0RU5 Bergenbio Asa

- Randomized first patient in the Phase 2b EU-SolidAct platform for hospitalized COVID-19 patients -
- Initiated Phase 1b/2a trial in 1^st line NSCLC patients harboring STK11 mutations -
- Strengthened financial position with support from largest shareholder -

BERGEN, Norway, Nov. 15, 2022 /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 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 1^st 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 1^st 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/

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. 

Contacts 

Martin Olin CEO, BerGenBio ASA 
ir@bergenbio.com 

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

Investor Relations / Media Relations 

Graham Morrell 
graham.morrell@bergenbio.com 

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. 

The following files are available for download:

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