BERGEN, Norway, November 14, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced financial results for the quarter
ended September 30, 2023, and provided a business update.
"We are pleased to report continued advancement of our focused strategy to study
our lead compound bemcentinib, a highly selective AXL inhibitor, in first line
(1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring mutations in the
STK11 gene (STK11m). The increasing recognition of STK11m as a poor prognostic
factor for 1L NSCLC patients, as evidenced by real-world data presented at
prestigious medical conferences, continues to substantiate high unmet medical
needs and our clinical data continues to validate the potential role of
bemcentinib in combination with standard of care therapies to improve the
outcome for these patients. During the quarter, we activated additional clinical
trial sites in the US and prepared for the addition of sites in Europe in
anticipation of the expected initiation of the Ph2a portion of our study in 1L
NSCLC STK11m patients in the first half of 2024. Our operating expenses in the
quarter amounted to NOK 28.1 million compared to NOK 62.4 million in Q3 2022
reflecting the effects of our focused strategy and cost containment implemented
in connection with the Rights Issue. At 30th September 2023 our cash position
stood at NOK 169.3 million. We believe that our singular focus on advancing
bemcentinib in 1L NSCLC STK11m combined with the potential funding from the
exercise of outstanding warrants issued in the Rights Issue enable us to
generate data that can position the significant potential of bemcentinib in
NSCLC," said Martin Olin, Chief Executive Officer of BerGenBio.
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 several 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 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
1L STK11m NSCLC (BGBC016)
We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11m and no actionable mutations. Sites in the US have been activated and
enrollment is ongoing while expansion into European sites is well underway, with
regulatory approval to proceed received from regulatory authorities in the US
and several European countries.
The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. To date, no significant safety concerns have arisen
in the Phase 1b study. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11m.
A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11m, which are associated with
immunosuppression and poor prognosis with standard 1L NSCLC treatment. Data
suggests that STK11m NSCLC patients almost universally express AXL in tumors
and/or on immune cells, resulting in the development of drug resistance, immune
evasion, and metastases.
Post-quarter, the Company announced that the final data from the BGBC008 study
(2L+ NSCLC, bemcentinib in combination with pembrolizumab) presented on October
23rd at the European Society for Medical Oncology (ESMO) 2023 Annual Meeting
held in Madrid. The Company believes that these data along with study BGBIL005
(2L+ NSCLC, bemcentinib in combination with docetaxel) 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. We
believe that the reversal of the effects of AXL with bemcentinib holds the
promise of providing substantial survival benefits to NSCLC patients and
specifically in patients harboring STK11m and potentially other hard-to treat
mutations such as KRAS and KEAP1. We expect to report additional clinical data
at upcoming major medical meetings during the remainder of 2023, including the
Society for Immunotherapy of Cancer (SITC) Annual Meeting and the American
Society of Hematology (ASH) Annual Meeting.
Description of the 2L+ NSCLC Trial (BGBC008)
The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC patients who had received
at least one prior line of therapy:chemotherapy, immunotherapy or the
combination.
· An analysis of AXL biomarker status indicates that the presence of AXL
expression on either tumor cells and/or immune cells is predictive of improved
survival in patients treated with bemcentinib + pembrolizumab. The vast majority
(88%) of patients met the criteria for AXL presence (AXL positive patients) and
obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients.
· Analysis of available data for patients treated in subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab identified a higher
than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1%) benefit from the combination treatment of bemcentinib and
pembrolizumab. Currently PD-L1 negative patients respond less well to immune
checkpoint inhibition, potentially providing an opportunity to expand the
patient population eligible for treatment with bemcentinib.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L NSCLC patients.
Severe Respiratory Infections (SRIs)
The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it for the treatment of severerespiratory infections.
On April 25, 2023, the Company decided to pause the bemcentinib arm of the
Phase2b EUSolidAct trial evaluatingbemcentinibin hospitalized COVID-19 patients
due to the limited number of hospitalizations observed across all European
countries. The Company and the EU-SolidAct have agreed to maintain this study
on pause until and unless such time both parties agree to resume the trial arm
due to increased COVID hospitalizations or should a new pandemic arise.
Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.
Corporate Activities
Rights Offering
On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.
Warrants
The outstanding warrants issued in the Rights Issue can be exercised in two
defined windows; from 15 November 2023 09:00 am CET to 28 November 2023 4:30 pm
CET, or 1 April 2024 to 14 April 2024 at an exercise price of the volume
-weighted average price (VWAP) of the Company's shares on the Oslo Stock
Exchange over the three last trading days prior to the exercise period less 30%,
but in any event not less than NOK 0.10 and not higher than NOK 0.13. Additional
information and instructions for exercise of warrants can be found on the
Company's website (https://www.bergenbio.com/investors/investor
-relations/warrants).
Our Chief Operating Officer James Barnes, decided to pursue new opportunities
and will leave the company during December 2023. In connection with the
implementation of the focused strategy, the role of Chief Operating Officer will
not be replaced.
Third Quarter 2023 Financial Highlights
(Figures in brackets = same period 2022 unless otherwise stated)
- Revenue was NOK 0 million (NOK 0 million) for the third quarter.
- Total operating expenses for the third quarter were NOK 28.1 million
(NOK 62.4 million)
- The operating loss for the quarter came to NOK 28.1 million (NOK 62.4
million)
- Cash and cash equivalents amounted to NOK 169.3 million by the end of
September 2023 (NOK 226.0 million by end of June 2023).
Presentation and Webcast Details
The Q3 2023 presentation and Financial Report are available at the Company's
website (https://www.bergenbio.com/investors/financial-reports).
BerGenBio's senior management team will provide a business update today at 10:00
am CET. The presentation will webcast live. To participate in the webcast please
use the following link:
https://channel.royalcast.com/landingpage/hegnarmedia/20231114_1/ (https://eur03.
safelinks.protection.outlook.com/?url=https%3A%2F%2Fchannel.royalcast.com%2Flandi
ngpage%2Fhegnarmedia%2F20231114_1%2F&data=05%7C01%7Crune.skeie%40bergenbio.com%7C
1fd0ccaebb9f4d3fb3b808dbce1d0f3b%7C2b50b422ca6d42af9fc0741b248bb071%7C0%7C0%7C638
330396444059263%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBT
iI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=YjunypihEEXae6fFWZiIFPkoFSz0mFwmy
vfTMnxhS0A%3D&reserved=0)
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.
-End-
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 development for STK11 mutated NSCLC
and 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, visitwww.bergenbio.com
About Bemcentinib
Bemcentinib is a potentially first-in-class, potent and highly selective
inhibitor of the tyrosine kinase AXL. Extensive studies confirm the ability to
combine bemcentinib with immune checkpoint inhibitors, chemotherapies and
targeted therapies with the goal of improving a patient's immune response and
delaying the development of chemoresistance. Bemcentinib is currently being
investigated in combination with immune checkpoint inhibition and chemotherapy
in first line NSCLC patients harboring mutations in the STK11 gene, a known
prognostic factor of poor response to existing therapies.
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.