Mr. Cameron Groome reports

MICROBIX'S CLOT-BUSTER DRUG PROJECT ADVANCES

Microbix Biosystems Inc.'s financing and commercialization partner, Sequel Pharma LLC, has executed, with support from Microbix, an agreement with a leading international contract development and manufacturing organization (CDMO) for production of the active ingredient (drug substance) of Kinlytic urokinase, 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 financing needed to return Kinlytic to global markets, initially for the $350-million (U.S.) U.S. market for dissolving clots in indwelling venous catheters.

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 United States 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 time frame 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 an sBLA for the project, which may occur in calendar 2026 or 2027.

Cameron Groome, chief executive officer 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, chief operating officer 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 endeavours."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and annualized sales now targeting $2-million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory-quality assessment products (QAPs) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers while QAPs are sold to clinical lab accreditation organizations, diagnostics companies and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and ISO 13485 accredited, U.S. Food and Drug Administration registered, Australian Therapeutic Goods Administration registered, and Health Canada establishment licensed, and it provides CE-marked (Conformite Europeenne) products.

Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic urokinase, a biologic thrombolytic drug used to treat blood clots, and reagents or media to support molecular diagnostic testing (for example, its DxTM for patient sample collection). Microbix is traded on the Toronto Stock Exchange and the OTCQX and is headquartered in Mississauga, Ont., Canada.

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