BerGenBio

Legal Proceedings Report • Mar 20, 2024

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

BerGenBio Announces Initiation of Phase 2a in First Line Non-Small Lung Cancer Patients with a STK11 mutation

BerGenBio receives positive recommendation from independent

Data and Safety Monitoring Board to proceed without study modification

Bergen, Norway, March 20, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, announced today it has initiated the Phase 2a

portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib

in combination with standard of care therapy in first-line Non Small Cell Lung

Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

The initiation of Phase 2a follows apositive recommendationby the independent

Drug Safety Monitoring Board (DSMB) which evaluated the safety of the

combination of bemcentinib with pembrolizumab (Keytruda®) and doublet

chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion

of the study.

Patients with STK11m NSCLC have a significantly poorer response to current

therapies, including immune checkpoint inhibitors, when compared with patients

with wild-type (non-mutated) STK11. AXL plays a significant role in the survival

and spread of cancer and STK11m NSCLC patients have a high expression of AXL

suggesting that AXL is an important target to prevent disease progression and

resistance to existing therapies. Bemcentinib's selective inhibition of AXL has

been shown to improve the response to immune checkpoint inhibition in STK11m

patient-derived preclinical models and in early clinical studies. There are

currently no targeted therapies available for the STK11m NSCLC patient

population, which represents up to 20% of 1L NSCLC patients.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very

pleased that no new safety signals have been identified and are encouraged by

the recommendation of the DSMB to continue the study as planned. We have

therefore, opened the Ph2a portion of the study with the goal of reporting

initial efficacy data as the next step in validating the benefit of bemcentinib

in combination with standard therapies in 1L NSCLC."

Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical

need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a

novel treatment modality which may significantly improve the outcome for

patients, and we are pleased to have achieved this important milestone."

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, 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 considered to be inside information pursuant to the EU

Market Abuse Regulation and subject to the disclosure requirements pursuant to

section 5-12 of the Norwegian Securities Trading Act.