According to Tempest, its options include a partnership or licensing deal, as well as a merger or an acquisition.
Tempest Therapeutics is looking for “strategic alternatives” that will allow it to take its investigational PPARα antagonist amezalpat forward into late-stage development, the biotech announced on Thursday.
Some of Tempest’s options include searching for a partner, licensing deals or joint ventures over amezalpat. The company is also open to a merger or an acquisition, as per its news release. Tempest has not provided a timeline for this strategic review, nor did it make any promises that Thursday’s announcement will result in a business transaction.
Tempest’s scramble for funding isn’t surprising. In a March 27 note to investors, William Blair analysts noted that the biotech had just over $30 million in cash and cash equivalents—only enough to cover the “start-up costs” of a Phase III trial for amezalpat.
Tempest already has a partner for amezalpat—and a powerhouse one at that. In October 2024, the California-based biotech inked a collaboration agreement with Roche to study amezalpat in combination with Tecentriq and bevacizumab (marketed by Roche under the brand name Avastin), positioning the regimen as a frontline option for unresectable or metastatic hepatocellular carcinoma (HCC). Roche has committed to providing a supply of Tecentriq for the trial, while Tempest will remain the study’s principal sponsor. That 2024 deal is a follow-up to a 2021 collaboration on the same drug combos in a Phase Ib/II trial. Tempest retains all development and commercial rights to amezalpat.
“Clearly additional funding will be needed to fully conduct the Phase III study,” the William Blair analysts noted, “which we believe could come from an additional development partner and/or equity financing.” Still, William Blair expressed optimism about Tempest and amezalpat, which it called “an attractive development opportunity for multiple partners.”
Designed to be taken orally, amezalpat is a small-molecule drug that selectively binds to and blocks PPARα, a transcription factor protein involved in various lipid-related metabolic processes. Tempest is studying amezalpat for HCC, a cancer of the liver that some studies have linked to sustained and excessive PPARα activation.
In June 2024, Tempest released Phase Ib/II data for the drug, showing that when used with Tecentriq and bevacizumab, the oral PPARα blocker elicited a 35% improvement in overall survival (OS) versus Tecentriq plus bevacizumab alone. Patients given the amezalpat regimen saw median OS of 21 months as compared to 15 months in control comparators.
In its news release on Thursday, Tempest also revealed that it had already completed an end-of-Phase II meeting with the FDA and has aligned with the regulator on a Phase III study for the amezalpat combo regimen.
