BioLineRx Reports Year End 2016 Financial Results
TEL AVIV, Israel, March 23, 2017 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX, TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, today reports its financial results for the year ended December 31, 2016.
Highlights and achievements in 2016 and to date:
Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing immunotherapeutic cancer treatments, thereby broadening and bolstering BioLineRx's presence in immuno-oncology. Agalimmune's novel lead compound, AGI-134, harnesses the body's pre-existing, highly abundant, anti-alpha-Gal antibodies to drive a patient-specific, systemic, anti-tumor response for various cancer indications. AGI-134 may also bring about a long-lasting, protective, follow-on, anti-tumor immune response, and has exhibited synergies in combination with check-point inhibitor therapies;
Signed extensive 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, including pancreatic cancer, gastric cancer and non-small cell lung cancer, as well as AML. The collaboration may also be expanded into additional indications;
Signed immuno-oncology collaboration with MSD (known as Merck in the US and Canada), and subsequently initiated a Phase 2a study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA®;
Initiated Phase 2b immuno-oncology collaboration with MD Anderson Cancer Center for additional BL-8040 and KEYTRUDA combination study in pancreatic cancer, as part of strategic clinical research immunotherapy collaboration between MSD and MD Anderson Cancer Center;
Reported partial results data on Phase 2 open label study for BL-8040 as novel stem cell mobilization treatment. Interim results support BL-8040 as a one-day dosing regimen for rapid mobilization of substantial amounts of stem cells, a significant improvement over the current standard of care which requires four-to-six daily injections of G-CSF.
In-licensed 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;
Presented growing body of clinical evidence surrounding BL-8040 at leading medical and scientific conferences, including the American Society of Hematology (ASH), Society of Hematologic Oncology (SOHO), and American Association for Cancer Research (AACR);
Expanded geographic reach with new joint venture in China for development of novel drug candidates; and
Appointed Philip A. Serlin as CEO.
Expected upcoming significant milestones for 2017 and 2018:
Initiation of Phase 2/3 registrational study for BL-8040 in stem-cell mobilization for autologous transplantation expected in H2 2017;
Completion of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation, expected by year end;
Partial results from the immuno-oncology Phase 2a study for 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 1b immuno-oncology studies for BL-8040 in combination with Genentech's Atezolizumab in multiple solid tumor indications and AML expected in H2 2017; partial results expected in H2 2018; and
Initiation of Phase 1 immuno-oncology study for AGI-134 in multiple solid tumor indications expected in H1 2018.
Philip A. Serlin, Chief Executive Officer of BioLineRx, remarked, "2016 demonstrated BioLineRx's strengths, as we leveraged our BL-8040 oncology platform to initiate combination studies with industry leaders in the field of immuno-oncology, while steadily advancing our multiple other clinical studies. In addition, we continued to validate our asset discovery and development capabilities, with the addition of an immunology and fibrosis franchise following the in-licensing of three programs under our Novartis collaboration. As we enter 2017, we are pleased to have just announced our first acquisition, of Agalimmune Ltd., adding a unique oncology platform to our pipeline, which significantly expands and strengthens our immuno-oncology offering."
"We remain focused on building a robust clinical-stage oncology and immunology therapeutic pipeline offering us exciting potential business opportunities. We believe BioLineRx is at a very significant stage, with key milestones in the next 12-18 months," Mr. Serlin concluded.
Financial Results for the Year Ended December 31, 2016
Research and development expenses for the year ended December 31, 2016 were $11.2 million, a decrease of $0.3 million, or 2.6%, compared to $11.5 million for the year ended December 31, 2015. The decrease results primarily from a decrease in spending on BL-7010, partially offset by increased spending on new projects.
Sales and marketing expenses for the year ended December 31, 2016 were $1.4 million, an increase of $0.4 million, or 40.0%, compared to $1.0 million for the year ended December 31, 2015. The increase results primarily from consultancy services related to BL-8040 and new projects.
General and administrative expenses for the year ended December 31, 2016 were $4.0 million, an increase of $0.3 million or 8.1%, compared to $3.7 million for the year ended December 31, 2015. The increase results primarily from one-time salary-related payments and an increase in professional fees.
The Company's operating loss for the year ended December 31, 2016 amounted to $16.5 million, compared with an operating loss of $16.2 million for the year ended December 31, 2015.
Net non-operating income of $0.2 million was recognized for the year ended December 31, 2016, a decrease of $1.2 million compared to net non-operating income of $1.4 million for the year ended December 31, 2015. Non-operating expenses and income for both periods primarily relate to fair-value adjustments of liabilities on account of 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.
Net ?nancial income for the year ended December 31, 2016 was $0.5 million, compared to net financial income of $0.4 million for the year ended December 31, 2015. Net financial income for the two periods primarily relates to investment income earned on our bank deposits, as well as banking fees.
The Company's net loss for the year ended December 31, 2016 amounted to $15.8 million, compared with a net loss of $14.4 million for the year ended December 31, 2015.
The Company held $35.6 million in cash, cash equivalents and short-term bank deposits as of December 31, 2016.
Net cash used in operating activities for the year ended December 31, 2016 was $14.5 million, compared to $14.2 million for the year ended December 31, 2015. The increase in net cash used in operating activities in 2016 was primarily the result of an increase in our operating loss.
Net cash provided by investing activities for the year ended December 31, 2016 was $9.3 million, compared to $15.6 million cash used in investing activities for the year ended December 31, 2015. 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.
