Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces the reconfirmation of its agreement
(“
Agreement”) with Sequel Pharma, LLC
(“
Sequel”) to return Kinlytic® urokinase
(“
Kinlytic”) to market, initially for dissolving
blood clots that block venous catheters (“
Catheter
Clearance”) in the United States
(“
U.S.”), 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 US$ 2.0 million 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 U.S. 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 fund and
undertake the necessary work to complete the sBLA and return
Kinlytic® to the U.S. for the clinical indication of Catheter
Clearance, currently a market of at least US$ 350 million 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% of such catheters become blocked with
blood clots which, if not cleared, require costly surgical catheter
replacement.
Microbix received a closing payment of US$ 2.0
million 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 US$ 2.0 million. The
parties are now proceeding toward filing of the sBLA, with funding
for needed work fully provided by Sequel. As detailed in May,
Microbix will receive further milestone and royalty payments tied
to the re-launch of Kinlytic.
Advancement of the Agreement is initially
expected to influence Microbix’s results for the fourth quarter of
fiscal 2023 (“Q4 2023” ending September 30, 2023)
and the first quarter of fiscal 2024 (“Q1 2024”
ending December 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 C$ 3.1 million. In Q1 2024, Microbix expects to
record additional revenues of US$ 3.0 million, comprised of US$ 1.0
million of the May 2023 closing payment and the full US$ 2.0
million of the current milestone payment.
Cameron Groome, CEO 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 via a webinar
hosted by Adelaide Capital at 10:00 AM ET on Friday, November 17,
2023. Participants can register here:
https://us02web.zoom.us/webinar/register/WN_ssbGvk0gT9arZNyp6BkHcQ.
The session will also be live-streamed and a
replay will be posted on Adelaide Capital’s YouTube Channel here:
https://www.youtube.com/channel/UC7Jpt_DWjF1qSCzfKlpLMWw.
About Microbix Biosystems
Inc.Microbix Biosystems Inc. creates proprietary
biological products for human health, with over 100 skilled
employees and annualized sales targeting C$ 2.0 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 & 13485 accredited, U.S. FDA registered, Australian
TGA registered, Health Canada establishment licensed, and provides
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 viral transport
medium (DxTM™), to stabilize patient samples for lab-based
molecular diagnostic testing. Microbix is traded on the TSX and
OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking InformationThis
news release includes “forward-looking information,” as such term
is defined in applicable securities laws. Forward-looking
information includes, without limitation, discussion of Sequel, the
Agreement, Kinlytic® or its 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, 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.
Please visit https://microbix.com or
https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix
at:
Cameron Groome, CEO(905) 361-8910 |
Jim Currie, CFO(905) 361-8910 |
Deborah Honig, Investor RelationsAdelaide Capital Markets(647)
203-8793 ir@microbix.com |
Copyright © 2023 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, and QAPs™ are trademarks of Microbix
Biosystems Inc.
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