Amezalpat

Builds on clearances already received by FDA and EMA China has the largest population of patients with hepatocellular carcinoma in the world BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal trial to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC). “This regulatory clearance to proceed with a pivotal trial in China is a significant milestone towards reaching global markets where HCC has high prevalence,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “It is rewarding that the regulatory officials in China see the promise and potential of amezalpat and have provided the green light to begin a registration-directed trial. We strongly believe amezalpat is a drug that can make a difference in the lives of patients with HCC and believe it should be advanced to pivotal testing.” About the TPST-1120-301 Study (NCT06680258) The planned Phase 3 study is a global, blinded, 1:1 randomized study of amezalpat plus atezolizumab and bevacizumab versus placebo plus atezolizumab and bevacizumab, the standard of care, for the first-line treatment of patients with unresectable or metastatic HCC. The company has also received agreement from the FDA and EMA on its Phase 3 study design, dose of amezalpat, and the statistical plan, including a pre-specified efficacy analysis that could shorten the time to primary analysis. About Hepatocellular Carcinoma HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.1 Every year, more than 900,000 people worldwide are diagnosed with HCC.2 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US.3 In the US, HCC represents the fastest-rising cause of cancer-related death.3 Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.4 Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.5 Early recurrence is associated with poorer prognosis and shorter survival.5,6 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.6 About Amezalpat 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 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. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat; anticipated therapeutic benefit and regulatory development of the Company’s product candidates the Company’s ability to advance into a late-stage clinical company; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. 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 Quarterly Report on Form 10-Q filed for the quarter ended March 31, 2025 and other documents filed by the Company from time to time with the Securities and Exchange Commission. 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 Contacts: Sylvia Wheeler Wheelhouse Life Science Advisors swheeler@wheelhouselsa.com Aljanae Reynolds Wheelhouse Life Science Advisors areynolds@wheelhouselsa.com 1 Rahib, L. et al. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 74, 2913-2921 (2014). 2 World Health Organization. Liver Cancer Factsheet. Globocan. 2020. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Last accessed: April 2023. 3 Llovet, J. M., Kelley, R. K., Villanueva, A., et al. Hepatocellular carcinoma. Nature Reviews Disease Primers. 2021, 7(1), 6. 4 Office for Health Improvement & Disparities. Liver disease profiles: November 2021 update. Available at: https://www.gov.uk/government/statistics/liver-disease-profiles-november-2021-update/liver-disease-profiles-november-2021-update. Last accessed: April 2023. 5 Hack SP, Spahn J, Chen M et al. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncology. 2020 May;16(15):975-989. 6 Saito A, Toyoda H, Kobayashi M et al. Prediction of early recurrence of hepatocellular carcinoma after resection using digital pathology images assessed by machine learning. Modern Pathology. 2021. 34, 417-425.

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /PRNewswire/ -- After the close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers are optimistic, especially in the fields of immunotherapy, Car T-cell therapy, liquid biopsies, breast cancer, AI, and even exercise. However, with reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors, there have been several oncology innovators and healthcare providers with recent developments to pay attention to, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Tempest Therapeutics, Inc. (NASDAQ: TPST), Citius Oncology, Inc. (NASDAQ: CTOR), Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), and Cardinal Health (NYSE: CAH). As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to analysts at ResearchAndMarkets, the global oncology market is projected to reach US$866.1 billion by 2034, rising at a 10.8% CAGR, while Vision Research Reports projects the global oncology market to surpass US$903.81 billion by 2034, at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC)—a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls— and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Tempest Therapeutics, Inc. (NASDAQ: TPST), has secured Orphan Drug Designation from the European Medicines Agency (EMA) for amezalpat, its lead small molecule immunotherapy for hepatocellular carcinoma (HCC). The news builds on prior FDA Fast Track and Orphan Drug status granted earlier this year. "We're incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we've already received from the FDA," said Stephen Brady, president and chief executive officer of Tempest Therapeutics. "These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease." In a randomized Phase 1b/2 study, amezalpat added to standard-of-care therapy extended median overall survival by six months and showed preserved benefit across key subpopulations. The compound is designed to inhibit PPAR⍺ activity and enhance immune response in the HCC tumor microenvironment. Citius Oncology, Inc. (NASDAQ: CTOR), the oncology division of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), has signed a U.S. distribution agreement with Cardinal Health (NYSE: CAH) as it prepares to launch LYMPHIR, its recently FDA-approved treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL). "This agreement marks a key step forward in our launch readiness efforts," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. " Cardinal Health's proven distribution capabilities will help ensure LYMPHIR reaches healthcare providers and patients efficiently and reliably, as we work to build a robust commercial distribution network." LYMPHIR is a targeted recombinant fusion protein that binds IL-2 receptors and delivers diphtheria toxin fragments to malignant cells. The drug is indicated for adult patients with Stage I–III CTCL after at least one prior systemic therapy and was approved by the FDA in August 2024. Under the agreement, Cardinal Health will serve as an authorized distributor of record and provide specialty pharmaceutical distribution services across the U.S. market. This collaboration is designed to ensure patients and providers have reliable access to LYMPHIR as demand grows. Citius estimates the addressable market for this indication exceeds $400 million and remains underserved by current treatment options. Source: Logo: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. 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