On May 17, 2016 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, reported its financial results for the first quarter ended March 31, 2016 (Press release, BioLineRx, MAY 17, 2016, View Source;p=RssLanding&cat=news&id=2168907 [SID:1234512464]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Highlights and achievements during the first quarter of 2016, and to date:
Signing of immuno-oncology collaboration with Merck for BL-8040 Phase 2a study in pancreatic cancer
Successful top-line results from Phase 2a study for BL-8040 in r/r AML
Continued ramp-up of Phase 2b study for BL-8040 as consolidation treatment for AML patients following standard induction treatment
Initiation of Phase 2 study for BL-8040 in allogeneic stem-cell transplantation
Receipt of medical device classification for BL-7010 for celiac disease in Europe
BL-5010 for non-surgical removal of skin lesions receives CE mark and begins initial product launch in Europe
Expected upcoming significant milestones for the remainder of 2016:
Initiation of Phase 2a study for BL-8040 in combination with KEYTRUDA, in patients with metastatic pancreatic cancer, expected mid-year
Full set of data from Phase 2a study for BL-8040 in r/r AML to be provided at an upcoming US-based scientific conference
Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by end of 2016
Initiation of efficacy study in gluten sensitivity for BL-7010
Roll-out of BL-5010 product launch by Omega to additional countries and selection of 2nd OTC indication for development
Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "During the first quarter of 2016, we made significant progress in advancing BL-8040, our lead oncology platform. We announced successful results in our Phase 2a study for relapsed and refractory AML and we continue to push forward in our Phase 2b trial in an earlier treatment line for AML – as a consolidation treatment following standard induction treatment. We also announced our entering into the exciting field of immuno-oncology, through our collaboration with Merck on a Phase 2a study to investigate BL-8040 in combination with KEYTRUDA for the treatment of pancreatic cancer. In addition, we are progressing with our strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. Novartis has flagged several pre-clinical projects, which we intend to bring into our pipeline over the next few months. With $45 million of cash on our balance sheet as of the end of the first quarter, we are well positioned to carry out our strategic and operational plans through the end of 2018, and look forward to achieving our expected milestones during the second half of 2016."
Financial Results for First Quarter Ended March 31, 2016
Research and development expenses for the three months ended March 31, 2016 were $2.5 million, a decrease of $0.7 million, or 20.9%, compared to $3.2 million for the three months ended March 31, 2015. The decrease resulted primarily from the conclusion of one of the clinical trials for BL-8040 in 2015, and the wind-down of a second clinical trial for BL-8040 during the 2016 period.
Sales and marketing expenses for the three months ended March 31, 2016 were $0.2 million, substantially similar to the comparable period in 2015.
General and administrative expenses for the three months ended March 31, 2016 were $1.0 million, an increase of $0.1 million, or 15.5%, compared to $0.9 million for the three months ended March 31, 2015. The small increase was the cumulative effect of an increase in several categories of expenses, none of which individually was material.
The Company’s operating loss for the three months ended March 31, 2016 amounted to $3.8 million, compared with an operating loss of $4.3 million for the corresponding 2015 period.
Non-operating income (expenses) for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to fair-value adjustments of warrant liabilities on the Company’s balance sheet.
Financial income (expenses), net for the three months ended March 31, 2016 and 2015 were not material, and primarily relate to investment income earned on bank deposits, as well as banking fees.
The Company’s net loss for the three months ended March 31, 2016 amounted to $3.5 million, compared with a net loss of $4.3 million for the corresponding 2015 period.
The Company held $45.0 million in cash, cash equivalents and short-term bank deposits as of March 31, 2016
Net cash used in operating activities was $4.2 million for the three months ended March 31, 2016, compared with net cash used in operating activities of $3.5 million for the 2015 period. The $0.7 million increase in net cash used in operating activities was primarily the result of a decrease in trade payables and accruals.
Net cash provided by investing activities for the three months ended March 31, 2016 was $1.7 million, compared to net cash used in investing activities of $20.7 million for the corresponding 2015 period. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits and other investments during the respective periods.
Net cash provided by financing activities for the three months ended March 31, 2016 was $1.6 million, compared to net cash provided by financing activities of $26.5 million for the corresponding 2015 period. The decrease in cash flows from financing activities reflects the underwritten public offering completed by the Company in March 2015.