Onco-Innovations Ltd. (CBOE CA: ONCO) (OTCQB: ONNVF)

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Onco-Innovations Ltd. (CBOE CA: ONCO) (OTCQB: ONNVF) is a research and development clinical-stage oncology company focused on advancing a new class of DNA Damage Response (“DDR”) therapies and developing artificial intelligence-driven precision oncology solutions. The company is engaged in research and development of Polynucleotide Kinase Phosphatase (“PNKP”) inhibitors, an emerging category of DDR therapeutics designed to target DNA repair pathways involved in cancer survival and resistance. Onco-Innovations utilizes AI-enabled technologies to support oncology research, clinical development, patient stratification and evidence generation.

The company’s strategy is centered on building a scalable oncology platform supported by proprietary intellectual property, strategic collaborations and integrated development capabilities. Onco-Innovations has expanded its operational footprint through acquisitions, collaborations and manufacturing initiatives, including the acquisition in February 2025 of Inka Health Corp. and its SynoGraph™ platform, a proprietary causal AI technology designed to support predictive oncology modeling and evidence generation. The company has also established relationships across pharmaceutical development, analytics and clinical research environments as it advances its broader oncology ecosystem.

Alongside its therapeutic and AI-focused initiatives, Onco-Innovations continues to advance manufacturing, regulatory and preclinical programs intended to support future clinical studies. The company’s stated mission is to develop cutting-edge therapies that improve patient outcomes and bring hope in the fight against cancer.

Onco-Innovations Ltd. is headquartered in Calgary, Alberta.

Products and Development Pipeline

Onco-Innovations is advancing ONC010™, a nanoparticle-encapsulated drug candidate built around the company’s proprietary PNKP inhibitor technology. PNKP plays a central role in repairing damaged DNA, and the company’s approach is designed to disrupt these repair mechanisms, resulting in the accumulation of DNA damage within cancer cells.

PNKP represents a novel drug target, with PNKP inhibitors emerging as a new and distinct class of DNA Damage Response cancer therapies. Inhibition of PNKP has been shown to kill tumor cells by sensitizing them to radiation and DNA-damaging chemotherapies, and by exploiting tumors with certain DNA repair defects. The company’s lead program initially focused on the potential to exploit these repair vulnerabilities in biomarker-selected solid tumors and hematologic cancers, with future development planning to incorporate combinations with chemotherapy or radiotherapy. In preclinical testing, PNKP inhibition is active in colorectal cancer, lung cancer, breast cancer, prostate cancer, lymphoma, leukemia, and ovarian cancer.

A key component of ONC010 is its proprietary nanoparticle delivery system, which combines the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier designed to improve drug delivery to tumors. The platform was developed to address historical toxicity and delivery challenges associated with DNA Damage Response inhibitors by extending circulation time, enhancing tumor accumulation and limiting off-target exposure. Preclinical studies have demonstrated tumor reduction, increased median survival and favorable toxicity profiles in animal models, supporting the company’s ongoing efforts to advance the program toward first-in-human clinical studies.¹

To support clinical advancement, Onco-Innovations continues to execute an integrated Chemistry, Manufacturing and Controls (“CMC”) program in collaboration with Dalton Pharma Services while conducting pharmacokinetic and biodistribution studies with Nucro-Technics. Recent activities have included analytical method development, impurity profiling, polymer characterization, manufacturing scale-up, formulation development and validation work designed to support IND-enabling studies and future clinical readiness. The company has also established a subsidiary in Australia to support planned Phase I development activities and regulatory progression through the Therapeutic Goods Administration pathway.

In addition to its therapeutics platform, Onco-Innovations has expanded its capabilities through the acquisition of Inka Health Corp. and its SynoGraph™ platform. The company describes SynoGraph™ as a proprietary causal AI platform designed to support prediction of oncology clinical trial outcomes, treatment efficacy, safety and adverse events through the integration of real-world data, clinical evidence and molecular insights. The platform is intended to support patient stratification, trial design, translational decision-making and evidence generation while helping reduce the time, cost and risk associated with oncology drug development. Through Inka Health, Onco-Innovations has announced collaborations involving AstraZeneca, GlaxoSmithKline and other strategic partners focused on predictive modeling, real-world evidence and AI-enabled oncology research.

Market Opportunity

Onco-Innovations is targeting opportunities across the oncology, precision medicine and DNA Damage Response (“DDR”) therapy markets. Company materials state that DDR inhibitors represented more than $7 billion in global sales during 2025, reflecting growing interest in therapies designed to disrupt cancer cells’ ability to repair damaged DNA. The company believes PNKP inhibitors represent an emerging class within the broader DDR landscape, positioning Onco-Innovations within a rapidly evolving segment of oncology drug development.

The company’s lead therapeutic program will evaluate PNKP inhibition in biomarker-selected solid tumors and hematologic cancers. Beyond monotherapy, Onco-Innovations anticipates combining PNKP inhibitor with chemotherapy and radiation. Onco-Innovations is also actively engaged in extending its PNKP inhibitor technology and related intellectual property, and in expanding its portfolio of cancer therapies.

According to company materials, the global oncology market is projected to approach approximately $500 billion by 2032, representing projected growth of 131% over a 10-year period. The company also cites projections indicating that global cancer cases may rise by 47% by 2040, while the broader oncology market is expected to grow at a compound annual growth rate of 8.9%. A Grand View Research report projects the global precision medicine market could reach approximately $405.1 billion by 2033, growing at a compound annual growth rate of 16.99% from 2026 through 2033.²

Leadership Team

Thomas O’Shaughnessy, Chief Executive Officer, brings more than 25 years of experience across healthcare, life sciences, strategy and operations. A former partner at Deloitte Canada, he previously led national health industry growth initiatives and digital health programs. He is also the founder of Carnarvon Strategies and serves as a senior advisor focused on healthcare and life sciences strategy, operational execution and value creation.

Dave Antony, Vice President, Corporate Finance, brings more than 35 years of experience assisting companies with financial planning, financial reporting, corporate governance, and public company advisory. He has served as a director or officer of numerous public and private companies, and as Chairman of the TSXV Advisory Committee for Alberta and as a member of the TSXV National Advisory Committee.

Dr. Islam Mohamed, Chief Medical Officer, oversees the company’s clinical strategy, including protocol development, medical oversight and regulatory engagement activities. His role includes supporting IND-enabling initiatives and helping guide the advancement of the company’s PNKP inhibitor program into early-stage clinical development while maintaining relationships with investigators, regulators and oncology stakeholders.

Stephen M. Novak, Chief of Research and Development, leads the company’s development operations across manufacturing, preclinical activities, Chemistry, Manufacturing and Controls programs and global program execution. His background includes advancing therapeutic programs through multiple stages of development with experience in GMP and GLP oversight, regulatory readiness and coordination with CRO and CDMO partners.

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1. Sadat et al. A synthetically lethal nanomedicine delivering novel inhibitors of polynucleotide kinase 3′-phosphatase (PNKP) for targeted therapy of PTEN-deficient colorectal cancer.
   J Control Release. 2021 Jun 10;334:335-352. doi:10.1016/j.jconrel.2021.04.034.
2. https://www.grandviewresearch.com/industry-analysis/clinical-diagnostics-market

Forward-Looking Statements Caution

This document contains forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking information herein includes, but is not limited to, statements regarding the Company’s strategy, pipeline development, anticipated clinical progression, regulatory activities, partnerships, market opportunity, and the expected capabilities and impact of its PNKP inhibitor platform and AI-enabled technologies, including SynoGraph™. Such forward-looking information is often identified by words such as “anticipate”, “expect”, “intend”, “plan”, “potential”, “may”, “will”, and similar expressions.

Forward-looking information is based on a number of material assumptions, including assumptions regarding the successful advancement of preclinical and clinical programs, the ability to translate preclinical and computational results into clinical outcomes, the continued development and performance of AI-driven platforms, the availability of capital and resources, and the Company’s ability to execute its business and development plans.

Forward-looking information is subject to significant risks and uncertainties, including, without limitation, risks relating to the early-stage nature of the Company’s technologies, uncertainties inherent in drug discovery and development, including the risk that preclinical results may not be replicated in clinical studies, reliance on third-party partners and service providers, evolving regulatory requirements, competitive developments, and general economic, market and industry conditions. There can be no assurance that forward-looking information will prove to be accurate, and actual results and future events may differ materially from those anticipated.

Readers are cautioned not to place undue reliance on forward-looking information. The forward-looking information contained herein is made as of the date of this document, and the Company undertakes no obligation to update or revise such information except as required by applicable law.