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Like a **Moderna** or **BioNTech**, but focused on developing innovative small molecule therapies for cancer instead of vaccines.

An early-stage **Genentech** (now part of Roche), but specializing in precision small molecules for oncology.

An early-stage **Gilead Sciences** or **Amgen**, but entirely focused on developing new precision medicines for cancer.

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• TPST-1120: An investigational dual antagonist of peroxisome proliferator-activated receptor alpha (PPARα) and delta (PPARδ) being evaluated in a Phase 1/2 study for the treatment of various advanced solid tumors.
• TPST-1685: An investigational dual antagonist of the EP2 and EP4 receptors, which are prostaglandin E2 (PGE2) pathway targets, currently in preclinical development for solid tumors.

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Tempest Therapeutics (TPST) is a clinical-stage oncology company focused on developing novel small molecule therapeutics. As a clinical-stage company, it does not currently have commercial product sales to individuals or traditional business-to-business customers who purchase finished drugs.

The company generates its revenue primarily through research and development collaboration agreements with larger pharmaceutical companies. According to its latest SEC filings (e.g., 10-K for the fiscal year ended December 31, 2023), all of Tempest Therapeutics' revenue from collaboration agreements has been derived from its partnership with:

• Bristol Myers Squibb Company (NYSE: BMY)

This collaboration primarily involves the evaluation of Tempest's drug candidates, such as TPST-1120, in combination with Bristol Myers Squibb's own therapies, rather than traditional product sales.

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Stephen Brady, President and Chief Executive Officer

Mr. Brady joined Tempest Therapeutics in September 2019, becoming chief executive officer in June 2021, and president and chief executive officer in September 2023. Prior to Tempest, he served as executive vice president, strategy and finance at Immune Design, a biopharmaceutical company that was sold to Merck in 2019. At Immune Design, Mr. Brady was instrumental in the company's successful IPO, financings, and eventual sale, leading strategy, corporate development, finance, and investor and public relations. Before Immune Design, he held the role of vice president of corporate development at Proteolix, where he was primarily responsible for the company's business development activities and its sale to Onyx Pharmaceuticals.

Nicholas Maestas, Chief Financial Officer and Head of Corporate Strategy

Mr. Maestas is the chief financial officer and head of corporate strategy at Tempest, having joined the company as vice president, strategy and finance in July 2021. He previously served as head of FP&A and strategic finance at Alector, where he was responsible for setting the company's roadmap and building its FP&A function, as well as establishing a global collaboration with GSK. Before Alector, Mr. Maestas held responsibilities in corporate and business development, FP&A, alliance management, strategic planning, and general operations at Immune Design, where he played a key role in the company's sale to Merck in 2019.

Sam Whiting, M.D., Ph.D., Chief Medical Officer and Head of Research & Development

Dr. Whiting joined Tempest as executive vice president and chief medical officer in November 2020, expanding his role to chief medical officer and head of research & development in September 2023. Before joining Tempest, Dr. Whiting served as senior vice president of clinical development at Calithera Biosciences, a clinical-stage biotech company focused on cancer treatments. His prior experience includes serving as vice president of research and clinical development at Gradalis and working on small molecule targeted and immune-oncology agents at VentiRx Pharmaceuticals and Oncothyreon. Prior to his industry roles, Dr. Whiting held academic and clinical positions, including assistant professor of medical oncology at the University of Washington and clinical head of gastrointestinal oncology at the Seattle Cancer Care Alliance.

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1. Financial Health and Funding: Tempest Therapeutics faces significant financial challenges, characterized by a limited cash runway and a critical need for substantial additional capital to fund its clinical development programs, especially the pivotal Phase 3 trial for its lead candidate, amezalpat (TPST-1120). The company has reported ongoing operational losses and negative earnings per share. The unavailability of capital markets for financing late-stage clinical trials has led the company to explore strategic alternatives, including partnerships, licensing deals, or a potential sale, and has necessitated significant cost-cutting measures, such as a substantial workforce reduction. Without securing such a lifeline, the company faces an acute risk of a liquidity crisis.
2. Clinical Trial Success and Regulatory Approval: As a clinical-stage biotechnology company, Tempest Therapeutics' future is highly dependent on the successful outcome of its clinical trials and subsequent regulatory approvals for its drug candidates. While preliminary data for TPST-1120 in hepatocellular carcinoma (HCC) has shown promise, there is no guarantee that updated or final data from ongoing trials will remain positive or that future pivotal trials, such as the planned Phase 3 study for amezalpat, will be successful. Failure to demonstrate efficacy or safety in clinical trials, or delays and difficulties in obtaining regulatory approval, would significantly hinder the company's ability to commercialize its products.
3. Market Competition: The oncology market, particularly for therapies targeting liver cancer (HCC), is highly competitive and includes numerous established products like checkpoint inhibitors and targeted therapies. Even if Tempest Therapeutics' lead candidate, amezalpat, successfully navigates clinical development and secures regulatory approval, intense competition could limit its potential commercial success and market penetration.

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Tempest Therapeutics (TPST) is developing novel oncology therapeutics, with two main product candidates in its pipeline: Amezalpat (TPST-1120) and TPST-1495.

For Amezalpat (TPST-1120), primarily being developed for Hepatocellular Carcinoma (HCC), the addressable market size is substantial:

• The global liver cancer drug market is anticipated to reach approximately $7.6 billion by 2033.
• The Global HCC (Hepatocellular Carcinoma) Market was valued at USD 3.5 billion in 2024 and is projected to grow to USD 9.85 billion by the end of 2030, at a Compound Annual Growth Rate (CAGR) of 22.99% (global).
• Across the top 7 major markets (US, EU4, UK, and Japan), the hepatocellular carcinoma market reached a value of USD 830 million in 2024, with expectations to reach USD 1,650 million by 2035, exhibiting a CAGR of 6.49% from 2025-2035.

For TPST-1495, which is being advanced for Familial Adenomatous Polyposis (FAP) and explored for advanced endometrial cancer, the addressable markets are as follows:

• For Familial Adenomatous Polyposis (FAP), the global treatment market is projected to grow from USD 1.20 billion in 2024 to USD 1.86 billion by 2030, at a CAGR of 7.47%. Another estimate values the global FAP treatment market at USD 2.09 billion in 2024, with an expected rise to USD 6.42 billion by 2032, at a CAGR of 15.00%.
• In the 7 major FAP markets (United States, EU4, United Kingdom, and Japan), the market was valued at USD 39.9 million in 2024 and is forecast to reach USD 62.3 million by 2035, with a CAGR of 4.13% from 2025-2035.
• For advanced endometrial cancer, the global market size was estimated at USD 29.41 billion in 2024 and is projected to reach approximately USD 51.15 billion by 2034, with a CAGR of 5.69% (global). Another source indicates the global endometrial cancer treatment market reached US$9.31 billion in 2024 and is expected to reach US$17.72 billion by 2033, growing at a CAGR of 7.5%.

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Tempest Therapeutics (TPST) has several key drivers that are expected to contribute to its future revenue growth over the next two to three years:

1. Commercialization of Amezalpat (TPST-1120) for Hepatocellular Carcinoma (HCC): Tempest's lead candidate, amezalpat (TPST-1120), is progressing into pivotal Phase 3 trials for first-line hepatocellular carcinoma (HCC) in major markets, including China, the U.S., and Europe. The drug has received Orphan Drug and Fast Track designations from the U.S. FDA, as well as Orphan Drug designation from the European Medicines Agency (EMA) for HCC, which may accelerate its regulatory pathway and offer market incentives. A collaboration with Roche is supporting the advancement of amezalpat into its Phase 3 trial. Positive Phase 1b/2 study results demonstrated a six-month improvement in median overall survival when amezalpat was combined with standard-of-care therapy, indicating its potential to become a preferential first-line treatment option in a global liver cancer market projected to reach $7.6 billion by 2033.
2. Advancement and Potential Commercialization of TPST-1495 for Familial Adenomatous Polyposis (FAP): TPST-1495, a dual EP2/EP4 receptor antagonist, has received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis (FAP). A Phase 2 study for TPST-1495 in FAP is expected to commence in 2025, supported by the National Cancer Institute (NCI), representing a significant step towards potential commercialization in this rare disease.
3. Expansion of TPST-1495 into Broader Solid Tumor Indications: Beyond FAP, TPST-1495's mechanism of targeting EP2 and EP4 receptors, which are highly expressed in various malignancies, positions it for potential expansion into other solid tumor types, including colorectal and gastric cancers. Successful clinical development in these broader indications could significantly enlarge its market potential and future revenue streams.
4. Strategic Partnerships and Licensing Opportunities: Given the capital-intensive nature of drug development, Tempest Therapeutics is actively exploring strategic alternatives, including partnerships and licensing opportunities. These collaborations could provide non-dilutive funding, leverage the resources of larger pharmaceutical companies, and accelerate the development and potential commercialization of its promising oncology pipeline, thereby driving future revenue growth.

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Share Issuance

• In June 2021, Tempest Therapeutics completed a $30 million private investment in public equity (PIPE) financing concurrent with its merger with Millendo Therapeutics.
• The company announced a $15 million private placement financing in April 2022, involving the sale of common stock and pre-funded warrants to EcoR1 Capital, LLC and Versant Venture Capital.
• Tempest entered into a registered direct offering agreement in June 2025 for 739,000 shares of common stock at $6.25 per share, projected to generate approximately $4.6 million in gross proceeds.

Inbound Investments

• In June 2021, Tempest secured $30 million through a PIPE financing from a syndicate of healthcare investors including Versant Ventures, Rock Springs Capital, and F-Prime Capital.
• A private placement financing in April 2022 brought in approximately $15.0 million from EcoR1 Capital, LLC and Versant Venture Capital.
• As of April 2025, Tempest is actively exploring strategic alternatives, such as mergers, acquisitions, partnerships, joint ventures, or licensing arrangements, to secure funding for its clinical programs due to challenges in the capital markets.

Outbound Investments

• Tempest Therapeutics has not made any investments or acquisitions.

Capital Expenditures

• Capital expenditures were recorded at $3,000 for December 2024.
• Over the last 12 months (as of November 2025), capital expenditures were -$3,000.