Microbix's Clot-Buster Drug Project Advances

Executive Summary

• Microbix Biosystems reports that its CDMO, engaged by partner Sequel Pharma, has modernized the drug‑substance manufacturing process for Kinlytic® urokinase, eliminating or reducing animal‑origin components.
• The modernization supports preparation of a supplemental Biologics License Application (sBLA) and moves the project toward formulation, fill‑and‑finish, and market re‑entry in the United States, with a target timeline of calendar 2028.
• No financial terms were disclosed; the update is forward‑looking and indicates progress but does not constitute a material earnings or financing event.

Key Details

• Partner involvement: Sequel Pharma commits all funding needed to return Kinlytic to global markets, initially focusing on U.S. catheter‑clearance indications.
• Manufacturing change: CDMO work completed in March 2024 modernized the drug‑substance process by reducing/eliminating animal‑origin media components, enhancing safety and aligning with FDA best practices.
• Regulatory path: The updated manufacturing platform is being validated for inclusion in a forthcoming sBLA filing; work is proceeding per FDA guidance into formulation, fill‑and‑finish phases.
• Timeline: Targeted re‑approval and market re‑introduction of Kinlytic anticipated by calendar 2028, as reflected in continuous disclosure filings.
• Future disclosures: Microbix will update shareholders on additional manufacturing, clinical, regulatory, or commercial milestones related to Kinlytic as they become material.

Notable Quotes

• Cameron Groome, CEO & President: “We’re pleased to report this important progress toward the re‑approval and re‑introduction of Kinlytic… with a targeted timeline of calendar 2028.”
• Dr. Ken Hughes, COO: “The recently‑completed drug‑substance work has cleared pivotal and technically challenging hurdles.”