Earnings Release • May 19, 2021
Earnings Release
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BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2021
Bergen, Norway, 19 May 2021 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces its results for the first quarter of 2021.
A presentation and live webcast by BerGenBio's senior management will take place
at 10.00 am CEST today, please see below for details.
Operational Highlights - first quarter of 2021 (including post-period end)
COVID-19
Update from investigational Phase II trials assessing bemcentinib in
hospitalised COVID-19 patients
Latest data from BGBC020 and ACCORD2 show bemcentinib was well tolerated in
hospitalised COVID-19 patients
· Recruitment closed in BGBC020 trial assessing bemcentinib in COVID-19 at 96%
of target enrolment, with a total of 115 patients enrolled in the Phase II study
· ACCORD2 study stopped recruitment at 50% due to a reduction in UK COVID-19
incidence, and to permit a prompt analysis of data
· In May 2021 we reported Ventilator Free Survival of 90% in COVID-19 patients
treated with bemcentinib plus standard of care, vs 72% in the patients treated
with standard of care, in a patient subset with increased disease severity,
representing more than 50% of the hospitalised patients in the study.
· Survival benefit for patients receiving bemcentinib was numerically greater
than for those receiving standard of care only, 96% vs 91% respectively.
Preclinical bemcentinib COVID-19 data presented at the annual Conference on
Retroviruses and Opportunistic Infections (CROI)
· Bemcentinib demonstrated potent antiviral effects in preclinical SARS-CoV-2
and other coronavirus models
Non-Small Cell Lung Cancer
Updated data from the Phase II bemcentinib combination study (BGBC008) in
refractory non-small cell lung cancer (NSCLC) presented at the annual World
Conference on Lung Cancer (WCLC)
· Data from cohort B (in refractory patients previously treated with PD-L1 or
PD-1 checkpoint inhibitor (CPI) as monotherapy) showed that bemcentinib is well
-tolerated and may reverse acquired resistance to checkpoint inhibition
Completed enrolment of cohort C1 in Phase II bemcentinib combination study in
refractory NSCLC
· Enrolment of 13 patients into cohort C1 (second line patients refractory to
first line treatment with CPIs in combination with chemotherapy) of bemcentinib
/ pembrolizumab combination study
Tilvestamab
First patient dosed in Phase Ib trial of anti-AXL antibody tilvestamab (BGB149)
· Study aims to determine safety, tolerability and recommended phase 2 dose of
tilvestamab in patients with platinum resistant high-grade serous ovarian cancer
Financial Highlights - first quarter of 2021
(Figures in brackets = same period 2020 unless otherwise stated)
· Revenue amounted to NOK 0.0 million (NOK 0.0 million)
· Total operating expenses were NOK 83.4 million (NOK 56.2 million),
reflecting the increased level of activity related to new clinical trials and
organizational expansion
· Operating loss of NOK 83.4 million (NOK 56.2 million)
· Cash and cash equivalents amounted to NOK 659.4 million (NOK 721.6 million
at year end 2020)
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
"Against the continued backdrop of the COVID-19 pandemic, there has
understandably been a great deal of interest in the progress of our clinical
programme investigating bemcentinib as a potential treatment. While vaccine
rollouts in some areas of the world have been proving successful, the severity
of the virus' impact in India, Brazil and elsewhere, combined with the very real
risk that vaccine-resistant strains could emerge, clearly show that there
remains an urgent need for effective therapeutic interventions, alongside
vaccines.
"While we are pleased to be playing a role in the continued effort against COVID
-19, BerGenBio's primary focus remains the continued clinical development of
bemcentinib as a treatment for cancer indications including acute myeloid
leukaemia (AML), myelodysplastic syndrome (MDS) and non-small cell lung cancer
(NSCLC). We remain well financed, have a clear strategy and our organisation is
developing to meet the demands of late-stage drug development and delivering
value for our shareholders."
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take place today at
10:00 am CET and be webcast live.
Webcast link:
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210519_1
Dial-in numbers:
NO: +47 21 956342
UK: +44 203 7696819
US: +1 646 787 0157
PIN: 712491
The Q1 2021 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
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
International Media Relations
Mary-Jane Elliot, 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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