BergenBio Fundamentale Forhold (BGBIO)

[Skeptikern]

@Ekornet

For a subset… median OS not reached at >16 months

Hva er forventete mOS for tilsvarende subset fra historiske kontroller da? Ser at de sier historiske kontroller er 4.1-5.6 mnd, men det er vel ikke for tilsvarende subset som mottar 2 eller flere sykluser med LDAC, men alle inkludert de som dør eller faller fra før de rekker å motta 2 sykluser? Eller fjernes “tidlige frafall” fra historiske kontroller også? (Beklager om det er dumt spørsmål er ikke fra dette fagfeltet)

[busk1]

Synes ikke det er et dumt spørsmål. Opplagt fare for overlevelsesbias i den måten å velge ut undergrupper på. Skulle gjerne sett fordelingen på overlevelsestid for alle på LDAC i en tilsvarende populasjon for å se om det er vanlig å ha en undergruppe med langtidslevende selv om medianoverlevelsen er lav.

EDIT: Nå er dette en gruppe med skrøpelige, eldre pasienter som tidligere har hatt effekt av en behandling og som har fått tilbakefall. Noen som vet hva slags behandling de da mest sannsynlig har fått fra før? Er det LDAC eller noe annet?

[InfoLeecher]

@TekBot

In a subset of eleven relapsed AML patients, who received two or more cycles of
the combination, an increased clinical benefit was demonstrated;

Noen som har tilgang på posteren?
Hva var det som skilte ut subsettet.

Fikk bare de i dette subsettet “2 or more cycles of the combination”?
Om det er tilfellet viser det jo at flere doseringer gir vesentlig bedre effekt og survival.
Men det høres ut som noe annet enn number of combocycles var skillet for subsettet.

[busk1]

Posteren ligger på hjemmesiden til Bergenbio.

Så vidt jeg kan se er utvalgskriteriet kun at de har fått minst 2 behandlinger. Og så lister de 3 karakteristikker for gruppen, der 2 av egenskapene er at de har fått 2 behandlinger og nok tid til å få to behandlinger. Jeg synes ikke det er så tillitvekkende dataanalyse, for å være ærlig. Jeg klarer ikke å tolke beinmargsanalyseplottene så vet ikke om de gir en bedre begrunnelse for hvorfor disse pasientene lever lenger.

Vi ser at behandlingstiden på Bem+LDAC er relativt kort sammenlignet med overlevelsestiden. Jeg lurer på hva pasientene har fått av behandling i etterkant av denne behandlingen. Har det påvirket overlevelsen?

[InfoLeecher]

takker. ettersom det sto i meldinga at poster var tilgjenglig for de som hadde registret seg på konferansesiden. Så antok jeg bare at selskapet ikke hadde den på siden sin.

Enig i betrakningen din om utvalget i dataanalysen. De bør ha en god argumentasjon for å trekke ut det utvalget i såfall.
Utfra de 2 benmargsplotta ser det ut for meg at de hadde både non-responders og responders for alle type celler
Jeg er kunnskapløs i medisinfelter da.

Utfra hele datasettet ser det ut til at Refractory ikke hadde respons å snakke om. Lavere antall enn relapsed. Så kanskje for tidlig å droppe refractory i neste runde.

[TekBot]

BerGenBio ASA: Increase of share capital, exercise of share options and disclosure of trade by primary insider

Bergen, Norway, 11 June 2021

The Board of Directors in BerGenBio ASA (the “Company”) (OSE: BGBIO) have, to
…

Vis børsmeldingen

fulfil the Company’s obligations under the share option agreements and in
accordance with the authorization granted by the general meeting on 19 March
2021, today resolved to increase the Company’s share capital by NOK 7,500 by
issuance of 75,000 new shares. The new shares are subscribed for by option owner
who wishes and are entitled to exercise options in accordance with the Company’s
option scheme. Each option gives a right to receive one share in the Company.
The subscription price is in accordance with the prevailing options price
pursuant to the Company´s option scheme NOK 10.62 per share.

The 75,000 options are exercised by primary insider Richard Godfrey (CEO) and
the options are granted 13 June 2013 and expiry on 13 June 2021. Primary insider
notification pursuant to the market abuse regulation article 19 is attached.

The primary insider has transferred his rights to receive shares resulting from
the exercise of options to a third party. The third party has sold the shares at
a price of NOK 25.67 per share.

Following the exercise, primary insider Richard Godfrey are holding 1,684,978
options in the Company of which 1,096,462 is vested, in addition to 21,005
shares in the Company through Gnist Holding AS.

The capital increase is expected to be registered within 7 days, and following
the issuance of the new shares, the issued share capital of BerGenBio ASA will
be NOK 8,796,275.50 consisting of 87,962,755 shares, each with a par value of
NOK 0.10.

-End-

Contacts

Richard Godfrey

CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie

CFO, BerGenBio ASA

rune.skeie@bergenbio.com

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 the
market abuse regulation article 19 and section 5-12 of the Norwegian Securities
Trading Act.

Kilde

[Inveliten]

@TekBot

Following the exercise, primary insider Richard Godfrey are holding 1,684,978
options in the Company of which 1,096,462 is vested, in addition to 21,005
shares in the Company through Gnist Holding AS.

Hvem er det som korrekturleser disse?

[Neutral]

Hva var galt i det utdraget?

[Inveliten]

To be bøyes “is” for tredjeperson entall, “are” for tredjeperson flertall?

[Neutral]

Shit… Vedkommende bør straffes, og ny melding bør sendes ut førstkommende mandag. Her er det ikke rom for en liten menneskelig feil.

@pdx bare fjern

[Hocjoc]

Jeg la merke til det samme. Jeg synes det er underlig dersom et børsnotert selskap ikke har rutiner som sikrer at det som publiseres av offentlig informasjon, er riktig skrevet. Det viktigste er selvsagt innholdet, men et poeng er også å fremstå som seriøs og «proff».

De oppnår ikke det når man kunne tro de hadde overlatt skrivingen til en ungdomsskoleelev på arbeidsuke.

[tverilytt]

USA skal investere 25 milliarder i coronapiller

[vcp]

BP har feite og fine sugerør, laget til formålet.
Nå er aksjekursen kjørt nedunder grusen på de fleste biotechs med en mulig løsning. Enkelt for BP å plukke smulene. Eneste som stopper en hostile takover i bgbio er my man Mohn.

[TekBot]

BERGENBIO TO PRESENT AT 4th ANNUAL NEXT GEN IMMUNO-ONCOLOGY VIRTUAL CONGRESS

Bergen, Norway, 28 June 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, is pleased to announce that Prof. Hani Gabra MD PhD,
…

Vis børsmeldingen

Chief Medical Officer of BerGenBio, will deliver a virtual presentation at the
4th Annual Next Gen Immuno-Oncology Congress, which is taking place virtually
from 28 June - 1 July 2021.

Prof. Gabra will discuss the important role of AXL kinase in regulation of
immune suppression in the tumour microenvironment. As part of the presentation,
Prof Gabra will also discuss how targeting AXL with BerGenBio’s lead asset,
bemcentinib, involves innate immune activation and reduced cancer cell and
immune-evasion to leverage an anticancer T-cell response.

The presentation will be made available on the Company website under
‘Presentations’ at the date of the presentation
on www.bergenbio.com/investors/presentations/

Title: The role of AXL in immuno-oncology: A translational perspective

Date and time: Thursday 01 July 2021 at 11.30-12.00 EST

-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
+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.

Kilde

[TekBot]

BERGENBIO PRESENTING COVID-19 DATA IN LATE-BREAKING ABSTRACT PRESENTATION AT ECCMID 2021

Bergen, Norway, 29 June 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that its late-breaking abstract,
…

Vis børsmeldingen

outlining Phase II clinical trial of bemcentinib, a first-in-class selective
oral AXL inhibitor, in hospitalised COVID-19 patients has been published at the
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID),
taking place online from 9-12 July 2021.

The abstract outlines data from two randomised, open-label Phase II studies in
South Africa and India (BGBC020) and the UK (ACCORD2). 177 eligible patients
were enrolled across 3 countries in both studies between May 2020 and March 2021
in bemcentinib and SOC arms. Results showed that from baseline to day 29, there
were fewer deaths in the bemcentinib treated patients (2 of 58 and 1 of 28)
versus SOC (3 of 57 and 5 of 32) for BGBC020 and ACCORD2 respectively.
Bemcentinib was well tolerated throughout both studies.

These exploratory studies demonstrate encouraging evidence for the effect of
bemcentinib in hospitalised COVID-19 patients receiving steroids ± remdesivir.
Bemcentinib is an orally administered, well-tolerated AXL kinase inhibitor which
targets a host receptor to achieve antiviral effects; this mechanism is unlikely
to be attenuated by viral evolution.

Further analysis of the data will be shared in a presentation during the
congress, details below. The presentation will also be made available on the
Company website:

Presenting Author: Akil Jackson

Title: Bemcentinib, an oral AXL kinase inhibitor, results in lower mortality
compared to standard of care (steroids ± remdesivir) in hospitalised patients
with COVID-19

Session Name: LB: Interventions for improving COVID outcome

Session code: S191

Date: 12 July 2021

Time: 1:15 PM - 2:45 PM CEST

-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 subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

Kilde

[Tekspert]

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

1. @anon28800809 (502 likes)

@anon28800809

AXL receptor tyrosine kinase: a possible therapeutic target in acute promyelocytic leukemia | BMC Cancer | Full Text (publisert 17. juni 2021)

2. @vcp (441 likes)

@vcp

Godfrey min gode mann, kom igjen nå.

3. @Direkte (189 likes)

@Direkte

Festen forstsetter den🏃‍♂️

Resten av topp 10:

4. @Hayen (174 likes)

5. @Scrivener (150 likes)

6. @Multiple (137 likes)

7. @Mykle (135 likes)

8. @Tekk (117 likes)

9. @William71 (98 likes)

10. @Flottesen (91 likes)

Gratulerer!

[HeldigFyr]

Takk @anon28800809 , har noe her kvalitativt kommersielt innspill som jeg kan forstå

Få håpe at BP blir med BGBIO i videre steps snarlig!

[TekBot]

PRECLINICAL BEMCENTINIB AND TILVESTAMAB DATA PRESENTED AT EAU 2021

Bergen, Norway, 10 July 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that preclinical data from a study
…

Vis børsmeldingen

investigating the anti-tumor efficacy of BerGenBio’s AXL
-inhibitors bemcentinib and tilvestamab in renal cell carcinoma (RCC) was
presented at the European Association of Urology 2021 virtual congress.

Data from the study, conducted by researchers at the University of Bergen,
Department of Clinical Medicine, showed that both bemcentinib and tilvestamab
prevented Gas6-induced AXL phosphorylation in vitro and effectively prevented
tumour growth in an orthotopic RCC xenograft model in vivo.

Tony J. Chen, Principal Investigator of the study commented: “Our data shows
that AXL-inhibitors effectively reduce tumor size in an orthotopic RCC model.
Following these encouraging results, we believe AXL-inhibition represents a
promising strategy in treatment of RCC and warrants further investigation.”

Details of the presentation are as follows:

Title: The Successful therapy of experimental, orthotopic renal cell carcinoma
with two different types of AXL-inhibiting agents

Date/Time: 10th July at 13-14.00 CET

The presentation can be found at the company website www.bergenbio.com

-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 that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.

Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes the anti-viral Type I interferon response. Data from a Phase II in
human clinical trial has shown that treatment with AXL inhibitor bemcentinib
increased the rate ventilator free survival in hospitalised COVID-19 patients.

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 subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

Kilde

[TekBot]

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
…

Vis børsmeldingen

· 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.

Kilde

[fuzzy]

Tydelig at det er sommermodus når den ikke popper mer enn 8% på den… Regner med vi får oppfølgingsmelding rimelig snart vedrørende veien videre.