(via TheNewswire)
Calgary, Canada – September 9, 2026 – TheNewswire – 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 June 26 , 2026, that it has received interim results from the ongoing three-species liver microsome metabolism studies supporting the preclinical development of ONC010, the Company's lead nanoparticle-formulated PNKP inhibitor. The studies are evaluating the metabolism of A83B4C63, ONC010's active pharmaceutical ingredient ( API ), across human, rat and dog test systems. The original program was initiated to characterize intrinsic clearance, metabolic degradation pathways and species-specific metabolism.
The interim results indicate that A83B4C63 is metabolized in all three species evaluated, primarily through pathways characteristic of cytochrome P450 enzymes, with species differences in the rate of metabolism observed. System controls performed as expected across all three species. The Company intends to conduct additional metabolite characterization work, including enzyme phenotyping, as the program advances. The interim findings were consistent with expectations and did not identify findings that would preclude continuation of the planned preclinical development program.
The studies are being conducted by Nucro-Technics Inc. (" Nucro-Technics ") as part of the Company's broader preclinical development program for ONC010. As previously announced, the program is designed to characterize intrinsic clearance, metabolic degradation pathways and species-specific metabolism to help inform future toxicology studies, pharmacokinetic modelling, dose selection and regulatory planning. The use of both hepatocytes (results pending) and liver microsomes is intended to provide complementary information, allowing broader cell-based metabolic activity to be considered alongside more enzyme-focused metabolism.
The Company believes the interim findings are consistent with the anticipated progression of the program and support the continuation of the planned preclinical work for ONC010. The initial API microsome study results are being finalized, the API hepatocyte study results are pending, and additional testing will evaluate how the polymeric nanoparticle component of ONC010 is degraded as well. The metabolism studies form part of Nucro-Technics' broader work supporting Onco's preclinical development program, which includes bioanalytical method development, pharmacokinetics, biodistribution, toxicology and three-species metabolism studies.
" These interim findings provide us with an important early view of the metabolic profile of A83B4C63 across the species being evaluated in our preclinical program. The results observed to date are consistent with our expectations and provide additional information to support the continued progression of the planned preclinical development program for ONC010, " stated Dr. Islam Mohamed, Chief Medical Officer of Onco-Innovations.
" The interim results add to the body of data being generated as we systematically advance ONC010 through preclinical development. We are encouraged that the program continues to progress in accordance with our development plan, as we work to build the scientific and regulatory foundation needed to support ONC010's continued advancement, " stated Thomas O'Shaughnessy, Chief Executive Officer 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
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 within the meaning of applicable securities laws, including, without limitation, statements regarding: the Company’s research and development plans; the scope, objectives and anticipated outcomes of the hepatocyte and liver microsome metabolism studies; the potential use of data generated from such studies in connection with toxicology studies, pharmacokinetic modelling, dose selection and regulatory submissions; the advancement of ONC010 toward a First in Human study; the Company’s broader IND‑enabling development strategy; and the anticipated benefits of the Company’s relationship with Nucro-Technics, including the possibility of entering into a definitive services agreement.
Forward-looking statements are often identified by words such as “will”, “may”, “potential”, “should”, “anticipate”, “expects”, “intends”, “plans” and similar expressions. Such statements are based on management’s current expectations, assumptions and estimates, including, without limitation, assumptions that: the studies will be completed in a timely manner and in accordance with their intended design; the results obtained will be informative and supportive of further development decisions; ONC010 will demonstrate characteristics suitable for continued preclinical advancement; and the Company will be able to maintain key relationships, obtain required approvals and secure adequate funding to advance its programs.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those expressed or implied in such forward-looking statements. Such risks and uncertainties include, without limitation: risks inherent in preclinical drug development, including that study results may not be as anticipated or may not support further development; risks that metabolism or other data may not translate across species or may not support dosing, safety or regulatory assumptions; the risk that ONC010 may not advance to clinical trials or obtain regulatory approval; risks associated with reliance on third-party service providers, including contract research organizations; and general business, operational, financing and regulatory risks.
Although the Company believes that the expectations reflected in the forward-looking statements are reasonable at the time of preparation, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements contained in this news release are made as of the date of this news release and are expressly qualified by this cautionary statement, and the Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

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