Sabrina Martucci Johnson built Daré Bioscience around a simple but radical premise: women’s health is not a niche market. It’s a decade-long bet that is now beginning to pay out.
THE GAP NO ONE WAS FILLING
There is a drug that has been commercially available for nearly thirty years. It increases blood flow, improves physical response, and has been prescribed to tens of millions of patients. That drug is sildenafil — the active ingredient in Viagra — and until late 2025, not a single cGMP-manufactured, clinically studied topical formulation of it existed for women.
That absence is not an accident of science. It is an artifact of a healthcare system that has historically treated women’s health — especially women’s sexual health — as low priority, high taboo, and poor investment. Sabrina Martucci Johnson, Founder, President, and CEO of San Diego-based Daré Bioscience, has spent a decade building a company on exactly that premise: that the gaps in women’s healthcare are not gaps in opportunity. They are failures of attention.
“Women’s health is not niche,” Johnson has said. “It’s not niche for half the population. I feel like these are billion-dollar opportunities hiding in plain sight.”
Sabrina Martucci Johnson Founder and CEO, Daré Bioscience
In 2015, Sabrina founded Daré Bioscience Operations with a singular focus. Following a business combination with Cerulean Pharma in 2017, the company was renamed and listed on the Nasdaq Capital Market under the ticker DARE. Johnson has served as President, CEO, and board member since the company’s inception — a continuity of leadership that is uncommon in small-cap biotech and speaks to the deliberate nature of what she set out to build.
MULTIPLE BETS ON NEGLECTED SCIENCE
Daré does not operate as a single-product company. Its strategy has always been to build a portfolio of first-in-category or potential best-in-class candidates across multiple indications in women’s reproductive and sexual health — an approach Johnson described plainly in the company’s most recent earnings statement: “Daré is not a single-event binary bet. This is a portfolio with multiple potential catalysts, multiple pathways to value, and multiple ways to win.”
XACIATO — FDA Approved, Commercially Licensed
Daré’s first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), is indicated for the treatment of bacterial vaginosis in patients 12 and older. The product is under a global license agreement with Organon, and royalty income from that arrangement contributes to Daré’s non-dilutive revenue base.
DARE to PLAY — Sildenafil Cream for Female Sexual Arousal
The company’s most visible commercial advance in the past six months has been the launch of DARE to PLAY™ Sildenafil Cream. Described by the company as the first and only evidence-backed sildenafil cream formulation for women, the product was designed to increase genital blood flow within approximately ten to fifteen minutes of application and improve arousal response without systemic effects.
Prescription intake began through the DARE Health Hub in December 2025. By February 11, 2026, DARE to PLAY was available for pre-fulfillment prescriptions in all 50 states, with telehealth access enabled in most. Product revenue is expected to begin in Q2 2026.
The product is currently available as a Section 503B compounded drug — manufactured under FDA-inspected cGMP conditions, but not yet FDA approved. Daré is simultaneously pursuing full FDA approval through the 505(b)(2) NDA pathway. An estimated 20 million women in the United States experience challenges related to genital arousal, and there is currently no FDA-approved therapeutic to address it.
Ovaprene — Hormone-Free Monthly Contraception in Phase 3
Among the most strategically significant programs in Daré’s pipeline is Ovaprene®, an investigational monthly intravaginal, hormone-free contraceptive currently in a pivotal Phase 3 clinical trial. The Data Safety Monitoring Board reviewed interim data in July 2025 and recommended the study continue without modification. Daré anticipates completing enrollment in 2026, which would position a 2027 topline data readout as within reach.
A notable strategic development arrived in December 2025, when Bayer HealthCare LLC elected to terminate its U.S. license agreement for Ovaprene as part of a broader strategic reprioritization, with the termination effective February 2026. Daré framed the move constructively: with the Phase 3 study advancing on non-dilutive grant funding, the company now holds full global rights to the asset. “We will have maximum strategic flexibility to capture the value of this opportunity,” Johnson said when the news was announced.
Ovaprene addresses a growing shift in the contraceptive market. A rising number of women — particularly younger women — are actively seeking non-hormonal, non-implanted options. The current market offers nothing in that category beyond in-the-moment barrier methods or spermicidal gels.
DARE-HPV — Therapeutic for High-Risk HPV, ARPA-H Funded
Approximately six million women in the United States are estimated to carry a high-risk HPV infection, according to Daré’s market characterization. There is currently no FDA-approved pharmacologic treatment for existing HPV infections anywhere in the world. DARE-HPV has secured up to $10 million from ARPA-H, the Advanced Research Projects Agency for Health. The FDA cleared the company’s IND application on February 23, 2026, and Daré is preparing to advance DARE-HPV into a Phase 2 clinical study later this year.
Additional Pipeline Programs
Daré’s pipeline extends further into menopause (DARE-HRT1, a bioidentical estradiol and progesterone intravaginal ring targeting hormone therapy), vaginal health consumer products (the DARE to RESTORE brand family, launching with Flora Sync LF5 vaginal probiotic suppositories in Q2 2026), long-acting contraception (DARE-LARC1, fully grant-funded through foundation support), and treatment of dyspareunia (DARE-VVA1).
THE BUSINESS MODEL: ASSET-LIGHT, GRANT-DRIVEN
One of the more distinctive aspects of Daré’s approach is its deliberate avoidance of building a traditional commercial infrastructure. The company operates without an internal sales force, relying instead on 503B outsourcing facilities, licensed pharmacy partners, and telehealth platforms to bring products to market. The DARE Health Hub, powered by Medvantx Pharmacy, serves as the digital commercial spine for DARE to PLAY and forthcoming products.
On the funding side, Daré has used non-dilutive capital — NIH SBIR grants, ARPA-H awards, and foundation funding — to support a significant portion of its R&D. This approach offsets reported research expenses and reduces the degree of shareholder dilution required to advance the pipeline. The company has also monetized commercial assets through royalty arrangements, most notably the Organon license for XACIATO.
The model carries execution risk. Daré has acknowledged the need to secure additional capital before Phase 3 can begin for sildenafil cream (via the 505(b)(2) route) and DARE-HRT1. Successful enrollment completion for Ovaprene through 2026 and beyond, and effective commercialization of cash-pay products in specialized women’s health segments, are among the company’s stated risks.
WHY THIS MOMENT MATTERS
2026 is shaping up as a genuine inflection year for Daré. The company is entering a multi-product commercial phase for the first time, with revenue expected from both its topical sildenafil arousal cream and its vaginal probiotic line in the second quarter. A Phase 2 study for its investigational HPV therapeutic is being prepared. Ovaprene enrollment, if completed this year, sets up what could be one of the more consequential clinical data readouts in women’s contraception in years.
At the same time, the broader environment for women’s health investment has materially shifted. According to its most recent women’s health market analysis, Silicon Valley Bank found that investment in the sector reached a record $2.6 billion in 2024 — a 55 percent increase from the prior year. The World Economic Forum’s 2026 Women’s Health Investment Outlook noted that women’s health has historically captured only about 6 percent of private healthcare investment despite representing roughly half the population — a framing that has become both an indictment and an investment thesis.
Johnson has been making that argument since before it was fashionable. The company she built was not assembled to chase a trend. It was constructed to create one.
THE BOTTOM LINE
Daré Bioscience is a small-cap biotech with an outsized portfolio ambition, a distinctive commercial model, and a founder-CEO who has committed more than a decade to proving that the unmet needs in women’s health are both real and investable. XACIATO is approved and licensed. DARE to PLAY is in national rollout. Ovaprene is in pivotal trials, now fully owned by Daré following Bayer’s exit. DARE-HPV is backed by federal innovation funding and cleared for Phase 2. The pipeline is not theoretical — it is in motion.
Whether the commercial execution of DARE to PLAY converts prescription intent into sustained revenue, and whether Ovaprene’s Phase 3 data delivers, will determine much of what comes next. But the architecture Johnson has built — first-in-category assets, lean operations, grant-backed science, and a decade of institutional knowledge in a field that most of the industry ignored — is not easily replicated.
In a sector that has spent years underfunding half the population, Sabrina Martucci Johnson is building her case one clinical milestone at a time.
