Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 7

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 7
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 on The Nasdaq Capital Market. See the risk factor titled, If we fail to regain and maintain compliance with the continued listing requirements of The Nasdaq Capital Market, our common stock could be suspended and delisted, which could, among other things, limit demand for our common stock, substantially impair our ability to raise additional capital and have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock, under "Risks Related to Our Securities" in ITEM 1A. RISK FACTORS of this report.

NICHD Performance under the CRADA for the Pivotal Phase 3 Study of Ovaprene

See ITEM 1. “BUSINESS– Our Pipeline: Clinical-Stage Programs– Ovaprene®– Pivotal Phase 3 Clinical Study” in Part I of this report for a discussion of the impact of executive orders and other actions taken by the new U.S. presidential administration in the first quarter of 2025 on the Phase 3 clinical study of Ovaprene and NICHD’s ability to carry out its responsibilities under the CRADA.

Theramex Co-Development and Licensing Agreement

See ITEM 1. “BUSINESS– Strategic Agreements for Pipeline Development– Theramex Co-Development and License Agreement” in Part I of this report for a discussion of the agreement we entered into with Theramex in February 2025.

Receipt of Grant Funding Installment to Support DARE-LARC1

In December 2024, we received a payment of $2.5 million as the latest installment under a grant to advance the development of our investigational contraceptive DARE-LARC1 in 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. Under the terms of the grant agreement, we may receive a total of up to approximately $49.0 million to support nonclinical development of DARE-LARC1. As of the filing date of this report, we had received a cumulative total of approximately $31.8 million of such total potential amount under the grant agreement. Additional payments are conditioned on the program meeting specified development and reporting milestones. See Note 15, "Grant Awards- Other Non-Dilutive Grant Funding- 2021 DARE-LARC1 Grant Agreement" to the accompanying  consolidated financial statements for additional information regarding the grant agreement.

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Non-Dilutive Funding Awards for