BerGenBio

Regulatory Filings • Sep 27, 2022

BERGENBIO ANNOUCES FIRST PATIENT RANDOMIZED IN BEMCENTINIB TRIAL IN EU-SOLIDACT PLATFORM FOR HOSPITALIZED COVID-19 PATIENTS

BERGENBIO ANNOUCES FIRST PATIENT RANDOMIZED IN BEMCENTINIB TRIAL IN EU-SOLIDACT PLATFORM FOR HOSPITALIZED COVID-19 PATIENTS

BERGEN, Norway, September 27, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical

-stage biopharma-ceutical company developing novel, selective AXL kinase

inhibitors for severe unmet medical needs, and Oslo University Hospital

announced today that the first patient has been included in a study of

BerGenBio's oral, highly selective AXL inhibitor, bemcentinib, as part of the EU

-SolidAct trial in hospitalized COVID-19 patients.

The EU-SolidAct trial (European DisCoVeRy for Solidarity: An Adaptive Pandemic

and Emerging Infection Platform Trial) is part of EU-RESPONSE, a pan-European

research project designed to investigate treatment options for hospitalized

patients with COVID-19 and emerging infectious diseases.

Bemcentinib was selected by an international group of experts to be studied in

the EU-SolidAct platform in up to 500 hospitalized COVID-19 patients in a Phase

2b, multi-center, randomized, placebo-controlled trial.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "COVID-19

infections and hospital admissions continues to evolve with new variants and the

expected fall/winter season impact. There is a need to identify new effective

therapies for hospitalized patients and bemcentinib represents a promising

treatment modality for this patient population through its unique mechanism of

action, blocking viral entry, stimulating the innate immune system and promoting

lung tissue repair. Importantly, bemcentinib enhances the Type I interferon

response, causing these cytokines to activate immune cells to fight the

infection regardless of spike protein or mutation. Based on the results of our

Phase 2a studies and learnings throughout the pandemic, we are eager to further

study the effectiveness of bemcentinib in COVID-19 and are delighted to now have

randomized the first patient in the EU-SolidAct platform."

The EU-SolidAct platform trial 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).

Professor Marius Trøseid, Oslo University Hospital, Chief Investigator of the EU

-SolidAct trial, commented: "As new subvariants continue to evolve, it is

critical to have greater treatment options in order to reduce hospital stays and

halt disease progression. We're pleased to be partnering with BerGenBio in the

initiation of this trial, as we look to enroll up to 500 hospitalized COVID-19

patients."

Contacts

For the EU-SolidAct:

Marius Trøseid, Chief Investigator of the EU-SolidAct trial, Senior Consultant

and Professor, Oslo University Hospital

+4792440240,marius.troseid@medisin.uio.no

For BerGenBio:

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

+1 781 686 9600

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.

About Oslo University Hospital

Oslo University Hospital is a highly specialized hospital in charge of extensive

national, regional and local hospital assignments. As Scandinavia's largest

hospital, we carry out more than 1.2 million patient treatments each year. Oslo

University Hospital is responsible for approximately 50 percent of all medical

and health care research conducted at Norwegian hospitals. We have a leading

role in the development of research and innovation, as well as the development

of tomorrow's healthcare, precision medicine and treatment.

About Inserm

Founded in 1964, Inserm is a public science and technology institute. It is

dedicated to biomedical research and human health and is involved every step of

the way from the research laboratory to patient care. It is one of the most

prestigious institutions in the world that is committed to scientific challenges

and progress in these fields. Inserm brings together more than 15,000

researchers, engineers, technicians and administrative staff to improve the

health of all.www.inserm.fr/en/

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. Suchrisks, 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.