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Tuesday, November 22, 2016 8:29:40 AM
TEL AVIV, Israel, Nov. 22, 2016 /PRNewswire/ -- BioLineRx Ltd.
(NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reports its financial results for the third quarter ended September 30, 2016.
Highlights and achievements during third quarter of 2016 and to date:
Signing of significant immuno-oncology collaboration with Genentech, a member of the Roche Group, for several Phase 1b studies for BL-8040 in combination with Genentech's Atezolizumab, in multiple solid tumor indications and AML
Steady progress in existing immuno-oncology collaboration with MSD (known as Merck in the US and Canada), with initiation of a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA®
Signing of immuno-oncology collaboration with MD Anderson Cancer Center for additional Phase 2a combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD and MD Anderson Cancer Center
In-licensing of three new projects under strategic collaboration with Novartis, including two novel liver fibrosis/failure projects, and a novel anti-inflammatory treatment for dry eye syndrome
Presentation of growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including an oral presentation at the upcoming ASH 2016
Expanded geographic reach with new joint venture in China for development of novel drug candidates
Expected upcoming significant milestones for 2017:
Partial results from Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by Q1 2017
Partial results in immuno-oncology Phase 2a study for pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA® expected by H2 2017
Phase 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezolizumab, in multiple solid tumor indications and AML, expected to commence during 2017
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "The third quarter of 2016 demonstrated our continued ability to leverage our leading BL-8040 oncology platform, as well as our access to cutting edge technologies. In particular, our immunotherapy collaboration efforts continued to bear fruit, with the signing of a significant agreement with Genentech to carry out multiple clinical trials in a variety of oncology indications, as well as a collaboration agreement with MD Anderson Cancer Center. Meanwhile, our immunotherapy collaboration with Merck, announced earlier in the year, steadily progressed, with our Phase 2a clinical trial in pancreatic cancer now in active enrollment. Further, following extensive due diligence, we are now pleased to roll out three programs under our Novartis collaboration, including two in the exciting field of liver fibrosis. We expect a number of additional novel assets to enter our pipeline in 2017, including several within the framework of the Novartis collaboration. Finally, we continue to highlight growing clinical evidence supporting our lead oncology program, BL-8040, which is regularly featured at leading medical and scientific conferences."
"We are excited about our prospects ahead and are focused on achieving our expected milestones for 2017 and beyond. With $39 million of cash on hand, we remain well positioned to carry out our operational plans for the next few years," Mr. Serlin concluded.
Financial Results for the Third Quarter Ended September 30, 2016
Research and development expenses for the three months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.7%, compared to $2.6 million for the comparable period in 2015. The increase resulted primarily from spending on new projects and from increased spending on BL-8040 in the 2016 period. Research and development expenses for the nine months ended September 30, 2016 were $8.2 million, a decrease of $0.4 million, or 5.1%, compared to $8.7 million for the comparable period in 2015. The decrease resulted primarily from lower expenditures for BL-7010 during the 2016 period and conclusion of one of the clinical trials for BL-8040 in 2015, partially offset by increased spending on a new project.
Sales and marketing expenses for the three months ended September 30, 2016 were $0.41 million, an increase of $0.14 million, or 54.3%, compared to $0.27 million for the comparable period in 2015. The increase resulted primarily from consultancy and legal expenses related to increased business development activity in the 2016 period. Sales and marketing expenses for the nine months ended September 30, 2016 were $0.9 million, an increase of $0.1 million, or 12.6%, compared to $0.8 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.
General and administrative expenses for the three months ended September 30, 2016 were $1.1 million, an increase of $0.4 million, or 47.6%, compared to $0.8 million for the comparable period in 2015. The increase resulted primarily from an increase in non-cash share-based compensation. General and administrative expenses for the nine months ended September 30, 2016 were $3.0 million, an increase of $0.4 million, or 14.4%, compared to $2.6 million for the nine months ended September 30, 2015. The reason for the increase is similar to the one discussed above in the three-month comparison.
The Company's operating loss for the three months ended September 30, 2016 amounted to $4.5 million, compared with an operating loss of $3.6 million for the corresponding 2015 period. The Company's operating loss for the nine months ended September 30, 2016 amounted to $12.1 million, similar to the comparable period in 2015.
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