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 we make 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 the 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 status, the first step in center adoption and we anticipate that by year-end we will have secured formulary placement within these top 80 transplant centers managing approximately 60% of all stem cell transplant procedures at these institutions. We are pleased with this progress and momentum, which is right in line with our expectations. Our customer-facing teams have done a fantastic job working with centers to support them in developing protocols following P&T approvals and we are very pleased by the number of clinical champions we are gaining every day. We have also received several repeat orders from multiple institutions. These centers were early adopters and moved quickly through the formulary process and subsequent design and adoption of new treatment protocols. Importantly, one highly regarded transplant center has already transitioned to all of its patients to APHEXDA, as it recognizes the value of greater apheresis certainty. We are pleased by this early momentum despite the fact that some customers have benefited from lower acquisition costs for generic mozobil or plerixafor relative to reimbursement rates. This cost recovery advantage has been diminishing with time as reimbursement rates adjust to having generic plerixafor in the landscape. Meanwhile, transplantation centers are gaining the opportunity to experience the value APHEXDA can bring to their centers that extend beyond drug cost, including the overall economic benefit of reducing apheresis days and the predictability regarding the number of apheresis days and the impact this reduction has on patients as well as nursing and technical staffing for apheresis, particularly in today's difficult hiring environment and the competition for apheresis chair time. Staying on the topic of stem cell mobilization, recall that in October, we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of motixafortide across all indications in Asia. In order to receive market authorization for APHEXDA in China, a small bridging study is required. I'm pleased to share that the IND for this bridging study was filed in February with the Center for Drug Evaluation of the National Medical Products Administration and we anticipate regulatory action in May. The first patient dosed in this study is expected in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Bao region of China, in Singapore and in Macau over the next few quarters. We believe that commercialization in these territories will provide significant revenue in the second half of the year or early next year subject to regulatory approval. We estimate that Asia had over 51,000 reported cases of multiple myeloma, the largest number of cases globally, and stem cell mobilization for autologous transplantation represents a significant opportunity for both companies in the region. Needless to say, we are very pleased with how our Gloria collaboration is progressing. We are also pleased by the progress that we have made since our last quarterly update on our other motixafortide programs, notably, pancreatic cancer and sickle cell disease. I will provide updates on those programs in a moment. But at this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S. for a more detailed review of our early launch progress. Holly, please go ahead.

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 sessions needed to collect the targeted number of CD34+ positive 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 teams on the benefits of APHEXDA. Physician reactions from our meetings at ASH 2023 and more recently at Tandem 2024 have demonstrated a strong belief in our clinical data. Our poster session at both congresses further bolstered our clinical story. Since launch, we have made successful in-person contact with all top-tier centers. Overall, we estimate the top 80 transplant centers in the U.S. manage approximately 85% of all transplants annually. To date, we have been granted formulary approval by institutions which manage approximately 20% of all stem cell transplant procedures within these institutions. By the end of quarter two, we anticipate that this will increase to approximately 35% of transplant procedures at these top 80 centers. And as stated, by the end of the year, we anticipate formulary status in those managing 60% of the transplants in these centers. Now regarding the entrance of generic mozobil or plerixafor into the market. As we've said, while we consider plerixafor to be in the same overall market basket as APHEXDA, we do not see the generic plerixafor as comparable to our drug. APHEXDA is a second-generation CXCR4 inhibitor and has a highly differentiated product profile based on stronger and more predictable mobilization outcomes. Furthermore, our early discussions have shown a center to appreciate the innovation as they look to address their need for a better mobilizer. Turning now to payers. Payers view the APHEXDA clinical data very favorably and as a result, we have, to date, established access for 95% of covered lives across a mix of both commercial and government payers. We continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. Additionally, the Centers for Medicare and Medicaid Services issued us a unique J-Code for APHEXDA, which is critical for obtaining timely reimbursement from all commercial and government payers. Another way we provide reimbursement confidence is through BioLineRx Connect, our provider and patient services hub. Through this hub, providers can enroll patients to obtain assistance in benefits verification and prior authorization. If coverage issues arise, the hub can step in and help resolve issues. Additionally, payers can enroll their patients in the patient assistance program if they cannot afford the cost of APHEXDA. Those who qualify can receive the drug at no cost. In summary, I'm very pleased with our launch progress to date. Our commercial and medical affairs teams are generating results in the early stages of this launch as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option. Now let me turn the call back over to Phil.

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. Seven of 11 patients, or 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, or 27%, experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48% respectively, reported with the current standard of care. Based on these compelling data, the collaboration partners in this study, Columbia, Regeneron, and BioLineRx, agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase 2b study of 108 patients with two arms. Motixafortide, the PD-1 inhibitors, zimberelimab and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression-free survival. Secondary objectives include safety, response rates, disease control rate, duration of clinical benefit, and overall survival. And last month, we announced that the first patient was dosed in this randomized Phase 2b study. We believe the combination potential of motixafortide and PD-1 inhibitors in pancreatic cancer and other solid tumors could be a significant multibillion-dollar opportunity, and our work in pancreatic cancer, one of the most difficult to treat cancers, is the starting point. Also in pancreatic cancer, a license agreement with Gloria Biosciences covers pancreatic cancer as well and we are working with them on the design of a randomized Phase 2b clinical trial evaluating motixafortide in combination with the commercially approved PD-1 inhibitor, zimberelimab, and standard of care combination chemotherapy in first line pancreatic cancer. Zimberalimab is approved in the Asia region for relapsed or refractory classical Hodgkin's lymphoma and for recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimberalimab and its first indication in China within four years. So we believe they are uniquely positioned to explore the potential utility of motixafortide in combination trials against this difficult to treat cancer. Their Phase 2b trial in China is expected to commence in the first half of 2025. We are also evaluating motixafortide as a mobilization agent in autologous hematopoietic stem cell-based gene therapy patients suffering from sickle cell disease, one of the most common genetic diseases globally. Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with sickle cell disease. However, significant quantities of hematopoietic stem cells are required for genetic manipulation and transplant success, and the most commonly used drug for the collection of stem cells, G-CSF, is contraindicated in patients with sickle cell disease. Therefore, peripheral blood mobilization of stem cells using plerixafor is the current strategy to collect hematopoietic stem cells for sickle cell disease gene therapies. As with multiple myeloma patients, in many cases, the current mobilization treatment fails to reliably yield the targeted number of stem cells and sickle cell disease patients often require two to four mobilization cycles with each cycle including two or more apheresis sessions with a minimum 14-day washout period between each cycle to collect an adequate number; as such, this patient population is very much in need of an effective new mobilization regimen. To that end, last March, we announced a clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide in this indication. Together with Wash U, we're conducting a proof-of-concept trial to study motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ hematopoietic stem cells in patients with sickle cell disease as well as efficacy endpoints. Sickle cell disease is an important lifecycle strategy for APHEXDA and we are in discussions with multiple stakeholders to understand its potential usage in patients who may qualify for the two recently approved gene therapies in the United States. We were very pleased to have dosed the first patient in this important trial in December and we anticipate data in the second half of this year. In summary, we are very excited by both our pancreatic cancer and sickle cell disease clinical development programs, which may provide incredible value to patients and shareholders. At this point, I'd now like to turn the call over to Mali, who will review our financials. Mali, please go ahead.

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 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 the completion of the AGI-134. Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million as compared to $6.5 million for the year ended December 31, 2022. The increase resulted primarily from the ramp-up of pre-commercialization and commercialization activities related to motixafortide. Non-operating expenses for the year ended December 31, 2023 were $10.8 million compared to non-operating income of $5.7 million for the year ended December 31, 2022. Non-operating expenses and income primarily relate to the non-cash revaluation of outstanding warrants resulting from changes in the company's share price during the respective periods. Net loss for the year ended December 31, 2023 was $60.6 million compared to $25 million for the year ended December 31, 2022. The net loss for 2023 included $17.8 million of non-cash expenses, specifically an expense of $11.1 million for the revaluation of warrants and a one-time $6.7 million impairment of intangible assets associated with the discontinuation of the AGI-134 development program. The net loss for 2022 included $6.4 million of non-cash income, specifically related to the reevaluation of warrants. As of December 31, 2023, the company had cash, cash equivalents, and short-term bank deposits of $43 million. The company anticipates that this amount and other available resources, including amounts available under a debt facility with Kreos Capital, will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.

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 the 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 met 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 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.

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 alternatives or is there it sounds like there's some education that's required to get students on board with it. Is that correct?

John, I want to clarify that the line of understanding isn't very clear. First of all, good morning. Are you asking about how the formulary process works and how long it takes? Did I get that right?

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 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 is 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 a retail product etc. 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 believe that every transplant center is unique, leading to varying levels of ease or difficulty in the process. Identifying the key decision makers is the first challenge, and reaching those individuals is crucial. I realize I didn’t fully answer part of your previous question regarding the importance of education during and after the formulary decision. It's essential that there is proper education and support in place so that everyone knows how to properly dose and administer the product for optimal patient care. The process is indeed different across institutions; some are more efficient while others may have a longer formulary process. Our field teams are aware of these differences and tailor their approach accordingly, addressing the specific needs of each center.

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?

First of all, John, I think there may be a mistake or misunderstanding because we are conducting a Phase 1 trial for mobilizing sickle cell patients at Wash-U, but these patients are not receiving any gene therapy, neither from Vertex nor Bluebird at this time. I wanted to clarify that, and if there was any confusion, I apologize. We are actively engaging with companies and institutions in this area, which is of significant interest to us. We view it as a substantial potential opportunity for the company. These patients require large quantities of cells, around 15 million to 20 million hematopoietic cells per kilogram, and they face considerable challenges in mobilization, particularly since they cannot receive G-CSF. We believe we have an excellent product for them and are eager to obtain safety and initial efficacy data to generate interest in this space and explore further collaborations as we move toward bringing the product to market.

I want to clarify the opportunity we are focusing on. Specifically, we are looking at ex-vivo approaches or gene therapies that involve CD34+ stem cells, which do not apply to gene therapies like AAV gene therapy. Our main interest will be in gene therapy options that necessitate stem cells to be completed. This is definitely our focus, particularly with sickle cell, as Phil mentioned.

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. Regarding the Phase 2 study in pancreatic cancer in China with Gloria, could you share some details about the preparations? Do you expect any challenges with the Chinese agency, recruitment, or site activation of the trial? Also, are there plans to expand to additional Asian territories beyond Macau and Singapore?

Hi, this is Ella. Regarding the PDAC study in China, we are planning to submit it to the regulatory authorities, and we hope to initiate the study by the end of this year or early next year at the latest. In relation to your question about expanding into additional territories, were you referring 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. I can address that. Firstly, regarding PDAC, we expect Gloria to recruit patients relatively quickly. As I noted earlier, they managed to secure approval for a drug in two indications in China within four years, which is quite impressive by Western standards. Thus, their capability to recruit patients for the Phase 2b study in PDAC is considerable, and some institutions there are significantly larger than those in the West. Concerning their expansion into other territories, we can differentiate between stem cell mobilization and PDAC. For stem cell mobilization, there are several regions, especially in Southeast Asia, where we have FDA approval, such as Singapore and certain areas in China like Macau. These locations have early access programs that allow for the use of a U.S.-label drug based on FDA approval in local hospitals. Gloria is actively working to initiate commercialization in these smaller markets. However, for larger markets like China, Japan, and Korea, both our evaluations indicate that one or more bridging studies involving Asian patients will likely be necessary to obtain regulatory approval for stem cell mobilization. Regarding pancreatic cancer, since it currently lacks any approvals, the process is more prolonged. They are set to start the trial in China, which is currently the primary focus for pancreatic cancer. Depending on the results of this trial, there may be opportunities to expand into other regions later. We are also considering the possibility of partnering for a large registrational Phase 2, 3 global trial based on this data, but that is something for the future. This outlines Gloria's plans in Asia. I hope that clarifies 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 the year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing you our next comprehensive quarterly update in 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.