Good morning, and welcome to the BioLineRx event. At this time, all participants are in a listen-only mode. A Q&A session will follow today's formal presentations. Please note Dr. DiPersio will not be able to join us for the Q&A session today. With that in mind, you may begin submitting your questions at any time throughout the event, and we will address them following the formal presentations. I would now like to turn the call over to your host, Phil Serlin, Chief Executive Officer of BioLineRx. Please go ahead. Good morning, and thank you for joining our investor update and KOL webinar today. I'd like to start out the morning with some brief opening remarks. As you've seen over the past few weeks, the company has taken several important steps to support its long-term growth with a focus on achieving the near-term potential of becoming a revenue stage company with a best-in-class therapeutic product. Let me recap these achievements. On Friday, September 9, we submitted our new drug application to the FDA for motixafortide and stem cell mobilization for patients with multiple myeloma. This is our first NDA submission and a significant accomplishment for the company. We anticipate the FDA's decision on acceptance of the NDA by November, and if accepted, we expect a PDUFA date in Q2 2023 under a priority review process, if applicable, or Q3 2023 under a standard review process. On Thursday, September 15, we secured a $40 million debt financing agreement with Kreos Capital. Kreos has been a supportive partner since 2018 when we sought to increase our ownership stake in motixafortide. We are pleased to have the opportunity to work again with a lender that is very familiar with our company and continues to support the development and commercialization of our lead product. Pursuant to the terms, we can draw down the initial tranche of $10 million immediately. Two additional tranches totaling $30 million can be drawn down upon the achievement of pre-specified milestones. This agreement strengthens our balance sheet and, more importantly, gives us access to capital on a non-dilutive basis. On Monday of last week, we announced the pricing of a $15 million equity offering. The Kreos facility, together with the $15 million equity raise and our cash on hand, enable us to fully finance a robust U.S. commercial launch of motixafortide while maximizing the value of the asset for our company. Yesterday, we introduced motixafortide's trade name, APHEXDA, and announced our plans to commercialize it independently in the United States, assuming FDA approval. As we have noted previously, the target market here is quite concentrated. We have been advancing key pre-launch activities for the past several months, and with these recent financings, we believe we are very well-positioned to build out the relatively modest infrastructure that would be required for stem cell mobilization as compared to a new product launch in a broader oncology indication. We believe the compelling financial model is scalable over a lower expense burden with a quicker path to break even in profitability versus the traditional pharma model. As you can see, we have made a significant amount of progress toward our strategic goals, and we will use today's webinar to review our planned commercialization approach and the benefits that it brings to patients and the value it will contribute to the company. Let's go to the forward-looking information slide for a few moments. Now let me talk about today's agenda. We will begin this morning with a presentation by Dr. John DiPersio, Chief of the Division of Oncology, Washington University School of Medicine in St. Louis. Dr. DiPersio served as the lead investigator for our very successful GENESIS-3 clinical trial that formed the basis of our new drug application in stem cell mobilization. His presentation will focus on the unmet clinical need that exists in stem cell mobilization and where a superior mobilization agent, such as APHEXDA, can fit into the evolving treatment landscape. Following Dr. DiPersio, Lissa Gray, BioLineRx's Patient Advocacy Lead, will moderate a panel discussion between a multiple myeloma patient, her caretaker, and an apheresis nurse. This presentation will highlight the challenges of apheresis from a patient and institutional perspective and further highlight the need for more effective mobilization agents. Our last presentation will be done by BioLineRx USA President Holly May, who will provide a detailed overview of the alternatives that we considered when developing our APHEXDA US commercialization strategy, our rationale for commercializing independently, and a high-level review of our plan and preparations to date. I will then come back with brief closing comments before we open the call up for your questions. At this point, I'd like to introduce Dr. DiPersio. Please go ahead. Good morning. It's great to be with you this morning, and what I'm gonna do in the next 30 minutes is give you a little, lowdown and description of stem cell mobilization and why motixafortide may fit into the general scheme of how we treat patients in the future undergoing, stem cell transplantation and gene therapy. Well, transplantation is an interesting process, and most of the transplants done in the United States and throughout the world, in fact, are done using peripheral blood stem cells. These stem cells sit in the bone marrow, and they rarely, Move from the bone marrow into the blood and into the bone marrow. Again, the steady-state process is very low level, but in order to get sufficient numbers of stem cells to do a transplant, we have to mobilize. That's this process called egress or mobilization. For that, we can collect those stem cells, purify them if necessary for gene therapy, or just let them be used for stem cell transplantation. These are collected by an apheresis procedure and quantified, and then infused back into the patient where they home to the bone marrow niche and start growing and differentiate into mature stem cells, mature hematopoietic cells, including myeloid cells, erythroid cells, and platelets. This results in multilineage reconstitution of patients, which is life-saving. This is just a cartoon showing how this is done. Stem cells are removed from the donor after a mobilization through a process called apheresis, and that usually takes 5-8 days with G-CSF, which is the standard of care. I'll tell you in a minute how that happens biologically. Those stem cells are collected, cryopreserved, and then, after the patient has received ablative chemotherapy to destroy their underlying stem cell population, those new stem cells, which were collected before the ablation procedure, are then infused into the patient. Those stem cells home to the bone marrow and mature into normal myeloid cells, erythroid cells, and platelets, which again, is life-saving to the patient. The clinical needs for optimal mobilization are really twofold today. Number one, we need optimal stem cells for transplantation. Currently, approximately 95,000 transplants are done annually in the world. Approximately 35,000-37,000 are done in the United States, and 55,000 are done in Europe and other areas of the world. This process of mobilization utilizes G-CSF, which requires, again, 5-8 days of individual injections, results in unpredictable yields, is associated sometimes with adverse events such as severe bone pain, and even at times splenic rupture. It is not used in all diseases. For instance, in sickle cell disease, G-CSF is contraindicated because of the increased risk of inducing vaso-occlusive crises and death, actually, so it's completely contraindicated. That means that there is really a need for novel mobilization regimens to mobilize more stem cells, shorten the time for mobilization, and to do this with fewer adverse events. The goal of any optimal mobilizing regimen is to develop a predictable and reliable approach to stem cell mobilization with minimal apheresis sessions. The second major reason for optimal mobilization has to do with the collection of stem cells for a genetic manipulation. This is the beginning of the age of gene therapy, and there was a period of time that gene therapy had sort of waxed and had disappeared from our armamentarium, but now it's back in full force, not only for the treatment of malignancies with things like CAR T, but also for genetic manipulation of stem cells to cure inherited diseases of the bone marrow, such as thalassemia and sickle cell anemia. In order to perform these procedures, one needs to collect not only stem cells, but a lot of stem cells, and we need to collect stem cells that are of high quality, so that various approaches to modifying these stem cells can be done with the expected losses which occur at every step during genetic manipulation. These losses occur at the time of lentiviral transduction, gene editing, base editing, and all of the treatments that are used now for the genetic reversal of diseases such as sickle cell anemia require lots of stem cells, and they need to be obtained safely and without the use of G-CSF. These stem cells not only can treat diseases such as thalassemia and sickle cell anemia, but there are a number of other diseases now that stem cells are going to be genetically manipulated to reconstitute local microenvironments to cure diseases. This is a report showing that the intracerebral ventricular delivery of hematopoietic progenitors resulted in robust engraftment of microglial cells in the central nervous system. This can be used to actually reverse some of the storage diseases that occur, resulting in CNS defects and death in patients. Stem cells are going to be used in many other diseases in addition to some of these inherited diseases like sickle cell anemia and thalassemia. While the optimal use of this approach was a proof of principle experiment just published a month or two ago by my friend and colleague, Luigi Naldini from Milan. He showed in a very important paper published in Cell that if you optimize stem cell mobilization and you couple that with figuring out how to condition patients for stem cell transplantation for non-malignant diseases using non-radiation and non-chemotherapy regimens, then you can safely reverse these genetic diseases. Now, he did this in a mouse model, but this is ultimately the goal of gene therapy, to use genetically manipulated stem cells in patients that have been conditioned with non-radiation, non-chemotherapy regimens so that they're safe and don't have any long-term consequences. The bottom line for all of these genetic manipulations is you need a lot of stem cells. To do these procedures safely, efficiently, and stably over time. Well, even, you know, we think of gene therapy as an ex vivo. You take the stem cells out that you mobilize and then genetically manipulate them. This group and André Lieber's group at the University of Washington have been pioneering an effort to actually do this in vivo in patients. For instance, using adenovirus to genetically correct diseases such as thalassemia or sickle cell anemia by actually just injecting adenovirus in the peripheral blood. What they find, just like with all the other approaches to genetic manipulation, is that stem cells have to be mobilized efficiently into the peripheral blood for this to work. Even in this setting where there's no conditioning that's necessary and that you do in vivo transduction, which is going to be something that everyone is going to look for in the future, that will require lots of good mobilized stem cells in the peripheral blood to do this effectively. This is here to stay, and I think that optimizing mobilization quickly and safely is optimal. This is just the numbers of autologous and allogeneic stem cell transplants done in the United States today. This shows you the kinds of diseases that most patients are being transplanted for. You can see that most of the allogeneic transplants in the dark blue are being done for malignant diseases such as AML and ALL, while most of the autologous transplants, which are the dominant transplantation procedure done in the world today, are done for multiple myeloma and to a lesser extent, non-Hodgkin's lymphoma. This is the transplant activity report of the United States showing over the past 3 years. This is a little bit dated, between 2013 and 2017. Approximately 106,000 procedures have been done. This translates in today's world to about 36,000 transplant procedures done in the United States today, and as I mentioned, there's approximately 55,000-60,000 done in Europe and other areas of the world, 95,000 altogether. Well, to mobilize stem cells, you've got to get these stem cells out of the bone marrow into the peripheral blood. This is an old scanning electron micrograph that I took of purified stem cells that are bound to the bone marrow microenvironment. Those little pieces of threads that attach the stem cell to the microenvironment, those are the things that need to be disrupted for those stem cells to leave the bone marrow and circulate in the peripheral blood. The goal of a mobilizing agent is either to modulate the microenvironment so that these tethers are broken or to just immediately and competitively block those interactions so the stem cells float away into the peripheral blood. Think of it this way, as a boat at a dock, and the dock has multiple mooring lines, and there are redundant processes such as CXCR4, VLA-4 are the major ones that are expressed on stem cells, and there are ligands which are expressed in the microenvironment. Those ligand receptor interactions hold those stem cells into the bone marrow, and you must break those to actually get those, stem cells to release into the blood. Now, G-CSF does it by decreasing the expression of SDF-1 in the bone marrow. That takes 5 to 7 days to work, and so you have to give shots of G-CSF for 5 to 7 days for this to actually, work, and so that's a very slow process. Alternatively, you can use competitive inhibitors of these interactions and directly block those interactions, and that results in the cutting of these mooring lines. For instance, motixafortide and plerixafor are two examples of drugs that block the CXCR4 SDF-1 ligand receptor interaction, and there are other compounds on the VLA-4 side that are being developed preclinically that may help in the mobilization as well. This is the first trial that we did, and I was the PI of this study. This is the registration studies for non-Hodgkin's lymphoma, but more importantly for multiple myeloma, in which plerixafor plus G-CSF was compared to G-CSF alone for mobilizing stem cells in multiple myeloma patients going on to autologous stem cell transplant. You can see from this graph that there's a dramatic improvement in the mobilization of stem cells when patients were given plerixafor plus G-CSF versus G-CSF alone. The interesting thing here is that the non-Hodgkin's lymphoma patients were even a worse group of patients that had a higher rate of failure to both G-CSF and plerixafor plus G-CSF because they're more heavily pretreated. You can see that a number of patients that get G-CSF, you know, in fact, almost 85% of them fail to mobilize sufficient numbers of stem cells in a single day with G-CSF, and even 50% with plerixafor and G-CSF. There's lots of unmet medical need here. Let's fast-forward a number of years to the development of BL-8040, or motixafortide. Motixafortide is a novel 14-amino acid cyclic synthetic peptide inhibitor of CXCR4. It's present, CXCR4 is present, as I showed you, on all hematopoietic stem cells, and it's the principal regulator of stem cell homing and egress from the bone marrow into the peripheral blood. BL-8040 or motixafortide binds to CXCR4 with high affinity, higher than plerixafor, and has a very long occupancy rate due to a very slow off rate, and this has implications for both quantitative and qualitative mobilization of stem cells compared to other CXCR4 inhibitors in G-CSF. This is what I mean in that this is a little tough to follow, but this is at time zero after giving plerixafor or BL-8040. This is a tool compound for BL-8040 called T140. This is the same as motixafortide. You can see that at time 0, both plerixafor and motixafortide block the binding of this antibody called 12G5, which actually binds to CXCR4. At time 0, both plerixafor, which is also called AMD3100, and motixafortide, which is called T140, block that interaction. However, at 60 mins. After adding these two compounds, only motixafortide continues to block that receptor while the effect of AMD3100 or plerixafor is completely gone in just 30 mins.. A much tighter binding and a very much slower off rate and continued blocking of the receptor, as you can see in this slower graph on the right here. This has clinical implications as well in that these drugs, specifically motixafortide, needs to be given only once every 2 days, while plerixafor needs to be given at least once a day. This is the kind of stem cells that are mobilized. This is from our lab, and you can see that all the kinds of stem cells, the very primitive stem cells, the more differentiated progenitors are mobilized in response to a motixafortide. That is related to a certain extent on the expression of CXCR4 in the surface of these cells, which you might expect to be the case. You can see comparing the mobilization of CD34 cells pre and post, there's a nice mobilization with plerixafor, which is even improved with motixafortide. What is the competitive landscape for mobilization? Today, the standard of care is just G-CSF alone. Some transplant centers use a combination of Cytoxan and G-CSF, but you know, Cytoxan is a toxic chemotherapy. It does have life-threatening complications in both short-term and long-term because it's an alkylating agent. People can die after stem cell mobilization with Cytoxan because it causes profound neutropenia. But it is a way of mobilizing stem cells with G-CSF, but it even actually ironically takes longer than G-CSF. G-CSF, you can mobilize stem cells in 5-8 days, but with chemotherapy, it takes 10-14 days, and there are lots of complications associated with it. It's really not considered in the competitive landscape. The competitors in addition to BL-8040, which is motixafortide, include MGTA-145 from Magenta, which is a GRO-beta or CXCR2 agonist, which is now in development. It had been initiated in trials for allogeneic transplant patients and in multiple myeloma patients. Those trials are currently on hold as Magenta focuses on their approach to sickle cell anemia. Their studies looking at mobilization of sickle cell anemia patients for gene therapy are now just moving forward but not open yet. That is the major competitor. There's one other competitor out there called AVA4746 from Aviara, which is an alpha-4 inhibitor. This is a VLA-4 inhibitor, and it's an oral medication, and it really has been tested very minimally in preclinical models only, and they're not close to the clinic. This is just a little bit more information about the Aviara drug. The MGTA-145 from Magenta, as I mentioned, it's a CXCR2 agonist. It's a truncated GRO-beta. It induces neutrophil activation, which may be a problem in sickle cell anemia as well. It induces the release of metalloproteinases, which cleave some of those tethers which I showed you previously on the slides, that are responsible for holding those stem cells into the microenvironment. They're combining MGTA with plerixafor as a rapid mobilizing approach for sickle cell anemia patients, so they can avoid G-CSF. Now, when they tested this in normal volunteers, they found that MGTA was a very weak mobilizing agent, as you can see on the left panel here. Even when added to plerixafor, there was only a slight increase in mobilization. I think this is probably why they're really reconsidering their approach and focusing more on sickle cell anemia because that increase is not dramatic compared to just plerixafor alone, which is known to be a very weak mobilizing agent by itself. Getting back to the issue at hand here, that's motixafortide, as I said, it's a novel cyclic peptide. It has high affinity for CXCR4 and long receptor occupancy. Based on this biology, BioLineRx has initiated and completed a Phase 3 two-part multicenter randomized double-blind placebo-controlled study testing motixafortide + G-CSF versus placebo + G-CSF in multiple myeloma patients undergoing auto transplant. The dose of motixafortide was established at 1.25 milligrams per kilogram, and the FDA asked for a lead-in part of the study, which was to do a number of patients, 12 in fact, with this current dosing, just to determine that this was the correct dose, and that there were no obvious safety issues which was performed. Then the second part of the study was a randomized, double-blind, placebo-controlled study with 122 patients, which was ended early at the interim analysis, which ended up being the final analysis because of a superiority of the motixafortide + G-CSF arm versus G-CSF. The key inclusion criteria shown here and the exclusion criteria are shown here, and this will be hopefully published soon in a good journal so that we can all see it together and evaluate the results. This is the design of the GENESIS study, was exactly modeled after the plerixafor study, except, motixafortide was given on the evening on the fourth day of G-CSF, and then it was not given again until two days later, while, in the plerixafor study, it was given in the evening before the collection and then daily after that if the collection goals were not met. The primary goal was to collect greater than 6 × 10 to the 6 CD34 per kilogram with, in 2 collections, with secondary endpoints, looking at the the number of stem cells collected after a single apheresis procedure. This is the results of the study, showing a dramatic and highly statistically significant difference between the placebo + G-CSF mobilization shown in the blue line versus the motixafortide + G-CSF shown in the green line, whereas the primary endpoint was highly statistically significant, where 92.5% of the patients with motixafortide and G-CSF reached the goal, and only 26% of the control group. The secondary endpoint was 88%, almost 90% of the patients reached the goal after a single apheresis procedure, while only 9.5% in the G-CSF plus control group reached that benchmark. The interesting aspect of this study is that, 70% of the patients in this trial had received multiple cycles of lenalidomide as standard induction therapy for their myeloma. That's very important since we know that lenalidomide is a stem cell poison, and it's been shown by a number of groups to dramatically reduce the chance of effective and successful mobilization. These patients, compared to the previous registration study with plerixafor, really was studying a much worse population of patients since in this study, where the results do not, on the surface, appear to be comparable, and they seem to be better with motixafortide, although no randomized studies between the two have been done. Only 4.6% of these patients actually had any lenalidomide as part of their induction therapy for their, before stem cell mobilization, which is this is an important point. This also can explain the reduction not only in the success rate, but also in the success rate of the G-CSF control group, which in this arm, 17.3% got there in one day, and in our study, only 9.5%. This could easily be explained by the difference in utilization of lenalidomide between the two trials. Well, this slide shows it all, I think. This is the control group on the right that received G-CSF plus control, and you can see that their mobilization was very modest. Here are the patients that received motixafortide on day four, and you can see that there's a dramatic and monumental increase in the CD34 in the peripheral blood in these patients. Some of them got up into the 100, 200, and 300 numbers, which is pretty remarkable. Most importantly, the median number of CD34 cells per kilogram collected in 1 apheresis with the motixafortide and G-CSF was 10.8 × 10^6 versus 2.25 × 10^6 in the control group. Well, what about the quality of the stem cells? We did multiparameter flow cytometry, 40-color flow cytometry, and single-cell RNA-seq to determine the quality of the stem cells mobilized with motixafortide and G-CSF versus G-CSF alone. These are some of the phenotypic markers that we use to define these populations. I think these are standard and accepted around the world for people who are experts in stem cell biology. We found, interestingly enough, when we did t-SNE plots and looked at all of these subpopulations, that patients mobilized with motixafortide and G-CSF had a not only more stem cells, but had a significantly higher percentage of stem cells that were considered the most primitive and had the greatest potential for a multi-lineage differentiation, compared to G-CSF in control. When we looked at an exactly parallel group of patients, a contemporaneous control group that during the same period of time were mobilized in the exact same way with plerixafor plus G-CSF as standard of care, same ages, same previous treatments, et cetera, we found that in every setting, not only were the primitive stem cell numbers better in the motixafortide plus G-CSF, but the total number of stem cells in all of these more differentiated progenitors exceeded the plerixafor group almost in every case. We were happy to see that number one, the number of these primitive multipotential stem cells was enhanced, but also not only compared to G-CSF in control, but to our contemporaneous control group that received plerixafor and G-CSF. This is what's called a fate mapping pseudo-time analysis for stem cells, and the most primitive stem cells are these green cells in the HSC one population. We could track these stem cells using single-cell RNA-seq data. We were able to show that there are significant differences between G-CSF, G-CSF plus plerixafor, and G-CSF plus motixafortide in the proportion of these different subpopulations of the cells. You can see these green population right here from the motixafortide only. This was done in normal allo donors and is almost as efficient in patients receiving plerixafor or G-CSF. These are really the most primitive and most durable and long-lasting multipotential stem cells. Well, what does lenalidomide have? Just getting back to my point that I was trying to make previously, this is just to show you three studies. This is a study from the Mayo Clinic looking at patients who had received a standard G-CSF mobilization or G-CSF plus chemotherapy mobilization. They looked at total collection of stem cells and the daily average in the collection on day 1. You can see that if you were exposed to lenalidomide prior to stem cell collection, it reduced the total number of CD34 cells you could collect significantly, and also the daily average was reduced, and the day 1 collection was reduced. This also occurred in patients mobilized with G-CSF + chemotherapy. The effect of lenalidomide had a significant negative impact on G mobilization and G + chemotherapy mobilization. These are two other studies which show the same thing, one from the Mayo Clinic, one from Memorial Sloan Kettering, which showed if you had received standard non-lenalidomide therapy, your chance of CD34 collection was significantly higher, and the number of days and percentage that required for collection and the percentage of patients who failed collection was significantly lower if you had not been exposed to lenalidomide. This is the same in the Memorial Sloan Kettering study shown on the right. We just finished a study showing that daratumumab when added to lenalidomide had a significant negative impact on mobilization in patients receiving plerixafor and G-CSF. In the future, all patients in the United States at least will be receiving four drug induction therapy for their myeloma. All of these patients will not only be exposed to lenalidomide, but another stem cell poison, daratumumab, bringing forth the need for even a more improved stem cell mobilization approach. This is just an abstract showing. There was no data here, but I just thought I'd show you this. This showed a significant difference in mobilization. This was the only other report that, besides our group, showing that there's a significant negative impact of daratumumab on collection of stem cells as well. This again shows the comparison of motixafortide with two other CXCR4 inhibitors in normal allo donors, so significantly improved. The actual mobilization showed that in a retrospective analysis that our center published in Blood Advances recently showed that patients receiving motixafortide as the only mobilizing agent in allo donors was superior to plerixafor only. There are other drugs that are being developed for the mobilization. I'm only showing you this to show you how plerixafor and motixafortide compare with one another when other drugs are added as well. Here's an example of a drug that we've been developing, which is a very weak mobilizing agent. It's a VLA-4 inhibitor, but you can see compare the orange line here. This is plerixafor + our drug with motixafortide in our drug. This results in a dramatic, only almost a doubling of the mobilization, and also a much longer period of mobilization. This is extended mobilization and a higher mobilization when combined with another drug. Just showing you that, you know, again, in these sort of comparisons in these models suggest that motixafortide is superior to plerixafor. This could be pursued in the autologous gene therapy approach. One approach would be to combine a VLA-4 inhibitor with motixafortide. That's what we're planning to do as a proof of principle that motixafortide, not only by itself or with G-CSF, is an effective and superior mobilizing agent. We're really interested to see if it can be combined with VLA-4 inhibitors, which would actually allow it to be potentially used in the future as a single active mobilizing approach for gene therapy for patients with sickle cell anemia and thalassemia and other inherited diseases of the bone marrow. In conclusion, I hope I've convinced you that there continues to be a significant unmet medical need for optimal, safe, and rapid stem cell mobilization. We need this for optimal multi-lineage stable engraftment after stem cell transplant and for successful gene therapy using transduction gene editing and base editing. The GENESIS trial, which I've reviewed with you today, confirms the superiority of motixafortide plus G-CSF over G-CSF alone for mobilization of multiple myeloma patients. The GENESIS trial, interestingly, had 70% of all the patients were exposed to significant doses of lenalidomide, while only 4.6% in the plerixafor registration study, making those differences even more dramatic. Daratumumab will be also an additional agent added to all induction regimens for myeloma and will have a negative impact on mobilization, requiring even better mobilization approaches if we're going to move forward. Not only are the stem cell numbers dramatically increased after motixafortide and G-CSF, but also the quality was increased with increased numbers of primitive stem cells and progenitors. The expectation is that similar results would be seen in other indications such as non-Hodgkin's lymphoma and allogeneic donor mobilization. Although no randomized studies comparing motixafortide to plerixafor plus or minus G-CSF have been performed, retrospective analyses of both human and mouse studies suggest that motixafortide compares very favorably to plerixafor in all of these models. I want to thank you for your attention, and I'll hand it over. Thank you very much, Dr. DiPersio, for your interesting and comprehensive presentation. I'd now like to introduce Lissa Gray, BioLineRx's patient advocacy lead, who will moderate a panel discussion between Mary Quarterman, who is a multiple myeloma patient, her husband and caretaker, Albert Quarterman, as well as Shirin Bosavan Chen, an apheresis nurse. Lissa, please go ahead. Thank you, Phil. As Phil mentioned, we are so fortunate today to have a myeloma patient, her caretaker, a transplant coordinator join us to share their experiences so that we can better understand what it's like to undergo the critical process of stem cell mobilization and collection. The three panelists will highlight some of the aspects that you heard brought up by Dr. DiPersio and bring to life some of the current challenges with the process, which underscore the need for novel mobilization agents. We're first going to talk to Shirin, who works at a large academic center, a multiple myeloma center that performs over 200 transplants a year, and she'll give us an overview of the current stem cell mobilization and collection routine. Shirin, if you wouldn't mind starting to introduce yourself, including your background and then your current role. Yeah. Hi, good morning, everybody. Happy to be here. I've been a nurse for almost 20 years, and I've always been in hematology stem cell transplant. Worked inpatient for almost 10 years as a bedside nurse, charge nurse, and assistant manager. Then in the last 10 years, I've been a transplant coordinator, so meeting patients and their families who are going to undergo a stem cell transplant for their next step in their care. Great. Thank you. If you wouldn't mind, Dr. DiPersio has already outlined it somewhat, but from a nursing perspective, could you give an overview of stem cell mobilization and collection, that process for multiple myeloma patients? Yeah. I meet patients who are kind of along their journey for their multiple myeloma treatment and get them through their stem cell collection and their transplant. We get them set up for their days of apheresis, and it's as you can kind of imagine from what Dr. DiPersio said, too, it is a very complicated procedure. Our patients will receive multiple days of growth factor to stimulate those stem cells to come out of the bone marrow and into the peripheral blood where we can collect them. Patients do experience side effects with these injections. They a lot of times experience bone pain, and this is the bone marrow swelling with these stem cells that we want to collect. At the center I work at, the day before patients have their stem cells collected, they will have a very large, rigid IV catheter placed here in the neck. We call it a Quinton catheter. It's one of the more challenging aspects of this part of the apheresis procedure for the patients because it's pretty uncomfortable and cumbersome. There's not a lot of head movement allowed, and it can be painful. We try to keep in as little days as possible, but it will really depend on how many days of apheresis the patient needs. The catheter has two lumens. From one lumen, the blood is extracted and goes through the apheresis machine where all the blood components are separated. We take those stem cells from the blood, and that's what's saved for the future transplant, and then the rest of the blood is returned through that second lumen. Our patient is lying in the bed for about 5-6 hours, very long day. They can't get up for a walk break or to go up to the bathroom. We can't interrupt the flow of the apheresis machine. That takes another couple of hours to get results of that collection. We get our patients to our center at 7:45 A.M., and they're with us until about 6:00 P.M. or later, depending on how the collection went and how long it takes to get those results. If we do need to get another day of collection, they come back for a second day of that, sometimes third or fourth or even, you know, fifth day if we need to. It's a pretty rigorous process, really hard on the patients and the family in terms of going through that type of procedure. Great. Thanks for outlining that. Given what you've described, can you highlight some of the stressors that a patient may face when they go through, in particular, multiple apheresis days? Yeah. You know, it is a stressful procedure for the patients. It's also very logistically challenging, too. A lot of times our patients have to travel many miles to get to our center for their treatment. So their caregiver is taking time off work, they're staying in a hotel, working on how to, you know, figure out meal planning, things like that. So it is a long day and, you know, they're worried because they're not sure how it's gonna go, because we do say, "Okay, it's gonna take either 1 or 4 days to collect enough stem cells for your transplant," and they know that the transplant is such an important aspect of their care to get into that deep remission that we're looking for. It is a lot of pressure on the patients to, like, perform well during that collection. It's very emotionally exhausting for the patients, and also just physically exhausting as well. The other thing that I should point out, too, is that patients have to be off their therapy, and that's kind of what Dr. DiPersio was talking about being off the lenalidomide or whatever else they're on. Here they are on their myeloma treatment, and it's going really well, they're responding, and then we have to say, "Okay, take a break from that medication because we need your bone marrow to take a rest before we collect stem cells." That can be really anxiety-provoking, too, because they're off their treatment that's working so well, they might have pain associated with their diagnosis, so even just coming to us daily like that and being in a bed all day, lots of pieces that can be challenging for our patients. We just try to, you know, we do it every day, so we give them a lot of reassurance, but it's still really hard and can be scary and exhausting, too. Great. What benefits do you see with the possibility of fewer apheresis sessions or even a single apheresis session? I mean, if we could really predict and say, "Okay, we have all these patients that need to collect, for example, in a given month or a given week," we would be able to just so much more efficiently collect patients and not push them out many weeks because we don't have a slot per se to collect them. We're a pretty busy center, and it's just really difficult to predict who is gonna collect in one day or four days. If we could anticipate from knowing that they could just collect in one day, we could be a lot more efficient in our practice. I mean, even just yesterday was a busy Monday at my workplace, and we were juggling all these different people that were gonna be collecting that week and having to decide, you know, how to kind of balance the whole staffing and how many chairs we have. If we knew that we could reliably collect somebody in one day, it would help our center to just anticipate how to plan. And again, going back to the patient, just saying, "Okay, most likely you'll collect in one day," it would just be a huge milestone for that kind of procedure. Great. Finally, is there anything else you'd like to add that I didn't ask about or? No. I mean, I think we kinda covered it. In general, I mean, having that predictability to know that we can collect our patients in just one day would just be a huge, just a huge gift for the patients and then also for our center, too, just to know that we can plan accordingly and, get our patients through this process as easily and quickly as possible. Great. Well, thank you so much, Shirin. We're thankful for your time and also the opportunity to learn from your expertise. Yeah. Welcome. Mary? Hi. Thank you. Hi. Thank you again for joining us today. If you wouldn't mind just reintroducing yourself and then giving us a description of your experience with multiple myeloma, from your diagnosis through to, you know, your stem cell collection in preparation for your transplant. Well, first of all, my name is Mary Quarterman, and I am 66 years old. We have three daughters and seven grandchildren. I have multiple myeloma since 2017. You know, just to put a human face to it is a non-curable cancer, so it's a lifetime diagnosis. Up to the point where I was suggested that I have stem cell, I had multiple treatments every week, and they all failed, so I got my oncology team I need a stem cell transplant. Starting that process was a little different than Shirin talked about at their center. At our center, two weeks before I was scheduled for the transplant, I went in to have a port put in, and it was like a three lumen port. It was a little lower, it wasn't so high in my neck. Went in for a surgical procedure and had to go to the hospital and have my caretaker drive me. That port was put in, and he had to learn how to flush it because it was in so long. It was in approximately two weeks before I had my stem cell, and then it stayed in the entire time until the day I left the hospital. That's a little different the way our center does their process. I then had to go to the hospital with my caretaker, and he had to learn how to give me injections of a medication that would boost my stem cells. We did that. He gave me the medication, and I had that for 8 days. I went in on a Wednesday for my apheresis process, and I was scheduled to go in the hospital for the stem cell transplant on Monday. On Wednesday, I went to the hospital. We live 60 miles from the hospital, and we had to be there at 7:30 A.M. every morning. Just like Shirin Bosavan Chen said, it is a long 5- or 6-hour process. I did have bone pain and discomfort from the other medications, the boosting medications. I just didn't feel that great. When we got there, we were put in a little room that is very similar. It's not like a chemotherapy room. It's very similar to a surgical recovery room. The curtain's drawn, there's huge machines, there's a bed for me, and then there's a little plastic chair for my husband to sit in all humped up all day long. After the first day, we were told we needed 2 million cells. After the first day, we had to wait, and again, it was beginning to get late. We were told that I only collected 400,000 cells. That was a little shocking to me, considering I needed 2 million. I was worried. We went home, turned right around, came back at 7:30 A.M. the next morning, had the apheresis process. My husband sat there and waited for me. We waited afterwards, and we were told that I wasn't anywhere close to collecting enough cells. They had me go back up to the hospital, and they gave me up to the treatment, and they gave me another dose of some type of cell boosting. At that point, I was physically and emotionally exhausted, and I just couldn't at 6:00 P.M., go drive 60 miles and make that turnaround the next day. I opted to stay in a hotel close to the hospital and use their shuttle service. My husband had to go home because we have dogs, and we needed someone to be here to care for our dogs that night. He went home. I went to the hotel room. I went the next morning at 7:30 A.M. by shuttle over to the hospital by myself. I had another day of apheresis. I waited there and that was horrible anxiety, fear that I was not gonna have enough cells and fear that I wasn't gonna be able to have my stem cell transplant. Ultimately, at that point, that was the therapy that was suggested to me, and I was afraid I was gonna die if I couldn't get it. They said that I had enough cells and I could go home. I had to call my husband. He had to drive 60 miles, come and get me. You know, we had the expense of a hotel. We had the expense of valet parking, gas, a hotel room. I mean, it was just an expensive process that we had not planned on. I had Saturday and Sunday and Monday I had to be taken to the hospital. Now, I wanna add, during this time it was COVID, and the restrictions were terrible. I originally was going to go into the hospital in March of 2020, and the transplant center was shut down and not reopened till May of 2020. I had all of that anxiety. I had the COVID anxiety. My husband couldn't go with me. It was just a horrible process and that apheresis segment of it really made it very difficult when I went into the hospital. I was already very stressed and very anxious and had a lot of anxiety. That's pretty much my story with the apheresis and the start of the stem cell journey. Well, thank you for sharing it with us. I heard a lot of, you know, the various challenges. I think you did, you know, the challenges of the process came through very, very clearly. I'll just ask sort of finally then, if you would, if there was a medication that would allow you to only need potentially one apheresis session, what would the benefits of that be to you as a patient, and how could you foresee that improving your stem cell mobilization and collection experience? Well, it would improve it in the fact that I wouldn't have the three days, I wouldn't have the expense. You know, I'm not just one person that it happens to. I am on social media myeloma pages, and this is the routine, if not even patients having more trouble than that. I only know of one person that ever got their cells in one day. It would help emotionally, financially, it would help with the anxiety. You know, it would lessen the amount of time. There would just be a lot of things that it would help, 'cause that three days caused so much anxiety in our life. All right. Well, thank you again, Mary, and we wish you the very best in your upcoming treatments. Now we'll hear from Albert. Albert, would you please start by introducing yourself and then your connection to Mary and your role in her care? Okay. Hi, my name is Albert Quarterman, and I'm a caretaker to my wife, Mary Quarterman, who had been diagnosed with this disease since 2017. Backing up some of what she said, we had to go see a doctor, a special doctor for this stem cells transplant. He told us that there was a risk factor in this, that she could die from this. I wasn't about to make the decision on her either doing it or not doing it, you know. It was totally in her ballpark, you know. She had to make that decision herself, and she did make the decision, you know. Making that decision, had to go back up to the hospital again a couple days or whatever it was, and learn how to give her injections and everything and learn how to flush out the line and things like that, you know. I never done nothing like that before in my entire life, but it was all new to me. I gotta keep it together for sure. When we started collecting the cells, the first day went up there, it was a long day. It was really a long day. Sitting there and watching her and thinking in my mind that, you know, I could possibly lose my wife during this process, you know, it was terrifying, you know. Having to go back up again the second day, my goodness, you know, it's just like, okay, are we gonna get enough this time, or are we gonna be able to do this? Are they gonna have to come up with something else? We didn't know what, you know. The emotions was just running and running and running. My head was just whirling around constantly just trying to figure it all out. Having to leave her at the hospital on that second day, at the hotel that second day, you know, and then go home and I'm thinking about it all the way home and all night long, just the anxiety, the physical part of it, everything was just, it was overwhelming. Totally overwhelming. I love my wife to death. If I had to drive from Ohio to New York every day, I would to take her, you know. There's just nothing I wouldn't do for her. On the third day that we got everything, we had the weekend to think about this. Still the thoughts of everything that could possibly go wrong was in my mind. You know, what can I do to make this better for her? You know what? The hardest thing is there wasn't a darn thing I could do but just try to give her some moral support. I'm hoping I did a good job with that, you know. It come time for her to go in for the stem cell transplant, you know. During COVID and everything, I had to go up there and drop her off at the hospital with her bag and, you know, kiss her goodbye, and that was it. Was that my last kiss? Was that my last hug? Didn't know. Couldn't go in. We, you know, text back and forth and we called and, you know, it was really hard for her being in there for 16 days, and it was hard on me as well. You know, I had to cook for myself. I, you know, just the thinking about what's going on, how are we gonna do this, how are we gonna do that, and, you know. I never even took care of the bills. She takes care of the bills. I didn't know what I was gonna do, you know. It's just a roller coaster ride is what it is. You know, I would wish this disease on anybody, you know. I hear, Albert, you know, the description you're giving of the roller coaster, the logistical, the physical, the emotional pieces. I appreciate you highlighting everything in your experience. Thank you to all three. I just wanna take this opportunity to say that, you know, it is so important that we hear directly from the people that go through the mobilization and apheresis process, the people that it impacts most. Thanks for joining us today. Thank you for having us. Thank you. Thank you very much, everyone, for the very important and compelling panel discussion. I'd now like to introduce Holly May, our newly appointed President of BioLineRx USA, who has 13 product launches under her belt, and we are looking forward to her successfully completing her 14th launch with APHEXDA. Holly, the floor is yours. Thank you, Phil. I'm so excited to be here today. The first thing is we do have a brand name, and so BL-8040 motixafortide will now be referred to as APHEXDA. In my early days with BioLineRx, we dove into a deep analysis of our commercial options, and we really considered two main pathways, to partner or to go it on our own. Looking at the partnering, there were a couple different optionalities there where we thought we could out-license or even bring in a kind of a co-commercialization turnkey type partner. While there were many considerations, the option here really was leading to, like, a lower profit percentage. Also, BioLineRx would have to give up some of that market development control as we fit into the portfolio of another company. The self-commercialization route was given good consideration because here the thinking is that we wouldn't be having to do a profit split. We wouldn't lose out that very important market development control. Quite frankly, it was a much more attractive option from an overall cost perspective. Would like to give a little bit of thinking about the key considerations that we had behind that optionality of going it ourselves versus using a partner. The first thing I think that's been very clear today is that we have a highly differentiated clinical candidate, and that makes the ability and the story and the value proposition of going into the marketplace very strong. We also, as you're gonna hear in a moment, and I know that Dr. DiPersio touched on this. It's a well-defined marketplace, especially for a smaller company that wants to launch into the U.S. market. With a lot of the experience that I have, we knew. I've gone through this kind of playbook before of recruiting a knowledgeable commercial and U.S. team, so that was a knowable thing. Also, BioLineRx has very strong manufacturing already in place from being the clinical company that it is. Bringing on the right thinking from a distribution perspective, it was something that I thought was very doable. Of course, both models, we looked at what the revenue would be, but also most importantly, the profitability picture. With that, with the deep analysis that we did, we made the determination that we would go it alone. Let's just look at the decision of doing this ourselves to see exactly how and what we've been doing thus far. First of all, we've made the decision to put the U.S. headquarters in Massachusetts in the Greater Boston area. What that affords us is a very deep talent pool since we know that there's strong talent in the biotech hub of the Greater Boston area. Thus far, I've been very happy to be able to bring on some experts, some subject matter experts with very deep multi-product launch experience and backgrounds. As I said previously, I myself have gone through this playbook before with career experience on successful launches and very on-time launches. We it's very important to say that all of this planning is focused on not just an on-time launch, but the potential of having a priority review. That's the timeline that we're anchoring against because it is the ultimate goal to be able to launch within a week or two of PDUFA approval. What's been happening? We've already worked extensively on the things that would be defined as long lead time items, things such as manufacturing, distribution. For those who know about this whole U.S. commercialization process, serialization does take a long time, and we're well on our way there, as well as getting the appropriate state licensing. We have done foundational market research, which is going to feed into both marketing and market access plans very nicely, so that we really understand the market that we're going into, the customers and stakeholders and the needs there. We've already launched some work on our thinking around pricing, and then early activation of medical affairs and building relationships is key and critically important, and I'll talk a little bit more about that in just a moment. I think before we talk about more activities, it's really important to think about what the opportunity is as we define kind of commercially the value of this APHEXDA. Based on the Phase 3 GENESIS data, we do know that APHEXDA achieves optimal stem cell collection for nearly all multiple myeloma autologous transplant procedures with just one dose of administration on top of G-CSF. Looking at those transplant patients with multiple myeloma really starts to define what that market potential is. This graph here speaks to that opportunity in the US. With thinking about multiple myeloma, with the potential to possibly expand into other indications, approximately 80%-90% of all autologous hematopoietic stem cell transplants are in the multiple myeloma and lymphoma space. It's important to know that this is not a longitudinal slide. However, the number of multiple myeloma autologous transplants has been growing and has more than doubled since 2010. Just looking at the autologous stem cell transplants on the left gives a good perception and idea of the market that we are targeting in the United States. I think the other thing in really thinking about going to market is what has already been discussed from an unmet needs perspective, but this is really the anchor to the value proposition. We've heard that currently there is still great unmet need, even with the therapies that are in the market right now. We know that there's still unmet need, and we've heard from both the clinical, the physician perspective as well as the patient caregiver perspective on this, that still today there's the potential for extended mobilization days as patients could possibly be collecting, as we've seen upwards anywhere from as many as 4-8 days. With the goal being to limit the number of days from a quality of life perspective and also from just a logistical perspective in the institutions, the apheresis centers. Also with increased mobilization days comes the increase of costs to the healthcare system, to the patient, et cetera. As I said, the scheduling piece is another logistical issue that needs to be thought here. Despite the advances that have already occurred in stem cell mobilization, some patients are really unable to mobilize enough in their mobilization sessions. Historically, there's anywhere from 15%-35% of the patients who really aren't able to mobilize enough, and that's what our market research has been showing. This just results in higher procedure costs to both the systems and to the payers. I think that this, Dr. DiPersio really did a good job of talking about how the mobilization and induction has changed over the years. There's more and more elderly patients who are currently able to go to transplant, and with this, as many as for the quad induction, four drugs regimen for induction, that is also, as we've heard, starting to reduce those overall yields. There's good opportunity and space for a product like APHEXDA to potentially fulfill the unmet need and become the standard of care. Now let's talk a little bit more about why I mean, that's a good background, I think, but let's really talk about what this means for going to the market. From my experience, I can say that this is really an ideal product and market for a small company with the goal of establishing themselves as a commercial entity in the US. If you think about this, BioLineRx has the balance sheet, has the management experience, building the management experience with deep subject matter expertise. We've got a great clinical product. Let's take a little bit of a deeper dive into some of these elements. First of all, right product. Why do we say right product? We just heard from an apheresis nurse and from a multiple myeloma patient and her caregiver about the difficult patient journey, which really sets up that unmet need that I just described in my previous slide. There's definitely room in this market for improved treatment. It should not be too difficult to get the word out because autologous transplants, and hence stem cell apheresis, is highly concentrated with an unknown number of centers, making a targeted approach with a fairly small team of MSLs, account managers, and sales professionals. It makes it fairly easy. In other words, I guess what I'm trying to say is a small field footprint minimizes the costs and can also facilitate a large impact. That's the right product, right market. Let's talk now about the right people. As I've described, we have had great success in Vespera in our recruiting efforts, and we've developed a plan to phase in talent, systems, and resources according to both the pre-marketing, relationship building, and scientific exchange needs. In addition, we are right-sizing the hiring process to not overbuild, but to hire the necessary U.S. entity support functions that will be required for BioLineRx to be able to do business in the U.S. Right product plus right market plus right people equals successful launch. We believe this focused and targeted approach will allow us to launch successfully into the marketplace, fulfilling the needs of the stakeholders while not unduly giving up too much shareholder value. Additionally, I think it's important to know that we are planning for a launch as close to our PDUFA date as possible. Let's now look at a very important pre-launch, pre-marketing activity. A real important part of market preparedness is relationship building and understanding individual medical center practices. This paves the way for stakeholder perceptions of both who BioLineRx is, as well as what that stem cell mobilization landscape looks like. The best way to accomplish this is via scientific exchange through medical science liaisons. Additionally, creating awareness of the company, our product, and its data can be achieved through real solid scientific communication plans. Therefore, the early deployment of medical affairs activities is just foundational to physician and nurse education and something that I would put on that list of that long lead time item category. BioLineRx USA has already begun this deployment. We started with a solid strategy which encompassed data generation through thinking about what the publication plan would be and the hiring and training of MSLs. We have used and will be using our U.S. medical affairs team to gather important insights on medical center practices and the protocols, and also to assist in putting in place, an advisory board to make sure that we have the most informed launch as possible. I think that. You wanna move forward? Great. Thank you. I just wanna summarize the U.S. commercialization plan to say that we are targeting that $360+ million US stem cell mobilization marketplace. That's the space that we're looking at from a overall kind of sales perspective. Right now, BioLineRx is at a real crucial point in the US launch readiness because we have in fact very excited to say that we filed our NDA. We have this differentiated clinical profile around efficacy, safety and dosing from our randomized Genesis Phase 3 data. We have the early market research which shows a very strong pharmacoeconomic outcomes. We've got limited and manageable requirements for a footprint in the U.S. with very successful uptake. Also we have significant activities that have been initiated to meet the potential for a priority review. This is all built around the thinking of what those real key success drivers or value drivers would be. These include a belief in APHEXDA value proposition by the decision-makers, prescribers and payers, the rapid uptake in major transplant centers via increased awareness of BioLineRx and APHEXDA, the publications and CME, the continuing medical education activities to broaden the understanding in the stem cell transplant marketplace with differentiated outcomes, and also coverage and reimbursement to secure good formulary status in the treatment centers and our key accounts. Probably lastly, it's important to say that we're really leveraging our US infrastructure that we're building for APHEXDA for the potential for growth of BioLineRx in the U.S. for future commercial candidates. With that, I would like to turn it back over to Phil. Thanks, Holly. Thank you, Dr. DiPersio, for your enlightening talk. Thanks also to the patient and caregiver for sharing your treatment journey with us. It was truly inspiring. This concludes our formal presentation. In summary, we believe that if approved, APHEXDA + G-CSF can quickly become the standard of care for all multiple myeloma patients by offering compelling value to both patients and to transplant facilities. Recapping the overwhelmingly positive results from our GENESIS Phase 3 study, which compared APHEXDA + G-CSF versus placebo plus G-CSF, the study met all primary and secondary endpoints with an exceptionally high level of statistical significance. Of particular note, almost 90% of patients receiving APHEXDA + G-CSF underwent transplantation after only one administration and one apheresis session. In addition, patients in the APHEXDA + G-CSF arm collected a median of approximately 11 million stem cells per kilogram in only one apheresis session versus 2 million in the G-CSF arm. This confers significant benefits to transplant facilities by allowing them to more efficiently schedule the apheresis sessions at the apheresis centers, since apheresis machines tend to be in short supply at many of these centers. Also, reducing the number of sessions required to mobilize the optimal number of stem cells for transplantation lessens the burden on patients. This is particularly important as the advancement of new induction treatment regimens for multiple myeloma patients, which generally include multiple therapeutic compounds within the combination, has been shown to substantially decrease the ability of patients to mobilize the target number of cells with existing products. It is for these reasons, in addition to the very positive pharmacoeconomic data that we reported previously, that we believe APHEXDA + G-CSF can quickly become the standard of care for all multiple myeloma patients. While our initial focus will be on autologous stem cell transplantation in multiple myeloma, longer term, we see opportunities to expand into peripheral indications in additional therapeutic areas. Autologous stem cell-based gene therapy is just one example of an area where improved mobilization agents are highly needed. In closing, we are proud to have the opportunity to introduce APHEXDA as a significant advancement in stem cell mobilization. We plan to work closely with the FDA during its review process, while in parallel prepare for a robust commercial launch that ensures rapid and broad access for patients. At this point, we'll open up the call for questions. Thank you, Phil. At this time, we'll begin conducting our Q&A session. As a reminder to the audience, you may submit your questions through the Q&A function at the bottom of the webcast player. To our analysts, please raise your hand to indicate you would like to join the queue. A kind reminder to the audience, Dr. DiPersio is not available for questions today. With that, we'll open it up with our first question from Mark Breidenbach at Oppenheimer. Hi there. Can you hear me? We can. Thanks. Yes. Hey, thanks for this presentation, and thanks for taking our question. Just maybe was hoping to get Holly's thoughts on how motixafortide could compete with generic plerixafor, given that this drug's going to be going off patent likely in 2023. Thank you. Great. Well Go ahead, Holly. Thank you. Thanks for the question. We're well aware of the market dynamics in the market that we're entering. I will say that we expect to distinguish APHEXDA based on its compelling clinical efficacy and pharmacoeconomic benefit. When I speak about the clinical efficacy piece, I mean both from a quantity and a quality of the cells perspective. I think it's important to reflect back on what we just heard from Dr. DiPersio, that there is a very strong clinical need for better mobilization agents, particularly with the treatment regimens that we see today, including Revlimid and Darzalex. He speaks about, you know, what that's actually doing from kind of an overall treatment perspective. We really think that there's a very compelling benefit to both the patients and the transplant centers for just more reliable transplant procedures. We've also heard today from the nurse practicing at a major transplant center as well as from a multiple myeloma patient caregiver, that there really is an opportunity to secure more stem cells from transplant. That would really relieve a lot of the burdens to the patient and to the transplant facility. All of this together wraps into the broader perspective on value proposition. Based on those factors, we really believe that APHEXDA has the potential to be the preferred and optimal agent. That said, we are also doing market research around price and price sensitivity, and that will all be wrapped into the final decision on go-to-market. Okay. Thank you. Just, you know, in terms of with the approval of Abecma and Carvykti in multiple myeloma, these products are being run in earlier settings. What are your expectations for the, you know, the trend for autologous stem cell transplant in multiple myeloma, you know, over the next 5, 10 years? Are you expecting continued growth or are you expecting CAR T to start eating into this market? Abi, would you like to take that one? Yes, sure. Hi. Hi, Mark. Thank you for the question. Actually, you know, every time there are things that, you know, are in development and more and more drugs are in development, but at the end of the day, stem cell transplantation is still the standard of care for treatment in multiple myeloma. In any case, for example, if in the future, and I don't think in the near future, maybe in the far future, it will be not the first treatment, it will be the second one, then autologous transplantation will still be there. This is the standard of care right now. Even with the, you know, with the approval of Darzalex, there are still this patient need to underwent still a transplantation. Furthermore, I must just say that, you know, in the last years, more and more elderly patients are undergoing transplantation, even if they are over the age of 67. 67 was the cutoff age a few years ago, and now we are going up and up. We have seen this. If you take studies from few years ago, the median age was lower, and in our study, which was much higher than in the past. You know, even with the new advances of therapies, I still believe that. I'm not just believe, you know, we have seen that it's an increase in autologous transplantation for multiple myeloma. Can I add on to that? Yes, you can. Okay. Thank you. That's exactly what is being. I think, you know, we've mentioned a few like eyes in the perspective of BioLineRx, but our perspectives are being rooted in very deep market research. We know that with our first launch, we can't miss. We can't afford to miss. We are looking at the marketplace from multiple angles. This question that you ask is a good one because it is exactly what we are exploring right now with physicians who are practicing, and with, you know, multiple myeloma hematology experts. The feedback that we are getting from all of our deep analytics is that that's not necessarily a near-term horizon, you know, competitive concern. You know, the future may look a little bit different, but in our near-term projections, we are not hearing from the marketplace that there's anything that's going to imminently change the need for stem cell transplant. Thank you. Yeah. Great. Thanks, Mark. Thanks for the questions, Mark. The next question comes from John Vandermosten at Zacks. John, you may unmute your line. Great. Thank you. Good morning and afternoon, everyone. We've got the $360 million market size. How much of that do you expect to take? Will APHEXDA replace or build on the sales in the existing market? Holly, would you like to take that? Sure. At this point in time, we aren't talking deeply about our revenue forecasts, but we are again, from the insights that we're generating in the market right now, we are projecting to be very much focused on that multiple myeloma. That's our label indication. We are looking at that totality, and we have, you know, projections over where we think we can be with peak sales, which should be occurring within the first few years. Wish I could give you more from a, you know, the deeper perspective, but right now we're not necessarily able to share all of our perspectives on, you know, where we're landing from a revenue perspective. Okay, thank you. What you just mentioned kind of brought up another question that I had on when you feel that profitability may be reached. You said you're gonna probably achieve peak sales relatively quickly. How long do you think that'll take to get to that point? Yeah, John. I mean, I'm gonna take this instead of Holly. I mean, we're really not able to give any guidance on, you know, breakeven or profitability at this point. I will just say, as Holly mentioned, this is a small footprint. This is a very manageable launch from a cost perspective because it's a limited number of transplantation centers throughout the United States. Therefore, we do believe that this could be, you know, quite a nice nicely profitable product. But I can't give you any more guidance than that at this point. No, I got it. Lots of unknown there. You know, one of the trends in HSCT is that the addressable population's increased pretty dramatically. I think, we heard that it doubled on the call today, and I've seen, you know, other information to support that. You know, improvements in the space have enabled older and sicker patients to receive transplants. Will APHEXDA continue this trend and kind of expand that even greater? Just because, you know, I mean, it was a great story from the patient on, you know, the burdens of the apheresis. What are the thoughts on that? Holly, you wanna take that? Yeah. We are seeing, you know, an increased trend over the last decade, and I think that if we, you know, some of the information that Dr. DiPersio shared with us is showing that that market is expanding due to age, due to better treatments for multiple myeloma. It's allowing more patients, older patients, the opportunity for treatment and for longevity. Yes. I'm not sure if I'm answering your question, but we are looking at trends over time in autologous stem cell transplants, specifically autologous, and using that for our future projections, and that is the trend that we are definitely seeing. Okay, great. Yeah. I mean, we're always learning. Technology is improving. Last one for me is just the opportunity for combination therapies. You know, we had in the initial part of the presentation just some of the mechanism of action of the drugs and how they, you know, release the mooring line, so to speak. And there are several different types of mooring lines. So I'm wondering if, you know, a combination approach might be appropriate, you know, maybe with the Magenta drug or something else. What are the thoughts on that? Abby, do you wanna take that? Yes, sure. For sure, we will think for the lifecycle management for further indications and combinations. We are already working on that. There are, instead, on top of the unmet need in the autologous stem cell transplantation in multiple myeloma, there are other unmet needs in, for example, sickle cell anemia, in which patients are not able to receive G-CSF and need very good mobilizers because they need a lot of cells to do the gene therapy. We are already working on that, again, as a single agent and in combination for several indications. The Magenta drug, I don't know it's the fit for us, but we have several things in mind. Okay, great. Actually, you know, I do have one more, and maybe you can follow up with me on this. I'm just wondering what the capacity utilization is of the apheresis unit that was referenced in the panel discussion or even just overall, if we have that information? 'Cause, you know, it seems like that would be an important driver of uptake of the product. Go ahead. I can kind of answer some. I think I can answer the question. Again, this is one of the things that we are approaching from two different directions. We have been, we've been doing, you know, blinded market research, and so that is giving us a very fair assessment of the burden to the apheresis centers. We're hearing about how many days that are automatically booked for a patient right now, you know, up to four days just automatically. Those chairs are held for patients. We believe that we can shift that dynamic knowing that most patients will only require one apheresis session. You know, that's important. We're also approaching this from a different direction, and I spoke about that in my section as well, where we have deployed medical science liaisons to do, you know, very early discussions and work around scientific exchange. You know, not making any claims about APHEXDA, but really trying to understand, center by center, how those, how decisions are made and how scheduling occurs, because that is a key critical part of the overall economic story. We are on it. We are on understanding the way that this is working right now in the U.S. marketplace. There's a good story. I mean, it's a good story is what we're learning. Yeah. Thank you for the questions, John. The last analyst question will come from Joe Pantginis at H.C. Wainwright. Joe, you may go ahead. Great. Hey, everybody. Thanks for all the details and visibility around the program. I think my questions are mostly logistical. First, I guess, Holly, you know, you really gave a lot of details about the plan. Can you give maybe some numbers with regard to the size of the field force? Obviously, it's very targeted, very niche, and how we're looking at, you know, how that number might change as you look towards additional indication. Yeah. Small is what I'm gonna say. Small and targeted. I mean, I clearly have ideas right now, but some of this also has to do with, you know, how we finish looking at some of the data. We know that it's that, you know, 80/20 or 80/30 rule about where most of the autologous stem cell transplants are done in the United States. It's very concentrated into, you know, less than 100 centers. Even though there's more centers doing transplants, but, you know, that's where the majority, we can really make a big impact in that type of footprint. We know that being able to get rapid uptake and market share is critically important. We will be doing some traditional things, like not only thinking about promotional sales, but also what we need to deploy as far as you know, payer and account type folks. Again, not a lot. We feel like we can do this with you know, a small footprint, and we already have begun to deploy and have MSLs working in the field as well. We do believe that three-prong deployment will afford us the best possibility for quick uptake. All that said, it's really small. I've actually led this type of deployment before in transplant centers, and it doesn't really require a lot of people. That I think I said this, but I wanna say this again. This is an ideal product for a company like BioLineRx to step into the commercial world in the United States. It just doesn't take extensive resource and OpEx in order to gain a really high impact. I think that was a primary driving force for us making the decision to go this alone and be able to retain profits. Got it. If you look at sort of the last end of my question about, you know, how the size thoughts might change, you know, as you go into additional indication, I would sort of, you know, ask that question again, but also more specifically, you know, 'cause Phil mentioned it, Dr. DiPersio mentioned all the different aspects that you guys would be considering potentially. You know, do you have any early thoughts or plans beyond multiple myeloma that are sort of, you know, at the protocol stage at this point, and when we might see potential visibility on those programs? I don't know who to give it to. Holly, do you want, I mean, or maybe Abby, do you wanna talk a little bit about that? Yeah. I'm wondering whether I can talk about this program. I don't know how much you can say. All I can say, I mean, you know, listen, we're always looking at lifecycle management possibility. Yeah. We're speaking with multiple potential collaborators all the time. We have a lot of ideas. I will say that our number one priority is to have a successful launch of APHEXDA in multiple myeloma at this point. That's our number one priority. We wanna get there. We wanna successfully launch it. We wanna get to profitability as soon as possible. Everything else will come afterwards at some point, whether it's in the short term or the medium term. I think that we wanna be clear that right now we're focusing the company completely on the successful launch. Got it. It totally makes sense with that focus. Just really two more questions. One sort of a little, maybe non-answerable at this point, but you know I have to ask it anyway. You know, it's always about what's next. It's like great visibility today on the commercial plans initially and, you know, what are your current thoughts and where does the process stand with regard to the ex-US opportunity? 'Cause you obviously you've had a lot of visibility with regard to regulatory authorities over there recently and, you know, anything to share? Yeah, sure. I mean, I'll say that, you know, we're actively evaluating, you know, the European market in substantial detail, both from a, from a pharmacoeconomic perspective, a regulatory, and a commercial perspective. When, based on this analysis, we are going to decide on the best pathway forward regarding submission in Europe. In any event, I think that we've made it very clear, we are not going to commercialize in Europe on our own. We are going to look for a partner. I also wanna mention that there are also other markets in the Asia-Pacific, of course, and we're not ruling those markets out, at all. Some of which rely somewhat on FDA approval in order to be able to, you know, launch into those markets from a regulatory perspective, again, with a partner, not on our own. You know, we have future plans, and we think that there is a potential, you know, upside to this program, significant upside to this program, you know, both in Europe and in other places in the world. I will say again, we're focusing right now on the U.S. and on a successful launch in the U.S. Got it. Just the last logistical question. I apologize if I missed this in any of your filings. I just wanted to make sure. With regard to the $40 million debt that you just announced recently, the additional $30, did you or have you identified what those milestones are to trigger those tranches? Obviously, one is probably obvious with like approval or something like that, but are they disclosed? We have not disclosed them from a business and competitive perspective. We're just not able to disclose what the milestones are, but they are contingent of course. You know, when we reach those milestones, of course, they will be available to us. Great. Thanks a lot, guys, and thanks for the visibility. All right. Thanks, Joe. Thanks, Joe. I'll now hand it over to Tim McCarthy of LifeSci Advisors to answer or read off any questions that came in over the webcast. Tim. Thanks, Sarah. Several of the questions were asked and answered by the analysts. There's one remaining question, which is regarding the location and manufacturing of the product. Yeah. We are using you know, high quality, well-known manufacturers to manufacture both the drug substance and the drug product. The drug substance is being manufactured in the U.S., and the drug product is being manufactured in Western Europe. They're high quality, well-known, previously FDA-inspected facilities. Okay, great. There is actually one more. One moment, please. Can you please advise if there are any issues in meeting the CMC requirements? Is the company well prepared for the FDA inspection of the manufacturing facility? Okay. For that, I'll turn it over to Ella. Go ahead. Yes. Hi. Okay. So with regards, you know, the APHEXDA is a peptide, and we have developed it according to all regulatory requirements, and therefore we do not anticipate any particular challenges with regard to the regulatory requirements. Regarding the second part of the question of the FDA inspections of the manufacturing facilities, we are working with them, and what I can say is this, we are as prepared as can be. Thanks, Ella. Okay, that's the end of the question and answer period. Phil, would you like to wrap up the call? Yeah, sure. I'd like to thank the participants as well as all those who have joined us on the webinar today. A recording of the entire webinar will be available on the company's website starting in about 2 hours from now, and it will be available through October 31st, 2022. That's it for now. Thanks for joining us and have a great day.