Onco-Innovations Advances 1kg Scale-Up of B4 Precursor Supporting ONC010 Manufacturing and Clinical Development Program

Executive Summary

• Onco-Innovations successfully scaled up manufacturing of the B4 precursor component for its lead drug candidate ONC010, producing approximately 952 grams of material.
• The milestone validates the company's manufacturing platform and supports future formulation development, GMP production, and planned clinical studies.
• The company also announced a $76,500 marketing and communications contract with InvestorBrandNetwork, funded by an $80,000 refund from a previous provider.

Key Details

• Manufacturing Milestone: Successful advancement of kilogram-scale manufacturing activities for the B4 precursor component supporting ONC010 development.
• Production Output: Approximately 952 grams of B4 material successfully produced and isolated, representing a meaningful increase in manufacturing scale while maintaining quality standards necessary for continued development.
• Manufacturing Partner: Ongoing chemistry, manufacturing and controls (CMC) collaboration with Dalton Pharma Services.
• Strategic Impact: Validates scalability of the manufacturing approach, supports formulation development, engineering batches, GMP production, and planned clinical studies.
• Broader Manufacturing Ecosystem: Part of an integrated program including precursor synthesis, Active Pharmaceutical Ingredient (API) production, polymer development, nanoparticle formulation, analytical characterization, and future GMP manufacturing. Additional partner Nucro-Technics contributes specialized expertise across critical development workstreams.
• Marketing Program Engagement: Company engaged InvestorBrandNetwork (IBN) to provide market awareness, corporate communications, and digital media services (editorial content, press release recaps, newsletter coverage, social media relations, podcast distribution/syndication).
• Contract Terms & Funding: Aggregate cash fee of USD $76,500 for the Services. The Company will allocate a returned unused balance of USD $80,000 from a prior market awareness engagement (dated May 1, 2026) toward the Consideration.
• Service Duration & Structure: Services scheduled to run until September 30, 2026, or budget exhaustion. Structure allows for ongoing evaluation and may be shortened or extended at the Company's discretion. No securities provided to IBN or its principals as compensation.
• ONC010 Overview: Novel nanoparticle-formulated inhibitor of Polynucleotide Kinase Phosphatase (PNKP), a key DNA damage repair enzyme, intended to exploit vulnerabilities in cancer cells for difficult-to-treat malignancies.

Notable Quotes

• Thomas O'Shaughnessy, CEO: "This milestone represents another important advancement in the maturation of our ONC010 manufacturing platform. Successfully scaling the production of key precursor materials is essential to building a reliable and scalable supply chain capable of supporting future clinical development. The continued progress achieved by our manufacturing partners demonstrates the strength of our integrated development strategy and reinforces our commitment to advancing ONC010 toward the clinic."
• Dr. Islam Mohamed, CMO: "Manufacturing readiness is a fundamental component of successful clinical translation. The advancement of kilogram-scale precursor production strengthens the foundation of the ONC010 program and supports the Company's broader objective of delivering a clinically viable and scalable therapeutic candidate. As we continue progressing through IND-enabling activities, these manufacturing achievements contribute directly to reducing development risk and supporting future regulatory readiness."