Daré Bioscience(US:DARE)2025-03-31 20:01Product Development and Approval - XACIATO™ (clindamycin phosphate) vaginal gel received FDA approval in December 2021 for the treatment of bacterial vaginosis in females aged 12 and older[29]. - In 2022, the company licensed exclusive worldwide rights for XACIATO to Organon, which began U.S. marketing in Q4 2023 and announced nationwide availability in January 2024[21]. - The company is developing Ovaprene®, a hormone-free monthly contraceptive currently in a pivotal Phase 3 clinical study, with expected typical use efficacy of approximately 86% to 91% at 6 months[34]. - The FDA granted XACIATO a total of 8 years of data exclusivity, expiring on December 7, 2029, due to its Qualified Infectious Disease Product (QIDP) designation[32]. - The company plans to utilize 503B compounding to bring proprietary formulations to market, targeting availability of Sildenafil Cream in Q4 2025 while pursuing FDA approval[23]. - The company is developing Sildenafil Cream, 3.6%, targeting the estimated 10 million women in the U.S. suffering from female sexual arousal disorder[47]. - DARE-HRT1, an intravaginal ring, is designed to deliver bio-identical 17β-estradiol and progesterone continuously over 28 days, targeting menopausal symptoms[65]. - DARE-VVA1 received FDA clearance for its IND application in December 2023, with plans for a Phase 2 randomized, double-blinded, placebo-controlled study for moderate-to-severe dyspareunia[76]. - DARE-HPV is being developed for the treatment of genital HPV infection and cervical intraepithelial neoplasia, with no FDA-approved treatments currently available for these conditions[83]. - DARE-PDM1 is designed to treat primary dysmenorrhea using a proprietary hydrogel formulation of diclofenac, potentially offering a first-in-category product for vaginal administration[88]. Clinical Trials and Efficacy - Ovaprene clinical trial met its primary endpoint, with 100% of women and cycles showing an average of less than five progressively motile sperm per high power field after intercourse[39]. - In the baseline cycle, women had a mean of 27.21 progressively motile sperm per high power field, which decreased to 0.48 during Ovaprene use[39]. - The pivotal Phase 3 clinical study of Ovaprene commenced in December 2023, aiming to enroll approximately 250 participants over 13 menstrual cycles[42]. - The study anticipates that approximately 125 women will complete six months of Ovaprene use by the end of Q2 2025, marking a checkpoint for interim data review[42]. - The Phase 3 program is set to include a 12-week double-blind treatment period, with co-primary efficacy endpoints assessing arousal sensations and associated distress, consistent with the Phase 2b RESPOND study[61]. - The Phase 1 clinical trial of DARE-HRT1 showed similar steady-state concentrations of estradiol compared to FDA-approved products for treating menopausal symptoms, with no serious adverse events reported[69]. - In a Phase 1/2 study of DARE-VVA1, participants showed approximately 30% improvement in vaginal pH scores and approximately 63% improvement in vaginal dryness scores after three months[78]. - The topline data from the DARE-PDM1-001 study indicated that all 42 participants tolerated the treatment well, with 85% of adverse events being mild[90]. - The exploratory endpoint showed a statistically significant decrease in pelvic/vaginal and lower back pain scores in the 1% diclofenac DARE-PDM1 treatment group compared to placebo[92]. Collaborations and Funding - The company has received non-dilutive funding from federal agencies and private foundations to support various R&D activities across eight programs[28]. - The company is collaborating with ADVA-Tec, Inc. and Bayer HealthCare LLC for the development and commercialization of Ovaprene[46]. - The Phase 3 study is supported by a $5.5 million contribution from the company to the NICHD for conducting the study, all of which had been paid as of September 30, 2024[44]. - The company plans to submit the protocol for the Phase 3 clinical study to the FDA in Q2 2025, pending additional recommendations[62]. - The company has received approximately $31.8 million under a grant agreement to advance the development of DARE-LARC1, with total potential funding of up to $49.0 million[104]. Financial Agreements and Royalties - In 2022, the company received a $10.0 million non-refundable payment from Organon as part of a licensing agreement, with additional milestone revenue of $1.8 million in 2023[115]. - Organon agreed to pay tiered double-digit royalties based on net sales and potential future milestone payments of up to $180.0 million[116]. - Bayer will provide a total of up to $310.0 million in milestone payments if all milestones are achieved, including a low double-digit million payment upon the first commercial sale of Ovaprene[121]. - The license agreement with Bayer includes tiered royalties starting in the low double digits based on annual net sales of Ovaprene[121]. - The company is responsible for providing $5.5 million to NICHD for the Phase 3 study of Ovaprene, all of which had been paid as of September 30, 2024[136]. - The acquisition of Dare MB Inc. includes contingent payments of up to $46.5 million based on specified milestones and tiered royalty payments based on annual net sales[138]. - The company paid MilanaPharm $500,000 upon the first commercial sale of XACIATO in Q4 2023, with additional payments tied to future sales milestones[142]. Intellectual Property and Competition - The company holds exclusive licenses for five granted U.S. patents related to Ovaprene, with terms expiring between 2025 and 2028[190]. - The Sildenafil Cream program includes 27 issued patents worldwide, with U.S. patents expiring in June 2029 and several foreign patents expiring in late 2031[191]. - The company is the exclusive licensee of three issued U.S. patents related to XACIATO, with terms expiring between 2028 and 2036[189]. - The company is focused on women's health, a highly competitive and fragmented market, facing competition from established pharmaceutical companies and generics[200]. - XACIATO competes with multiple generic and branded prescription drugs for bacterial vaginosis treatment, with its commercial success being outside the company's control[202]. - The investigational contraceptive product Ovaprene will face competition from various existing contraceptive options, including hormone-free and hormonal products[203]. - DARE-HRT1, if approved, will compete with numerous existing products for menopausal symptoms, including FDA-approved hormone therapies and compounded products[206]. - DARE-VVA1, if approved, will compete with both hormonal and non-hormonal treatments for dyspareunia, including FDA-approved and compounded products[207]. - The company's ability to develop and market products will depend on FDA approvals, regulatory compliance, and competition from other organizations[210].