BerGenBio

Regulatory Filings • May 16, 2018

BerGenBio to present interim clinical and biomarker data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO

BerGenBio to present interim clinical and biomarker data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO

·

Four peer reviewed BerGenBio abstracts on clinical data with bemcentinib

accepted for presentation at ASCO

·

BerGenBio to host KOL reception to showcase bemcentinib studies and potential as

a cornerstone of cancer therapy

Bergen, Norway, 16 May 2018 - BerGenBio ASA (OSE:BGBIO) announces that the

company and its collaborators will present new interim clinical and biomarker

data from its extensive Phase II clinical development programme with

bemcentinib, a selective, oral AXL inhibitor, at the 2018 annual meeting of the

American Society of Clinical Oncology (ASCO) at McCormick Place in Chicago, IL

(1-5 June 2018). Abstracts are now available online at https://am.asco.org/ and

details of the presentations are below. The posters presented at ASCO will be

made available on www.bergenbio.com in the Investors / Presentations section

following the sessions.

Presentations at ASCO

Monday 4 June, 8:00 AM - 11:30 AM Central Daylight Time (Hall A)

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in

-class selective AXL inhibitor, in combination with pembrolizumab in patients

with advanced NSCLC.

· James Lorens, PhD et al

· Session: Developmental Therapeutics - Immunotherapy

· Poster Board: #292, Abstract 3078

Identification of predictive and pharmacodynamic biomarkers associated with the

first-in-class selective AXL inhibitor bemcentinib across multiple Phase II

clinical trials.

· Robert J Holt, PhD et al

· Session: Developmental Therapeutics - Clinical Pharmacology and

Experimental Therapeutics

· Poster Board: #385, Abstract 2559

Analysis of anti-leukemic activity, predictive biomarker candidates, immune

activation and pharmakodynamics in R/R AML and MDS in response to treatment with

bemcentinib (BGB324), a first-in class selective AXL inhibitor, in a Phase II

open-label, multi-centre study.

· Bjørn T. Gjertsen, MD, PhD et al

· Session: Hematologic Malignancies - Leukemia, Myelodysplastic Syndromes, and

Allotransplant

· Poster Board: #80, Abstract 7020

· To be discussed at the Poster Discussion Session on Monday 4 June, 11:30 AM

- 12:45 PM, at E450

Monday 4 June, 1:15 PM - 4:45 PM CDT (Hall A)

A randomized Phase Ib/II study of the selective small molecule AXL inhibitor

bemcentinib (BGB324) in combination with either dabrafenib/trametinib or

pembrolizumab in patients with metastatic melanoma.

· Oddbjørn Straume, MD, PhD et al

· Session: Melanoma/Skin Cancers

· Poster Board: #375, Abstract 9548

BerGenBio reception

Coinciding with ASCO, BerGenBio will host a reception for collaborators,

investors, analysts, media and other interested parties on 2 June at The School

of the Art Institute Ballroom in Chicago. At this event, short presentations

will be given by clinical investigators participating in the bemcentinib

clinical trials and by KOL experts in AXL kinase function. For further details

and to receive an invitation, please click here (asco2018@bergenbio.com) or

email: asco2018@bergenbio.com.

The presentations will be made available on BerGenBio's website in the Investors

/ Presentations section following the event.

-End-

About BerGenBio ASA

BerGenBio ASA is a clinical-stage biopharmaceutical company focused on

developing a pipeline of first-in-class AXL kinase inhibitors as a potential

cornerstone of combination cancer therapy. The Company is a world leader in

understanding the essential role of AXL kinase in mediating aggressive disease,

including immune evasive, drug resistant, metastatic solid and haematological

cancers.

BerGenBio's lead product, bemcentinib (BGB324), is a selective, potent and

orally bio- available small molecule AXL inhibitor in four Company sponsored

Phase II clinical trials in major cancer indications, with read-outs anticipated

during 2018. It is the only selective AXL inhibitor in clinical development.

The Company sponsored clinical trials are:

· Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-

small cell lung cancer (NSCLC)

· Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and

· Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).

· Bemcentinib as a single agent and combination therapy in acute myeloid

leukaemia (AML) / myeloid dysplastic syndrome (MDS)

The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the

lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth,

NJ, USA), through a subsidiary.

In addition, a number of investigator-sponsored trials are underway, including a

trial to investigate bemcentinib with either MEKINIST® (trametinib) plus

TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial

combining bemcentinib with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify

patient subpopulations most likely to benefit from treatment with bemcentinib.

This will facilitate more efficient registration trials and support a precision

medicine based commercialisation strategy.

The Company is also developing a diversified pre-clinical pipeline of drug

candidates, including BGB149, an anti-AXL monoclonal antibody.

For further information, please visit: www.bergenbio.com

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary

of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of

OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a

registered trademark of Novartis International AG and MEKINIST® is a registered

trademark of GSK plc.

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

+47 917 86 513

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+47 995 13 891

International Media Relations

David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson

bergenbio@citigatedewerogerson.com

+44 207 638 9571

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.