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.
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)
- 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
- 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)
- Patient recruitment progressing well at leading cancer centres in Norway, UK, Spain and the US
- 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 million) | Q3 2017 | Q3 2016 | YTD2017 | YTD2016 | FY 2016 |
| 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 earnings (loss) per share (NOK) | (0.71) | (45.64) | (3.06) | (339.63) | (419.68) |
| Net cash flow in the period | (41.1) | 82.1 | 237.3 | 113.2 | 87.8 |
| Cash position end of period | 399.2 | 187.2 | 399.2 | 187.2 | 161.8 |
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.
