Daré Bioscience Enters into $10.0 Million Subaward Agreement with VentureWell for DARE-HPV Development

Daré Bioscience, Inc. (NASDAQ: DARE) announced on October 23, 2024, that it has entered into a significant subaward agreement with National Collegiate Inventors and Innovators Alliance, Inc. d/b/a VentureWell (CMF), marking a pivotal step in its DARE-HPV development program. The Agreement entails Daré receiving funding of up to $10.0 million in milestone-based payments to bolster the advancement of its investigational DARE-HPV program.

DARE-HPV, Daré Bioscience’s proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, is designed as a self-administered at-home treatment for human papillomavirus (HPV)-related cervical diseases. The Consortium Management Firm (CMF), funded by the Advanced Research Projects Agency for Health (ARPA-H), a division of the U.S. Department of Health and Human Services, is overseeing the flow of funding under the Prime Agreement.

The Agreement outlines a 24-month Performance Period for Daré to achieve specified research activities related to advancing the DARE-HPV program. These tasks include completion of investigational new drug (IND)-enabling nonclinical studies, FDA clearance of an IND application, manufacturing milestones, and the initiation of a Phase 2 clinical study to assess the safety and preliminary efficacy of DARE-HPV for high-risk HPV infection in women.

More than half of the Award Amount is slated for disbursement within the first year of the Performance Period, subject to Daré’s satisfactory performance as per the terms of the Agreement. Additionally, the Agreement mandates ARPA-H to retain certain licensing rights to access and share research outcomes and data, including intellectual property governed by the Bayh-Dole Act of 1980.

The Agreement also provides provisions for termination, allowing the CMF to terminate under specific circumstances, including material changes to the Prime Agreement or unresolved disputes. Daré Bioscience intends to file the full Agreement as an exhibit to its annual report on Form 10-K by the end of 2024, albeit with confidential terms redacted.

Furthermore, a press release issued on October 23, 2024, confirmed Daré’s selection under the ARPA-H Sprint for Women’s Health program. This announcement is furnished as an exhibit to the report and highlights the Company’s ongoing commitment to advancing innovative solutions in women’s health.

While the Agreement marks a significant advancement for Daré Bioscience, investors are reminded to approach forward-looking statements with caution. The company advises that actual results may vary due to inherent risks and uncertainties associated with drug development endeavors. Interested parties are encouraged to review Daré’s recent filings with the Securities and Exchange Commission for a comprehensive understanding of potential risks and business factors affecting the Company’s operations.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Daré Bioscience’s 8K filing here.

About Daré Bioscience

Daré Bioscience, Inc, a biopharmaceutical company, identifies, develops, and markets products for women's health in the United States. It develops therapies in the areas of contraception, reproductive health, menopause, fertility, and sexual and vaginal health. The company offers XACIATO for the treatment of bacterial vaginosis in female patients 12 years of age and older.