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Tempest Therapeutics’ Business Model, Simplified for Investors
Unlock the strategic blueprint behind Tempest Therapeutics, Inc.’s business model. This concise Business Model Canvas highlights how the company creates value, builds partnerships, and navigates a highly competitive biotech market. Perfect for investors, analysts, and founders who want actionable insight—get the full version for the complete picture.
Partnerships
CROs and trial sites
Tempest Therapeutics, Inc. relies on CROs and oncology trial sites to run its Phase 1 work, where partners handle patient screening, dosing, safety follow-up, and data capture. These sites are key to moving Tempest’s two lead programs, TPST-1495 and TPST-1120, through early testing fast and cleanly.
CMOs and API suppliers
Tempest Therapeutics, Inc. relies on CMOs and API suppliers because its clinical-stage small-molecule programs need outside capacity for drug substance and drug product supply. These partners handle chemistry, scale-up, testing, and batch release, which keeps ongoing trials supplied without Tempest building full manufacturing plants.
Oncology investigators
Oncology investigators are key for Tempest Therapeutics, Inc. because specialist physicians and principal investigators enroll solid-tumor patients, run protocol steps, and give clinical readouts that shape dose and safety calls in first-in-human studies. Their input is especially critical when only a small number of early-stage patients can define a program’s next move.
Academic biomarker labs
Academic biomarker labs help Tempest Therapeutics link TREX1 and prostaglandin signaling to real patient biology. They support biomarker discovery, sample analysis, and immune-response work, which is key in oncology programs where Tempest tracks one clinical readout per mechanism in early development.
- Biomarker discovery
- Sample analysis
- Immune-response readouts
- Mechanism-to-clinic linkage
Regulatory and IP advisers
Tempest Therapeutics, Inc. relies on regulatory and IP advisers because clinical work lives or dies on IND filings, ethics approvals, and patent scope. In the U.S., an IND can move forward after a 30-day FDA review window, and core patent life is 20 years from filing, so tight legal and regulatory support helps keep trials compliant and assets protected.
- INDs need fast, accurate filings.
- Ethics submissions reduce trial risk.
- Patents protect value and partnering power.
These advisers also help with lifecycle planning, so Tempest can defend data, manage amendments, and avoid gaps that can slow a study or weaken exclusivity.
Tempest’s Trial Progress Relies on Key Outsourced Partners
Tempest Therapeutics, Inc. depends on CROs, oncology sites, CMOs, API suppliers, and biomarker labs to keep TPST-1495 and TPST-1120 moving through early trials. These partners cover patient enrollment, safety follow-up, drug supply, and biomarker work, which matters because early solid-tumor studies often hinge on small patient counts and fast readouts.
| Partner | Role | Key data |
|---|---|---|
| CROs/sites | Phase 1 ops | 30-day IND review |
| CMOs/API | Supply | 20-year patent life |
What is included in the product
Detailed Word Document
A concise Business Model Canvas capturing Tempest Therapeutics’ oncology drug development strategy, key partners, funding needs, and value creation path.
Customizable Excel Spreadsheet
Quickly maps Tempest Therapeutics’ business model pain points in one clear, editable snapshot.
Reference Sources
Provides a traceable source trail for Tempest Therapeutics, Inc., boosting credibility and helping decision-makers verify key claims fast.
Activities
Phase 1 oncology trials
Tempest Therapeutics, Inc. is advancing first-in-human phase 1 oncology studies in solid tumors, with clinical work centered on site activation, enrollment, safety monitoring, and dose escalation. This is its main value-creation engine: in 2025, research and development spending was $36.4 million, reflecting heavy focus on clinical development.
Small-molecule discovery
Tempest Therapeutics, Inc. centers its key activities on small-molecule cancer drug discovery, using chemistry to sharpen target selectivity and improve drug-like traits such as potency and oral exposure. That matters because the company still had no product revenue in its latest annual filings, so discovery is the main engine for building new pipeline assets beyond its current programs.
Translational biomarker research
Tempest Therapeutics, Inc. uses translational biomarker research to map immune and tumor biology around EP2, EP4, PPAR alpha, and TREX-1. This work helps spot likely responders and shape combination plans, which lowers clinical risk and speeds go or no-go decisions in 2025 development programs.
CMC and manufacturing control
Tempest Therapeutics, Inc. keeps clinical drug supply in GMP-ready shape by managing formulation, stability, release testing, and vendor oversight, so trial sites get usable material and regulators get clean quality records. This work is a core CMC (chemistry, manufacturing, and controls) gate for every batch.
Key focus: vendor control, batch release, and stability tracking.
- Clinical-grade supply only
- Formulation and stability control
- Release testing before use
- Vendor oversight and audit trail
Regulatory and clinical planning
Tempest Therapeutics, Inc. uses regulatory and clinical planning to build IND packages, write clinical protocols, and keep trial work aligned with FDA rules. An IND starts a 30-day FDA review clock, so tracking safety data, protocol amendments, and adverse-event reports is critical in a setting where one missed filing can slow development.
- Prepare IND and protocol docs
- Track safety and amendments
- Meet FDA reporting deadlines
Tempest Therapeutics: 2025 Oncology R&D Fueled Early-Stage Clinical Progress
Tempest Therapeutics, Inc. key activities in 2025 were small-molecule oncology discovery, translational biomarker work, and first-in-human trial execution for solid tumors. R&D expense was $36.4 million in 2025, showing clinical development was the main use of cash. CMC, vendor control, and FDA-ready IND work kept programs trial-safe.
| Key activity | 2025 data |
|---|---|
| R&D spend | $36.4 million |
| Clinical focus | Phase 1 solid tumors |
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Resources
2 clinical candidates
Tempest Therapeutics’ key resources are its 2 clinical candidates, TPST-1495 and TPST-1120, both still in early-stage development for solid tumors. These programs anchor the pipeline’s value, and Tempest reported just 2 active clinical assets in its 2025 filings, making pipeline progress the main driver of future cash generation.
Proprietary oncology IP
Tempest Therapeutics, Inc. depends on proprietary oncology IP to protect its small-molecule programs and target biology; the Company’s latest SEC filings show its value is tied to patents, know-how, and trade secrets that block fast copycats. That IP base also strengthens future partnering and licensing talks, where stronger exclusivity can improve deal terms.
Clinical data set
Tempest Therapeutics, Inc.’s core clinical data set comes from Phase 1 readouts, where safety, pharmacokinetics, and pharmacodynamics show whether a program can move forward. As more patients and cohorts are added, this data set becomes more valuable because it sharpens dose, expansion, and partner decisions.
Scientific and management team
Tempest Therapeutics, Inc. depends on a small but senior scientific and management team to move discovery, clinical trials, regulatory work, and business development in sync. In a clinical-stage biotech, human capital is the core resource, because execution, speed, and data quality drive value more than physical assets.
- Oncology and drug-development expertise
- Coordinates trials and regulation
- Supports partnering and financing
South San Francisco base
Tempest Therapeutics, Inc. is headquartered in South San Francisco, California, which puts it in the heart of the Bay Area biotech cluster. That location supports hiring, access to specialized vendors, and faster partnering with nearby life-science firms.
- Near major biotech talent pools
- Shorter path to vendors
- Better access to partners
Tempest’s Value Hinges on Two Early-Stage Oncology Assets
Tempest Therapeutics, Inc. key resources are its 2 clinical-stage oncology assets, TPST-1495 and TPST-1120, plus the proprietary IP and early human data that support them. Its 2025 filings show a very small resource base, so scientific execution and trial data are the main value drivers. Its South San Francisco base also helps it tap Bay Area biotech talent and vendors.
| Resource | Latest data |
|---|---|
| Clinical assets | 2 |
| Stage | Early-stage solid tumors |
| HQ | South San Francisco, CA |
Value Propositions
Novel EP2 and EP4 inhibition
TPST-1495 is a dual inhibitor of 2 prostaglandin E2 receptors, EP2 and EP4, targeting a cancer pathway tied to immune suppression. That gives Tempest Therapeutics, Inc. a differentiated immuno-oncology angle in a field where PGE2 signaling is a known driver of tumor escape and resistance.
PPAR alpha blockade
TPST-1120 blocks peroxisome proliferator-activated receptor alpha (PPARα), giving Tempest Therapeutics, Inc. a second clinical mechanism with solid-tumor relevance. As one of Tempest Therapeutics, Inc.’s 2 lead oncology programs, it broadens scientific and clinical optionality and can support pipeline risk spread if the 1st asset underdelivers.
Solid-tumor focus
Tempest Therapeutics focuses on solid tumors, which account for about 90% of adult cancers and include the company’s two lead assets. That gives Tempest a clear path for development and partnering in high-unmet-need markets, where even small gains can matter.
Immune-pathway biology
Tempest Therapeutics is using immune-pathway biology to target tumor immune escape, including TREX-1, a DNA exonuclease tied to innate immune response control in cancer. The 2025 focus on this biology can support future immune-combination programs by sharpening patient selection and response signals.
- TREX-1 links to innate immunity
- May improve combo trial design
- Supports future oncology pipeline
Small-molecule modality
Tempest Therapeutics focuses on small molecules, not cell therapies or antibodies, so its drugs can be taken in repeat doses and made through standard chemical manufacturing. That fit can also make combo regimens easier to design; for example, the company reported $16.5 million in cash and equivalents at Dec. 31, 2025.
- Repeat dosing is practical
- Standard manufacturing lowers complexity
- Small molecules fit combinations
Tempest’s Two-Drug Solid Tumor Bet Targets a Big Unmet Need
Tempest Therapeutics, Inc. offers a focused solid-tumor pipeline built on small-molecule immuno-oncology, led by TPST-1495 (EP2/EP4) and TPST-1120 (PPARα), aimed at tumor immune escape and combination use. That mix gives the Company differentiated biology, oral dosing flexibility, and a clear fit in high-unmet-need cancers.
| 2025 data | Value |
|---|---|
| Cash and equivalents | $16.5 million |
| Lead clinical assets | 2 |
| Target area | Solid tumors |
Customer Relationships
Site-led trial execution
Tempest Therapeutics, Inc. keeps site-led trial execution tied to hospitals and oncology centers through hands-on protocol support, enrollment tools, and fast safety updates. In oncology, where patient recruitment can be slow and site activation often takes weeks to months, strong site ties help keep studies on track and lower the risk of missed data or delayed enrollment.
Scientific collaboration
Tempest Therapeutics, Inc. works closely with investigators and translational experts to read biomarker and efficacy signals in early oncology studies, where small cohorts can make results hard to judge. In 2025, as a clinical-stage company with no approved products, that scientific collaboration remained central to advancing its pipeline.
Partner-managed development
Tempest Therapeutics uses partner-managed development, so clinical, manufacturing, and regulatory work is run through CROs, CMOs, and specialist vendors under close oversight. That fits a lean, clinical-stage biotech with no product revenue, where cash goes to trials and pipeline work instead of building a large internal operations team.
Investor communication
Tempest Therapeutics, Inc. kept investor communication active in 2025 through earnings materials, SEC filings, and corporate updates, which helps support access to capital for a public biotech. The core touchpoints were one annual 10-K and regular 10-Q reporting, plus investor releases tied to trial and financing updates.
- 2025: 10-K plus quarterly 10-Qs
- Used earnings, SEC, and update channels
- Supports future funding access
Regulatory engagement
Tempest Therapeutics, Inc. keeps regulatory ties formal and compliance-led: filings, safety updates, and ongoing trial oversight with agencies like the FDA shape when programs can start, change, or advance. In oncology, this can affect every milestone, from protocol design to dose escalation and expansion.
- Filings drive trial permissions
- Oversight shapes protocol changes
- Timing depends on regulator review
Tempest’s 2025 lifeline: trial sites, regulators, and investors
Tempest Therapeutics, Inc. in 2025 had no approved products, so customer ties centered on oncology trial sites, investigators, CROs, regulators, and investors. Those links kept Phase 1/2 study work moving and supported financing through SEC reporting and investor updates.
| Customer group | 2025 touchpoint | Why it mattered |
|---|---|---|
| Sites | Protocol support | Enrollment and data flow |
| Investors | 10-K, 10-Q | Capital access |
Channels
Clinical trial sites
Clinical trial sites are Tempest Therapeutics, Inc.’s main channel to reach study participants, because they handle screening, consent, dosing, and follow-up. As a clinical-stage company with no product revenue, Tempest depends on these sites to generate the patient-level data that drive its pipeline and all regulatory progress.
Oncology centers
Oncology centers connect Tempest Therapeutics, Inc. to investigators and to the 2,041,910 new U.S. cancer patients projected for 2025. Specialty centers matter most for rare or complex solid tumors, where enrollment speed, protocol fit, and physician trust can decide trial success.
They also lift clinical credibility by placing Tempest Therapeutics, Inc. in high-expertise settings that handle advanced cases and biomarker-driven studies. That helps recruit the right patients faster and supports cleaner data from the start.
Scientific conferences
Tempest Therapeutics, Inc. uses scientific conferences and oncology meetings to share mechanism data and early clinical findings, which helps explain how its oncology assets work and where they may fit. These forums also support key opinion leader and partner engagement, giving Tempest direct visibility with researchers, clinicians, and potential collaborators.
SEC and investor relations
Tempest Therapeutics, Inc. uses SEC filings and investor relations to reach shareholders and the capital markets with financing updates, trial progress, and risk factors. As a public biotech, it relies on the core SEC set: 10-K, 10-Q, and 8-K, so investors can track cash runway, program milestones, and setbacks in near real time.
- 3 core SEC filing types
- Funding and cash updates
- Clinical trial and risk news
Business development outreach
Tempest Therapeutics, Inc. uses outbound business development to open direct partnering talks with pharma and biotech firms, which supports licensing and collaboration deals. As a pre-revenue oncology company, this channel matters because it can create non-dilutive value without issuing new equity; its latest annual filings show no product revenue.
- Drives licensing and co-development talks
- Targets pharma and biotech partners
- Supports non-dilutive value creation
Tempest Therapeutics Builds Growth Through Trials and Investor Updates
Tempest Therapeutics, Inc. relies on trial sites and oncology centers to enroll patients, run dosing and follow-up, and build biomarker-rich data. For market reach, it uses SEC filings, scientific conferences, and partnering talks to update investors, raise capital, and seek non-dilutive deals; it reported no product revenue in its latest annual filing.
| Channel | Role | Data point |
|---|---|---|
| Trial sites | Enroll and follow patients | 2,041,910 U.S. cancer cases projected for 2025 |
| SEC filings | Investor updates | 10-K, 10-Q, 8-K |
Customer Segments
Solid-tumor patients
Solid-tumor patients with advanced or refractory disease are Tempest Therapeutics, Inc.'s core clinical segment, and they enter through oncology trials, not commercial buying. Their response rates, progression-free survival, and safety data decide whether programs advance; in solid tumors, even a 10-20% objective response can matter in late-line settings.
Oncologists and cancer centers
Oncologists and cancer centers are Tempest Therapeutics, Inc.'s core clinical users: they treat the 20 million new cancer cases reported worldwide in 2022, so their buy-in drives adoption and trial enrollment. Their day-to-day use of clinical data, plus feedback from specialist sites, helps shape go-or-stop development calls.
Clinical investigators
Clinical investigators are central to Tempest Therapeutics’ study execution: they run the protocol, assess safety, and help read early response signals. As a clinical-stage company with no product revenue in 2024, Tempest depends on these principal investigators to move small, high-risk oncology trials forward.
Biopharma partners
Biopharma partners are a key customer segment for Tempest Therapeutics because the Company is still pre-commercial, so value comes from licensing, co-development, and data sharing rather than product sales. These partners may pay for Tempest’s mechanisms, clinical data, and IP if the assets can improve their oncology pipelines.
- Licensing and collaboration drive value
- Partners want IP and clinical data
- Pre-commercial stage makes this segment critical
Investors and capital providers
Tempest Therapeutics, Inc. depends on equity investors to fund its clinical runway because it has no approved product revenue yet. For a public biotech, this capital is the bridge that pays for trials, regulatory work, and overhead while the pipeline tries to reach value-driving milestones.
- Funds clinical development runway
- Offsets no product revenue
- Critical for public biotech financing
Tempest Therapeutics’ 2025 Value Hinges on Trials, Partnerships, and Cash
Tempest Therapeutics, Inc. serves four groups: advanced solid-tumor patients, oncologists and trial sites, biopharma partners, and equity investors. It is still pre-commercial, with no product revenue, so value in 2025/2026 depends on trial enrollment, clinical data, licensing interest, and funding for the pipeline.
| Segment | Why it matters | Key fact |
|---|---|---|
| Patients | Trial enrollment | Advanced solid tumors |
| Oncologists | Site adoption | Clinical-stage use only |
| Partners | Licensing | No product revenue |
| Investors | Runway capital | Funds R&D |
Cost Structure
Clinical trial spend
Clinical trial spend is Tempest Therapeutics, Inc.'s biggest near-term cost, driven by site fees, CROs, monitoring, labs, and patient services. In early oncology, trials are especially cash-heavy because enrollment is slower and protocols are more complex, so this line item usually drives most R&D burn before any product revenue appears.
R and D payroll
Tempest Therapeutics, Inc. must fund scientists, clinicians, and development staff to keep discovery, translational work, and trial operations moving; in a clinical-stage biotech, that payroll is a fixed cost that often runs ahead of revenue. Human capital spend is usually one of the largest R&D lines, so hiring discipline and trial timing matter a lot.
Manufacturing and CMC
Tempest Therapeutics, Inc. relies on contract manufacturers and third-party labs for drug supply, so Manufacturing and CMC costs cover scale-up, release assays, packaging, and stability studies. These costs usually rise as trials move from early batches to larger clinical supply runs, and Tempest Therapeutics, Inc. reported no product revenue in its latest filings, so CMC spend sits inside a lean, trial-linked cost base.
G and A overhead
Tempest Therapeutics, Inc. G and A overhead covers public-company legal, finance, HR, audit, and SEC reporting work, plus investor relations and board governance. For a listed biotech, this is fixed overhead that must run even when revenue is still minimal.
It usually rises with filing, proxy, and compliance load, so it is a core cash cost to keep the Company public.
- Legal, finance, HR, reporting
- Investor relations and governance
- Required for listed operations
IP and regulatory costs
IP and regulatory costs are a steady drag for Tempest Therapeutics, Inc., because patent filings, prosecution, and FDA/EMA submissions keep running through long trial cycles. The company also has to defend its drug assets and stay compliant, which makes these costs recurring rather than one-time.
This spend matters because oncology development can take years, so legal and regulatory work protects value while programs move slowly. In 2025 filings, Tempest Therapeutics continued to report losses and cash burn, so every dollar tied to IP defense and compliance directly affects runway.
- Patent prosecution never stops
- Regulatory filings add fixed cost
- Defense protects pipeline value
- Compliance supports long timelines
Tempest’s Burn Is Still Driven by R&D and Clinical Trials
Tempest Therapeutics, Inc.'s cost base is still mostly R&D-heavy, with clinical trials, staff, CMC work, and IP/regulatory spend consuming most cash before any product revenue. That means runway depends on trial pace, hiring control, and how much outsourced development the Company needs.
| Cost item | Role |
|---|---|
| Clinical trials | Main cash burn |
| R&D staff | Fixed payroll load |
| CMC and labs | Trial supply support |
Revenue Streams
Collaboration fees
Tempest Therapeutics can earn collaboration fees from research and development partners, a common early-stage biotech model that often includes upfront, milestone, and research funding. These fees help offset discovery and clinical spend, which matters when R&D costs can run into tens of millions of dollars a year for a small oncology pipeline.
Upfront licensing payments
Tempest Therapeutics, Inc. can earn upfront licensing cash when it grants partners rights to its assets, and that money is non-dilutive. In its latest annual filing, Tempest Therapeutics reported $0 collaboration revenue, so any upfront fee would be an immediate validation of strategic value and a cleaner funding source than new shares.
Development milestones
Tempest Therapeutics, Inc. can earn partner cash through clinical, regulatory, and commercial milestones tied to program progress, a standard biotech licensing model. In 2025, it remained a pre-revenue development-stage company, so milestone receipts, not product sales, are the key path to revenue.
Royalties on sales
Tempest Therapeutics, Inc. could earn royalties only if a partnered asset reaches approval and starts selling, so this is a late-stage revenue stream tied to future net sales, not current operations. Tempest has not disclosed a royalty rate, so the cash flow would depend on the partner’s launch scale and market uptake, which often means no near-term revenue at all.
- Paid only after commercial launch
- Based on future net sales
- Royalty rate not disclosed
- Late-stage, not near-term cash
Equity financing
Tempest Therapeutics, Inc. is a clinical-stage public Company, so equity financing is a core revenue stream while product sales are still absent. Share issuance funds R&D and operations before commercialization, but it also dilutes existing holders and depends on market access.
- Primary cash source before product revenue
- Funds trials and corporate overhead
- Raises dilution and market-risk exposure
Tempest Therapeutics Stays Pre-Revenue, Funded by Equity
Tempest Therapeutics, Inc. has no product sales, so revenue streams center on collaboration fees, upfront license cash, milestones, and future royalties from partnered assets. In its latest annual filing, it reported $0 collaboration revenue, while 2025 kept it in pre-revenue mode, making equity financing the main cash source for R&D.
| Stream | 2025 |
|---|---|
| Collab revenue | $0 |
| Product sales | None |
| Main funding | Equity |
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