Release Date: May 08, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• 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.

Negative Points

• 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.

Q & A Highlights

• 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)