Earnings Release • May 15, 2018
Earnings Release
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BerGenBio ASA: Results for the First Quarter 2018
Bergen, Norway, 15 May 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 first quarter 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 made during Q1 2018. Patient recruitment into our
global Phase II clinical proof-of-concept trials with bemcentinib is progressing
well and we expect to deliver interim read-outs across all studies during 2018.
Presentation of these results will be at major clinical congresses, including
the annual American Society of Clinical Oncology (ASCO) meeting in June.
Coinciding with ASCO, we will host a satellite event that will allow us to meet
with our stakeholders and provide insights from KOLs and clinical experts on our
selective AXL inhibitor bemcentinib as a potential cornerstone of cancer
combination therapy. We believe that we will be able to demonstrate the
significant potential of bemcentinib in cancer therapy by making tumour cells
visible to the immune system and more susceptible to treatment with
chemotherapy, targeted therapy and immuno-oncology drugs."
Highlights - First Quarter 2018
Good progress advancing bemcentinib's proof-of-concept clinical development
·
First efficacy endpoint met in Phase II trial of bemcentinib/TARCEVA®
(erlotinib) combination in advanced lung cancer (NSCLC) patients
·
Recruitment completed in first stage of Phase II trial of bemcentinib in
combination with KEYTRUDA® in advanced breast cancer (TBNC) patients
·
Bemcentinib shown to be well tolerated in all patients enrolled across three
combination trials with KEYTRUDA - data presented at ASCO-SITC 2018
·
Single agent therapy with bemcentinib led to increased immune activity in
relapsed / refractory leukaemia (AML & MDS) patients - data presented at ASCO
-SITC 2018
Post period
·
Private placement raising gross NOK 187.5 million from international
institutional investors including from the USA, specialising in the
biotechnology sector
·
Recruitment completed in the first stage of Phase II trial of bemcentinib in
combination with KEYTRUDA® in NSCLC patients
·
Preclinical data highlighting bemcentinib's potential to reverse tumour immune
suppression and enhance immune checkpoint inhibitor efficacy, presented at AACR
annual meeting
·
Publications describe the role of AXL signalling in, and potential therapeutic
effect of selective AXL inhibition to counteract the progression of aggressive
fibrosis in lung and liver diseases
Financial Summary
+-------------------------------------------------+-------+-------+--------+
|(NOK million) |Q1 2018|Q1 2017|FY 2017 |
+-------------------------------------------------+-------+-------+--------+
|Operating revenues | - | - | - |
+-------------------------------------------------+-------+-------+--------+
|Operating expenses | 54.8 | 65.8 | 183.7 |
+-------------------------------------------------+-------+-------+--------+
|Operating profit (loss) | -54.8 | -65.8 | -183.7 |
+-------------------------------------------------+-------+-------+--------+
|Profit (loss) after tax | -53.8 | -65.1 | -182.2 |
+-------------------------------------------------+-------+-------+--------+
|Basic and diluted earnings (loss) per share (NOK)| -1.08 | -1.93 | -4.01 |
+-------------------------------------------------+-------+-------+--------+
|Net cash flow in the period | -41.1 | -66.4 | 208.5 |
+-------------------------------------------------+-------+-------+--------+
|Cash position end of period | 329.2 | 95.4 | 370.3 |
+-------------------------------------------------+-------+-------+--------+
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
+47 917 86 513
International Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
+44 207 638 9571
Media relations in Norway
Jan Petter Stiff,
Crux Advisers
+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.
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