BerGenBio

Earnings Release • Aug 21, 2018

BerGenBio ASA: Results for the Second Quarter and First Half 2018

BerGenBio ASA: Results for the Second Quarter and First Half 2018

· Encouraging clinical data emerging from several phase II trials with highly

selective AXL inhibitor bemcentinib (BGB324)

· Advanced lung cancer (NSCLC): First stage fully recruited, and first

efficacy endpoint met in phase II trial of bemcentinib in combination with anti

-PD-1 therapy KEYTRUDA®

· Advanced leukaemia (AML/MDS): Encouraging bemcentinib single agent activity

in hard to treat relapsed / refractory (R/R) leukaemia

· Pipeline update: AXL antibody preparing for Phase I clinical trial

Bergen, Norway, 21 August 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

multiple cancer indications, announces its results for the second quarter and

first half 2018. A presentation of the results by the Company's management will

take place today at 10.00 am CET in Oslo - details below.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

pleased with the progress of our clinical development

programme (https://www.bergenbio.com/pipeline/) for bemcentinib in the first

half 2018. The emerging results in several clinical trials, which we showcased

at our successful satellite reception coinciding with the ASCO meeting in June,

are very encouraging and continue to support our view that bemcentinib could

become a cornerstone of future cancer therapy. These data provide further

evidence of bemcentinib's activity in patients whose cancer progression is

mediated by AXL. In addition, we are making good progress with our studies to

identify predictive biomarkers that could be developed as companion diagnostics

for personalized therapy with bemcentinib. We look forward to advancing these

studies to completion and defining the future development strategy of

bemcentinib with the greatest value for patients."

Highlights - Second Quarter & First Half 2018

· Advanced lung cancer (NSCLC): First stage fully recruited, and first

efficacy endpoint met in trial of bemcentinib in combination with KEYTRUDA®.

Clinical responses seen following treatment with bemcentinib/KEYTRUDA in

patients negative for PD-L1 for whom KEYTRUDA monotherapy is not effective.

· Advanced leukaemia (AML/MDS): Encouraging single agent activity in hard to

treat relapsed / refractory (R/R) leukaemia: Superior response rates of > 40%

observed in biomarker subgroup analyses.

· Triple negative Breast cancer (TNBC): First stage fully recruited, patients

negative for Axl and PDL1 and first efficacy endpoint not met.

· Tissue- and blood-based biomarkers with potential for development as

companion diagnostics: AXL IHC method reporting encouraging correlation data.

Low plasma soluble AXL predicts patient benefit in R/R  AML/MDS.

· Pipeline update: AXL antibody preparing for Phase I clinical trial.

· Cash position NOK441m.

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place at 10.00 am

CET at:

Felix Konferansesenter, Bryggetorget 3, 0125 Oslo

The presentation will webcast live and the link will be available at

www.bergenbio.com in the section Investors/ Financial Reports. A recording will

be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com

in the section: Investors/ Financial Reports from 7:00 am CET the same day.

-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 commercialization 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

International Media Relations

David Dible, Mark Swallow, Marine Perrier

Citigate Dewe Rogerson

bergenbio@citigatedewerogerson.com

+44 207 638 9571

Media relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+47 995 13 891

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.