Development Program Highlights and Anticipated 2024 Milestones Ovaprene® hormone-free monthly intravaginal contraceptive candidate pivotal Phase 3 contraceptive efficacy study recruiting across the United States Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder successful completion of end-of-Phase 2 meeting with FDA; forthcoming additional FDA feedback; Phase 3 design, development, and collaboration strategy updates SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in innovation for the health and wellbeing of women, today reported financial results for the quarter ended March 31, 2024 and provided a company update. "The progress across our portfolio in the first quarter, along with the $22 million we secured in the non-dilutive strategic royalty financing we announced a couple of weeks ago, puts Daré on track for meaningful milestones in 2024," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "In addition to the continued commercialization by our collaborator Organon of XACIATO™ (clindamycin phosphate) vaginal gel 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older* that is available by prescription nationwide, we are pleased with the progress of our first-in-category Phase 3 development candidates. We continue to enroll our Phase 3 study of Ovaprene, our potentially first-in-category hormone-free monthly intravaginal contraceptive candidate, at sites across the U.S. and are thrilled with the response to the central advertising campaign that went live in March. We are also progressing toward a Phase 3 trial of Sildenafil Cream 3.6% in female sexual arousal disorder, for which there are currently no FDA-approved treatments. We are excited about the increased attention in the media, government, and grant making agencies on the health and wellbeing of women, and continue to execute on our mission to accelerate development of and bring to market innovative treatments that women want and need by advancing our late-stage candidates – all of which represent a first-in-category opportunity – as we seek to deliver value for all Daré stakeholders." *Please see below for important safety and other information. Ovaprene® Phase 3 StudyOvaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) and commercial collaborator Bayer, Daré commenced patient enrollment in the Ovaprene® pivotal Phase 3 clinical study in December 2023. Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly, hormone-free contraceptives approved by the FDA. Ovaprene® has potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Recruitment is currently underway at 18 sites across the United States, supported by a central advertising campaign for the study that launched in March 2024. Phase 3 study recruitment and data updates will be provided as relevant throughout 2024. Sildenafil Cream, 3.6% Progress toward Phase 3 StudySildenafil Cream is a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder. Daré has completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study and held an end-of-Phase 2 meeting with the FDA in December 2023. In prior quantitative studies, Sildenafil Cream increased genital tissue blood flow, and the Phase 2b at-home study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them that best reflect that improvement. The patient population and the endpoints identified in the Phase 2b study and proposed to the FDA for Phase 3 clinical development were those where Daré's post-hoc analyses of the Phase 2b study data showed that Sildenafil Cream demonstrated statistically significant and meaningful patient improvement. Daré is continuing to interact with the FDA as the FDA reviews, specifically, the data generated on the proposed endpoints to take forward into Phase 3 development. The FDA has indicated it anticipates providing additional feedback on the Phase 3 design in 2Q-2024. Daré's planned Phase 3 study of Sildenafil Cream, 3.6% would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. Daré intends to provide updates on the FDA's feedback, Phase 3 study design and plans, as well as any relevant updates on Daré's collaboration strategy as available in 2024. Financial Highlights for the Quarter ended March 31, 2024 Cash and cash equivalents: $3.6 million at March 31, 2024. In April 2024, Daré received $22 million in gross proceeds in a non-dilutive royalty monetization transaction with XOMA (US) LLC and a $1 million payment as the latest installment under an up to $49 million grant agreement with a foundation in support of nonclinical development of the investigational contraceptive, DARE-LARC1. To date, Daré has received approximately $29.4 million under the DARE-LARC1 grant agreement. General and administrative expenses: $2.7 million in 1Q-2024 as compared to $3.3 million in 1Q-2023, with the current quarter's decrease primarily attributable to decreases in general corporate overhead. Research and development (R&D) expenses: $3.3 million in 1Q-2024 as compared to $5.0 million in 1Q-2023, a 34% decrease compared to Q1-2023. Close-out expenses related to the Phase 2b RESPOND clinical study of Sildenafil Cream and other clinical studies conducted in 2023 contributed significantly to Daré's 1Q-2024 R&D expenses, which will not be the case in future quarters. Until Daré commences a Sildenafil Cream Phase 3 clinical study, Daré expects R&D expenses for future quarters to be lower than its 1Q-2024 R&D expenses. Conference Call Daré will host a conference call and live webcast today, May 14, 2024, at 4:30 p.m. Eastern Time to review financial results for the quarter ended March 31, 2024 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 5582540. The live webcast can be accessed under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under "Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com and available for replay until May 28, 2024. About XACIATOTM (clindamycin phosphate) vaginal gel 2% XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5g of vaginal gel containing 100mg of clindamycin. Selected Safety Information XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used. XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment. The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug. There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition. Please see the Prescribing Information, Patient Information, and Instructions for Use. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women's health. The company's mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. The first FDA-approved product to emerge from Daré's portfolio of women's health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré's full ...