Tempest Therapeutics, Inc.

What they do

Tempest advances a pipeline of advanced CAR-T candidates, including lead program TPST-4003, a CD7-targeted in vivo CD19/BCMA CAR-T, and TPST-2003, an autologous CD19/BCMA CAR-T in clinical development for relapsed or refractory multiple myeloma and POEMS syndrome. In February 2026 it acquired rights to four dual-targeting CAR-T programs from Erigen LLC and Factor Bioscience. It also holds two clinical-stage small molecules, amezalpat in hepatocellular carcinoma and TPST-1495 planned for familial adenomatous polyposis. It is a research-and-development organization with no approved products.

Revenue drivers

• CAR-T pipeline (TPST-4003, TPST-2003, TPST-2206, TPST-3003, TPST-3206) — No product revenue to date; value rests on clinical data and partnering. TPST-2003 has interim Phase 1/2a and Phase 1 data from partner Novatim; TPST-4003 is preclinical with first dosing targeted for Q4 2026.
• Amezalpat (formerly TPST-1120) — Completed a Phase 2 study in first-line hepatocellular carcinoma; described as Phase 3-ready, with the company seeking business development partners rather than funding pivotal development itself.
• TPST-1495 — Planned Phase 2 study in familial adenomatous polyposis expected to be funded by the National Cancer Institute through CP-CTNet and to enroll a first patient in 2026, limiting internal capital use.
• Grant and collaboration funding — Prior periods show small grant-type revenue (e.g., $277K in 2015, $653K in 2016, $295K in 2017) and no recurring commercial revenue since; NCI funding may offset TPST-1495 costs.

Recent performance

Tempest reported a net loss of $26.3 million for 2025, narrower than the $41.8 million loss in 2024, with diluted EPS of $-6.33 versus $-19.5. Operating cash use was $26.8 million in 2025, versus $33.0 million in 2024. At June 30, 2026, total assets were $9.6 million, total liabilities $10.7 million and shareholders' equity was negative $1.1 million, with cash and equivalents of $779,000. The company has no annual revenue in recent years and finances operations through equity issuances, including 8,268,495 shares issued to Erigen for the asset acquisition and a warrant distribution of 6,784,989 warrants.

Strategy

Tempest is prioritizing a capital-efficient development strategy across the portfolio, seeking partner support and external funding in place of wholly internal spend. It plans to pursue business development for amezalpat in hepatocellular carcinoma rather than fund Phase 3 itself, and to run the TPST-1495 FAP study with NCI and CP-CTNet funding. It executed a development collaboration with Hebei Senlang Biotechnology for TPST-4003, beginning with an investigator-initiated trial in approximately 10 patients with myasthenia gravis or multiple sclerosis in China, with first patient dosing expected in Q4 2026 and initial data in the first half of 2027. It selected Cincinnati Children's AGCTC as lead CDMO for TPST-2003 technology transfer and received a $2.1 million waiver of Factor MSA payments plus return of a $0.2 million deposit.

Risks

• Going concern — The 10-K states there is substantial doubt about the ability to continue as a going concern, and the company had $779,000 of cash at June 30, 2026 against negative shareholder equity of $1.1 million.
• Need for additional capital — The company states it will require significant additional funding, and failure to raise it could force delays, reductions or termination of development programs.
• History of losses — Net losses were $41.8 million in 2024 and $26.3 million in 2025 with no product revenue, and losses are expected to continue for the foreseeable future.
• Asset integration — The 10-K warns that integrating the acquired CAR-T assets may be more difficult, costly or time consuming than expected and that the anticipated benefits may not be realized.

Outlook

Management expects first patient enrollment and dosing of TPST-4003 in an investigator-initiated trial in China in the fourth quarter of 2026, with initial clinical data in the first half of 2027. The company also expects first patient enrollment in the TPST-1495 FAP Phase 2 study in 2026 and plans to pursue business development for amezalpat. It has stated that it will use best efforts to promptly raise additional funds to expand its cash runway.