09-05-2025
Cidara Therapeutics Inc (CDTX) Q1 2025 Earnings Call Highlights: Promising Advances in ...
Release Date: May 08, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Cidara Therapeutics Inc (NASDAQ:CDTX) is advancing its CD 388 program, which aims to revolutionize influenza prevention with a novel drug conjugate.
The CD 388 drug has shown promising preclinical data, published in Nature Microbiology, highlighting its potential as a universal antiviral for influenza A and B.
The phase 2B Navigate study for CD 388 is underway, with dosing completed for over 5,000 subjects, and top-line data expected by the end of June.
Cidara Therapeutics Inc (NASDAQ:CDTX) is in discussions with the FDA to potentially evaluate statistical significance in their phase 2B study due to the severity of the flu season.
The company plans to initiate a phase 3 study in high-risk populations, focusing on those underserved by current vaccines and antivirals, in the spring of 2026.
Cidara Therapeutics Inc (NASDAQ:CDTX) is currently a non-revenue generating company, which may pose financial sustainability challenges.
The Navigate study was not initially powered for statistical significance, which could impact the robustness of the results.
There is uncertainty regarding the pricing and market size for CD 388, with discussions on potential pricing above initial estimates.
The company is still finalizing the definition of high-risk patient populations for its phase 3 study, indicating ongoing strategic planning.
The final data for the phase 2B study, including pharmacokinetic data, will not be available until September, delaying comprehensive analysis.
Warning! GuruFocus has detected 8 Warning Signs with CDTX.
Q: Have you had discussions with the FDA regarding the statistical analysis for the Phase 2B study, or are those discussions still ongoing? A: Yes, we have had those discussions and look forward to sharing the statistical analysis plan update at our May 22nd R&D Day event. (Jeff Stein, CEO)
Q: Historically, you've mentioned a potential patient population of 20 million. Do you see a broader opportunity than that, and what about pricing dynamics? A: Our thinking has evolved, and we see a substantial opportunity in high-risk comorbid and immune-compromised populations. We also see potential for pricing above the previously mentioned range, reflecting the product's value. More details will be shared at the R&D Day. (Jeff Stein, CEO and Jim Bidel, Chief Business Officer)
Q: How should we think about CD 388's positioning amidst discussions about vaccines and evolving views on them? A: CD 388 is initially targeted at high-risk populations underserved by vaccines. There's potential for complementarity with vaccines, as CD 388 targets a different mechanism. We aim to develop it in conjunction with existing vaccines. (Jeff Stein, CEO)
Q: Can you provide details on the primary endpoint for the Navigate study and the data collection process? A: The primary endpoint is preventive efficacy, evaluated by centrally confirmed influenza infection, which includes nasopharyngeal PCR positivity, body temperature, and symptom criteria. It's a robust evaluation to confirm symptomatic and severe flu. (Nicole Dorapan, Chief Medical Officer)
Q: Are you expecting a dose-dependent response on efficacy in the Phase 2B study, and how important is it to see this dose response? A: We expect to see a dose dependence, but more importantly, an exposure dependence. The relationship between exposure and efficacy will be crucial, and we hope to discuss this when we disclose top-line data. (Jeff Stein, CEO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
