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Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak ® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced it has received an award valued up to $339M from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The multi-year agreement consists of a Base contract with Option periods. The Base period funding of $58M over 24 months supports the onshoring of CD388 manufacturing to the United States as an addition to the initial commercial supply chain. This initial funding will also be used to 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 Option periods funding up to $281M, if requested by Cidara and exercised by the U.S. government, would support additional clinical and non-clinical studies of CD388 in specific populations, as a complement to the company's plans for potential Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).
"Clinical and non-clinical data generated to date suggest that CD388 has the potential to be an effective non-vaccine preventative for both pandemic and seasonal influenza," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "A long-acting, universal influenza preventative that confers broad protection against all strains of influenza across all populations is critical for pandemic preparedness, especially for the millions of Americans who are immune-compromised, have comorbidities that can lead to severe complications from influenza infection, or the elderly who have diminished response to vaccines. We welcome BARDA's partnership that will enable us to accelerate domestic supply options for CD388 production. This will both expand our commercial supply capacity, as well as ensure U.S. supply of CD388 in the event of an influenza pandemic."
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.
About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/ .
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak ® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara's lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com .
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," "expect," "intends," "believes," "may," "plan" or "will". Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of and future plans for CD388, whether we will be able to transfer manufacturing to U.S. contract manufacturers, whether an influenza pandemic will occur and if it does whether CD388 will be purchased by the U.S. government. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles associated with the enrollment of patients or other aspects of CD388 or other DFC development, having to use cash in ways other than as expected and other risks and uncertainties associated with Cidara's business in general. These and other risks are identified under the caption "Risk Factors" in Cidara's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
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Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
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LifeSci Communications
(628) 234-3889
mfitzhugh@lifescicomms.com
