Financial Data and Key Metrics Changes - Cidara Therapeutics reported a strong financial position with approximately $476 million in cash as of September 30, 2025, fully funding its phase three development program [12] - A $45 million milestone payment was triggered by the initiation of the phase three trial, which will be recorded in Q3 but paid in Q4 [6] Business Line Data and Key Metrics Changes - The lead candidate, CD388, has advanced into phase three development, with the trial starting six months earlier than planned [4][5] - The phase two B Navigate Study demonstrated a 76.1% protective efficacy with a single 450 milligram dose of CD388, reinforcing its potential as a long-acting antiviral for influenza prophylaxis [9][10] Market Data and Key Metrics Changes - The enrollment for the phase three trial has expanded to include healthy adults over 65, increasing the potential patient population from 50 million to over 100 million in the U.S. [7][8] - The study is over 50% enrolled and is on track to achieve target enrollment by December [9] Company Strategy and Development Direction - Cidara's strategy focuses on the development of CD388 as a non-vaccine preventative for influenza, leveraging its proprietary Cloudbreak platform [5] - The company received breakthrough therapy designation from the FDA, which will enhance access to regulatory guidance and potentially accelerate development timelines [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data supporting CD388 and its differentiated profile compared to existing vaccines and antivirals [10] - The company plans to host a virtual R&D day on December 15, 2025, to provide updates on the CD388 program and market research insights [12] Other Important Information - Cidara received a $339 million award from BARDA to support expanded manufacturing and clinical development of CD388, with a base period valued at $58 million over the first 24 months [11][12] - The company is working on establishing a full U.S. commercial supply chain to meet potential market demand [36] Q&A Session Summary Question: How will the external statistician decide on additional patient enrollment at the interim analysis? - The external statistician will assess data at a pre-specified time point to determine if the powering assumptions were met, without sharing specific data with Cidara [15][16] Question: Will efficacy data be available at the interim analysis? - No efficacy data will be shared at the interim analysis; only whether the powering assumptions have been met will be communicated [19][21] Question: How does the inclusion of healthy individuals over 65 impact vaccine rates and event rates? - The addition of this population is expected to expedite enrollment and maintain similar placebo attack rates, with a higher background vaccination rate anticipated [46][48] Question: What is the scale of manufacturing at WuXi and what are the rate-limiting factors for BLA filing? - WuXi is expected to produce around 5 million doses per year, with rate-limiting factors related to qualification requirements for BLA readiness [39][40] Question: What is the potential for CD388 in pandemic settings? - Cidara is conducting studies on CD388's efficacy against pandemic strains, with promising results against H5N1, and plans to continue research on other strains [56][57]