Mr. Cameron Groome reports

MICROBIX CLOT-BUSTER DRUG FULLY-FUNDED FOR RETURN TO U.S. MARKET

Microbix Biosystems Inc. has confirmed its agreement with Sequel Pharma LLC to return Kinlytic urokinase to market, initially for dissolving blood clots that block venous catheters (catheter clearance) in the United States, followed by other geographies and clinical indications.

Sequel is a U.S.-based specialty pharma company with expertise in developing and commercializing niche drugs. A further payment of $2-million (U.S.) has been received by Microbix relating to this reconfirmation.

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 agreement provides for Sequel to finance and undertake the necessary work to complete the sBLA and return Kinlytic to the United States for the clinical indication of catheter clearance, currently a market of at least $350-million (U.S.) per year. Long-term venous catheters are used to administer pharmaceuticals, nutrition or dialysis, often needing to remain in place for extended periods. About 25 per cent of such catheters become blocked with blood clots, which, if not cleared, require costly surgical catheter replacement.

Microbix received a closing payment of $2-million (U.S.) in May, 2023. Following a satisfactory consultation with the U.S. Food and Drug Administration (FDA) to reconfirm and build upon prior regulatory guidance, Microbix has received this second payment of a further $2-million (U.S.). The parties are now proceeding toward filing of the sBLA, with financing for needed work fully provided by Sequel. As detailed in May, Microbix will receive further milestone and royalty payments tied to the relaunch of Kinlytic.

Advancement of the agreement is initially expected to influence Microbix's results for the fourth quarter of fiscal 2023 (ended Sept. 30, 2023) and the first quarter of fiscal 2024 (ending Dec. 31, 2023). In Q4 2023, Microbix expects to reverse an impairment of the value of its Kinlytic assets recorded in fiscal 2020, resulting in an increase to net earnings of approximately $3.1-million. In Q1 2024, Microbix expects to record additional revenues of $3-million, comprising $1-million (U.S.) of the May, 2023, closing payment and the full $2-million (U.S.) of the current milestone payment.

Cameron Groome, chief executive officer and president of Microbix, commented: "Reconfirming our fully funded partnership to return Kinlytic to widespread clinical use is a most fitting tribute to Microbix's founder, Bill Gastle, whose vision drove this important program. We are now delighted to be working closely with Sequel leadership to restore availability of this clinically important biologic drug. We expect that Kinlytic will return to the U.S. market, meaningfully help patients, and significantly contribute to Microbix's revenues and net earnings."

Microbix will update shareholders about Kinlytic, the agreement and its overall operations through a webinar hosted by Adelaide Capital at 10 a.m. ET on Friday, Nov. 17, 2023.

The session will also be live streamed and a replay will be posted on Adelaide Capital's YouTube channel.

About Microbix Biosystems Inc.

Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales 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 10 international distributors. Microbix is ISO 9001 and ISO 13485 accredited, U.S. Food and Drug Administration (FDA) registered, Australian Therapeutic Goods Administration (TGA) 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 viral transport medium (DxTM), to stabilize patient samples for lab-based molecular diagnostic testing. Microbix is traded on the Toronto Stock Exchange and OTCQX and is headquartered in Mississauga, Ont., Canada.

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