On February 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company with a diversified portfolio of cell therapy and small molecule product candidates, reported its post-transaction strategy to advance its newly acquired CAR-T assets while maintaining a capital-efficient operation model.
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Following the recent closing of its strategic transaction, Tempest plans to prioritize development of its clinical-stage dual-targeting CD19/BCMA CAR-T program, TPST-2003, while expanding the portfolio into next-generation modalities, including TPST-4003, a newly disclosed in vivo CAR-T program designed to deliver the same dual-targeting CD19/BCMA construct without the need for ex vivo cell manufacturing.
"Our strategy is to leverage partner-funded and externally supported development where possible to generate high-value clinical data before committing significant internal capital," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "This approach allows us to advance multiple programs in parallel, expand the long-term optionality of our CAR-T portfolio and preserve flexibility as we evaluate the most compelling path forward."
Strategic Priorities:
Advance TPST-2003 through upcoming clinical milestones
Tempest plans to continue development of TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, with near-term clinical data expected from an ongoing Phase 1 clinical trial in China. The company anticipates initiation of a registrational Phase 2b in China by the end of 2026, with interim data expected in 2027. Development activities in China are funded by a strategic partner, providing access to pivotal data while preserving internal capital.
Expand the portfolio with in vivo CAR-T development (TPST-4003)
TPST-4003 represents Tempest’s first in vivo CAR-T program and is designed to extend the TPST-2003 biology into a potentially more scalable and patient-friendly modality. The company expects to advance the program through preclinical development and evaluate potential clinical entry through a strategic partner-funded Investigator Initiated Trial in the near-term.
Position amezalpat for pivotal development through business development
Amezalpat remains Phase 3-ready in first-line hepatocellular carcinoma ("HCC"), supported by global regulatory alignment and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development.
Advance TPST-1495 through externally funded clinical development
Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP"), with first patient enrollment expected in Q1 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement with limited internal capital deployment.
Advance a diversified next-generation CAR-T pipeline
Tempest plans to progress additional dual-targeting CAR-T programs that broaden the platform across modalities and indications, including:
TPST-3003: an allogeneic dual-targeting CD19/BCMA CAR-T
TPST-2206: a dual-targeting CD70/CD70 CAR-T
TPST-3206: an allogeneic dual-targeting CD70/CD70 CAR-T
(Press release, Tempest Therapeutics, FEB 11, 2026, View Source [SID1234662606])