Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRX Fourth Quarter and Full Year 2014 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 Josh Drumm of Tiberend Strategic Advisors to read the Safe Harbor statement. Josh, 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, confident, 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 conditions 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 the 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.

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…

Thank you, Phil, and good morning, everyone. As we mentioned, BioLine continues to focus primarily on our lead clinical candidates in oncology and immunology. Those are our BL-8040 oncology platform and BL-7010 for the treatment of celiac disease. As Phil highlighted, we recently expanded our clinical strategy for BL-8040 to include three additional hematological indications beyond our ongoing program in relapsed/refractory AML and stem cell mobilization. The reason for our further investment in the BL-8040 platform is to capitalize fully on this compound demonstrated best-in-class potential, which stems from its unique dual mechanism of action. Based on compelling clinical results to-date including the partial Phase 2a data that were presented at the ASH conference in early December, we look forward to executing our comprehensive development plan for BL-8040 and through reaching several meaningful value inflection points. The first new study for which we recently announced filing of the regulatory package to begin enrolling patients will be a Phase 2b study in consolidation therapy for AML patients. We expect to initiate this trial in the next couple of months followed by initiating of a Phase 1/2 trial for BL-8040 in combination with the FLT3 inhibitor sorafenib in patients with FLT3-ITD mutated AML. We will also access BL-8040 as a treatment for certain conditions where there is a deficiency in the number of blood cells produced in the bone marrow namely MDS and aplastic anemia. For this program, we are planning a Phase 1/2 trial for BL-8040 in combination with the standard of care, which we also expect will commence in the second quarter. We are very excited to begin these studies and to further explore the potential of BL-8040 to be a market-leading drug in methodological oncology and other methodological conditions. In terms of our ongoing studies, we completed the randomized,…

Thank you, Kinneret. Let me please turn your attention to the financials for the year ended December 31, 2014. Although our reporting currency through December 31, 2014 was Israeli Shekel, for the convenience of the listeners on this call, the analysis will be done on a dollar basis only. The transition into dollars has been done at the representative rate of exchange as of December 31, 2014 of NIS3.8889 to $1. Parenthetically, I would like to take this opportunity to mention that starting January 1, 2015, our functional and reporting currency will be the U.S. dollar and we will no longer be reporting in Shekels. Now to the financials. Research and development expenses for the year ended December 31, 2014 were $10.9 million, a decrease of $0.4 million or 3.7% compared to $11.3 million for 2013. The decrease resulted primary from termination of the BL-1020 CLARITY trial in March 2013 as well as certain one-time costs associated with several clinical-stage projects in 2013, which were partially offset by increased spending on BL-8040, BL-7010 and BL-5010 in 2014. Sales and marketing expenses for the year ended December 31, 2014 were $1.5 million, an increase of $0.4 million or 38.6% compared to $1.1 million for 2013. This larger increase resulted primarily from professional fees related to increased business development activities, including professional services related to the collaboration agreement with Novartis and the out-licensing agreement with Omega regarding BL-5010. G&A expenses for the year ended December 31, 2014 were $3.5 million, an increase of $0.1 million or 2.8% compared to $3.4 million for 2013. This small increase resulted primarily from an increase in salary-related payments. Our operating loss for the year ended December 31, 2014 amounted to $15.9 million compared with an operating loss of $15.8 million for 2013. We recognized net non-operating…

Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. [Operator Instructions]. The first question is from Joe Pantginis of ROTH Capital Partners. Please go ahead.

Hi. Good morning and good afternoon. Actually, Phil, first question for you if you don’t mind. Regarding G&A, there was obviously a bit of a jump now. I was just curious if this is considered a baseline for a run rate going forward?

There wasn’t much of a jump. We’ve been more or less at the $3 million – first of all, good morning to you as well, sorry. There wasn’t much of a jump. We’ve been in the neighborhood of $3 million to $3.5 million for quite a while, so this should be our baseline more or less going forward and as it’s been in the past.

Okay, great. And then maybe for both of you, I guess, obviously the focus is with 8040 for AML and the collaboration with Novartis. I was just wondering maybe if you can add a little more detail regarding the value proposition as the drug is a potential stem cell mobilizing agent and what are the potential next steps in the clinical development plans for that arena?

Okay, great. It’s Arnon. I’ll answer that. In terms of the value proposition for BL-8040 for stem cell mobilization and hematological stem cell transplant, we find that our target product profile of a single day procedure in which we give the drug the single injection and then collect the cells at the same day is actually quite promising value proposition as both for allogeneic and autologous stem cell transplant where the whole procedure can be done in a single day without the need for use for G-CSF or other stem cell mobilizing agents in that procedure. So by that it’s quite a significant change to the procedure that’s done today, which is a five-day procedure and involves one or potentially more up to three apparatus to get the amount of cells required for a transplant. In terms of our next steps, we plan to finalize and summarize the study’s data and approach the FDA during Q3 this year to discuss the development path forward both for allogeneic and autologous transplants and we expect to be in the clinic again in the next half of 2016 executing the agreed program with the FDA towards registration.

Okay. Thank you very much. It was very helpful.

I just would like to add, it’s Kinneret, that the same issue that is relevant to the proliferation activity that is due to G-CSF treatment is not expected to be part of the treatment with BL-8040, which is another advantage over the current therapy.

Okay. Thanks, again.

You’re welcome.

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

Hi, guys. Thanks for taking my questions. I appreciate it. A couple; would also like to start with 8040 and just ask you what your thought process is on – I know you’re doing the one study in combination with sorafenib in the FLT3 positive AML population but I am wondering is there any other thought been given to patient enrichment strategies, and if so what might they be and would you be looking at those in the early part of the trials or in the dose expansion cohorts?

Well, in terms of the FLT3-ITD positively mutated patients, our clinical design currently is a Simon Two-stage design and which will start with a dose definition, then will enrich the population into three distinct populations; one is patients that are younger than 65 years of age that have relapse and did not receive any type of FLT3-TKI treatment in the past. Ones that were exposed to a FLT3-TKI that is not sorafenib. That’s the second population. The third population is elderly patients that are naïve that have just been diagnosed with AML and FLT3 positive. So actually the trial designs there already include enrichment to three type of populations from which we can select the best population for further studies.

I guess the question was more to do with genetic risk factors or other potential prognostic genetic factors rather than just by age.

Yes. We do follow the genetic panel of mutations and what we envision is that we will be able to correlate each one of those populations with the different genetic panel that they started with. By that we can in our future study when we decide which one of those populations is to be taken forward to focus more on a subset of genetic markers in addition to the FLT3-ITD.

Okay. And would the same be true in a broader AML population or --?

Yes. For the relapsed and refractory, we’re following that but we’re not sure that that will play a significant role as those patients are already in their second and third line of treatment, so the effect there is less. In our consolidation study, for sure that is part of the stratification we’re doing and we’re stratifying the groups between treatment and placebo based on the risk factors and we have defined those as high, medium and low risk.

Okay, fair enough. And then just a couple of quick questions about celiac. I understand that the trial is structured as a challenge trial. Just curious if you can perhaps talk about that for how long it may take to execute such a study and also curious about if you could talk about how you arrived at a dose? Is it relative to the amount of gluten burden [ph] or body weight or some other metric that you’re using to decide the dose?

Sure. Starting with the study design and the duration to execute it, we’re planning six-week long challenge study with additional two weeks of follow up following the end of treatment. We’re planning it as an adaptive design, which will give us an early insight to which one of the tested doses is effective and will focus on that dose compared to placebo for part two of that study. We envision that we’ll need around 90 to 120 patients. We’re still calculating numbers there, but that’s the ballpark of celiac patients and we expect that the total study will take us somewhere between 18 to 24 months to execute. In terms of the study population and how do we get to the dose, so it actually is very standard to use a gluten challenge of 3 grams as the placebo group needs to develop some damage to the intestinal mucosa for us to compare this to the protective effect of BL-7010. So the challenge dose is quite fixed. It’s 1 gram three times daily and the doses that is selected for treatment or to prevent the damage are based on the safety profile that we got from our Phase 1b study and from what we expect for preclinical work is a sufficient enough dose to counter effect this 1 gram of gluten challenge. So there will be two doses there active versus placebo at the first part. Both are expected to be preclinical work effective and we’ll choose one of those two doses to go forward into the Phase 2 of this study.

Great. That’s very helpful. I appreciate the color. And then can you comment also about your plans for U.S. IND and what requirements you might need to fulfill in order to open the U.S. IND [indiscernible]?

Sure, no problem. So what we are looking at here is in order to get to the U.S., there’s going to be a change in population where in Europe based on our device specification we’re conducting this challenge study. In the U.S., we’ll be targeting sort of a different population as all the U.S. programs for celiac are, and those are symptomatic patients that are symptomatic on top of a gluten-free diet. And there we’ll not be looking at a challenged study but rather on a study that will look at our relief of symptoms and we’ll also evaluate the mucosa using biopsies. So what we’ll require for that study will be some additional preclinical toxicology work that we intend to execute next year and our program in the U.S. will be going forward as we get positive results from our interim analysis in the celiac study. In any case, what we are looking for in the U.S. is a subset of the population. The FDA currently is only accepting drugs and treatments for GI diseases that are triggering clinical benefit. By that we’re going for symptomatic patients and those are 30% of all the celiac patients. So in the U.S., the registration is going to be for symptomatic patients. In the EU, the label is going to be a bit broader as this is a medical device.

Right. Okay, terrific. That’s again very helpful. One final quick question and it has to do with – go ahead, Kinneret.

I just want to add that about 1% of the world population suffer from celiac and out of this 1%, about 30% are symptomatic patients although they are on gluten-free diet. So this is the population that we are going to treat in the U.S.

Yes, got it. Okay, great. And then finally, just on Novartis, that relationship, I was just wondering if you can talk about sort of the mechanics of that. I’m just wondering how the idea generation takes place? Do the Israeli institutions come to you and say, hey, we’ve got this great idea. Why don’t you show it to Novartis? Does Novartis come to you and say, hey, we’ve got interest in this area at this moment. Do you know anybody at one of your institutions in your network that might be able to help us? Just without getting into all the gory details, just wondering how that relationship operates on a daily basis?

So in general, I think that the interaction is both ways. These can be universities, the TTOs and we also get request from the universities to meet us and to present to us the programs that they have either new programs or programs that made some progress in the last, let’s say, year or so since we sold the data. So we keep on having very close relationship with the universities but I have to say that not just talking to the technology transfer officers but also to the scientists; we are trying to attend the seminars, we are trying to visit the labs and actually to see exactly what’s going on in each university in Israel. Having said that, we are starting a kind of due diligence. We have a process, which we call Screen A, Screen B and then later on in a certain stage, we are starting to share this information with Novartis and at this point we’re trying to understand better what they are looking for, what are the projects that they would like to see earlier stage data, other projects that they will consider only when they are more advanced. So, it depends on the field, it depends on the program, so it’s a bit more than just two dimension.

Great. Okay. Thanks for indulging all my questions.

Thank you, Mike.

Thank you, Mike.

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

Thank you. Thanks, guys. Let’s switch gears and talk a little bit about 1040 and help me understand how much dialogue you’re having with the partner in terms of the U.S. clinical trial that should follow results from the European trial? And if you could take a few moments, I know that there was a dispute originally with Bellerophon, how was that resolved and what’s the relationship like now between the two companies?

Yes. Hi, Jason. Before I turn it over to Kinneret, I’ll just take the second part of that question. So, we recently reported that the dispute with Bellerophon was resolved to both party’s satisfaction and the relationship now I’d have to say is excellent. They have a new management team there from a formal management team. They have a new management team at Bellerophon. We’re very happy with the way things are going. We speak to them regularly. We have obviously our regular JDC meetings or what have you. And so, as I said, everything was resolved and the relationship is going very well.

Regarding the discussions with the FDA or about the U.S. study, the PRESERVATION 2 study, I cannot disclose all the information. Of course, I have my limitation and I can just say that the discussion with the FDA started long ago. We had a pre-IDE meeting with the FDA when the project was still in BioLine. And since then, the communication with this group continued and Bellerophon is now of course leading this discussion. I have to say that the EU study, which was the study of about 95, which is still ongoing, in this study there are 16 sites [ph] in the U.S. So the FDA is well involved in their ongoing study and the discussion is ongoing with them regarding the next step for the U.S. study.

Okay, thank you. I appreciate that. Can you help me understand a little bit better what the – how the timeline might develop particularly around commercialization if we have good data from the European study, when would that be announced? And then how long does it take for approval and would it be broad European approval? And then help me understand kind of the commercialization plan so that we can understand the timeline in terms of revenues and/or royalties back to you?

Yes. Okay, so first as Bellerophon announced, the top line results are expected around mid-2015. So this is public information. You need to take into account that following this study, the CE Mark registration will start and it’s a process of about 6 to 12 months. Regarding the commercialization, at this point I cannot disclose this information. We get an update from Bellerophon on a regular base. There is a communication meeting once a year, but we cannot disclose this information.

Okay. Thanks, guys. I appreciate all the progress. And I guess the last question and I just wanted to confirm, the current cash balance including the raise, can you just touch on those numbers again?

Yes, sure, absolutely. We haven’t announced our current cash numbers but we had, as I mentioned, $34.7 million as of the end of the year. We had gross proceeds from this offering of $28.8 million. We have enough cash resource – we have resources to bring us into the first half of 2018, so we’ve got at least a three-year runway of cash at this point.

Okay, great. And that would be excluding any milestones or royalties or things coming in from partners?

Absolutely. That’s on the most conservative basis. Of course, if we do have any milestones we have some type of commercialization or partnering transaction that obviously could extend our runway for quite a long time. But on a conservative basis, we have at least three years of cash.

Okay. And Phil, just one last comment which is can you give me any insight into the last share count?

Yes, sure. The last share count – I wish I had that number in front of me, hold on for one second. I believe the last share count is – I’ll tell you in one moment, bear with me. Yes, I don’t have that off the top of my head here. I believe it’s 50 – it’s about 54. I can tell you exactly – I think it’s around 54 million.

Okay. That’s good for modeling purposes. That’s all we need. Thanks, guys, and congratulations on all the progress.

Thank you very much.

[Operator Instructions]. There are no further questions at this time. Before I ask Dr. Kinneret Savitsky to go ahead with her closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-877-456-0009. In Israel, please call, 039-25-5944. Internationally, please call 972-3-925-5944. Dr. Savitsky, would you like to make your concluding statement?

Yes. I want to thank all of you for joining us on today’s call. Just to summarize, we achieved all of our R&D objectives for 2014 across all three of our lead development programs. We demonstrated clinical evidence for BL-8040 best-in-class mechanism of action in our ongoing AML study showing a direct effect on cancer cells as well as substantial mobilization from the bone marrow. We also completed the initial dose escalation stage of the first clinical study of the stem cell mobilization and announced our plans to expand into several new indications for this unique oncology platform. We completed a Phase 1/2 study for our novel celiac disease treatment BL-7010 and showed that the product was safe and well tolerated, and that there was no systemic absorption of the BL-7010 in the body. Finally, our partner Bellerophon successfully completed enrollment in the ongoing pivotal study of BL-1040, which is our most advanced partner asset as of to-date. In addition to our R&D achievements, we signed a landmark deal with Novartis that established BioLine as a partner of choice for the drug discovered and developed in Israel and out-licensed one of our non-core assets to a lead European OTC drug company Omega Pharma. Looking forward, we have several key inflection points anticipated for 2015 that we expect will be the primary value drivers for the company over the next year. We expect to have data readout for both of our BL-8040 studies first top line results from the stem cell mobilization study within the next week as well as for our Phase 2 relapsed and refractory AML study in the second half of 2015. Around mid-year, we expect to report top line results from the CE Mark registration study for BL-1040. In addition, we expect to receive approval for the device regulatory pathway in EU for 7010 from the Notified Body after we plan to initiate the pivotal study in Europe in the second half of 2015. Finally, we hope that other activities in the business development area will also mature this year. As you can see, we anticipate another exciting year for BioLine and we look forward to providing further updates. Thank you again for joining us today. Good-bye.

Thank you. This concludes the BioLineRX fourth quarter 2014 conference call. Thank you for your participation. You may go ahead and disconnect.