Mr. Cameron Groome reports

MICROBIX EXPANDING ADDRESSABLE MARKET SHARE WITH TEST MAKERS AUGMENTING ITS RECOMBINANT ANTIGEN CAPABILITIES FOR IMMUNOASSAY MARKETS

Microbix Biosystems Inc. intends to broaden its platform capabilities to enable production of a wider range of test ingredients (antigens) by using recombinant production technologies. Directing existing in-house synthetic biology capabilities to this project will create large-scale recombinant antigen production to complement and expand Microbix's addressable market share as a key supplier to manufacturers of immunoassays -- the class of diagnostic tests that establishes exposure to or immunity from pathogens.

Microbix has been a leading producer of purified and inactivated antigens from native (natural) bacterial and viral organisms for more than three decades. It supplies these critical biological ingredients to more than 100 international manufacturers of immunoassays, where test accuracy is maximized by using such antigens. Microbix's sales of native antigens totalled $13.8-million in fiscal 2024, an increase of 44 per cent from the prior year and generated from a catalogue of dozens of these complex and valuable biomaterials.

However, to date, Microbix has not broadly participated in making antigens using the recombination of genetic materials from different species (that is, recombinant technologies). Such recombinant antigens can have price advantages relative to native antigens and are the choice of immunoassay makers in situations where they can be used without sacrificing assay performance. Microbix offering recombinant antigens will increase the extent to which it can grow sales of this important segment of its business.

Microbix has therefore decided to finance the augmentation of its internal capabilities in synthetic biology in order to build the processes and capacity for production of recombinant antigens. This will entail adding trained staff, equipment, biological vectors and cell lines. With the infrastructure and capabilities already built out over the past several years, the incremental investment needed to drive the opening of these new market opportunities will be modest, at about $500,000 per year.

Cameron Groome, chief executive officer and president of Microbix, commented: "With our improved financial position and greater internal capabilities, we are now moving to fully resource a recombinant antigens program. By year-end 2025, this initiative will increase our total addressable market by way of providing existing and new customers with a broader range of infectious-disease antigens and at a variety of price points."

Dr. Ken Hughes, chief operating officer of Microbix, also commented: "Few, if any, companies have keener insight than Microbix regarding how recombinant antigens must perform to effectively emulate their native versions, which will provide material benefits to our test-maker clients. Additionally, we will use our recombinant antigens as ingredients for our QAPs [quality assessment products] test controls -- providing an immediate internal client to provide performance validation for external customers while also strengthening our supply chain."

About Microbix Biosystems Inc.

Microbix Biosystems creates proprietary biological products for human health, with over 100 skilled employees and sales now targeting $2-million or more per month. It makes and exports 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 provides IVDR-compliant (In Vitro Diagnostic Regulation) CE-marked (Conformite Europeene) 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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