Key Takeaways CDTX secured FDA Breakthrough Therapy designation for CD388 to prevent seasonal influenza.The FDA decision follows phase IIb data showing CD388's significant prevention of seasonal influenza.CDTX's ANCHOR phase III study began ahead of schedule and may support regulatory filing if successful.Cidara Therapeutics (CDTX) announced that the FDA has granted a Breakthrough Therapy designation to its lead pipeline candidate, CD388, for the prevention of seasonal influenza.Shares of the company were u ...

Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics [2] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [2] - Cidara received Fast Track Designation from the FDA for CD388 in June 2023 and announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 [2] - Additional DFCs are being developed for oncology, with Cidara receiving investigational new drug application clearance for CBO421 in July 2024, targeting CD73 in solid tumors [2] Upcoming Events - Cidara management will participate in the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:00 PM ET in a corporate presentation format [1] - The company will also take part in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:00 AM ET in a fireside chat format [1] - Cidara will engage in one-on-one investor meetings during these conferences [1]

Financial Data and Key Metrics Changes - The company reported a substantial financing of $400 million to support its operations and clinical development [5][13] - The observed placebo attack rate in the NAVIGATE study was 2.8%, allowing for statistically significant efficacy results for CD388 [9] Business Line Data and Key Metrics Changes - CD388 demonstrated protection rates of 76%, 61%, and 58% at doses of 450 mg, 300 mg, and 150 mg respectively, significantly exceeding the historical average vaccine effectiveness of approximately 40% [9][10] - The safety and tolerability data for CD388 were consistent with prior studies, showing no safety signals across all dose groups [10] Market Data and Key Metrics Changes - The company plans to focus on high-risk populations, including immunocompromised patients, who are disproportionately affected by influenza [12] - The company is preparing to advance CD388 into Phase 3 trials, with plans to initiate in the Southern Hemisphere in 2026, pending FDA feedback [11][12] Company Strategy and Development Direction - The company aims to address high unmet needs in influenza prevention with CD388, which has received fast track and priority review designations from the FDA [12][13] - The company is also pursuing a breakthrough therapy designation for CD388, expecting to hear the outcome later this year [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of CD388 to provide robust seasonal protection against influenza, particularly for immune-compromised individuals [14] - The company is operationally prepared to start the Phase 3 study this fall, depending on the outcome of the end of Phase 2 meeting with the FDA [12] Other Important Information - The company has submitted proposals to BARDA for funding to support manufacturing and clinical development of CD388, with expectations to learn the outcome by the end of the year [13] - The company plans to present additional details from the NAVIGATE trial at scientific conferences later this year [10][14] Q&A Session Summary Question: Differences from the Type C meeting with FDA and Phase III design - Management does not anticipate substantial differences from the Type C meeting, as alignment was largely reached prior to the NAVIGATE Phase 2B results [19][20] Question: BARDA grant expectations - The base period of the BARDA grant would fund manufacturing, particularly onshoring to the US, with options for additional clinical studies in the option period [20] Question: Update on FDA meeting outcomes - The company will await the FDA meeting minutes to communicate the results and any potential changes to the study design [28][30] Question: Cash runway assumptions - The company believes it is adequately funded through the end of the Phase III program, including additional studies [45] Question: Commercial outlook in light of Sanofi's decline - Management noted downward pressure on vaccine businesses but emphasized the unique value proposition of CD388 in addressing high-risk populations [47] Question: Upcoming scientific presentations - The company has submitted abstracts to ISIRV and IDWeek, with expectations for acceptance and presentations on Phase 2B data [51][52]

Core Points - Cidara Therapeutics, Inc. granted non-qualified stock option awards and restricted stock units (RSUs) totaling 12,100 shares to two new employees under the 2020 Inducement Incentive Plan, with a grant date of June 30, 2025 [1][2] - The stock option has an exercise price of $48.71 per share, equal to the closing price on the grant date, and will vest over four years [1] - The Inducement Plan is specifically for granting equity awards to individuals who were not previously employees or who have had a bona fide period of non-employment [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugates (DFCs), including the lead candidate CD388, aimed at universal prevention of seasonal and pandemic influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [3] - The company has also developed additional DFCs for oncology, including CBO421, which received investigational new drug application clearance in July 2024 [3]

SAN DIEGO, April 24, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced that it will report its first quarter 2025 financial results and operational highlights after the close of the U.S. financial markets on Thursday, May 8, 2025. The Company will host a conference call and webcast at 5:00 PM Eastern Time to discuss the results and provide an update on busine ...