BerGenBio Reports Third Quarter 2022 Financial Results and Business Update

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– First randomized patient of the phase 2b EU-SolidAct platform for hospitalized COVID-19 patients –
– Initiated phase 1b/2one test in 1st line NSCLC patients harboring STK11 mutations –
– Strengthened financial position with the support of the main shareholder –

BERGEN, Norway, November 15, 2022 /PRNewswire/ — BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for serious unmet medical needs, today announced financial results for the third quarter ended September 30, 2022 and provided a company update.

“The recent launch of two clinical trials and the strengthening of our cash position have been transformational for the company as we continue to execute on our strategy,” said Martin Olin, CEO of BerGenBio. “Growing evidence proves that AXL plays a significant role in the exacerbation of many cancers and serious respiratory diseases. We believe that the inhibition of AXL by our lead compound, bemcentinib, can be life-changing for patients suffering from NSCLC STK11m and hospitalized with COVID-19.

Clinical development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, highly selective inhibitor of the AXL receptor tyrosine kinase, which is activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in number of deleterious effects in cancer and serious respiratory diseases. Bemcentinib inhibits AXL activation to prevent progression of severe disease through modulation of resistance mechanisms and the adaptive immune system.

The Company is advancing the development of bemcentinib in two pulmonary indications, STK11 mutated non-small cell lung cancer (NSCLC) (STK11m) and hospitalized COVID-19 patients, where novel mechanisms of action of bemcentinib and its primary accumulation in the lungs place it in a unique position to treat serious lung diseases.

Frontline NSCLC STK11m

After the end of the quarter, BerGenBio announced in October the launch of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard treatment, the checkpoint inhibitor pembrolizumab, and platinum doublet chemotherapy, for the treatment of patients with 1L NSCLC with STK11 mutations.

Approximately 20% of patients with non-squamous NSCLC carry STK11m, which is a recognized resistance mechanism for anti-PD-1/L1 therapy and currently results in a poor prognosis with standard 1-in-1 therapy.st NSCLC line. The Company believes that STK11m patients almost universally express AXL, causing a severely immunocompromised 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 patients with NSCLC STK11m to checkpoint inhibitors and enhances the effects of chemotherapy.

The global open phase 1b/2a is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in 1st line untreated advanced/metastatic NSCLC patients with STK11 mutations and no other actionable co-mutations. The first patient is expected to start treatment in the fourth quarter of 2022.

COVID-19 hospitalized patients

BerGenBio announced in September that the first patient had been randomized into 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 increased disease severity. The interaction of AXL and SARS-CoV-2 is thought to promote entry and enhancement of infection in lung and bronchial epithelial cells. Through inhibition of AXL, bemcentinib blocks viral entry, stimulates the innate immune system and promotes lung tissue repair.

The sentence 2bmulticenter, randomized, placebo-controlled trial will enroll up to 500 patients, includes 68 clinical sites in 8 countries, and is sponsored by University of Oslo Hospital, Norwayin collaboration with the National Institute of Health and Medical Research (Inserm), Franceand the intergovernmental non-profit organization European Clinical Research Infrastructure Network (ECRIN).

Update on Relapsed/Relapsed AML (BGBC003) and 2L NSCLC (BGBC008) Studies

In the BGBC003 study of patients with relapsed/recurrent AML, the last patient completed their last visit at the end of the second quarter, with the database lock being completed in the third quarter. In study BGBC008 in patients with NSCLC 2L, the last patient visit was in the fourth quarter of 2022. The company expects to provide the results of these studies after the database lock and analysis later data in the first half of 2023.

Corporate activities

After the end of the third quarter, BerGenBio announced in October that it had obtained a NOK 100 million shareholder loan from Meteva AS, 27.23% shareholder of BerGenBio. In addition to the company’s existing cash position, the facility will allow BerGenBio to continue to advance its lead compound, bemcentinib, in STK11m 1L NSCLC and hospitalized COVID-19 patients.

Third Quarter 2022 Financial Highlights

(Figures in parentheses = same period 2021 unless otherwise indicated)

  • Revenues amounted to NOK 0.0 million (NOK 0.0 million) for the third quarter of 2022

  • Total operating expenses for the third quarter were NOK 62.4 million (NOK 71.4 million)

  • The third quarter operating loss was 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 of 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 ends.

Webcast link: https://channel.royalcast.com/landingpage/hegnarmedia/20221115_2/

Call numbers:

NO: +47-21-956342
UK: +44-203-7696819
USA: +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 available shortly after the webcast ends.

contacts

Martin Olin CEO, BerGenBio ASA
[email protected]

Skei RuneCFO, BerGenBio ASA
[email protected]

Investor Relations / Media Relations

Graham Morel
[email protected]

About BerGenBio ASA

BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone in the treatment of aggressive diseases, including cancer and serious respiratory infections. The Company is focused on its lead proprietary 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, United Kingdom. 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 on various assumptions, many of which are based, in turn, on other assumptions. These assumptions are inherently subject to important known and unknown risks, uncertainties and other important factors. These 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 inside information under the EU Market Abuse Regulation and is subject to disclosure requirements under Section 5-12 of the Norwegian Securities Act.

The following files are available for download:

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