Cidara Therapeutics to Host Virtual R&D Day to Discuss CD388 as a Potential Universal, Once-Per-Flu Season Preventative of Seasonal and Pandemic Influenza on May 22, 2025

SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak^® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that it will host a virtual research and development (R&D) day on Thursday, May 22, 2025, from 10:00 to 11:30 AM ET. To register,

The event will feature key opinion leaders (KOLs) Fred Hayden, MD, FACP (University of Virginia School of Medicine) and Rick Bright, PhD (Pandemic Prevention Institute, The Rockefeller Foundation), who will join company management to discuss CD388, Cidara's long-acting antiviral drug designed to revolutionize influenza protection as a potential universal, once-per-flu season preventative.

Key topics will include a review of the 2024-2025 influenza season in the northern hemisphere, the design and objectives of the Company’s ongoing Phase 2b NAVIGATE trial with updates on the anticipated statistical analysis plan to evaluate the Phase 2b efficacy results when available, current thoughts on the planned Phase 3 study design, a review of the commercial opportunity and competitive landscape for CD388, and the prospects for pandemic influenza.

A live question and answer session will follow the formal presentations.

About Frederick G. Hayden, MD, FACP

Frederick G. Hayden, MD, FACP, is a Stuart S. Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine at the University of Virginia School of Medicine in Charlottesville, Virginia, USA. His principal research interests have been on respiratory viral infections with a particular focus on the development and application of antiviral agents for influenza, rhinovirus, and coronavirus infections. He has contributed to the development of seven influenza antivirals and two vaccines approved for clinical use in one or more countries. During the COVID-19 pandemic he collaborated with colleagues in China to conduct the first controlled trials of candidate antivirals in hospitalized patients and has served as a consultant to platform studies (UK CTAP, ACTIV, AGILE), academic groups, and industry regarding the selection of therapeutics for clinical trials. Dr. Hayden received his medical degree from Stanford University School of Medicine in 1973 and completed his clinical training in internal medicine and infectious diseases at Strong Memorial Hospital, University of Rochester, New York.

About Rick Bright, PhD

Rick Bright, PhD, is an international expert on pandemic preparedness and response. In his most recent role as the Chief Executive Officer of the Pandemic Prevention Institute (PPI) at The Rockefeller Foundation, Dr. Bright led the development of the Foundation’s pandemic data-to-action platform that integrates modern technology, data analytics and global partners to help the world detect, prevent, and mitigate pandemic threats to achieve containment as quickly as possible. Dr. Bright serves as an international subject matter expert in biodefense, emergency preparedness and response, pharmaceutical innovation, vaccine, drug and diagnostic development and served as an advisor to the Biden Administration, the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Academies of Sciences, Engineering & Medicine Forum on Microbial Threats. Dr. Bright received a Ph.D. in Immunology and Molecular Pathogenesis from Emory University and a B.S. magna cum laude in Biology and Physical Sciences from Auburn University at Montgomery.

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 which are 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: . 

About Cidara Therapeutics

Cidara Therapeutics is using its proprietary Cloudbreak^® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). 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 U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit . 

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, the expected timing for reporting top-line data from the Phase 2b NAVIGATE clinical trial, the potential impact of data from the Phase 2b NAVIGATE clinical trial, the design of a potential Phase 3 study, and the potential commercial opportunity for CD388. 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 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 March 31, 2025 and other filings subsequently made with the SEC. 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.

INVESTOR CONTACT:

Brian Ritchie

LifeSci Advisors

(212) 915-2578

MEDIA CONTACT:

Michael Fitzhugh

LifeSci Communications