BerGenBio

Regulatory Filings • Sep 24, 2020

BERGENBIO RECEIVES APPROVAL FROM NORWEGIAN REGIONAL ETHICS COMMITTEE FOR COVID-19 SOUTH AFRICA TRIAL

BERGENBIO RECEIVES APPROVAL FROM NORWEGIAN REGIONAL ETHICS COMMITTEE FOR COVID-19 SOUTH AFRICA TRIAL

Bergen, Norway, 24 September 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, announces that it has received approval from Norway's

Regional Ethics Committee (REK) for its company sponsored Phase II trial

(BGBC020)  to assess the efficacy and safety of bemcentinib for the treatment of

COVID-19 in hospitalised patients in South Africa.

All necessary approvals have now been received and dosing is due to commence

imminently. The Company will provide an update in due course.

Further details regarding the trial can be found

here (https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=381528

6⟨=en-GB&companycode=no-bergen&v=).

- END -

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the

biological mechanisms underlying many life-threatening diseases. In cancer, AXL

suppresses the body's immune response to tumours and drives cancer treatment

failure across many indications. AXL expression defines a very poor prognosis

subgroup in most cancers. AXL inhibitors, therefore, have potential high value

at the centre of cancer combination therapy, addressing significant unmet

medical needs and multiple high-value market opportunities. Research has also

shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class

selective AXL inhibitor in a broad phase II clinical development programme.

Ongoing clinical trials are investigating bemcentinib in multiple solid and

haematological tumours, in combination with current and emerging therapies

(including immunotherapies, targeted therapies and chemotherapy), and as a

single agent. Bemcentinib targets and binds to the intracellular catalytic

kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

Increase in AXL function has been linked to key mechanisms of drug resistance

and immune escape by tumour cells, leading to aggressive metastatic cancers.

About BerGenBio ASA

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,

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 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

Contacts

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 20 3709 5700

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.