Important progress made in 2018:
- PoC for bemcentinib reported in multiple cancer
indications
- AML/MDS and NSCLC confirmed as target indications for
forward development towards registration, starting in 2019
- Increasing confidence in bemcentinib safety profile
with more than 250 patients dosed
BERGEN, Norway ,
Feb. 12, 2019 /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 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: "BerGenBio made important progress in
2018 and met all its key operational milestones. The strength of
the clinical data coupled with correlation with AXL biomarker
expression has allowed us to confirm our clinical development
strategy in AML and NSCLC. In 2019 we will focus on initiating late
stage clinical trials in these indications and we look forward
to providing further details and updates during the coming
year."
Highlights – Fourth Quarter 2018
Superior monotherapy efficacy of bemcentinib in
relapsed/refractory (R/R) AML/MDS patients reported at ASH 2018 – a
possible first registration path
- 43% ORR with bemcentinib monotherapy in
AXL-biomarker-positive R/R AML/MDS patients
- Enrolment complete into the phase II combination cohort of the
study testing bemcentinib and decitabine in first-line AML,
top-line results anticipated in 1Q 2019
Superior progression-free-survival (PFS) and response rate
(ORR) in AXL positive advanced NSCLC patients
receiving bemcentinib/ KEYTRUDA® combination presented as late
breaking abstract at SITC 2018
- 5.9 months median PFS in AXL-positive vs. 3.3 months in
AXL-negative patients
- 40% ORR & 70% clinical benefit rate in AXL-positive
patients, including PD-L1 negative patients for whom KEYTRUDA
monotherapy is not expected to work
- Stage 2 of the two-part trial open and enrolling
Novel tissue- and blood-based biomarkers of AXL expression
identified and qualified across multiple clinical trials
with bemcentinib: potential for development as companion
diagnostics
- Selected as a poster discussion at ESMO and presented as poster
at SITC 2018
Clinical development team strengthened
- Team strengthened and expanded, particularly in key medical,
clinical operations and regulatory functions in preparation for
advancing bemcentinib into the next stages of clinical
development
Financial Highlights
(Figures in brackets = same period 2017 unless otherwise
stated)
- Total operating expenses for the fourth quarter were
NOK 53.2 million (NOK 47.5 million). Total operating expenses for
the full year 2018 amounted to NOK 196.9
million (NOK 183.7
million
- Research and development expenses accounted for 78.1 % of total
operating expenses in Q4, and 73.7 % for the full year
2018
- Comprehensive loss for the fourth quarter amounted to
NOK 51.1 million (loss of
NOK 47.6 million). Comprehensive loss
for the full year 2018 was NOK 191.7
million (loss of NOK 182.2
million)
- Cash and cash equivalents amounted to NOK 360.4 million at the end of December 2018 (NOK 398.2
million at 30 September 2018
and NOK 370.3 million at 31 December 2017)
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take
place at 10.00 am CET at: Hotel
Continental, Stortingsgaten 24/26, 0117 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 AXL
AXL kinase is cell membrane receptor and an essential mediator
of the biological mechanisms that drive aggressive and
life-threatening diseases. In cancer, AXL drives tumour
survival, treatment resistance and spread, as well as
suppressing the body's immune response to tumours.
AXL expression has been established as a negative prognostic
factor in many cancers. AXL inhibitors, therefore, have
potential value at the centre of cancer combination therapy,
addressing significant unmet medical needs and multiple
high-value market opportunities.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for advanced and aggressive
cancers.
The company's proprietary lead candidate, bemcentinib, is a
potentially first-in-class selective AXL inhibitor in a broad phase
II clinical development programme. Ongoing clinical trials are
investigating bemcentinib in multiple solid and haematological
tumours, in combination with current and emerging therapies
(including immunotherapies, targeted therapies and chemotherapy),
and as a single agent.
In parallel, BerGenBio is developing companion diagnostics test
to identify patient populations most likely to benefit from
bemcentinib; this is expected to facilitate more efficient
registration trials and support a precision medicine-based
commercialisation strategy.
BerGenBio is based in Bergen,
Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo
Stock Exchange (ticker: BGBIO).
www.bergenbio.com
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
Advisers
stiff@crux.no
+47-995-13-891
International Media Relations
Mary-Jane Elliott
Chris Welsh
Nicholas Brown
Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-20-3709-5700
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-2018,c2738626
The following files are available for download:
https://mb.cision.com/Main/15728/2738626/989292.pdf
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PDF
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https://mb.cision.com/Public/15728/2738626/8a65999370ca8c17.pdf
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BGBIO 2018-Q4-FY
presentation
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https://mb.cision.com/Public/15728/2738626/a4cd4dcc056660dd.pdf
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BGBIO 2018-Q4-FY
report
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