Dare Bioscience, Inc. (DARE) came out with a quarterly loss of $0.64 per share versus the Zacks Consensus Estimate of a loss of $0.66. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 3.03%. A quarter ago, it was expected that this company would post a loss of $0.60 per share when it actually produced a loss of $0.55, delivering a surprise of 8.33%. Over the last four quarters, the company has su ...

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].

Conference call today at 4:30 p.m. ET to discuss the expanded business strategy to integrate 503B compounding as part of a dual-path approach to bring select Daré proprietary formulations to market as soon as practicable SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today reported financial results for the year ended December 31, 2024 and provided a company upda ...

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].

Core Insights - DARE-HPV is a potential first-in-category treatment for HPV-related cervical disease, which could significantly alter the treatment landscape for clinical HPV management [1][3] - The National Institute of Allergy and Infectious Diseases (NIAID) may provide up to $2 million in grant funding to support DARE-HPV development, increasing total non-dilutive funding to $12 million [1][4] Company Overview - Daré Bioscience, Inc. 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 infectious diseases [9] - The company has previously received a $10 million milestone-based funding award to support IND and Phase 2 clinical study activities for DARE-HPV [3][4] Product Details - DARE-HPV is an investigational treatment that combines lopinavir and ritonavir in a soft gel vaginal insert, aiming to be the first FDA-approved pharmaceutical intervention for high-grade cervical lesions and HPV infections [7] - Currently, there are no FDA-approved non-surgical pharmaceutical treatments for high-grade cervical lesions, highlighting the potential market opportunity for DARE-HPV if approved [7][8] Market Context - HPV is the most common sexually transmitted infection in the U.S., with nearly all cervical cancers caused by HPV infection, leading to significant health concerns for women [6][8] - An estimated 100,000 women are treated for cervical precancer annually in the U.S., with over 4,000 deaths from cervical cancer each year, indicating a critical need for effective treatments [2][8]

Core Insights - The J.P. Morgan Healthcare Conference is emphasizing the importance of investing in women's health, with a series of panels dedicated to this topic [1][2] - Daré Bioscience, a leader in women's health innovation, is participating in the conference, highlighting its commitment to advancing therapies for women's health [1][3] Company Overview - Daré Bioscience is focused on developing innovative products for women's health, aiming to improve treatment options and outcomes in areas such as contraception, sexual health, and menopause [3] - The company has a diverse portfolio of product candidates, including XACIATO™, Ovaprene®, Sildenafil Cream, and DARE-HRT1, targeting various women's health issues [4] Recent Developments - Sabrina Martucci Johnson, CEO of Daré Bioscience, will speak at the conference about the potential for increased investment in women's health and the company's investigational products [2] - Daré has received two non-dilutive funding awards of approximately $10 million each in 2024 to support the development of a novel non-hormonal contraceptive and an HPV treatment [2] Recognition and Awards - Daré Bioscience has been recognized in the biopharmaceutical industry, with its leadership featured in notable lists such as Medicine Maker’s Power List and Endpoints News’ Women in Biopharma [5][6] - The company was ranked 1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards [6]

Core Insights - Daré Bioscience is developing Sildenafil Cream, a topical formulation of sildenafil, as a potential first FDA-approved treatment for female sexual arousal disorder (FSAD) [2][4][5] - Approximately 10 million women in the U.S. are affected by FSAD, indicating a significant market opportunity for effective treatments [6][4] - The company plans to initiate a Phase 3 clinical study in mid-2025, following FDA recommendations for evaluating safety and efficacy [3][9] Company Overview - Daré Bioscience focuses on innovative products for women's health, aiming to expand treatment options and improve outcomes in various areas including sexual health [11] - The company has previously launched XACIATO, a vaginal gel for bacterial vaginosis, and is developing other products like Ovaprene and DARE-HRT1 [12] Market Potential - FSAD is clinically similar to erectile dysfunction (ED) in men, with a notable prevalence among women, suggesting a substantial unmet need in the market [4][6] - The planned Phase 3 study will evaluate the efficacy of Sildenafil Cream against a placebo, with co-primary endpoints focusing on arousal sensations and associated distress [9][10] Clinical Development - The Phase 3 study will follow a 12-week double-blind treatment design, consistent with the previously completed Phase 2b RESPOND study [9][8] - Secondary endpoints will assess improvements in orgasm, desire, and interpersonal difficulties, further supporting the treatment's potential benefits [10][9]

Financial Data and Key Metrics Changes - General and administrative expenses for Q3 2024 were approximately $2 million, a 24% decrease compared to Q3 2023 due to reduced professional services and commercial readiness expenses [20] - Research and development (R&D) expenses were approximately $2.7 million for Q3 2024, representing a 60% decrease compared to Q3 2023, with expectations that full-year 2024 R&D expenses will be less than those in 2023 [21] - Comprehensive loss for Q3 2024 was approximately $4.7 million, with cash and cash equivalents at approximately $11.2 million as of the end of the quarter [22] Business Line Data and Key Metrics Changes - The company continues to advance its late-stage candidates, including ongoing enrollment in the Phase III study of Ovaprene and constructive interactions with the FDA regarding Sildenafil Cream [14][35] - XACIATO, the first FDA-approved product from the company's portfolio, has seen steady month-over-month increases in total prescriptions since its launch [32] Market Data and Key Metrics Changes - The company has identified a significant market opportunity in non-hormonal contraception, with approximately 35 million women in the U.S. as potential candidates for Ovaprene [40] - The DARE-HPV program targets a significant health issue, as nearly all cervical cancer cases are caused by HPV infection, with an estimated 100,000 women treated for cervical precancer annually in the U.S. [46] Company Strategy and Development Direction - The company focuses on women's health pharmaceutical product development across various areas, including contraception and sexual health, aiming to address existing therapeutic gaps [6][7] - The company has secured over $20 million in non-dilutive funding recently, which will support the advancement of its product candidates [5][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increased attention on women's health and the potential for their innovative treatments to fill significant gaps in the market [10][12] - The company is well-positioned for meaningful milestones in 2025, supported by recent funding agreements and ongoing clinical trials [16][58] Other Important Information - The company has received a $10 million award from ARPA-H for the DARE-HPV program and a $10.7 million grant from the Bill & Melinda Gates Foundation to support the development of non-hormonal contraceptive products [10][11][57] Q&A Session Summary Question: Potential interim look by the end of 2Q '25 for the Ovaprene study - Management confirmed that the interim look will focus on safety and possibly some efficacy data, with ongoing discussions with the commercialization collaborator Bayer [60][62] Question: Operational progress towards Phase III for Sildefanil - Management indicated that discussions with the FDA are focused on appropriate endpoints for the Phase III program, with operational readiness being a priority [66][72] Question: Additional sites for the Ovaprene trial - Management plans to add a handful of additional sites to the study, focusing on those with a strong track record of efficient enrollment [85][88] Question: Funding requirements for the Sildefanil program - Management estimated that approximately $15 million is needed for the individual study, with flexibility in funding timing due to the study's shorter duration [100][102]