On November 16, 2015 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 third quarter ended September 30, 2015 (Press release, BioLineRx, NOV 16, 2015, View Source;p=RssLanding&cat=news&id=2112560 [SID:1234508243]).
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Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, "Our focus during the third quarter of 2015 was on continued clinical execution, primarily for BL-8040, our lead platform for the treatment of acute myeloid leukemia (AML) and other oncology and hematology indications. While we continued to advance the development of BL-8040 for the treatment of relapsed or refractory AML, as well as stem cell mobilization for transplantation purposes, in August we initiated a clinical study for BL-8040 as a novel consolidation treatment for AML, and we expect to initiate clinical studies in two additional indications in the upcoming months. We are also currently performing an extensive evaluation of BL-8040’s potential in the exciting immuno-oncology space, expanding upon our unique oncology platform. CXCR4 antagonists have been identified as potentially synergistic with immune checkpoint inhibitors. In this regard, we believe BL-8040’s best-in-class qualities make it a great candidate to explore such combinations."
"Earlier this month we reported positive results from the dose-escalation part of BL-8040’s Phase 2 clinical trial in relapsed or refractory AML, including clinical response (remission) data. The encouraging composite response rate of 38%, which will be presented for the first time at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, together with continued robust mobilization and apoptotic effects, strongly suggest that BL-8040 has potent anti-leukemic activity and, in combination with Ara-C, may improve the response typically achieved in this advanced AML population. We are looking forward to reporting top-line results from this study in early 2016. With regard to BL-8040 as a novel stem cell mobilization treatment, last month we held a meeting with the FDA, which has provided us with substantial clarification regarding the future development plan for this indication. We are gearing up to start a Phase 2 study in stem cell mobilization in the first quarter of 2016.
Dr. Savitsky continued, "After successfully completing a Phase 1/2 study for BL-7010 for the treatment of celiac disease, we are waiting for a response from the EU regulatory authorities regarding classification of BL-7010 as a medical device in Europe. Contingent upon this decision, we are planning to start the next efficacy study in celiac disease in the first half of 2016. In parallel, we are investing considerable efforts in examining alternative development and commercialization pathways for this promising product, including as a food supplement, in order to potentially address the multi-billion dollar market for gluten sensitivity, which also has a significantly shorter time to market, especially in the US.
"Our partner Omega Pharma, now part of Perrigo, is swiftly progressing in the development of BL-5010 as an OTC solution for the non-surgical removal of benign skin lesions. In September, they submitted an application for CE Mark designation for this product. Assuming successful completion of the CE Mark registration process, we expect the first sales in Europe to begin in 2016."
Dr. Savitsky concluded, "We continue to pursue various collaboration agreements to maximize the value of our current pipeline assets, including discussions with additional partners for the purpose of monetizing some of our non-core programs. In parallel to our internal pipeline development, we continue to screen potential assets to develop under our strategic partnership with Novartis, and we look forward to in-licensing promising therapeutic candidates for development under the collaboration in the near future. Finally, with over $50 million on our balance sheet, we remain well capitalized to execute on our development program and to achieve significant milestones across our expanded therapeutic pipeline well into 2018, and we look forward to demonstrating our enhanced value proposition over the coming months."
Financial Results for Quarter and Nine Months Ended September 30, 2015
Research and development expenses for the three months ended September 30, 2015 were $2.6 million, a decrease of $0.4 million, or 13.4%, compared to $3.0 million for the three months ended September 30, 2014. The decrease resulted primarily from decreased spending on BL-1110, BL-7010 and BL-5010 in the 2015 period, partially offset by increased spending on BL-8040. Research and development expenses for the nine months ended September 30, 2015 were $8.7 million, an increase of $0.2 million, or 2.3%, compared to $8.5 million for the nine months ended September 30, 2014. The small increase resulted primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-7040, BL-5010 and BL-8020.
Sales and marketing expenses for the three months ended September 30, 2015 were $0.3 million, substantially similar to the comparable period in 2014. Sales and marketing expenses for the nine months ended September 30, 2015 were $0.8 million, a decrease of $0.1 million, or 13.9%, compared to $0.9 million for the nine months ended September 30, 2014. The decrease resulted primarily from significant professional fees related to a number of material business development activities carried out during the nine-month period in 2014, which resulted in collaboration and outlicensing agreements.
General and administrative expenses for the three months ended September 30, 2015 were $0.8 million, substantially similar to the comparable period in 2014. General and administrative expenses for the nine months ended September 30, 2015 were $2.6 million, substantially similar to the comparable period in 2014.
The Company’s operating loss for the three months ended September 30, 2015 amounted to $3.6 million, compared with an operating loss of $4.1 million for the corresponding 2014 period. The Company’s operating loss for the nine months ended September 30, 2015 amounted to $12.1 million, substantially similar to the corresponding 2014 period.
Net non-operating income amounted to $2.0 million for the three months ended September 30, 2015, an increase of $0.6 million, compared to net non-operating income of $1.4 million for the three months ended September 30, 2014. Net non-operating income amounted to $1.1 million for the nine months ended September 30, 2015, a decrease of $2.3 million, compared to net non-operating income of $3.4 million for the nine months ended September 30, 2014. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of liabilities on account of the warrants issued in the private and direct placements which we conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by our share price at each period end (revaluation date).
Net financial income was immaterial for the three months ended September 30, 2015, compared to net financial income of $2.0 million for the three months ended September 30, 2014. Net financial income amounted to $0.3 million for the nine months ended September 30, 2015, compared to net financial income of $1.8 million for the nine months ended September 30, 2014. Net financial income (expenses) for the 2015 period primarily relates to investment income earned on our bank deposits, as well as banking fees. The 2014 period also includes significant exchange rate differences primarily relating to changes in the USD/NIS exchange rate.
The Company’s net loss for the three months ended September 30, 2015 amounted to $1.6 million, compared with a net loss of $0.7 million for the corresponding 2014 period. The Company’s net loss for the nine months ended September 30, 2015 amounted to $10.7 million, compared with a net loss of $6.9 million for the corresponding 2014 period.
The Company held $50.7 million in cash, cash equivalents and short-term bank deposits as of September 30, 2015.
Net cash used in operating activities was $11.0 million for the nine months ended September 30, 2015, substantially similar to the comparable period in 2014.
Net cash used in investing activities for the nine months ended September 30, 2015 was $18.7 million, compared to net cash used in investing activities of $15.6 million for the nine months ended September 30, 2014. 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 nine months ended September 30, 2015 was $29.3 million, compared to net cash provided by financing activities of $22.6 million for the nine months ended September 30, 2014. The cash flows from financing activities primarily reflect the underwritten public offerings of our ADSs in March 2015 and 2014.