BerGenBio

Regulatory Filings • Jun 2, 2020

BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL

BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL

Bergen, Norway - 02 June 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, today announces that dosing has commenced in the UK

Government-backed Phase II clinical trial assessing bemcentinib in hospitalised

COVID-19 patients.

Bemcentinib was selected as the first candidate to be tested as part of the

ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched

by the Department of Health and Social Care (DHSC) and UK Research and

Innovation (UKRI) on 28[th] April 2020.  ACCORD brings together a single, UK

-wide clinical trial platform to rapidly test potential drugs through early

stage clinical trials and feed them into the UK's large-scale COVID-19 studies.

The first patient has been dosed with bemcentinib at the University Hospital

Southampton NHS Foundation Trust. The study is open in a further seven sites

across the UK. The Phase II study will recruit 120 subjects in total, assessing

the safety and efficacy of bemcentinib as an add-on therapy to standard of care

(SoC) in 60 hospitalised COVID-19 patients with a further 60 control group

patients receiving SoC.

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

will be open source and freely available to enable global knowledge sharing and

collaboration. If positive results are seen, bemcentinib will advance rapidly

into the large-scale Phase III trials in the UK.

The study is fully funded by the DHSC and UKRI and is being managed by clinical

research company IQVIA. Drug material and other trial resources will be provided

by BerGenBio.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are

delighted that dosing has commenced with bemcentinib in the ground-breaking

ACCORD study and we hope that patients will swiftly start to see benefits.

Initiating this clinical trial in such short order is the result of tremendous

teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS,

among many others. This illustrates exactly what can be achieved when we all

work together and focus on delivering the best experimental drug candidates to

patients that so urgently need them.  We look forward to providing results as

soon as is practically possible and very much hope our drug can fulfil the aims

of the study and be used to treat thousands of COVID-19 patients worldwide."

Professor Tom Wilkinson, ACCORD clinical academic lead based at the National

Institute for Health Research (NIHR) Southampton Biomedical Research Centre,

said: "The ACCORD platform is allowing us to rapidly test potential new

treatments in response to the COVID-19 emergency. This unique national platform

for developing COVID-19 drug candidates will access the world-class expertise

and resources of the NIHR Respiratory Translational Research Collaboration and

allied centres nationwide. We believe this programme will be key to developing

effective new treatments and are delighted to see the first candidate,

bemcentinib, enter the clinic today."

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

COVID-19 infections. 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 those

patient populations most likely to benefit from bemcentinib or tilvestamab: this

is expected to facilitate more efficient registration trials and support 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

rune.skeie@bergenbio.com

+47 917 86 513

International Media Relations

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

Consilium Strategic Communications

bergenbio@consilium-comms.com

+44 7780 600290

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no

+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.