BerGenBio

Regulatory Filings • Apr 18, 2023

BerGenBio Presents Data on STK11 Loss of Function and AXL Activation at AACR

BerGenBio Presents Data on STK11 Loss of Function and AXL Activation at AACR

- In addition to STK11 mutations, KEAP1m identified as being associated with

STK11 loss of function -

- STK11 loss of function correlated to AXL activation and poorer outcomes in

NSCLC -

BERGEN, Norway, April 18, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced that it presented data linking AXL

activation to STK11 loss of function in Non-Small Cell Lung Cancer (NSCLC) in an

abstract titled, AXL as a Therapeutic Target in STK11 mutant NSCLC, at the

American Association for Cancer Research (AACR) Annual Meeting 2023.

An analysis of tumors lacking STK11 function from BerGenBio's 2nd line NSCLC

trial (BGBC008) and publicly available datasets suggest that STK11 and KEAP1

mutations are transcriptionally similar and share a common signature for STK11

loss of function. Loss of function leading to inactivation of STK11 is found in

approximately 30% of lung adenocarcinomas as a result of both mutational and non

-mutational mechanisms. These tumors with inactivated STK11 are likely to

promote AXL activation due to high levels of energetic and metabolic stress,

resulting in a poorer prognosis in NSCLC.

AXL, a member of the TAM family of receptor tyrosine kinases, is expressed in

over 80% of NSCLC tumors that demonstrate loss of STK11 function. AXL is

activated in response to inflammation, hypoxia, cellular stress or drug

treatment. AXL is expressed in both tumor cells, where it enhances survival and

drug resistance, and in innate immune cells, such as dendritic cells and

macrophages, where AXL drives immune suppression. BerGenBio's selective AXL

inhibitor bemcentinib targets key survival and resistance mechanisms within the

tumor and restores the anti-tumor characteristics of innate immune cells within

the tumor microenvironment.

"There is accumulating evidence substantiating the importance of targeting AXL

within the tumor and innate immune cells of the tumor microenvironment," said

Nigel McCracken,Ph.D., Chief Scientific Officer of BerGenBio. "A loss of STK11

function due to STK11 or KEAP1 mutations is associated with a poorer prognosis,

irrespective of treatment modality and represents a large subgroup of NSCLC

patients with high unmet need. Our preclinical data and the clinical data from

our Phase 2 trial evaluating bemcentinib in combination with pembrolizumab

support targeting AXL in both STK11 and KEAP1 mutated NSCLC patients."

The abstract will be available on the Company's website in the Scientific

Presentations (https://www.bergenbio.com/investors/presentations/) portion of

the Investors section.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

graham.morrell@bergenbio.com

Media Relations Norway

Jan Lilleby

jl@lillebyfrisch.no

+47 90 55 16 98

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 COVID-19.

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.