Key Points Bought 520,310 additional shares; position value rose by approximately $167.48 million Post-trade stake: 3,020,990 shares valued at $289.29 million CDTX is now the fund's 3rd-largest holding, accounting for approximately 19.2% of AUM These 10 stocks could mint the next wave of millionaires › On November 14, 2025, Bain Capital Life Sciences Investors, LLC disclosed a purchase of 520,310 shares of Cidara Therapeutics (NASDAQ:CDTX), increasing its position value by approximately $167.48 m ...

Company Updates - Cidara Therapeutics, Inc. (NASDAQ:CDTX) experienced a stock price surge to $217.89, marking a 105.57% increase, attributed to advancements in its lead product candidate, rezafungin acetate, and the Cloudbreak platform targeting high mortality fungal infections and COVID-19 [1][4] - Cycurion, Inc. (NASDAQ:CYCU) saw its stock rise to $6.10, a 45.93% increase, driven by its focus on AI-driven cybersecurity solutions for government and critical infrastructure [2][4] Industry Insights - The significant price movements of these companies underscore the importance of innovation and strategic focus in enhancing company value within their respective sectors [3] - The growing emphasis on cybersecurity solutions highlights a key growth area in the digital age, positioning Cycurion as a critical player in this market [2][3]

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]

Core Insights - Cidara Therapeutics (CDTX) received FDA Breakthrough Therapy designation for its lead candidate CD388 aimed at preventing seasonal influenza, resulting in a 12.4% increase in share price following the announcement [1][7]. Regulatory Developments - The FDA's Breakthrough Therapy designation accelerates the development and review of drugs for serious conditions, granted based on early clinical evidence suggesting significant improvement over existing treatments [2]. - CD388 is developed using CDTX's proprietary Cloudbreak platform and is designed as a long-acting small molecule inhibitor targeting influenza [2][9]. - The FDA's decision was supported by positive results from the phase IIb NAVIGATE study, which showed statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64 [3][7]. Clinical Trials and Future Prospects - CDTX previously received Fast Track designation for CD388, and the recent Breakthrough Therapy designation specifically targets prevention of influenza A and B in high-risk adults and adolescents [5][8]. - The company initiated the phase III ANCHOR study six months ahead of schedule, which may support regulatory filing if successful [8]. - CD388 offers broad protection against both seasonal and pandemic flu strains with a single injection, independent of the body's immune response, making it a promising option for individuals with varying immune statuses [9]. Market Performance - Year-to-date, Cidara Therapeutics shares have increased by 312%, significantly outperforming the industry average rise of 8.7% [4].

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]

Core Insights - Cidara Therapeutics will report its Q1 2025 financial results and operational highlights on May 8, 2025, after U.S. market close [1] - A conference call and webcast will be held at 5:00 PM Eastern Time to discuss the results and business updates [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies, including its lead candidate CD388, aimed at universal prevention of influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023 and completed Phase 2b enrollment in December 2024 [3] - The company has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024 [3]