Tempest Therapeutics is looking for new partners to help push forward its liver cancer program, citing tough capital market conditions that have hindered its ability to independently fund upcoming clinical trials.
Based in Brisbane, California, the biotech firm has pinned its hopes on amezalpat, a PPARα antagonist aimed at treating hepatocellular carcinoma (HCC), the most common form of liver cancer. The drug has shown significant promise, particularly in combination with Roche’s Tecentriq and Avastin. A previous phase 1/2 study conducted in 2023 revealed an objective response rate (ORR) of 30% for the amezalpat combination therapy, more than double the 13.3% ORR seen in the control group.
With positive feedback and the green light from both U.S. and European regulators, Tempest is poised to begin a pivotal phase 3 trial. However, according to CEO Stephen Brady, the company has not been able to secure the financing needed to reenter the clinic.
“In spite of the compelling randomized phase 2 data and blockbuster potential of amezalpat in first-line HCC, as well as the emerging promise of TPST-1495, the capital markets have been unavailable to support the next stage of advancement,” Brady said in a statement issued on April 9.
TPST-1495, Tempest’s second lead program, is a dual EP2/4 antagonist that has received FDA clearance to enter a phase 2 study for familial adenomatous polyposis (FAP), a rare inherited condition that significantly increases the risk of colon cancer.
Now, Tempest is launching an initiative to explore strategic alternatives. This includes seeking a development partner with the financial resources and infrastructure to carry both amezalpat and TPST-1495 forward. The goal, according to Brady, is to maximize shareholder value while continuing the pursuit of treatments that could benefit patients with few therapeutic options.
“We believe this is a rare opportunity for a partner,” Brady added, emphasizing the combination of positive clinical data, regulatory alignment, and commercial potential across the company’s pipeline.
Tempest, which went public in 2021 through a reverse merger with Millendo Therapeutics, reported having $30.3 million in cash at the beginning of 2025. While this provides a limited financial runway, it is not enough to independently support the commencement of a phase 3 study.
As the company works through this transitional period, its ability to secure a strategic partner could determine the future trajectory of its promising oncology programs.
Source: https://www.fiercebiotech.com/biotech/tempest-weathering-stormy-capital-market-calls-partners-liver-cancer-drug
This is non-financial/medical advice and made using AI so could be wrong