Tempest Therapeutics, Inc.

https://www.tempesttx.com

Tempest Therapeutics, Inc. is a clinical-stage oncology biotechnology company dedicated to developing novel small molecule therapeutics. The company's mission is to leverage its understanding of cancer biology and medicinal chemistry to create treatments that combine both targeted and immune-mediated mechanisms to address a wide range of tumors. Headquartered in Brisbane, California, USA, Tempest Therapeutics operates within the dynamic biotechnology and pharmaceutical industries, focusing on the oncology sector. [1, 2, 4, 6, 15, 17, 20, 22, 23, 29, 31, 35]

The company's pipeline includes several clinical-stage product candidates. Key programs feature amezalpat (TPST-1120), an oral PPARα antagonist being developed for hepatocellular carcinoma (HCC), and TPST-1495, a dual antagonist of EP2 and EP4 receptors for various cancers, including familial adenomatous polyposis (FAP). Additionally, Tempest Therapeutics has expanded its portfolio to include dual-targeting CAR-T programs, such as TPST-2003, aimed at treating relapsed/refractory multiple myeloma, following an all-stock acquisition in February 2026. [2, 4, 5, 6, 17, 19, 21, 25, 27, 29, 30, 31, 33, 35]

Recent developments include the appointment of Dr. Matt Angel as President and CEO in February 2026, with Stephen Brady transitioning to Chair of the Board. [6, 8, 10, 14, 25, 26] The company has reported positive interim data for TPST-2003 in relapsed/refractory multiple myeloma and is advancing TPST-1495 into a Phase 2 study for FAP, supported by the National Cancer Institute. [6, 16, 17, 18, 25, 27] Tempest Therapeutics is actively exploring strategic alternatives to further advance its clinical programs and maximize shareholder value. [17]

Latest updates

Tempest CAR-T Data Bolsters Dual-Targeting Approach in Myeloma

Event summary

  • Tempest Therapeutics will present updated clinical data from the REDEEM-1 Phase 1/2a trial for its dual-targeting CD19/BCMA CAR-T therapy, TPST-2003, at the ISCT Annual Meeting on May 6-9, 2026.
  • Interim data previously announced showed a 100% complete response rate among six evaluable patients.
  • REDEEM-1 is a multicenter trial enrolling 29 patients in China, sponsored and conducted by Novatim.
  • Tempest has exclusive rights to TPST-2003 outside of China, India, Turkey, and Russia.

The big picture

Tempest’s focus on dual-targeting CAR-T therapies aims to address antigen escape and improve response durability in relapsed/refractory multiple myeloma, a market with significant unmet need and intense competition. The REDEEM-1 data represents a potentially significant step forward, but the therapy’s commercial viability hinges on replicating these early results in a larger trial and securing regulatory approval. The partnership with Novatim introduces geographic and operational dependencies that investors should monitor closely.

What we're watching

Clinical Validation
The full REDEEM-1 trial results will be critical to assess whether the initial 100% complete response rate can be replicated across the entire patient cohort, influencing the therapy’s potential for regulatory approval.
Partner Dynamics
Novatim's execution of the REDEEM-1 trial and other ongoing studies will be key, as Tempest’s commercial prospects outside of China are contingent on Novatim’s performance.
Competitive Landscape
The success of TPST-2003 will be weighed against the progress of other dual-targeting CAR-T therapies in development, particularly given the crowded field and increasing scrutiny of CAR-T safety and efficacy.

Tempest CAR-T Manufacturing Milestone Paves Way for Pivotal Trial

Event summary

  • Tempest Therapeutics received lentiviral vector delivery from Cincinnati Children’s Applied Gene and Cell Therapy Center, a key component for TPST-2003 manufacturing.
  • The milestone supports the initiation of a potentially registrational study for TPST-2003 in rrMM by Q4 2026.
  • Interim data from the REDEEM-1 trial showed 100% complete response in six evaluable patients, with a median PFS of 23.1 months.
  • Tempest has accumulated data from 36 patients, representing one of the largest datasets for a dual-targeting CD19/BCMA CAR-T therapy.

The big picture

Tempest's progress with TPST-2003 highlights the continued innovation in CAR-T therapies, particularly the move towards dual-targeting approaches to overcome resistance and improve efficacy in relapsed/refractory multiple myeloma. The reliance on contract manufacturing organizations (CMOs) like AGCTC underscores the capital-intensive nature of cell therapy development and the importance of these partnerships for clinical advancement. The 100% complete response rate, while promising, needs to be validated in a larger, pivotal trial to confirm the therapy's clinical benefit and commercial viability.

What we're watching

Clinical Efficacy
The upcoming presentation of REDEEM-1 and IIT data will be critical in validating the observed complete response rates and assessing the therapy’s long-term durability, particularly in patients with extramedullary disease.
Manufacturing Scale
The ability of Cincinnati Children’s AGCTC to consistently manufacture TPST-2003 lentiviral vector at the scale required for a pivotal trial will be a key determinant of the trial’s timeline and success.
Regulatory Pathway
The FDA’s assessment of the TPST-2003 data and the proposed trial design will influence the likelihood of accelerated approval and the overall commercial potential of the therapy.

Tempest Bolsters China Strategy with Business Development Hire

Event summary

  • Tempest Therapeutics appointed Andrew Fang, Ph.D., as Head of Business Development, effective immediately.
  • Fang’s mandate includes leading China outreach and cross-border partnership efforts, particularly for amezalpat.
  • Amezalpat, Tempest’s Phase 3-ready small molecule program for hepatocellular carcinoma (HCC), has already received clearance for a pivotal trial in China.
  • Fang previously served as a Founding Partner and Principal at YQ Advisors, specializing in biotech transactions and licensing.

The big picture

Tempest’s strategic shift towards prioritizing business development, particularly in China, reflects the increasing importance of partnerships for biotech companies seeking to accelerate drug development and expand market access. The move signals a recognition that navigating the Chinese regulatory landscape and securing local partnerships is crucial for commercial success, especially for programs like amezalpat targeting HCC, a significant unmet medical need.

What we're watching

China Market
The success of Fang's China outreach will hinge on navigating regulatory complexities and establishing relationships with local partners, potentially impacting amezalpat’s commercial prospects in a significant market.
Partnership Dynamics
Tempest’s ability to secure a partner for amezalpat will be a key indicator of the program’s perceived value and the company’s negotiating leverage, given the Phase 3-ready status.
CAR-T Portfolio
The integration of Fang's expertise into Tempest’s broader CAR-T portfolio development will determine if the company can accelerate its pipeline beyond amezalpat and capitalize on the growing cell therapy market.

Tempest Therapeutics Acquires CAR-T Assets, Burns Cash Amid Leadership Shift

Event summary

  • Tempest Therapeutics (TPST) acquired a portfolio of dual-targeting CAR-T assets from Factor Bioscience in an all-stock transaction.
  • Matt Angel, Ph.D., has been appointed CEO & President of Tempest Therapeutics.
  • Interim data from the REDEEM-1 Phase 1/2a trial of TPST-2003 in relapsed/refractory multiple myeloma (rrMM) showed a 100% complete response rate among six evaluable patients.
  • Tempest ended 2025 with $7.7 million in cash, a significant decrease from $30.3 million in 2024, funded by ~$8.5 million in registered direct offerings.
  • Tempest received clearance to proceed with a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China.

The big picture

Tempest's acquisition of Factor Bioscience's CAR-T assets represents a bet on next-generation therapies in a crowded and competitive oncology market. The company's rapid cash depletion, however, raises concerns about its long-term financial stability and reliance on dilutive financing. The appointment of a new CEO signals a potential shift in strategy, but execution risks remain significant given the company's current financial position.

What we're watching

Clinical Efficacy
The sustainability of the 100% complete response rate observed in the REDEEM-1 trial will be critical to TPST-2003’s commercial viability, and the upcoming Phase 2b trial will be a key inflection point.
Capital Needs
Given the substantial cash burn and reliance on equity offerings, Tempest’s ability to secure additional funding will dictate its operational runway and pipeline advancement.
Integration Risk
The integration of the acquired CAR-T assets and the leadership transition under Matt Angel could impact the company’s strategic direction and execution capabilities.

Tempest Therapeutics Secures $6 Million Private Placement

Event summary

  • Tempest Therapeutics is raising up to $6 million via a private placement of 925,927 shares and accompanying warrants.
  • The offering price is $2.16 per share, with warrants providing potential for an additional $4 million in proceeds.
  • H.C. Wainwright & Co. is acting as the exclusive placement agent.
  • Proceeds will be used for working capital and general corporate purposes.
  • The placement is expected to close on March 23, 2026, pending shareholder approval.

The big picture

This private placement underscores the continued need for capital within the CAR-T cell therapy space, where clinical development costs are substantial. While the $6 million injection provides near-term runway, the reliance on warrants and a resale registration suggests a strategy to manage dilution and potentially unlock further value. The involvement of H.C. Wainwright & Co. indicates a focus on reaching a specific investor base, likely those familiar with biotech and willing to accept the risks associated with early-stage clinical development.

What we're watching

Capital Needs
The reliance on private placements suggests ongoing capital needs beyond current burn rates, potentially indicating challenges in securing larger public offerings or partnerships.
Warrant Exercise
The significant potential additional proceeds from warrant exercise hinges on future stock performance and investor confidence, which could dilute existing shareholders if not fully realized.
Resale Registration
The timeline for the resale registration statement’s effectiveness will be critical, as it dictates when investors can freely trade the newly issued shares, impacting liquidity and potential price volatility.

Tempest Outsources Manufacturing for Key CAR-T Candidate Ahead of 2026 Trial

Event summary

  • Tempest Therapeutics has selected Cincinnati Children’s Applied Gene and Cell Therapy Center (AGCTC) as a contract development and manufacturing organization (CDMO) for TPST-2003, its dual-targeting CAR-T therapy.
  • The agreement focuses on technology transfer and IND-enabling manufacturing, with most activities planned for completion by Q3 2026.
  • Interim Phase 1/2a data showed 100% complete response (CR) in six evaluable patients, accelerating the development timeline.
  • Tempest intends to file an Investigational New Drug (IND) application in Q4 2026, targeting a U.S. registrational study in 2026.
  • TPST-2003 is being developed in China by Novatim, with Tempest holding exclusive rights outside of China, India, Turkey, and Russia.

The big picture

Tempest's reliance on a CDMO for critical manufacturing steps is a common strategy for biotech firms lacking in-house capabilities, but introduces external dependencies and potential delays. The accelerated timeline and promising early data position TPST-2003 as a potential competitor in the crowded multiple myeloma CAR-T landscape, where existing therapies have already generated billions in revenue. The partnership with AGCTC, a recognized leader in CGT CDMO services, suggests Tempest is prioritizing speed and expertise in preparation for a competitive market.

What we're watching

Execution Risk
The success of TPST-2003 hinges on AGCTC’s ability to efficiently execute the technology transfer and manufacturing processes within the aggressive Q3 2026 timeline, which could impact the IND filing and subsequent trial initiation.
Clinical Data
The upcoming presentation of REDEEM-1 trial data will be critical in validating the interim results and influencing investor sentiment regarding TPST-2003’s efficacy and potential.
Regulatory Pathway
The FDA’s receptiveness to a dual-targeting CAR-T approach, particularly given the complexity of manufacturing and potential safety concerns, will significantly shape the trajectory of TPST-2003’s development.

Tempest CAR-T Trial Data Bolsters 2026 Registrational Study Plans

Event summary

  • Interim results from Tempest's REDEEM-1 Phase 1/2a trial of TPST-2003 showed a 100% complete response (CR) rate among six evaluable patients.
  • A prior investigator-initiated trial (IIT) demonstrated a median progression-free survival (PFS) of 23.1 months, including patients with extramedullary disease.
  • 36 patients with relapsed/refractory multiple myeloma (rrMM) have been treated across two studies as of February 25, 2026.
  • Tempest plans to submit a U.S. Investigational New Drug (IND) application and initiate a registrational study in 2026, contingent on clearance.

The big picture

Tempest's early data for TPST-2003 represents a potentially significant advancement in CAR-T therapy for relapsed/refractory multiple myeloma, a market with a substantial unmet need and significant commercial potential. The dual-targeting approach aims to address a key limitation of current therapies – antigen escape – and could position TPST-2003 as a best-in-class option. However, the success hinges on replicating these initial findings in larger trials and securing regulatory approval, a process that carries inherent risks and timelines.

What we're watching

Regulatory Pathway
The FDA’s response to Tempest’s planned IND submission will be critical, as it will dictate the timeline and potential design of the registrational study and influence investor sentiment.
Data Replication
Whether the observed efficacy and safety profile can be consistently replicated across the remaining patients in the REDEEM-1 trial and in a larger, controlled registrational study will be key to validating TPST-2003’s potential.
Competitive Landscape
The success of TPST-2003 will depend on its ability to demonstrate a meaningful advantage over existing CAR-T therapies, particularly in terms of durability of response and safety profile, given the increasing competition in the rrMM treatment space.

Tempest Shifts CAR-T Strategy to Partner Funding, Expands Pipeline

Event summary

  • Tempest Therapeutics recently completed a strategic transaction involving CAR-T assets.
  • The company is prioritizing development of TPST-2003, a dual-targeting CD19/BCMA CAR-T, with Phase 2b clinical trial initiation planned by end-2026.
  • Tempest is expanding its pipeline with TPST-4003, an in vivo CAR-T program, and pursuing business development for its Phase 3-ready HCC drug, amezalpat.
  • The development strategy emphasizes partner-funded and externally supported programs to conserve internal capital.

The big picture

Tempest's shift towards a partner-funded development model reflects a broader trend in the biotech sector, where companies are increasingly relying on external capital to advance pipelines and manage risk. This strategy allows Tempest to pursue a diversified portfolio of CAR-T therapies, including next-generation modalities, while mitigating the financial burden of clinical development. The company's focus on China for TPST-2003 highlights the growing importance of the Chinese market for global biotech firms.

What we're watching

Financial Health
The success of Tempest’s capital-efficient strategy hinges on securing consistent external funding for its programs, particularly given the ongoing need for substantial investment in clinical trials.
Regulatory Risk
The anticipated Phase 2b trial in China for TPST-2003 carries regulatory risk, as approval timelines and data requirements in China can be unpredictable.
Execution Risk
The transition to in vivo CAR-T development with TPST-4003 presents execution risk, as this is a relatively novel approach with potential manufacturing and delivery challenges.

Tempest Acquires Dual-Targeting CAR-T Assets, Appoints New CEO

Event summary

  • Tempest Therapeutics completed an all-stock acquisition of dual-targeting CAR-T assets from Factor Bioscience.
  • The acquisition extends Tempest’s operational runway to mid-2027 and includes TPST-2003, a clinical-stage CD-19/BCMA CAR-T.
  • Matt Angel, Ph.D., has been appointed as Tempest’s new President and CEO.
  • Amezalpat (TPST-1120) remains Phase 3 ready for HCC, with plans for business development discussions.
  • Development activities for TPST-2003 in China will be funded by a strategic partner.

The big picture

The acquisition signals Tempest’s strategic pivot towards cell therapies, a rapidly growing but capital-intensive segment of the oncology market. The all-stock deal and partner funding suggest a focus on de-risking development and conserving cash, reflecting broader investor caution in the biotech sector. The appointment of a new CEO indicates a desire to accelerate the company’s transformation and potentially attract new investment.

What we're watching

Execution Risk
The success of TPST-2003 hinges on the strategic partner’s commitment and ability to navigate the Chinese regulatory landscape, which could introduce delays or unexpected hurdles.
Governance Dynamics
The transition to a new CEO and board changes could impact strategic direction and operational efficiency, particularly as Tempest balances legacy small molecule programs with the new cell therapy assets.
Regulatory Headwinds
The probability of success for TPST-2003 will be heavily influenced by the data generated in the planned China BLA, and any setbacks there could significantly impact investor sentiment and future development plans.

Tempest to Distribute Warrants as Part of Asset Purchase

Event summary

  • Tempest Therapeutics plans to distribute warrants to existing stockholders as a dividend, linked to a previously announced Asset Purchase Agreement.
  • The record date for warrant eligibility is January 30, 2026, with distribution expected around February 3, 2026, contingent on closing conditions.
  • Stockholder approval (Proposal 5) is required for the distribution, necessitating a positive vote on a proxy statement filed December 31, 2025.
  • Each share of common stock held as of the record date will receive one warrant, exercisable at $18.48 per share, expiring five years after distribution.

The big picture

This warrant distribution appears to be a component of a larger strategic move involving the Asset Purchase Agreement with Erigen LLC and Factor Bioscience Inc., likely aimed at expanding Tempest's therapeutic pipeline. The structure, using warrants as a dividend, suggests a desire to incentivize existing shareholders while potentially managing the immediate cash impact of the acquisition. The need for stockholder approval highlights the importance of maintaining investor alignment in the execution of this strategy.

What we're watching

Governance Dynamics
The outcome of Proposal 5 is critical; a failure to secure stockholder approval will delay or potentially derail the warrant distribution and associated asset purchase.
Registration Risk
The timing and success of the Registration Statement filing will dictate when warrant holders can actually exercise their options, impacting the perceived value of the dividend.
Market Sentiment
The warrant exercise price of $18.48 will be a key indicator of investor confidence in Tempest's pipeline and future prospects, and whether the warrants will be viewed as a valuable asset.
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