BerGenBio

Legal Proceedings Report • Apr 19, 2021

BERGENBIO ANNOUNCES UPDATE FROM INVESTIGATIONAL PHASE II TRIALS ASSESSING BEMCENTINIB IN HOSPITALISED COVID-19 PATIENTS

BERGENBIO ANNOUNCES UPDATE FROM INVESTIGATIONAL PHASE II TRIALS ASSESSING BEMCENTINIB IN HOSPITALISED COVID-19 PATIENTS

· Day 29 follow-up of last patient enrolled has now occurred in BGBC020 and

ACCORD2_002

· Data receipt is ongoing and evaluation of efficacy data is underway

· Exploratory analyses are looking to define subsets of patients with baseline

markers indicative of increased disease severity with the potential for greater

benefit

· Bemcentinib was well tolerated throughout both studies, in the ACCORD2 study

there was a numerically lower number of deaths up to day 29 in the bemcentinib

arm (1 of 28 with bemcentinib + standard of care vs 5 of 32 in patients treated

with standard of care alone); in BGBC020 it was 2 vs 3 respectively

· More detailed top line data expected to report in May

Bergen, Norway, 19[th] April 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, provides an update from the Phase II clinical study

evaluating the efficacy and safety of bemcentinib in hospitalised COVID-19

patients (BGBC020).

The BGBC020 BerGenBio-sponsored trial completed 96% of its targeted enrolment

with a total of 115 patients participating (60 in India and 55 in South Africa,

with 58 receiving bemcentinib). In addition, the Investigator sponsored study

ACCORD2-002 study stopped recruitment at 50% of the original recruitment target

due to a reduction in UK COVID-19 case incidence, and to permit a prompt

analysis. Both trials were undertaken with the same study design and clinical

endpoints. As such data from the two studies will be analysed separately and in

combination in a meta-analysis to inform next steps for this potential new COVID

-19 treatment.

Throughout both studies, bemcentinib was well tolerated by patients and no

safety signals of concern were reported. At day 29, there was a numerically

lower number of deaths reported in the bemcentinib arm of both studies: In

ACCORD2, 1 death in 28 patients treated with bemcentinib and SoC versus 5 in 32

patients treated with SoC alone, and 2 vs 3 in BGBC020.

BGBC020 is an investigational phase II study, which enrolled adult patients

within a day of admission to hospital with COVID-19, who were not intubated and

ventilated (grades 3-5 of the 9-point WHO ordinal scale for clinical

improvement[1]). Patients were randomised to receive standard of care or

bemcentinib plus standard of care. 81% of the COVID-19 patients were assessed as

grade 4 within 24 hours of admission to hospital (requiring oxygen but not

ventilatory assistance) according to the WHO ordinal scale; 75% of patients

received steroids as part of their standard of care and 50% received remdesivir,

this was evenly distributed between the two arms across both studies.

A thorough analysis of the entire patient population and subsets of the

population will be undertaken on both the primary and key secondary endpoints.

The primary endpoint of the trial is time to clinical improvement of at least

two points (from randomisation) on the 9-point WHO ordinal scale, or live

discharge from the hospital, whichever comes first. A preliminary analysis shows

the primary endpoint is numerically in bemcentinib's favour, although in this

small study, in a diverse population and demographic, it did not reach the pre

-defined statistical threshold of p<0.05. Key secondary endpoints include

avoidance of worsening of the WHO scale throughout hospitalisation up to day 29,

duration for which patients required oxygen, and changes over time in levels of

virus detected in different body fluids.

More detailed top line data expected to report in May and will be followed by

preparation for presentation at a scientific conference and publication in a

peer-review journal.

Professor Tom Wilkinson, MA Cantab MBBS PhD FRCP FERS, Professor of Respiratory

Medicine and Chief Investigator on the ACCORD programme commented: "The COVID-19

pandemic persists as the most serious global health crisis we currently face and

there is still an urgent need for safe, convenient and more effective treatment

for a broad spectrum of patients. The novel mechanism of action of bemcentinib

is independent of the SARS-CoV-2 spike protein and thus would be expected to

retain its effect with the emergence of new, potentially vaccine-resistant,

strains of the virus. The drug has a good safety profile and holds potential

promise at this vital time."Richard Godfrey, Chief Executive Officer of

BerGenBio, commented: "Our phase II studies have been completed in three

distinct geographies, with differing demographics and ethnicities and evolving

standards of care. Bemcentinib has shown to be generally safe and well-tolerated

in hospitalised COVID-19 patients. We look forward to receiving further data and

continuing our analysis of the patient populations and datasets, and

subsequently discussing these results with the market, regulators, industry and

Government partners and KOLs to determine next steps."

[1) ]WHO R&D Blueprint novel Coronavirus COVID-19 Therapeutic Trial Synopsis;

available at https://www.who.int/blueprint/priority-diseases/key-action/COVID

-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf; Accessed

18 April, 2021

-Ends-

About AXL

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

biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor

to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters

the host cell, and AXL expression is upregulated in infected organs with an

activation of the signalling pathway leading to suppression of the Type 1

Interferon immune response by infected cells and neighbouring cells, in their

environment. Pre-clinical research studies demonstrate that bemcentinib inhibits

SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug

resistance and immune escape by tumour cells, leading to aggressive metastatic

cancers. AXL suppresses the body's immune response to tumours and drives

treatment failure across many cancers. High AXL expression defines a very poor

prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,

therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.

About Bemcentinib

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

and highly selective AXL inhibitor, currently in a broad phase II clinical

development programme. It is administered as an oral capsule and taken once per

day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and

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.

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 clinical development

programme focused on combination and single agent therapy in 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 a 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

Contacts

Richard Godfrey CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

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.