BergenBio Fundamentale Forhold (BGBIO)

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BerGenBio ASA - Information about the Warrants issued in connection with the Rights Issue

NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED
STATES, CANADA, AUSTRALIA, THE HONG KONG SPECIAL ADMINISTRATIVE REGION OF THE
PEOPLE’S REPUBLIC OF CHINA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE
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DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE.
PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS STOCK EXCHANGE ANNOUNCEMENT.

Bergen 23 June 2023: Reference is made to the stock exchange announcement by
BerGenBio ASA (the “Company”) on 22 June 2023 regarding the registration of new
share capital following completion of the rights issue raising gross proceeds of
NOK 250 million (the “Rights Issue”). The subscribers in the Rights Issue have
been allocated one warrant for every two Offer Shares allocated to them and paid
by them in the Rights Issue (the “Warrants”).

The Rights Issue resulted in the issuance to subscribers in the Rights Issue of
1,249,999,617 Warrants, which will be listed and tradable on Oslo Stock Exchange
under the ticker code “BGBIS” for a period commencing today, 23 June 2023 and
ending at 16:30 (CEST) on 8 April 2024.

If all Warrants are exercised, the Company expects to raise additional between
NOK 125 million and NOK 162 million in gross proceeds. In the event that
Warrants are not exercised, the gross proceeds will be reduced corresponding to
the proportion of Warrants that are not exercised.

Each Warrant will give the holder a right to subscribe for one new share in the
Company at an exercise price per share equal to the volume-weighted average
price (VWAP) of the Company’s shares on the Oslo Stock Exchange in the three
last trading days prior to the first date on which the holder can exercise the
Warrant in each exercise period less 30%, but in any event (i) not lower than
the nominal value (NOK 0.10) and (ii) not exceeding the subscription price in
the Rights Issue plus 30% (i.e. NOK 0.13).

The Warrants may be exercised during two exercise periods: (i) within the first
14 days after the Company’s announcement of its Q3 2023 quarterly financial
report and (ii) from 1 April 2024 to 14 April 2024.

Exercise is carried out by written notification to the Company which must be
received by the Company by the expiry of the deadline. The notice shall include
the number of Warrants the holder has and how many of these are exercised.

Holders of Warrants may either sell the Warrants or use them to subscribe for
shares in the Company within the deadlines stated above. As such, the Warrants
may have a financial value for the holders, depending on the prevailing market
price for the shares in the Company. Holders of Warrants who do not sell or use
the Warrants to subscribe for shares in the Company will experience a dilution
of their shareholding in the Company, see Section 6.29 “Dilution” in the
prospectus for a further description of such dilutive effect.

If the Warrants are not sold within 16:30 (CEST) on 8 April 2024 or exercised
within 16:30 (CEST) on 14 April 2024, the Warrants will lapse with no
compensation to the holders.

For more information pertaining to the Warrants, please see the prospectus
prepared in connection with the Rights Issue, which is, subject to applicable
local securities laws, available at the websites of the Company
(www.bergenbio.com), Carnegie AS (www.carnegie.no/ongoing-prospectuses-and
-offerings/) and Arctic Securities AS (www.arctic.com/secno/en/offerings).

For further information, please contact:

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

For information about the Rights Issue please contact the managers:

Arctic Securities AS, tel.: + 47 21 01 30 40

Carnegie AS, tel.: +47 22 00 93 40

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 severe respiratory infections.

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.

• IMPORTANT INFORMATION -

This announcement is not and does not form a part of any offer to sell, or a
solicitation of an offer to purchase, any securities of the Company. Copies of
this announcement are not being made and may not be distributed or sent into any
jurisdiction in which such distribution would be unlawful or would require

registration or other measures. Any offering of the securities referred to in
this announcement has been made by means of a prospectus approved by the
Financial Supervisory Authority of Norway on 26 May 2023 and published by the
Company.

Investors should not subscribe for any securities referred to in this
announcement except on the basis of information contained in the aforementioned
prospectus, which is, subject to applicable local securities laws, available at
the websites of the Company (www.bergenbio.com), Carnegie AS
(www.carnegie.no/ongoing-prospectuses-and-offerings/) and Arctic Securities AS
(www.arctic.com/secno/en/offerings).

This information is published pursuant to the requirements of the Continuing
Obligations.

The securities referred to in this announcement have not been and will not be
registered under the U.S. Securities Act of 1933, as amended (the “Securities
Act”) or with any securities regulatory authority of any state or other
jurisdiction in the United States and may not be offered, sold, pledged or
otherwise transferred within the United States. The Company does not intend to
register any part of the offering in the United States or to conduct a public
offering of securities in the United States.

In any member state of the European Economic Area (each, an “EEA Member State”),
this communication is only addressed to and is only directed at qualified
investors in that EEA Member State within the meaning of the Prospectus
Regulation, i.e., only to investors who can receive the offer without an
approved prospectus in such EEA Member State. The expression “Prospectus
Regulation” means Regulation (EU) 2017/1129 as amended (together with any
applicable implementing measures in any EEA Member State).

This communication is only being distributed to and is only directed at persons
in the United Kingdom that are (i) investment professionals falling within
Article 19(5) of the Financial Services and Markets Act 2000 (Financial
Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities,
and other persons to whom this announcement may lawfully be communicated,
falling within Article 49(2)(a) to (d) of the Order (all such persons together
being referred to as “relevant persons”). This communication must not be acted
on or relied on by persons who are not relevant persons. Any investment or
investment activity to which this communication relates is available only for
relevant persons and will be engaged in only with relevant persons. Persons
distributing this communication must satisfy themselves that it is lawful to do

so.

Matters discussed in this announcement may constitute forward-looking
statements. Forward-looking statements are statements that are not historical
facts and may be identified by words such as “believe”, “expect”, “anticipate”,
“strategy”, “intends”, “estimate”, “will”, “may”, “continue”, “should” and
similar expressions. The forward-looking statements in this release are based
upon various assumptions, many of which are based, in turn, upon further
assumptions. Although the Company believe that these assumptions were reasonable
when made, these assumptions are inherently subject to significant known and
unknown risks, uncertainties, contingencies and other important factors which
are difficult or impossible to predict, and are beyond their control. Actual
events may differ significantly from any anticipated development due to a number
of factors, including without limitation, changes in public sector investment
levels, changes in the general economic, political and market conditions in the
markets in which the Company operates, the Company’s ability to attract, retain
and motivate qualified personnel, changes in the Company’s ability to engage in
commercially acceptable acquisitions and strategic investments, and changes in
laws and regulation and the potential impact of legal proceedings and actions.
Such risks, uncertainties, contingencies and other important factors could cause
actual events to differ materially from the expectations expressed or implied in
this release by such forward-looking statements. The Company does not make any
guarantee that the assumptions underlying the forward-looking statements in this
announcement are free from errors nor does it accept any responsibility for the
future accuracy of the opinions expressed in this announcement or any obligation
to update or revise the statements in this announcement to reflect subsequent
events. You should not place undue reliance on the forward-looking statements in
this announcement.

The information, opinions and forward-looking statements contained in this
announcement speak only as at its date, and are subject to change without
notice. The Company does not undertake any obligation to review, update,
confirm, or to release publicly any revisions to any forward-looking statements
to reflect events that occur or circumstances that arise in relation to the
content of this announcement.

Neither the Managers nor any of their affiliates makes any representation as to
the accuracy or completeness of this announcement and none of them accepts any
responsibility for the contents of this announcement or any matters referred to
herein.

This announcement is for information purposes only and is not to be relied upon
in substitution for the exercise of independent judgment. It is not intended as
investment advice and under no circumstances is it to be used or considered as
an offer to sell, or a solicitation of an offer to buy any securities or a
recommendation to buy or sell any securities of the Company. Neither the
Managers nor any of their affiliates accepts any liability arising from the use
of this announcement.

The distribution of this announcement and other information may be restricted by
law in certain jurisdictions. Persons into whose possession this announcement or
such other information should come are required to inform themselves about and
to observe any such restrictions.

Kilde

[TekBot]

BerGenBio ASA: Resolution to increase the share capital for settlement of underwriting commission

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN CANADA,
JAPAN, AUSTRALIA OR THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH SUCH
RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. THIS ANNOUNCEMENT DOES
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NOT CONSTITUTE AN OFFER OF ANY OF THE SECURITIES DESCRIBED HEREIN.

Bergen 27 June 2023: Reference is made to previous stock exchange announcements
from BerGenBio ASA (“BerGenBio” or the “Company”) regarding the partially
underwritten rights issue of up to 2,500,000,000 new shares (the “Offer Shares”)
in the Company, raising gross proceeds of up to NOK 250 million (the “Rights
Issue”).

Pursuant to the underwriting agreements for the Rights Issue dated 25 April
2023, each underwriter is entitled to an underwriting fee of 12% of its
respective underwriting obligation, to be settled in cash or new shares in the
Company issued at the subscription price in the Rights Issue (the “Fee Shares”),
or through a combination of cash and Fee Share, at the Underwriter’s election.

A total of 31,872,000 Fee Shares will be issued to certain underwriters.

The Company’s Board of Directors has resolved to increase the share capital with
NOK 3,187,200 in connection with the issuance of the Fee Shares. The share
capital increase is resolved pursuant to the Board authorization to increase the
share capital that was granted at the Company’s ordinary general meeting held on
22 May 2023.

The Fee Shares are currently expected to be delivered to the underwriters on or
about 29 June 2023.

For further information, please contact:

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 severe respiratory infections. BerGenBio is based in Bergen, Norway with a
subsidiary in Oxford, UK. T

he Company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more
information, visit www.bergenbio.com.

• IMPORTANT NOTICE -

This announcement is not and does not form a part of any offer to sell, or a
solicitation of an offer to purchase, any securities of the Company. Copies of
this announcement are not being made and may not be distributed or sent into any
jurisdiction in which such distribution would be unlawful or would require
registration or other measures. Any offering of the securities referred to in
this announcement will be made by means of a prospectus approved by the
Financial Supervisory Authority of Norway and published by the Company.
Investors should not subscribe for any securities referred to in this
announcement except on the basis of information contained in the aforementioned
prospectus.

This information is subject to the disclosure requirements pursuant to Section 5
-12 of the Norwegian Securities Trading Act.

The securities referred to in this announcement have not been and will not be
registered under the U.S. Securities Act of 1933, as amended (the “Securities
Act”) or with any securities regulatory authority of any state or other
jurisdiction in the United States and may not be offered, sold, pledged or
otherwise transferred within the United States. The Company does not intend to
register any part of the offering in the United States or to conduct a public
offering of securities in the United States. In any member state of the European
Economic Area (each, an “EEA Member State”), this communication is only
addressed to and is only directed at qualified investors in that EEA Member
State within the meaning of the Prospectus Regulation, i.e., only to investors
who can receive the offer without an approved prospectus in such EEA Member
State. The expression “Prospectus Regulation” means Regulation (EU) 2017/1129 as
amended (together with any applicable implementing measures in any EEA Member
State).

This communication is only being distributed to and is only directed at persons
in the United Kingdom that are (i) investment professionals falling within
Article 19(5) of the Financial Services and Markets Act 2000 (Financial
Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities,
and other persons to whom this announcement may lawfully be communicated,
falling within Article 49(2)(a) to (d) of the Order (all such persons together
being referred to as “relevant persons”). This communication must not be acted
on or relied on by persons who are not relevant persons. Any investment or
investment activity to which this communication relates is available only for
relevant persons and will be engaged in only with relevant persons. Persons
distributing this communication must satisfy themselves that it is lawful to do
so. Matters discussed in this announcement may constitute forward-looking
statements.

Forward-looking statements are statements that are not historical facts and may
be identified by words such as “believe”, “expect”, “anticipate”, “strategy”,
“intends”, “estimate”, “will”, “may”, “continue”, “should” and similar
expressions. The forward-looking statements in this release are based upon
various assumptions, many of which are based, in turn, upon further assumptions.
Although the Company believe that these assumptions were reasonable when made,
these assumptions are inherently subject to significant known and unknown risks,
uncertainties, contingencies and other important factors which are difficult or
impossible to predict, and are beyond their control. Actual events may differ
significantly from any anticipated development due to a number of factors,
including without limitation, changes in public sector investment levels,
changes in the general economic, political and market conditions in the markets
in which the Company operates, the Company’s ability to attract, retain and
motivate qualified personnel, changes in the Company’s ability to engage in
commercially acceptable acquisitions and strategic investments, and changes in
laws and regulation and the potential impact of legal proceedings and actions.
Such risks, uncertainties, contingencies and other important factors could cause
actual events to differ materially from the expectations expressed or implied in
this release by such forward-looking statements. The Company does not make any
guarantee that the assumptions underlying the forward-looking statements in this
announcement are free from errors nor does it accept any responsibility for the
future accuracy of the opinions expressed in this announcement or any obligation
to update or revise the statements in this announcement to reflect subsequent
events. You should not place undue reliance on the forward-looking statements in
this announcement. The information, opinions and forward-looking statements
contained in this announcement speak only as at its date, and are subject to
change without notice. The Company does not undertake any obligation to review,
update, confirm, or to release publicly any revisions to any forward-looking
statements to reflect events that occur or circumstances that arise in relation
to the content of this announcement.

Neither the Managers nor any of their affiliates make any representation as to
the accuracy or completeness of this announcement and none of them accepts any
responsibility for the contents of this announcement or any matters referred to
herein.

This announcement is for information purposes only and is not to be relied upon
in substitution for the exercise of independent judgment. It is not intended as
investment advice and under no circumstances is it to be used or considered as
an offer to sell, or a solicitation of an offer to buy any securities or a
recommendation to buy or sell any securities of the Company. Neither the
Managers nor any of their affiliates accepts any liability arising from the use
of this announcement.

In connection with the Rights Issue, the Managers and any of their affiliates,
acting as investors for their own accounts, may subscribe for or purchase shares
and in that capacity may retain, purchase, sell, offer to sell or otherwise deal
for their own accounts in such shares and other securities of the Company or
related investments in connection with the Rights Issue or otherwise.
Accordingly, references in any subscription materials to the shares being
issued, offered, subscribed, acquired, placed or otherwise dealt in should be
read as including any issue or offer to, or subscription, acquisition, placing
or dealing by, the Manager and any of its affiliates acting as investors for
their own accounts. The Managers do not intend to disclose the extent of any
such investment or transactions otherwise than in accordance with any legal or
regulatory obligations to do so.

The distribution of this announcement and other information may be restricted by
law in certain jurisdictions. Persons into whose possession this announcement or
such other information should come are required to inform themselves about and
to observe any such restrictions. The distribution of this announcement and
other information may be restricted by law in certain jurisdictions. Persons
into whose possession this announcement or such other information should come
are required to inform themselves about and to observe any such restrictions.

Kilde

[TekBot]

BerGenBio ASA: Share capital increase registered

Bergen 29 June 2023: Reference is made to previous stock exchange announcements
from BerGenBio ASA (“BerGenBio” or the “Company”) regarding the partially
underwritten rights issue of up to 2,500,000,000 new shares (the “Offer Shares”)
…

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in the Company, raising gross proceeds of up to NOK 250 million (the “Rights
Issue”). Reference is further made to the stock exchange notice published on 27
June 2023 regarding a resolution to increase the share capital for settlement of
parts of the underwriting commission through the issuance of 31,872,000 new
shares (the “Fee Shares”) to certain underwriters of the Rights Issue.

The share capital increases relating to the issuance of the Fee Shares have now
been registered with the Norwegian Register of Business Enterprises. The share
capital has been increased with NOK 3,187,200 through the issuance of 31,872,000
new shares.

The new share capital is NOK 262,053,253.20 divided into 2,620,532,532 shares,
each with a par value of NOK 0.10.

The Fee Shares are expected to be delivered to the underwriters on or about 30
June 2023.

For further information, please contact:

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 severe respiratory infections. 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.

This information is published in accordance with the requirements of the Oslo
Rule Book II and 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. @anon8907229 (147 likes)

@anon8907229

Det selskapet egentlig sier med denne emisjonen, er at vi har nå gjort aksjene dine tilnærmet verdiløse, men ber deg “pent” om gi oss friske penger på nytt, og vi vil til gjengeld gi deg aksjer tilbake som enda ikke er blitt verdiløse.

2. @Hotdog (73 likes)

@Hotdog

Et lite dikt til ettertanke før vi går løs på en ny massakre av kursen denne uken!

3. @polygon (51 likes)

@polygon

MCAP har gått fra 106 millioner til implisitt nå 1,1 milliarder på tre dager - det må jo være ny rekord på Oslo Børs?

Resten av topp 10:

4. @Roc (48 likes)

5. @stAMy (41 likes)

6. @Matadoren (37 likes)

7. @Aristo78 (35 likes)

8. @drdr (30 likes)

9. @Boms (24 likes)

10. @Buffet (21 likes)

Gratulerer!

[Hotdog]

Jeg skal prøve å svare deg på en skikkelig måte.
Tegningsrettene som det finnes ca 1,25 milliarder av kan benyttes i 2 omganger.
Den første er 14 dager etter at q3 er annonsert og den andre perioden er 1-14 april 2024.
Innløsingsprisen vil være mellom 10-13 øre.
Denne emisjonen har vært klar lenge.
All info finner du her:
https://www.bergenbio.com/news/AD60D220C863C3A4

[anon8907229]

@Gymsokk

Samtidig selges tegningsretter for 0,0001

Jeg påpekte at kurs 0,0001 er feil på en så pen måte som jeg kunne. Posten ble flagget og fjernet. Jeg forsøker derfor å formulere meg enda mer forsiktig. Dagens kurs på BGBIS er lavere enn i går, og akkurat nå er kursen 0,0078. Det er veldig stor forskjell på 0,0001 og 0,0078. Det må da være rom for å påpeke når det skrives noe som er direkte feil her?

[TekBot]

BerGenBio ASA: Invitation to second quarter and half year 2023 results webcast

Bergen, Norway, 16 August 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 second quarter and
…

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half year 2023 on Wednesday 23 August 2023. The briefing will take place at the
Conference “Vestland på Børs” at 10:45 am CEST where BerGenBio’s senior
management team will provide a business update.

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

The second quarter and half year financial report and presentation will be made
available on the Company’s website in the Investors/Financial Reports
section (Financial reports - BerGenBio) from 7:00am CEST
the same day.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

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

Media Relations

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 severe respiratory infections. 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 MAR
article 17 and section 5-12 of the Norwegian Securities Trading Act.

Kilde

[TekBot]

BerGenBio announces clinical data presentations highlighting the activity of its selective AXL inhibitor bemcentinib in Non-Small Cell Lung Cancer

BERGEN, Norway, August 22, 2023- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, announcedtoday that additional clinical data of
…

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bemcentinib in combination with chemotherapy and with immunotherapy in Non-Small
Cell Lung Cancer (NSCLC) have been recently published and accepted for
presentation at two upcoming international oncology conferences:

· Comprehensive results from the investigator led trial of bemcentininb +
docetaxel in previously treated NSCLC patients (Study BGBIL005) were published
in the August 2023 issue of Lung Cancer. “Phase 1 trial of bemcentinib (BGB324),
a first-in-class, selective AXL inhibitor, with docetaxel in patients with
previously treated advanced non-small cell lung cancer.” Lung Cancer 182 (2023)
The trial was led by David Gerber, MD., Professor at the UT Southwestern Harold
C. Simmons Comprehensive Cancer Center.
· The abstract “Bemcentinib + Pembrolizumab show promising efficacy in
metastatic NSCLC harbouring mutations associated with poor prognosis:
Exploratory sub-analysis from the BGBC008 trial (NCT03184571)” has been accepted
for posterpresentationat the SITC 38th Annual Meeting, to be held November 3-5,
2023,in San Diego, CA (Abstract #598).
· The abstract "Final top-line results of the BGBC008 phase 2, multicenter
study of bemcentinib and pembrolizumab (bem+pembro) in 2nd line (2L) advanced
non-squamous (NS) non-small cell lung cancer (NSCLC) (NCT03184571)"has been
accepted for poster presentation at the ESMO Congress 2023, to be held October
20-24, 2023, in Madrid, Spain (Abstract #5343)

“The accumulating evidence supporting the potential role of bemcentinib in NSCLC
aligns with our strategic focus on this disease where a large portion of
patients still have very poor clinical outcome from existing therapies” said
Martin Olin, Chief Executive Officer of BerGenBio. “The publication of data in a
prestigious peer reviewed publication and at ESMO and SITC provides us with the
opportunity to share our data with a broad audience of oncologists and key
opinion leaders in the field of NSCLC and the pharmaceutical industry.”

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Media Relations

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 severe respiratory infections.

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, visitwww.bergenbio.com

This information is subject to the disclosure requirements pursuant to MAR
article 17 and section 5-12 of the Norwegian Securities Trading Act.

Kilde

[TekBot]

BerGenBio Reports Second Quarter 2023 Financial Results

BERGEN, Norway, August 23, 2023 - 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 second
…

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quarter and first half ended June 30, 2023, and provided a business update.

A briefing by BerGenBio’s senior management team will take place at 10:45 am
CEST today via a webcast presentation, followed by a Q&A session. Please see
below for details.

“For the second quarter we are pleased to report the outcomes of our cost
-savings efforts and the successful closure of the Rights Issue. In combination
this will fund our planned activities into the fourth quarter of 2024 and
potentially into the second half of 2025 if all granted warrants at the Rights
Issue are exercised. Our highest priority is to progress the ongoing Phase 1b/2a
clinical trial in first-line STK11m NSCLC patients (“BGBC016”) where we are
working towards enrolling the Phase 1b cohorts and initiate the Ph 2a part.
During the second quarter, we obtained a wealth of additional clinical data
which further validate the efficacy and tolerability of our lead compound
bemcentinib. The data provide us with strong confidence in our focused strategy
to study the compound’s potential to treat 1L NSCLC patients harboring STK11
mutations. Further, explorative biomarker data from our BGBC008 trial (2L NSCLC)
indicate that bemcentinib in combination with pembrolizumab provides encouraging
survival benefits in patients harboring other hard-to-treat mutations such as
KRAS and KEAP1. During 2023, we have seen increased awareness for the need for
improved treatments for this prevalent patient population with high unmet
needs.”, said Martin Olin, Chief Executive Officer of BerGenBio.

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral,
highly 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 several 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 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.

Oncology: NSCLC

1L STK11m NSCLC (BGBC016)

We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11 mutations and no actionable mutations. Sites in the US have been
activated and enrolment is ongoing while expansion into European sites is well
underway, with regulatory approval to proceed received from regulatory
authorities in the US and several European countries.

The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11 mutations, which are
associated with immunosuppression and poor prognosis with standard 1L NSCLC
treatment. Data suggests that STK11m NSCLC patients almost universally express
AXL in tumors and/or on immune cells, resulting in the development of drug
resistance, immune evasion, and metastases.

The data from the BGBC008 (2L+ NSCLC, bemcentinib in combination with
pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with
docetaxel) trials provide clinical evidence of the anti-tumor effects of
bemcentinib and its ability to modulate the tumor microenvironment to enhance
the effects of immunotherapy and chemotherapy. We believe that the reversal of
the effects of AXL with bemcentinib holds the promise of providing substantial
survival benefits to NSCLC patients and specifically in patients harboring
STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1.

2L+ NSCLC Trial (BGBC008)

Additional biomarker analyses of the BGBC008 data in the second quarter yielded
promising data which further support the potential for bemcentinib in our on
-going 1L STK11m NSCLC trial and may represent an opportunity to further expand
the patient population that may benefit from the addition of bemcentinib to
their treatment regimens. The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC
patients who had received at least one prior line of therapy:chemotherapy,
immunotherapy or the combination.

· An updated analysis of AXL biomarker status indicates that the presence of
AXL expression on either tumor cells and/or immune cells is predictive of
improved survival in patients treated with bemcentinib + pembrolizumab. The vast
majority (88%) of patients met the criteria for AXL presence (AXL positive
patients) and obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients

· Analysis of available data for patients treated in a subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab in 2L identified a
higher than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1) benefit from the combination treatment of bemcentinib and
pembrolizumab.
· Currently the PD-L1 negative patient population is not widely treated with
immune checkpoint inhibitors potentially providing an opportunity to expand the
patient population eligible for treatment.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L patients.

Oncology: Relapsed/Refractory AML/MDS

In the second quarter, topline results of the Phase 1b/2a BGBC003 multicenter
open-label studyofbemcentinibas a single agent and in combination with low-dose
cytarabine (LDAC) ordecitabine in patients with acute myeloid leukemia or as a
single agent in patients withmyelodysplastic syndrome.

· Two cohorts of patients in BGBC003 were treated withbemcentinibas a single
agent(monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R)
AML, (n=11),bemcentinib provided an ORR of 18.2% and a mOS of 18 months.In
Cohort B4, in patientswith relapsed/high risk MDS,bemcentinibmonotherapy
provided an ORR of 18.8% with a mOSof 9.2months.

· Furthermore,bemcentinibin combination with the chemotherapy LDAC appeared to
provide substantial mOSbenefit to patients with R/R AML (n=27) achieving an ORR
of 18.5% and a mOS of 8months.

Oncology: Mesothelioma

In the second quarter, topline results of the investigator led BGBIL011/MiST3
mesothelioma trial were presentedon June 5, 2023, in an oral presentation at the
2023 American Society of ClinicalOncology (ASCO) meeting in an abstract
titled:Bemcentiniband pembrolizumab in patients withrelapsed mesothelioma:
MiST3, a phaseIIatrial with cellular and molecular correlates of efficacy.

Key results include:

· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received
at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met:
46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of
38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%
CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well
-tolerated.

In totality, the Company is very encouraged by the additional clinical data
generated with bemcentinib and reported year-to-date 2023. Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.

Severe Respiratory Infections (SRIs)

The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it well for the treatment of severerespiratory infections.

On April 25, 2023, the Company decided to pause the Phase2b trial
evaluatingbemcentinibin hospitalized COVID-19 patients until a potential
accelerationin hospitalizations warrant further evaluation ofbemcentinibin this
population.

Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.

Corporate Activities

Rights Offering

On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.

Focused organizational structure aligned with strategy

The Company has taken measures to further reduce its operational costs
includinga significant reduction in workforce and total compensation to the
executive management andthe board of directors. This includes a transition of
the CSO to a part-time consultancy position. These prudent actions will reduce
total operating expenses by at least30% compared to historic operational
expenses when fully implemented.

Second Quarter 2023 Financial Highlights

(Figures in brackets = same period 2022 unless otherwise stated)

· Revenue was NOK 0 million (NOK 0 million) for the second quarter.
· Total operating expenses for the second quarter were NOK 47.8 million (NOK
88.2 million).
· The operating loss for the quarter came to NOK 47.8 million (NOK 88.2
million).
· Cash and cash equivalents amounted to NOK 226 million by the end of June
2023 (NOK 73.0 million by end of March 2023). This includes the net proceeds
from the Rights Issue completed in June 2023.

The Q2 2023 presentation and Financial Report is available at the Company’s
website (Financial reports - BerGenBio).

Presentation and Webcast Details
The live webcast
link (https://channel.royalcast.com/landingpage/hegnarmedia/20230823_8/) is
available at www.bergenbio.com in the Investors/Financial Reports section.

A recording will be available shortly after the webcast has finished.

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xzaTb1iPBsto%3D&reserved=0)

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Media Relations

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 severe respiratory infections.

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, visitwww.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]

Correction: BerGenBio ASA Seccond Quarter and half year 2023 Financial Report

Bergen 25 August 2023: Reference is made to the publication of the Second
quarter and first half 2023 Financial Report on the 23 of August at 07:00 CET.
The Financial Report is updated to include the Board of Directors Responsibility
…

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statement and is attached to this announcement and on our website.

Kilde

[TekBot]

Additional data on BerGenBio’s selective AXL inhibitor bemcentinib to be presented at the 2023 ESMO meeting

BERGEN, Norway, October 16, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced that a poster and an oral
…

Vis børsmeldingen

presentation summarizing completed studies with its lead product candidate
bemcentinib will be presented at the upcoming European Society of Clinical
Oncologists (ESMO) Annual Meeting 2023, to be held October 20-24 in Madrid.

Enriqueta Felip, M.D., Ph.D., Head of the Thoracic Cancer Unit at Vall d’Hebron
University Hospital, Spain will present the following poster summarizing the
final results from the BGBC008 Phase II study of bemcentinib in combination with
pembrolizumab in 2L NSCLC:

Poster Title: Final top-line results of the BGBC008 phase 2, multicenter study
of bemcentinib and pembrolizumab (bem+pembro) in 2nd line (2L) advanced non
-squamous (NS) non-small cell lung cancer (NSCLC) (NCT03184571) of S
Session Date: Onsite poster display date, Monday October 23
Poster Board Number: 1440P

The poster will be available on BerGenBio’s website shortly following
presentation.

In addition, Dr. Oddbjorn Straume, M.D., Ph.D., Assistant Professor, Clinical
Science at the Haukeland University Hospital in Bergen, Norway will make an oral
presentation summarizing the results of the Investigator Led Study LBA52 with
bemcentinib in addition to pembrolizumab or dabrafenib/trametinib in 1L and 2L
metastatic melanoma patients:

Oral Presentation Title: A randomized Phase Ib/II study of the selective small
molecule AXL inhibitor bemcentinib in combination with either
dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma

Session Name: LBA 52 “Melanoma and other skin tumors”
Session Date and Time: Saturday October 21, 15:50-15:55 CET
Location: Leon Auditorium, Hall 7

Martin Olin, Chief Executive Officer of BerGenBio, commented: “We are pleased to
share more data on bemcentinib which we believe substantiates our strategy to
focus on the treatment of Non-Small Cell Lung Cancer patients with a goal of
potentiating the effects of standard of care treatments. We thank the patients
who participated in these studies, their families, and all participating
investigators as well as their clinical and nursing staff for contributing to
our understanding of bemcentinib as a potential cancer therapeutic.”

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

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, visitwww.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]

New Data on BerGenBio’s Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

BERGEN, Norway, October 23, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced that the full results of its Phase 2
…

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BGBC008 study of bemcentinib and pembrolizumab in second line Non-Small Cell
Lung Cancer (NSCLC) were presented during the European Society of Clinical
Oncologists (ESMO) Annual Meeting 2023.

The poster presentation is now available on BerGenBio’s website under
?Pipeline?Scientific Publications.

In addition, on October 21st, Dr. Oddbjorn Straume, M.D., Ph.D., Assistant
Professor, Clinical Science at the Haukeland University Hospital in Bergen,
Norway presented results of the Investigator Led Study LBA52 of bemcentinib in
addition to pembrolizumab or the targeted therapies dabrafenib/trametinib in 1L
and 2L metastatic melanoma patients.

Cristina Oliva, Chief Medical Officer of BerGenBio, commented: “The full data
analysis of the BGBC008 second line NSCLC study of bemcentinib in combination
with the immune checkpoint inhibitor pembrolizumab showed promising long-term
clinical benefits in patients regardless of their prior therapies, or PD-L1
status. In addition, the combination of bemcentinib with pembrolizumab was well
tolerated with no new safety signals identified. These data provide a strong
foundation for further clinical investigations of bemcentinib in NSCLC patients
with high unmet needs, including those with STK11 mutations.”

Dr. Oliva continued, “During the meeting, our collaborator, Dr. Oddbjorn
Straume, also presented data on the combination of bemcentinib with standard of
care therapies in first line and second line melanoma patients. While this small
study failed to show the benefit of adding a selective AXL inhibitor to the
treatment for melanoma patients, the results are consistent with the current
limited understanding of the function of AXL in melanoma.In totality, these new
data substantiate BerGenBio’s focused strategy on the treatment of first line
NSCLC patients with STK11m patients in our on-going BGBC016 study.”

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

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, visitwww.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]

BerGenBio Announces Poster Presentation at Upcoming SITC Meeting

BERGEN, Norway, October 31, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced that a poster highlighting data from
…

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pre-planned biomarker analyses in second line Non-Small Cell Lung Cancer (NSCLC)
patients treated with bemcentinib, a highly selective AXL inhibitor in
combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) will be
presented at the Society for Immunotherapy for Cancer (SITC) meeting being held
on November 1-5, 2023 in San Diego, California.

The poster abstract was published today in the Journal for Immunotherapy of
Cancer (JITC), an open-access journal. The full poster will be available on
BerGenBio’s website shortly following presentation on November 4th.

Poster Details

Title: Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC
patients harboring mutations associated with poor prognosis: exploratory sub
-analysis from the BGBC008 trial

Poster Board Number: 598

Presentation Time: Saturday, Nov. 4, 2023 beginning at 0900 Pacific Time

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of
Merck & Co., Inc., Rahway, NJ, USA

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective
inhibitor of the tyrosine kinase AXL. Extensive studies confirm the ability to
combine bemcentinib with immune checkpoint inhibitors, chemotherapies and
targeted therapies with the goal of improving a patient’s immune response and
delaying the development of chemoresistance. Bemcentinib is currently being
investigated in combination with immune checkpoint inhibition and chemotherapy
in first line NSCLC patients harboring mutations in the STK11 gene, a known
prognostic factor of poor response to existing therapies.

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, visitwww.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]

BerGenBio Announces Poster Presentation at Upcoming ASH Meeting

BERGEN, Norway, November 2, 2023, BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced that a poster highlighting final
…

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results from a clinical study of its highly selective AXL inhibitor bemcentinib
in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
will be presented during the American Society of Hematology (ASH) Annual Meeting
being held December 9-12, 2023 in San Diego, CA.

Poster Details:

Publication Number: 4287
Title: Phase Ib/II Study (NCT02488408 / BGBC003) of Bemcentinib Monotherapy or
in Combination with Cytarabine or Decitabine in Acute Myeloid Leukemia (AML) or
Myelodysplastic Syndrome (MDS): FINAL Results

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding
Transplantation and Cellular Immunotherapies: Poster III
Session Date: Monday, December 11, 2023
Presentation Time: 6:00 PM - 8:00 PM
Location: San Diego Convention Center, Halls G-H

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective
inhibitor of the tyrosine kinase AXL. Extensive studies confirm the ability to
combine bemcentinib with immune checkpoint inhibitors, chemotherapies and
targeted therapies with the goal of improving a patient’s immune response and
delaying the development of chemoresistance. Bemcentinib is currently being
investigated in combination with immune checkpoint inhibition and chemotherapy
in first line NSCLC patients harboring mutations in the STK11 gene, a known
prognostic factor of poor response to existing therapies.

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, visitwww.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]

BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

Presented at 2023 SITC Meeting

• A pre-planned biomarker analysis of patients treated with bemcentinib in
  …

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combination with KEYTRUDA® (pembrolizumab) yields new understandings-

BERGEN, Norway, November 6, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, announced that a poster presentation detailing
additional data from a Phase II trial of bemcentinib in combination with MSD’s
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second line Non-Small Cell Lung
Cancer (NSCLC) patients was presented on November 4th at the 2023 Society of
Immunotherapy of Cancer Annual Meeting.

The pre-planned biomarker analysis of the BGBC008 study in 2L NSCLC patients
adds to the clinical data recently announced at the 2023 ESMO meeting. The
poster presentation entitled “Bemcentinib + Pembrolizumab show promising
efficacy in metastatic NSCLC patients harboring mutations associated with poor
prognosis: exploratory sub-analysis from the BGBC008 Trial”, is now available on
BerGenBio’s website under the Scientific Publications section.

Martin Olin, Chief Executive Officer of BerGenBio, commented “The findings add
to the industry’s understanding of the outcomes in 2L NSCLC patients and the
potential for bemcentinib to benefit patients in combination with immune
checkpoint inhibition. While the dataset in the analyses is relatively small, we
believe bemcentinib in combination with pembrolizumab has the potential to
improve outcomes in NSCLC patient sub-groups that have been associated with poor
survival, including patients with negative/low PD-L1 levels, STK11 mutations,
and KEAP1 mutations”.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of
Merck & Co., Inc., Rahway, NJ, USA

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby

jl@lillebyfrisch.no

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective
inhibitor of the tyrosine kinase AXL. Extensive studies confirm the ability to
combine bemcentinib with immune checkpoint inhibitors, chemotherapies and
targeted therapies with the goal of improving a patient’s immune response and
delaying the development of chemoresistance. Bemcentinib is currently being
investigated in combination with immune checkpoint inhibition and chemotherapy
in first line NSCLC patients harboring mutations in the STK11 gene, a known
prognostic factor of poor response to existing therapies.

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, visitwww.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

[urban66]

ChatGPT gir en forklaring for ikke-forskere (som meg):
I denne meldingen forteller BerGenBio om nye funn fra en undersøkelse de gjorde på pasienter med lungekreft. De brukte et legemiddel som heter bemcentinib sammen med et annet legemiddel kalt KEYTRUDA® (pembrolizumab) for å behandle pasienter i andre linje av lungekreft. De fant ut at kombinasjonen av disse to legemidlene viser lovende resultater hos pasienter med lungekreft som har visse mutasjoner som vanligvis gir dårlig prognose.

Resultatene av undersøkelsen ble presentert på et møte om kreftimmunterapi og er tilgjengelig på BerGenBio sin nettside. Administrerende direktør, Martin Olin, sier at selv om undersøkelsen var på et begrenset antall pasienter, så tyder funnene på at bemcentinib i kombinasjon med pembrolizumab kan forbedre behandlingsresultatene for visse grupper av lungekreftpasienter som vanligvis har dårlig prognose.

[TekBot]

BerGenBio ASA: Invitation to third quarter 2023 results webcast

Bergen, Norway, 6 November 2023 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, will announce its results for the third quarter 2023 on
…

Vis børsmeldingen

Tuesday 14 November 2023.

BerGenBio’s senior management team will provide a business update at 10:00 am
CET.

The presentation will webcast live. To participate in the webcast please use the
following link:

https://channel.royalcast.com/landingpage/hegnarmedia/20231114_1/

A recording of the webcast will be available at www.bergenbio.com in the
Investors/Financial Reports
section (Financial reports - BerGenBio) shortly
afterwards.

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

Warrants

As part of the Rights Issue offering completed in June 2023, BerGenBio issued
Warrants to the subscribers in the offering. The Warrants are tradable under the
ticker BGBIS on the Oslo Stock Exchange. The holders of the Warrants can
exercise the Warrants in two periods, the first of which will start on 15
November 2023 and end on 28 November 2023. Additional information about the
Warrants is available on the Company’s website in the
Investors/Warrants (https://www.bergenbio.com/investors/investor
-relations/warrants) section. More details about how to exercise will be
communicated by the Company before or on 15 November 2023.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

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

Media Relations

Jan Lilleby

jl@lillebyfrisch.no

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 severe respiratory infections. 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 MAR
article 17 and section 5-12 of the Norwegian Securities Trading Act.

Kilde

[TekBot]

Financial calendar

Financial calendar for BerGenBio ASA

FINANCIAL YEAR 2023
…

Vis børsmeldingen

30.04.2024 - Annual Report
23.05.2024 - Annual General Meeting

14.11.2023 - Quarterly Report - Q3
14.02.2024 - Quarterly Report - Q4

FINANCIAL YEAR 2024

21.08.2024 - Half-yearly Report

29.05.2024 - Quarterly Report - Q1
13.11.2024 - Quarterly Report - Q3
19.02.2025 - Quarterly Report - Q4

This information is published pursuant to the requirements set out in the Continuing obligations.

Kilde

[TekBot]

BerGenBio Reports Third Quarter 2023 Financial Results

BERGEN, Norway, November 14, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced financial results for the quarter
…

Vis børsmeldingen

ended September 30, 2023, and provided a business update.

“We are pleased to report continued advancement of our focused strategy to study
our lead compound bemcentinib, a highly selective AXL inhibitor, in first line
(1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the
STK11 gene (STK11m). The increasing recognition of STK11m as a poor prognostic
factor for 1L NSCLC patients, as evidenced by real-world data presented at
prestigious medical conferences, continues to substantiate high unmet medical
needs and our clinical data continues to validate the potential role of
bemcentinib in combination with standard of care therapies to improve the
outcome for these patients. During the quarter, we activated additional clinical
trial sites in the US and prepared for the addition of sites in Europe in
anticipation of the expected initiation of the Ph2a portion of our study in 1L
NSCLC STK11m patients in the first half of 2024. Our operating expenses in the
quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022
reflecting the effects of our focused strategy and cost containment implemented
in connection with the Rights Issue. At 30th September 2023 our cash position
stood at NOK 169.3 million. We believe that our singular focus on advancing
bemcentinib in 1L NSCLC STK11m combined with the potential funding from the
exercise of outstanding warrants issued in the Rights Issue enable us to
generate data that can position the significant potential of bemcentinib in
NSCLC,” said Martin Olin, Chief Executive Officer of BerGenBio.

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral,
highly 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 several 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 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.

Oncology: NSCLC

1L STK11m NSCLC (BGBC016)

We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11m and no actionable mutations. Sites in the US have been activated and
enrollment is ongoing while expansion into European sites is well underway, with
regulatory approval to proceed received from regulatory authorities in the US
and several European countries.

The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. To date, no significant safety concerns have arisen
in the Phase 1b study. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11m.

A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11m, which are associated with
immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data
suggests that STK11m NSCLC patients almost universally express AXL in tumors
and/or on immune cells, resulting in the development of drug resistance, immune
evasion, and metastases.

Post-quarter, the Company announced that the final data from the BGBC008 study
(2L+ NSCLC, bemcentinib in combination with pembrolizumab) presented on October
23rd at the European Society for Medical Oncology (ESMO) 2023 Annual Meeting
held in Madrid. The Company believes that these data along with study BGBIL005
(2L+ NSCLC, bemcentinib in combination with docetaxel) provide clinical evidence
of the anti-tumor effects of bemcentinib and its ability to modulate the tumor
microenvironment to enhance the effects of immunotherapy and chemotherapy. We
believe that the reversal of the effects of AXL with bemcentinib holds the
promise of providing substantial survival benefits to NSCLC patients and
specifically in patients harboring STK11m and potentially other hard-to treat
mutations such as KRAS and KEAP1. We expect to report additional clinical data
at upcoming major medical meetings during the remainder of 2023, including the
Society for Immunotherapy of Cancer (SITC) Annual Meeting and the American
Society of Hematology (ASH) Annual Meeting.

Description of the 2L+ NSCLC Trial (BGBC008)

The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received
at least one prior line of therapy:chemotherapy, immunotherapy or the
combination.

· An analysis of AXL biomarker status indicates that the presence of AXL
expression on either tumor cells and/or immune cells is predictive of improved
survival in patients treated with bemcentinib + pembrolizumab. The vast majority
(88%) of patients met the criteria for AXL presence (AXL positive patients) and
obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients.

· Analysis of available data for patients treated in subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab identified a higher
than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1%) benefit from the combination treatment of bemcentinib and
pembrolizumab. Currently PD-L1 negative patients respond less well to immune
checkpoint inhibition, potentially providing an opportunity to expand the
patient population eligible for treatment with bemcentinib.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L NSCLC patients.

Severe Respiratory Infections (SRIs)

The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it for the treatment of severerespiratory infections.

On April 25, 2023, the Company decided to pause the bemcentinib arm of the
Phase2b EUSolidAct trial evaluatingbemcentinibin hospitalized COVID-19 patients
due to the limited number of hospitalizations observed across all European
countries. The Company and the EU-SolidAct have agreed to maintain this study
on pause until and unless such time both parties agree to resume the trial arm
due to increased COVID hospitalizations or should a new pandemic arise.

Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.

Corporate Activities

Rights Offering

On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.

Warrants

The outstanding warrants issued in the Rights Issue can be exercised in two
defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm
CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume
-weighted average price (VWAP) of the Company’s shares on the Oslo Stock
Exchange over the three last trading days prior to the exercise period less 30%,
but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional
information and instructions for exercise of warrants can be found on the
Company’s website (https://www.bergenbio.com/investors/investor
-relations/warrants).

Our Chief Operating Officer James Barnes, decided to pursue new opportunities
and will leave the company during December 2023. In connection with the
implementation of the focused strategy, the role of Chief Operating Officer will
not be replaced.

Third Quarter 2023 Financial Highlights

(Figures in brackets = same period 2022 unless otherwise stated)

•      Revenue was NOK 0 million (NOK 0 million) for the third quarter.
  

•      Total operating expenses for the third quarter were NOK 28.1 million
  

(NOK 62.4 million)

•      The operating loss for the quarter came to NOK 28.1 million (NOK 62.4
  

million)

•      Cash and cash equivalents amounted to NOK 169.3 million by the end of
  

September 2023 (NOK 226.0 million by end of June 2023).

Presentation and Webcast Details

The Q3 2023 presentation and Financial Report are available at the Company’s
website (Financial reports - BerGenBio).

BerGenBio’s senior management team will provide a business update today at 10:00
am CET. The presentation will webcast live. To participate in the webcast please
use the following link:

https://channel.royalcast.com/landingpage/hegnarmedia/20231114_1/ (https://eur03.
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A recording of the webcast will be available at www.bergenbio.com in the
Investors/Financial Reports
section (Financial reports - BerGenBio) shortly
afterwards.

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Media Relations

Jan Lilleby

jl@lillebyfrisch.no

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 severe respiratory infections.

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, visitwww.bergenbio.com

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective
inhibitor of the tyrosine kinase AXL. Extensive studies confirm the ability to
combine bemcentinib with immune checkpoint inhibitors, chemotherapies and
targeted therapies with the goal of improving a patient’s immune response and
delaying the development of chemoresistance. Bemcentinib is currently being
investigated in combination with immune checkpoint inhibition and chemotherapy
in first line NSCLC patients harboring mutations in the STK11 gene, a known
prognostic factor of poor response to existing therapies.

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

[LarsErik64]

Ovennevnte melding GPT-forenklet tekstmessig:

“We’re excited to share progress on our strategy for studying bemcentinib, a highly selective AXL inhibitor. Our focus is on first-line Non-Small Cell Lung Cancer (NSCLC) patients with mutations in the STK11 gene (STK11m). Real-world data at medical conferences underscores the urgent medical need for these patients. Our clinical data supports bemcentinib’s potential in combination with standard therapies to improve outcomes. In this quarter, we expanded clinical trial sites in the US and prepared for European sites, anticipating the Ph2a study initiation in 1L NSCLC STK11m patients in H1 2024. Operating expenses were NOK 28.1 million, down from NOK 62.4 million in Q3 2022, reflecting our focused strategy and cost containment. As of September 30, 2023, our cash position is NOK 169.3 million. We’re confident that our focused approach, along with potential funding from outstanding warrants, will allow us to generate valuable data showcasing bemcentinib’s significant potential in NSCLC,” said Martin Olin, CEO of BerGenBio.

Clinical Development - Bemcentinib

Bemcentinib, BerGenBio’s leading compound, is a promising oral inhibitor targeting the AXL receptor tyrosine kinase. AXL is activated in response to various stressors, contributing to harmful effects in cancer and severe respiratory infections. Bemcentinib selectively blocks AXL activation, hindering disease progression by modulating resistance mechanisms and the adaptive immune system.

Currently, Bemcentinib is under development for 1L STK11 mutated NSCLC and severe respiratory infections. Its unique mechanisms and lung-targeted accumulation make it suitable for addressing these challenging lung diseases.

Oncology: NSCLC

In the pursuit of our focused strategy, we are progressing with the BGBC016 trial, a global Phase 1b/2a study evaluating Bemcentinib’s safety and efficacy in combination with standard treatments for untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations. The study, already active in the US, is expanding into European sites following regulatory approvals.

The Phase 1b portion assesses the safety of Bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, irrespective of STK11 status. No significant safety concerns have been observed. The Phase 2a expansion will further evaluate Bemcentinib’s safety and efficacy in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.

A substantial subgroup of 1L non-squamous NSCLC patients (up to 20%) with STK11 mutations faces challenges with standard treatments. Bemcentinib aims to address these challenges, potentially providing survival benefits. Recent data from the BGBC008 study supports Bemcentinib’s anti-tumor effects, showing promise in modulating the tumor microenvironment and enhancing the effects of immunotherapy and chemotherapy. Additional clinical data will be presented at major medical meetings throughout 2023.

Description of the 2L+ NSCLC Trial (BGBC008)

The Phase 2 BGBC008 trial, involving 90 evaluable 2L+ NSCLC patients, demonstrates that the presence of AXL expression predicts improved survival in patients treated with Bemcentinib + pembrolizumab. AXL-positive patients showed statistically significant benefits, with a median overall survival of 14.1 months compared to 6.5 months in AXL-negative patients. Analysis of subsequent therapies (3L+) suggests a higher response rate, indicating potential long-lasting immune response benefits.

Bemcentinib also appears beneficial for PD-L1 negative patients, traditionally less responsive to immune checkpoint inhibition. The combination of Bemcentinib and pembrolizumab shows promise for patients with mutations associated with poor outcomes, including STK11, KRAS, KEAP-1, and SMARCA4 mutations.

Severe Respiratory Infections (SRIs)

Bemcentinib is believed to block viral entry and replication, stimulate the innate immune system, and promote lung tissue repair, positioning it for severe respiratory infection treatment. The Phase 2b EUSolidAct trial evaluating Bemcentinib in hospitalized COVID-19 patients is paused due to limited hospitalizations, with ongoing preclinical studies for SRIs causing Acute Respiratory Distress Syndrome (ARDS). Initial results are expected in 2023.