Agile Therapeutics (AGXRW) 10-Q 28 Oct 19 2019 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2019	Oct. 28, 2019
Document and Entity Information
Entity Registrant Name	AGILE THERAPEUTICS INC
Document Type	10-Q
Document Period End Date	Sep. 30, 2019
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		59,302,126
Entity Central Index Key	0001261249
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q3
Amendment Flag	false

Balance Sheets

Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 18,370	$ 7,851
Prepaid expenses	1,316	607
Total current assets	19,686	8,458
Property and equipment, net	13,932	13,916
Right of use and other assets	214	18
Total assets	33,832	22,392
Current liabilities:
Accounts payable	603	875
Accrued expenses	1,114	1,343
Lease liability, current portion	178
Total current liabilities	1,895	2,218
Lease liability, long-term	34
Commitments and contingencies (Note 11)
Stockholders' equity
Common stock, $.0001 par value, 150,000,000 shares authorized, 59,302,126 and 34,377,329 issued and outstanding at September 30, 2019 and December 31, 2018, respectively	6	3
Additional paid-in capital	286,246	261,722
Accumulated deficit	(254,349)	(241,551)
Total stockholders' equity	31,903	20,174
Total liabilities and stockholders' equity	$ 33,832	$ 22,392

Balance Sheets (Parenthetical)

Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2019	Dec. 31, 2018
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)	59,302,126	34,377,329
Common stock, outstanding (in shares)	59,302,126	34,377,329

Statements of Operations

Statements of Operations - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Operating expenses:
Research and development	$ 2,361	$ 1,549	$ 7,021	$ 7,921
General and administrative	2,138	1,767	5,732	7,173
Restructuring Charges		299		715
Total operating expenses	4,499	3,615	12,753	15,809
Loss from operations	(4,499)	(3,615)	(12,753)	(15,809)
Other income (expense)
Interest income	67	91	168	289
Interest expense		(268)		(955)
Change in fair value of warrants				29
Total other income (expense), net	67	(177)	168	(637)
Loss before benefit from income taxes	(4,432)	(3,792)	(12,585)	(16,446)
Benefit from income taxes				477
Net loss	$ (4,432)	$ (3,792)	$ (12,585)	$ (15,969)
Net loss per share (basic and diluted) (in dollars per share)	$ (0.08)	$ (0.11)	$ (0.28)	$ (0.47)
Weighted-average common shares (basic and diluted) (in shares)	53,609,511	34,377,329	44,957,809	34,295,240

Statements of Changes in Stockh

Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands	Common StockPublic offering	Common StockPrivate Placement	Common StockAt-the-market sales	Common Stock	Additional Paid-in CapitalPublic offering	Additional Paid-in CapitalPrivate Placement	Additional Paid-in CapitalAt-the-market sales	Additional Paid-in Capital	Accumulated Deficit	Public offering	Private Placement	At-the-market sales	Total
Balance at Dec. 31, 2017				$ 3				$ 258,092	$ (221,772)				$ 36,323
Balance (in shares) at Dec. 31, 2017				34,186,342
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs								1,119					1,119
Vesting of RSUs (in shares)				61,926
Net loss									(6,833)				(6,833)
Balance at Mar. 31, 2018				$ 3				259,211	(228,605)				30,609
Balance (in shares) at Mar. 31, 2018				34,248,268
Balance at Dec. 31, 2017				$ 3				258,092	(221,772)				36,323
Balance (in shares) at Dec. 31, 2017				34,186,342
Increase (decrease) in stockholders' equity
Net loss													(15,969)
Balance at Sep. 30, 2018				$ 3				260,919	(237,741)				23,181
Balance (in shares) at Sep. 30, 2018				34,377,329
Balance at Mar. 31, 2018				$ 3				259,211	(228,605)				30,609
Balance (in shares) at Mar. 31, 2018				34,248,268
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs								987					987
Vesting of RSUs (in shares)				129,061
Net loss									(5,344)				(5,344)
Balance at Jun. 30, 2018				$ 3				260,198	(233,949)				26,252
Balance (in shares) at Jun. 30, 2018				34,377,329
Increase (decrease) in stockholders' equity
Share-based compensation - stock options and RSUs								721					721
Net loss									(3,792)				(3,792)
Balance at Sep. 30, 2018				$ 3				260,919	(237,741)				23,181
Balance (in shares) at Sep. 30, 2018				34,377,329
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
Adjustment to derivative liabilities upon adoption of ASU 2017-11								213	(213)
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				271,094	(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 Mar. 31, 2019				$ 4				271,094	(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)
Balance at Sep. 30, 2019				$ 6				$ 286,246	$ (254,349)				$ 31,903
Balance (in shares) at Sep. 30, 2019				59,302,126

Statements of Cash Flows

Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Cash flows from operating activities:
Net loss	$ (12,585)	$ (15,969)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	14	18
Amortization	107
Noncash stock based compensation	1,347	2,827
Noncash interest		367
Change in fair value of warrants		(29)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(709)	31
Accounts payable and accrued expenses	(481)	(1,004)
Lease liability	(112)
Net cash used in operating activities	(12,419)	(13,759)
Cash flows from investing activities:
Acquisition of property and equipment	(30)	(318)
Net cash used in investing activities	(30)	(318)
Cash flows from financing activities:
Proceeds from issuance of common stock in private placement, net of offering costs	7,810
Principal payments of loan payable		(4,949)
Proceeds from exercise of stock options	15
Net cash provided by (used in) financing activities	22,968	(4,949)
Net increase (decrease) in cash and cash equivalents	10,519	(19,026)
Cash and cash equivalents, beginning of period	7,851	35,952
Cash and cash equivalents, end of period	18,370	16,926
Supplemental cash flow information
Interest paid		$ 625
At-the-market sales
Cash flows from financing activities:
Proceeds from sales or issuance of common stock, net of offering costs	2,456
Public offering
Cash flows from financing activities:
Proceeds from sales or issuance of common stock, net of offering costs	$ 12,687

Organization and Description of

Organization and Description of Business	9 Months Ended
	Sep. 30, 2019
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 Twirla ® , also known as AG200-15. The Company is headquartered in Princeton, New Jersey. Twirla ® is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development. Substantially all of the Company's resources are currently dedicated to developing and seeking regulatory approval for 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 U.S. Food and Drug Administration (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, 2019, the Company had an accumulated deficit of approximately $254.3 million. The Company expects to continue to incur net losses into the foreseeable future. The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 8), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern On December 21, 2017, the Company received a complete response letter (the "2017 CRL") from the FDA citing deficiencies related to the manufacturing process for Twirla and raising questions on the in vivo adhesion properties of Twirla and their potential relationship to the Company's Phase 3 clinical trial results. The Company's ability to commercialize Twirla, and the timing of Twirla commercialization, is dependent on the FDA's review of the Company's response to the 2017 CRL and its new drug application ("NDA") for Twirla, and other items such as timely and successful completion of the validation of equipment for commercial manufacturing, ultimate FDA approval, and the Company’s ability to secure additional capital. In January 2018, following the Company's receipt of the 2017 CRL, the Company significantly scaled back its preparations for commercialization of Twirla, including commercial pre-launch and manufacturing validation activities, pending its ability to address the 2017 CRL and receive approval of Twirla. In April 2018, the Company met with the FDA in a Type A meeting to discuss the deficiencies in the Twirla NDA and the regulatory path for approval of Twirla, and the Company announced the content of the official minutes from the meeting in May 2018. In June 2018, the Company announced it had submitted a formal dispute resolution request (“FDRR”) with the FDA for Twirla. The dispute pertained to the determination from the FDA’s reviewing Division of Bone, Reproductive and Urologic Products (“DBRUP”) that concerns surrounding the in vivo adhesion properties of Twirla prevent the approval and could not be addressed through the Company’s proposed patient compliance programs. The initial FDRR was submitted in June 2018 and was reviewed by the Office of Drug Evaluation III, which denied the Company’s appeal on July 20, 2018. The Company then escalated its appeal to the Office of New Drugs (“OND”). In October 2018, the OND formally denied the Company’s appeal and provided a path forward that may not require that the Company reformulate Twirla or conduct a bioequivalence study between formulations, as previously suggested by DBRUP. Specifically, OND suggested that the Company conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane ® , the generic version of the previously marketed Ortho Evra ® contraceptive patch, a product the FDA considers to have acceptable adhesion. If this result is demonstrated, OND stated that the study would support the conclusion of adequate Twirla adhesion. DBRUP later agreed that Twirla would show adequate adhesion if it demonstrated statistical non-inferiority to Xulane by a margin of less than +0.15. On February 11, 2019, the Company announced the top-line results of the comparative wear study, which demonstrated that Twirla was statistically non-inferior to Xulane. The wear study suggested by OND to address adhesion provides a path forward but is not intended to address efficacy. The Company resubmitted the NDA for Twirla which was received by the FDA on May 16, 2019 and the Company was given a target Prescription Drug User Fee Act ("PDUFA") goal date of November 16, 2019. The Company was also notified that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA has been scheduled for October 30, 2019 to review the Company’s NDA for Twirla. Twirla's efficacy, including the Pearl Index that FDA noted is substantially higher than other previously approved combined hormonal contraceptives when weighed against the FDA's view of the product candidate's safety profile, is the primary issue that the FDA plans to bring to Advisory Committee. In advance of the Advisory Committee meeting, the FDA issued its briefing document in which it expresses a number of concerns regarding Twirla’s approvability, including, but not limited to concerns related to Twirla’s efficacy when balanced against its safety. In its briefing materials, the FDA also did not appear to agree with our proposal to include a limitation of use based on patient weight and BMI in the product label. The Company believes that its cash and cash equivalents as of September 30, 2019 will be sufficient to meet its operating requirements through the end of the first quarter of 2020. The Company will require additional capital to fund operating needs for the remainder of the first quarter of 2020 and beyond, which primarily will be used for the completion of our commercial plan for Twirla, if approved, including the completion of the validation of our commercial manufacturing process, the commercial launch, and advancing the development of our other potential product candidates. The Company cannot assure you that the FDA will approve Twirla, or that the Company along with Corium International, Inc. ("Corium"), its third-party manufacturer, will be able to complete validation of the Company's commercial manufacturing successfully and in a timely manner. The Company anticipates it will continue to incur net losses for the foreseeable future and the Company's ability to continue operations for the remainder of 2020 and beyond will depend on its ability to obtain additional funding, as to which no assurances can be given. There can be no assurance that any financing by the Company 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. As of September 30, 2019, the Company had cash and cash equivalents of $18.4 million. The Company continues to analyze various alternatives, including strategic and refinancing alternatives, asset sales and mergers and acquisitions. The Company's future success depends on its ability to raise additional capital and/or implement the various strategic alternatives 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 complete the development of Twirla, and may also be required to further cut operating costs, forego future development and other opportunities and may need to seek bankruptcy protection. The unaudited financial statements as of September 30, 2019 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 equity and/or debt financing and reduce expenditures. The accompanying financial statements as of September 30, 2019 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements. Basis of Presentation The accompanying unaudited interim financial statements have been prepared by the Company, without audit, 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 have 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, 2018 filed with the SEC. 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 have been made. The results of operations for the three and nine months ended September 30, 2019 are not necessarily indicative of the operating results for the full fiscal year or any future period.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2019
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, 2018 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. 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 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. 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, 2019. Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Prior to January 1, 2019, warrants with non-standard anti-dilution provisions (referred to as down round protection) were classified as liabilities and re-measured each reporting period. 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 1) 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 indicates 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. As of September 30, 2019, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019. The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 7) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of September 30, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied. 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 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, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2019 2018 Common stock warrants 242,779 242,779 Unvested restricted stock units — 147,554 Common stock options 7,299,560 5,687,901 Total 7,542,339 6,078,234 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. The recent accounting pronouncements did not have a material impact of the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2019
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 — Quotes prices in active markets for identical assets and liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities. · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. · Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participant price the fair value of the assets or liabilities. The Company’s Level 3 liabilities consist of the warrant liability. The Company is required to mark the value of its warrant liability to market and recognize the change in valuation in its statements of operations each reporting period. 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, 2019 and December 31, 2018. Level 1 Level 2 Level 3 September 30, 2019 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Level 1 Level 2 Level 3 December 31, 2018 Assets: Cash and cash equivalents $ 7,776 $ — $ — Total assets at fair value $ 7,776 $ — $ — Liabilities: Common stock warrants $ — $ — $ — Total liabilities at fair value $ — $ — $ — As indicated in Note 2, on January 1, 2019, the Company adopted the provisions of ASU 2017-11 to account for the down round feature of its warrants issued in December 2012 and converted into warrants to purchase common stock in connection with its initial public offering in May 2014. As a result of the adoption of ASU 2017-11, effective January 1, 2019 the Company no longer measures these warrants at fair value The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2018 include (i) volatility (70.0%), (ii) risk free interest rate of 2.57% (estimated using treasury bonds with a 1-year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($0.58) and (v) expected life (1 year). There were no transfers between Level 1, 2 or 3 during 2019 or 2018. If the Company’s estimates regarding the fair value of its warrants are inaccurate, a future adjustment to these estimated fair values may be required. Additionally, these estimated fair values could change significantly.

Prepaid Expenses

Prepaid Expenses	9 Months Ended
	Sep. 30, 2019
Prepaid Expenses
Prepaid Expenses	4. Prepaid Expenses Prepaid expenses consist of the following: September 30, December 31, 2019 2018 Prepaid insurance $ $ 484 Prepaid Advisory Committee Costs — Other 123 Total prepaid expenses $ $ 607

Accrued Liabilities

Accrued Liabilities	9 Months Ended
	Sep. 30, 2019
Accrued Liabilities
Accrued Liabilities	5. Accrued Liabilities Accrued liabilities consist of the following: September 30, December 31, 2019 2018 Employee bonuses $ 638 $ 621 Accrued retention bonus — 638 Accrued professional fees and other 476 84 Total accrued liabilities $ 1,114 $ 1,343

Leases

Leases	9 Months Ended
	Sep. 30, 2019
Leases
Leases	6. 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, 2019, respectively. Operating cash flows used for operating leases during the three and nine months ended September 30, 2019 were $37 and $112, respectively. As of September 30, 2019, the weighted-average remaining lease term was 1.2 years and the weighted average discount rate was 21.2%. Future minimum lease payments under non-cancellable leases as of September 30, 2019 were as follows: Remainder of 2019 $ 2020 Total $ Less: Interest Present value of lease liability $

Loan and Security Agreement

Loan and Security Agreement	9 Months Ended
	Sep. 30, 2019
Loan and Security Agreement
Loan and Security Agreement	7. Loan and Security Agreement Hercules Capital, Inc. In February 2015, the Company entered into a loan and security agreement (the "Hercules Loan Agreement") with Hercules Capital, Inc. ("Hercules") for a term loan of up to $25.0 million (the "Term Loan"). In August 2016, the Company entered into the First Amendment to Loan and Security Agreement (the "First Amendment") with Hercules which amended certain terms of the Hercules Loan Agreement. In May 2017, the Company entered into the Second Amendment to Loan and Security Agreement (the "Second Amendment") with Hercules which further amended certain terms of the Hercules Loan Agreement. A first tranche of $16.5 million was funded upon execution of the Hercules Loan Agreement, approximately $15.5 million of which was used to repay the Company’s existing term loan with Oxford Finance LLC. The First Amendment provided that the Term Loan matured on December 1, 2018. In connection with the execution of the First Amendment, the Company paid Hercules a facility fee of $165. The facility fee represented a debt issue cost which was reflected as a reduction to the carrying amount of the loan payable in accordance with ASU 2015-03. Such issue costs were amortized to interest expense over the life of the Term Loan using the effective interest method. The Term Loan accrued interest at a rate of the greater of 9.0% or 9.0% plus Prime minus 4.25% and was payable monthly. Principal was due in 23 consecutive monthly installments beginning on February 1, 2017 and ending on December 1, 2018. In addition to the outstanding principal balance, the Company was required to make a final payment of approximately $611 on the maturity date of the Term Loan (December 1, 2018). The amount of the end of term final payment was accrued over the loan term as interest expense. In connection with the Hercules Loan Agreement, the Company issued Hercules a warrant to purchase 180,274 shares of the Company’s common stock at an exercise price of $5.89 per share which expires on February 24, 2020 and granted Hercules the right to participate in future equity financings in an amount up to $2.0 million while the loan and warrant are outstanding. The Company allocated the proceeds of $16.5 million in accordance with ASC 470 based on the relative fair values. The relative fair value of the warrants of approximately $1.2 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 warrant issued to Hercules include (i) volatility (75.0%), (ii) risk free interest rate of 1.22% (estimated using treasury bonds with a 4-year life), (iii) strike price ($5.89) for the common stock warrant, (iv) fair value of common stock ($9.82) and (v) expected life (4 years). The discount on the debt was amortized to interest expense over the term of the debt. Interest expense on the Hercules Loan Agreement including the accretion of the value of the related warrants, accrual of term loan back-end fee and amortization of the deferred financing costs was $0, for the three and nine months ended September 30, 2019 and was approximately $268 thousand and $955 thousand for the three and nine months ended September 30, 2018, respectively.

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2019
Stockholders' Equity
Stockholders' Equity	8. Stockholders’ Equity Shelf Registration Statement On November 2, 2018, the Company filed a universal shelf registration statement with the Securities and Exchange Commission (“SEC”) for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $100.0 million (the "2018 Shelf Registration Statement"). On November 14, 2018, the 2018 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 2018 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 Offering of Common Stock 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 In January 2019, the Company entered into an ATM Agreement (the "2019 ATM Agreement ") under which the Company was authorized to issue and sell shares of its common stock having aggregate sales proceeds of up to $10.0 million from time to time. The Company paid a commission of 3% of the gross proceeds from the sales of its common stock under the 2019 ATM Agreement. For the nine months ended September 30, 2019, the Company sold 1,801,528 shares of common stock under the 2019 ATM Agreement, resulting in net proceeds of approximately $2.5 million. The Company terminated the 2019 ATM Agreement on July 31, 2019. Stock-Based Compensation Expense Stock-based compensation expense was allocated as follows: Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ $ 286 $ $ 975 General and administrative 435 1,852 Total $ $ 721 $ $ 2,827

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2019
Income Taxes
Income Taxes	9. Income Taxes Sale of New Jersey Net Operating Losses In January 2018, the Company received net proceeds of approximately $0.5 million in non-dilutive financing through the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”). The Program enables approved biotechnology companies to sell their unused Net Operating Loss Carryovers and unused Research and Development Tax Credits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation administer the Program. The Company used the proceeds from the sale for working capital purposes. The Company has now reached the maximum lifetime benefit of $15.0 million under the Program and will no longer be eligible to participate in the Program.

Restructuring Costs

Restructuring Costs	9 Months Ended
	Sep. 30, 2019
Restructuring Costs
Restructuring Costs	10. Restructuring Costs In June 2018, the Company announced a reduction in its workforce, which resulted in the termination of several employees primarily from the Company’s commercial and clinical teams, representing approximately thirty percent of its employees. This workforce reduction, along with other reductions in planned operating expenses is designed to preserve cash while the Company pursued formal dispute resolution with the FDA for Twirla and determines a regulatory path forward for the resubmission of the Company’s NDA for Twirla. In June 2018, the Company also announced that it had adopted a retention plan (the “Retention Plan”) to provide (i) cash retention payments to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2018 and (ii) stock option grants to all remaining employees in order to induce such employees to remain employed by the Company through December 31, 2019. Each employee who participated in the Retention Plan (“Retention Plan Participants”) and (i) remained continuously employed by the Company through December 31, 2018 or (ii) had been terminated by the Company other than for cause (as defined in an applicable employment agreement, or, if no employment agreement existed, as determined by the Company in good faith) prior to December 31, 2018, were paid a lump-sum cash payment in an amount determined by the compensation committee (“Compensation Committee”) of the Company’s board of directors at the time of the adoption of the Retention Plan. The total amount of the cash portion of the Retention Plan was approximately $0.6 million and was paid out to the Retention Plan Participants in January 2019. In addition, each Retention Plan Participant was 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 $0.58, representing the closing price of the Company’s common stock as reported by Nasdaq on the date the Retention Plan was approved by the Compensation Committee. Each option vests in four equal 25% installments on the following dates: (i) June 20, 2018, (ii) December 31, 2018, (iii) June 30, 2019 and (iv) December 31, 2019. A summary of accrued restructuring costs, included as a component of accrued liabilities on the Company’s unaudited September 30, 2019 balance sheet is as follows: December 31, September 30, 2018 Charges Payments 2019 2018 Restructuring (severance) $ 638 $ — $ (638) $ — Total $ 638 $ — $ (638) $ —

2019 Retention Plan

2019 Retention Plan	9 Months Ended
	Sep. 30, 2019
2019 Retention Plan
2019 Retention Plan	11. 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 PDUFA goal date of November 16, 2019. Each employee who participates in the 2019 Retention Plan and remains continuously employed by the Company through the Approval shall 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 terminates employment prior to the Approval for any reason, no such retention payment shall be made to the eligible employee. The total amount of the cash portion of the 2019 Retention Plan is approximately $0.3 million. Given the uncertainty of the approval of Twirla, the Company has not recorded compensation expense related to these potential cash awards for the period ended September 30, 2019. 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. Each option will vest in two equal 50% installments on the following dates (i) July 3, 2020 and (ii) December 31, 2020. In addition, the vesting for the stock options granted in January 2019 have been amended for all employees holding such options who were employed on July 3, 2019 as follows: 50% of the option will vest on January 29, 2020, 25% on June 30, 2020 and the remaining 25% on December 31, 2020.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2019
Commitments and Contingencies
Commitments and Contingencies	12. Commitments and Contingencies 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, 2019, the Company has not recorded a provision for any contingent losses.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2019
Summary of Significant Accounting Policies
Use of Estimates	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.
Fair Value of Financial Instruments	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 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.
Long-Lived Assets	Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment , the Company’s policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of September 30, 2019.
Warrants	Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer’s equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations. In connection with the completion of the Company’s initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. Prior to January 1, 2019, warrants with non-standard anti-dilution provisions (referred to as down round protection) were classified as liabilities and re-measured each reporting period. 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 1) 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 indicates 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. As of September 30, 2019, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019. The warrants issued in connection with the Company’s debt financing completed in February 2015 (see Note 7) are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. As of September 30, 2019, there were outstanding 180,274 warrants to purchase common stock at $5.89 per share related to this debt financing. These warrants expire on February 24, 2020.
Stock-Based Compensation	Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied.
Net Loss Per Share	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 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, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2019 2018 Common stock warrants 242,779 242,779 Unvested restricted stock units — 147,554 Common stock options 7,299,560 5,687,901 Total 7,542,339 6,078,234
Recent Accounting Pronouncements	Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. The recent accounting pronouncements did not have a material impact of the financial statements unless otherwise disclosed, and the Company does not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	9 Months Ended
	Sep. 30, 2019
Summary of Significant Accounting Policies
Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share	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, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): September 30, 2019 2018 Common stock warrants 242,779 242,779 Unvested restricted stock units — 147,554 Common stock options 7,299,560 5,687,901 Total 7,542,339 6,078,234

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2019
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, 2019 Assets: Cash and cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Level 1 Level 2 Level 3 December 31, 2018 Assets: Cash and cash equivalents $ 7,776 $ — $ — Total assets at fair value $ 7,776 $ — $ — Liabilities: Common stock warrants $ — $ — $ — Total liabilities at fair value $ — $ — $ —

Prepaid Expenses (Tables)

Prepaid Expenses (Tables)	9 Months Ended
	Sep. 30, 2019
Prepaid Expenses
Schedule of prepaid expenses	September 30, December 31, 2019 2018 Prepaid insurance $ $ 484 Prepaid Advisory Committee Costs — Other 123 Total prepaid expenses $ $ 607

Accrued Liabilities (Tables)

Accrued Liabilities (Tables)	9 Months Ended
	Sep. 30, 2019
Accrued Liabilities
Schedule of accrued liabilities	September 30, December 31, 2019 2018 Employee bonuses $ 638 $ 621 Accrued retention bonus — 638 Accrued professional fees and other 476 84 Total accrued liabilities $ 1,114 $ 1,343

Leases (Tables)

Leases (Tables)	9 Months Ended
	Sep. 30, 2019
Leases
Maturity of lease liabilities	Future minimum lease payments under non-cancellable leases as of September 30, 2019 were as follows: Remainder of 2019 $ 2020 Total $ Less: Interest Present value of lease liability $

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2019
Stockholders' Equity
Schedule of allocation of stock-based compensation expense	Three Months Ended Nine Months Ended September 30, September 30, 2019 2018 2019 2018 Research and development $ $ 286 $ $ 975 General and administrative 435 1,852 Total $ $ 721 $ $ 2,827

Restructuring Costs (Tables)

Restructuring Costs (Tables)	9 Months Ended
	Sep. 30, 2019
Restructuring Costs
Summary of accrued restructuring costs, included as a component of accrued liabilities	December 31, September 30, 2018 Charges Payments 2019 2018 Restructuring (severance) $ 638 $ — $ (638) $ — Total $ 638 $ — $ (638) $ —

Organization and Description _2

Organization and Description of Business (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
Organization and Description of Business
Product revenue	$ 0
Accumulated deficit	(254,349)	$ (241,551)
Cash and cash equivalents	$ 18,370	$ 7,851

Summary of Significant Accoun_4

Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands	Jan. 01, 2019	Mar. 31, 2019	Sep. 30, 2019	Feb. 28, 2015
Common stock warrants | Oxford Finance LLC
Warrants
Common stock that can be purchased with warrants (in shares)			62,505
Exercise price of warrants (in dollars per share)			$ 6
Additional Paid-in Capital
Warrants
Cumulative effect adjustment		$ 213
Accumulated Deficit
Warrants
Cumulative effect adjustment		$ (213)
Warrants | Common stock warrants | Hercules Capital, Inc.
Warrants
Common stock that can be purchased with warrants (in shares)			180,274	180,274
Exercise price of warrants (in dollars per share)			$ 5.89	$ 5.89
ASU 2017-11 | Adjustment | Additional Paid-in Capital
Warrants
Cumulative effect adjustment	$ 213
ASU 2017-11 | Adjustment | Accumulated Deficit
Warrants
Cumulative effect adjustment	$ (213)

Summary of Significant Accoun_5

Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	7,542,339	6,078,234
Common stock warrants
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	242,779	242,779
Restricted Stock Units
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)		147,554
Common stock options
Anti-dilutive securities
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares)	7,299,560	5,687,901

Fair Value Measurements - Finan

Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - Level 1 - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Assets:
Cash and cash equivalents	$ 18,314	$ 7,776
Total assets at fair value	$ 18,314	$ 7,776

Fair Value Measurements - Warra

Fair Value Measurements - Warrant Valuation Assumptions (Details) - Liabilities - Common stock warrants - Option pricing model	Dec. 31, 2018Yitem
Significant assumptions used in valuation of the Company's warrants
Life of treasury bonds	1 year
Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	0.700
Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	0.0257
Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	6
Share price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input	0.58
Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | Y	1

Fair Value Measurements - Trans

Fair Value Measurements - Transfers Between Levels (Details) - USD ($)	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018
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

Prepaid Expenses (Details)

Prepaid Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Prepaid Expenses
Prepaid insurance	$ 788	$ 484
Prepaid Advisory Committee Costs	353
Other	175	123
Total prepaid expenses	$ 1,316	$ 607

Accrued Liabilities (Details)

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Accrued Liabilities
Employee bonuses	$ 638	$ 621
Accrued retention bonus		638
Accrued professional fees and other	476	84
Total accrued liabilities	$ 1,114	$ 1,343

Leases - Summary (Details)

Leases - Summary (Details) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2019USD ($)lease	Sep. 30, 2019USD ($)lease	Jan. 01, 2019USD ($)	Dec. 31, 2018USD ($)
Leases
Lease assets	$ 214	$ 214		$ 18
Lease liability	$ 212	$ 212
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	$ 37	$ 112
Weighted-average remaining lease term (years)	1 year 2 months 12 days	1 year 2 months 12 days
Weighted-average discount rate	21.20%	21.20%
ASU 2016-02 | Adjustment
Leases
Lease assets			$ 300
Lease liability			$ 300

Leases - Maturity of lease liab

Leases - Maturity of lease liabilities (Details) $ in Thousands	Sep. 30, 2019USD ($)
Operating Leases
Remainder of 2019	$ 51
2020	190
Total	241
Less: Interest	(29)
Present value of lease liability	$ 212

Loan and Security Agreements (D

Loan and Security Agreements (Details) $ / shares in Units, $ in Thousands	1 Months Ended	3 Months Ended		9 Months Ended
	Feb. 28, 2015USD ($)Yitem$ / sharesshares	Sep. 30, 2019USD ($)$ / sharesshares	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)installment$ / sharesshares	Sep. 30, 2018USD ($)	Dec. 01, 2018USD ($)	Aug. 31, 2016USD ($)
Warrants | Option pricing model
Significant assumptions used in valuation of the Company's warrants
Life of treasury bonds	4 years
Warrants | Common stock warrants | Option pricing model | Volatility
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | item	0.750
Warrants | Common stock warrants | Option pricing model | Risk free interest rate
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | item	0.0122
Warrants | Common stock warrants | Option pricing model | Strike price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | item	5.89
Warrants | Common stock warrants | Option pricing model | Share price
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | item	9.82
Warrants | Common stock warrants | Option pricing model | Expected life
Significant assumptions used in valuation of the Company's warrants
Warrants, Measurement Input | Y	4
Secured debt
Interest expense
Interest expense, including accretion of value of related warrants and amortization of deferred financing costs		$ 0	$ 268	$ 0	$ 955
Secured debt | Oxford Loan
Loan and Security Agreement
Repayment of existing debt	$ 15,500
Oxford Finance LLC | Common stock warrants
Loan and Security Agreement
Common stock that can be purchased with warrants (in shares) | shares		62,505		62,505
Exercise price of warrants (in dollars per share) | $ / shares		$ 6		$ 6
Hercules Capital, Inc. | Hercules Loan ("Term Loan") | Right to participate in future equity financings | Maximum
Loan and Security Agreement
Equity financings amount	$ 2,000
Hercules Capital, Inc. | Warrants | Common stock warrants
Loan and Security Agreement
Common stock that can be purchased with warrants (in shares) | shares	180,274	180,274		180,274
Exercise price of warrants (in dollars per share) | $ / shares	$ 5.89	$ 5.89		$ 5.89
Hercules Capital, Inc. | Additional Paid-in Capital
Loan and Security Agreement
Fair value of common stock warrants issued with debt financing	$ 1,200
Hercules Capital, Inc. | Secured debt | Hercules Loan ("Term Loan")
Loan and Security Agreement
Maximum borrowing capacity	25,000
Facility Fee							$ 165
Fixed interest rate (as a percent)		9.00%		9.00%
Number of consecutive monthly principal installments | installment				23
Final payment amount due						$ 611
Discount on debt	1,200
Hercules Capital, Inc. | Secured debt | Hercules Loan Tranche One
Loan and Security Agreement
Amount borrowed	$ 16,500
Hercules Capital, Inc. | Secured debt | Prime | Hercules Loan ("Term Loan")
Loan and Security Agreement
Variable rate basis				Prime minus 4.25%
Variable interest rate margin (as a percent)				9.00%
Variable rate adjustment (as a percent)				(4.25%)

Stockholders' Equity - Common S

Stockholders' Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		3 Months Ended			9 Months Ended
	Aug. 31, 2019	Mar. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Sep. 30, 2019	Jan. 31, 2019	Nov. 02, 2018
Sale of stock
Proceeds from issuance of common stock in private placement, net of offering costs						$ 7,810
2018 Shelf Registration Statement
Sale of stock
Aggregate amount of securities issuable								$ 100,000
Private Placement | Common Stock
Sale of stock
Issuance of common stock (in shares)		8,426,750			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
Commission paid on sale of stock (as a percent)			3.00%			3.00%
Proceeds from sales or issuance of common stock, net of offering costs						$ 2,456
At-the-market sales | Maximum
Sale of stock
Authorized value for shares issuance							$ 10,000
At-the-market sales | Common Stock
Sale of stock
Issuance of common stock (in shares)			143,482	992,072	665,974	1,801,528
Public offering
Sale of stock
Proceeds from sales or issuance of common stock, net of offering costs						$ 12,687
Public offering | Common Stock
Sale of stock
Issuance of common stock (in shares)	14,526,315		14,526,315
Share price (in dollars per share)	$ 0.95
Proceeds from sales or issuance of common stock, net of offering costs	$ 12,700

Stockholders' Equity - Stock-Ba

Stockholders' Equity - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 378	$ 721	$ 1,347	$ 2,827
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	103	286	413	975
General and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 275	$ 435	$ 934	$ 1,852

Income Taxes (Details)

Income Taxes (Details) - State - New Jersey - Sale of unused NOLs and research and development credits $ in Millions	1 Months Ended
	Jan. 31, 2018USD ($)
Sale of New Jersey Net Operating Losses
Proceeds from the issuance of common stock, net	$ 0.5
Maximum lifetime benefit under the Program	$ 15
Minimum
Sale of New Jersey Net Operating Losses
Allowable sale of unused tax benefits as a percentage of total value	80.00%

Restructuring Costs (Details)

Restructuring Costs (Details) $ / shares in Units, $ in Thousands	1 Months Ended	3 Months Ended	9 Months Ended
	Jun. 30, 2018	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)installment$ / shares	Sep. 30, 2018USD ($)
Restructuring Costs
Reduction in workforce (as a percent)	30.00%
Restructuring Costs
Beginning balance			$ 638
Charges		$ 299		$ 715
Payments			(638)
2018 Restructuring (severance)
Restructuring Costs
Beginning balance			638
Charges			0
Payments			(638)
Ending balance			0
Retention Plan
Restructuring Costs
Cash portion of the retention plan			$ 600
Stock option exercise price (in dollars per share) | $ / shares			$ 0.58
Number of installments for option to vest | installment			4
Retention Plan | Vesting on June 20, 2018
Restructuring Costs
Percentage of options to vest			25.00%
Retention Plan | Vesting on December 31, 2018
Restructuring Costs
Percentage of options to vest			25.00%
Retention Plan | Vesting on June 30, 2019
Restructuring Costs
Percentage of options to vest			25.00%
Retention Plan | Vesting on December 31, 2019
Restructuring Costs
Percentage of options to vest			25.00%

2019 Retention Plan (Details)

2019 Retention Plan (Details) - 2019 Retention Plan $ / shares in Units, $ in Millions	Jul. 03, 2019	Sep. 30, 2019installment$ / shares	Jul. 31, 2019USD ($)
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) | $ / shares		$ 1.48
Number of installments for option to vest | installment		2
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%