Predictive Oncology Inc. Issues Shareholder Letter Titled, "Revolutionizing Medicine: AI-Driven Biomarker and Drug Discovery for Precision Health"

Rhea-AI Summary

Predictive Oncology (NASDAQ: POAI) has shared significant progress in its AI-driven drug discovery and biomarker development initiatives. The company has achieved key milestones including: successful development of AI-powered survival prediction models for ovarian cancer in collaboration with UPMC Magee-Womens Hospital, identification of novel cancer biomarkers, and expansion of their ChemoFx® assay into Europe. The company leverages its biobank of 150,000 tumor samples across 137 cancer types to validate AI drug response predictions. Operating in the biomarker discovery market, valued at $14.5 billion in 2024 with projected 19.4% CAGR through 2030, POAI is exploring strategic partnerships and advancing drug repurposing initiatives, having identified three promising candidates for ovarian and colon cancer treatment.

Positive

• Successfully developed AI-powered survival prediction models for ovarian cancer that outperform traditional clinical data models
• Access to extensive biobank with 150,000 tumor samples across 137 cancer types
• Expansion of ChemoFx® assay into European markets
• Identified three potential drug candidates through repurposing initiative for ovarian and colon cancer
• Operating in high-growth biomarker discovery market ($14.5B with 19.4% CAGR)

Negative

• High clinical trial failure rates in oncology, particularly in Phases II and III
• Currently focused primarily on gynecologic cancers, indicating limited market reach

Insights

AI and Healthcare Technology Analyst

POAI expands AI platform to biomarker discovery and drug repurposing, targeting $14.5B market growing at 19.4% CAGR through 2030.

Predictive Oncology's shareholder letter reveals a strategic pivot beyond their core AI-driven drug discovery platform. The company is now leveraging their proprietary biobank of 150,000 tumor samples across 137 cancer types to expand into two high-value areas: biomarker discovery and drug repurposing.

Their biomarker discovery initiative stems from a successful collaboration with UPMC Magee-Womens Hospital, where they developed multi-omic machine learning models that outperformed clinical-data-only approaches in predicting ovarian cancer survival outcomes. The company is targeting the $14.5 billion biomarker discovery market, which is projected to grow at a 19.4% CAGR through 2030.

Their drug repurposing capability has already identified three abandoned oncology drug candidates worth re-evaluating for ovarian and colon cancer. This approach potentially offers significant value by revitalizing shelved pharmaceutical assets at a fraction of new drug development costs.

The company's ChemoFx assay, which profiles patient tumors to guide personalized treatment selection, is being expanded into Europe while broadening U.S. availability. This assay not only provides clinical utility but also generates valuable data that feeds back into their AI models, creating a virtuous cycle for their technology platform.

What's particularly compelling is how POAI addresses a critical industry pain point - the late introduction of patient heterogeneity in clinical trials. By integrating real-world tumor diversity at the earliest discovery stages, they potentially improve the Probability of Technical Success (PTS) for drug development programs, addressing the high failure rates in Phase II and III oncology trials.

Latest developments expand Predictive’s AI-driven drug discovery platform to include biomarker discovery and drug repurposing

With the global biomarker discovery market valued at $14.5 billion in 2024 and projected to grow at a 19.4% CAGR through 2030, Predictive Oncology is poised to lead in precision oncology innovation

PITTSBURGH, May 20, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery, today issued the following shareholder update recapping recent progress:

To Our Shareholders,

Thank you for the opportunity to share an update on the progress we're making at Predictive Oncology as we work to position ourselves as a leader—and partner of choice—in the critical and fast-evolving field of AI-driven biomarker and drug discovery.

Today, I am more confident than ever that our unique combination of assets and capabilities—most notably our vast biobank of diverse live-cell tumor specimens—sets us apart in the industry. These advantages provide us with a strong foundation to drive long-term value and play a significant role in shaping the future of cancer treatment, drug development, and clinical decision-making tools.

Advancing Survival Prediction Models in Ovarian Cancer

One of our most important achievements this past year was our collaboration with UPMC Magee-Womens Hospital, where we successfully developed AI-powered multi-omic machine learning models that predict short- and long-term survival outcomes in ovarian cancer patients—outperforming models based solely on clinical data.

These breakthrough results were presented at the prestigious American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024.

The implications are far-reaching. Beyond improving early drug discovery, these models may also enhance clinical decision-making by helping providers tailor treatments to individual patients more effectively—potentially improving patient monitoring, management, and outcomes.

This is particularly important for high-grade serous ovarian cancer, a difficult cancer to treat, where relapse rates after frontline treatment remain high. We are actively refining these models with the goal of integrating them into clinical practice at leading cancer centers worldwide.

Pioneering Biomarker Discovery

Building on the success of the Magee study, we identified novel ovarian cancer biomarkers linked to patient survival and drug response using advanced deep learning methods. These insights were achieved using our existing datasets and tools.

We believe biomarker discovery represents a transformative opportunity for our AI platform—not only in ovarian cancer, but across a wide range of tumor types. According to Grand View Research, the biomarker discovery market reached $14.5 billion in 2024, with expected growth of 19.4% CAGR through 2030. We are actively exploring strategic partnerships with biopharmaceutical companies and healthcare networks to further capitalize on this momentum.

Enhancing Drug Discovery Success

Our efforts in early-stage drug discovery remain core to our mission. With clinical trial failure rates in oncology remaining high, particularly in Phases II and III, we address a critical industry challenge: the late introduction of patient heterogeneity.

By integrating real-world diversity from our biobank of 150,000 tumor samples across 137 cancer types, we validate AI drug response predictions with wet-lab testing in the earliest stages—boosting the Probability of Technical Success (PTS) and improving decision-making for target selection, clinical trial design, and pipeline development.

This capability allows our partners to accelerate timelines, reduce risk, and optimize R&D investments—making it a central component of ongoing business development discussions.

Unlocking Value in Drug Repurposing

A unique and often overlooked advantage of our platform is its ability to repurpose previously abandoned oncology drugs. Recently, we screened a curated set of such compounds using active machine learning and identified three candidates worth re-evaluating in ovarian and colon cancer.

This capability provides enormous value to drug developers by unlocking the potential of shelved assets and efficiently transitioning them back into clinical readiness. We are now applying this approach to a broader range of publicly available compounds.

Expanding ChemoFx® and Personalized Treatment Selection

In January, we announced plans to expand the reach of our flagship assay, ChemoFx®, into Europe and to broaden its availability in the United States. ChemoFx is a live-cell tumor profiling assay that uses a patient’s own cells to measure chemotherapy responses in vitro, providing personalized guidance for treatment selection.

Used alongside our BioSpeciFx® molecular biomarker portfolio, ChemoFx allows oncologists to determine which chemotherapies are most likely to benefit a specific patient—initially focusing on gynecologic cancers with plans to expand to additional tumor types.

This platform directly supports our AI-driven drug discovery initiatives by generating high-quality data that feeds into predictive models and supports biomarker discovery, companion diagnostics, and clinical trial design.

Looking Ahead

The progress we’ve made in 2024 lays a strong foundation for future growth. With a powerful combination of AI innovation, proprietary data, and deep scientific expertise, Predictive Oncology is uniquely positioned to lead the next wave of advancement in precision oncology.

We are grateful to our team—past and present—for their tireless commitment to our mission, and to you, our shareholders, for your continued support. I remain optimistic about the road ahead and look forward to updating you on the exciting opportunities we are actively pursuing.

Sincerely,

Raymond

Raymond Vennare
Chief Executive Officer and Chairman of the Board, Predictive Oncology

About Predictive Oncology

Predictive Oncology is on the cutting edge of the rapidly growing use of artificial intelligence and machine learning to expedite early drug discovery and enable drug development for the benefit of cancer patients worldwide. The company’s scientifically validated AI platform, PEDAL, is able 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 for subsequent in-vitro testing. 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 facility. Predictive Oncology is headquartered in Pittsburgh, PA.

Investor Relations Contact:
Mike Moyer
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward- looking statements reflect Predictive Oncology’s current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about Predictive Oncology’s operations and the investments Predictive Oncology makes. 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. Predictive Oncology’s 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 Predictive Oncology’s filings with the SEC. Except as expressly required by law, Predictive Oncology disclaims any intent or obligation to update these forward-looking statements. Predictive Oncology does not give any assurance that Predictive Oncology will achieve its expectations described in this press release.

FAQ

What is POAI's main competitive advantage in the biomarker discovery market?

POAI's main competitive advantage is its vast biobank of 150,000 diverse live-cell tumor specimens across 137 cancer types, which enables AI drug response predictions and validation through wet-lab testing in early stages.

How is Predictive Oncology (POAI) expanding its market presence in 2025?

POAI is expanding by launching its ChemoFx® assay in Europe, developing AI-powered survival prediction models, and exploring strategic partnerships with biopharmaceutical companies and healthcare networks.

What are the key applications of POAI's ChemoFx® assay?

ChemoFx® is a live-cell tumor profiling assay that helps oncologists determine which chemotherapies will most benefit specific patients, currently focusing on gynecologic cancers with plans for expansion to other tumor types.

What is the market potential for POAI's biomarker discovery business?

The biomarker discovery market was valued at $14.5 billion in 2024 and is projected to grow at a 19.4% CAGR through 2030, presenting significant opportunity for POAI.

What progress has POAI made in drug repurposing?

POAI has identified three promising drug candidates for ovarian and colon cancer through screening previously abandoned oncology drugs using active machine learning.