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Jun 30, 2024
Tempest Q2 2024 Earnings Report
Reported positive survival data for amezalpat and advanced amezalpat towards a pivotal Phase 3 trial in first-line HCC.
Key Takeaways
Tempest Therapeutics reported positive survival data for amezalpat in first-line liver cancer patients and is advancing the program towards a pivotal study. The company ended the quarter with $31.1 million in cash and cash equivalents. Net loss for the quarter was $9.6 million, or $0.42 per share.
Amezalpat demonstrated positive survival benefit as a potential treatment for first-line liver cancer patients.
A six-month improvement in median overall survival was observed with amezalpat in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab alone.
Amezalpat showed a manageable safety profile consistent with Phase 1 data.
The company is planning to advance amezalpat into a registrational Phase 3 study in first-line HCC patients.
Tempest
Tempest
Forward Guidance
Tempest Therapeutics plans to advance amezalpat into a registrational Phase 3 study in first-line HCC patients, subject to obtaining feedback from the FDA. The company also plans to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (“FAP”) in 2024.
Positive Outlook
- Advancing amezalpat into a registrational Phase 3 study in first-line HCC patients
- Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (“FAP”) in 2024
- Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024
- Amezalpat demonstrated positive survival benefit as a potential treatment for first-line liver cancer patients
- A six-month improvement in median overall survival was observed with amezalpat in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab alone
Challenges Ahead
- The Phase 3 study for amezalpat is subject to obtaining feedback from the FDA.
- The Phase 2 study for TPST-1495 is subject to final approval of NCI.
- Unexpected safety or efficacy data observed during preclinical or clinical trials
- Clinical trial site activation or enrollment rates that are lower than expected
- Changes in expected or existing competition