Tempest Therapeutics Seeks Partners for Liver Cancer Drug Amid Financial Challenges

Tempest Therapeutics, a Brisbane, California-based biotech company, is actively seeking partners to advance its promising liver cancer drug, amezalpat, into phase 3 trials. The move comes as the company faces difficulties securing additional financing in a challenging capital market environment.

Amezalpat: A Potential Blockbuster for Hepatocellular Carcinoma

Amezalpat, a PPAR𝛼 antagonist, has shown significant potential in the treatment of hepatocellular carcinoma (HCC). In a phase 1/2 study completed in 2023, the combination of amezalpat with Tecentriq and Avastin demonstrated a 30% objective response rate, compared to 13.3% in the control arm. This impressive performance has led Tempest to tout the drug as having blockbuster potential in first-line HCC treatment.

The company has already completed necessary interactions with U.S. and EU regulators to initiate a phase 3 trial of the amezalpat combination therapy. However, the current market conditions have made it challenging for Tempest to secure the required funding to move forward with the clinical program.

Financial Constraints and Strategic Alternatives

Tempest Therapeutics, which went public through a reverse merger with Millendo Therapeutics in 2021, entered 2025 with $30.3 million in cash reserves. Despite the positive clinical data and regulatory clearances, the company has struggled to raise additional capital in the current market climate.

Stephen Brady, CEO of Tempest, addressed the situation, stating, "Notwithstanding the positive randomized data set from the amezalpat phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement."

In response to these challenges, Tempest has initiated a process to explore strategic alternatives to maximize stockholder value. The primary focus is on finding a strategic partner with the resources necessary to develop what the company believes are potentially life-saving therapies for patients in need.

Additional Pipeline Assets

While amezalpat remains the lead candidate, Tempest's pipeline also includes TPST-1495, a dual EP2/4 antagonist. The company has received FDA approval to begin a phase 2 study of TPST-1495 in familial adenomatous polyposis (FAP), a genetic colon disorder.

Brady emphasized the unique opportunity this presents for potential partners, stating, "Given the positive data and commercial potential with this pipeline, as well as the clearance from FDA on the lead program's pivotal study, we believe this is a rare opportunity for a partner."

As Tempest Therapeutics navigates these challenging waters, the pharmaceutical industry will be watching closely to see how this promising pipeline progresses and whether a strategic partnership materializes to unlock the full potential of amezalpat and TPST-1495.