Philip A. Serlin
Analyst · ROTH Capital Partners. Please go ahead
Thanks, Josh, and good morning to everyone. There have been many substantial and positive developments since our last quarterly call, so I’d like to get right into it. On the call we have Dr. Kinneret Savitsky, CEO and myself and we will first discuss some general highlights for the company since our last quarterly call before focusing your attention on our specific programs. Dr. Arnon Aharon, our VP of Medical Affairs is also with us and he will be available towards the end of the call to respond to questions on our clinical studies as necessary. During the fourth quarter of 2014 in addition to securing two significant business development deals, which I’ll discuss shortly, the most critical company update was provided in December at a live investor event in New York where we laid out BioLine’s long-term clinical development strategy for advancing our lead hematology platform BL-8040. We were fortunate to be joined by Dr. Jorge Cortes, Distinguished Professor of Leukemia Research at the MD Anderson Cancer Center as well as our internal clinical team to update investors about our plans to initiate three additional BL-8040 clinical studies in 2015. In fact, we recently filed the regulatory paperwork to commence enrolling patients into the first of these three studies in consolidation AML following standard induction therapy. In outlining our multiyear clinical plans, we would like to reiterate our strategic focus and our commitment to maximizing the clinical opportunity for this best-in-class compound. We view BL-8040 as our lead oncology platform and expect it to be the primary value driver for our business in the near future. In a few moments, Dr. Savitsky will go into further detail on these and our other lead clinical programs including our second lead asset BL-7010 for treating celiac disease, for which we are preparing to initiate a pivotal CE Mark registration study in Europe later in 2015, as well as BL-1040 for the prevention of cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon and is in the midst of the pivotal CE Mark registration trial schedule for completion in mid 2015. Before we begin the clinical update, I want to highlight the strategic transactions we completed this quarter. The first collaboration is a very significant multiyear drug screening and co-development agreement with Novartis, which we announced in mid-December. We view the strategic alliance as potentially transformative for BioLine because it establishes a framework for us to add several programs to our pipeline with significantly reduced financial risks through co-development. In addition, by selecting BioLine to serve as its lead partner in Israel for the screening, identification and co-development of novel drug candidate, Novartis provides exceptional validation for our core competencies and business model. So in addition to helping us fuel a big pharma grade pipeline, we believe the strategic collaboration also puts us on the global stage in terms of being recognized for our successful track record. In parallel with our internal development initiatives, we are extremely motivated to ensure a successful collaboration with Novartis, which we believe will add significant value for BioLine shareholders. Having said this, we would still like to underline the fact that Novartis has no rights over our existing pipeline. Secondly, I’d like to briefly mention the successful out-licensing agreement with Omega Pharma for rights to BL-5010, our novel product for the nonsurgical removal of benign skin lesions. Omega is one of the largest OTC healthcare companies in Europe and will soon be formally acquired by Perrigo Company making it part of one of the leading global OTC healthcare companies. And under our agreement they will develop BL-5010 for OTC indications in Europe, Australia and additional selected countries. This exclusive out-licensing agreement significantly accelerates BL-5010’s pathway to commercialization with the first OTC products expected to enter the market in 2016, and it is in line with our strategic vision for BioLine, which is to focus on our lead clinical programs and pursue efficient ways to monetize our non-core pipeline assets. We look forward to providing updates on BL-5010 as appropriate. Finally, earlier this month, we completed an underwritten secondary public offering of our ADSs, which yielded gross proceeds of almost $29 million. The ADSs were offered from an existing shelf registration and JMP Securities lead the offering with support from ROTH Capital and Maxim Securities. The primary purpose of this raise was to maintain a strong balance sheet in light of the very significant data announcements we plan to report in the second half of the year. We want to be able to maximize these key events without any undue pressure on our stock over concerns about our cash runway, which prior to this raise would have brought us through Q4 2016. We determined that before mid-year was the best or the ideal timing for financing given our need to maintain greater than 12 months of cash combined with the current favorable market conditions. The proceeds from this offering allow us to move forward with our aggressive clinical development strategy for BL-8040, to continue to advance clinical development in BL-7010 and to efficiently pursue the multiple opportunities we hope to realize under our Novartis collaboration. Even with our expanded initiatives following the successful financing, we believe we have sufficient cash runway of at least three years. With that, I’ll hand the call over to Kinneret who will provide more detail on our lead programs and an overview of our upcoming clinical milestones.