Key Takeaways:
NIH funding and a Phase 2 trial put Daré Bioscience's DARE-HPV on track to challenge the watchful-waiting standard for high-risk HPV.
Daré Bioscience received a second $1 million tranche from the National Institute of Allergy and Infectious Diseases, bringing total NIH funding for its experimental HPV treatment to $2 million as the company begins enrolling patients in a Phase 2 trial.
"An estimated 6 million women in the United States each year experience a high-risk HPV infection and have no FDA-approved pharmacologic option," Sabrina Martucci Johnson, president and chief executive officer of Daré Bioscience, said.
The Phase 2 study, initiated May 18, is a randomized, placebo-controlled, double-blind trial enrolling about 100 women with confirmed persistent high-risk HPV infection. Patients receive up to 21 days of daily treatment with DARE-HPV, a proprietary fixed-dose formulation of the protease inhibitors lopinavir and ritonavir delivered as a soft gel vaginal insert. Topline data are expected in 2027.
High-risk HPV causes virtually all cervical cancer cases in the U.S., yet no pharmacologic treatment has received FDA approval for the infection. Daré's DARE-HPV, if successful, would become the first, offering an alternative to the current standard of watchful waiting. The program also benefits from an up to $10 million contract from the Advanced Research Projects Agency for Health.
The NIH award, issued under the Small Business Innovation Research program, supports non-clinical and translational work alongside the Phase 2 trial. The second tranche covers the budget period from December 2025 through November 2026. Daré's Investigational New Drug application for DARE-HPV was cleared by the FDA in February 2026.
The company's strategy of pursuing non-dilutive government funding reduces shareholder dilution while advancing a pipeline focused on women's health. Daré, a female-led biotech, targets conditions including contraception, menopause, pelvic pain, and infectious disease. Its broader pipeline includes Ovaprene, a non-hormonal contraceptive candidate that posted positive interim Phase 3 data in May. Unlike large-cap pharma companies such as Merck & Co. and GlaxoSmithKline, which market HPV vaccines like Gardasil and Cervarix for prevention, Daré is pursuing a therapeutic approach for existing infections — a market with no approved products.
Daré shares closed at $2.37, slipping 1.66 percent on the day, with volume of 435,219 shares below the 20-day average of 857,609. The stock trades 74 percent below its 52-week high but 87 percent above its low, reflecting cautious market positioning ahead of clinical data. With $2 million in NIH backing and up to $10 million from ARPA-H, Daré has non-dilutive support to reach the 2027 topline readout — a milestone that will determine whether DARE-HPV can break the watchful-waiting paradigm for 6 million U.S. women annually.
This article is for informational purposes only and does not constitute investment advice.
