Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 Conference Call. All participants are presently in a listen-only mode. Following 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 Tim McCarthy of LifeSci Advisors. 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 first quarter results conference call today. Earlier this morning, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I will begin with an overview of our first quarter. Then Mali Zeevi, our Chief Financial Officer, will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Joining the call as well for Q&A are Abi Vainstein, our Chief Medical Officer; and Ella Sorani, our Chief Development Officer. I'll start with a brief introduction. As we approach the most important milestone of the company's history, we are increasingly optimistic about the potential of Motixafortide as part of a new treatment paradigm in stem cell mobilization for multiple myeloma patients, physicians and transplant centers. Driven by this enthusiasm, we have been working tirelessly to both prepare a new drug application and to position this therapy for a robust and successful commercial launch in 2023 if approved. Moving on to the NDA submission. As mentioned, we are moving forward aggressively and efficiently with the completion of our NDA and remain on target for a mid-year submission consistent with what we have stated previously. Recall that in mid-December of last year, we held a pre-NDA meeting with the FDA to obtain agreement from the agency that our single Phase 3 Genesis study would be sufficient to submit an NDA from a tech support site as a stem cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients. Needless to say, we were very pleased that the FDA agreed that our proposed data package would be sufficient to support an…

Thank you, Phil. As is our practice, in our financial discussion, we will only go over a few significant items on this call, research and development expenses and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, operating and financial review and press release for additional information. Research and Development expenses for the quarter ended March 31, 2022 were $4.4 million, an increase of $0.1 million, or 3.7%, compared to $4.3 million for the comparable period in 2021. The increase resulted primarily from an increase in expenses associated with the AGI-134 study, offset by lower expenses associated with the completed Motixafortide, Genesis and combat clinical trials. Turning to cash, the company held $50.6 million of cash, cash equivalents and short term bank deposits as of March 31, 2022. We believe we are well financed to achieve multiple potentially value creating milestone milestones into the first half of 2024. And with that, I'll turn the call back over to Phil.

Thank you, Mali. In closing, as is our custom, I'd like to take a few moments to summaries our key upcoming milestones. First submission of an NDA to the FDA Motixafortide as a novel mobilization agent for multiple myeloma patients undergoing autologous stem cell transplantation in mid-2022. Second, announcement of initial results for part two of the Phase 1/2a trial of AGI-134 in solid tumors in the second half of 2022. And now for some slightly longer term milestones. We plan to initiate a Phase 2 study for AGI-134 in 2023. We hope for potential FDA approval from Motixafortide in 2023. And we hope to potentially launch Motixafortide in the U.S. in stem cell mobilization in 2023. With that, we have now concluded the formal part of our presentation. Operator we will now open up the call to questions.

[Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Thanks for taking the questions, and congrats on the quarter progress. Phil, I guess I'm just wondering if you've commissioned any European market assessment for pharmacoeconomic studies for Motixafortide and maybe you can offer some comments on the potential timeline for an [indiscernible] from Motixafortide

Yes, so first of all, Mark, it's good to speak to. So yes, with regard to a market assessment and pharmacoeconomic study, we do plan to do that we have not yet done so. And when we do so, we will be of course, disclosing that and giving some information on that. But that is -- that is definitely something that we plan to do. With regard to Europe in general, our approach is to complete the FDA submission. And once we've completed the FDA submission, to use that submission as part of our submission to the EU, and so that should hopefully be happening, you know, sometime, you know, later this year, early next year.

Okay, got it. And just looking at clinical trials.gov. It looks like the Columbia University study of Motixafortide in pancreatic cancer is still running. You know, I'm just wondering if they're - if we can expect to see any data from that in 2022, or maybe next year? Any clarity on that would be helpful.

Yes. So, as we disclosed in our in our public filings, we're now looking at potentially some data coming out in the second half of this year. However, I do want to say that since we're not controlling the study, and it's being done, you know, it's an investigator initiated study, we have more or less control over the timing. So our current estimates are sometime in the second half of this year. But again, it's caveated by the fact that it's an investigator initiated study.

The next question is from John Vandermosten of Zacks. Please go ahead.

Good afternoon, Phil, Mali, how you doing? Wondering first step you made so far to fill out the commercialization process and I'm also wondering how the pitch would go to payers and providers, you know, assuming approval for Motixafortide and SCM?

So, you would like to know what activity -- I didn't hear the first part of the question, you want to sort of know what the pre-launch activities are that we're doing right now? Is that the first part of the question?

Yes.

Okay. So, I mean, the first one, so we're doing I mean, there are a lot of things that, you know, I think we've mentioned that we're maintaining optionality, we're speaking with potential partners, co-commercialization, commercialization partners. But we're also looking at, you know, launching independently, and a lot will depend on the value that we believe would be -- would bring the highest amount of value for the product. And so we really have two main principles here. One is launching on time doing whatever it takes to launch on time. And the second principle, of course, is to maximize the value of the asset. And so with that overall philosophy and approach in mind, we have initiated a number of critical activities that would be required for us to do under any circumstance. So those are things like a supply chain partnerships, like commercial packaging, serialization, we've also initiated Medical Affairs activities, because we want to already sort of drive the key scientific messages in our areas of interest in an investigator initiated study program. We completed our brand name selection, and we've submitted it to the FDA. And we've also initiated branding efforts to make sure they're all in place for, you know, for those submissions, we're looking at also with a market access and activities that we're starting to initiate, for example, third party logistics, 3Pl selection, distribution, network strategy, et cetera. So we are [indiscernible] studies. So, you know, we're moving forward with these kinds of activities that need to be done under any circumstance, so that we can, you know, whether if we partner along the way, then we'll be able to still make sure that the launch happens on time? And if not, and if we decide to go forth independently, and then of course, these are activities that must be done. So that's the first part of your question. Can you remind me of the second part of the question. The pitch?

That was just -- it's just a pitch that you'd make to payers and providers, but before I ask that, actually, what about a hybrid model? Might that make sense at all? Or does it not make sense to split it up with only 80 targeted places in the U.S.

I mean that was sort of, that I think, in any event, the idea would be, I think even you know, when we're speaking with partners, obviously, this is a, this is a market that's, you know, custom-made to really focus on the top 80 institutions, because they represented the -- top 79 institutions represent over 80% of all the Stem Cell Transplantations in the U.S. So I think that, you know, based on, you know, our discussions with also potential partners, but also just our own analyses, it makes sense to really focus on those institutions. And by the way of those institutions, we have a number of those institutions were part of our phase three trial. So we already have, you know, the physicians there. The hospital itself, they're aware of the efficacy and the clinical benefit of our, of our drug. And then, of course, on an opportunistic basis, it would make sense to then spread out to some of the larger institutions amongst the 130 additional institutions that make up the full 212 hospitals across the U.S. So does that answer your question?

Yes, it does.

Okay. Now, of course --

Just on the pitch, I guess, like the short elevator pitch that you'd make, you know.

Yes, well, the short elevator pitch would be a bit depending on how many stories there are in the building, but I have to say that one aphoresis session, we can mobilize the target number of cells, and 90% of the cases, we can give much more certainty to the aphoresis units regarding the amount of aphoresis sessions that the patients have to undergo because right now, the scheduling and logistic issues are, you know, a nightmare at these institutions. In fact, we hear that sometimes transportations or the whole process has to be delayed because they cannot guarantee that a new patient will have, you know, a seat or a machine that they can -- that they can use. I think also the safety benefits are of course, of having lower aphoresis sessions, a very important. I think the fact that even if you require more than one apheresis session, we because of the receptor occupancy and along with receptor occupancy of our molecule, we can get two apheresis sessions at only one administration, which is on top of G-CSF which is a huge advantage. I think that's the main elevator pitch. You know, obviously, we're -- we believe in our studies show that we're also more cost effective. So the logistics, the clinical benefit to the patients, the cost benefit to the entire system and payers et cetera. So I think that's our main pitch.

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 in two hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 925-5904. Internationally, please call (972) 392-55904. Mr. Serlin, would you like to make your concluding statement?

Yes, I would. Thank you, Operator. To summarize we remain on track to submit our NDA from Motixafortide and stem cell mobilization mid-year. While we in parallel advanced key pre-launch activities that would be required under any commercialization scenario. We are maintaining full optionality with respect to the commercialization of Motixafortide in the U.S. with the ultimate goal of executing a robust launch if approved, that maximizes the value of the asset. We believe we can capture a significant share of the U.S. market estimated to be in excess of $360 million. From both the clinical and pharmacoeconomic perspective, we believe Motixafortide on top of G-CSF can quickly become the standard-of-care in this important indication. At the same time, we are working to expand the use of Motixafortide in other indications including PDAC, and are moving forward with the development of AGI-134. As we stated last quarter, we believe we have set the stage for a catalyst rich year that will inform the evolution of the BioLineRx portfolio. Thank you all very much for your continued interest in BioLineRx, and we look forward to providing our next comprehensive update in August. Be safe and have a great day.

Thank you. This concludes the BioLineRx first quarter 2022 conference call. Thank you for your participation you may go ahead and disconnect.