Financial Data and Key Metrics Changes - General and administrative expenses decreased by 14% to approximately $2.3 million compared to Q1 2024, primarily due to reduced stock-based compensation and headcount [13] - Research and development expenses decreased by 31% to approximately $2.3 million compared to Q1 2024 [13] - Comprehensive loss for the quarter was approximately $4.4 million, with cash and cash equivalents at approximately $10.3 million and a working capital deficit of approximately $9.4 million [13][14] Business Line Data and Key Metrics Changes - The company plans to commercialize three additional solutions for women, including two vaginal probiotics in 2025 and a proprietary monthly hormone therapy in 2026, targeting a $4.5 billion compounded hormone therapy market [5][19] - The company expects to start recording revenue in the fourth quarter of 2025 [6][67] Market Data and Key Metrics Changes - The women's health sector is described as underfunded and fragmented, presenting significant opportunities for returns [7][67] - The company is leveraging a dual path strategy to commercialize products via 503B compounding while seeking FDA approval [7][24] Company Strategy and Development Direction - The company is focused solely on women's health, aiming to provide evidence-based solutions through various channels, including telehealth and online platforms [8][21] - The strategy includes forming partnerships with telehealth providers and online retailers to enhance product accessibility [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's unique position to deliver value amidst distractions in the healthcare and biotech sectors [6] - The company aims to meet the increasing demand for evidence-based treatments and is committed to rapid commercialization [16][17] Other Important Information - The company is actively evaluating the dual path approach for other proprietary formulations to expedite market access [24] - The company received a grant from the Gates Foundation to identify evidence-based formulations for vaginal probiotics [10][19] Q&A Session Summary Question: Will there be unique partnerships for each product or multiple partnerships for an individual product? - Management clarified that they intend to have multiple partnerships for individual products to ensure wide access [33] Question: Is there sufficient manufacturing capacity for Sildenafil Cream by year-end? - Management confirmed the need to support their 503B collaborator to ensure manufacturing readiness [35] Question: What additional information has the FDA requested for Sildenafil? - Management indicated that the FDA requested information regarding patient-reported outcomes and psychometrics, which is critical for the Phase III study [44][46] Question: Will the grant cover costs to add additional sites for Ovaprene? - Management confirmed that the grant is designed to cover costs associated with adding subjects to the study [56] Question: Should R&D expenses be expected to continue at the current lower level? - Management stated that the current trend reflects the absence of ongoing studies, and expenses may remain lower until new studies commence [58]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents Daré Bioscience's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' deficit, and cash flows, highlighting a going concern uncertainty, XACIATO royalty sale, and new 503B compounding strategy Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,329,967 | $15,698,174 | | Total current assets | $11,822,549 | $18,447,863 | | Total assets | $18,618,941 | $22,101,131 | | Total current liabilities | $21,188,074 | $21,609,013 | | Total liabilities | $28,182,642 | $28,113,220 | | Total stockholders' deficit | $(9,563,701) | $(6,012,089) | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | | Total operating expenses | $4,606,545 | $6,031,775 | | Loss from operations | $(4,581,118) | $(6,022,473) | | Net loss | $(4,378,307) | $(6,755,356) | | Loss per common share - basic and diluted | $(0.50) | $(0.81) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,470,543) | $(6,812,962) | | Net cash used in investing activities | $(157,331) | $(7,296) | | Net cash provided by financing activities | $246,577 | $14,032 | | Net change in cash, cash equivalents and restricted cash | $(5,368,207) | $(6,845,453) | - The company's financial statements were prepared on a going concern basis, but a history of losses, negative cash flows, and insufficient cash to fund operations for the next 12 months raise substantial doubt about its ability to continue as a going concern. As of March 31, 2025, the company had an accumulated deficit of approximately **$179.7 million** and a working capital deficit of **$9.4 million**[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - In March 2025, the company expanded its business strategy to include Section 503B compounding as a dual-path approach to bring certain proprietary formulations to market more quickly while continuing to pursue FDA approval for its product candidates[28](index=28&type=chunk) - In April 2024, the company sold its rights to all royalty and potential milestone payments from net sales of XACIATO to XOMA (US) LLC. After XOMA receives a specified return, the company will share equally in subsequent payments from Organon[30](index=30&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's women's health strategy, including a new 503B compounding approach, Q1 2025 financial results showing decreased net loss and operating expenses, and the critical need for additional capital due to going concern doubts and Nasdaq compliance efforts [Business Overview and Recent Events](index=32&type=section&id=Business%20Overview%20and%20Recent%20Events) The biopharmaceutical company focuses on women's health with a pipeline including Ovaprene and Sildenafil Cream, recently expanded its strategy to include 503B compounding, and faces challenges with Ovaprene study recruitment and Nasdaq listing compliance - The company expanded its business strategy in March 2025 to include Section 503B compounding, aiming to bring proprietary formulations like Sildenafil Cream and DARE-HRT1 to market faster while continuing to pursue FDA approval[148](index=148&type=chunk)[156](index=156&type=chunk)[157](index=157&type=chunk) - Enrollment in the pivotal Phase 3 study of Ovaprene is ongoing but has been paused at NICHD-affiliated sites due to administrative issues, though recruitment continues at five company-funded sites[153](index=153&type=chunk) - The company is preparing for a Phase 3 study of Sildenafil Cream for female sexual arousal disorder (FSAD) but does not plan to conduct the study until additional capital is secured[154](index=154&type=chunk) - The company received an extension from Nasdaq until August 12, 2025, to regain compliance with listing requirements, specifically the Stockholders' Equity Rule or the Minimum Market Value of Listed Securities Rule[161](index=161&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) For Q1 2025, the company reported a net loss of $4.4 million, a 35% decrease from Q1 2024, driven by a 24% reduction in total operating expenses, primarily from lower R&D and G&A costs Comparison of Operations for Three Months Ended March 31 | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | $16,125 | 173% | | General and administrative | $2,309,164 | $2,670,581 | $(361,417) | (14)% | | Research and development | $2,297,381 | $3,353,520 | $(1,056,139) | (31)% | | Loss from operations | $(4,581,118) | $(6,022,473) | $1,441,355 | (24)% | | Net loss | $(4,378,307) | $(6,755,356) | $2,377,049 | (35)% | - General and administrative expenses decreased by approximately **$0.4 million**, mainly due to lower stock-based compensation, professional services, and personnel costs[181](index=181&type=chunk) - Research and development expenses decreased by approximately **$1.1 million**, primarily due to reduced manufacturing costs for Ovaprene and lower development activity costs for Sildenafil Cream and preclinical programs[185](index=185&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company had $10.3 million cash and a $9.4 million working capital deficit, raising substantial doubt about its going concern ability, necessitating additional capital, which it is actively pursuing through various options - The company has a history of losses and negative cash flows, leading to substantial doubt about its ability to continue as a going concern. Additional capital is required to fund operations into Q3 2025[188](index=188&type=chunk)[189](index=189&type=chunk) - The company is pursuing capital through various means, including an equity line agreement with Lincoln Park, under which it sold **150,000 shares** for net proceeds of approximately **$0.4 million** in Q1 2025[190](index=190&type=chunk)[196](index=196&type=chunk) - If additional capital cannot be raised, the company may need to delay, scale back, or eliminate development programs, reduce expenses, or cease operations[191](index=191&type=chunk) Summary of Cash Flows | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,470,543) | $(6,812,962) | | Net cash used in investing activities | $(157,331) | $(7,296) | | Net cash provided by financing activities | $246,577 | $14,032 | [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Daré Bioscience is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[218](index=218&type=chunk) [Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation, the principal executive and financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[220](index=220&type=chunk) - No change in internal control over financial reporting occurred during the fiscal quarter that has materially affected, or is reasonably likely to materially affect, internal controls[221](index=221&type=chunk) [PART II. OTHER INFORMATION](index=48&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=48&type=section&id=Item%201.%20Legal%20Proceedings) As of the filing date, the company is not a party to any material pending legal proceedings, nor is management aware of any contemplated governmental proceedings - There are no material pending legal proceedings to which the company is a party[223](index=223&type=chunk) [Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the significant risk of the company's common stock being delisted from Nasdaq due to non-compliance with listing requirements, which could severely impair capital raising and negatively affect stock price - The company is not in compliance with Nasdaq's continued listing requirement for minimum market value of listed securities (**$35.0 million**)[225](index=225&type=chunk) - Nasdaq has granted an extension until August 12, 2025, for the company to regain compliance with either the market value rule or the stockholders' equity rule (at least **$2.5 million**)[228](index=228&type=chunk) - Failure to regain compliance could lead to the delisting of the company's common stock, which would substantially impair its ability to raise capital, harm investor confidence, and adversely affect the stock's market price and trading efficiency[232](index=232&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked as "None" [Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[233](index=233&type=chunk) [Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[234](index=234&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) During the first quarter of 2025, none of the company's directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - From January 1, 2025, to March 31, 2025, no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[235](index=235&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, which include the Amended and Restated Non-Employee Director Compensation Policy, certifications by the Principal Executive Officer and Principal Financial Officer, and XBRL data files

[Daré Bioscience First Quarter 2025 Update](index=1&type=section&id=Dar%C3%A9%20Bioscience%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Provides%20Company%20Update) [Expanded Business Strategy and 2025/2026 Milestones](index=1&type=section&id=Expanded%20Business%20Strategy%20and%202025%2F2026%20Milestones) The company is pursuing a dual commercialization strategy to accelerate revenue generation starting in Q4 2025 - The company is implementing a dual-path strategy, commercializing products via 503B compounding for near-term revenue while simultaneously seeking full FDA approval[3](index=3&type=chunk) - Daré expects to begin recording revenue in the **fourth quarter of 2025**[2](index=2&type=chunk) - Key commercialization targets include **Sildenafil Cream and vaginal probiotics in 2025**, followed by **DARE-HRT1 in 2026**[1](index=1&type=chunk)[2](index=2&type=chunk) - The company is targeting the compounded hormone therapy market, which is estimated to be up to **$4.5 billion**[1](index=1&type=chunk) [Therapeutic Development Pipeline Highlights](index=2&type=section&id=Therapeutic%20Development%20Pipeline%20Highlights) The company is advancing its clinical pipeline, with a key data review for Ovaprene® scheduled for July 2025 - **Ovaprene®:** Enrollment is ongoing in the pivotal Phase 3 contraceptive efficacy study, with a data safety monitoring board scheduled to review interim data in July 2025[2](index=2&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - **Sildenafil Cream, 3.6%:** The company continues interactions with the FDA regarding the planned Phase 3 study and expects to submit the protocol by the end of Q2 2025[6](index=6&type=chunk)[9](index=9&type=chunk) - **DARE-HPV:** Daré is preparing to submit an IND application for a Phase 2 clinical study for the clearance of high-risk HPV, supported by a non-dilutive award of up to $10 million[7](index=7&type=chunk)[9](index=9&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=Financial%20Highlights%20for%20the%20Quarter%20ended%20March%2031%2C%202025) The company reported a reduced net loss and ended the quarter with $10.3 million in cash and cash equivalents [Financial Highlights Summary](index=2&type=section&id=Financial%20Highlights%20Summary) Daré demonstrated fiscal discipline by significantly reducing operating expenses compared to the prior-year period Key Financial Position & Expense Changes (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $10.3 million | N/A | - | | Research and development expenses | $2.3 million | $3.4 million | -31% | | General and administrative expenses | $2.3 million | $2.7 million | -15% | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The net loss for Q1 2025 improved to $4.4 million, down from a $6.8 million loss in Q1 2024 Consolidated Statements of Operations (Three Months Ended March 31) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Total revenue | $25,427 | $9,302 | | Total operating expenses | $4,606,545 | $6,031,775 | | Loss from operations | ($4,581,118) | ($6,022,473) | | **Net loss** | **($4,378,307)** | **($6,755,356)** | | Loss per common share | ($0.50) | ($0.81) | [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20Data) The balance sheet showed $10.3 million in cash and a working capital deficit of $9.4 million as of March 31, 2025 Condensed Consolidated Balance Sheet Data | Metric | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,329,967 | $15,698,174 | | Working capital deficit | ($9,365,525) | ($3,161,150) | | Total assets | $18,618,941 | $22,101,131 | | Total stockholders' deficit | ($9,563,701) | ($6,012,089) | [Company Information and Forward-Looking Statements](index=3&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) This section outlines Daré's business focus, investor call details, and significant risks and uncertainties - A conference call to discuss the financial results and company update was scheduled for May 13, 2025, at 4:30 p.m. Eastern Time[11](index=11&type=chunk) - Daré Bioscience is a biopharmaceutical company focused on advancing innovative products for women's health in areas like contraception, sexual health, and menopause[13](index=13&type=chunk)[14](index=14&type=chunk) - The report contains extensive forward-looking statements concerning go-to-market strategies, product timelines, and clinical development, which are subject to significant risks[17](index=17&type=chunk)

Core Insights - Daré Bioscience is focused on women's health and aims to commercialize multiple solutions by 2025 and 2026, leveraging a dual path strategy for product approval and commercialization [1][3][5] Financial Performance - For the quarter ended March 31, 2025, total revenue was $25.4 million, a significant increase from $9.3 million in the same quarter of 2024 [21] - The company reported a net loss of $4.4 million for Q1 2025, compared to a net loss of $6.8 million in Q1 2024, indicating improved financial performance [21] - Cash and cash equivalents as of March 31, 2025, were approximately $10.3 million, down from $15.7 million at the end of 2024, with a working capital deficit of approximately $9.4 million [22] Product Development and Pipeline - The company is advancing several products, including Ovaprene®, a hormone-free contraceptive, and Sildenafil Cream, targeting female sexual arousal disorder, with expected revenue generation starting in Q4 2025 [4][5][6] - The ongoing pivotal Phase 3 study for Ovaprene® aims to assess its efficacy over 13 menstrual cycles, with interim data review scheduled for July 2025 [6][7] - Daré is also developing DARE-HRT1 for menopausal symptoms and vaginal probiotics, with plans to launch these as consumer health products [5][14] Strategic Positioning - Daré is uniquely positioned as a publicly traded company focused solely on women's health, addressing underfunded and fragmented areas such as contraception, sexual health, and menopause [3][13] - The company is leveraging multiple commercialization channels, including FDA-approved treatments, compounded products, and over-the-counter consumer health products [3][5] Market Opportunity - The compounded hormone therapy market is estimated to be up to $4.5 billion, presenting significant commercial opportunities for Daré's products [5] - The company anticipates that its innovative business model will allow for rapid commercialization and access to a broad range of women's health solutions [3][5]

Company Overview - Daré Bioscience, Inc. is a biopharmaceutical company focused on women's health, aiming to provide innovative solutions for unmet needs in areas such as contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause [3][4] - The company leverages existing clinical proof of concept and safety data for its active ingredients, allowing for flexible and fiscally responsible market access strategies [3] Product Portfolio - The first FDA-approved product from Daré is XACIATO™ (clindamycin phosphate) vaginal gel 2%, indicated for bacterial vaginosis treatment in females aged 12 and older, under a global license agreement with Organon [4] - Other products in development include Ovaprene®, a hormone-free monthly contraceptive licensed to Bayer; Sildenafil Cream, 3.6%, for female sexual arousal disorder; and DARE-HRT1, a bio-identical hormone therapy for menopause [4] Leadership and Recognition - Daré Bioscience's leadership has received accolades, including recognition on Medicine Maker's Power List and Endpoints News' Women in Biopharma, with the CEO honored as one of Fierce Pharma's Most Influential People in Biopharma [5] Investor Communication - The company plans to announce material information regarding finances, products, and clinical trials through its website, SEC filings, press releases, and social media [5]

Core Insights - Daré Bioscience, Inc. has announced a new dual-path approach for its proprietary Sildenafil Cream formulation, targeting prescription availability by Q4 2025 [1][3] - The company emphasizes its commitment to women's health and aims to address unmet needs through innovative solutions [3][4] - CEO Sabrina Martucci Johnson will present at the Fierce Pharma Engage summit, discussing the importance of strategic communication in unveiling the company's expanded business strategy [1][2] Company Overview - Daré Bioscience is focused on women's health, aiming to bring innovative, evidence-based solutions to market that address long-standing unmet needs [3] - The company’s product portfolio includes XACIATO™, Ovaprene®, Sildenafil Cream, and DARE-HRT1, targeting various aspects of women's health [4] - Daré has received recognition for its contributions to innovation and advocacy in the women's health sector, with leadership featured in notable industry lists [5] Upcoming Events - Daré will participate in the Fierce Pharma Engage summit on April 29, 2025, where CEO Sabrina Martucci Johnson will deliver a keynote address [2]

Core Viewpoint - Daré Bioscience is expanding its business strategy to integrate 503B compounding for bringing proprietary formulations to market, starting with Sildenafil Cream in 2025 [1][7]. Company Strategy - The company is adopting a dual-path approach for its proprietary formulations, which includes both prescription and over-the-counter consumer health products [2]. - An update on the timing and strategic partnerships for these objectives is expected in the current quarter [2]. Product Development - Daré's first FDA-approved product is XACIATO™, a vaginal gel for bacterial vaginosis, and it has several candidates in clinical development, including Ovaprene® and Sildenafil Cream [5]. - The proprietary Sildenafil Cream formulation is targeted for prescription availability in Q4 2025 [7]. Company Mission - Daré Bioscience focuses on addressing unmet needs in women's health, with a commitment to innovation and evidence-based solutions [4]. - The company aims to enhance outcomes and convenience in areas such as contraception, sexual health, and menopause [4]. Leadership Recognition - Daré's leadership has received accolades for contributions to innovation and advocacy in women's health, highlighting the company's influence in the biopharmaceutical sector [6].

Company Performance - Dare Bioscience reported a quarterly loss of $0.64 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.66, and an improvement from a loss of $0.72 per share a year ago, indicating an earnings surprise of 3.03% [1] - The company posted revenues of -$0.06 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 101.60%, compared to revenues of $1.81 million in the same quarter last year [2] - Over the last four quarters, Dare Bioscience has surpassed consensus EPS estimates three times but has not been able to beat consensus revenue estimates [2] Stock Outlook - Dare Bioscience shares have declined approximately 7.7% since the beginning of the year, while the S&P 500 has decreased by 5.1% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $0.6 million, and for the current fiscal year, it is -$1.90 on revenues of $9.81 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Dare Bioscience belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Product Development and Approval - XACIATO™ (clindamycin phosphate) vaginal gel received FDA approval in December 2021 for the treatment of bacterial vaginosis in females aged 12 and older[29]. - In 2022, the company licensed exclusive worldwide rights for XACIATO to Organon, which began U.S. marketing in Q4 2023 and announced nationwide availability in January 2024[21]. - The company is developing Ovaprene®, a hormone-free monthly contraceptive currently in a pivotal Phase 3 clinical study, with expected typical use efficacy of approximately 86% to 91% at 6 months[34]. - The FDA granted XACIATO a total of 8 years of data exclusivity, expiring on December 7, 2029, due to its Qualified Infectious Disease Product (QIDP) designation[32]. - The company plans to utilize 503B compounding to bring proprietary formulations to market, targeting availability of Sildenafil Cream in Q4 2025 while pursuing FDA approval[23]. - The company is developing Sildenafil Cream, 3.6%, targeting the estimated 10 million women in the U.S. suffering from female sexual arousal disorder[47]. - DARE-HRT1, an intravaginal ring, is designed to deliver bio-identical 17β-estradiol and progesterone continuously over 28 days, targeting menopausal symptoms[65]. - DARE-VVA1 received FDA clearance for its IND application in December 2023, with plans for a Phase 2 randomized, double-blinded, placebo-controlled study for moderate-to-severe dyspareunia[76]. - DARE-HPV is being developed for the treatment of genital HPV infection and cervical intraepithelial neoplasia, with no FDA-approved treatments currently available for these conditions[83]. - DARE-PDM1 is designed to treat primary dysmenorrhea using a proprietary hydrogel formulation of diclofenac, potentially offering a first-in-category product for vaginal administration[88]. Clinical Trials and Efficacy - Ovaprene clinical trial met its primary endpoint, with 100% of women and cycles showing an average of less than five progressively motile sperm per high power field after intercourse[39]. - In the baseline cycle, women had a mean of 27.21 progressively motile sperm per high power field, which decreased to 0.48 during Ovaprene use[39]. - The pivotal Phase 3 clinical study of Ovaprene commenced in December 2023, aiming to enroll approximately 250 participants over 13 menstrual cycles[42]. - The study anticipates that approximately 125 women will complete six months of Ovaprene use by the end of Q2 2025, marking a checkpoint for interim data review[42]. - The Phase 3 program is set to include a 12-week double-blind treatment period, with co-primary efficacy endpoints assessing arousal sensations and associated distress, consistent with the Phase 2b RESPOND study[61]. - The Phase 1 clinical trial of DARE-HRT1 showed similar steady-state concentrations of estradiol compared to FDA-approved products for treating menopausal symptoms, with no serious adverse events reported[69]. - In a Phase 1/2 study of DARE-VVA1, participants showed approximately 30% improvement in vaginal pH scores and approximately 63% improvement in vaginal dryness scores after three months[78]. - The topline data from the DARE-PDM1-001 study indicated that all 42 participants tolerated the treatment well, with 85% of adverse events being mild[90]. - The exploratory endpoint showed a statistically significant decrease in pelvic/vaginal and lower back pain scores in the 1% diclofenac DARE-PDM1 treatment group compared to placebo[92]. Collaborations and Funding - The company has received non-dilutive funding from federal agencies and private foundations to support various R&D activities across eight programs[28]. - The company is collaborating with ADVA-Tec, Inc. and Bayer HealthCare LLC for the development and commercialization of Ovaprene[46]. - The Phase 3 study is supported by a $5.5 million contribution from the company to the NICHD for conducting the study, all of which had been paid as of September 30, 2024[44]. - The company plans to submit the protocol for the Phase 3 clinical study to the FDA in Q2 2025, pending additional recommendations[62]. - The company has received approximately $31.8 million under a grant agreement to advance the development of DARE-LARC1, with total potential funding of up to $49.0 million[104]. Financial Agreements and Royalties - In 2022, the company received a $10.0 million non-refundable payment from Organon as part of a licensing agreement, with additional milestone revenue of $1.8 million in 2023[115]. - Organon agreed to pay tiered double-digit royalties based on net sales and potential future milestone payments of up to $180.0 million[116]. - Bayer will provide a total of up to $310.0 million in milestone payments if all milestones are achieved, including a low double-digit million payment upon the first commercial sale of Ovaprene[121]. - The license agreement with Bayer includes tiered royalties starting in the low double digits based on annual net sales of Ovaprene[121]. - The company is responsible for providing $5.5 million to NICHD for the Phase 3 study of Ovaprene, all of which had been paid as of September 30, 2024[136]. - The acquisition of Dare MB Inc. includes contingent payments of up to $46.5 million based on specified milestones and tiered royalty payments based on annual net sales[138]. - The company paid MilanaPharm $500,000 upon the first commercial sale of XACIATO in Q4 2023, with additional payments tied to future sales milestones[142]. Intellectual Property and Competition - The company holds exclusive licenses for five granted U.S. patents related to Ovaprene, with terms expiring between 2025 and 2028[190]. - The Sildenafil Cream program includes 27 issued patents worldwide, with U.S. patents expiring in June 2029 and several foreign patents expiring in late 2031[191]. - The company is the exclusive licensee of three issued U.S. patents related to XACIATO, with terms expiring between 2028 and 2036[189]. - The company is focused on women's health, a highly competitive and fragmented market, facing competition from established pharmaceutical companies and generics[200]. - XACIATO competes with multiple generic and branded prescription drugs for bacterial vaginosis treatment, with its commercial success being outside the company's control[202]. - The investigational contraceptive product Ovaprene will face competition from various existing contraceptive options, including hormone-free and hormonal products[203]. - DARE-HRT1, if approved, will compete with numerous existing products for menopausal symptoms, including FDA-approved hormone therapies and compounded products[206]. - DARE-VVA1, if approved, will compete with both hormonal and non-hormonal treatments for dyspareunia, including FDA-approved and compounded products[207]. - The company's ability to develop and market products will depend on FDA approvals, regulatory compliance, and competition from other organizations[210].

Financial Performance - Total revenue for 2024 was $9,784, compared to $2,807,885 in 2023, indicating a significant decrease[28]. - The net loss for 2024 was $4,053,299, a substantial improvement from the net loss of $30,161,391 in 2023[28]. - The company reported a comprehensive loss of $4,121,212 in 2024, down from $30,170,976 in 2023, marking a notable decrease[28]. - The loss per common share improved to $0.48 in 2024 from $4.15 in 2023, indicating a significant reduction in per-share losses[28]. - Cash and cash equivalents increased to $15,698,174 in 2024 from $10,476,056 in 2023, reflecting a growth of approximately 50.5%[30]. - Total assets rose to $22,101,131 in 2024, up from $21,282,215 in 2023, showing an increase of about 3.8%[30]. - Total liabilities increased to $28,113,220 in 2024 from $26,329,855 in 2023, representing a rise of approximately 6.8%[30]. - Working capital deficit slightly worsened to $(3,161,150) in 2024 from $(2,936,897) in 2023[30]. - The weighted average number of common shares outstanding increased to 8,497,459 in 2024 from 7,275,308 in 2023, reflecting a growth of approximately 16.7%[28]. Expenses - General and administrative expenses decreased by 24% to approximately $9.2 million in 2024, primarily due to reduced commercial readiness expenses and headcount[24]. - Research and development expenses were approximately $14.2 million in 2024, reflecting a 34% decrease compared to the prior year, mainly due to manufacturing activities and ongoing enrollment in the Phase 3 study of Ovaprene[24]. - Research and development expenses decreased to $14,205,208 in 2024 from $21,538,074 in 2023, a reduction of approximately 34.4%[28]. Clinical Development - Daré is conducting a pivotal Phase 3 contraceptive efficacy study for Ovaprene, with a non-dilutive grant of up to $10.7 million announced in November 2024 to support the addition of 5 new investigator sites[7]. - The company anticipates that approximately 125 women will complete six months of Ovaprene use by the end of the second quarter of 2025, which is a designated checkpoint for interim data review[7]. - Daré plans to submit the protocol and statistical analysis plan for a Phase 3 clinical study of Sildenafil Cream to the FDA in the second quarter of 2025[11]. Strategic Outlook - Daré expects to start recording revenue and cash flow from its proprietary Sildenafil Cream formulation in the 4th quarter of 2025[1]. - The company is targeting the second quarter of 2025 to provide updates on strategic partnerships and the timing for bringing other proprietary formulations to market[5]. - The company is evaluating a dual-path approach for some proprietary formulations to optimize access for women in a fiscally responsible manner[5]. Leadership and Recognition - Daré's leadership has been recognized for contributions to innovation and advocacy in women's health, highlighting the company's commitment to addressing unmet needs[22].