2 February 2023

BerGenBio ASA: BerGenBio Announces the Establishment of Oncology Scientific Advisory Board

– Distinguished global experts appointed to strengthen bemcentinib development in STK11m NSCLC –

BERGEN, Norway, February 2, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the formation of a scientific advisory board consisting of four world-renowned non-small cell lung cancer (NSCLC) experts from top oncology centers around the globe to enhance the development of bemcentinib for the treatment of NSCLC patients with STK11 mutations (STK11m).

“We are very proud and honored to have assembled a group of leading international NSCLC experts to guide us as we investigate bemcentinib in 1st line NSCLC STK11m in combination with today’s standard of care,” said Cristina Oliva, M.D., Chief Medical Officer of BerGenBio. “Their expertise will play an integral role in our evaluation of bemcentinib and its potential to provide significant benefits to patients who today face a particularly poor prognosis.”

Despite significant advances in immuno-oncology treatments, NSCLC is still one of the leading causes of cancer-related deaths worldwide. Patients harboring STK11m, which represent approximately ~20% of non-squamous NSCLC cases, almost universally demonstrate high levels of AXL activation and show lower response rates to current standard of care therapy of anti-PD-1/L1 combined with chemotherapy. BerGenBio’s lead compound, bemcentinib, is designed to selectively inhibit AXL, which may potentially sensitize STK11m NSCLC patients to checkpoint inhibitors and improve the effects of chemotherapy. The Company has initiated a global Phase 1a/2b trial to assess bemcentinib with standard of care in 1st line NSCLC patients with STK11m.

Members of the BerGenBio NSCLC Scientific Advisory Board:

Enriqueta Felip, M.D., Ph.D.

Dr. Enriqueta Felip is the Head of the Thoracic Cancer Unit at Vall d’Hebron University Hospital, Spain, where she is responsible for thoracic malignancy management and all lung cancer trials. She is President of the Spanish Society of Medical Oncology (SEOM) 2021-23, a member of the Spanish Lung Cancer Group (SLCG) and a Professor of Medicine at the Universitat de Vic. Previously, Dr. Felip was on the Board of Directors of the International Association for the Study of Lung Cancer (IASLC). She received her M.D. and Ph.D. from Autonomous University of Barcelona.

John Heymach, M.D., Ph.D.

Dr. John Heymach is the Chair of Thoracic/Head and Neck Medical Oncology at the MD Anderson Cancer Center, Texas, and holds the David Bruton Endowed Chair in Cancer Research. Dr. Heymach is a co-leader of the MD Anderson Lung Cancer Moon Shot, in addition to serving as a Principal Investigator of lung cancer programs funded by the National Cancer Institute (NCI), LUNGevity and American Association for Cancer Research (AACR), and earning several prestigious awards for excellence in basic science, translational research and mentoring. He received his M.D. and Ph.D. from Stanford University.

Tony Mok, M.D., BMSc

Dr. Tony Mok is a Professor and Chairman of the Department of Clinical Oncology at the Chinese University of Hong Kong. Dr. Mok’s research was instrumental in establishing the use of precision medicine in advanced lung cancer. He co-founded the Lung Cancer Research Group and served as the associate editor for thoracic oncology for the Journal of Clinical Oncology. Dr. Mok is a Fellow of the American Society of Clinical Oncology (ASCO), former President of IASLC and received the ESMO Lifetime Achievement Award. He received his M.D. and BMSc from the University of Alberta, Canada.

Solange Peters, M.D., Ph.D.

Dr. Solange Peters is a Professor and Head of Medical Oncology and Thoracic Malignancies at the Department of Oncology at Lausanne University, Switzerland, where she is also building a translational program in collaboration with molecular oncology laboratories. Dr. Peters was recently the President of the European Society for Medical Oncology (ESMO) 2020-22, and was formerly an IASLC Board member and co-chair of the Swiss Lung Cancer Research Group. She is Associate Editor of the Annals of Oncology and Deputy Editor of Lung Cancer. She received her M.D. and Ph.D. from the University of Lausanne.

-End-

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

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

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About Oncoinvent

Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.

This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.

Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).

Øystein Soug

Chief Executive Officer

soug@oncoinvent.com

Oystein Soug has over 15 years of experience in biotechnology, holding several management positions. Most recently, Mr. Soug was CEO of Arxx Therapeutics, where he led the company to initiate the clinical programme and was responsible for the merger with Dutch pharma company Oxitope Pharma to create Calluna Pharma. Prior to Arxx, he served as CFO and then CEO of Targovax, an Oslo listed biotechnology company, which went public during Mr. Soug’s tenure. Mr. Soug started his career in biotech as CFO of Oslo-listed radiopharmaceutical company Algeta. During this period, the company conducted a successful phase 3 trial, launched its radium-223 based prostate cancer drug Xofigo® and out-licensed the drug. Mr. Soug co-led the sale of the company to Bayer in 2014.

Mr. Soug holds an MSc in Economics and
Financial Markets from Universität St. Gallen in Switzerland in 1997

Anders Månsson

Chief Executive Officer

mansson@oncoinvent.com

Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.