BergenBio Fundamentale Forhold (BGBIO)

anon80503862 · september 7, 2022, 12:54pm

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TekBot · september 27, 2022, 1:02pm

BERGENBIO ANNOUCES FIRST PATIENT RANDOMIZED IN BEMCENTINIB TRIAL IN EU-SOLIDACT PLATFORM FOR HOSPITALIZED COVID-19 PATIENTS

BERGEN, Norway, September 27, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical
-stage biopharma-ceutical company developing novel, selective AXL kinase
inhibitors for severe unmet medical needs, and Oslo University Hospital
…

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announced today that the first patient has been included in a study of
BerGenBio’s oral, highly selective AXL inhibitor, bemcentinib, as part of the EU
-SolidAct trial in hospitalized COVID-19 patients.

The EU-SolidAct trial (European DisCoVeRy for Solidarity: An Adaptive Pandemic
and Emerging Infection Platform Trial) is part of EU-RESPONSE, a pan-European
research project designed to investigate treatment options for hospitalized
patients with COVID-19 and emerging infectious diseases.

Bemcentinib was selected by an international group of experts to be studied in
the EU-SolidAct platform in up to 500 hospitalized COVID-19 patients in a Phase
2b, multi-center, randomized, placebo-controlled trial.

Martin Olin, Chief Executive Officer of BerGenBio, commented: “COVID-19
infections and hospital admissions continues to evolve with new variants and the
expected fall/winter season impact. There is a need to identify new effective
therapies for hospitalized patients and bemcentinib represents a promising
treatment modality for this patient population through its unique mechanism of
action, blocking viral entry, stimulating the innate immune system and promoting
lung tissue repair. Importantly, bemcentinib enhances the Type I interferon
response, causing these cytokines to activate immune cells to fight the
infection regardless of spike protein or mutation. Based on the results of our
Phase 2a studies and learnings throughout the pandemic, we are eager to further
study the effectiveness of bemcentinib in COVID-19 and are delighted to now have
randomized the first patient in the EU-SolidAct platform.”

The EU-SolidAct platform trial includes 68 clinical sites in 8 countries and is
sponsored by Oslo University Hospital, Norway, in collaboration with the
Institut National de la Santé Et de la Recherche Médicale (Inserm), France, and
the not-for-profit intergovernmental organization European Clinical Research
Infrastructure Network (ECRIN).

Professor Marius Trøseid, Oslo University Hospital, Chief Investigator of the EU
-SolidAct trial, commented: “As new subvariants continue to evolve, it is
critical to have greater treatment options in order to reduce hospital stays and
halt disease progression. We’re pleased to be partnering with BerGenBio in the
initiation of this trial, as we look to enroll up to 500 hospitalized COVID-19
patients.”

Contacts

For the EU-SolidAct:

Marius Trøseid, Chief Investigator of the EU-SolidAct trial, Senior Consultant
and Professor, Oslo University Hospital

+4792440240,marius.troseid@medisin.uio.no

For BerGenBio:

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

Graham.morrell@bergenbio.com

+1 781 686 9600

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate, bemcentinib, a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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.

About Oslo University Hospital

Oslo University Hospital is a highly specialized hospital in charge of extensive
national, regional and local hospital assignments. As Scandinavia’s largest
hospital, we carry out more than 1.2 million patient treatments each year. Oslo
University Hospital is responsible for approximately 50 percent of all medical
and health care research conducted at Norwegian hospitals. We have a leading
role in the development of research and innovation, as well as the development
of tomorrow’s healthcare, precision medicine and treatment.

About Inserm

Founded in 1964, Inserm is a public science and technology institute. It is
dedicated to biomedical research and human health and is involved every step of
the way from the research laboratory to patient care. It is one of the most
prestigious institutions in the world that is committed to scientific challenges
and progress in these fields. Inserm brings together more than 15,000
researchers, engineers, technicians and administrative staff to improve the
health of all.www.inserm.fr/en/

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. Suchrisks, 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 · oktober 1, 2022, 10:00am

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:

@anon95652491 (244 likes)

@Roc (196 likes)

@Matadoren (127 likes)

Resten av topp 10:

@Hayen (70 likes)
@Hotdog (55 likes)
@stAMy (49 likes)
@PankPinter (45 likes)
@Scrivener (43 likes)
@Multiple (34 likes)
@William71 (29 likes)

Gratulerer!

TekBot · oktober 25, 2022, 5:01am

BerGenBio ASA Secures NOK 100 million Shareholder Loan Facility from Meteva AS

BERGEN, Norway, October 25, 2022: BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, and Meteva AS, a 27.23% shareholder in BerGenBio,
…

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today announced that they have entered into a shareholder loan facility,
pursuant to which Meteva will make available to BerGenBio up to NOK 100 million.

In addition to the cash position of NOK 225 million at the end of September
2022, this facility will enable BerGenBio to continue its previously announced
focused strategy of advancing its lead compound bemcentinib in 1st line Non
-Small Cell Lung Cancer (NSCLC) and hospitalized COVID-19 patients. The facility
will be available for use until the earlier of an equity issue or March 31,
2024, and contains customary covenants and event of default provisions.

BerGenBio may, subject to certain conditions, draw on the facility from Q2 2023.
The facility will not be amortizing and any drawn amounts are to be repaid or
converted to equity on or before December 31, 2024. Amounts drawn under the
facility will carry interest at a rate of 6% per annum and a commitment fee of
1.5% per annum on any undrawn part of the facility.

“We are truly grateful for the strong support of our largest shareholder,
Meteva,” stated Martin Olin, Chief Executive Officer of BerGenBio. “Their
continued commitment to our mission will make a significant impact in developing
bemcentinib to its fullest potential for patients suffering from NSCLC and
severe COVID-19.”

As previously announced, the Company will present its Q3 2022 report on 15
November 2022.

Contacts:

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

Graham.morrell@bergenbio.com

+1 781 686 9600

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 and COVID
-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is
undergoing phase I clinical testing.

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.

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

E24Bot · oktober 25, 2022, 5:10am

Trond Mohn låner 100 millioner kroner til Bergenbio

Tekspert · november 1, 2022, 10:00am

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:

@Roc (215 likes)

@Matadoren (122 likes)

@anon95652491 (100 likes)

Resten av topp 10:

@Hotdog (60 likes)
@stAMy (53 likes)
@Scrivener (48 likes)
@Multiple (40 likes)
@Hayen (37 likes)
@William71 (20 likes)
@Savepig (20 likes)

Gratulerer!

TekBot · november 8, 2022, 6:02am

BerGenBio ASA: Invitation to third quarter 2022 results webcast

Bergen, Norway, 8 November 2022- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, will be announcing its results for the third quarter 2022
…

Vis børsmeldingen

on Tuesday 15 November 2022. The briefing will take place at 10:00 am CET at:
Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo
where BerGenBio’s senior management team will provide an update on the
Company followed by a Q&A session. To attend in person please register by mail
to
ir@bergenbio.com

The presentation will webcast live and a link will be available at
www.bergenbio.com in the Investors/Financial Reports section and a recording
will be available shortly after the webcast has finished.

The third quarter financial report and presentation will be made available on
the Company’s website in the Investors/Financial Reports section from 7:00am CET
the same day.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

Graham.morrell@bergenbio.com

+1 781 686 9600

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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

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 · november 15, 2022, 6:01am

BerGenBio reports third quarter 2022 financial results and provides business update

Randomized first patient in the Phase 2b EU-SolidAct platform for hospitalized
COVID-19 patients -

…

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Initiated Phase 1b/2a trial in 1st line NSCLC patients harboring STK11
mutations -

Strengthened financial position with support from largest shareholder -

BERGEN, Norway, November 15, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced financial results for the third
quarter ended September 30, 2022 and provided a business update.

“The recent initiation of two clinical trials and bolstering of our cash
position has been transformational for the Company as we continue to execute on
our strategy,” said Martin Olin, Chief Executive Officer of BerGenBio. "Mounting
evidence substantiates that AXL plays a significant role in exacerbating many
severe cancers and respiratory diseases. We believe that AXL inhibition by our
lead compound, bemcentinib, can make a life-changing difference in patients
suffering from STK11m NSCLC and hospitalized COVID-19.

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class highly
selective inhibitor of the receptor tyrosine kinase AXL, which is activated in
response to oxidative stress, inflammation, hypoxia and drug treatment,
resulting in a number of deleterious effects in cancer and severe respiratory
diseases. Bemcentinib inhibits AXL activation to prevent the progression of
serious disease through the modulation of resistance mechanisms and the adaptive
immune system.

The Company is advancing bemcentinib development in two lung indications, STK11
mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19
patients, where bemcentinib’s novel mechanisms of action and primary
accumulation in the lungs make it uniquely positioned to address severe lung
diseases.

First-Line STK11m NSCLC

Subsequent to the quarter end, BerGenBio announced in October the initiation of
a Phase 1b/2a trial evaluating bemcentinib in combination with the current
standard of care, the checkpoint inhibitor pembrolizumab and platinum doublet
chemotherapy, for the treatment of 1L NSCLC patients harboring STK11 mutations.

Approximately 20% of non-squamous NSCLC patients harbor STK11m, which are a
recognized resistance mechanism for anti-PD-1/L1 therapy and currently result in
a poor prognosis with standard of care treatment in 1st line NSCLC. The Company
believes that STK11m patients almost universally express AXL, causing a severely
immunosuppressed tumor microenvironment, the development of drug resistance,
immune evasion, and metastasis. Preclinical and clinical data suggest that
bemcentinib’s inhibition of AXL on immune and cancer cells sensitizes STK11m
NSCLC patients to checkpoint inhibitors and improves the effects of
chemotherapy.

The global, open-label Phase 1b/2a trial is designed to determine the safety,
tolerability and efficacy of bemcentinib with standard of care in 1st line
untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations
and no other actionable co-mutations. The first patient is expected to begin
treatment in the fourth quarter of 2022.

Hospitalized COVID-19 Patients

BerGenBio announced in September that the first patient was randomized in a
Phase 2b trial evaluating bemcentinib in hospitalized COVID-19 patients. The
trial is part of the EU-SolidAct platform, a pan-European research project
designed to investigate treatment options for hospitalized patients with COVID
-19 and emerging infectious diseases.

Higher levels of AXL expression and activation caused by COVID-19 infection have
been linked to an increase in disease severity. The interaction of AXL and SARS
-CoV-2 is believed to promote the entry and enhancement of infection in
pulmonary and bronchial epithelial cells. Through the inhibition of AXL,
bemcentinib blocks viral entry, stimulates the innate immune system and promotes
lung tissue repair.

The Phase 2b, multi-center, randomized, placebo-controlled trial will enroll up
to 500 patients, includes 68 clinical sites in 8 countries and is sponsored by
Oslo University Hospital, Norway, in collaboration with the Institut National de
la Santé Et de la Recherche Médicale (Inserm), France, and the not-for-profit
intergovernmental organization European Clinical Research Infrastructure Network
(ECRIN).

Update on Relapsed/Recurrent AML (BGBC003) and 2L NSCLC (BGBC008) studies

In study BGBC003 of Relapsed/Recurrent AML patients, the last patient completed
their last visit in late Q2, with database lock completed in Q3. In study
BGBC008 of 2L NSCLC patients, the last patient’s last visit occurred in Q4
2022. The Company expects to provide results of these studies following
database lock and subsequent data analysis in 1H of 2023.

Corporate Activities

Following the end of the third quarter, BerGenBio announced in October that it
secured a NOK 100 million shareholder loan facility from Meteva AS, a 27.23%
shareholder in BerGenBio. In addition to the Company’s existing cash position,
the facility will enable BerGenBio to continue advancing its lead compound,
bemcentinib, in 1L STK11m NSCLC and hospitalized COVID-19 patients.

Third Quarter 2022 Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

· Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the third
quarter 2022
· Total operating expenses for the third quarter were NOK 62.4 million (NOK
71.4 million)
· The operating loss for the third quarter came to NOK 62.4 million (NOK
71.4 million)

· Cash and cash equivalents amounted to NOK 225.1 million (NOK 292.1
million at the end of the second quarter 2022).

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the
Investors/Financial Reports section. A recording will be available shortly after
the webcast has finished.

Webcast link:
https://channel.royalcast.com/landingpage/hegnarmedia/20221115_2/ (https://eur03.
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Dial-in numbers:

NO: +47-21-956342

UK: +44-203-7696819

US: +1 646-787-0157

SE: +46-4-0682-0620

DK: +45 78768490

Pin: 712491

The third quarter report and presentation are available on the Company’s website
in the Investors/Financial Reports section and a recording of the webcast will
be made available shortly after the webcast has finished.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

graham.morrell@bergenbio.com

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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

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

Kilde

TekBot · november 21, 2022, 8:31pm

BerGenBio ASA: Grant of share options

Bergen, Norway, 21 November 2022 - BerGenBio ASA (the “Company”) (OSE:BGBIO), a
clinical-stage biopharmaceutical company developing novel, selective AXL kinase
inhibitors for severe unmet medical needs, today announce that the Board of
…

Vis børsmeldingen

Directors has granted options to employees.

The annual general meeting in the Company 28 April 2022 approved the share
option program and authorised the board of directors of the Company to issue
shares to the Company’s employees as part of a long-term incentive plan and
share option program.

Options granted under the share option program will vest equally over a three
-year vesting period following the grant and each option, when exercised, will
give the right for each option to acquire one share in the Company at a fixed
strike price. Options granted under the share option program expire eight years
after grant date.

A total of 2,114,230 share options, equal to 2.38% of total shares issued in the
Company, were granted at strike price at NOK 7.59 per option, constituting the
volume weighted average share price over the last two weeks before the grant.

The board considers an option program as an important element in attracting and
retaining employees to foster long-term success. The board considers the option
program terms and allocation to be at the market for comparable peers.

Due to changes in Executive Management over the last two years, this grant is
above the average annual grant which has been 1.87% over the last five years.
After this grant the total issued options is 4.92% of the total issued shares in
the Company, below the average level over the last five years of 5.93%.

Of the total grant the following were granted to primary insiders (total
holdings of share options following this grant):

Martin Olin - CEO: 950,000 (950,000)

Rune Skeie - CFO: 100,000 (397,097)

James Barnes - COO: 110,000 (411,522)

Cristina Oliva - CMO: 200,000 (200,000)

Nigel McCracken - CSO: 275,000 (275,000)

In total 1,635,000 share options were granted to primary insiders.

Following this grant a total of 4,358,505 share options are issued, equal to
4.92% of the total shares issued in the Company. Of this, 1,753,726 share
options are vested and 2,604,779 not vested.

-End-

Contacts

Martin Olin

CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie

CFO, BerGenBio ASA

rune.skeie@bergenbio.com

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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

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 · desember 1, 2022, 10:00am

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:

@Roc (147 likes)

@Matadoren (132 likes)

@anon95652491 (80 likes)

Resten av topp 10:

@stAMy (53 likes)
@Hayen (44 likes)
@Hotdog (39 likes)
@Scrivener (32 likes)
@Multiple (25 likes)
@PankPinter (24 likes)
@Savepig (22 likes)

Gratulerer!

Tekspert · januar 1, 2023, 10:00am

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:

@anon95652491 (175 likes)

@Matadoren (79 likes)

@Roc (67 likes)

Resten av topp 10:

@Hayen (41 likes)
@drdr (30 likes)
@PankPinter (26 likes)
@Savepig (22 likes)
@Multiple (20 likes)
@Hotdog (17 likes)
@Scrivener (12 likes)

Gratulerer!

TekBot · februar 1, 2023, 6:00am

BerGenBio ASA: Invitation to fourth quarter 2022 results webcast

Bergen, Norway, 1 February 2023- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, will be announcing its results for the fourth quarter 2022
…

Vis børsmeldingen

on Thursday 16 February 2023. The briefing will take place at 10:00 am CET at:
Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo
where BerGenBio’s senior management team will provide an update on the
Company followed by a Q&A session. To attend in person please register by mail
to ir@bergenbio.com

The presentation will webcast live and a link will be available at
www.bergenbio.com in the Investors/Financial Reports section and a recording
will be available shortly after the webcast has finished.

The fourth quarter financial report and presentation will be made available on
the Company’s website in the Investors/Financial Reports section from 7:00am CET
the same day.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

Graham.morrell@bergenbio.com

+1 781 686 9600

Media Relation Norway

Jan Lilleby

jl@lillebyfrisch.no

+47 90 55 16 98

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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

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 · februar 1, 2023, 10:00am

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:

@anon95652491 (183 likes)

@Matadoren (50 likes)

@PankPinter (31 likes)

Resten av topp 10:

@Roc (24 likes)
@drdr (23 likes)
@Hayen (20 likes)
@Hotdog (14 likes)
@laplagam (11 likes)
@Zuba (7 likes)
@Aristo78 (7 likes)

Gratulerer!

TekBot · februar 2, 2023, 6:02am

BerGenBio Announces the Establishment of Oncology Scientific Advisory Board

Distinguished global experts appointed to strengthen bemcentinib development
in STK11m NSCLC -

…

Vis børsmeldingen

BERGEN, Norway, February 2, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced the formation of a scientific
advisory board consisting of four world-renowned non-small cell lung cancer
(NSCLC) experts from top oncology centers around the globe to enhance the
development of bemcentinib for the treatment of NSCLC patients with STK11
mutations (STK11m).

“We are very proud and honored to have assembled a group of leading
international NSCLC experts to guide us as we investigate bemcentinib in 1st
line NSCLC STK11m in combination with today’s standard of care,” said Cristina
Oliva, M.D., Chief Medical Officer of BerGenBio. “Their expertise will play an
integral role in our evaluation of bemcentinib and its potential to provide
significant benefits to patients who today face a particularly poor prognosis.”

Despite significant advances in immuno-oncology treatments, NSCLC is still one
of the leading causes of cancer-related deaths worldwide. Patients harboring
STK11m, which represent approximately ~20% of non-squamous NSCLC cases, almost
universally demonstrate high levels of AXL activation and show lower response
rates to current standard of care therapy of anti-PD-1/L1 combined with
chemotherapy. BerGenBio’s lead compound, bemcentinib, is designed to selectively
inhibit AXL, which may potentially sensitize STK11m NSCLC patients to checkpoint
inhibitors and improve the effects of chemotherapy. The Company has initiated a
global Phase 1a/2b trial to assess bemcentinib with standard of care in 1st line
NSCLC patients with STK11m.

Members of the BerGenBio NSCLC Scientific Advisory Board:

Enriqueta Felip, M.D., Ph.D.

Dr. Enriqueta Felip is the Head of the Thoracic Cancer Unit at Vall d’Hebron
University Hospital, Spain, where she is responsible for thoracic malignancy
management and all lung cancer trials. She is President of the Spanish Society
of Medical Oncology (SEOM) 2021-23, a member of the Spanish Lung Cancer Group
(SLCG) and a Professor of Medicine at the Universitat de Vic. Previously, Dr.
Felip was on the Board of Directors of the International Association for the
Study of Lung Cancer (IASLC). She received her M.D. and Ph.D. from Autonomous
University of Barcelona.

John Heymach, M.D., Ph.D.

Dr. John Heymach is the Chair of Thoracic/Head and Neck Medical Oncology at the
MD Anderson Cancer Center, Texas, and holds the David Bruton Endowed Chair in
Cancer Research. Dr. Heymach is a co-leader of the MD Anderson Lung Cancer Moon
Shot, in addition to serving as a Principal Investigator of lung cancer programs
funded by the National Cancer Institute (NCI), LUNGevity and American
Association for Cancer Research (AACR), and earning several prestigious awards
for excellence in basic science, translational research and mentoring. He
received his M.D. and Ph.D. from Stanford University.

Tony Mok, M.D., BMSc

Dr. Tony Mok is a Professor and Chairman of the Department of Clinical Oncology
at the Chinese University of Hong Kong. Dr. Mok’s research was instrumental in
establishing the use of precision medicine in advanced lung cancer. He co
-founded the Lung Cancer Research Group and served as the associate editor for
thoracic oncology for the Journal of Clinical Oncology. Dr. Mok is a Fellow of
the American Society of Clinical Oncology (ASCO), former President of IASLC and
received the ESMO Lifetime Achievement Award. He received his M.D. and BMSc from
the University of Alberta, Canada.

Solange Peters, M.D., Ph.D.

Dr. Solange Peters is a Professor and Head of Medical Oncology and Thoracic
Malignancies at the Department of Oncology at Lausanne University, Switzerland,
where she is also building a translational program in collaboration with
molecular oncology laboratories. Dr. Peters was recently the President of the
European Society for Medical Oncology (ESMO) 2020-22, and was formerly an IASLC
Board member and co-chair of the Swiss Lung Cancer Research Group. She is
Associate Editor of the Annals of Oncology and Deputy Editor of Lung Cancer. She
received her M.D. and Ph.D. from the University of Lausanne.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Graham Morrell

graham.morrell@bergenbio.com

Media Relations Norway

Jan Lilleby

jl@lillebyfrisch.no

+47 90 55 16 98

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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.

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

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

Zuba · februar 2, 2023, 6:37am

Hva er egentlig dette godt for? Noen som kan spisse det litt?

Roc · februar 2, 2023, 7:12am

Dette er veldig vanlig å ha. Er snakk om et panel med eksperter (klinikere/forskere) som man kan søke råd hos og som er med på å gi innspill på strategi og utviklingen i forhold til deres kliniske hverdag. Spesielt gjelder dette det kliniske programmet.

Jeg antok at BGBIO hadde etablert et SAB for lenge siden de tross alt er i klinisk fase med flere indikasjoner og at selskapet hadde rådgivere for de ulike indikasjonene.

Direkte · februar 2, 2023, 6:57am

Hvem betaler for disse eksperter?

Roc · februar 2, 2023, 7:10am

BGBIO så klart. Det er ikke dyrt. Disse er som regel bindet av regler fra arbeidssted, internasjonale/nasjonale regler og har en «fair market value» som de kan ta betalt per time. For noen så går honoreringen til arbeidssted.

Mye forgår også over Zoom, men en F2F møte på en flyplass er også fint

TekBot · februar 15, 2023, 4:01pm

BerGenBio Announces Positive Data From Phase 2 Trial of Bemcentinib in Combination with Pembrolizumab in 2L+ NSCLC Patients

The Company will discuss the topline results during its Q4 2022 results
presentation on Thursday, February 16, 2023, at 10:00 AM CET -

…

Vis børsmeldingen

BERGEN, Norway, February 15, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced topline data from BGBC008, a phase 2
trial evaluating its lead compound bemcentinib in combination with MSD’s anti-PD
-1 therapy pembrolizumab in 2L+ Non-Small Cell Lung Cancer (NSCLC) patients.

BGBC008 Topline Data

The open-label, multi-center, single arm, multi-cohort, international phase 2
trial conducted in collaboration with MSD (Merck and Co., Inc. Rahway, NJ, USA),
enrolled 90 evaluable patients with disease progression at study entry, who had
received at least one prior line of chemotherapy, immunotherapy, or the
combination. Enrolled patients received the combination of bemcentinib and
pembrolizumab until disease progression as assessed by investigators. Topline
results from the total evaluable population:

· A clinically meaningful survival benefit and evidence of disease control was
demonstrated with bemcentinib in combination with pembrolizumab regardless of
prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI:
10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6,
9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall
response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).

· A significant (p-value < 0.05) and clinically meaningful improvement in mOS
based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS >
5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6)
compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI:
6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months
(95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with
AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.

· The observed mOS was similar regardless of patient PD-L1 status.

· Treatment with bemcentinib in combination with pembrolizumab was well
-tolerated.

“We are very encouraged by the topline data” said Martin Olin, Chief Executive
Officer of BerGenBio. “Treatment with bemcentinib in combination with
pembrolizumab demonstrated long survival benefit and sustained disease control,
particularly in patients with AXL TPS > 5, substantiating the relevance of AXL
as a target and bemcentinib’s selective inhibition capabilities in NSCLC.
Notably, the survival benefit was observed regardless of PD-L1 status. The data
support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom
approximately 80% have AXL expression. This subgroup of NSCLC represents more
than 30,000 patients in the US and five largest European countries, for whom
there is currently no effective targeted therapy available.”

James Spicer, PhD, FRCP, Professor of Experimental Cancer Medicine at King’s
College London and Principal Investigator of the BGBC008 trial, remarked, “The
reported data shows that the combination of bemcentinib and pembrolizumab is
well-tolerated in patients with NSCLC, and is particularly active in patients
with tumour AXL expression. Other evidence suggests that current therapies are
less effective in NSCLC with loss of the tumour suppressor gene STK11, and that
AXL inhibition can restore susceptibility. Further investigation is warranted to
confirm the role of AXL inhibition in STK11-mutated NSCLC patients, who are
under-served by currently available therapeutic options.”

The Company plans to present further details of the BCBG008 trial at an upcoming
medical conference.

First-Line STK11m NSCLC Trial (BGBC016)

BerGenBio is studying bemcentinib in a global, open-label, phase 1b/2a trial
evaluating bemcentinib in combination with the current standard of care of
pembrolizumab and platinum doublet chemotherapy, for the treatment of 1L NSCLC
patients with mutations in the STK11 gene. More than 30,000 NSCLC patients (US
and EU5) harbor STK11 mutations which are associated with poor prognosis with
currently available therapies. The Company believes that STK11 mutations create
a severely immunosuppressed tumor microenvironment associated with AXL
expression and activation, resulting in the development of drug resistance,
immune evasion, and metastases.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / International Media Relations

Graham Morrell

graham.morrell@bergenbio.com

Media Relations Norway

Jan Lilleby

jl@lillebyfrisch.no

+47 90 55 16 98

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. The Company is focused on advancing its lead candidate,
bemcentinib, a potentially first-in-class, oral, selective AXL inhibitor in
STK11 mutated NSCLC and severe respiratory infections including COVID-19.

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

About Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral,
selective inhibitor of the receptor tyrosine kinase AXL, which is expressed and
activated in response to oxidative stress, inflammation, hypoxia, and drug
treatment, resulting in a number of deleterious effects in cancer and severe
respiratory infections. Bemcentinib selectively inhibits AXL activation to
prevent the progression of serious diseases through the modulation of resistance
mechanisms and the adaptive immune system.

Bemcentinib is currently being developed in STK11 mutated NSCLC and severe
respiratory infections including COVID-19. Its novel mechanisms of action and
primary accumulation in the lungs uniquely position it to address these severe
lung diseases.

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

Kilde

HJB · februar 15, 2023, 4:20pm

Dette kan bli gøy