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Onco-Innovations Reports Continued Advancement of Key Materials Used in the Synthesis of its Active Pharmaceutical Ingredient for ONC010 Development Program

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Onco-Innovations (OTCQB:ONNVF) reported continued progress in scaling up A83 and B4 precursor materials for its lead oncology program ONC010, a nanoparticle-formulated PNKP inhibitor in IND-enabling development.

Work with Dalton Pharma Services focuses on process optimization, analytical characterization, and reproducible intermediate-scale manufacturing to support future GMP production and planned First-in-Human studies in Australia.

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VANCOUVER, BC / ACCESS Newswire / May 19, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt:W1H, WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce, further to its news release dated April 28, 2026, continued progress in the intermediate1 scale-up and process development activities for the A83 and B4 precursor components supporting the Company's lead oncology program, ONC010, a novel nanoparticle-formulated PNKP inhibitor currently advancing through IND-enabling development.

The work is being conducted through the Company's integrated chemistry, manufacturing and controls (CMC) development program in collaboration with Dalton Pharma Services and forms part of the broader manufacturing strategy designed to support future GMP production, regulatory readiness and planning towards First-in-Human clinical development activities in Australia.

Recent development activities have focused on process optimization, intermediate-scale synthesis, analytical characterization and manufacturing reproducibility for both the A83 and B4 precursor materials, which represent foundational components within the ONC010 nanoparticle delivery and formulation platform.

Dalton Pharma Services has successfully advanced multiple intermediate scale-up activities while continuing to optimize process conditions, purification methodologies and quality control parameters intended to support scalable downstream manufacturing and formulation integration. The Company indicated that recent manufacturing work has demonstrated encouraging purity and reproducibility characteristics across key intermediate production steps.

"These continued manufacturing advancements represent another important step in strengthening the operational foundation of the ONC010 program. The successful progression of A83 and B4 precursor scale-up activities reflects the disciplined execution of our integrated CMC strategy and supports our broader objective of advancing ONC010 toward clinical translation. We remain highly focused on building a scalable, reproducible and regulatory-aligned manufacturing pathway capable of supporting long-term clinical and commercial development," said Thomas O'Shaughnessy, CEO of Onco-Innovations.

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 in relation to the Company's research and development plans, 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. 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. In particular, the Company may not be able to carry out its research and development plans for a variety of reasons, including, but not limited to, the failure to receive regulatory approvals, the failure to maintain contractual relations and the failure to obtain financing and retain key personnel. 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



View the original press release on ACCESS Newswire

FAQ

What did Onco-Innovations (ONNVF) announce about ONC010 manufacturing progress on May 19, 2026?

Onco-Innovations announced ongoing progress in scaling up key ONC010 precursor materials and refining manufacturing processes. According to Onco-Innovations, recent work with Dalton Pharma Services improved process optimization, intermediate-scale synthesis, and quality control to support future GMP production and clinical development planning.

What are the A83 and B4 precursors in Onco-Innovations' ONC010 development program (ONNVF)?

A83 and B4 are precursor materials that form foundational components of the ONC010 nanoparticle delivery and formulation platform. According to Onco-Innovations, current development emphasizes intermediate-scale synthesis, analytical characterization, and reproducibility of these materials to enable scalable downstream manufacturing and formulation integration.

How is Dalton Pharma Services involved in Onco-Innovations' ONC010 manufacturing strategy (ONNVF)?

Dalton Pharma Services is collaborating on intermediate-scale manufacturing and process optimization for ONC010 precursors A83 and B4. According to Onco-Innovations, Dalton has advanced multiple scale-up activities, refining purification methods and quality control parameters to support scalable, regulatory-aligned CMC and future GMP production.

What stage of development is Onco-Innovations' ONC010 program (ONNVF) currently in?

ONC010 is described as a novel nanoparticle-formulated PNKP inhibitor in IND-enabling development. According to Onco-Innovations, current CMC work and precursor scale-up are part of a broader manufacturing strategy supporting regulatory readiness and planning for First-in-Human clinical activities in Australia.

How could ONC010 manufacturing progress impact future First-in-Human trials for Onco-Innovations (ONNVF)?

Progress in ONC010 precursor scale-up may help build a scalable, reproducible manufacturing pathway for future trials. According to Onco-Innovations, the CMC strategy aims to support regulatory readiness and long-term clinical and commercial development, including planned First-in-Human studies in Australia.

What did Onco-Innovations' CEO say about the ONC010 CMC progress (ONNVF)?

The CEO said recent manufacturing advances strengthen the operational foundation of the ONC010 program and reflect disciplined CMC execution. According to Onco-Innovations, the focus remains on building a scalable, reproducible, regulatory-aligned manufacturing pathway for long-term clinical and commercial development.