Tempest Shifts Focus to CAR-T, Seeks Partners for Phase 3-Ready HCC Drug

TL;DR

**Tempest's bold bet on CAR-T and external funding for its small molecules is a high-stakes play for survival and growth in the cutthroat biotech arena.**

AI Summary

Tempest Therapeutics, Inc. (TPST) reported a strategic shift in its 2025 fiscal year, expanding its pipeline through the acquisition of dual-targeting CAR-T product candidates from Erigen LLC and Factor Bioscience Inc. on February 3, 2026. This acquisition, valued at 8,268,495 shares of common stock, introduced TPST-2003, an autologous CD19/BCMA CAR-T therapy for relapsed or refractory multiple myeloma, into its lead programs. The company also maintains two small-molecule candidates: amezalpat (TPST-1120), which is Phase 3-ready for first-line hepatocellular carcinoma (HCC) after positive Phase 2 data showing a six-month improvement in median overall survival with a hazard ratio of 0.65, and TPST-1495, slated for a NCI-funded Phase 2 study in familial adenomatous polyposis (FAP) in 2026. Tempest is pursuing a capital-efficient development strategy, seeking external funding and partnerships, such as Novatim Immune Therapeutics funding for TPST-2003 development in China, to extend its operational runway and advance multiple programs. The aggregate market value of non-affiliate common equity was approximately $30.1 million as of June 30, 2025.

Why It Matters

Tempest's strategic pivot into CAR-T therapies, particularly with the acquisition of TPST-2003, positions it in a highly competitive and rapidly evolving oncology market. For investors, this diversification could offer new growth avenues, but also introduces significant development risks inherent in cell therapies. Employees and customers could benefit from the potential for novel treatments for challenging cancers like multiple myeloma and HCC, addressing critical unmet medical needs. The capital-efficient strategy, leveraging external funding from partners like Novatim and the NCI, is crucial for a smaller biotech to sustain operations and advance its pipeline against larger pharmaceutical competitors.

Risk Assessment

Risk Level: high — The company is a clinical-stage biotechnology company with no approved products and relies heavily on the successful development and regulatory approval of its product candidates, which is inherently risky. The Asset Acquisition on February 3, 2026, involved issuing 8,268,495 shares of common stock, indicating significant dilution for existing shareholders. Furthermore, the strategy explicitly states reliance on 'business development discussions' and 'externally funded clinical development' for key programs like amezalpat and TPST-1495, highlighting dependence on external partnerships and funding that may not materialize.

Analyst Insight

Investors should closely monitor Tempest's ability to secure the stated external funding and partnerships for amezalpat and TPST-1495, as well as the clinical progress of its newly acquired CAR-T programs. Given the high-risk profile and reliance on future milestones, a cautious approach is warranted, focusing on concrete partnership announcements and positive clinical data readouts before considering a significant position.

Financial Highlights

debt To Equity

0.0

revenue

$0

operating Margin

N/A

total Assets

$37.7M

total Debt

$0

net Income

$-103.9M

eps

$-2.91

gross Margin

N/A

cash Position

$10.7M

revenue Growth

N/A

Key Numbers

• $30.1M — Market Value of Non-Affiliate Equity (As of June 30, 2025, indicating a smaller market capitalization.)
• 8.27M — Shares Issued for Acquisition (Represents significant dilution for existing shareholders due to the Asset Acquisition.)
• 6 months — Improvement in Median Overall Survival (Achieved by amezalpat in Phase 2 HCC study, a key positive clinical outcome.)
• 0.65 — Hazard Ratio for OS (Demonstrated by amezalpat in Phase 2 HCC study, indicating a reduced risk of death.)
• 2026 — Expected Phase 2 Initiation for TPST-1495 (Marks a key clinical milestone for the small-molecule pipeline, funded by NCI.)
• 2026 — Anticipated Registrational Phase 2b Initiation for TPST-2003 in China (A critical step towards potential market approval for the lead CAR-T candidate.)

Key Players & Entities

• Tempest Therapeutics, Inc. (company) — Registrant
• Erigen LLC (company) — Seller in Asset Purchase Agreement
• Factor Bioscience Inc. (company) — Seller in Asset Purchase Agreement
• Novatim Immune Therapeutics (company) — Strategic partner funding TPST-2003 development in China
• National Cancer Institute (regulator) — Funding Phase 2 study for TPST-1495
• U.S. Food and Drug Administration (regulator) — Granted Orphan Drug and Fast Track Designations for amezalpat
• European Medical Agency (regulator) — Granted Orphan Drug Designation for amezalpat
• $30.1 million (dollar_amount) — Aggregate market value of non-affiliate common equity as of June 30, 2025
• 8,268,495 shares (dollar_amount) — Shares of common stock issued for Asset Acquisition
• $6.80 (dollar_amount) — Closing price per share on June 30, 2025

FAQ

Risk Factors

• Limited Operating History and Need for Additional Funding [high — financial]: The company has a limited operating history and has incurred significant net losses since its inception. It anticipates that it will continue to incur substantial losses in the future. The company's ability to continue as a going concern is dependent on its ability to secure additional funding through equity financings, debt financings, collaborations, or other arrangements. As of June 30, 2025, the aggregate market value of non-affiliate common equity was approximately $30.1 million, indicating a need for substantial capital to fund operations and development.
• Dependence on Key Personnel and Third-Party Manufacturers [medium — operational]: The success of the company is highly dependent on the continued service of its key scientific and management personnel. The company also relies on third-party contract manufacturing organizations (CMOs) for the manufacturing of its product candidates. Any disruption in the supply chain or inability to secure manufacturing capacity could materially impact the company's ability to advance its clinical programs.
• Uncertainty of Regulatory Approval and Market Acceptance [high — regulatory]: The development of novel therapeutics is a lengthy, expensive, and uncertain process. There is no guarantee that any of the company's product candidates will receive regulatory approval from the FDA or other regulatory authorities. Even if approved, the products may not achieve market acceptance.
• Dilution from Future Equity Financings [medium — financial]: The company has issued and may continue to issue a significant number of shares of common stock in connection with its operations, including the acquisition of 8,268,495 shares for the Erigen/Factor Bioscience asset purchase. Future equity financings to fund operations could result in substantial dilution to existing shareholders.
• Clinical Trial Risks and Delays [high — operational]: The company's product candidates are in clinical development, and the results of ongoing and future clinical trials are uncertain. The Phase 2 study for TPST-1495 is expected to initiate in 2026, and the company is seeking business development discussions to advance pivotal development for amezalpat. Delays or adverse results in these trials could significantly impact the company's development timelines and financial condition.

Industry Context

The biotechnology industry, particularly in oncology, is characterized by rapid innovation and significant investment in novel therapeutic modalities like CAR-T and small molecule inhibitors. Companies are increasingly focused on dual-targeting strategies and capital-efficient development through partnerships and external funding. The competitive landscape is intense, with numerous players vying for breakthroughs in areas of high unmet medical need, such as relapsed/refractory multiple myeloma and hepatocellular carcinoma.

Regulatory Implications

Tempest Therapeutics faces significant regulatory hurdles inherent in drug development. The success of its pipeline hinges on successful clinical trials and subsequent FDA approval. The company's reliance on external funding for certain studies, like the NCI-funded TPST-1495 trial, highlights the financial pressures associated with navigating complex regulatory pathways.

What Investors Should Do

1. Monitor progress of TPST-2003 clinical trials and potential partnership discussions for pivotal development of amezalpat.
2. Evaluate the company's cash burn rate and its ability to secure additional funding to extend its operational runway.
3. Assess the competitive landscape and potential market penetration for TPST-2003 in rrMM and amezalpat in HCC.
4. Review the terms and progress of any new strategic partnerships or collaborations, particularly regarding the China development for TPST-2003.

Key Dates

• 2026-02-03: Acquisition of dual-targeting CAR-T product candidates from Erigen LLC and Factor Bioscience Inc. — Significantly expands the company's pipeline with TPST-2003, a CAR-T therapy for multiple myeloma, and other CAR-T candidates.
• 2025-11-19: Execution of Asset Purchase Agreement with Erigen LLC and Factor Bioscience Inc. — Formalized the agreement to acquire rights to multiple CAR-T product candidates, including TPST-2003.
• 2025-06-30: Market value of non-affiliate common equity reported as $30.1 million. — Indicates the company's market capitalization at a specific point in time, relevant for assessing financial standing.
• 2026: Expected Phase 2 study initiation for TPST-1495 in familial adenomatous polyposis (FAP). — Marks a key clinical milestone for the small-molecule pipeline, with NCI funding.
• 2026: Anticipated Phase 2b initiation for TPST-2003 in China. — A critical step towards potential market approval for the lead CAR-T candidate in a key international market.

Glossary

CAR-T

Chimeric Antigen Receptor T-cell therapy, a type of immunotherapy that uses a patient's own T-cells to fight cancer. (Central to the company's expanded pipeline with TPST-2003 and other CAR-T candidates.)

rrMM

Relapsed or refractory Multiple Myeloma, a type of blood cancer that has returned or not responded to treatment. (The indication for which TPST-2003, the lead CAR-T candidate, is being developed.)

HCC

Hepatocellular Carcinoma, a type of liver cancer. (The indication for which amezalpat (TPST-1120) has completed Phase 2 studies and is Phase 3-ready.)

FAP

Familial Adenomatous Polyposis, an inherited condition that increases a person's risk of developing colorectal cancer. (The indication for which TPST-1495 is planned for a Phase 2 study.)

NCI

National Cancer Institute, a U.S. government agency responsible for cancer research and training. (Funding the Phase 2 study for TPST-1495, reducing the company's capital deployment.)

Hazard Ratio

A statistical measure used in survival analysis to compare the hazard rates of two groups. A hazard ratio of less than 1 indicates a reduced risk of an event (e.g., death) in one group compared to the other. (A key metric from the amezalpat Phase 2 study showing a 0.65 hazard ratio for overall survival.)

Autologous

Relating to or derived from one's own body. (Describes TPST-2003 and TPST-2206 CAR-T therapies, meaning they are derived from the patient's own T-cells.)

Allogeneic

Relating to or derived from a different individual of the same species. (Describes TPST-3003 and TPST-3004 CAR-T therapies, meaning they are derived from a donor's T-cells.)

Year-Over-Year Comparison

The company's financial position shows a decrease in cash from $30.1 million to $10.7 million year-over-year, alongside an increase in net loss from $-75.8 million to $-103.9 million. This reflects significant investment in R&D and operations, including the substantial acquisition of CAR-T assets. While revenue remains negligible, the strategic expansion of the pipeline with promising candidates like TPST-2003 and the Phase 3-ready amezalpat suggests a shift towards potentially higher-value assets, albeit with increased financial risk and dilution concerns.

Key Financial Figures

• $0.001 — nge on which Registered Common Stock, $0.001 par value TPST The Nasdaq Stock Mar
• $6.80 — l quarter), based on a closing price of $6.80 per share of the registrant's common st

Filing Documents

• tpst-20251231.htm (10-K) — 2946KB
• tpst-ex4_1.htm (EX-4.1) — 82KB
• tpst-ex10_12.htm (EX-10.12) — 11KB
• tpst-ex10_25.htm (EX-10.25) — 332KB
• tpst-ex10_26.htm (EX-10.26) — 353KB
• tpst-ex10_27.htm (EX-10.27) — 130KB
• tpst-ex10_28.htm (EX-10.28) — 88KB
• tpst-ex10_29.htm (EX-10.29) — 83KB
• tpst-ex23_1.htm (EX-23.1) — 13KB
• tpst-ex31_1.htm (EX-31.1) — 20KB
• tpst-ex31_2.htm (EX-31.2) — 21KB
• tpst-ex32_1.htm (EX-32.1) — 11KB
• img81402019_0.jpg (GRAPHIC) — 50KB
• img81402019_1.jpg (GRAPHIC) — 31KB
• img81402019_2.jpg (GRAPHIC) — 218KB
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• img81402019_5.jpg (GRAPHIC) — 66KB
• img81402019_6.jpg (GRAPHIC) — 96KB
• img81402019_7.jpg (GRAPHIC) — 232KB
• img81402019_8.jpg (GRAPHIC) — 306KB
• img81402019_9.jpg (GRAPHIC) — 150KB
• 0001193125-26-130490.txt ( ) — 14656KB
• tpst-20251231.xsd (EX-101.SCH) — 1230KB
• tpst-20251231_htm.xml (XML) — 1379KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 35 Item 1B. Unresolved Staff Comments 90 Item 1C. Cybersecurity 90 Item 2.

Properties

Properties 92 Item 3.

Legal Proceedings

Legal Proceedings 92 Item 4. Mine Safety Disclosures 92 PART II 93 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 93 Item 6. [Reserved] 93 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 94 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 104 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 105 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 129 Item 9A.

Controls and Procedures

Controls and Procedures 129 Item 9B. Other Information 129 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 130 PART III 130 Item 10. Directors, Executive Officers and Corporate Governance 130 Item 11.

Executive Compensation

Executive Compensation 133 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 139 Item 13. Certain Relationships and Related Transactions, and Director Independence 140 Item 14. Principal Accountant Fees and Services 142 PART IV 144 Item 15. Exhibit and Financial Statement Schedules 144 Item 16 Form 10-K Summary 146

Signatures

Signatures SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report"), contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, (the "Exchange Act"), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. "Business," Part I, Item 1A. "Risk Factors," and Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this Annual Report. In some cases, you can identify forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include statements about: the Asset Acquisition (as defined below), including, but not limited to, our expectations regarding the benefits and expected synergies of the Asset Acquisition; our new strategy and the potential benefits thereof; our expected future growth and our ability to manage such growth; our, or our partner's, ability to develop, obtain regulatory approval fo

BUSINESS

ITEM 1. BUSINESS Overview We are a clinical-stage biotechnology company advancing a diversified portfolio of cell therapy and small molecule product candidates. In February 2026, we expanded our pipeline through a strategic transaction under which we acquired rights to a portfolio of dual-targeting chimeric antigen receptor T-cells ("CAR-T") product candidates with the potential to treat certain blood cancers, solid tumors and immunology indications, including TPST-2003, an autologous CD19/B-cell maturation antigen ("BCMA") CAR-T therapy currently in clinical development for relapsed or refractory multiple myeloma ("rrMM"). Our portfolio also includes two clinical-stage small molecule product candidates with the potential to treat certain cancer indications. One of our small-molecule product candidates, amezalpat (previously known as TPST-1120), has completed a Phase 2 study in first-line hepatocellular carcinoma ("HCC"). Amezalpat remains Phase 3-ready in HCC and we plan to pursue business development discussions to advance pivotal development. Our second small-molecule product candidate is TPST-1495, which we plan to initiate a Phase 2 study for in familial adenomatous polyposis ("FAP"), with first patient enrollment expected in 2026. The study is expected to be funded by the National Cancer Institute ("NCI") and conducted through the Cancer Prevention Clinical Trials Network ("CP-CTNet"), enabling advancement with limited internal capital deployment. Our mission is to develop therapeutic products with the potential to address high unmet medical needs by identifying promising clinical-stage candidates and advancing their development to create products that will improve patients' lives. Recent Developments Strategic Acquisition of Dual-Targeting CAR-T Programs On November 19, 2025, we executed an Asset Purchase Agreement (the "Asset Purchase Agreement") with Erigen LLC, a Delaware limited liability company ("Erigen"), and Factor Bioscience Inc., a Del

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