major customers \| customer					4
Customer Concentration Risk \| Accounts Receivable \| Customer One
Concentration risk, financial liabilities
Concentration risk, percentage			36.00%		28.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two
Concentration risk, financial liabilities
Concentration risk, percentage			26.00%		29.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Three
Concentration risk, financial liabilities
Concentration risk, percentage			18.00%		25.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Four
Concentration risk, financial liabilities
Concentration risk, percentage			15.00%		15.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Five
Concentration risk, financial liabilities
Concentration risk, percentage			0.00%
Customer Concentration Risk \| Accounts Receivable \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer				5

Summary of Significant Accounting Policies (Policies)

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Summary of Significant Accounting Policies

Basis of Presentation

Basis of Presentation

Use of Estimates

Use of Estimates

Risks and Uncertainties

Risks and Uncertainties

Cash and Cash Equivalents

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Cash and Cash Equivalents

The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit.

Trade Accounts Receivable and Allowances

Trade Accounts Receivable and Allowances

Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2022 and 2021, respectively.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Fair Value of Financial Instruments

In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents and Warrant liability are carried at fair value (see Note 3).

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature.

Inventory

Inventory

Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf-life date. As of December 31, 2022 inventory reserves approximated $0.6 million.

Property and Equipment

Property and Equipment

Long-Lived Assets

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2022.

Research and Development Expense

Research and Development Expenses

Research and Development Expense

Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development.

Advertising Costs

Advertising Costs

Deferred Financing Costs

Deferred Financing Costs

Concentrations of Credit Risk

Concentrations of Credit Risk

credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has no financial instruments with off balance sheet risk of accounting loss.

Concentrations of Credit Risk

Revenue Recognition

Revenue Recognition

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows:

Revenue Recognition

●

Distribution services fees

●

Prompt pay and other discounts

●

Product returns

●

Chargebacks

●

Rebates

●

Co-payment assistance

In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of variable consideration.

The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows.

Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and with limited historical sales data, an estimate for product returns as of December 31, 2022 was made based on industry standard data and trend analysis. Estimated product returns are recorded as contra trade accounts receivable on the balance sheet.

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2022 which have been deducted in arriving at revenues, net.


	December 31,		Allowances for		Payments &		December 31,
	2021		current period sales		credits		2022
Customer credits, discounts and allowances (contra accounts receivable)	$	371	$	5,891	$	(3,268)	$	2,994
Rebates and co-pay assistance (accrued expenses)		669		4,434		(2,771)		2,332
Total	$	1,040	$	10,325	$	(6,039)	$	5,326

Warrants

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity.

Income Taxes

Income Taxes

Stock-Based Compensation

Stock-Based Compensation

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital.

Segment Information

Segment Information

Net Loss Per Share

Net Loss Per Share


	September 30,
	2023	2022
Common stock warrants	4,484,077	36,691
Unvested restricted stock units	135,037	142
Common stock options	43,510	5,778
Total	4,662,624	42,611

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented.


	Year Ended December 31,
	2022	2021	2020
Common stock warrants	56,501,249	379,583	35,000
Unvested restricted stock units	6,461	8,325	3,995
Common stock options	397,818	259,145	212,977
Total	56,905,528	647,053	251,972

Recent Accounting Pronouncements

Recent Accounting Pronouncements

The Company did not adopt any new accounting pronouncements during the nine months ended September 30, 2023 that had a material effect on its financial statements.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures.

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements.

Restatement of Previously Issued Financial Statements

12 Months Ended

Dec. 31, 2022

Restatement of Previously Issued Financial Statements

Restatement of Previously Issued Financial Statements

2. Restatement of Previously Issued Financial Statements

In February 2023, the Company concluded that it incorrectly classified certain warrants (the “Warrants”) that were issued to investors in connection with a public offering of the Company’s common stock (“Common Stock”) in October 2021, a registered direct offering of the Company’s preferred stock (“Preferred Stock”) in March 2022 and a public offering of the Company’s Common Stock in July 2022.

Historically, the Warrants were reflected as a component of equity as opposed to liabilities on the balance sheets and the statements of operations did not include the subsequent non-cash changes in estimated fair value of the Warrants. The Company reassessed its accounting for the Warrants and determined that the Warrants should be classified as liabilities measured at fair value upon issuance, with subsequent changes in fair value reported in the Company Statement of Operations each reporting period.

Impact of the Restatement

The Company has restated herein its audited financial statements at December 31, 2022 for the year ended December 31, 2021. We have also restated interim financial statement periods for the first, second and third quarters of 2022, see Note 14.

Balance Sheet


	December 31, 2021
	As Previously
	Reported		Adjustment		As Restated
Assets
Current assets:
Cash and cash equivalents	$	19,143	$	—	$	19,143
Accounts receivable, net		1,533		—		1,533
Inventory, net		966		—		966
Prepaid expenses and other current assets		2,283		—		2,283
Total current assets		23,925		—		23,925
Property and equipment, net		12,447		—		12,447
Right of use asset		949		—		949
Other non-current assets		2,012		—		2,012
Total assets	$	39,333	$	—	$	39,333

Liabilities and stockholders’ equity
Current liabilities:
Long-term debt, current portion	$	16,833		—	$	16,833
Accounts payable		8,707		—		8,707
Accrued expenses		3,563		—		3,563
Lease liability, current portion		175		—		175
Total current liabilities		29,278		—		29,278

Lease liabilities, long-term		784		—		784
Warrant liability		—		5,356		5,356
Total liabilities		30,062		5,356		35,418
Commitments and contingencies (Note 13)
Stockholders’ equity
Preferred stock, $.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2022 and no shares issued and outstanding at December 31, 2021		—		—		—
Common stock, $.0001 par value, 300,000,000 shares authorized, 42,970,134 and 3,034,901 issued and outstanding at December 31, 2022 and December 31, 2021, respectively *		—		—		—
Additional paid-in capital *		396,388		(9,183)		387,205
Accumulated deficit		(387,117)		3,827		(383,290)
Total stockholders’ equity		9,271		(5,356)		3,915
Total liabilities and stockholders’ equity	$	39,333	$	—	$	39,333

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Operations and Comprehensive Loss


	Year Ended December 31, 2021
	As Previously Reported		Adjustment		As Restated

Revenues, net	$	4,101	$	—	$	4,101
Cost of product revenues		10,718		—		10,718
Gross profit (loss)		(6,617)		—		(6,617)

Operating expenses:
Research and development	$	6,246	$	—	$	6,246
Selling and marketing		43,444		—		43,444
General and administrative		14,698		—		14,698
Loss on disposition of assets		—		—		—
Total operating expenses		64,388		—		64,388
Loss from operations		(71,005)		—		(71,005)

Other income (expense)
Interest income		25		—		25
Interest expense		(3,914)		—		(3,914)
Unrealized gain on warrant liability		—		3,827		3,827
Total other income (expense), net		(3,889)		3,827		(62)
Loss before benefit from income taxes		(74,894)		3,827		(71,067)
Benefit from income taxes		—		—		—
Net loss	$	(74,894)	$	3,827	$	(71,067)

Net loss per share (basic and diluted)*	$	(30.86)	$	1.58	$	(29.28)

Weighted-average common shares (basic and diluted)		2,426,821		2,426,821		2,426,821

Comprehensive loss:
Net loss	$	(74,894)	$	3,827	$	(71,067)
Other comprehensive income:
Unrealized (loss) gain on marketable securities		(3)		—		(3)
Comprehensive loss	$	(74,897)	$	3,827	$	(71,070)

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Changes in Stockholders’ Equity


	Common Stock			Additional		Accumulated				Net
	Number of			Paid-in		Other Comprehensive		Accumulated		Stockholders'
	Shares *	Amount		Capital *		Income		Deficit		Equity
As Previously Reported
Balance December 31, 2020	2,189,100	$	—	$	361,548	$	3	$	(312,223)	$	49,328
Share-based compensation - stock options and RSUs	—		—		3,338		—		—		3,338
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	172,879		—		9,266		—		—		9,266
Issuance of common stock in public offering, net of expenses	666,666		—		21,081		—		—		21,081
Issuance of common stock upon exercise of stock options	3,160		—		75		—		—		75
Vesting of RSUs	3,096		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		1,080		—		—		1,080
Unrealized net gain on marketable securities	—		—		—		(3)		—		(3)
Net loss	—		—		—		—		(74,894)		(74,894)
Balance December 31, 2021	3,034,901	$	—	$	396,388	$	—	$	(387,117)	$	9,271

Adjustment
Balance December 31, 2020	—		—		—		—		—		—
Share-based compensation - stock options and RSUs	—		—		—		—		—		—
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	—		—		—		—		—		—
Issuance of common stock in public offering, net of expenses	—		—		(9,183)		—		—		(9,183)
Issuance of common stock upon exercise of stock options	—		—		—		—		—		—
Vesting of RSUs	—		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		—		—		—		—
Unrealized net gain on marketable securities	—		—		—		—		—		—
Net loss	—		—		—		—		3,827		3,827
Total adjustment December 31, 2021	—	$	—	$	(9,183)	$	—	$	3,827	$	(5,356)

As Restated
Balance December 31, 2020	2,189,100	$	—	$	361,548	$	3	$	(312,223)	$	49,328
Share-based compensation - stock options and RSUs	—		—		3,338		—		—		3,338
Issuance of common stock pursuant to at‑the‑market stock sales, net of expenses	172,879		—		9,266		—		—		9,266
Issuance of common stock in public offering, net of expenses	666,666		—		11,898		—		—		11,898
Issuance of common stock upon exercise of stock options	3,160		—		75		—		—		75
Vesting of RSUs	3,096		—		—		—		—		—
Warrants issued in connection with long-term debt	—		—		1,080		—		—		1,080
Unrealized net gain on marketable securities	—		—		—		(3)		—		(3)
Net loss	—		—		—		—		(71,067)		(71,067)
Balance December 31, 2021 (Restated)	3,034,901	$	—	$	387,205	$	—	$	(383,290)	$	3,915

* Adjustment reflected as a result of the 1-for-40 reverse stock split effectuated on April 26, 2022.

Statement of Cash Flows


	Year Ended
	December 31, 2021
	As Previously Reported		Adjustment		As Restated
Cash flows from operating activities:
Net loss	$	(74,894)	$	3,827	$	(71,067)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve		5,323		—		5,323
Depreciation		2,064		—		2,064
Amortization		159		—		159
Noncash stock-based compensation		3,338		—		3,338
Noncash amortization of deferred financing costs		1,661		—		1,661
Unrealized gain on warrants		—		(3,827)		(3,827)
Changes in operating assets and liabilities:
Accounts receivable		(668)		—		(668)
Inventory		(6,289)		—		(6,289)
Prepaid expenses and other assets		(967)		—		(967)
Accounts payable and accrued expenses		5,202		—		5,202
Lease liability		(131)		—		(131)
Net cash used in operating activities		(65,202)		—		(65,202)

Cash flows from investing activities:
Purchases of marketable securities		—		—		—
Sales and maturities of marketable securities		39,729		—		39,729
Acquisition of property and equipment		(269)		—		(269)
Net cash provided by investing activities		39,460		—		39,460

Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		—		—		—
Proceeds from issuance of common stock in public offering, net of offering costs		21,081		—		21,081
Proceeds from At-the-Market sales of common stock, net of offering costs		9,266		—		9,266
Proceeds from exercise of stock options		75		—		75
Net cash provided by financing activities		30,422		—		30,422

Net (decrease) increase in cash and cash equivalents		4,680		—		4,680
Cash and cash equivalents, beginning of period		14,463		—		14,463
Cash and cash equivalents, end of period	$	19,143	$	—	$	19,143

Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt	$	1,080	$	—	$	1,080
Operating right-of-use assets obtained in exchange for new operating lease liabilities		969		—		969
Supplemental cash flow information
Interest paid	$	2,383	$	—	$	2,383

Summary of Significant Accounting Policies - Warrants (Details) - shares	May 31, 2023	Jul. 31, 2022	Apr. 30, 2022	Mar. 31, 2022	Oct. 31, 2021	Feb. 28, 2021	Feb. 26, 2021	Feb. 29, 2020	Feb. 10, 2020
Warrants
Common stock that can be purchased with warrants (in shares)			4,243
Common stock that can be purchased with warrants (in shares)				24,856	6,660
Public offering
Warrants
Common stock that can be purchased with warrants (in shares)	3,792,572	1,093,333
Common stock that can be purchased with warrants (in shares)					6,660
Common stock warrants \| Public offering
Warrants
Common stock that can be purchased with warrants (in shares)		533,333
Warrants
Warrants
Common stock that can be purchased with warrants (in shares)				225
Perceptive Credit Agreement \| Warrants
Warrants
Common stock that can be purchased with warrants (in shares)	225	225			225
Perceptive Credit Agreement \| Perceptive Warrants
Warrants
Common stock that can be purchased with warrants (in shares)						225		700
Common stock that can be purchased with warrants (in shares)							225		700

Restatement of Previously Issued Financial Statements - Impact on Statement of Changes in Stockholders' Equity (Details) $ in Thousands			1 Months Ended				3 Months Ended						6 Months Ended	9 Months Ended		12 Months Ended
	Apr. 10, 2023	Jul. 06, 2022 shares	May 31, 2023 shares	Jul. 31, 2022 USD ($) shares	Oct. 31, 2021 shares	Mar. 31, 2021 shares	Sep. 30, 2023 USD ($) shares	Jun. 30, 2023 USD ($) shares	Mar. 31, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Jun. 30, 2022 USD ($) shares	Mar. 31, 2022 USD ($) shares	Jun. 30, 2022 USD ($) shares	Sep. 30, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Dec. 31, 2022 USD ($) shares	Dec. 31, 2021 USD ($) shares	Dec. 31, 2020 USD ($) shares
Increase (decrease) in stockholders' equity
Balance				$ 2,369			$ (12,121)	$ (9,433)	$ (5,545)	$ 2,369	$ (5,358)	$ 3,915	$ 3,915	$ (5,545)	$ 3,915	$ 3,915	$ 49,328	$ 45,745
Share-based compensation - stock options and RSUs							439	482	498	536	669	764				2,492	3,338	2,818
Issuance of common stock							70
Issuance of common stock upon exercise of options																	75	610
Warrants issued in connection with long-term debt																	1,080	3,570
Unrealized net gain on marketable securities																	(3)	3
Net loss							(799)	(3,809)	(5,389)	(5,930)	(5,168)	(10,385)		(9,995)	(21,481)	(25,412)	(71,067)	(51,853)
Balance							$ (12,411)	$ (12,121)	$ (9,433)	$ (3,025)	$ 2,369	$ (5,358)	$ 2,369	$ (12,411)	$ (3,025)	$ (5,545)	$ 3,915	$ 49,328
Reverse stock split conversion ratio	0.02															0.025	0.025
Common stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares				247,202			1,640,805	932,101	859,402	247,202	67,308	60,698	60,698	859,402	60,698	60,698	2,189,100	1,745,264
Issuance of common stock (in shares) \| shares							29,842			533,333
Issuance of common stock upon exercise of options (in shares) \| shares																	3,160	12,586
Vesting of RSUs (in shares) \| shares							10	76			82	35				6,555	3,096
Balance (in shares) \| shares							2,277,657	1,640,805	932,101	780,535	247,202	67,308	247,202	2,277,657	780,535	859,402	60,698	2,189,100
Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance				$ 401,212			$ 405,779	$ 404,658	$ 403,157	$ 401,212	$ 388,317	$ 387,205	$ 387,205	$ 403,157	$ 387,205	$ 387,205	$ 361,548	$ 306,115
Share-based compensation - stock options and RSUs							439	482	498	536	669	764				2,492	3,338	2,818
Issuance of common stock							70
Issuance of common stock upon exercise of options																	75	610
Warrants issued in connection with long-term debt																	1,080	3,570
Balance							406,288	405,779	404,658	401,748	401,212	388,317	401,212	406,288	401,748	403,157	387,205	361,548
Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																	3
Unrealized net gain on marketable securities																	(3)	3
Balance																		3
Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance				$ (398,843)			(417,900)	(414,091)	(408,702)	(398,843)	(393,675)	(383,290)	(383,290)	(408,702)	(383,290)	(383,290)	(312,223)	(260,370)
Net loss							(799)	(3,809)	(5,389)	(5,930)	(5,168)	(10,385)				(25,412)	(71,067)	(51,853)
Balance							$ (418,699)	$ (417,900)	(414,091)	(404,773)	(398,843)	(393,675)	(398,843)	$ (418,699)	(404,773)	(408,702)	(383,290)	(312,223)
Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																3	$ 11,898	$ 48,435
Issuance of common stock (in shares) \| shares			3,792,572	150,366
Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock																$ 3
Issuance of common stock (in shares) \| shares			95,000	382,966	13,333			95,000								26,666,666	666,666	431,250
Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 11,898	$ 48,435
At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock								$ 652	$ 1,003		$ 12,226	$ 348				$ 13,457	$ 9,266
At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock																$ 1
Issuance of common stock (in shares) \| shares						172,879		105,342	72,699		173,750	512				12,655,773	3,457
At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock								$ 652	$ 1,003		$ 12,226	$ 348				$ 13,456	$ 9,266
As Previously Reported
Increase (decrease) in stockholders' equity
Balance												$ 3,915	$ 3,915		$ 3,915	$ 3,915	49,328
Share-based compensation - stock options and RSUs																	3,338
Issuance of common stock upon exercise of options																	75
Warrants issued in connection with long-term debt																	1,080
Unrealized net gain on marketable securities																	(3)
Net loss																	(71,067)
Balance																	$ 3,915	$ 49,328
As Previously Reported \| Common stock
Increase (decrease) in stockholders' equity
Balance (in shares) \| shares												3,034,901	3,034,901		3,034,901	3,034,901	2,189,100
Issuance of common stock upon exercise of options (in shares) \| shares																	3,160
Vesting of RSUs (in shares) \| shares																	3,096
Balance (in shares) \| shares																	3,034,901	2,189,100
As Previously Reported \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance												$ 387,205	$ 387,205		$ 387,205	$ 387,205	$ 361,548
Share-based compensation - stock options and RSUs																	3,338
Issuance of common stock upon exercise of options																	75
Warrants issued in connection with long-term debt																	1,080
Balance																	387,205	$ 361,548
As Previously Reported \| Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																	3
Unrealized net gain on marketable securities																	(3)
Balance																		3
As Previously Reported \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance												(383,290)	(383,290)		(383,290)	(383,290)	(312,223)
Net loss																	(71,067)
Balance																	(383,290)	(312,223)
As Previously Reported \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 11,898
Issuance of common stock (in shares) \| shares		7,518,334		7,518,334
As Previously Reported \| Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares		19,148,332		19,148,332	666,666												666,666
As Previously Reported \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 11,898
As Previously Reported \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 9,266
As Previously Reported \| At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares																	172,879
As Previously Reported \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 9,266
Error Correction, Accounting for Warrants \| As Previously Reported
Increase (decrease) in stockholders' equity
Balance				$ 3,419						3,419	2,743	9,271	9,271		9,271	$ 9,271	49,328
Share-based compensation - stock options and RSUs										536	669	764					3,338
Issuance of common stock											12,226
Issuance of common stock upon exercise of options																	75
Warrants issued in connection with long-term debt																	1,080
Unrealized net gain on marketable securities																	(3)
Net loss										(19,666)	(12,219)	(11,769)	(23,988)		(43,652)		(74,894)
Balance										6,260	$ 3,419	$ 2,743	$ 3,419		$ 6,260		$ 9,271	$ 49,328
Error Correction, Accounting for Warrants \| As Previously Reported \| Common stock
Increase (decrease) in stockholders' equity
Balance				$ 1						$ 1
Balance (in shares) \| shares				12,360,157						12,360,157	3,365,422	3,034,901	3,034,901		3,034,901	3,034,901	2,189,100
Issuance of common stock											$ 1
Issuance of common stock (in shares) \| shares											8,687,502
Issuance of common stock upon exercise of options (in shares) \| shares																	3,160
Vesting of RSUs (in shares) \| shares											4,118	1,773					3,096
Balance										$ 4	$ 1		$ 1		$ 4
Balance (in shares) \| shares										39,026,823	12,360,157	3,365,422	12,360,157		39,026,823		3,034,901	2,189,100
Error Correction, Accounting for Warrants \| As Previously Reported \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance				$ 414,523						$ 414,523	$ 400,742	$ 396,388	$ 396,388		$ 396,388	$ 396,388	$ 361,548
Share-based compensation - stock options and RSUs										536	669	764					3,338
Issuance of common stock											12,225
Issuance of common stock upon exercise of options																	75
Warrants issued in connection with long-term debt																	1,080
Balance										437,027	414,523	400,742	414,523		437,027		396,388	$ 361,548
Error Correction, Accounting for Warrants \| As Previously Reported \| Accumulated Other Comprehensive Income
Increase (decrease) in stockholders' equity
Balance																	3
Unrealized net gain on marketable securities																	(3)
Balance																		3
Error Correction, Accounting for Warrants \| As Previously Reported \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance				(411,105)						(411,105)	(398,886)	(387,117)	(387,117)		(387,117)	(387,117)	(312,223)
Net loss										(19,666)	(12,219)	(11,769)					(74,894)
Balance										(430,771)	(411,105)	(398,886)	(411,105)		(430,771)		(387,117)	$ (312,223)
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 21,081
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares) \| shares																	666,666
Error Correction, Accounting for Warrants \| As Previously Reported \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ 21,081
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock										21,971		$ 348					$ 9,266
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales \| Common stock
Increase (decrease) in stockholders' equity
Issuance of common stock										$ 3
Issuance of common stock (in shares) \| shares										26,666,666		25,623					172,879
Error Correction, Accounting for Warrants \| As Previously Reported \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock										$ 21,968		$ 348					$ 9,266
Error Correction, Accounting for Warrants \| Error Correction, Adjustment
Increase (decrease) in stockholders' equity
Balance				(1,050)						(1,050)	(8,101)	$ (5,356)	$ (5,356)		$ (5,356)	$ (5,356)
Balance (in shares) \| shares												(5,356,000)	(5,356,000)		(5,356,000)	(5,356,000)
Net loss										13,736	7,051	$ 1,384	$ 8,435		$ 22,171		3,827
Balance										(9,285)	(1,050)	(8,101)	(1,050)		(9,285)		$ (5,356)
Balance (in shares) \| shares																	(5,356,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Balance				(13,312)						(13,312)	(12,425)	$ (9,183)	$ (9,183)		$ (9,183)	$ (9,183)
Balance (in shares) \| shares												(9,183,000)	(9,183,000)		(9,183,000)	(9,183,000)
Balance										(35,283)	(13,312)	$ (12,425)	$ (13,312)		$ (35,283)		$ (9,183)
Balance (in shares) \| shares																	(9,183,000)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Accumulated Deficit
Increase (decrease) in stockholders' equity
Balance				$ 12,262						12,262	5,211	$ 3,827	$ 3,827		$ 3,827	$ 3,827
Balance (in shares) \| shares												3,827,000	3,827,000		3,827,000	3,827,000
Net loss										13,736	7,051	$ 1,384					$ 3,827
Balance										25,998	$ 12,262	$ 5,211	$ 12,262		$ 25,998		$ 3,827
Balance (in shares) \| shares																	3,827,000
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Public offering
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ (9,183)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| Public offering \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock																	$ (9,183)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| At-the-market sales
Increase (decrease) in stockholders' equity
Issuance of common stock										(21,971)
Error Correction, Accounting for Warrants \| Error Correction, Adjustment \| At-the-market sales \| Additional Paid-in Capital.
Increase (decrease) in stockholders' equity
Issuance of common stock										$ (21,971)

Prepaid Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Prepaid Expenses
Prepaid insurance	$ 697	$ 628	$ 775
Other	562	775	1,508
Total prepaid expenses and other current assets	$ 1,259	$ 1,403	$ 2,283

Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 2,873			$ 5,246				$ 19,143
Accounts receivable, net	3,521			3,377				1,533
Inventory, net	2,411			1,332				966
Prepaid expenses and other current assets	1,259			1,403				2,283
Total current assets	10,064			11,358				23,925
Property and equipment, net	101			177				12,447
Right of use asset	486			695				949
Other non-current assets	238			2,012				2,012
Total assets	10,889			14,242				39,333
Current liabilities:
Long-term debt, current portion	1,589			1,426				16,833
Notes payable, current portion	379
Accounts payable	6,879			7,734				8,707
Accrued expenses	8,338			3,908				3,563
Lease liability, current portion	353			319				175
Total current liabilities	17,538			13,387				29,278
Lease liabilities, long-term	196			466				784
Warrant liability	5,566			5,934				5,356
Total liabilities	23,300			19,787				35,418
Commitments and contingencies (Note 10)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at September 30, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,277,657 and 859,402 issued and outstanding at September 30, 2023 and December 31, 2022, respectively				4
Additional paid-in capital	406,288			403,157				387,205
Accumulated deficit	(418,699)			(408,702)				(383,290)
Total stockholders' deficit	(12,411)	$ (12,121)	$ (9,433)	(5,545)	$ (3,025)	$ 2,369	$ (5,358)	3,915	$ 49,328	$ 45,745
Total liabilities and stockholders' deficit	$ 10,889			$ 14,242				$ 39,333

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Dec. 31, 2021
Accrued Liabilities
Gross to net accruals	$ 3,933	$ 2,332	$ 670
Accrued compensation	2,721	833	2,086
Accrued professional fees and other	1,684	743	807
Total accrued liabilities	$ 8,338	$ 3,908	$ 3,563

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Taxes

Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets


	December 31,
	2022		2021
Deferred tax assets:
Net operating loss carryforwards	$	87,216	$	81,102
Research credit carryforward		7,071		7,943
Stock options and other		2,297		2,114
Total gross deferred tax assets		96,584		91,159
Valuation allowance for deferred tax assets		(96,584)		(91,159)
Net deferred tax assets	$	—	$	—

Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate


	December 31,
	2022		2021 (Restated)		2020
Federal income tax at statutory rate	21.0	%	21.0	%	21.0	%
State income tax benefit, net of federal benefit	0.1	%	0.2	%	1.0	%
Unrealized gain on warrants	18.8	%	1.1	%	—	%
Research and development tax credits	0.1	%	0.2	%	0.7	%
Other	(5.6)	%	(2.2)	%	(2.0)	%
Increase to valuation allowance	(18.5)	%	(20.3)	%	(20.7)	%
Effective income tax rate	15.9	%	0.0	%	0.0	%

Leases

9 Months Ended

12 Months Ended

Sep. 30, 2023

Dec. 31, 2022

Leases

Leases

6. Leases

and 2022 were approximately $235,000 and $132,000 respectively. As of September 30, 2023, the weighted average remaining lease term was 1.50 years, and the weighted average discount rate was 11.8%.

Future minimum lease payments under non-cancellable leases as of September 30, 2023 were as follows (in thousands):


2023	$	98
2024		397
2025		101
Total	$	596
Less: Interest		(47)
Present value of lease liability	$	549

8. Leases

Future minimum lease payments under non-cancellable leases as of December 31, 2022 were as follows:


2023	$	391
2024		397
2025		101
Total	$	889
Less: Interest		(104)
Present value of lease liability	$	785

Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Deferred tax assets:
Net operating loss carryforwards	$ 87,216	$ 81,102
Research credit carryforward	7,071	7,943
Stock options and other	2,297	2,114
Total gross deferred tax assets	96,584	91,159
Valuation allowance for deferred tax assets	(96,584)	(91,159)
Net deferred tax assets	0	0
Valuation allowance
Increase (decrease) in the valuation allowance	$ 5,400	$ 14,400

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model	Sep. 30, 2023 Y USD ($)	Dec. 31, 2022 Y USD ($)	Dec. 31, 2021 Y USD ($)
Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input			136.4
Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		4.2	1.1
Fair value
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	2.40	11.50	31.63
Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y			4.98
Preferred Warrants [Member] \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		520.00
Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.69	0.90	34.08
Maximum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	123.42	137.4
Maximum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	5.46	4.7
Maximum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	4.65	4.5
Maximum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1,700.00	1,700
Minimum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	86.06	136.8
Minimum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	4.62	4.2
Minimum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	1.15	0.70
Minimum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	45.00	45.00