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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 gave a late-breaking presentation on its non-vaccine influenza preventative candidate, CD388, at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain.
"We are encouraged by the translational efficacy data on CD388 we are presenting at ESWI, which demonstrate a clear link between our preclinical findings and recent clinical outcomes from our Phase 2b NAVIGATE study," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "These results reinforce our confidence in CD388 as a potential single-dose influenza preventative for strains tested in preclinical studies and ultimately support our ongoing Phase 3 ANCHOR trial to protect the most vulnerable populations."
Late-Breaking Abstract Title: Translational efficacy of CD388, a novel Drug Fc-Conjugate (DFC), in mouse influenza infection models: application to prevention efficacy in the recently completed Ph2b NAVIGATE clinical study
Presenter: Voon Ong, Ph.D.
Session: Late Breakers: Novel and Outstanding Discoveries
Session Date and Time: Thursday, October 23, 2025, 2:00-3:30 pm CET
Summary: Following lethal dosing of influenza, mice that received a single dose of CD388 demonstrated potent activity against 12 seasonal and multiple pandemic influenza subtypes, and plasma concentrations at the time of infection conferred complete protection. In Cidara's Phase 2b study, CD388 demonstrated statistically significant prevention efficacy for all dose groups, and plasma concentration analysis at onset of infection showed that lower drug concentrations correlated with higher infection rates. Exposure response modeling revealed a clear concentration-response relationship, indicating a strong alignment between efficacious exposures in preclinical mouse influenza models and prevention efficacy observed in Cidara's recent Phase 2b NAVIGATE trial.
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 and initiated its Phase 3 ANCHOR trial in September 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, and whether the nonclinical data will be predictive of response in humans against specific seasonal and pandemic influenza strains. 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 participants 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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