0001558370-20-013706 | 10-Q | XBRL Viewer

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2020	Nov. 09, 2020
Document and Entity Information
Entity Registrant Name	AGILE THERAPEUTICS INC
Document Type	10-Q
Document Period End Date	Sep. 30, 2020
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
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		87,434,604
Entity Central Index Key	0001261249
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Amendment Flag	false

Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 24,163	$ 34,479
Marketable securities	47,742
Prepaid expenses	1,414	840
Total current assets	73,319	35,319
Property and equipment, net	14,271	14,044
Right of use asset	31	158
Other non-current assets	1,791	19
Total assets	89,412	49,540
Current liabilities:
Accounts payable	5,016	1,819
Accrued expenses	2,154	1,804
Lease liability, current portion	34	172
Total current liabilities	7,204	3,795
Long-term debt	16,078
Total liabilities	23,282	3,795
Commitments and contingencies (Note 13)
Stockholders' equity
Common stock, $.0001 par value, 150,000,000 shares authorized, 87,434,604 and 69,810,305 issued and outstanding at September 30, 2020 and December 31, 2019, respectively	9	7
Additional paid-in capital	360,713	306,108
Accumulated other comprehensive income	11
Accumulated deficit	(294,603)	(260,370)
Total stockholders’ equity	66,130	45,745
Total liabilities and stockholders’ equity	$ 89,412	$ 49,540

Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Balance Sheets
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, authorized (in shares)	150,000,000	150,000,000
Common stock, issued (in shares)	87,434,604	69,810,305
Common stock, outstanding (in shares)	87,434,604	69,810,305

Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Statements of Operations - USD ($) $ in Thousands	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Operating expenses:
Research and development	$ 3,663	$ 2,361	$ 10,488	$ 7,021
General and administrative	10,993	2,138	21,824	5,732
Total operating expenses	14,656	4,499	32,312	12,753
Loss from operations	(14,656)	(4,499)	(32,312)	(12,753)
Other income (expense)
Interest income	37	67	284	168
Interest expense	(905)		(2,205)
Total other income (expense), net	(868)	67	(1,921)	168
Loss before benefit from income taxes	(15,524)	(4,432)	(34,233)	(12,585)
Net loss	$ (15,524)	$ (4,432)	$ (34,233)	$ (12,585)
Net loss per share (basic and diluted) (in dollars per share)	$ (0.18)	$ (0.08)	$ (0.41)	$ (0.28)
Weighted-average common shares (basic and diluted) (in shares)	87,350,505	53,609,511	83,754,550	44,957,809
Comprehensive loss:
Net loss	$ (15,524)	$ (4,432)	$ (34,233)	$ (12,585)
Other comprehensive income:
Unrealized gain on marketable securities	1		11
Comprehensive loss	$ (15,523)	$ (4,432)	$ (34,222)	$ (12,585)

Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands	Common Stock Public offering	Common Stock Private Placement	Common Stock At-the-market sales	Common Stock	Additional Paid-in Capital Public offering	Additional Paid-in Capital Private Placement	Additional Paid-in Capital At-the-market sales	Additional Paid-in Capital Cumulative Effect, Period of Adoption, Adjustment [Member]	Additional Paid-in Capital	AOCI Attributable to Parent [Member] Cumulative Effect, Period of Adoption, Adjustment [Member]	AOCI Attributable to Parent [Member]	Accumulated Deficit Public offering	Accumulated Deficit Private Placement	Accumulated Deficit At-the-market sales	Accumulated Deficit	Private Placement	At-the-market sales	Total
Balance at Dec. 31, 2018				$ 3					$ 261,722		$ (241,551)				$ 20,174
Balance (in shares) at Dec. 31, 2018				34,377,329
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs									490						490
Issuance of common stock		$ 1				$ 7,809	$ 860						$ 7,810	$ 860
Issuance of common stock (in shares)		8,426,750	665,974
Vesting of RSUs (in shares)				145,204
Net loss											(4,669)				(4,669)
Balance at Mar. 31, 2019				$ 4				$ 213	271,094	$ (213)	(246,433)				24,665
Balance (in shares) at Mar. 31, 2019				43,615,257
Balance at Dec. 31, 2018				$ 3					261,722		(241,551)				20,174
Balance (in shares) at Dec. 31, 2018				34,377,329
Increase (decrease) in stockholders' equity
Issuance of common stock (in shares)																	1,801,528
Net loss																		$ (12,585)
Balance at Sep. 30, 2019				$ 6					286,246		(254,349)				31,903
Balance (in shares) at Sep. 30, 2019				59,302,126
Balance at Dec. 31, 2018				$ 3					261,722		(241,551)				20,174
Balance (in shares) at Dec. 31, 2018				34,377,329
Balance at Dec. 31, 2019				$ 7					306,108						(260,370)			45,745
Balance (in shares) at Dec. 31, 2019				69,810,305
Balance at Mar. 31, 2019				$ 4				$ 213	271,094	$ (213)	(246,433)				24,665
Balance (in shares) at Mar. 31, 2019				43,615,257
Increase (decrease) in stockholders' equity
Share-based compensation - stock options									479						479
Issuance of common stock							1,389							1,389
Issuance of common stock (in shares)			992,072
Issuance of common stock upon exercise of options									15						15
Issuance of common stock upon exercise of options (in shares)				25,000
Net loss											(3,484)				(3,484)
Balance at Jun. 30, 2019				$ 4					272,977		(249,917)				23,064
Balance (in shares) at Jun. 30, 2019				44,632,329
Increase (decrease) in stockholders' equity
Share-based compensation - stock options									378						378
Issuance of common stock	$ 1		$ 1		$ 12,686		$ 205					$ 12,687		$ 206
Issuance of common stock (in shares)	14,526,315		143,482
Net loss											(4,432)				(4,432)			(4,432)
Balance at Sep. 30, 2019				$ 6					286,246		(254,349)				31,903
Balance (in shares) at Sep. 30, 2019				59,302,126
Balance at Dec. 31, 2019				$ 7					306,108						(260,370)			45,745
Balance (in shares) at Dec. 31, 2019				69,810,305
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs									621									621
Issuance of common stock		$ 2				$ 48,433										$ 48,435
Issuance of common stock (in shares)		17,250,000
Issuance of common stock upon exercise of options									119									119
Issuance of common stock upon exercise of options (in shares)				152,907
Warrants issued in connection with long-term debt									3,570									3,570
Net loss															(7,883)			(7,883)
Balance at Mar. 31, 2020				$ 9					358,851						(268,253)			90,607
Balance (in shares) at Mar. 31, 2020				87,213,212
Balance at Dec. 31, 2019				$ 7					306,108						(260,370)			45,745
Balance (in shares) at Dec. 31, 2019				69,810,305
Increase (decrease) in stockholders' equity
Unrealized net gain on marketable securities																		11
Net loss																		(34,233)
Balance at Sep. 30, 2020				$ 9					360,713		11				(294,603)			66,130
Balance (in shares) at Sep. 30, 2020				87,434,604
Balance at Mar. 31, 2020				$ 9					358,851						(268,253)			90,607
Balance (in shares) at Mar. 31, 2020				87,213,212
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs									839									839
Issuance of common stock upon exercise of options									166									166
Issuance of common stock upon exercise of options (in shares)				84,393
Unrealized net gain on marketable securities											10							10
Net loss															(10,826)			(10,826)
Balance at Jun. 30, 2020				$ 9					359,856		10				(279,079)			80,796
Balance (in shares) at Jun. 30, 2020				87,297,605
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs									647									647
Issuance of common stock upon exercise of options									210									210
Issuance of common stock upon exercise of options (in shares)				136,999
Unrealized net gain on marketable securities											1							1
Net loss															(15,524)			(15,524)
Balance at Sep. 30, 2020				$ 9					$ 360,713		$ 11				$ (294,603)			$ 66,130
Balance (in shares) at Sep. 30, 2020				87,434,604

Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended	9 Months Ended		12 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Sep. 30, 2020	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Cash flows from operating activities:
Net loss		$ (34,233)	$ (12,585)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		20	14
Amortization		127	107
Noncash stock-based compensation		2,107	1,347
Noncash interest		898
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(2,347)	(709)
Accounts payable and accrued expenses		3,597	(481)
Lease liability	$ (48)	(138)	(112)
Net cash used in operating activities		(29,969)	(12,419)
Cash flows from investing activities:
Purchases of marketable securities		(52,921)
Sales and maturities of marketable securities		5,000
Acquisition of property and equipment		(296)	(30)
Net cash used in investing activities		(48,217)	(30)
Cash flows from financing activities:
Proceeds from issuance of long-term debt		20,000
Debt financing costs paid		(1,059)
Proceeds from issuance of common stock in private placement, net of offering costs			7,810
Proceeds from exercise of stock options		495	15
Net cash provided by financing activities		67,870	22,968
Net (decrease) increase in cash and cash equivalents		(10,316)	10,519
Cash and cash equivalents, beginning of period		34,479	7,851	$ 7,851
Cash and cash equivalents, end of period	$ 24,163	24,163	18,370	$ 34,479
Supplemental disclosure of noncash financing activities
Warrants issued in connection with long-term debt		3,570
Supplemental cash flow information
Interest paid		1,498
At-the-market sales
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs			(2,456)
Public offering
Cash flows from financing activities:
Proceeds from issuance of common stock in public offering, net of offering costs		$ 48,434	$ 12,687

Organization and Description of Business	9 Months Ended
Organization and Description of Business	Sep. 30, 2020
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 and performing research and development, including development of the Company’s lead product candidate. The Company is headquartered in Princeton, New Jersey. The Company’s sole approved product, Twirla®, also known as AG200 15, is a once weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA in February 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the potential need to obtain additional capital necessary to fund the development of its products, competition from larger companies and compliance with the FDA and other government regulations. If the Company does not successfully commercialize any product candidates, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of September 30, 2020, the Company had an accumulated deficit of approximately $295 million. The Company expects to continue to incur significant expenses and increased operating losses for the foreseeable future and that its operating expenses will increase substantially in connection with its ongoing activities, as the Company: •maintains a sales and marketing infrastructure to commercialize Twirla in the United States; •finalizes the validation process related to Corium’s manufacturing facility in preparation for commercial operations; •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 •adds 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. Basis of Presentation The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the SEC on February 20, 2020. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the operating results for the full fiscal year or any future period. Certain reclassifications have been made to prior periods to conform with current reporting. On the balance sheet, our right of use asset has been stated separately from other non-current assets. The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. Based on the Company’s current business plan and ability to launch Twirla, the Company believes that its cash, cash equivalents and marketable securities as of September 30, 2020 will be sufficient to meet its projected operating requirements through the end of 2021. If the COVID-19 pandemic or other factors impact the Company’s current business plan or its ability to generate revenue from the launch of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2020

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2019 included in its Annual Report on Form 10-K filed with the SEC.

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 expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those 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 the Company is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations.

It should be noted that current public health threats could adversely affect the Company’s ongoing or planned business operations. In particular, the World Health Organization has declared the outbreak of a novel strain of coronavirus, now referred to as COVID-19, a pandemic resulting in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, restrictions on public gatherings, and stay at home orders. The effect of these orders, government imposed quarantines and measures the Company has taken, such as implementing work-at-home policies, may negatively impact productivity, disrupt the Company’s business and could delay the Company’s commercialization timeline. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom it engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. While it is unknown how long these conditions will last and what the complete effect will be on the Company, to date, the Company has been able to continue to execute on its plans according to the related timelines. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed.

Cash and Cash Equivalents

The Company 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.

Marketable Securities

The Company invests a portion of its excess cash balances in marketable securities, including U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheet because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders' equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in other income.

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, cash equivalents, and marketable securities are carried at fair value (see Note 3).

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

Pre-Launch Validation Product

The Company’s third-party manufacturer, Corium, is undertaking the validation of our commercial manufacturing process for Twirla. The costs associated with validation are being expensed as research and development expenses during the period the costs are incurred. If validation testing is successful, the Company plans to utilize this validation product for commercial supplies and samples of Twirla. The Company does not plan to capitalize any validation product. After validation is complete, the Company will capitalize commercial supplies as inventory on subsequent production.

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.

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.

Long-Lived Assets

In accordance with ASC 360, Property, Plant and Equipment, the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of September 30, 2020.

Research and Development Expenses

Research and development costs are expensed as incurred. Research and development expenses consist 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.

Deferred Financing Costs

Costs directly attributable to the Company’s senior secured term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent a 1% facility fee paid directly to the lender, legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $69 and $162 for the three and nine months ended September 30, 2020.

Concentrations of Credit Risk

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

Warrants

The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity. On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception, which indicate that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital.

The warrants issued in connection with the Company’s debt financing completed in February 2015 are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. These warrants expired without being exercised on February 24, 2020.

In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 1,400,000 shares of its common stock. These warrant instruments qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. See Note 8 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 September 30, 2020 that qualify for either recognition or disclosure in the financial statements under this guidance.

Stock-Based Compensation

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

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.

Net Loss Per Share

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

The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2020 and 2019, respectively, because to do so would be anti-dilutive (in common equivalent shares):


	September 30,
	2020	2019
Common stock warrants	1,400,000	242,779
Unvested restricted stock units	159,795	—
Common stock options	8,602,755	7,299,560
Total	10,162,550	7,542,339

Recent Accounting Pronouncements

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

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). This guidance simplifies the accounting for income taxes by, among other things, reducing complexity in the interim-period accounting for year-to-date loss limitations and changes in tax laws. The guidance is effective for the Company on January 1, 2021. The Company is currently evaluating the impact of adopting this standard and does not expect the guidance to have a material impact on its consolidated financial statements.

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

Fair Value Measurements

9 Months Ended

Sep. 30, 2020

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. Level 2 assets consist of marketable securities. The Company has no Level 2 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 or liabilities.

The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of September 30, 2020 and December 31, 2019.


	Level 1		Level 2		Level 3
September 30, 2020
Assets:
Cash and cash equivalents	$	24,163	$	—	$	—
Marketable securities		—		47,742		—
Total assets at fair value	$	24,163	$	47,742	$	—


	Level 1		Level 2		Level 3
December 31, 2019
Assets:
Cash and cash equivalents	$	34,479	$	—	$	—
Total assets at fair value	$	34,479	$	—	$	—

There were no transfers between Level 1, 2 or 3 during 2020 or 2019.

- 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

Marketable Securities

9 Months Ended

Sep. 30, 2020

Marketable Securities

Marketable Securities

4. Marketable Securities

The following is a summary of marketable securities, classified as available-for-sale:


			Gross Unrealized
	Amortized							Fair
	Cost		Gains			Losses		Value
September 30, 2020

U.S. government obligations (maturing in one year or less)	$	7,072	$	3	$	—	$	7,075
Corporate debt securities (maturing in one year or less)		40,659		8				40,667
Total marketable securities	$	47,731	$	11	$	—	$	47,742

The Company holds investment-grade marketable securities. There were no continuous unrealized loss positions in excess of twelve months as of September 30, 2020. Marketable securities include $0.2 million of accrued interest income at September 30, 2020.

Prepaid Expenses

9 Months Ended

Sep. 30, 2020

Prepaid Expenses

Prepaid Expenses

5. Prepaid Expenses

Prepaid expenses consist of the following:


	September 30,		December 31,
	2020		2019
Prepaid insurance	$	941	$	656
Other		473		184
Total prepaid expenses	$	1,414	$	840

Accrued Liabilities

9 Months Ended

Sep. 30, 2020

Accrued Liabilities

Accrued Liabilities

6. Accrued Liabilities

Accrued liabilities consist of the following:


	September 30,		December 31,
	2020		2019
Employee bonuses	$	1,166	$	1,437
Accrued professional fees and other		988		367
Total accrued liabilities	$	2,154	$	1,804

Leases

9 Months Ended

Sep. 30, 2020

Leases

Leases

7. Leases

In February 2016, the FASB issued ASU No. 2016-02, Leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The Company adopted ASU No. 2016-02 on January 1, 2019. The Company recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no material impact on its statement of operations.

The Company has no finance leases and one operating lease for office space in Princeton, NJ. Operating lease expense was $48 and $145 for the three and nine months ended September 30, 2020.

Operating cash flows used for operating leases during the three and nine months ended September 30, 2020 were $48 and $138, respectively. As of September 30, 2020, the weighted-average remaining lease term was 0.17 years and the weighted average discount rate was 21.2%.

Future minimum lease payments under non-cancellable leases as of September 30, 2020 were as follows:


Remainder of 2020	$	35
Total	$	35
Less: Interest		(1)
Present value of lease liability	$	34

Credit Agreement and Guaranty

9 Months Ended

Sep. 30, 2020

Credit Agreement and Guaranty

Credit Agreement and Guaranty

8. Credit Agreement and Guaranty

On February 10, 2020 (the “Closing Date”), the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP, a related party (“Perceptive”), for a senior secured term loan credit facility of up to $35.0 million, (the “Perceptive Credit Agreement”). A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA. Another $15.0 million tranche will be available to the Company based on the achievement of certain revenue milestones.

The facility will mature on February 10, 2024 (“Maturity Date”). The Company is scheduled to make interest-only payments on the loans under the Perceptive Credit Agreement until February 10, 2023. Thereafter, the Company is required to make monthly principal payments in an amount equal to 1.50% of the principal amount of the outstanding loans until February 10, 2024.

Borrowings under the Perceptive Credit Agreement will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus 10.25%, provided that LIBOR shall not be less than 1.5%. The rate of interest in effect as of the Closing Date and at September 30, 2020 was 11.75%. 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 fee of 10.0% if such prepayment occurs on or prior to February 10, 2021; 8.0% if such prepayment occurs after February 10, 2021 and on or prior to February 10, 2022; 4.0% if such prepayment occurs after February 10, 2022 and on or prior to February 10, 2023; and 2.0% if such prepayment occurs after February 10, 2023 and prior to February 10, 2024.

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, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending March 31, 2021, report revenues for the trailing 12-month period that exceed the amounts set forth in the Perceptive Credit Agreement, which range from $3.8 million for the fiscal quarter ending March 31, 2021 to $93.5 million for the fiscal quarter ending December 31, 2023. At September 30, 2020, the Company was in compliance with all of the covenants contained in the Perceptive Credit Agreement.

In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 1,400,000 shares of the Company’s common stock (together, the “Perceptive Warrants”). The first warrant is exercisable for 700,000 shares of common stock at an exercise price of $3.74 per share. The second warrant is exercisable for 700,000 shares of common stock at an exercise price of $4.67 per share. The Perceptive Warrants contain anti-dilution provisions and other warrant holder protections. The Perceptive Warrants are not exercisable to the extent that Perceptive would beneficially own more than 19.99% of the Company’s common stock as a result of the exercise. The Perceptive Warrants expire on February 10, 2027.

The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and warrants. The relative fair value of the 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 preparing the option pricing model for valuing the Company’s warrants issued to Perceptive include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 3-year life), (iii) strike prices of $3.74 and $4.67 for the common stock warrants, (iv) fair value of common stock ($4.01) 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.


	September 30,
	2020
Notes payable	$	20,000
Debt issuance costs		(897)
Warrant discount		(3,025)
Long-term debt	$	16,078

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 $303 and $707 for the three and nine months ended September 30, 2020.

Stockholders' Equity

9 Months Ended

Sep. 30, 2020

Stockholders' Equity

Stockholders' Equity

9. Stockholders’ Equity

Shelf Registration Statement

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

Public Offerings

In February 2020, the Company completed a public offering of 17,250,000 shares of its common stock at a price of $3.00 per share. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $48.4 million.

In August 2019, the Company completed a public offering of 14,526,315 shares of its common stock at a price of $0.95 per share. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $12.7 million.

Private Placement

In March 2019, the Company completed a private placement of 8,426,750 shares of common stock at $0.93 per share. Proceeds from the Company’s private placement, net of offering costs were approximately $7.8 million.

ATM Sales Agreements

In January 2019, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $10.0 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 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the three months ended September 30, 2019, the Company issued and sold 143,482 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $0.2 million. During the nine months ended September 30, 2019, the Company issued and sold 1,801,528 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $2.5 million. The Company terminated the Sales Agreement on July 31, 2019.

In November 2019, the Company entered into a second common stock sales agreement (the “Second Sales Agreement”) under which the Company was authorized to issue and sell shares of common stock having aggregate sales proceeds of up to $20.0 million from time to time. The Company agreed to pay a commission of 3% of the gross proceeds from the sales of common stock under the Second Sales Agreement. In the year ended December 31, 2019, the Company issued and sold 10,440,908 shares of common stock under the Second Sales Agreement, representing all of the capacity of the Second Sales Agreement, resulting in net proceeds of approximately $19.3 million.

Stock-Based Compensation Expense

Stock-based compensation expense was allocated as follows:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Research and development	$	134	$	103	$	471	$	413
General and administrative		513		275		1,636		934
Total	$	647	$	378	$	2,107	$	1,347

Accumulated Other Comprehensive Income

9 Months Ended

Sep. 30, 2019

Accumulated Other Comprehensive Income

Accumulated Other Comprehensive Income

10. Accumulated Other Comprehensive Income

The change in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the nine months ended September 30, 2020 is summarized below:


	Unrealized
	Gain on
	Marketable
	Securities
Balance December 31, 2019	$	—
Other comprehensive income		11
Balance September 30, 2020	$	11

No amounts were classified out of accumulated other comprehensive income during the nine months ended September 30, 2020.

Income Taxes	9 Months Ended
Income Taxes	Sep. 30, 2020
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 is not expected to have a material impact on its income tax provision.

- 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 + Details

2019 Retention Plan	9 Months Ended
2019 Retention Plan	Sep. 30, 2020
2019 Retention Plan
2019 Retention Plan	12. 2019 Retention Plan In July 2019, the Company adopted a retention plan (the “2019 Retention Plan”) for all employees (with the exception of the Chairman and Chief Executive Officer) in order to induce such employees to remain employed by the Company through at least the extended PDUFA goal date of February 14, 2020. Each employee who participated in the 2019 Retention Plan and remained continuously employed by the Company through the approval of Twirla was to be paid a lump-sum cash payment in an amount determined for each eligible employee by the Compensation Committee at the time of the adoption of the 2019 Retention Plan. If an eligible employee terminated employment prior to the approval for any reason, no such retention payment was payable to the eligible employee. With the approval of Twirla in February, the cash portion of the 2019 Retention Plan in the amount of approximately $0.3 million was expensed and paid to eligible employees in February 2020. All employees (with the exception of the Chairman and Chief Executive Officer) who were employed by the Company as of July 3, 2019 were also granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $1.48, representing the closing price of the Company’s common stock as reported by Nasdaq on the date of grant. For each option, 50% of the option vested on July 3, 2020 and the remaining 50% will vest on December 31, 2020. In addition, the vesting schedule for the stock options granted in January 2019 was amended for all employees (with the exception of the Chairman and Chief Executive Officer) holding such options who were employed on July 3, 2019 as follows: 50% of the option vested on January 29, 2020, 25% vested on June 30, 2020 and the remaining 25% will vest on December 31, 2020.

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2020
Commitments and Contingencies
Commitments and Contingencies	13. Commitments and Contingencies The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2030, total $17.8 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 into 2021 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of September 30, 2020, the Company has not recorded a provision for any contingent losses.

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2020

Summary of Significant Accounting Policies

Use of Estimates

Risks and Uncertainties

Cash and Cash Equivalents

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

Marketable Securities

Fair Value of Financial Instruments

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

Pre-Launch Inventory

Pre-Launch Validation Product

Property and Equipment

Long-Lived Assets

Research and Development Expense

Research and Development Expenses

Deferred Financing Costs

Concentrations of Credit Risk

Warrants

Income Taxes

Stock-Based Compensation

Net Loss Per Share


	September 30,
	2020	2019
Common stock warrants	1,400,000	242,779
Unvested restricted stock units	159,795	—
Common stock options	8,602,755	7,299,560
Total	10,162,550	7,542,339

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.

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2020

Summary of Significant Accounting Policies

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


	September 30,
	2020	2019
Common stock warrants	1,400,000	242,779
Unvested restricted stock units	159,795	—
Common stock options	8,602,755	7,299,560
Total	10,162,550	7,542,339

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2020

Fair Value Measurements

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


	Level 1		Level 2		Level 3
September 30, 2020
Assets:
Cash and cash equivalents	$	24,163	$	—	$	—
Marketable securities		—		47,742		—
Total assets at fair value	$	24,163	$	47,742	$	—


	Level 1		Level 2		Level 3
December 31, 2019
Assets:
Cash and cash equivalents	$	34,479	$	—	$	—
Total assets at fair value	$	34,479	$	—	$	—

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2020

Marketable Securities

Summary of marketable securities, classified as available-for-sale


			Gross Unrealized
	Amortized							Fair
	Cost		Gains			Losses		Value
September 30, 2020

U.S. government obligations (maturing in one year or less)	$	7,072	$	3	$	—	$	7,075
Corporate debt securities (maturing in one year or less)		40,659		8				40,667
Total marketable securities	$	47,731	$	11	$	—	$	47,742

Prepaid Expenses (Tables)

9 Months Ended

Sep. 30, 2020

Prepaid Expenses

Schedule of prepaid expenses


	September 30,		December 31,
	2020		2019
Prepaid insurance	$	941	$	656
Other		473		184
Total prepaid expenses	$	1,414	$	840

Accrued Liabilities (Tables)

9 Months Ended

Sep. 30, 2020

Accrued Liabilities

Schedule of accrued liabilities


	September 30,		December 31,
	2020		2019
Employee bonuses	$	1,166	$	1,437
Accrued professional fees and other		988		367
Total accrued liabilities	$	2,154	$	1,804

Leases (Tables)

9 Months Ended

Sep. 30, 2020

Leases

Maturity of lease liabilities

Future minimum lease payments under non-cancellable leases as of September 30, 2020 were as follows:


Remainder of 2020	$	35
Total	$	35
Less: Interest		(1)
Present value of lease liability	$	34

Credit Agreement and Guaranty (Tables)

9 Months Ended

Sep. 30, 2020

Credit Agreement and Guaranty

Schedule of carrying amount of term loan


	September 30,
	2020
Notes payable	$	20,000
Debt issuance costs		(897)
Warrant discount		(3,025)
Long-term debt	$	16,078

- Definition

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

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Topic 210
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.5-02.22)
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-Name Accounting Standards Codification
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-Section 45
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-Topic 505
-SubTopic 10
-Section 50
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Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08.(e),(f))
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-Topic 942
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Reference 9: http://fasb.org/us-gaap/role/ref/legacyRef
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-SubTopic 10
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-URI http://asc.fasb.org/extlink&oid=109259400&loc=d3e21475-112644

+ Details

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2020

Stockholders' Equity

Schedule of allocation of stock-based compensation expense


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2020		2019		2020		2019
Research and development	$	134	$	103	$	471	$	413
General and administrative		513		275		1,636		934
Total	$	647	$	378	$	2,107	$	1,347

Accumulated Other Comprehensive Income (Tables)

9 Months Ended

Sep. 30, 2020

Accumulated Other Comprehensive Income

Schedule of change in accumulated other comprehensive income, which is reported as a component of stockholders’ equity


	Unrealized
	Gain on
	Marketable
	Securities
Balance December 31, 2019	$	—
Other comprehensive income		11
Balance September 30, 2020	$	11

Organization and Description of Business (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Organization and Description of Business
Accumulated deficit	$ (294,603)	$ (260,370)
Cash and cash equivalents	$ 24,163	$ 34,479

Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2020
Deferred Financing Costs
Facility fee percentage		1.00%
Interest expense [Member]
Deferred Financing Costs
Amortization of deferred financing costs	$ 69	$ 162

Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Feb. 29, 2020	Dec. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Jan. 01, 2019	Dec. 31, 2018
Warrants
Cumulative effect adjustment	$ 66,130	$ 80,796	$ 90,607		$ 45,745
Common stock warrants
Warrants
Common stock that can be purchased with warrants (in shares)				1,400,000
Additional Paid-in Capital
Warrants
Cumulative effect adjustment	360,713	359,856	358,851		306,108	$ 286,246	$ 272,977	$ 271,094		$ 261,722
Accumulated Deficit
Warrants
Cumulative effect adjustment	$ (294,603)	$ (279,079)	$ (268,253)		$ (260,370)	$ 31,903	$ 23,064	24,665		$ 20,174
Cumulative Effect, Period of Adoption, Adjustment [Member] \| Additional Paid-in Capital
Warrants
Cumulative effect adjustment								$ 213
Cumulative Effect, Period of Adoption, Adjustment [Member] \| ASU 2017-11 \| Adjustment \| Additional Paid-in Capital
Warrants
Cumulative effect adjustment									$ 213
Cumulative Effect, Period of Adoption, Adjustment [Member] \| ASU 2017-11 \| Adjustment \| Accumulated Deficit
Warrants
Cumulative effect adjustment									$ (213)

- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

+ References + Details

Summary of Significant Accounting Policies - Income Taxes (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Uncertainty in tax positions
Uncertain tax positions	$ 0

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	10,162,550	7,542,339
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	1,400,000	242,779
Restricted Stock Units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	159,795
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	8,602,755	7,299,560

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Level 1
Assets:
Cash and cash equivalents	$ 24,163	$ 34,479
Total assets at fair value	24,163	$ 34,479
Level 2
Assets:
Marketable securities	47,742
Total assets at fair value	$ 47,742

Fair Value Measurements - Transfers Between Levels (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Fair value measurements
Asset transfers out of Level 1 into Level 2	$ 0	$ 0
Asset transfers out of Level 2 into Level 1	0	0
Asset transfers into (out of) Level 3	0	0
Liability transfers out of Level 1 into Level 2	0	0
Liability transfers out of Level 2 into Level 1	0	0
Liability transfers into (out of) Level 3	$ 0	$ 0

Marketable Securities (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Marketable Securities [Line Items]
Amortized Cost (maturing in one year or less)	$ 47,731
Gross Unrealized Gain (maturing in one year or less)	11
Fair Value (maturing in one year or less)	47,742
Accrued interest	200
U.S. government obligations
Marketable Securities [Line Items]
Amortized Cost (maturing in one year or less)	7,072
Gross Unrealized Gain (maturing in one year or less)	3
Fair Value (maturing in one year or less)	7,075
Corporate debt securities
Marketable Securities [Line Items]
Amortized Cost (maturing in one year or less)	40,659
Gross Unrealized Gain (maturing in one year or less)	8
Fair Value (maturing in one year or less)	$ 40,667

Prepaid Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Prepaid Expenses
Prepaid insurance	$ 941	$ 656
Other	473	184
Total prepaid expenses	$ 1,414	$ 840

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Accrued Liabilities
Employee bonuses	$ 1,166	$ 1,437
Accrued professional fees and other	988	367
Total accrued liabilities	$ 2,154	$ 1,804

Leases - Summary (Details) $ in Thousands	3 Months Ended	9 Months Ended
Leases - Summary (Details) $ in Thousands	Sep. 30, 2020 USD ($) lease	Sep. 30, 2020 USD ($) lease	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)	Jan. 01, 2019 USD ($)
Leases
Lease assets	$ 31	$ 31		$ 158
Present value of lease liability	$ 34	$ 34
Number of finance leases \| lease	0	0
Number of operating leases \| lease	1	1
Operating lease expense	$ 48	$ 145
Operating lease expense information:
Cash paid for amounts included in measurement of lease liabilities	$ 48	$ 138	$ 112
Weighted-average remaining lease term (years)	2 months 1 day	2 months 1 day
Weighted-average discount rate	21.20%	21.20%
ASU 2016-02 \| Adjustment
Leases
Lease assets					$ 300
Present value of lease liability					$ 300

Leases - Maturity of lease liabilities (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Operating Leases
Remainder of 2020	$ 35
Total	35
Less: Interest	(1)
Present value of lease liability	$ 34

Credit Agreement and Guaranty (Details) $ / shares in Units, $ in Thousands		3 Months Ended		9 Months Ended
	Feb. 10, 2020 USD ($) item Y $ / shares shares	Dec. 31, 2023 USD ($)	Mar. 31, 2021 USD ($)	Sep. 30, 2020 USD ($)
Debt Instrument [Line Items]
Amount borrowed				$ 20,000
Interest rate (as a percent)	11.75%
Percentage of annual interest rate	3.00%
Proceeds from warrant exercises	$ 20,000
Fair value of warrants	$ 3,600
Warrants, Measurement Input \| Y	3
Facility fee percentage				1.00%
Perceptive Credit Agreement
Debt Instrument [Line Items]
Percentage of outstanding debt	1.50%
Minimum cash covenants	$ 3,000
Revenue generated under debt		$ 93,500	$ 3,800
Perceptive Credit Agreement \| Perceptive Warrants
Debt Instrument [Line Items]
Common stock that can be purchased with warrants (in shares) \| shares	1,400,000
Beneficial ownership percentage	19.99%
Facility fee percentage	1.00%
Perceptive Credit Agreement \| First Seven Lakhs Shares
Debt Instrument [Line Items]
Exercise price of warrants (in dollars per share) \| $ / shares	$ 3.74
Common stock that can be purchased with warrants (in shares) \| shares	700,000
Perceptive Credit Agreement \| Remaining Seven Lakhs Shares
Debt Instrument [Line Items]
Exercise price of warrants (in dollars per share) \| $ / shares	$ 4.67
Common stock that can be purchased with warrants (in shares) \| shares	700,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Maximum borrowing capacity	$ 35,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche One
Debt Instrument [Line Items]
Amount borrowed	5,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche Two
Debt Instrument [Line Items]
Amount borrowed	15,000
Senior secured delayed draw term loan facility \| Perceptive Credit Agreement, Tranche Three
Debt Instrument [Line Items]
Additional amount available	$ 15,000
LIBOR \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Variable interest rate margin (as a percent)	10.25%
Interest rate for the base rate	1.50%
Prepayment Occur on or Before February, 10, 2021 \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Prepayment fee percent	10.00%
Prepayment Occur on or Before February, 10, 2022 \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Prepayment fee percent	8.00%
Prepayment Occur on or Before February, 10, 2023 \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Prepayment fee percent	4.00%
Prepayment Occur on or Before February, 10, 2024 \| Perceptive Credit Agreement
Debt Instrument [Line Items]
Prepayment fee percent	2.00%
Option pricing model \| Common stock warrants \| Perceptive Warrants
Debt Instrument [Line Items]
Warrants and rights outstanding, term	7 years
Option pricing model \| Common stock warrants \| Perceptive Warrants \| Volatility
Debt Instrument [Line Items]
Warrants, Measurement Input \| item	0.700
Option pricing model \| Common stock warrants \| Perceptive Warrants \| Risk free interest rate
Debt Instrument [Line Items]
Warrants, Measurement Input \| item	0.0147
Option pricing model \| Common stock warrants \| Perceptive Warrants \| Expected life
Debt Instrument [Line Items]
Warrants, Measurement Input \| Y	3
Option pricing model \| Common stock warrants \| Perceptive Warrants \| Share price
Debt Instrument [Line Items]
Warrants, Measurement Input \| item	4.01
Option pricing model \| Common stock warrants \| Maximum \| Perceptive Warrants \| Strike price
Debt Instrument [Line Items]
Warrants, Measurement Input \| item	4.67
Option pricing model \| Common stock warrants \| Minimum \| Perceptive Warrants \| Strike price
Debt Instrument [Line Items]
Warrants, Measurement Input \| item	3.74

Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2020 USD ($)
Credit Agreement and Guaranty
Notes payable	$ 20,000	$ 20,000
Debt issuance costs	(897)	(897)
Warrant discount	(3,025)	(3,025)
Total	16,078	16,078
Warrants and debt issue costs	$ 303	$ 707

Stockholders' Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended				3 Months Ended					9 Months Ended		12 Months Ended
	Feb. 29, 2020	Aug. 31, 2019	Mar. 31, 2019	Jan. 31, 2019	Sep. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Oct. 02, 2020	Nov. 30, 2019
Sale of stock
Proceeds from issuance of common stock in private placement, net of offering costs											$ 7,810
Commission percentage				3.00%
2018 Shelf Registration Statement
Sale of stock
Aggregate amount of securities issuable													$ 200,000
Private Placement \| Common Stock
Sale of stock
Issuance of common stock (in shares)			8,426,750			17,250,000			8,426,750
Share price (in dollars per share)			$ 0.93						$ 0.93
Proceeds from issuance of common stock in private placement, net of offering costs			$ 7,800
At-the-market sales
Sale of stock
Issuance of common stock (in shares)											1,801,528
Gross Proceeds											$ 2,500
Proceeds from issuance of common stock in public offering, net of offering costs											(2,456)
At-the-market sales \| Common Stock
Sale of stock
Issuance of common stock (in shares)							143,482	992,072	665,974
Public offering
Sale of stock
Proceeds from issuance of common stock in public offering, net of offering costs										$ 48,434	12,687
Public offering \| Common Stock
Sale of stock
Issuance of common stock (in shares)	17,250,000	14,526,315					14,526,315
Share price (in dollars per share)	$ 3.00	$ 0.95
Proceeds from issuance of common stock in public offering, net of offering costs	$ 48,400	$ 12,700
At The Market Offering
Sale of stock
Issuance of common stock (in shares)					143,482
Gross Proceeds				$ 10,000
Proceeds from issuance of common stock in public offering, net of offering costs											$ 200
Second Sales Agreement
Sale of stock
Issuance of common stock (in shares)												10,440,908
Authorized value for shares issuance														$ 20,000
Commission paid on sale of stock (as a percent)														3.00%
Proceeds from issuance of common stock in public offering, net of offering costs												$ 19,300

Stockholders' Equity - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 647	$ 378	$ 2,107	$ 1,347
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	134	103	471	413
General and administrative expenses
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 513	$ 275	$ 1,636	$ 934

Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Sep. 30, 2020
Accumulated Other Comprehensive Income
Other comprehensive income of unrealized gain on marketable securities	$ 1	$ 10	$ 11
Balance at	$ 11		11
Amounts classified out of accumulated other comprehensive income			$ 0

- Definition

Accumulated change in equity from transactions and other events and circumstances from non-owner sources, net of tax effect, at period end. Excludes Net Income (Loss), and accumulated changes in equity from transactions resulting from investments by owners and distributions to owners. Includes foreign currency translation items, certain pension adjustments, unrealized gains and losses on certain investments in debt and equity securities, other than temporary impairment (OTTI) losses related to factors other than credit losses on available-for-sale and held-to-maturity debt securities that an entity does not intend to sell and it is not more likely than not that the entity will be required to sell before recovery of the amortized cost basis, as well as changes in the fair value of derivatives related to the effective portion of a designated cash flow hedge.

+ References + Details

2019 Retention Plan (Details) - 2019 Retention Plan - USD ($) $ / shares in Units, $ in Millions		9 Months Ended
	Jul. 03, 2019	Sep. 30, 2020	Jul. 31, 2019
2019 Retention Plan
Cash portion of the retention plan			$ 0.3
Options granted In January 2019 \| Vesting on January 29, 2020
2019 Retention Plan
Percentage of options to vest	50.00%
Options granted In January 2019 \| Vesting on June 30, 2020
2019 Retention Plan
Percentage of options to vest	25.00%
Options granted In January 2019 \| Vesting on December 31, 2020
2019 Retention Plan
Percentage of options to vest	25.00%
Options granted in July 2019
2019 Retention Plan
Stock option exercise price (in dollars per share)		$ 1.48
Options granted in July 2019 \| Vesting on July 3, 2020
2019 Retention Plan
Percentage of options to vest		50.00%
Options granted in July 2019 \| Vesting on December 31, 2020
2019 Retention Plan
Percentage of options to vest		50.00%

Commitments and Contingencies (Details) $ in Millions	Sep. 30, 2020 USD ($)
Commitments and Contingencies
Future purchase commitments	$ 17.8