Tempest Therapeutics Reports 2025 Financial Results and Clinical Progress

Tempest Therapeutics, Inc. has reported financial results for the year ended December 31, 2025, and provided a corporate update highlighting significant clinical and regulatory progress. The company announced positive interim data from its lead CAR-T program and received multiple regulatory designations for its pipeline candidates.

The company reported positive interim results from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with relapsed/refractory multiple myeloma, which is being sponsored and conducted by Tempest's partner, Novatim Immune Therapeutics. The data showed a 100% complete response rate among all six efficacy evaluable patients as of the January 31, 2026 data cutoff, with a favorable safety profile showing no Grade >3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome. Prior investigator-initiated trial reached median progression free survival of 23.1 months, including in patients with extramedullary disease, with 36 patients with rrMM treated to date across two studies.

Tempest completed a strategic acquisition of dual-targeting CAR-T assets from Factor Bioscience Inc., bringing the company a portfolio of next-generation CAR-T assets including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application filing in China planned for 2027. The company also named Matt Angel, Ph.D., as Chief Executive Officer & President.

For its clinical PPARα antagonist amezalpat (TPST-1120), Tempest received both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration for the treatment of patients with hepatocellular carcinoma. The company also received clearance to proceed with a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma in China and was granted orphan drug designation from the European Medicines Agency for amezalpat for the treatment of patients with HCC. The company reported new data at the 2025 American Association for Cancer Research Annual Meeting supporting the immune component of amezalpat's dual mechanism of action.

For TPST-1495, a clinical dual EP2/4 prostaglandin receptor antagonist, Tempest was granted Orphan Drug designation by the FDA to treat patients with Familial Adenomatous Polyposis and received a "Study May Proceed" letter from the FDA to evaluate TPST-1495 in a Phase 2 Trial for the treatment of FAP.

Looking ahead, Tempest plans to present results from the ongoing Phase 1/2a REDEEM-1 study, as well as updated data from the Phase 1/2 investigator-initiated trial, in 2026. The company also plans to submit a U.S. IND application and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in patients with rrMM in 2026. For TPST-1495, Tempest expects to initiate a Phase 2 study in FAP, with first patient enrollment expected in 2026.

Financially, Tempest ended the year with $7.7 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The company announced up to $8.35 million registered direct offering of common stock and concurrent private placement of warrants in November 2025, and in March 2026 announced up to $6 million private placement of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants.