SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that all rights to Ovaprene®, the company’s first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as p ...

Grant funding will support continued progress on a preclinical research program to identify and develop a non-hormonal intravaginal contraceptive innovation aimed at addressing unmet global needsSAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that it has received an approximately $3.6 million payment under an exist ...

DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product RevenuePositive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal ContraceptionFour Commercially Available Solutions for Women Expected Over the Next Two Years In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of DARE to RESTORE™ Vaginal Probi ...

Business Development - XOMA Royalty has completed acquisitions of Turnstone Biologics and HilleVax, and announced acquisitions of LAVA Therapeutics and Mural Oncology [1][6] - The company acted as a structuring agent for XenoTherapeutics' acquisition of ESSA Pharma [1] Key Pipeline Advancements - Zevra Therapeutics submitted a Marketing Authorization Application (MAA) for arimoclomol to treat Niemann-Pick Type C [2] - Rezolute Bio expects to announce topline data in December from its Phase 3 ersodetug trial for congenital hyperinsulinism [2] - Gossamer Bio anticipates topline results from its Phase 3 trial of seralutunib in pulmonary atrial hypertension in February 2026 [2] Financial Performance - In the first nine months of 2025, XOMA Royalty received $43.9 million in royalties and milestones, with $14.3 million received in the third quarter [3][10] - Income for the three and nine months ended September 30, 2025, was $9.4 million and $38.4 million, respectively, compared to $7.2 million and $19.8 million for the same periods in 2024 [10] - Net income for the three and nine months ended September 30, 2025, was $14.1 million and $25.6 million, compared to net losses of $17.2 million and $9.9 million in the corresponding periods of 2024 [17] Cash Position - As of September 30, 2025, XOMA Royalty had cash and cash equivalents of $130.6 million, including $85.4 million in restricted cash [18][19] - The company received $14.3 million in cash receipts from royalties and commercial payments in the third quarter of 2025 [20] Acquisitions and Royalty Interests - XOMA Royalty will secure economic interests in partnered assets from LAVA Therapeutics, including PF-08046052 and JNJ-89853413 [5] - The acquisition of Mural Oncology is expected to close in the fourth quarter of 2025, with cash payments ranging from $2.035 to $2.24 per share [6] Research and Development Expenses - R&D expenses for the three and nine months ended September 30, 2025, were $69 thousand and $1.4 million, respectively [11] - The increase in R&D expenses in 2025 was primarily related to clinical trial costs following the acquisition of Kinnate [11] General and Administrative Expenses - G&A expenses for the three and nine months ended September 30, 2025, were $9.7 million and $25.7 million, respectively [12] - The increase in G&A expenses for the three months ended September 30, 2025, was due to higher business development costs [12]

Core Insights - Daré Bioscience is on track to launch DARE to PLAY™ Sildenafil Cream in Q4 2025 through a 503B compounding pathway, with expected product revenue beginning in the same quarter [1][4][6] - Positive interim results from the Ovaprene® Phase 3 study support continued enrollment, highlighting the potential of this hormone-free contraceptive [1][4][6] - The company is advancing multiple grant-funded programs targeting HPV and long-acting contraception, with four commercially available solutions for women anticipated [1][2][4] Financial Highlights - For Q2 2025, Daré reported a total revenue of $(21.2) million, a decrease from $22.4 million in Q2 2024 [19] - General and administrative expenses were $2.4 million, slightly down from $2.5 million year-over-year, while research and development expenses decreased significantly by 71% to $1.4 million [11][19] - The company had approximately $5.0 million in cash and cash equivalents as of June 30, 2025, with a working capital deficit of approximately $12.6 million [11][21] Product Development and Pipeline - DARE to PLAY™ Sildenafil Cream is positioned as a near-term commercial opportunity, with a direct-to-patient campaign launched in collaboration with Rosy Wellness [4][6] - Ovaprene® is being developed as a first-in-category, hormone-free intravaginal contraceptive, with interim pregnancy rates aligning with company expectations [4][6] - The DARE-HPV program is funded by an ARPA-H award and NIH grant, focusing on treating persistent high-risk HPV infections [4][6] Strategic Initiatives - The company is executing a dual-path strategy aimed at unlocking both near-term revenue and long-term value through the commercialization of its products [6] - Discussions with the FDA are ongoing regarding endpoint assessments for the Phase 3 clinical studies of Sildenafil Cream [4][6] - Daré is also targeting the compounded hormone therapy market, estimated at $4.5 billion, with proprietary monthly hormone therapy expected to launch in late 2026 [4][6]

Core Insights - XOMA Royalty Corporation has made significant acquisitions, including mezagitamab royalty rights from BioInvent International and partnered assets through the acquisition of LAVA Therapeutics, enhancing its portfolio of early- and late-stage assets [1][2][5]. Business Development - XOMA Royalty acquired future royalty and milestone rights for mezagitamab from BioInvent for $20 million, with an additional $10 million contingent on regulatory milestones, potentially earning up to $16.25 million in milestones from Takeda and mid-single digit royalties on future sales [5]. - The acquisition of LAVA Therapeutics will secure economic interests in two partnered assets, PF 08046052 (developed by Pfizer) and JNJ-89853413 (developed by Johnson & Johnson) [5]. Company Acquisitions - XOMA Royalty has entered into definitive agreements to acquire Turnstone Biologics for $0.34 per share plus a contingent value right (CVR) [7]. - The acquisition of HilleVax is set at $1.95 per share, with additional CVR payments based on future cash distributions and potential sales of norovirus programs [7][8]. - The acquisition of LAVA Therapeutics is expected to close in Q4 2025, with a cash payment between $1.16 and $1.24 per share plus a CVR for future proceeds [8]. Key Pipeline Advancements - Rezolute completed enrollment in the Phase 3 sunRIZE study for ersodetug, receiving a $5 million milestone payment [3][9]. - The Marketing Authorization Application (MAA) for tovorafenib by Day One Biopharmaceuticals was accepted for review by the EMA, resulting in a $4 million milestone payment to XOMA Royalty [3][9]. - Zevra Therapeutics submitted an MAA to the EMA for arimoclomol as a treatment for Niemann-Pick Type C [3]. Financial Performance - In the first half of 2025, XOMA Royalty received $29.6 million in royalties and milestones, with $11.7 million in the second quarter [4][12]. - Income for the second quarter of 2025 was reported at $13.1 million, an increase from $11.1 million in the same period of 2024 [12]. - General and administrative expenses decreased to $7.8 million in Q2 2025 from $11.0 million in Q2 2024, primarily due to prior exit packages [14]. Cash Position - As of June 30, 2025, XOMA Royalty had cash and cash equivalents of $78.5 million, down from $106.4 million at the end of 2024 [20][32]. - The company repurchased approximately 81,700 shares for $1.8 million in Q2 2025, totaling over 107,500 shares repurchased in 2025 [21].

Core Insights - Daré Bioscience announced positive interim results from its Phase 3 clinical trial for Ovaprene, a hormone-free intravaginal contraceptive, highlighting its potential as a first-in-category product [1][3][5] Clinical Trial Results - The independent Data Safety Monitoring Board recommended the continuation of the trial without modifications after a planned interim analysis [2] - Approximately 9% of participants experienced pregnancy, aligning with pre-pivotal study expectations, indicating Ovaprene's effectiveness [3] - No new safety concerns were reported, with 17% of participants discontinuing due to vaginal odor, the most common adverse event [4] Market Potential - The CEO emphasized the significant unmet need for effective, hormone-free contraceptives in the U.S., suggesting Ovaprene could transform the contraceptive landscape [5] - The ongoing trial aims to enroll about 250 participants, assessing the typical use pregnancy rate over 13 menstrual cycles [6] Commercialization and Financials - Bayer holds the option to obtain exclusive U.S. commercialization rights for Ovaprene upon completion of the pivotal trial, contingent on a $20 million payment [7] - Daré could receive up to $310 million in milestone payments and tiered royalties on net sales, subject to third-party agreements [7] Company Overview - Daré Bioscience focuses on innovative solutions in women's health, aiming to address unmet needs in areas such as contraception and sexual health [8] - The company has previously launched XACIATO™, a vaginal gel for bacterial vaginosis, and is developing other first-in-category candidates [9]

Core Insights - Daré Bioscience, Inc. has received a $6 million non-dilutive funding installment, increasing total funding to approximately $37.8 million out of a potential $49 million for the development of DARE-LARC1, a contraception-focused application of its intelligent drug delivery system [1][10] - DARE-LARC1 is a preclinical-stage long-acting reversible contraceptive utilizing a programmable drug delivery device to administer levonorgestrel, with broader applications in various chronic conditions [2][6] - The DARE-IDDS platform, originally developed at MIT, has been enhanced by Daré to improve its functionality and is capable of delivering multiple doses over extended periods without the need for recharging or surgical replacement [3][4] Funding and Development - The recent funding milestone will support the advancement of DARE-LARC1 and the development of a versatile drug delivery platform across high-value therapeutic areas [3][10] - Daré is eligible for additional non-dilutive funding of up to approximately $11.2 million, contingent on achieving specified technical milestones [10] Market Potential - The DARE-IDDS platform has potential applications beyond reproductive health, including obesity, diabetes, and other chronic conditions, which could significantly improve patient adherence and reduce healthcare costs [6][7] - The platform's features include precision dosing, extended duration of action, and remote programmability, making it suitable for various therapeutic areas [9] Strategic Partnerships - Daré is actively exploring strategic partnerships to expand the evaluation of the DARE-IDDS platform into additional therapeutic categories [2][10] - The company aims to leverage its innovative technology to address unmet needs in women's health and enhance treatment options [11]

Core Points - Daré Bioscience, Inc. convened its 2025 annual meeting of stockholders but adjourned it due to a lack of quorum, with plans to reconvene on July 9, 2025 [1][2] - Stockholders who have already submitted proxies or voted do not need to vote again, as their submissions will remain valid [3] - The company emphasizes the importance of voting for stockholders who have not yet participated, providing instructions for online and telephone voting [4] Company Overview - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to address unmet needs through innovative solutions [8] - The company has developed products such as XACIATO™, a vaginal gel for bacterial vaginosis, and is working on other candidates like Ovaprene® and Sildenafil Cream for various women's health issues [9][10] - Daré's leadership has received recognition for contributions to innovation and advocacy in women's health [11]

Core Insights - Daré Bioscience, Inc. has announced a strategic collaboration with Rosy Wellness to support the marketing and awareness campaign for its DARE to PLAY Sildenafil Cream, aimed at enhancing women's sexual health [1][3][4] Company Overview - Daré Bioscience is a biopharmaceutical company focused on women's health, aiming to address unmet needs through innovative solutions [10] - The company is set to start recording revenue in the fourth quarter of 2025 with the launch of DARE to PLAY Sildenafil Cream, a topical formulation of sildenafil citrate [1][2] Product Details - DARE to PLAY Sildenafil Cream is designed to increase local blood flow to genital tissues, addressing female sexual arousal disorder [2][11] - The product is expected to be available by prescription in the U.S. as a compounded drug under Section 503B of the FDCA [2] Collaboration Highlights - The partnership combines Daré's clinical expertise with Rosy's extensive digital reach and community engagement, which includes over 250,000 women [1][3] - The collaboration will focus on educational outreach and destigmatizing conversations around female sexual health [3][5] Market Context - Female sexual health is identified as a significantly underserved area, with 65% of women reporting concerns with arousal [3][4] - The partnership aims to enhance sexual wellness education and access for women, addressing a historically stigmatized topic [5][8]