22 August 2023

BerGenBio ASA: BerGenBio announces clinical data presentations highlighting the activity of its selective AXL inhibitor bemcentinib in Non-Small Cell Lung Cancer

BERGEN, Norway, August 22, 2023- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announcedtoday that additional clinical data of bemcentinib in combination with chemotherapy and with immunotherapy in Non-Small Cell Lung Cancer (NSCLC) have been recently published and accepted for presentation at two upcoming international oncology conferences:

  • Comprehensive results from the investigator led trial of bemcentininb + docetaxel in previously treated NSCLC patients (Study BGBIL005) were published in the August 2023 issue of Lung Cancer. “Phase 1 trial of bemcentinib (BGB324), a first-in-class, selective AXL inhibitor, with docetaxel in patients with previously treated advanced non-small cell lung cancer.” Lung Cancer 182 (2023) The trial was led by David Gerber, MD., Professor at the UT Southwestern Harold C. Simmons Comprehensive Cancer Center.
  • The abstract “Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC harbouring mutations associated with poor prognosis: Exploratory sub-analysis from the BGBC008 trial (NCT03184571)” has been accepted for posterpresentationat the SITC 38th Annual Meeting, to be held November 3-5, 2023,in San Diego, CA (Abstract #598).
  • The abstract “Final top-line results of the BGBC008 phase 2, multicenter study of bemcentinib and pembrolizumab (bem+pembro) in 2nd line (2L) advanced non-squamous (NS) non-small cell lung cancer (NSCLC) (NCT03184571)”has been accepted for poster presentation at the ESMO Congress 2023, to be held October 20-24, 2023, in Madrid, Spain (Abstract #5343)

“The accumulating evidence supporting the potential role of bemcentinib in NSCLC aligns with our strategic focus on this disease where a large portion of patients still have very poor clinical outcome from existing therapies” said Martin Olin, Chief Executive Officer of BerGenBio. “The publication of data in a prestigious peer reviewed publication and at ESMO and SITC provides us with the opportunity to share our data with a broad audience of oncologists and key opinion leaders in the field of NSCLC and the pharmaceutical industry.”

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Contacts

Martin Olin CEO, BerGenBio ASA

ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA

rune.skeie@bergenbio.com

Media Relations

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 severe respiratory infections.

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, visitwww.bergenbio.com

This information is subject to the disclosure requirements pursuant to MAR article 17 and section 5-12 of the Norwegian Securities Trading Act.

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

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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.

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