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LandNorge
ListaOB Match
SektorHälsovård
IndustriBioteknik
BerGenBio är ett norskt onkologibolag. Idag bedriver bolaget forskning och utveckling av hämmande läkemedel för behandling av aggressiva cancertyper. Bolaget har utvecklat ett flertal produkter vars sammansättning ämnar blockera proteinet AXL, ett protein positivt relaterat med spridning av cancercellerna. Bolaget grundades under 2007 och har sitt huvudkontor i Bergen.

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2022-02-16 07:00:41
Bergen, Norway, 16 February 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, announces its results for the fourth quarter and
full year 2021.

A briefing by BerGenBio's senior management team will take place at 10:00am CET
today via a webcast presentation, followed by a Q&A session. Please see below
for details.

Operational Highlights - fourth quarter 2021 (including post-period end)

· Post-period end, BerGenBio announced its participation in the EU-SolidAct
trial, part of EU-RESPONSE, a pan-European research project involved with the
rapid and coordinated investigation of medications to treat COVID-19 during the
ongoing pandemic allowing BerGenBio to potentially confirm encouraging clinical
data at significantly reduced cost.
· Licensed key exclusive intellectual property rights from UT Southwestern
Medical Center, which strengthen the intellectual property estate for the
potential treatment of Non-Small Cell Cancer (NSCLC) patients with STK11
mutations.
· Granted Fast Track designation by the FDA for bemcentinib in combination
with an anti-PD-(L)1 agents as treatment for patients with STK11 altered
advanced/metastatic NSCLC patients without actionable mutations.
· Presented pre-clinical and clinical data on bemcentinib in STK11 mutated
NSCLC at SITC Annual Meeting 2021, indication that bemcentinib restores response
to anti-PD-1 treatments in NSCLC patients with STK11 mutations.
· Presented updated data from Phase II trial (BGBC003) of bemcentinib in
combination with low dose cytarabine (LDAC) in older, relapsed and refractory
AML patients at the 63rd Annual American Society of Hematology (ASH) Meeting.
· Anders Tullgren appointed as Chairman of the Board, bringing over 35 years
of global experience in both large pharmaceutical and small/mid-size biotech
environments.

Financial Highlights - fourth quarter and full year 2021

(Figures in brackets = same period 2020 unless otherwise stated)

· Revenue amounted toNOK 0.8 million (NOK 0.6 million) for the fourth quarter
and NOK 0.8 million (NOK 0.6 million) for the full year 2021
· Total operating expenses for the fourth quarter were NOK 68.1 million (NOK
72.4 million) and total operating expenses for the full year 2021 amounted to
315.2 million (NOK 261.7 million)
· The operating loss for the quarter came toNOK67.3million (NOK71.8million)
and NOK 314.5 million (NOK 261.1 million) for the full year 2021
· Cash and cash equivalents amounted to NOK 436.4 million at the end of
December 2021 (NOK 721.6 million by end of December 2020)

Martin Olin, Chief Executive Officer of BerGenBio, commented: "In the fourth
quarter of 2021 we continued to make significant progress in defining our
strategy and priorities to advance our two AXL development candidates. Our lead
development candidate, bemcentinib, a potentially first-in-class selective AXL
inhibitor currently undergoing Phase II clinical trials in NSCLC, AML and
respiratory infections (COVID-19), is well positioned for further advancement.

"Our strategy and priorities going forward will be anchored within a rigorous
data-driven framework, where the scientific rationale, pre-clinical and clinical
data define a compelling rationale for advancing our development candidates
towards potential treatment modalities addressing high unmet medical needs.

"With a clear strategy in place, I believe BerGenBio is well positioned to
progress and deliver on its potential. I look forward to providing you with
further updates on our progress."

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the
Investors/Financial Reports section. A recording will be available shortly after
the webcast has finished.

Webcast link:
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220216_7

Dial-in numbers:

NO: +47-21-956342

UK: +44-203-7696819

US: +1 646-787-0157

SE: +46-4-0682-0620

DK: +45 78768490

Pin: 712491

The fourth quarter and full year report and presentation will be made 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
ir@bergenbio.com

Rune Skeie
Chief FinancialOfficer, BerGenBio ASA
rune.skeie@bergenbio.com

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

ConsiliumStrategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

AboutBerGenBioASA

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 a
potential companion diagnostic test to 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. 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 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.