Onsdag 12 Mars | 11:53:45 Europe / Stockholm

Kalender

Est. tid*
2026-02-19 13:00 Bokslutskommuniké 2025
2025-11-19 07:00 Kvartalsrapport 2025-Q3
2025-08-20 07:00 Kvartalsrapport 2025-Q2
2025-05-21 N/A X-dag ordinarie utdelning BGBIO 0.00 NOK
2025-05-21 07:00 Kvartalsrapport 2025-Q1
2025-05-20 N/A Årsstämma
2025-02-26 - Bokslutskommuniké 2024
2024-11-13 - Kvartalsrapport 2024-Q3
2024-10-10 - Extra Bolagsstämma 2024
2024-08-21 - Kvartalsrapport 2024-Q2
2024-05-30 - Split BGBIO 100:1
2024-05-29 - Kvartalsrapport 2024-Q1
2024-05-24 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2024-05-23 - Årsstämma
2024-02-14 - Bokslutskommuniké 2023
2023-11-14 - Kvartalsrapport 2023-Q3
2023-08-23 - Kvartalsrapport 2023-Q2
2023-06-22 - Kvartalsrapport 2023-Q1
2023-05-22 - Årsstämma
2023-04-21 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2023-02-16 - Bokslutskommuniké 2022
2022-11-15 - Kvartalsrapport 2022-Q3
2022-08-23 - Kvartalsrapport 2022-Q2
2022-05-24 - Kvartalsrapport 2022-Q1
2022-04-29 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2022-04-28 - Årsstämma
2022-02-16 - Bokslutskommuniké 2021
2022-01-06 - Extra Bolagsstämma 2022
2021-11-16 - Kvartalsrapport 2021-Q3
2021-08-17 - Kvartalsrapport 2021-Q2
2021-05-19 - Kvartalsrapport 2021-Q1
2021-03-22 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2021-03-19 - Årsstämma
2021-02-10 - Bokslutskommuniké 2020
2020-12-09 - Extra Bolagsstämma 2020
2020-11-17 - Kvartalsrapport 2020-Q3
2020-08-18 - Kvartalsrapport 2020-Q2
2020-05-19 - Kvartalsrapport 2020-Q1
2020-03-17 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2020-03-16 - Årsstämma
2020-02-11 - Bokslutskommuniké 2019
2019-11-19 - Kvartalsrapport 2019-Q3
2019-08-19 - Kvartalsrapport 2019-Q2
2019-05-08 - Kvartalsrapport 2019-Q1
2019-03-14 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2019-03-13 - Årsstämma
2019-02-19 - Bokslutskommuniké 2018
2018-11-13 - Kvartalsrapport 2018-Q3
2018-08-21 - Kvartalsrapport 2018-Q2
2018-05-15 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2018-05-15 - Kvartalsrapport 2018-Q1
2018-05-14 - Årsstämma
2018-03-09 - Extra Bolagsstämma 2018
2018-02-13 - Bokslutskommuniké 2017
2017-11-17 - Kvartalsrapport 2017-Q3
2017-08-18 - Kvartalsrapport 2017-Q2
2017-05-23 - Kvartalsrapport 2017-Q1
2017-03-23 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2017-03-22 - Årsstämma
2016-06-22 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2016-06-21 - Årsstämma
2015-06-23 - X-dag ordinarie utdelning BGBIO 0.00 NOK
2015-06-22 - Årsstämma

Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriBioteknik
BerGenBio är ett norskt onkologibolag. Idag bedriver bolaget forskning och utveckling av hämmande läkemedel för behandling av aggressiva cancertyper. Bolaget har utvecklat ett flertal produkter vars sammansättning ämnar blockera proteinet AXL, ett protein positivt relaterat med spridning av cancercellerna. Bolaget grundades under 2007 och har sitt huvudkontor i Bergen, Norge.
2025-02-25 19:58:42
Bergen, Norway, February 25, 2025 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing the novel, selective AXL kinase inhibitor
bemcentinib for serious diseases today announced its decision to close its
BGBC016 study of bemcentinib in combination with standard of care therapy in
first line (1L) non-squamous Non-Small Cell Lung Cancer (NSCLC) patients with a
mutation in the STK11 gene (STK11m).

"It is, of course, disappointing and unexpected that we are now discontinuing
the study. I would like to extend my gratitude to the patients and investigators
who participated in our study for this particularly difficult-to-treat patient
group, as well as to our team members who have worked tirelessly on this
effort", stated Olav Hellebø, Chief Executive Officer of BerGenBio. "We do not
believe these preliminary results are strong enough for the company to obtain
additional funding within the current cash runway to complete the study as
originally designed. The company is now entering a new phase in which strategic
alternatives will be explored, which may include a potential sale, merger, or
other strategic transaction."

Background:

In 2024, the company announced the completion of enrollment in the Ph1b portion
of the study which demonstrated acceptable safety in 1L NSCLC patients
regardless of STK11 mutational status, as evaluated by an independent Data
Safety Monitoring Board (DSMB). Early encouraging data were seen in three STK11m
patients, including one patient who experienced a complete response and who
remains in response and on treatment after nearly two years. The company, in
agreement with the independent DSMB, determined that these initial results
warranted the continuation of the study into the Ph2a portion.

In March 2024, the company initiated the Ph2a portion of the study designed to
recruit 40 evaluable 1L STK11m NSCLC patients. The primary endpoint for the Ph2a
was overall response rate (ORR). To determine the feasibility of obtaining near
-term funding, the company performed a preliminary analysis of the responses in
the 10 efficacy evaluable STK11m patients. While there was 1 response in the
Ph1b we did not observe additional responses in the Ph2a patients. Consequently,
the company has decided to discontinue the BGBC016 study.

The Board of Directors has now initiated an exploration of strategic
alternatives. As part of this process, the board will consider a range of
options for the company including, among other things, a potential sale, merger,
or other strategic transaction. There can be no assurance that this exploration
process will result in any transaction.

Contacts

Olav Hellebø, CEO BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Jan Lilleby, Investor Relations / Media Relations

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. 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.