Mr. Thomas O'Shaughnessy reports

ONCO-INNOVATIONS REPORTS COMPLETION OF 300G ACTIVE PHARMACEUTICAL INGREDIENT FOR ONC010 SCALE-UP SUPPORTING IND-ENABLING DEVELOPMENT

Onco-Innovations Ltd. has completed a 300-gram scale-up batch of A83B4C63, the active pharmaceutical ingredient underpinning the company's proprietary drug candidate, ONC010 (the polynucleotide kinase phosphatase inhibitor technology).

The completed 300-gram scale-up batch forms part of Dalton Pharma Services' process optimization and intermediate scale-up program and follows the successful completion of process development activities and multiple intermediate scale-up campaigns. The program was designed to demonstrate manufacturing reproducibility, establish scalability of the synthetic process and generate sufficient material to support continuing IND-enabling activities.

Importantly, the completed batch underwent a comprehensive quality control review and certificate of analysis assessment. Analytical testing confirmed that the API achieved approximately 99.3-per-cent purity while residual solvent testing demonstrated undetectable levels of residual solvents, representing an important manufacturing and quality milestone for the ONC010 program. The company believes these results provide strong evidence that the A83B4C63 manufacturing process can reliably produce high-purity API material at increasingly relevant development scales while meeting stringent quality expectations as necessary for future clinical development activities.

"The successful completion of the 300g A83B4C63 scale-up campaign represents another significant manufacturing milestones achieved to date within the ONC010 program. Not only were we able to successfully manufacture the API at a 300-gram scale, but the resulting material demonstrated approximately 99.3-per-cent purity with no detectable residual solvents following a rigorous quality control review," stated Thomas O'Shaughnessy, chief executive officer of Onco-Innovations.

"Manufacturing quality and scalability are fundamental components of successful clinical translation. Achieving approximately 99.3-per-cent purity with no detectable residual solvents at the 300-gram scale represents an important demonstration of process control and product quality. These results further strengthen confidence in the development pathway for ONC010 and support our ongoing efforts to advance the program through IND-enabling studies and toward first-in-human evaluation," stated Dr. Islam Mohamed, chief medical officer of Onco-Innovations.

The successful completion of the 300-gram scale-up campaign is expected to contribute to future manufacturing activities, including analytical qualification programs, formulation development, engineering batch production and eventual GMP manufacturing campaigns intended to support first-in-human clinical studies.

The company also announces the appointment of Dave Antony as chief financial officer and corporate secretary, effective immediately. Mr. Antony replaces Nico Mah. The company is grateful to Mr. Mah for his service as CFO.

About ONC010

ONC010 is a novel nanoparticle-formulated inhibitor of polynucleotide kinase phosphatase (PNKP), a key DNA damage repair enzyme. The program is being developed to exploit vulnerabilities in cancer cells dependent on DNA repair pathways and is intended to provide a differentiated therapeutic approach for patients with difficult-to-treat malignancies.

About Onco-Innovations Ltd.

Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco's mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide licence to patented technology that targets solid tumours.

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