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Daré Bioscience Receives $6 Million Non-Dilutive Grant Installment; $37.8M to Date of up to $49M Commitment Supporting Smart Drug Delivery Device for Contraception; Platform has Broader Application Potential in Obesity and Metabolic Disorders
Globenewswire· 2025-07-11 12:00
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]
Daré Bioscience (DARE) Earnings Call Presentation
2025-07-03 14:11
June 9, 2025 1 NASDAQ: DARE www.darebioscience.com ©2025 Daré Bioscience | All rights reserved 1 TRANSFORMING WOMEN'S HEALTH We founded Daré with the sole focus of putting women's health first – to boldly address existing gaps and give women the treatment options they want and deserve In Italian, it means "TO GIVE" DARE: In English, it means "TO BE BOLD" 2 2 Forward-Looking Statements; Disclaimers This presentation is for informational purposes only and is not an offer to sell or a solicitation of an offer ...
Daré Bioscience Announces Adjournment of Annual Meeting of Stockholders
Globenewswire· 2025-06-12 21:00
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]
Daré Bioscience and Rosy Wellness Announce Strategic Collaboration to Educate and Market Daré’s DARE to PLAY Sildenafil Cream
Globenewswire· 2025-06-04 12:00
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]
Daré Bioscience(DARE) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:32
Daré Bioscience (DARE) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants MarDee Haring-Layton - Chief Accounting OfficerSabrina Johnson - President, CEO & DirectorDouglas Tsao - Managing DirectorLeona Nease - Biotech Equity Research AssociateWill Hidell - Equity Research Associate Operator Welcome to the conference call hosted by Dare Bioscience to review the company's First Quarter twenty twenty five Financial Results and to provide a business update. This call is being recorded. My name ...
Daré Bioscience(DARE) - 2025 Q1 - Earnings Call Transcript
2025-05-13 21:30
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]
Daré Bioscience Reports First Quarter 2025 Financial Results and Provides Company Update
GlobeNewswire News Room· 2025-05-13 20:01
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]
XOMA Royalty Reports First Quarter 2025 Financial Results and Highlights Business Achievements
Globenewswire· 2025-05-13 11:30
Core Insights - XOMA Royalty Corporation reported a strong first quarter for 2025, with total income and revenues of $15.9 million, a significant increase from $1.5 million in the same period in 2024, driven by various milestone payments and royalties [7][21]. - The company received $18.0 million in cash receipts during the first quarter, including $13.4 million from royalties and commercial payments, and $4.6 million from milestones and fees [15][7]. - XOMA Royalty is focused on prudent cash deployment, strict expense control, and opportunistic share repurchases, indicating a commitment to generating shareholder value [2][6]. Pipeline Advancements - The Marketing Authorization Application (MAA) for tovorafenib by Day One Biopharmaceuticals and Ipsen was accepted for review by the European Marketing Authority (EMA) [1]. - Takeda initiated a Phase 3 trial for mezagitamab, targeting chronic primary immune thrombocytopenia [1]. Business Development - XOMA Royalty acquired a royalty interest in Castle Creek Biosciences' D-Fi (FCX-007), a Phase 3 asset for dystrophic epidermolysis bullosa, contributing $5 million to a $75 million syndicated royalty financing transaction [3][1]. - The company successfully sold all unpartnered Kinnate assets, with a portion of any upfront payments to be distributed to Kinnate CVR holders [1][3]. Financial Performance - The company recorded a net income of $2.4 million for the first quarter of 2025, compared to a net loss of $8.6 million in the first quarter of 2024 [14][22]. - Research and Development (R&D) expenses increased to $1.3 million in Q1 2025 from $33,000 in Q1 2024, primarily due to licensing fees and clinical trial costs [9][21]. - General and Administrative (G&A) expenses decreased to $8.1 million in Q1 2025 from $8.5 million in Q1 2024, mainly due to lower stock compensation costs [10][11]. Anticipated Events - Key upcoming events include the EMA's decision on the MAA for tovorafenib and the completion of enrollment in the sunRIZE Phase 3 clinical trial for ersodetug, with topline data expected in December 2025 [6][1].
Daré Bioscience Reports Full Year 2024 Financial Results and Provides Company Update
Newsfilter· 2025-03-31 20:01
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].