Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 8

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 8
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 DARE-HPV

In December 2024, we received a notice of award from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, that we were awarded a $1.0 million grant in support of non-clinical activities for the development of DARE-HPV for an initial project year of December 2024 through November 2025, and that an additional $1.0 million was recommended for a subsequent year, subject to the availability of funds and satisfactory progress of the project, as determined by NIAID. 

In October 2024, we entered into a subaward agreement with National Collegiate Inventors and Innovators Alliance, Inc. d/b/a VentureWell under which we are entitled to receive up to $10.0 million in milestone-based payments subject to our achievement of specified research activities and objectives relating to advancement of our DARE-HPV program, including commencement of a Phase 2 clinical study to evaluate the safety and preliminary efficacy of DARE-HPV for the clearance of high-risk HPV infection in women, over an approximately 24-month period ending in October 2026. We anticipate that more than half of the award amount will become payable to us during the first 12 months of the performance period under the subaward agreement. To date, we have received payments totaling $2.5 million. The subaward agreement was the result of our selection as an awardee by an agency within the HHS. 

Grant Agreement to Support the Ovaprene Phase 3 Study and Identification & Development of a New Non-Hormonal Contraceptive Candidate

In November 2024, we entered into a grant agreement with the Foundation, under which we were awarded a new grant of up to approximately $10.7 million to support (i) expansion of the number of study sites in the ongoing Phase 3 clinical trial of Ovaprene, and (ii) activities that will aid in the identification and  development of a novel non-hormonal intravaginal contraceptive candidate, suitable for and acceptable to women in low- and middle-income country settings who need or would prefer to use such a product to avoid an unplanned pregnancy. We received an initial payment under the grant agreement of approximately $5.4 million in November 2024. Additional payments are contingent upon our achievement of specified development and reporting milestones during the term of the grant agreement, which extends through October 2026. See Note 15