16 November 2021
BerGenBio ASA: BERGENBIO ASA: RESULTS FOR THE THIRD QUARTER OF 2021
Bergen, Norway, 16 November 2021 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, announces its results for the third quarter of 2021.
A presentation and live webcast by BerGenBio’s senior management will take place at 10am CET today, please see below for details.
Operational Highlights – third quarter of 2021 (including post-period end)
- Martin Olin appointed Chief Executive Officer, bringing 20 years of executive experience in the pharmaceutical and biotechnology industry. Previous roles include CEO of Symphogen
- Post-period end, NSCLC data presented at SITC, highlighting bemcentinib’s potential in NSCLC patients harbouring STK11 mutations
- AML data presented at EHA indicate bemcentinib/LDAC combination is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy
- COVID-19 data in a late-breaking abstract presentation at ECCMID demonstrate encouraging evidence for the effect of bemcentinib in hospitalised patients receiving steroids ± remdesivir
Financial Highlights – third quarter of 2021
- Revenue amounted to NOK 0.0 million (Q3 2020: NOK 0.0 million)
- Total operating expenses were NOK 71.4 million (Q3 2020: NOK 68.3 million)
- Q3 operating loss of NOK 70.5 million, decreased compared to previous quarters, (Q3 2020: NOK 67.3 million)
- A strong cash position of NOK 509.4 million at end of Q3 2021
Martin Olin, Chief Executive Officer of BerGenBio, commented: “It is my great pleasure to provide an update on BerGenBio’s progress over the last quarter, my first since joining the Company as CEO in September 2021. Having completed a strategic review of operations following my appointment, we have reiterated our focus on pursuing a rigorous data driven approach of connecting a consistent scientific rationale, pre-clinical and clinical data to high unmet medical needs will enable us to define the best possible path to registration as well as unlocking significant market potential.
“Our focus will be the clinical development of bemcentinib as a second line treatment in relapsed AML, building on the promising data accumulated so far with the planned initiation of a confirmatory randomized placebo-controlled trial in H2 2022. The clinical development of the NSCLC program continues, and a Phase 1b trial investigating bemcentinib in patients with STK11 mutations in 1L NSCLC is also scheduled to be initiated in H1 2022.
“We will also look to validate our COVID-19 clinical data through a confirmatory randomized placebo-controlled trial supported by a major, multinational collaboration that provides access to a large number of sites across Europe and established infrastructure at significantly reduced cost to BerGenBio. We anticipate this study to commence in H1 2022.
“The Company is well-funded with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders. I look forward to providing further updates on our progress in due course.”
Presentation and Webcast Details
An in-person briefing will take place at 10:00 am CET at: Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo whereBerGenBio’ssenior management team will provide an update on the Company followed by a Q&A session.
The presentation will also be webcast live, details below.
Webcast link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20211116_4
NO: +47-21-956342
UK: +44-203-7696819
US: +1 646-787-0157
PIN: 712491
The Q3 2021 report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.
-Ends-
Contacts
Martin Olin
Chief Executive Officer, BerGenBio ASA
ir@bergenbio.com
Rune Skeie
Chief FinancialOfficer, BerGenBio ASA
rune.skeie@bergenbio.com
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700
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 immune-evasive, therapy resistant cancers. The company’s proprietary lead candidate, bemcentinib, is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme focused on combination and single agent therapy in cancer and COVID-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to potentially identify patient populations most likely to benefit from AXL inhibition. This is expected to facilitate more efficient registration trials supporting a precision medicine-based commercialisation strategy.
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. Suchrisks, 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 is 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).
