Daré Bioscience(DARE) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Condensed Consolidated Financial Statements (Unaudited) This section provides the unaudited condensed consolidated financial statements, highlighting significant declines in assets and cash, a widening stockholders' deficit, and a shift to net loss due to the absence of a prior-year royalty sale Condensed Consolidated Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and stockholders' deficit at specific points in time Condensed Consolidated Balance Sheet Highlights | Metric | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------- | :-------------- | :---------------- | :--------- | :--------- | | Total Assets | $12,979,525 | $22,101,131 | $(9,121,606) | (41.27)% | | Cash and Cash Equivalents | $5,035,006 | $15,698,174 | $(10,663,168) | (67.93)% | | Total Liabilities | $25,712,785 | $28,113,220 | $(2,400,435) | (8.54)% | | Total Stockholders' Deficit | $(12,733,260) | $(6,012,089) | $(6,721,171) | (111.79)% | Condensed Consolidated Statements of Operations and Comprehensive Loss This section details the company's revenues, expenses, and net income or loss over specific reporting periods Three Months Ended June 30, 2025 vs. 2024 | Metric | 2025 | 2024 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :----------- | :--------- | | Royalty Revenue | $(21,172) | $22,438 | $(43,610) | (194)% | | Total Operating Expenses | $3,806,628 | $7,381,904 | $(3,575,276) | (48)% | | Loss from Operations | $(3,827,800) | $(7,359,466) | $3,531,666 | (48)% | | Sale of Royalty & Milestone Rights, net | $0 | $20,379,376 | $(20,379,376) | (100)% | | Net Income (Loss) | $(4,016,483) | $12,910,656 | $(16,927,139) | (131)% | Six Months Ended June 30, 2025 vs. 2024 | Metric | 2025 | 2024 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :----------- | :--------- | | Royalty Revenue | $4,255 | $31,740 | $(27,485) | (87)% | | Total Operating Expenses | $8,413,173 | $13,413,679 | $(4,992,832) | (37)% | | Loss from Operations | $(8,408,918) | $(13,381,939) | $4,973,021 | (37)% | | Sale of Royalty & Milestone Rights, net | $0 | $20,379,376 | $(20,379,376) | (100)% | | Net Income (Loss) | $(8,394,790) | $6,155,300 | $(14,550,090) | (236)% | Condensed Consolidated Statements of Stockholders' Deficit This section outlines changes in the company's stockholders' deficit, including net loss, stock-based compensation, and common stock issuance Stockholders' Deficit Highlights (Six Months Ended June 30, 2025) | Metric | Amount | | :------------------------------------ | :----------- | | Balance at December 31, 2024 | $(6,012,089) | | Stock-based compensation | $736,375 | | Issuance of common stock, net of costs | $911,261 | | Net loss | $(8,394,790) | | Foreign currency translation adjustments | $25,983 | | Balance at June 30, 2025 | $(12,733,260) | Condensed Consolidated Statements of Cash Flows This section summarizes the cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :------------------------------------------ | :----------- | :----------- | :----------- | :--------- | | Net cash (used in) provided by operating activities | $(10,887,999) | $6,091,723 | $(16,979,722) | (279)% | | Net cash used in investing activities | $(3,935) | $(292,522) | $288,587 | (99)% | | Net cash provided by financing activities | $202,783 | $129,398 | $73,385 | 57% | | Net change in cash, cash equivalents and restricted cash | $(10,663,168) | $5,903,936 | $(16,567,104) | (281)% | Notes to Condensed Consolidated Financial Statements (Unaudited) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements 1. ORGANIZATION AND DESCRIPTION OF BUSINESS This section describes the company's core business, strategic focus, and key product offerings - The company is a biopharmaceutical firm focused on women's health, aiming to bridge the gap between science and solutions[27] - In March 2025, the company expanded its business strategy to a dual-path approach, pursuing both FDA approval and earlier market access via Section 503B compounding for certain proprietary formulations[29] - XACIATO™ (clindamycin phosphate) vaginal gel 2% is the first FDA-approved product from the company's portfolio, with exclusive worldwide rights licensed to Organon, which commenced U.S. marketing in Q4 2023[31] 2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES This section outlines the accounting principles used in preparing the financial statements and significant accounting policies - The company's financial statements are prepared in accordance with U.S. GAAP for interim financial information[32] - There is substantial doubt about the company's ability to continue as a going concern within the next 12 months, given its history of losses, current working capital deficit of ~$12.6 million, and net loss of ~$8.4 million for the six months ended June 30, 2025[34][36] - A 1-for-12 reverse stock split was effected on July 1, 2024, with all common stock share and per share data retroactively adjusted[39][40] - The company is assessing recently issued accounting pronouncements (ASU 2024-03 and ASU 2023-09), noting that adoption impacts disclosure only[46][47][48] 3. STRATEGIC AGREEMENTS This section details key licensing, collaboration, and royalty agreements that impact the company's product development and revenue streams - The company licensed exclusive worldwide rights for XACIATO to Organon in 2022, and subsequently sold its rights to all royalty and potential milestone payments from Organon to XOMA in April 2024[49][53] - Bayer HealthCare holds a license option for Ovaprene, which, if exercised, would involve a $20.0 million payment to the company and transfer commercialization responsibility to Bayer[56] - The company has various pipeline development agreements, including for DARE-HPV (potential milestones up to $69.25 million), DARE-GML (potential milestones up to $51.25 million), DARE-LARC1 (potential milestones up to $101.5 million), and Sildenafil Cream (potential milestones up to $118.0 million)[63][65][67][79] 4. STOCKHOLDERS' EQUITY This section details changes in the company's equity, including stock sales, warrants, and their impact on capital structure - The company has an equity line with Lincoln Park Capital Fund, LLC, allowing it to sell up to $15.0 million of common stock over 24 months. During the six months ended June 30, 2025, 330,000 shares were sold for approximately $0.9 million in net proceeds[84][86] - As of June 30, 2025, 1,268,572 common stock warrants were outstanding and exercisable, with a weighted average exercise price of $7.49 and a remaining life of 3.60 years[90] 5. STOCK-BASED COMPENSATION This section details the company's stock-based compensation plans and the associated expenses recognized - The 2014 Employee Stock Purchase Plan (ESPP) was suspended in June 2024, and no further awards will be granted under the Amended and Restated 2014 Stock Incentive Plan following the approval of the 2022 Plan[91][92] - As of June 30, 2025, 1,121,802 stock options were outstanding under the company's incentive plans, with a weighted average exercise price of $11.27[97] Stock-Based Compensation Expense (Six Months Ended June 30) | Category | 2025 | 2024 | Change ($) | Change (%) | | :---------------------- | :----------- | :----------- | :----------- | :--------- | | Research and development | $325,212 | $423,521 | $(98,309) | (23)% | | General and administrative | $411,163 | $766,897 | $(355,734) | (46)% | | Total | $736,375 | $1,190,418 | $(454,043) | (38)% | 6. LEASED PROPERTIES This section describes the company's lease agreements for properties, including clean room space and office facilities - The company entered into a finance lease for clean room space in Burlington, Massachusetts, with a 22-month term commencing March 1, 2025, recording an initial finance lease right-of-use asset and related liability of approximately $3.3 million and $2.8 million, respectively[101][102] - Operating leases for corporate headquarters and MBI's office/laboratory space expire in October 2027 and December 2026, respectively[103][104] Total Lease Cost (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :---------------- | :----------- | :----------- | :----------- | :--------- | | Operating lease cost | $424,000 | $391,000 | $33,000 | 8% | | Finance lease cost | $673,000 | $0 | $673,000 | N/A | | Total lease cost | $1,097,000 | $391,000 | $706,000 | 181% | Present Value of Lease Liabilities (June 30, 2025) | Lease Type | Amount | | :--------------- | :----------- | | Operating Leases | $1,037,000 | | Finance Lease | $1,996,000 | | Total | $3,033,000 | 7. ROYALTY INTEREST FINANCING This section details the company's royalty interest financing arrangements, including the sale of future royalties and associated liabilities - In December 2023, the company received $5.0 million from United in Endeavour, LLC (UiE) for a portion of its royalty interest in XACIATO, recorded as a liability related to the sale of future royalties[109][112] - The royalty obligation is amortized using the effective interest method over the estimated term, with an estimated effective annual interest rate of approximately 22.48%[112][114] Royalty Obligation Activity (Through June 30, 2025) | Item | Amount | | :---------------------------------------------------------- | :----------- | | 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 | $(6,444) | | Non-cash interest expense and interest payable | $1,184,047 | | Liability related to the sale of future royalties | $5,066,990 | 8. ROYALTY PURCHASE AGREEMENTS This section describes agreements for the sale of royalty and milestone payment rights to third parties - In April 2024, the company received $22.0 million from XOMA through traditional and synthetic royalty purchase agreements[117] - XOMA acquired 100% of the company's net royalties and potential milestone payments from Organon for XACIATO (from April 1, 2024), 25% of a potential $20.0 million payment from Bayer for Ovaprene, and synthetic royalties on future net sales of Ovaprene (4.0%) and Sildenafil Cream (2.0%)[118] - XOMA will pay the company $11.0 million for each successive $22.0 million XOMA receives above $88.0 million under these agreements[117] 9. COMMITMENTS AND CONTINGENCIES This section outlines the company's financial commitments, potential liabilities, and ongoing legal or contractual obligations - An insurance financing arrangement for approximately $0.6 million, with an 8.0% annual interest rate, was fully repaid by June 30, 2025[121] - The company is not aware of any material claims, disputes, or unsettled legal matters that would adversely affect its financial position[122] - A consulting agreement with the former Chief Financial Officer for transition matters, paying $31,667 per month, commenced in January 2024 for a nine-month period[123] 10. GRANT AWARDS This section details the non-dilutive grant funding received by the company to support its research and development programs - The company received a $10.0 million grant from VentureWell in October 2024 to support the DARE-HPV program, with $3.5 million received through June 30, 2025[124][126] - Additional non-dilutive grant funding includes $1.0 million from NIAID for DARE-HPV, $2.0 million from NICHD for DARE-PTB1, and various grants from the Gates Foundation for Ovaprene (up to ~$10.7 million) and DARE-LARC1 (up to ~$49.0 million, with ~$31.8 million received cumulatively)[128][129][133][136][137] - Grant funding is recognized as a reduction to R&D expenses (contra R&D expense), totaling approximately $7.6 million for the six months ended June 30, 2025[187][208][209] 11. NET LOSS PER SHARE This section presents the basic and diluted net loss per common share for the reporting periods Income (Loss) Per Common Share (Six Months Ended June 30) | Metric | 2025 | 2024 | | :--------- | :----- | :----- | | Basic | $(0.95) | $0.73 | | Diluted | $(0.95) | $0.72 | - Potentially dilutive securities, including 1,121,802 stock options and 1,268,572 warrants, were excluded from diluted EPS calculations for the six months ended June 30, 2025, due to their anti-dilutive effect[141] 12. SEGMENT INFORMATION This section clarifies that the company operates as a single segment focused on Women's Health, with performance evaluated on a consolidated basis - The company operates and manages its business as a single operating segment: Women's Health[142] - The Chief Executive Officer (CEO) serves as the Chief Operating Decision Maker (CODM) and evaluates performance and allocates resources on a consolidated basis, using net loss as the measure of segment profit or loss[142] Total Research and Development Direct Program Costs (Six Months Ended June 30) | Program | 2025 | 2024 | | :------------------------------------ | :----------- | :----------- | | Ovaprene | $2,812,101 | $5,163,358 | | Sildenafil Cream, 3.6% | $261,270 | $1,166,510 | | Other advanced clinical stage programs | $1,466,051 | $845,304 | | Phase 1 and Phase 1-ready clinical stage programs | $1,125,342 | $434,443 | | Preclinical stage programs | $2,767,058 | $2,678,222 | | Contra-R&D expenses | $(6,399,167) | $(4,647,358) | | Total direct program costs | $2,032,655 | $5,663,405 | 13. SUBSEQUENT EVENTS This section reports significant events that occurred after the balance sheet date but before the financial statements were issued - On July 24, 2025, the company regained compliance with Nasdaq's stockholders' equity requirement but is subject to a one-year mandatory panel monitor, limiting future cure periods if non-compliance recurs[145][146] - In July 2025, the company sold 4,329,116 shares of common stock under its ATM offering program for approximately $17.6 million in net proceeds[147] - On July 10, 2025, the company received a $6.0 million payment from the Gates Foundation for the DARE-LARC1 program, bringing cumulative funding to approximately $37.8 million[148] - Stockholders approved an amendment to the 2022 Stock Incentive Plan on July 9, 2025, increasing the number of shares available for issuance by 600,000[149] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's financial condition and operational results, including its dual-path business strategy, product candidate updates, and ongoing liquidity challenges despite recent capital raises Business Overview This section provides an overview of the company's biopharmaceutical focus on women's health and its dual-path business strategy - The company is a biopharmaceutical firm dedicated to women's health, focusing on advancing evidence-based solutions for unmet needs[154] - In March 2025, the business model expanded to a dual-path approach, pursuing both traditional FDA approval and earlier market access via Section 503B compounding for select proprietary formulations[156] - The company plans to allocate resources to commercial execution activities, including third-party manufacturing and strategic partnerships, rather than building its own sales, marketing, or distribution infrastructure[157] Product Candidates This section outlines the company's product candidates across various development stages, from pre-clinical to pivotal Phase 3 studies - The company's product candidates are in various stages, from pre-clinical to pivotal Phase 3 clinical studies, requiring FDA or comparable foreign regulatory approval[160] - Key advanced candidates include Ovaprene (Phase 3 contraceptive), Sildenafil Cream (Phase 3 for FSAD), DARE-HRT1 (menopausal hormone therapy), DARE-VVA1 (dyspareunia), and DARE-HPV (HPV infection)[160] Section 503B Compounding This section details the company's strategy to use Section 503B compounding for non-dilutive capital generation and timely market access - The Section 503B compounding business strategy aims to generate non-dilutive capital and provide timely market access for proprietary formulations[161] - Successful execution requires identifying and partnering with 503B-registered outsourcing facilities and third parties with marketing, sales, or distribution capabilities[163] - Formulations considered for 503B compounding must have drug substance(s) on the FDA's interim Category 1 list, be ready for cGMP manufacturing at scale, and have compelling nonclinical/clinical data[162] XACIATO™ This section provides an update on XACIATO, its FDA approval, licensing to Organon, and the subsequent sale of royalty rights to XOMA - XACIATO, approved by the FDA in December 2021 for bacterial vaginosis, was licensed to Organon, which began U.S. marketing in Q4 2023[165] - In April 2024, the company sold its rights to all royalty and potential milestone payments from Organon for XACIATO to XOMA[165] Recent Events This section summarizes recent developments, including product candidate updates, the 503B business strategy, and consumer health product plans Product Candidate Updates This section provides updates on the progress of key product candidates, including Ovaprene, Sildenafil Cream, DARE-HRT1, DARE-VVA1, and DARE-HPV - Enrollment is ongoing in the pivotal Phase 3 study of Ovaprene, with 5 study sites initiated using grant funding. The study's DSMB recommended continuation without modification after an interim analysis in July 2025, identifying no new safety concerns[166][168] - Approximately 9% of treated women in the Ovaprene study experienced pregnancy, and 17% discontinued due to vaginal odor, the most commonly reported product-related adverse event[168] - Initiation of the first Phase 3 study for Sildenafil Cream is not anticipated in 2025 due to ongoing FDA feedback and uncertainty regarding protocol and statistical analysis plan alignment[170] - The company continues to advance DARE-HRT1 (IND for Phase 3), DARE-VVA1 (Phase 2 study preparation), and DARE-HPV (IND for Phase 2)[171] Section 503B Business Strategy Update This section provides an update on the company's 503B compounding strategy, including target availability for DARE to PLAY Sildenafil Cream and DARE-HRT1 - DARE to PLAY Sildenafil Cream is targeted for availability by prescription in the U.S. in Q4 2025, with an anticipated investment of no more than $1.0 million for technology transfer and market activation[172] - DARE-HRT1 is targeted for availability under 503B in late 2026, addressing the lack of FDA-approved non-oral monthly estradiol and progesterone combination products[173] Consumer Health Products This section outlines plans to introduce vaginal probiotics as consumer health products and their commercialization strategy - The company plans to introduce vaginal probiotics from Europe as consumer health products in the U.S. after DARE to PLAY Sildenafil Cream becomes available[174] - Commercialization of consumer health products will rely on strategic agreements and collaborations with third parties for marketing, sales, or distribution[175] Nasdaq Listing This section details the company's recent compliance with Nasdaq's listing requirements and the associated mandatory panel monitor - The company regained compliance with Nasdaq's stockholders' equity requirement on July 24, 2025, after being non-compliant since August 2024[176] - A one-year mandatory panel monitor is in effect from July 24, 2025; any future non-compliance with the stockholders' equity rule during this period will result in a delist determination without a cure period[176] Macroeconomic, Political, and Regulatory Uncertainty This section discusses the potential adverse impacts of macroeconomic, political, and regulatory conditions on the company's business - The company's business is exposed to adverse impacts from evolving macroeconomic, political, and regulatory conditions, including inflation, high interest rates, and changes in federal policy[177] - Significant reductions in funding and staffing at federal agencies like the FDA and NIH could delay regulatory approvals, impact grant funding, and negatively affect development timelines and costs[178] Financial Overview This section provides a high-level summary of the company's revenue streams, research and development expenses, and general and administrative costs - Revenue primarily consists of non-cash royalty revenue from XACIATO, which, since April 1, 2024, is payable to XOMA[179] - Research and development (R&D) expenses are a core operational focus, with a significant portion offset by non-dilutive grant funding and other financial awards (contra R&D expense)[180][181] Contra R&D Expenses (Six Months Ended June 30) | Year | Amount | | :--- | :----------- | | 2025 | $(7,606,559) | | 2024 | $(5,148,795) | - General and administrative (G&A) expenses include personnel costs, facility expenses, professional services, commercial-readiness expenses, and commercial milestone payments[193] Results of Operations This section analyzes the company's financial performance, comparing revenues and expenses across different reporting periods Comparison of Three Months Ended June 30, 2025 and 2024 (Unaudited) This section compares the company's financial performance for the three months ended June 30, 2025, against the same period in 2024 - Total revenue decreased by 194% to a negative $21,172, primarily due to an adjustment for lower actual royalty revenue than previously estimated for Q1 2025[195][196] - Research and development (R&D) expenses decreased by $3.5 million (71%) to $1.4 million, mainly due to increased contra R&D expenses and reduced manufacturing costs for Ovaprene and Sildenafil Cream[195][201] - The company reported a net loss of $4.0 million, a significant change from $12.9 million net income in the prior-year period, primarily due to the absence of the $20.4 million gain from the sale of royalty and milestone rights in Q2 2024[195][202] Comparison of Six Months Ended June 30, 2025 and 2024 (Unaudited) This section compares the company's financial performance for the six months ended June 30, 2025, against the same period in 2024 - Total revenue decreased by 87% to $4,255, primarily due to lower non-cash royalty revenue recognized from the XACIATO license agreement[204][205] - Research and development (R&D) expenses decreased by $4.6 million (55%) to $3.7 million, driven by increased contra R&D expenses and reduced manufacturing costs for Ovaprene and Sildenafil Cream[204][210] - The company reported a net loss of $8.4 million, a significant shift from $6.2 million net income in the prior-year period, primarily due to the absence of the $20.4 million gain from the sale of royalty and milestone rights in H1 2024[204][212] - Other income (expense), net, increased by $0.9 million, mainly due to a $0.6 million loss on fixed asset disposal in the prior year and $0.2 million in employee retention credits received in the current year[204][213] Liquidity and Capital Resources This section discusses the company's cash position, working capital, going concern status, and future capital requirements - As of June 30, 2025, the company had approximately $5.0 million in cash and cash equivalents and a working capital deficit of approximately $12.6 million, with all cash representing funds from grant agreements[215] - Post-June 30, 2025, the company received $17.6 million in net proceeds from common stock sales and $6.0 million in grant funding, mitigating near-term liquidity risk[216] - The company faces substantial doubt about its ability to continue as a going concern due to an accumulated deficit of $183.7 million, a net loss of $8.4 million, and negative cash flows from operations of $10.9 million for the six months ended June 30, 2025[217] - Future capital requirements are difficult to predict and depend on various factors, including clinical trial results, regulatory developments, and commercial potential of product candidates[218] - The company's ATM sales agreement is currently limited by the SEC's 'baby shelf rule' to one-third of its public float, restricting additional sales unless the public float exceeds approximately $54.0 million[220] - Net cash used in operating activities was $10.9 million for the six months ended June 30, 2025, a significant change from $6.1 million provided in the prior-year period, primarily due to the net loss and a decrease in deferred grant funding liability[226][227] - The company has various contractual obligations, including license and royalty payments, grant agreements, royalty purchase agreements with XOMA, a royalty interest financing agreement with UiE, and operating/finance leases totaling approximately $3.0 million in present value[231][233][234][238][240] - The company did not have any off-balance sheet arrangements during the periods presented[243] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is exempt from providing quantitative and qualitative disclosures about market risk[244] Item 4. Controls and Procedures The company's management, including its principal executive and financial officer, concluded that its disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting were identified during the quarter - The company's disclosure controls and procedures were deemed effective as of June 30, 2025, providing reasonable assurance of achieving desired control objectives[245][246] - No material changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025[247] PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and equity sales Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings and is unaware of any contemplated proceedings by governmental authorities that would have a material adverse effect on its operations or financial position - The company is not a party to any material pending legal proceedings and is unaware of any contemplated governmental proceedings against it[249] Item 1A. Risk Factors This section highlights that an investment in the company's common stock carries a high degree of risk. It specifically addresses the risk of maintaining Nasdaq Capital Market listing, noting recent compliance issues and a one-year mandatory panel monitor that limits future cure periods if non-compliance recurs - An investment in the company's common stock involves a high degree of risk[250] - The company regained compliance with Nasdaq's stockholders' equity rule on July 24, 2025, but is subject to a one-year mandatory panel monitor. Any non-compliance during this period will result in a delist determination without a cure period[252][253] - Delisting could significantly impair the company's ability to raise capital, reduce investor confidence, and lead to costly litigation[254] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds During the second quarter of 2025, the company sold 180,000 shares of its common stock to Lincoln Park Capital Fund, LLC, for approximately $0.5 million in gross proceeds, relying on exemptions from Securities Act registration requirements - From April 1, 2025, to June 30, 2025, the company sold 180,000 shares of common stock to Lincoln Park Capital Fund, LLC, for approximately $0.5 million in aggregate gross proceeds[255] - These shares were issued in reliance upon an exemption from registration requirements under Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D[255] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[256] Item 4. Mine Safety Disclosures This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[257] Item 5. Other Information No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2025 - No directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the period from April 1, 2025, to June 30, 2025[258] Item 6. Exhibits This section lists the exhibits filed as part of the Form 10-Q, including an amendment to the 2022 Stock Incentive Plan, certifications, and XBRL documents - Exhibit 10.1 is Amendment No. 1 to Daré Bioscience, Inc. 2022 Stock Incentive Plan[261] - Exhibit 31.1 and 32.1 are Certifications of Principal Executive Officer and Principal Financial Officer[261] - XBRL Instance Document and Taxonomy Extension Documents (Schema, Calculation, Definition, Label, Presentation) are included as Exhibits 101.INS through 101.PRE[261] SIGNATURES This section confirms the official signing and submission of the report by authorized company officers - The report was signed on August 14, 2025, by Sabrina Martucci Johnson, President and Chief Executive Officer (Principal Executive Officer and Principal Financial Officer), and MarDee Haring-Layton, Chief Accounting Officer (Principal Accounting Officer)[265]