v3.26.1
Grant Awards
12 Months Ended
Dec. 31, 2025
Receivables [Abstract]  
Grant Awards GRANT AWARDS
October 2024 Grant Award
In October 2024, the Company entered into a subaward agreement with National Collegiate Inventors and Innovators Alliance, Inc. d/b/a VentureWell (the "CMF") under which the Company is entitled to receive funding of up to $10.0 million in milestone-based payments subject to the Company's achievement over an approximately 24-month period of specified research activities and objectives relating to the advancement of the Company's DARE-HPV development 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. The subaward agreement was the result of the Company's selection by Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services. The CMF is a consortium management firm that received funding from the federal agency for the subaward agreement.
The Company receives funding in advance and tracks and reports eligible expenses incurred to the federal agency. The Company is required to apply the funds it receives solely toward direct costs for the funded project, other than an approximately 22% indirect cost allowance. An "indirect cost allowance" refers to the portion of the grant funds the Company receives that it may apply toward general overhead and administrative expenses that support the entire operations of the Company and which may be applied as the direct costs for the funded project are incurred. Funds received that have not been spent are recorded both in cash and cash equivalents and in deferred grant funding
liability in the Company’s consolidated balance sheets. Funds that have been spent but not yet expensed in accordance with GAAP or not spent on direct costs for the funded project in excess of the indirect cost allowance are also recorded in deferred grant funding liability.
Through December 31, 2025, the Company had received payments totaling $5.5 million under this award. The Company recorded credits to research and development expense of approximately $3.1 million and $0.4 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, the Company recorded approximately $2.0 million and $0.6 million in deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.
See Note 17, Subsequent Events, for information regarding a payment received in February 2026 under this award.
NICHD and NIH Non-Dilutive Grant Funding
The Company has received notices of awards and grant funding from NICHD and the National Institutes of Health, or NIH, to support the development of several of its product candidates. NICHD and the NIH issue notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. If the Company receives payments under the award, the amounts of such payments are recognized in the statements of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period. The federal agency that administers funding to the NIH is the Small Business Innovation Research (SBIR). In October 2025, legislative authority for the SBIR program expired and, to date, it has not been reauthorized by Congress. In November 2025, NIH announced that it will not issue continuation awards for existing projects until the SBIR program is reauthorized. As a result of this funding freeze, the Company currently does not anticipate receiving additional funding under this award until and unless the SBIR program is reauthorized by Congress.
DARE-HPV
In December 2024, the Company received a notice of award from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, that the Company was 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 the subsequent project year, subject to the availability of funds and satisfactory progress of the project, as determined by NIAID. The Company recorded $0.7 million and $0 credits to research and development expense for costs related to the NIH award for the years ended December 31, 2025 and 2024, respectively. The Company recorded a receivable of approximately $11,000 at December 31, 2025 for expenses incurred through such date that it believes are eligible for reimbursement under this award.
DARE-PTB1
In December 2023, the Company received a notice of award from NICHD of approximately $2.0 million to support the development of DARE-PTB1. The award is to be used to support what is referred to as the "Phase II" segment of the project outlined in the Company's grant application through November 2026. The Company recorded credits to research and development expense for costs related to this award of approximately $0.7 million and $0.7 million for the years ended December 31, 2025 and 2024, respectively. The Company recorded a receivable of $0 and approximately $84,000 at December 31, 2025 and 2024, respectively, for expenses incurred through such date that it believes are eligible for reimbursement under this award.
DARE-PTB2
In July 2023, the Company received a notice of award from NICHD of approximately $0.4 million to support preclinical development of a potential new therapeutic for the prevention of idiopathic preterm birth. The grant funds supported activities related to the conduct and completion of proof-of-concept target validation studies in collaboration with the University of South Florida.
The Company received aggregate reimbursements under this award of approximately $0.4 million during the grant period, which ended in July 2024. No further funds are available under this award.
Other Non-Dilutive Grant Funding
As described below, the Company has received substantial funding under grant agreements it entered into with the Gates Foundation, or the Foundation. The Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation. The Company is required to apply the funds it receives solely toward direct costs for the funded projects, other than an approximately 5%-15% indirect cost allowance (see "October 2024 Grant Awards" for more information regarding the indirect cost allowance). Funds received that have not been spent are recorded both in cash and cash equivalents and in deferred grant funding liability in the Company’s consolidated balance sheets. Funds spent but not yet expensed in accordance with GAAP or not spent on direct costs for the funded project in excess of the indirect cost allowance are also recorded in deferred grant funding liability.
The grant agreements include the Foundation's standard discretionary termination provisions. Any grant funds received that have not been committed to the funded project or spent in compliance with the applicable grant agreement must be returned promptly to the Foundation upon expiration or termination of the agreement.
2024 Contraceptive Product Candidate Grant Agreement
In November 2024, the Company entered into a grant agreement with the Foundation under which the Company was awarded a 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. The term of the agreement, as amended, extends through March 2027. An initial payment of approximately $5.4 million was made to the Company in November 2024 and a second payment of approximately $3.6 million was made to the Company in November 2025. Additional payments are contingent upon the Company's achievement of specified development and reporting milestones during the term of the grant agreement. The Company will track and report eligible expenses incurred to the Foundation.
The Company recorded credits to research and development expense of approximately $3.7 million and $0.2 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, the Company recorded approximately $5.1 million and $5.2 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.
2024 Biotherapeutic Product Grant Agreement
In January 2024, the Company entered into an agreement with the Foundation under which the Company was awarded $750,000 to fund activities related to bacteria-based live biotherapeutic product development. The Company received the full amount of the award in January 2024. The Company recorded credits to research and development expense of approximately $0.7 million for costs related to this award for the year ended December 31, 2024. The grant period ended in November 2024. No further funds are available under this award.
2021 DARE-LARC1 Grant Agreement
In June 2021, the Company entered into an agreement with the Foundation under which the Company was awarded up to approximately $49.0 million to support the development of DARE-LARC1. The term of the agreement, as amended, extends through December 2027. The agreement supports technology development and preclinical activities to advance DARE-LARC1 through nonclinical proof-of-principle studies and other IND-enabling work to allow for the submission of an IND application with the FDA, approval of which will be required to commence testing in humans.
As of December 31, 2025, the Company had received a cumulative total of approximately $41.8 million in funding under the agreement. Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones. The Company recorded credits to research and development expense of approximately $8.2 million and $6.2 million for costs related to this award for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, the Company recorded approximately $12.6 million and $10.8 million of deferred grant funding liability related to this award in the Company's consolidated balance sheets, respectively.
2022 DARE-LBT Grant Agreement
In November 2022, the Company entered into an agreement with the Foundation under which the Company was awarded $585,000 to support the development of DARE-LBT over the period of November 11, 2022 to February 29, 2024. The Company received the full amount of the award in November 2022. The Company recorded credits to
research and development expense of approximately $0.2 million for costs related to this award for the year ended December 31, 2024. The Company had no remaining deferred grant funding liability related to this award as of December 31, 2024.