Microbix partner Sequel continues work on Kinlytic

Mr. Cameron Groome reports MICROBIX'S CLOT-BUSTER DRUG PROJECT ADVANCES The contract development and manufacturing organization (CDMO) engaged by Microbix Biosystems Inc.'s financing and commercialization partner, Sequel Pharma LLC, has modernized production methods for the active ingredient (drug substance) of Kinlytic urokinase, 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 financing 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 United States 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 licence 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 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, chief executive officer 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, chief operating officer 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 creates proprietary biological products for human health, with over 120 skilled employees and revenues of $18.6-million in its latest fiscal year (2025). It enables the worldwide commercialization of diagnostic assays by making 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 and 13485 accredited, U.S. FDA (U.S. Food and Drug Administration) registered, Australian TGA (Therapeutic Goods Administration) registered, and Health Canada establishment licensed, and it provides IVDR-compliant (In Vitro Diagnostic Regulation) 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 OTCQX and is headquartered in Mississauga, Ont., Canada. We seek Safe Harbor.