Tempest Seeks Strategic Partners to Launch Phase 3 Liver Cancer Trial Amid Funding Challenges

Lead Candidate:
Tempest Therapeutics' primary drug, amezalpat (TPST-1120), is a small-molecule PPAR⍺ antagonist designed to treat hepatocellular carcinoma (HCC), the most common form of liver cancer. It demonstrated a 30% objective response rate in previous clinical trials compared to 13.3% in control groups1 6.

Phase 3 Approval:
The FDA has cleared Tempest to proceed with a pivotal Phase 3 trial for amezalpat in combination with Tecentriq (atezolizumab) and Avastin (bevacizumab) versus the standard-of-care alone for first-line treatment of unresectable or metastatic HCC2 6.

Funding Challenges:
Tempest only holds $30.3 million in cash, insufficient to fully conduct the 700-patient Phase 3 trial. The company has been unsuccessful in securing additional financing and is seeking strategic alternatives, including partnerships, joint ventures, licensing deals, or acquisitions, to fund the trial1 5 9.

Regulatory and Commercial Potential:
Amezalpat has received Orphan Drug and Fast Track designations due to its promising Phase 2 data. It has shown improvements in multiple endpoints, including survival, progression-free survival, and overall response rate2 6.

Partnership Opportunity:
Despite previous collaborations with Roche for Tecentriq supply, Roche and other potential partners (e.g., AstraZeneca, Bristol Myers Squibb) have shown limited financial collaboration interest. Tempest retains full development and commercial rights for amezalpat5 8.

Additional Pipeline Asset:
Tempest is also advancing TPST-1495, a dual EP2/4 antagonist, for familial adenomatous polyposis (FAP), with funding support from the National Cancer Institute for an upcoming Phase 2 trial in 20254 9.

Exploring Strategic Alternatives:
Tempest has engaged MTS Health Partners to evaluate options, with no timeline set for completing this process. The company remains optimistic about the commercial potential of its pipeline but acknowledges the precarious position of its financial resources1 4 8.