Daré Bioscience (NASDAQ:DARE) outlined plans to expand commercialization of women’s health products while advancing late-stage clinical programs that could produce data readouts in 2027, President and Chief Executive Officer Sabrina Martucci Johnson said during the company’s virtual bus tour.
Johnson described Daré as a women’s health-focused biotechnology company addressing conditions across contraception, menopause, sexual health, fertility, vaginal health and infectious disease. She said the company’s strategy combines commercial-stage products, clinical development programs and grant funding intended to reduce reliance on equity capital for pipeline advancement.
Commercial Products Begin Rolling Out
The company is also preparing to begin dispensing prescriptions for DARE to PLAY Sildenafil Cream during the third quarter, according to Johnson. The prescription product is a compounded topical cream designed to address physical sexual arousal in women. It uses sildenafil, the active ingredient in Viagra, and is intended to increase genital blood flow following application.
Johnson said DARE to PLAY is being introduced as a 503B compounded product while Daré continues to pursue an FDA approval pathway. She said the product is manufactured under pharmaceutical quality standards, though it is not yet FDA-approved. The cream is expected to be priced at $99 per tube, with each tube containing 10 doses.
Daré plans to use its Daré Health Hub as a central platform for prescriptions, telehealth access, fulfillment, payment processing and patient education. The company also expects to work with healthcare providers, clinician offices, third-party telehealth providers and digital channels to support product awareness and access.
For the initial Flora Sync LF5 launch, Johnson said the company will focus on indicators beyond early sales dollars, including the sources of customer demand, performance across channels and repeat use. Daré is also evaluating additional retail channels for the product, she said.
Pipeline Readouts Expected Next Year
Johnson highlighted Ovaprene, Daré’s investigational once-monthly, non-hormonal vaginal contraceptive, as a key late-stage program. The product is currently in a pivotal Phase 3 trial, and the company expects to complete enrollment later this year. Top-line data are anticipated in 2027.
Ovaprene has received two positive interim reviews from its data safety monitoring board, Johnson said. If successful, the product could become the first FDA-approved monthly hormone-free contraceptive, according to the company. Development of Ovaprene, including the Phase 3 program, has been primarily supported through grants from the National Institutes of Health and the Gates Foundation.
Daré also expects a 2027 data readout from its Phase 2 trial of DARE-HPV, an investigational treatment for persistent high-risk human papillomavirus infection. Johnson said there is currently no pharmacologic treatment for women diagnosed with a high-risk HPV strain, which can cause cervical cancer. The Phase 2 study is supported by a grant contract from ARPA-H, an agency within the U.S. Department of Health and Human Services.
Another planned commercial opportunity is DARE to RECLAIM, a once-monthly vaginal ring designed to deliver estradiol and progesterone for menopause hormone therapy. Johnson said Daré is targeting commercialization next year through a 503B compounded-product approach while continuing its NDA pathway efforts.
The company also has FDA clearance to conduct a Phase 2 study of a non-hormonal product for sexual symptoms associated with menopause, including for women for whom hormone therapy may not be suitable. In addition, Daré plans to begin an NIH-funded Phase 1 study of a progesterone vaginal ring intended as a potential alternative to progesterone injections used in IVF and at-risk pregnancies.
NASDAQ Compliance Process Underway
During the question-and-answer session, Johnson provided an update on Daré’s Nasdaq listing compliance process. She said the company had received a notice related to its stockholders’ equity metric and requested a Nasdaq panel hearing in July. The hearing was expected to occur in late August, with a panel determination typically issued within about 30 days of the hearing.
Johnson said Daré recently completed an equity offering that increased stockholders’ equity. While the company has received approximately $75 million in non-dilutive grant funding since 2018, she said that funding does not contribute to the stockholders’ equity calculation under generally accepted accounting principles.
Johnson said the company intends to continue pursuing grant support for development programs while building commercial momentum through its current and planned product launches.
About Dare Bioscience (NASDAQ:DARE)
Dare Bioscience, Inc is a clinical-stage biopharmaceutical company focused on developing innovative therapies for women’s reproductive health. The company’s flagship development candidate is Ovaprene, a monthly, self-administered, non-hormonal contraceptive vaginal ring designed to offer an alternative to traditional hormone-based birth control methods. Through its proprietary intravaginal drug delivery platform, Dare seeks to address unmet medical needs in gynecology and contraception with products that prioritize efficacy, safety and ease of use.
In addition to its lead contraceptive program, Dare is advancing a pipeline of early-stage assets aimed at treating gynecologic conditions through local, non-systemic drug delivery.
