Star Metro - Microbix's Clot-Buster Drug Project Advances

MISSISSAUGA, ON / ACCESS Newswire / March 10, 2026 / Microbix Biosystems Inc. (TSX:MBX)(OTCQX:MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that the contract development and manufacturing organization ("CDMO") engaged by its funding and commercialization partner, Sequel Pharma, LLC ("Sequel"), has modernized production methods for the active ingredient (i.e., "Drug Substance") of Kinlytic^® urokinase ("Kinlytic"), a biologic 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 U.S. market for dissolving clots in indwelling venous catheters ("Catheter Clearance").

Kinlytic's active ingredient is an enzyme derived from cell culture that safely dissolves blood clots. 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 filing a supplemental biologics license application ("sBLA").

In March 2024, a CDMO was engaged by Sequel to modernize aspects of Drug Substance manufacturing of Kinlytic - Specifically to reduce or eliminate the use of products of animal origin in cell culturing media. This relates to modern best-practices and is an extra safety precaution above (i) cell-source and medium ingredient screening and (ii) manufacturing processes for product purification. Work toward the sBLA filing is progressing as expected, is in accordance with FDA guidance, and is proceeding into the formulation, fill, and finish "Drug Product" phases of development.

Microbix's intends to continue updating its shareholders on further Kinlytic-related achievements as they become meaningful. Anticipated future disclosures related to Kinlytic may include, among other matters, other manufacturing, clinical, regulatory, or commercial milestones.

Cameron Groome, CEO and President of Microbix, commented, "We're pleased to report this important progress toward the reapproval and reintroduction of Kinlytic, initially for Catheter Clearance in the United States. Microbix appreciates the work and support from Sequel and our CDMO partners and we are excited about the prospect of returning this medically-important drug to widespread clinical use, with a targeted timeline of calendar 2028 as provided and updated in our continuous disclosure filings."

Dr. Ken Hughes, COO of Microbix, also commented, "It remains a pleasure to be working alongside Sequel, with Microbix's scientists able to support the modernization of Drug Substance manufacturing. While there are further steps to complete in the course of preparing for our sBLA file submission, we believe that the recently-completed Drug Substance work has cleared pivotal and technically challenging hurdles."

About Microbix Biosystems Inc.

Microbix Biosystems Inc. creates proprietary biological products for human health, with over 120 skilled employees and revenues of C$ 18.6 million in its latest fiscal year (2025). 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^™) and reference materials (QUANTDx^™) 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 or QUANTDx 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 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides IVDR-compliant CE marked 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 to support diagnostic testing (e.g., its DxTM^™ for patient-sample collection). Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.

Forward-Looking Information

This news release includes "forward-looking information," as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, all discussion of the Kinlytic^® project, Sequel, the CDMOs, or their relevance, Microbix's products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, access to and sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management's current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain, and actual performance may be affected by many material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix's judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information except as required by applicable law.

Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.

For further information, please contact Microbix at:

Copyright © 2026 Microbix Biosystems Inc.
Microbix^®, DxTM^™, Kinlytic^®, QAPs^™, and QUANTDx^™ are trademarks of Microbix Biosystems Inc.

SOURCE: Microbix Biosystems Inc.

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T. MacDonald--SMC