BioLineRx Reports Second Quarter 2017 Financial Results
TEL AVIV, Israel, Aug. 8, 2017 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, today reports its financial results for the second quarter ended June 30, 2017.
Highlights and achievements during the second quarter 2017 and to date:
Continued execution on multiple clinical development programs for the Company's lead project, BL-8040:
Announced plans to initiate Phase 3 pivotal study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation in H2 2017, following successful meeting with the FDA;
Reported regulatory submissions of three Phase 1b/2 trials for BL-8040 in combination with atezolizumab, Genentech's anti-PDL1 cancer immunotherapy agent, in pancreatic, gastric and non-small cell lung cancers, under immunotherapy collaboration with Genentech, a member of the Roche Group. All three studies will be conducted as part of MORPHEUS, Roche's Novel Cancer Immunotherapy Development Platform, and are expected to commence in H2 2017;
Reported filing of regulatory submissions to commence Phase 1b/2 trial for BL-8040 in combination with Genentech's atezolizumab in acute myeloid leukemia (AML), to be led by BioLineRx. This study is expected to commence in H2 2017;
Announced initiation of first Phase 1b/2 trial under immunotherapy collaboration with Genentech - in pancreatic cancer;
The Company also announced an additional, direct investment by BVF Partners, L.P., its largest shareholder, increasing its economic interest in the Company to 24.9%. The $9.6 million investment was priced at $1.13 per unit, each unit consisting of 1 ordinary share, 0.35 of Series A warrant with an exercise price of $2.00 per share, and 0.35 of Series B warrant with an exercise price of $4.00 per share. The warrants are exercisable for a period of 4 years.
Expected significant upcoming milestones for 2017 and 2018:
Partial results from immuno-oncology Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA® expected in H2 2017; top line results expected in H2 2018;
Initiation of Phase 3 pivotal study for BL-8040 in stem-cell mobilization for autologous transplantation planned for H2 2017;
Initiation of Phase 1b/2 immuno-oncology studies for BL-8040 in combination with Genentech's atezolizumab in gastric cancer and non-small cell lung cancer, as well as AML, all expected in H2 2017; partial results expected in H2 2018;
Initiation of Phase 1 immuno-oncology study for AGI-134 in several solid tumor indications expected in H1 2018;
Top-line results of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by mid-2018.
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "We are pleased to report second quarter-to-date activities that reinforce our focus to deliver on our objectives. This included timely initiation of our cancer immunotherapy collaboration with Genentech for pancreatic cancer, as well as regulatory advancements for additional indications in other solid tumors, AML, and stem cell mobilization. Thus, by the end of the year, we remain poised to have one Phase 3 and seven Phase 2 or 1b/2 clinical trials up and running, in addition to announcing partial results in our Phase 2 study in pancreatic cancer under our immunotherapy collaboration with Merck."
"We are also pleased to have received a strong vote of confidence from BVF Partners last month. The $9.6 million direct investment we received will allow us to accelerate the development of our clinical programs. With over $60 million in cash on a pro forma basis, including BVF's investment, as of June 30th, we have a strong balance sheet which will enable us to fully execute on our current operating plans," Mr. Serlin concluded.
Financial Results for the Second Quarter Ended June 30, 2017
Research and development expenses for the three months ended June 30, 2017 were $4.0 million, an increase of $1.3 million, or 48.2%, compared to $2.7 million for the three months ended June 30, 2016. The increase resulted primarily from spending on AGI-134 and BL-8040 in the 2017 period. Research and development expenses for the six months ended June 30, 2017 were $7.7 million, an increase of $2.4 million, or 45.0%, compared to $5.3 million for the six months ended June 30, 2016. The reason for the increase is the same as that presented in the three-month comparison above.
Sales and marketing expenses for the three months ended June 30, 2017 were $0.3 million, similar to the comparable period in 2016. Sales and marketing expenses for the six months ended June 30, 2017 were $1.0 million, an increase of $0.5 million, or 86.3%, compared to $0.5 million for the six months ended June 30, 2016. The increase resulted primarily from market research activities and one-time professional fees related to business development activities.
General and administrative expenses for the three months ended June 30, 2017 were $0.8 million, similar to the comparable period in 2016. General and administrative expenses for the six months ended June 30, 2017 were $1.8 million, similar to the comparable period in 2016.
The Company's operating loss for the three months ended June 30, 2017 amounted to $5.2 million, compared with an operating loss of $3.9 million for the corresponding 2016 period. The Company's operating loss for the six months ended June 30, 2017 amounted to $10.5 million, compared with an operating loss of $7.6 million for the corresponding 2016 period.
Non-operating income (expenses) for the three and six months ended June 30, 2017 and 2016 were not material, and primarily relate to fair-value adjustments of warrant liabilities on the balance sheet.
Net financial income amounted to $0.3 million for the three months ended June 30, 2017 compared to net financial income of $0.1 million for the three months ended June 30, 2016. Net financial income amounted to $0.8 million for the six months ended June 30, 2017 compared to net financial income of $0.2 million for the six months ended June 30, 2016. The increase in net financial income relates primarily to gains recorded on foreign currency hedging transactions and investment income earned our bank deposits.
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