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]

Group 1 - Dare Bioscience, Inc. reported a quarterly loss of $0.55 per share, better than the Zacks Consensus Estimate of a loss of $0.60, and an improvement from a loss of $1.08 per share a year ago, representing an earnings surprise of 8.33% [1] - The company posted revenues of $0.04 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 98.64%, and down from $1 million in the same quarter last year [2] - Dare Bioscience shares have increased by approximately 3.4% since the beginning of the year, while the S&P 500 has gained 25.5% [3] Group 2 - The earnings outlook for Dare Bioscience is mixed, with the current consensus EPS estimate for the coming quarter at -$0.39 on revenues of $4.19 million, and -$0.27 on revenues of $3.67 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 29% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $41,691, a decrease from $1,000,000 in the same period of 2023, representing a decline of 95.8%[28] - Operating expenses for the same period were $4,723,040, down from $9,396,415 in the prior year, indicating a reduction of 49.7%[28] - Net loss for the three months ended September 30, 2024, was $4,702,501, compared to a net loss of $8,299,096 in the same period of 2023, reflecting an improvement of 43.5%[28] Cash and Assets - Daré Bioscience reported cash and cash equivalents of $11.2 million as of September 30, 2024[11] - Cash and cash equivalents as of September 30, 2024, were $11,232,609, an increase from $10,476,056 at the end of 2023[29] - Working capital improved to $1,790,546 as of September 30, 2024, compared to a deficit of $2,936,897 at the end of 2023[29] - Total assets decreased to $18,058,801 as of September 30, 2024, down from $21,282,215 at the end of 2023, a decline of 15.5%[29] - Total stockholders' deficit improved to $(1,484,483) as of September 30, 2024, compared to $(5,047,640) at the end of 2023, indicating a reduction of 70.7%[29] Research and Development - Research and development expenses were $2.7 million in Q3 2024, a 60% decrease from $6.7 million in Q3 2023, mainly due to the completion of the Phase 2b RESPOND clinical study for Sildenafil Cream[13] - The planned Phase 3 study of Sildenafil Cream, 3.6% is expected to cost approximately $15 million in direct costs, with two successful studies required for NDA submission[10] - Daré is advancing the Phase 3 study of Ovaprene®, with recruitment currently at 10 sites across the U.S., aiming for 125 women to complete the study by mid-2025[9] - The company is preparing for a Phase 2 clinical study of DARE-VVA1 and a Phase 1 study of DARE-PTB1, the latter supported by a $2 million grant from NICHD[5] Grants and Funding - The company received a $10 million award from ARPA-H for the DARE-HPV program, aimed at treating HPV-related cervical diseases[3] - A foundation grant of approximately $10.7 million was announced to fund the development of a novel non-hormonal intravaginal contraceptive product candidate and to expand clinical sites for the ongoing Ovaprene® pivotal study[1] - The company expects to receive $10 million in funding under ARPA-H's Sprint for Women's Health initiative[27] - Daré anticipates accessing $15 million in additional capital under its equity line arrangement with Lincoln Park Capital Fund[27] Product Development and Focus - Daré's first FDA-approved product, XACIATO™, is a treatment for bacterial vaginosis and is available by prescription nationwide[5] - The company aims to deliver innovative treatments that prioritize women's health and well-being, focusing on areas such as contraception and sexual health[23]

Financial Performance - Total revenue for the three months ended September 30, 2023, was $41,691, compared to $1,000,000 for the same period in 2022, representing a significant decrease [8]. - Total operating expenses for the three months ended September 30, 2023, were $4,723,040, down from $9,396,415 in the same period last year, indicating a reduction of approximately 50% [8]. - The net loss for the three months ended September 30, 2023, was $(4,702,501), compared to a net loss of $(8,299,096) for the same period in 2022, showing an improvement of approximately 43% [8]. - The company reported a basic loss per share of $(0.55) for the three months ended September 30, 2023, compared to $(1.09) for the same period in 2022, indicating a reduction in loss per share [8]. - The company experienced a comprehensive loss of $(4,679,566) for the three months ended September 30, 2023, compared to $(8,314,126) for the same period in 2022, reflecting an improvement [8]. - Net loss for the nine months ended September 30, 2023, was $(25,103,829), compared to $(1,452,799) for the same period in 2024 [13]. - The Company incurred a loss from operations of approximately $18.1 million for the nine months ended September 30, 2024 [26]. Research and Development - Research and development expenses for the three months ended September 30, 2023, were $2,656,772, down from $6,674,636 in the same period last year, reflecting a decrease of about 60% [8]. - The company’s primary operations focus on research and development activities to advance product candidates through clinical development and regulatory approval [16]. - The company recorded research and development expense credits of approximately $4.8 million related to the DARE-LARC1 award for the nine months ended September 30, 2024 [124]. - The company is entitled to receive up to $10.0 million in milestone-based payments for the DARE-HPV development program, contingent upon achieving specified research objectives over a 24-month period [131]. Cash and Liquidity - Cash and cash equivalents increased to $11,532,609 at the end of the period from $10,811,056 at the beginning of the period [13]. - The company’s total cash, cash equivalents, and restricted cash decreased to $11,532,609 from $14,229,424 [13]. - Unrestricted cash and cash equivalents amount to approximately $11.2 million as of September 30, 2024 [26]. - The Company has working capital of approximately $1.8 million as of September 30, 2024 [26]. - The Company prepared its financial statements on a going concern basis, raising substantial doubt about its ability to continue operations without additional capital [25]. - The Company expects to need to raise substantial additional capital to fund its operations and execute its current strategy [27]. Agreements and Milestones - The Company entered into a royalty purchase agreement with XOMA, receiving $22.0 million for future net royalty and milestone payments related to XACIATO, Ovaprene, and Sildenafil Cream [29]. - The Company is entitled to receive tiered double-digit royalties based on net sales and up to $180.0 million in tiered commercial and regulatory milestones under the license agreement with Organon [42]. - The Company has potential future payments of up to $5.25 million for development and regulatory milestones and up to $64.0 million for commercial sales milestones under the Douglas License Agreement [55]. - The Company agreed to pay former MBI stockholders up to $46.5 million contingent upon achieving specified funding and product development milestones, and up to $55.0 million based on aggregate net sales [59]. - The Company entered into an exclusive license agreement with Catalent JNP, Inc., paying a $250,000 upfront fee and a $100,000 annual maintenance fee, with potential milestone payments totaling up to $43.8 million [70]. Stock and Equity - The weighted average number of shares outstanding for the three months ended September 30, 2023, was 8,534,433, compared to 7,587,637 for the same period in 2022, indicating an increase in shares outstanding [8]. - A reverse stock split on July 1, 2024, reduced the number of outstanding shares from approximately 101.1 million to approximately 8.5 million [79]. - The Company has a total of 1,268,572 warrants outstanding as of September 30, 2024, with a weighted average exercise price of $7.49 [89]. - The Company recorded a warrant value of $2.9 million from the September 2023 offering using the Black-Scholes model [87]. Future Commitments and Obligations - The Company has a total obligation of approximately $3.5 million related to a clean room space lease, with fixed payments due quarterly [98]. - Total future minimum lease payments under the Company's operating leases as of September 30, 2024, amounted to $1.61 million [102]. - The company is responsible for providing $5.5 million in payments to NICHD for the Ovaprene Phase 3 study, with $0.5 million paid in July 2024 and $5.0 million paid in prior years [115]. Grants and Funding - The company has received approximately $29.3 million in non-dilutive funding from the Bill & Melinda Gates Foundation for the DARE-LARC1 project as of September 30, 2024 [124]. - The company received a grant of up to approximately $10.7 million to support the expansion of study sites for the Phase 3 clinical trial of Ovaprene, with an initial payment of $5.4 million due in 2024 [130].