Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 09, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-36395 | |
Entity Registrant Name | Dare 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 | 8,546,361 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001401914 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 16,414,992 | $ 10,476,056 |
Other receivables | 902,174 | 949,211 |
Prepaid expenses | 3,512,289 | 6,118,272 |
Total current assets | 20,829,455 | 17,543,539 |
Property and equipment, net | 322,283 | 655,975 |
Deposits | 480,107 | 1,163,477 |
Operating lease right-of-use assets | 1,445,823 | 1,319,630 |
Other non-current assets | 528,571 | 599,594 |
Total assets | 23,606,239 | 21,282,215 |
Current liabilities | ||
Accounts payable | 1,909,760 | 3,385,551 |
Accrued expenses | 1,254,358 | 2,889,005 |
Deferred grant funding | 10,937,663 | 13,737,154 |
Current portion of lease liabilities | 488,152 | 468,726 |
Total current liabilities | 14,589,933 | 20,480,436 |
Deferred revenue, non-current | 1,000,000 | 1,000,000 |
Liability related to the sale of future royalties, net | 4,308,117 | 3,913,676 |
Lease liabilities long-term | 1,036,683 | 935,743 |
Total liabilities | 20,934,733 | 26,329,855 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity (deficit) | ||
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; 8,546,361 and 8,331,161 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 854 | 833 |
Accumulated other comprehensive loss | (385,560) | (360,896) |
Additional paid-in capital | 168,136,943 | 166,548,454 |
Accumulated deficit | (165,080,731) | (171,236,031) |
Total stockholders' equity (deficit) | 2,671,506 | (5,047,640) |
Total liabilities and stockholders' equity (deficit) | $ 23,606,239 | $ 21,282,215 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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) | 8,546,361 | 8,331,161 |
Common stock, shares outstanding (in shares) | 8,546,361 | 8,331,161 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Income Statement [Abstract] | ||||
Revenue from Contract with Customer, Product and Service [Extensible Enumeration] | License [Member] | License [Member] | Royalty revenue | License [Member] |
Revenue | ||||
Total revenue | $ 22,438 | $ 0 | $ 31,740 | $ 0 |
Total revenue | 22,438 | 0 | 31,740 | 0 |
Operating expenses | ||||
General and administrative expenses | 2,448,130 | 2,920,672 | 5,118,711 | 6,258,098 |
Research and development expenses | 4,908,774 | 6,043,684 | 8,237,294 | 11,063,907 |
Royalty expenses | 0 | 0 | 7,674 | 0 |
License fee expenses | 25,000 | 25,000 | 50,000 | 50,000 |
Total operating expenses | 7,381,904 | 8,989,356 | 13,413,679 | 17,372,005 |
Loss from operations | (7,359,466) | (8,989,356) | (13,381,939) | (17,372,005) |
Other income (expense) | ||||
Sale of royalty and milestone rights, net | 20,379,376 | 0 | 20,379,376 | 0 |
Other income (expense), net | (109,254) | 227,124 | (842,137) | 567,272 |
Net income (loss) | 12,910,656 | (8,762,232) | 6,155,300 | (16,804,733) |
Foreign currency translation adjustments | 14,563 | (31,151) | (24,664) | (53,156) |
Comprehensive income (loss) | $ 12,925,219 | $ (8,793,383) | $ 6,130,636 | $ (16,857,889) |
Income (loss) per common share: | ||||
Income (loss) per common share - basic (in usd per share) | $ 1.53 | $ (1.22) | $ 0.73 | $ (2.32) |
Income (loss) per common share - diluted (in usd per share) | $ 1.52 | $ (1.22) | $ 0.72 | $ (2.32) |
Weighted average number of shares outstanding: | ||||
Basic (in shares) | 8,411,242 | 7,200,260 | 8,456,270 | 7,248,011 |
Diluted (in shares) | 8,476,231 | 7,200,260 | 8,523,223 | 7,248,011 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) - USD ($) | Total | Common stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 7,068,790 | ||||
Beginning balance at Dec. 31, 2022 | $ 11,112,110 | $ 707 | $ 152,537,355 | $ (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) | 112,793 | ||||
Issuance of common stock from the exercise of warrants | 1,299,375 | $ 11 | 1,299,364 | ||
Net income (loss) | (8,042,501) | (8,042,501) | |||
Foreign currency translation adjustments | (22,005) | (22,005) | |||
Ending balance (in shares) at Mar. 31, 2023 | 7,181,583 | ||||
Ending balance at Mar. 31, 2023 | 4,971,600 | $ 718 | 154,461,340 | (373,316) | (149,117,141) |
Beginning balance (in shares) at Dec. 31, 2022 | 7,068,790 | ||||
Beginning balance at Dec. 31, 2022 | 11,112,110 | $ 707 | 152,537,355 | (351,311) | (141,074,640) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income (loss) | (16,804,733) | ||||
Foreign currency translation adjustments | (53,156) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 7,219,466 | ||||
Ending balance at Jun. 30, 2023 | (2,719,402) | $ 722 | 155,563,717 | (404,467) | (157,879,373) |
Beginning balance (in shares) at Mar. 31, 2023 | 7,181,583 | ||||
Beginning balance at Mar. 31, 2023 | 4,971,600 | $ 718 | 154,461,340 | (373,316) | (149,117,141) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 650,186 | 650,186 | |||
Issuance of common stock from the exercise of warrants (in shares) | 37,883 | ||||
Issuance of common stock from the exercise of warrants | 452,195 | $ 4 | 452,191 | ||
Net income (loss) | (8,762,232) | (8,762,232) | |||
Foreign currency translation adjustments | (31,151) | (31,151) | |||
Ending balance (in shares) at Jun. 30, 2023 | 7,219,466 | ||||
Ending balance at Jun. 30, 2023 | $ (2,719,402) | $ 722 | 155,563,717 | (404,467) | (157,879,373) |
Beginning balance (in shares) at Dec. 31, 2023 | 8,331,161 | 8,331,161 | |||
Beginning balance at Dec. 31, 2023 | $ (5,047,640) | $ 833 | 166,548,454 | (360,896) | (171,236,031) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 627,700 | 627,700 | |||
Issuance of common stock from the exercise of warrants (in shares) | 50,664 | ||||
Issuance of common stock from the exercise of warrants | 215,113 | $ 5 | 215,108 | ||
Net income (loss) | (6,755,356) | (6,755,356) | |||
Foreign currency translation adjustments | (39,227) | (39,227) | |||
Ending balance (in shares) at Mar. 31, 2024 | 8,381,825 | ||||
Ending balance at Mar. 31, 2024 | $ (10,999,410) | $ 838 | 167,391,262 | (400,123) | (177,991,387) |
Beginning balance (in shares) at Dec. 31, 2023 | 8,331,161 | 8,331,161 | |||
Beginning balance at Dec. 31, 2023 | $ (5,047,640) | $ 833 | 166,548,454 | (360,896) | (171,236,031) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net income (loss) | 6,155,300 | ||||
Foreign currency translation adjustments | $ (24,664) | ||||
Ending balance (in shares) at Jun. 30, 2024 | 8,546,361 | 8,546,361 | |||
Ending balance at Jun. 30, 2024 | $ 2,671,506 | $ 854 | 168,136,943 | (385,560) | (165,080,731) |
Beginning balance (in shares) at Mar. 31, 2024 | 8,381,825 | ||||
Beginning balance at Mar. 31, 2024 | (10,999,410) | $ 838 | 167,391,262 | (400,123) | (177,991,387) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 562,719 | 562,719 | |||
Issuance of common stock from the exercise of warrants (in shares) | 42,583 | ||||
Issuance of common stock from the exercise of warrants | 182,978 | $ 4 | 182,974 | ||
Reverse stock split adjustment (in shares) | 121,953 | ||||
Reverse stock split adjustment | 0 | $ 12 | (12) | ||
Net income (loss) | 12,910,656 | 12,910,656 | |||
Foreign currency translation adjustments | $ 14,563 | 14,563 | |||
Ending balance (in shares) at Jun. 30, 2024 | 8,546,361 | 8,546,361 | |||
Ending balance at Jun. 30, 2024 | $ 2,671,506 | $ 854 | $ 168,136,943 | $ (385,560) | $ (165,080,731) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities | ||
Net income (loss) | $ 6,155,300 | $ (16,804,733) |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||
Depreciation | 26,215 | 19,123 |
Right of use asset - operating lease | 232,122 | 181,775 |
Stock-based compensation | 1,190,418 | 1,274,807 |
Disposal of property and equipment | 600,000 | 0 |
Non-cash royalty revenue related to sale of future royalties | (22,438) | 0 |
Non-cash interest expense on liability related to sale of future royalties | 170,864 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (27,979) | 0 |
Other receivables | 75,016 | 1,130,694 |
Prepaid expenses | 2,605,983 | (1,403,634) |
Deposits | 683,370 | (3,939) |
Other current assets | 0 | (272,100) |
Other non-current assets | 36,023 | (40,995) |
Operating lease liability | (237,949) | (193,586) |
Accounts payable | (1,475,791) | 4,513,162 |
Accrued expenses | (1,367,460) | (6,700,216) |
Interest payable | 247,520 | 0 |
Deferred grant funding | (2,799,491) | (4,609,482) |
Deferred revenue - current | 0 | 205,206 |
Net cash provided by (used in) operating activities | 6,091,723 | (22,703,918) |
Cash flows from investing activities | ||
Purchases of property and equipment | (292,522) | 0 |
Net cash used in investing activities | (292,522) | 0 |
Cash flows from financing activities | ||
Net proceeds from issuance of common stock | 398,091 | 452,195 |
Proceeds from the exercise of common stock warrants | 0 | 1,299,375 |
Repayment of liability on sale of future royalties | (1,505) | 0 |
Payments on note payable | (267,188) | 0 |
Net cash provided by financing activities | 129,398 | 1,751,570 |
Effect of exchange rate changes on cash and cash equivalents | (24,663) | (53,156) |
Net change in cash and cash equivalents | 5,903,936 | (21,005,504) |
Cash and cash equivalents, beginning of period | 10,811,056 | 34,669,605 |
Cash and cash equivalents, end of period | 16,714,992 | 13,664,101 |
Reconciliation of cash, cash equivalents and restricted cash to amounts reported in the consolidated balance sheets: | ||
Cash and cash equivalents | 16,414,992 | 13,329,101 |
Restricted cash included in other non-current assets | 300,000 | 335,000 |
Total cash, cash equivalents and restricted cash | 16,714,992 | 13,664,101 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities, net | $ 358,315 | $ 0 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2024 | |
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 drug and drug/device product candidates and potential product candidates in various stages of development. The first U.S. Food and Drug Administration (FDA)-approved product to emerge from the Company's portfolio of women's health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, or XACIATO. 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, which became fully effective in June 2022. Under the license agreement, Organon (and/or its affiliates, agents or sublicensees) is solely responsible for the marketing, distribution and sale of XACIATO in the United States (and outside the U.S. if approved in non-U.S. jurisdictions in the future). Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023 and, in January 2024, Organon announced that XACIATO was available nationwide. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
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, 2023, or the 2023 10-K. Reclassifications Certain reclassifications have been made to the Company’s prior year amounts to conform to the current year presentation. Reverse Stock Split The Company effected a 1-for-12 reverse split of its issued common stock on July 1, 2024. At the effective time of the reverse stock split, every 12 shares of the Company’s common stock was automatically reclassified and combined into one share of common stock. No fractional shares were issued as a result of the reverse stock split. Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share. The reverse stock split did not change the number of authorized shares or the par value per share of the Company’s common stock. See Note 12, Subsequent Events, for additional information regarding the reverse stock split. All common stock share and per share data presented in the accompanying condensed consolidated financial statements have been retroactively adjusted to reflect the impact of the reverse stock split for all periods presented, without giving effect to whole shares issued in lieu of fractional shares. In addition, proportionate adjustments were made in accordance with the applicable terms of outstanding stock options and warrants, the Company’s stock incentive plans and an existing agreement to the (a) per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, (b) number of shares available for the grant of awards under the Company’s stock incentive plans, and (c) per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock and warrants potentially issuable by the Company in its sole discretion pursuant to an existing agreement. 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 has an aggregate of approximately $0.3 million in restricted cash as of June 30, 2024, related to (i) a letter of credit established under a real property lease for the Company's wholly-owned subsidiary, Dare MB Inc., that serves as security for potential future default of lease payments, and (ii) collateralized cash for the Company's credit cards. The restricted cash is unavailable for withdrawal or for general obligations and is included in other non-current assets on the Company's consolidated balance sheet. 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, net losses, and negative cash flows from operations and, although it reported net income and positive cash flow from operations for the six months ended June 30, 2024, the Company expects significant losses from operations, net losses and negative cash flows from operations 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 June 30, 2024, the Company had an accumulated deficit of approximately $165.1 million, cash and cash equivalents of approximately $16.4 million, deferred grant funding liabilities under the Company's grant agreements related to DARE-LARC1, DARE-LBT and its bacteria-based live biotherapeutic product of approximately $10.9 million, and working capital of approximately $6.2 million. The Company's cash and cash equivalents at June 30, 2024 includes grant funds received under such agreements that may be applied solely toward direct costs for the development of DARE-LARC1, DARE-LBT and its bacteria-based live biotherapeutic product, 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 six months ended June 30, 2024, the Company incurred a loss from operations of approximately $13.4 million and reported net income of approximately $6.2 million and cash flow from operations of approximately $6.1 million. The Company's net income and cash flow from operations for the six months ended June 30, 2024 were positively impacted by the approximately $20.4 million of net proceeds the Company received from the sale in April 2024 of its rights to future royalty and milestone payments and revenue. See Note 8, Royalty Purchase Agreements. 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 these uncertainties. Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 to the consolidated financial statements included in the 2023 10-K. Since the date on which the 2023 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 except for as follows: Sale of Future Payments On April 29, 2024, the Company entered into and closed a traditional royalty purchase agreement and a synthetic royalty purchase agreement with XOMA (US) LLC (“XOMA”) pursuant to which the Company sold its right, title and interest in the following to XOMA (i) all future net royalty and potential net milestone payments the Company would otherwise receive from Organon based on net sales of XACIATO, (ii) a portion of future net sales of Ovaprene and a portion of a potential future milestone payment the Company may receive under its license agreement with Bayer related to Ovaprene, and (iii) a portion of future net sales of Sildenafil Cream. The Company received $22.0 million from XOMA in connection with entering into the royalty purchase agreements. Under the terms of the royalty purchase agreements, if XOMA receives total payments under the royalty purchase agreements equal to an amount that exceeds $88.0 million, XOMA will pay $11.0 million to the Company for each successive $22.0 million XOMA receives under the royalty purchase agreements. If the Company earns any such payments, they will be accounted for as variable consideration under ASC 606, Revenue Recognition, and will be recorded as income when such payments are received. See Note 8, Royalty Purchase Agreements for additional information regarding the terms of the royalty purchase agreements. The Company evaluated the expected cash flows to XOMA from royalties and milestone payments expected to be earned on XACIATO, Ovaprene and Sildenafil Cream over the period that the Company expects it will take for XOMA to receive total payments of $88.0 million under the royalty purchase agreements, and determined to allocate the $22.0 million it received from XOMA in connection with entering into the royalty purchase agreements, net of transaction costs of approximately $1.6 million, to the traditional royalty purchase agreement for XACIATO, and none of it to the synthetic royalty purchase agreement for Ovaprene and Sildenafil Cream. The cash flows to XOMA from royalties and milestone payments expected to be earned on Ovaprene and Sildenafil Cream are expected to be de minimis over the period that the Company expects it will take for XOMA to receive total payments of $88.0 million under the royalty purchase agreements because, unlike XACIATO, Ovaprene and Sildenafil Cream are still in development stage and not commercial assets. The Company determined that the traditional royalty purchase agreement represents a complete sale of a nonfinancial asset (the Company's right, title and interest in and to future payments related to commercial sales of XACIATO) for which XOMA bears all benefit and for which the Company has no obligations or involvement going forward, and therefore should be accounted for within the scope of Accounting Standards Codification (" ASC") 610-20, Other Income - Gains and Losses from the Derecognition of Nonfinancial Assets . The $22.0 million net of transaction costs of approximately $1.6 million was recorded as other income on the Company's condensed consolidated statements of operations. 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 June 30, 2024 and December 31, 2023. 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 June 30, 2024 or December 31, 2023. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at June 30, 2024 Current assets: Cash equivalents (1) $ 16,070,561 $ — $ — $ 16,070,561 Balance at December 31, 2023 Current assets: Cash equivalents (1) $ 9,982,079 $ — $ — $ 9,982,079 (1) Represents cash held in money market funds. Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or ASU 2023-07, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is evaluating the disclosure impact of ASU 2023-07 on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. ASU 2023-09 will be effective for annual periods beginning January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively. The Company is evaluating the disclosure impact of ASU 2023-09 on its consolidated financial statements. The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the condensed consolidated financial statements. |
Strategic Agreements
Strategic Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Strategic Agreements | STRATEGIC AGREEMENTS Strategic Agreements for Product Commercialization Organon Exclusive License Agreement In March 2022, the Company entered into an exclusive license agreement with Organon 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 a $10.0 million non-refundable and non-creditable payment from Organon, which was recorded as license fee revenue. In July 2023, the Company received a $1.0 million payment from Organon in connection with the amendment to the license agreement the parties entered into, which was also recorded as license fee revenue. In the fourth quarter of 2023, in connection with the first commercial sale in the U.S. of XACIATO in accordance with the license agreement, as amended, the Company received the $1.8 million milestone payment from Organon. Under the terms of the license agreement, as amended, the Company is entitled to receive tiered double-digit royalties based on net sales and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. Royalty payments will be subject to customary reductions and offsets. At the inception of the license agreement, the Company concluded 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. The transaction price was updated to $12.8 million as of June 30, 2024. 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). Refer to Note 8, Royalty Purchase Agreements, regarding the Company's sale to XOMA of all the Company's right, title and interest in and to, from and after April 1, 2024, all net royalty and potential net milestone payments from Organon based on net sales of XACIATO. The Company was responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumed such responsibilities, which occurred in December 2023. Prior to that time, Organon purchased 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, 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 (i) 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 (ii) the termination of the agreement. As of June 30, 2024, 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 June 30, 2024 and December 31, 2023. If Bayer elects to make the license effective, the Company will be entitled to receive (a) a milestone payment in the low double-digit millions upon the first commercial sale of Ovaprene in the U.S. and escalating milestone payments based on annual net sales of Ovaprene during a calendar year, totaling up to $310.0 million if all such milestones, including 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. Refer to Note 8, Royalty Purchase Agreements, regarding XOMA's rights to a portion of potential future payments from Bayer under the Company's license agreement with Bayer. 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 Douglas License Agreement / The University of Manchester Stand-by Direct License Arrangement In August 2023, the Company entered into a license agreement with Douglas Pharmaceuticals Limited, or Douglas, under which the Company acquired the exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of cervical intraepithelial neoplasia and other HPV-related pathologies, and an agreement with The University of Manchester, pursuant to which The University of Manchester consented to Douglas' sublicense to the Company of certain rights it previously granted to Douglas and agreed to grant the Company a direct license to such rights if its license agreement with Douglas is terminated. Under the Company's agreement with Douglas, it received an exclusive, royalty-bearing license to research, develop and commercialize the licensed intellectual property in the United States for the treatment or prevention of all indications for women in female reproductive health. As a result of this license, the Company commenced its DARE-HPV program. The Company is entitled to sublicense the rights granted to it under the agreement. Under the terms of the Douglas agreement, the Company agreed to make potential future payments of up to $5.25 million in the aggregate upon achievement of certain development and regulatory milestones, and of up to $64.0 million in the aggregate upon achievement of certain commercial sales milestones for each product covered by the licenses granted under the agreement. The development and regulatory milestones may be paid in shares of the Company’s common stock, in the Company's sole discretion subject to specified limitations. Additionally, Douglas is eligible to receive tiered royalties in low single-digit to low double-digit percentages based on annual net sales of products and processes covered by the licenses granted under the agreement. As of June 30, 2024, no payments had been made under the Douglas agreement. 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 program. 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 of up to $6.25 million in the aggregate upon achievement of certain development and regulatory milestones, and up to $45.0 million in the aggregate upon achievement of 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 June 30, 2024, no payments have been made under this agreement. MBI Acquisition In November 2019, the Company acquired Dare MB 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 58,334 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 of $300,000 in the aggregate to MilanaPharm, the final payment of which was made in 2021, and $500,000 in connection with the first commercial sale in the United States of XACIATO in the fourth quarter of 2023. Additionally, the Company may pay up to $250,000 upon the first commercial sale in the United States of 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 June 30, 2024. 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 achievement of certain clinical development and regulatory milestones by licensed products, and (b) up to $47.0 million in the aggregate upon achievement of 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. As of June 30, 2024, no payments have been made under this agreement. The Company agreed to pay licensors of Pear Tree (a) up to approximately $3.2 million in the aggregate upon achievement of 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., or 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. As a result of this license agreement, the Company commenced its DARE-HRT1, DARE-FRT1 and DARE-PTB1 programs. 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 June 30, 2024; 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., or 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 and/or female sexual interest/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 achievement of certain clinical and regulatory milestones in the U.S. and worldwide, and up to $100.0 million in the aggregate upon achievement of 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. As of June 30, 2024, no payments have been made under this agreement. 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 | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY September 2023 Registered Direct Offering In August 2023, the Company entered into a securities purchase agreement with an institutional investor and an investor affiliated with Douglas for the purchase and sale of 833,334 shares of the Company's common stock and warrants to purchase additional shares of the Company's common stock in a registered direct offering priced at-the-market under Nasdaq rules. The offering closed on September 1, 2023. Each warrant is exercisable for one share of the Company's common stock. The terms of the warrants are further described below in this Note 4. The offering price was $8.40 per share of common stock and accompanying warrant. The aggregate gross proceeds to the Company from the offering were $7.0 million, and net proceeds were approximately $7.0 million. The offering was made pursuant to the Company's registration statement on Form S-3 (File No. 333-254862), filed with the SEC on March 30, 2021, and declared effective by the SEC on April 7, 2021, and a prospectus supplement thereunder. 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. Through and including May 10, 2024, shares of the Company's common stock sold under the agreement were offered and sold under 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, and the prospectus supplements thereto, the most recent of which was dated March 28, 2024 relating to the offering of up to $19.0 million of shares of the Company's common stock. From and after May 11, 2024, shares of the Company's common stock sold under the agreement were and will be offered and sold under the Company's shelf registration statement on Form S-3 (File No. 333-278380), the base prospectus included therein, originally filed with the SEC on March 29, 2024 and declared effective by the SEC on May 10, 2024, the prospectus supplement thereto dated May 10, 2024 relating to the offering of up to $18.1 million of shares of the Company's common stock, and any subsequent prospectus supplement related to the offering of shares of the Company's common stock under the sales agreement. During the six months ended June 30, 2024 and 2023, the Company sold 93,247 and 37,883 shares of common stock, respectively, under this agreement for net proceeds of approximately $0.4 million and $0.5 million, respectively. Common Stock Warrants December 2023 Warrants In connection with the royalty interest financing agreement the Company entered into in December 2023, the Company issued a warrant to purchase up to an aggregate of 422,805 shares of the Company's common stock. The warrant has a term of five years from the date of issuance and an exercise price of $4.10 per share, subject to customary adjustment for stock splits and similar transactions. A holder (together with its affiliates) may not exercise any portion of the warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder 9.99%) of the Company's outstanding common stock immediately after exercise. The warrant includes certain rights in favor of the holder upon a “fundamental transaction” as described in the warrant, including the right of the holder to receive from the Company or the successor entity an amount of cash equal to the Black-Scholes value (as described in the warrants) of the unexercised portion of the warrant on the date of the consummation of such fundamental transaction. The warrant was allocated a value of $0.8 million using a Black-Scholes option pricing model based on the relative fair value method. The Black-Scholes model used the following assumptions: expected volatility: 85.91%; risk-free interest rate: 4.05%; expected dividend yield: 0%; and expected term: 5 years. The warrant was deemed to be classified as equity and recorded within additional paid in capital on the 2023 consolidated balance sheet. As of June 30, 2024, no portion of the warrant has been exercised. September 2023 Warrants In connection with the registered direct offering completed in September 2023, the Company issued warrants to purchase up to an aggregate of 845,225 shares of the Company's common stock. The warrants became exercisable on March 1, 2024, expire March 1, 2029 and have an exercise price of $9.11 per share, subject to customary adjustment for stock splits and similar transactions. A holder (together with its affiliates) may not exercise any portion of a warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder 9.99%) of the Company's outstanding common stock immediately after exercise. The warrants include certain rights in favor of the holders upon a “fundamental transaction” as described in the warrants, including the right of the holders to receive from the Company or the successor entity an amount of cash equal to the Black-Scholes value (as described in the warrants) of the unexercised portion of the warrants on the date of the consummation of such fundamental transaction. The warrants were allocated a value of $2.9 million using a Black-Scholes option pricing model based on the relative fair value method as they were issued with common stock. The Black-Scholes model used the following assumptions: expected volatility: 87.77%; risk-free interest rate: 4.29%; expected dividend yield: 0%; and expected term: 5.5 years. The warrants were deemed to be classified as equity and recorded within additional paid in capital on the 2023 consolidated balance sheet. As of June 30, 2024, none of the warrants have been exercised. February 2018 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 $36.00 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 resulted in automatic reductions to the exercise price of the warrants in April 2019 and July 2020 to $11.76 per share and $11.52 per share, respectively. In January 2023, February 2018 warrants to purchase 112,793 shares of common stock were exercised for gross proceeds of approximately $1.3 million and the remaining unexercised February 2018 warrants expired on February 15, 2023. Summary of Warrant Activity A summary of warrant activity during the six months ended June 30, 2024 is presented below: Common Stock Number of Shares Underlying Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Outstanding December 31, 2023, 1,268,572 $ 7.49 5.17 $ — Granted — — Exercised — — Forfeited or expired — — Outstanding and exercisable June 30, 2024, 1,268,572 $ 7.49 4.67 $ — |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
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. In June 2024, the Company's board of directors suspended the ESPP. There was no stock-based compensation related to the ESPP for the six months ended June 30, 2024 or June 30, 2023. 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 stock-based awards to employees, directors, consultants and advisors. 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 since June 23, 2022. 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, directors, consultants, and advisors. The number of shares of common stock authorized for issuance under the 2022 Plan is (a) 843,108; plus (b) up to 512,056 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 six months ended June 30, 2024. The exercise price of all options granted during the six months ended June 30, 2024 was equal to the market value of the Company’s common stock on the date of grant. As of June 30, 2024, unamortized stock-based compensation expense of approximately $3.5 million will be amortized over a weighted average period of 2.12 years. The number of shares of common stock available for future awards granted under the 2022 Plan as of June 30, 2024 was 387,594. Number of Shares Weighted Average Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value* Outstanding at December 31, 2023 788,569 $ 17.50 7.51 $ — Granted 224,530 5.48 — Exercised — — — Cancelled/forfeited (51,554) 11.76 10,150 Expired (114) 1,270.85 — Outstanding at June 30, 2024 961,431 $ 14.86 7.54 — Exercisable at June 30, 2024 573,546 $ 17.33 6.63 — *The aggregate intrinsic value is the sum of the amounts by which the quoted market price of the Company's common stock exceeded the exercise price of the stock options at June 30, 2024 for those stock options for which the quoted market price was in excess of the exercise price. The weighted average grant-date fair value of stock options granted during the six months ended June 30, 2024 was $4.16. 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 Six Months Ended 2024 2023 2024 2023 Research and development $ 216,919 $ 210,198 $ 423,521 $ 410,499 General and administrative $ 345,800 $ 439,988 $ 766,897 $ 864,308 Total $ 562,719 $ 650,186 $ 1,190,418 $ 1,274,807 |
Leased Properties
Leased Properties | 6 Months Ended |
Jun. 30, 2024 | |
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 through August 31, 2024. On March 8, 2024, the Company entered into another amendment to extend the term of the lease for three years such that the term now expires on October 31, 2027, and resulted in additional operating lease liabilities and ROU assets of approximately $0.4 million in March 2024. MBI, a wholly owned subsidiary the Company acquired in November 2019, leased 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, which right was exercised by the landlord in September 2022. MBI entered into a new lease for general office space and laboratory space in June 2023 that commenced on November 1, 2023 for three years, expiring on December 31, 2026, and resulted in an increase in operating lease liabilities and ROU assets of approximately $1.3 million in November 2023. 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. The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term. At June 30, 2024, the Company reported operating lease ROU assets of approximately $1.4 million in operating lease ROU assets in the condensed consolidated balance sheets. Total operating lease costs were approximately $191,000 and $391,000 for the three and six months ended June 30, 2024, respectively, and $145,000 and $284,000 for the three and six months ended and June 30, 2023, 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 $159,000 and $318,000 for the three and six months ended June 30, 2024, and $105,000 and $209,000 for the three and six ended June 30, 2023, respectively, and these amounts are included in operating activities in the condensed consolidated statements of cash flows. At June 30, 2024, operating leases had a weighted average remaining lease term of 2.92 years and a weighted average interest rate of 10.50%. As of June 30, 2024, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2024 $ 297,000 2025 660,000 2026 680,000 2027 130,000 Total future minimum lease payments 1,767,000 Less: accreted interest 242,000 Total operating lease liabilities $ 1,525,000 |
Royalty Interest Financing
Royalty Interest Financing | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions [Abstract] | |
Royalty Interest Financing | ROYALTY INTEREST FINANCING On December 21, 2023, the Company entered into a royalty interest financing agreement, or the Royalty Interest Agreement, with United in Endeavour, LLC, or UiE, under which UiE acquired a portion of the Company's royalty interest in XACIATO. The Company received $5.0 million from UiE when the parties entered into the Royalty Interest Agreement (the "Initial Investment"), and between January 1, 2024 and December 31, 2026, the Company may, in its sole discretion but subject to XOMA's prior written consent (see Note 8, Royalty Purchase Agreements), elect to receive three additional payments (each a "Supplemental Investment") from UiE of up to an aggregate of $7.0 million, for a total of up to $12.0 million. Under the Royalty Interest Agreement, the Company agreed to make the following payments to UiE, until such time when UiE has received aggregate payments equaling a 12% internal rate of return (the “IRR”) on the Initial Investment and each Supplemental Investment, if any (the "Hard Cap"): (i) from December 21, 2023 through December 31, 2025, 50% of the amount of royalty payments remaining after all amounts that are due and payable and actually paid by the Company to any licensor or sublicensee on the royalty payments generated and received by the Company on net sales of XACIATO by Organon have been deducted (the “Net Royalty Payments”), (ii) from January 1, 2026 through December 31, 2029, 75% of the Net Royalty Payments, and (iii) from December 21, 2023 through December 31, 2029, 10% of the amount of milestone payments remaining after all amounts that are due and payable and actually paid by the Company to any licensor or sublicensee on the milestone payments generated and received by the Company on net sales of XACIATO by Organon have been deducted. After December 31, 2029, the Company will be required to make certain additional payments to UiE to the extent UiE has not received payments equaling the Hard Cap by December 31, 2029, December 31, 2033, and December 31, 2034, respectively. In addition, if UiE has not received payments equaling the Hard Cap by December 31, 2035 and the Company has other sources of assets or income besides XACIATO sufficient to complete such payments, the Company has agreed to pay UiE quarterly payments evenly divided over a two-year term, such that UiE will have obtained the IRR, taking into account all other payments received by UiE from the Company under the Royalty Interest Agreement. UiE’s right to receive payments will terminate when UiE has received payments in an amount equal to the Hard Cap. The Company evaluated the terms of the Royalty Interest Agreement and concluded that the features of the Royalty Interest Agreement were similar to those of a debt instrument. As a result, the Company applied the debt recognition guidance under ASC 470, Debt, and recorded the Initial Investment as a liability related to the sale of future royalties (“Royalty Obligation”) on the Company's 2023 consolidated balance sheet, which will be amortized under the effective interest method over the estimated term of the Royalty Interest Agreement. If the Company elects to receive additional Supplemental Investments, such additional Supplemental Investments will also be recorded as a liability related to the sale of future royalties when they are received and amortized under the interest method over the estimated remaining term of the Royalty Interest Agreement. In addition, in accordance with ASC 470, Debt, the Company will account for any royalties received in the future as non-cash royalty revenue in the consolidated statements of operations as a reduction to the debt balance. As royalties and milestone payments are received by or on behalf of the Company from Organon and the Company subsequently pays or causes to be paid the amounts due to UiE in respect thereof in accordance with the Royalty Interest Agreement, the Royalty Obligation will be effectively repaid during the term of the Royalty Interest Agreement. In order to determine the amortization of the Royalty Obligation, the Company is required to estimate the total amount of future payments to UiE during the term of the Royalty Interest Agreement. At execution of the Royalty Interest Agreement, the Company’s estimate of this total interest expense resulted in an effective annual interest rate of approximately 22.48%. This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the royalty period. The Company will periodically assess the estimated amounts due and payable to UiE and to the extent the amount or timing of such payments is materially different than the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect XACIATO's commercial success, and therefore the amount and timing of the Company's payments to UiE, and correspondingly, the amount of interest expense recorded by the Company, most of which are not within the Company’s control. Such factors include, but are not limited to, the capabilities of Organon and its commitment of sufficient resources to market, distribute and sell the product; timely and adequate commercial supply of the finished product and its components; perceived superiority of its cure rates compared to other available treatments; patient satisfaction and willingness to use it again and refer it to others; price pressure given the high level of generic treatments and changes in health care laws and regulations; adequate coverage, pricing and reimbursement from third-party payors; and approval of new entrants, including alternative, non-antibiotic treatment options. These factors could result in increases or decreases to both royalty revenues and interest expense. Warrants In connection with entering into the Royalty Interest Agreement, the Company issued to UiE a warrant (the “Initial Royalty Warrant”) to purchase up to 422,804 shares of the Company’s common stock. In addition, for every $1,000,000 of Supplemental Investment, the Company will issue a warrant to purchase 84,561 shares of common stock, for an aggregate of warrants to purchase up to 591,927 shares of common stock (collectively the “Additional Royalty Warrants,” and together with the Initial Royalty Warrant, the “Royalty Interest Agreement Warrants”). The Royalty Interest Agreement Warrants are exercisable, in full or in part, at any time on or prior to the fifth anniversary of their issuance date at an exercise price of $4.10 per share, subject to customary anti-dilution adjustments. The Royalty Interest Agreement Warrants may be exercised for cash, or if at the time of exercise there is no effective registration statement registering for resale the shares underlying the Royalty Interest Agreement Warrants, then in lieu of paying the exercise price in cash, the holders may elect to exercise on a cashless basis. The Royalty Interest Agreement Warrants were deemed to be equity classified warrants and recorded under additional paid in capital. The fair value of the Initial Royalty Warrant was determined to be $0.8 million (Note 4) and was recorded as a debt discount against the Initial Investment. The following table shows the activity of the Royalty Obligation since the transaction inception through the period indicated: June 30, 2024 Upfront payment from the sale of future royalties $ 5,000,000 Debt issuance cost (276,101) Relative fair value of Initial Royalty Warrant (834,512) Royalty payments (23,942) Non-cash interest expense and interest payable associated with the sale of future royalties 442,672 Liability related to the sale of future royalties $ 4,308,117 |
Royalty Purchase Agreements
Royalty Purchase Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Royalty Purchase Agreements | ROYALTY PURCHASE AGREEMENTS On April 29, 2024, the Company entered into a traditional royalty purchase agreement (the "XACIATO RPA"), and a synthetic royalty purchase agreement, (the "Synthetic RPA and together with the XACIATO RPA, the “Royalty Purchase Agreements”) with XOMA pursuant to which XOMA paid $22.0 million to the Company. In addition, if XOMA receives total payments under the Royalty Purchase Agreements (as described below) equal to an amount that exceeds $88.0 million, XOMA will pay $11.0 million to the Company for each successive $22.0 million XOMA receives under the Royalty Purchase Agreements (such $11.0 million payments to the Company, the “Contingent Purchase Price Payments”). Under the Royalty Purchase Agreements, the Company sold, assigned, transferred and conveyed its right, title and interest in and to the following to XOMA: (a) 100% of the royalties and potential milestone payments the Company would otherwise have the right to receive from and after April 1, 2024 under the Company's exclusive license agreement with Organon, based on net sales of XACIATO, net of (i) all royalty and milestone payments due and payable and actually paid by or on behalf of the Company under its exclusive license agreement with third-party licensors TriLogic and MilanaPharm, and (ii) all payments due and payable and actually paid by or on behalf of the Company under the Royalty Interest Agreement between the Company and UiE (such net amount, the “Purchased Receivables”); (b) 25% of the potential future $20.0 million payment that the Company would otherwise have the right to receive under the Company's license agreement with Bayer, if Bayer, in its sole discretion, elects to make the license granted thereunder effective following completion of the pivotal clinical trial of Ovaprene; and (c) a synthetic royalty of 4.0% of the Company's, its affiliates’ and its sublicensees’ future net sales of the Company's investigational product Ovaprene, and 2.0% of the Company's, its affiliates’ and its sublicensees’ future net sales of the Company's investigational product Sildenafil Cream, 3.6%; provided, however , that, if XOMA receives total payments under the Royalty Purchase Agreements, net of any Contingent Purchase Price Payments made to the Company, equal to an amount that exceeds $110.0 million, the foregoing percentages will be reduced to 2.5% and 1.25%, respectively (such amounts described in the foregoing clauses (b) and (c), collectively, the “Revenue Participation Right”). Pursuant to the XACIATO RPA, XOMA, at its sole cost and discretion, may repay in full and retire all of the Company's payment obligations to UiE under the Royalty Interest Agreement. If XOMA does so, no further amounts in respect of the Royalty Interest Agreement will be deducted from the net royalties and net milestone payments that XOMA is entitled to receive under the XACIATO RPA. As of April 29, 2024, the Company cannot elect to receive any additional funding from UiE under the Royalty Interest Agreement without XOMA’s prior written consent. In connection with the synthetic royalty purchase agreement, the Company granted to XOMA a security interest in certain product assets related to Ovaprene and Sildenafil Cream.( Note 7) The $22.0 million the Company received from XOMA, less transaction costs of approximately $1.6 million, was allocated to the XACIATO RPA and recorded as other income on the Company's consolidated statements of operations in the second quarter of 2024. See Note 2, Basis of Presentation and Summary of Significant Accounting Policies, for additional information. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Insurance Financing In July 2023, the Company obtained financing for director and officer and other insurance premiums. The total premiums, taxes and fees financed was approximately $0.6 million with an annual interest rate of approximately 8.0%. In consideration of the premium payment by the lender to the insurance companies or the agent or broker, the Company promised to pay the lender the amount financed plus interest and other charges permitted under the agreement. The Company made monthly installment payments on the financed amount through April 20, 2024. The financed amount, or note payable, is recognized as an insurance financing cost included in other current assets and accrued expenses in the Company's consolidated balance sheets. As of June 30, 2024, the Company had no remaining obligation under the agreement. CRADA with NICHD for the Pivotal Phase 3 Study of Ovaprene In July 2021, the Company entered into a Cooperative Research and Development Agreement, or the CRADA, with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, for the conduct of a multi-center, non-comparative, pivotal Phase 3 clinical study of Ovaprene, or the Ovaprene Phase 3. The Ovaprene Phase 3 will be conducted within NICHD’s Contraceptive Clinical Trial Network with NICHD's contract research organization providing clinical coordination and data collection and management services for the Ovaprene Phase 3. The Company and NICHD will each provide medical oversight and final data review and analysis for the Ovaprene Phase 3 and will work together to prepare the final report of the results of the Ovaprene Phase 3. The Company is responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million in payments to NICHD to be applied toward the costs of conducting the Ovaprene Phase 3. NICHD is responsible for the other costs related to the conduct of the Ovaprene Phase 3. The Company has made aggregate payments of $5.0 million to NICHD, all of which was paid before January 1, 2023. The Company's remaining obligation under the CRADA at June 30, 2024 was $0.5 million. |
Grant Awards
Grant Awards | 6 Months Ended |
Jun. 30, 2024 | |
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 several of its product candidates. 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 of approximately $300,000 was to be used for what is referred to as the "Phase I" segment of the project outlined in the Company's grant application. The Phase I segment ended in July 2023. The Company received aggregate reimbursements under the award of approximately $216,000 during the grant period which ended in July 2023. No further funds are available under this award for the Phase I segment. In December 2023, the Company received a notice of award of approximately $2.0 million for the "Phase II" segment of the project. The Company recorded credits to research and development expense for costs related to the NICHD award of approximately $163,000 and $275,000 during the three and six months ended June 30, 2024, respectively. At June 30, 2024, the Company recorded a receivable of approximately $163,000 for expenses incurred through such date that it believes are eligible for reimbursement under the grant. DARE-LARC1 In September 2021, the Company received a notice of award of a grant from NICHD to support the development of DARE-LARC1. The award in the amount of approximately $300,000 was to be used to explore device insertion and removal in nonclinical studies. The Company recorded credits to research and development expense of approximately $32,000 for costs related to the NICHD award during the three and six months ended June 30, 2023. The Company received aggregate reimbursements under the NICHD award of approximately $278,000 during the grant period, which ended in June 2023. No further funds are available under this award. 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 $33,000 and $81,500 for costs related to the NICHD award during the three and six months ended June 30, 2023, respectively. The Company received aggregate reimbursements under the NICHD award of approximately $249,000 during the grant period, which ended in September 2023. No further funds are available under this award. DARE-PTB2 In July 2023, the Company received a notice of award of a grant from NICHD of approximately $385,000 to support preclinical development of a potential new therapeutic for the prevention of idiopathic preterm birth. The grant funds will support activities related to the conduct and completion of proof-of-concept target validation studies in collaboration with the University of South Florida, which are to occur over a 12-month period. The Company recorded credits to research and development expense of approximately $142,000 and $268,000 for costs related to the NICHD award for the three and six months ended June 30, 2024, respectively. The Company recorded a receivable of approximately $83,000 and $100,000 at June 30, 2024 and December 31, 2023, respectively, for expenses incurred through such date that it believes are eligible for reimbursement under the grant. Other Non-Dilutive Grant Funding As described below, the Company has received funding under grant agreements it entered into with the Bill & Melinda Gates Foundation, or the Foundation, in June 2021, November 2022, and January 2024. The Company is required to apply the funds it receives under the agreements solely toward direct costs for the applicable funded projects, other than approximately 5%-15% of such funds, which it may apply toward general overhead and administrative 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. Funds received that have not been spent are recorded as cash and cash equivalents and as a deferred grant funding liability in the Company’s consolidated balance sheets. The deferred grant funding liability also includes grant funds spent but not yet expensed in accordance with GAAP. The grant agreements include the Foundation's standard discretionary termination provisions. Any grant funds that have not been used or committed to the funded project must be returned promptly to the Foundation upon expiration or termination of the agreement. 2021 DARE-LARC1 Grant Agreement In June 2021, the Company entered into an agreement with the Foundation under which the Company was awarded up to $49.0 million to support the development of DARE-LARC1. The agreement, as amended, 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 and other IND-enabling work to allow for the submission of an IND application with the FDA, approval of which will be required to commence testing in humans. As of June 30, 2024, the Company has received a cumulative total of approximately $29.3 million in non-dilutive funding under the agreement, including $4.5 million during 2023 and $1.0 million during the three months ended June 30, 2024. Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones. The Company recorded credits to research and development expense of approximately $1.7 million and $3.9 million for costs related to this award for the three and six months ended June 30, 2024, respectively, and $2.1 million and $4.6 million for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, the Company has recorded approximately $10.6 million of deferred grant funding liability related to this award in the Company's condensed consolidated balance sheets. 2022 DARE-LBT Grant Agreement In November 2022, the Company entered into an agreement with the Foundation under which the Company was awarded $585,000 to support the development of DARE-LBT over the period of November 11, 2022 to February 29, 2024. The Company received the full amount of the award in November 2022. The Company recorded credits to research and development expense of approximately $6,000 and $0.2 million for costs related to this award for the three and six months ended June 30, 2024, respectively, and $8,000 and $29,000 for the three and six months ended June 30, 2023, respectively. As of June 30, 2024, the Company has recorded approximately $5,000 of deferred grant funding liability related to this award in the Company's condensed consolidated balance sheets. 2024 Biotherapeutic Product Grant Agreement In January 2024, the Company entered into an agreement with the Foundation under which the Company was awarded $750,000 to fund activities related to bacteria-based live biotherapeutic product development. The Company received the full amount of the award in January 2024. The Company recorded credits to research and development expense of approximately $0.2 million and $0.4 million |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share | NET INCOME (LOSS) PER SHARE The Company computes basic net income (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 Six Months Ended 2024 2023 2024 2023 Stock options 961,431 789,185 961,431 789,185 Warrants 1,203,583 542 1,201,620 542 Total 2,165,014 789,727 2,163,051 789,727 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENTS Insurance Financing On July 26, 2024, the Company obtained financing for certain director and officer and other liability insurance premiums. The total premiums, taxes and fees financed is approximately $0.6 million with an annual interest rate of approximately 8.0%. In consideration of the premium payment by the lender to the insurance companies or the agent or broker, the Company unconditionally promises to pay the lender the amount financed plus interest and other charges permitted under the agreement and the Company assigns to the lender a first priority lien on and a security interest in the financed insurance policies. The Company will pay the insurance financing through monthly installment payments through April 20, 2025. The financed amount, or note payable, will be recognized as an insurance financing cost included in other current assets and accrued expenses in the Company's consolidated balance sheets. License and Services Agreement On July 24, 2024, MBI entered into a 22-month license and services agreement and related statement of work (collectively, the "LSA") for a controlled clean room space in Burlington, Massachusetts that is expected to commence on March 1, 2025. Upon execution of the LSA, a payment of approximately $459,000 became due. Fixed payments, or License Fees, will be due at the beginning of each quarter, and monthly invoices for variable amounts related to support services will be due based on services provided. The Company's total obligation for License Fees under the LSA is approximately $3.9 million. The LSA may be renewed each year upon, subject to a 5% maximum increase in the amount of the License Fees. Reverse Stock Split On July 1, 2024, the Company effected a 1-for-12 reverse split of its issued common stock. At the effective time of the r everse stock split , every 12 shares of the Company’s common stock was automatically reclassified and combined into one share of common stock. No fractional shares were issued as a result of the reverse stock split. Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share. The reverse stock split reduced the number of issued and outstanding shares of the Company’s common stock from approximately 101.1 million to approximately 8.5 million |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net income (loss) | $ 12,910,656 | $ (6,755,356) | $ (8,762,232) | $ (8,042,501) | $ 6,155,300 | $ (16,804,733) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
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, 2023, or the 2023 10-K. Reclassifications Certain reclassifications have been made to the Company’s prior year amounts to conform to the current year presentation. |
Reverse Stock Split | Reverse Stock Split The Company effected a 1-for-12 reverse split of its issued common stock on July 1, 2024. At the effective time of the reverse stock split, every 12 shares of the Company’s common stock was automatically reclassified and combined into one share of common stock. No fractional shares were issued as a result of the reverse stock split. Stockholders who would have otherwise been entitled to receive a fractional share instead automatically had their fractional interests rounded up to the next whole share. The reverse stock split did not change the number of authorized shares or the par value per share of the Company’s common stock. See Note 12, Subsequent Events, for additional information regarding the reverse stock split. All common stock share and per share data presented in the accompanying condensed consolidated financial statements have been retroactively adjusted to reflect the impact of the reverse stock split for all periods presented, without giving effect to whole shares issued in lieu of fractional shares. In addition, proportionate adjustments were made in accordance with the applicable terms of outstanding stock options and warrants, the Company’s stock incentive plans and an existing agreement to the (a) per share exercise prices of, and the number of shares underlying, the Company’s outstanding stock options, (b) number of shares available for the grant of awards under the Company’s stock incentive plans, and (c) per share exercise prices of, and the number of shares underlying, outstanding warrants to purchase shares of the Company’s common stock and warrants potentially issuable by the Company in its sole discretion pursuant to an existing agreement. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
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, net losses, and negative cash flows from operations and, although it reported net income and positive cash flow from operations for the six months ended June 30, 2024, the Company expects significant losses from operations, net losses and negative cash flows from operations 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 June 30, 2024, the Company had an accumulated deficit of approximately $165.1 million, cash and cash equivalents of approximately $16.4 million, deferred grant funding liabilities under the Company's grant agreements related to DARE-LARC1, DARE-LBT and its bacteria-based live biotherapeutic product of approximately $10.9 million, and working capital of approximately $6.2 million. The Company's cash and cash equivalents at June 30, 2024 includes grant funds received under such agreements that may be applied solely toward direct costs for the development of DARE-LARC1, DARE-LBT and its bacteria-based live biotherapeutic product, 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 six months ended June 30, 2024, the Company incurred a loss from operations of approximately $13.4 million and reported net income of approximately $6.2 million and cash flow from operations of approximately $6.1 million. The Company's net income and cash flow from operations for the six months ended June 30, 2024 were positively impacted by the approximately $20.4 million of net proceeds the Company received from the sale in April 2024 of its rights to future royalty and milestone payments and revenue. See Note 8, Royalty Purchase Agreements. 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 these uncertainties. |
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. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or ASU 2023-07, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is evaluating the disclosure impact of ASU 2023-07 on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires companies to disclose, on an annual basis, specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. In addition, ASU 2023-09 requires companies to disclose additional information about income taxes paid. ASU 2023-09 will be effective for annual periods beginning January 1, 2025 and will be applied on a prospective basis with the option to apply the standard retrospectively. The Company is evaluating the disclosure impact of ASU 2023-09 on its consolidated financial statements. The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the condensed consolidated financial statements. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 June 30, 2024 and December 31, 2023. 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 June 30, 2024 or December 31, 2023. Fair Value Measurements Level 1 Level 2 Level 3 Total Balance at June 30, 2024 Current assets: Cash equivalents (1) $ 16,070,561 $ — $ — $ 16,070,561 Balance at December 31, 2023 Current assets: Cash equivalents (1) $ 9,982,079 $ — $ — $ 9,982,079 (1) Represents cash held in money market funds. |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Schedule of Common Stock Warrants Outstanding | A summary of warrant activity during the six months ended June 30, 2024 is presented below: Common Stock Number of Shares Underlying Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value Outstanding December 31, 2023, 1,268,572 $ 7.49 5.17 $ — Granted — — Exercised — — Forfeited or expired — — Outstanding and exercisable June 30, 2024, 1,268,572 $ 7.49 4.67 $ — |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
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 six months ended June 30, 2024. The exercise price of all options granted during the six months ended June 30, 2024 was equal to the market value of the Company’s common stock on the date of grant. As of June 30, 2024, unamortized stock-based compensation expense of approximately $3.5 million will be amortized over a weighted average period of 2.12 years. The number of shares of common stock available for future awards granted under the 2022 Plan as of June 30, 2024 was 387,594. Number of Shares Weighted Average Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value* Outstanding at December 31, 2023 788,569 $ 17.50 7.51 $ — Granted 224,530 5.48 — Exercised — — — Cancelled/forfeited (51,554) 11.76 10,150 Expired (114) 1,270.85 — Outstanding at June 30, 2024 961,431 $ 14.86 7.54 — Exercisable at June 30, 2024 573,546 $ 17.33 6.63 — *The aggregate intrinsic value is the sum of the amounts by which the quoted market price of the Company's common stock exceeded the exercise price of the stock options at June 30, 2024 for those stock options for which the quoted market price was in excess of the exercise price. |
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 Six Months Ended 2024 2023 2024 2023 Research and development $ 216,919 $ 210,198 $ 423,521 $ 410,499 General and administrative $ 345,800 $ 439,988 $ 766,897 $ 864,308 Total $ 562,719 $ 650,186 $ 1,190,418 $ 1,274,807 |
Leased Properties (Tables)
Leased Properties (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Schedule of Future Minimum Lease Payments | As of June 30, 2024, future minimum lease payments under the Company's operating leases are as follows: Remainder of 2024 $ 297,000 2025 660,000 2026 680,000 2027 130,000 Total future minimum lease payments 1,767,000 Less: accreted interest 242,000 Total operating lease liabilities $ 1,525,000 |
Royalty Interest Financing (Tab
Royalty Interest Financing (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Related Party Transactions [Abstract] | |
Schedule of Changes in the Liability Related to the Royalty Interest Financing | The following table shows the activity of the Royalty Obligation since the transaction inception through the period indicated: June 30, 2024 Upfront payment from the sale of future royalties $ 5,000,000 Debt issuance cost (276,101) Relative fair value of Initial Royalty Warrant (834,512) Royalty payments (23,942) Non-cash interest expense and interest payable associated with the sale of future royalties 442,672 Liability related to the sale of future royalties $ 4,308,117 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Potential Dilutive Outstanding Securities Excluded From Diluted Net Income (Loss) Per Common Share | Potentially dilutive securities Three Months Ended Six Months Ended 2024 2023 2024 2023 Stock options 961,431 789,185 961,431 789,185 Warrants 1,203,583 542 1,201,620 542 Total 2,165,014 789,727 2,163,051 789,727 |
Organization and Description _2
Organization and Description of Business (Details) | 6 Months Ended |
Jun. 30, 2024 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | 6 Months Ended | |||||||
Jul. 01, 2024 shares | Apr. 29, 2024 USD ($) | Jun. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Significant Accounting Policies [Line Items] | |||||||||
Restricted cash included in other non-current assets | $ 300,000 | $ 335,000 | $ 300,000 | $ 335,000 | |||||
Accumulated deficit | 165,080,731 | 165,080,731 | $ 171,236,031 | ||||||
Cash and cash equivalents | 16,414,992 | 13,329,101 | 16,414,992 | 13,329,101 | 10,476,056 | ||||
Deferred grant funding | 10,937,663 | 10,937,663 | $ 13,737,154 | ||||||
Working capital | 6,200,000 | 6,200,000 | |||||||
Loss from operations | 7,359,466 | 8,989,356 | 13,381,939 | 17,372,005 | |||||
Net income (loss) | 12,910,656 | $ (6,755,356) | (8,762,232) | $ (8,042,501) | 6,155,300 | (16,804,733) | |||
Cash flow from operations | 6,100,000 | ||||||||
Sale of royalty and milestone rights, net | 20,379,376 | 0 | $ 20,379,376 | 0 | |||||
Period of insufficient cash and liquidity requirements | 12 months | ||||||||
Other income (expense), net | $ (109,254) | $ 227,124 | $ (842,137) | $ 567,272 | |||||
XOMA | Royalty Purchase Agreement | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Revenue tier threshold, upper range limit | $ 22,000,000 | ||||||||
Maximum royalty payments | 88,000,000 | ||||||||
Contingent purchase price payments | 11,000,000 | ||||||||
Issuance costs | 1,600,000 | ||||||||
Other income (expense), net | $ 1,600,000 | ||||||||
Subsequent Event | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Stock split, conversion ratio | 0.0833 | ||||||||
Basis prior to conversion (in shares) | shares | 12 | ||||||||
Basis after conversion (in shares) | shares | 1 |
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 ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 16,070,561 | $ 9,982,079 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 16,070,561 | 9,982,079 |
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 - Addition
Strategic Agreements - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||||||
Jul. 31, 2023 USD ($) | Aug. 31, 2022 USD ($) | Jul. 31, 2022 USD ($) | Sep. 30, 2021 USD ($) shares | Jun. 30, 2021 USD ($) | Jan. 31, 2020 USD ($) expert obligation | Nov. 30, 2019 USD ($) | May 31, 2018 USD ($) | Apr. 30, 2018 USD ($) | Feb. 28, 2018 USD ($) | Mar. 31, 2017 USD ($) | Jun. 30, 2024 USD ($) | Dec. 31, 2023 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2022 | Dec. 31, 2021 USD ($) | Aug. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Total revenue | $ 22,438 | $ 0 | $ 31,740 | $ 0 | |||||||||||||||
License And Collaboration Revenue | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Total revenue | 12,800,000 | ||||||||||||||||||
Upon Achievement of Specified Development and Regulatory Milestones | Related Party | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | 50,000,000 | ||||||||||||||||||
Microchips Biotech, Inc. | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Payment of additional consideration | $ 1,250,000 | ||||||||||||||||||
Microchips Biotech, Inc. | Upon Achievement of Specified Development and Regulatory Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments | $ 46,500,000 | ||||||||||||||||||
Current portion of contingent consideration | $ 55,000,000 | ||||||||||||||||||
ADVA Tec Agreement | Upon Achievement of Specified Development and Regulatory Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments | $ 14,600,000 | ||||||||||||||||||
ADVA Tec Agreement | Maximum | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Percentage of royalty rate | 10% | ||||||||||||||||||
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 | 1,000,000 | 1,000,000 | |||||||||||||||||
Number of experts | expert | 2 | ||||||||||||||||||
Total revenue | $ 20,000,000 | ||||||||||||||||||
Number of significant performance obligations | obligation | 1 | ||||||||||||||||||
Milestone payments, contingent amount | $ 310,000,000 | ||||||||||||||||||
Bayer Healthcare License Agreement | Minimum | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Expiration period | 15 years | ||||||||||||||||||
Hennepin License Agreement | Clinical and Regulatory Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | $ 6,250,000 | ||||||||||||||||||
Hennepin License Agreement | Sales Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | $ 45,000,000 | ||||||||||||||||||
Licensing Agreements | Related Party | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | 1,000,000 | ||||||||||||||||||
Licensing Agreements | Related Party | Upon Achieving Certain Commercial Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | 850,000 | ||||||||||||||||||
Licensing Agreements | Related Party | Licensed Product or Process for Vaginal or Urological Use | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | 250,000 | ||||||||||||||||||
Licensing Agreements | Maximum | Related Party | Upon Achieving Certain Development Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | $ 500,000 | $ 300,000 | |||||||||||||||||
Licensing Agreements | Upon Achievement of Specified Development and Regulatory Milestones | Related Party | Upon Achieving Certain Commercial Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | $ 1,200,000 | ||||||||||||||||||
Licensing Agreements | ADVA Tec Agreement | Upon Reaching Certain Worldwide Net Sales Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments | $ 20,000,000 | ||||||||||||||||||
Assignment Agreement | Related Party | Upon Achieving Certain Clinical and Regulatory Development Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | 1,100,000 | ||||||||||||||||||
Merger Agreement | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | $ 15,500,000 | ||||||||||||||||||
Milestone payments | 3,200,000 | ||||||||||||||||||
Pear Tree Pharmaceuticals, Inc. | Sales Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | $ 47,000,000 | ||||||||||||||||||
Juniper Pharmaceuticals, Inc | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Upfront license fee paid | $ 250,000 | ||||||||||||||||||
Potential annual license maintenance fee payments, thereafter | 100,000 | ||||||||||||||||||
Juniper Pharmaceuticals, Inc | Clinical and Regulatory Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | 13,500,000 | ||||||||||||||||||
Juniper Pharmaceuticals, Inc | Sales Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Maximum potential milestone payments | $ 30,300,000 | ||||||||||||||||||
License and Collaboration Agreement | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | $ 18,000,000 | ||||||||||||||||||
License and Collaboration Agreement | Upon Achieving Certain Commercial Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | $ 100,000,000 | ||||||||||||||||||
Douglas License Agreement | Upon Achieving Certain Development Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Sales based milestones amount | $ 5,250,000 | ||||||||||||||||||
Douglas License Agreement | Upon Achieving Certain Commercial Milestones | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Sales based milestones amount | $ 64,000,000 | ||||||||||||||||||
Organon | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Upfront license fee paid | $ 10,000,000 | ||||||||||||||||||
Milestone payments, reimburse amount, PDUFA fees and other manufacturing expenses | $ 1,000,000 | ||||||||||||||||||
First commercial sale amount | 1,800,000 | ||||||||||||||||||
Sales based milestones amount | $ 180,000,000 | $ 180,000,000 | |||||||||||||||||
Advanced written notice period | 120 days | ||||||||||||||||||
Former Stockholders of MBI | Microchips Biotech, Inc. | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | shares | 58,334 | ||||||||||||||||||
Cash paid to stockholders' representative | $ 75,000 | ||||||||||||||||||
Catalent and MilanaPharm | Licensing Agreements | |||||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||||
Milestone payments, contingent amount | $ 1,000,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended | ||||||||||
Dec. 31, 2023 $ / shares shares | Sep. 30, 2023 USD ($) yr $ / shares shares | Aug. 31, 2023 USD ($) $ / shares shares | Mar. 31, 2023 | Jan. 31, 2023 USD ($) shares | Jul. 31, 2020 $ / shares | Apr. 30, 2019 $ / shares | Jun. 30, 2024 USD ($) yr shares | Jun. 30, 2023 USD ($) shares | May 10, 2024 USD ($) | Mar. 28, 2024 USD ($) | Feb. 15, 2018 USD ($) $ / shares | |
Class of Stock [Line Items] | ||||||||||||
Exercise Price (in usd per share) | $ / shares | $ 36 | |||||||||||
Estimated fair value of warrants recorded in equity | $ 3 | |||||||||||
Warrant, exercise price, decrease (in usd per share) | $ / shares | $ 11.52 | $ 11.76 | ||||||||||
Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, number of shares issued (in shares) | shares | 112,793 | |||||||||||
Shares of common stock for net proceeds | $ 1.3 | |||||||||||
Registered Direct Offering | Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, number of shares issued (in shares) | shares | 845,225 | |||||||||||
Class of warrant or right, number of securities called by each warrant or right | shares | 1 | |||||||||||
Exercise Price (in usd per share) | $ / shares | $ 9.11 | |||||||||||
Class of warrant or right, extent holder own percentage | 0.0499 | |||||||||||
Class of warrant or right, extent holder own percentage | 0.0999 | |||||||||||
Class of warrant or right, exercises | shares | 0 | |||||||||||
Registered Direct Offering | Warrants | Measurement Input, Price Volatility | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0.8777 | |||||||||||
Registered Direct Offering | Warrants | Measurement Input, Risk Free Interest Rate | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0.0429 | |||||||||||
Registered Direct Offering | Warrants | Measurement Input, Expected Dividend Payment | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0 | |||||||||||
Registered Direct Offering | Warrants | Measurement Input, Expected Term | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | yr | 5.5 | |||||||||||
Registered Direct Offering | Warrants | Estimate of Fair Value Measurement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding (in shares) | $ 2.9 | |||||||||||
March 2023 At The Market Sales Agreement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, number of shares issued (in shares) | shares | 93,247 | 37,883 | ||||||||||
Shares of common stock for net proceeds | $ 0.4 | $ 0.5 | ||||||||||
Commission percent | 3% | |||||||||||
March 2023 At The Market Sales Agreement | Maximum | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, prospectus offering amount | $ 18.1 | $ 19 | ||||||||||
Royalty Investment Financing Agreement | Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, number of shares issued (in shares) | shares | 422,805 | |||||||||||
Warrant term | 5 years | |||||||||||
Exercise Price (in usd per share) | $ / shares | $ 4.10 | |||||||||||
Class of warrant or right, extent holder own percentage | 0.0499 | |||||||||||
Class of warrant or right, extent holder own percentage | 0.0999 | |||||||||||
Royalty Investment Financing Agreement | Warrants | Measurement Input, Price Volatility | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0.8591 | |||||||||||
Royalty Investment Financing Agreement | Warrants | Measurement Input, Risk Free Interest Rate | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0.0405 | |||||||||||
Royalty Investment Financing Agreement | Warrants | Measurement Input, Expected Dividend Payment | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | 0 | |||||||||||
Royalty Investment Financing Agreement | Warrants | Measurement Input, Expected Term | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding, measurement input | yr | 5 | |||||||||||
Royalty Investment Financing Agreement | Warrants | Estimate of Fair Value Measurement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants and rights outstanding (in shares) | $ 0.8 | |||||||||||
Common stock | Registered Direct Offering | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Sale of stock, number of shares issued (in shares) | shares | 833,334 | |||||||||||
Shares issued (in usd per share) | $ / shares | $ 8.40 | |||||||||||
Shares of common stock for net proceeds | $ 7 | |||||||||||
Aggregate net proceeds on sales of shares of common stock | $ 7 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) - Warrants - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares Underlying Warrants | ||
Outstanding beginning balance (in shares) | 1,268,572 | |
Granted (in shares) | 0 | |
Exercised (in shares) | 0 | |
Forfeited or expired (in shares) | 0 | |
Outstanding ending balance (in shares) | 1,268,572 | |
Outstanding and exercisable (in shares) | 1,268,572 | |
Weighted Average Exercise Price | ||
Outstanding beginning balance (in usd per share) | $ 7.49 | |
Granted (in usd per share) | 0 | |
Exercised (in usd per share) | 0 | |
Forfeited or expired (in usd per share) | 0 | |
Outstanding ending balance (in usd per share) | $ 7.49 | |
Options exercisable, ending (in usd per share) | $ 7.49 | |
Weighted Average Remaining Life in Years | ||
Outstanding, Weighed Average Remaining Life in Years | 5 years 2 months 1 day | |
Outstanding and exercisable, Weighed Average Remaining Life in Years | 4 years 8 months 1 day | |
Intrinsic Value | ||
Outstanding, Intrinsic Value | $ 0 | |
Outstanding and exercisable, Intrinsic Value | $ 0 |
Stock Based Compensation - Addi
Stock Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 23, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unamortized stock-based compensation expense | $ 3,500,000 | $ 3,500,000 | |||
Weighted average amortization period | 2 years 1 month 13 days | ||||
Employee Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 562,719 | $ 650,186 | $ 1,190,418 | $ 1,274,807 | |
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 2014 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) | 843,108 | ||||
Common stock reserved for future issuance (in shares) | 512,056 | ||||
Amended and Restated 2014 Stock Incentive Plan | Employee Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock reserved for future issuance (in shares) | 387,594 | 387,594 | |||
Weighted-average fair value of options granted (in usd per share) | $ 4.16 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Details) - Amended and Restated 2014 Stock Incentive Plan - Employee Stock Option - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Number of Shares | ||
Outstanding beginning balance (in shares) | 788,569 | |
Granted (in shares) | 224,530 | |
Exercised (in shares) | 0 | |
Canceled/forfeited (in shares) | (51,554) | |
Expired (in shares) | (114) | |
Outstanding ending balance (in shares) | 961,431 | 788,569 |
Exercisable (in shares) | 573,546 | |
Weighted Average Exercise Price | ||
Outstanding beginning balance (in usd per share) | $ 17.50 | |
Granted (in usd per share) | 5.48 | |
Exercised (in usd per share) | 0 | |
Canceled/forfeited (in usd per share) | 11.76 | |
Expired (in usd per share) | 1,270.85 | |
Outstanding ending balance (in usd per share) | 14.86 | $ 17.50 |
Exercisable (in usd per share) | $ 17.33 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted Average Remaining Contractual Term (Years), Outstanding | 7 years 6 months 14 days | 7 years 6 months 3 days |
Weighted Average Remaining Contractual Term (Years), Exercisable | 6 years 7 months 17 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value* | $ 10,150 |
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 | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 562,719 | $ 650,186 | $ 1,190,418 | $ 1,274,807 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 216,919 | 210,198 | 423,521 | 410,499 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 345,800 | $ 439,988 | $ 766,897 | $ 864,308 |
Leased Properties - Additional
Leased Properties - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Nov. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Mar. 08, 2024 | Dec. 31, 2023 USD ($) | Feb. 28, 2022 | Jul. 01, 2018 ft² | |
Lessee, Lease, Description [Line Items] | |||||||||
Square footage of office space | ft² | 3,169 | ||||||||
Renewal term of operating lease | 3 years | ||||||||
Operating right-of-use assets obtained in exchange for new operating lease liabilities, net | $ 358,315 | $ 0 | |||||||
Right of use asset | $ 1,445,823 | 1,445,823 | $ 1,319,630 | ||||||
Non-cash lease expenses | 191,000 | $ 145,000 | 391,000 | 284,000 | |||||
Cash paid for measurement of operating lease liabilities | $ 159,000 | $ 105,000 | $ 318,000 | $ 209,000 | |||||
Operating lease weighted average remaining lease term | 2 years 11 months 1 day | 2 years 11 months 1 day | |||||||
Weighted average interest rate | 10.50% | 10.50% | |||||||
Maximum | |||||||||
Lessee, Lease, Description [Line Items] | |||||||||
Incremental borrowing rate, amount over prime rate | 0.0200 | 0.0200 | |||||||
MBI | |||||||||
Lessee, Lease, Description [Line Items] | |||||||||
Renewal term of operating lease | 3 years | 3 years | |||||||
Operating right-of-use assets obtained in exchange for new operating lease liabilities, net | $ 1,300,000 |
Leased Properties - Future Mini
Leased Properties - Future Minimum Lease Payments (Details) | Jun. 30, 2024 USD ($) |
Leases [Abstract] | |
Remainder of 2024 | $ 297,000 |
2025 | 660,000 |
2026 | 680,000 |
2027 | 130,000 |
Total future minimum lease payments | 1,767,000 |
Less: accreted interest | 242,000 |
Total operating lease liabilities | $ 1,525,000 |
Royalty Interest Financing - Ad
Royalty Interest Financing - Additional Information (Details) | Dec. 21, 2023 USD ($) payment $ / shares shares | Feb. 15, 2018 $ / shares |
Class of Warrant or Right [Line Items] | ||
Exercise Price (in usd per share) | $ / shares | $ 36 | |
United in Endeavor, LLC | ||
Class of Warrant or Right [Line Items] | ||
Proceeds from royalties received | $ 5,000,000 | |
Number of additional payment | payment | 3 | |
Internal rate of return | 12% | |
Hard cap rate | 50% | |
Net royalty payments rate | 75% | |
Milestone payments rate | 10% | |
Quarterly payment period | 2 years | |
Effective annual interest rate | 22.48% | |
United in Endeavor, LLC | Maximum | ||
Class of Warrant or Right [Line Items] | ||
Supplemental investment payment | $ 12,000,000 | |
United in Endeavor, LLC | Minimum | ||
Class of Warrant or Right [Line Items] | ||
Supplemental investment payment | $ 7,000,000 | |
United in Endeavor, LLC | Warrants | ||
Class of Warrant or Right [Line Items] | ||
Issuable upon additional investment made number of securities called by warrants | shares | 422,804 | |
Additional investment amount | $ 1,000,000 | |
Exercise Price (in usd per share) | $ / shares | $ 4.10 | |
United in Endeavor, LLC | Warrants | Estimate of Fair Value Measurement | ||
Class of Warrant or Right [Line Items] | ||
Warrants and rights outstanding (in shares) | $ 800,000 | |
United in Endeavor, LLC | Warrants | Maximum | ||
Class of Warrant or Right [Line Items] | ||
Issuable upon additional investment made number of securities called by warrants | shares | 591,927 | |
Supplemental investment (in shares) | shares | 84,561 |
Royalty Interest Financing - Sc
Royalty Interest Financing - Schedule of Changes in the Liability Related to the Sale of Future Royalties (Details) - USD ($) | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Class of Warrant or Right [Line Items] | |||
Non-cash interest expense on liability related to sale of future royalties | $ 170,864 | $ 0 | |
Liability related to the sale of future royalties, net | 4,308,117 | $ 3,913,676 | |
Royalty revenue | |||
Class of Warrant or Right [Line Items] | |||
Upfront payment from the sale of future royalties | 5,000,000 | ||
Debt issuance cost | (276,101) | ||
Relative fair value of Initial Royalty Warrant | (834,512) | ||
Royalty payments | (23,942) | ||
Non-cash interest expense on liability related to sale of future royalties | 442,672 | ||
Liability related to the sale of future royalties, net | $ 4,308,117 |
Royalty Purchase Agreements (De
Royalty Purchase Agreements (Details) - Royalty Purchase Agreement - USD ($) $ in Millions | 3 Months Ended | |
Apr. 29, 2024 | Jun. 30, 2024 | |
XACIATO | ||
Commitments And Contingencies [Line Items] | ||
Transaction costs | $ 1.6 | |
Synthetic | ||
Commitments And Contingencies [Line Items] | ||
Proceeds from sale of royalty and milestone rights | $ 22 | |
XOMA | ||
Commitments And Contingencies [Line Items] | ||
Proceeds from royalties received | 22 | |
Maximum royalty payments | 88 | |
Contingent purchase price payments | 11 | |
Revenue tier threshold, upper range limit | $ 22 | |
XOMA | XACIATO | ||
Commitments And Contingencies [Line Items] | ||
Milestone payments rate | 100% | |
XOMA | Ovaprene | ||
Commitments And Contingencies [Line Items] | ||
Net royalty payments rate | 4% | |
XOMA | Sildenafil Cream, 2.0% | ||
Commitments And Contingencies [Line Items] | ||
Future net sales | 0.020 | |
XOMA | Sildenafil Cream, 3.6% | ||
Commitments And Contingencies [Line Items] | ||
Maximum royalty payments | $ 110 | |
Future net sales | 0.036 | |
XOMA | Sildenafil Cream, 3.6% | Maximum | ||
Commitments And Contingencies [Line Items] | ||
Percentage of royalty rate | 2.50% | |
XOMA | Sildenafil Cream, 3.6% | Minimum | ||
Commitments And Contingencies [Line Items] | ||
Percentage of royalty rate | 1.25% | |
Bayer | ||
Commitments And Contingencies [Line Items] | ||
Potential future payment, percentage | 0.25 | |
Potential future payment | $ 20 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | ||
Jul. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2024 | Jul. 31, 2021 | |
Commitments And Contingencies [Line Items] | ||||
Premiums, taxes and fees | $ 600 | |||
Interest rate on insurance financing | 8% | |||
Remaining performance obligation, amount | $ 0 | |||
NICHD | ||||
Commitments And Contingencies [Line Items] | ||||
Total payment | $ 5,500 | |||
Other cost | $ 5,000 | |||
CRADA | ||||
Commitments And Contingencies [Line Items] | ||||
Remaining performance obligation, amount | $ 500 |
Grant Awards (Details)
Grant Awards (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2023 | Jul. 31, 2023 | May 31, 2022 | Sep. 30, 2021 | Aug. 31, 2020 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Jan. 31, 2024 | Nov. 30, 2022 | Jun. 30, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Research and development expenses | $ 4,908,774 | $ 6,043,684 | $ 8,237,294 | $ 11,063,907 | ||||||||||
Deferred grant funding | $ 13,737,154 | 10,937,663 | 10,937,663 | $ 13,737,154 | ||||||||||
Minimum | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Non-dilutive grant funding, percentage excluded | 5% | |||||||||||||
Maximum | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Non-dilutive grant funding, percentage excluded | 15% | |||||||||||||
Grant, DARE-PTB1 | Phase I Segment | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | $ 216,000 | $ 300,000 | 163,000 | |||||||||||
Credits recorded to research and development expense for costs related to award | 163,000 | 275,000 | ||||||||||||
Grant, DARE-PTB1 | Phase II Segment | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | 2,000,000 | |||||||||||||
DARE-LARC1 | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | $ 300,000 | 29,300,000 | $ 278,000 | 4,500,000 | ||||||||||
Credits recorded to research and development expense for costs related to award | 32,000 | 32,000 | ||||||||||||
Initial payment | $ 49,000,000 | |||||||||||||
Research and development expenses | 1,700,000 | 2,100,000 | 3,900,000 | 4,600,000 | ||||||||||
Deferred grant funding | 10,600,000 | 10,600,000 | ||||||||||||
DARE-LARC1 | DARE-LARC1 2021 Grant Agreement | Foundation | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | 1,000,000 | |||||||||||||
Grant, ADARE-204 and ADARE-214 | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | $ 249,000 | |||||||||||||
Credits recorded to research and development expense for costs related to award | 33,000 | 81,500 | ||||||||||||
Receivable for expenses eligible for reimbursement | $ 249,000 | |||||||||||||
NICHD | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Proceeds from award of grants | $ 385,000 | |||||||||||||
Grant, DARE-PTB2 | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Credits recorded to research and development expense for costs related to award | 142,000 | 268,000 | ||||||||||||
Receivable for expenses eligible for reimbursement | $ 100,000 | 83,000 | 83,000 | $ 100,000 | ||||||||||
DARE-LBT | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Initial payment | $ 585,000 | |||||||||||||
Deferred grant funding | 5,000 | 5,000 | ||||||||||||
Credits to research and development expense | 6,000 | $ 8,000 | 200,000 | $ 29,000 | ||||||||||
Biotherapeutic Product Grant Agreement | ||||||||||||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||||||||||||
Credits recorded to research and development expense for costs related to award | 200,000 | 400,000 | ||||||||||||
Initial payment | $ 750,000 | |||||||||||||
Deferred grant funding | $ 400,000 | $ 400,000 |
Net Income (Loss) Per Share - P
Net Income (Loss) Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Income (Loss) Per Common Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 2,165,014 | 789,727 | 2,163,051 | 789,727 |
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) | 961,431 | 789,185 | 961,431 | 789,185 |
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding (in shares) | 1,203,583 | 542 | 1,201,620 | 542 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Thousands | Jul. 24, 2024 USD ($) | Jul. 01, 2024 shares | Jul. 26, 2024 USD ($) | Jul. 02, 2024 shares | Jun. 30, 2024 shares | Dec. 31, 2023 shares |
Subsequent Event [Line Items] | ||||||
Common stock, shares issued (in shares) | 8,546,361 | 8,331,161 | ||||
Common stock, shares outstanding (in shares) | 8,546,361 | 8,331,161 | ||||
Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Stock split, conversion ratio | 0.0833 | |||||
Basis prior to conversion (in shares) | 12 | |||||
Basis after conversion (in shares) | 1 | |||||
Common stock, shares issued (in shares) | 101,100,000 | 8,500,000 | ||||
Common stock, shares outstanding (in shares) | 101,100,000 | 8,500,000 | ||||
Subsequent Event | License and Services | MBI | ||||||
Subsequent Event [Line Items] | ||||||
License and services agreement term | 22 months | |||||
Amount due upon execution | $ | $ 459 | |||||
Total obligation | $ | $ 3,900 | |||||
Maximum percentage increase | 5% | |||||
Subsequent Event | Insurance Financing | ||||||
Subsequent Event [Line Items] | ||||||
Amount financed | $ | $ 600 | |||||
Interest rate | 8% |