Daré Bioscience(DARE) - 2025 Q2 - Quarterly Results

Company Overview & Q2 2025 Highlights 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 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 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][2] - 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][7] - The company aims to enter the $4.5 billion compounded hormone therapy market[2] Pipeline Advancement & Clinical Milestones 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] - 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] - 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][7] CEO's Statement 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] - 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] Financial Results for Q2 2025 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 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] 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] Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) 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 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 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 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][5] - The 503B compounding pathway allows registered outsourcing facilities to produce and supply compounded drugs without patient-specific prescriptions[9] Ovaprene® (Hormone-Free Contraceptive) 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][13] - 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] - 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] Sildenafil Cream, 3.6% (FSAD) 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] - Discussions with the FDA regarding the endpoint assessment for the Sildenafil Cream, 3.6% Phase 3 clinical study are ongoing[2] - Sildenafil Cream, 3.6% is a novel sildenafil citrate cream formulation for the treatment of Female Sexual Arousal Disorder (FSAD)[13] DARE-HRT1 (Hormone Therapy) 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][13] - 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][7] DARE-HPV (HPV Treatment) 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] - This program is currently funded by ARPA-H awards and NIH grants[7] DARE-LARC1 (Long-Acting Contraception) 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] - Preclinical development is expected to be fully supported by a foundation grant, with $6 million in funding received in July 2025[7] Vaginal Probiotics 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] - The launch of these probiotics is anticipated to follow DARE to PLAY™ Sildenafil Cream[2][7] Corporate Information 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 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][12] - 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] - 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] Conference Call 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] - 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] Forward-Looking Statements 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] - 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] - 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] Contacts Investor relations contact information for Daré Bioscience is provided - Investor Relations contact: innovations@darebioscience.com[18]