BerGenBio

Legal Proceedings Report • Dec 11, 2023

BerGenBio Announces Final Bemcentinib Phase 2 Data in AML and MDS Presented at the 2023 ASH Meeting

BerGenBio Announces Final Bemcentinib Phase 2 Data in AML and MDS Presented at the 2023 ASH Meeting

· Bemcentinib is an oral highly selective AXL inhibitor in development for

cancer and severe respiratory infections

· Final Phase 2 data indicates a favorable safety profile with promising

efficacy in AML and MDS patients

BERGEN, Norway, December 11, 2023, - BerGenBio ASA (OSE: BGBIO), a clinical

-stage biopharmaceutical company developing novel, selective AXL kinase

inhibitors for severe unmet medical needs, today announced that a poster

highlighting final results from a Phase 2 clinical study of its highly selective

AXL inhibitor bemcentinib in patients with Acute Myeloid Leukemia (AML) or

Myelodysplastic Syndrome (MDS) was presented during the 2023 American Society of

Hematology (ASH) Annual Meeting being on December 9th in San Diego, CA.

The data presented by Professor Sonja Loges, MD, Ph.D. of the University Medical

Centre Mannheim, Heidelberg, Germany, showed that bemcentinib was well tolerated

in AML and MDS patients. Durable responses were observed across all cohorts with

bemcentinib as monotherapy and in combination with chemotherapy. In addition,

longitudinal samples analyzed from patients enrolled in the study showed that

bemcentinib inhibited pAXL and downstream markers of activation.

Martin Olin, Chief Executive Officer of BerGenBio commented "This large Phase 2

study included 122 patients in several cohorts of AML and MDS patients treated

with bemcentinib monotherapy or in combination with two different

chemotherapies.  We are particularly encouraged by the monotherapy activity of

bemcentinib in this study which adds to the mounting evidence of the role of

bemcentinib in restoring the function of patients' immune response to cancer."

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 Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective

inhibitor of the tyrosine kinase AXL.  Extensive studies confirm the ability to

combine bemcentinib with immune checkpoint inhibitors, chemotherapies and

targeted therapies with the goal of improving a patient's immune response and

delaying the development of chemoresistance.  Bemcentinib is currently being

investigated in combination with immune checkpoint inhibition and chemotherapy

in first line NSCLC patients harboring mutations in the STK11 gene, a known

prognostic factor of poor response to existing therapies.

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.