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BerGenBio

Regulatory Filings Feb 7, 2024

3555_rns_2024-02-07_26b7b8ed-356a-450b-b007-e09800f634af.html

Regulatory Filings

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BerGenBio Announces New Preclinical Data Indicating Broadened Potential for Bemcentinib to Treat Severe Respiratory Infections

BerGenBio Announces New Preclinical Data Indicating Broadened Potential for Bemcentinib to Treat Severe Respiratory Infections

Bergen, Norway, February 7, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced that Dr. Mirella Spalluto of the

University of Southampton today presented "Investigating the effects of AXL

inhibition during respiratory viral infections" during the 6th Forum on

Respiratory Infections in Glasgow, Scotland.

The data presented by Dr. Spalluto showed bemcentinib had activity in human in

vitro models of infection caused by Respiratory Syncytial Virus (RSV), influenza

and rhinovirus. In these models, bemcentinib downregulated IL-6 and IL-8, two

important inflammatory cytokines associated with the severity of hospitalized

respiratory infections.

Clinically, patients with viral respiratory infections can develop acute

respiratory distress syndrome (ARDS), a life-threatening condition.  In ARDS

patients, cytokines - a type of inflammatory protein - are released bringing

neutrophils to the lung to fight infection. These proteins, however, can leak

into blood vessels, traveling through the body resulting in inflammation of

other organs which may lead to organ failure.

Cristina Oliva, MD, Chief Medical Officer at BerGenBio commented on the

relevance of these new data: "The findings of cytokine down-regulation in

preclinical models align with samples from patients treated with bemcentinib in

previous clinical studies of hospitalized COVID-19. These data indicate that

bemcentinib may be a helpful addition to supportive care in patients with ARDS

resulting from a variety of common viral infections.  The need for new

therapeutics in this patient population is acute, with the morality rate from

viral ARDS estimated at between 27-45%.  We look forward to conducting

additional preclinical evaluation of bemcentinib's activity in severe

respiratory infections to further bolster our understanding in this important

area."

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

Investor Relations / Media Relations

Jan Lilleby

[email protected]

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective

inhibitor of the tyrosine kinase AXL.  Extensive studies confirm the ability to

combine bemcentinib with immune checkpoint inhibitors, chemotherapies and

targeted therapies with the goal of improving a patient's immune response and

delaying the development of chemoresistance.  Bemcentinib is currently being

investigated in combination with immune checkpoint inhibition and chemotherapy

in first line NSCLC patients harboring mutations in the STK11 gene, a known

prognostic factor of poor response to existing therapies.

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, visitwww.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.

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