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Tempest Q4 2024 Earnings Report
Tempest Therapeutics reported its financial results for the year ended 2024, highlighting significant progress in its clinical programs and a decrease in cash and cash equivalents.
Key Takeaways
Tempest Therapeutics reported a net loss of $41.8 million for the year ended 2024, an increase from $29.5 million in 2023. The company's cash and cash equivalents decreased to $30.3 million from $39.2 million at the end of 2023, primarily due to operating activities offset by proceeds from common stock issuance. Research and development expenses significantly increased to $28.5 million, driven by preparations for the pivotal Phase 3 trial of amezalpat.
Granted both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of Hepatocellular Carcinoma (HCC).
Announced agreement with Roche to advance Amezalpat combination therapy into a First-Line HCC Pivotal Trial.
Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of Familial Adenomatous Polyposis (FAP).
Cash and cash equivalents decreased to $30.3 million at year-end 2024 from $39.2 million at year-end 2023.
Tempest
Tempest
Forward Guidance
Tempest Therapeutics plans to advance its key drug candidates, Amezalpat and TPST-1495, into later-stage clinical trials, with data expected in 2026 for TPST-1495. The company aims to secure additional resources to support these advancements.
Positive Outlook
- Plan to advance amezalpat into a registrational study in first-line liver cancer patients.
- Plan to advance TPST-1495 into a Phase 2 study in patients with FAP under the auspices of the Cancer Prevention Clinical Trials Network.
- Data for TPST-1495 Phase 2 study expected in 2026.
- Focus remains on execution with excellence while securing necessary resources.
- Expanded leadership team to strengthen global clinical expertise.
Challenges Ahead
- Advancement of amezalpat into a registrational study is subject to obtaining additional resources.
- Challenging capital markets mentioned as a backdrop for operations.
- Unexpected safety or efficacy data observed during preclinical or clinical trials could impact progress.
- Clinical trial site activation or enrollment rates lower than expected could delay timelines.
- Changes in the regulatory environment or unexpected litigation could affect operations.