0001558370-24-004262 | 10-K | XBRL Viewer

Commitments and Contingencies	12 Months Ended
Dec. 31, 2023
Commitments and Contingencies
Commitments and Contingencies	12. 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, as well as the Company’s operating lease (see Note 7) total $227.9 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 2024 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 2024 and each year thereafter is $22.5 million. 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 December 31, 2023, the Company has not recorded a provision for any contingent losses.

Commitments and Contingencies

12 Months Ended

Dec. 31, 2023

12. 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, as well as the Company’s operating lease (see Note 7) total $227.9 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 2024 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 2024 and each year thereafter is $22.5 million. 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 December 31, 2023, the Company has not recorded a provision for any contingent losses.

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

Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 2,557	$ 5,246
Accounts receivable, net	3,392	3,377
Inventory, net	2,738	1,332
Prepaid expenses and other current assets	843	1,403
Total current assets	9,530	11,358
Property and equipment, net	75	177
Right of use asset	412	695
Other non-current assets	238	2,012
Total assets	10,255	14,242
Current liabilities:
Long-term debt, current portion	1,515	1,426
Notes payable, current portion	191
Accounts payable	9,574	7,734
Accrued expenses	9,131	3,908
Lease liability, current portion	366	319
Total current liabilities	20,777	13,387
Lease liabilities, long-term	100	466
Warrant liability	5,696	5,934
Total liabilities	26,573	19,787
Commitments and contingencies (Note 12)
Stockholders' deficit
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2023 and no shares issued and outstanding at December 31, 2022
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,963,657 and 859,402 issued and outstanding at December 31, 2023 and December 31, 2022, respectively	4
Additional paid-in capital	406,846	403,157
Accumulated deficit	(423,168)	(408,702)
Total stockholders' deficit	(16,318)	(5,545)
Total liabilities and stockholders' deficit	$ 10,255	$ 14,242

Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities:
Net loss	$ (14,465)	$ (25,412)	$ (71,067)
Adjustments to reconcile net loss to net cash used in operating activities:
Noncash inventory reserve	801	397	5,323
Depreciation	102	1,280	2,064
Amortization	284	254	159
Loss on disposition of assets		11,122
Noncash stock-based compensation	1,981	2,493	3,338
Noncash amortization of deferred financing costs	1,063	1,969	1,661
Unrealized gain on warrants	(6,760)	(25,520)	(3,827)
Changes in operating assets and liabilities:
Accounts receivable	(15)	(1,844)	(668)
Inventory	(2,207)	(763)	(6,289)
Prepaid expenses and other assets	2,270	880	(967)
Accounts payable and accrued expenses	7,688	(628)	5,202
Lease liability	(319)	(175)	(131)
Net cash used in operating activities	(9,577)	(35,947)	(65,202)
Cash flows from investing activities:
Sales and maturities of marketable securities			39,729
Acquisition of property and equipment		(133)	(269)
Net cash (used in) provided by investing activities		(133)	39,460
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs	6,510	21,936	21,081
Repayments of long-term debt	(975)	(17,375)
Proceeds from exercise of stock options			75
Repayments of note payable	(372)
Net cash provided by financing activities	6,888	22,183	30,422
Net (decrease) increase in cash and cash equivalents	(2,689)	(13,897)	4,680
Cash and cash equivalents, beginning of period	5,246	19,143	14,463
Cash and cash equivalents, end of period	2,557	5,246	19,143
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt			1,080
Operating right-of-use assets obtained in exchange for new operating lease liabilities			969
Supplemental cash flow information
Interest paid	356	1,162	2,383
Public offering
Cash flows from financing activities:
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs		4,128
At-the-market sales
Cash flows from financing activities:
Proceeds from At-the-Market sales of common stock, net of offering costs	$ 1,725	$ 13,494	$ 9,266

Leases - Maturity of lease liabilities (Details) $ in Thousands	Dec. 31, 2023 USD ($)
Operating Leases
2024	$ 397
2025	101
Total	498
Less: Interest	(32)
Present value of lease liability	$ 466

Subsequent Events

12 Months Ended

Dec. 31, 2023

Subsequent Events

Subsequent Events

13. Subsequent Events

Warrant Exercise

On February 22, 2024, the Company entered into a warrant exercise agreement (the “Exercise Agreement”) with a certain holder of its Warrants issued on July 6, 2022 and May 23, 2022 which were amended on December 3, 2023 (the “Exercising Holder”) wherein the Exercising Holder agreed to exercise a total of 3,892,572 warrants for cash, at an exercise price reduced by the Company to $1.25 per share (the “Warrant Exercise”).

The gross proceeds from the Warrant Exercise were approximately $4.8 million before deducting placement agent fees and other expenses.

In consideration for the Warrant Exercise, the Company issued new unregistered warrants to purchase shares of Common Stock (the “New Warrants”). The New Warrants are exercisable for an aggregate of up to 7,785,144 shares of Common Stock, at an exercise price of $1.00 per share and will be immediately exercisable upon issuance. 3,992,572 of the New Warrants will have a term of five years from the issuance date and 3,792,572 of the New Warrants will have a term of eighteen months from the issuance date. The exercise price of the New Warrants is subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in the New Warrants.

H.C. Wainwright & Co., LLC acted as placement agent and financial advisor in connection with the transaction and will receive a cash fee of 7.0% of the gross proceeds resulting from the Warrant Exercise, a management fee of 1.0% of the gross proceeds resulting from the Warrant Exercise and warrants (the “Placement Agent Warrants”) to purchase a number of shares of Common Stock equal to 5.0% of the number of Warrants exercised at an exercise price of $1.5625.

Perceptive Credit Agreement

On February 9, 2024, the Company and Perceptive entered into an eighth amendment to the Perceptive Credit Agreement (the “Eighth Amendment”). The Eighth Amendment extended the maturity date of the Perceptive Credit Agreement from February 10, 2024 until March 11, 2024 (the “Maturity Date”). Effective December 1, 2023, the Company has been making monthly payments of $150,000 on the outstanding loan balance and on March 11, 2024, the Company paid off the remainder of the principal balance of $1.35 million.

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Dec. 31, 2023
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Modification	false
Rule 10b5-1 Arrangement Modification	false

Fair Value Measurements

12 Months Ended

Dec. 31, 2023

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 tables set forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2023 and 2022:


	Level 1		Level 2		Level 3
December 31, 2023
Assets:
Cash and cash equivalents	$	2,557	$	—	$	—
Total assets at fair value	$	2,557	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,696
Total assets at fair value	$	—	$	—	$	5,696


	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 December 31, 2023 include (i) volatility 101.5% - 126.0%, (ii) risk-free interest rate 3.8% - 4.0%, (iii) strike price for the common warrants $3.69 and $1,700.00, (iv) fair value of common stock $1.95, and (v) expected life 2.8 – 4.4 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 $1,700.00, (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		12,537
Change in fair value		(12,775)
Ending Balance December 31, 2023	$	5,696

There were no transfers between Level 1, 2 or 3 during 2023 or 2022.

- 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 (Deficit) - Amended and Restated Certificate of Incorporation (Details)	Apr. 10, 2023 shares	Dec. 31, 2023 shares	Apr. 09, 2023 shares	Dec. 31, 2022 shares	Jan. 07, 2022 shares	Jan. 06, 2022 shares
Stockholders' Equity (Deficit)
Common stock, authorized (in shares)		300,000,000		300,000,000	300,000,000	150,000,000
Reverse stock split conversion ratio	0.02
Common stock, issued (in shares)	932,101	2,963,657	46,605,134	859,402
Common Stock, Shares, Outstanding	932,101	2,963,657	46,605,134	859,402

Equity Incentive Plans - Stock Option Activity (Details) - Common stock options - $ / shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Dec. 29, 2023
Options
Options outstanding at beginning of year (in shares)	7,928	5,183
Options granted (in shares)	35,825	3,749
Options exercised (in shares)		0
Options cancelled/forfeited (in shares)	(710)	(1,004)
Options outstanding at end of year (in shares)	43,043	7,928	5,183
Options exercisable at end of year (in shares)	5,007
Vested and expected to vest at end of year (in shares)	43,043
Weighted Average Exercise Price
Options outstanding at beginning of year (in dollars per share)	$ 3,187.50	$ 5,666.50
Options granted (in dollars per share)	2.64	198.50
Options exercised (in dollars per share)		0
Options cancelled/forfeited (in dollars per share)	2,398.42	4,872.00
Options outstanding at end of year (in dollars per share)	548.70	$ 3,187.50	$ 5,666.50
Options exercisable at end of year (in dollars per share)	$ 4,438.73
Weighted Average Remaining Contractual Life (Years)
Options outstanding	9 years	7 years 8 months 12 days	6 years 1 month 6 days
Options exercisable	5 years 9 months 18 days
Estimated stock price (in dollars per share)				$ 1.95

Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Beginning balance	$ 5,326	$ 1,040
Allowances for current period sales	29,541	10,325
Payments and credits	(23,661)	(6,039)
Ending balance	11,206	5,326
Customer credits, discounts And allowances
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Beginning balance	2,994	371
Allowances for current period sales	18,385	5,891
Payments and credits	(16,665)	(3,268)
Ending balance	4,714	2,994
Rebates and co-pay assistance
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Beginning balance	1,989	528
Allowances for current period sales	8,192	4,035
Payments and credits	(5,564)	(2,574)
Ending balance	4,617	1,989
Product returns
Accounts Receivable, Allowance for Credit Loss [Roll Forward]
Beginning balance	343	141
Allowances for current period sales	2,964	399
Payments and credits	(1,432)	(197)
Ending balance	$ 1,875	$ 343

Credit Agreement and Guaranty (Tables)

12 Months Ended

Dec. 31, 2023

Credit Agreement and Guaranty

Schedule of carrying amount of term loan


	December 31,		December 31,
	2023		2022
Long-term debt	$	1,650	$	2,625
Debt issuance costs		(23)		(209)
Warrant discount		(112)		(990)
Total debt	$	1,515	$	1,426
Less, current portion		1,515		1,426
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

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+ Details

Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
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
Warrants issued	12,537
Change in fair value	(12,775)
Ending balance	$ 5,696	$ 5,934

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2023

Property and Equipment

Schedule of components of property and equipment



	December 31,				Estimated
	2023		2022		Life
Office equipment	$	132	$	132	5 years
Computer equipment		121		121	3 Years
Manufacturing equipment		—		—	7 years
		253		253
Less: accumulated depreciation		(178)		(76)
Property and equipment	$	75	$	177

Prepaid Expenses

12 Months Ended

Dec. 31, 2023

Prepaid Expenses

Prepaid Expenses

4. Prepaid Expenses

Prepaid expenses consist of the following:


	December 31,
	2023		2022
Prepaid insurance	$	441	$	628
Other		402		775
Total prepaid expenses and other current assets	$	843	$	1,403

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	5,806,197	1,138,111	12,941
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	5,589,637	1,130,025	7,592
Unvested restricted stock units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	173,517	129	167
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	43,043	7,956	5,183

Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Equity Incentive Plans
Total stock-based compensation expense	$ 1,981	$ 2,493	$ 3,338
Common stock options
Equity Incentive Plans
Total stock-based compensation expense	$ 1,981	$ 2,492	$ 3,338
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	$ 1,400
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)	$ 2.64
Common stock options \| Cost of product revenues
Equity Incentive Plans
Total stock-based compensation expense	$ 107	$ 133	$ 271
Common stock options \| Research and development
Equity Incentive Plans
Total stock-based compensation expense	358	372	490
Common stock options \| Selling and marketing
Equity Incentive Plans
Total stock-based compensation expense	102	155	148
Common stock options \| General and administrative
Equity Incentive Plans
Total stock-based compensation expense	$ 1,414	$ 1,832	$ 2,429
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)	3.87%	1.71%	0.66%
Expected volatility (as a percent)	115.90%	107.00%	105.00%
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)	3.90%	4.22%	1.51%
Expected volatility (as a percent)	118.60%	118.00%	106.00%
Unvested restricted stock units
Unrecorded deferred stock-based compensation
Unrecorded deferred stock-based compensation balance related to stock options	$ 300
Weighted-average amortization period over which cost is expected to be recognized	3 years 1 month 9 days

Accrued Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Accrued Liabilities
Gross to net accruals	$ 6,492	$ 2,332
Accrued compensation	832	833
Accrued professional fees and other	1,807	743
Total accrued liabilities	$ 9,131	$ 3,908

Equity Incentive Plans - Stock Options Summary (Details) - Common stock options	12 Months Ended
	Dec. 31, 2023 $ / shares shares
Minimum
Equity Incentive Plans
Exercise prices of options granted through the end of the year (in dollars per share)	$ 10.00
Maximum
Equity Incentive Plans
Exercise prices of options granted through the end of the year (in dollars per share)	$ 21,500.00
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	6,200

Prepaid Expenses (Tables)

12 Months Ended

Dec. 31, 2023

Prepaid Expenses

Schedule of prepaid expenses


	December 31,
	2023		2022
Prepaid insurance	$	441	$	628
Other		402		775
Total prepaid expenses and other current assets	$	843	$	1,403

Pay vs Performance Disclosure - USD ($) $ in Thousands	12 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Pay vs Performance Disclosure
Net Income (Loss)	$ (14,465)	$ (25,412)	$ (71,067)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

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+ Details

Organization and Description of Business

12 Months Ended

Dec. 31, 2023

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 December 31, 2023, the Company had an accumulated deficit of approximately $423.2 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 9), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding.

Going Concern

As of December 31, 2023, the Company had cash and cash equivalents of $2.5 million and a $11.2 million working capital deficit. The Company’s current liquidity is sufficient to fund operations into April 2024. 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 December 31, 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 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, 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 its business plan and successfully commercialize Twirla. The audited financial statements as of December 31, 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.

Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Property and Equipment
Property and equipment, gross	$ 253	$ 253
Less: accumulated depreciation	(178)	(76)
Property and equipment, net	75	177
Office equipment
Property and Equipment
Property and equipment, gross	$ 132	$ 132
Estimated Life (in years)	5 years	5 years
Computer equipment
Property and Equipment
Property and equipment, gross	$ 121	$ 121
Estimated Life (in years)	3 years	3 years
Manufacturing equipment
Property and Equipment
Estimated Life (in years)	7 years	7 years

Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Deferred tax assets:
Net operating loss carryforwards	$ 88,279	$ 87,216
Research credit carryforward	7,026	7,071
Capitalized research and development expenses	164	205
Stock options and other	5,028	2,092
Total gross deferred tax assets	100,497	96,584
Valuation allowance for deferred tax assets	(100,497)	(96,584)
Net deferred tax assets	0	0
Valuation allowance
Increase (decrease) in the valuation allowance	$ 3,900	$ 5,400

Equity Incentive Plans - Restricted Stock (Details) - Unvested restricted stock units - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Shares
Restricted stock outstanding at beginning of year (in shares)	125	167
Granted (in shares)	155,004	94
Vested (in shares)	(112)	(135)
Forfeited (in shares)	(1,500)
Restricted stock outstanding at end of year (in shares)	153,517	125	167
Weighted Average Grant Date Fair Value
Granted (in dollars per share)	$ 2.46	$ 52.50
Vested (in dollars per share)	674.63	$ 3,815.00
Forfeited (in dollars per share)	$ 2.48
Aggregate Intrinsic Value
Intrinsic value of vested shares	$ 299	$ 163	$ 163
Executive officers
Shares
Granted (in shares)			35
Vesting period			1 year
Directors
Shares
Granted (in shares)		94	113
Directors \| Minimum
Shares
Vesting period		1 year	1 year
Directors \| Maximum
Shares
Vesting period			3 years
Employees and directors
Shares
Granted (in shares)	155,004
Employees and directors \| Minimum
Shares
Vesting period	1 year
Employees and directors \| Maximum
Shares
Vesting period	4 years

Property and Equipment

12 Months Ended

Dec. 31, 2023

Property and Equipment

Property and Equipment

5. 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
	2023		2022		Life
Office equipment	$	132	$	132	5 years
Computer equipment		121		121	3 Years
Manufacturing equipment		—		—	7 years
		253		253
Less: accumulated depreciation		(178)		(76)
Property and equipment	$	75	$	177

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.

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Interest expense
Deferred Financing Costs
Amortization of deferred financing costs	$ 185,000	$ 342,000	$ 277,000

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

Leases - Summary (Details)	12 Months Ended
Leases - Summary (Details)	Dec. 31, 2023 USD ($) item	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)
Leases
Number of finance leases \| item	0
Number of operating leases \| item	1
Lessee, Operating Lease, Existence of Option to Extend [true false]	true
Renewal term	5 years
Operating lease expense \| $	$ 355,000	$ 355,000	$ 180,000
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities \| $	$ 319,000	$ 175,000	$ 131,000
Weighted-average remaining lease term (years)	1 year 3 months
Weighted-average discount rate	11.80%

Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Summary of Significant Accounting Policies
Advertising costs	$ 0.0	$ 8.2	$ 13.8

Income Taxes

12 Months Ended

Dec. 31, 2023

Income Taxes

Income Taxes

11. 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, 2023, the Company had available net operating loss carryforwards (“NOLs”) of approximately $396.5 million for federal and $77.4 million for state income tax reporting purposes. Under the TCJA, the federal NOLs generated after 2017, approximately $209.6 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $186.9 million, are available to offset future federal taxable income, if any, through 2037 and will begin to expire in 2024 in varying amounts if not utilized. The Company also has research and development tax credit carryforwards of approximately $6.3 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 federal credits will begin to expire in 2024 in varying amounts if not utilized.

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.

The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the income tax provision; however, as of December 31, 2023, the Company has not accrued any interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2020 through December 31, 2022 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, 2023, 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 is 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,
	2023		2022
Deferred tax assets:
Net operating loss carryforwards	$	88,279	$	87,216
Research credit carryforward		7,026		7,071
Capitalized research and development expenses		164		205
Stock options and other		5,028		2,092
Total gross deferred tax assets		100,497		96,584
Valuation allowance for deferred tax assets		(100,497)		(96,584)
Net deferred tax assets	$	—	$	—

The net change in the valuation allowance for the years ended December 31, 2023 and 2022 was an increase of $3.9 million and an increase of $5.4 million, respectively.

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


	December 31,
	2023		2022		2021
Federal income tax at statutory rate	21.0	%	21.0	%	21.0	%
State income tax benefit, net of federal benefit	0.9	%	0.1	%	0.2	%
Unrealized gain on warrants	9.8	%	17.8	%	1.1	%
Research and development tax credits	—	%	0.1	%	0.2	%
Other	(4.6)	%	(5.5)	%	(2.2)	%
Increase to valuation allowance	(27.1)	%	(18.0)	%	(20.3)	%
Effective income tax rate	0.0	%	15.5	%	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

Income Taxes - Sale of New Jersey Net Operating Losses (Details) - New Jersey - USD ($) $ in Millions	1 Months Ended		12 Months Ended
	Jan. 31, 2021	Jan. 31, 2018	Dec. 31, 2022	Mar. 31, 2022
Sale of New Jersey Net Operating Losses
Net proceeds from sale of NOL and tax credit			$ 4.7
Sale of unused NOLs
Sale of New Jersey Net Operating Losses
Maximum lifetime benefit under the Program	$ 20.0	$ 15.0
Sale of unused NOLs \| 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
Sale of New Jersey Net Operating Losses
NOLs				$ 44.3
Research and Development.
Sale of New Jersey Net Operating Losses
NOLs				$ 1.0

Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Preferred Stock Series A Convertible Preferred Stock	Preferred Stock Series B Convertible Preferred Stock	Preferred Stock Series A and B Convertible 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, 2020											$ 361,548	$ 3	$ (312,223)			$ 49,328
Balance (in shares) at Dec. 31, 2020								43,782
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs											3,338					3,338
Issuance of common stock									$ 11,898	$ 9,266				$ 11,898	$ 9,266
Issuance of common stock (in shares)				13,333	3,458
Issuance of common stock upon exercise of options											75					75
Issuance of common stock upon exercise of options (in shares)								63
Vesting of RSUs (in shares)								62
Warrants issued in connection with long-term debt											1,080					1,080
Unrealized net gain on marketable securities												$ (3)				(3)
Net Income (Loss)													(71,067)			(71,067)
Balance at Dec. 31, 2021											387,205		(383,290)			3,915
Balance (in shares) at Dec. 31, 2021								60,698
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs											2,492					2,492
Issuance of common stock				$ 3	$ 1					13,456				$ 3	13,457
Issuance of common stock (in shares)				533,333	253,115
Conversion of convertible preferred stock (in shares)	(2,425)	(2,425)	4,850			6,063	6,063
Vesting of RSUs (in shares)								130
Net Income (Loss)													(25,412)			(25,412)
Balance at Dec. 31, 2022								$ 4			403,153		(408,702)			(5,545)
Balance (in shares) at Dec. 31, 2022								859,402
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs											1,981					1,981
Fractional shares retired as a result of reverse split											(13)					(13)
Issuance of common stock										$ 1,725					$ 1,725
Issuance of common stock (in shares)				95,000	207,883
Exercise of pre-funded warrants (in shares)								1,801,286
Vesting of RSUs (in shares)								86
Net Income (Loss)													(14,465)			(14,465)
Balance at Dec. 31, 2023								$ 4			$ 406,846		$ (423,168)			$ (16,318)
Balance (in shares) at Dec. 31, 2023								2,963,657

Income Taxes - Reconciliation of U.S. statutory income tax rate to effective tax rate (Details)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
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)	0.90%	0.10%	0.20%
Unrealized gain on warrants	9.80%	17.80%	1.10%
Research and development tax credits (as a percent)		0.10%	0.20%
Other (as a percent)	(4.60%)	(5.50%)	(2.20%)
Increase to valuation allowance (as a percent)	(27.10%)	(18.00%)	(20.30%)
Effective income tax rate (as a percent)	0.00%	15.50%	0.00%

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model	Dec. 31, 2023 USD ($) Y	Dec. 31, 2022 USD ($) Y
Fair value
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1.95	11.50
Preferred Warrants [Member] \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		520.00
Maximum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	126.0	137.4
Maximum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	4.0	4.7
Maximum \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		1,700.00
Maximum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	4.4	4.5
Maximum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	1,700.00
Minimum \| Option Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	101.5	136.8
Minimum \| Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.8	4.2
Minimum \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input		45.00
Minimum \| Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input \| Y	2.8	0.7
Minimum \| Common stock warrants \| Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	3.69

Organization and Description of Business (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022
Nature of Operations
Cash, cash equivalents and marketable securities	$ 2,500
Working capital deficit	(11,200)
Accumulated deficit	$ 423,168	$ 408,702

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Equity Incentive Plans (Tables)

12 Months Ended

Dec. 31, 2023

Equity Incentive Plans

Schedule of stock-based compensation expense


	Year Ended
	December 31,
	2023		2022		2021
Cost of product revenues	$	107	$	133	$	271
Research and development		358		372		490
Selling and marketing		102		155		148
General and administrative		1,414		1,832		2,429
Total	$	1,981	$	2,492	$	3,338

Schedule of assumptions used to compute employee stock-based compensation


	2023		2022		2021
Risk‑free interest rate	3.87%-3.90	%	1.71% - 4.22	%	.66% - 1.51	%
Expected volatility	115.9%-118.6	%	107% ‑ 118	%	105% ‑ 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, 2021	5,183	5,666.50	6.1
Options granted	3,749	198.50
Options exercised	—	—
Options cancelled/forfeited	(1,004)	4,872.00
Options outstanding at December 31, 2022	7,928	3,187.50	7.7
Options granted	35,825	2.64
Options exercised	—	—
Options cancelled/forfeited	(710)	2,398.42
Options outstanding at December 31, 2023	43,043	548.70	9.0	$	—
Options exercisable at December 31, 2023	5,007	4,438.73	5.8	$	—
Vested and expected to vest at December 31, 2023	43,043			$	—

Schedule of restricted stock activity


		Weighted Average	Aggregate
	Shares	Grant Date Fair Value	Intrinsic Value
Restricted stock units outstanding at December 31, 2021	167		$	163
Granted	94	52.50
Vested	(135)	3,815.00
Restricted stock units outstanding at December 31, 2022	125	—	$	163
Granted	155,004	2.46
Vested	(112)	674.63
Forfeited	(1,500)	2.48
Restricted stock units outstanding at December 31, 2023	153,517		$	299

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2023

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. 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, 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.

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.

Accounts Receivable and Allowances

Accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The 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 December 31, 2023 and 2022, respectively.

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 December 31, 2023 and 2022 inventory reserves approximated $1.4 million and $0.6 million, respectively.

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 the carrying values of any long-lived assets are impaired as of December 31, 2023.

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.

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, $8.2 million and $13.8 million for the years ended December 31, 2023, 2022 and 2021, respectively.

Deferred Financing Costs

Costs directly attributable to the Company’s term loan (see Note 8) 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 $185,000, $342,000 and $277,000 for the years ended December 31, 2023, 2022 and 2021, 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 2023, the Company had sales to five customers that individually accounted for more than 10% of total revenue. These customers had sales of $4.7 million, $3.8 million, $3.7 million, $3.5 million and $2.8 million, respectively, which represented 94% of the Company’s total revenue for 2023. Accounts receivable related to these five customers comprised 6%, 30%, 30%, 29% and 0% of the Company’s total accounts receivable, respectively, as of December 31, 2023. In 2022, the Company had sales to four customers that individually accounted for more than 10% of 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 the Company’s total revenue for 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. Accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described later in this section and in the 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 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 had relied on quantitative and qualitative data from various internal and external sources to estimate its 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 primarily 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 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 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, an estimate for product returns as of December 31, 2023 was made based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by third-parties including a third-party data provider which collects and publishes prescription data (iv) expired returns credits issued to date, and (v) the estimated remaining shelf life of Twirla previously shipped and currently being shipped to distributors. Estimated product returns are recorded as 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 accounts receivable on the balance sheet.

Rebates – The Company is 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’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as 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 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, 2023 which have been deducted in arriving at revenues, net.


	Customer credits,		Rebates and co-pay
		discounts and allowances		assistance		Product returns
	(contra accounts receivable)		(accrued expenses)		(accrued expenses)		Total
Balance as of December 31, 2021	$	371	$	528	$	141	$	1,040
Allowances for current period sales		5,891		4,035		399		10,325
Payments and credits		(3,268)		(2,574)		(197)		(6,039)
Balance as of December 31, 2022		2,994		1,989		343		5,326
Allowances for current period sales		18,385		8,192		2,964		29,541
Payments and credits		(16,665)		(5,564)		(1,432)		(23,661)
Balance as of December 31, 2023	$	4,714	$	4,617	$	1,875	$	11,206

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 8 and 9 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 8 and 9 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 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 8 and 9 for additional information.

In connection with a letter agreement and waiver entered into with an investor in 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 and Comprehensive Loss each reporting period. See Note 9 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 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.

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 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.

On December 3, 2023, the Company entered into a Warrant Amendment and Additional Issuance Agreement (“Warrant Amendment and Additional Issuance Agreement”) relating to the amendment of warrants to purchase shares of common stock that were issued in transactions on March 14, 2022, April 25, 2022, and May 25, 2023 (collectively, the “Warrants”). Collectively, the Warrants represent the right to purchase approximately 3.8 million shares of common stock. See Note 9 for additional information.

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, 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 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.

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, 2023, 2022 and 2021, respectively, because to do so would be anti-dilutive (in common equivalent shares):


	Year Ended December 31,
	2023	2022	2021
Common stock warrants	5,589,637	1,130,025	7,592
Unvested restricted stock units	173,517	129	167
Common stock options	43,043	7,956	5,183
Total	5,806,197	1,138,111	12,941

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the year ended December 31, 2023 that had a material effect on its financial statements.

In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”). The guidance in ASU 2023-07 expands prior reportable segment disclosure requirements by requiring entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and details of how the CODM uses financial reporting to assess their segment’s performance. The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07 may have on its financial statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its 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.

Commitments and Contingencies (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Dec. 31, 2022	Dec. 31, 2023
Commitments and Contingencies
Future purchase commitments			$ 227.9
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%
2024 and Each Year Thereafter			$ 22.5

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2023

Income Taxes

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


	December 31,
	2023		2022
Deferred tax assets:
Net operating loss carryforwards	$	88,279	$	87,216
Research credit carryforward		7,026		7,071
Capitalized research and development expenses		164		205
Stock options and other		5,028		2,092
Total gross deferred tax assets		100,497		96,584
Valuation allowance for deferred tax assets		(100,497)		(96,584)
Net deferred tax assets	$	—	$	—

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


	December 31,
	2023		2022		2021
Federal income tax at statutory rate	21.0	%	21.0	%	21.0	%
State income tax benefit, net of federal benefit	0.9	%	0.1	%	0.2	%
Unrealized gain on warrants	9.8	%	17.8	%	1.1	%
Research and development tax credits	—	%	0.1	%	0.2	%
Other	(4.6)	%	(5.5)	%	(2.2)	%
Increase to valuation allowance	(27.1)	%	(18.0)	%	(20.3)	%
Effective income tax rate	0.0	%	15.5	%	0.0	%

Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2023

Summary of Significant Accounting Policies

Summary of sales allowances and related accruals


	Customer credits,		Rebates and co-pay
		discounts and allowances		assistance		Product returns
	(contra accounts receivable)		(accrued expenses)		(accrued expenses)		Total
Balance as of December 31, 2021	$	371	$	528	$	141	$	1,040
Allowances for current period sales		5,891		4,035		399		10,325
Payments and credits		(3,268)		(2,574)		(197)		(6,039)
Balance as of December 31, 2022		2,994		1,989		343		5,326
Allowances for current period sales		18,385		8,192		2,964		29,541
Payments and credits		(16,665)		(5,564)		(1,432)		(23,661)
Balance as of December 31, 2023	$	4,714	$	4,617	$	1,875	$	11,206

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


	Year Ended December 31,
	2023	2022	2021
Common stock warrants	5,589,637	1,130,025	7,592
Unvested restricted stock units	173,517	129	167
Common stock options	43,043	7,956	5,183
Total	5,806,197	1,138,111	12,941

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2023

Summary of Significant Accounting Policies

Basis of Presentation

Basis of Presentation

Use of Estimates

Use of Estimates

Risks and Uncertainties

Risks and Uncertainties

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.

Cash and Cash Equivalents

Cash and Cash Equivalents

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

Accounts Receivable and Allowances

Accounts Receivable and Allowances

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.

Inventory

Inventory

Property and Equipment

Property and Equipment

Long-Lived Assets

Long-Lived Assets

Research and Development Expense

Research and Development Expense

Advertising Costs

Advertising Costs

The Company has elected to expense advertising costs when incurred. Advertising costs totaled zero, $8.2 million and $13.8 million for the years ended December 31, 2023, 2022 and 2021, respectively.

Deferred Financing Costs

Deferred Financing Costs

Concentrations of Credit Risk

Concentrations of Credit Risk

$2.9 million, $2.7 million, $2.6 million and $1.2 million, respectively, which represented 86% of the Company’s total revenue for 2022.

Revenue Recognition

Revenue Recognition

●

Distribution services fees;

●

Prompt pay and other discounts;

●

Product returns;

●

Chargebacks;

●

Rebates; and

●

Co-payment assistance.

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

The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2023 which have been deducted in arriving at revenues, net.


	Customer credits,		Rebates and co-pay
		discounts and allowances		assistance		Product returns
	(contra accounts receivable)		(accrued expenses)		(accrued expenses)		Total
Balance as of December 31, 2021	$	371	$	528	$	141	$	1,040
Allowances for current period sales		5,891		4,035		399		10,325
Payments and credits		(3,268)		(2,574)		(197)		(6,039)
Balance as of December 31, 2022		2,994		1,989		343		5,326
Allowances for current period sales		18,385		8,192		2,964		29,541
Payments and credits		(16,665)		(5,564)		(1,432)		(23,661)
Balance as of December 31, 2023	$	4,714	$	4,617	$	1,875	$	11,206

Warrants

Warrants

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

Income Taxes

Income Taxes

uncertain tax positions as of December 31, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance.

Stock-Based Compensation

Stock-Based Compensation

Segment Information

Segment Information

Net Loss Per Share

Net Loss Per Share


	Year Ended December 31,
	2023	2022	2021
Common stock warrants	5,589,637	1,130,025	7,592
Unvested restricted stock units	173,517	129	167
Common stock options	43,043	7,956	5,183
Total	5,806,197	1,138,111	12,941

Recent Accounting Pronouncements

Recent Accounting Pronouncements

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.

Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2023	Mar. 27, 2024	Jun. 30, 2023
Document and Entity Information
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2023
Document Transition Report	false
Entity File Number	001-36464
Entity Registrant Name	AGILE THERAPEUTICS INC
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	23-2936302
Entity Address, Address Line One	500 College Road East, Suite 310
Entity Address, City or Town	Princeton
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	08540
City Area Code	609
Local Phone Number	683-1880
Title of 12(g) Security	Common Stock, par value $0.0001 per share
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Document Financial Statement Error Correction [Flag]	false
Entity Shell Company	false
Entity Public Float			$ 4.8
Entity Common Stock, Shares Outstanding		6,856,229
Entity Central Index Key	0001261249
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	FY
Amendment Flag	false
Auditor Name	Ernst & Young LLP
Auditor Firm ID	42
Auditor Location	Iselin, New Jersey

Summary of Significant Accounting Policies - Segment Information (Details)	12 Months Ended
	Dec. 31, 2023 segment
Segment Information
Number of operating segments	1
Number of reporting segments	1

Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2023	Dec. 31, 2022
Balance Sheets
Preferred stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred stock, authorized (in shares)	10,000,000	10,000,000
Preferred stock, issued (in shares)	4,850	0
Preferred stock, outstanding (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized (in shares)	300,000,000	300,000,000
Common stock, issued (in shares)	2,963,657	859,402
Common stock, outstanding (in shares)	2,963,657	859,402

Prepaid Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Prepaid Expenses
Prepaid insurance	$ 441	$ 628
Other	402	775
Total prepaid expenses and other current assets	$ 843	$ 1,403

Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Statements of Operations and Comprehensive Loss
Revenues, net	$ 19,593	$ 10,884	$ 4,101
Cost of product revenues	8,978	6,836	10,718
Gross profit	10,615	4,048	(6,617)
Operating expenses:
Research and development	2,225	3,253	6,246
Selling and marketing	17,769	30,369	43,444
General and administrative	10,505	11,860	14,698
Loss on disposition of assets		11,122
Total operating expenses	30,499	56,604	64,388
Loss from operations	(19,884)	(52,556)	(71,005)
Other income (expense)
Interest income	78	80	25
Interest expense	(1,419)	(3,131)	(3,914)
Unrealized gain on warrant liability	6,760	25,520	3,827
Total other income (expense), net	5,419	22,469	(62)
Loss before benefit from income taxes	(14,465)	(30,087)	(71,067)
Benefit from income taxes		4,675
Net loss	$ (14,465)	$ (25,412)	$ (71,067)
Net loss per share (basic) (in dollars per share)	$ (6.71)	$ (58.79)	$ (1,464.20)
Net loss per share (diluted) (in dollars per share)	$ (6.71)	$ (58.79)	$ (1,464.20)
Weighted-average common shares (basic) (in shares)	2,156,726	432,219	48,536
Weighted-average common shares (diluted) (in shares)	2,156,726	432,219	48,536
Comprehensive loss:
Net loss	$ (14,465)	$ (25,412)	$ (71,067)
Other comprehensive income:
Unrealized (loss) on marketable securities			(3)
Comprehensive loss	$ (14,465)	$ (25,412)	$ (71,070)

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($)	12 Months Ended
	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021
Credit Agreement and Guaranty
Long-term debt	$ 1,650,000	$ 2,625,000
Debt issuance costs	(23,000)	(209,000)
Warrant discount	(112,000)	(990,000)
Total debt	1,515,000	1,426,000
Less, current portion	1,515,000	1,426,000
Amortization and debt issue costs	$ 1,063,000	$ 1,969,000	$ 1,661,000

- Definition

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

+ References + Details

Accrued Liabilities

12 Months Ended

Dec. 31, 2023

Accrued Liabilities

Accrued Liabilities

6. Accrued Liabilities

Accrued liabilities consist of the following:


	December 31,
	2023		2022
Gross to net accruals	$	6,492	$	2,332
Accrued compensation		832		833
Accrued professional fees and other		1,807		743
Total accrued liabilities	$	9,131	$	3,908

Stockholders' Equity (Deficit) - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions								1 Months Ended				3 Months Ended	5 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	Mar. 31, 2022	Sep. 30, 2022	Dec. 31, 2023	Dec. 31, 2022	Dec. 31, 2021	Feb. 22, 2024	Dec. 03, 2023	Apr. 12, 2023	Oct. 02, 2020
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)										6,660		24,856
Stock stated value														$ 0.0001	$ 0.0001
Subsequent Event
Stockholders' Equity (Deficit)
Exercise price of warrants (in dollars per share)																	$ 1.25
Maximum
Stockholders' Equity (Deficit)
Proceeds from issuance of common stock in public offering, net of offering costs	$ 75.0
Common stock
Stockholders' Equity (Deficit)
Stock Issued During Period, Shares, Warrants Exercised														1,801,286
Conversion of stock shares converted					6,063
Conversion of convertible preferred stock (in shares)				6,063
Series B Warrants
Stockholders' Equity (Deficit)
Warrants and rights outstanding, term						5 years
Warrants
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)														3,800,000				3,800,000
Additional New Warrants
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)														1,005,560
Exercise price of warrants (in dollars per share)														$ 2.09
2020 Shelf Registration Statement
Stockholders' Equity (Deficit)
Aggregate amount of securities issuable																				$ 200.0
2022 Preferred Stock Offering
Stockholders' Equity (Deficit)
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
Stockholders' Equity (Deficit)
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
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)						12,125
Exercise price of warrants (in dollars per share)						$ 520.00
Exercisable term						6 months
Warrants and rights outstanding, term						1 year 6 months
At-the-market sales \| Common stock
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)														207,883	253,115	3,458
Proceeds from issuance of common stock in public offering, net of offering costs																$ 9.3
At-the-market sales \| Common stock \| Maximum
Stockholders' Equity (Deficit)
Commission percentage		3.00%									3.00%
Authorized value for shares issuance		$ 12.8									$ 50.0
Public offering
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)								3,792,572	150,367
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
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)								95,000	382,966	13,333				95,000	533,333	13,333
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
Stockholders' Equity (Deficit)
Warrant Exercisable Term									5 years
Public offering \| Pre-funded warrants
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)								1,801,286
Class of Warrant or Right, Exercisable														1,801,286
Public offering \| Series B Pre-funded Warrants
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)									150,366
2022 ATM
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)													173,750	207,883	78,853
Proceeds from issuance of common stock in public offering, net of offering costs													$ 12.2	$ 1.7	$ 0.9
Eligible Amount Authorized To Sell																			$ 4.5
2022 ATM \| Common stock
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)												512
Proceeds from issuance of common stock in public offering, net of offering costs												$ 0.3
2022 ATM \| Common stock \| Maximum
Stockholders' Equity (Deficit)
Commission percentage							3.00%
Authorized value for shares issuance							$ 50.0
2022 ATM \| New Warrant [Member]
Stockholders' Equity (Deficit)
Warrant Exercisable Term			6 months
H.C. Wainwright & Co., LLC, Sales Agent [Member]
Stockholders' Equity (Deficit)
Common stock that can be purchased with warrants (in shares)								94,814	26,666
Commission percentage								7.00%	7.00%
Exercise price of warrants (in dollars per share)								$ 4.9439	$ 56.25
Series A Preferred Stock
Stockholders' Equity (Deficit)
Conversion of stock shares converted					2,425
Series A Preferred Stock \| 2022 Preferred Stock Offering
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)						2,425
Exercise price of warrants (in dollars per share)			$ 520.00
Series B Preferred Stock
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)				2,425
Series B Preferred Stock \| 2022 Preferred Stock Offering
Stockholders' Equity (Deficit)
Issuance of common stock (in shares)						2,425

Equity Incentive Plans

12 Months Ended

Dec. 31, 2023

Equity Incentive Plans

Equity Incentive Plans

10. 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. In June 2023 the Company’s stockholders approved the Agile Therapeutics, Inc. 2023 Equity Incentive Plan. As of December 31, 2023, there were 6,200 shares available for future grant under the 2023 Plan.

Through December 31, 2023, the Company granted options to certain employees and non-employees to purchase shares of common stock at exercise prices ranging from $10.00 to $21,500.00 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2023, 2022 and 2021 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,
	2023		2022		2021
Cost of product revenues	$	107	$	133	$	271
Research and development		358		372		490
Selling and marketing		102		155		148
General and administrative		1,414		1,832		2,429
Total	$	1,981	$	2,492	$	3,338

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


	2023		2022		2021
Risk‑free interest rate	3.87%-3.90	%	1.71% - 4.22	%	.66% - 1.51	%
Expected volatility	115.9%-118.6	%	107% ‑ 118	%	105% ‑ 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. Since August 2020, the Company transitioned to its own expected volatility based on 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 historical 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, 2023, the unrecorded deferred stock-based compensation balance related to stock options was approximately $1.4 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, 2023 was $2.64.

The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2023, 2022 and 2021:


			Weighted
		Weighted	Average
		Average	Remaining
		Exercise	Contractual	Aggregate
	Options	Price	Life (Years)	Intrinsic Value
Options outstanding at December 31, 2021	5,183	5,666.50	6.1
Options granted	3,749	198.50
Options exercised	—	—
Options cancelled/forfeited	(1,004)	4,872.00
Options outstanding at December 31, 2022	7,928	3,187.50	7.7
Options granted	35,825	2.64
Options exercised	—	—
Options cancelled/forfeited	(710)	2,398.42
Options outstanding at December 31, 2023	43,043	548.70	9.0	$	—
Options exercisable at December 31, 2023	5,007	4,438.73	5.8	$	—
Vested and expected to vest at December 31, 2023	43,043			$	—

Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 29, 2023, of $1.95 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 35 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 113 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 94 RSUs to directors of the Company. These RSUs vest ratably over one year.

During the year ended December 31, 2023, the Company granted a total of 155,004 RSUs to certain employees and directors of the Company. These RSUs vest ratably over one and four years.

As of December 31, 2023, the unrecorded deferred stock-based compensation balance related to RSUs was approximately $0.3 million and will be recognized over an estimated weighted-average amortization period of 3.11 years. The following table shows the Company's restricted stock unit activity during the years ended December 31, 2023, and 2022:


		Weighted Average	Aggregate
	Shares	Grant Date Fair Value	Intrinsic Value
Restricted stock units outstanding at December 31, 2021	167		$	163
Granted	94	52.50
Vested	(135)	3,815.00
Restricted stock units outstanding at December 31, 2022	125	—	$	163
Granted	155,004	2.46
Vested	(112)	674.63
Forfeited	(1,500)	2.48
Restricted stock units outstanding at December 31, 2023	153,517		$	299

Income Taxes (Details) - USD ($) $ in Millions	12 Months Ended
Income Taxes (Details) - USD ($) $ in Millions	Dec. 31, 2023	Dec. 31, 2018
Federal \| Net Operating Losses
Income Taxes
Net operating loss carryforwards	$ 396.5	$ 186.9
Indefinite net operating loss carryforward	209.6
Federal \| Research and Development.
Income Taxes
Tax credit carryforwards	6.3
State \| Net Operating Losses
Income Taxes
Net operating loss carryforwards	77.4
State \| Research and Development.
Income Taxes
Tax credit carryforwards	$ 0.9

Subsequent Events (Details) - USD ($)							12 Months Ended
Subsequent Events (Details) - USD ($)	Mar. 11, 2024	Feb. 22, 2024	Feb. 09, 2024	Jul. 08, 2022	Jan. 07, 2022	Feb. 10, 2020	Dec. 31, 2023	Dec. 31, 2022	Mar. 31, 2022	Oct. 31, 2021
Subsequent Events
Proceeds from warrant exercises						$ 20,000,000.0
Shares issuable upon exercise of warrants									24,856	6,660
Repayments							$ 975,000	$ 17,375,000
Perceptive Credit Agreement
Subsequent Events
Repayments				$ 5,000,000.0	$ 5,000,000.0
Subsequent event
Subsequent Events
Number of warrants agreed to exercise for cash		3,892,572
Exercise price of warrants (in dollars per share)		$ 1.25
Proceeds from warrant exercises		$ 4,800,000
Subsequent event \| Perceptive Credit Agreement
Subsequent Events
Monthly paayments on loan			$ 150,000
Repayments	$ 1,350,000
Subsequent event \| New warrants
Subsequent Events
Exercise price of warrants (in dollars per share)		$ 1.00
Shares issuable upon exercise of warrants		7,785,144
Subsequent event \| Warrants with five year term
Subsequent Events
Shares issuable upon exercise of warrants		3,992,572
Warrants term		5 years
Subsequent event \| Warrants with eighteen months term
Subsequent Events
Shares issuable upon exercise of warrants		3,792,572
Warrants term		18 months
Subsequent event \| Placement Agent Warrants
Subsequent Events
Exercise price of warrants (in dollars per share)		$ 1.5625
Cash fee percentage		7.00%
Management fee percentage		1.00%
Stock issuable as a percentage on warrants exercised		5.00%

Leases (Tables)

12 Months Ended

Dec. 31, 2023

Leases

Maturity of lease liabilities

Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows:


2024	$	397
2025		101
Total	$	498
Less: Interest		(32)
Present value of lease liability	$	466

Summary of Significant Accounting Policies - Warrants (Details) - shares	Dec. 31, 2023	Dec. 03, 2023	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)	3,800,000	3,800,000
Additional New Warrants
Warrants
Common stock that can be purchased with warrants (in shares)	1,005,560
Perceptive Credit Agreement \| Warrants
Warrants
Common stock that can be purchased with warrants (in shares)			225	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

Leases

12 Months Ended

Dec. 31, 2023

Leases

Leases

7. 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 $355,000, $355,000 and $180,000 for the years ended December 31, 2023, 2022 and 2021, respectively. Operating cash flows used for operating leases during the years ended December 31, 2023, 2022 and 2021 were $319,000, $175,000 and $131,000, respectively. As of December 31, 2023, the weighted-average remaining lease term was 1.25 years, and the weighted average discount rate was 11.8%.

Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows:


2024	$	397
2025		101
Total	$	498
Less: Interest		(32)
Present value of lease liability	$	466

Credit Agreement and Guaranty

12 Months Ended

Dec. 31, 2023

Credit Agreement and Guaranty

Credit Agreement and Guaranty

8. 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 which was paid 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 was scheduled to mature on February 10, 2024 (“Maturity Date”) but was extended to March 11, 2024 (see Note 13).

Borrowings under the Perceptive Credit Agreement accrue interest at an annual rate equal to the Secured Overnight Financing Rate for one-month deposits (“SOFR”) plus 10.25%. The rate of interest in effect as of December 31, 2023 was 15.60%. 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 9), 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).


	December 31,		December 31,
	2023		2022
Long-term debt	$	1,650	$	2,625
Debt issuance costs		(23)		(209)
Warrant discount		(112)		(990)
Total debt	$	1,515	$	1,426
Less, current portion		1,515		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 $1,063,000, $1,969,000 and $1,661,000 for the years ended December 31, 2023, 2022, and 2021 respectively.

- 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

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2023

Fair Value Measurements

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


	Level 1		Level 2		Level 3
December 31, 2023
Assets:
Cash and cash equivalents	$	2,557	$	—	$	—
Total assets at fair value	$	2,557	$	—	$	—

Liabilities:
Warrant Liability	$	—	$	—	$	5,696
Total assets at fair value	$	—	$	—	$	5,696


	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

Schedule of rollforward of the fair value of Level 3 warrants


Beginning balance at December 31, 2022	$	5,934
Warrants issued		12,537
Change in fair value		(12,775)
Ending Balance December 31, 2023	$	5,696

Credit Agreement and Guaranty (Details)								1 Months Ended	2 Months Ended	3 Months Ended	4 Months Ended	12 Months Ended
Credit Agreement and Guaranty (Details)	Mar. 11, 2024 USD ($)	Feb. 22, 2024 USD ($) $ / shares	Feb. 09, 2024 USD ($)	Jul. 25, 2022 USD ($)	Jul. 08, 2022 USD ($)	Jan. 07, 2022 USD ($)	Feb. 10, 2020 USD ($) $ / shares Y item shares	Feb. 10, 2024 USD ($)	Dec. 31, 2023 USD ($) Y $ / shares	Sep. 30, 2023 USD ($)	Oct. 31, 2023 USD ($)	Dec. 31, 2023 USD ($) Y $ / shares	Dec. 31, 2022 USD ($) Y	Oct. 30, 2023 USD ($)	May 31, 2023 $ / shares shares	Jul. 31, 2022 $ / shares shares	Mar. 31, 2022 $ / shares shares	Oct. 31, 2021 $ / shares shares	Feb. 26, 2021 $ / shares shares
Credit Agreement and Guaranty
Repayments of debt												$ 975,000	$ 17,375,000
Interest rate (as a percent)									15.60%			15.60%
Percentage of annual interest rate							3.00%
Common stock that can be purchased with warrants (in shares) \| shares																	24,856	6,660
Proceeds from warrant exercises							$ 20,000,000.0
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
Prepayment of outstanding principal				$ 7,000,000.0
Variable interest rate margin (as a percent)							10.25%
Perceptive Credit Agreement \| Perceptive Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares																			$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares							700												225
Number of warrants issued \| item							2
Facility fee percentage							1.00%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares							$ 7,480								$ 3.69	$ 618.50	$ 4,330.50	$ 5,760
Common stock that can be purchased with warrants (in shares) \| shares							350								350	350	350	350
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares							$ 9,340								$ 3.69	$ 745	$ 5,276	$ 7,080
Common stock that can be purchased with warrants (in shares) \| shares							350								350	350	350	350
Perceptive Credit Agreement \| Warrants
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares															$ 3.69	$ 501.50	$ 3,456.50	$ 4,540	$ 5,740
Common stock that can be purchased with warrants (in shares) \| shares															225	225	225	225
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Maximum borrowing capacity							$ 35,000,000.0
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche One
Credit Agreement and Guaranty
Amount borrowed							5,000,000.0
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche Two
Credit Agreement and Guaranty
Amount borrowed							$ 15,000,000.0
Subsequent Event
Credit Agreement and Guaranty
Exercise price of warrants (in dollars per share) \| $ / shares		$ 1.25
Proceeds from warrant exercises		$ 4,800,000
Subsequent Event \| Perceptive Credit Agreement
Credit Agreement and Guaranty
Repayments of debt	$ 1,350,000
Monthly principal payments			$ 150,000
Prepayment Occur on or Before February, 10, 2024 \| Perceptive Credit Agreement
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
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			$ 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			$ 1.82
Option pricing model \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input									1.95			1.95	11.50
Option pricing model \| Maximum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input									4.0			4.0	4.7
Option pricing model \| Maximum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y									4.4			4.4	4.5
Option pricing model \| Maximum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input													1,700.00
Option pricing model \| Minimum \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input									3.8			3.8	4.2
Option pricing model \| Minimum \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y									2.8			2.8	0.7
Option pricing model \| Minimum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input													45.00
Option pricing model \| Common stock warrants \| Maximum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input									1,700.00			1,700.00
Option pricing model \| Common stock warrants \| Minimum \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input									3.69			3.69
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input							0.700
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input							0.0147
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y							7
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Perceptive Warrants \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares							8,020
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Maximum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares							9,340
Option pricing model \| Two Thousand Twenty Perceptive Warrants [Member] \| Minimum \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares							7,480
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Volatility
Credit Agreement and Guaranty
Warrants, Measurement Input							1.035
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Risk free interest rate
Credit Agreement and Guaranty
Warrants, Measurement Input							0.0115
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Expected life
Credit Agreement and Guaranty
Warrants, Measurement Input \| Y							7
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Strike price
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares							5,740
Option pricing model \| Two Thousand Twenty One Perceptive Warrants [Member] \| Perceptive Warrants \| Fair value
Credit Agreement and Guaranty
Warrants, Measurement Input \| $ / shares							5,740

Accrued Liabilities (Tables)

12 Months Ended

Dec. 31, 2023

Accrued Liabilities

Schedule of accrued liabilities


	December 31,
	2023		2022
Gross to net accruals	$	6,492	$	2,332
Accrued compensation		832		833
Accrued professional fees and other		1,807		743
Total accrued liabilities	$	9,131	$	3,908

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - USD ($) $ in Thousands	Dec. 31, 2023	Dec. 31, 2022
Liabilities:
Warrant liability	$ 5,696	$ 5,934
Recurring \| Level 1
Assets:
Cash and cash equivalents	2,557	5,246
Total assets at fair value	2,557	5,246
Recurring \| Level 3
Liabilities:
Warrant liability	5,696	5,934
Total liabilities at fair value	$ 5,696	$ 5,934

Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2023 USD ($) customer	Dec. 31, 2022 USD ($) customer	Dec. 31, 2021 USD ($)
Concentration risk, financial liabilities
Financial instruments with off-balance sheet risk of accounting loss, liabilities	$ 0
Total revenue	19,593	$ 10,884	$ 4,101
Customer Concentration Risk \| Sales Revenue \| Customer One
Concentration risk, financial liabilities
Total revenue	4,700	2,900
Customer Concentration Risk \| Sales Revenue \| Customer Two
Concentration risk, financial liabilities
Total revenue	3,800	2,700
Customer Concentration Risk \| Sales Revenue \| Customer Three
Concentration risk, financial liabilities
Total revenue	3,700	2,600
Customer Concentration Risk \| Sales Revenue \| Customer Four
Concentration risk, financial liabilities
Total revenue	3,500	$ 1,200
Customer Concentration Risk \| Sales Revenue \| Customer Five
Concentration risk, financial liabilities
Total revenue	$ 2,800
Concentration risk, percentage	94.00%
Customer Concentration Risk \| Sales Revenue \| Five Customers
Concentration risk, financial liabilities
Number of major customers \| customer	5
Customer Concentration Risk \| Sales Revenue \| Four Customers
Concentration risk, financial liabilities
Number of major customers \| customer		4
Concentration risk, percentage		86.00%
Customer Concentration Risk \| Accounts Receivable \| Customer One
Concentration risk, financial liabilities
Concentration risk, percentage	6.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Two
Concentration risk, financial liabilities
Concentration risk, percentage	30.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Three
Concentration risk, financial liabilities
Concentration risk, percentage	30.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Four
Concentration risk, financial liabilities
Concentration risk, percentage	29.00%
Customer Concentration Risk \| Accounts Receivable \| Customer Five
Concentration risk, financial liabilities
Concentration risk, percentage	0.00%
Customer Concentration Risk \| Accounts Receivable \| Five Customers
Concentration risk, financial liabilities
Number of major customers \| customer	5

Summary of Significant Accounting Policies - Income Taxes (Details) $ in Millions	Dec. 31, 2023 USD ($)
Uncertainty in tax positions
Uncertain tax positions	$ 0.0

Stockholders' Equity (Deficit)

12 Months Ended

Dec. 31, 2023

Stockholders' Equity (Deficit)

Stockholders' Equity (Deficit)

9. Stockholders’ Equity (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. The 2020 Shelf Registration Statement expired on October 13, 2023.

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 150,367 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 December 31, 2023 all of the 1,801,286 pre-funded warrants had been exercised. 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.

In December 2023, the Company entered into a Warrant Amendment and Additional Issuance Agreement relating to the amendment of warrants to purchase shares of common stock that were issued in transactions on March 14, 2022, April 25, 2022, and May 25, 2023. Collectively, the Warrants represent the right to purchase approximately 3.8 million shares of common stock. Under the terms of the Warrant Amendment and Additional Issuance Agreement, the holder agreed to revise certain provisions and in exchange for the holder’s agreement to amend the Warrants, the Company agreed to issue an additional new warrant (the “New Warrant”) to purchase 1,005,560 shares of common stock. The New Warrant has an exercise price of $2.09 per share of common stock. The New Warrant is exercisable six months after issuance and will expire five years from the date that the New Warrant is initially exercisable. The exercise price of the New Warrant is subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in the New Warrant.

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 Agreements

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 3,458 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 78,853 shares of common stock under the August 2022 ATM resulting in net proceeds of approximately $0.9 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. During the year ended December 31, 2023, the Company issued and sold 207,883 shares for net proceeds of approximately $1.7 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 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 6,063 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 6,063 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.

- 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
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-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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+ Details