Core Insights - Predictive Oncology Inc. has announced a $10 million Securities Purchase Agreement to support its strategic growth initiatives, particularly the expansion of ChemoFx in the U.S. and its launch in Europe [1][13][14] - ChemoFx is a proprietary live-cell tumor profiling assay that provides personalized chemotherapy guidance by testing multiple chemotherapies on a patient's cancer cells [2][3] - The company has a biobank of over 150,000 tumor samples, which enhances its drug response data and supports recurring revenue opportunities [3][9] ChemoFx Expansion - The groundwork for expanding ChemoFx in the U.S. is underway, with discussions ongoing with potential channel partners and pharmaceutical manufacturers [3] - Future developments of ChemoFx are expected to extend beyond gynecological cancers to include breast, colon, and lung cancers [4] High-Throughput Screening Market - The high-throughput screening market is projected to reach $69.5 billion by 2032, with a compound annual growth rate (CAGR) of 12.18%, indicating a growing adoption of 3D cell cultures for more relevant screening models [6] AI-Driven Drug Discovery - The company is advancing its AI-driven drug discovery initiatives, which include biomarker discovery and drug repurposing, leveraging its extensive biobank [8][9] - Successful collaborations, such as with UPMC Magee-Womens Hospital, have led to the development of AI-powered models that predict survival outcomes in ovarian cancer patients [10][11] Drug Repurposing Initiatives - The company has identified three drug candidates for re-evaluation in ovarian and colon cancer through active machine learning, showcasing its potential in transitioning shelved drug candidates back into clinical development [12] Funding and Financial Strategy - The Securities Purchase Agreement with Yorkville Advisors provides an efficient and flexible funding source, allowing the company to opportunistically sell shares when market conditions are favorable [13][14] - The company views this agreement as a partnership that will support its vision and growth strategy [14] Company Overview - Predictive Oncology is at the forefront of using AI and machine learning to expedite drug discovery, with a platform that predicts tumor responses with 92% accuracy [16]

Core Insights - Predictive Oncology Inc. has entered into a standby equity purchase agreement (SEPA) with YA II PN, LTD, managed by Yorkville Advisors Global, LP, to secure funding for its drug discovery initiatives [1][2] - The SEPA allows Predictive Oncology to sell up to $10 million worth of its stock at its discretion, with no minimum commitments or penalties for non-use [2] - The company leverages its AI-driven platform, PEDAL, which predicts drug response with 92% accuracy, enhancing drug discovery for cancer treatment [4] Funding Agreement - The SEPA provides Predictive Oncology with a flexible funding source to support ongoing drug discovery, biomarker discovery, and drug repurposing efforts [1] - Yorkville is obligated to purchase the stock, but Predictive Oncology controls the timing and amount of sales [2] - There are no associated warrants, derivatives, or other share classes with the SEPA, and it does not restrict the company's operational activities [2] Company Overview - Predictive Oncology specializes in AI and machine learning applications in drug discovery, aiming to expedite the development of cancer treatments [4] - The company has a biobank of over 150,000 tumor samples, enhancing its drug discovery capabilities [4] - Predictive Oncology is headquartered in Pittsburgh, PA, and offers one of the industry's broadest AI-based drug discovery solutions [4]

Core Insights - Predictive Oncology Inc. has developed 3D organoid models for Labcorp to enhance drug discovery and preclinical analysis of cancer therapies [1][2][3] - The new models include human and rat liver toxicity models that simulate the liver microenvironment for evaluating drug metabolism and toxicity [2][3] - These organoid models aim to predict in vivo drug clearance, transport, and hepatotoxicity, providing species-specific data that captures hepatic cellular heterogeneity [3][4] Company Developments - The 3D organoid models complement Predictive Oncology's existing AI-driven 2D platform and 3D spheroids, which utilize a biobank of over 150,000 frozen tumor samples [3][6] - The company’s AI platform, PEDAL, predicts with 92% accuracy whether a tumor sample will respond to specific drug compounds, aiding in informed drug selection [6] Industry Trends - The use of organoid-based platforms is seen as a key driver in transforming healthcare, accelerating drug development, and reducing reliance on animal models [4] - There is a growing investment in personalized medicine and biotechnology, with organoids offering cost-effective and high-fidelity alternatives to traditional research methods [4]

Core Viewpoint - Predictive Oncology Inc. is engaged in a legal dispute with Renovaro, Inc., with the Delaware Court of Chancery rejecting RENB's request for an expedited trial, citing delays in RENB's actions [1][2]. Company Overview - Predictive Oncology is a leader in AI-driven drug discovery, utilizing its AI platform, PEDAL, which predicts with 92% accuracy whether a tumor sample will respond to specific drug compounds [3]. - The company has a biobank of over 150,000 assay-capable heterogeneous human tumor samples, providing extensive AI-based drug discovery solutions [3]. - Predictive Oncology is headquartered in Pittsburgh, PA, and operates a wholly owned CLIA laboratory facility [3]. Legal Proceedings - The court has scheduled the trial for November 12-13, 2025, and Predictive Oncology intends to defend against RENB's claims, which are deemed inaccurate and without merit [2].

Core Viewpoint - Renovaro Inc. has initiated legal action against Predictive Oncology Inc. to enforce a merger agreement, alleging breaches of contract and seeking specific performance and damages [1][4]. Group 1: Legal Proceedings - Renovaro filed a lawsuit on May 9, 2025, in the Delaware Court of Chancery against Predictive Oncology to enforce a merger agreement executed on January 1, 2025 [1]. - The court has ruled to expedite the trial for this lawsuit, which is pending under Case No. 2025-0509 [4]. - Renovaro claims that Predictive Oncology breached the agreement by conducting a public offering of $545,000 in securities on February 19, 2025, and later attempted to unilaterally terminate the agreement on April 3, 2025 [3]. Group 2: Financial Impact - Following the public disclosure of the merger agreement on January 6, 2025, Predictive Oncology's stock price increased by over 50% [2]. - The litigation seeks specific performance, injunctive relief, and damages for the alleged breaches, indicating potential financial implications for both companies [4]. Group 3: Company Background - Renovaro Inc. focuses on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, aiming to accelerate precision and personalized medicine [5]. - The company includes subsidiaries such as RenovaroBio, which specializes in advanced cell-gene immunotherapy, and RenovaroCube, leveraging AI for diagnostics and drug development [5].

Core Viewpoint - Renovaro Inc. has initiated legal action against Predictive Oncology Inc. to enforce a merger agreement, alleging breaches of contract and seeking specific performance and damages [1][4]. Group 1: Legal Proceedings - Renovaro filed a lawsuit on May 9, 2025, in the Delaware Court of Chancery against Predictive Oncology to enforce a merger agreement executed on January 1, 2025 [1]. - The court has ruled to expedite the trial for this lawsuit, which is pending under Case No. 2025-0509 [4]. - Renovaro claims that Predictive Oncology breached the agreement by conducting a public offering of $545,000 in securities on February 19, 2025, and later attempted to unilaterally terminate the agreement [3]. Group 2: Financial Impact - Following the public disclosure of the merger agreement on January 6, 2025, Predictive Oncology's stock price increased by over 50% [2]. - The litigation seeks specific performance, injunctive relief, and damages for the alleged breaches, indicating potential financial implications for both companies [4]. Group 3: Company Background - Renovaro Inc. focuses on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, aiming to accelerate precision and personalized medicine [5]. - The company includes subsidiaries such as RenovaroBio, which specializes in advanced cell-gene immunotherapy, and RenovaroCube, leveraging AI for diagnostics and drug development [5].

Core Insights - Predictive Oncology Inc. is leveraging over 150,000 live cell tumor samples and drug response data to enhance drug discovery and biomarker identification using AI and machine learning [1][12] - Regeneron Pharmaceuticals' acquisition of 23andMe for $256 million signifies a strategic shift towards data-driven drug discovery, emphasizing the value of genomic databases in therapeutic development [2][5] - 23andMe's extensive genomic dataset provides insights into disease progression and treatment efficacy, making it a valuable asset for precision drug development [3][4] Company Developments - Predictive Oncology has achieved a milestone in AI-enabled cancer drug discovery by developing predictive tumor response models for 21 previously untested molecules targeting common cancer types [7][8] - The company's AI platform, PEDAL, predicts with 92% accuracy whether a tumor sample will respond to a specific drug compound, facilitating informed drug selection for testing [11][12] - The integration of AI and machine learning with real-world drug response data allows Predictive Oncology to expedite early-stage drug discovery and reduce risks in drug development [9][10] Industry Trends - The acquisition of 23andMe by Regeneron reflects a broader trend in the biopharma industry towards the convergence of AI, real-world data, and predictive analytics to enhance therapeutic outcomes [5][10] - The life sciences sector is undergoing a transformation where the integration of genomics and machine learning is becoming a foundational element in precision medicine [10]

Core Insights - Predictive Oncology is expanding its AI-driven drug discovery platform to include biomarker discovery and drug repurposing, positioning itself as a leader in precision oncology innovation [1][7] - The global biomarker discovery market is valued at $14.5 billion in 2024, with a projected growth rate of 19.4% CAGR through 2030, indicating significant market potential for the company [1][7] Company Developments - The company has developed AI-powered multi-omic machine learning models in collaboration with UPMC Magee-Womens Hospital, which predict survival outcomes in ovarian cancer patients, outperforming traditional clinical data models [3][4] - Predictive Oncology has identified novel ovarian cancer biomarkers linked to patient survival and drug response using advanced deep learning methods, enhancing its capabilities in biomarker discovery [6][7] - The company is actively refining its survival prediction models for integration into clinical practice at leading cancer centers worldwide, particularly for high-grade serous ovarian cancer [5][6] Drug Discovery and Repurposing - The company addresses high clinical trial failure rates in oncology by integrating real-world diversity from its biobank of 150,000 tumor samples, which enhances the Probability of Technical Success (PTS) in drug discovery [9][10] - Predictive Oncology has identified three candidates for re-evaluation in ovarian and colon cancer from previously abandoned oncology drugs, showcasing its drug repurposing capabilities [11][12] Product Expansion - The company plans to expand its flagship assay, ChemoFx®, into Europe and broaden its availability in the United States, which provides personalized treatment selection based on live-cell tumor profiling [13][14] - ChemoFx® works alongside the BioSpeciFx® molecular biomarker portfolio to help oncologists determine effective chemotherapy options for patients, initially focusing on gynecologic cancers [14] Future Outlook - The progress made in 2024 lays a strong foundation for future growth, with the company positioned to lead advancements in precision oncology through its AI innovation and proprietary data [15]

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]

Core Viewpoint - Predictive Oncology reported a loss from continuing operations of approximately $2.3 million on total revenue of $110,310 for Q1 2025, highlighting the company's ongoing focus on leveraging AI and machine learning for drug discovery and development [1][9]. Q1 2025 and Recent Highlights - The company expanded its AI and machine learning platform to identify abandoned drugs with potential for new cancer indications, aiming to repurpose existing clinical candidates [3][5]. - The launch of the ChemoFx drug response assay in Europe and expanded availability in the U.S. is a significant step towards personalized cancer care, initially focusing on ovarian and gynecological cancers [3][5]. - The sale of Skyline Medical assets to DeRoyal Industries has allowed the company to concentrate on its core AI-driven capabilities while reducing cash usage [3][5]. - A partnership with Tecan Group Ltd. aims to enhance high-throughput drug screening using human tumor spheroids [5]. Q1 2025 Financial Summary - The company recorded revenue of $110,310 for Q1 2025, a significant increase from $4,858 in the same period in 2024, primarily due to the completion of a tumor-specific 3D model [9][11]. - General and administrative expenses decreased by $497,464 to $1,828,200, while research and development expenses decreased by $109,679 to $520,406 [9][12]. - The net cash used in operating activities decreased to $985,840 in Q1 2025 from $2,709,688 in Q1 2024, reflecting lower cash operating losses [9]. Financial Results - The company concluded Q1 2025 with $3.1 million in cash and cash equivalents, up from $611,822 as of December 31, 2024 [9][10]. - Basic and diluted loss per common share from continuing operations was $0.32, compared to $0.88 for the same quarter in 2024 [9][11]. - The total net loss for Q1 2025 was $2,442,873, a reduction from $4,218,843 in Q1 2024 [11].