Legal Proceedings Report • Feb 25, 2025
Legal Proceedings Report
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BerGenBio announces discontinuation of 1L STK11M NSCLC study and exploration of strategic alternatives
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
Rune Skeie, CFO, BerGenBio ASA
Jan Lilleby, Investor Relations / Media Relations
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.
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