Tempest Therapeutics

Biotech funding dropped 57% to $2.7 billion in May 2025, marking one of the worst funding periods in three years according to Jefferies investment bank analysis.

• Tempest Therapeutics is exploring strategic partnerships to advance its promising liver cancer drug amezalpat to Phase III trials after positive Phase II results showed a six-month improvement in overall survival. • The company cites challenging capital markets as the primary obstacle, with CEO Stephen Brady actively seeking partners with resources to develop what they believe are "potentially life-saving therapies." • Amezalpat, a novel PPAR-alpha antagonist with FDA fast track and orphan drug designations, will be evaluated in combination with Roche's Tecentriq and Genentech's Avastin for unresectable or metastatic hepatocellular carcinoma.

Tempest Therapeutics is actively seeking strategic partnerships to advance its liver cancer drug amezalpat to Phase III trials after positive Phase II results showed a six-month improvement in overall survival.

Tempest Therapeutics received FDA clearance to proceed with a Phase 2 clinical trial of TPST-1495, a novel dual receptor inhibitor of prostaglandin signaling, for treating Familial Adenomatous Polyposis (FAP).

Amezalpat, a PPARα antagonist, receives Fast Track Designation from the FDA, following its prior Orphan Drug Designation for hepatocellular carcinoma (HCC).

• Tempest Therapeutics has secured a drug supply agreement with Roche for its Phase 3 study in first-line Hepatocellular Carcinoma (1L HCC). • The FDA has agreed to Tempest's Phase 3 study plan, including dosing and overall survival (OS) as the primary endpoint, potentially shortening the timeline with an early efficacy analysis. • Tempest Therapeutics estimates the Phase 3 study will cost around $100 million, but the Roche agreement is expected to reduce expenses by $30-50 million. • Despite positive clinical advancements, Tempest Therapeutics acknowledges the need for significant funding to support the Phase 3 study.

• Tempest Therapeutics partners with Roche for a Phase 3 trial of amezalpat in first-line Hepatocellular Carcinoma (1L HCC). • The FDA agreed to the Phase 3 study plan, potentially reducing the timeline to primary analysis by eight months. • Roche will supply atezolizumab for the study, significantly reducing Tempest's expenses by an estimated $30-50 million. • Tempest's amezalpat, combined with Roche's atezolizumab and bevacizumab, showed a six-month median overall survival improvement.

• Tempest Therapeutics and Roche have partnered to initiate a Phase 3 trial of amezalpat in combination with atezolizumab and bevacizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). • The Phase 3 trial builds on positive Phase 2 data showing a six-month improvement in median overall survival with the combination therapy compared to standard care in HCC patients. • The FDA has agreed to the Phase 3 study design, amezalpat dosage, and primary endpoint, with a pre-specified early efficacy analysis potentially shortening the study timeline by eight months. • Tempest retains all development and commercial rights to amezalpat, while Roche will supply atezolizumab for the global trial, expected to begin in the first quarter of 2025.

• Tempest Therapeutics announced positive feedback from the FDA regarding the Phase 3 trial design for amezalpat (TPST-1120) in first-line hepatocellular carcinoma (HCC). • The FDA agreed on key aspects of the Phase 3 study, including the control arm, study endpoints, amezalpat dose, and statistical plan with an early efficacy analysis. • The Phase 3 trial, expected to begin in Q1 2025, will evaluate amezalpat plus atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone. • Amezalpat, a PPARα antagonist, has shown clinical superiority in combination with atezolizumab and bevacizumab in a Phase 1b/2 study for advanced HCC.