Onco-Innovations Reports Completion of 300g Active Pharmaceutical Ingredient for ONC010 Scale-Up Supporting IND-Enabling Development

Executive Summary

• Onco-Innovations successfully completed a 300-gram scale-up batch of its proprietary API (A83B4C63) for drug candidate ONC010, achieving 99.3% purity with undetectable residual solvents.
• The milestone validates manufacturing reproducibility and scalability, providing material to support ongoing IND-enabling activities and paving the way for future GMP manufacturing and First-in-Human clinical trials.
• The Company also announced the immediate appointment of Mr. Dave Antony as Chief Financial Officer and Corporate Secretary, succeeding outgoing CFO Mr. Nico Mah.

Key Details

• Completed a 300-gram scale-up batch of A83B4C63, the active pharmaceutical ingredient (API) underpinning the ONC010 (PNKP Inhibitor Technology) drug candidate.
• Batch manufactured as part of Dalton Pharma Services' Process Optimization and Intermediate Scale-Up Program.
• Comprehensive quality control review and Certificate of Analysis (CoA) confirmed API purity of approximately 99.3%.
• Residual solvent testing demonstrated undetectable levels of residual solvents.
• Program designed to demonstrate manufacturing reproducibility, establish scalability of the synthetic process, and generate sufficient material for ongoing IND-enabling activities.
• Future manufacturing roadmap includes analytical qualification programs, formulation development, engineering batch production, and eventual GMP manufacturing campaigns to support First-in-Human clinical studies.
• Appointment of Mr. Dave Antony as Chief Financial Officer and Corporate Secretary, effective immediately.
• Mr. Antony replaces outgoing CFO Mr. Nico Mah.

Notable Quotes

• Thomas O'Shaughnessy, CEO: "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% purity with no detectable residual solvents following a rigorous quality control review."
• Dr. Islam Mohamed, CMO: "Manufacturing quality and scalability are fundamental components of successful clinical translation. Achieving approximately 99.3% 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."