Market Overview

cGMP Compliance Status for Promethera Biosciences' Production Site in Durham, NC Confirmed by Health Canada


Promethera Biosciences SA, a global innovator in cell-based medicines
and liver diseases, today announced that Health Canada has confirmed a
cGMP compliance status for the company's production facility in Durham,
North Carolina. The Durham facility will be focused on achieving the
goals of Promethera's current strategic focus, developing and producing
the starting material of HepaStem as a treatment for chronic liver
disorders such as Non-alcoholic steatohepatitis (NASH) and
Acute-on-chronic liver failure (ACLF). As part of this strategy, the
company has decided on a full out-licensing of the Heparesc program to a
commercial partner, and hence cancelled its New Drug Submission (NDS)
before a final decision was reached by Health Canada in order to keep
full negotiation flexibility with a future partner.

"The confirmation of our Durham factory's cGMP compliance status brings
us a step closer to commercial capabilities for the production of our
HepaStem treatment," says John Tchelingerian, PhD, President & CEO of
Promethera Biosciences SA. "HepaStem's multiple mechanisms of action
could be a potential alternative to reverse the NASH disease process
forming a possible solution for the damage inflicted by advanced NASH or
other chronic liver diseases that can lead to ACLF. With our new focus,
we decided the time was right to bring in a commercial partner that
would carry the Heparesc technology across the regulatory finish line."

"Our experienced manufacturing and quality teams in the US continue to
work in line with very high-quality standards, as evident in our cGMP
status confirmation, helping the site continue to play an important role
in the overall group structure," said Mark Johnston, Managing Director,
Promethera Biosciences LLC.

About Promethera Biosciences

Promethera Biosciences is a global innovator in liver therapeutics whose
mission is to enable patients to overcome acute and chronic liver
diseases. Our lead clinical program, derived from our patented cell
technology platform HepaStem, is designed to benefit from its
immune-modulatory and anti-fibrotic properties. In addition to our
cell-based pipeline we develop antibody technologies, such as the
anti-TNF-R1 antibody Atrosimab, to complement and diversify our
therapeutic options. We are a team of international experts operating
out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA,
Tokyo, Japan and Basel, Switzerland.

Promethera®, HepaStem®, H2stem®, Cytonet®, Heparesc®, Hepabridge® are
all registered trademarks of the PROMETHERA group.



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