Financial Performance - The company reported a loss from continuing operations of approximately $2.3 million on total revenue of $110,310 for Q1 2025, compared to a loss of $3.6 million in Q1 2024[1][11] - Revenue increased significantly from $4,858 in Q1 2024 to $110,310 in Q1 2025, primarily due to the completion of a tumor-specific 3D model[8][11] - Loss per common share from continuing operations improved to $0.32 in Q1 2025 from $0.88 in Q1 2024[8][11] Cash and Expenses - The company concluded Q1 2025 with $3.1 million in cash and cash equivalents, up from $611,822 as of December 31, 2024[8] - General and administrative expenses decreased by $497,464 to $1,828,200 in Q1 2025, compared to $2,325,664 in Q1 2024[8][11] - Net cash used in operating activities decreased to $985,840 in Q1 2025 from $2.7 million in Q1 2024, reflecting lower cash operating losses[8] Product Development and Partnerships - The company identified three promising compounds for repurposing in new cancer indications, including Afuresertib for breast cancer and Alisertib for colon cancer[4] - The company launched its ChemoFx drug response assay in Europe and expanded its availability in the United States, initially focusing on ovarian and gynecological cancers[3][4] - The company partnered with Tecan Group Ltd. to expand high-throughput drug screening capabilities using human tumor spheroids[4] Strategic Focus - The company completed the sale of Skyline Medical assets to DeRoyal Industries, which sharpened its focus on core AI-driven drug discovery capabilities[4]

PITTSBURGH, May 15, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), a science- driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended March 31, 2025, and provided a corporate update. The Company reported a loss from continuing operations of approximately ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________________ to _________________________ Commission File Number: 001-36790 Predictive Oncology Inc. (Exact name of registrant as specified in it ...

New indications discovered by applying active machine learning and using samples from the company's vast biobank of live-cell tumors specimens "This efficient screening approach on a small, curated cohort of abandoned drugs identified three compounds that warrant further exploration in tumor indications that have never been examined in this way," said Dr. Arlette Uihlein, SVP of Translational Medicine and Drug Discovery and Medical Director at Predictive Oncology. "The work that we have done successfully de ...

Financial Performance - For the year ended December 31, 2024, Predictive Oncology reported a loss from continuing operations of approximately $10.8 million on total revenue of $1.6 million[1] - The company recorded revenue of $1,623,817 in 2024, a slight decrease from $1,627,697 in 2023, primarily derived from its Eagan operating segment[9] - Basic and diluted net loss per common share from continuing operations decreased approximately 33% to $1.99 in 2024, compared to $2.99 in 2023[9] - Cash and cash equivalents decreased to $734,673 as of December 31, 2024, down from $8.7 million as of December 31, 2023[9] - General and administrative expenses decreased by $961,025 to $7,419,892 in 2024 from $8,380,917 in 2023, primarily due to lower employee-related expenses[9] Strategic Initiatives - The company announced an agreement to merge with Renovaro, which is expected to enhance its AI/ML drug discovery capabilities[2] - Predictive Oncology plans to launch its ChemoFx drug response assay in Europe, initially focusing on ovarian and other gynecological cancers[5] Revenue Growth - The Eagan operating segment contributed $1,539,005 in revenue for 2024, compared to $1,135,101 in 2023, indicating growth in this segment[9] Financing Activities - Predictive Oncology received more than $3.0 million in combined gross proceeds during the first three months of 2025 from various financing activities[5] Asset Management - The company completed the sale of assets related to its subsidiary, Skyline Medical Inc., to DeRoyal Industries, which is expected to reduce ongoing expenses significantly[5]

PITTSBURGH, April 01, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ:POAI), a science- driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory, to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended December 31, 2024, and provided a corporate update. The Company reported a loss from continuing operations of approxim ...

Drug Discovery and Development - The company operates a proprietary biobank of over 150,000 tumor samples to enhance drug discovery and increase the probability of drug compound success [14]. - The PEDAL platform, an AI-driven solution, aims to provide high-confidence drug-response predictions and is designed to improve clinical success rates in drug development [24][42]. - The company’s 3D tumor-specific models are utilized for oncology drug discovery, providing drug response predictions with high correlation to clinical outcomes [29]. - The AI-driven models address a key unmet need in the pharmaceutical and biotech industries for actionable insights into cancer treatment [27]. - The company aims to leverage its unique historical database to enhance drug discovery and improve patient outcomes through its proprietary solutions [25][28]. - The global market for AI in drug development is expected to grow due to increasing demand for efficient and accurate drug discovery processes [41]. - The company has a competitive advantage due to access to a unique biobank with tumor drug responses and genomics data, which enhances drug response prediction capabilities [48]. - It is estimated that 90-95% of oncology drug compounds fail between the first human dose and commercial launch, highlighting the challenges in drug discovery [47]. - The company holds exclusive worldwide licenses for its CORE computational drug discovery platform, protected by multiple patents [56]. - The 3D modeling technology replicates the human tumor microenvironment, providing high correlation with clinical responses and enhancing drug testing accuracy [57]. Financial Performance - Revenue for the year ended December 31, 2024, was $1,623,817, a slight decrease of $3,880 compared to $1,627,697 in 2023 [192]. - The company incurred net losses of $12,664,388 and $13,983,967 for the years ended December 31, 2024, and 2023, respectively [188]. - As of December 31, 2024, the company had an accumulated deficit of $180,426,271, up from $167,761,883 as of December 31, 2023 [188]. - The Eagan segment contributed 95% and 70% of the company's revenues from continuing operations for the years ended December 31, 2024, and 2023, respectively [185]. - Cost of sales increased to $826,137 in 2024 from $609,212 in 2023, resulting in a gross profit margin decline to 49% from 64% [193]. - General and administrative expenses decreased by $961,025 to $7,419,892 in 2024, primarily due to lower employee-related expenses and legal fees [194]. - Operations expenses decreased by $417,120 to $2,851,045 in 2024, mainly due to reduced employee-related costs and lower research and development expenses [195]. - Sales and marketing expenses decreased by $20,926 to $1,466,213 in 2024, attributed to reduced staff-related expenses and changes in commission structure [196]. - Other income decreased to $89,367 in 2024 from $152,685 in 2023, primarily due to lower cash balances earning interest [197]. - Net cash used in operating activities was $10,974,568 in 2024, a decrease from $11,784,070 in 2023, due to lower cash operating losses [201]. - Cash and cash equivalents decreased by $7,994,732 to $734,673 as of December 31, 2024 [200]. - The company incurred an accumulated deficit of $180,426,271 as of December 31, 2024, raising concerns about its ability to continue as a going concern [205]. Strategic Initiatives and Transactions - A strategic cost savings initiative was implemented, resulting in the discontinuation of the Birmingham laboratory segment, which was reported as discontinued operations in Q3 2024 [16]. - The company entered into a binding letter of intent with Renovaro, Inc. for a stock exchange transaction, with a minimum fundraising requirement of $15 million by Renovaro [17][18]. - The company divested its Eagan segment, including the STREAMWAY® System, as of March 14, 2025, which was involved in automated medical fluid waste management [19][38]. - The divestiture of the STREAMWAY product line resulted in a significant decrease in revenue, contributing 95% and 70% of revenues from continuing operations for the years ended December 31, 2024 and 2023, respectively [79]. - The proposed acquisition by Renovaro is subject to satisfactory due diligence and further negotiation, with no assurance of completion [70]. - The company raised $3.58 million in net proceeds through an at-the-market offering in May 2024 and $1.0 million in July 2024 through cash exercises of certain outstanding warrants [78]. - On January 1, 2025, the company entered into a binding letter of intent for Predictive Oncology to be acquired by Renovaro in exchange for preferred stock [180]. - The company raised approximately $545,004 from a registered direct offering of 363,336 shares at a price of $1.50 per share on February 19, 2025 [182]. Regulatory and Compliance Risks - The company is subject to extensive and frequently changing regulations, which could impact its operations and financial performance [60]. - The FDA Modernization Act 2.0 is expected to increase the use of non-animal testing methods, which may lead to market growth due to more efficient and predictive models [44]. - Regulatory scrutiny from the FDA and other authorities is intense, with potential consequences for non-compliance including fines and operational restrictions [113]. - Proposed changes to FDA regulations on Laboratory Developed Tests (LDTs) could result in substantial costs and delays for the company [115]. - Compliance with numerous federal and state regulations is costly and time-consuming, with risks of significant penalties for violations [119]. - The company is subject to strict laboratory licensing requirements, and failure to comply could disrupt operations and adversely affect financial performance [118]. - Liability for hazardous materials used in operations could lead to significant damages and remediation costs, impacting financial stability [121]. - The company is subject to evolving healthcare regulations, which could adversely affect its financial condition and operations [123]. Operational Challenges - The company relies on sole suppliers for certain materials, which poses a risk of interruptions in molecular diagnostic test processing if these suppliers fail [52]. - The company has limited operating history in drug discovery and development, making it difficult to evaluate performance and future prospects [86]. - The company has committed significant capital to developing drug discovery solutions and may need to raise additional capital to continue these investments [87]. - Scaling operations for molecular diagnostic tests may face challenges, potentially leading to supply interruptions and limiting revenue growth [93]. - Difficulties in meeting market demand or quality standards could harm the company's reputation and future business prospects [95]. - The company faces risks related to employee retention and potential disruptions to business relationships during the acquisition process [71]. - The company is dependent on key executive officers, and losing them could impede business plans and growth strategies [96]. Intellectual Property and Cybersecurity - Intellectual property rights are crucial for the company's operations, and failure to protect these rights could adversely affect competitive positioning [99]. - Changes in patent law and potential patent term limitations could impact the company's ability to enforce patent rights and reduce revenue from products [105]. - The implementation of the AIA has increased uncertainties and costs related to patent applications and enforcement, affecting both existing and future patents [108]. - Changes in U.S. patent laws could weaken the ability to obtain and enforce patents, with potential adverse effects on business operations [109]. - The company may face claims regarding the wrongful use of confidential information, which could lead to significant legal expenses and distract management [110]. - Enforcement of intellectual property rights may be challenging in foreign jurisdictions, particularly in developing countries, impacting the ability to stop patent infringements [111]. - The introduction of the Unified Patent Court in Europe could lead to vulnerabilities in patent enforcement, with potential for widespread revocation challenges [112]. - Cybersecurity risks are a critical concern, with measures in place to protect sensitive data and respond to incidents, although breaches could still disrupt operations and harm reputation [150][155]. - The company's cybersecurity program includes governance, technical safeguards, employee education, and third-party risk management to mitigate threats [156][157]. - The Senior Director of IT and Cybersecurity leads efforts to monitor and respond to cybersecurity threats, ensuring compliance with security standards and effective incident management [160]. Stock and Market Risks - The company received a notice from Nasdaq on November 20, 2024, indicating that its stockholders' equity of $1,966,969 was below the required minimum of $2.5 million [131]. - The company submitted a plan to Nasdaq on January 6, 2025, to regain compliance with the Stockholders' Equity Requirement, citing a proposed merger with Renovaro [131]. - The company executed a 20-for-1 reverse stock split on April 23, 2023, which resulted in a significant increase in stock price and regained compliance with Nasdaq's Minimum Bid Price Requirement [129]. - The company has no plans to pay cash dividends in the foreseeable future, intending to retain earnings for business development and expansion [138]. - The company was notified on September 19, 2024, that it did not meet the Minimum Bid Price Requirement, with a deadline to regain compliance by March 18, 2025 [130]. - The company may face additional costs if the exclusive forum provision in its certificate of incorporation is found to be unenforceable [126]. - The company may experience dilution from future equity offerings, which could negatively impact the price of its common stock [135]. - The company has been granted extensions by Nasdaq to regain compliance with listing requirements, contingent upon the completion of its merger with Renovaro [131]. - The board of directors has the authority to issue up to 20 million shares of preferred stock, with 2,300,000 designated as series B convertible preferred stock, of which only 79,246 shares are currently outstanding [139]. - The company's stock price may experience significant volatility, influenced by factors beyond its control, potentially leading to substantial investment losses [140]. - Business disruptions from geopolitical events, pandemics, or natural disasters could negatively impact operations, revenue, and costs, with uncertain financial implications [143].

Core Insights - Predictive Oncology Inc. has developed predictive models from 21 unique compounds sourced from the Natural Products Discovery Core at the University of Michigan, marking a significant advancement in AI-driven drug discovery [1][2] Group 1: Drug Discovery and Development - The predictive models were created using an active machine learning platform that aims to reduce the time required for drug candidate selection while enhancing the likelihood of technical success [2] - The Natural Products Discovery Core houses one of the largest pharmaceutically viable natural products libraries in the U.S., with specimens collected from diverse global regions [3] - Natural products have been crucial in drug discovery, with at least 50% of small-molecule drugs approved in the last three decades derived from these compounds [4] Group 2: Testing and Results - Three compounds showed strong tumor drug responses across all tested tumor types, outperforming Doxorubicin, a benchmark anti-cancer drug [5] - The predictive machine learning model was able to make confident predictions covering 73% of all experiments after only 7% of possible wet lab experiments were conducted, potentially saving up to two years of laboratory testing [6] - Initial results were achieved using only about 1% of the available NPDC library, indicating significant potential for further exploration of additional compounds [7] Group 3: Company Overview - Predictive Oncology utilizes a scientifically validated AI platform, PEDAL, which predicts with 92% accuracy whether a tumor sample will respond to a specific drug compound [8] - The company maintains a biobank of over 150,000 assay-capable heterogeneous human tumor samples, providing extensive resources for drug discovery [8]

Core Insights - Predictive Oncology has completed the sale of its subsidiary Skyline Medical to DeRoyal Industries, allowing it to focus on its core AI-driven drug discovery capabilities [1][2] - The transaction is part of Predictive Oncology's strategy to merge with Renovaro Biosciences, enhancing its operational focus [2] Company Overview - Predictive Oncology specializes in AI-driven drug discovery, utilizing machine learning to expedite early drug discovery for cancer treatment [5] - The company operates the PEDAL platform, which predicts with 92% accuracy the response of tumor samples to drug compounds, supported by a biobank of over 150,000 tumor samples [5] - Skyline Medical, the sold subsidiary, markets the STREAMWAY System, a technology for managing hazardous fluids in healthcare settings [3] Transaction Details - The acquisition by DeRoyal Industries includes the STREAMWAY System, which enhances waste fluid management in medical facilities [3][4] - DeRoyal aims to integrate the STREAMWAY product line into its offerings, improving its position in healthcare waste management solutions [4] - The transaction was structured as an asset sale, with all necessary approvals obtained prior to completion [4] Strategic Implications - The sale allows Predictive Oncology to concentrate on its primary mission of advancing AI in drug discovery, while DeRoyal expands its product portfolio [1][4] - The restructuring plan implemented for Skyline Medical aimed to improve its operating metrics and profitability before the sale [4]

Core Insights - Predictive Oncology has received the first tranche of financing from Renovaro Biosciences to integrate AI/ML platform technologies and enhance laboratory capabilities in Europe and the United States [1] - The strategic acquisition of BioSymetrics by Renovaro significantly expands Predictive's biomarker and drug discovery opportunities, particularly in oncology diagnostics [1][2] - The merger is expected to enhance shareholder value, accelerate business development, and solidify the companies' positions in capital markets [1] Company Overview - Predictive Oncology is a leader in AI-driven drug discovery, utilizing a vast biobank of over 150,000 patient tumor samples and a scientifically validated AI/ML platform that predicts drug response with 92% accuracy [7][8] - Renovaro aims to accelerate precision and personalized medicine through AI and biotechnology platforms, focusing on early diagnosis and targeted treatments [5][6] - Renovaro Cube, a subsidiary of Renovaro, has developed an award-winning AI platform for early cancer detection and monitoring, leveraging multi-omics and multi-modal data [6] Strategic Developments - The companies are committed to improving cancer patient outcomes through earlier diagnosis and targeted therapies by integrating their respective technologies and data [2][3] - The merger discussions are ongoing, with expectations to sign a definitive agreement in the coming weeks, despite the complexities involved in combining their technologies and teams [4]