Earnings Release • Feb 16, 2023
Earnings Release
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BerGenBio Reports Fourth Quarter 2022 Financial Results and Provides Business Update
BERGEN, Norway, February 16, 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 fourth
quarter ended December 31, 2022, and provided a business update.
A briefing by BerGenBio's senior management team will take place at 10:00 am CET
today via a webcast presentation, followed by a Q&A session. Please see below
for details.
"The recent announcement of the topline data from our BCBG008 NSCLC trial
corroborates the strategy we enacted and the great strides we took in 2022,"
said Martin Olin, Chief Executive Officer of BerGenBio. "The trial showed a
survival benefit and disease control provided by bemcentinib in combination with
pembrolizumab, substantiating the relevance of AXL inhibition in NSCLC,
particularly in patients with AXL-expressing tumors. The results of the trial
strongly support our efforts to treat 1L NSCLC patients harboring STK11
mutations, a group in which AXL expression commonly occurs. Bemcentinib's
ability to selectively inhibit AXL may serve as a key component in delivering
hope to this large, hard-to-treat patient population."
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 a number of 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 STK11 mutated NSCLC and severe
respiratory infections including COVID-19. Its novel mechanisms of action and
primary accumulation in the lungs uniquely position it to address these severe
lung diseases.
Oncology: NSCLC
2L+ NSCLC Trial (BGBC008)
Subsequent to quarter end, the Company announced topline data from the BGBC008
(2L+) NSCLC trial on February 15, 2023. The trial enrolled 90 evaluable patients
who received at least one prior line of therapy: chemotherapy, immunotherapy or
the combination. Topline results from the total evaluable population:
· A clinically meaningful survival benefit and evidence of disease control was
demonstrated with bemcentinib in combination with pembrolizumab regardless of
prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI:
10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6,
9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall
response rate (ORR) of 11.1% (95% CI: 6.2, 18.1).
· A significant (p-value < 0.05) and clinically meaningful improvement in mOS
based on AXL tumor proportion score (TPS) was observed. Patients with AXL TPS >
5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6)
compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI:
6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months
(95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with
AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%.
· The observed mOS was similar regardless of patient PD-L1 status.
· Treatment with bemcentinib in combination with pembrolizumab was well
-tolerated.
2L+ NSCLC Trial (BGBIL005)
In addition to the encouraging ORR and DCR data previously presented from the
Investigator Led Study phase 1 trial in which bemcentinib was combined with
docetaxel, the final mPFS of 3.1 months and mOS of 12.3 months support the
clinical benefit of combining bemcentinib with chemotherapy.
1L STK11m NSCLC (BGBC016)
BerGenBio announced in October 2022 the initiation of a global, open label phase
1b/2a trial evaluating bemcentinib in combination with the current standard of
care, pembrolizumab and platinum doublet chemotherapy, for the treatment of 1L
NSCLC patients harboring STK11 mutations. The trial is designed to determine the
safety, tolerability, and efficacy of bemcentinib with standard of care in 1L
advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no
other actionable co-mutations.
A significant subgroup comprising approximately 20% (> 30,000 patients in US and
EU5) of non-squamous NSCLC patients harbor STK11 mutations, which are associated
with immunosuppression and poor prognosis with standard treatment in 1L NSCLC.
Data suggests that STK11m NSCLC patients almost universally have AXL tumor
expression and activation, resulting in the development of drug resistance,
immune evasion, and metastases.
Topline data from the 2L+ NSCLC (BGBC008) trial show clinically meaningful mOS,
mPFS and DCR with the combination of bemcentinib and pembrolizumab, regardless
of prior therapy. In patients with an AXL TPS > 5, a clinically significant
improvement in mOS was observed providing supporting evidence for the relevance
of AXL inhibition in the treatment of NSCLC. Further, data from the 2L+ NSCLC
(BGBIL005) trial indicated promising clinical benefits from administering
bemcentinib with chemotherapy.
The results of the BCBG008 and BCBIL005 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 and
provide strong support for the ongoing 1L NSCLC trial in patients harboring
STK11 mutations, that are characterized by a severely immunosuppressed, pro
-tumorigenic microenvironment and AXL activation.
Screening of patients for the 1L STK11m NSCLC (BCBG016) trial is ongoing.
Oncology: Relapsed/Refractory AML
As previously announced, the Company expects to report topline results from the
phase 2 BGBC003 trial in Relapsed/Refractory AML in H1 2023.
Severe Respiratory Infections (SRIs)
The Company believes that bemcentinibblocks viral entry and replication,
stimulates the innate immune system, and promotes lung tissue repair positioning
it for the treatment of severe respiratory infections including COVID-19.
Previously the Company has completed two phase 2 trials with bemcentinib in
hospitalized COVID-19 patients, showing promising clinical activity and is
currently enrolling patients into theEUSolidActphase 2b platform trial in
hospitalized COVID-19 patients.
The trial is sponsored,and majority funded by the EUSolidAct platform, a pan
-European research project designed to investigate treatment options for
hospitalized patients with COVID-19 and emerging infectious diseases. Thesponsor
and theCompany are currently monitoring the evolution of thepandemic and its
impact on the trial execution.Further guidance on the trial is expected in
H12023.
Additionally, bemcentinib is being evaluated in preclinical studies for SRIs
causingAcute Respiratory Distress Syndrome (ARDS) and initial results are
expected during 2023.
Corporate Activities
Shareholder Loan Facility
BerGenBio announced in October that it secured a shareholder loan facility of up
to NOK 100 million from Meteva AS, a 27.23% shareholder in BerGenBio. The
Company can draw on the facility from Q2 2023. 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.
Oncology Scientific Advisory Board
Subsequent to the quarter end, BerGenBio announced in February the formation of
a scientific advisory board to enhance the development of bemcentinib for the
treatment of NSCLC patients with STK11m, consisting of four world-renowned non
-small cell lung cancer experts from top oncology centers around the globe:
Enriqueta Felip, M.D., Ph.D., Head of the Thoracic Cancer Unit at Vall d'Hebron
University Hospital, Spain; John Heymach, M.D., Ph.D., Chair of Thoracic/Head
and Neck Medical Oncology at the MD Anderson Cancer Center, Texas; Tony Mok,
M.D., BMSc., Professor and Chairman of the Department of Clinical Oncology at
the Chinese University of Hong Kong; and Solange Peters, M.D., Ph.D., Professor
and Head of Medical Oncology and Thoracic Malignancies at the Department of
Oncology at Lausanne University, Switzerland.
Fourth Quarter 2022 and Full Year Financial Highlights
(Figures in brackets = same period 2021 unless otherwise stated)
- Revenue amounted to NOK 0.4 million (NOK 0.8 million) for the fourth
quarter and NOK 0.4 million (NOK 0.8 million) for the full year 2022
- Total operating expenses for the fourth quarter were NOK 76.8 million
(NOK 68.1 million) and total operating expenses for the full year 2022 amounted
to 306.0 million (NOK 315.2 million)
- The operating loss for the quarter came to NOK 76.4 million (NOK 67.3
million) and NOK 305.6 million (NOK 314.5 million) for the full year 2022
- Cash and cash equivalents amounted to NOK 150.8 million at the end of
December 2022 (NOK 436.6 million by end of December 2021). The cash position in
addition to the shareholder loan facility secured from Meteva AS of up to NOK
100 million is estimated to fund planned activities through 2023 on a going
concern basis.
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/20230216_14/ (https:/
/eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fchannel.royalcast.com%
2Flandingpage%2Fhegnarmedia%2F20230216_14%2F&data=05%7C01%7Crune.skeie%40bergenbi
o.com%7Cb823a5a1341740f421a708db02b68023%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7
C0%7C638106755093046661%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luM
zIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=5chsFpg9akBDMyUY7AI7ugQ8X
Ntq4PCq9giLgrjKS9w%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 fourth quarter and full year report and presentation are available on the
Company's website in the Investors/Financial Reports section.
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
Investor Relations / International Media Relations
Graham Morrell
Media Relations Norway
Jan Lilleby
+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. The Company is focused on advancing its lead candidate,
bemcentinib, a potentially first-in-class, oral, selective AXL inhibitor in
STK11 mutated NSCLC and severe respiratory infections including 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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