17 November 2017
BerGenBio ASA: Results for the Third Quarter 2017
Bergen, Norway, 17 November 2017 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective Axl kinase inhibitors for multiple cancer indications, announces its results for the third quarter 2017. A presentation of the results by the Company’s senior management team will take place today at 9.00 am CET in Oslo – details below.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:
“We are very pleased with the progress the company has made during Q3 2017. Our broad clinical development programme of Phase 2 trials with BGB324, our selective Axl inhibitor, in combination with standard therapies in multiple aggressive cancers is well underway and recruiting patients at leading hospitals in Europe and the US. These trials are on track to deliver important clinical milestones in 2H 2018, demonstrating the significant potential of BGB324 to become a universal approach to cancer therapy by making tumour cells visible to the immune system and more susceptible to treatment with chemotherapy, targeted therapy and immuno-oncology drugs.”
Operational highlights
- Good progress advancing broad clinical development programme with BGB324 in all indications under investigation
- Patient recruitment underway for four company sponsored Phase II trials with key read-outs expected in 2H 2018: two trials in non-small cell lung cancer (NSCLC), one in triple negative breast cancer (TNBC), and in acute myeloid leukaemia (AML) / myelodysplastic syndrome (MDS)
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Two Phase II investigator-sponsored studies evaluating BGB324 in combination with chemotherapy in NSCLC and with targeted or immune-oncology drugs in melanoma continue to recruit well
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Design and rationale for Phase II trial of BGB324 in combination with chemotherapy, targeted therapy and immunotherapy in NSCLC presented at Precision: Lung Cancer Conference, Boston.
- Clinical trial programme demonstrating BGB324’s ability to counteract Axl-driven immune evasion and acquired drug resistance to standard therapies with potential to improve clinical outcomes
Post period events
- First patients enrolled and dosed in Phase II trials of BGB324 in combination with KEYTRUDA® (pembrolizumab) in NSCLC and TNBC (October)
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Patient recruitment progressing well at leading cancer centres in Norway, UK, Spain and the US
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Clinical and scientific presentations at global cancer conferences (October)
- Data from BGB324/docetaxel study showed combination was well-tolerated and one (of three) NSCLC patients had partial remission at ten months and tumour shrinkage – presented at 18th World Conference on Lung Cancer
- Strong recruitment and encouraging safety profile of BGB324 in randomised Phase II trial of BGB324 in combination with targeted or immuno-oncology drugs in melanoma patients presented at 9th World Congress of Melanoma
Key Figures (NOK Q3 2017 Q3 2016 YTD2017 YTD2016 FY 2016
million)
Operating revenues – – – – –
Operating expenses 36.6 16.3 136.2 103.5 131.6
Operating profit (loss) (36.6) (16.3) (136.2) (103.5) (131.6)
Profit (loss) after tax (35.4) (15.4) (134.6) (101.9) (129.8)
Basic and diluted (0.71) (45.64) (3.06) (339.63) (419.68)
earnings (loss) per
share (NOK)
Net cash flow in the (41.1) 82.1 237.3 113.2 87.8
period
Cash position end of 399.2 187.2 399.2 187.2 161.8
period
Presentation and Webcast Details
A presentation by BerGenBio’s senior management team will take place at 9.00 am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: Bjørvika
The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Reports and presentations/Webcasts. A recording will be available shortly after the webcast has finished.
The results report and the presentation will be available at www.bergenbio.com in the section: Investors/Reports and presentations from 7:00 am CET the same day.
-End-
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class Axl kinase inhibitors to treat multiple cancer indications. The Company is a world leader in understanding the essential role of Axl kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive solid and haematological cancers.
BerGenBio’s lead product, BGB324, is a selective, potent and orally bio-available small molecule Axl inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated in the second half of 2018. It is the only selective Axl inhibitor in clinical development.
The Company sponsored clinical trials are:
- BGB324 as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
- BGB324 with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
- BGB324 with KEYTRUDA in advanced adenocarcinoma of the lung, and
- BGB324 with KEYTRUDA in triple negative breast cancer (TNBC).
The clinical trials combining BGB324 with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc., Kenilworth, N.J., USA.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate BGB324 with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining BGB324 with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with BGB324. This will facilitate more efficient registration trials and support a precision medicine based commercialisation strategy.
The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-Axl monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Tom Henrik Sundby
Finance Director, BerGenBio ASA
tom.sundby@bergenbio.com
+47 477 54 415
Media Relations
David Dible, Mark Swallow, Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571
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 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).
