Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 | |
City Area Code | 858 | |
Local Phone Number | 926-7655 | |
Entity Address, Postal Zip Code | 92122 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | DARE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 86,284,827 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001401914 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 19,829,404 | $ 34,669,605 |
Other receivables | 2,398,708 | 1,703,160 |
Prepaid expenses | 7,082,452 | 6,665,988 |
Other current assets | 201,385 | 0 |
Total current assets | 29,511,949 | 43,038,753 |
Property and equipment, net | 55,400 | 64,908 |
Other non-current assets | 799,327 | 722,722 |
Total assets | 30,366,676 | 43,826,383 |
Current liabilities | ||
Accounts payable | 2,695,612 | 2,027,953 |
Accrued expenses | 5,480,203 | 10,894,016 |
Deferred grant funding | 15,826,369 | 18,303,567 |
Current portion of lease liabilities | 335,764 | 398,391 |
Total current liabilities | 24,337,948 | 31,623,927 |
Deferred license revenue | 1,000,000 | 1,000,000 |
Lease liabilities long-term | 57,128 | 90,346 |
Total liabilities | 25,395,076 | 32,714,273 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value; 240,000,000 shares authorized; 86,178,996 and 84,825,481 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 8,618 | 8,482 |
Accumulated other comprehensive loss | (373,316) | (351,311) |
Additional paid-in capital | 154,453,439 | 152,529,579 |
Accumulated deficit | (149,117,141) | (141,074,640) |
Total stockholders' equity | 4,971,600 | 11,112,110 |
Total liabilities and stockholders' equity | $ 30,366,676 | $ 43,826,383 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 240,000,000 |
Common stock, shares issued (in shares) | 86,178,996 | 84,825,481 |
Common stock, shares outstanding (in shares) | 86,178,996 | 84,825,481 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses | ||
General and administrative | $ 3,337,426 | $ 2,569,987 |
Research and development | 5,020,223 | 5,805,462 |
License fee expense | 25,000 | 25,000 |
Total operating expenses | 8,382,649 | 8,400,449 |
Loss from operations | (8,382,649) | (8,400,449) |
Other income | 340,148 | 1,779 |
Net loss | (8,042,501) | (8,398,670) |
Net loss to common shareholders | (8,042,501) | (8,398,670) |
Foreign currency translation adjustments | (22,005) | (9,150) |
Comprehensive loss | $ (8,064,506) | $ (8,407,820) |
Loss per common share - basic (in usd per share) | $ (0.09) | $ (0.10) |
Loss per common share - diluted (in usd per share) | $ (0.09) | $ (0.10) |
Weighted average number of shares outstanding: | ||
Basic (in shares) | 85,517,540 | 83,944,119 |
Diluted (in shares) | 85,517,540 | 83,944,119 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 83,944,119 | ||||
Beginning balance at Dec. 31, 2021 | $ 38,754,321 | $ 8,394 | $ 149,027,802 | $ (154,973) | $ (110,126,902) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 532,409 | 532,409 | |||
Net loss | (8,398,670) | (8,398,670) | |||
Foreign currency translation adjustments | (9,150) | (9,150) | |||
Ending balance (in shares) at Mar. 31, 2022 | 83,944,119 | ||||
Ending balance at Mar. 31, 2022 | 30,878,910 | $ 8,394 | 149,560,211 | (164,123) | (118,525,572) |
Beginning balance (in shares) at Dec. 31, 2022 | 84,825,481 | ||||
Beginning balance at Dec. 31, 2022 | 11,112,110 | $ 8,482 | 152,529,579 | (351,311) | (141,074,640) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 624,621 | 624,621 | |||
Issuance of common stock from the exercise of warrants (in shares) | 1,353,515 | ||||
Issuance of common stock from the exercise of warrants | 1,299,375 | $ 136 | 1,299,239 | ||
Net loss | (8,042,501) | (8,042,501) | |||
Foreign currency translation adjustments | (22,005) | (22,005) | |||
Ending balance (in shares) at Mar. 31, 2023 | 86,178,996 | ||||
Ending balance at Mar. 31, 2023 | $ 4,971,600 | $ 8,618 | $ 154,453,439 | $ (373,316) | $ (149,117,141) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (8,042,501) | $ (8,398,670) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 9,508 | 5,227 |
Stock-based compensation | 624,621 | 532,409 |
Non-cash operating lease cost | (5,906) | (9,758) |
Changes in operating assets and liabilities: | ||
Other receivables | (695,548) | (584,534) |
Prepaid expenses | (416,464) | (4,293,814) |
Other current assets | (201,385) | 0 |
Other non-current assets | (166,545) | 87,891 |
Accounts payable | 667,661 | 727,783 |
Accrued expenses | (5,413,814) | 401,613 |
Deferred grant funding | (2,477,198) | (811,620) |
Net cash used in operating activities | (16,117,571) | (12,343,473) |
Cash flows from investing activities | ||
Purchases of property and equipment | 0 | (4,553) |
Net cash used in investing activities | 0 | (4,553) |
Cash flows from financing activities | ||
Proceeds from the exercise of common stock warrants | 1,299,375 | 0 |
Net cash provided by financing activities | 1,299,375 | 0 |
Effect of exchange rate changes on cash and cash equivalents | (22,005) | (9,150) |
Net change in cash and cash equivalents | (14,840,201) | (12,357,176) |
Cash and cash equivalents, beginning of period | 34,669,605 | 51,674,087 |
Cash and cash equivalents, end of period | 19,829,404 | 39,316,911 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities, net | $ 0 | $ 1,043,590 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | ORGANIZATION AND DESCRIPTION OF BUSINESS Daré Bioscience, Inc. is a biopharmaceutical company committed to advancing innovative products for women’s health. Daré Bioscience, Inc. and its wholly owned subsidiaries operate one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires. The Company began assembling its diverse portfolio in 2017 through acquisitions, exclusive in-licenses and other collaborations. The Company's programs target unmet needs in women's health in the areas of contraception, 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 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 in June 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 Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, or the 2022 10-K. 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. Going Concern The Company prepared its condensed consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and to potentially acquire, license and develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of March 31, 2023, the Company had an accumulated deficit of approximately $149.1 million, cash and cash equivalents of approximately $19.8 million, a deferred grant funding liability of $15.8 million and working capital of approximately $5.2 million. The amount of the deferred grant funding liability is included in the Company's cash and cash equivalents, and represents grant funds received that may be applied solely toward direct costs for the development of DARE-LARC1 and DARE-LBT, other than approximately 10% of such funds, which may be applied toward general overhead and administration expenses that support the entire operations of the Company. For the three months ended March 31, 2023, the Company incurred a net loss of approximately $8.0 million and had negative cash flow from operations of approximately $16.1 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 condensed consolidated 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 condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 2 to the consolidated financial statements included in the 2022 10-K. Since the date on which the 2022 10-K was filed with the U.S. Securities and Exchange Commission, or the SEC, there have been no material changes to the Company’s significant accounting policies. Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of March 31, 2023 and December 31, 2022. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of March 31, 2023 or December 31, 2022. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2023 Current assets: Cash equivalents (1) $ 18,380,017 $ — $ — $ 18,380,017 Balance at December 31, 2022 Current assets: Cash equivalents (1) $ 33,238,658 $ — $ — $ 33,238,658 (1) Represents cash held in money market funds. 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. As of March 31, 2023, 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). As of March 31, 2023, 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. As of March 31, 2023, 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. As of March 31, 2023, 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 March 31, 2023, 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 March 31, 2023 and December 31, 2022. 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.) |
Strategic Agreements
Strategic Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Strategic Agreements | STRATEGIC AGREEMENTSStrategic Agreements 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 was recorded as license fee revenue. 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 quarter ended March 31, 2023, 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 $20.0 million fee. After payment of the $20.0 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 March 31, 2023, 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 March 31, 2023 and December 31, 2022. 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. As of March 31, 2023, no payments have been 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, $850,000 of which has been paid as of March 31, 2023. 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 has been paid as of March 31, 2023; 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. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
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 240,000,000. March 2023 ATM Sales Agreement In March 2023, the Company entered into a sales agreement with Stifel, Nicolaus & Company, Incorporated, or Stifel, and Cantor Fitzgerald & Co., or Cantor, to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program under which Stifel and Cantor act 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 or such lower amount as the Company and Stifel and Cantor agree, 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), the base prospectus included therein, originally filed with the SEC on March 30, 2021 and declared effective by the SEC on April 7, 2021, the prospectus supplement dated March 31, 2023 relating to the offering of up to $50.0 million of shares of the Company's common stock under the sales agreement, and any subsequent prospectus supplement related to the offering of shares of the Company's common stock under the sales agreement. During the three months ended March 31, 2023, the Company sold no shares of common stock under this agreement. 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 ATM equity offering program under which SVB Securities acted as the Company's agent. The Company sold no shares of its common stock under the agreement during either of the three months ended March 31, 2023 or 2022. The Company terminated the agreement in March 2023. April 2021 ATM Sales Agreement In April 2021, the Company entered into a sales agreement with SVB Securities LLC to sell shares of its common stock from time to time through an ATM equity offering program under which SVB Securities acted as the Company's agent. The Company sold no shares of its common stock under the agreement during either of the three months ended March 31, 2023 or 2022. The Company terminated the agreement in March 2023. Common Stock Warrants In connection with an underwritten public offering in February 2018, the Company issued to the investors in that offering, warrants exercisable through February 2023 with an initial exercise price of $3.00 per share. 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 warrants included a price-based anti-dilution provision, which provided that, subject to certain limited exceptions, the exercise price of the warrants would be reduced each time the Company issued or sold (or was deemed to have issued or sold) 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 issued, sold or entered into any agreement to issue or sell securities at a price which varied or may vary with the market price of the shares of the Company’s common stock, the warrant holders had the right to substitute such variable price for the exercise price of the warrant then in effect. 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. During the three months ended March 31, 2023, warrants to purchase 1,353,515 shares of common stock were exercised for gross proceeds of approximately $1.3 million and the remaining unexercised warrants expired on February 15, 2023. No warrants were exercised during the three months ended March 31, 2022. As of March 31, 2023, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 6,500 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION 2014 Employee Stock Purchase Plan The Company’s 2014 Employee Stock Purchase Plan, or the ESPP, became effective in April 2014, but no offering period has been initiated thereunder since January 2017. There was no stock-based compensation related to the ESPP for the three months ended March 31, 2023 or March 31, 2022. Amended and Restated 2014 Stock Incentive Plan The Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan, provided for the grant of options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards to employees, officers and directors, and consultants and advisors. There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018. The number of authorized shares increased annually on the first day of each fiscal year 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. As a result of the approval of the 2022 Plan (as defined below) by the Company's stockholders on June 23, 2022, no further awards have been or will be granted under the Amended 2014 Plan. Outstanding awards previously granted under the Amended 2014 Plan continue to remain outstanding in accordance with their terms. 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 three months ended March 31, 2023. The exercise price of all options granted during the three months ended March 31, 2023 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2023, unamortized stock-based compensation expense of approximately $5.9 million will be amortized over a weighted average period of 2.71 years. At March 31, 2023, 7,078,916 shares of common stock were available for future awards granted under the 2022 Plan. Number of Shares Weighted Average Outstanding at December 31, 2022 6,612,554 $ 1.60 Granted 2,497,665 1.16 Exercised — Cancelled/forfeited — Expired — Outstanding at March 31, 2023 9,110,219 $ 1.48 Exercisable at March 31, 2023 4,009,997 $ 1.51 Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2023 2022 Research and development $ 200,301 $ 174,613 General and administrative $ 424,320 $ 357,796 Total $ 624,621 $ 532,409 |
Leased Properties
Leased Properties | 3 Months Ended |
Mar. 31, 2023 | |
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 was 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 March 31, 2023, the Company reported operating lease right of use assets Total operating lease costs were approximately $139,000 and $169,000 for the three months ended March 31, 2023 and March 31, 2022, respectively. Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the condensed consolidated statements of operations. Cash paid for amounts included in the measurement of operating lease liabilities was approximately $105,000 and $123,000 for the three months ended March 31, 2023 and March 31, 2022, respectively. These amounts are included in operating activities in the condensed consolidated statements of cash flows. At March 31, 2023, operating leases had a weighted average remaining lease term of 1.08 years. As of March 31, 2023, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2023 $ 317,000 2024 93,000 Total future minimum lease payments 410,000 Less: accreted interest 17,000 Total operating lease liabilities $ 393,000 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIESCRADA with NICHD for the Pivotal Phase 3 Study of OvapreneIn 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 is responsible for the other costs related to the conduct of the Ovaprene Phase 3. In accordance with the payment schedule under the CRADA, the Company has made aggregate payments of $5.0 million to NICHD, $3.5 million of which was paid in 2022. The Company's remaining obligation under the CRADA at March 31, 2023 was $0.5 million. |
Grant Awards
Grant Awards | 3 Months Ended |
Mar. 31, 2023 | |
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 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. 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 for costs related to the NICHD award of $0 and approximately $17,000 during the three months ended March 31, 2023 and 2022, respectively. At March 31, 2023 and December 31, 2022, the Company did not record any receivable for expenses incurred through such date that it believes are eligible for reimbursement under the grant. DARE-LARC1 In September 2021, the Company received a notice of award of a grant from NICHD to support the development of DARE-LARC1. The award in the amount of approximately $300,000 is to be used to explore device insertion and removal in nonclinical studies, which is ongoing. The Company recorded credits to research and development expense of approximately $32,000 and $165,000 for costs related to the NICHD award during the three months ended March 31, 2023 and 2022, respectively. The Company recorded a receivable of approximately $65,000 and $33,000 at March 31, 2023 and December 31, 2022, respectively, for expenses incurred through such date that it believes are eligible for reimbursement under the grant. 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 $49,000 for costs related to the NICHD award during the three months ended March 31, 2023. The Company recorded a receivable of approximately $73,000 and $24,000 at March 31, 2023 and December 31, 2022, respectively, for expenses incurred through such date that it believes is eligible for reimbursement under the grant. Other Non-Dilutive Grant Funding 2022 DARE-LBT Grant Agreement In November 2022, the Company entered into an agreement with the Bill & Melinda Gates Foundation, or the Foundation, under which the Company was awarded $585,000 to support the development of DARE-LBT. The Company is required to apply the funds it receives under the agreement solely toward direct costs for the development of DARE-LBT1, other than approximately 10% of such funds, which it may apply toward general overhead and administration expenses that support the entire operations of the Company. 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 condensed consolidated balance sheets. The Company received the full amount of the award in November 2022. As of March 31, 2023, the Company has recorded a deferred grant funding liability of approximately $552,000 in the Company's condensed consolidated balance sheets. 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 Company is required to apply the funds it receives under the agreement solely toward direct costs for the development of DARE-LARC1, other than approximately 10% of such funds, which it may apply toward general overhead and administration expenses that support the entire operations of the Company. 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. 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 condensed consolidated balance sheets. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The Company computes basic net loss per share, or EPS, using the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted EPS is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Dilutive securities include the dilutive effect of in-the-money options and warrants, which is calculated based on the average share price for each period using the treasury stock method. Under the treasury stock method, the exercise price of an option or warrant, the amount of compensation cost, if any, for future service that the Company has not yet recognized, and the amount of estimated tax benefits that would be recorded in paid-in capital, if any, when the option or warrant is exercised are assumed to be used to repurchase shares in the current period . Dilutive securities are excluded from the diluted EPS calculation if their effect is anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted EPS for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2023 2022 Stock options 9,110,219 6,277,282 Warrants 6,500 1,381,015 Total 9,116,719 7,658,297 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS ATM Sales During April and May 2023, the Company sold an aggregate of 106,000 shares of common stock under its ATM equity offering program and received aggregate gross proceeds of approximately $109,000 and incurred sales agent commissions and fees of approximately $2,700 (see Note 4). |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, or the 2022 10-K. |
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. |
Going Concern | Going Concern The Company prepared its condensed consolidated financial statements on a going concern basis, which assumes that the Company will realize its assets and satisfy its liabilities in the normal course of business. The Company has a history of losses from operations, expects negative cash flows from its operations to continue for the foreseeable future, and expects that its net losses will continue for at least the next several years as it develops and seeks to bring to market its existing product candidates and to potentially acquire, license and develop additional product candidates. These circumstances raise substantial doubt about the Company's ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern. As of March 31, 2023, the Company had an accumulated deficit of approximately $149.1 million, cash and cash equivalents of approximately $19.8 million, a deferred grant funding liability of $15.8 million and working capital of approximately $5.2 million. The amount of the deferred grant funding liability is included in the Company's cash and cash equivalents, and represents grant funds received that may be applied solely toward direct costs for the development of DARE-LARC1 and DARE-LBT, other than approximately 10% of such funds, which may be applied toward general overhead and administration expenses that support the entire operations of the Company. For the three months ended March 31, 2023, the Company incurred a net loss of approximately $8.0 million and had negative cash flow from operations of approximately $16.1 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 condensed consolidated 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 condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock. The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s significant accounting policies are described in Note 2 to the consolidated financial statements included in the 2022 10-K. Since the date on which the 2022 10-K was filed with the U.S. Securities and Exchange Commission, or the SEC, there have been no material changes to the Company’s significant accounting policies. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Revenue Recognition | Revenue Recognition 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. As of March 31, 2023, 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). As of March 31, 2023, 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. As of March 31, 2023, 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. As of March 31, 2023, the Company has not recognized any milestone revenue. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Financial Assets and Liabilities Remeasured on a Recurring Basis | The following tables present the classification within the fair value hierarchy of financial assets and liabilities that are remeasured on a recurring basis as of March 31, 2023 and December 31, 2022. There were no financial assets or liabilities that were remeasured using a quoted price in active markets for identical assets (Level 2) or using unobservable inputs (Level 3) as of March 31, 2023 or December 31, 2022. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at March 31, 2023 Current assets: Cash equivalents (1) $ 18,380,017 $ — $ — $ 18,380,017 Balance at December 31, 2022 Current assets: Cash equivalents (1) $ 33,238,658 $ — $ — $ 33,238,658 (1) Represents cash held in money market funds. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Schedule of Common Stock Warrants Outstanding | As of March 31, 2023, the Company had the following warrants outstanding: Shares Underlying Exercise Price Expiration Date 6,500 $ 10.00 04/04/2026 6,500 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity for Amended 2014 Plan and Related Information | The table below summarizes stock option activity under the Company's stock incentive plans and related information for the three months ended March 31, 2023. The exercise price of all options granted during the three months ended March 31, 2023 was equal to the market value of the Company’s common stock on the date of grant. As of March 31, 2023, unamortized stock-based compensation expense of approximately $5.9 million will be amortized over a weighted average period of 2.71 years. At March 31, 2023, 7,078,916 shares of common stock were available for future awards granted under the 2022 Plan. Number of Shares Weighted Average Outstanding at December 31, 2022 6,612,554 $ 1.60 Granted 2,497,665 1.16 Exercised — Cancelled/forfeited — Expired — Outstanding at March 31, 2023 9,110,219 $ 1.48 Exercisable at March 31, 2023 4,009,997 $ 1.51 |
Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors | Total stock-based compensation expense related to stock options granted to employees and directors recognized in the condensed consolidated statements of operations is as follows: Three Months Ended 2023 2022 Research and development $ 200,301 $ 174,613 General and administrative $ 424,320 $ 357,796 Total $ 624,621 $ 532,409 |
Leased Properties (Tables)
Leased Properties (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Schedule of Future Minimum Lease Payments | As of March 31, 2023, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2023 $ 317,000 2024 93,000 Total future minimum lease payments 410,000 Less: accreted interest 17,000 Total operating lease liabilities $ 393,000 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share | The following potentially dilutive outstanding securities were excluded from diluted EPS for the period indicated because of their anti-dilutive effect: Potentially dilutive securities Three Months Ended 2023 2022 Stock options 9,110,219 6,277,282 Warrants 6,500 1,381,015 Total 9,116,719 7,658,297 |
Organization and Description _2
Organization and Description of Business (Details) $ in Millions | 1 Months Ended | 3 Months Ended |
Jul. 31, 2022 USD ($) | Mar. 31, 2023 segment | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Number of operating segments | segment | 1 | |
License fee revenue | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
License and collaboration revenue | $ | $ 10 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jul. 31, 2022 | Jan. 31, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Significant Accounting Policies [Line Items] | |||||||
Letter of credit related to lease of real property | $ 35,000 | $ 35,000 | |||||
Accumulated deficit | (149,117,141) | (149,117,141) | $ (141,074,640) | ||||
Cash and cash equivalents | 19,829,404 | $ 39,316,911 | 19,829,404 | 34,669,605 | $ 51,674,087 | ||
Deferred grant funding | 15,826,369 | 15,826,369 | $ 18,303,567 | ||||
Working capital | 5,200,000 | 5,200,000 | |||||
Net loss | 8,042,501 | $ 8,398,670 | |||||
Cash flow from operations | $ 16,100,000 | ||||||
Period of insufficient cash and liquidity requirements | 12 months | ||||||
Bayer Healthcare License Agreement | |||||||
Significant Accounting Policies [Line Items] | |||||||
Upfront license fee paid | $ 1,000,000 | ||||||
License and collaboration revenue | 20,000,000 | ||||||
Milestone payment paid in common stock | $ 310,000,000 | ||||||
Organon | |||||||
Significant Accounting Policies [Line Items] | |||||||
Upfront license fee paid | $ 10,000,000 | $ 10,000,000 | |||||
Milestone payment paid in common stock | $ 182,500,000 |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Financial Assets and Liabilities Remeasured on a Recurring Basis (Details) - Fair Value, Measurements, Recurring - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 18,380,017 | $ 33,238,658 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 18,380,017 | 33,238,658 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 0 | $ 0 |
Strategic Agreements (Details)
Strategic Agreements (Details) - USD ($) shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||||||
Aug. 31, 2022 | Jul. 31, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Jan. 31, 2020 | Nov. 30, 2019 | May 31, 2018 | Apr. 30, 2018 | Feb. 28, 2018 | Mar. 31, 2017 | Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2023 | Dec. 31, 2021 | Dec. 31, 2020 | |
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 | |||||||||||||||
Microchips Biotech, Inc. | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Payment of additional consideration | $ 1,250 | |||||||||||||||
Common stock issued to microchips capital stock holders (in shares) | 700 | |||||||||||||||
Cash paid to stockholders' representative | $ 75 | |||||||||||||||
Asset acquisition, contingent consideration | $ 250 | $ 500 | ||||||||||||||
Microchips Biotech, Inc. | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payments | $ 46,500 | |||||||||||||||
Current portion of contingent consideration | $ 55,000 | |||||||||||||||
ADVA Tec Agreement | Upon Achievement of Specified Development and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payments | $ 14,600 | |||||||||||||||
ADVA Tec Agreement | Maximum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Percentage of royalty rate | 10% | |||||||||||||||
ADVA Tec Agreement | Minimum | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Percentage of royalty rate | 1% | |||||||||||||||
Bayer Healthcare License Agreement | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Upfront license fee paid | $ 1,000 | |||||||||||||||
Milestone payment paid in common stock | 310,000 | |||||||||||||||
Total revenue | $ 20,000 | |||||||||||||||
Hennepin License Agreement | Clinical and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 6,250 | |||||||||||||||
Hennepin License Agreement | Sales Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 45,000 | |||||||||||||||
Licensing Agreements | MilanaPharm | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 1,000 | |||||||||||||||
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 | |||||||||||||||
Licensing Agreements | Upon Achieving Certain Commercial Milestones | MilanaPharm | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | 850 | |||||||||||||||
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 | |||||||||||||||
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 | |||||||||||||||
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 | |||||||||||||||
Assignment Agreement | Maximum | 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 | |||||||||||||||
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 | |||||||||||||||
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 | |||||||||||||||
Pear Tree Pharmaceuticals, Inc. | Sales Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 47,000 | |||||||||||||||
Juniper Pharmaceuticals, Inc | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Upfront license fee paid | $ 250 | |||||||||||||||
Potential annual license maintenance fee payments, thereafter | 100 | |||||||||||||||
Juniper Pharmaceuticals, Inc | Clinical and Regulatory Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | 13,500 | |||||||||||||||
Juniper Pharmaceuticals, Inc | Sales Milestones | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Maximum potential milestone payments | $ 30,300 | |||||||||||||||
License and Collaboration Agreement | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 18,000 | |||||||||||||||
License and Collaboration Agreement | Upon Achieving Certain Commercial Milestones | Strategic Science and Technologies D Limited Liability Company and Strategic Science Technologies Limited Liability Company | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 100,000 | |||||||||||||||
Organon | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Upfront license fee paid | $ 10,000 | $ 10,000 | ||||||||||||||
Milestone payment paid in common stock | 182,500 | |||||||||||||||
First commercial sale amount | 2,500 | |||||||||||||||
Sales based milestones amount | 180,000 | $ 180,000 | ||||||||||||||
Catalent and MilanaPharm | Licensing Agreements | ||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||||
Milestone payment paid in common stock | $ 1,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |||||||
Mar. 31, 2023 | Jul. 31, 2020 | Apr. 30, 2019 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jul. 31, 2022 | Feb. 28, 2018 | Feb. 15, 2018 | |
Stockholders Equity [Line Items] | |||||||||
Common stock, shares authorized (in shares) | 240,000,000 | 240,000,000 | 240,000,000 | ||||||
Exercise price (in usd per share) | $ 3 | ||||||||
Warrant, exercise price, decrease (in usd per share) | $ 0.96 | $ 0.98 | |||||||
Number of common stock warrants exercised (in shares) | 1,353,515 | 0 | |||||||
Warrant exercises, gross | $ 1.3 | ||||||||
Accounting Standards Update 2017-11 | |||||||||
Stockholders Equity [Line Items] | |||||||||
Estimated fair value of warrants recorded in equity | $ 3 | ||||||||
March 2023 At The Market Sales Agreement | |||||||||
Stockholders Equity [Line Items] | |||||||||
Commission percent | 3% | ||||||||
Sale of stock, number of shares issued (in shares) | 0 | ||||||||
October 2021 At The Market Sales Agreement | |||||||||
Stockholders Equity [Line Items] | |||||||||
Sale of stock, number of shares issued (in shares) | 0 | ||||||||
April 2021 At The Market Sales Agreement | |||||||||
Stockholders Equity [Line Items] | |||||||||
Sale of stock, number of shares issued (in shares) | 0 | 0 | |||||||
Maximum | |||||||||
Stockholders Equity [Line Items] | |||||||||
Common stock, shares authorized (in shares) | 240,000,000 | ||||||||
Issued shares | $ 50 | $ 50 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Feb. 28, 2018 | |
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 6,500 | |
Exercise price (in usd per share) | $ 3 | |
Warrants Expiring on April 4, 2026 | ||
Class of Warrant or Right [Line Items] | ||
Shares underlying outstanding warrants (in shares) | 6,500 | |
Exercise price (in usd per share) | $ 10 | |
Expiration Date | Apr. 04, 2026 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||||
Jan. 01, 2022 | Jul. 31, 2018 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jun. 23, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unamortized stock-based compensation expense | $ 5,900,000 | |||||
Weighted average amortization period | 2 years 8 months 15 days | |||||
Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 624,621 | $ 532,409 | ||||
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% | |||||
Increase in number of shares authorized (in shares) | 2,000,000 | |||||
Common stock reserved for future issuance (in shares) | 2,201,855 | |||||
2014 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 0 | $ 0 | ||||
Amended and Restated Two Thousand Fourteen Stock Incentive Plan | Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options outstanding (in shares) | 9,110,219 | 6,612,554 | ||||
Common stock reserved for future issuance (in shares) | 7,078,916 | |||||
Amended and Restated Two Thousand Fourteen Stock Incentive Plan | 2022 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 - Summ
Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Details) - Amended and Restated Two Thousand Fourteen Stock Incentive Plan - Employee Stock Option | 3 Months Ended |
Mar. 31, 2023 $ / shares shares | |
Number of Shares | |
Outstanding beginning balance (in shares) | shares | 6,612,554 |
Granted (in shares) | shares | 2,497,665 |
Exercised (in shares) | shares | 0 |
Canceled/forfeited (in shares) | shares | 0 |
Expired (in shares) | shares | 0 |
Outstanding ending balance (in shares) | shares | 9,110,219 |
Exercisable (in shares) | shares | 4,009,997 |
Weighted Average Exercise Price | |
Outstanding beginning balance (in usd per share) | $ / shares | $ 1.60 |
Granted (in usd per share) | $ / shares | 1.16 |
Exercised (in usd per share) | $ / shares | |
Canceled/forfeited (in usd per share) | $ / shares | |
Expired (in usd per share) | $ / shares | |
Outstanding ending balance (in usd per share) | $ / shares | 1.48 |
Exercisable (in usd per share) | $ / shares | $ 1.51 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors (Details) - Employee Stock Option - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 624,621 | $ 532,409 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 200,301 | 174,613 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 424,320 | $ 357,796 |
Leased Properties - Additional
Leased Properties - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Feb. 28, 2022 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | Jul. 01, 2018 ft² | |
Lessee, Lease, Description [Line Items] | |||||
Square footage of office space | ft² | 3,169 | ||||
Renewal term of operating lease | 2 years | ||||
Increase (decrease) operating lease liability | $ (504,000) | ||||
Decrease in operating lease ROU assets | 458,000 | ||||
Gain on early termination of lease | 46,000 | ||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other non-current assets | ||||
Right of use asset | $ 368,000 | ||||
Current portion of lease liabilities | 335,764 | 398,391 | |||
Lease liabilities long-term | 57,128 | $ 90,346 | |||
Non-cash lease expenses | 139,000 | $ 169,000 | |||
Cash paid for measurement of operating lease liabilities | $ 105,000 | $ 123,000 | |||
Operating lease weighted average remaining lease term | 1 year 29 days | ||||
Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Incremental borrowing rate, amount over prime rate | 0.0200 | ||||
MBI | |||||
Lessee, Lease, Description [Line Items] | |||||
Renewal term of operating lease | 3 years | ||||
Increase (decrease) operating lease liability | $ 1,000,000 |
Leased Properties - Future Mini
Leased Properties - Future Minimum Lease Payments (Details) | Mar. 31, 2023 USD ($) |
Leases [Abstract] | |
Remainder of 2023 | $ 317,000 |
2024 | 93,000 |
Total future minimum lease payments | 410,000 |
Less: accreted interest | 17,000 |
Total operating lease liabilities | $ 393,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2023 | Jul. 31, 2021 | |
NICHD | |||
Commitments And Contingencies [Line Items] | |||
Total payment | $ 5.5 | ||
Other cost | $ 3.5 | $ 5 | |
CRADA | |||
Commitments And Contingencies [Line Items] | |||
Remaining performance obligation, amount | $ 0.5 | $ 0.5 |
Grant Awards (Details)
Grant Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
May 31, 2022 | Sep. 30, 2021 | Aug. 31, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 30, 2022 | Jun. 30, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||||
Deferred grant funding | $ 15,826,369 | $ 18,303,567 | |||||||
Grant, DARE-PTB1 | |||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||||
Amount awarded for grant | $ 300,000 | ||||||||
Additional potential grant funding | $ 2,000,000 | ||||||||
Credits recorded to research and development expense for costs related to award | 0 | $ 17,000 | |||||||
Receivable for expenses eligible for reimbursement | 0 | 0 | |||||||
DARE-LARC1 | |||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||||
Amount awarded for grant | $ 300,000 | 23,900,000 | 12,400,000 | $ 11,500,000 | |||||
Credits recorded to research and development expense for costs related to award | 32,000 | $ 165,000 | |||||||
Receivable for expenses eligible for reimbursement | 65,000 | 33,000 | |||||||
Initial payment | $ 49,000,000 | ||||||||
Deferred grant funding | 15,300,000 | ||||||||
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 | 49,000 | ||||||||
Receivable for expenses eligible for reimbursement | 73,000 | $ 24,000 | |||||||
DARE-LBT | |||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||||||
Initial payment | $ 585,000 | ||||||||
Deferred grant funding | $ 552,000 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Income (Loss) Per Common Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 9,116,719 | 7,658,297 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 9,110,219 | 6,277,282 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 6,500 | 1,381,015 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - April and May 2023 At The Market Sales shares in Thousands | 1 Months Ended |
May 11, 2023 USD ($) shares | |
Subsequent Event [Line Items] | |
Sale of stock, number of shares issued (in shares) | shares | 106 |
Shares of common stock for net proceeds | $ 109,000 |
Offering expenses | $ 2,700 |