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]

Core Viewpoint - Predictive Oncology Inc. has successfully closed a registered direct offering of 363,336 shares of common stock at a price of $1.50 per share, generating gross proceeds of approximately $545,004 before expenses [1][2]. Company Overview - Predictive Oncology is a leader in AI-driven drug discovery and biologics, utilizing its AI platform, PEDAL, which predicts with 92% accuracy the response of tumor samples to drug compounds [5]. - The company has a biobank of over 150,000 assay-capable heterogeneous human tumor samples, providing extensive AI-based drug discovery solutions [5]. - Predictive Oncology is headquartered in Pittsburgh, PA [5]. Offering Details - The offering was conducted under a "shelf" registration statement declared effective by the SEC on May 21, 2024, and the final prospectus supplement was filed on February 19, 2025 [3]. - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [1].

Core Viewpoint - Predictive Oncology Inc. has announced a registered direct offering of 363,336 shares of common stock at a price of $1.50 per share, aiming to raise approximately $545,004 before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on or about February 19, 2025, pending customary closing conditions [1]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2]. - The net proceeds from the offering will be used for working capital and general corporate purposes [2]. Group 2: Regulatory Information - The shares are being offered under a "shelf" registration statement on Form S-3, which was declared effective by the SEC on May 21, 2024 [3]. - A final prospectus supplement and accompanying prospectus will be filed with the SEC [3]. Group 3: Company Overview - Predictive Oncology is focused on AI-driven drug discovery and biologics, utilizing its AI platform, PEDAL, which predicts with 92% accuracy the response of tumor samples to drug compounds [5]. - The company has a biobank of over 150,000 assay-capable heterogeneous human tumor samples, providing extensive AI-based drug discovery solutions [5]. - Predictive Oncology is headquartered in Pittsburgh, PA [5].

Core Viewpoint - Predictive Oncology Inc. has successfully identified several abandoned or discontinued drugs for further testing and development, particularly in ovarian and other cancer types, creating significant business development opportunities with large pharmaceutical companies [1][6]. Group 1: Drug Repurposing Initiative - The company has developed a registry of promising drug candidates that can potentially be repurposed for additional or alternative indications using publicly available datasets [2]. - By leveraging its proprietary AI and machine learning platform, along with a vast biobank of primary tumor samples, Predictive has identified drug candidates with promising mechanisms of action for clinical testing, focusing initially on ovarian, colon, and breast cancer [3][5]. - Early results from the AI platform indicate that it can predict an additional 10 times the number of measured experiments, significantly reducing the time required for wet lab testing and identifying two drugs that outperformed a known standard of care for colon cancer [4]. Group 2: Market Potential and Growth - The market for repurposed drugs is projected to grow from $32.1 billion in 2023 to $51.8 billion by 2033, representing a compound annual growth rate (CAGR) of 4.5% [6]. - The company believes that repurposing approved or abandoned drugs for additional indications offers a meaningful opportunity to develop new therapies faster and at a lower cost compared to traditional drug discovery methods [6]. Group 3: Technological Capabilities - Predictive Oncology's AI platform, PEDAL, has a prediction accuracy of 92% regarding tumor response to specific drug compounds, enhancing the selection process for drug/tumor type combinations for further testing [8]. - The company possesses a biobank of over 150,000 assay-capable heterogeneous human tumor samples, providing one of the industry's broadest AI-based drug discovery solutions [8].

Core Insights - Predictive Oncology Inc. announced positive results from a study in collaboration with Tecan, presented at the 2025 SLAS International Conference, focusing on the use of patient-derived tumor spheroids for drug discovery [1][4] Group 1: Company Overview - Predictive Oncology is a leader in AI-driven drug discovery and biologics, utilizing a vast biobank of cryopreserved live cell tumor specimens [1][9] - The company’s AI platform, PEDAL, predicts with 92% accuracy whether a tumor sample will respond to specific drug compounds, enhancing drug selection processes [9] - Tecan, a partner in the study, is a global leader in laboratory automation, with 2023 sales of CHF 1,074 million (approximately USD 1,194 million) [7] Group 2: Research and Development - The study utilized patient-derived tumor models (PDTMs) to develop personalized therapies, addressing challenges in accessibility and scalability of primary tumor cells through cryopreserved dissociated tumor cells (DTCs) [2][5] - Optimized growth conditions and drug treatment protocols were established for tumor models derived from cryopreserved DTCs, demonstrating that 3D models are more representative of in vivo conditions compared to 2D models [3] - The research highlights the importance of monitoring tumor growth and drug response through advanced imaging techniques and automated analysis [6] Group 3: Market Insights - The high throughput screening (HTS) market is projected to reach $69.5 billion by 2032, with a compound annual growth rate (CAGR) of 12.18%, driven by the adoption of 3D cell cultures and organoids [4]

Core Insights - Predictive Oncology Inc. plans to launch its ChemoFx® drug response assay in Europe, focusing on gynecological cancers, particularly ovarian cancer, while expanding its availability in the United States [1][3] - The ChemoFx® assay quantifies individual cancer patients' tumor responses to various chemotherapeutic agents, aiding in personalized treatment selection [2][4] - The company has a biobank of approximately 150,000 live cell tumor samples, with nearly half being gynecological cancers, which supports its AI-driven drug discovery platform [4][6] Company Overview - Predictive Oncology utilizes AI and machine learning to enhance biomarker and drug discovery, achieving a 92% accuracy rate in predicting tumor responses to drug compounds [6] - The ChemoFx® assay previously generated over $25 million in annual gross revenues when first introduced to the market, indicating its potential for significant revenue generation [5] - The company is headquartered in Pittsburgh, PA, and operates a CLIA laboratory to support its drug discovery solutions [6]

Acquisition provides access to critical resources encompassing a biobank of more than 150,000 tumor specimens, 200,000 pathology slides and decades of longitudinal drug response data Data provides a critical pathway to progress AI using the high-speed computing power provided through collaboration with Nebul Combines Predictive Oncology's AI-driven multi-omic drug discovery platform with Renovaro's AI Cube multi-omic artificial intelligence to advance both cancer diagnostics and early drug discovery Planne ...