BerGenBio

Earnings Release • Jul 12, 2021

BERGENBIO PRESENTS ENCOURAGING COMBINED DATA FOR BEMCENTINIB FROM TWO PHASE II COVID-19 STUDIES AT ECCMID

BERGENBIO PRESENTS ENCOURAGING COMBINED DATA FOR BEMCENTINIB FROM TWO PHASE II COVID-19 STUDIES AT ECCMID

· Survival 96.6% vs 91.2%

· Significantly reduced likelihood (69%) of progression to ventilation in

higher severity cohort

· Significantly increased likelihood (88%) of shorter time to recovery or

discharge in higher severity cohort

· Clinical evidence of anti-viral mechanism of action

· Preclinical analysis highlights bemcentinib's potential against COVID-19

variants

Bergen, Norway, 12 July 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical need, has presented a combined analysis of data from two

Phase II studies investigating bemcentinib in hospitalised COVID-19 patients at

the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

Data was presented from the UKRI PhaseII ACCORD2 platform study, sponsored by

University Hospital Southampton, UK and BGBC020, BerGenBio's open-label Phase II

study conducted in South Africa and India. In total, 179 eligible patients were

enrolled across both studies between May 2020 and March 2021, randomly allocated

on an open-label basis to treatment with bemcentinib in addition to standard of

care (SoC) compared to SoC alone. The two studies shared an identical design,

and combined data presented today showed encouraging survival benefit of 96.5%

vs 91.2%, with fewer deaths within 29 days of enrolment in bemcentinib treated

patients (1 of 30 and 2 of 58, 3.4%) versus SoC (5 of 34 and 3 of 57, 8.8%),

respectively.

As previously reported for BGBC020, a post-hoc analysis identified a sub-group

of patients with higher disease severity on enrolment within 24 hours of

admission to hospital in whom evidence of a treatment benefit with bemcentinib

was observed. Patients in the subgroup were receiving oxygen (Grade 4) or non

-invasive ventilation (Grade 5) and recorded serum levels of the inflammatory

marker C-Reactive Protein (CRP) greater than 30mg/L. This subgroup represents

more than 60% of the patients in the combined study population, and the

previously reported treatment benefit in this group of patients in India and

South Africa is reproduced in analysis of the patients studied in the UK.

Across both studies, evaluation of the primary endpoint of time to recovery or

discharge, in this defined patient subgroup with higher baseline disease

severity, showed there was a statistically significant greater likelihood of

faster time to recovery or hospital discharge with bemcentinib added to SoC,

compared to SoC alone; 88% greater than SoC, representing a hazard ratio of 1.88

95% confidence intervals (1.24, - 2.87) log-rank p=0.003 (not adjusted for

multiple comparisons).

A 69% lower likelihood of progression of patients to need for any form of

increased ventilatory assistance from enrolment, or to death, within 29 days,

was also observed with statistical significance in this higher severity subgroup

treated with bemcentinib, compared to SoC alone. A hazard ratio of 0.31 (95%

C.I. 0.12, 0.78), log-rank p=0.0088 unadjusted for multiple comparisons was

shown. This benefit of bemcentinib on ventilator-free survival was observed in

rates of admission to Intensive Care in the UK study; four patients (14%)

treated with bemcentinib in addition to SoC, compared to ten (31%) of matched

eligible patients treated with SoC alone.

Bemcentinib was well tolerated throughout both studies. An independent data

monitoring committee has reviewed each study and concluded there is no evidence

of safety concerns from the Phase II evaluation in COVID-19 patients.

In a separate preclinical analysis, bemcentinib's mechanism of action has been

shown to be independent of the SARS-CoV-2 spike protein. In vitro analysis of

alpha and beta COVID-19 virus variants has shown continued bemcentinib efficacy.

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

Medicine and Chief Investigator on the ACCORD programme commented: "This

encouraging data demonstrates bemcentinib's novel mechanism of action, which

appears to have efficacy independent of the SARS-CoV-2 spike protein, which

could be significant with the emergence of new and potentially vaccine resistant

variants of the virus. The result of the combined analysis underlines the

potential for bemcentinib to treat a substantial portion of hospitalised COVID

-19 patients, offering a survival benefit."

Richard Godfrey, CEO of BerGenBio, commented: "We are pleased to present these

encouraging data at ECCMID.  As the data has matured, we can see that

bemcentinib offered a survival benefit to patients and we remain confident that

bemcentinib could prove a valuable treatment option for patients severely

affected by COVID-19 and reduce their need for ventilation for recovery. We'll

continue to provide updates as our development activities to treat COVID-19

patients evolve."

Presentation details

Presenting author: Akil Jackson

Title: Bemcentinib, an oral AXL kinase inhibitor, results in lower mortality

compared to standard of care (steroids with or without remdesivir) in

hospitalised patients with COVID-19

Session name: LB: Interventions for improving COVID outcome

Session code: S191

Date: 12 July 2021

Recording will be available for registered attendees to the conference from the

day after presentation for three months.

-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

ir@bergenbio.com

Richard Godfrey CEO, BerGenBio ASA

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 considered to be inside information pursuant to the EU

Market Abuse Regulation and is subject to the disclosure requirements pursuant

to section 5-12 of the Norwegian Securities Trading Act.