On May 8, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported financial results for the first quarter ended March 31, 2025, and provided recent business updates (Press release, Cidara Therapeutics, MAY 8, 2025, View Source [SID1234652738]).

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"Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have established April 30, 2025 as the data cutoff for the primary efficacy analysis of the 5,041 subjects dosed in the Phase 2b NAVIGATE clinical trial. We are expecting top-line results in late June of this year. The severity of the 2024-2025 flu season has provided an opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA to evaluate the potential statistical significance of CD388 versus placebo," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We believe CD388 is highly differentiated from vaccines and monoclonal antibodies and we believe these differences can significantly improve upon the protective efficacy against influenza in healthy, high-risk, and immunocompromised patients with a single dose per flu season."

Recent and Expected Corporate Highlights

Phase 2b NAVIGATE trial evaluating CD388 for prevention of seasonal influenza ongoing. Dosing of 5,041 subjects in the Phase 2b NAVIGATE study were completed in early December of 2024 across clinical sites in the U.S. and UK. This is a randomized, double-blind, controlled trial designed to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of seasonal influenza. Three CD388 dose groups, comprised of 150mg, 300mg and 450mg doses, and one placebo group were randomized and dosed in a 1:1:1:1 ratio at the beginning of the 2024-25 influenza season. Subjects were followed for efficacy through the end of April 2025 to monitor for breakthrough cases. Rates of laboratory and clinically confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo.
Phase 2b NAVIGATE efficacy data expected in late June 2025. Due to the severity of the 2024-25 flu season, Cidara has the opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA, to evaluate possible statistical significance of CD388 versus placebo. Assuming agreement with the FDA on the changes to the statistical analysis plan, we expect that data from this trial will enable dose selection for Phase 3 as well as the determination of statistically meaningful comparisons of each dose to the placebo arm of the study.
Published preclinical data of CD388 in Nature Microbiology in March 2025. The article, entitled "Drug-FC Conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice," highlighted the potential of CD388 as a potent, universal antiviral for influenza A and B prevention regardless of immune status. The full press release can be found here.
Presented two posters on CD388 in influenza at the 38th International Conference on Antiviral Research (ICAR) in March 2025. The Company’s presentations highlighted the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for its planned Phase 3 development program. The preliminary safety profile shows that CD388 is well-tolerated and the majority of injection site reactions are considered mild in severity.
Promoted Nicole Davarpanah to Chief Medical Officer and Corrina Pavetto to Senior Vice President, Clinical Development. In May 2025, Cidara announced the promotions of Nicole Davarpanah, M.D., J.D., to Chief Medical Officer and Corrina Pavetto to Senior Vice President, Clinical Development. Dr. Davarpanah and Ms. Pavetto have shown exceptional leadership in the execution of the Phase 2b NAVIGATE Study, the revision of its statistical analysis plan, and the design of the Phase 3 development and regulatory strategy for CD388. Their continued guidance and oversight will be invaluable for the successful development of CD388 as a novel option for the universal prevention of influenza.
First Quarter 2025 Financial Results

Cash, cash equivalents and restricted cash totaled $174.5 million as of March 31, 2025, compared with $196.2 million as of December 31, 2024.
Collaboration revenue was zero for the three months ended March 31, 2025, compared to $1.0 million for the same period in 2024. Collaboration revenue related to research and development (R&D) and clinical supply services provided to J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), under our license and collaboration agreement with Janssen (the Janssen Collaboration Agreement). The Janssen Collaboration Agreement was terminated upon the effectiveness of our license and technology transfer agreement with Janssen on April 24, 2024.
R&D expenses were $24.6 million for the three months ended March 31, 2025, compared to $5.9 million for the same period in 2024. The increase in R&D expenses is primarily driven by higher expenses associated with our ongoing CD388 Phase 2b NAVIGATE study and higher one-time personnel costs, partially offset by lower nonclinical expenses associated with our Cloudbreak platform.
General and administrative (G&A) expenses were $6.2 million for the three months ended March 31, 2025, compared to $3.6 million for the same period in 2024. The increase in G&A expenses is primarily due to higher personnel costs, partially offset by lower legal costs.
Net loss from discontinued operations for the three months ended March 31, 2025 was zero, compared to net loss from discontinued operations of $2.1 million for the same period in 2024. On April 24, 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), an affiliate of Mundipharma Medical Company, pursuant to which all rezafungin assets and related contracts were sold to Napp. All conditions of the sale were completed on April 24, 2024, and the financial results of rezafungin have been reported separately as discontinued operations.
Net loss for the three months ended March 31, 2025 was $23.5 million, compared to a net loss of $10.3 million for the same period in 2024.
First Quarter 2025 Conference Call and Webcast Details

Cidara Therapeutics management will host a conference call and webcast beginning at 5:00 pm ET / 2:00 pm PT today, May 8, 2025. A live webcast may be accessed here. The conference call can be accessed by dialing toll-free (800) 717-1738 or (646) 307-1865 (international). The passcode for the conference call is 90743.

A replay of the webcast will be archived on www.cidara.com for one year under the "Events & Presentations" tab in the Investors section of the company’s website.