BerGenBio

Legal Proceedings Report • Jul 29, 2024

BerGenBio Announces Selection of 2nd Dose in Phase 2a First Line STK11m Non-Small Lung Cancer Trial

BerGenBio Announces Selection of 2nd Dose in Phase 2a First Line STK11m Non-Small Lung Cancer Trial

BerGenBio receives positive recommendation from independent

Data and Safety Monitoring Board to initiate second dose in Ph2a of BGBC016

trial

Bergen, Norway, July 29, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, announced today that the independent Data and Safety

Monitoring Board (DSMB) for BerGenBio's Phase 1b/2a BGBC016 study confirmed

acceptable safety at the highest dose tested in the Phase 1b. As a result, the

DSMB also recommended that under the study protocol, no additional patients will

be required for Phase 1b.

The recommendation of the DSMB allows BerGenBio to proceed per study protocol

and open the second dose level in the Phase 2a part of the study in NSCLC

patients with STK11 mutations. This portion of the study is already open for

enrollment and is designed to evaluate the efficacy of the combination of

bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We continue to be

reassured by the safety profile of bemcentinib when combined with the standard

of care for 1L NSCLC patients.  Opening the second dose level in the Phase 2a

portion of the BGBC016 study will allow us to carefully evaluate the dose

response to bemcentinib, an important goal to guide the dose optimization for

future trials."

Martin Olin, Chief Executive Officer of BerGenBio added, "The BGBC016 clinical

trial is our highest priority, and I am happy to see it continues to progress as

planned. NSCLC STK11m patients are not currently eligible for targeted therapy

and unfortunately face a very poor prognosis. The medical need is significant,

and so are the commercial opportunities.

The Phase 2a is assessing the safety and efficacy of two different doses of

bemcentinib in the same treatment combination. As previously communicated, the

company expects to present an interim analysis in the second half of this year.

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 STK11m NSCLC

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.

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.