Earnings Release • Nov 16, 2021
Earnings Release
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BERGENBIO ASA: RESULTS FOR THE THIRD QUARTER OF 2021
Bergen, Norway, 16 November 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 third quarter of 2021.
A presentation and live webcast by BerGenBio's senior management will take place
at 10am CET today, please see below for details.
Operational Highlights - third quarter of 2021 (including post-period end)
· Martin Olin appointed Chief Executive Officer, bringing 20 years of
executive experience in the pharmaceutical and biotechnology industry. Previous
roles include CEO of Symphogen
· Post-period end, NSCLC data presented at SITC, highlighting bemcentinib's
potential in NSCLC patients harbouring STK11 mutations
· AML data presented at EHA indicate bemcentinib/LDAC combination is
efficacious and well tolerated in relapsed elderly AML patients unfit for
intensive chemotherapy
· COVID-19 data in a late-breaking abstract presentation at ECCMID demonstrate
encouraging evidence for the effect of bemcentinib in hospitalised patients
receiving steroids ± remdesivir
Financial Highlights - third quarter of 2021
· Revenue amounted to NOK 0.0 million (Q3 2020: NOK 0.0 million)
· Total operating expenses were NOK 71.4 million (Q3 2020: NOK 68.3 million)
· Q3 operating loss of NOK 70.5 million, decreased compared to previous
quarters, (Q3 2020: NOK 67.3 million)
· A strong cash position of NOK 509.4 million at end of Q3 2021
Martin Olin, Chief Executive Officer of BerGenBio, commented: "It is my great
pleasure to provide an update on BerGenBio's progress over the last quarter, my
first since joining the Company as CEO in September 2021. Having completed a
strategic review of operations following my appointment, we have reiterated our
focus on pursuing a rigorous data driven approach of connecting a consistent
scientific rationale, pre-clinical and clinical data to high unmet medical needs
will enable us to define the best possible path to registration as well as
unlocking significant market potential.
"Our focus will be the clinical development of bemcentinib as a second line
treatment in relapsed AML, building on the promising data accumulated so far
with the planned initiation of a confirmatory randomized placebo-controlled
trial in H2 2022. The clinical development of the NSCLC program continues, and a
Phase 1b trial investigating bemcentinib in patients with STK11 mutations in 1L
NSCLC is also scheduled to be initiated in H1 2022.
"We will also look to validate our COVID-19 clinical data through a confirmatory
randomized placebo-controlled trial supported by a major, multinational
collaboration that provides access to a large number of sites across Europe and
established infrastructure at significantly reduced cost to BerGenBio. We
anticipate this study to commence in H1 2022.
"The Company is well-funded with a strong team in place to continue the
advancement of its pipeline and working towards delivering new treatment options
for patients in need and value for shareholders. I look forward to providing
further updates on our progress in due course."
Presentation and Webcast Details
An in-person briefing will take place at 10:00 am CET at: Carnegie AS,
Fjordalleen 16, Aker Brygge, 5th Floor, Oslo whereBerGenBio'ssenior management
team will provide an update on the Company followed by a Q&A session.
The presentation will also be webcast live, details below.
Webcast link:
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20211116_4
NO: +47-21-956342
UK: +44-203-7696819
US: +1 646-787-0157
PIN: 712491
The Q3 2021 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-
Contacts
Martin Olin
Chief Executive Officer, BerGenBio ASA
Rune Skeie
Chief FinancialOfficer, BerGenBio ASA
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
+44 20 3709 5700
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 clinical development
programme focused on combination and single agent therapy in cancer 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 potentially identify patient populations most
likely to benefit from AXL inhibition. 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. Suchrisks, 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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.
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