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

Rhea-AI Summary

Onco-Innovations (OTCQB:ONNVF) reported completion of a 300-gram scale-up batch of A83B4C63, the API for its ONC010 PNKP inhibitor program, under Dalton Pharma Services’ optimization and scale-up initiative.

Analytical testing showed ~99.3% purity with undetectable residual solvents, supporting IND-enabling development and future GMP manufacturing. The company also appointed Dave Antony as CFO and Corporate Secretary, replacing Nico Mah.

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Positive

• Completion of 300 g A83B4C63 API scale-up batch for ONC010
• API batch achieved approximately 99.3% purity in analytical testing
• Residual solvent testing showed no detectable residual solvents in API
• Scale-up supports ongoing IND-enabling activities for ONC010 program
• 300 g campaign expected to support future GMP manufacturing for First-in-Human studies
• Appointment of Dave Antony as CFO and Corporate Secretary, effective immediately

Negative

• None.

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Also Announces Appointment of Mr. Dave Antony as CFO

VANCOUVER, BC / ACCESS Newswire / June 19, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H) (WKN:A3EKSZ) ("Onco" or the "Company") announced the successful completion of a 300-gram scale-up batch of A83B4C63, the active pharmaceutical ingredient ("API") underpinning the Company'sproprietary drug candidate, ONC010 (the "PNKP Inhibitor Technology").

The completed 300g 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 ongoing IND-enabling activities.

Importantly, the completed batch underwent a comprehensive quality control review and Certificate of Analysis ("CoA") assessment. Analytical testing confirmed that the API achieved approximately 99.3% 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% 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% 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 300g 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 Mr. Dave Antony as Chief Financial Officer and Corporate Secretary, effective immediately. Mr. Antony replaces Mr. 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 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
investors@oncoinnovations.com

Forward-Looking Statements Caution. This news release contains forward-looking statements, including with respect to the anticipated advancement of the Company's ONC010 program, the expected contribution of the 300g API scale-up batch to future manufacturing activities, the timing and completion of IND-enabling studies, and the potential progression to First-in-Human clinical trials. Forward-looking statements are often identified by terms such as 'will', 'may', 'potential', 'should', 'anticipate', 'expects' and similar expressions. These forward-looking statements are subject to specific risks and uncertainties, including risks relating to the Company's ability to successfully scale manufacturing processes beyond current levels; maintain API quality, purity and reproducibility in future batches; complete analytical qualification, formulation development and GMP manufacturing on anticipated timelines; obtain required regulatory approvals to commence clinical studies; secure sufficient funding to support ongoing development; and retain key scientific, technical and operational personnel. In addition, preclinical results, including manufacturing and analytical outcomes, may not be predictive of clinical performance or regulatory acceptance. 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 due to these and other risks and uncertainties, many of which are beyond the Company's control. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are made as of the date hereof and the Company undertakes no obligation to update such statements except as required by applicable law.

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

FAQ

What did Onco-Innovations (OTCQB:ONNVF) announce about the ONC010 API scale-up on June 19, 2026?

Onco-Innovations announced completion of a 300 g scale-up batch of A83B4C63, the API for ONC010. According to Onco-Innovations, this batch is part of Dalton Pharma Services’ process optimization and supports ongoing IND-enabling development activities.

What purity did Onco-Innovations achieve for the ONC010 API A83B4C63?

The ONC010 API A83B4C63 achieved approximately 99.3% purity in analytical testing. According to Onco-Innovations, residual solvent testing also showed undetectable levels, demonstrating process control and product quality for future development and clinical manufacturing scales.

How does the 300 g A83B4C63 batch support IND-enabling studies for ONC010 (ONNVF)?

The 300 g batch provides material to support ongoing IND-enabling activities for ONC010. According to Onco-Innovations, the program was designed to show manufacturing reproducibility, scalability, and to supply API for analytical qualification and formulation development.

What future manufacturing steps will follow Onco-Innovations’ 300 g ONC010 API scale-up?

The 300 g scale-up is expected to contribute to analytical qualification, formulation development, and engineering batch production. According to Onco-Innovations, it also supports eventual GMP manufacturing campaigns intended to enable First-in-Human clinical studies for ONC010.

Who is the new CFO of Onco-Innovations (OTCQB:ONNVF) and when was he appointed?

Onco-Innovations appointed Mr. Dave Antony as Chief Financial Officer and Corporate Secretary, effective immediately. According to Onco-Innovations, he replaces Mr. Nico Mah, and the company expressed gratitude for Mr. Mah’s prior service as CFO.

What role does Dalton Pharma Services play in Onco-Innovations’ ONC010 program?

Dalton Pharma Services runs the Process Optimization and Intermediate Scale-Up Program for A83B4C63. According to Onco-Innovations, this program completed process development and multiple intermediate scale-up campaigns leading to the 300 g batch supporting IND-enabling work.

Why is manufacturing quality important for Onco-Innovations’ ONC010 First-in-Human plans?

Manufacturing quality and scalability are described as fundamental for clinical translation of ONC010. According to Onco-Innovations, achieving ~99.3% purity with no detectable residual solvents at 300 g strengthens confidence in ONC010’s development path toward First-in-Human evaluation.