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BerGenBio

Regulatory Filings Nov 4, 2021

3555_rns_2021-11-04_b7798517-452b-469d-ba05-71c54a74a1ea.pdf

Regulatory Filings

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BERGENBIO TO PRESENT UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING

Bergen, Norway, 4 November 2021 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for significant unmet medical needs, is pleased to announce a poster presentation at the 63rd Annual American Society of Hematology (ASH) Meeting, taking place 11-14th December 2021 in Atlanta, GA.

Prof Sonja Loges will provide an update from the Company's Phase II study (BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in older, relapsed and refractory AML patients unfit for intensive chemotherapy.

The data to be presented suggest that bemcentinib in combination with LDAC is well tolerated and offers promising survival benefit to relapsed AML patients. Translational research has further identified immune-based activity associated with response to treatment, suggesting that bemcentinib elicits activation of the two major adaptive immune cell populations responsible for anti-AML immune effect.

Abstracts have been announced online and details of the presentation are below.

Title: Bemcentinib (Oral AXL Inhibitor) in combination with Low-dose Cytarabine Is Well Tolerated and Efficacious in Older Relapsed AML Patients. Updates from the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results indicating Bemcentinib elicits anti-AML immune responses.

Date: Monday, December 13, 2021

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III

Time, Location: 6.00 – 8.00 PM Eastern, Georgia World Congress Center, Hall B5

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA [email protected]

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

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 immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme focused on combination and single agent therapy in cancer, leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is developing a potential companion diagnostic test to identify patient populations most likely to benefit from AXL inhibition: this is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy.

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.

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