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year 2020.
A presentation and live webcast by BerGenBio’s senior management will take place
at 10.00 am CET today, please see below for details.
Operational Highlights - fourth quarter (including post-period end)
· First patient enrolled in South Africa and India as part of Company
sponsored randomised Phase II trial assessing bemcentinib as a potential
treatment for COVID-19 (October)
· Randomised Phase II study will recruit 120 hospitalised COVID-19 patients
across five sites in South Africa and seven sites in India
· Post period-end, the trial’s independent data monitoring committee has met
twice and confirmed no safety concerns and recommended the continuation of
patient recruitment into the study
· First patient dosed with bemcentinib in combination with pembrolizumab in
relapsed malignant pleural mesothelioma investigator sponsored Phase IIa study
(October)
· Trial assessing bemcentinib in combination with pembrolizumab, in relapsed
malignant pleural mesothelioma patients, sponsored by the University of
Leicester and in collaboration with Merck.
· Part of world’s first molecularly stratified umbrella study in
mesothelioma named Mesothelioma Stratified Therapy (MiST)
· Updated clinical and translational analysis from Phase II bemcentinib
combination study in NSCLC (BGBC008) Cohort B presented at annual SITC meeting
(November)
· The combination with pembrolizumab was shown to be well tolerated and
signs of clinical activity were observed in evaluable CPI-refractory composite
AXL (cAXL) positive NSCLC patients
· Median progression-free survival among cAXL positive patients was reported
as 2.5 fold greater than cAXL-negative patients
· Updated clinical data from two Phase II studies of bemcentinib in AML and
MDS patients presented at ASH 2020 (December)
· In relapsed AML patients, interim data from an ongoing study (BGBC003
cohort B5, bemcentinib combination with LDAC) reported clinical benefit rate of
8/11 (73%) in evaluable patients, with encouraging duration of treatment of 6.2
months in CR/CRi patients.
· In the High Risk MDS patient cohort of the BERGAMO investigator led study,
an Overall Response Rate of 36% and CR/CRi rate of 18% was reported, median
response duration was reported as over 8 months with some patients remaining on
study, and encouraging biomarker correlation was also reported.
· ACCORD 2 clinical trial in the UK in hospitalised COVID-19 patients
reinitiated patient recruitment
· Funding for the study was suspended by UKRI in July due to the falling
number of hospitalised COVID-19 patients, but reinstated in September following
a rise in UK cases, and the trial recruitment resumed in December.
Q4 2020 / FY 2020 Financial Highlights
(Figures in brackets = same period 2019 unless otherwise stated)
· Revenue amounted to NOK 0.6 million (NOK 0.2 million) for the fourth quarter
and NOK 0.6 million (NOK 8.9 million) for the full year 2020
· Total operating expenses for the fourth quarter were NOK 72.4 million (NOK
59.3 million) and total operating expenses for the full year 2020 amounted to
261.7 million (NOK 213.3 million)
· The operating loss for the quarter came to NOK 71.8 million
(NOK 59.1 million) and NOK 261.1 million (NOK 204.4 million) for the full year
2020
· Cash and cash equivalents amounted to NOK 721.6 million at the end of
December 2020 (NOK 253.6 million by end of December 2019)
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
"In the final quarter of 2020, we maintained our focus on progressing the broad
Phase II clinical development programme investigating our lead product candidate
bemcentinib, a highly selective, potent, once-a-day oral inhibitor of AXL
kinase, in several indications and settings.
During the period we continued to make progress in our clinical trials,
presenting new data and translational research at several leading international
congresses. As reported in November at The Society for Immunotherapy of Cancer
(SITC) conference, the combination of bemcentinib and CPI pembrolizumab
continued to report encouraging clinical activity, the median progression-free
survival was 2.5 times greater for cAXL positive patients. At the American
Society of Hematology conference (ASH) in December, we were pleased to share
updated preliminary clinical data from two ongoing Phase II studies of
bemcentinib in acute myeloid leukaemia (AML) and high-risk myelodysplastic
syndrome (MDS), in particular the clinical benefit rate of over 70% in relapsed
AML patients. Collectively, these continuing promising data readouts strengthen
our confidence in bemcentinib as a potential therapy in these relapsed
haematological cancer indications.
In addition, we have been able to push ahead with two trials assessing the
potential of bemcentinib as a treatment for hospitalised patients with COVID-19.
We remain optimistic that bemcentinib could play an important role in the global
effort to combat the disease.
I am encouraged by our continued research and clinical development progress
which has of course been achieved against the backdrop of the COVID-19 pandemic.
I am pleased to report that our operations and trials have all been able to
remain active throughout the year and our mitigation plans have been successful
in limiting the impact of the pandemic on operations."
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place today at
10:00 am CET:
Webcast link:
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210210_5
Dial-in numbers:
NO: +47-21-956342
SE: +46-4-0682-0620
DK: +45 78768490
UK: +44-203-7696819
US: +1 646-787-0157
Pin: 712491
The Q4 2020 Financial report and presentation are available on the Company’s
website in the Investors/Financial Reports section and a recording of the
webcast will be made available shortly after the webcast has finished.
-Ends-
About BerGenBio ASA
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. 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,
leukaemia and COVID-19. 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 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
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
Mary-Jane Elliot, 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
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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