Earnings Release • Nov 15, 2022
Earnings Release
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BerGenBio reports third quarter 2022 financial results and provides business update
- Randomized first patient in the Phase 2b EU-SolidAct platform for hospitalized
COVID-19 patients -
- Initiated Phase 1b/2a trial in 1st line NSCLC patients harboring STK11
mutations -
- Strengthened financial position with support from largest shareholder -
BERGEN, Norway, November 15, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced financial results for the third
quarter ended September 30, 2022 and provided a business update.
"The recent initiation of two clinical trials and bolstering of our cash
position has been transformational for the Company as we continue to execute on
our strategy," said Martin Olin, Chief Executive Officer of BerGenBio. "Mounting
evidence substantiates that AXL plays a significant role in exacerbating many
severe cancers and respiratory diseases. We believe that AXL inhibition by our
lead compound, bemcentinib, can make a life-changing difference in patients
suffering from STK11m NSCLC and hospitalized COVID-19.
Clinical Development
Bemcentinib
BerGenBio's lead compound, bemcentinib, is a potentially first-in-class highly
selective inhibitor of the receptor tyrosine kinase AXL, which is activated in
response to oxidative stress, inflammation, hypoxia and drug treatment,
resulting in a number of deleterious effects in cancer and severe respiratory
diseases. Bemcentinib inhibits AXL activation to prevent the progression of
serious disease through the modulation of resistance mechanisms and the adaptive
immune system.
The Company is advancing bemcentinib development in two lung indications, STK11
mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19
patients, where bemcentinib's novel mechanisms of action and primary
accumulation in the lungs make it uniquely positioned to address severe lung
diseases.
First-Line STK11m NSCLC
Subsequent to the quarter end, BerGenBio announced in October the initiation of
a Phase 1b/2a trial evaluating bemcentinib in combination with the current
standard of care, the checkpoint inhibitor pembrolizumab and platinum doublet
chemotherapy, for the treatment of 1L NSCLC patients harboring STK11 mutations.
Approximately 20% of non-squamous NSCLC patients harbor STK11m, which are a
recognized resistance mechanism for anti-PD-1/L1 therapy and currently result in
a poor prognosis with standard of care treatment in 1st line NSCLC. The Company
believes that STK11m patients almost universally express AXL, causing a severely
immunosuppressed tumor microenvironment, the development of drug resistance,
immune evasion, and metastasis. Preclinical and clinical data suggest that
bemcentinib's inhibition of AXL on immune and cancer cells sensitizes STK11m
NSCLC patients to checkpoint inhibitors and improves the effects of
chemotherapy.
The global, open-label Phase 1b/2a trial is designed to determine the safety,
tolerability and efficacy of bemcentinib with standard of care in 1st line
untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations
and no other actionable co-mutations. The first patient is expected to begin
treatment in the fourth quarter of 2022.
Hospitalized COVID-19 Patients
BerGenBio announced in September that the first patient was randomized in a
Phase 2b trial evaluating bemcentinib in hospitalized COVID-19 patients. The
trial is part of the EU-SolidAct platform, a pan-European research project
designed to investigate treatment options for hospitalized patients with COVID
-19 and emerging infectious diseases.
Higher levels of AXL expression and activation caused by COVID-19 infection have
been linked to an increase in disease severity. The interaction of AXL and SARS
-CoV-2 is believed to promote the entry and enhancement of infection in
pulmonary and bronchial epithelial cells. Through the inhibition of AXL,
bemcentinib blocks viral entry, stimulates the innate immune system and promotes
lung tissue repair.
The Phase 2b, multi-center, randomized, placebo-controlled trial will enroll up
to 500 patients, includes 68 clinical sites in 8 countries and is sponsored by
Oslo University Hospital, Norway, in collaboration with the Institut National de
la Santé Et de la Recherche Médicale (Inserm), France, and the not-for-profit
intergovernmental organization European Clinical Research Infrastructure Network
(ECRIN).
Update on Relapsed/Recurrent AML (BGBC003) and 2L NSCLC (BGBC008) studies
In study BGBC003 of Relapsed/Recurrent AML patients, the last patient completed
their last visit in late Q2, with database lock completed in Q3. In study
BGBC008 of 2L NSCLC patients, the last patient's last visit occurred in Q4
2022. The Company expects to provide results of these studies following
database lock and subsequent data analysis in 1H of 2023.
Corporate Activities
Following the end of the third quarter, BerGenBio announced in October that it
secured a NOK 100 million shareholder loan facility from Meteva AS, a 27.23%
shareholder in BerGenBio. In addition to the Company's existing cash position,
the facility will enable BerGenBio to continue advancing its lead compound,
bemcentinib, in 1L STK11m NSCLC and hospitalized COVID-19 patients.
Third Quarter 2022 Financial Highlights
(Figures in brackets = same period 2021 unless otherwise stated)
· Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the third
quarter 2022
· Total operating expenses for the third quarter were NOK 62.4 million (NOK
71.4 million)
· The operating loss for the third quarter came to NOK 62.4 million (NOK
71.4 million)
· Cash and cash equivalents amounted to NOK 225.1 million (NOK 292.1
million at the end of the second quarter 2022).
Presentation and Webcast Details
The live webcast link is available at www.bergenbio.com in the
Investors/Financial Reports section. A recording will be available shortly after
the webcast has finished.
Webcast link:
https://channel.royalcast.com/landingpage/hegnarmedia/20221115_2/ (https://eur03.
safelinks.protection.outlook.com/?url=https%3A%2F%2Fchannel.royalcast.com%2Flandi
ngpage%2Fhegnarmedia%2F20221115_2%2F&data=05%7C01%7Crune.skeie%40bergenbio.com%7C
5be63b7cdd9a47f0d04408dab8cd4383%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C638
025488995468784%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBT
iI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=f5NGecxnHBO90rvRqN0iO6%2FUdMMNvLX
jRMexfhOm%2Bkk%3D&reserved=0)
Dial-in numbers:
NO: +47-21-956342
UK: +44-203-7696819
US: +1 646-787-0157
SE: +46-4-0682-0620
DK: +45 78768490
Pin: 712491
The third quarter report and presentation are available on the Company's website
in the Investors/Financial Reports section and a recording of the webcast will
be made available shortly after the webcast has finished.
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
Investor Relations / Media Relations
Graham Morrell
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate bemcentinib a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and COVID-19.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The
company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more
information, visit?www.bergenbio.com
Forward looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties, and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and subject to the disclosure requirements pursuant to
section 5-12 of the Norwegian Securities Trading Act.
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