Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2019 Conference Call. All participants are at present in a 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 over the call to Timothy McCarthy of LifeSci Advisors to read the Safe Harbor statement. Tim, 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 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 Executive Officer of BioLineRx?

Thank you, Tim, and good morning, everyone. And thank you for joining us on our third quarter earnings conference call today. Earlier this morning, we issued our Q3 earnings press release, a copy of which is available in the Investor Relations section of our website. It was also filed in the 6-K. I will begin with the brief review of our programs and activities recap our milestones over the next several quarters. And then, Mali Zeevi, our Chief Financial Officer will provide a short discussion of our financial results. We will then open up the call to your questions. Also during the call for Q&A, are Abi Vainstein, our Vice President, Clinical Development; and Ella Sorani, our Vice President, Research and Development. During the third quarter, we continue to progress our lead therapeutic candidates BL-8040 and AGI-134 both of which were developing for the treatment of multiple cancer indications. Beginning with BL-8040, which we are evaluating in a number of phase 2 and phase 3 clinical trials in multiple oncology indications, including pancreatic cancer, acute myeloid leukemia and stem cell mobilization for multiple myeloma patients. Given the breadth of our development program we see BL-8040 as a platform molecule that can be combined with a wider array of different agents to potentially treat a range of cancers at various stages of disease. Our target indications are all difficult to treat cancers in urgent need of better therapeutic options, and this is reflected in the fact that BL-8040 has been granted FDA orphan drug designation in all three, pancreatic cancer, AML and stem cell mobilization. We're going to focus this morning on an update of our pancreatic cancer program where we expect a significant data readout by the end of this year. Recall that during the fourth quarter of last year,…

Thank you, Phil. In our financial discussion, we will go over only a few significant items on this call, research and development expenses and cash. Therefore, let me invite you to your views of the hour [ph] we issued this morning, which contains more detailed information. Research and Development expenses for the nine months ended September 30, 2019 were $15.3 million, an increase of $0.7 million, or 5%, compared to $14.6 million for the nine months ended September 30, 2018. The increase resulted primarily from higher expenses associated with the BL-8040, GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to BL-1230, a project which was terminated last year. Turning to cash. The Company held $30.1 million of cash, cash equivalents and short-term bank deposits as of September 30, 2019. We reiterate our previous cash guidance that our current resources are sufficient to fund our operations through our more significant clinical milestones. And with that, I will turn the call back over to Phil.

Thank you, Mali. In closing, I would like to take a few moments to summarize our upcoming data milestones, beginning with two milestones between now and the end of the year. First, response results from the Phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial of BL-8040 KEYTURDA and chemotherapy under the collaboration with Merck. And secondly, an oral presentation with additional data from the phase 2a triple combination COMBAT/KEYNOTE-202 pancreatic cancer trial at the European Society of Medical Oncology, Immuno Oncology Congress in December. And in 2020, we expect as follows; progression free survival and overall survival data from the COMBAT/KEYNOTE phase 2a triple combination study in mid-2020. Interim results from the phase 2b/a AML consolidation study during the first half of 2020. Topline results from the phase 3 GENESIS registrational study in stem cell mobilization in the second half of 2020. And finally, initial results from part 2 of the phase 1/2a trial of AGI-134 by yearend 2020. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.

Thank you. [Operator instructions] The first question is from Joe Pantginis of HC Wainwright. Please go ahead.

Hi, everyone. Thanks for taking the question. So I wanted to focus on sort of the broader potential commercial profile for BL-8040. And I know, I might be asking you to take some broad strokes here and you know, forward looking statements, but starting with the GENESIS trial, so obviously you said this is your potential first path or accelerated path through registration. Is this something you would potentially look to commercialize yourself? But of course, this is I guess a little more complex because you can't necessarily separate out indications for a drug, as you look for the oncology profile to expand as well and the potential partnering events around BL-8040 as well. So I guess how do we look at the commercial profile in the future?

Thanks, Joe. Yes, so, we are looking to partner out BL-8040 the entire asset for all indications. We think, we after bringing the data later this year, in pancreatic cancer, the data in AML in the first half of next year, and/or the data in stem cell mobilization in the second half of next year. We think that it would – BL-8040 would be a likely candidate for -- for licensing, for out-licensing for partnering. And so that's our strategy. If you recall, last year, we acquired an additional 20% of the economics of BL-8040. And one of the reasons was one of the outcomes of that acquisition was that it is a lot more commercially feasible to out-license the stem cell mobilization program at this point. The AML and pancreatic cancer solid tumor markets were much larger, and therefore, even without that additional 20% it was, had economic sense but, but subsequent to the acquisition is the addition -- additional 20% last year. The stem cell mobilization indication is also something that we believe we should be able to partner.

Great. And so I mean, I guess you're in a good position to have, I guess important potential first looks obviously from your current collaboration between Merck and Genentech as I guess potential players in there, if not others, but definitely looking forward to the December data and thanks for the color.

Thanks a lot.

The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Hey guys, congrats on the progress. And thanks for taking the questions. And congrats on the oral presentation at ESMO IO. Phil, I was wondering, or maybe this is better directed toward Abi. I was wondering on a on a very qualitative level, are you expecting any big difference between the types of pediatric patients that are being enrolled in the triple combination versus the types that were enrolled in the doublet combos? Either in the earlier keynote cohort or in the MD Anderson trial, we just thought to see this weekend?

Hey go ahead, Abi.

Okay. Yes, is a good question. Definitely, the patient population is different. It's more a homogeneous in order to try to have data who is more powerful and the strength of the data is, it's more valuable when you have a very, very well defined population as we have in this part of the study. As you may remind the first part of the study we have all patients in any line of treatment we have patients from second line through fifth line of treatments. And for this part of the study – and as well MD Anderson study as well. And in this part in the second cohort of the combat trial, we are only focusing in patients who are in second line who progressed in Gen-based treatment and they were diagnosis from the beginning as a metastatic disease. This is very important to remark because that might be a lot of difference based on the background of the patient. We believe that the results for a study which is multinational in so many sites with difference investigators and within a well-defined population, and with strength the results of our study.

Okay, that's very helpful. And also, would you expect in your presentation maybe at ESMO IO? Do you think, you'll be able to include spider plots so we can really get a sense for how the treatment may be offering or changing the growth trajectory of tumors in patients? Thank you.

Yes, definitely as one of the graphical representation of the data that we have. As you know, we don't have a lot of exposure to see a lot of long term assessment and this will be as Phil said before, in 2020 we will see more data on progression for survival and overall survival, but yes, we are planning to make some biographical presentations and data that will help the patient.

Okay, perfect. Thank you for taking the questions.

Thanks a lot of Mark.

[Operator Instructions] Please stand by while we poll for some more questions. There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his 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 1-888-782-4291. In Israel, please call 03-925-5904. Internationally, please call 972-3925-5904. Mr. Serlin, would you like to make a concluding statement?

Yes, I would. Thank you. That concludes our call this morning. I'd like to thank you again for your interest in BioLineRx and we look forward to providing future updates on our continued progress. Have a good day.

Thank you. This concludes the BioLineRx third quarter 2019 conference call. Thank you for your participation. You might go ahead and disconnect.