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BerGenBio

Board/Management Information Aug 6, 2021

3555_rns_2021-08-06_84d3c58d-f7c3-4ac7-baeb-5e8522a4342c.html

Board/Management Information

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BERGENBIO ANNOUNCES CHANGES TO SENIOR MANAGEMENT

BERGENBIO ANNOUNCES CHANGES TO SENIOR MANAGEMENT

Bergen, Norway, 6 August 2021 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, today announces changes to its clinical development

team structure in preparation for late-stage clinical trials of lead candidate

bemcentinib and increased activity in medical and scientific regulatory affairs.

Prof. Hani Gabra has transitioned from Chief Medical Officer to a part-time

position as Director of Clinical Development, to focus on the scientific

elements of clinical trial design and the important parallel translational

research being undertaken by BerGenBio. Dr E. Gwyn Thomas has joined the Company

as interim Head of Clinical Development.

Dr E. Gwyn Thomas is a physician specializing in medical oncology and clinical

pharmacology and has over 25 years of experience in pharmaceutical medicine,

drug development and medical affairs. Dr Thomas has held senior leadership roles

at Wyeth Research, Genzyme Europe, Ibsen, Blue Earth Diagnostics and Mundipharma

Research. During his career, Dr Thomas has successfully managed several New Drug

Applications in the US, Japan and Singapore, as well as Marketing Authorisation

Applications across Europe.

Richard Godfrey, Chief Executive Officer of BerGenBio commented "We are pleased

to welcome Gwyn to BerGenBio. This is an exciting time for the Company as we

continue to advance our lead candidate bemcentinib. With strong data obtained so

far, Gwyn's extensive experience will be crucial as we continue our dialogue

with both EU and US regulators on the potential initiation of pivotal

registration trials for this promising candidate."

- END -

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the

biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor

to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters

the host cell, and AXL expression is upregulated in infected organs with an

activation of the signalling pathway leading to suppression of the Type 1

Interferon immune response by infected cells and neighbouring cells, in their

environment. Pre-clinical research studies demonstrate that bemcentinib inhibits

SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug

resistance and immune escape by tumour cells, leading to aggressive metastatic

cancers. AXL suppresses the body's immune response to tumours and drives

treatment failure across many cancers. High AXL expression defines a very poor

prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,

therefore, have potential high value as monotherapy and as the cornerstone of

cancer combination therapy, addressing significant unmet medical needs and

multiple high-value market opportunities. Research has also shown that AXL

mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent

and highly selective AXL inhibitor, currently in a broad phase II clinical

development programme. It is administered as an oral capsule and taken once per

day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and

multiple solid and haematological tumours, in combination with current and

emerging therapies (including immunotherapies, targeted therapies and

chemotherapy), and as a single agent. Bemcentinib targets and binds to the

intracellular catalytic kinase domain of AXL receptor tyrosine kinase and

inhibits its activity.

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 immune-evasive, therapy resistant cancers. The

company's proprietary lead candidate, bemcentinib, is a potentially first-in

-class selective AXL inhibitor in a broad phase II clinical development

programme focused on combination and single agent therapy in cancer, leukaemia

and COVID-19. A first-in-class functional blocking anti-AXL

antibody, tilvestamab, is undergoing phase I clinical testing. In

parallel, BerGenBio is developing a companion diagnostic test to identify

patient populations most likely to benefit from AXL inhibition: this is expected

to facilitate more efficient registration trials supporting a precision medicine

-based commercialisation strategy.

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

Contacts

Richard Godfrey CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

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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