0RU5 Bergenbio Asa

BERGEN, Norway, Feb. 16, 2023 /PRNewswire/ -- 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 bemcentinib blocks 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 the EUSolidAct phase 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. The sponsor and the Company are currently monitoring the evolution of the pandemic and its impact on the trial execution. Further guidance on the trial is expected in H1 2023.

Additionally, bemcentinib is being evaluated in preclinical studies for SRIs causing Acute 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/ 

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.

Contacts  
Martin Olin CEO, BerGenBio ASA 
ir@bergenbio.com  

Rune Skeie, CFO, BerGenBio ASA 
rune.skeie@bergenbio.com 

Investor Relations / International Media Relations  

Graham Morrell 
graham.morrell@bergenbio.com 

Media Relations Norway

Jan Lilleby
jl@lillebyfrisch.no 
+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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