Daré Bioscience (DARE) 10-Q 12 May 22 2022 Q1 Quarterly report Financial data

Cover Page

Cover Page - shares	3 Months Ended
	Mar. 31, 2022	May 10, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
Document Transition Report	false
Entity Registrant Name	DARÉ BIOSCIENCE, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-36395
Entity Tax Identification Number	20-4139823
Entity Address, Address Line One	3655 Nobel Drive
Entity Address, Address Line Two	Suite 260
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
City Area Code	858
Local Phone Number	926-7655
Entity Address, Postal Zip Code	92122
Title of 12(b) Security	Common Stock
Trading Symbol	DARE
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		84,711,346
Amendment Flag	false
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Entity Central Index Key	0001401914
Current Fiscal Year End Date	--12-31

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 39,316,911	$ 51,674,087
Other receivables	1,729,851	1,145,317
Prepaid expenses	6,770,426	2,476,612
Total current assets	47,817,188	55,296,016
Property and equipment, net	25,366	26,041
Other non-current assets	1,344,028	485,120
Total assets	49,186,582	55,807,177
Current liabilities
Accounts payable	2,830,866	2,103,083
Accrued expenses	3,537,856	3,136,244
Deferred grant funding	9,731,363	10,542,983
Current portion of lease liabilities	294,474	270,546
Total current liabilities	16,394,559	16,052,856
Deferred license revenue	1,000,000	1,000,000
Lease liabilities long-term	913,113	0
Total liabilities	18,307,672	17,052,856
Commitments and contingencies (Note 7)
Stockholders' equity
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding	0	0
Common stock, $0.0001 par value; 120,000,000 shares authorized; 83,944,119 shares issued and outstanding at March 31, 2022 and December 31, 2021	8,394	8,394
Accumulated other comprehensive loss	(164,123)	(154,973)
Additional paid-in capital	149,560,211	149,027,802
Accumulated deficit	(118,525,572)	(110,126,902)
Total stockholders' equity	30,878,910	38,754,321
Total liabilities and stockholders' equity	$ 49,186,582	$ 55,807,177

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred stock, par value (in usd per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par value (in usd per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized (in shares)	120,000,000	120,000,000
Common stock, shares issued (in shares)	83,944,119	83,944,119
Common stock, shares outstanding (in shares)	83,944,119	83,944,119

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Operating expenses
General and administrative	$ 2,569,987	$ 1,940,328
Research and development	5,805,462	5,728,206
License fees	25,000	25,000
Total operating expenses	8,400,449	7,693,534
Loss from operations	(8,400,449)	(7,693,534)
Other income	1,779	3
Gain on extinguishment of note payable	0	369,887
Net loss	(8,398,670)	(7,323,644)
Foreign currency translation adjustments	(9,150)	(6,841)
Comprehensive loss	$ (8,407,820)	$ (7,330,485)
Loss per common share - basic (in usd per share)	$ (0.10)	$ (0.16)
Loss per common share - diluted (in usd per share)	$ (0.10)	$ (0.16)
Weighted average number of common shares outstanding:
Basic (in shares)	83,944,119	44,502,582
Diluted (in shares)	83,944,119	44,502,582

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) - USD ($)	Total	Common stock	Additional paid-in capital	Accumulated other comprehensive loss	Accumulated deficit
Beginning balance (in shares) at Dec. 31, 2020		41,596,253
Beginning balance at Dec. 31, 2020	$ (1,151,733)	$ 4,159	$ 70,366,293	$ (91,388)	$ (71,430,797)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation	365,911		365,911
Issuance of common stock, net of issuance costs (in shares)		5,664,069
Issuance of common stock, net of issuance costs	11,324,140	$ 567	11,323,573
Issuance of common stock from the exercise of warrants (in shares)		52,500
Issuance of common stock from the exercise of warrants	50,400	$ 5	50,395
Net loss	(7,323,644)				(7,323,644)
Foreign currency translation adjustments	(6,841)			(6,841)
Ending balance (in shares) at Mar. 31, 2021		47,312,822
Ending balance at Mar. 31, 2021	3,258,233	$ 4,731	82,106,172	(98,229)	(78,754,441)
Beginning balance (in shares) at Dec. 31, 2021		83,944,119
Beginning balance at Dec. 31, 2021	38,754,321	$ 8,394	149,027,802	(154,973)	(110,126,902)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Stock-based compensation	532,409		532,409
Net loss	(8,398,670)				(8,398,670)
Foreign currency translation adjustments	(9,150)			(9,150)
Ending balance (in shares) at Mar. 31, 2022		83,944,119
Ending balance at Mar. 31, 2022	$ 30,878,910	$ 8,394	$ 149,560,211	$ (164,123)	$ (118,525,572)

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash flows from operating activities
Net loss	$ (8,398,670)	$ (7,323,644)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	5,227	6,410
Stock-based compensation	532,409	365,911
Non-cash operating lease cost	(9,758)	(24,224)
Gain on extinguishment of notes payable and accrued interest	0	(369,887)
Changes in operating assets and liabilities:
Other receivables	(584,534)	158,333
Prepaid expenses	(4,293,814)	217,188
Other non-current assets	87,891	(128,086)
Accounts payable	727,783	450,298
Accrued expenses	401,613	(837,191)
Deferred grant funding	(811,620)	(892,123)
Net cash used in operating activities	(12,343,473)	(8,377,015)
Cash flows from investing activities
Purchases of property and equipment	(4,553)	0
Net cash used in investing activities	(4,553)	0
Cash flows from financing activities
Net proceeds from issuance of common stock	0	11,324,140
Proceeds from the exercise of common stock warrants	0	50,400
Net cash provided by financing activities	0	11,374,540
Effect of exchange rate changes on cash and cash equivalents	(9,150)	(6,841)
Net change in cash and cash equivalents	(12,357,176)	2,990,684
Cash and cash equivalents, beginning of period	51,674,087	4,669,467
Cash and cash equivalents, end of period	39,316,911	7,660,151
Supplemental disclosure of non-cash investing and financing activities:
Forgiveness of Paycheck Protection Program note payable	0	369,887
Operating right-of-use assets obtained in exchange for new operating lease liabilities	$ 1,043,590	$ 308,533

Organization and Description of

Organization and Description of Business	3 Months Ended
	Mar. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	ORGANIZATION AND DESCRIPTION OF BUSINESS Daré Bioscience, Inc. is a biopharmaceutical company committed to advancing innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries operate one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company began assembling its diverse portfolio in 2017 through acquisitions, exclusive in-licenses and other collaborations. The Company's programs target unmet needs in women's health in the areas of contraception, fertility, and vaginal and sexual health, and aim to expand treatment options, enhance outcomes and improve ease of use for women. To date, the Company has not generated any revenue. The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, research and development activities to advance its product candidates through clinical development and regulatory approval. The Company's first product, XACIATO™ (clindamycin phosphate vaginal gel, 2%), was approved by the FDA in December 2021, as a single-dose prescription medication for the treatment of bacterial vaginosis in female patients 12 years of age and older. In March 2022, the Company entered into an exclusive global license agreement with an affiliate of Organon & Co., Organon International GmbH, or Organon, to commercialize XACIATO. XACIATO is expected to be available commercially in the United States in the fourth quarter of 2022. The Company's portfolio includes drug and drug/device product candidates and potential product candidates in various stages of development, from pre-clinical to advanced clinical development.

Basis of Presentation and Summa

Basis of Presentation and Summary of Significant Accounting Policies	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation and Summary of Significant Accounting Policies	BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, or the 2021 10-K. Going Concern The Company prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and to potentially acquire, license and develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of March 31, 2022, the Company had an accumulated deficit of approximately $118.5 million, cash and cash equivalents of approximately $39.3 million, and working capital of approximately $31.4 million. For the three months ended March 31, 2022, the Company incurred a net loss of approximately $8.4 million and had negative cash flow from operations of approximately $12.3 million. The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-parties under the Company's in-license and acquisition agreements including upon the occurrence of commercial milestones for XACIATO and development milestones for the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs. The Company’s future funding requirements could also include significant costs related to commercialization of its product candidates, if approved, depending on the type, nature and terms of commercial collaborations the Company establishes. The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2022 compared to 2021 as the Company continues to develop and seek to bring to market its product candidates, with a focus on its product candidates that have reached the human clinical study development phase. To date, the Company has one FDA-approved product, XACIATO, and has generated no revenue. Commercial launch of XACIATO in the U.S. by the Company's licensee, Organon, is expected in the fourth quarter of 2022. Under the terms of its license agreement with Organon, the Company will receive a $10.0 million non-refundable and non-creditable payment following the effective date of the license agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments as follows: $2.5 million following the first commercial sale of a licensed product in the United States; and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates. The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S. The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current strategy. The Company may continue to seek to raise capital through the sale of shares of its common stock under its ATM sales agreement or through other types of equity transactions. However, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors including, among others, market conditions, the trading price of its common stock, its determination as to the appropriate sources of funding for its operations, and the number of authorized shares of common stock that are available for issuance, which is approximately 27 million as of the date hereof. For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies. The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of expansion of its product candidate portfolio, if any. If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates the Company would otherwise seek to develop or commercialize. There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in its assets. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 1 to the consolidated financial statements included in the 2021 10-K. Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies. Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of March 31, 2022 and December 31, 2021. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of March 31, 2022 or December 31, 2021. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2022 Current assets: Cash equivalents (1) $ 36,330,411 $ — $ — $ 36,330,411 Balance at December 31, 2021 Current assets: Cash equivalents (1) $ 49,666,064 $ — $ — $ 49,666,064 (1) Represents cash held in money market funds. Revenue Recognition The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company assesses the goods or services agreed upon within each contract, assesses whether each good or service is distinct, and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company develops estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Collaboration Revenues . The Company enters into collaboration and licensing agreements under which it out-licenses certain rights to its products or product candidates to third parties. The terms of these arrangements typically include payment of one or more of the following to the Company: non-refundable, up-front license fees; development, regulatory and/or commercial milestone payments; and royalties on net sales of licensed products. License Fees. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. To date, the Company has not recognized any license fee revenue. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue. Product Supply. Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company evaluates whether it is the principal or agent in the arrangement. The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer. Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent. To date, the Company has not recognized any revenue associated with product supply arrangements. Milestones. At the inception of each arrangement in which the Company is a licensor and that includes developmental, regulatory or commercial milestones, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments not within the Company's control, such as where achievement of the specified milestone depends on activities of a third party or regulatory approval, are not considered probable of being achieved until the specified milestone occurs. To date, the Company has not recognized any milestone revenue.

Strategic Agreements

Strategic Agreements	3 Months Ended
	Mar. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Strategic Agreements	STRATEGIC AGREEMENTS Strategic Agreements for Product Commercialization Organon Exclusive License Agreement In March 2022, the Company entered into an exclusive license agreement with Organon pursuant to which Organon will obtain exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company. The effective date of the agreement will occur following the satisfaction of closing conditions that include receipt of all applicable approvals, or the expiration or termination of all applicable waiting periods, required under applicable antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The following is a summary of other terms of the Organon license agreement: Upfront Payment . The Company will receive a $10.0 million non-refundable and non-creditable payment following the effective date of the agreement. Royalty and Milestone Payments. The Company will be entitled to receive tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments as follows: $2.5 million following the first commercial sale of a licensed product in the United States; and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. Royalty payments will be subject to customary reductions and offsets. The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country. Regulatory Interactions and Product Supply. The Company will be responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumes such responsibilities. Until such time, Organon will purchase all of its product requirements of XACIATO from the Company at a transfer price equal to the Company's manufacturing costs plus a single-digit percentage markup. Term. Unless terminated earlier, the agreement will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product. In addition to customary termination rights for both parties, following the first anniversary of the effective date of the agreement, Organon may terminate the agreement in its entirety or on a country-by-country basis at any time in Organon's sole discretion on 120 days' advance written notice. Other . The terms of the agreement provide Organon exclusive worldwide rights of first negotiation for specified potential future products of the Company. Bayer HealthCare License Agreement In January 2020, the Company entered into a license agreement with Bayer, regarding the further development and commercialization of Ovaprene in the U.S. The Company received a $1.0 million upfront non-refundable license fee payment from Bayer, and Bayer agreed to support the Company in development and regulatory activities by providing the equivalent of two experts to advise the Company in clinical, regulatory, preclinical, commercial, CMC and product supply matters. Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $20.0 million, referred to as the Clinical Trial and Manufacturing Activities Fee. Such license would be exclusive with regard to the commercialization of Ovaprene for human contraception in the U.S. and co-exclusive with the Company with regard to development. The Company concluded there was one significant performance obligation related to the $1.0 million upfront payment: a distinct license to commercialize Ovaprene effective upon the receipt of the $20.0 million fee. The $1.0 million upfront payment will be recorded as license revenue at the earlier of (1) the point in time the Company receives the $20.0 million fee, the license is transferred to Bayer and Bayer is able to use and benefit from the license and (2) the termination of the agreement. As of March 31, 2022, neither of the foregoing had occurred. The $1.0 million payment is recorded as long-term deferred license revenue in the Company's condensed consolidated balance sheet at March 31, 2022 and December 31, 2021. The following is a summary of other terms of the Bayer license agreement: Milestone & Royalty Payments . The Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including first commercial sale, are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue. Efforts. The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. Term. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.; or (b) 15 years from the first commercial sale of Ovaprene in the U.S. In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the Clinical Trial and Manufacturing Activities Fee if and when due. Strategic Agreements for Pipeline Development Hammock/MilanaPharm Assignment and License Agreement In December 2018, the Company entered into (a) an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and (b) a First Amendment to License Agreement with TriLogic Pharma, LLC and MilanaPharm LLC, or the License Amendment. Both agreements relate to the Exclusive License Agreement among Hammock, TriLogic and MilanaPharm dated as of January 9, 2017, or the MilanaPharm License Agreement. Under the Assignment Agreement and the MilanaPharm License Agreement, as amended by the License Amendment, the Company acquired an exclusive, worldwide license under certain intellectual property to, among other things, develop and commercialize products for the diagnosis, treatment and prevention of human diseases or conditions in or through any intravaginal or urological applications. The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726. In XACIATO, this proprietary technology is formulated with clindamycin for the treatment of bacterial vaginosis. Each of the Assignment Agreement and License Amendment was amended in December 2019 and the License Agreement was further amended in September 2021 and March 2022. The following is a summary of other terms of the License Amendment, as amended: License Fees. A total of $235,000 in license fees were payable to MilanaPharm, the final installment of which was $110,000 paid in 2020. Milestone Payments. The Company paid MilanaPharm $300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones, $50,000 of which was paid in 2020 and $250,000 of which was paid in 2021. The Company may also pay MilanaPharm up to $500,000 upon the first commercial sale in the United States of the first licensed product for each vaginal use and urological use, and up to $250,000 upon the first commercial sale in the United States of successive licensed products for vaginal or urological use. In addition, upon achievement of $50.0 million in cumulative worldwide net sales of licensed products, the Company must pay $1.0 million to MilanaPharm. Foreign Sublicense Income. The Company will pay MilanaPharm a low double-digit percentage of all income received by the Company or its affiliates in connection with any sublicense granted to a third party for use outside of the United States, subject to certain exclusions. Royalty Payments. During the royalty term, the Company will pay MilanaPharm high single-digit to low double-digit royalties based on annual worldwide net sales of licensed products and processes. The royalty term, which is determined on a country-by-country basis and licensed product-by-product basis (or process-by-process basis), begins with the first commercial sale of a licensed product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim of the licensed patent rights that cover the method of use of such product or process in such country, or (2) 10 years following the first commercial sale of such product or process in such country. Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by the Company, or payments to third parties for rights or know-how required for the Company to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales. Efforts. The Company must use commercially reasonable efforts and resources to (1) develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (2) continue to commercialize that product or process following the first commercial sale of a licensed product or process in the applicable jurisdiction. Term. Unless earlier terminated, the license term continues until (1) on a licensed product-by-product (or process-by-process basis) and country-by-country basis, the date of expiration of the royalty term with respect to such licensed product in such country, and (2) the expiration of all applicable royalty terms under the MilanaPharm License Agreement with respect to all licensed products and processes in all countries. Upon expiration of the term with respect to any licensed product or process in a country (but not upon earlier termination of the MilanaPharm License Agreement), the licenses granted to the Company under the MilanaPharm License Agreement will convert automatically to an exclusive, fully paid-up, royalty-free, perpetual, non-terminable and irrevocable right and license under the licensed intellectual property. In addition to customary termination rights for all parties, MilanaPharm may terminate the license granted to the Company solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) the Company or its affiliates or sublicensees discontinue the sale of such product or process in such country and MilanaPharm notifies the Company of such termination within 60 days of having first been notified by the Company of such discontinuation, or (2) the Company or its affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company. The following is a summary of other terms of the Assignment Agreement, as amended: Assignment; Technology Transfer . Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm License Agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan to be agreed upon by the parties, with a goal for the Company to independently practice the licensed intellectual property as soon as commercially practical in order to develop and commercialize the licensed products and processes. Fees . A total of $512,500 in fees were payable to Hammock, the final installment of which was $137,500 paid in 2020. Milestone Payments . The Company will pay Hammock up to $1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones, $100,000 of which was paid in 2020 and $750,000 of which was paid in 2021. The remaining milestone does not relate to a bacterial vaginosis product. Term. The Assignment Agreement will terminate upon the later of (1) completion of the parties' technology transfer plan, and (2) payment to Hammock of the last of the milestone payments. ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. The Company must use commercially reasonable efforts to develop and commercialize Ovaprene and must meet certain minimum spending amounts per year, including $2.5 million per year to cover such activities until a final PMA is filed, or until the first commercial sale of Ovaprene, whichever occurs first. ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a PMA from the FDA and will provide the Company with clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, on commercially reasonable terms. Under the license agreement, in addition to an exclusive license to ADVA-Tec's and its affiliates' intellectual property rights for all uses of Ovaprene as a human contraceptive device, the Company has a right of first refusal to license these patents and patent applications for additional indications. The following is a summary of other terms of the ADVA-Tec license agreement: Milestone Payments. The Company will pay to ADVA-Tec: (1) up to $14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $200,000 of which was paid in 2021; and (2) up to $20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones. The remaining development and regulatory milestones include: the FDA's approval to commence a pivotal clinical trial; successful completion of such pivotal clinical trial; the FDA's acceptance of a PMA filing for Ovaprene; the FDA's approval of the PMA for Ovaprene; CE Marking of Ovaprene in at least three designated European countries; obtaining regulatory approval in at least three designated European countries; and obtaining regulatory approval in Japan. Royalty Payments . After the commercial launch of Ovaprene, the Company will pay to ADVA-Tec royalties based on aggregate annual net sales of Ovaprene in specified regions, at a royalty rate that will vary between 1% and 10% and will increase based on various net sales thresholds. Term . Unless earlier terminated, the license the Company received under the agreement continues on a country-by-country basis until the later of the life of the licensed patents or the Company's last commercial sale of Ovaprene. In addition to customary termination rights for both parties: (A) the Company may terminate the agreement with or without cause in whole or on a country-by-country basis upon 60 days prior written notice; and (B) ADVA-Tec may terminate the agreement if the Company develops or commercializes any non-hormonal ring-based vaginal contraceptive device competitive to Ovaprene or if the Company fails to: (1) in certain limited circumstances, commercialize Ovaprene in certain designated countries within three years of the first commercial sale of Ovaprene; (2) satisfy the annual spending obligation described above, (3) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, (4) conduct clinical trials as set forth in the development plan to which the Company and ADVA-Tec agree, and as may be modified by a joint research committee, unless such failure is caused by events outside of the Company’s reasonable control, or (5) enroll a patient in the first non-significant risk medical device study or clinical trial as allowed by an institutional review board within six months of the production and release of Ovaprene, unless such failure is caused by events outside of the Company’s reasonable control. SST License and Collaboration Agreement In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, including the treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen, or the Licensed Products. The following is a summary of other terms of the SST license and collaboration agreement: Invention Ownership. The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party owns a 50% undivided interest in all joint inventions. Joint Development Committee. The parties will collaborate through a joint development committee that will determine the strategic objectives for, and generally oversee, the development efforts of both parties under the agreement. Development. The Company must use commercially reasonable efforts to develop the Licensed Products in the Field of Use in accordance with a development plan in the agreement, and to commercialize the Licensed Products in the Field of Use. The Company is responsible for all reasonable internal and external costs and expenses incurred by SST in its performance of the development activities it must perform under the agreement. Royalty Payments. SST will be eligible to receive tiered royalties based on percentages of annual net sales of Licensed Products in the single digits to the mid double digits, subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. Milestone Payments. SST will be eligible to receive payments (1) ranging from $0.5 million to $18.0 million in the aggregate on achieving certain clinical and regulatory milestones in the U.S. and worldwide, and (2) between $10.0 million to $100.0 million in the aggregate upon achieving certain commercial sales milestones. If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST. Term. The Company’s license continues on a country-by-country basis until the later of 10 years from the date of the first commercial sale of such Licensed Product or the expiration of the last valid claim of patent rights covering the Licensed Product in the Field of Use. Upon expiration (but not termination) of the agreement in a particular country, the Company will have a fully paid-up license under the licensed intellectual property to develop and commercialize the applicable Licensed Products in the applicable country on a non-exclusive basis. Termination. In addition to customary termination rights for both parties: (1) prior to receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA approval, the Company may terminate the agreement without cause upon 90 days prior written notice; (2) following receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA approval, the Company may terminate the agreement without cause upon 180 days prior written notice; and (3) SST may terminate the agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days’ notice if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and do not cure such failure within 60 days of receipt of SST's notice thereof. Catalent JNP License Agreement In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc. (formerly known as Juniper Pharmaceuticals, Inc., and which the Company refers to as Catalent), under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes, and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes. The Company is entitled to sublicense the rights granted to it under this agreement. Upfront Fee. The Company paid a $250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement. Annual Maintenance Fee. The Company will pay an annual license maintenance fee to Catalent on each anniversary of the date of the agreement, the amount of which will be $50,000 for the first two years and $100,000 thereafter, and which will be creditable against royalties and other payments due to Catalent in the same calendar year but may not be carried forward to any other year. The Company made the first payments in April 2019. Milestone Payments. The Company must make potential future development and sales milestone payments of (1) up to $13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, $1.0 million of which became payable in the third quarter of 2021, and in accordance with the license agreement, the amount payable was offset by the $100,000 annual maintenance fee, resulting in a net amount of $900,000 paid during the third quarter of 2021, and (2) up to $30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement. Royalty Payments . During the royalty term, the Company will pay Catalent mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the agreement. In lieu of such royalty payments, the Company will pay Catalent a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the agreement to a third party. The royalty term, which is determined on a country-by-country basis and product-by-product basis (or process-by-process basis), begins with the first commercial sale of a product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim within the licensed patent rights with respect to such product or process in such country, (2) 10 years following the first commercial sale of such product or process in such country, and (3) when one or more generic products for such product or process are commercially available in such country, except that if there is no such generic product by the 10th year following the first commercial sale in such country, then the royalty term will terminate on the 10-year anniversary of the first commercial sale in such country. Efforts. The Company must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the agreement. Term. Unless earlier terminated, the term of the agreement will continue on a country-by-country basis until the later of (1) the expiration date of the last valid claim within such country, or (2) 10 years from the date of first commercial sale of a product or process in such country. Upon expiration (but not early termination) of the agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses. Catalent may terminate the agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the agreement, (2) if the Company fails to maintain required insurance, (3) immediately upon the Company’s insolvency or the making of an assignment for the benefit of the Company’s creditors or if a bankruptcy petition is filed for or against the Company, which petition is not dismissed within 90 days, or (4) upon 60 days’ notice for any uncured material breach by the Company of any of the Company’s other obligations under the agreement. The Company may terminate the agreement on a country-by-country basis for any reason by giving 180 days’ notice (or 90 days’ notice if such termination occurs prior to receipt of marketing approval in the United States). If Catalent terminates the agreement for the reason described in clause (4) above or if the Company terminates the agreement, Catalent will have full access including the right to use and reference all product data generated during the term of the agreement that is owned by the Company. Adare Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharma Solutions (formerly known as Adare Pharmaceuticals and Orbis Biosciences, and which the Company refers to as Adare), for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (now known as ADARE-204 and ADARE-214, respectively). The agreement provides the Company with an option to negotiate an exclusive license agreement for the programs if the Company funds the conduct of specified development work by Adare. MBI Acquisition In November 2019, the Company acquired Dare MB Inc. (formerly, Microchips Biotech, Inc.), or MBI, to secure the rights to develop a long-acting reversible contraception method that a woman can turn on or off herself, according to her own needs. This candidate is now known as DARE-LARC1. At the closing of the acquisition, the Company issued an aggregate of approximately 3.0 million shares of its common stock to the holders of shares of MBI's capital stock outstanding immediately prior to the effective time of the merger. The transaction was valued at $2.4 million, based on the fair value of the approximately 3.0 million shares issued at $0.79 per share, which was the closing price per share of the Company's common stock on the date of closing. The shares were issued in exchange for MBI’s cash and cash equivalents of $6.1 million, less net liabilities of $3.5 million and transaction costs of $202,000, which was allocated based on the relative fair value of the assets acquired and the liabilities assumed. The Company also agreed to pay the following additional consideration to the former MBI stockholders: (a) up to $46.5 million contingent upon the achievement of specified funding, product development and regulatory milestones; (b) up to $55.0 million contingent upon the achievement of specified amounts of aggregate net sales of products incorporating the intellectual property acquired by the Company in the merger; (c) tiered royalty payments ranging from low single-digit to low double-digit percentages of annual net sales of such products, subject to customary provisions permitting royalty reductions and offset; and (d) a percentage of sublicense revenue related to such products. The Company agreed to use commercially reasonable efforts to achieve specified development and regulatory objectives relating to DARE-LARC1. In June 2021, a total of $1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $1.0 million of which was recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $250,000 of which was expensed in 2021. In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $75,000 in cash to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021. See Note 7. Pear Tree Acquisition In May 2018, the Company completed its acquisition of Pear Tree Pharmaceuticals, Inc., or Pear Tree. The Company acquired Pear Tree to secure the rights to develop a proprietary vaginal formulation of tamoxifen, now known as DARE-VVA1, as a potential treatment for vulvar and vaginal atrophy. Milestone Payments . The Company must make contingent payments to certain Pear Tree licensors and former stockholders of Pear Tree that become payable upon achievement of specified clinical, regulatory and commercial milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2022
Equity [Abstract]
Stockholders' Equity	STOCKHOLDERS’ EQUITY October 2021 ATM Sales Agreement In October 2021, the Company entered into a sales agreement with SVB Leerink LLC to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program under which SVB Leerink acts as the Company's agent. The Company agreed to pay a commission equal to 3% of the gross proceeds of any common stock sold under the agreement, plus certain legal expenses. Shares of the Company's common stock sold under the agreement will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-254862) and the base prospectus included therein, originally filed with the SEC on March 30, 2021, and declared effective on April 7, 2021, and the prospectus supplement dated October 13, 2021 relating to the offering of up to $50.0 million in shares of the Company's common stock under this sales agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program. During the three months ended March 31, 2022, the Company sold no shares under this agreement. April 2021 ATM Sales Agreement In April 2021, the Company entered into a sales agreement with SVB Leerink LLC to sell shares of its common stock from time to time through an ATM, equity offering program under which SVB Leerink acts as the Company's agent. Under the sales agreement, the Company may issue and sell up to $50.0 million of shares of its common stock. The Company agreed to pay a commission equal to 3% of the gross proceeds of any common stock sold under the agreement, plus certain legal expenses. Any shares of the Company's common stock sold under the agreement will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-254862) and the base prospectus included therein, originally filed with the SEC on March 30, 2021, and declared effective on April 7, 2021, and the prospectus supplement dated April 7, 2021 filed with the SEC on April 8, 2021. During the three months ended March 31, 2022, the Company sold no shares under this agreement. 2018 ATM Sales Agreement In January 2018 the Company entered into a common stock sales agreement with H.C. Wainwright & Co., LLC, or Wainwright, relating to the offering and sale of shares of its common stock from time to time in an ATM equity offering program through Wainwright, acting as sales agent. Under the agreement, Wainwright was entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per share sold under the agreement. In March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021. Equity Line In April 2020, the Company entered into a purchase agreement, or the Purchase Agreement, and a registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park. Under the terms and subject to the conditions of the Purchase Agreement, the Company had the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park was obligated to purchase up to $15.0 million of the Company’s common stock. The Company incurred legal, accounting, and other fees related to the Purchase Agreement of approximately $374,000. These costs were amortized and expensed as shares were sold under the Purchase Agreement. As of December 31, 2021, the Company had sold and Lincoln Park had purchased $15.0 million of the Company's common stock under the Purchase Agreement, there were no unamortized costs, and no more shares of common stock may be sold by the Company to Lincoln Park under the Purchase Agreement. Common Stock Warrants In February 2018, the Company closed an underwritten public offering in connection with which the Company issued to the investors in that offering warrants exercisable through February 2023 and that initially had an exercise price of $3.00 per share. The warrants include a price-based anti-dilution provision, which provides that, subject to certain limited exceptions, the exercise price of the warrants will be reduced each time the Company issues or sells (or is deemed to issue or sell) securities for a net consideration per share less than the exercise price of those warrants in effect immediately prior to such issuance or sale. In addition, subject to certain exceptions, if the Company issues, sells or enters into any agreement to issue or sell securities at a price which varies or may vary with the market price of the shares of the Company’s common stock, the warrant holders have the right to substitute such variable price for the exercise price of the warrant then in effect. These warrants are exercisable only for cash, unless a registration statement covering the shares issued upon exercise of the warrants is not effective, in which case the warrants may be exercised on a cashless basis. A registration statement covering the shares issued upon exercise of the warrants is currently effective. The Company estimated the fair value of the warrants as of February 15, 2018 to be approximately $3.0 million which was recorded in equity as of the grant date. The Company early adopted ASU 2017-11 as of January 1, 2018 and recorded the fair value of the warrants as equity. In April 2019 and July 2020, in accordance with the price-based anti-dilution provision discussed above, the exercise price of these warrants was automatically reduced to $0.98 per share and to $0.96 per share, respectively, and as a result of the triggering of the anti-dilution provision, $0.8 million and $6,863, respectively, was recorded to additional paid-in capital. During the three months ended March 31, 2022, no warrants were exercised. During the three months ended March 31, 2021, warrants to purchase 52,500 shares of common stock were exercised for gross proceeds of $50,000. As of March 31, 2022, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 1,374,515 $ 0.96 02/15/2023 1,381,015

Stock-Based Compensation

Stock-Based Compensation	3 Months Ended
	Mar. 31, 2022
Share-based Payment Arrangement [Abstract]
Stock-Based Compensation	STOCK-BASED COMPENSATION 2014 Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, became effective in April 2014, but no offering period has been initiated thereunder since January 2017. There was no stock-based compensation related to the ESPP for the three months ended March 31, 2022 or March 31, 2021. Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan, which provides for the grant of options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards to employees, officers and directors, and consultants and advisors. There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018. The number of authorized shares increases annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000, (ii) 4% of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. On January 1, 2022, the number of authorized shares increased by 2,000,000 to 2,201,855. Summary of Stock Option Activity The table below summarizes stock option activity under the Amended 2014 Plan and related information for the three months ended March 31, 2022. The exercise price of all options granted during the three months ended March 31, 2022 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2022, unamortized stock-based compensation expense of approximately $5.3 million will be amortized over a weighted average period of 2.98 years. At March 31, 2022, 642,175 shares of common stock were available for future awards granted under the Amended 2014 Plan. Number of Shares Weighted Average Outstanding at December 31, 2021 4,717,602 $ 1.65 Granted 1,759,692 1.59 Exercised — — Canceled/forfeited (200,012) 1.96 Expired — — Outstanding at March 31, 2022 6,277,282 $ 1.63 Exercisable at March 31, 2022 2,597,775 $ 1.45 Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2022 2021 Research and development $ 174,613 $ 115,625 General and administrative $ 357,796 $ 250,286 Total $ 532,409 $ 365,911 The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the three months ended March 31, 2022 are as follows: Three Months Ended Expected life in years 6.02 Risk-free interest rate 1.65% Expected volatility 122% Forfeiture rate 0.0% Dividend yield 0.0% Weighted-average fair value of options granted $1.38

Leased Properties

Leased Properties	3 Months Ended
	Mar. 31, 2022
Leases [Abstract]
Leased Properties	LEASED PROPERTIES The Company's lease for its corporate headquarters (3,169 square feet of office space) commenced on July 1, 2018. In February 2022, the Company entered into an amendment to extend the term of the lease for two years such that the term now expires on August 31, 2024. MBI, a wholly owned subsidiary the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts. The Lexington lease commenced on July 1, 2013. In February 2022, the Company entered into an amendment to extend the term of the lease for three years such that the term now expires on December 31, 2025, subject to the landlord's right to terminate the lease on December 31, 2023. The Billerica lease commenced on October 1, 2016 and terminated on March 31, 2022. Under the terms of each lease, the lessee pays base annual rent (subject to an annual fixed percentage increase), plus property taxes, and other normal and necessary expenses, such as utilities, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The leases do not require material variable lease payments, residual value guarantees or restrictive covenants. The leases do not provide an implicit rate, and therefore the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease within a particular currency environment. The Company uses an incremental borrowing rate of 7% for operating leases that commenced prior to January 2019 (and all of the Company's operating leases commenced prior to such date). The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term. At March 31, 2022, the Company reported operating lease ROU assets Total operating lease costs were approximately $169,000 and $135,000 for the three months ended March 31, 2022 and March 31, 2021, respectively. Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the condensed consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $123,000 and $112,000 for the three months ended March 31, 2022 and March 31, 2021, respectively. These amounts are included in operating activities in the condensed consolidated statements of cash flows. Further, at March 31, 2022, operating leases had a weighted average remaining lease term of 3.13 years. As of March 31, 2022, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2022 $ 288,000 2023 422,000 2024 384,000 2025 297,000 Total future minimum lease payments 1,391,000 Less: accreted interest 183,000 Total operating lease liabilities $ 1,208,000

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	COMMITMENTS AND CONTINGENCIES CRADA with NICHD for the Pivotal Phase 3 Study of Ovaprene In July 2021, the Company entered into a Cooperative Research and Development Agreement, or the CRADA, with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, for the conduct of a multi-center, non-comparative, pivotal Phase 3 clinical study of Ovaprene, or the Ovaprene Phase 3. The Ovaprene Phase 3 will be conducted within NICHD’s Contraceptive Clinical Trial Network with NICHD contractor Health Decisions Inc., a contract research organization, providing clinical coordination and data collection and management services for the Ovaprene Phase 3. The Company and NICHD will each provide medical oversight and final data review and analysis for the Ovaprene Phase 3 and will work together to prepare the final report of the results of the Ovaprene Phase 3. The Company is responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million in payments to NICHD to be applied toward the costs of conducting the Ovaprene Phase 3. NICHD will be responsible for the other costs related to the conduct of the Ovaprene Phase 3. In accordance with the payment schedule under the CRADA, the Company has made aggregate payments of $5.0 million of the total amount payable to NICHD, $3.5 million of which was paid during the first quarter of 2022. At March 31, 2022, the remaining amount of the Company's payment obligation under the CRADA was $0.5 million. Contingent Consideration As discussed in Note 3 above, in connection with the acquisition of MBI, the Company agreed to pay additional consideration of up to $46.5 million to the former stockholders of MBI contingent upon the achievement of specified funding, product development and regulatory milestones. In June 2021, $1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $1.0 million of which was previously recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $250,000 of which was expensed in 2021. In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $75,000 to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021. Note Payable

Grant Awards

Grant Awards	3 Months Ended
	Mar. 31, 2022
Receivables [Abstract]
Grant Awards	GRANT AWARDS NICHD Non-Dilutive Grant Funding The Company has received notices of awards and non-dilutive grant funding from NICHD to support the development of Ovaprene, DARE-PTB1 and DARE-LARC1. NICHD issues notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. If the Company receives payments under the award, the amounts of such payments are recognized in the statements of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period. Ovaprene From 2018 through 2021, the Company received approximately $1.9 million of non-dilutive grant funding from NICHD for clinical development efforts supporting Ovaprene. All funds under the final notice of award had been disbursed as of December 31, 2021. DARE-PTB1 In August 2020, the Company received a notice of award of a grant from NICHD to support the development of DARE-PTB1. The award in the amount of $300,000 was for the "Phase I" segment of the project outlined in the Company's grant application, which is ongoing. Additional potential funding of up to approximately $2.0 million for the "Phase II" segment of the project outlined in the grant application is contingent upon satisfying specified requirements, including, assessment of the results of the Phase I segment, determination that the Phase I goals were achieved, and availability of funds. There is no guarantee the Company will receive any Phase II award. The Company recorded credits to research and development expense for costs related to the NICHD award of approximately $17,000 during the three months ended March 31, 2022. At March 31, 2022, the Company recorded a receivable of approximately $19,000 for expenses incurred through such date that it believes are eligible for reimbursement under the grant. DARE-LARC1 In September 2021, the Company received a notice of award of a grant from NICHD to support the development of DARE-LARC1. The award in the amount of approximately $300,000 is to be used to explore device insertion and removal in non-clinical studies, which is to occur during the period of September 2021 through August 2022. The Company recorded credits to research and development expense of approximately $165,000 for costs related to the NICHD award during the three months ended March 31, 2022. At March 31, 2022, the Company recorded a receivable of approximately $173,000 for expenses incurred through such date that it believes is eligible for reimbursement under the grant. DARE-LARC1 Non-Dilutive Grant Funding MBI Grant Agreement The Company's wholly-owned subsidiary, MBI, was awarded $5.4 million to support the development of DARE-LARC1 under a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation. The funding period under this agreement ended on June 30, 2021. Expenses eligible for funding were incurred, tracked and reported to the Foundation. MBI received aggregate payments under this agreement of approximately $5.4 million. At June 30, 2021, all payments under this agreement associated with research and development expenses for DARE-LARC1 had been incurred and reported to the Foundation. 2021 DARE-LARC1 Grant Agreement In June 2021, the Company entered into an agreement with the Foundation, or the 2021 DARE-LARC1 Grant Agreement, under which the Company was awarded up to $48.95 million to support the development of DARE-LARC1. The 2021 DARE-LARC1 Grant Agreement will support technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in non-clinical proof of principle studies. The Company received an initial payment of $11.45 million in July 2021. Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones. At March 31, 2022, approximately $9.7 million of deferred grant funding liability under this agreement was recorded in the Company's condensed consolidated balance sheet.

Net Loss Per Share

Net Loss Per Share	3 Months Ended
	Mar. 31, 2022
Earnings Per Share [Abstract]
Net Loss Per Share	NET LOSS PER SHARE The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under outstanding options and warrants to purchase shares of the Company’s common stock. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2022 2021 Stock options 6,277,282 4,311,291 Warrants 1,381,015 1,856,143 Total 7,658,297 6,167,434

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2022
Subsequent Events [Abstract]
Subsequent Events	SUBSEQUENT EVENTS Sales of Common Stock Between April 1, 2022 and May 10, 2022, the Company sold an aggregate of approximately 751,000 shares of common stock for net proceeds of approximately $1.2 million under its ATM equity offering program. Commencement of Phase 1/2 Clinical Study of DARE-HRT1 In April 2022, the Company announced commencement of its Phase 1/2 clinical study of DARE-HRT1. The open-label study will evaluate the pharmacokinetics (PK) of two versions of DARE-HRT1 in approximately 20 healthy, post-menopausal women over approximately three consecutive months of use. The study will also collect safety, usability, acceptability and symptom-relief data. The study is being conducted by the Company's wholly owned subsidiary in Australia.

Basis of Presentation and Sum_2

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, or the 2021 10-K.
Going Concern	Going Concern The Company prepared its consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and to potentially acquire, license and develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of March 31, 2022, the Company had an accumulated deficit of approximately $118.5 million, cash and cash equivalents of approximately $39.3 million, and working capital of approximately $31.4 million. For the three months ended March 31, 2022, the Company incurred a net loss of approximately $8.4 million and had negative cash flow from operations of approximately $12.3 million. The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-parties under the Company's in-license and acquisition agreements including upon the occurrence of commercial milestones for XACIATO and development milestones for the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs. The Company’s future funding requirements could also include significant costs related to commercialization of its product candidates, if approved, depending on the type, nature and terms of commercial collaborations the Company establishes. The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2022 compared to 2021 as the Company continues to develop and seek to bring to market its product candidates, with a focus on its product candidates that have reached the human clinical study development phase. To date, the Company has one FDA-approved product, XACIATO, and has generated no revenue. Commercial launch of XACIATO in the U.S. by the Company's licensee, Organon, is expected in the fourth quarter of 2022. Under the terms of its license agreement with Organon, the Company will receive a $10.0 million non-refundable and non-creditable payment following the effective date of the license agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments as follows: $2.5 million following the first commercial sale of a licensed product in the United States; and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates. The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S. The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates. Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements. The Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current strategy. The Company may continue to seek to raise capital through the sale of shares of its common stock under its ATM sales agreement or through other types of equity transactions. However, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors including, among others, market conditions, the trading price of its common stock, its determination as to the appropriate sources of funding for its operations, and the number of authorized shares of common stock that are available for issuance, which is approximately 27 million as of the date hereof. For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies. The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of expansion of its product candidate portfolio, if any. If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates the Company would otherwise seek to develop or commercialize. There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders. In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in its assets. If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations. If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 1 to the consolidated financial statements included in the 2021 10-K. Since the date of those consolidated financial statements, there have been no material changes to the Company’s significant accounting policies.
Fair Value of Financial Instruments	Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Revenue Recognition	Revenue Recognition The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligations. At contract inception, the Company assesses the goods or services agreed upon within each contract, assesses whether each good or service is distinct, and determines those that are performance obligations. The Company then recognizes as revenue the amount of the transaction price allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In a contract with multiple performance obligations, the Company develops estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price(s) may include estimates regarding forecasted revenues or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time. Any change made to estimated progress towards completion of a performance obligation and, therefore, revenue recognized will be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Collaboration Revenues . The Company enters into collaboration and licensing agreements under which it out-licenses certain rights to its products or product candidates to third parties. The terms of these arrangements typically include payment of one or more of the following to the Company: non-refundable, up-front license fees; development, regulatory and/or commercial milestone payments; and royalties on net sales of licensed products. License Fees. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in a contract, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. To date, the Company has not recognized any license fee revenue. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue. Product Supply. Arrangements that include a promise for future supply of product for commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company evaluates whether it is the principal or agent in the arrangement. The evaluation is based on the degree the Company controls the specified product at any time before transfer to the customer. Revenues are recognized on a gross basis if the Company is in the capacity of principal and on a net basis if the Company is in the capacity of an agent. To date, the Company has not recognized any revenue associated with product supply arrangements. Milestones. At the inception of each arrangement in which the Company is a licensor and that includes developmental, regulatory or commercial milestones, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments not within the Company's control, such as where achievement of the specified milestone depends on activities of a third party or regulatory approval, are not considered probable of being achieved until the specified milestone occurs. To date, the Company has not recognized any milestone revenue.

Basis of Presentation and Sum_3

Basis of Presentation and Summary of Significant Accounting Policies (Tables)	3 Months Ended
	Mar. 31, 2022
Accounting Policies [Abstract]
Schedule of Financial Assets and Liabilities Remeasured on a Recurring Basis	The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of March 31, 2022 and December 31, 2021. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of March 31, 2022 or December 31, 2021. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2022 Current assets: Cash equivalents (1) $ 36,330,411 $ — $ — $ 36,330,411 Balance at December 31, 2021 Current assets: Cash equivalents (1) $ 49,666,064 $ — $ — $ 49,666,064 (1) Represents cash held in money market funds.

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2022
Equity [Abstract]
Schedule of Common Stock Warrants Outstanding	As of March 31, 2022, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 1,374,515 $ 0.96 02/15/2023 1,381,015

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	3 Months Ended
	Mar. 31, 2022
Share-based Payment Arrangement [Abstract]
Summary of Stock Option Activity for Amended 2014 Plan and Related Information	The table below summarizes stock option activity under the Amended 2014 Plan and related information for the three months ended March 31, 2022. The exercise price of all options granted during the three months ended March 31, 2022 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2022, unamortized stock-based compensation expense of approximately $5.3 million will be amortized over a weighted average period of 2.98 years. At March 31, 2022, 642,175 shares of common stock were available for future awards granted under the Amended 2014 Plan. Number of Shares Weighted Average Outstanding at December 31, 2021 4,717,602 $ 1.65 Granted 1,759,692 1.59 Exercised — — Canceled/forfeited (200,012) 1.96 Expired — — Outstanding at March 31, 2022 6,277,282 $ 1.63 Exercisable at March 31, 2022 2,597,775 $ 1.45
Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors	Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2022 2021 Research and development $ 174,613 $ 115,625 General and administrative $ 357,796 $ 250,286 Total $ 532,409 $ 365,911
Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Directors	The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the three months ended March 31, 2022 are as follows: Three Months Ended Expected life in years 6.02 Risk-free interest rate 1.65% Expected volatility 122% Forfeiture rate 0.0% Dividend yield 0.0% Weighted-average fair value of options granted $1.38

Leased Properties (Tables)

Leased Properties (Tables)	3 Months Ended
	Mar. 31, 2022
Leases [Abstract]
Schedule of Future Minimum Lease Payments	As of March 31, 2022, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2022 $ 288,000 2023 422,000 2024 384,000 2025 297,000 Total future minimum lease payments 1,391,000 Less: accreted interest 183,000 Total operating lease liabilities $ 1,208,000

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	3 Months Ended
	Mar. 31, 2022
Earnings Per Share [Abstract]
Schedule of Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share	The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2022 2021 Stock options 6,277,282 4,311,291 Warrants 1,381,015 1,856,143 Total 7,658,297 6,167,434

Organization and Description _2

Organization and Description of Business (Details)	3 Months Ended
	Mar. 31, 2022segment
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Number of operating segments	1

Basis of Presentation and Sum_4

Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($) shares in Millions	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Dec. 31, 2020
Significant Accounting Policies [Line Items]
Accumulated deficit	$ (118,525,572)		$ (110,126,902)
Cash and cash equivalents	39,316,911	$ 7,660,151	$ 51,674,087	$ 4,669,467
Working capital	31,400,000
Net loss	8,398,670	$ 7,323,644
Cash flow from operations	$ (12,300,000)
Period of insufficient cash and liquidity requirements	12 months
Common stock reserved for future issuance (in shares)	27
Organon
Significant Accounting Policies [Line Items]
Upfront license fee paid	$ 10,000,000
Milestone payment paid in common stock	182,500,000
First commercial sale amount	2,500,000
Sales based milestones amount	$ 180,000,000

Basis of Presentation and Sum_5

Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	$ 36,330,411	$ 49,666,064
Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	36,330,411	49,666,064
Level 2
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	0	0
Level 3
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash equivalents	$ 0	$ 0

Strategic Agreements (Details)

Strategic Agreements (Details) - USD ($)

1 Months Ended

3 Months Ended

12 Months Ended

Sep. 30, 2021

Jun. 30, 2021

Jan. 31, 2020

Dec. 31, 2019

Nov. 30, 2019

Apr. 30, 2018

Feb. 28, 2018

Mar. 31, 2017

Mar. 31, 2022

Sep. 30, 2021

Mar. 31, 2021

Dec. 31, 2021

Dec. 31, 2020

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

License fee

$ 25,000

$ 25,000

Accrued expenses

3,537,856

$ 3,136,244

Payment of additional consideration

46,500,000

Microchips Biotech, Inc.

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Asset acquisition, contingent consideration

$ 50,000

Common stock issued to microchips capital stock holders (in shares)

700,000

Business acquisition transaction value

$ 2,400,000

Business combination shares issued (in usd per share)

$ 0.79

Cash and cash equivalents

$ 6,100,000

Contingent consideration, liability

3,500,000

Current portion of contingent consideration

$ 1,000,000

1,000,000

Potential additional consideration payable

1,250,000

Accrued expenses

250,000

250,000

Cash paid to stockholders' representative

$ 75,000

Payment of additional consideration

$ 1,250,000

Microchips Biotech, Inc. | Upon Achievement of Specified Development and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payments

46,500,000

Current portion of contingent consideration

55,000,000

Microchips Biotech, Inc. | Research and development

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Business acquisition transaction value

$ 202,000

Microchips Biotech, Inc. | Common stock

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Common stock issued to microchips capital stock holders (in shares)

3,000,000

ADVA Tec Agreement | Upon Achievement of Specified Development and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payments

$ 2,500,000

Maximum | ADVA Tec Agreement

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Percentage of royalty rate

10.00%

Maximum | ADVA Tec Agreement | Upon Achievement of Specified Development and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payments

$ 14,600,000

Minimum | ADVA Tec Agreement

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Percentage of royalty rate

1.00%

MilanaPharm | Upon Achievement of Specified Development and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 50,000,000

Bayer Healthcare License Agreement

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 310,000,000

Upfront license fee paid

1,000,000

Revenue from grant for notice of award

$ 20,000,000

Initial term of license agreement

15 years

Licensing Agreements | ADVA Tec Agreement | Upon Reaching Certain Worldwide Net Sales Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payments term

3 years

Milestone payments

$ 20,000,000

Licensing Agreements | MilanaPharm

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 1,000,000

250,000

License fee

$ 235,000

License fee to be paid upon contingency

110,000

Royalty agreement term

10 years

License agreement termination periodic discontinued sale of product

60 days

License agreement termination period due to performance failure

120 days

Certain clinical and regulatory development milestone payments

90 days

Licensing Agreements | MilanaPharm | Upon Achieving Certain Development Milestones | Maximum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 300,000

Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

750,000

100,000

Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones | Upon Achievement of Specified Development and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 200,000

Licensing Agreements | MilanaPharm | Upon Achieving Certain Commercial Milestones | Maximum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 500,000

Licensing Agreements | MilanaPharm | Licensed Product or Process for Vaginal or Urological Use

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

250,000

Assignment Agreement

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

License fee

512,500

Assignment Agreement | Hammock Pharmaceuticals, Inc

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

License fee to be paid upon contingency

$ 137,500

Assignment Agreement | Hammock Pharmaceuticals, Inc | Upon Achieving Certain Clinical and Regulatory Development Milestones | Maximum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 1,100,000

License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Percentage of rights to inventions by employees under license agreement

50.00%

License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Maximum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 18,000,000

License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Minimum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

500,000

License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Upon Achieving Certain Commercial Milestones | Maximum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

100,000,000

License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | Upon Achieving Certain Commercial Milestones | Minimum

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 10,000,000

Juniper Pharmaceuticals, Inc

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Upfront license fee paid

$ 250,000

Potential annual license maintenance fee, payments in year one

50,000

Potential annual license maintenance fee payments, thereafter

100,000

Juniper Pharmaceuticals, Inc | Clinical and Regulatory Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Maximum potential milestone payments

13,500,000

Juniper Pharmaceuticals, Inc | Sales Milestones

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Maximum potential milestone payments

$ 30,300,000

Organon

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Upfront license fee paid

10,000,000

Milestone payment paid in common stock

182,500,000

First commercial sale amount

2,500,000

Sales based milestones amount

$ 180,000,000

Milestone payments term

10 years

Catalent and MilanaPharm

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Annual maintenance fee

$ 100,000

Net amount payable

$ 900,000

Catalent and MilanaPharm | Licensing Agreements

Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]

Milestone payment paid in common stock

$ 1,000,000

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Details) - USD ($)	1 Months Ended				3 Months Ended
	Apr. 30, 2021	Jul. 31, 2020	Apr. 30, 2019	Jan. 31, 2018	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Feb. 28, 2018	Feb. 15, 2018
Stockholders Equity [Line Items]
Commission percent	3.00%			3.00%
Issues shares					$ 8,394		$ 8,394
Unamortized costs related to legal, accounting, and other fees							$ 0
Exercise price (in usd per share)								$ 3
Warrant, exercise price, decrease (in usd per share)		$ 0.96	$ 0.98
Deemed dividend from trigger of down round provision feature		$ 6,863	$ 800,000
Number Of Common Stock Warrants Exercised					0	52,500
Warrant exercises, gross						$ 50,000
Accounting Standards Update 2017-11
Stockholders Equity [Line Items]
Estimated fair value of warrants recorded in equity									$ 3,000,000
Lincoln Park
Stockholders Equity [Line Items]
Obligation to purchase common stock	$ 15,000,000
April 2021 At The Market Sales Agreement
Stockholders Equity [Line Items]
Issues shares	50,000,000
Purchase Agreement
Stockholders Equity [Line Items]
Legal, accounting and other fees related to purchase agreement	$ 374,000

Stockholders' Equity - Schedule

Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares	3 Months Ended
	Mar. 31, 2022	Feb. 28, 2018
Class of Warrant or Right [Line Items]
Shares underlying outstanding warrants (in shares)	1,381,015
Exercise price (in usd per share)		$ 3
Warrants Expiring on April 4, 2026
Class of Warrant or Right [Line Items]
Shares underlying outstanding warrants (in shares)	6,500
Exercise price (in usd per share)	$ 10
Expiration Date	Apr. 4, 2026
Warrants Expiring on February 15, 2023
Class of Warrant or Right [Line Items]
Shares underlying outstanding warrants (in shares)	1,374,515
Exercise price (in usd per share)	$ 0.96
Expiration Date	Feb. 15, 2023

Stock Based Compensation - Addi

Stock Based Compensation - Additional Information (Details) - USD ($)	Jan. 01, 2021	Jul. 31, 2018	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reserved for future issuance (in shares)			27,000,000
Unamortized stock-based compensation expense			$ 5,300,000
Weighted average amortization period			2 years 11 months 23 days
Employee Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense			$ 532,409	$ 365,911
Options to purchase number of outstanding shares of common stock (in shares)		2,046,885
Stock options outstanding (in shares)		2,000,000
Annual percentage increase in outstanding number of common stock		4.00%
Increase in number of shares authorized (in shares)	2,000,000
Common stock reserved for future issuance (in shares)	2,201,855
2014 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense			$ 0	$ 0
Amended and Restated Two Thousand Fourteen Stock Incentive Plan | Employee Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options outstanding (in shares)			6,277,282		4,717,602
Common stock reserved for future issuance (in shares)			642,175

Stock-Based Compensation - Summ

Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Details) - Amended and Restated Two Thousand Fourteen Stock Incentive Plan - Employee Stock Option	3 Months Ended
	Mar. 31, 2022$ / sharesshares
Number of Shares
Outstanding beginning balance (in shares) | shares	4,717,602
Granted (in shares) | shares	1,759,692
Exercised (in shares) | shares	0
Canceled/forfeited (in shares) | shares	(200,012)
Expired (in shares) | shares	0
Outstanding ending balance (in shares) | shares	6,277,282
Exercisable (in shares) | shares	2,597,775
Weighted Average Exercise Price
Outstanding beginning balance (in usd per share) | $ / shares	$ 1.65
Granted (in usd per share) | $ / shares	1.59
Exercised (in usd per share) | $ / shares	0
Canceled/forfeited (in usd per share) | $ / shares	1.96
Expired (in usd per share) | $ / shares	0
Outstanding ending balance (in usd per share) | $ / shares	1.63
Exercisable (in usd per share) | $ / shares	$ 1.45

Stock-Based Compensation - Su_2

Stock-Based Compensation - Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors (Details) - Employee Stock Option - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 532,409	$ 365,911
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	174,613	115,625
General and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 357,796	$ 250,286

Stock-Based Compensation - Su_3

Stock-Based Compensation - Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Directors (Details)	3 Months Ended
	Mar. 31, 2022$ / shares
Share-based Payment Arrangement [Abstract]
Expected life in years	6 years 7 days
Risk-free interest rate	1.65%
Expected volatility	122.00%
Forfeiture rate	0.00%
Dividend yield	0.00%
Weighted-average fair value of options granted (in usd per share)	$ 1.38

Leased Properties - Additional

Leased Properties - Additional Information (Details)	3 Months Ended
	Mar. 31, 2022USD ($)	Mar. 31, 2021USD ($)	Feb. 28, 2022	Dec. 31, 2021USD ($)	Dec. 31, 2019	Jul. 01, 2018ft²
Lessee, Lease, Description [Line Items]
Square footage of office space | ft²						3,169
Renewal term of operating lease			2 years
Incremental borrowing rate					7.00%
Operating lease, right-of-use asset, statement of financial position [Extensible List]	Other non-current assets
Current portion of lease liabilities	$ 294,474			$ 270,546
Lease liabilities long-term	913,113			$ 0
Non-cash lease expenses	169,000	$ 135,000
Cash paid for measurement of operating lease liabilities	$ 123,000	$ 112,000
Operating lease weighted average remaining lease term	3 years 1 month 17 days
Other Non Current Assets
Lessee, Lease, Description [Line Items]
Right of use asset	$ 1,200,000
MBI
Lessee, Lease, Description [Line Items]
Renewal term of operating lease			3 years

Leased Properties - Future Mini

Leased Properties - Future Minimum Lease Payments (Details)	Mar. 31, 2022USD ($)
Leases [Abstract]
Remainder of 2022	$ 288,000
2023	422,000
2024	384,000
2025	297,000
Total future minimum lease payments	1,391,000
Less: accreted interest	183,000
Total operating lease liabilities	$ 1,208,000

Commitments and Contingencies (

Commitments and Contingencies (Details) - USD ($)	1 Months Ended				3 Months Ended
	Sep. 30, 2021	Jul. 31, 2021	Jun. 30, 2021	Apr. 30, 2020	Mar. 31, 2022	Dec. 31, 2021	Jan. 31, 2021	Nov. 30, 2019
Commitments And Contingencies [Line Items]
Payment of additional consideration					$ 46,500,000
Accrued expenses					3,537,856	$ 3,136,244
Loan under paycheck protection program				$ 367,285
Notes payable including accrued interest							$ 369,887
Microchips Biotech, Inc.
Commitments And Contingencies [Line Items]
Payment of additional consideration			$ 1,250,000
Potential additional consideration payable			1,250,000
Current portion of contingent consideration			$ 1,000,000					$ 1,000,000
Accrued expenses					250,000	$ 250,000
Common stock issued to microchips capital stock holders (in shares)	700,000
Cash paid to stockholders' representative	$ 75,000
NICHD
Commitments And Contingencies [Line Items]
Total payment		$ 5,500,000
Other cost		$ 5,000,000			3,500,000
CRADA
Commitments And Contingencies [Line Items]
Remaining performance obligation, amount					$ 500,000

Grant Awards (Details)

Grant Awards (Details) - USD ($)	1 Months Ended			3 Months Ended	12 Months Ended
	Sep. 30, 2021	Jul. 31, 2021	Aug. 31, 2020	Mar. 31, 2022	Dec. 31, 2018	Dec. 31, 2021	Jun. 30, 2021
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant		$ 11,450,000			$ 1,900,000
Deferred grant funding				$ 9,731,363		$ 10,542,983
Grant, DARE-FRT1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant			$ 300,000
Additional potential grant funding			$ 2,000,000
Initial payment							$ 48,950,000
Grant, DARE-PTB1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Credits recorded to research and development expense for costs related to award				17,000
Receivable for expenses eligible for reimbursement				19,000
DARE-LARC1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant	$ 300,000
Credits recorded to research and development expense for costs related to award				165,000
Receivable for expenses eligible for reimbursement				173,000
Business development				$ 5,400,000

Net Loss Per Share - Potential

Net Loss Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares)	7,658,297	6,167,434
Stock options
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares)	6,277,282	4,311,291
Warrants
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares)	1,381,015	1,856,143

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent Event - ATM Equity Offering Program shares in Thousands, $ in Millions	1 Months Ended
	May 10, 2022USD ($)shares
Subsequent Event [Line Items]
Sale of stock, number of shares issued (in shares) | shares	751
Shares of common stock for net proceeds | $	$ 1.2