Business Context and Reporting Period
Company: Tempest Therapeutics, Inc. (TPST)
Filing Type: Form 10-K (Annual Report)
Reporting Period: Fiscal year ended December 31, 2025
Business Overview: Tempest is a clinical-stage biotechnology company focused on cell therapy (CAR-T) and small molecule product candidates for oncology and immunology. The company operates as a single segment and is headquartered in Brisbane, California.
Recent Strategic Developments:
- Asset Acquisition: On February 3, 2026, the company completed the acquisition of a portfolio of dual-targeting CAR-T assets from Erigen LLC and Factor Bioscience Inc. for approximately 8.27 million shares of common stock (valued at ~$19.9 million).
- Pipeline Expansion: The acquisition added TPST-2003 (autologous CD19/BCMA CAR-T for multiple myeloma), TPST-2206 (autologous CD70/CD70 CAR-T for solid tumors), and allogeneic/in vivo programs (TPST-3003, TPST-3206, TPST-4003).
- Leadership Change: Matthew Angel was appointed CEO and President effective February 3, 2026, succeeding Stephen Brady.
Key Financial Metrics
| Metric (in thousands) | 2025 | 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(26,262) | $(41,843) |
| Operating Loss | $(26,575) | $(42,026) |
| Cash and Cash Equivalents (Dec 31) | $7,707 | $30,268 |
| Accumulated Deficit | $(233,368) | $(207,106) |
| Research & Development Expenses | $12,606 | $28,476 |
| General & Administrative Expenses | $13,969 | $13,550 |
Liquidity: As of December 31, 2025, the company held $7.7 million in cash. Management states this is expected to fund operations for less than 12 months from the date of the report issuance. The company has a funding commitment from Factor Bioscience for up to $20.0 million, with $13.75 million available as of the report date, subject to conditions.
Material Changes vs. Prior Period
- Reduced Operating Loss: Net loss decreased by 37% (from $41.8M to $26.3M) primarily due to a 56% reduction in R&D expenses ($15.9M decrease) driven by cost-cutting measures and a reduction in workforce (21 of 26 employees terminated in April 2025).
- Debt Repayment: The company fully repaid its $3.5 million outstanding loan to Oxford Finance in April 2025, eliminating interest expense associated with that facility.
- Capital Structure: The company executed a 1-for-13 reverse stock split in April 2025. Subsequent to year-end, the company issued a warrant dividend and completed a private placement raising approximately $2.0 million in March 2026.
- Asset Base: Total assets decreased from $41.5M to $16.9M, reflecting the burn of cash and the write-down of assets, offset by the subsequent acquisition of intangible assets (CAR-T programs) post-year-end.
Guidance, Outlook, and Risks
Going Concern: The filing explicitly states there is substantial doubt regarding the company's ability to continue as a going concern for 12 months from the issuance date due to finite cash resources and a history of losses. Continued operations depend on securing additional financing.
Outlook and Strategy:
- Capital Efficiency: The company is pursuing a capital-efficient strategy, seeking partner support and external funding (e.g., NCI funding for TPST-1495) to extend its runway.
- Clinical Milestones:
- Amezalpat: Phase 3-ready for first-line Hepatocellular Carcinoma (HCC); seeking business development partners for pivotal development.
- TPST-2003: Aiming to initiate a U.S. registrational study in 2026 based on positive data from China-based trials (funded by partner Novatim).
- TPST-1495: Phase 2 study in Familial Adenomatous Polyposis (FAP) expected to begin in 2026, funded by the National Cancer Institute.
Key Risks:
- Financing Risk: Inability to raise additional capital could force the company to delay, limit, or terminate operations.
- Regulatory Risk: Uncertainty regarding FDA acceptance of clinical data generated in China for TPST-2003.
- Integration Risk: Challenges in integrating the newly acquired CAR-T assets and realizing anticipated synergies.
- Intellectual Property: Reliance on in-licensed patents and potential challenges to patent validity.
Investor Verification Checklist
- Cash Runway: Verify the current cash balance and the specific conditions required to access the $13.75 million funding commitment from Factor Bioscience.
- Asset Acquisition Valuation: Review the final allocation of the $19.9 million consideration for the Erigen/Factor asset acquisition and the impact on future dilution.
- China Data Acceptance: Confirm the FDA's stance on accepting the clinical data from Novatim-sponsored trials in China for the TPST-2003 registrational filing.
- Business Development: Monitor progress on securing a partner for the Phase 3 development of amezalpat, as internal funding is insufficient for a pivotal trial.
- Executive Retention: Assess the stability of the new management team (CEO Matthew Angel) and the transition from the previous leadership.