BerGenBio

Regulatory Filings • Jun 2, 2018

BerGenBio ASA US CLINICAL TRIAL UPDATE

BerGenBio ASA US CLINICAL TRIAL UPDATE

BERGEN, Norway, June 2 , 2018 - BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces that the Norwegian National Ethics Committee (NEM) have granted approval for clinical trials related to Non-Small Cell Lung Cancer.

In November 2017, BerGenBio informed that the Company was in voluntary discussions with the Regional Ethics Committee (REK) in Bergen and the Norwegian Board of Health about gaining retrospective approval for the study.

In March 2018, BerGenBio informed that NEM gave a notice of non-acceptance.

BerGenBio is pleased to inform that a acceptance now is in place.

Hence, as of today all necessary domestic and foreign approvals have now been acquired.

-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 cancer spread, immune evasion and drug resistance in multiple aggressive 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

Media Relations in Norway

Jan Petter Stiff

Crux Advisors

stiff@crux.no

+47-995-13-891