BERGEN, Norway, May 15, 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 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.
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
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations
David Dible, Mark Swallow, Marine
Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
Media relations in Norway
Jan
Petter Stiff,
Crux Advisers
stiff@crux.no
+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.
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/bergenbio-asa/r/bergenbio-asa--results-for-the-first-quarter-2018,c2520434
The following files are available for download:
http://mb.cision.com/Main/15728/2520434/841032.pdf
|
PDF
|
http://mb.cision.com/Public/15728/2520434/b13604f77e225915.pdf
|
2018 1Q pres final
reduced-size
|
http://mb.cision.com/Public/15728/2520434/b28c6cb35ffb07aa.pdf
|
2018 1Q Report
reduced-size
|
http://news.cision.com/bergenbio-asa/i/richard-godfrey,c2409693
|
Richard
Godfrey
|
View original
content:http://www.prnewswire.com/news-releases/bergenbio-asa-results-for-the-first-quarter-2018-300648321.html
SOURCE BerGenBio ASA