Microbix Biosystems Eyes Diagnostic Growth, Kinlytic Revenue in 2028

Microbix Biosystems (TSE:MBX) is positioning its diagnostic-test ingredients and quality-control products for growth through deeper relationships with multinational test manufacturers, expanded direct sales to laboratories and a planned return of its Kinlytic clot-dissolving drug to market, Chief Executive Officer Cameron Groome said at Planet MicroCap Toronto 2026.

Groome said Microbix supports medical diagnostic testing by supplying purified, inactivated viruses and bacteria known as antigens, which are used as ingredients in certain infectious-disease antibody tests. The company also makes products designed to mimic positive and negative patient samples, allowing laboratories and test manufacturers to verify that diagnostic workflows are functioning correctly.

“Medical tests have very complex workflows,” Groome said, adding that regular quality checks are needed to identify errors involving technicians, instruments or reagents.

Diagnostics business and customer base

Microbix sells to external quality-assessment organizations, diagnostic-test manufacturers and, increasingly, directly to clinical laboratories. Quality-assessment organizations send blinded samples to labs to evaluate their testing performance and help maintain certification requirements, according to Groome.

The company’s disclosed collaborators and customers include Abbott, Becton Dickinson, Roche, Cepheid, Danaher, the American Proficiency Institute, the College of American Pathologists and Labquality in Scandinavia, Groome said. More than 95% of Microbix’s sales are exports, with markets including the United States, Western Europe, Scandinavia, Australia, the Indo-Pacific region and South America.

Groome said Microbix has about 120 employees and operates three facilities in Mississauga, Ontario. It manufactures roughly 400 products for customers globally and has built capacity intended to support larger production runs.

The company is also working with multinational diagnostic companies on next-generation assays in which its test-control materials could be embedded in liquid vials, swabs and molecular-pathology sample formats, he said. In September, Microbix announced it had become an audited and qualified supplier for five of the world’s 10 largest diagnostics companies, according to Groome.

Quantitative testing and quality controls

During a question-and-answer session, Groome discussed Microbix’s QUANTDx product development effort. He said diagnostic testing is increasingly moving beyond positive-or-negative results toward quantification of the signal detected in a patient sample.

Using human papillomavirus as an example, Groome said a high viral signal can have different interpretations depending on the size and nature of the sample. QUANTDx reference materials are intended to help test developers refine their assays and interpret results more effectively, he said.

Groome also said the company’s quality-assessment products can potentially be included in testing cartridges or boxes of cartridges, creating opportunities for Microbix to become more deeply integrated into customer products. He described the products as controls that can help identify when diagnostic tests are not performing as expected.

The company is developing reference materials for molecular cervical-cancer screening and for tests involving RNA viruses, Groome said. He added that synthetic biology can be used to emulate dangerous viruses without requiring work with the native organisms.

Financial position and growth plans

Groome said Microbix has a market capitalization in the “CAD 40-odd million” range and expects fiscal 2026 revenue of approximately CAD$16.5 million to CAD$17 million. He attributed the company’s recent weaker revenue performance to the loss of two customers in the same quarter during mid-2025, which he said left revenue about CAD$10 million below where management had hoped it would be.

Microbix’s break-even revenue level is about CAD$22 million, Groome said, meaning the company currently has a modest cash burn. He said management expects growth to come from expanding existing customer relationships, adding customers, broadening the product portfolio and benefiting from increased regulatory emphasis on diagnostic-test quality.

Groome said the company expects margins to improve as manufacturing shifts from smaller runs to larger-volume production, given its existing infrastructure and capacity.

Kinlytic partnership

Beyond diagnostics, Microbix holds rights to Kinlytic, an FDA-approved biological drug intended to dissolve blood clots in venous catheters. Groome said the company acquired the drug master file and is validating new manufacturing to return the product to market for its approved clinical uses.

Rather than funding the program through what Groome said could have required more than CAD$50 million in capital, Microbix partnered the project with U.S. private equity. He said the partner is providing the funding, while Microbix expects milestone payments and ongoing double-digit royalties if the product returns to market.

Groome said Kinlytic could begin contributing revenue around 2028. In response to an analyst question, he said management believes the drug could capture about 40% of unit volume over five years, citing potential advantages including room-temperature stability, pricing and supply-chain security.

About Microbix Biosystems (TSE:MBX)

Microbix Biosystems Inc creates proprietary biological products for human health, with over 120 skilled employees and revenues of C$ 18.6 million in its last reported 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.