BerGenBio

Regulatory Filings • Dec 15, 2023

BerGenBio announces closure of EU-SolidAct bemcentinib study arm in hospitalized COVID-19 patients

BerGenBio announces closure of EU-SolidAct bemcentinib study arm in hospitalized COVID-19 patients

BERGEN, Norway, December 15, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced that the Trial Steering Committee of

the EU-SolidAct has recommended to discontinue the bemcentinib study arm in the

Ph2b EU-SolidAct platform study in hospitalized COVID-19 patients due to a lack

of eligible patients. This recommendation is supported by BerGenBio. The

regulatory sponsor of the study, Oslo University Hospital, will enact this

decision.

In April 2023, BerGenBio announced that the parties unanimously decided to pause

the bemcentinib study arm due to a lack of eligible patients.  The parties also

agreed that a potential resumption of the study arm would be subject to eligible

patients being available.

BerGenBio will not incur any financial impact from the closure of the

bemcentinib study arm.

Martin Olin, BerGenBio's Chief Executive Officer stated, "The changing nature of

the COVID-19 pandemic makes further conduct of this study arm infeasible and we

agree with the Trial Steering Committee's decision.  Our prior work in

hospitalized COVID-19, including two Phase 2 studies, confirms that bemcentinib

may reduce patient morbidity and mortality when severe respiratory infections

are present.  This extensive dataset gives us reassurance that further work in

this area is warranted and we continue to evaluate the potential of bemcentinib

in severe respiratory infections caused by other viral pathogens, including

Respiratory Syncytial Virus (RSV) and influenza."

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing

transformative drugs targeting AXL as a potential cornerstone of therapy for

aggressive diseases, including cancer and severe respiratory infections. The

Company is focused on its proprietary lead candidate, bemcentinib, a potentially

first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC

and severe respiratory infections.

BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The

company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more

information, visit?www.bergenbio.com

Forward looking statements

This announcement may contain forward-looking statements, which as such are not

historical facts, but are based upon various assumptions, many of which are

based, in turn, upon further assumptions. These assumptions are inherently

subject to significant known and unknown risks, uncertainties, and other

important factors. Such risks, uncertainties, contingencies and other important

factors could cause actual events to differ materially from the expectations

expressed or implied in this announcement by such forward-looking statements.

This information is subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.