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BerGenBio

Regulatory Filings Jan 8, 2018

3555_rns_2018-01-08_ef5f882d-30e0-42eb-b99d-8bcc305629e2.pdf

Regulatory Filings

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BerGenBio to present at Biotech Showcase 2018

Bergen, Norway, 8 January 2018 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces that the Company will present a corporate update during the Biotech Showcase 2018 held at the Hilton San Francisco Union Square. The presentation will include a discussion of recent progress across BerGenBio's phase II clinical trial programme with selective Axl inhibitor BGB324 (bemcentinib).

Details of the presentation are as follows:

  • Date: January 9, 2018
  • Time: 10:00 am PST
  • Room: Hilton/Yosemite C
  • Venue: Hilton San Francisco Union Square Hotel, 333 O'Farrell Street, San Francisco, CA

The presentation will be delivered by Richard Godfrey, CEO; slides will be available at time of presentation on the Company's website: www.bergenbio.com.

-Ends-

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 haematological and solid cancers.

BerGenBio's lead product, BGB324 (bemcentinib), is a unique and highly selective, potent and orally bio-available small molecule Axl inhibitor, currently 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 oral 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® (pembrolizumab) 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. (MSD), through a subsidiary.

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 byRoche-Genentech. TAFLINAR®is a registered trademark of Novartis International AGand MEKINIST®is a registered trademark of GSKplc.

Contacts

Richard Godfrey

CEO, BerGenBio ASA

+47 917 86 304

Tom Henrik Sundby

Finance Director, BerGenBio ASA

[email protected]

+47 477 54 415

Media Relations

David Dible, Mark Swallow, Marine Perrier

Citigate Dewe Rogerson

+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.

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