Tempest Therapeutics, Inc. (NASDAQ:TPST) is a 2011-founded, Brisbane-based oncology innovator that has quietly risen from a niche research venture into a clinical-stage company advancing first-in-class small-molecule medicines that combine targeted tumor-killing activity with immune-mediated mechanisms. Guided by a leadership team drawn from Genentech, Exelixis, and Gilead, Tempest built its scientific strategy around exploiting tumor-intrinsic metabolic pathways and the prostaglandin axis—areas long recognized as cancer-promoting but historically resistant to drugging. This focus produced two headline programs: amezalpat, a selective PPAR-α antagonist that reprograms the tumor microenvironment and has delivered a 21-month median overall-survival signal in hepatocellular carcinoma when paired with atezolizumab + bevacizumab; and TPST-1495, the first dual EP2/EP4 antagonist to earn FDA Orphan Drug status for familial adenomatous polyposis while also showing promise in colorectal and gastric malignancies. Regulatory momentum has accelerated in 2025: both the FDA and China’s NMPA have cleared a global Phase 3 study for amezalpat, and Europe’s EMA recently granted orphan designation, setting a synchronized path to market across the world’s largest liver-cancer regions.
To fund this late-stage push, Tempest executed a disciplined balance-sheet reset—completing a 1-for-13 reverse split in late 2024, trimming non-core spend, and, on June 11 2025, securing a $4.6 million registered direct offering led by H.C. Wainwright. The fresh capital extends runway beyond mid-2026, underwriting pivotal-trial start-up, the NCI-sponsored Phase 2 launch for TPST-1495, and an ongoing strategic-alternative review that could culminate in a partnership or outright sale. Despite these de-risking milestones, Tempest’s valuation remains under $100 million—well below peers with comparable Phase 3 assets—creating a classic asymmetric setup for investors who believe a survival-benefit read-out can rewrite the standard of care in first-line liver cancer and unleash significant shareholder value. As the company advances toward multiple data read-outs and potential business-development catalysts, Tempest Therapeutics stands poised to transform from overlooked micro-cap to sought-after oncology franchise.
Focused Pipeline: Amezalpat and TPST-1495 Lead the Charge
Tempest’s lead asset, amezalpat, is a novel PPAR⍺ antagonist currently being developed for first-line hepatocellular carcinoma (HCC), one of the world’s deadliest cancers. Amezalpat has shown strong clinical promise when used in combination with the standard-of-care checkpoint inhibitors atezolizumab and bevacizumab. In a Phase 1b/2 randomized clinical study, the drug combination demonstrated a median overall survival benefit of 21 months—six months longer than the control arm—alongside durable disease control in specific patient populations. These results have laid the groundwork for a pivotal Phase 3 trial, which has already received regulatory clearance in both the U.S. and China. Furthermore, amezalpat has earned FDA Fast Track and Orphan Drug designations, highlighting both its potential impact and regulatory support.
Complementing this lead program is TPST-1495, an oral EP2/EP4 antagonist targeting the prostaglandin E2 pathway. This immune-suppressive signaling axis is known to play a significant role in colorectal and other epithelial tumors. The asset recently received Orphan Drug Designation from the FDA for familial adenomatous polyposis (FAP), an inherited cancer syndrome with no approved pharmacologic therapies. A Phase 2 study sponsored by the National Cancer Institute (NCI) is set to commence shortly, allowing Tempest to generate critical data with minimal financial burden.
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Strategic Funding Through a Registered Direct Offering
On June 11, 2025, Tempest Therapeutics announced a new capital infusion via a $4.6 million registered direct offering of common stock. Under the terms of the agreement, a single institutional investor will purchase 739,000 shares at $6.25 each. H.C. Wainwright & Co. acted as the exclusive placement agent. This offering, while modest in scale, comes at a crucial time for the company, as it works to support ongoing development of its clinical programs and continue its strategic alternative process.
According to the company, net proceeds from the offering will be used to support working capital, general corporate needs, and to further initiatives related to its strategic alternative review. This capital provides additional runway as Tempest continues to advance amezalpat and TPST-1495, while also exploring out-licensing opportunities, M&A, or partnership transactions. The move underscores prudent capital management and investor interest even in the face of volatile biotech markets.
Regulatory Momentum and Global Expansion Potential
Tempest’s regulatory pathway is now clearly aligned across major markets. The pivotal trial for amezalpat has been cleared to proceed by both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA), setting the stage for a global Phase 3 trial that could significantly accelerate commercialization. The company has built a synchronized development plan with global endpoints that are expected to satisfy regulators in multiple jurisdictions.
This global regulatory clarity is critical. Hepatocellular carcinoma is a particularly high-need cancer in Asia, where prevalence is disproportionately higher. A successful trial across U.S. and Asian patient populations could catapult amezalpat into frontline relevance, offering an improved therapeutic alternative over current standards that suffer from modest overall survival benefits.
Streamlined Corporate Structure and Strategic Reengineering
In late 2024, Tempest implemented a 1-for-13 reverse stock split to remain compliant with NASDAQ listing requirements and improve capital market visibility. While reverse splits are often seen as negative signals, Tempest coupled this move with tangible progress in its clinical programs and corporate realignment. The company also reduced its operating expenses by restructuring internal teams and reducing headcount—moves aimed at focusing resources entirely on clinical execution and value-driving milestones.
This restructuring resulted in a leaner, more capital-efficient organization poised to execute its late-stage strategy with precision. With approximately $30 million in cash at the start of 2025 and the new $4.6 million direct offering added, Tempest now has the financial flexibility to continue development without excessive shareholder dilution in the short term. Management’s disciplined approach could attract larger biopharma players looking for acquisition or partnership opportunities, especially in immuno-oncology.
Undervalued by the Market, Overlooked by the Crowd
Despite its strong clinical data, regulatory tailwinds, and streamlined focus, Tempest’s market capitalization remains strikingly low—under $100 million as of mid-2025. Analyst price targets project significant upside, with some estimates nearing $70 per share, reflecting nearly 10x growth from current levels. This dislocation between potential and valuation is a textbook setup for high-risk, high-reward investors, particularly those who understand the asymmetric payoff dynamics of small-cap biotech investments.
As the company begins enrollment in its pivotal amezalpat trial and delivers updates on TPST-1495’s NCI-sponsored study, catalysts will continue to build. Investor interest in oncology assets—especially those with Fast Track and Orphan Drug status—remains high, and Tempest sits on a short list of publicly traded companies with multiple near-term value inflection points.
A Path to Acquisition or Independent Growth
Given its focused pipeline, regulatory momentum, and lean structure, Tempest is a clear candidate for acquisition. Larger pharmaceutical companies are increasingly looking to bolster their oncology pipelines through strategic M&A, and a de-risked, late-stage asset like amezalpat—backed by compelling survival data—could be particularly attractive. TPST-1495, with its orphan designation and novel mechanism, offers additional optionality for buyers seeking early access to first-in-class therapies in colorectal and gastrointestinal cancers.
However, even without an acquisition, Tempest’s path to independent success remains viable. The company’s clinical strategy is clear, its regulatory groundwork is solid, and its financials are now reinforced by fresh capital. With two programs advancing and meaningful readouts expected within the next 12 to 18 months, Tempest is transitioning from a speculative micro-cap to a legitimate clinical-stage contender.
Final Thoughts: A Biotech Turnaround with Asymmetric Potential
Tempest Therapeutics has emerged from restructuring with sharper focus, renewed investor confidence, and a pipeline capable of transforming cancer care across multiple indications. The $4.6 million direct offering announced in June 2025 is just one of several recent moves that support a carefully choreographed turnaround strategy. With late-stage programs, regulatory clearances in hand, strategic partnerships under discussion, and a now-extended cash runway, the company is positioned for a powerful move forward.
For investors seeking under-the-radar biotech names with real clinical data, strategic funding, and regulatory momentum, Tempest Therapeutics offers a compelling case. The risk is real—but so is the opportunity. In a biotech landscape filled with overhyped preclinical stories and underdelivering platforms, Tempest is standing out by doing what matters most: advancing medicines that work.
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