0001401914-23-000013 | 10-K | XBRL Viewer

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Cover Page - USD ($) $ in Thousands	12 Months Ended
Cover Page - USD ($) $ in Thousands	Dec. 31, 2022	Mar. 29, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Document Annual Report	true
Document Period End Date	Dec. 31, 2022
Current Fiscal Year End Date	--12-31
Document Transition Report	false
Entity File Number	001-36395
Entity Registrant Name	DARÉ BIOSCIENCE, INC.
Entity Incorporation, State or Country Code	DE
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
Entity Address, Postal Zip Code	92122
City Area Code	858
Local Phone Number	926-7655
Title of 12(b) Security	Common Stock, Par Value $0.0001 Per Share
Trading Symbol	DARE
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Public Float			$ 102,284
Entity Common Stock, Shares Outstanding		86,178,996
Documents Incorporated by Reference	DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement relating to its 2023 annual meeting of shareholders (the “2023 Proxy Statement”) are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2023 Proxy Statement will be filed with the U.S. Securities and Exchange Commission within 120 days after the end of the fiscal year to which this report relates.
Amendment Flag	false
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Entity Central Index Key	0001401914

Audit Information	12 Months Ended
Audit Information	Dec. 31, 2022
Audit Information [Abstract]
Auditor Firm ID	199
Auditor Name	Mayer Hoffman McCann P.C.
Auditor Location	San Diego, California

Consolidated Balance Sheets - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Current Assets
Cash and cash equivalents	$ 34,669,605	$ 51,674,087
Other receivables	1,703,160	1,145,317
Prepaid expenses	6,665,988	2,476,612
Total current assets	43,038,753	55,296,016
Property and equipment, net	64,908	26,041
Other non-current assets	722,722	485,120
Total assets	43,826,383	55,807,177
Current Liabilities
Accounts payable	2,027,953	2,103,083
Accrued expenses	10,894,016	3,136,244
Deferred grant funding	18,303,567	10,542,983
Current portion of lease liabilities	398,391	270,546
Total current liabilities	31,623,927	16,052,856
Deferred license revenue	1,000,000	1,000,000
Lease liabilities long-term	90,346	0
Total liabilities	32,714,273	17,052,856
Commitments and contingencies
Stockholders' equity
Preferred stock issued	0	0
Common stock: $0.0001 par value, 240,000,000 and 120,000,000 shares authorized, 84,825,481 and 83,944,119 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively	8,482	8,394
Accumulated other comprehensive loss	(351,311)	(154,973)
Additional paid-in capital	152,529,579	149,027,802
Accumulated deficit	(141,074,640)	(110,126,902)
Total stockholders' equity	11,112,110	38,754,321
Total liabilities and stockholders' equity	$ 43,826,383	$ 55,807,177

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 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)	240,000,000	120,000,000
Common stock, shares issued (in shares)	84,825,481	83,944,119
Common stock, shares outstanding (in shares)	84,825,481	83,944,119

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Statement [Abstract]
Revenue from Contract with Customer, Product and Service [Extensible Enumeration]	License	License
Revenues [Abstract]
Total revenue	$ 10,000,000	$ 0
Total revenue	10,000,000	0
Operating expenses
General and administrative	11,243,271	8,350,945
Research and development	30,042,217	30,617,567
License fee expense	100,000	100,000
Total operating expenses	41,385,488	39,068,512
Loss from operations	(31,385,488)	(39,068,512)
Other income	437,750	2,520
Gain on extinguishment of note payable	0	369,887
Net loss	(30,947,738)	(38,696,105)
Net loss to common shareholders	(30,947,738)	(38,696,105)
Foreign currency translation adjustments	(196,338)	(63,585)
Comprehensive loss	$ (31,144,076)	$ (38,759,690)
Loss per common share - basic (in usd per share)	$ (0.37)	$ (0.63)
Loss per common share - diluted (in usd per share)	$ (0.37)	$ (0.63)
Weighted average number of common shares outstanding:
Basic (in shares)	84,571,805	61,154,157
Diluted (in shares)	84,571,805	61,154,157

Consolidated Statement of Stockholders' Equity (Deficit) - 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	$ 1,599,692		1,599,692
Issuance of common stock, net of issuance costs (in shares)	7,100,000	41,094,657
Issuance of common stock, net of issuance costs	$ 75,314,091	$ 4,109	75,309,982
Issuance of common stock from the exercise of warrants (in shares)		520,985
Issuance of common stock from the exercise of warrants	500,146	$ 52	500,094
Stock options exercised (in shares)		35,500
Stock options exercised	32,529	$ 4	32,525
Issuance of common stock in connection with milestone payment (in shares)		696,724
Issuance of common stock in connection with milestone payment	1,219,286	$ 70	1,219,216
Net loss	(38,696,105)				(38,696,105)
Foreign currency translation adjustments	(63,585)			(63,585)
Ending balance (in shares) at Dec. 31, 2021		83,944,119
Ending 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	$ 2,158,511		2,158,511
Issuance of common stock, net of issuance costs (in shares)	751,000	751,040
Issuance of common stock, net of issuance costs	$ 1,218,750	$ 75	1,218,675
Stock options exercised (in shares)		130,322
Stock options exercised	124,604	$ 13	124,591
Net loss	(30,947,738)				(30,947,738)
Foreign currency translation adjustments	(196,338)			(196,338)
Ending balance (in shares) at Dec. 31, 2022		84,825,481
Ending balance at Dec. 31, 2022	$ 11,112,110	$ 8,482	$ 152,529,579	$ (351,311)	$ (141,074,640)

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Cash flows from operating activities
Net loss	$ (30,947,738)	$ (38,696,105)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	24,202	26,413
Stock-based compensation	2,158,511	1,599,692
Non-cash operating lease cost	23,415	(96,132)
Gain on early termination of lease	(46,477)	0
Non-cash loss on settlement of contingent liability	0	44,286
Gain on extinguishment of note payable and accrued interest	0	(369,887)
Changes in operating assets and liabilities:
Other receivables	(557,842)	(685,149)
Prepaid expenses	(4,189,376)	(622,336)
Other non-current assets	3,650	20,873
Accounts payable	(75,132)	1,081,749
Accrued expenses	7,757,774	(45,871)
Deferred grant funding	7,760,584	8,978,430
Net cash used in operating activities	(18,088,429)	(28,764,037)
Cash flows from investing activities
Purchases of property and equipment	(63,069)	(14,524)
Net cash used in investing activities	(63,069)	(14,524)
Cash flows from financing activities
Net proceeds from issuance of common stock	1,218,750	75,314,091
Proceeds from the exercise of common stock warrants	0	500,146
Proceeds from the exercise of stock options	124,604	32,529
Net cash provided by financing activities	1,343,354	75,846,766
Effect of exchange rate changes on cash and cash equivalents	(196,338)	(63,585)
Net change in cash and cash equivalents	(17,004,482)	47,004,620
Cash and cash equivalents, beginning of year	51,674,087	4,669,467
Cash and cash equivalents, end of year	34,669,605	51,674,087
Supplemental disclosure of non-cash investing and financing activities:
Operating right-of-use assets obtained in exchange for new operating lease liabilities	585,942	308,533
Settlement of contingent closing consideration liability with stock issuance in connection with acquisition of business	0	925,000
Milestone payment paid in common stock	$ 0	$ 250,000

Organization and Description of Business	12 Months Ended
Organization and Description of Business	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization and Description of Business	ORGANIZATION AND DESCRIPTION OF BUSINESS Organization and 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, vaginal health, reproductive health, menopause, sexual health, and fertility, and aim to expand treatment options, enhance outcomes and improve ease of use for women. 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 portfolio includes one FDA-approved product, drug and drug/device product candidates and potential product candidates in various stages of development. 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. That agreement became effective on June 30, 2022, and in July 2022, the Company received the $10.0 million non-refundable and non-creditable payment due upon the effectiveness of the agreement.

Basis of Presentation and Summary of Significant Accounting Policies

12 Months Ended

Dec. 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 consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB.

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 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.

At December 31, 2022, the Company had an accumulated deficit of approximately $141.1 million, cash and cash equivalents of approximately $34.7 million, a deferred grant funding liability of $18.3 million (representing grant funds received that may be applied solely toward direct costs and a portion of indirect costs for the development of DARE-LARC1 and DARE-LBT and which are included in cash and cash equivalents), and working capital of approximately $11.4 million. For the year ended December 31, 2022, the Company incurred a net loss of $30.9 million and had negative cash flow from operations of approximately $18.1 million.

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.

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. 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 consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Principles of Consolidation

The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation.

Grant Funding

The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Foundation. Under the Foundation grant, which the Company considers to be a research and development contract under FASB Accounting Standards Codification, or ASC, Topic 730 Research and Development, the Company granted the Foundation a Humanitarian License which gives the Foundation the right to make the funded developments accessible at an affordable price to people within developing countries. Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to International Accounting Standards 20, Accounting for Grants and Disclosure of Government Assistance, or IAS 20. Under IAS 20, the Company recognizes grant funding in the statements of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period. The Company adopted this policy in 2018. For the years ended December 31, 2022 and December 31, 2021, the Company recognized approximately $5.6 million and $2.5 million, respectively, in the statements of operations as a reduction to research and development expense. Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant funding liability in the Company's consolidated balance sheets.

Use of Estimates

The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results.

Risks and Uncertainties

The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. The Company received approval from the FDA for its first product, XACIATO™, in December 2021. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

Cash and Cash Equivalents

The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Dare MB Inc., has a $35,000 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheets.

Concentration of Credit Risk

The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents.

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 December 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) as of December 31, 2022.


	Fair Value Measurements
	Level 1		Level 2		Level 3		Total
Balance at December 31, 2022
Current assets:
Cash equivalents (1)	$	33,238,658	$	—	$	—	$	33,238,658
Balance at December 31, 2021
Current assets:
Cash equivalents (1)	$	49,666,064	$	—	$	—	$	49,666,064
(1) Represents cash held in money market funds.

The following table presents a reconciliation of contingent consideration, which was measured at fair value on a recurring basis using significant unobservable inputs (Level 3):


	Year Ended December 31,
	2022		2021
Balance at beginning of period	$	—	$	1,000,000
Satisfaction of contingent consideration (1)	—		(1,000,000)
Balance at end of period	$	—	$	—
(1) In June 2021, the contingent consideration payable by the Company related to an acquisition completed in November 2019 became due. In September 2021, the Company issued approximately 700,000 shares of its common stock in satisfaction of the milestone payments associated with milestones achieved, as described in Note 3.

Revenue Recognition

Under Accounting Standards Codification Topic 606, or ASC 606, 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. To date, the Company has not recognized any collaboration revenues.

License Fee Revenue. 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 recognized $10.0 million in license fee revenue, all of which represents the upfront payment due under its license agreement for XACIATO.

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.

Bayer License. In January 2020, the Company entered into a license agreement with Bayer HealthCare LLC, or Bayer, regarding the further development and commercialization of Ovaprene in the U.S. Upon execution of the agreement, the Company received a $1.0 million upfront non-refundable license fee payment from Bayer. Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $20.0 million. The Company concluded that 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 December 31, 2022, neither of the foregoing had occurred. The $1.0 million payment is recorded as deferred license revenue in the Company's consolidated balance sheets at December 31, 2022 and December 31, 2021.

The Company will also be entitled to receive (a) milestone payments totaling up to $310.0 million related to the commercial sales of Ovaprene, if all such milestones 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.

Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place. Potential future royalty payments will be recorded as revenue when the associated sales occur. (See Note 3, Strategic Agreements.)

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in other non-current assets as right-of-use, or ROU, lease assets, current portion of lease liabilities, and long-term lease liabilities on the Company's consolidated balance sheets.

ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset also includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 11, Leased Properties.)

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Its chief operating decision maker is the chief executive officer. The Company has one operating segment, women’s health.

Australian Research and Development Tax Incentive Program

The Company is eligible under the Australian Research and Development Tax Incentive Program, or the Tax Incentive, to receive a cash refund from the Australian Taxation Office for eligible research and development

expenditures. To be eligible, the Company must have revenue of less than AUD $20.0 million during the reimbursable period and cannot be controlled by income tax exempt entities. Grants received by the Company that do not require the transfer of goods or services to a customer are accounted for by analogy to IAS 20. Under IAS 20, the Company recognizes the Tax Incentive as a reduction to research and development expense when there is reasonable assurance that the Tax Incentive will be received, the relevant expenditure has been incurred, and the amount can be reliably measured. The Company classifies its estimate for the Tax Incentive as other current assets on its consolidated balance sheets. For the years ended December 31, 2022 and 2021, the Company recognized approximately $1.6 million and approximately $0.8 million, respectively, as a reduction to research and development expense for expenses incurred that it believes are eligible for the Tax Incentive. At December 31, 2022, the Company recorded a receivable for the estimated Tax Incentive of approximately $1.6 million in other current assets on the accompanying consolidated balance sheets.

Research and Development Costs

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed.

Patent Costs

The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statements of operations.

Net Loss Per Share

Basic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive.

There were stock options exercisable into 6,612,554 and 4,717,602 shares of common stock outstanding at December 31, 2022 and 2021, respectively. There were warrants exercisable into 1,381,015 shares of common stock outstanding at each December 31, 2022 and 2021. These securities were not included in the computation of diluted loss per share because they are antidilutive, but they could potentially dilute earnings (loss) per share in future years.

Stock-Based Compensation

The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant. The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, estimating the market price volatility of the Company's common stock, risk free interest rate, and dividend yield. Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards. The Company compared U.S. Treasury Bills in determining the risk-free interest rate appropriate given the expected term. The Company has not established and has no plans to establish, a dividend policy, and the Company has not declared, and has no plans to declare dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value.

Income Taxes

The Company accounts for income taxes using the asset and liability method in accordance with FASB ASC 740, Income Taxes. Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect

taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

The Company follows the two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not, that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50% likely of being realized upon ultimate settlement. The Company considers many factors when evaluating and estimating the Company's tax positions and tax benefits, which may require periodic adjustments. At December 31, 2022, the Company did not record any liabilities for uncertain tax positions.

During each of 2022 and 2021, the Company recorded no provision for income taxes. Management evaluated the Company’s tax positions and, as of December 31, 2022, the Company had approximately $2.3 million of unrecognized benefits. The tax years 2018 to 2022 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S. net operating losses generated remain open beginning in the year of utilization.

Indemnification Obligations

As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify its directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification is for the officer’s or director’s lifetime. During the year ended December 31, 2022, the Company did not experience any losses related to those indemnification obligations. The Company does not expect significant claims related to these indemnification obligations, and consequently, has concluded the fair value of the obligations is not material. Accordingly, as of December 31, 2022 and 2021, no amounts have been accrued related to such indemnification provisions.

Strategic Agreements	12 Months Ended
Strategic Agreements	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Strategic Agreements	STRATEGIC AGREEMENTS Strategic Agreement for Product Commercialization Organon Exclusive License Agreement In March 2022, the Company entered into an exclusive license agreement with Organon which became effective in June 2022, whereby Organon licensed 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. In July 2022, the Company received the $10.0 million non-refundable and non-creditable payment, which is recorded as license fee revenue in the accompanying consolidated statement of operations. Under the terms of the license agreement, the Company is 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 Company concluded at the inception of the agreement that the transaction price was $10.0 million and should not include the variable consideration related to unachieved development, regulatory, commercial milestones and future sales-based royalty payments. This consideration was determined to be constrained as it is probable that the inclusion of such variable consideration could result in a significant reversal in cumulative revenue. The Company re-evaluates the transaction price at each reporting period as uncertain events are resolved and other changes in circumstances occur. For the year ended December 31, 2022, no adjustments were made to the transaction price. The Company will recognize any consideration related to sales-based payments, including milestones and royalties which relate predominantly to the license granted, at the later of (i) when or as 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). The Company is 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. 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. 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. The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations. 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 $20 million fee. After payment of the $20 million fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S. Such license would be exclusive as 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 either 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 or the termination of the agreement. As of December 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 consolidated balance sheets at December 31, 2022 and 2021. The Company is 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 the 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. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S. or 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 $20.0 million fee if and when due. Strategic Agreements for Pipeline Development Hennepin License Agreement In August 2022, the Company entered into a license agreement with Hennepin Life Sciences LLC, or Hennepin, under which the Company acquired the exclusive global rights to develop and commercialize treatments delivering the novel antimicrobial glycerol monolaurate (GML) intravaginally for a variety of health conditions including bacterial, fungal, and viral infections. As a result of this license, the Company commenced its DARE-GML. Under the agreement, the Company received an exclusive, worldwide, royalty-bearing license to research, develop and commercialize the licensed technology. The Company is entitled to sublicense the rights granted to it under the agreement. Under the terms of the license agreement, the Company agreed to make potential future payments and sales milestone payments of up to $6.25 million in the aggregate upon achieving certain development and regulatory milestones, and of up to $45.0 million in the aggregate upon achieving certain commercial sales milestones for each product covered by the licenses granted under the agreement, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock. Additionally, Hennepin is eligible to receive tiered royalties in low single-digit to low double-digit percentages based on worldwide net sales of products and processes covered by the licenses granted under the agreement. During the year ended December 31, 2022, no payments were made under this agreement. 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. Under the terms of the merger agreement, the Company agreed to pay 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 the Company acquired in the merger; and (c) tiered royalty payments ranging from low single-digit to low double-digit percentages based on annual net sales of such products sold by the Company (but not by sublicensee) and a percentage of sublicense revenue related to such products. In June 2021, a total of $1.25 million of the contingent consideration became payable upon the achievement of certain of the funding and product development milestone events. In accordance with the terms of the merger agreement, the Company’s board of directors elected to pay a portion of these milestone payments in shares of the Company’s common stock, 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 satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021. TriLogic and MilanaPharm License Agreement / Hammock Assignment Agreement In December 2018, the Company entered into an Assignment Agreement with Hammock Pharmaceuticals, Inc., or the Assignment Agreement, and 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. In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment. In September 2021, the Company entered into a second amendment to the License Agreement. In March 2022, the Company entered into a consent, waiver and stand-By license Agreement with TriLogic, MilanaPharm and Organon, which further amended the License Agreement. Under the terms of the License Agreement, the Company paid clinical and regulatory development milestones in the aggregate of $300,000 to MilanaPharm, the final payment of $250,000 was expensed 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 and urological use, and up to $250,000 upon the first commercial sale in the United States of each successive licensed products for each vaginal or urological use. In addition, upon achievement of $50.0 million in cumulative worldwide net sales of licensed products the Company must pay MilanaPharm $1.0 million. MilanaPharm is also eligible to receive (a) 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, and (b) high single-digit to low double-digit royalties based on annual worldwide net sales of licensed products and processes. 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. Hammock is eligible to receive 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. Pear Tree Acquisition In May 2018, the Company acquired Pear Tree Pharmaceuticals, Inc., or Pear Tree, to secure exclusive, sublicensable, worldwide rights under certain patents and know-how to develop and commercialize a proprietary formulation of tamoxifen for vaginal administration. This acquisition led to the Company's DARE-VVA1 program. Under the terms of the merger agreement, the Company agreed to pay the former stockholders of Pear Tree: (a) up to $15.5 million in the aggregate upon achieving certain clinical development and regulatory milestones by licensed products, and (b) up to $47.0 million in the aggregate upon achieving certain commercial milestones by licensed products. Additionally, the former stockholders of Pear Tree are eligible to receive tiered royalties based on single-digit to low double-digit percentages of annual net sales of licensed products by the Company or its affiliates, subject to customary reductions and offsets, and a portion of royalties the Company receives from sublicensees. Both the milestone and royalty payments may be made, in the Company's sole discretion, in cash or in shares of its common stock in accordance with the terms of the merger agreement. Under the merger agreement, in addition to customary royalty reductions and offsets, royalty payments and payments based on income received from sublicensees of licensed products made by the Company to Pear Tree's licensors are creditable against all royalty and sublicense revenue share payments payable to the former stockholders of Pear Tree. The Company agreed to pay licensors of Pear Tree (a) up to approximately $3.2 million in the aggregate upon achieving certain clinical development, regulatory and commercial milestones by each licensed product, and (b) semi-annual royalties based on a single-digit percentage of net sales of licensed products by the Company or its affiliates, subject to customary reductions and offsets, or a portion of any royalties the Company or its affiliates receives from sublicensees, and a low double-digit percentage of all sublicensing fees or other lump sum payments or compensation the Company receives from sublicensees, subject to customary exclusions. The milestone payments to the licensors of Pear Tree may be made, in the Company's sole discretion, in cash or in shares of its common stock in accordance with the terms of the license agreements. Portions of certain milestone payments made to Pear Tree's licensors may be creditable against royalty payments due to Pear Tree's licensors. 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. Under the terms of the license agreement, the Company paid a $250,000 non-creditable upfront license fee to Catalent in connection with the execution of the agreement and will pay a $100,000 annual license maintenance fee on each anniversary of the date of the agreement. The annual maintenance fee 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. Catalent is eligible to receive up to (a) $13.5 million in the aggregate in payments based on the achievement of specified development and regulatory milestones, $1.0 million of which became payable in 2021 and was offset by the $100,000 annual maintenance fee, resulting in a net amount of $900,000 paid during the year ended December 31, 2021; and (b) up to $30.3 million in the aggregate in payments based on the achievement of specified commercial sales milestones for each product or process covered by the licenses granted under the agreement. Additionally, Catalent is eligible to receive 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. Adare Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals USA, Inc. (formerly known as Orbis Biosciences, Inc., and which the Company refers to as Adare), for the development and potential exclusive worldwide license of injectable formulations of etonogestrel for contraceptive protection over 6-month and 12-month periods (which the Company refers to as DARE-204 and DARE-214, respectively). The agreement, as amended, provides the Company with an option to negotiate an exclusive, worldwide, royalty-bearing license, with rights to sublicense, for the programs if the Company funds the conduct of specified development work. The Company has no obligation to exercise its option. 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 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. SST will be eligible to receive payments of up to $18.0 million in the aggregate upon achieving certain clinical and regulatory milestones in the U.S. and worldwide, and up 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. Additionally, SST is eligible to receive tiered royalties based on percentages of annual net sales of licensed products in the single-digit to mid double-digits subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., or ADVA-Tec, under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. Under the terms of the license agreement, the Company will pay ADVA-Tec (a) up to $14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $1.2 million of which has been paid; and (b) up to $20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones. Additionally, ADVA-Tec is eligible to receive 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, subject to customary reductions and offsets. If the Company sublicenses its rights under the agreement, in lieu of royalty payments to ADVA-Tec, ADVA-Tec is eligible to receive a double-digit percentage of sublicense revenue received by the Company during the royalty term; provided, however, that for sublicense revenue the Company receives prior to the first commercial sale of a licensed product that represents an upfront payment or license fee due on or around the effective date of the sublicense, ADVA-Tec is eligible to receive a single-digit percentage of that sublicense revenue.

Prepaid Expenses

12 Months Ended

Dec. 31, 2022

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Prepaid Expenses

PREPAID EXPENSES

Prepaid expenses consisted of the following:


	As of December 31,
	2022		2021
Prepaid clinical expense	$	5,928,090	$	1,728,421
Prepaid insurance expense	502,981		552,354
Prepaid legal and professional expenses	234,917		195,837
Total prepaid expenses	$	6,665,988	$	2,476,612

Other Non-Current Assets

12 Months Ended

Dec. 31, 2022

Other Assets, Noncurrent Disclosure [Abstract]

Other Non-Current Assets

OTHER NON-CURRENT ASSETS

Other non-current assets consisted of the following:


	As of December 31,
	2022		2021
Prepaid insurance, long-term portion	$	—	$	87,891
Other non-current assets	115,092		—
Deferred financing costs	139,203		143,002
Deposits	10,502		37,554
Operating lease assets	457,925		216,673
Total other non-current assets	$	722,722	$	485,120

Accrued Expenses

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Accrued Expenses

ACCRUED EXPENSES

Accrued expenses consisted of the following:


	As of December 31,
	2022		2021
Accrued clinical expense	$	6,665,443	$	1,242,414
Accrued compensation and benefits	1,720,501		1,533,475
Accrued development expense	2,102,310		158,103
Accrued legal and professional	239,348		129,858
Other accruals	99,747		5,727
Accrued license fee expense	66,667		66,667
Total accrued expenses	$	10,894,016	$	3,136,244

Vendor Concentration	12 Months Ended
Vendor Concentration	Dec. 31, 2022
Risks and Uncertainties [Abstract]
Vendor Concentration	VENDOR CONCENTRATIONThe Company had a major vendor that accounted for approximately 10% and 23% of the Company's research and development expenditures for the years ended December 31, 2022 and 2021, respectively. The same vendor also accounted for approximately 17% and 4% of the Company's total accounts payable and accrued expenses as of December 31, 2022 and 2021, respectively. The Company continues to maintain its relationship with this vendor and anticipates incurring significant expenses with this vendor over the next 12 months.

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

INCOME TAXES

The components of loss from continuing operations before provision for income taxes consists of the following (in thousands):


	Years Ended December 31,
	2022		2021
Domestic	$	28,391	$	37,083
Foreign	2,557		1,613
Loss before taxes	$	30,948	$	38,696

The difference between the provision for income taxes (benefit) and the amount computed by applying the U.S. federal income tax rate for the years ended December 31, 2022 and 2021 are as follows:


	Years Ended December 31,
	2022		2021
Federal statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	(2.96)	%	9.64	%
State tax rate change	(9.08)	%	—	%
Permanent differences	(0.02)	%	0.19	%
Research and development credit	6.84	%	2.70	%
Stock compensation	(0.57)	%	(0.41)	%
Other	(0.74)	%	0.25	%

Change in valuation allowance	(14.48)	%	(33.38)	%
Effective income tax rate	(0.01)	%	(0.01)	%

The major components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are shown below (in thousands).


	2022		2021
Net operating loss carryforwards	$	81,761	$	81,817
Research and development credit carryforwards	8,833		7,186
Capitalized research and development costs	10,009		7,417
Other	1,468		801
Stock compensation	2,170		2,540
Total deferred tax assets	104,241		99,761
Valuation allowance	(104,241)		(99,761)
Net deferred tax assets	$	—	$	—

The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Under applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a valuation allowance of $104.2 million and $99.8 million was established at December 31, 2022 and 2021, respectively, to offset the net deferred tax assets. When and if management determines that it is more likely than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated.

The increase in valuation allowance of approximately $4.5 million and $14.5 million for the years ending December 31, 2022 and 2021, respectively, is primarily related to an increase in net operating losses generated during the year.

The Company has U.S. federal net operating loss, or NOL, carryforwards available at December 31, 2022 of approximately $295.3 million of which $0.9 million begin expiring in 2023 unless previously utilized and $117.8 million that do not expire. The Company has state NOL carryforwards of $283.4 million that begin expiring in 2031 unless previously utilized. The Company has U.S. federal research credit carryforwards available at December 31, 2022 of approximately $8.7 million that begin expiring in 2027 unless previously utilized. The Company has state research credit carryforwards of $2.8 million of which $0.1 million begin expiring in 2023 unless previously utilized. These federal and state research and development credits are subject to a 20% reserve under FASB ASC 740. The difference between federal and state NOL carryforwards is primarily due to previously expired state NOL carryforwards.

Utilization of the NOL and research and development credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company has not yet completed an evaluation of ownership changes. To the extent an ownership change occurs, the NOL and credit carryforwards and other deferred tax assets may be subject to limitations.

A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands):


	Years Ended December 31,
	2022		2021
Beginning uncertain tax benefits	$	1,909	$	1,341
Current year - increases	$	427	$	426
Prior year - additions (reductions)	$	(20)	$	142
Ending uncertain tax benefits	$	2,316	$	1,909

Included in the balance of uncertain tax benefits at December 31, 2022 are $2.3 million of tax benefits that, if recognized, would impact the effective tax rate. The Company anticipates that no material amounts of unrecognized tax benefits will be settled within 12 months of the reporting date.

The Company's policy is to record estimated interest and penalties related to uncertain tax benefits as income tax expense. As of December 31, 2022 and 2021, the Company had no accrued interest or penalties recorded related to uncertain tax positions.

The tax years 2018 through 2022 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the U.S. The statute of limitations for U.S. net operating losses utilized in future years will remain open beginning in the year of utilization.

No additional provision has been made for U.S. income taxes related to undistributed foreign earnings of the Company’s wholly owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences related to investments in subsidiaries. As such, earnings are expected to be permanently reinvested, the investments are permanent in duration, or the Company has estimated that no additional tax liability will arise as a result of the distribution of such earnings. A liability could arise if amounts are distributed by the subsidiary or if the subsidiary is ultimately disposed. It is not practical to estimate the additional income taxes, if any, related to permanently reinvested earnings. There are no unremitted earnings as of December 31, 2022.

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
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-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Stockholders' Equity

12 Months Ended

Dec. 31, 2022

Equity [Abstract]

Stockholders' Equity

STOCKHOLDERS’ EQUITY

Increase in Authorized Shares of Common Stock

In July 2022, following the approval of the Company's stockholders at its annual meeting of stockholders, the Company amended its restated certificate of incorporation to increase the Company's authorized shares of common stock to 240.0 million.

October 2021 ATM Sales Agreement

In October 2021, the Company entered into a sales agreement with SVB Securities LLC (formerly known as 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 Securities 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 the agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program.

During 2022, the Company sold approximately 751,000 shares of common stock under the agreement for gross proceeds of approximately $1.3 million and incurred offering expenses of approximately $42,000. During 2021, the Company sold approximately 7.1 million shares of common stock under the agreement for gross proceeds of approximately $16.3 million and incurred offering expenses of approximately $537,000.

The Company terminated the agreement in March 2023. (See Note 14, Subsequent Events.)

April 2021 ATM Sales Agreement

In April 2021, the Company entered into a sales agreement with SVB Securities to sell up to $50.0 million of shares of its common stock from time to time through an ATM equity offering program under which SVB Securities 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. 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 2022, the Company sold no shares of common stock under the agreement. During 2021, the Company sold approximately 26.0 million shares of common stock under the agreement for gross proceeds of approximately $46.9 million and incurred offering expenses of approximately $1.6 million.

The Company terminated the agreement in March 2023. (See Note 14, Subsequent Events.)

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% 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. During 2021, the Company sold approximately 3.3 million shares of common stock under this agreement for gross proceeds of approximately $7.7 million and incurred offering expenses of approximately $245,000.

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. Those costs were amortized and expensed as shares were sold under the Purchase Agreement. During 2021, the Company sold, and Lincoln Park purchased, approximately 4.8 million shares under the Purchase Agreement for gross proceeds to the Company of approximately $7.0 million and recognized offering expenses of approximately $175,000. As of December 31, 2021, the Company had sold and Lincoln Park had purchased a total of $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 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 2022, no warrants were exercised. During 2021, warrants to purchase an aggregate of 520,985 shares of common stock were exercised for gross proceeds of approximately $0.5 million. As of December 31, 2022, the Company had the following warrants outstanding:


Shares Underlying Outstanding Warrants		Exercise Price	Expiration Date
6,500	$	10.00	04/04/2026
1,374,515	$	0.96	02/15/2023
1,381,015

Common Stock

The authorized capital of the Company consists of 240,000,000 shares of common stock with a par value of $0.0001 per share and 5,000,000 shares of preferred stock with a par value of $0.01 per share. The issued and outstanding common stock of the Company consisted of 84,825,481 and 83,944,119 shares of common stock as of December 31, 2022 and 2021, respectively. There were no shares of preferred stock outstanding as of December 31, 2022 or 2021.

Common Stock Reserved for Future Issuance

The following table summarizes common stock reserved for future issuance at December 31, 2022:


Common stock reserved for issuance upon exercise of warrants outstanding			1,381,015
Common stock reserved for issuance upon exercise of options outstanding			6,612,554
Common stock reserved for future equity awards			9,576,581
Total			17,570,150

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-Paragraph 13
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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-Section 50
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-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
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-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 505
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Stock-Based Compensation

12 Months Ended

Dec. 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 and there was no stock-based compensation related to the ESPP for the years ended December 31, 2022 or December 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. 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. On June 23, 2022, the Amended 2014 Plan was superseded by the 2022 Plan (as defined below), and no further awards were or will be granted under the Amended 2014 Plan since that date. Awards outstanding under the Amended 2014 Plan will continue to remain outstanding pursuant to their terms and conditions.

2022 Stock Incentive Plan

In April 2022, the Company's board of directors approved the Daré Bioscience, Inc. 2022 Stock Incentive Plan, or the 2022 Plan, which was subsequently approved by the Company's stockholders on June 23, 2022, and became effective as of that date. The 2022 Plan provides for the grant of stock-based incentive awards to employees, consultants, advisors, and directors.

The number of shares of common stock authorized for issuance under the 2022 Plan is (a) 10,117,305; plus (b) up to 6,144,682 shares subject to awards granted under the Amended 2014 Plan or the 2007 Stock Incentive Plan that expire, terminate or are otherwise forfeited on or after June 23, 2022.

Summary of Stock Option Activity

The table below summarizes stock option activity under the Company's stock incentive plans and related information for the years ended December 31, 2022 and 2021. The exercise price of all options granted during the years ended December 31, 2022 and 2021 was equal to the market value of the Company’s common stock on the date of grant. As of December 31, 2022, unamortized stock-based compensation expense of approximately $4.1 million will be amortized over the weighted average period of 2.4 years. As of December 31, 2022, 9,576,581 shares of common stock were available for future award grants under the 2022 Plan.


	Number of Shares	Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (Years)	Aggregate Intrinsic Value
Outstanding at December 31, 2020	2,786,591	$	1.16
Granted	2,052,075	2.31
Exercised	(35,500)	0.92
Canceled/forfeited	(85,564)	1.82
Expired	—	—
Outstanding at December 31, 2021	4,717,602	$	1.65
Granted	2,346,692	1.50
Exercised	(130,322)	0.96
Canceled/forfeited	(321,418)	1.94
Expired	—	—
Outstanding at December 31, 2022	6,612,554	$	1.60	7.82	$	41,679
Options exercisable at December 31, 2022	3,632,467	$	1.50	7.05	$	40,102
Options vested and expected to vest at December 31, 2022	6,612,554	$	1.60	7.82	$	41,679

Compensation Expense

Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows:


	Years Ended December 31,
	2022		2021
Research and development	$	676,645	$	524,071
General and administrative	1,481,866		1,075,621
Total	$	2,158,511	$	1,599,692

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 years ended December 31, 2022 and 2021 is as follows:


	2022			2021
Expected life in years	6.0			6.0
Risk-free interest rate	2.00		%	0.67		%
Expected volatility	121		%	122		%
Dividend yield	0.0		%	0.0		%
Weighted-average fair value of options granted	$	1.30		$	2.01

Leased Properties

12 Months Ended

Dec. 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. The lease for that space commenced on July 1, 2013. In February 2022, the Company entered into an amendment to extend the term of the lease for three years to December 31, 2025, subject to the landlord's right to terminate the lease on December 31, 2023. The extension of the lease in February 2022 resulted in an increase in operating lease liabilities and ROU assets of approximately $1.0 million. In September 2022, the landlord exercised its option to terminate the lease, resulting in the new lease term ending on December 31, 2023. The termination of the lease resulted in a reduction of operating lease liabilities and ROU assets of approximately $504,000 and $458,000, respectively, and a $46,000 gain on the modification of the lease which is included as a reduction to research and development expense for the year ended December 31, 2022.

MBI previously leased warehouse space in Billerica, Massachusetts, under a lease that 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 consisting of the current prime rate plus 200 basis points 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 December 31, 2022, the Company reported operating lease right of use assets of approximately $458,000 in other non-current assets, approximately $398,000 in current liabilities, and approximately $90,000 in long-term liabilities on the consolidated balance sheets.

Total operating lease costs were approximately $602,000 and $561,000 for the years ended December 31, 2022 and 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 consolidated statements of operations.

Cash paid for amounts included in the measurement of operating lease liabilities was approximately $346,000 and $462,000 for the years ended December 31, 2022 and 2021, respectively, and these amounts are included in operating activities in the consolidated statements of cash flows. At December 31, 2022, operating leases had a weighted average remaining lease term of 1.33 years.

At December 31, 2022, future minimum lease payments under the Company's operating leases are as follows:


Year ending December 31,
2023	$	422,000
2024	$	93,000
Total future minimum lease payments	515,000
Less: accreted interest	26,000
Total operating lease liabilities	$	489,000

Commitments and Contingencies	12 Months Ended
Commitments and Contingencies	Dec. 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's 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 made aggregate payments of $1.5 million to NICHD in 2021 and a payment of $3.5 million to NICHD in 2022. The Company's remaining obligation under the CRADA at December 31, 2022 is $0.5 million. Note Payable In April 2020, due to the economic uncertainty resulting from the impact of the COVID-19 pandemic on the Company's operations and to support its ongoing operations and retain all employees, the Company applied for and received a loan of $367,285 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S. Small Business Administration, or the SBA. In January 2021, the Company was notified that the principal balance of the loan and all accrued interest, which together totaled $369,887, were fully forgiven by the SBA. The Company recorded a gain on extinguishment of note payable and debt forgiveness income with respect to such loan forgiveness in the first quarter of 2021. Legal Proceedings From time to time, the Company may be involved in various claims arising in the normal course of business. Management is not aware of any material claims, disputes or unsettled matters that would have a material adverse effect on the Company’s results of operations, liquidity or financial position that the Company has not adequately provided for in the accompanying consolidated financial statements. Employment Agreements Certain executive officers of the Company are entitled to payments if their employment is terminated by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, or if their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company. Upon termination by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, such executives are entitled to receive a payment of an amount equal to either nine or twelve months of base salary and to receive continuing health benefits coverage for periods equal to either nine or twelve months following the termination of employment or until such officer is covered under a separate plan from another employer. If their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company, such executives will be entitled to receive a payment of an amount equal to either twelve or eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between twelve and eighteen months following the termination of employment. In addition, upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement. Employee Benefit – 401(k) Plan The Company has a 401(k) retirement plan, or the 401(k) Plan, covering all qualified employees. The 401(k) Plan allows each participant to contribute a portion of their base wages up to an amount not to exceed an annual statutory maximum. The 401(k) Plan includes a Safe Harbor Plan that provides a Company match up to 4% of salary. The Company made matching contributions of approximately $200,000 and $160,000 during the years ended December 31, 2022 and 2021, respectively.

Grant Awards	12 Months Ended
Grant Awards	Dec. 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, DARE-LARC1 and DARE-204/214. 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 notices of awards received by the Company 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 what is referred to as 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 of approximately $20,000 and $65,000 for costs related to the NICHD award for the years ended December 31, 2022 and 2021, respectively. 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 nonclinical studies, which is ongoing. The Company recorded credits to research and development expense of approximately $239,000 and $7,400 for costs related to the NICHD award for the year ended December 31, 2022 and 2021, respectively. The Company recorded receivables of approximately $33,000 and $7,400 for expenses incurred through such date that it believes is eligible for reimbursement under the grant at December 31, 2022 and 2021, respectively. DARE-204 and DARE-214 In May 2022, the Company received a notice of award of a grant from NICHD of approximately $249,000 to support end-user research to better understand women's preferences for a long-acting injectable contraceptive method. The findings from the research will inform the Company's target product profile and guide its development priorities for DARE-204 and DARE-214. The Company recorded credits to research and development expense of approximately $116,000 for costs related to the NICHD award for the year ended December 31, 2022. At December 31, 2022, the Company recorded a receivable of approximately $24,000 for expenses incurred through such date that it believes is eligible for reimbursement under the grant. Other Non-Dilutive Grant Funding MBI Grant Agreement for DARE-LARC1 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 and no future funding has been or will be received under this agreement. 2021 DARE-LARC1 Grant Agreement In June 2021, the Company entered into an agreement with the Foundation under which the Company was awarded up to $49.0 million to support the development of DARE-LARC1. The agreement supports technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in nonclinical proof of principle studies. Under the agreement, the Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation. Any unspent funds are recorded as a deferred grant funding liability in the Company's consolidated balance sheets. The Company received an initial payment of $11.5 million in July 2021, approximately $8.0 million in July 2022 and approximately $4.4 million in December 2022. As of December 31, 2022, the Company has received an aggregate of approximately $23.9 million in non-dilutive funding under the agreement and recorded approximately $17.7 million of deferred grant funding in the Company's consolidated balance sheets. Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones. 2022 DARE-LBT Grant Agreement In November 2022, the Company entered into an agreement with the Foundation under which the Company was awarded $585,000 to support the development of DARE-LBT. Under the agreement, the Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation. Any unspent funds are recorded as a deferred grant funding liability in the Company's consolidated balance sheets. The Company received the full amount of the award in November 2022. As of December 31, 2022, the Company has recorded approximately $573,000 of deferred grant funding in the Company's consolidated balance sheets.

Subsequent Events	12 Months Ended
Subsequent Events	Dec. 31, 2022
Subsequent Events [Abstract]
Subsequent Events	SUBSEQUENT EVENTS Termination of ATM Sales Agreements Effective March 30, 2023, the Company terminated its ATM equity offering program sales agreements with SVB Securities LLC (see Note 9). Exercise of February 2018 Warrants In January and February 2023, warrants to purchase an aggregate of 1,353,515 shares of common stock were exercised at an exercise price of $0.96 per share resulting in gross proceeds to the Company of approximately $1.3 million (see Note 9).

Basis of Presentation and Summary of Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation	Basis of presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB.
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 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. At December 31, 2022, the Company had an accumulated deficit of approximately $141.1 million, cash and cash equivalents of approximately $34.7 million, a deferred grant funding liability of $18.3 million (representing grant funds received that may be applied solely toward direct costs and a portion of indirect costs for the development of DARE-LARC1 and DARE-LBT and which are included in cash and cash equivalents), and working capital of approximately $11.4 million. For the year ended December 31, 2022, the Company incurred a net loss of $30.9 million and had negative cash flow from operations of approximately $18.1 million. 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. 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. 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 consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Principles of Consolidation	Principles of Consolidation The consolidated financial statements of the Company are stated in U.S. dollars. These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. One wholly owned subsidiary, Daré Bioscience Australia Pty LTD, operates primarily in Australia. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss. All intercompany transactions and accounts have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of stock-based compensation. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results.
Risks and Uncertainties	Risks and Uncertainties The Company will require approvals from the U.S. Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products. The Company received approval from the FDA for its first product, XACIATO™, in December 2021. There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.
Cash and Cash Equivalents	Cash and Cash EquivalentsThe Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents. The Company’s wholly owned subsidiary, Dare MB Inc., has a $35,000 letter of credit related to the lease of real property that serves as security for future default of lease payments. The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheets.
Concentration of Credit Risk	Concentration of Credit Risk The Company maintains cash balances at various financial institutions and such balances commonly exceed the $250,000 amount insured by the Federal Deposit Insurance Corporation. The Company also maintains money market funds at various financial institutions which are not federally insured although are invested primarily in the U.S. The Company has not experienced any losses in such accounts and management believes that the Company does not have significant risk with respect to such cash and cash equivalents.
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 Under Accounting Standards Codification Topic 606, or ASC 606, 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. To date, the Company has not recognized any collaboration revenues. License Fee Revenue. 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 recognized $10.0 million in license fee revenue, all of which represents the upfront payment due under its license agreement for XACIATO. 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.
Leases	Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in other non-current assets as right-of-use, or ROU, lease assets, current portion of lease liabilities, and long-term lease liabilities on the Company's consolidated balance sheets. ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease. Operating ROU lease assets and obligations are recognized at the commencement date based on the present value of lease payments over the lease term. If the lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The ROU lease asset also includes any lease payments made and excludes lease incentives. The Company's lease terms may include options to extend or terminate the lease and the related payments are only included in the lease liability when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. (See Note 11, Leased Properties.)
Segment Reporting	Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Its chief operating decision maker is the chief executive officer. The Company has one operating segment, women’s health.
Research and Development Costs	Research and Development Costs Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses. Research and development costs are expensed as incurred. Nonrefundable advance payments, if any, for goods and services used in research and development are recognized as an expense as the related goods are delivered or services are performed. Patent Costs The Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated statements of operations.
Net Loss Per Share	Net Loss Per ShareBasic net loss attributable to common stockholders per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive.
Stock-Based Compensation	Stock-Based Compensation The Company records compensation expense for all stock-based awards granted based on the fair value of the award at the time of grant. The Company uses the Black-Scholes Pricing Model to determine the fair value of each of the awards which considers factors such as expected term, estimating the market price volatility of the Company's common stock, risk free interest rate, and dividend yield. Due to the limited history of the Company, the simplified method was utilized in order to determine the expected term of the awards. The Company compared U.S. Treasury Bills in determining the risk-free interest rate appropriate given the expected term. The Company has not established and has no plans to establish, a dividend policy, and the Company has not declared, and has no plans to declare dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value.
Income Taxes	Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with FASB ASC 740, Income Taxes. Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company follows the two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more likely than not, that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount, which is more than 50% likely of being realized upon ultimate settlement. The Company considers many factors when evaluating and estimating the Company's tax positions and tax benefits, which may require periodic adjustments. At December 31, 2022, the Company did not record any liabilities for uncertain tax positions. During each of 2022 and 2021, the Company recorded no provision for income taxes. Management evaluated the Company’s tax positions and, as of December 31, 2022, the Company had approximately $2.3 million of unrecognized benefits. The tax years 2018 to 2022 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S. net operating losses generated remain open beginning in the year of utilization.
Indemnification Obligations	Indemnification Obligations As permitted under Delaware law, the Company has entered into indemnification agreements with its officers and directors that provide that the Company will indemnify its directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification is for the officer’s or director’s lifetime. During the year ended December 31, 2022, the Company did not experience any losses related to those indemnification obligations. The Company does not expect significant claims related to these indemnification obligations, and consequently, has concluded the fair value of the obligations is not material. Accordingly, as of December 31, 2022 and 2021, no amounts have been accrued related to such indemnification provisions.

Basis of Presentation and Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Schedule of Financial Assets and Liabilities Remeasured on a Recurring Basis


	Fair Value Measurements
	Level 1		Level 2		Level 3		Total
Balance at December 31, 2022
Current assets:
Cash equivalents (1)	$	33,238,658	$	—	$	—	$	33,238,658
Balance at December 31, 2021
Current assets:
Cash equivalents (1)	$	49,666,064	$	—	$	—	$	49,666,064
(1) Represents cash held in money market funds.

The following table presents a reconciliation of contingent consideration, which was measured at fair value on a recurring basis using significant unobservable inputs (Level 3):


	Year Ended December 31,
	2022		2021
Balance at beginning of period	$	—	$	1,000,000
Satisfaction of contingent consideration (1)	—		(1,000,000)
Balance at end of period	$	—	$	—
(1) In June 2021, the contingent consideration payable by the Company related to an acquisition completed in November 2019 became due. In September 2021, the Company issued approximately 700,000 shares of its common stock in satisfaction of the milestone payments associated with milestones achieved, as described in Note 3.

Prepaid Expenses (Tables)

12 Months Ended

Dec. 31, 2022

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]

Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure

Prepaid expenses consisted of the following:


	As of December 31,
	2022		2021
Prepaid clinical expense	$	5,928,090	$	1,728,421
Prepaid insurance expense	502,981		552,354
Prepaid legal and professional expenses	234,917		195,837
Total prepaid expenses	$	6,665,988	$	2,476,612

Other Non-Current Assets (Tables)

12 Months Ended

Dec. 31, 2022

Other Assets, Noncurrent Disclosure [Abstract]

Schedule of Other Non-Current Assets

Other non-current assets consisted of the following:


	As of December 31,
	2022		2021
Prepaid insurance, long-term portion	$	—	$	87,891
Other non-current assets	115,092		—
Deferred financing costs	139,203		143,002
Deposits	10,502		37,554
Operating lease assets	457,925		216,673
Total other non-current assets	$	722,722	$	485,120

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Schedule of Accounts Payable and Accrued Expenses

Accrued expenses consisted of the following:


	As of December 31,
	2022		2021
Accrued clinical expense	$	6,665,443	$	1,242,414
Accrued compensation and benefits	1,720,501		1,533,475
Accrued development expense	2,102,310		158,103
Accrued legal and professional	239,348		129,858
Other accruals	99,747		5,727
Accrued license fee expense	66,667		66,667
Total accrued expenses	$	10,894,016	$	3,136,244

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Summary of Components of Loss from Continuing Operations Before Provision for Income Taxes

The components of loss from continuing operations before provision for income taxes consists of the following (in thousands):


	Years Ended December 31,
	2022		2021
Domestic	$	28,391	$	37,083
Foreign	2,557		1,613
Loss before taxes	$	30,948	$	38,696

Difference Between Provision for Income Taxes (Benefit) and the Amount Computed by Applying U.S. Federal Income Tax Rate

The difference between the provision for income taxes (benefit) and the amount computed by applying the U.S. federal income tax rate for the years ended December 31, 2022 and 2021 are as follows:


	Years Ended December 31,
	2022		2021
Federal statutory rate	21.0	%	21.0	%
State income tax, net of federal benefit	(2.96)	%	9.64	%
State tax rate change	(9.08)	%	—	%
Permanent differences	(0.02)	%	0.19	%
Research and development credit	6.84	%	2.70	%
Stock compensation	(0.57)	%	(0.41)	%
Other	(0.74)	%	0.25	%

Change in valuation allowance	(14.48)	%	(33.38)	%
Effective income tax rate	(0.01)	%	(0.01)	%

Summary of Major Components of Company's Deferred Tax Assets

The major components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are shown below (in thousands).


	2022		2021
Net operating loss carryforwards	$	81,761	$	81,817
Research and development credit carryforwards	8,833		7,186
Capitalized research and development costs	10,009		7,417
Other	1,468		801
Stock compensation	2,170		2,540
Total deferred tax assets	104,241		99,761
Valuation allowance	(104,241)		(99,761)
Net deferred tax assets	$	—	$	—

Schedule of Reconciliation of the Beginning and Ending Amount of Uncertain Tax Benefits

A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands):


	Years Ended December 31,
	2022		2021
Beginning uncertain tax benefits	$	1,909	$	1,341
Current year - increases	$	427	$	426
Prior year - additions (reductions)	$	(20)	$	142
Ending uncertain tax benefits	$	2,316	$	1,909

Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2022

Equity [Abstract]

Schedule of Common Stock Outstanding Warrant to Purchase Shares

As of December 31, 2022, the Company had the following warrants outstanding:


Shares Underlying Outstanding Warrants		Exercise Price	Expiration Date
6,500	$	10.00	04/04/2026
1,374,515	$	0.96	02/15/2023
1,381,015

Summary of Common Stock Reserved for Future Issuance

The following table summarizes common stock reserved for future issuance at December 31, 2022:


Common stock reserved for issuance upon exercise of warrants outstanding			1,381,015
Common stock reserved for issuance upon exercise of options outstanding			6,612,554
Common stock reserved for future equity awards			9,576,581
Total			17,570,150

Stock-based Compensation (Tables)

12 Months Ended

Dec. 31, 2022

Share-Based Payment Arrangement [Abstract]

Summary of Stock Option Activity for 2015 Plan and Current Plan and Related Information


	Number of Shares	Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Life (Years)	Aggregate Intrinsic Value
Outstanding at December 31, 2020	2,786,591	$	1.16
Granted	2,052,075	2.31
Exercised	(35,500)	0.92
Canceled/forfeited	(85,564)	1.82
Expired	—	—
Outstanding at December 31, 2021	4,717,602	$	1.65
Granted	2,346,692	1.50
Exercised	(130,322)	0.96
Canceled/forfeited	(321,418)	1.94
Expired	—	—
Outstanding at December 31, 2022	6,612,554	$	1.60	7.82	$	41,679
Options exercisable at December 31, 2022	3,632,467	$	1.50	7.05	$	40,102
Options vested and expected to vest at December 31, 2022	6,612,554	$	1.60	7.82	$	41,679

Schedule of Stock-Based Compensation Expense

Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statements of operations is as follows:


	Years Ended December 31,
	2022		2021
Research and development	$	676,645	$	524,071
General and administrative	1,481,866		1,075,621
Total	$	2,158,511	$	1,599,692

Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees, and Non-Employee Directors


	2022			2021
Expected life in years	6.0			6.0
Risk-free interest rate	2.00		%	0.67		%
Expected volatility	121		%	122		%
Dividend yield	0.0		%	0.0		%
Weighted-average fair value of options granted	$	1.30		$	2.01

Leased Properties (Tables)

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Future Minimum Lease Payment

At December 31, 2022, future minimum lease payments under the Company's operating leases are as follows:


Year ending December 31,
2023	$	422,000
2024	$	93,000
Total future minimum lease payments	515,000
Less: accreted interest	26,000
Total operating lease liabilities	$	489,000

Organization and Description of Business (Details)	1 Months Ended	12 Months Ended
Organization and Description of Business (Details)	Jul. 31, 2022 USD ($)	Dec. 31, 2022 USD ($) segment	Dec. 31, 2021 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of operating segments \| segment		1
Total revenue		$ 10,000,000	$ 0
License
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Total revenue	$ 10,000,000

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
-Paragraph 30
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 280
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI https://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Detail) $ in Millions	1 Months Ended	12 Months Ended
	Jan. 31, 2020 USD ($)	Dec. 31, 2022 USD ($) segment shares	Dec. 31, 2022 AUD ($) segment	Dec. 31, 2021 USD ($) shares	Jan. 01, 2022 shares	Dec. 31, 2020 USD ($) shares	Jul. 31, 2018 shares
Significant Accounting Policies [Line Items]
Accumulated deficit		$ (141,074,640)		$ (110,126,902)
Cash and cash equivalents		34,669,605		51,674,087		$ 4,669,467
Deferred grant funding		18,303,567		10,542,983
Working capital increase		11,400,000
Net loss		30,947,738		38,696,105
Cash flow from operations		$ 18,100,000
Period of insufficient cash and liquidity requirements		12 months	12 months
Grant funding recognized during period		$ 5,600,000		2,500,000
Letter of credit related to lease of real property		35,000
Total revenue		$ 10,000,000		0
Number of operating segments \| segment		1	1
Research and development		$ 30,042,217		30,617,567
Common stock reserved for issuance (in shares) \| shares		17,570,150
Income tax provision		$ 0		0
Unrecognized tax benefits		2,316,000		1,909,000		$ 1,341,000
Accrued indemnification provisions		0		0
Australian Taxation Office
Significant Accounting Policies [Line Items]
Research and development		1,600,000		$ 800,000
Other Current Assets
Significant Accounting Policies [Line Items]
Estimated tax incentive		1,600,000
License And Collaboration Revenues
Significant Accounting Policies [Line Items]
Total revenue		10,000,000
Bayer Healthcare License Agreement
Significant Accounting Policies [Line Items]
Total revenue	$ 20,000,000
Minimum
Significant Accounting Policies [Line Items]
Cash balance of financial institutions insured by federal deposits insurance corporation		$ 250,000
Minimum \| Australian Taxation Office
Significant Accounting Policies [Line Items]
Total revenue			$ 20.0
Stock Options
Significant Accounting Policies [Line Items]
Stock options outstanding (in shares) \| shares							2,000,000
Common stock reserved for issuance (in shares) \| shares					2,201,855
Exercise of Warrants Outstanding
Significant Accounting Policies [Line Items]
Common stock reserved for issuance (in shares) \| shares		1,381,015		1,381,015
Amended And Restated Two Thousand Fourteen Stock Incentive Plan \| Stock Options
Significant Accounting Policies [Line Items]
Stock options outstanding (in shares) \| shares		6,612,554		4,717,602		2,786,591
Common stock reserved for issuance (in shares) \| shares		9,576,581

Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis Level - 2 (Details) - Fair Value, Measurements, Recurring - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Significant Accounting Policies [Line Items]
Cash equivalents	$ 33,238,658	$ 49,666,064
Level 1
Significant Accounting Policies [Line Items]
Cash equivalents	33,238,658	49,666,064
Level 2
Significant Accounting Policies [Line Items]
Cash equivalents	0	0
Level 3
Significant Accounting Policies [Line Items]
Cash equivalents	$ 0	$ 0

Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis Level - 3 (Details) - USD ($) shares in Thousands, $ in Millions	1 Months Ended	12 Months Ended
	Sep. 30, 2021	Dec. 31, 2022	Dec. 31, 2021
Asset Acquisition, Contingent Consideration, Rollforward [Abstract]
Shares issued in satisfaction of milestone payments associated with milestones achieved (in shares)	700
Level 3
Asset Acquisition, Contingent Consideration, Rollforward [Abstract]
Asset acquisition, contingent consideration, beginning balance		$ 0	$ 1
Satisfaction of contingent consideration		0	(1)
Asset acquisition, contingent consideration, ending balance		$ 0	$ 0

Strategic Agreements - Additional Information (Details) - USD ($) shares in Thousands		1 Months Ended									3 Months Ended		6 Months Ended	12 Months Ended
	Jan. 10, 2020	Aug. 31, 2022	Jul. 31, 2022	Sep. 30, 2021	Jan. 31, 2020	Dec. 31, 2019	May 31, 2018	Apr. 30, 2018	Feb. 28, 2018	Mar. 31, 2017	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Nov. 30, 2019
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock														$ 0	$ 250,000
Total revenue														10,000,000	0
Upon Achievement Of Specified Development And Regulatory Milestones \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock														50,000,000
Microchips Biotech, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Registration payment arrangement, maximum potential consideration													$ 1,250,000
Equity issued in consideration of acquisition (in shares)				700
Payments to stockholders' representative in business combination				$ 75,000
Payment of additional consideration in business combination													$ 1,250,000
Contingent consideration															250,000	$ 500,000
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
Asset Acquisition, Contingent Consideration, Current																	$ 55,000,000
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
ADVA Tec Agreement \| Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalty rate										10.00%
ADVA Tec Agreement \| Minimum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Percentage of royalty rate										1.00%
Bayer Healthcare License Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront license fee paid					$ 1,000,000
Milestone payment paid in common stock	$ 310,000,000
Total revenue					$ 20,000,000
License fee, agreement retention, minimum required amount to be received																20,000,000
Hennepin License Agreement \| Clinical And Regulatory Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum potential milestone payments		$ 6,250,000
Hennepin License Agreement \| Sales Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum potential milestone payments		$ 45,000,000
Licensing Agreements \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock															1,000,000
Licensing Agreements \| Upon Achieving Certain Commercial Milestones \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock															750,000	$ 100,000
Licensing Agreements \| Licensed Product or Process for Vaginal or Urological Use \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock											$ 250,000
Licensing Agreements \| Maximum \| Upon Achieving Certain Development Milestones \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock						$ 300,000
Licensing Agreements \| Upon Achievement Of Specified Development And Regulatory Milestones \| Upon Achieving Certain Commercial Milestones \| MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock															$ 1,200,000
Licensing Agreements \| ADVA Tec Agreement \| Upon Reaching Certain Worldwide Net Sales Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments										$ 20,000,000
Assignment Agreement \| Upon Achieving Certain Clinical And Regulatory Development Milestones \| Hammock Pharmaceuticals, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock						$ 1,100,000
Merger Agreement \| Upon Achieving Certain Clinical And Regulatory Development Milestones \| Pear Tree Pharmaceuticals, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum potential milestone payments							$ 15,500,000
Merger Agreement \| Upon Achieving Certain Clinical Development, Regulatory And Commercial Milestones \| Pear Tree Pharmaceuticals, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments							3,200,000
Pear Tree Pharmaceuticals, Inc. \| Sales Milestones
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Maximum potential milestone payments							$ 47,000,000
Juniper Pharmaceuticals, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront license fee paid								$ 250,000
Potential annual license maintenance fee payments, 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
License And Collaboration Agreement \| SST
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock									$ 18,000,000
License And Collaboration Agreement \| Upon Achieving Certain Commercial Milestones \| SST
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payment paid in common stock									$ 100,000,000
Organon
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Upfront license fee paid			$ 10,000,000											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
Catalent and MilanaPharm
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Cost, maintenance												$ 100,000
Milestone payments, contingent amount payable, net				$ 900,000								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

Prepaid Expenses (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid clinical expense	$ 5,928,090	$ 1,728,421
Prepaid insurance expense	502,981	552,354
Prepaid legal and professional expenses	234,917	195,837
Total prepaid expenses	$ 6,665,988	$ 2,476,612

Other Non-Current Assets - Schedule of Other Non-Current Assets (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Other Assets, Noncurrent Disclosure [Abstract]
Prepaid insurance, long-term portion	$ 0	$ 87,891
Other non-current assets	115,092	0
Deferred financing costs	139,203	143,002
Deposits	10,502	37,554
Operating lease assets	457,925	216,673
Total other non-current assets	$ 722,722	$ 485,120

Accrued Expenses - Schedule of Accounts Payable and Accrued Expenses (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Accrued clinical expense	$ 6,665,443	$ 1,242,414
Accrued compensation and benefits	1,720,501	1,533,475
Accrued development expense	2,102,310	158,103
Accrued legal and professional	239,348	129,858
Other accruals	99,747	5,727
Accrued license fee expense	66,667	66,667
Total accrued expenses	$ 10,894,016	$ 3,136,244

Vendor Concentration (Details) - Supplier Concentration Risk - Major Vendor	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Research and development
Concentration Risk [Line Items]
Concentration risk percentage	10.00%	23.00%
Accounts payable and accrued expenses
Concentration Risk [Line Items]
Concentration risk percentage	17.00%	4.00%

Income Taxes - Summary of Components of Loss from Continuing Operations Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Domestic	$ 28,391	$ 37,083
Foreign	2,557	1,613
Loss before taxes	$ 30,948	$ 38,696

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=126941158&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI https://asc.fasb.org/extlink&oid=126953954&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI https://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI https://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 31
-URI https://asc.fasb.org/extlink&oid=126901519&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI https://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

Income Taxes - Reconciliation of Provision for Income Taxes (Benefit) and Amount Computed by Applying U.S. Federal Income Tax Rate (Detail)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Federal statutory rate	21.00%	21.00%
State income tax, net of federal benefit	(2.96%)	9.64%
State tax rate change	(9.08%)	0.00%
Permanent differences	(0.02%)	0.19%
Research and development credit	6.84%	2.70%
Stock compensation	(0.57%)	(0.41%)
Other	(0.74%)	0.25%
Change in valuation allowance	(14.48%)	(33.38%)
Effective income tax rate	(0.01%)	(0.01%)

Income Taxes - Summary of Major Components of Company's Deferred Tax Assets (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Net operating loss carryforwards	$ 81,761	$ 81,817
Research and development credit carryforwards	8,833	7,186
Capitalized research and development costs	10,009	7,417
Other	1,468	801
Stock compensation	2,170	2,540
Total deferred tax assets	104,241	99,761
Valuation allowance	(104,241)	(99,761)
Net deferred tax assets	$ 0	$ 0

Income Taxes - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Operating Loss Carryforwards [Line Items]
Deferred tax valuation allowance	$ 104,241,000	$ 99,761,000
Deferred tax assets, increase in valuation allowance	4,500,000	14,500,000
Operating loss carryforward, subject to expiration	900,000
Operating loss carryforwards not subject to expiration	117,800,000
Unrecognized tax benefits	2,316,000	1,909,000	$ 1,341,000
Accrued interest or penalties recorded related to uncertain tax positions	0	$ 0
Unremitted earnings	0
Federal
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	$ 295,300,000
Net operating loss carryforwards expiration year	2023
Federal \| Research Credit Carryforwards
Operating Loss Carryforwards [Line Items]
Research credit carryforwards	$ 8,700,000
Research credit carryforwards expiration year	2027
State
Operating Loss Carryforwards [Line Items]
Net operating loss carryforwards	$ 283,400,000
Net operating loss carryforwards expiration year	2031
State \| Research Credit Carryforwards
Operating Loss Carryforwards [Line Items]
Research credit carryforwards	$ 2,800,000
Research credit carryforward, subject To expiration	$ 100,000
Research credit carryforwards expiration year	2023

Income Taxes - Summary of Reconciliation of Beginning and Ending Amount of Uncertain Tax Benefits (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward]
Beginning uncertain tax benefits	$ 1,909	$ 1,341
Current year - increases	427	426
Prior year - (reductions)	(20)
Prior year - additions		142
Ending uncertain tax benefits	$ 2,316	$ 1,909

Stockholders' Equity - Additional Information (Detail) - USD ($)	1 Months Ended					12 Months Ended
	Oct. 31, 2021	Apr. 30, 2021	Jul. 31, 2020	Apr. 30, 2019	Jan. 31, 2018	Dec. 31, 2022	Dec. 31, 2021	Jul. 31, 2022	Oct. 13, 2021	Apr. 30, 2020	Feb. 28, 2018	Feb. 15, 2018
Class of Stock [Line Items]
Common stock, shares authorized (in shares)						240,000,000	120,000,000
Aggregate commission rate	3.00%	3.00%
Common stock, value, issued						$ 8,482	$ 8,394		$ 50,000,000
Issuance of common stock, net of issuance costs (in shares)						751,000	7,100,000
Net proceeds from issuance of common stock						$ 1,300,000	$ 16,300,000
Offering expenses						42,000	537,000
Recognized offering expenses							$ 175,000
Deferred financing costs						$ 0
Exercise price (in usd per share)											$ 3.00
Warrant, exercise price, decrease			$ 0.96	$ 0.98
Deemed dividend from trigger of down round provision feature			$ 6,863	$ 800,000
Warrants exercised (in shares)						0	520,985
Proceeds from warrant exercises							$ 500,000
Common stock, par value (in usd per share)						$ 0.0001	$ 0.0001
Preferred stock, shares authorized (in shares)						5,000,000	5,000,000
Preferred stock, par value (in usd per share)						$ 0.01	$ 0.01
Common stock, shares issued (in shares)						84,825,481	83,944,119
Common stock, shares outstanding (in shares)						84,825,481	83,944,119
Preferred stock, shares outstanding (in shares)						0	0
Accounting Standards Update 2017-11
Class of Stock [Line Items]
Estimated fair value of warrants												$ 3,000,000
Lincoln Park
Class of Stock [Line Items]
Purchase obligation										$ 15,000,000
Maximum
Class of Stock [Line Items]
Common stock, shares authorized (in shares)								240,000,000
April 2021 ATM Sales Agreement
Class of Stock [Line Items]
Common stock, value, issued		$ 50,000,000
Issuance of common stock, net of issuance costs (in shares)						0	26,000,000
Net proceeds from issuance of common stock							$ 46,900,000
Offering expenses							$ 1,600,000
2018 ATM Sales Agreement
Class of Stock [Line Items]
Issuance of common stock, net of issuance costs (in shares)							3,300,000
Net proceeds from issuance of common stock							$ 7,700,000
Offering expenses							245,000
2018 ATM Sales Agreement \| Maximum
Class of Stock [Line Items]
Aggregate commission rate					3.00%
Purchase Agreement
Class of Stock [Line Items]
Net proceeds from issuance of common stock							$ 7,000,000
Purchase agreement		$ 374,000
Purchase Agreement \| Lincoln Park
Class of Stock [Line Items]
Regular Repurchase (in shares)							4,800,000

Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares	12 Months Ended
	Dec. 31, 2022	Feb. 28, 2018
Class of Stock [Line Items]
Shares underlying outstanding warrants (in shares)	1,381,015
Exercise price (in usd per share)		$ 3.00
Warrants Expiring on April 4, 2026
Class of Stock [Line Items]
Shares underlying outstanding warrants (in shares)	6,500
Exercise price (in usd per share)	$ 10.00
Expiration Date	Apr. 04, 2026
Warrants Expiring On February 15, 2023
Class of Stock [Line Items]
Shares underlying outstanding warrants (in shares)	1,374,515
Exercise price (in usd per share)	$ 0.96
Expiration Date	Feb. 15, 2023

Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares	Dec. 31, 2022	Jan. 01, 2022	Dec. 31, 2021
Class of Stock [Line Items]
Common stock reserved for issuance (in shares)	17,570,150
Exercise of Warrants Outstanding
Class of Stock [Line Items]
Common stock reserved for issuance (in shares)	1,381,015		1,381,015
Exercise of Options Outstanding
Class of Stock [Line Items]
Common stock reserved for issuance (in shares)	6,612,554
Stock Options
Class of Stock [Line Items]
Common stock reserved for issuance (in shares)		2,201,855
Amended And Restated Two Thousand Fourteen Stock Incentive Plan \| Stock Options
Class of Stock [Line Items]
Common stock reserved for issuance (in shares)	9,576,581

Stock-based compensation - Additional Information (Detail) - USD ($)		1 Months Ended	12 Months Ended
	Jan. 01, 2022	Jul. 31, 2018	Dec. 31, 2022	Dec. 31, 2021	Jun. 23, 2022	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense			$ 2,158,511	$ 1,599,692
Common stock reserved for future issuance (in shares)			17,570,150
Unamortized stock-based compensation expense			$ 4,100,000
Amortized weighted average period			2 years 4 months 24 days
Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
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%
Number of authorized shares, period increase	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 \| Stock Options
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options outstanding (in shares)			6,612,554	4,717,602		2,786,591
Common stock reserved for future issuance (in shares)			9,576,581
Amended And Restated Two Thousand Fourteen Stock Incentive Plan \| Two Thousand Twenty Two Stock Incentive Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options to purchase number of outstanding shares of common stock (in shares)					10,117,305
Common stock reserved for future issuance (in shares)					6,144,682

Stock-based Compensation - Summary of Stock Option Activity (Detail) - Amended And Restated Two Thousand Fourteen Stock Incentive Plan - Stock Options - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Number of Shares
Outstanding beginning balance (in shares)	4,717,602	2,786,591
Granted (in shares)	2,346,692	2,052,075
Exercised (in shares)	(130,322)	(35,500)
Forfeited (in shares)	(321,418)	(85,564)
Expired (in shares)	0	0
Outstanding ending balance (in shares)	6,612,554	4,717,602
Options exercisable, ending (in shares)	3,632,467
Options vested and expected to vest, ending (in shares)	6,612,554
Weighted- Average Exercise Price
Outstanding beginning balance (in usd per share)	$ 1.65	$ 1.16
Granted (in usd per share)	1.50	2.31
Exercised (in usd per share)	0.96	0.92
Expired (in usd per share)	0	0
Forfeited (in usd per share)	1.94	1.82
Outstanding ending balance (in usd per share)	1.60	$ 1.65
Options exercisable, ending (in usd per share)	1.50
Options vested and expected to vest, ending (in usd per share)	$ 1.60
Weighted- Average Remaining Contractual Life (Years)
Outstanding, ending	7 years 9 months 25 days
Options exercisable, ending	7 years 18 days
Options vested and expected to vest, ending	7 years 9 months 25 days
Aggregate Intrinsic Value
Outstanding, ending	$ 41,679
Options exercisable, ending	40,102
Options vested and expected to vest, ending	$ 41,679

Stock-based Compensation - Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 2,158,511	$ 1,599,692
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	676,645	524,071
General and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,481,866	$ 1,075,621

Stock-based Compensation - Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Non-Employee Directors (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Expected life in years	6 years	6 years
Risk-free interest rate	2.00%	0.67%
Expected volatility	121.00%	122.00%
Dividend yield	0.00%	0.00%
Weighted-average fair value of options granted (in usd per share)	$ 1.30	$ 2.01

Leased Properties - Additional Information (Details)	1 Months Ended	3 Months Ended	12 Months Ended
Leased Properties - Additional Information (Details)	Feb. 28, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2021 USD ($)	Jul. 01, 2018 ft²
Lessee, Lease, Description [Line Items]
Square feet of office space \| ft²					3,169
Renewal term of operating lease	2 years
Increase (decrease) in operating lease liability		$ (504,000)
Decrease in operating lease right-of-use asset			$ 458,000
Gain (Loss) on Termination of Lease			$ 46,477	$ 0
Operating lease, right-of-use asset, statement of financial position [Extensible List]		Other non-current assets	Other non-current assets
Right-of-use asset		$ 458,000	$ 458,000
Current portion of lease liabilities		398,391	398,391	270,546
Lease liabilities long-term		$ 90,346	90,346	0
Operating lease cost			602,000	561,000
Operating lease, payments			$ 346,000	$ 462,000
Operating lease weighted average remaining lease term		1 year 3 months 29 days	1 year 3 months 29 days
Maximum
Lessee, Lease, Description [Line Items]
Operating lease, incremental borrowing rate, prime rate		0.0200	0.0200
MBI
Lessee, Lease, Description [Line Items]
Renewal term of operating lease	3 years
Increase (decrease) in operating lease liability	$ 1,000,000

Leased Properties - Future Minimum Lease Payment (Details)	Dec. 31, 2022 USD ($)
Leases [Abstract]
2023	$ 422,000
2024	93,000
Total future minimum lease payments	515,000
Less: accreted interest	26,000
Total operating lease liabilities	$ 489,000

Commitments and Contingencies - Additional Information (Detail) - USD ($)	1 Months Ended	12 Months Ended
	Apr. 30, 2020	Dec. 31, 2022	Dec. 31, 2021	Jul. 31, 2021	Jan. 31, 2021
Commitments And Contingencies [Line Items]
Loan under Paycheck Protection Program	$ 367,285
Notes payable including accrued interest					$ 369,887
Defined contribution plan, employer matching contribution, percent of match		4.00%
Defined contribution plan, employer matching contributions		$ 200,000	$ 160,000
NICHD
Commitments And Contingencies [Line Items]
Research and development agreement, commitment, amount				$ 5,500,000
Research and Development Arrangement, Contract to Perform for Others, Costs Incurred, Gross		3,500,000	$ 1,500,000
CRADA
Commitments And Contingencies [Line Items]
Revenue, Remaining Performance Obligation, Amount		$ 500,000
Minimum
Commitments And Contingencies [Line Items]
Change in control of company, termination without cause or resignation for good reason, period		3 months
Payment to be received upon termination without cause		9 months
Health coverage to be received upon termination without cause		9 months
Change in control of company, termination for cause or for good reason		3 months
Payment to be received upon termination for cause or for good reason		12 months
Health coverage to be received upon termination for cause or for good reason		12 months
Maximum
Commitments And Contingencies [Line Items]
Change in control of company, termination without cause or resignation for good reason, period		12 months
Payment to be received upon termination without cause		12 months
Health coverage to be received upon termination without cause		12 months
Change in control of company, termination for cause or for good reason		12 months
Payment to be received upon termination for cause or for good reason		18 months
Health coverage to be received upon termination for cause or for good reason		18 months

Grant Awards - Additional Information (Details) - USD ($)	1 Months Ended						12 Months Ended		60 Months Ended
	Dec. 31, 2022	Jul. 31, 2022	May 31, 2022	Sep. 30, 2021	Jul. 31, 2021	Aug. 31, 2020	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2022	Nov. 30, 2022	Jun. 30, 2021
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant									$ 1,900,000
Total revenue							$ 10,000,000	$ 0
Deferred grant funding	$ 18,303,567						18,303,567	10,542,983	18,303,567
Grant, DARE-FRT1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant						$ 300,000
Additional potential grant funding						$ 2,000,000
Grant, DARE-FRT1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Credits recorded to research and development expense for costs related to award							20,000	65,000
DARE-LARC1
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant	4,400,000	$ 8,000,000		$ 300,000	$ 11,500,000		23,900,000
Credits recorded to research and development expense for costs related to award							239,000	7,400
Receivable for expenses eligible for reimbursement	33,000						33,000	7,400	33,000
Business development							5,400,000
Initial payment											$ 49,000,000
Deferred grant funding	17,700,000						17,700,000		17,700,000
Grant, ADARE-204 and ADARE-214
Accounts, Notes, Loans and Financing Receivable [Line Items]
Amount awarded for grant			$ 249,000
Credits recorded to research and development expense for costs related to award							116,000
Receivable for expenses eligible for reimbursement	24,000						24,000		24,000
Grant Awards \| Bill And Melinda Gates Foundation
Accounts, Notes, Loans and Financing Receivable [Line Items]
Total revenue								$ 5,400,000
DARE-LBT
Accounts, Notes, Loans and Financing Receivable [Line Items]
Initial payment										$ 585,000
Deferred grant funding	$ 573,000						$ 573,000		$ 573,000

Subsequent Events - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	2 Months Ended	12 Months Ended
	Feb. 28, 2023	Dec. 31, 2021	Feb. 28, 2018
Subsequent Event [Line Items]
Exercise price (in usd per share)			$ 3.00
Proceeds from warrant exercises		$ 0.5
Subsequent Event
Subsequent Event [Line Items]
Warrants exercised (in shares)	1,353,515
Exercise price (in usd per share)	$ 0.96
Proceeds from warrant exercises	$ 1.3