# Tempest Therapeutics, Inc. > Clarifo company profile — qualitative business description generated from > the company's filings. Financial statements, charts and ratios are > available on Clarifo (https://www.clarifo.com/en/companies/Tempest Therapeutics, Inc.). ## Overview 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. ## Products & services • TPST-1495 oncology product candidate • amezalpat immunotherapy product candidate • Preclinical and clinical development programs • Regulatory and clinical trial advancement • Potential partnering and licensing of pipeline assets - **Clinical-stage oncology candidates** (100%) — Small-molecule drug candidates being developed for cancer and related indications. - **Preclinical research programs** (0%) — Discovery and early-stage research activities supporting future therapeutic candidates. - **Clinical development services** (0%) — Internal and outsourced trial execution, regulatory support, and development operations. - **Partnering and licensing opportunities** (0%) — Potential out-licensing or collaboration structures for pipeline commercialization. - TPST-1495 oncology product candidate - amezalpat immunotherapy product candidate - Preclinical and clinical development programs - Regulatory and clinical trial advancement - Potential partnering and licensing of pipeline assets ## 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. - **Future oncology patients** (primary) — Patients with cancer indications who would receive approved therapies through healthcare providers. - **Healthcare providers** (primary) — Oncologists, hospitals, and treatment centers that would prescribe and administer products. - **Strategic partners** (secondary) — Biopharma partners that may license, co-develop, or commercialize pipeline assets. - **CROs and CMOs** (secondary) — Contract research and manufacturing providers used for trials, testing, and supply. - Oncology patients, if product candidates are approved - Hospitals and cancer centers that would administer treatment - Oncologists and specialists who prescribe therapy - CROs and CMOs that support development and manufacturing - Potential alliance partners that may commercialize products ## 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. - Headquartered in the United States - U.S. regulatory pathway is central to development - Potential commercialization may extend outside the U.S. - Clinical and manufacturing work is outsourced to third parties - Geographic reach may depend on alliance partners ## 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. - **Advance TPST-1495 in clinical development** (short-term) — Clinical progress is the main value driver for a pre-revenue biotech company. - **Evaluate strategic alternatives** (short-term) — Partnerships, licensing, or transactions may provide capital and development support. - **Use external partners for development and commercialization** (medium-term) — The company lacks internal sales and marketing infrastructure and needs third-party capabilities. - Advance TPST-1495 through clinical development - Pursue strategic alternatives to maximize stockholder value - Seek partnerships to add expertise and geographic reach - Preserve capital by using third-party development capabilities - Retain ownership of pipeline rights while evaluating options ## 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 operations** [critical] — The company has no operating revenue and expects cash to fund less than 12 months. - **Strategic alternatives may not produce a transaction** [critical] — If no transaction is completed, the company may need to raise capital or wind down. - **Clinical development failure** [high] — Drug candidates may not show sufficient efficacy or safety in trials. - **Third-party manufacturing and trial execution risk** [high] — CROs and CMOs can miss deadlines, fail quality requirements, or disrupt supply. - **Reimbursement and pricing pressure** [medium] — Even approved therapies may face payer resistance and pricing constraints. - Going-concern risk and need for additional funding - Clinical trial failure or delays could halt pipeline value creation - Regulatory approval is uncertain and time-consuming - Dependence on CROs, CMOs, and partners creates execution risk - Future reimbursement and pricing pressure could limit product uptake ## Accounting Tempest’s accounting is dominated by R&D expense recognition, stock-based compensation, and estimates tied to outsourced clinical and manufacturing work. Lease obligations, accrued expenses, and going-concern disclosures are also important because the company has limited cash and material near-term obligations relative to its stage of development. - **Research and development expense accruals** — Can cause volatility in operating expenses and accrued liabilities - **Stock-based compensation** — Affects reported losses without immediate cash outflow - **Lease accounting** — Affects balance sheet leverage and cash commitment disclosures - **Going-concern assessment** — Influences financial statement presentation and investor risk assessment - R&D expense timing depends on CRO, CMO, and trial milestone activity - Stock-based compensation affects reported operating losses - Accrued expenses and payables reflect unpaid development costs - Lease accounting matters because office lease obligations are material - Going-concern disclosure is critical given limited cash resources --- *Last updated: 2026-04-29T05:03:17.402763+00:00*