Vivian Cervantes - PCG Advisory Kinneret Savitsky - CEO Phil Serlin - CFO and COO Arnon Aharon - VP of Medical Affairs.

Mike King - JMP Securities Jason Kolbert - Maxim Group Assaf Vestin - Roth Capital Partners.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2015 Conference Call. All participants are at present in listen-only mode. Following the management's formal presentation, instructions will be given for the question-and-answer session. [Operator Instructions] I would now like to turn the call over to Ms.

Vivian Cervantes of PCG Advisory to read the Safe Harbor statement. Vivian, please go ahead..

Thank you, Operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call other than historical facts are indeed forward-looking statements.

The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements.

These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLineRx's business, financial condition and other operating results.

These include, but are not limited to the risk factors and other qualifications contained in BioLineRx's annual report on Form 20-F, quarterly reports that we filed in our 6-K and other reports filed by BioLineRx with the SEC to which your attention is directed.

Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLineRx expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Financial and Operating Officer of BioLineRx.

Phil, please go ahead..

Thank you Vivian and good morning everyone. Thank you for joining us on our third quarter earnings conference call. On the call today, we have Dr. Kinneret Savitsky, CEO of BioLine and myself. We will first discuss some highlights since our last quarterly call and then go into further details regarding our specific programs. Dr.

Arnon Aharon, VP of Medical Affairs is also with us and will be available towards the end of the call to respond to questions on our clinical studies if necessary. During the third quarter of 2015, our primary focus was on continued clinical execution primarily for BL-8040 our lead oncology and hematology platform.

We are currently conducting and planning multiple clinical trials in parallel in a number of indications. With two Phase 2 studies running at full steam and three additional Phase 2 studies expected to commence in the upcoming months.

These include a Phase 2 trial in relapse to refractory AML through which we recently announced positive clinical results from the dose escalation part. Our Phase 2b study which was recently initiated for BL-8040 has an AML consolidation treatment.

Our Phase 2 study in the planning stages is a novel stem cell mobilization treatment based on input that we received from the FDA last month, an initiation of two additional studies in certain bone marrow failure indications and for the treatment of AML patients with the FLT3 ITD mutation. Shortly Dr.

Savitsky will discuss in details the progress made to-date in each one of these clinical studies, as well as expected milestones in the near to mid-term.

Moving on to the BL-7010 program after successfully completing a Phase 1/2 study for the treatment of celiac disease, we’re waiting response from the notified body in the EU regarding the classification of BL-7010 as a medical device in Europe. Following this, we hope to start the next efficacy study for celiac disease in H1 2016.

In parallel, we're also evaluating BL-7010 for other commercial pathways including as a food supplement in the multibillion dollar market for gluten sensitivity, which also has a significantly shorter time to market.

And finally regarding the BL-5010 in early September we announced that our partner Omega Pharma now part of the Perrigo submitted BL-5010 for CE Mark registration as a novel OTC solution for the non-surgical removal of benign skin lesions.

Assuming successful completion of the CE Mark registration progress, we expect first sales in Europe to begin in 2016.

We believe that BioLine's true value remains in our ability to advance our current pipeline to meaningful inflexion point, as well as our proven capability to identify in life and advanced new promising assets to fuel our continued growth including the future programs we expect to initiate in the coming months under our strategic collaboration with Novartis.

I'll now turn the call over to Dr. Savitsky who will discuss our lead program BL-8040 in detail. Following Dr. Savitsky's remarks, I will provide a brief overview of our finances before opening the call up to Q&A. Kinneret, the floor is yours..

Thank you, Phil and good morning to everyone. As Phil mentioned, I will dedicate most of my prepared remarks to BL-8040 our unique oncology platform as we look forward to some very exciting milestones in the coming months.

First, we expect to report top line results from our ongoing Phase 2 clinical study of BL-8040 for treating relapsed/refractory AML in early 2016.

Our recently announced results from their dose escalation stage of the study continue to show highly encouraging results including strong anti-leukemic activity as reflected in a clinical composite remission response rate of 38%, consistent demonstration of robust mobilization of cancer cells from the bone marrow and significant induction of cancer cell death.

Following only two days of immunotherapy BL-8040 triggers an average 44 mobilization of immature AML progenitor cells from the bone marrow to the peripheral blood thereby synthesizing these cells to the RFC chemotherapy and improving its efficacy.

BL-8040 also showed a direct and significant [indiscernible] effect on the immature leukemic progenitor cells in the bone marrow following the two days of monotherapy.

Finally BL-8040 induced leukemia progenitor cells covers differentiation as evidenced by a 58% median decrease in the number of bone marrow leukemia progenitor cells along with the three fall increase in differentiated granular size in the bone marrow biopsy conducted on day three of the treatment cycle prior to the RFC treatment as compared to the biopsy performed at baseline.

We are very encouraged by these results and look forward to presenting the full results for the first time at ASH 2015 in Orlando. We also look forward to reporting topline results in early 2016.

Building on this clinical proof-of-concept we’re on track in developing BL-8040 for a number of other oncology and hematology indication where we believe it may demonstrate best in class potential. One of these indications is consolidation therapy for AML patient. In mid-August we announced the initiation of our Phase 2b study in consolidation AML.

This is a double bind Placebo-controlled study in up to 194 patients. This Phase 2b study will examine BL-8040 as part of the second stage treatment for AML patient who have achieved remission after the standard first-line treatment regimen.

The consolidation therapy is aimed to eliminating the minimal residual disease left in the bone marrow that can lead to a relapse. Approximately, 40% of AML patient who achieved first remission end up relapsing within one year despite the current standard consolidation therapy. And the relapsation has a very poor prognosis despite further therapy.

We are hopeful that our BL-8040 platform will help reduce or eliminate the minimal residual disease due to the dual mechanism of action. On the one end, this drug induces mobilization of leukemia cells from the bone marrow which enhances the cytotoxic effects of chemotherapy.

And on the other end, it has anti-leukemic pro-apoptotic properties that help to eliminate AML cells directly.

Based on positive results from our ongoing Phase 2 clinical trial for BL-8040, which show substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, as well as induction of apoptosis of AML cell we believe BL-8040 will be a promising addition to consolidation therapy for AML patients.

In addition indication for our BL-8040 platform is stem cell mobilization to support bone marrow transplantation. As previously noted in March we reported positive safety and efficacy results from a Phase 1 study in this indication. And we then presented the full study finding at the European Hematology Association Conference in June.

Our study showed that BL-8040 was safe and well-tolerated at the dose of up to 1 mg/kg and induced dramatic mobilization of hematopoietic stem and progenitor cells at all doses tested. The cell collected from the healthy volunteers were also accessed for viability and quality in vitro and in vivo.

Importantly, we show that collection of CD34+ cells was accompanied by mobilization and collection of colony-forming cells as well as T, B and NK cells. These recovered cells were of exceptional quality and showed excellent engraftment in irradiated mice followed by a rapid reconstitution of normal hematopoiesis.

Collectively this data supports the use of BL-8040 as a single-agent, single-injection, one-day regimen for the collection of stem cells. This is a major improvement over currently available procedures, which are longer and require multiple administration and multiple time-consuming apheresis sessions.

Moreover, we see an improvement in composition of the collective cells suggesting the potential offer better quality graft this may improve stem cell transplantation outcome. Last month, we have a productive meeting with the FDA this provided us substantial clarification regarding the development plan for BL-8040 for this indication.

We are looking for a historic Phase 2 study for the stem cell mobilization in the first quarter of 2016. In early September, we announced the filing of the regulatory submission for the Phase 2 study for BL-8040 as a combination treatment with standard-of-care immunosuppressive for two bone marrow failure condition MDS and aplastic anemia.

Treatment for these two bone marrow failure condition represents a significant unmet medical need and we hope that BL-8040 is a part of a novel treatment regimen will significantly improve bone marrow cellularity and peripheral blood count.

We anticipate regulatory approval in the next few weeks and hope to commence these Phase 2 trials by the end of the year. Interim results for this study are expected by the end of 2016. Last but not least regarding BL-8040 during the first half of next year we plan to initiate an additional Phase 2 study in AML patient with FLT3-ITD-mutation.

We would also like to mention that we are currently performing an extensive evaluation of BL-8040s potential in the exciting immuno-oncology space further expanding upon our unique oncology platform. CXCR4 antagonist has 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 combination.

We plan to continue to move forward with our aggressive clinical development strategy for BL-8040 and anticipate reaching several key inflection points and builds significant value across our BL-8040 oncology platform in the next six to 12 months.

The multiple indications provide us with the ability to pursue several high potential unmet medical needs while reducing the overall development risk for this novel platform.

Finally, in addition to what I have highlighted on today's call, we continue to pursue the various collaboration agreements to maximize the value of our current pipeline assets, as well as talk to potential partners for the purpose of monetizing some of the non-core programs.

In parallel to our internal pipeline development, we continue to screen potential assets to the developed under our strategic partnership with Novartis for core development of novel clinical stage therapeutics originating from Israel.

We are very pleased with the feedback we have received from Novartis and we will provide timely update on therapeutic candidate selected by Novartis if and when this promising candidate emerge. Before I conclude my prepared remarks, I would like to remind everyone about our Investor Breakfast in New York on December 03, 2015.

We look forward to providing a detailed update at the breakfast on our BL-8040 clinical development strategy for 2016 and beyond. We will also ask Dr.

John DiPersio, a well known KOL from the bone marrow transplantation in leukemia section and stem cell biology section at the oncology division of the Washington University School of Medicine who will be the keynote speaker. His presentation will focus on a review of the CXCR4 landscape.

With that let me turn the call back to Phil to give the financial overview..

Thank you, Kinneret. Let me please turn your attention to the financials for the nine months ended September 30, 2015. I will only go into detail on the most important financial statement items.

Research and development expenses for the nine months ended September 30, 2015 were $8.7 million, a small increase of $0.2 million or 2.3% compared to $8.5 million for the nine months ended September 30, 2014.

The small increases result primarily from increased spending on BL-8040 in the 2015 period, partially offset by decreased spending on BL-7010, BL-5010 and several other smaller projects.

G&A expenses as well as sales and marketing expenses for the nine month periods in both 2015 and 2014 were substantially similar as we continue to keep a tight vein on our fixed cost. Our operating loss for the nine months ended September 30, 2015 amounted to $12.1 million dollars substantially similar to the corresponding 2014 period.

Our 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 2014 period reflects significant non-operating income related to the reevaluation of warrants for accounting purposes on our balance sheet, as well as financial income relating to exchange rate changes. Our operating cash burn was $11 million for the nine months ended September 30, 2015 substantially similar to the comparable period in 2014.

We ended the September quarter with almost $51 million in cash, cash equivalent and short-term bank deposits leading us with a cash runway of over three years and allowing us to move forward with our aggressive clinical development strategy for BL-8040, continue to advanced clinical development to BL-7010, and efficiently pursue the multiple opportunities we hope to realize under our Novartis collaboration.

That concludes the formal part of our presentation. Operator, we are now opening up the call to questions. Thank you..

[Operator Instructions] The first question is from Mike King of JMP Securities. Please go ahead..

You may have addressed this during the call, I had a little bit of as you can tell connectivity issues with call.

So, couple of questions on 8040 first is, have you guys settled on a dose for Phase 2 yet, I mean I know you get exceptional mobilization with dose, but I am thinking for therapy and consolidation can you talk a bit about the - your thoughts on whether you feel patients will get repeated doses and whether there is any additional benefit from that.

And then second related to that is the interest in immune oncology throughout the industry I just wondering what - if you can talk about any kind of IO sort of partnerships be able to enter into given the fact that you got one of the few CXCR4 antagonist? Thank you..

Hi, Mike and everyone, that's Arnon. I'll answer your questions by the order they were asked.

In terms of stem cell mobilization we have set a dose for that studies and for the future Phase 2 and that will be 1 mg/kg that is a complete match in terms of safety and efficacy in terms of mobilization to support the program and we believe that that dose can serve us all the way up to registry on that indication.

In regards with the combination with immune checkpoint inhibitors, I guess everyone is aware about the increasing interest that lot of companies have in regards to chemokines that might promote the activity of different immune checkpoint inhibitors.

Obviously, CXCR4 is one of those chemokines that is of interest and obviously we are interested in the field. We are conducting our own preclinical work at this stage and we've evaluated several potential agents that we can combine our CXCR4 with.

At this point in time, we haven’t made a firm selection about which one of the agent we want to team up with. And I guess we'll have more data to share once we will make that decision..

Thanks very much..

The next question is from Jason Kolbert of Maxim Group. Please go ahead..

Hi, guys this is actually Jason McCarthy for Jason Kolbert.

I want to build on what was just talked about in the immune oncology and it's more directed towards the CAR-T space because [celiac] showed, 10 days ago or so that they cured a little girl with allogeneic CAR-T that did have AML and it seems like you have a whole space knows that CAR-T is not going to be a single agent type of treatment or cure and is going to have to be some type of combination.

So I guess my question is BL-8040 does seem to have parallels with the allogeneic CAR-T and is that something that you’re thinking about for BL-8040. And the reason I asked that is because GlycoMimetics they are involved in sickle cell, they advancing a CXCR4 antagonist to the clinic and AML and they are thinking about CAR –T.

Could you guys comment on what's next will be BL-8040 if you're thinking about CAR-T?.

Sure, first of all are aware of this one incidence in a case report which is very optimistic about the activity of CAR-T and we're happy with it.

In terms of the combination we are aligned with your thinking and others that potentially the CAR-T will need to be a combination, and it's part of what we are doing again we cannot disclose our thoughts and activities around that but we share your enthusiasm with the CAR-T field and the involvement or potential involvement of CXCR4 in that treatment..

Okay, thanks very much..

The next question is from Assaf Vestin of Roth Capital Partners. Please go ahead..

Hi, thanks for taking the questions. So I'll have few follow-up on the checkpoint inhibitors and then the other assets.

So I am just wondering, what can you point to specific data that you’ve seen that suggest that the potential CXCR4 antagonist in combination with checkpoint inhibitors and then what kind of indication and study you see the potential for the BL-8040?.

Obviously, I can only describe things that we've seen and investigated pre-clinically. And in essence what we are looking at as many other companies in the chemokine area is the involvement of our chemokine in our instance is that CXCR4 for antagonist in the -- micro environment.

We're looking to see areas and indications in which the immune checkpoint inhibitors are not active in and the mechanism that sort of a block the activity of immune checkpoint inhibitor is either related to the microenvironment or to any blockage of the cells from entering the tumors by death coming to mind and again that’s a pre-clinical evaluation we're looking at tumors at the area of pancreatic or [indiscernible] in terms of solid tumors, as well as several hematology, oncology type tumors that in which the immune checkpoint inhibitors have not shown activity as a single agent..

Just point to add, we are not the only CXCR4 antagonist thinking about the combining, actually combining it with immunotherapies. We do know about the [MSD cell] we are using there as the CXCR4 antagonist and checkpoint inhibitor and also recently Lilly and AstraZeneca are collaborating on Lilly's CXCR4 with their immunotherapies..

Great, that’s very helpful.

Now just moving on to 7010, I am just wondering what steps would be needed to go with food supplements routes, what would you need to there?.

Well if we will find that route to be attractive probably we will have to submit our safety data and graft notification and by that open the area for discussions with companies that are experts in food supplementation which is obviously not our prime expertise.

And in terms of registry outside that, there is not a lot of regulatory hurdles to get into the supplement area. But as mentioned we will first need to go through graft designation..

And just a follow-up on that are there any I mean do you know any kind of supplements to that clinical data that can back up their claim of new efficacy in the study?.

That’s a good question. Data that out there food supplements - there is not many food supplements out there that are targeting celiac, and the data that they have is – it's rather in vivo, vitro type data or some questionnaire type very low regulated studies in not in celiac patients but gluten sensitive patient.

So the answer to that will be there is no significant type clinical data out there supporting other or any food supplements at the gluten free environment..

Got it. So that will be a good advantage. And lastly I know you can't comment too much on it, but just trying to get some additional color on in.

So you mentioned near term in licensing [for generic] under Novartis collaboration, is there any do you know of any rough timeline for when this event may occur and is there any particular area of interest for those what type of indications are you and Novartis interested in?.

At this point, we cannot disclose any information about timeline, sorry..

Okay, got it. Thank you very much..

[Operator Instructions] There are no further questions at this time. Before I ask Dr. Kinneret Savitsky, go ahead with her closing statement, I would like to remind participants that our replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-254-7270. In Israel, please call, 039-255-928.

Internationally, please call 972-3-925-592. Dr.

Savitsky, would you like to make your concluding statement?.

Yes, I would like to thank all of you for joining us on today's call. We continue to aggressively expand upon our BL-8040 oncology platform and expect to maintain that momentum as we commence additional studies for this potentially best-in-class molecule.

Our other lead assets BL-7010 is moving through a parallel program as a potential medical device product for celiac disease and as we evaluate other commercial pathways including the multibillion dollar market for gluten sensitivity.

We are also pleased to note the potential first sales in 2016 for BL-5010 as an OTC solution for the non-surgical removal of benign skin lesion following a successful CE Mark registration process.

And finally we continue to pursue new opportunities through our collaboration with Novartis and hope to announce the in-licensing of our first clinical program under the collaboration in the near future.

We remain well capitalized to achieve all of the significant milestone we have discussed today and look forward to entering this exciting period for BioLineRX and our shareholders. Thank you again for joining us and for your continued support. Good bye..

Thank you. This concludes the BioLineRx third quarter 2015 conference call. Thank you for your participation. You may go ahead and disconnect..