Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2016 Conference Call. All participants are 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 hand 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, believes, 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 filed in a 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 on ahead.

Thank you, Vivian, and good morning, everyone. Thank you for joining us on our second quarter earnings conference call. I’d like to begin by relating to the press release we issued this morning outlining senior management changes at BioLine. As announced, Dr. Kinneret Savitsky is stepping down from the role of CEO, and I’m assuming this position as of October 10, 2016. We are also pleased to announce the promotion of Miss Mali Zeevi to Chief Financial Officer, also effective October 10th . Mali currently serves as BioLineRx’s Senior Director of Finance and Reporting. With these changes we expect a seamless transition in the coming weeks and look forward to communicating and corresponding with you in our new roles. The Board and Management team of BioLineRx would like to take this opportunity to thank Kinneret for her dedicated leadership and solid commitment to the Company in these last 12 years. Kinneret was one of the first employees hired by BioLine. Joining the Company in 2004, as VP of Research and Development and General Manager of BioLine Innovations, a BioLine subsidiary and taking over the CEO role in 2010. During Kinneret’s tenure the Company has recorded a number of significant achievements in development, partnering and strategic collaboration activities. In passing the baton, we look forward to realizing the full potential of BioLine’s pipeline and collaborations as we leverage our core capabilities and global access to cutting edge technologies to deliver best-in-class therapeutics in areas of large unmet clinical need. To that end, we invite you to join us at our annual investor breakfast, where we plan to elaborate on our vision and pipeline programs specifically, BL-8040. Our investor breakfast this year will be held in New York at the Convene Conference Center near Grant Central Station, on September 22, 2016. Now…

Thank you Phil and good morning everyone. We are pleased to highlight steady progress made across our BL-8040 program. In late March, we announced successful topline result of BL-8040 in combination with Cytarabine, one of the standard of care chemotherapies in our Phase 2a study in relapse and refractory AML. In this proof of concept study, BL-8040 showed a triple effect on the leukemic cells, robust mobilization, apoptosis and terminal differentiation. As a result of these factors, we reported a 38% complete remission rate in the study compared to historical remission rate in similar patient populations with similar treatment regimens of approximately 20% for Cytarabine on a standalone basis. We now look for it to providing the full result of this study in a presentation at the upcoming SOHO Conference in Houston in September. We are excited by the Phase 2 relapse and refractory AML as a result. We believe they show a clear anti-leukemic effect and give us confidence to continue clinical development of the compound in AML with focus on an earlier treatment line for AML known as consolidation therapy. The purpose of this treatment line is to improve outcome for AML patients who have achieved remission after the standard initial treatment regimen known as induction therapy. The consolidation therapy is aimed to eliminate the minimal residual disease left in the bone marrow after induction therapy that can lead to a relapse. Following current standard consolidation therapy, approximately 40% of AML patients who achieved first complete remission end up relapsed within the first year, and these relapsed patients have a very poor prognosis despite further therapy. The positive data recently reported from our Phase 2 relapsed and refractory AML clinical trial for BL-8040 are potentially relevant to a reduction or elimination of minimal residual disease. Accordingly, we are…

Thank you, Kinneret. Now turning to the remainder of our program updates. During the second quarter we’ve been pleased to note our first partnered assets have become commercially available, BL-5010 by Omega Pharma in a number of European countries. This follows receipt of a CE Mark approval in March as a novel OTC solution for the non surgical removal of warts. Omega continues to expect to gradually introduce the product in a number of additional countries over the next six to nine months and beyond that timeframe for additional territories. We do not expect royalty revenues to be significant in 2016 as the product is in the initial launch phase. Overtime, however we expect revenues to gradually increase as the product penetrates and gains market traction. Our current estimate for peak future royalty revenues in the Omega territories from this first indication is in the $2 million to $4 million per year range and it may take a few years to gradually reach this level. In parallel, Omega has also started to develop a second OTC indication for BL-5010. We believe that the size of the market for the second indication will be similar to the first. I would just like to remind everyone on this call that we invested only about $3 million in this program and that we have strong patent protection all the way through 2034. Looking forward, building on our Omega relationship we expect to extend the OTC rights to this product to additional markets such as the U.S. as well as the Rx [ph] indications where we still hold the global rights. Our additional BL-5010 development efforts are also aided by the clinical and manufacturing data accumulated by our Omega Pharma to which we have full access. Now turning to BL-7010, we are increasingly looking…

Thank you. [Operator Instructions] Your first question is from Joe Pantginis of ROTH Capital Partners. Please go ahead.

Hi, guys. Good morning. Thank you for taking the question. First, I'd like to start at the top, first, Phil, congratulations on the movement and management. And Kinneret, thank you very, very much for all the effort that you put in. You know, it's been great having the professional relationship with you. And I wish you the best going forward. With that said, I just curious what the potential impedes [ph] was to these management changes as well as can we anticipate any sort of strategy changes in the company or is it basically steady [Indiscernible]?

I'll let Kinneret answer the questions, as far as the reasons for the change.

Okay. So, I was out there over 12th years in BioLine and almost seven years as the CEO. I saw this was the time for me to make a change. Also from Company's perspective I believe that this is a good for us to make this change than Novartis collaboration is already producing projects, our oncology program BL-8040 shows already clinical data efficacy data in AML and stem cell mobilization. And we have the high profile collaboration in the IO, the Immuno-Oncology space. So, I feel that this is the right time to make this move. So I approach the Board and ask them to find a replacement. And I was very happy to learn that Phil was selected and I wish him lot of success in this new role.

Thanks. I'll just add to that, that we expect the seamless transition in the next few weeks and I don't see, as Kinneret pointed out, we have a lot going on, a lot of positive things going on. I think our most important effort in the next number of months would just to be to execute on our current business plan and meet our targets and meet our milestones.

That's very helpful. Thank you. And best of luck to both of you. I guess, if I could just switch gears to 8040, I just want to make sure with regard to your earlier comments that I hear correctly and that I have the overall profile correct for AML. Kinneret, you mentioned that the focus is going to be obviously on the consolidation study and the opportunity there. So, how should we view the relapsed/refractory setting and even with the upcoming data, how are you viewing it as the benchmark -- I'm sorry, what you viewing as the benchmarks for success in that study, you're looking more for just continued activity at driving that population to help your views towards the consolidation or just your general views on the profile for AML? Thanks.

Arnon, do you want to take that?

Yes. Sure. Thanks Joe for those questions. So, let me start with that the first part addressing the reference and what we see as the Standard of Care that we compare our results to in the relapsed/refractory AML study. So, we used and we've already made it public. The control group from the VALOR study that was done by Sunesis that included around 370 patients in his control ARM. Similar population more or less that were treated with high dose Ara-C, those were are latest scientifically valid type control and they have been performing at around 18% overall response rate similar to what we have seen at a rate of around 38%. That is to stick about what we've seen in clinical trials, but we've also have approached our KOLs and the treating physicians and we learned as we expect that the real life numbers are also around the 20% response at the salvage setting for high dose Ara-C. So, we're quite confident that the results that we're seeing at a range of 40% response are better than what we see with Cytarabine alone if you look at that salvage setting. With that said, we are not only focusing on the response data, we look at into the, our pharmacodynamic by that and that was also published. We have seen that BL-8040 has some properties that other compounds do not have as the Cytarabine are very robust mobilizer. It has [Indiscernible] capabilities, differentiative capabilities so on and so forth. From all those we have learned that potentially the best place for BL-8040 in the AML treatment sequence is not necessarily the salvage setting, but rather the earlier line of consolidation were the micro-environment plays a significant role in the outcome of the patient. We are using the data we have and extrapolating those data into the treatment setting which is now becoming more and more popular with aims to reduce minimal residual disease, by that increasing the relapse-free survival of the patients and endpoint that is becoming more and more attractive and we're in discussions with the regulatory agencies in regards to the ability to use that as an endpoint for registration. That is the rationale in AML of this earlier line treatment shift to explore BL-8040 in what we think might be a more favourable treatment line.

That's very helpful. And I guess, is it possible to extrapolate that the market size for the consolidation setting for 8040 could be potentially increased based on the anticipated approval for the sales?

Absolutely, when you look at the initial treatment line for AML, we are expecting 70% of patients to respond to initial induction treatment, out of those 70% that responded the vast majority will be treated with consolidation treatment that is as opposite to the amount of patients that are requiring re-salvage treatment down line the treatment line.

Okay, great. Thank you very much guys.

Thank you.

Thank you.

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

Hi, guys. This is Jason McCarthy for Jason Kolbert. Phil, congratulations on the change in management. Kinneret, I'm so sorry to see you leave. We've joined interactions together. If we can go back to – I just want to build on what Joe was talking about the Phase 2b study. Can you give us a sense of the speed of enrolment, now that data is coming in 2019 and maybe what delta progression that your survival that you're expecting to see? And trying to give us a sense of what a pivotal study, the size and scope could look like, because if you're moving from relapse/refractory back and focusing on consolidation, I would have imagine that you need at least one pivotal study potential two?

Hi, Jason. That's Arnon. Thanks for the question. So, first in regards to the ongoing study we haven't disclosed the recruitment rate, but what I can tell you now is that it took us a bit of time to get all those close to 30 sites enrolling patient and now we're in full gear. So, we are recruiting quite nicely. In terms of the duration of the study please note that we will require 12 to 18 months of follow-up before those patients recur. So that's the reason why it's prolonged. Although its look that relapse-free survival, it doesn't open label extension that looks at overall survival. However, the follow-up period there is a bit longer than what we did to-date. That's why we are looking at that. We are also based on what you said our building a program for an interim analysis that interim analysis will be an evaluation of the responses at around mid study between the treatment groups and that will give us an initial indication whether we have or not a single in-depth patient population. We also haven't disclosed the delta or the percentage change that we are looking for in between the treatment arms and what the studies powered for. However as a general concept without specific study related number, I can tell you that anywhere above 10% difference in our RFS [ph] in 18 month between any treatment will be a significant result.

Okay, great. And if you're in consolidation in that patient population versus relapse/ refractory, could you use this data for registration if its significance or do you need a pivotal study and maybe the size of a pivotal study that you might need?

So, we are in discussions with the regulatory authorities about that. It obviously will depend on the results and their robustness of their results. Our initial plans although these are not finalized with the regulatory authorities, yet we are – I would say building on another single pivotal study the most.

Okay, great. Thanks for taking the questions. Congratulations again, Phil.

Thank you very much. I appreciate it.

The next question is from Mike King of JMP Securities. Please go ahead.

Hey, good morning, guys. Thanks for taking the questions. And let me eco everyone's else sentiments to both Phil and Kinneret. Just a quick question on 8040. In the pancreatic setting I remind you that a publication recently in – I want to say, nature medicine, that had to do with different molecule FAK inhibitor that had effect on the tumor trauma in micro-environment. I just wonder if you could remind us what role of 8040 maybe presenting a similar biological effect and if that's what you're looking for as far as the combination studies with [Indiscernible] concern?

Great. Go ahead, Arnon.

Thanks Mike. In essence what we're looking for is quite similar to the study I've mentioned. With the bit more detail and some more mechanistic rationale, what we're looking for here is we know that the tumors that are not responsive for any immuno-oncology type treatment as single agent are suffering from a variety of causes that are driving those lack of responses, one of those being the infiltration and the attraction of the immune cells into the tumor mass [ph]. There's a lot of chemokines that have been shown, they have something in animals through that. One the robust, ones was CXCR4 that based on the CXCR4 and CXCL12, Access is actually dissolving the micro-environment resistance or lack of penetration of T-cells into the tumor mass. We have preclinical data that support this. Others have preclinical data to support it. In our studies both of them, the one that we run separately with Merck and the one that Merck and MD Anderson Cancer Center are running, both will look carefully into the changes in the micro-environment, the infiltration, as well as the correlation of these findings with clinical response. So, we feel that between these two studies if there is in effect there either pharmacodynamic or pharmacodynamic that is accompanied by clinical benefit, both will be flashed in those two studies supporting further developments in the pancreatic arena.

Okay. That's helpful. And then I just, you know, I think, Joe P. ask the question about, future strategy of the company, and I know we've had this discussion in number of times about what is BioLine want to be when it grows up? And I'm just wondering if we're going to see any folks going forward, let's say further on oncology as suppose to various outside of oncology? Thank you.

Yes. So, I mean, obviously as we've mentioned in the past, we're focusing on oncology and immunology, I will say and I'm not trying to avoid the question, but I do think that we mentioned that we're having Investor Breakfast in New York on September 22, and at the breakfast we are intending to set forth our overall strategy for the company. How we would like to -- BioLine to look in five years from now – three to five years from now. And so, I would like to push that off until that time when we will both discuss that at the Investor Breakfast and also put out a press release relating to that.

Okay. Fair enough, Phil. Thanks, appreciate for taking my question.

Thank you.

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his concluding statement, I would like remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-326-9310. In Israel, please call 03-925-5904. Internationally, please call 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

Yes. I would. I would like to thank all of you for joining us on today’s call. We remain commitment to making steady progress on our existing clinical programs as well as the introduction of promising new programs and assigning of new collaborations. We remain well funded to achieve all of these significant milestones we've mentioned and look forward to keeping you updated as we execute on our plans. Thank you again for joining us and for your continued support. Have a good day.

Thank you. This concludes the BioLineRx second quarter 2016 conference call. Thank you for your participation. You may go ahead and disconnect.