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BerGenBio

Earnings Release May 19, 2020

3555_rns_2020-05-19_7fce0312-e624-48b9-9c3c-c1598591b88a.html

Earnings Release

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BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2020

BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2020

Bergen, Norway, 19 May 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

unmet medical need, announces its results for the first quarter 2020.

A live webcast presentation by the Company's management will take place today at

10:00 am CET, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "During these

past few months, with the unprecedented global challenges caused by the COVID-19

crisis, we have been focussed on executing our strategy while prioritising the

health, safety and well-being of our employees and their families, our patients

and collaborators. The impact of COVID-19 on our clinical trials started to

become visible towards the end of the first quarter and on our preclinical

research operations in April.  As far as feasibly possible whilst protecting

enrolled patients, their families and hospital staff, we are pleased to have

been able to ensure that the dozens of patients currently participating in our

clinical trials with our lead candidate, bemcentinib, are continuing their

treatment throughout the current restrictions. Overall, the Company is in a

robust cash position, with good control of costs and is well placed to weather

the current global disruption.

"In April we were delighted to have been invited to take part in a ground

-breaking partnership between government, academia and industry to respond to

COVID-19, with bemcentinib chosen as the first potential treatment to be fast

-tracked in a new UK national multi-centre randomised Phase II clinical ACCORD

(ACcelerating COVID-19 Research & Development platform) trial initiative. The

aim of the trial is to get an early indication of bemcentinib's effectiveness in

treating hospitalised patients with COVID-19. With strong pre-clinical data

showing the role that AXL plays in infectious disease and promising anti-viral

activity shown by bemcentinib, we are hopeful that we can play a significant

role in the global effort to find suitable treatment options for COVID-19

patients. Four hospitals in the UK have already been initiated in the trial and

are now screening for patients and we will provide updates and results as soon

as is practically possible."

Q1 2020 Operational Highlights (including post-period end)

· Efficacy endpoint met for first stage of Phase II trial in

bemcentinib/KEYTRUDA® combination study in NSCLC patient's refractory to check

point inhibitors

·

In January BerGenBio announced that it had met the efficacy endpoint for the

first stage of its Phase II clinical trial combining bemcentinib with Merck's

anti-PD-1 therapy KEYTRUDA® in patients with advanced NSCLC having progressed on

previous CPI therapy (BGBC008, cohort B1) enabling the trial to advance to the

second stage enrolling 16 patients. A third cohort of the study (BGBC008, cohort

C) is actively enrolling patients that have progressed on a first line

combination therapy of CPI plus chemotherapy.

· Bemcentinib selected to be fast-tracked as a potential; treatment for COVID

-19 through UK Government clinical trial initiative

·

The study is fully funded by the UK Department of Health and Social Care and UK

Research and Innovation, sponsored by University Hospital Southampton, with drug

material provided by BerGenBio. 120 hospitalised COVID-19 patients (60 will

receive bemcentinib and 60 control group patients receiving standard of care

treatment) will be enrolled across 8 UK NHS hospital trusts.  BerGenBio

anticipates that top line data will readout later in the summer.

Q1 2020 Financial Highlights (including post-period end)

(Figures in brackets = same period 2019 unless otherwise stated)

· Revenue in the first quarter amounted to NOK 0 million (NOK 8.7 million)

· Total operating expenses were NOK 56.2 million (NOK 54.5 million)

· The operating loss for the quarter came to NOK 56.2 million (NOK 45.8

million)

· Cash and cash equivalents amounted to NOK 419.4 million at the end of March

2020 (NOK 306.7 million)

· Private placement completed in January 2020, with gross proceeds of NOK

219.9 million

· Post-period private placement completed in May 2020, with gross proceeds of

NOK 500 million

Presentation and Webcast Details

A presentation by BerGenBio's senior management team will take place today at

10:00 am CET and be webacast live.

Webcast link: https://channel.royalcast.com/webcast/hegnarmedia/20200519_3/

Dial-in numbers:

NO: +47 2195 6342

SE: +46 81241 0952

UK: +44 203 769 6819

DK: +45 7876 8490

US: +1 646 787 0157

PIN: 712491

The Q1 Financial report, presentation and link to the webcast are available

at www.bergenbio.com in the section Investors/Financial Reports. A recording

will be available shortly after the webcast has finished.

-END-

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, therapy resistant cancers and

infectious diseases. 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 and leukaemia. 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: 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

For more information, please contact

Richard Godfrey CEO, BerGenBio ASA

+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA

[email protected]

+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications

[email protected]

+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

[email protected]

+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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