BERGEN, Norway, Aug. 18, 2020 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for unmet medical need
indications, announces its results for the second quarter and first
half of 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.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "Set against
the unprecedented backdrop of a global pandemic, this has been an
eventful period for BerGenBio. During this time we have continued
our focus on progressing clinical trials of our lead candidate
bemcentinib in non-small cell lung cancer (NSCLC) and Acute Myeloid
Leukaemia (AML) and more recently COVID-19, while ensuring that the
safety and wellbeing of our staff and the patients participating in
our clinical trials has been and remains our top priority.
"The COVID-19 crisis has and will likely continue to delay
clinical trials throughout the sector and as anticipated has
impacted patient recruitment into BerGenBio clinical studies and
extended previously anticipated timelines. The impact of the
pandemic on our clinical trials has continued through the second
quarter, but we are pleased that new patients continue to be
recruited into our clinical studies with bemcentinib, and already
enrolled patients have been able to continue their treatment
throughout the restrictions.
"We continue to make progress, with a latest milestone in
NSCLC trial presented at the Next Gen Immuno-Oncology Congress
conference where 6 of the 7 identified AXL positive patients
reported clinical benefit and data showed a 2.5-fold improvement in
median Progression-free Survival.
"The Company remains in a strong cash position, with two drug
candidates backed by pioneering biology, continued favourable
clinical results and important data readouts on the horizon in two
major cancer indications, as well as a potential COVID-19
treatment. This is an exciting time for us."
Operational Highlights - second quarter and the first half of
2020 (including post-period end)
- Positive interim clinical and translational phase II data
with bemcentinib in combination with KEYTRUDA® in checkpoint
inhibitor refractory NSCLC
patients
-
- In June, BerGenBio presented positive data from its Cohort B,
stage 1, in the phase II trial evaluating bemcentinib in
combination with KEYTRUDA® in patients with advanced non-small cell
lung cancer (NSCLC) and with confirmed progression on prior immune
checkpoint therapy.
- The trial included 12 evaluable patients for cAXL, BerGenBio's
proprietary composite-AXL (cAXL) immunohistochemistry biomarker. 7
of these 12 patients were cAXL-positive whereby 6 of these 7
patients reported clinical benefit and 2.5-fold improvement in
mPFS.
- BerGenBio also reported an update on Overall Survival data from
Cohort A, where cAXL-positive patients reported 12-month Overall
Survival of 79% and median Overall Survival of 17.3 months, whereas
cAXL-negative reported 60% and 12.4 months respectively.
- Data was presented at the NextGen Immuno-Oncology Congress, 25
June
- First patient dosed in bemcentinib COVID-19 study in
June
2020
-
- In April, BerGenBio announced the selection of bemcentinib as
the first candidate in a UK Government-backed national ACCORD
study.
- The study was a multicentre, seamless, Phase II adaptive
randomisation platform trial to assess the efficacy and safety of
multiple candidate agents for the treatment of COVID-19 in
hospitalised UK NHS patients, and the first patient was dosed in
June.
- At the end of July, the incidence of COVID-19 in the UK had
drastically reduced and the UK Research and Innovation's (UKRI)
decided to cease grant funding. Subsequently, the University
Hospital Southampton NHS Trust notified all sites in the ACCORD
programme to cease the recruitment of new patients into the trial
for all candidate agents. Patients already recruited, including
those dosed with bemcentinib, will continue on treatment as per the
protocol.
- The decision to halt the study reflected the significant
decrease in the incidence of COVID-19 in the UK and difficulty
recruiting a sufficient number of patients and in no way reflected
any interpretation of the efficacy or safety of any of the
candidate agents.
- BerGenBio is now in the late stage set-up phase to sponsor
a similar study to ACCORD in a country of high COVID-19
incidence.
- First patient dosed in bemcentinib Glioblastoma study in
July 2020
(post-period)
-
- In July, BerGenBio announced the first patient was dosed in an
investigator-initiated trial (IIT) assessing bemcentinib in
recurrent glioblastoma (GBM). The study will enrol up to 20
recurrent GBM patients, at up to 15 sites in the USA.
- Increased expression of the receptor tyrosine kinase AXL is
significantly correlated with poor prognosis in GBM patients and
preclinical data has suggested that bemcentinib may be a promising
therapeutic agent for GBM, particularly in post-irradiation
mesenchymal-transformed GBM tumors.
- A comprehensive translational research programme will run in
parallel with the clinical trial.
Q2 2020 Financial Highlights
(Figures in brackets = same period 2019 unless otherwise
stated)
- Revenue for the second quarter amounted to NOK 0.0 million
(NOK 0.0 million) and for the six
months ended 30 June NOK 0.0 million
(NOK 8.7 million). The revenue in
2019 reflects clinical milestone payments from ADCT.
- Total operating expenses for the second quarter amounted
to NOK 64.7 million
(NOK 52.0 million) and for the six months ended 30 June
NOK 121.0 million (NOK 106.5 million). NOK
7.5 million (NOK - 2.5 million) of operating expenses was
non cash accruals for option cost.
- The operating loss for the quarter came
to NOK 64.7 million (NOK 52.0 million) and
for the six months ended 30 June NOK 121.0
million (NOK 97.8 million),
reflecting the level of activity related to the clinical
trials BerGenBio are conducting.
- Cash and cash equivalents increased to NOK 828.4 million by 30 June (NOK 419.4 by 31 March
2020).
- Private placement completed in May
2020, with gross proceeds NOK 520
million (including NOK 20
million from repair issue in July). Net proceeds to be used
to take full advantage of clinical development opportunities
stemming from the Company's technology and to progress readiness
for early commercialisation possibilities and general corporate
purposes.
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/webcast/hegnarmedia/20200818_6/
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 second quarter report and presentation is 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.
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 and 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 those patient
populations most likely to benefit from bemcentinib or tilvestamab:
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).
For further information, please 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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The following files are available for download:
https://mb.cision.com/Main/15728/3170257/1292296.pdf
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Release
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https://mb.cision.com/Public/15728/3170257/8229aada42531dad.pdf
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Q2 2020 Financial
Report BerGenBio ASA
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