Nov 14, 2025 6:45 AM Eastern Standard Time Merck to Acquire Cidara Therapeutics, Inc., Diversifying Its Portfolio to Include Late-Phase Antiviral Agent Share CD388 is an investigational long-acting, strain-agnostic antiviral agent currently in Phase 3, designed to prevent influenza infection in individuals at higher risk of influenza complications Acquisition aligns with Merck's science-led business development strategy, diversifying and expanding the company's pipeline RAHWAY, N.J. & SAN DIEGO, Calif.--(BU ...

Group 1: Merck and Cidara Therapeutics Acquisition - Merck is nearing an acquisition of Cidara Therapeutics, potentially valuing the deal above $3.3 billion, with Cidara's stock up 85% following the news [3][4] - Cidara is recognized for its long-acting antibody medicine that protects against flu, and the deal could be announced as soon as Friday [4] - The acquisition is expected to involve cash upfront and additional payouts tied to future clinical trial milestones [5] Group 2: U.S.-Argentina Trade Agreement - The U.S. plans to lift tariffs on certain foods and imports from Argentina, Ecuador, Guatemala, and El Salvador to expand market access for U.S. companies [5] - Argentina will provide preferential access for various U.S. exports, including medicines, chemicals, and agricultural goods [6] - Ecuador will lower or eliminate tariff barriers on key products, including tree nuts and fresh fruit, and remove a variable tariff on many agricultural products [6] Group 3: DoorDash Cybersecurity Incident - DoorDash reported a cybersecurity breach involving unauthorized access to user information, but there is no indication of data misuse for fraud or identity theft [7][8] - The company is enhancing its security measures, increasing employee training, and collaborating with an outside firm for investigation [8] - This incident follows a previous breach in 2019, where information from about 5 million customers and merchants was exposed [8]

Group 1: Merck and Cidara Therapeutics Acquisition - Merck is nearing an acquisition of Cidara Therapeutics, potentially valuing the deal above $3.3 billion, with Cidara's stock up 85% following the news [3][4] - Cidara is recognized for its long-acting antibody medicine aimed at flu protection, and the deal could be announced as soon as Friday [4] - The acquisition is expected to involve cash upfront and additional payouts linked to future clinical trial milestones [5] Group 2: U.S.-Argentina Trade Agreement - The U.S. plans to lift tariffs on certain foods and imports from Argentina, Ecuador, Guatemala, and El Salvador to enhance market access for U.S. companies [5] - Argentina will provide preferential access for various U.S. exports, including medicines, chemicals, and agricultural goods [6] - Ecuador will reduce or eliminate tariff barriers on key products, including tree nuts and fresh fruit, and will remove a variable tariff on many agricultural products [6] Group 3: DoorDash Cybersecurity Incident - DoorDash reported a cybersecurity breach involving unauthorized access to user information, although there is no evidence of data misuse for fraud or identity theft [7][8] - The company is enhancing its security measures, increasing employee training, and engaging an outside firm for investigation [8] - This incident follows a previous breach in 2019, where information from approximately 5 million customers and merchants was exposed [8]

Group 1: RLX Technology Inc - RLX Technology Inc reported quarterly earnings of 3 cents per share on sales of $158.600 million [1] - Shares of RLX Technology rose 6% to $2.47 in pre-market trading following the earnings report [1] Group 2: Other Stocks in Pre-Market Trading - Cidara Therapeutics, Inc. surged 92% to $203.50 after a Schedule 13D Amendment revealed beneficial ownership of 3.37 million shares [4] - Binah Capital Group, Inc. gained 52.2% to $2.17 after posting stronger-than-expected third-quarter results [4] - Expion360 Inc. rose 42.4% to $1.81 following its third-quarter results [4] - Aspire Biopharma Holdings, Inc. surged 31.2% to $0.1380 in pre-market trading [4] - Invivyd, Inc. gained 28.8% to $2.28 after reporting better-than-expected third-quarter financial results [4] - Milestone Scientific Inc. surged 26.3% to $0.4801 after reporting better-than-expected third-quarter sales [4] - Lazydays Holdings, Inc. gained 23.3% to $1.85 after a previous surge [4] - Omeros Corp gained 12.5% to $7.08 following a narrower-than-expected quarterly loss [4] - Nouveau Monde Graphite Inc rose 10% to $3.25 after a decline the previous day [4] Group 3: Declining Stocks in Pre-Market Trading - TSS Inc tumbled 40.2% to $9.10 after reporting a year-over-year decrease in third-quarter results [4] - enVVeno Medical Corp declined 35.8% to $0.42 after an unfavorable FDA appeal decision [4] - Nuvve Holding Corp fell 29.3% to $0.34 after announcing third-quarter results [4] - ESS Tech Inc shares dipped 24.2% to $3.22 after reporting weak quarterly sales [4] - Direct Digital Holdings Inc fell 18.8% to $0.23 after a significant gain the previous day [4] - StubHub Holdings Inc fell 18.8% to $15.28 after worse-than-expected third-quarter EPS results [4] - Mangoceuticals Inc dipped 17.7% to $0.98 after a decline the previous day [4] - Red Cat Holdings Inc dipped 15.1% to $6.57 after worse-than-expected financial results and a lowered FY25 sales guidance [4] - WhiteFiber Inc fell 13.4% to $17.21 after reporting worse-than-expected financial results [4] - Sobr Safe Inc fell 12.4% to $2.21 after a decline the previous day [4]

Merck is closing in on a deal to buy Cidara Therapeutics in a deal valuing the biotechnology company at a premium to its $3.3 billion market capitalization, the Financial Times reported on Thursday. ...

Summary of Cidara Therapeutics FY Conference Call Company Overview - Cidara Therapeutics is an 11-year-old biotechnology company focused on developing a universal influenza preventative, CD388, based on its Cloudbreak platform [4][5][6] Core Points and Arguments - **Clinical Development**: CD388 has progressed through preclinical testing and multiple clinical phases, with a successful phase 2b study demonstrating a 76.1% efficacy rate against influenza [7][10] - **FDA Interaction**: The FDA has recommended expanding the phase 3 trial to include high-risk populations, specifically those over 65 years old, in addition to immunocompromised individuals [10][12] - **Phase 3 Study Design**: The ongoing phase 3 study involves 6,000 participants testing the 450 mg dose of CD388 versus placebo, with an interim analysis expected by March 2026 [12][13] - **Efficacy Expectations**: The study is designed to be 90% powered to detect a 60% efficacy rate, with the potential for stronger results if the flu season is severe [12][13] - **Real-World Testing**: The phase 3 study allows for vaccination among participants to assess CD388's effectiveness in both vaccinated and unvaccinated individuals [19][20] Market Opportunity - **Target Population**: Cidara estimates over 100 million patients could be eligible for CD388, including 50 million with moderate to severe comorbidities and another 100 million at increased risk according to CDC guidelines [25][26] - **Pricing and Access**: Ongoing market research is being conducted to understand pricing and access opportunities, with updates expected at the upcoming analyst day [26][27] Manufacturing and Supply Chain - **Manufacturing Plans**: Cidara is preparing to have millions of doses ready at launch, with a focus on establishing a domestic supply chain through a contract with BARDA for onshore manufacturing [29][33] Additional Insights - **Safety and Efficacy**: CD388 is characterized as a long-acting antiviral, distinct from vaccines, and is expected to maintain efficacy throughout the flu season [7][20] - **Regulatory Support**: The FDA has indicated that the phase 2b study could support the registration package, enhancing the potential for a broad label upon approval [23] This summary encapsulates the key points discussed during the Cidara Therapeutics FY Conference Call, highlighting the company's strategic direction, clinical advancements, market potential, and operational plans.

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-36912 CIDARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorpora ...

Exhibit 99.1 • Announced expanded and accelerated Phase 3 Plan for CD388, its non-vaccine influenza preventative therapeutic • Enrolled and dosed first patients in Phase 3 ANCHOR study; target enrollment on track for completion in the Northern Hemisphere by December 2025; Phase 3 initiation triggered $45.0 million milestone payment to Janssen • BARDA award to support expanded manufacturing and clinical development of CD388 • FDA granted Breakthrough Therapy designation to CD388 • Conference call and webcast ...

Core Insights - Cidara Therapeutics reported financial results for Q3 2025 and provided updates on its CD388 program, which is in Phase 3 development as a potential universal preventative for influenza [1][2][4] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling $476.5 million, a significant increase from $196.2 million as of December 31, 2024 [7][17] - Collaboration revenue was zero for Q3 2025 and the nine months ended September 30, 2025, compared to $1.3 million for the same periods in 2024 [7] - The net loss for Q3 2025 was $83.2 million, compared to a net loss of $16.0 million for Q3 2024 [8][15] CD388 Development Updates - The Phase 3 ANCHOR study for CD388 is over 50% enrolled, with a target of 6,000 participants expected to be reached by December 2025 [2][5] - The study population has been expanded to include healthy adults over 65 years old, increasing the potential eligible population from approximately 50 million to over 100 million in the U.S. [5] - The FDA granted Breakthrough Therapy designation to CD388, which is intended to expedite the review process for therapies that show substantial improvement over existing options [5][11] Corporate Highlights - Cidara received a BARDA award valued at up to $339.2 million to support the manufacturing and clinical development of CD388 [4][5] - The company initiated the ANCHOR study in September 2025, which includes an interim analysis planned for Q1 2026 [5][6] - Presentations highlighting CD388 were made at various medical conferences, showcasing positive results from the Phase 2b NAVIGATE study [6]