Tempest Therapeutics, Inc. (TPST): ANSOFF MATRIX [Dec-2025 Updated]

You're looking at Tempest Therapeutics, Inc.'s next moves, and frankly, the strategy map is dense, showing clear paths from near-term execution to big swings. As someone who's watched companies like this for two decades, I see a clear near-term focus: driving amezalpat through its pivotal Phase 3 HCC trial with Roche, while simultaneously prepping for a global launch-that's pure Market Penetration. But the real action is balancing that with developing TPST-1495 for FAP (data coming in 2026) and exploring diversification, like integrating that new CAR-T platform into autoimmune work, all while managing the cash runway which stood at $7.5 million in Q3 2025; they are defintely planning for multiple horizons here. This matrix shows you exactly where they plan to win now and where they are placing bets for the future, so let's break down the concrete actions for each quadrant below.

Tempest Therapeutics, Inc. (TPST) - Ansoff Matrix: Market Penetration

You're looking at how Tempest Therapeutics, Inc. plans to capture more of the existing Hepatocellular Carcinoma (HCC) market with amezalpat (TPST-1120). This is about maximizing the reach and adoption of their lead asset right now, which means pushing hard on the clinical and regulatory fronts.

The foundation for market penetration rests on finalizing the pivotal trial setup. Tempest Therapeutics executed an agreement with Roche on October 10, 2024, to advance amezalpat in combination with atezolizumab and bevacizumab into a Phase 3 trial for first-line HCC. This planned Phase 3 study, designated TPST-1120-301 (NCT06680258), is structured as a global, blinded, 1:1 randomized study. The study is scheduled to start in Q1 2025. A key detail for expediting market entry is the FDA agreement on a statistical plan that includes a pre-specified early efficacy analysis, which management estimates could shorten the timeline to primary analysis by 8 months.

Regulatory momentum is being used to speed up US market access. Tempest Therapeutics secured two key designations for amezalpat:

• Orphan Drug Designation (ODD) granted in January 2025.
• Fast Track Designation (FTD) granted on February 10, 2025.

To target specific high-value segments within the HCC market, the company is leveraging strong data from a specific sub-population. In patients with $\beta$-catenin activating mutations, which represented 21% of the study population (n=7), the results showed:

Preparing for a global commercial rollout means securing access across major territories. Tempest Therapeutics announced on June 30, 2025, that it received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal trial for amezalpat in first-line HCC. This clearance is a direct step toward global market penetration.

Physician education and marketing materials are being built around the demonstrated clinical superiority from the Phase 1b/2 study. The data package highlights a significant survival benefit when amezalpat is added to the standard of care (atezolizumab and bevacizumab):

• Median Overall Survival (OS) improvement: 6 months.
• Median OS: 21 months (amezalpat arm) versus 15 months (control arm) at the February 14, 2024, cutoff.
• Hazard Ratio (HR) favoring amezalpat arm: 0.65.
• Overall Confirmed ORR: 30% (amezalpat arm) versus 13.3% (control arm).
• Confirmed ORR in PD-L1 negative tumors: 27% versus 7% in the control arm.

The financial reality of advancing this strategy is tight. For the nine months ended September 30, 2025, Tempest Therapeutics reported a net loss of $22.24 million. The company ended Q3 2025 with $7.5 million in cash and cash equivalents, a significant drop from $30.3 million on December 31, 2024. Research and development expenses for the third quarter of 2025 were only $0.6 million, down from $7.6 million in the same period last year, reflecting a strategic re-prioritization. Finance: draft 13-week cash view by Friday.

Tempest Therapeutics, Inc. (TPST) - Ansoff Matrix: Market Development

You're looking at how Tempest Therapeutics, Inc. can take its existing assets into new markets or indications, which is the core of Market Development in the Ansoff Matrix. Given the current financial runway, action here needs to be efficient.

For amezalpat (TPST-1120), the path to new markets beyond Hepatocellular Carcinoma (HCC) is supported by earlier data. Phase 1 clinical trial results showed clinical activity, including tumor shrinkage, in heavily pretreated advanced solid tumors, specifically mentioning renal cell carcinoma and cholangiocarcinoma. This suggests a direct path to initiate trials in these new, PPAR$\alpha$-high cancer markets.

Regarding TPST-1495, the development for Familial Adenomatous Polyposis (FAP) is moving forward with existing infrastructure. The Phase 2 study, conducted under the National Cancer Institute (NCI) Cancer Prevention Clinical Trials Network, is scheduled to begin in 2025, with data readouts anticipated in 2026. While TPST-1495 has Orphan Drug Designation (ODD) from the FDA for FAP, amezalpat has its own EMA ODD for HCC, which speaks to the broader European regulatory receptiveness for the pipeline assets.

Securing a regional licensing partner in Asia is a critical action, especially when you look at the capital situation. Tempest Therapeutics, Inc. received approval from the National Medical Products Administration (NMPA) in China on June 30, 2025, to proceed with the registration-directed, pivotal TPST-1120-301 study for first-line HCC. This clearance is the leverage point for a deal, as it de-risks the asset in a high-prevalence market. Honestly, the urgency is clear when you see the cash position.

Here's a quick look at the financial context as of the third quarter of 2025:

The reduction in cash from $30.3 million at the end of 2024 to $7.5 million by September 30, 2025, driven by cash used in operating activities of $23.2 million year-to-date, means external resources are essential to fund these market expansions.

The Market Development strategy centers on these key activities:

• Initiate amezalpat (TPST-1120) trials in Renal Cell Carcinoma based on Phase 1 signals.
• Expand TPST-1495 FAP trial footprint, leveraging FDA ODD and the planned 2025 start.
• Target new solid tumor ISTs for TPST-1120 outside of HCC.
• Finalize a regional licensing agreement in Asia, using the June 30, 2025, NMPA clearance for the China pivotal trial as primary negotiation currency.

Finance: draft 13-week cash view by Friday.

Tempest Therapeutics, Inc. (TPST) - Ansoff Matrix: Product Development

You're looking at the core of Tempest Therapeutics, Inc.'s (TPST) near-term growth strategy-the product development pipeline. This is where the capital investment translates into potential clinical milestones, so the numbers here are what really matter for valuation.

Advancing TPST-1495 in Familial Adenomatous Polyposis (FAP)

The focus for TPST-1495, which is a first-in-class oral EP2/4 dual antagonist, is the Phase 2 trial for Familial Adenomatous Polyposis (FAP). This indication received Orphan Drug Designation from the FDA. The trial is set to begin in 2025, specifically with data expected in 2026. The study is being conducted by the Cancer Prevention Clinical Trials Network and is funded by the National Cancer Institute (NCI) Division of Cancer Prevention. FAP itself affects approximately 1 in 5,000 to 10,000 individuals in the US, highlighting a significant unmet need where the standard of care involves surgical removal of the colon. The planned Phase 2 study will evaluate the efficacy and safety in patients who have previously undergone colectomy, with a primary efficacy objective to assess the activity in reducing duodenal polyp burden. The trial is noted to involve approximately 38 pts, with a primary completion date estimated for Dec 2026.

Here's a quick look at the FAP trial specifics:

Prioritizing the Acquired Dual-Targeting CAR-T Program (TPST-2003)

Tempest Therapeutics is moving to prioritize the development of TPST-2003, a dual CD19/BCMA CAR-T program acquired from Factor Bioscience Inc. in an all-stock transaction expected to close in early 2026. This acquisition is key because it extends the Company's cash runway to mid 2027. TPST-2003 is specifically designed to target patients with extramedullary disease (EMD). The development timeline is quite specific for the initial indication:

• Phase 1 complete in patients with relapsed multiple myeloma ("rrMM"), with data expected in 2026.
• A Biologics License Application ("BLA") in China is planned for 2027 for rrMM.
• Phase 1 is currently enrolling patients with POEMs syndrome, with data anticipated in 2027.
• Tempest will hold global rights outside of China, India, Turkey and Russia.
• A potential registrational study in rrMM in the U.S. is planned to start in 2027.

Exploring Combination Studies for TPST-1495

While the FAP trial is the immediate focus, the small molecule platform's history shows an exploration of combination use for TPST-1495 in solid tumors. Preclinical data supported the drug's ability to cause tumor shrinkage and prolonged disease control when used in combination with pembrolizumab. This was evaluated in a first-in-human Phase 1a/1b study (NCT04344795) designed to determine the maximum tolerated dose (MTD), safety, and preliminary anti-tumor activity in subjects with advanced solid tumors.

Leveraging the Small Molecule Platform for Next-Generation Antagonists

The small molecule platform is leveraged through Amezalpat (TPST-1120), which is a first-in-class oral, selective PPAR$\alpha$ antagonist. This asset is advancing toward a pivotal Phase III study in first-line hepatocellular carcinoma (HCC) in combination with atezolizumab and bevacizumab. The data from the ongoing global Phase Ib/II study showed a six-month improvement in median overall survival (OS) versus standard of care alone. The primary completion estimate for this pivotal Phase III study is Mar 2028. This data provides a concrete example of the platform's potential to generate differentiated clinical outcomes, which is the basis for identifying next-generation candidates.

Tempest Therapeutics, Inc. (TPST) - Ansoff Matrix: Diversification

You're looking at how Tempest Therapeutics, Inc. is moving beyond its core focus to secure its future, especially given the current financial footing.

Tempest Therapeutics, Inc. ended the third quarter of 2025 with $7.5 million in cash and cash equivalents. This figure is a significant decrease from the $30.3 million reported on December 31, 2024. The company is actively continuing its strategic alternatives process to maximize stockholder value.

To address the cash position and gain immediate product revenue potential, Tempest entered into definitive agreements for an all-stock transaction to acquire certain dual-targeting chimeric antigen receptor (CAR)-T programs from Factor Bioscience Inc. This transaction is designed to extend the Company's runway to mid-2027. The deal structure involves issuing 8,268,495 shares of common stock to an affiliate of Factor, which equals 65% of the outstanding shares as of November 19, 2025. Existing Tempest stockholders will receive one common stock warrant for every share held, with an initial exercise price of $18.48.

The integration of the Factor Bioscience CAR-T platform centers on the clinical-stage candidate TPST-2003, a dual CD19/BCMA CAR-T program. This asset is being integrated into a new therapeutic focus on extramedullary disease (EMD), which is an aggressive form of multiple myeloma where tumors form outside the bone marrow. Furthermore, the dual CAR-T is being tested in an early clinical trial for POEMs syndrome, a rare blood disorder.

The development plan for the acquired CAR-T programs specifically targets these distinct market segments with clear timelines.

• Phase 1 data in patients with relapsed multiple myeloma (rrMM) is expected in 2026.
• A Biologics License Application (BLA) in China for rrMM is planned for 2027.
• Data from the Phase 1 trial in POEMs syndrome is slated for 2027.
• A BLA in China for the POEMs indication is expected in 2028.
• Tempest plans to pursue a potentially registrational study in rrMM in the U.S. starting in 2027.

The investment commitment from Factor, combined with existing cash at closing, is expected to support planned operations to mid-2027, covering key development and data milestones in 2026 and 2027. This directly addresses the need to cover operations beyond the current cash runway. The plan to advance amezalpat (TPST-1120) in first-line hepatocellular carcinoma (HCC) is explicitly stated to be subject to securing additional resources or partnerships. This dependency highlights the need for external funding or strategic deals to advance non-acquired, core pipeline assets, which serves a similar function to exploring out-licensing for immediate, non-core revenue generation against the Q3 2025 cash balance of $7.5 million.

The transaction also brings in additional preclinical assets for continued development, including:

The company is also advancing TPST-1495 into a Phase 2 trial for familial adenomatous polyposis (FAP), which is expected to start near term.