Core Insights - Daré Bioscience has entered into an agreement with the Gates Foundation to receive up to approximately $499,000 for mentorship and project management support for research projects addressing preeclampsia, a significant unmet need in maternal care [1][2][3] Company Overview - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to bridge the gap between scientific innovation and practical solutions [1][5] - The company seeks to bring innovative, evidence-based solutions to market that address long-standing unmet needs in women's health, including areas such as contraception, sexual health, and menopause [5] Engagement Details - The engagement with the Gates Foundation will involve providing strategic mentorship and technical guidance to organizations conducting preclinical research on preeclampsia prevention, diagnosis, and treatment [2][3] - Preeclampsia is a leading cause of maternal and infant morbidity and mortality, with approximately 76,000 mothers and 500,000 babies dying from the condition each year [3][4] Strategic Alignment - This initiative aligns with Daré's long-term strategy to lead in women's health areas that have significant needs and limited treatment options [4][5] - The multi-year engagement aims to enhance the impact and sustainability of research funded through the Gates Foundation's Grand Challenges initiative [3][4]

Company Performance - Dare Bioscience, Inc. reported a quarterly loss of $0.45 per share, which was better than the Zacks Consensus Estimate of a loss of $0.55, representing an earnings surprise of +18.18% [1] - The company has surpassed consensus EPS estimates for the last four quarters, but it reported revenues of -$0.02 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 103.68% [2] - The stock has lost approximately 32.4% since the beginning of the year, contrasting with the S&P 500's gain of 10% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.52 on revenues of $0.59 million, and for the current fiscal year, it is -$1.99 on revenues of $1.67 million [7] - The estimate revisions trend for Dare Bioscience was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Dare Bioscience belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, suggesting potential challenges for stock performance [8]

Financial Data and Key Metrics Changes - The company ended the quarter with approximately $5 million in cash and cash equivalents and a working capital deficit of approximately $12.6 million [17] - General and administrative expenses were $2.4 million compared to $2.5 million in 2024, primarily due to decreases in personnel costs and stock-based compensation [18] - Research and development expenses were $1.4 million, a 71% decrease versus Q2 2024, mainly due to reductions in R&D expenses recognized from non-dilutive funding awards [18] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of DARE2PLAY Sildenafil Cream through a 503B outsourcing facility in Q4 2025, representing a significant milestone in women's sexual health [5][6] - Ovaprene, a hormone-free contraceptive candidate, continues to progress with the Phase three trial, receiving a recommendation to continue from the Independent Data and Safety Monitoring Board [10] - DARE HRT1, an intravaginal ring for hormone therapy, is pursuing both FDA approval and a 503B compounding opportunity, targeting availability in late 2026 [12][13] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the contraceptive landscape with Ovaprene, which could transform the market for hormone-free birth control [11] - The compounded hormone therapy market is estimated at $4.5 billion, where DARE HRT1 is expected to generate meaningful revenue [12] Company Strategy and Development Direction - The company is executing a dual path strategy, focusing on commercializing proprietary formulations while pursuing FDA approval for innovative women's health solutions [2][5] - The strategy includes leveraging non-dilutive capital and a disciplined investment approach to unlock value efficiently [6] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant interest and unmet need in supporting women with arousal concerns, as evidenced by the feedback from the direct-to-patient awareness campaign [7] - The company remains optimistic about the potential of DARE2PLAY Sildenafil Cream as a near-term revenue driver and is excited about the ongoing clinical programs addressing women's health needs [9][15] Other Important Information - The company received approximately $17.6 million in net proceeds from sales of common stock and a $6 million grant payment after the quarter end, strengthening its balance sheet [17] - The company is preparing to launch two non-prescription vaginal probiotics designed to support vaginal microbiome health, complementing its prescription offerings [13] Summary of Q&A Session - Due to technical difficulties, there was no Q&A session held during the call [18]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) 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)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(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](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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) | $(6,721,171) | (111.79)% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net income or loss over specific reporting periods Three Months Ended June 30, 2025 vs. 2024 | Metric | 2025 | 2024 | Change ($) | 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Deficit) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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)](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. ORGANIZATION AND DESCRIPTION OF BUSINESS](index=11&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) 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](index=27&type=chunk) - 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](index=29&type=chunk) - 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](index=31&type=chunk) [2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=2.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) 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](index=32&type=chunk) - 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](index=34&type=chunk)[36](index=36&type=chunk) - 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](index=39&type=chunk)[40](index=40&type=chunk) - The company is assessing recently issued accounting pronouncements (ASU 2024-03 and ASU 2023-09), noting that adoption impacts disclosure only[46](index=46&type=chunk)[47](index=47&type=chunk)[48](index=48&type=chunk) [3. STRATEGIC AGREEMENTS](index=14&type=section&id=3.%20STRATEGIC%20AGREEMENTS) 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](index=49&type=chunk)[53](index=53&type=chunk) - 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](index=56&type=chunk) - 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](index=63&type=chunk)[65](index=65&type=chunk)[67](index=67&type=chunk)[79](index=79&type=chunk) [4. STOCKHOLDERS' EQUITY](index=20&type=section&id=4.%20STOCKHOLDERS'%20EQUITY) 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](index=84&type=chunk)[86](index=86&type=chunk) - 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](index=90&type=chunk) [5. STOCK-BASED COMPENSATION](index=22&type=section&id=5.%20STOCK-BASED%20COMPENSATION) 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](index=91&type=chunk)[92](index=92&type=chunk) - 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 **$11.27**[97](index=97&type=chunk) Stock-Based Compensation Expense (Six Months Ended June 30) | Category | 2025 | 2024 | Change ($) | 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](index=23&type=section&id=6.%20LEASED%20PROPERTIES) 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 **$2.8 million**, respectively[101](index=101&type=chunk)[102](index=102&type=chunk) - Operating leases for corporate headquarters and MBI's office/laboratory space expire in October 2027 and December 2026, respectively[103](index=103&type=chunk)[104](index=104&type=chunk) Total Lease Cost (Six Months Ended June 30) | Metric | 2025 | 2024 | Change ($) | 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](index=25&type=section&id=7.%20ROYALTY%20INTEREST%20FINANCING) 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](index=109&type=chunk)[112](index=112&type=chunk) - 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](index=112&type=chunk)[114](index=114&type=chunk) 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](index=27&type=section&id=8.%20ROYALTY%20PURCHASE%20AGREEMENTS) 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](index=117&type=chunk) - 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](index=118&type=chunk) - XOMA will pay the company **$11.0 million** for each successive **$22.0 million** XOMA receives above **$88.0 million** under these agreements[117](index=117&type=chunk) [9. COMMITMENTS AND CONTINGENCIES](index=28&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) 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](index=121&type=chunk) - The company is not aware of any material claims, disputes, or unsettled legal matters that would adversely affect its financial position[122](index=122&type=chunk) - 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](index=123&type=chunk) [10. GRANT AWARDS](index=28&type=section&id=10.%20GRANT%20AWARDS) 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](index=124&type=chunk)[126](index=126&type=chunk) - 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](index=128&type=chunk)[129](index=129&type=chunk)[133](index=133&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - 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](index=187&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) [11. NET LOSS PER SHARE](index=31&type=section&id=11.%20NET%20LOSS%20PER%20SHARE) 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](index=141&type=chunk) [12. SEGMENT INFORMATION](index=31&type=section&id=12.%20SEGMENT%20INFORMATION) 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](index=142&type=chunk) - 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](index=142&type=chunk) 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](index=33&type=section&id=13.%20SUBSEQUENT%20EVENTS) 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](index=145&type=chunk)[146](index=146&type=chunk) - 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](index=147&type=chunk) - 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](index=148&type=chunk) - 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](index=149&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=34&type=section&id=Business%20Overview) 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](index=154&type=chunk) - 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](index=156&type=chunk) - 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](index=157&type=chunk) [Product Candidates](index=35&type=section&id=Product%20Candidates) 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](index=160&type=chunk) - 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](index=160&type=chunk) [Section 503B Compounding](index=35&type=section&id=Section%20503B%20Compounding) 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](index=161&type=chunk) - Successful execution requires identifying and partnering with 503B-registered outsourcing facilities and third parties with marketing, sales, or distribution capabilities[163](index=163&type=chunk) - 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](index=162&type=chunk) [XACIATO™](index=36&type=section&id=XACIATO%E2%84%A2) 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](index=165&type=chunk) - In April 2024, the company sold its rights to all royalty and potential milestone payments from Organon for XACIATO to XOMA[165](index=165&type=chunk) [Recent Events](index=36&type=section&id=Recent%20Events) This section summarizes recent developments, including product candidate updates, the 503B business strategy, and consumer health product plans [Product Candidate Updates](index=36&type=section&id=Product%20Candidate%20Updates) 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](index=166&type=chunk)[168](index=168&type=chunk) - 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](index=168&type=chunk) - 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](index=170&type=chunk) - 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](index=171&type=chunk) [Section 503B Business Strategy Update](index=37&type=section&id=Section%20503B%20Business%20Strategy%20Update) 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](index=172&type=chunk) - 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](index=173&type=chunk) [Consumer Health Products](index=37&type=section&id=Consumer%20Health%20Products) 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](index=174&type=chunk) - Commercialization of consumer health products will rely on strategic agreements and collaborations with third parties for marketing, sales, or distribution[175](index=175&type=chunk) [Nasdaq Listing](index=38&type=section&id=Nasdaq%20Listing) 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](index=176&type=chunk) - 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](index=176&type=chunk) [Macroeconomic, Political, and Regulatory Uncertainty](index=38&type=section&id=Macroeconomic,%20Political,%20and%20Regulatory%20Uncertainty) 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](index=177&type=chunk) - 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](index=178&type=chunk) [Financial Overview](index=39&type=section&id=Financial%20Overview) 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](index=179&type=chunk) - 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](index=180&type=chunk)[181](index=181&type=chunk) 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](index=193&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) 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)](index=42&type=section&id=Comparison%20of%20Three%20Months%20Ended%20June%2030,%202025%20and%202024%20(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](index=195&type=chunk)[196](index=196&type=chunk) - 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](index=195&type=chunk)[201](index=201&type=chunk) - 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](index=195&type=chunk)[202](index=202&type=chunk) [Comparison of Six Months Ended June 30, 2025 and 2024 (Unaudited)](index=44&type=section&id=Comparison%20of%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(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](index=204&type=chunk)[205](index=205&type=chunk) - 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](index=204&type=chunk)[210](index=210&type=chunk) - 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](index=204&type=chunk)[212](index=212&type=chunk) - 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](index=204&type=chunk)[213](index=213&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=215&type=chunk) - 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](index=216&type=chunk) - 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](index=217&type=chunk) - 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](index=218&type=chunk) - 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](index=220&type=chunk) - 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](index=226&type=chunk)[227](index=227&type=chunk) - 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](index=231&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[238](index=238&type=chunk)[240](index=240&type=chunk) - The company did not have any off-balance sheet arrangements during the periods presented[243](index=243&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=244&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=245&type=chunk)[246](index=246&type=chunk) - No material changes in internal control over financial reporting occurred during the fiscal quarter ended **June 30, 2025**[247](index=247&type=chunk) [PART II. OTHER INFORMATION](index=52&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and equity sales [Item 1. Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=249&type=chunk) [Item 1A. Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) 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](index=250&type=chunk) - 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](index=252&type=chunk)[253](index=253&type=chunk) - Delisting could significantly impair the company's ability to raise capital, reduce investor confidence, and lead to costly litigation[254](index=254&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=255&type=chunk) - 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](index=255&type=chunk) [Item 3. Defaults Upon Senior Securities](index=53&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[256](index=256&type=chunk) [Item 4. Mine Safety Disclosures](index=53&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[257](index=257&type=chunk) [Item 5. Other Information](index=53&type=section&id=Item%205.%20Other%20Information) 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](index=258&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) 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](index=261&type=chunk) - Exhibit 31.1 and 32.1 are Certifications of Principal Executive Officer and Principal Financial Officer[261](index=261&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents (Schema, Calculation, Definition, Label, Presentation) are included as Exhibits 101.INS through 101.PRE[261](index=261&type=chunk) [SIGNATURES](index=55&type=section&id=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](index=265&type=chunk)

[Company Overview & Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20%26%20Q2%202025%20Highlights) Daré Bioscience is rapidly transforming its business model through a dual-path strategy, aiming for near-term revenue from 503B compounded and consumer health products, while advancing its clinical pipeline for long-term value [Executive Summary & Strategic Focus](index=1&type=section&id=Executive%20Summary%20%26%20Strategic%20Focus) Daré Bioscience is rapidly transforming its business model via a dual-path strategy, targeting near-term revenue from 503B compounded and consumer health products, and long-term value from advancing its clinical pipeline [Near-Term Commercial Opportunities](index=1&type=section&id=Near-Term%20Commercial%20Opportunities) The company anticipates launching DARE to PLAY™ Sildenafil Cream via 503B outsourcing in Q4 2025, followed by vaginal probiotics and DARE-HRT1, targeting the $4.5 billion compounded hormone therapy market - DARE to PLAY™ Sildenafil Cream is expected to launch via the 503B compounding pathway in **Q4 2025**, with Phase 1 direct-to-patient marketing initiated in partnership with Rosy Wellness[1](index=1&type=chunk)[2](index=2&type=chunk) - Commercialization of vaginal probiotics and the proprietary monthly hormone therapy, DARE-HRT1, is expected to follow the Sildenafil Cream, with DARE-HRT1's 503B compounded solution targeted for launch by **late 2026**[2](index=2&type=chunk)[7](index=7&type=chunk) - The company aims to enter the **$4.5 billion** compounded hormone therapy market[2](index=2&type=chunk) [Pipeline Advancement & Clinical Milestones](index=1&type=section&id=Pipeline%20Advancement%20%26%20Clinical%20Milestones) Ovaprene® Phase 3 study received positive DSMB interim results, supporting continuation without modification and confirming no new safety concerns, while funded programs like DARE-HPV and DARE-LARC1 also advance - The independent Data Safety Monitoring Board (DSMB) for the Ovaprene® Phase 3 study reviewed interim safety data and recommended the study continue without modification, finding no new safety or tolerability concerns[2](index=2&type=chunk) - Pregnancy rates in the Ovaprene® study are consistent with company expectations based on prior postcoital test studies, with the primary endpoint evaluating typical use pregnancy rates (Pearl Index) over **13 menstrual cycles**[7](index=7&type=chunk) - DARE-HPV (vaginal therapy for high-risk genital human papillomavirus infection) and DARE-LARC1 (long-acting contraceptive) are advancing through funded programs, with DARE-HPV receiving ARPA-H and NIH funding, and DARE-LARC1 receiving **$6 million** in grant funding in July 2025[1](index=1&type=chunk)[7](index=7&type=chunk) [CEO's Statement](index=2&type=section&id=CEO%27s%20Statement) CEO Sabrina Martucci Johnson emphasized Daré's rapid transformation via a dual-path strategy to achieve near-term revenue and long-term value, building a strong commercial foundation with upcoming product launches and advancing a differentiated pipeline through funded programs - CEO Sabrina Martucci Johnson stated that Daré is “rapidly transforming its business model by executing a dual-path strategy designed to unlock near-term revenue and long-term value”[5](index=5&type=chunk) - This strategy includes building a strong commercial foundation with the anticipated launch of DARE to PLAY™ Sildenafil Cream (Q4 2025), DARE-HRT1, and vaginal probiotics, while advancing a differentiated clinical pipeline of funded programs[5](index=5&type=chunk) [Financial Results for Q2 2025](index=2&type=section&id=Financial%20Results%20for%20Q2%202025) Daré Bioscience reported a net loss of approximately $4 million in Q2 2025, a significant shift from Q2 2024's net income, with R&D expenses substantially reduced due to non-dilutive funding, and a strengthened balance sheet post-quarter through equity sales and grant funding [Key Financial Highlights](index=2&type=section&id=Key%20Financial%20Highlights) Daré Bioscience recorded a net loss of approximately **$4 million** in Q2 2025, contrasting with net income in Q2 2024, with R&D expenses significantly decreasing due to non-dilutive funding, and the balance sheet strengthened post-quarter by **$23.6 million** in equity sales and grant funds - Post-quarter, Daré significantly strengthened its balance sheet by receiving approximately **$17.6 million** in net proceeds from common stock sales (primarily through its at-the-market offering program) and **$6 million** in grant funding[8](index=8&type=chunk) Key Financial Data for Q2 2025 (Summary) | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change (YoY) | | :-------------------------- | :------------ | :------------ | :----------- | | Royalty revenue | (21,172) | 22,438 | -194.3% | | General and administrative | 2,377,866 | 2,448,130 | -2.9% | | Research and development | 1,428,762 | 4,933,774 | -71.0% | | Total operating expenses | 3,806,628 | 7,381,904 | -48.5% | | Loss from operations | (3,827,800) | (7,359,466) | 48.0% | | Sale of royalty and milestone rights, net | - | 20,379,376 | -100.0% | | Net income (loss) | (4,016,483) | 12,910,656 | -131.1% | | Basic EPS | (0.45) | 1.53 | -129.4% | | Diluted EPS | (0.45) | 1.52 | -129.6% | | Cash and cash equivalents (as of June 30) | 5,035,006 | N/A | N/A | | Working capital (deficit) (as of June 30) | (12,618,726) | N/A | N/A | | Total assets (as of June 30) | 12,979,525 | N/A | N/A | | Total stockholders' equity (deficit) (as of June 30) | (12,733,260) | N/A | N/A | - Research and development expenses decreased by **71% year-over-year**, primarily due to increased non-dilutive grant awards (offsetting R&D expenses) and a 3.6% decrease in manufacturing and development costs for Ovaprene and Sildenafil Cream, partially offset by increased development costs for other clinical and preclinical stage R&D programs like DARE-HPV and DARE-LARC1[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) In Q2 2025, Daré Bioscience reported total revenue of **$(21,172)** and a net loss of **$(4,016,483)**, with basic and diluted EPS of **$(0.45)**, contrasting with Q2 2024's revenue of **$22,438** and net income of **$12,910,656**, largely due to **$20.38 million** from the sale of royalty and milestone rights Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | Metric | Three months ended June 30, 2025 (USD) | Three months ended June 30, 2024 (USD) | | :------------------------------------ | :------------------------------------- | :------------------------------------- | | Royalty revenue | (21,172) | 22,438 | | Total revenue | (21,172) | 22,438 | | General and administrative expenses | 2,377,866 | 2,448,130 | | Research and development expenses | 1,428,762 | 4,933,774 | | Total operating expenses | 3,806,628 | 7,381,904 | | Loss from operations | (3,827,800) | (7,359,466) | | Sale of royalty and milestone rights, net | - | 20,379,376 | | Other income (expense), net | (188,683) | (109,254) | | Net income (loss) | (4,016,483) | 12,910,656 | | Comprehensive income (loss) | (4,003,590) | 12,925,219 | | Basic income (loss) per common share | (0.45) | 1.53 | | Diluted income (loss) per common share | (0.45) | 1.52 | | Weighted average number of shares outstanding (Basic) | 8,871,155 | 8,411,242 | | Weighted average number of shares outstanding (Diluted) | 8,871,155 | 8,476,231 | [Condensed Consolidated Balance Sheets Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20Data) As of June 30, 2025, Daré Bioscience reported cash and cash equivalents of **$5 million**, a working capital deficit of **$12.6 million**, total assets of **$13 million**, and a total stockholders' equity deficit of **$12.7 million**, reflecting decreases in cash and expanded deficits compared to December 31, 2024 Condensed Consolidated Balance Sheets Data | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :-------------------------- | :-------------------- | :---------------------- | | Cash and cash equivalents | 5,035,006 | 15,698,174 | | Working capital (deficit) | (12,618,726) | (3,165,204) | | Total assets | 12,979,525 | 22,101,131 | | Total stockholders' equity (deficit) | (12,733,260) | (6,012,089) | [Product Pipeline & Development Programs](index=1&type=section&id=Product%20Pipeline%20%26%20Development%20Programs) Daré is advancing its product pipeline through a dual-path commercialization strategy, leveraging 503B compounding for rapid market entry and pursuing FDA approvals, with key programs including Ovaprene®, Sildenafil Cream, DARE-HRT1, DARE-HPV, DARE-LARC1, and vaginal probiotics [Commercialization Pathways](index=1&type=section&id=Commercialization%20Pathways) Daré is pursuing a dual-path commercialization strategy, utilizing 503B compounding for rapid market entry of products like DARE to PLAY™ Sildenafil Cream and DARE-HRT1, while also seeking FDA approvals for long-term value and planning to commercialize OTC vaginal probiotics - Daré is executing a dual-path strategy to unlock near-term revenue and long-term value, including commercialization via the 503B compounding pathway and pursuing FDA approval[2](index=2&type=chunk)[5](index=5&type=chunk) - The 503B compounding pathway allows registered outsourcing facilities to produce and supply compounded drugs without patient-specific prescriptions[9](index=9&type=chunk) [Ovaprene® (Hormone-Free Contraceptive)](index=1&type=section&id=Ovaprene%C2%AE%20%28Hormone-Free%20Contraceptive%29) Ovaprene® is an investigational hormone-free monthly vaginal contraceptive, whose Phase 3 study received positive DSMB interim recommendations, supporting continuation without modification and confirming no new safety issues, with interim pregnancy rates consistent with prior studies - Ovaprene® is an investigational hormone-free monthly vaginal contraceptive, with U.S. commercial rights licensed to Bayer[2](index=2&type=chunk)[13](index=13&type=chunk) - The independent DSMB reviewed interim safety data from the Phase 3 study and recommended the study continue without modification, finding no new safety or tolerability concerns[2](index=2&type=chunk) - Interim pregnancy rates are consistent with expectations from prior postcoital test studies, with the primary endpoint evaluating typical use pregnancy rates (Pearl Index) over **13 menstrual cycles**[7](index=7&type=chunk) [Sildenafil Cream, 3.6% (FSAD)](index=1&type=section&id=Sildenafil%20Cream%2C%203.6%25%20%28FSAD%29) DARE to PLAY™ Sildenafil Cream, a novel cream formulation for Female Sexual Arousal Disorder (FSAD), is expected to launch via a 503B outsourcing facility in **Q4 2025**, with direct-to-patient marketing initiated and ongoing discussions with the FDA regarding its Phase 3 clinical study endpoints - DARE to PLAY™ Sildenafil Cream is expected to launch via a 503B outsourcing facility in **Q4 2025**, with Phase 1 direct-to-patient marketing initiated in partnership with Rosy Wellness[2](index=2&type=chunk) - Discussions with the FDA regarding the endpoint assessment for the Sildenafil Cream, 3.6% Phase 3 clinical study are ongoing[2](index=2&type=chunk) - Sildenafil Cream, 3.6% is a novel sildenafil citrate cream formulation for the treatment of Female Sexual Arousal Disorder (FSAD)[13](index=13&type=chunk) [DARE-HRT1 (Hormone Therapy)](index=2&type=section&id=DARE-HRT1%20%28Hormone%20Therapy%29) DARE-HRT1, a proprietary monthly vaginal ring delivering bio-identical estradiol and progesterone for menopausal hormone therapy, is targeted for launch as a 503B compounded solution by **late 2026**, with Daré simultaneously pursuing FDA approval and 503B compounding opportunities - DARE-HRT1 is a proprietary monthly vaginal ring designed to deliver bio-identical estradiol and progesterone for menopausal hormone therapy[7](index=7&type=chunk)[13](index=13&type=chunk) - DARE-HRT1's 503B compounded solution is targeted for launch by **late 2026**, with the company simultaneously pursuing FDA approval and 503B compounding pathways[2](index=2&type=chunk)[7](index=7&type=chunk) [DARE-HPV (HPV Treatment)](index=2&type=section&id=DARE-HPV%20%28HPV%20Treatment%29) DARE-HPV is under development as a novel intravaginal therapy for persistent high-risk genital human papillomavirus (HPV) infection in women, aiming to reduce cervical disease risk, with its development currently funded by ARPA-H awards and NIH grants - DARE-HPV is under development as a novel intravaginal therapy for persistent high-risk genital human papillomavirus (HPV) infection in women, aiming to reduce the risk of cervical disease[7](index=7&type=chunk) - This program is currently funded by ARPA-H awards and NIH grants[7](index=7&type=chunk) [DARE-LARC1 (Long-Acting Contraception)](index=2&type=section&id=DARE-LARC1%20%28Long-Acting%20Contraception%29) DARE-LARC1 is an investigational long-acting contraceptive designed to provide multi-year protection with remote pause/resume functionality, with its preclinical development expected to be fully supported by a foundation grant, including **$6 million** received in July 2025 - DARE-LARC1 is an investigational long-acting contraceptive designed to provide multi-year protection with remote pause/resume functionality[7](index=7&type=chunk) - Preclinical development is expected to be fully supported by a foundation grant, with **$6 million** in funding received in July 2025[7](index=7&type=chunk) [Vaginal Probiotics](index=2&type=section&id=Vaginal%20Probiotics) Daré is developing two over-the-counter vaginal probiotics to support vaginal microbiome health, complementing its prescription products, with their launch anticipated to follow DARE to PLAY™ Sildenafil Cream - Two over-the-counter vaginal probiotics are under development, designed to support vaginal microbiome health as a complement to Daré's prescription products[7](index=7&type=chunk) - The launch of these probiotics is anticipated to follow DARE to PLAY™ Sildenafil Cream[2](index=2&type=chunk)[7](index=7&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) This section provides an overview of Daré Bioscience as a women's health biopharmaceutical company, details of its Q2 2025 earnings conference call, important forward-looking statements, and investor contact information [About Daré Bioscience](index=3&type=section&id=About%20Dar%C3%A9%20Bioscience) Daré Bioscience is a biopharmaceutical company focused on women's health, dedicated to bringing innovative, evidence-based solutions to market by leveraging existing clinical proof-of-concept or safety data, with a portfolio including FDA-approved XACIATO™ and clinical-stage candidates like Ovaprene®, Sildenafil Cream 3.6%, and DARE-HRT1 - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to bring innovative, evidence-based solutions to market as quickly as possible by leveraging existing clinical proof-of-concept or active ingredient safety data[4](index=4&type=chunk)[12](index=12&type=chunk) - The company's first FDA-approved product in its portfolio is XACIATO™ (clindamycin phosphate) vaginal gel 2%, for the treatment of bacterial vaginosis in females 12 years of age and older, licensed globally to Organon[13](index=13&type=chunk) - Key clinical development candidates include Ovaprene® (novel hormone-free monthly vaginal contraceptive), Sildenafil Cream, 3.6% (for Female Sexual Arousal Disorder), and DARE-HRT1 (menopausal hormone therapy)[13](index=13&type=chunk) [Conference Call](index=3&type=section&id=Conference%20Call) Daré held a conference call and webcast on August 14, 2025, at 4:30 PM ET, to review Q2 2025 financial results and provide a company update, with dial-in numbers and webcast access details provided - The company held a conference call and webcast on **August 14, 2025, at 4:30 PM ET**, to review Q2 2025 financial results and provide a company update[10](index=10&type=chunk) - Conference call dial-in numbers are (646) 307-1963 or (800) 715-9871 (toll-free), with conference ID 2684883; the webcast is accessible under the “Presentations, Events & Webcasts” section of the company’s website investor page[11](index=11&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding Daré's strategy, product launches, market opportunities, clinical development, regulatory pathways, funding, and financial performance, which are subject to known and unknown risks and uncertainties, including financing capabilities, limited commercialization experience, reliance on third parties, regulatory changes, clinical trial outcomes, and market acceptance - This press release contains forward-looking statements regarding Daré’s market entry strategies, product launch timelines, market opportunities, clinical development plans for product candidates, trial design, timelines, costs, milestones, target indications, clinical trials and results, regulatory strategies, and FDA communications, submissions, and review applications[16](index=16&type=chunk) - Forward-looking statements involve known and unknown risks, uncertainties, and other factors, including the company’s ability to raise additional capital, reliance on government entities and private foundations for funding, limited commercialization experience, reliance on 503B registered outsourcing facilities, and the risk that the FDA may cease allowing 503B facilities to compound drugs[16](index=16&type=chunk) - Daré encourages investors to review its filings with the SEC, including Forms 8-K, 10-K, and 10-Q, for a detailed description of its risks and uncertainties, and cautions investors not to place undue reliance on forward-looking statements[17](index=17&type=chunk) [Contacts](index=5&type=section&id=Contacts) Investor relations contact information for Daré Bioscience is provided - Investor Relations contact: **innovations@darebioscience.com**[18](index=18&type=chunk)

Core Insights - Daré Bioscience is on track to launch DARE to PLAY™ Sildenafil Cream in Q4 2025 through a 503B compounding pathway, with expected product revenue beginning in the same quarter [1][4][6] - Positive interim results from the Ovaprene® Phase 3 study support continued enrollment, highlighting the potential of this hormone-free contraceptive [1][4][6] - The company is advancing multiple grant-funded programs targeting HPV and long-acting contraception, with four commercially available solutions for women anticipated [1][2][4] Financial Highlights - For Q2 2025, Daré reported a total revenue of $(21.2) million, a decrease from $22.4 million in Q2 2024 [19] - General and administrative expenses were $2.4 million, slightly down from $2.5 million year-over-year, while research and development expenses decreased significantly by 71% to $1.4 million [11][19] - The company had approximately $5.0 million in cash and cash equivalents as of June 30, 2025, with a working capital deficit of approximately $12.6 million [11][21] Product Development and Pipeline - DARE to PLAY™ Sildenafil Cream is positioned as a near-term commercial opportunity, with a direct-to-patient campaign launched in collaboration with Rosy Wellness [4][6] - Ovaprene® is being developed as a first-in-category, hormone-free intravaginal contraceptive, with interim pregnancy rates aligning with company expectations [4][6] - The DARE-HPV program is funded by an ARPA-H award and NIH grant, focusing on treating persistent high-risk HPV infections [4][6] Strategic Initiatives - The company is executing a dual-path strategy aimed at unlocking both near-term revenue and long-term value through the commercialization of its products [6] - Discussions with the FDA are ongoing regarding endpoint assessments for the Phase 3 clinical studies of Sildenafil Cream [4][6] - Daré is also targeting the compounded hormone therapy market, estimated at $4.5 billion, with proprietary monthly hormone therapy expected to launch in late 2026 [4][6]

Core Insights - Daré Bioscience, Inc. has announced the launch of DARE to PLAY Sildenafil Cream, a topical formulation aimed at improving women's sexual arousal, set to be available by prescription in Q4 2025 [1][9] - The product is clinically proven to enhance genital blood flow and sexual response, differentiating it from untested compounded products [2] - A consumer awareness campaign has been initiated in collaboration with Rosy Wellness to educate women about sexual health and the benefits of DARE to PLAY [3][8] Product Details - DARE to PLAY Sildenafil Cream contains sildenafil, the same active ingredient found in Viagra, specifically formulated for women [2] - The product aims to address the long-standing gap in women's sexual health solutions, providing a clinically backed option for those experiencing arousal concerns [2][11] Campaign and Educational Initiatives - The campaign includes the release of educational content and interactive modules designed to inform women about physical arousal and how DARE to PLAY can assist them [3][6] - Quickies, short-form videos reviewed for clinical accuracy, will combat misinformation and provide trustworthy education on female sexual health [4][5] - The Arousal Collection offers a deeper exploration of physical arousal, authored by Dr. Sameena Rahman, to guide women through understanding their sexual health [6][7] Collaboration and Community Engagement - The partnership with Rosy Wellness aims to empower women through evidence-based resources and community support, enhancing access to sexual health information [8][10] - The campaign represents a commitment to advancing sexual health equity and ensuring women have the necessary information and solutions [8] Company Background - Daré Bioscience focuses on addressing unmet needs in women's health, with a portfolio that includes innovative solutions for contraception, sexual health, and menopause [11][12] - The company aims to bring products to market that leverage existing clinical proof of concept, optimizing access for women in a fiscally responsible manner [11]

Core Insights - Daré Bioscience, Inc. has developed a proprietary topical formulation of sildenafil, the active ingredient in Viagra, specifically for women, aimed at addressing female sexual arousal issues [1][2] - The product, named DARE to PLAY™, is expected to be available by prescription in the fourth quarter of 2025 [1][5] - A live webinar is scheduled for August 6, 2025, to discuss the clinical evidence supporting the product and its potential impact on women's sexual health [2][3] Company Overview - Daré Bioscience focuses on women's health, aiming to bridge the gap between scientific advancements and practical solutions [1][9] - The company is committed to developing innovative, evidence-based solutions for various women's health issues, including sexual health, contraception, and menopause [9][10] - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, indicating the company's capability in bringing women's health products to market [10] Product Details - DARE to PLAY™ is clinically shown to improve genital blood flow and sexual response in women, distinguishing it from untested compounded products [2][7] - The formulation is designed to deliver sildenafil effectively, addressing a long-standing gap in women's sexual health solutions [2][7] - The product aims to provide a credible, evidence-based option for women experiencing difficulties with sexual arousal, orgasm, and desire [7][9] Webinar Information - The webinar titled "The DARE to PLAY™ Difference: The Sildenafil Cream That Raises the Bar" will feature leading sexual health experts [3][6] - Participants will have the opportunity to join a product alert list to receive updates on the availability of DARE to PLAY™ [5][6] - The event is open to clinicians, investors, and women interested in science-based approaches to improving sexual response [6]

Core Insights - Daré Bioscience, Inc. has developed a proprietary topical formulation of sildenafil, the active ingredient in Viagra, specifically for women, aimed at addressing female sexual arousal issues [1][2] - The product, named DARE to PLAY™, is expected to be available by prescription in the fourth quarter of 2025 [1][5] - A live webinar is scheduled for August 6, 2025, to discuss the clinical evidence supporting the efficacy of DARE to PLAY™ in improving genital blood flow and sexual response in women [2][3] Company Overview - Daré Bioscience focuses on women's health, aiming to bridge the gap between scientific advancements and practical solutions [1][9] - The company has a portfolio that includes innovative products targeting various aspects of women's health, including contraception, sexual health, and menopause [9][10] - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, indicating the company's commitment to addressing unmet needs in women's health [10] Product Details - DARE to PLAY™ is clinically shown to improve arousal, orgasm, and desire in women, distinguishing it from untested compounded products [2][7] - The formulation is designed to deliver sildenafil precisely where it can be effective, addressing a long-standing gap in women's sexual health solutions [2][7] - The webinar will feature leading experts in sexual health, emphasizing the credibility and evidence-based nature of DARE to PLAY™ [3][8] Market Positioning - The product aims to provide a trusted and science-based option for women experiencing difficulties with sexual arousal, which has historically been an underserved area in women's health [1][6] - Daré's approach leverages existing clinical proof of concept for the active ingredient, allowing for a more efficient path to market [9] - The company is positioned to optimize access for women in a fiscally responsible manner, reflecting a commitment to both innovation and accessibility [9]

Group 1: U.S. Stock Market Performance - U.S. stocks traded higher with the Nasdaq Composite gaining around 0.4% on Monday [1] - The Dow increased by 0.05% to 44,393.18, while the S&P 500 rose by 0.11% to 6,266.78 [1] - Utilities shares jumped by 0.4%, while energy stocks dipped by 1.2% [1] Group 2: Company Earnings - Fastenal Company reported better-than-expected second-quarter earnings of 29 cents per share, beating the analyst consensus estimate of 28 cents [2] - The company also reported quarterly sales of $2.08 billion, surpassing the analyst consensus estimate of $2.07 billion [2] Group 3: Stock Movements - Sonnet BioTherapeutics Holdings, Inc. shares surged 157% to $13.32 after announcing a business combination to launch a Crypto treasury reserve strategy [8] - Daré Bioscience, Inc. shares increased by 141% to $6.05 following interim safety and efficacy results from a Phase 3 clinical trial [8] - Veritex Holdings, Inc. shares rose by 20% to $32.97 after announcing an acquisition by Huntington Bancshares for $1.9 billion [8] - Ruanyun Edai Technology Inc. shares dropped 59% to $8.27 [8] - Unusual Machines, Inc. shares fell 16% to $10.14 after announcing a $48.5 million registered direct offering [8] - Diginex Limited shares decreased by 13% to $58.00 after reporting FY25 financial results [8]