Star Metro - Onco-Innovations Announces Successful Scale-Up of Key Materials Used in the Synthesis of its Active Pharmaceutical Ingredient for its PNKP Inhibitor Technology Program

Conducted in collaboration with Dalton Pharma Services, the scale-up program successfully advanced both intermediates from laboratory-scale synthesis to intermediate-scale production, demonstrating robust process, reproducibility, and scalability.

The successful scale-up of A83 and B4 supports the Company's broader objective of establishing a reliable and scalable manufacturing pathway for ONC010, ensuring sufficient material supply for ongoing preclinical studies, formulation development, and IND-enabling activities. The program also advances key process optimization efforts designed to support future GMP manufacturing and clinical-stage production.

"This achievement represents an important step forward in de-risking our manufacturing strategy," said Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations. "The successful scale-up of these critical intermediates strengthens the foundation of our CMC program and supports the continued advancement of ONC010 toward future first-in-human clinical studies."

Dalton Pharma Services, a North American CDMO with expertise in complex synthetic chemistry and pharmaceutical manufacturing, has played a central role in advancing process development and scale-up activities across the Company's program. The successful execution of the intermediate scale-up further validates Dalton's capabilities in supporting the development of complex drug substances and reinforces the strength of Onco-Innovations' integrated partner network.

The Company continues to advance additional CMC activities, including integrated synthesis of A83B4C63, analytical method development and qualification, and scale-up of its proprietary polymer platform. These efforts are being conducted in parallel with preclinical studies led by Nucro-Technics and clinical development planning in collaboration with Avance Clinical.

Collectively, these activities are designed to support a comprehensive IND-enabling program and position ONC010 for entry into first-in-human clinical trials.

About Onco-Innovations Limited

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 license to patented technology that targets solid tumours.

ON BEHALF OF ONCO-INNOVATIONS LIMITED,

"Thomas O'Shaughnessy"
Chief Executive Officer

For more information, please contact:

Thomas O'Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
[email protected]

Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements, other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties, including (but not limited to) in relation to: the Company's ability to carry out its planned research and development activities; its ability to further pursue or initiate human or other further clinical trials; and its ability to qualify for or maintain contractual relationships required for research and development activities. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

¹ A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. (See International Council for Harmonisation, ICH Q7 Guideline, p. 40.)

SOURCE: Onco-Innovations Limited

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