Tempest Therapeutics, Inc. (TPST): 5 FORCES Analysis [Nov-2025 Updated]

You're digging into a clinical-stage biotech, Tempest Therapeutics, Inc., and the reality is that its strategic position is defined by a high-stakes race against the clock. Honestly, with only $7.5 million in cash as of Q3 2025, following a $22.2 million year-to-date net loss for 2025, the near-term survival hinges on pipeline success and partnership deals. Our deep dive using Porter's Five Forces shows that while they face defintely intense rivalry from established oncology giants, suppliers command high fees for GMP materials, and the threat of superior substitutes is always present. To see precisely how these five forces-from customer power to new entrant barriers-shape the path to funding that pivotal Phase 3 trial for TPST-1120, read on below.

Tempest Therapeutics, Inc. (TPST) - Porter's Five Forces: Bargaining power of suppliers

You're looking at Tempest Therapeutics, Inc.'s (TPST) supplier landscape, and honestly, it looks tilted toward the vendors right now. For a clinical-stage company like Tempest, especially one preparing for a pivotal Phase 3 trial, the suppliers-the CMOs and CROs-hold significant sway.

High reliance on specialized Contract Manufacturing Organizations (CMOs).

Tempest Therapeutics' dependence on external partners for manufacturing its drug candidates, like amezalpat, creates an inherent power imbalance. This reliance is acute because developing and scaling up clinical-grade materials isn't something you can easily bring in-house overnight. We saw this cost pressure surface clearly in the first quarter of 2025. Research and development expenses jumped to $7.6 million in Q1 2025, up from $4.3 million in the same period in 2024. Management explicitly noted that this $3.3 million increase was primarily due to costs from engaging contract research and manufacturing organizations while preparing for the amezalpat Phase 3 trial. That's a concrete number showing supplier costs driving the burn rate.

Limited number of qualified suppliers for clinical-grade small molecule and new CAR-T materials.

The pool of suppliers capable of handling specialized small molecule production under strict protocols, or manufacturing novel cell therapies like the newly acquired TPST-2003 CAR-T program, is small. This scarcity naturally boosts supplier leverage. The broader biopharmaceutical CMO and CRO market is large, estimated to be worth USD 41.07 Billion globally in 2025, but the qualified niche suppliers for a specific molecule or therapy type are few. This concentration means Tempest has fewer alternatives if a key supplier relationship sours or demands unfavorable terms.

Suppliers hold leverage due to strict Good Manufacturing Practice (GMP) regulatory requirements.

Adherence to Good Manufacturing Practice (GMP) is non-negotiable for clinical materials, giving established, compliant suppliers a major moat. These vendors have already made the massive capital investments to meet regulatory standards, which Tempest must now pay a premium to access. Industry-wide, leading CMOs are making large-scale investments, like one announced in March 2025 for a $350 million facility expansion, to meet demand and GMP compliance. You pay for that validated infrastructure and regulatory history; there's no shortcutting that process.

Clinical Research Organizations (CROs) command high fees for Phase 3-ready trial execution.

Moving into a pivotal Phase 3 trial, as Tempest is planning for amezalpat, requires extensive CRO support, and those services command high fees. The global CRO market is projected to surpass $100 billion by 2028, showing the high value placed on their execution capabilities. The cost of preparing for this late-stage trial was a direct driver of that Q1 2025 R&D expense spike we just discussed. It's a necessary expense, but one where the CROs set the price, not the sponsor.

Here's a quick look at how Tempest's R&D spending, heavily influenced by these external partners, shifted as the company re-prioritized its focus later in the year:

If onboarding takes 14+ days longer than expected for a critical batch, the delay in trial initiation could cost millions in lost market opportunity, which is why Tempest has to pay the premium suppliers ask for.

Finance: draft 13-week cash view by Friday.

Tempest Therapeutics, Inc. (TPST) - Porter's Five Forces: Bargaining power of customers

You're a clinical-stage biotech, and your near-term customers aren't patients; they are the large pharma entities or government bodies funding the next critical step. For Tempest Therapeutics, Inc., this dynamic creates significant leverage for those partners, especially given the company's current financial position.

For Amezalpat (TPST-1120), the pivotal Phase 3 trial in first-line Hepatocellular Carcinoma (HCC) requires a high-value partnership to fund the estimated $100 million development cost, even with Roche supplying Tecentriq, which could offset costs by an estimated $30-50 million.

The company's cash position clearly illustrates this dependency. Tempest Therapeutics, Inc. ended the third quarter of 2025 with $7.5 million in cash and cash equivalents, a sharp drop from $30.3 million at the close of 2024. This financial reality, following the layoff of 80% of its staff in the spring of 2025, means securing a partner is not just an opportunity but a necessity to advance TPST-1120.

The bargaining power of these near-term customers is further cemented by the existing Standard of Care (SOC) efficacy bar that any new therapy must demonstrably clear. Oncologists managing advanced HCC already have several approved regimens to choose from, setting a high efficacy hurdle for Amezalpat.

Here's a quick look at the efficacy benchmarks Tempest Therapeutics, Inc. must surpass:

The need for external funding and partnership is a recurring theme, even as Tempest Therapeutics, Inc. advances other assets. For instance, the Phase 2 study for TPST-1495 in Familial Adenomatous Polyposis (FAP) is being conducted under the auspices of the Cancer Prevention Clinical Trials Network and is funded by the National Cancer Institute (NCI) Division of Cancer Prevention, showing a different, government-backed customer/funder relationship.

The leverage held by potential commercial customers-payers and hospitals-will be absolute upon approval, demanding clear superiority over the established SOC. This translates directly into the demands placed on near-term partners now:

• Near-term customer type: Large pharma partners or the National Cancer Institute (NCI).
• TPST-1120 Trial Status: FDA clearance for pivotal Phase 3 (NCT06680258), but 'not yet recruiting' as of April 2025.
• TPST-1495 Trial Status: Phase 2 study expected to start in 2025, funded by the NCI.
• Cash Runway: Extended to mid-2027 following a November 2025 transaction, but TPST-1120 advancement still requires additional resources or partnerships.
• Q3 2025 Cash: $7.5 million in cash and equivalents.
• Q3 2025 Net Loss: $3.5 million.

Tempest Therapeutics, Inc. (TPST) - Porter's Five Forces: Competitive rivalry

The competitive rivalry facing Tempest Therapeutics, Inc. is defintely intense, rooted in the high-stakes oncology sector where success hinges on clinical differentiation and deep pockets. You're looking at a company trying to carve out space against established pharmaceutical behemoths.

Tempest Therapeutics, Inc.'s primary small molecule candidate, amezalpat (TPST-1120), is positioned directly against the current standard of care (SOC) in unresectable or metastatic Hepatocellular Carcinoma (HCC). The planned pivotal Phase 3 study is a global, blinded, 1:1 randomized trial comparing amezalpat plus the existing SOC versus the SOC alone. The existing SOC arm consists of atezolizumab and bevacizumab,. This means Tempest Therapeutics, Inc. is not just competing with these established therapies, but is actively seeking to prove superiority when adding its molecule to the existing regimen.

The recent strategic move to acquire dual-CAR T programs from Factor Bioscience significantly escalates rivalry in the cell therapy space. The acquisition of TPST-2003, a clinical-stage CD19/BCMA dual-CAR T program for relapsed/refractory Multiple Myeloma (rrMM),, places Tempest Therapeutics, Inc. in direct competition with advanced cell therapy companies. This deal, announced November 19, 2025, involved issuing 8,268,495 shares of common stock to a Factor affiliate, representing 65% of outstanding shares inclusive of newly issued shares as of that date,. This massive equity issuance signals a major shift in competitive positioning, but also highlights the cost of entry into this advanced field.

The rivalry is perhaps most visible in the competition for capital resources, which is critical for advancing clinical assets. Tempest Therapeutics, Inc. is actively pursuing strategic alternatives to secure funding,,. The financial figures show the urgency:

The need to explore strategic alternatives, which began in April 2025, suggests that traditional capital markets were unavailable or insufficient to fund the costly Phase 3 trial preparation for amezalpat. The Factor acquisition is now expected to extend the company's runway to mid-2027,, which is a direct response to the intense capital competition. The market capitalization, which hovered around its cash holdings in early 2025, was reported at approximately $41.03 million around the time of the November 2025 acquisition announcement, though a prior figure was as low as $18.52 million.

The rivalry with established giants like Merck and Bristol-Myers Squibb is implicit in the oncology space, as these firms command significant market share and resources. Tempest Therapeutics, Inc. has an announced agreement with F. Hoffmann-La Roche Ltd. to support the advancement of amezalpat combination therapy into the pivotal trial,, which shows a necessary, albeit complex, form of engagement with a major competitor/partner.

The competitive pressures manifest in several key areas for Tempest Therapeutics, Inc.:

• Direct competition with SOC drugs like atezolizumab and bevacizumab for TPST-1120.
• Rivalry with established cell therapy players due to the TPST-2003 acquisition.
• Intense competition for financing, evidenced by the recent capital raises and strategic review,.
• The need to secure a deal or financing to advance amezalpat into a registrational study, as year-end 2024 cash of over $30 million was deemed insufficient for a full Phase 3 trial,.

The recent leadership change, with Factor's Matt Angel set to become President and CEO upon the acquisition closing, further underscores the high-stakes nature of this competitive environment.

Tempest Therapeutics, Inc. (TPST) - Porter's Five Forces: Threat of substitutes

The threat of substitutes for Tempest Therapeutics, Inc. products is substantial, given the rapid evolution of oncology standards of care and the availability of established, cost-effective alternatives in supportive settings.

For amezalpat (TPST-1120) in unresectable or metastatic hepatocellular carcinoma (HCC), the threat comes from established combination regimens. The Phase 1b/2 data showed that adding TPST-1120 to atezolizumab and bevacizumab resulted in a median overall survival (OS) of 21 months, compared to 15 months for atezolizumab and bevacizumab alone-a six-month advantage. This must be weighed against competitors already approved in the first-line setting.

Here is a look at the established competitive landscape in the first-line HCC setting:

New, superior clinical data from rival Phase 3 programs could quickly substitute TPST-1120's potential benefit. If a competitor's regimen, perhaps one of the approved checkpoint inhibitor combinations, demonstrates a significantly better hazard ratio (HR) than the 0.65 HR seen for the TPST-1120 combination arm, it would immediately raise the bar for what is considered standard of care, potentially sidelining amezalpat before it reaches a pivotal study conclusion. Honestly, the capital markets have been unavailable to support the next stage of advancement for the planned 700-patient Phase 3 study, forcing Tempest Therapeutics to explore strategic alternatives.

Generic small-molecule drugs for supportive care present a low-cost threat across the board. The global generic oncology drugs market size was valued at $27.24 billion in 2024 and is projected to grow to $28.75 billion in 2025. This massive, cost-sensitive market means that any supportive care component in a treatment regimen where a generic alternative exists offers a low-cost substitution option, pressuring overall treatment cost-effectiveness.

For TPST-1495, targeting Familial Adenomatous Polyposis (FAP), the threat of substitutes is bifurcated between established surgical intervention and emerging pharmacological alternatives. FAP affects approximately 1 in 5,000 to 10,000 individuals in the US.

• The current standard of care is the surgical removal of the colon (colectomy) early in life, which is a definitive, albeit drastic, intervention.
• Rapamycin (sirolimus), an oral tablet formulation, received Fast Track designation for adenomatous polyposis based on Phase 2 data showing a median 17% reduction in total polyp burden at 12 months and an overall 75% nonprogression rate.
• TPST-1495 is aiming to reduce duodenal polyp burden, with Phase 2 data expected in 2026.

If the rapamycin data matures or other FAP-targeting agents show superior efficacy or safety profiles before Tempest Therapeutics' data is available, the market opportunity for TPST-1495 could be significantly eroded.

Tempest Therapeutics, Inc. (TPST) - Porter's Five Forces: Threat of new entrants

The threat of new entrants for Tempest Therapeutics, Inc. in the immuno-oncology space is generally considered low to moderate, primarily due to the immense financial and regulatory hurdles required to establish a competitive presence. Honestly, setting up shop to compete directly with an established pipeline is a multi-billion dollar proposition.

Low barrier due to high capital requirements; the company reported a \$22.2 million year-to-date net loss in 2025. You see this capital intensity reflected in the balance sheet; Tempest Therapeutics, Inc. ended the third quarter of 2025 with only \$7.5 million in cash and cash equivalents, after burning \$23.2 million in operating activities over the preceding nine months. Any new entrant must secure substantial, sustained funding to cover years of preclinical work and multi-phase clinical trials before generating any revenue, a significant barrier to entry for all but the most heavily capitalized firms or those with immediate, breakthrough platform technology.

Long, complex, and expensive FDA regulatory approval process creates a significant barrier. Developing and bringing a novel oncology drug to market can cost upwards of \$4.5 billion when accounting for failures and the cost of capital. Even after the development outlay, the regulatory gauntlet itself is time-consuming. The standard FDA review timeline following an NDA (New Drug Application) submission is typically around 10 months, though priority review can shorten this to 6 months. For a new company, navigating this process without prior experience adds layers of complexity and delay.

The scientific and intellectual property (IP) landscape presents a formidable wall. New entrants need not only capital but also proprietary science that can demonstrate a clear advantage over existing standards of care, such as the immune checkpoint inhibitors that saw new approvals in the first half of 2025.

Need for specialized intellectual property (IP) and deep scientific expertise in immuno-oncology.

• Immuno-oncology requires deep specialization.
• IP protection is essential for market exclusivity.
• Clinical trial design complexity is very high.
• Phase 3 trials can cost \$50-100 million or more.

Acquiring a CAR-T program (TPST-2003) raises the technical bar for any new competitor. Tempest Therapeutics, Inc.'s late-2025 announcement to acquire the TPST-2003 program-a clinical-stage CD19/BCMA dual-CAR T program-immediately raises the technical bar for any competitor attempting to enter the cell therapy space against them. This asset has already completed Phase 1 trials in relapsed multiple myeloma patients, with data anticipated in 2026. A new entrant would need to replicate or surpass this advanced stage of development, which is a massive undertaking.

Here's a quick comparison of the financial scale involved in the current environment for Tempest Therapeutics, Inc. versus the general cost of entry:

What this estimate hides is the cost of failure; nearly 90% of drugs entering clinical trials never secure approval. So, while Tempest Therapeutics, Inc.'s current cash position might look low, the sheer scale of investment required to start where they are now is the real deterrent. The threat is less from a startup with a concept and more from a well-funded competitor acquiring an existing asset or platform.