Sequel Pharma Executes Agreement with CDMO for Drug Substance Production

Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its funding and commercialization partner, Sequel Pharma, LLC (“Sequel”), has executed, with support from Microbix, an agreement with a leading international contract development and manufacturing organization (“CDMO”) for production of the active ingredient (i.e., “Drug Substance”) of Kinlytic® urokinase (“Kinlytic”), a biologic drug for dissolving blood clots.

Sequel is a U.S. based specialty pharma company with expertise in developing and commercializing niche drugs. It has committed to provide all funding needed to return Kinlytic to global markets, initially for the US$ 350 million U.S. market for dissolving clots in indwelling venous catheters (“Catheter Clearance”).

Kinlytic is an enzyme derived from human cell cultures that dissolves the material of a blood clot. Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics licensing application (“sBLA”).

The referenced CDMO agreement is for all actions necessary to resume production of Kinlytic Drug Substance at a scale sufficient for the Catheter Clearance market. The CDMO has undertaken to complete this work over a timeframe specified by Sequel and in line with Microbix’s disclosed project objectives. The work of the CDMO will be overseen by Sequel, with scientific and technical assistance from Microbix.

It is Microbix’s intention to update its shareholders on further Kinlytic-related achievements as they become meaningful. Anticipated future disclosures related to Kinlytic may include, among other matters, successful production of Drug Substance, contracting for manufacture of clinically-formulated drug (“Drug Product”), first production of Drug Product, and clinical, regulatory, or commercial milestones. It is anticipated that Microbix will make two to three Kinlytic-related news release disclosures each year between now and the filing of a sBLA for the project, which may occur in calendar 2026 or 2027.

Cameron Groome, CEO and President of Microbix, commented, “We’re very pleased that a detailed agreement has been executed with a very well-qualified CDMO for the production of new Kinlytic Drug Substance. All parties will now move ahead at full speed to revalidate and restart manufacturing using state-of-the-art methods and best practices.”

Dr. Ken Hughes, COO of Microbix, also commented, “It is a pleasure to be working with Sequel, in this instance to identify and brief well-qualified CDMOs about Kinlytic, and to solicit and receive well-reasoned proposals from several such parties. We thank each of the CDMOs that participated in this Drug Substance contracting process and hope to have the opportunity to work with them on other aspects of this program, or in our future endeavors.”