Calgary, Canada – August 12, 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 July 30, 2026, that Nanosoft Polymers ("Nanosoft") has identified a non-tin catalyst for use in the continued development of the polymer synthesis process supporting ONC010, the Company’s lead nanoparticle-formulated inhibitor of Polynucleotide Kinase Phosphatase ("PNKP"). The identification builds on previously announced catalyst-evaluation activities aimed at improving the consistency and reproducibility of the polymer used in ONC010’s nanoparticle formulation. The non-tin approach is expected to support the Company’s strategy for controlling catalyst-related impurities and developing a well-characterized polymer manufacturing process suitable for future GMP manufacturing. Nanosoft will continue to evaluate the catalyst as part of the ongoing polymer development program.

In addition to this latest development, the Company provides an integrated development update for ONC010, its lead nanoparticle-formulated inhibitor of Polynucleotide Kinase Phosphatase (“PNKP”), highlighting progress across API manufacturing, analytical development, polymer and formulation optimization, preclinical characterization and preparation for a potential First-in-Human study in Australia. The developments summarized below were previously announced by the Company in separate news releases. This update brings those activities together to provide an integrated overview of progress across the ONC010 development program.

During the first half of 2026 and subsequent weeks in July, the Company completed a 300-gram development-scale API batch, expanded analytical controls supporting future manufacturing, initiated specialized polymer-process work with Nanosoft Polymers, and advanced bioanalytical and metabolism studies with Nucro-Technics. The Company also continued to develop the operational and clinical framework intended to support an Australian HREC and Clinical Trial Notification pathway.

Collectively, these activities are intended to reduce future manufacturing and development risk, strengthen the regulatory-enabling data package and align ONC010’s CMC, preclinical and clinical-planning workstreams as the program advances toward future human evaluation.

Executive Milestone Highlights

• Completion of a 300-gram A83B4C63 API scale-up batch with approximately 99.3% purity and no detectable residual solvents 

• Completion of an analytical reference-standard preparation program supporting future identity, purity, stability and batch-comparability testing 

• Initiation of polymer process optimization and characterization activities with Nanosoft Polymers to improve reproducibility and support future scalable manufacturing 

• Advancement of bioanalytical, pharmacokinetic and three-species metabolism studies, together with continued development planning for a potential First-in-Human study in Australia 

Manufacturing and CMC Progress

In collaboration with Dalton Pharma Services ("Dalton"), Onco advanced process development, manufacturing scale-up and analytical activities supporting A83B4C63, the active pharmaceutical ingredient ("API") used in ONC010.

The Company completed analytical method development for Monomer Intermediate 1 and subsequently advanced the A83 and B4 intermediates from laboratory-scale synthesis to larger-scale production. Additional process optimization, purification, analytical characterization and reproducibility work supported the scale-up of both intermediates and the development of a more reliable manufacturing pathway for the API.

Onco subsequently initiated a dedicated API process development and intermediate scale-up program focused on refining the synthetic process, improving yield and reproducibility, and strengthening control over impurities and other critical quality attributes. This work culminated in the completion of a 300-gram scale-up batch of A83B4C63, with quality-control testing confirming approximately 99.3% purity with residual solvents below the limits of detection of the analytical methods employed.

In July, the Company completed an analytical reference standard preparation program for A83B4C63, including the preparation, purification and analytical evaluation of highly characterized API material. The resulting reference standard is intended to support the consistent assessment of API identity, purity, stability, impurity profiles and batch-to-batch comparability in future manufacturing and analytical programs.

Together, these activities advanced precursor and API manufacturing and strengthened the analytical controls intended to support future formulation work, regulatory documentation and clinical-material production.

Polymer and Formulation Development

Onco also advanced the polymer and nanoparticle formulation components of ONC010. The Company advanced an analytical method using refractive index detection coupled with gel permeation chromatography ("RI-GPC") to characterize the molecular weight, molecular-weight distribution and polydispersity index ("PDI") of the polymer used in ONC010’s nanoparticle delivery system. Improved control of molecular-weight distribution and PDI is important because these attributes may influence nanoparticle formation, particle-size consistency, drug loading, formulation reproducibility and overall drug-product quality. This work is intended to strengthen analytical control, batch consistency and formulation reproducibility as the program progresses toward larger-scale manufacturing.

In collaboration with Nanosoft Polymers ("Nanosoft"), the Company initiated a polymer process development and characterization program focused on optimizing polymer synthesis conditions, evaluating reaction parameters, assessing molecular weight and polydispersity, refining purification strategies and examining manufacturing scalability. The program is intended to establish a more consistent, reproducible and scalable polymer manufacturing process while supporting continued formulation development, quality-control activities and potential technology transfer for future GMP manufacturing.

This work is helping to strengthen the nanoparticle delivery system used in ONC010 while advancing polymer production toward the manufacturing, quality and regulatory requirements of future clinical development.

Preclinical Advancement

In collaboration with Nucro-Technics Inc. ("Nucro-Technics"), Onco advanced bioanalytical and metabolism studies intended to characterize the behaviour of A83B4C63, the API used in ONC010, and support the program’s continued preclinical development.

Nucro-Technics commenced advanced bioanalytical work, including the development and execution of specialized liquid chromatography-mass spectrometry methods to measure the API in biological samples generated through the Company’s non-GLP pharmacokinetic and biodistribution animal study. These analytical capabilities are intended to support the assessment of compound exposure and distribution, refinement of future dosing strategies, and planning for formulation and subsequent GLP-compliant studies.

Onco also initiated hepatocyte and liver microsome metabolism studies across human, rat and dog systems. The studies are designed to characterize intrinsic clearance, metabolic degradation and species-specific metabolism, providing information intended to support future toxicology-study design, pharmacokinetic modelling, dose selection and regulatory planning.

In July, the Company initiated additional absorption, distribution, metabolism and excretion ("ADME") studies, focused initially on the metabolism of the API used in ONC010. The resulting data are expected to contribute to the Company’s understanding of the candidate’s pharmacokinetic and metabolic profile and inform manufacturing, formulation optimization, toxicology planning and future clinical translation.

The resulting analytical capabilities and preclinical datasets are expected to support informed development decisions as ONC010 advances through its IND-enabling program.

Clinical Translation Progress

As announced on April 7, 2026, Onco engaged Research & Development Incentives Partners ("RDI Partners") and established Onco-Innovations AU Pty. Ltd. ("ONCO AU") as a wholly owned Australian subsidiary.

The establishment of ONCO AU provides the Company with a local operating and governance structure to support its planned Phase I development activities in Australia. The initiative includes planning related to potential eligibility for Australia’s research and development tax incentive program, preparation for submission to a Human Research Ethics Committee, and progression through the Therapeutic Goods Administration’s Clinical Trial Notification pathway.

This Australian operational framework complements the Company’s existing engagement with Avance Clinical for planned Phase I trial execution in Australia. During the period, Onco continued clinical-development planning intended to align its manufacturing, formulation and preclinical programs with the requirements of future First-in-Human evaluation.

The Company also strengthened its internal scientific and clinical oversight through the appointments of Dr. Islam Mohamed as Chief Medical Officer and Stephen M. Novak as Chief of Research and Development. These appointments provide additional leadership across clinical strategy, research planning and coordination with the Company’s external development partners.

“The ONC010 program is moving from a collection of individual development activities into an increasingly integrated CMC, preclinical and clinical-readiness program. Our immediate priorities are to strengthen polymer reproducibility, establish formulation and analytical controls, characterize the API’s metabolic and pharmacokinetic profile and align each workstream with the requirements of future toxicology, regulatory and clinical activities,” said Dr. Islam Mohamed, Chief Medical Officer.

“The completion of development-scale API manufacturing, expansion of analytical controls, initiation of specialized polymer work and advancement of metabolism and bioanalytical studies collectively strengthen the program’s technical foundation. Our focus is now on converting this progress into a reproducible drug-product process, a fit-for-purpose preclinical package, and a coordinated pathway toward First-in-Human evaluation in Australia,” stated Thomas O’Shaughnessy, Chief Executive Officer of Onco-Innovations.

Looking Ahead

During the second half of 2026, the Company expects to continue advancing manufacturing scale-up activities, analytical qualification programs, polymer optimization initiatives, toxicology studies, biodistribution evaluations, clinical protocol development and regulatory preparation activities supporting the planned Australian First-in-Human development pathway.

Management believes that the continued execution of these activities will further strengthen the regulatory, manufacturing, and clinical foundation of the ONC010 program while positioning the Company for future development milestones.

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

Email: investors@oncoinnovations.com
Website: 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, including in relation to the anticipated benefits of the relationship with Nanosoft, and its future research and development plans. 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 known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements. 

 

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. Important factors that could cause actual results to differ materially from expectations include, without limitation, the Company’s ability to successfully integrate Nanosoft’s services into the Company’s development program, the results of research and development activities, the availability of financing, the ability to maintain contractual and commercial relationships, the ability to obtain and maintain regulatory approvals, risks relating to clinical development and commercialization, and general economic, market and industry conditions.  

  
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, including those discussed in the Company’s public disclosure record. In particular, the Company may not be able to derive any benefit from its relationship with Nanosoft, and 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, delays in development timelines, adverse results from research activities, or 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 undertakes no obligation to update or revise publicly any forward-looking statements except as expressly required by applicable law.