Funding award milestone follows Daré's announcement last week of the initiation of its Phase 2 clinical study of DARE-HPV, representing the first time women with persistent high-risk HPV infection may have access to this pharmacologic treatment as part of a clinical trial
DARE-HPV targets high-risk HPV infection, the cause of virtually all cervical cancer cases in the U.S., for which there are currently no FDA-approved pharmacologic treatments
Award reflects Daré's strategy of leveraging non-dilutive government funding, including both NIH grants and ARPA-H contract support for DARE-HPV, to advance a differentiated pipeline addressing some of the most persistent unmet needs in women's health
SAN DIEGO, May 26, 2026 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions, today announced receipt of a Notice of Award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), obligating the second and final tranche of $1.0 million under the previously announced up to $2.0 million NIAID grant award for DARE-HPV, Daré's investigational treatment for persistent high-risk human papillomavirus (HPV) infection. The total amount of the award across the project period, which commenced in late 2024, is $2.0 million.
This award (Award Number 5R44AI188623-02) was issued under the Small Business Innovation Research (SBIR) program in support of the project titled "A first-in-class product for the clearance of high-risk human papillomaviruses," with Andrea Ries Thurman, MD, Medical Director of Daré, serving as Project Director.
The receipt of this award notice follows Daré's announcement on May 18, 2026 of the initiation of its Phase 2 clinical study of DARE-HPV, a significant clinical development milestone that marks the first time women with persistent high-risk HPV infection may have access to this pharmacologic treatment as part of a clinical trial. The Phase 2 study is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and antiviral activity of DARE-HPV in approximately 100 women with confirmed persistent high-risk HPV infection over an up to 21-day course of daily treatment, with topline data expected in 2027.
"The NIH's continued commitment to DARE-HPV is a powerful validation of the unmet need driving this program," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "An estimated 6 million women in the United States each year experience a high-risk HPV infection and have no FDA-approved pharmacologic option. They are told to wait and watch as the virus either clears on its own or, in far too many cases, progresses to precancerous or cancerous disease. Last week, we initiated our Phase 2 study to advance our potential alternative to that 'watchful waiting' paradigm. The NIAID funding award we are announcing today will help sustain the non-clinical and translational work that underpins this program, together with our ARPA-H-funded contract that supports the Phase 2 study. Daré was built to pursue exactly these kinds of high-impact, underserved opportunities, and we are grateful to NIH, ARPA-H, our clinical investigators, and the women participating in the Phase 2 study for helping us do just that."
About the DARE-HPV NIAID AwardThis Notice of Award (Award Number 5R44AI188623-02) obligates $1.0 million for the second project year budget period from December 1, 2025 through November 30, 2026. The total federal award across the project period, which commenced December 17, 2024, is $2.0 million. The NIAID grant supports non-clinical activities to advance the development of DARE-HPV. The project is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R44AI188623.
The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health.
About DARE-HPV
DARE-HPV is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a ...
