Tempest Therapeutics, Inc.
Tempest Therapeutics, Inc. is a U.S.-based clinical-stage biopharmaceutical company focused on developing small-molecule oncology and immunotherapy product candidates. Its pipeline includes TPST-1495 and amezalpat, which are being advanced through preclinical and clinical development for cancer-related indications.
Fiscal year 2025 · change from previous year
Development 2020–2025
Business
Share of revenueSmall-molecule drug candidates being developed for cancer and related indications.
Discovery and early-stage research activities supporting future therapeutic candidates.
Internal and outsourced trial execution, regulatory support, and development operations.
Potential out-licensing or collaboration structures for pipeline commercialization.
Customers
Tempest does not currently sell commercial products, so its direct customers are not traditional end-market buyers. Its future customer base would consist of patients treated through oncologists and hospitals, with commercialization likely dependent on third-party partners, distributors, or alliance collaborators. In the near term, the company’s counterparties are research organizations, CROs, CMOs, and potential strategic partners that support development and eventual market access.
Patients with cancer indications who would receive approved therapies through healthcare providers.
Oncologists, hospitals, and treatment centers that would prescribe and administer products.
Biopharma partners that may license, co-develop, or commercialize pipeline assets.
Contract research and manufacturing providers used for trials, testing, and supply.
Strategy
Tempest’s strategy is to advance TPST-1495 in a Phase 2 study and continue developing its clinical-stage pipeline. The company is also evaluating strategic alternatives and partnering opportunities to extend financial resources, add development expertise, and broaden geographic reach for commercialization.
Clinical progress is the main value driver for a pre-revenue biotech company.
Partnerships, licensing, or transactions may provide capital and development support.
The company lacks internal sales and marketing infrastructure and needs third-party capabilities.
Geography
Tempest is headquartered in the United States and its development and commercialization plans are centered on U.S. regulatory pathways. The company also contemplates partnerships or commercialization arrangements outside the United States, which would broaden geographic reach if programs advance. Its operating footprint is therefore shaped more by clinical trial locations, contract manufacturing, and partner coverage than by owned manufacturing or sales infrastructure.
Risks
Tempest faces the core risks of a clinical-stage biotech: uncertain trial outcomes, regulatory approval risk, and dependence on third parties for research, manufacturing, and future commercialization. The company also has substantial going-concern and financing risk because it has no operating revenue and may need additional capital or a strategic transaction to continue operations.
- Insufficient capital to fund operationsImpact: CriticalLikelihood: High
The company has no operating revenue and expects cash to fund less than 12 months.
Exposure: Corporate liquidity and continuity of development programs
- Strategic alternatives may not produce a transactionImpact: CriticalLikelihood: High
If no transaction is completed, the company may need to raise capital or wind down.
Exposure: Enterprise value and continuation of operations
- Clinical development failureImpact: HighLikelihood: High
Drug candidates may not show sufficient efficacy or safety in trials.
Exposure - Third-party manufacturing and trial execution riskImpact: HighLikelihood: Medium
CROs and CMOs can miss deadlines, fail quality requirements, or disrupt supply.
Exposure - Reimbursement and pricing pressureImpact: MediumLikelihood: Low
Even approved therapies may face payer resistance and pricing constraints.
Exposure: Future commercial uptake and realized revenue
Accounting
Judgemental itemsClinical and manufacturing services are recognized as incurred, so timing of vendor invoices affects quarterly results.
Impact: Can cause volatility in operating expenses and accrued liabilities
Equity awards are a meaningful non-cash expense for a public biotech company.
Impact: Affects reported losses without immediate cash outflow
Office lease obligations create right-of-use assets and lease liabilities.
Impact: Affects balance sheet leverage and cash commitment disclosures
Limited cash and no operating revenue require explicit evaluation of funding sufficiency.
Impact: Influences financial statement presentation and investor risk assessment
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Last updated: 24/09/2026