BerGenBio

Regulatory Filings • Apr 25, 2022

BERGENBIO PRESENTS BEMCENTINIB COVID-19 CLINICAL TRIAL DATA AT ECCMID 2022

Bergen, Norway, 25 April 2022 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, announces that it is presenting data today from its Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) in a poster presentation at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), being held both online and in-person in Lisbon, Portugal, from April 23-26, 2022.

The poster presentation will share findings from the Company's Phase IIa open label study of 115 patients evaluating bemcentinib in combination with Standard of Care (SoC) compared to a SoC control arm in the treatment of moderate to severe COVID-19 patients, immediately after hospital admission (BGBC020).

Clinical data from the study show that bemcentinib treatment (up to 14 days) confers early and sustained protection, limiting clinical deterioration in patients. Bemcentinib treated patients were discharged earlier from the hospital, required less supplementary oxygen and demonstrated a significant reduction in the need for intubation or ventilation.

Biomarker analysis demonstrates that treatment with bemcentinib reduced markers of acute inflammation and profibrotic cytokines, and increased expression of protective factors. These changes were more pronounced in patients with more serious disease, determined by high C-Reactive Protein (CRP) rates, high neutrophil to lymphocyte ratio (N/L) ratio or increased oxygen usage.

Preclinical data is also being presented from in vitro studies in lung epithelial cells on bemcentinib's activity on variants of concern. These data suggest that bemcentinib inhibits infection of multiple SARS-CoV-2 variants, including Omicron, building on previous preclinical research from the Company.

Martin Olin, CEO of BerGenBio, commented: "The data we are presenting at ECCMID today further demonstrates the effectiveness of bemcentinib as a treatment for severe respiratory infections such as COVID-19. We have been pleased to see bemcentinib's impact on reducing disease deterioration in patients. In addition, we're encouraged to see that bemcentinib exerts a broad anti-inflammatory and pro-repair effect on blood biomarkers. We look forward to the initiation of the EUSolidAct platform trial which will further assess bemcentinib in hospitalised COVID-19 patients."

Details of today's poster presentation are as follows:

Abstract: 04778: Bemcentinib modulation of inflammatory, fibrotic and tissue repair pathways correspond with favourable clinical outcomes in hospitalised COVID-19 patients demonstrating higher severity cues: a biomarker perspective

Session Name: 12c. Clinical features, case management, outcome (incl long-term): programme no. L0383

Time, Location: Monday, 25th April 2022, 12:00pm - 13:00pm (WEST)

Contacts:

Martin Olin CEO, BerGenBio ASA ir@bergenbio.com

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

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone Consilium Strategic Communications bergenbio@consilium-comms.com +44 20 3709 5700

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 immune-evasive, therapy resistant cancers. The company's proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme focused on combination and single agent therapy in cancer and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing phase I clinical testing.

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 subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.