Tempest Therapeutics Seeks Strategic Alternatives for Liver Cancer Drug Amezalpat

Tempest Therapeutics, a California-based biotech company, has announced its pursuit of strategic alternatives to advance its promising liver cancer drug, amezalpat, into late-stage development. The company's decision comes amid financial constraints and a challenging capital market environment.

Amezalpat: A Potential Breakthrough in Liver Cancer Treatment

Amezalpat, an oral small-molecule PPAR⍺ antagonist, has shown significant promise in the treatment of hepatocellular carcinoma (HCC). In a Phase Ib/II trial completed in June 2024, the drug demonstrated a 35% improvement in overall survival when used in combination with Roche's Tecentriq and bevacizumab, compared to the standard treatment alone.

The trial results revealed a median overall survival of 21 months for patients receiving the amezalpat combination, versus 15 months for those on the standard regimen. This data has positioned amezalpat as a potential frontline option for unresectable or metastatic HCC.

Financial Challenges and Strategic Options

Despite the drug's promising clinical results, Tempest faces significant financial hurdles. As of March 2025, the company reported just over $30 million in cash and cash equivalents, an amount insufficient to cover the costs of a Phase III trial for amezalpat.

In response to these financial constraints, Tempest is exploring several strategic alternatives, including:

1. Seeking a partnership or licensing deal
2. Pursuing a merger or acquisition
3. Exploring joint venture opportunities

Stephen Brady, CEO of Tempest Therapeutics, stated, "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."

Existing Collaboration with Roche

Tempest already has a collaboration agreement with pharmaceutical giant Roche, established in October 2024. This partnership focuses on studying amezalpat in combination with Tecentriq and bevacizumab (Avastin) as a frontline treatment for HCC. Under the agreement, Roche provides Tecentriq for the trial, while Tempest remains the principal sponsor and retains all development and commercial rights to amezalpat.

Regulatory Progress and Future Plans

Tempest has made significant progress on the regulatory front, having completed an end-of-Phase II meeting with the FDA. The company has aligned with the regulator on the design of a Phase III study for the amezalpat combination regimen.

Additionally, Tempest has secured FDA approval to initiate a Phase II study for another drug in its pipeline, TPST-1495, a dual EP2/4 antagonist targeting familial adenomatous polyposis (FAP), a genetic colon disorder.

As Tempest navigates these challenging waters, the company remains optimistic about amezalpat's potential. Brady emphasized, "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."