Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2023 Financial Results 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. I would now like to turn the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

Thank you, Operator. Welcome, everyone. Thank you for joining us on our fourth quarter and full year 2023 results conference call. Earlier today, 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'd like to remind you that certain statements we make during the call will be forward-looking. If have such statements due to future events and are subject to many risks and uncertainty, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly report on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on our APHEXDA launch then turn the call over to Holly who will go into the Stem Cell Mobilization opportunity in more detail. I will then provide an update on our clinical programs in pancreatic cancer and sickle cell disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Following the launch of our product in stem cell mobilization just a few months ago in Q4, we expect substantially all of 2024 to continue to be a foundational period for the commercialization of APHEXDA, the first advancement in stem cell mobilization in over a decade. Since FDA approval in September and the subsequent launch of APHEXDA in U.S. in Q4 early signs among payers and top tier stem cell transplant centers suggest that the APHEXDA value proposition is resonating very well and evolving the stem cell mobilization treatment paradigm for patients with multiple myeloma. Recall that a key consideration when we elected to commercialize APHEXDA independently in the U.S. was that end users of APHEXDA transplant centers are well defined with approximately 80 of 212 transplant centers performing the vast majority approximately 85% of all procedures. Among this defined population, we have already secured formulary placement within these top 80 transplant centers managing approximately 20% of all stem cell transplant procedures at these institutions. Those familiar with commercial launches know that institutional pharmacy and therapeutic committees or P&Ts determine formulary…

Thank you, Phil. As Phil indicated, patients, physicians and transplant center teams have begun experiencing strong stem cell mobilization results with APHEXDA. We call this the A-plus A for apheresis experience. Importantly, each positive experience resonates within institutions already using APHEXDA and supports strong peer-to-peer conversations between physicians at other institutions. As Phil said earlier, last quarter and this full year is foundational for APHEXDA commercialization. The pathway to adoption of any new drug of this type is roughly the same. P&T committee scheduling and review, institutional protocol development and staff training, first patient scheduled and use, experience assessment, reorder. This cycle will happen across our top 80 centers and is occurring at a pace that we anticipated. We have a very strong value proposition for patients, transplant centers and payers and it is resonating. Our goal is to significantly reduce patient and caregiver burden by providing increased assurance in individual apheresis journeys. Additionally, for transplant centers with significant apheresis volume, we can show the advantages that APHEXDA provides for scheduling and use of chair time. Remember that patients with multiple myeloma in the United States are now often treated with quadruplet induction therapy, which includes lenalidomide and bortezomib. Quad therapy leads to the highest rate of complete responses and prolonged progression free survival. However, this combination is known to contribute to poor stem cell mobilization collection experiences, which leads to an increase in the amount of apheresis session needed to collect the targeted number of CD34+ positive stem cells stem cells required by institutional protocols. With treatment for multiple myeloma moving to quad therapy, we believe this further strengthens our value proposition. Our targeted field force which was hired based on their significant and relevant experience is educating transplant center and apheresis' leadership team on the benefits of APHEXDA.…

Thank you, Holly. Turning now to our second development indication for motixafortide pancreatic cancer. Remember that motixafortide has been shown to leverage the expression of CXCR4 on different immune cells and can increase the effectiveness of immune system treatments for solid tumors. CXCR4 is highly expressed in over 20 solid tumor types and correlates with poor patient prognosis. In studies with PD-1 inhibitors and chemotherapy in pancreatic cancer, PD-1 inhibitors, a major background of immune therapy today have shown almost no therapeutic advantage. However, in several preclinical studies and more importantly in an 80 patient Phase 2 study with two cohorts that we completed a few years ago, we demonstrated that motixafortide is synergistic with PD-1 inhibitors in the treatment of pancreatic cancer. This Phase 2 study showed proof of mechanism of synergistic effect with PD-1 in multiple late stage treatment lines as well as promising efficacy when motixafortide is combined with both a PD-1 inhibitor and chemotherapy in second line pancreatic cancer patients. Based on this promising data, we entered into a Phase 2 study collaboration in first line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron. Recall that the trial known as Chemo for met panc originally had an initial pilot phase and based on the results of this pilot phase an assessment would be made on advancing to an expansion phase of the study. As we presented at the AACR Special Conference on Pancreatic Cancer last September, the data in the pilot phase of the study was quite compelling. 7 of 11 patients were 64% experienced a partial response of which five were confirmed PRs as of the July 2023 cutoff date, with one patient experiencing complete resolution of the metastatic lesion in the liver. Along with the three patients are 27%…

Thank you, Phil. As is our practice in our financial discussion on this call, we will go over the most significant items in our financial statements; revenues, sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. I invite you to review the filings we made this morning that contain our financials 20-F and press release for additional information. Total revenues for the year ended December 31, 2023 were $4.8 million compared to no revenues for the year ended December 31, 2022. Revenues in 2023, all of which were recorded in the fourth quarter primarily reflect a portion of the upfront payment from the Gloria Biosciences license agreement of which $4.6 million was recorded in 2023 as well as $0.2 million of revenues from product sales of APHEXDA in the U.S. Cost of revenues for the year ended December 31, 2023 amounted to $3.7 million compared to no cost of revenues for the year ended December 31, 2022. The cost of revenues in 2023, all of which was recorded in the fourth quarter primarily reflect a $3 million sublicense fee to the upstream licensor of APHEXDA for payable on closing of the exclusive license agreement in Asia as well as amortization of an intangible asset in respect of this license revenues in the amount of $5 million. Cost of product sales were insignificant representing approximately 6% of related sales. Research and development expenses for the year ended December 31, 2023 were $12.5 million as compared to $17.6 million for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixafortide as NDA supporting activities as well as lower expenses associated with completion of the AGI-134. Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million as compared…

Thank you, Mali. In closing as is our custom, I would like to take a few moments to summarize our key upcoming milestones. First, continued commercial ramp up of APHEXDA in the U.S. Next, commercial expansion in Asia with collaboration partner Gloria Biosciences, then initiation of bridging study by Gloria Biosciences in 2024 to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China. Next is completion of recruitment in the Phase 1 pilot study of motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine with initial data expected in the second half of this year. Next is continued recruitment in the chemo for med panc Phase 2 randomized clinical trial in first line metastatic pancreatic cancer sponsored by Columbia University. And lastly, preparation activities with Gloria Biosciences on a randomized Phase 2 clinical trial evaluating motixafortide in combination with the PD-1 inhibitors in barilumab and standard of care chemotherapy in first line pancreatic cancer. 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 John Vandermosten of Zacks.

Just to get a little bit better understanding about how the formularies work and when APHEXDA's added to the formulary, is it immediately replacing the third support and other alternative or is there it sounds like there's some education that's required to get students to on board with it. Is that correct?

John, so I just want to make sure I guess the line isn't that clear. I want to make sure I understand. First of all, good morning. And, second, I think are you asking about the formulary process, how it works and how long the process takes? Is that -- did I understand correctly?

Yes. And also, are the teams immediately picking up the use of APHEXDA or is there some education required to get them to get on board with it?

Holly, would you like to take that?

Yes. That would be great. So you're right. With this type of a product, formulary acceptance is critically important. It behaves while this is an outpatient product, it is sold in transplant centers associated with hospital institutions and therefore does require a P&T approval. So the way that it works is that I mean this is work and that's exactly why we put the three field teams in place, sales, medical, as well as the payer team. And what required is, always having a clinical champion, an MD clinical champion, and then making sure that the message gets out to those who are associated with making the decision, and then you need to get on the schedule for formulary for the P&T committees. This can take several months. And then once the decision is made, the formulary decision is made then protocols need to be in place, order sets then need to go in place. So that takes, some time. Some institutions have P&T meetings, monthly. Some are every other month. These are things that the field team knows and understands and we are working critically hard on getting on those formularies. So once on, yes, we have gotten several acceptances, and we are very happy to be selling APHEXDA in many institutions. It's really very much up to the institution as to what those protocols look like and whether it's kind of sole formulary or if it's a shared formulary. I will say that we have had some institutions which have made the full switch over to APHEXDA for multiple myeloma. But I do want to make sure that, I've answered your question clearly and that everyone understands that this cycle does take some time and therefore the uptake ramp for APHEXDA is exactly as we were expecting. It's a little bit of a slower uptake than something such as like a retail product et cetera. Now does that answer the question?

Yes. That does. And then kind of continuing on from there, it sounds like there is somewhat of a standardized process to getting on the formulary, but is there a big level of difference in difficulty? I mean, maybe there's a lot more hoops you have to jump through for some formularies rather than others? Is it pretty similar or somewhat harder?

We have a saying that if you've seen one transplant center, you've seen one transplant center. So there are ranges of ease or difficulty by center. So it's not that standard. Getting to know who the decision makers are is always the first challenge, and then being able to get to those individuals is important. You did ask a question that I -- part of the question initially that I don't think I answered. It is really, really important that there is either during and then after the formulary decision that education and in servicing, we call it in servicing with the institutions is in place so that, everyone knows how to dose the product, everybody knows how to administer and have best patient care. So it is definitely a process and it differs most certainly by institutions. Some are quicker and some have a little bit more of a prolonged formulary process. So we, the field teams understand these differences and then they work center by center on what is required.

And second question is on the gene therapy opportunities. I think you suggested that the two approved sickle cell gene therapies, I think it's Casgevy and Lyfgenia, are being used in the Washington University study. Have you been contacted by other gene therapies to possibly look at other uses of motixafortide in gene therapy processes?

So first of all, John, I think there might be a mistake. I don't know or a misunderstanding because we are doing a Phase 1 trial for mobilization of sickle cell patients, at Wash-U, but these are not patients that are receiving any gene therapy, neither Vertex is nor Bluebirds at this point. So I just wanted to make sure that you understand that and if there was a misunderstanding, I apologize. So how -- but we are I mean, I just, I can say that we are speaking with companies and with institutions, et cetera, et cetera. This is an area of real interest to us. I mean, we see this as a huge potential upside for the company. These patients require huge amounts of cells, 15 million to 20 million hematopoietic cells per kilogram and have very a lot of difficulty mobilizing, especially since they can't get G-CSF. So we think that we have a great product for them and we're very much looking forward to getting the safety data and some initial efficacy data so that we can continue to make noise in this area and enter into other collaborations on the way towards being able to sell the product.

Can I add on to that? I just want to be clear about the opportunity. This would be for ex-vivo type of approaches or those approaches -- those gene therapy approaches which require CD34+ stem cells it would not be applicable for say a gene therapy, like an AAV gene therapy. So in looking at the gene therapy opportunities, our focus obviously would be on those that require stem cells in order to complete the gene therapy. That would be most definitely the focus as is with sickle cell as Phil just spoke of.

John, did that answer your question? Is there anything else?

No, I appreciate the answers, Phil. Thank you.

The next question is from Joe Pantginis of H. C. Wainwright.

This is [Lander] on for Joe. So regarding the Phase 2 study in pancreatic cancer in China with Gloria, I wonder if you could provide some color on the preparations. Do you anticipate any difficulties with the Chinese agency or recruitment or site activation of the trial? And also are there plans to expand to additional Asian territories besides Macau and Singapore?

Hi, this is Ella. With regards to the PDAC study in China -- we are Gloria is planning to submit it to the regulatory authorities and hopefully the study can be initiated early by the end of this year or by the latest early next year that's with regards to the PDAC. I think the question you asked of expanding in additional territories, you're relating to the PDAC, was this related to PDAC or stem cell mobilization?

Maybe both. It's Gloria. Are you planning on any agreement with Gloria to expand to additional territories beside China?

Yes. So maybe I can take that. So first of all, in PDAC, I also want to answer the second part of your question. We anticipate Gloria being able to recruit the patients quite quickly. As I mentioned in the prepared remarks, they were able to bring a drug in two indications for approval in China within four years, which is on Western terms very, very significant and very quick. And so I think their ability to recruit the patients for the Phase 2b study in PDAC is quite significant and some of the institutions there are quite large in comparison to institutions in the West. As far as where they're going with the, for in other territories, I guess we can separate that into stem cell mobilization and PDAC. So with regard to stem cell mobilization, there are a number of territories because we have FDA approval, there are a number of territories in the Asia region, mostly in southeast Asia, like Singapore, some areas of China I think Macau, et cetera that have a sort of an early access type of program where you can use a drug, a U.S.-label drug based on FDA approval and sell into the territory to various hospitals, et cetera, et cetera. And so they are working very diligently to try to start the commercialization very quickly in these smaller areas. But as far as the larger areas of the territory, for example, China, Japan and Korea, our assessment and their assessment as well is that there will probably be a bridging study, one or more bridging studies required that include Asian patients in order to get regulatory approval for stem cell mobilization. So that's regarding stem cell mobilization. With regard to pancreatic cancer because pancreatic cancer has no approval anywhere, the pathway is obviously much longer. They're still, they're going to be starting the trial in China and I think that right now that's sort of the main focus in pancreatic cancer is to get the trial up and initiated in China and see what the results are and then based on that expand perhaps into other areas. We would be thinking as well about at some time down the road based on this data, interesting a partner, getting a partner interested in a large registrational Phase 2, 3 global trial but that's a little bit down the road. But that's sort of the pathway right now for Gloria in Asia. I hope that answers your question.

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 1-888-295-2634. In Israel, please call 039-255-0904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with our ongoing commercial ramp of APHEXDA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I am excited for what we are poised to accomplish over the remainder of year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing you our next comprehensive quarterly May. Be safe, and have a great day.

Thank you. This concludes the BioLineRx fourth quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.