Cidara Therapeutics(CDTX)
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Cidara Therapeutics to Host Virtual R&D Day to Discuss CD388 as a Potential Universal, Once-Per-Flu Season Preventative of Seasonal and Pandemic Influenza on May 22, 2025
Globenewswire· 2025-05-15 12:00
Core Viewpoint - Cidara Therapeutics is hosting a virtual R&D day to discuss its long-acting antiviral drug CD388, aimed at providing universal influenza protection with a single administration [1][2]. Group 1: Event Details - The virtual R&D day is scheduled for May 22, 2025, from 10:00 to 11:30 AM ET [1]. - Key opinion leaders Fred Hayden, MD, and Rick Bright, PhD, will participate alongside company management [2]. Group 2: CD388 Overview - CD388 is a drug-Fc conjugate designed to offer long-lasting protection against all known strains of seasonal and pandemic influenza [7]. - It is not a vaccine but a low molecular weight biologic that does not rely on an immune response, making it effective regardless of an individual's immune status [7]. - The drug aims to provide season-long protection with a single subcutaneous or intramuscular dose [7]. Group 3: Clinical Trials and Commercial Potential - The ongoing Phase 2b NAVIGATE trial is a key focus, with updates on the statistical analysis plan for evaluating efficacy results expected [3]. - The event will also cover the commercial opportunity and competitive landscape for CD388, as well as prospects for pandemic influenza [3]. - CD388 received Fast Track Designation from the FDA in June 2023, and enrollment for the Phase 2b trial was completed in December 2024 [9].
Cidara Therapeutics to Host Virtual R&D Day to Discuss CD388 as a Potential Universal, Once-Per-Flu Season Preventative of Seasonal and Pandemic Influenza on May 22, 2025
GlobeNewswire News Room· 2025-05-15 12:00
Core Viewpoint - Cidara Therapeutics is hosting a virtual R&D day to discuss its long-acting antiviral drug CD388, aimed at providing universal influenza protection with a single administration [1][2][3] Group 1: Event Details - The virtual R&D day is scheduled for May 22, 2025, from 10:00 to 11:30 AM ET [1] - Key opinion leaders Fred Hayden, MD, and Rick Bright, PhD, will participate alongside company management [2] - A live Q&A session will follow the formal presentations [4] Group 2: CD388 Overview - CD388 is a drug-Fc conjugate designed to provide long-acting antiviral protection against seasonal and pandemic influenza [7][9] - It is not a vaccine but a low molecular weight biologic that does not rely on an immune response, making it effective regardless of an individual's immune status [7] - The drug aims to offer season-long protection with a single subcutaneous or intramuscular dose [7] Group 3: Clinical Trials and Commercial Potential - The ongoing Phase 2b NAVIGATE trial is being reviewed, with updates on the statistical analysis plan for efficacy results [3] - The company has completed enrollment for the Phase 2b NAVIGATE trial as of December 2024 [9] - CD388 received Fast Track Designation from the FDA in June 2023, indicating its potential commercial opportunity [9]
Cidara Therapeutics to Participate in Two Upcoming Investor Conferences
Globenewswire· 2025-05-13 12:00
Core Insights - Cidara Therapeutics, Inc. is participating in two upcoming investor conferences: RBC Global Healthcare Conference on May 21, 2025, and Jefferies Global Healthcare Conference on June 4, 2025 [1][2] - The company will also engage in one-on-one investor meetings during these events [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, which include targeted small molecules or peptides linked to a human antibody fragment [3] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose, having received Fast Track Designation from the FDA in June 2023 and completing Phase 2b enrollment in December 2024 [3] - Additional DFCs are being developed for oncology, with IND clearance received for CBO421 in July 2024, targeting CD73 in solid tumors [3]
Cidara Therapeutics(CDTX) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:02
Cidara Therapeutics (CDTX) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Brian Ritchie - Managing DirectorJeffrey Stein - President & CEOSeamus Fernandez - Senior Managing DirectorJim Beitel - Chief Business OfficerNicole Davarpanah - Chief Medical Officer Conference Call Participants Eric Schmidt - Biotechnology AnalystGregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchJoseph Stringer - Senior AnalystRoy Buchanan - Equity Research Analyst Operator Greetings. Wel ...
Cidara Therapeutics(CDTX) - 2025 Q1 - Earnings Call Transcript
2025-05-08 22:00
Cidara Therapeutics (CDTX) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Brian Ritchie - Managing DirectorJeffrey Stein - President & CEOSeamus Fernandez - Senior Managing DirectorJim Beitel - Chief Business OfficerNicole Davarpanah - Chief Medical Officer Conference Call Participants Eric Schmidt - Biotechnology AnalystGregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchJoseph Stringer - Senior AnalystRoy Buchanan - Equity Research Analyst Operator Greetings. Wel ...
Cidara Therapeutics(CDTX) - 2025 Q1 - Quarterly Report
2025-05-08 20:47
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 MARCH 31, 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 Incorporation ...
Cidara Therapeutics(CDTX) - 2025 Q1 - Quarterly Results
2025-05-08 20:25
Exhibit 99.1 Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results SAN DIEGO, May 8, 2025 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, today reported financial results for the first quarter ended March 31, 2025, and provided recent business updates. ® "Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have es ...
Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-08 20:15
Core Insights - Cidara Therapeutics reported financial results for Q1 2025, highlighting ongoing developments in its CD388 program and the Phase 2b NAVIGATE clinical trial [1][6][11] Recent and Expected Corporate Highlights - The data cutoff for the Phase 2b NAVIGATE trial was established on April 30, 2025, with top-line results expected in late June 2025 [2][4][5] - CD388 is positioned as a differentiated therapeutic option for influenza prevention, with discussions ongoing with the U.S. FDA regarding the statistical analysis plan [2][5] - Preclinical data published in Nature Microbiology indicates CD388's potential as a universal antiviral for influenza prevention [4][5] - Two posters on CD388 were presented at the 38th International Conference on Antiviral Research in March 2025, showcasing study design and preliminary safety data [5] - Recent promotions within the company include Nicole Davarpanah as Chief Medical Officer and Corrina Pavetto as Senior Vice President, Clinical Development [5] Financial Results - Cash, cash equivalents, and restricted cash totaled $174.5 million as of March 31, 2025, down from $196.2 million at the end of 2024 [11][16] - Collaboration revenue was zero for Q1 2025, compared to $1.0 million in Q1 2024, following the termination of the Janssen Collaboration Agreement [11] - R&D expenses increased to $24.6 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to the ongoing Phase 2b NAVIGATE study [11][14] - General and administrative expenses rose to $6.2 million in Q1 2025 from $3.6 million in Q1 2024, driven by higher personnel costs [11][14] - The net loss for Q1 2025 was $23.5 million, compared to a net loss of $10.3 million in Q1 2024 [11][14]
Cidara Therapeutics (CDTX) 2025 Conference Transcript
2025-05-07 16:00
Summary of Sadara Therapeutics Conference Call Company Overview - Sadara Therapeutics was founded in early 2014, focusing on bispecific immunotherapy for infectious diseases [3] - The company advanced an antifungal drug to approval before pivoting to the development of CD388, a drug targeting influenza [4] Core Product and Development - CD388 is a small molecule inhibitor of viral neuraminidase, crucial for the flu virus's exit from infected cells [4] - Sadara reacquired global rights to CD388 through a $240 million financing, enabling the initiation of a 5,000-subject Phase 2b study [7] - The Phase 2b study commenced in September 2022 and completed enrollment in December 2022, coinciding with a severe flu season [7][33] Clinical Data and Efficacy - The Phase 2a study showed a 57% placebo-adjusted response rate, with expectations for the Phase 2b study to meet or exceed this figure [26] - CD388 is not a vaccine; it has a half-life of 6-8 weeks and is dosed once per flu season [13] - The drug's mechanism does not rely on the immune system, making it effective in both immunocompromised and healthy populations [27][36] Target Population - The target population for CD388 includes high-risk, immunocompromised individuals, who have a mortality rate from influenza comparable to that of breast cancer [31] Future Plans and Research - Sadara plans to advance its oncology pipeline, including a CD73 inhibitor for triple-negative breast cancer [47] - The company is also considering opportunities in other infectious diseases, such as RSV [47] Financial Position - As of the end of the previous year, Sadara reported $196 million in cash, sufficient to last until the second half of 2027 without starting a Phase 3 study [50] - The company is in discussions for potential partnerships, especially if Phase 2b results are positive [51] Market Capitalization - The current market cap is reported at $250 million based on common shares, but the fully diluted market cap is approximately $700 million due to preferred shares [52][53] Upcoming Events - Sadara will hold an R&D day on May 22, where they will discuss the flu season's severity and the statistical analysis plan for the Phase 2b data [42][46]
Cidara Therapeutics: Strong Buy On Imminent Data Readout For Lead Flu Candidate
Seeking Alpha· 2025-05-05 09:00
Group 1 - The company Cidara Therapeutics (NASDAQ: CDTX) is initiating coverage with a Strong Buy rating, indicating a positive outlook for the stock [1] - Cidara has shifted its focus from antifungal treatments to its proprietary Cloudbreak drug Fc conjugate platform, suggesting a strategic pivot in its business model [1]