BERGEN, Norway, May 19, 2020 /PRNewswire/ -- 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.
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
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.
For more information, please contact
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
Mary-Jane Elliott, Chris Welsh, Lucy
Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-20-3709-5700
Media Relations in Norway
Jan Petter Stiff
Crux Advisers
stiff@crux.no
+47-995-13-891
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http://news.cision.com
https://news.cision.com/bergenbio-asa/r/bergenbio-asa--results-for-the-first-quarter-2020,c3115363
The following files are available for download:
https://mb.cision.com/Main/15728/3115363/1250104.pdf
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Release
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https://mb.cision.com/Public/15728/3115363/a9819740bf83c2ef.pdf
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Q1 2020 Financial
Report BerGenBio
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