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· 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, 12 February 2019 - 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.
-End-
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
http://www.netfonds.no/quotes/release.php?id=20190212.OBI.20190212S10