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Tempest Lays Out Strategic Plan to Advance Recently Acquired Dual-Targeting CAR-T Assets

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Tempest Therapeutics (Nasdaq: TPST) outlined a capital-efficient plan to advance newly acquired dual-targeting CAR-T assets, prioritizing partner-funded development to preserve internal capital. Key priorities include advancing TPST-2003 with near-term Phase 1 data from China, a registrational Phase 2b planned by end-2026, and interim data expected in 2027.

The pipeline expansion includes TPST-4003, an in vivo CD19/BCMA CAR-T program aimed at preclinical development and partner-funded investigator trials, plus continued development of amezalpat (Phase 3-ready HCC) and a NCI-funded Phase 2 for TPST-1495 with enrollment expected in Q1 2026.

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Positive

  • Partner-funded development preserves internal capital and reduces near-term cash needs
  • TPST-2003: registrational Phase 2b planned by end-2026
  • TPST-1495 Phase 2 enrollment expected in Q1 2026 funded by the National Cancer Institute
  • TPST-4003 in vivo program widens modality footprint and may improve scalability

Negative

  • Heavy reliance on external/partner funding limits internal program control
  • Key CAR-T programs remain early-stage (Phase 1 or preclinical), increasing clinical risk
  • Pivotal timeline extends into 2027 for interim data, delaying potential value inflection

Key Figures

TPST-2003 trial stage: Phase 1 Phase 2b timing: End of 2026 Interim data timing: 2027 +5 more
8 metrics
TPST-2003 trial stage Phase 1 Ongoing clinical trial in China with near-term data expected
Phase 2b timing End of 2026 Planned initiation of registrational Phase 2b for TPST-2003 in China
Interim data timing 2027 Interim data from TPST-2003 registrational Phase 2b in China expected
TPST-1495 Phase 2 start Q1 2026 First patient enrollment for FAP study, funded by NCI network
Amezalpat stage Phase 3-ready First-line hepatocellular carcinoma program positioned for pivotal development
Pre-news price $2.42 Close before article; below 52-week high of $6.24
52-week low $1.20 Shares trading above 52-week low prior to this announcement
Market cap $11,332,470 Equity value before publication of strategic CAR-T plan

Market Reality Check

Price: $2.42 Vol: Volume 52,840 is below th...
low vol
$2.42 Last Close
Volume Volume 52,840 is below the 20-day average of 216,073, suggesting limited pre-news positioning. low
Technical Shares trade below the 200-day MA, with price at 2.42 versus MA(200) at 3.53 before this release.

Peers on Argus

TPST was up 5.22% pre-news while key biotech peers showed mixed moves (e.g., BRN...

TPST was up 5.22% pre-news while key biotech peers showed mixed moves (e.g., BRNS -1.18%, RADX -3.08%, PSTV +1.9%), indicating a stock-specific reaction rather than a broad sector move.

Previous Acquisition Reports

2 past events · Latest: Feb 04 (Positive)
Same Type Pattern 2 events
Date Event Sentiment Move Catalyst
Feb 04 Acquisition closing Positive -1.2% Closed all-stock acquisition of dual-targeting CAR-T assets with partner funding.
Nov 19 Acquisition agreement Positive -48.6% Announced strategic acquisition of dual-CAR T programs and runway extension to mid-2027.
Pattern Detected

Recent acquisition-related announcements have been followed by negative price reactions despite strategic positioning and runway extension narratives.

Recent Company History

Over recent months, Tempest has focused on restructuring around dual-targeting CAR-T assets. The Nov 19, 2025 acquisition announcement added TPST-2003 and projected runway to mid‑2027, but shares fell after the news. The Feb 4, 2026 closing of the all-stock CAR-T acquisition, including partner funding from Factor Bioscience and CEO transition to Matt Angel, also coincided with a modest decline. Today’s strategic plan builds directly on these CAR-T acquisitions, detailing how Tempest intends to advance and fund the expanded pipeline.

Historical Comparison

acquisition
-24.9 %
Average Historical Move
Historical Analysis

Past acquisition news for TPST averaged a -24.92% move, so this strategic post-acquisition plan follows events that previously saw notably negative reactions.

Typical Pattern

Acquisition-related news progressed from announcing the Factor dual-CAR T deal to closing it, and now to operationalizing the acquired CD19/BCMA programs with a detailed development and partnering strategy.

Market Pulse Summary

This announcement outlines how Tempest plans to operationalize its recently acquired dual-targeting ...
Analysis

This announcement outlines how Tempest plans to operationalize its recently acquired dual-targeting CAR-T assets, prioritizing partner-funded progress on TPST-2003 and in vivo program TPST-4003. It also highlights externally supported development for TPST-1495 and business development plans for Phase 3‑ready amezalpat in HCC. Investors may track execution against milestones in 2026–2027, the balance between external and internal capital use, and how this strategy builds on prior acquisition and governance changes.

Key Terms

car-t, in vivo, phase 1, phase 2b, +3 more
7 terms
car-t medical
"portfolio of next-generation CAR-T and oncology assetsDevelopment approach"
CAR-T is a type of cancer therapy that reprograms a patient’s own immune cells to seek and destroy specific cancer cells, like teaching guard dogs a new scent to track intruders. It matters to investors because CAR-T treatments can command high prices, drive strong revenue for successful developers, and carry regulatory and manufacturing risks that can sharply affect a company’s valuation and long-term growth prospects.
in vivo medical
"TPST-4003, a newly disclosed in vivo CAR-T program designed to deliver"
In vivo describes tests or experiments performed inside a living organism, such as an animal or human, to observe how a drug, device or biological process behaves in a real, functioning body. Investors care because in vivo results reveal safety, effectiveness and possible side effects that lab tests cannot, much like road-testing a prototype car in traffic rather than only on a bench — outcomes can strongly influence regulatory approval, clinical success and a company’s valuation.
phase 1 medical
"near-term clinical data expected from an ongoing Phase 1 clinical trial in China"
Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.
phase 2b medical
"anticipates initiation of a registrational Phase 2b in China by the end of 2026"
Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.
hepatocellular carcinoma medical
"Amezalpat remains Phase 3-ready in first-line hepatocellular carcinoma"
Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.
familial adenomatous polyposis medical
"Phase 2 study of TPST-1495 in familial adenomatous polyposis"
An inherited condition caused by a gene mutation that leads to the early development of hundreds to thousands of growths (polyps) in the colon and rectum, which, if untreated, almost always progress to colorectal cancer. Investors care because it creates a clear medical need for genetic testing, ongoing monitoring, preventive surgeries and targeted therapies; like a high-risk household where early alarms and durable fixes have outsized value in diagnostics and treatment markets.
allogeneic medical
"TPST-3003: an allogeneic dual-targeting CD19/BCMA CAR-TTPST-2206"
Allogeneic describes a process or material involving different individuals of the same species, such as cells, tissues, or organs donated from one person to another. It is important to investors because products or treatments based on allogeneic sources can enable scalable, off-the-shelf solutions, potentially reducing costs and increasing accessibility in healthcare and biotech industries.

AI-generated analysis. Not financial advice.

  • Tempest outlines a capital-efficient post-transaction strategy to advance a diversified portfolio of next-generation CAR-T and oncology assets
  • Development approach prioritizes partner-funded and externally supported programs to generate clinical data before deploying significant internal capital
  • Pipeline expansion includes TPST-4003, an in vivo dual-targeting CD19/BCMA CAR-T, with potential near-term milestones

BRISBANE, Calif., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company with a diversified portfolio of cell therapy and small molecule product candidates, today outlined its post-transaction strategy to advance its newly acquired CAR-T assets while maintaining a capital-efficient operation model.

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

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company with a diverse portfolio of cell therapy and small molecule product candidates that leverage tumor-targeted and/or immune-mediated mechanisms to potentially treat a wide range of cancers. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at https://www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements contained in this press release include but are not limited to statements relating to: Tempest Therapeutics’ plan to advance its portfolio in a capital-efficient manner, including through partner-funded and externally supported programs; the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated initiation of a registrational Phase 2b in China for TPST-2003 by the end of 2026, the planned initiation of a Phase 2 study of TPST-1495 in FAP with first patient enrollment expected in Q1 2026 and the funding therefor, and the anticipated Phase 3 study for amezalpat; portfolio expansion with in vivo CAR-T development through a strategic partner-funded Investigator Initiated Trial in the near-term; the planned advancement of a diversified next-generation CAR-T pipeline; anticipated therapeutic benefit and regulatory development of Tempest Therapeutics’ product candidates; and Tempest Therapeutics’ ability to achieve its operational plans. Any forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to Tempest Therapeutics’ need for additional capital to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety or efficacy data observed during preclinical or clinical trials; funding from the National Cancer Institute for the expected Phase 2 study of TPST-1495 may not be available at the levels anticipated, or at all, and external from strategic partners may not be available on the timeline or at the levels anticipated, if at all, in which case Tempest Therapeutics’ decision and ability to continue the development of any such program will be subject to holistic program considerations and capital availability; past results may not be indicative of future results; clinical trial site activation or enrollment rates that are lower than expected; loss of key personnel; changes in expected or existing competition; changes in the regulatory environment; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; and unexpected litigation or other disputes. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of Tempest’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, the “Risk Factors” section under Proposal 5 contained in Tempest’s definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission (“SEC”) on December 31, 2025, and in other documents filed by Tempest from time to time with the SEC. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

Investor Contacts:

Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com

Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com


FAQ

What is Tempest's timeline for TPST-2003 dual-targeting CAR-T (TPST) clinical progress?

TPST-2003 will continue through Phase 1 with near-term data; a registrational Phase 2b is planned by end-2026. According to Tempest, interim data from that Phase 2b are expected in 2027, with development in China funded by a strategic partner to conserve internal capital.

How will TPST-4003 in vivo CAR-T affect Tempest's CAR-T strategy (TPST)?

TPST-4003 is an in vivo CD19/BCMA program intended to extend TPST-2003 biology into a scalable modality during preclinical work. According to Tempest, the company expects partner-funded investigator-initiated trials to evaluate clinical entry while limiting internal capital deployment.

What are the plans for amezalpat and its path to pivotal development for TPST shareholders?

Amezalpat is positioned as Phase 3-ready for first-line HCC with global regulatory alignment and positive Phase 2 data. According to Tempest, the company will pursue business development discussions to secure a partner or deal to advance pivotal development.

When will TPST-1495 Phase 2 in familial adenomatous polyposis begin and who funds it?

The Phase 2 study of TPST-1495 is expected to enroll its first patient in Q1 2026. According to Tempest, the study is funded by the National Cancer Institute and will be conducted through the Cancer Prevention Clinical Trials Network, reducing Tempest's capital outlay.

Does Tempest plan to use partner funding for its newly acquired CAR-T assets (TPST)?

Yes—Tempest will prioritize partner-funded and externally supported programs to generate clinical data before committing significant internal capital. According to Tempest, this strategy enables parallel advancement of multiple programs while preserving financial flexibility.
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