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]