BerGenBio

Regulatory Filings • Jul 28, 2020

UPDATE ON BEMCENTINIB'S INVOLVEMENT IN POTENTIAL TREATMENT OF COVID-19 PANDEMIC

UPDATE ON BEMCENTINIB'S INVOLVEMENT IN POTENTIAL TREATMENT OF COVID-19 PANDEMIC

· Bergenbio in late stage set-up phase to sponsor and conduct a clinical study

using bemcentinib in a country of high COVID-19 incidence

Bergen, Norway, 28[th] July 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

unmet medical need, notes the UK Research and Innovation's (UKRI) decision to

cease the grant funding to the University Hospital Southampton NHS Trust for the

COVID-19 ACCORD clinical study in which BerGenBio's bemcentinib was the lead

drug candidate to be tested. Subsequently the University Hospital Southampton

NHS Trust, who is the study sponsor,  has notified all sites in the ACCORD study

to cease recruitment of new patients into the trial.  Patients already

recruited, including those dosed with bemcentinib, will continue on treatment as

per the protocol.

Bergenbio also confirms it is in late stage set-up phase to sponsor and conduct

a similar study to ACCORD in a country of high COVID-19 incidence and expects to

be in a position to update the market in the near future.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Bemcentinib

still holds great potential for the treatment of COVID-19, hence its selection

by the UK Government for its urgent inclusion as the first drug to be dosed in

the ACCORD study.  In recent weeks the incidence of COVID-19 in the UK has

drastically reduced and as a result the ACCORD programme hasn't moved forward as

swiftly as we expected.  We are faced with the reality of the pandemic and need

to adapt quickly in order to move forward in the interests of patients.

"We look forward to sponsoring an oversees study and are pleased that we are

well positioned to do this important and rapid testing."

The ACcelerating COVID-19 Research & Development platform (ACCORD) study was

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

and Innovation (UKRI) to rapidly test potential drugs through early stage

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

the RECOVERY trial (https://www.nihr.ac.uk/urgent-public-health-research-studies

-for-covid-19/randomised-evaluation-of-covid-19-therapy-recovery/24513),

currently the world's largest randomised controlled clinical trial for COVID-19

treatment.

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. 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

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.