13 November 2024
BerGenBio ASA: BerGenBio Third Quarter Results 2024
Bergen, Norway, November 13, 2024 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharma-ceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced financial results for the quarter and half year ended September 30, 2024, and provided a business update.
Highlights, including post period:
BGBC016 1L NSCLC STK11m Study
- Ph1b enrollment completed; acceptable safety and pharmacokinetics announced in September 2024
- The Ph2a portion of the study continues to accrue patients both in the US and in Europe
1L STK11m NSCLC: a Widely Recognized Risk Factor
- New published data from MD Anderson continues to support the need for improved therapies in this patient population which is poorly served today
Tilvestamab
- After extensive out-reach, the Company has decided to discontinue all tilvestamab activities including out-licensing activities
Martin Olin, Chief Executive Officer of BerGenBio stated: “BerGenBio continues to progress its focused strategy to develop its lead AXL inhibitor bemcentinib in first-line NSCLC patients with mutations in the STK11 gene which, we believe, represent a significant commercial opportunity. The on-going BGBC016 study in this population continues to progress and recently announced Ph1b data supports the safety and adequate pharmacokinetics of bemcentinib in combination with current standard of care therapy. The Ph2a portion of the study continues to accrue patients both in the US and in Europe. We expect to share a first Interim Analysis in the first part of 2025.”
Third Quarter 2024 Financial Highlights
- The operating loss for the quarter was NOK 24.8 million (2023: NOK 27.9 million)
- Net cash flow was negative by NOK 27.7 million (2023: NOK 55.4 million)
- Cash and cash equivalents amounted to NOK 174.8 million by the end of September 2024 (NOK 200.1 million by end of June 2024 and NOK 169.3 million by end of September 2023).
Presentation and Financial Report
The Q3 2024 Financial report is attached to this stock exchange announcement and the report and the Q3 2024 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 link:
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.
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, 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 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.
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).
