Also Announces Extension of IR Program
VANCOUVER, BC / ACCESS Newswire / May 1, 2026 / Onco-Innovations Limited (CBOE CA:ONCO)(OTCQB:ONNVF)(Frankfurt: W1H, WKN: A3EKSZ) ("Onco" or the "Company") is pleased to announce that its manufacturing partner, Dalton Pharma Services ("Dalton"), has advanced into the next phase of intermediate-scale process development and scale-up for the Company's proprietary PNKP inhibitor technology. This next phase of work includes an expanded scale-up of precursor A83 to approximately 1,560 grams and the initiation of a multi-kilogram (2 kg) non-GMP synthesis of A83B4C63 as part of the Company's ongoing Chemistry, Manufacturing, and Controls (CMC) development program to support IND-enabling studies and future Phase I clinical readiness.
Building on Dalton's successful feasibility and earlier scale-up activities supporting preclinical material production, as referenced in the Company press releases dated May 26 and November 20, 2025, Onco has now advanced into larger-scale synthesis intended to refine process robustness, reproducibility, and manufacturing readiness as it works toward future GMP production. This progression is intended to generate additional scale-dependent manufacturing data, support further evaluation of process controls under pilot-scale conditions, and produce sufficient material to advance formulation development and IND-enabling activities ahead of future GMP clinical manufacturing.
The current program includes the scale-up of precursor A83 to 1,560 g to support downstream manufacturing readiness, the non-GMP synthesis of A83B4C63 at the 2 kg scale to provide significant material for formulation development and IND-enabling studies, and the initiation of stability and analytical characterization activities aligned with International Council for Harmonisation (ICH) expectations.
A83B4C63 is the active pharmaceutical ingredient (API) in the Company's drug candidate, ONC010, encapsulating the API within the Company's proprietary nanoparticle micelle. This delivery system is proven1 to enhance tumor-targeted delivery of PNKP inhibition in animal models, with the goal of improving therapeutic efficacy while reducing systemic toxicity.
Dalton will perform this work at its FDA-registered and Health Canada-approved facility in Toronto, Canada, using dedicated pilot-scale equipment and established quality systems to support scalable and reproducible process development.
"This manufacturing milestone represents another advancement in our ability to produce meaningful quantities of our lead PNKP inhibitor candidate," said Thomas O'Shaughnessy, Chief Executive Officer of Onco-Innovations. "Scaling A83 and initiating multi-kilogram non-GMP synthesis of A83B4C63 are intended to strengthen our CMC foundation as we continue to work towards IND-enabling studies and First-In-Human clinical readiness.
The manufacturing program also includes ongoing analytical method development, stability testing, and formal safety and risk assessments to support the long-term objective of GMP clinical material production.
The Company also a announces that it has extended the term of its engagement with MCS Market Communication Service GmbH (business address: Saarlandstraße 28 58511 Lüdenscheid, Germany, email: info@mcsmarket.de; telephone: +491772481220; and website: www.mcsmarket.de) ("MCS") to provide market awareness and corporate communications services, including through content creation, project management, third-party media distribution, and digital market awareness initiatives (the "Services"). The Company will pay a cash fee of €210,000 for the Services (the "Consideration").
The Company also announces that it has obtained a return of the remaining unused balance of USD $269,688 from its prior market awareness engagement with another provider (see Company press release dated Jan 21, 2026). The Company intends to allocate the returned unused balance toward the Consideration.
The Services are scheduled to run until July 30, 2026, or budget exhaustion, and is structured to allow for ongoing evaluation and, accordingly, may be shortened or extended at the discretion of the Company. No securities have been provided to MCS or its principals as compensation. The Company believes that maintaining consistent, compliant market awareness is an important component of supporting visibility, and long-term shareholder base development.
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 Sadat et al., Journal of Controlled Release 334: 335-352, 2021 (See Figure 7)
SOURCE: Onco-Innovations Limited
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/onco-innovations-expands-manufacturing-scale-up-of-its-pnkp-inhibitor-1163212
