BerGenBio

Regulatory Filings • Mar 9, 2023

BerGenBio Announces First Patient Dosed in Phase 1b/2a Trial Evaluating Bemcentinib in 1st Line Non-Small Cell Lung Cancer with STK11 Mutations

BerGenBio Announces First Patient Dosed in Phase 1b/2a Trial Evaluating Bemcentinib in 1st Line Non-Small Cell Lung Cancer with STK11 Mutations

- Global trial designed to study the safety, tolerability and efficacy of

bemcentinib in combination with current standard of care -

BERGEN, Norway, March 9, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, today announced the first patient was dosed in a

Phase 1b/2a trial evaluating bemcentinib in combination with the current

standard of care, immune checkpoint inhibitor pembrolizumab and doublet

chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer

(NSCLC) patients harboring STK11 mutations (STK11m).

"Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not

currently have effective treatment options," said Martin Olin, Chief Executive

Officer of BerGenBio. "One specific attribute of this group is that they almost

all demonstrate high levels of AXL activation. We are elated to have dosed the

first patient in our trial and to continue our evaluation of bemcentinib and its

ability to inhibit AXL to revive STK11m NSCLC patients' response to checkpoint

inhibitors and chemotherapy."

The trial's lead investigator, Rajwanth Veluswamy, M.D., MSCR, Assistant

Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine

at Mount Sinai (New York, NY), commented, "Today, STK11 mutations are correlated

with a very poor prognosis for patients suffering from NSCLC. These mutations

are widely recognized for their ability to impede the activity of anti-PD-1/L1

therapy. My colleagues and I are driven to find a better outcome for this large

patient population and are eager to assess bemcentinib's potential in achieving

this goal."

The global, open-label Phase 1b/2a trial is designed to determine the safety,

tolerability and efficacy of bemcentinib with standard of care treatments in

untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations

and no actionable mutations. The Phase 1b portion of the study will evaluate the

safety and feasibility of bemcentinib in combination with pembrolizumab and

doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,

regardless of STK11 status. The Phase 2a expansion part will assess the efficacy

of bemcentinib in the same treatment combination in 1L advanced/metastatic non

-squamous NSCLC patients with STK11 mutations.

-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. The Company is focused on advancing its lead candidate,

bemcentinib, a potentially first-in-class, oral, selective AXL inhibitor in

STK11 mutated NSCLC and severe respiratory infections including 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, 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.