29 May 2024
BerGenBio ASA: BerGenBio First Quarter Results 2024: Advancing to the Next Stage of Development
Bergen, Norway, May 29, 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 March 31, 2024, and provided a business update.
Highlights, including post period:
- Data Safety Monitoring Board review supported dose escalation in Ph 1b and initiation of Ph2a
- Site activation of Ph2a in US and Europe proceeding well
- Bemcentinib remains the leading selective AXL inhibitor in the clinic and was selected for inclusion in National Cancer Institute funded study in advanced NSCLC, led by the Mays Cancer Center at the University of Texas Health Science Center at San Antonio
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Financial position of NOK 117.3 million at 31 March – strengthened further with gross funding of NOK 138.9 million from warrants exercise in April 2024
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Continued reduction of operating expenses from NOK 72.4 million in Q1 2023 to NOK 39.9 million in Q1 2024
- Net cash flow of NOK -42.5 million
Martin Olin, Chief Executive Officer of BerGenBio stated:
“1L NSCLC STK11m patients are not currently eligible for targeted therapy and face a very poor prognosis. The total market for this patient group is estimated to be between 4 and 5 billion USD. The initiation of Phase 2a of the study of our lead compound bemcentinib in these patients represents an important milestone for the company. Our clinical progress in the quarter combined with the successful capital raise from the warrants exercise positions BerGenBio to advance a new much needed therapeutic option for these patients with high unmet medical need.”
Presentation and Financial Report
The Q1 2024 Financial report is attached to this stock exchange announcement and the report and the Q1 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).
