Tempest Therapeutics, Inc. (TPST): SWOT Analysis [Nov-2025 Updated]

You're looking for a clear, unvarnished view of Tempest Therapeutics, Inc.'s position right now, and the picture is one of high-potential clinical assets running headlong into a severe capital crunch. The company's lead drug, amezalpat (TPST-1120), has compelling Phase 2 data in liver cancer, but the firm's cash balance of only $7.5 million as of September 30, 2025, means its future hinges entirely on a successful strategic transaction. Tempest posted a year-to-date net loss of $22.2 million, so this isn't a long-term problem; it's a near-term crisis where the next announcement is everything. You need to know exactly how much runway is left and what the options are, because the value here is defintely binary.

Tempest Therapeutics, Inc. (TPST) - SWOT Analysis: Strengths

You're looking for the core assets that drive Tempest Therapeutics, Inc.'s valuation, and honestly, the strength is concentrated in the clinical data and regulatory momentum of its lead program. The most compelling strength is the superior overall survival data for Amezalpat (TPST-1120) in liver cancer, which has already translated into global pivotal trial clearances in 2025.

Amezalpat (TPST-1120) showed superior median overall survival in HCC.

The Phase 1b/2 clinical data for Amezalpat (TPST-1120), a selective PPAR$\alpha$ antagonist, is the cornerstone of the company's near-term value. In the randomized cohort of first-line unresectable or metastatic Hepatocellular Carcinoma (HCC) patients, the combination therapy arm showed a significant survival advantage over the standard-of-care (SOC) combination of atezolizumab and bevacizumab alone. This isn't a small win, it's a six-month improvement in median overall survival (mOS), which is a huge deal in oncology.

Here's the quick math from the data cutoff of February 14, 2024, which underpins the 2025 regulatory progress:

The 0.65 hazard ratio (HR) is strong, showing a 35% reduction in the risk of death, and importantly, this benefit was preserved even in key sub-populations like those with PD-L1 negative disease. That kind of clinical superiority is what de-risks a program for a pivotal Phase 3 study.

Lead asset is Phase 3-ready with FDA, EMA, and China regulatory clearances.

Amezalpat's path to market is significantly streamlined because of the regulatory alignment achieved in 2024 and 2025. The company has successfully navigated the End-of-Phase 2 process, securing agreement from major global regulatory bodies on the design of its pivotal, registration-directed Phase 3 trial (TPST-1120-301, NCT06680258). The FDA gave its 'Study May Proceed' letter in November 2024, allowing the company to target a Phase 3 start in the first quarter of 2025.

This global regulatory alignment is defintely a key strength for market access and trial execution:

• U.S. FDA: Agreement on the Phase 3 study design, dose, and statistical plan was secured in August 2024.
• European Medicines Agency (EMA): Agreement was also received on the Phase 3 study design, dose, and statistical plan.
• China NMPA: Approval to proceed with the pivotal trial was granted by the National Medical Products Administration (NMPA) in June 2025, opening the door to a critical market where HCC prevalence is high.

TPST-1120 holds Fast Track and Orphan Drug designations for HCC.

The FDA has granted two key designations for Amezalpat in HCC in early 2025, which not only validates the therapy's potential but also provides significant development and commercial advantages. The regulatory body is clearly recognizing the unmet medical need here.

• Orphan Drug Designation (ODD): Granted in January 2025 for HCC, this designation provides potential benefits like tax credits for clinical testing, fee waivers, and seven years of market exclusivity upon approval.
• Fast Track Designation (FTD): Granted in February 2025, this allows for expedited development and review, which could shorten the time to a final approval decision.

NCI-funded Phase 2 trial for TPST-1495 in Familial Adenomatous Polyposis (FAP).

The second clinical program, TPST-1495 (a dual EP2/EP4 antagonist), is advancing with significant external validation and funding, which reduces the financial burn rate for this asset. The company received an FDA 'Study May Proceed' letter in March 2025 for a Phase 2 study in Familial Adenomatous Polyposis (FAP), a rare, high-risk inherited syndrome.

The trial is being run by the Cancer Prevention Clinical Trials Network and is funded by the National Cancer Institute (NCI) Division of Cancer Prevention. This NCI funding is a massive non-dilutive strength, validating the drug's mechanism in cancer prevention and conserving Tempest Therapeutics' cash, which stood at only $7.5 million as of September 30, 2025. TPST-1495 also received Orphan Drug Designation for FAP in April 2025, marking the second program in the pipeline with this valuable status.

Tempest Therapeutics, Inc. (TPST) - SWOT Analysis: Weaknesses

You have to look at Tempest Therapeutics, Inc.'s financial position right now as a significant red flag, despite the promising clinical data. The core weakness isn't the science; it's the severe liquidity constraint, which has forced the company into survival mode and halted internal development. This is a critical near-term risk that overshadows everything else.

Severe liquidity constraint with only $7.5 million cash at Q3 2025 end

Tempest ended the third quarter of 2025 with cash and cash equivalents of only $7.5 million. That's a massive drop from the $30.3 million they held at the end of December 2024. Here's the quick math: the cash used in operating activities for the nine months ended September 30, 2025, was $23.2 million, which tells you the burn rate is unsustainable without a major capital infusion. They did manage to bring in some funds through a June 2025 registered direct offering ($4.1 million) and an at-the-market (ATM) offering program ($2.8 million), but that only slightly cushioned the fall. This cash position is defintely insufficient to fund the next stage of development.

The company's cash runway is extremely short, placing immense pressure on management to secure a deal quickly. This weakens their negotiating position in any strategic alternative discussions.

Actively exploring strategic alternatives due to inability to fund pivotal Phase 3 trial

The most telling sign of financial distress is the formal announcement that Tempest is exploring a full range of strategic alternatives, including mergers, acquisitions, partnerships, or licensing arrangements. The CEO stated plainly that the capital markets have been unavailable to support the next stage of advancement for their lead asset, amezalpat (TPST-1120). This is a Phase 3-ready drug for first-line hepatocellular carcinoma (HCC), which is a huge opportunity, but they simply cannot afford the pivotal trial.

The inability to fund a Phase 3 trial internally means the company is effectively dependent on a third party to realize the value of its most promising asset. This lack of control over their own destiny is a profound weakness.

Year-to-date net loss of $22.2 million through September 30, 2025

The company continues to operate at a significant loss, posting a year-to-date net loss of $22.2 million through the first nine months of 2025. While this is an improvement from the $28.0 million loss in the same period in 2024, the reduction is a direct result of slashing R&D spending, not increased revenue. The quarterly net loss for Q3 2025 was $3.5 million. This sustained negative cash flow is the root cause of the current liquidity crisis.

Here is a snapshot of the core financial constraints based on the Q3 2025 report:

Research and development expenses sharply cut to $0.6 million in Q3 2025, halting internal progress

The most alarming financial move is the drastic reduction in research and development (R&D) expenses, which fell to just $0.6 million in Q3 2025. This is a steep decline from the $7.6 million spent in the same quarter of 2024. The $7.0 million decrease was a direct result of 're-prioritizing efforts towards exploring strategic alternatives.' In other words, they stopped spending on internal drug development to save cash.

This R&D cut means internal progress on their pipeline has essentially been paused, which is a major weakness for a clinical-stage biotech. The reduction in R&D expenses for the nine months ended September 30, 2025, was $5.6 million, which was primarily due to:

• Decreased costs from contract research and manufacturing organizations.
• A strategic shift to exploring external funding options.
• A halt to most internal, company-funded clinical and pre-clinical work.

The company is relying on collaborations, like the one with the National Cancer Institute (NCI) and the Cancer Prevention Clinical Trials Network for the TPST-1495 Phase 2 trial, to keep any pipeline momentum going. That's not a sustainable long-term model.

Tempest Therapeutics, Inc. (TPST) - SWOT Analysis: Opportunities

Secure a major partnership or acquisition for TPST-1120 to fund the pivotal trial.

You are sitting on a potential goldmine with TPST-1120, but the capital markets have been tough for funding a massive Phase 3 trial. Tempest Therapeutics' primary opportunity is to secure a major strategic partnership for amezalpat (TPST-1120) to fund the pivotal trial in first-line Hepatocellular Carcinoma (HCC). The company's cash and cash equivalents stood at only $7.5 million as of September 30, 2025, down from $30.3 million at the end of 2024, which makes a partnership a financial necessity. The FDA has already cleared the Phase 3 study design, and the company has an agreement with F. Hoffmann-La Roche Ltd. to supply atezolizumab globally for the trial, which de-risks the logistics considerably. A partnership would immediately inject the non-dilutive capital needed to start the pivotal trial, a clear action that changes the entire valuation thesis.

The six-month overall survival benefit in HCC positions TPST-1120 for blockbuster potential.

The clinical data for TPST-1120 is the company's most valuable asset, giving it a legitimate shot at blockbuster status. The randomized Phase 1b/2 study in first-line HCC showed amezalpat, when combined with atezolizumab and bevacizumab, delivered a median overall survival (OS) of 21 months, a remarkable six-month improvement over the control arm's 15 months. This six-month OS benefit is highly significant, especially since OS is the gold standard regulatory endpoint in this setting. The hazard ratio (HR) of 0.65 further reinforces the strength of the data. For context, the standard-of-care component, Tecentriq, generated sales of $2.14 billion for Roche in 2024, indicating the massive market opportunity that TPST-1120 is positioned to enter as a superior combination therapy. The drug also holds both Orphan Drug and Fast Track designations from the FDA, which are regulatory tailwinds that can accelerate approval.

Diversify pipeline by integrating the acquired dual-targeting CAR-T programs (TPST-2003).

The recent acquisition of dual-targeting chimeric antigen receptor T-cell (CAR-T) programs from Factor Bioscience Inc., including TPST-2003, is a smart move to diversify the pipeline beyond small molecules. This transaction, expected to close in early 2026, is a key opportunity to expand the therapeutic focus into cell therapy. TPST-2003 is a clinical-stage CD19/BCMA dual-CAR T program designed to target patients with extramedullary disease (EMD) in relapsed multiple myeloma (rrMM). This acquisition, structured as an all-stock deal involving the issuance of 8,268,495 shares, not only expands the pipeline but, along with an investment commitment, is projected to extend the company's operational runway to mid-2027. That's a defintely critical runway extension.

Here's the quick math on the pipeline expansion:

TPST-1495 Phase 2 data in FAP, expected in 2026, could create a new value inflection point.

The TPST-1495 program offers a significant, non-oncology-focused value inflection point. TPST-1495 is a dual EP2/EP4 antagonist, and the Phase 2 trial for Familial Adenomatous Polyposis (FAP) is an important opportunity. This trial is being conducted in collaboration with the Cancer Prevention Clinical Trials Network and is funded by the National Cancer Institute (NCI) Division of Cancer Prevention, which is a major benefit as it reduces Tempest's cash burn on this asset. FAP is a rare, inherited syndrome with no approved medical therapies, affecting approximately 1 in 5,000 to 10,000 individuals in the US. Positive data, expected in 2026, demonstrating a reduction in duodenal polyp burden after 6 months of treatment, could validate the drug's mechanism for cancer prevention. The Orphan Drug Designation already secured for TPST-1495 provides a potential seven years of market exclusivity upon approval, making this a high-value, unmet-need market.

Tempest Therapeutics, Inc. (TPST) - SWOT Analysis: Threats

Failure of the strategic alternatives process could force a major program halt or wind-down.

You're watching a biotech company with a clinical-stage pipeline, so you know the biggest threat is always a funding cliff. Tempest Therapeutics, Inc. has been actively exploring strategic alternatives-mergers, acquisitions, or partnerships-since April 2025 to advance its programs, specifically the Phase 3-ready amezalpat (TPST-1120) for first-line Hepatocellular Carcinoma (HCC). The recent November 2025 acquisition of dual-CAR T programs from Factor Bioscience, Inc. is a partial solution, projected to extend the cash runway to mid-2027. But this deal does not fully fund the pivotal Phase 3 trial for amezalpat, which is the company's most valuable near-term asset. Honestly, the core threat remains: without a major partnership or additional financing for amezalpat's costly pivotal study, that program could still be halted or deprioritized, which would defintely crush shareholder value.

High cash burn rate, with $23.2 million used in operations in the first nine months of 2025.

The company's financial footing is precarious, even with the recent runway extension. Cash used in operating activities for the nine months ended September 30, 2025, hit $23.2 million. That's a high burn for a company that ended Q3 2025 with only $7.5 million in cash and cash equivalents. Here's the quick math: the company burned through $23.2 million in nine months, so that $7.5 million cash balance is a very short runway without the new acquisition's cash component. While the Factor Bioscience deal provides a bridge to mid-2027, this is a temporary fix, not a sustainable revenue stream. The company must execute a value-maximizing partnership before that new runway ends.

Competitors could advance similar mechanisms or superior HCC treatments faster.

Amezalpat (TPST-1120) is a first-in-class PPAR$\alpha$ antagonist, and its Phase 1b/2 data showing a median Overall Survival (OS) of 21 months against the 15 months for the standard of care (SOC) is compelling. But the HCC landscape is fiercely competitive and constantly evolving. The current SOC is the combination of Atezolizumab (Tecentriq) plus Bevacizumab (Avastin), and other major players are already launched or advancing their own novel regimens.

Key competitive threats include:

• AstraZeneca's Imfinzi (durvalumab) + Imjudo (tremelimumab): An approved ICI doublet already competing in the first-line setting.
• Lenvatinib: An approved multi-kinase inhibitor that remains a first-line option.
• NiKang Therapeutics' NKT2152: A novel HIF2$\alpha$ inhibitor in a randomized Phase 1b/II study for first-line HCC.
• Bayer's 225Ac-GPC3 (BAY 3547926): A targeted alpha radiopharmaceutical in Phase 1 for advanced HCC, representing a different modality.

The risk is that while Tempest Therapeutics, Inc. is scrambling for financing to start its Phase 3 trial, a well-capitalized competitor could release superior or equally compelling Phase 3 data, effectively closing the window for amezalpat to become the new SOC.

Near-term shareholder value is defintely binary, tied to a single transaction outcome.

The stock's value is now tied to a dual binary outcome, not a single one. First, the successful closing of the Factor Bioscience acquisition is crucial, as it provides the mid-2027 cash runway extension. Second, securing a partnership or major financing for the pivotal Phase 3 trial of amezalpat (TPST-1120) is the only path to realizing the drug's potential value. If either of these events fails to materialize, the stock price will suffer a severe correction. It is a high-risk, high-reward situation.

Action: Watch for an announcement on the amezalpat partnering/financing-that is the only thing that matters right now for the core asset's future.