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BerGenBio

Earnings Release Feb 16, 2022

3555_iss_2022-02-16_5f94cd9b-6bba-48db-9451-c67310d28869.html

Earnings Release

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BERGENBIO ASA: RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2021

BERGENBIO ASA: RESULTS FOR THE FOURTH QUARTER AND FULL YEAR 2021

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

[email protected]

Rune Skeie

Chief FinancialOfficer, BerGenBio ASA

[email protected]

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone

ConsiliumStrategic Communications

[email protected]

+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.

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