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Cidara Therapeutics (CDTX) investor relations material

Cidara Therapeutics Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary7 Aug, 2025

Executive summary

  • Positive top-line results from the Phase 2b NAVIGATE trial for CD388, meeting all primary and secondary endpoints and demonstrating strong efficacy and safety in over 5,000 subjects.

  • Focus shifted to CD388 after divesting rezafungin assets and reacquiring CD388 rights from Janssen in April 2024.

  • Closed a $402.5 million upsized public offering, significantly strengthening the balance sheet for Phase 3 execution.

  • Cash, cash equivalents, and restricted cash of $516.9 million as of June 30, 2025, expected to fund operations through the planned Phase 3 study.

  • No revenue from continuing operations post-Janssen collaboration termination; sole R&D focus is now on CD388.

Financial highlights

  • Net loss narrowed to $49.2 million for the first half of 2025, compared to $101.5 million for the same period in 2024.

  • R&D expenses increased to $49.4 million for the first half of 2025, driven by CD388 development.

  • G&A expenses rose to $12.7 million for the first half of 2025, mainly due to higher stock-based compensation.

  • Reversal of $9.4 million in indirect tax liabilities in 2025 due to compliance and voluntary disclosure.

  • Cash position more than doubled from year-end 2024, with $516.9 million at June 30, 2025.

Outlook and guidance

  • Phase 3 study for CD388 planned to initiate by spring 2026, pending FDA feedback, with operational readiness as early as fall 2025 if permitted.

  • Focus for Phase 3 will be on high-risk, comorbid, and immunocompromised populations, leveraging fast track and priority review designations.

  • Full primary analysis from the Phase 2b NAVIGATE trial will be submitted to scientific conferences in 2025.

  • Additional funding will be needed to advance CD388 beyond Phase 3 and to develop other Cloudbreak programs.

  • Expecting outcomes from FDA breakthrough therapy designation and BARDA funding applications by year-end.

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Frequently asked questions

Cidara Therapeutics Inc. is a biotechnology company focused on developing anti-infective and immunotherapy treatments. The company specializes in long-acting antifungal and antiviral therapies, utilizing its proprietary drug-Fc conjugate (DFC) platform to enhance targeted immune responses. Its pipeline includes investigational treatments for serious fungal infections and viral diseases. The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.

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