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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ FORM 10-K ___________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____ TO_____ Commission File No. 001-36395 DARÉ BIOSCIENCE, INC. (Exa ...

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].

Core Viewpoint - Daré Bioscience is advancing its business strategy to integrate 503B compounding for its proprietary Sildenafil Cream formulation, aiming to provide women with timely access to treatment options while pursuing FDA approval [2][3][4]. Financial Highlights - For the year ended December 31, 2024, Daré reported total revenue of approximately $9.78 million, a decrease from $2.81 million in 2023 [25]. - The company incurred total operating expenses of approximately $23.46 million in 2024, down from $33.75 million in the previous year, resulting in a net loss of approximately $4.05 million compared to a net loss of $30.16 million in 2023 [25]. - Cash and cash equivalents at the end of 2024 were approximately $15.70 million, an increase from $10.48 million in 2023 [26]. Product Development and Strategy - Daré plans to make its proprietary Sildenafil Cream formulation available via a 503B-registered outsourcing facility partner in the fourth quarter of 2025, targeting revenue generation from this product [2][4]. - The company is also focusing on a dual-path approach for other proprietary formulations, enhancing its portfolio diversity and potential revenue opportunities [2][3]. - Ongoing clinical studies include a pivotal Phase 3 contraceptive efficacy study for Ovaprene, with expectations to complete enrollment of approximately 125 women by the end of the second quarter of 2025 [9]. Research and Development - Research and development expenses for 2024 were approximately $14.2 million, a 34% decrease from the previous year, primarily due to reduced manufacturing activities and ongoing enrollment in clinical studies [25]. - Daré is preparing for a Phase 2 clinical study of DARE-HPV and a Phase 3 study of Sildenafil Cream, reflecting FDA feedback for safety and efficacy evaluations [9][10]. Market Position and Future Outlook - Daré aims to fulfill the urgent need for evidence-based treatment options in women's health, with a focus on innovative solutions that address unmet needs [18]. - The company anticipates starting to record revenue and cash flow from its Sildenafil Cream formulation in the fourth quarter of 2025, with updates on strategic partnerships expected in the second quarter of 2025 [2][4].

Core Insights - Daré Bioscience, Inc. will host a conference call on March 31, 2025, to review its financial results for the year ended December 31, 2024, and provide a company update [1] - The company focuses on advancing innovative products for women's health, aiming to develop a diverse portfolio of therapies that improve treatment options and outcomes [3] Financial Results and Conference Call - The conference call will take place at 4:30 p.m. Eastern Time, and participants can access it via phone or live webcast [2] - The webcast will be archived and available for replay until April 14, 2025 [2] Product Portfolio - Daré's first FDA-approved product is XACIATO™, a vaginal gel for treating bacterial vaginosis, under a global license agreement with Organon [4] - The company is developing several first-in-category candidates, including Ovaprene, Sildenafil Cream, and DARE-HRT1, targeting various aspects of women's health [4] Recognition and Leadership - Daré Bioscience leadership has received accolades, including being named on Medicine Maker's Power List and recognition for contributions to women's health innovation [5] - The CEO was honored as one of Fierce Pharma's Most Influential People in Biopharma in 2023 [5] - The company was ranked 1 in the Small Company category of the San Diego Business Journal's 2023 Best Places to Work Awards [5] Communication Channels - Daré will announce material information through its Investors section, SEC filings, press releases, and social media [6] - The company encourages stakeholders to review the information posted on its investor relations website and follow its social media accounts for updates [6]

Core Viewpoint - Daré Bioscience and Theramex have entered into a co-development and licensing agreement for a biodegradable contraceptive implant called Casea S, which is currently undergoing a fully funded Phase 1 study [2][3][5]. Company Overview - Daré Bioscience is focused on advancing innovative products for women's health, with a mission to develop a diverse portfolio of therapies that improve outcomes in areas such as contraception, sexual health, and menopause [6]. - Theramex is a global specialty pharmaceutical company dedicated to women's health, offering a range of products covering contraception, fertility, menopause, and osteoporosis [10]. Product Development - Casea S is designed to be a long-acting, minimally-invasive contraceptive that releases a contraceptive agent for 18-24 months before dissolving, eliminating the need for surgical removal [3][4]. - The ongoing Phase 1 study is fully funded by a foundation grant, meaning there are currently no development costs for either Daré or Theramex [5]. - If the Phase 1 study yields positive results, Daré will be responsible for conducting the subsequent Phase II study in the US, with funding for future studies to be shared between the two companies [5]. Leadership and Recognition - Daré's leadership has received accolades for their contributions to innovation in women's health, including recognition on Medicine Maker's Power List and Fierce Pharma's Most Influential People in Biopharma [8].