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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.

Total Revenue
$0
0
EPS
-$0.42
Previous year: -$0.54
-22.2%
Gross Profit
-$155K
Cash and Equivalents
$31.1M
Previous year: $17.6M
+76.7%
Free Cash Flow
-$5.76M
Previous year: -$6.51M
-11.5%
Total Assets
$42.2M
Previous year: $30.7M
+37.2%

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