BerGenBio

Earnings Release • Nov 17, 2017

BerGenBio ASA: Results for the Third Quarter 2017

BerGenBio ASA: Results for the Third Quarter 2017

Bergen, Norway, 17 November 2017 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective Axl kinase inhibitors for

multiple cancer indications, announces its results for the third quarter 2017. A

presentation of the results by the Company's senior management team will take

place today at 9.00 am CET in Oslo - details below.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"We are very pleased with the progress the company has made during Q3 2017. Our

broad clinical development programme of Phase 2 trials with BGB324, our

selective Axl inhibitor, in combination with standard therapies in multiple

aggressive cancers is well underway and recruiting patients at leading hospitals

in Europe and the US. These trials are on track to deliver important clinical

milestones in 2H 2018, demonstrating the significant potential of BGB324 to

become a universal approach to cancer therapy by making tumour cells visible to

the immune system and more susceptible to treatment with chemotherapy, targeted

therapy and immuno-oncology drugs."

Operational highlights

· Good progress advancing broad clinical development programme with BGB324 in

all indications under investigation

· Patient recruitment underway for four company sponsored Phase II trials

with key read-outs expected in 2H 2018: two trials in non-small cell lung cancer

(NSCLC), one in triple negative breast cancer (TNBC), and in acute myeloid

leukaemia (AML) / myelodysplastic syndrome (MDS)

· Two Phase II investigator-sponsored studies evaluating BGB324 in

combination with chemotherapy in NSCLC and with targeted or immune-oncology

drugs in melanoma continue to recruit well

· Design and rationale for Phase II trial of BGB324 in combination with

chemotherapy, targeted therapy and immunotherapy in NSCLC presented at

Precision: Lung Cancer Conference, Boston.

· Clinical trial programme demonstrating BGB324's ability to counteract Axl

-driven immune evasion and acquired drug resistance to standard therapies with

potential to improve clinical outcomes

Post period events

· First patients enrolled and dosed in Phase II trials of BGB324 in

combination with KEYTRUDA® (pembrolizumab) in NSCLC and TNBC (October)

· Patient recruitment progressing well at leading cancer centres in Norway,

UK, Spain and the US

· Clinical and scientific presentations at global cancer conferences (October)

· Data from BGB324/docetaxel study showed combination was well-tolerated and

one (of three) NSCLC patients had partial remission at ten months and tumour

shrinkage - presented at 18th World Conference on Lung Cancer

· Strong recruitment and encouraging safety profile of BGB324 in randomised

Phase II trial of BGB324 in combination with targeted or immuno-oncology drugs

in melanoma patients presented at 9th World Congress of Melanoma

Key Figures (NOK Q3 2017 Q3 2016 YTD2017 YTD2016 FY 2016

million)

Operating revenues  -    -    -    -    -

Operating expenses  36.6  16.3  136.2  103.5  131.6

Operating profit (loss)  (36.6)  (16.3)  (136.2)  (103.5)  (131.6)

Profit (loss) after tax  (35.4)  (15.4)  (134.6)  (101.9)  (129.8)

Basic and diluted  (0.71)  (45.64)  (3.06)  (339.63)  (419.68)

earnings (loss) per

share (NOK)

Net cash flow in the (41.1) 82.1 237.3 113.2 87.8

period

Cash position end of  399.2  187.2  399.2  187.2  161.8

period

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place at 9.00 am

CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

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

www.bergenbio.com in the section Investors/Reports and presentations/Webcasts. 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/Reports and presentations 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 to treat multiple

cancer indications. The Company is a world leader in understanding the essential

role of Axl kinase in mediating cancer spread, immune evasion and drug

resistance in multiple aggressive solid and haematological cancers.

BerGenBio's lead product, 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 in the

second half of 2018. It is the only selective Axl inhibitor in clinical

development.

The Company sponsored clinical trials are:

· BGB324 as a single agent and combination therapy in acute myeloid leukaemia

(AML) / myeloid dysplastic syndrome (MDS)

· BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small

cell lung cancer (NSCLC)

· BGB324 with KEYTRUDA in advanced adenocarcinoma of the lung, and

· BGB324 with KEYTRUDA in triple negative breast cancer (TNBC).

The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung

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

N.J., USA.

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

trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR®

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

BGB324 with docetaxel in advanced NSCLC.

BerGenBio is simultaneously developing a companion diagnostic test to identify

patient subpopulations most likely to benefit from treatment with BGB324. 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

Tom Henrik Sundby

Finance Director, BerGenBio ASA

tom.sundby@bergenbio.com

+47 477 54 415

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.