Mr. Thomas O'Shaughnessy reports

ONCO-INNOVATIONS COMPLETES ANALYTICAL REFERENCE STANDARD PREPARATION PROGRAM FOR ONC010'S API

Onco-Innovations Ltd. has completed its analytical reference standard preparation program for A83B4C63, the active pharmaceutical ingredient supporting the company's lead oncology program, ONC010 (the PNKP inhibitor technology).

The reference standard program, which was completed in collaboration with Dalton Pharma Services, included the preparation, purification, analytical evaluation and quality assessment of highly characterized A83B4C63 material intended for use as a reference standard in future analytical testing programs. Reference standards serve as foundational tools within pharmaceutical development and quality control systems, enabling consistent evaluation of identity, purity, potency, stability, impurity profiles and batch-to-batch comparability throughout the development life cycle.

Completion of the program establishes an important analytical benchmark for future manufacturing campaigns and supports the company's broader strategy of building a comprehensive quality infrastructure for ONC010.

"A qualified reference standard provides an essential foundation for maintaining analytical consistency and scientific rigour throughout the drug development process. This milestone strengthens the quality systems supporting ONC010 and contributes to the generation of reliable analytical data that will be used to support future manufacturing, regulatory and clinical activities," Dr. Islam Mohamed, chief medical officer of Onco-Innovations, stated.

The completion of the reference standard program follows several recent chemistry, manufacturing and control achievements within the ONC010 development program, including successful precursor scale-up activities, API manufacturing advancements, analytical method development, chiral purity testing, and continued progress toward manufacturing scale-up and regulatory readiness.

"The successful completion of our analytical reference standard program represents another important advancement in the maturation of the ONC010 development platform. Establishing qualified reference materials is a foundational element of pharmaceutical quality systems and supports consistency across manufacturing, analytical testing, regulatory documentation and future clinical development. This milestone further strengthens our chemistry, manufacturing and controls framework as we continue advancing ONC010 toward clinical readiness," Thomas O'Shaughnessy, chief executive officer of Onco-Innovations, commented.

The reference standard preparation program forms part of a broader analytical development strategy currently under way at Onco-Innovations. Additional activities include analytical method qualification, stability-indicating methodologies, residual solvent testing, impurity profiling, forced degradation studies, formulation characterization and quality control system development.

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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