14 February 2024

BerGenBio ASA: BerGenBio’s Fourth Quarter 2023 Results: Focused Strategy Gathers Momentum

Bergen (Norway), February 14, 2024 – BerGenBio ASA (OSE: BGBIO), a clinical-stage bio-pharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced financial results for the quarter ended December 31, 2023, and provided a business update. 

Highlights, including post period

  • Phase 1b part of BGBC016 (1L NSCLC STK11m) progressed as planned with no new safety signals identified.
  • Regulatory approvals received from European countries for Phase 2a part of BGBC016 (1L NSCLC STK11m) allowing initiation in H1 2024 in accordance with guidance.
  • Significant reduction of operating expenses – NOK 43.9 million for the fourth quarter 2023, down from NOK 76.8 million from same period in 2022, a reduction of 43%, reflecting a laser focused strategy on NSCLC.
  • Year-end cash position of NOK 156.4 million and a net cash flow in Q4 2023 of NOK -11.8 million including gross proceeds of NOK 8.9 million from exercise of warrants in Q4.
  • Multiple Phase 2 bemcentinib data presented at prestigious oncology meetings, including ESMO, SITC and ASH.
  • New preclinical data in models of severe respiratory infections continues to support the potential of bemcentinib beyond NSCLC.

Martin Olin, Chief Executive Officer of BerGenBio:

“As previously guided, we expect to initiate the Phase 2a part of the BGBC016 trial in 1L NSCLC STK11m patients during the first half of 2024. Bemcentinib represents a novel therapeutic option for NSCLC patients harboring mutations in the STK11 gene and we are gratified to see the medical community’s interest and support in exploring bemcentinib. The BGBC016 clinical trial is our highest priority and continues to progress as expected.”

“Our cost discipline coupled with our recently executed warrant offering provides the company with funding through the end of 2024 and potentially into the second half of 2025 if all outstanding warrants are exercised in April 2024.”

Presentation and Financial Report

The Q4 2023  Financial Report is attached to this stock exchange announcement and the Report and the Q4 2023 presentation are available at the Company’s website (https://www.bergenbio.com/investors/financial-reports). 

Webcast details

BerGenBio’s senior management team will provide a business update today at 10:00 am CET. The presentation will webcast live. To participate in the webcast please use the following registration link:

BerGenBio Q4 webcast (office.com) (https://forms.office.com/pages/responsepage.aspx?id=-QEn0CM7P0uPzintVGMr-Gxc6nJw_YlNh1teJiuU8DNUMFpXWFFUWVdLTkFZMkRNV1JJRTRWVVBXVy4u)

A recording of the webcast will be available at www.bergenbio.com in the Investors/Financial Reports section (https://www.bergenbio.com/investors/financial-reports) shortly afterwards.

Exercise of Warrants

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

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 clinical development for STK11 mutated NSCLC and preclinical development for 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

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 considered to be inside information pursuant to the EU Market Abuse Regulation and 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

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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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