Grant Awards |
3 Months Ended |
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Mar. 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 an agency within 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 approximately 22% of such funds, which it may apply toward general overhead and administrative expenses that support the entire operations of the Company. Funds received that have not been spent are recorded as cash and cash equivalents and as a deferred grant funding liability in the Company’s condensed consolidated balance sheets. The deferred grant funding liability also includes grant funds spent but not yet expensed in accordance with GAAP. The Company must track expenses incurred under the award and submit a detailed accounting of such expenses. Through March 31, 2025, the Company has received payments totaling $2.5 million under this award. The Company recorded credits to research and development expense of approximately $0.6 million for costs related to this award for the three months ended March 31, 2025. As of March 31, 2025 and December 31, 2024, the Company recorded approximately $1.5 million and $0.6 million of deferred grant funding liability related to this award in the Company's condensed consolidated balance sheets, respectively. NICHD and NIH Non-Dilutive Grant Funding The Company has received notices of awards and non-dilutive 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. 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 credits to research and development expense of approximately $31,000 for costs related to this award during the three months ended March 31, 2025. The Company recorded a receivable of approximately $16,000 and $0 at March 31, 2025 and December 31, 2024, respectively, 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. The Company recorded credits to research and development expense for costs related to this award of approximately $169,000 and $112,000 during the three months ended March 31, 2025 and 2024, respectively. At March 31, 2025 and December 31, 2024, the Company recorded a receivable of approximately $57,000 and $45,000, 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 will support activities related to the conduct and completion of proof-of-concept target validation studies in collaboration with the University of South Florida, which are to occur over a 12-month period. 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 is required to apply the funds it receives under the agreements solely toward direct costs for the applicable funded projects, other than approximately 5%-15% of such funds, which it may apply toward general overhead and administrative expenses that support the entire operations of the Company. The Company receives funding in advance and tracks and reports eligible expenses incurred to the Foundation. Funds received that have not been spent are recorded as cash and cash equivalents and as a deferred grant funding liability in the Company’s consolidated balance sheets. The deferred grant funding liability also includes grant funds spent but not yet expensed in accordance with GAAP. The grant agreements include the Foundation's standard discretionary termination provisions. Any grant funds that have not been used or committed to the funded project 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 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. An initial payment of approximately $5.4 million was made to the Company in November 2024. Additional payments are contingent upon the Company's achievement of specified development and reporting milestones during the term of the grant agreement, which extends through October 2026. The Company will track and report eligible expenses incurred to the Foundation. The Company recorded credits to research and development expense of approximately $0.8 million for costs related to this award for the three months ended March 31, 2025. As of March 31, 2025 and December 31, 2024, the Company has recorded approximately $4.4 million and $5.2 million of deferred grant funding liability related to this award in the Company's condensed 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 and $133,000 for costs related to this award for the three months ended March 31, 2025 and 2024, respectively. 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 agreement supports technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, 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 March 31, 2025, the Company has received a cumulative total of approximately $31.8 million in non-dilutive funding under the agreement, including $3.5 million during 2024. 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 $1.5 million and $2.3 million for costs related to this award for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, the Company has recorded approximately $9.2 million and $10.8 million of deferred grant funding liability related to this award in the Company's condensed 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 $235,000 for costs related to this award for the three months ended 2024. The Company had no remaining deferred grant funding liability related to this award as of December 31, 2024.
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