Predictive Oncology to Launch AI-Driven ChemoFx® Assay in Europe, Expanding Personalized Cancer Treatment

Predictive Oncology Announces Planned European Launch of its ChemoFx® Treatment Selection Marker and Tumor Profiling Assay - Predictive Oncology (NASDAQ:POAI)

Initial plans target European clinical trials while providing standard testing to clinicians for individual patients There are an estimated 250,000 gynecologic cancers diagnosed annually across Europe PITTSBURGH, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. POAI, a leader in AI-driven drug discovery, today announced plans to launch its validated flagship live cell ChemoFx® drug response assay in Europe and expanded availability in the United States. The ChemoFx® treatment selection marker and tumor profiling assay will initially focus on ovarian and other gynecological cancers and may include testing of other major tumor types of interest over time. The ChemoFx® drug response assay is a treatment selection marker for chemotherapies that quantifies an individual cancer patients' in vitro tumor response to various chemotherapeutic agents. "The drug response results are critical to Predictive Oncology's live tumor cell platform that uses AI to create predictive models of drug response to streamline and de-risk the drug discovery process," said Dr. Arlette Uihlein, Senior Vice President of Translational Medicine and Medical Director. "Data sets extracted from these models can be applied to clinical trial design as well as biomarker discovery and companion diagnostic development efforts." According to the American Cancer Society, nearly 115,000 new gynecological cancer cases are diagnosed in the United States each year with more than 34,000 deaths attributed to these cancers. In Europe, an estimated 250,000 gynecologic cancer cases are diagnosed each year, the most frequent of which are endometrial, cervical and ovarian. "Of the approximately 150,000 live cell tumor samples that Predictive has in its biobank, nearly half of those specimens are gynecological cancers, and half of those are ovarian," said Raymond Vennare, Chief Executive officer of Predictive Oncology. "Our artificial intelligence and machine learning platform was validated against 175 FDA-approved drugs and 130 primary samples from ovarian tumors, and the use of those same data sets to build multi-omic models to predict short and long-term survival in ovarian cancer patients speaks for itself." By testing multiple chemotherapies on a patients' cancer cells before treatment selection, the drug response assay helps determine which chemotherapies are more likely to be effective on the tumor and which are less likely to provide benefit to the patient. Mr. Vennare added, "While much can be said about the significance of our biobank for drug discovery, ChemoFx® not only represents an equally crucial asset for the personalized treatment and care of cancer patients, the development of AI-driven clinical decision support tools in oncology. Both opportunities come with the potential to generate significant short-term revenue and long-term gains. When first developed and introduced to the market, ChemoFx® generated gross revenues in excess of $25 million annually." About Predictive Oncology Predictive Oncology is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early biomarker and drug discovery and enable drug development for the benefit of cancer patients worldwide. The company's proprietary AI/ML platform has been scientifically validated to predict with 92% accuracy if a tumor sample will respond to a certain drug compound, allowing for a more informed selection of drug/tumor type combinations. Together with the company's vast biobank of more than 150,000 assay-capable heterogenous human tumor samples, Predictive Oncology offers its academic and industry partners one of the industry's broadest AI-based drug discovery solutions, further complimented by its wholly owned CLIA laboratory facilities. Predictive Oncology is headquartered in Pittsburgh, PA. Contacts: For Predictive Oncology (investors): Tim McCarthy LifeSci Advisors, LLC [email protected] Forward-Looking Statements: Certain matters discussed in this release contain forward-looking statements. These forward- looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, changes in management, plans and objectives of management are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "would," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading "Risk Factors" in our filings with the SEC. Except as expressly required by law, the company disclaims any intent or obligation to update these forward-looking statements. POAIPredictive Oncology Inc$1.3412.6%WatchlistOverviewMarket News and Data brought to you by Benzinga APIs

Predictive Oncology to launch ChemoFx assay in Europe By Investing.com

PITTSBURGH - Predictive Oncology Inc. (NASDAQ: NASDAQ:POAI), a company specializing in artificial intelligence (AI)-driven drug discovery with a current market capitalization of $7.93 million, announced its intention to introduce its ChemoFx® live cell drug response assay in Europe, with plans to broaden its availability in the United States. According to InvestingPro data, the company's stock has shown strong momentum with a 45% gain year-to-date, despite current profitability challenges. The assay, which is designed to aid in the selection of chemotherapies for ovarian and other gynecological cancers, quantifies how an individual patient's tumor cells react to various chemotherapeutic agents in vitro. The ChemoFx® assay is part of Predictive Oncology's platform that employs AI to create predictive models of drug response. These models aim to improve the efficiency of the drug discovery process by reducing associated risks. "The drug response results are critical to our live tumor cell platform," said Dr. Arlette Uihlein, Senior Vice President of Translational Medicine and Medical (TASE:PMCN) Director at Predictive Oncology. She highlighted the potential application of data sets from these models in clinical trial design, biomarker discovery, and companion diagnostic development. In the United States, nearly 115,000 new cases of gynecological cancer are diagnosed annually, with over 34,000 deaths. In Europe, the number of cases diagnosed each year is estimated at 250,000. Predictive Oncology boasts a biobank with approximately 150,000 live cell tumor samples, nearly half of which are gynecological cancers, with ovarian cancer specimens making up half of that group. While maintaining a healthy gross profit margin of 46%, InvestingPro analysis indicates the company is currently operating below its Fair Value, suggesting potential upside for investors who can tolerate the risks associated with early-stage biotech companies. The company's AI and machine learning platform has been validated against 175 FDA-approved drugs and 130 primary samples from ovarian tumors. CEO Raymond (NS:RYMD) Vennare emphasized the significance of the biobank for drug discovery and the role of ChemoFx® in personalized treatment and the development of AI-driven clinical decision support tools in oncology. He also noted the potential for significant revenue, recalling that ChemoFx® previously generated over $25 million annually in gross revenues. Predictive Oncology harnesses its proprietary AI/ML platform and extensive biobank to support drug discovery and development. The company is headquartered in Pittsburgh, PA, and operates a wholly owned CLIA laboratory facility. For a deeper understanding of POAI's financial health and growth prospects, investors can access comprehensive analysis and additional ProTips through InvestingPro, which offers detailed insights into the company's valuation metrics and future potential. This expansion into the European market represents Predictive Oncology's ongoing commitment to enhancing cancer treatment options through the integration of AI into personalized medicine. The information for this article is based on a press release statement. In other recent news, Predictive Oncology Inc. has been navigating substantial developments. The medical device company reported a decrease in Q2 2024 revenues from $490,000 to $279,000 compared to the same quarter in the previous year, but managed to reduce its net loss per share from $0.98 to $0.68. The company has also been notified by Nasdaq for non-compliance with the exchange's minimum stockholders' equity requirement and its stock price falling below the minimum bid price requirement. Following its Annual Meeting of Stockholders, Predictive Oncology announced the election of two Class III directors and the ratification of KPMG LLP as its independent auditor. However, a non-binding advisory resolution on the compensation of the company's named executive officers did not pass. The shareholders also approved the 2024 Equity Incentive Plan. The company has completed a significant ovarian cancer study with UPMC Magee-Womens Hospital and launched a 3D cell culture technology. It confirmed the long-term stability of its biobank's cryopreserved patient tumor samples, an important factor in predicting patient outcomes and personalizing therapies. Predictive Oncology has also expanded its artificial intelligence and machine learning capabilities for biomarker discovery and implemented cost reduction measures such as consolidating operations in Pittsburgh.