Tempest Reports Third Quarter 2024 Financial Results and Provides Business Update

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Tempest Therapeutics
Tempest Therapeutics
  • Building upon a successful end-of-Phase 2 meeting, received FDA “Study May Proceed” letter for pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line HCC

  • Announced agreement with Roche to support advancement of amezalpat into first-line HCC pivotal Phase 3 trial

  • Received final funding approval from NCI to move TPST-1495 into a Phase 2 trial in FAP

  • Expanded leadership team to strengthen global clinical expertise

BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended September 30, 2024, and provided a corporate update.

“During the third quarter, the team continued to move amezalpat successfully towards the pivotal study, achieving important milestones on both the regulatory and business fronts,” said Stephen Brady, president and chief executive officer of Tempest. “Based on the positive randomized Phase 2 data and a Phase 3 plan we believe is designed for success, we were thrilled to receive broad agreement with the FDA. Coupled with Roche’s support for the Phase 3 study, the third quarter further solidified the foundation of a pivotal study that we hope will result in a new and meaningful therapy for first-line HCC patients.”

Recent Highlights

  • Amezalpat (TPST-1120) (clinical PPARα antagonist):

    • Received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin®), the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma.

    • Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC, a form of liver cancer with high unmet need.

      • Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study. The agreement builds on a clinical collaboration between the companies pursuant to which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat.

    • Announced positive feedback from the end-of-Phase 2 meeting with the FDA for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic HCC. Key outcomes included:

      • Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints.

      • Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study.

      • Agreement on the Phase 3 statistical plan, including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months.

  • Corporate:

    • Expanded leadership team to strengthen global clinical expertise with the appointments of Troy M. Wagner as Vice President of Quality Assurance and Sheldon Mullins as Vice President of Regulatory Affairs.

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