BERGEN, Norway, Feb.
13, 2018 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a
clinical-stage biopharmaceutical company developing novel,
selective AXL kinase inhibitors for multiple cancer indications,
announces its results for the fourth quarter and full year 2017. A
presentation of the results by the Company's senior management team
will take place today at 10.00 am CET
in Oslo – details below.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "BerGenBio has made
solid progress during 2017 and achieved all of the milestones we
outlined at the time of our IPO in April. We have advanced, as
planned, our clinical development strategy for bemcentinib, the
recently accepted generic name for our lead candidate BGB324, such
that it is now being evaluated in six Phase II clinical studies in
multiple cancer indications. These trials are designed to deliver
initial proof-of-concept of bemcentinib's potential as a future
cornerstone of cancer therapy in combination with immuno-oncology
drugs, chemo- and targeted therapy. Initial clinical data presented
during the year continue to give us confidence that bemcentinib is
a very exciting drug candidate with broad application across many
types of cancer, and in combination with existing and emerging
modalities of cancer treatment. We will continue to drive these
trials towards interim read outs in mid-2018 and look forward to an
exciting year ahead."
Q4'17 highlights
- First patients enrolled and dosed in Phase II trials of
bemcentinib (BGB324) in combination with KEYTRUDA® (pembrolizumab)
in non-small cell lung cancer (NSCLC) and triple negative breast
cancer (TNBC).
- Clinical data presentations at global cancer conferences
continue to highlight bemcentinib's safety and promising efficacy
profile.
FY'17 highlights
- Successful initial public offering (IPO) raising NOK 400m has enabled BerGenBio to fund and
advance its broad and ambitious Phase II clinical development
programme with bemcentinib
- BerGenBio enters clinical collaborative agreement with Merck
& Co., Inc. (MSD) for two immunotherapy trials in patients with
advanced NSCLC and TNBC
- Six clinical trials open and recruiting to establish clinical
proof-of-concept of bemcentinib's potential to be a cornerstone of
cancer therapy across multiple cancer indications
- Clinical and scientific data updates at global conferences
consistently show improved clinical benefit and immune modulatory
effect of bemcentinib-containing therapy
- Good progress advancing the development of companion
diagnostics in parallel with all clinical trials to identify
patients who are most likely to benefit from bemcentinib
treatment
- BGB149 anti-AXL antibody programme on track to enter the clinic
in H2 2018
Post FY events
- First efficacy endpoint met in Phase II trial of
bemcentinib/TARCEVA® (erlotinib) combination in NSCLC
- Bemcentinib was well tolerated in all patients enrolled across
three combination trials with KEYTRUDA thus far (n=34)
- Single agent therapy with bemcentinib led to a diversification
of the T-cell receptor repertoire in relapsed / refractory acute
myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS)
patients indicative of immune activation
Financial Summary
Key Figures (NOK
million)
|
Q42017
|
Q42016
|
FY2017
|
FY2016
|
Operating
revenues
|
-
|
-
|
-
|
-
|
Operating
expenses
|
47.5
|
28.0
|
183.7
|
131.6
|
Operating profit
(loss)
|
(47.5)
|
(28.0)
|
(183.7)
|
(131.6)
|
Profit (loss) after
tax
|
(47.6)
|
(27.9)
|
(182.2)
|
(129.8)
|
|
|
|
|
|
Basic and diluted
earnings (loss) per share (NOK)
|
(0.96)
|
(82.81)
|
(4.01)
|
(419.68)
|
Net cash flow in the
period
|
(28.8)
|
(25.4)
|
208.5
|
87.8
|
Cash position end of
period
|
370.3
|
161.8
|
370.3
|
161.8
|
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/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.
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
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.
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/bergenbio-asa/r/bergenbio-asa--results-for-the-fourth-quarter-and-full-year-2017,c2451190
The following files are available for download:
http://mb.cision.com/Main/15728/2451190/791116.pdf
|
PDF
|
http://news.cision.com/bergenbio-asa/i/bemcentinib,c2342741
|
Bemcentinib
|
http://news.cision.com/bergenbio-asa/i/richard-godfrey,c2342742
|
Richard
Godfrey
|
http://mb.cision.com/Public/15728/2451190/bf260eb20fc577c6.pdf
|
BerGenBio Q4 results
presentation
|
http://mb.cision.com/Public/15728/2451190/8b2500b373d5627e.pdf
|
Q42017 Financial
Report
|