Earnings Release • May 19, 2020
Earnings Release
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BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2020
Bergen, Norway, 19 May 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, announces its results for the first quarter 2020.
A live webcast presentation by the Company's management will take place today at
10:00 am CET, please see below for details.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "During these
past few months, with the unprecedented global challenges caused by the COVID-19
crisis, we have been focussed on executing our strategy while prioritising the
health, safety and well-being of our employees and their families, our patients
and collaborators. The impact of COVID-19 on our clinical trials started to
become visible towards the end of the first quarter and on our preclinical
research operations in April. As far as feasibly possible whilst protecting
enrolled patients, their families and hospital staff, we are pleased to have
been able to ensure that the dozens of patients currently participating in our
clinical trials with our lead candidate, bemcentinib, are continuing their
treatment throughout the current restrictions. Overall, the Company is in a
robust cash position, with good control of costs and is well placed to weather
the current global disruption.
"In April we were delighted to have been invited to take part in a ground
-breaking partnership between government, academia and industry to respond to
COVID-19, with bemcentinib chosen as the first potential treatment to be fast
-tracked in a new UK national multi-centre randomised Phase II clinical ACCORD
(ACcelerating COVID-19 Research & Development platform) trial initiative. The
aim of the trial is to get an early indication of bemcentinib's effectiveness in
treating hospitalised patients with COVID-19. With strong pre-clinical data
showing the role that AXL plays in infectious disease and promising anti-viral
activity shown by bemcentinib, we are hopeful that we can play a significant
role in the global effort to find suitable treatment options for COVID-19
patients. Four hospitals in the UK have already been initiated in the trial and
are now screening for patients and we will provide updates and results as soon
as is practically possible."
Q1 2020 Operational Highlights (including post-period end)
· Efficacy endpoint met for first stage of Phase II trial in
bemcentinib/KEYTRUDA® combination study in NSCLC patient's refractory to check
point inhibitors
·
In January BerGenBio announced that it had met the efficacy endpoint for the
first stage of its Phase II clinical trial combining bemcentinib with Merck's
anti-PD-1 therapy KEYTRUDA® in patients with advanced NSCLC having progressed on
previous CPI therapy (BGBC008, cohort B1) enabling the trial to advance to the
second stage enrolling 16 patients. A third cohort of the study (BGBC008, cohort
C) is actively enrolling patients that have progressed on a first line
combination therapy of CPI plus chemotherapy.
· Bemcentinib selected to be fast-tracked as a potential; treatment for COVID
-19 through UK Government clinical trial initiative
·
The study is fully funded by the UK Department of Health and Social Care and UK
Research and Innovation, sponsored by University Hospital Southampton, with drug
material provided by BerGenBio. 120 hospitalised COVID-19 patients (60 will
receive bemcentinib and 60 control group patients receiving standard of care
treatment) will be enrolled across 8 UK NHS hospital trusts. BerGenBio
anticipates that top line data will readout later in the summer.
Q1 2020 Financial Highlights (including post-period end)
(Figures in brackets = same period 2019 unless otherwise stated)
· Revenue in the first quarter amounted to NOK 0 million (NOK 8.7 million)
· Total operating expenses were NOK 56.2 million (NOK 54.5 million)
· The operating loss for the quarter came to NOK 56.2 million (NOK 45.8
million)
· Cash and cash equivalents amounted to NOK 419.4 million at the end of March
2020 (NOK 306.7 million)
· Private placement completed in January 2020, with gross proceeds of NOK
219.9 million
· Post-period private placement completed in May 2020, with gross proceeds of
NOK 500 million
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take place today at
10:00 am CET and be webacast live.
Webcast link: https://channel.royalcast.com/webcast/hegnarmedia/20200519_3/
Dial-in numbers:
NO: +47 2195 6342
SE: +46 81241 0952
UK: +44 203 769 6819
DK: +45 7876 8490
US: +1 646 787 0157
PIN: 712491
The Q1 Financial report, presentation and link to the webcast are available
at www.bergenbio.com in the section Investors/Financial Reports. A recording
will be available shortly after the webcast has finished.
-END-
About BerGenBio
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers and
infectious diseases. The company's proprietary lead candidate, bemcentinib, is a
potentially first-in-class selective AXL inhibitor in a broad Phase II oncology
clinical development programme focused on combination and single agent therapy
in lung cancer and leukaemia. A first-in-class functional blocking anti-AXL
antibody, tilvestamab, is undergoing Phase I clinical testing. In parallel,
BerGenBio is developing companion diagnostic tests to identify those patient
populations most likely to benefit from bemcentinib: this is expected to
facilitate more efficient registration trials supporting 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). For more
information, visit www.bergenbio.com
For more information, please contact
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
+44 20 3709 5700
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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