Bergen, Norway, August 21, 2024 - 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 quarter
and half year ended June 30, 2024, and provided a business update.
Highlights, including post period:
· BGBC016 1L NSCLC STK11m study continues to progress as planned. Enrollment
in the Ph1b part completed. Data Safety Monitoring Board review of data from the
final Ph1b dose cohort supports safety and tolerability of the combination of
bemcentinib with standard of care chemo/immunotherapy allowing initiation of the
2nd dose in the Ph2a part. All Ph2a sites have now been activated.
· Innovative approach established with leading genomic AI provider to
accelerate development of bemcentinib. Established data and regulatory
collaboration with technology company Tempus AI (Nasdaq: TEM) to provide
prospective comparative clinical data from 1L STK11m NSCLC patients to aid in
the evaluation of BGBC016 results.
· Strengthened financial position. Secured gross funding of NOK 138.9 million
from warrant exercise in June 2024 securing funding into H2 2025. Financial
position of NOK 200.1 million end of Q2 2024.
· Stable cash use. Continued decreased and stabilized operating expenses at
NOK 90.5 million for first half 2024 compared to NOK 120.2 million in first half
2023. Operating expenses NOK 50.8 million in Q2 2024 compared to NOK 47.8
million in Q2 2023.
Martin Olin, Chief Executive Officer of BerGenBio stated:
"The BGBC016 clinical trial continued to progress well during the quarter. An
independent review of the final cohort in the Ph1b part showed acceptable safety
allowing initiation of the 2nd dose in the Ph2a part, and we completed the
activation of the Ph2a sites. We now look forward to sharing preliminary
efficacy data from the Ph2a portion of the study as they mature. During the
quarter we strengthened our financial position which will, combined with our
continuing cost discipline, fund our planned activities into the second half of
2025. The BGBC016 clinical trial is our highest priority, and we remain
dedicated to unlocking the significant value potential in bemcentinib."
Presentation and Financial Report
The Q2 2024 Financial report is attached to this stock exchange announcement and
the report and the Q2 2024 presentation are available at the Company's website
https://www.bergenbio.com/investors/financial-reports.
Webcast details
BerGenBio's senior management team will provide a business update today at 9:45
am CET. The presentation will webcast live. To participate in the webcast,
please use the following link:
https://channel.royalcast.com/landingpage/hegnarmedia/20240821_12/ (https://eur0
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A recording of the webcast will be available at www.bergenbio.com in the
Investors/Financial Reports section
(https://www.bergenbio.com/investors/financial-reports) shortly afterwards.
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 clinical development for STK11 mutated
NSCLC and preclinical development for 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 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.