Tempest Announces Plan to Explore Strategic Alternatives to Advance Promising Pipeline of Clinical Oncology Assets and Maximize Stockholder Value

Rhea-AI Summary

Tempest Therapeutics (NASDAQ: TPST) has announced plans to explore strategic alternatives to advance its clinical-stage oncology programs and maximize stockholder value. The company has retained MTS Health Partners as financial advisor for this process.

Key highlights include:

• Their lead drug amezalpat (TPST-1120) is Phase 3-ready for first-line hepatocellular carcinoma (HCC) treatment, having received both Orphan Drug and Fast Track designations
• Phase 1b/2 clinical study showed amezalpat improved median overall survival by six months when combined with atezolizumab and bevacizumab
• FDA has issued "Study May Proceed" letter for TPST-1495 in Phase 2 trial for familial adenomatous polyposis (FAP) treatment, with data expected in 2026
• The company has established an agreement with Roche for evaluating amezalpat in combination therapy

Positive

• Phase 3-ready status for amezalpat with FDA and EMA clearance
• Positive Phase 1b/2 data showing 6-month survival improvement in HCC
• Dual FDA designations (Orphan Drug & Fast Track) for amezalpat
• Strategic partnership with Roche for amezalpat development
• FDA clearance for TPST-1495 Phase 2 trial in FAP

Negative

• Company unable to secure capital market funding for next development stage
• Uncertainty surrounding strategic alternatives process outcome
• No guaranteed timeline for completing strategic evaluation process

Insights

Biotech Investment Analyst

Tempest's announcement to explore strategic alternatives is a clear indicator of capital constraints despite having promising clinical assets. The company's statement that "capital markets have been unavailable to support the next stage of advancement" is particularly telling - they simply cannot fund their programs independently despite positive clinical data.

With a market cap of just $22 million, Tempest presents a stark disconnect between their clinical progress and market valuation. Their lead candidate amezalpat has completed FDA and EMA interactions for a Phase 3 pivotal study in hepatocellular carcinoma, received both Orphan Drug and Fast Track designations, and demonstrated a six-month survival benefit in Phase 2 - yet the company cannot access sufficient capital to advance it.

The retention of MTS Health Partners signals a structured approach to finding a buyer or partner. Potential acquirers may view this as an opportunity to obtain Phase 3-ready assets with established regulatory pathways at a significant discount. However, strategic reviews don't always result in transactions, and the process creates uncertainty for current shareholders.

This situation reflects the challenging environment for small-cap biotechs with promising but capital-intensive late-stage programs. The company's inability to fund advancement of Phase 3-ready assets with positive data represents a fundamental business challenge that necessitates finding a partner with deeper pockets.

Clinical Development Expert

Tempest's clinical assets demonstrate significant potential despite the company's financial constraints. Their lead candidate amezalpat (TPST-1120), a PPARα antagonist, has shown compelling efficacy in hepatocellular carcinoma (HCC), with Phase 2 data indicating a six-month improvement in median overall survival when combined with standard-of-care atezolizumab and bevacizumab.

The regulatory progress is substantial - amezalpat has received both Orphan Drug and Fast Track designations from the FDA, plus clearance to proceed with a pivotal Phase 3 trial. The agreement with Roche to evaluate the triple combination therapy further validates the approach. For HCC, a difficult-to-treat cancer with treatment options, a six-month survival improvement represents clinically meaningful benefit.

The secondary program, TPST-1495 (dual EP2/4 prostaglandin receptor antagonist), has also gained Orphan Drug designation for familial adenomatous polyposis (FAP) and received FDA clearance to proceed with Phase 2 trials. FAP represents another area of high unmet need as a rare disease that inevitably progresses to colorectal cancer without intervention.

From a development perspective, these assets appear well-positioned with clear regulatory pathways and positive clinical signals. The strategic alternatives process will likely attract partners interested in oncology assets with de-risked development paths and established regulatory designations that could accelerate time-to-market.

• Amezalpat (TPST-1120) is Phase 3-ready: completed FDA and EMA interactions for first-line pivotal study in hepatocellular carcinoma (HCC); global investigator support in place
• Awarded both Orphan Drug & Fast Track designations for amezalpat based on positive randomized Phase 2 data in first-line HCC
• Received FDA “Study May Proceed” letter for TPST-1495 in a Phase 2 trial for the treatment of familial adenomatous polyposis (FAP); data expected 2026
  

BRISBANE, Calif., April 09, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classⁱ targeted and immune-mediated therapeutics to fight cancer, today announced that the company plans to explore a full range of strategic alternatives to advance its promising clinical stage programs and maximize stockholder value. Strategic alternatives under consideration may include, but are not limited to, mergers, acquisition, partnerships, joint ventures, licensing arrangements or other strategic transactions. The company has retained MTS Health Partners, L.P., an internationally recognized financial advisor with substantial experience in the biotechnology industry, to support it with the strategic evaluation process.

“Notwithstanding the positive randomized data set from the amezalpat Phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a Phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement,” said Stephen Brady, president and chief executive officer of Tempest. “We are initiating a process to explore alternatives available to the company to maximize stockholder value, which include finding a strategic partner with the resources to develop what we believe are potentially life-saving therapies for patients in need. Given the positive data and commercial potential with this pipeline, as well as the clearance from FDA on the lead program’s pivotal study, we believe this is a rare opportunity for a partner.”  

The company has not set a timetable for completion of the process for evaluating strategic alternatives and does not intend to disclose further developments or guidance on the status of its programs or the process for evaluating strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary. No agreement providing for any transaction has been reached and there can be no assurances that any transaction will result from the process for evaluating strategic alternatives. If the process for evaluating strategic alternatives results in an agreement regarding a transaction, there can be no assurances that any transaction will be completed.

Program Milestones and Status

Amezalpat (TPST-1120) (clinical PPARα antagonist):

• Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.
• Received a “Study May Proceed” letter from the FDA to evaluate amezalpat in combination with atezolizumab (TECENTRIQ^®) and bevacizumab (Avastin^®), the current standard of care for unresectable or metastatic HCC, in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
• Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
• Announced positive feedback from the end-of-Phase 2 meeting with the FDA for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic HCC.
• Reported new positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating that amezalpat delivered a six-month improvement in median overall survival (OS) when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone, the standard of care, in the first-line treatment of patients with unresectable or metastatic HCC.
• Published positive data from the Phase 1 trial of amezalpat in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that amezalpat demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers. These data complement the positive Phase 1b/2 data reported in October 2023 and June 2024 from a global randomized study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
• Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting demonstrating that amezalpat reduced kidney cancer growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy.
  

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist):

• Granted Orphan Drug designation by the FDA for TPST-1495 for the treatment of patients with FAP.
• Received a “Study May Proceed” letter from the FDA to evaluate TPST-1495 in a Phase 2 trial for the treatment of FAP.

About Amezalpat (TPST-1120)

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.

About TPST-1495

TPST-1495 is a novel, highly selective and potent EP2-EP4 dual antagonist designed to block the cancer-promoting EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed to enhance tumor progression through the stimulation of tumor proliferation, enhanced angiogenesis and suppression of immune function in the tumor microenvironment. The Phase 2 study of TPST-1495 in patients with FAP is expected to begin in 2025 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention.

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. Forward-looking statements contained in this press release include but are not limited to statements relating to Tempest Therapeutics’ evaluation of strategic alternatives available to the company to maximize stockholder value, as well as the design, initiation, progress, timing, scope and results of clinical trials, including the potential Phase 3 study for amezalpat and Phase 2 trial of TPST-1495; and anticipated therapeutic benefit and regulatory development of the Tempest Therapeutics product candidates. Any forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks relating to volatility and uncertainty in the capital markets for biotechnology companies; availability of suitable third parties with which to conduct contemplated strategic transactions; and whether we will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 27, 2025, as well as in other filings the company may make with the SEC in the future. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

Investor & Media Contacts:

Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com

Alexandra Santos
Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com

_______________________________
ⁱ If approved by the FDA

FAQ

What clinical results did TPST's amezalpat show in the Phase 1b/2 HCC trial?

Amezalpat demonstrated a six-month improvement in median overall survival when combined with atezolizumab and bevacizumab compared to standard of care in first-line HCC treatment.

What regulatory designations has TPST received for amezalpat in HCC treatment?

Amezalpat received both Orphan Drug and Fast Track designations from the FDA for hepatocellular carcinoma treatment.

When will TPST's Phase 2 trial results for TPST-1495 in FAP be available?

Data from the Phase 2 trial of TPST-1495 in familial adenomatous polyposis is expected in 2026.

What strategic alternatives is TPST currently exploring?

TPST is exploring mergers, acquisitions, partnerships, joint ventures, and licensing arrangements to advance its clinical programs and maximize stockholder value.