Cidara Therapeutics Inc.
10/06/2025 | Press release | Distributed by Public on 10/06/2025 04:01
Material Agreement (Form 8-K)
Item 1.01 Entry into a Material Definitive Agreement.
On September 30, 2025, Cidara Therapeutics, Inc. (the "Company") entered into an Award/Contract (the "BARDA Agreement") with the Biomedical Advanced Research and Development Authority ("BARDA"), part of the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response, to support expanded manufacturing and clinical development of CD388, the Company's non-vaccine influenza preventative therapeutic.
The BARDA Agreement provides for potential total investments by BARDA of up to $339.2 million. BARDA will invest approximately $58.1 million initially over a base period, commencing in September 2025, and extending through September 2027, to support the onshoring of CD388 manufacturing to the United States as an addition to the initial commercial supply chain and conduct a clinical trial to demonstrate the comparability of a higher-concentration formulation and different presentations of CD388, further characterize its activity against pandemic influenza strains in non-clinical models and initiate the development of clinical trial protocols for expanded populations. The balance of the award is subject to BARDA exercising up to nine options and would support additional clinical and non-clinical studies of CD388 in specific populations, as a complement to the Company's plans for a potential Biologics License Application ("BLA") submission to the U.S. Food and Drug Administration ("FDA"), and consists of up to $281.1 million for up to such nine options. In addition, the Company may be responsible for up to $192.2 million for the Company's portion of cost sharing applicable to up to a certain three of such options.
The BARDA Agreement has an initial term that commences on September 30, 2025, and extends through September 29, 2027, which may be extended by mutual agreement of the Company and BARDA, or, if any of the options are exercised by BARDA (as described above), to cover the period of such exercised option set forth in the BARDA Agreement; provided that the total duration of the BARDA Agreement shall not exceed beyond July 3, 2030.
The BARDA Agreement is terminable by BARDA or the Company at any time for any reason with 60 days' prior written notice, following consultation between the parties, or by BARDA for cause, if the Company materially fails to comply with the provisions of the BARDA Agreement (subject to a standard cure period). In the case of termination other than for cause, certain termination costs incurred by the Company may be reimbursable by BARDA.
This project is being supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50125C00017. The BARDA Agreement and federal funding are not an endorsement of the study results, product or company.
The foregoing description of the material terms of the BARDA Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the BARDA Agreement, a copy of which the Company plans to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025.
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