BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx third quarter 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. For operator assistance during the conference, please press star zero. 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, Johnny. Welcome, everyone. Thank you for joining us on our third quarter 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. We've also filed a B6K. I'd like to remind you that certain statements we make during the call will be forward-looking. Because such statements deal with future events and are subject to many risks and uncertainties, Actual results may differ materially from those in the four different statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly reports 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 Terland, Chief Executive Officer of BioLine RA.

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 Molly Zevi, our Chief Financial Officer. In addition, Ella Serrani, our Chief Development Officer, will be joining the call for Q&A. I will begin with an overview of our stem cell mobilization program, then Holly will provide an update on the effects to launch activities and progress. I will then provide an update on our other clinical programs, notably the metixifortide programs in PDAC and sickle cell disease. Finally, Molly will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. We have made substantial progress since our last quarterly update with our stem cell mobilization program. We were very pleased to announce in September the US FDA approval of metixifortide known commercially as Effecsta, in combination with GCSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of Effecsta is the culmination of tireless work by the entire BioLine Rx team and transitions us to a commercial stage company that is bringing to patients physicians, and caregivers their first true advancement in stem cell mobilization in more than a decade. As Holly will detail shortly, we have built out our U.S. commercial infrastructure, which has been engaging in pre- and post-launch activities to support a robust future for Afexta. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggests that Afexta fills a significant unmet need for a more effective mobilization regimen, conferring benefits to centers, payers, and patients alike. This encouraging feedback gives us great optimism, the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimen, several of which we have covered in our prior calls. The population of multiple myeloma patients undergoing autologous stem cell mobilization has expanded to include older patients over the past decade, with 36% of patients age 65 or over in 2021. Older age has been shown to impair stem cell mobilization as stem cell counts decrease with age. In addition, the introduction of stronger induction therapies has further impaired mobilization, including drugs such as lenalidomide and daratumumab, which are often given in combination. As a result, many patients may require multiple aporesis sessions. Recall that the approval of effects that was based on results from the highly successful Genesis Phase III clinical trial, and in this contemporary trial, most patients received lenalidomide-containing induction regimens, and the median age in the metixifortide treatment arm was approximately 64 years old. particularly relevant to transplant sensors in the Genesis trial, affects the plus GCSF-enabled almost 90% of patients who proceed to transplantation after only one aporesis session. Also, as a reminder, multiple myeloma is the second most common hematologic malignancy, and autologous stem cell transplantation remains the standard of care treatment and has been shown to prolong the lives of patients with this cancer type. And historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cells after one session. With Effecsta as the potential backbone of a new mobilization paradigm, we are optimistic that many more multiple myeloma patients will be candidates for this life-extending procedure and will benefit from what we are calling an A-plus transplantation experience. At this point, I'd like to turn the call over to Holly May, President of BioLineRxUSA, for review of our launch activities. Holly, please go ahead.

Thank you, Phil. As Phil indicated, the approval of Effexa for stem cell mobilization in multiple myeloma patients represents the first true advancement in stem cell mobilization in over a decade. Our decision to commercialize Effexa independently in the U.S. is key to our efforts to make this new mobilization agent available to transplant centers and patients as quickly as possible. I would now like to provide a brief update on our recent and ongoing activities supporting the commercial launch, which we initiated immediately after effect's approval. First, it may be helpful to provide some statistics that support the significant opportunity that is in front of us, not just in terms of potential sales, but also in the ability to help thousands of patients who today are having great difficulty mobilizing enough stem cells for transplantation. As a reminder, there are approximately 35,000 patients diagnosed with multiple myeloma each year in the U.S. And of those, we estimate that about 18,000 are eligible for autologous stem cell transplantation. Of these eligible patients, approximately 8,000 procedures occur annually, a figure that has nearly doubled since 2010. Autologous stem cell transplantation remains the preferred first-line treatment for patients with multiple myeloma. However, due to a number of factors, including an aging patient population and the increased use of three and four drug induction therapies, as Phil indicated, up to 47% of patients have had challenges collecting the target number of stem cells in one apheresis session. As we will cover in more detail shortly, the requirement for multiple apheresis sessions leads to potentially more adverse events, higher costs, and tremendous inconvenience and mental hardship for patients. With the efficacy demonstrated in phase three Genesis trial, which supported the approval of effects to indecent indication, we believe we can overcome these challenges. We believe we are highly differentiated as a novel second generation mobilization agent and that we have a significant value proposition for all stakeholders. That includes centers, patients, and payers. Staying on the topic of differentiation for a moment, we have done extensive research on the market and have deep appreciation of the evolving landscape. Since our last earnings call, and as expected, multiple abbreviated new drug applications, or ANDAs, have been approved for generic chloroxifor, leading to rapid and significant price erosion for this first generation mobilization agent. This was something that we anticipated and that we have incorporated into our models. And while we consider Plurixa 4 to be in the same overall market basket as Effexa, it is not the same as Effexa. We have a highly differentiated product profile based on our stronger and more consistent mobilization outcomes. And our early discussions with customers support that the centers appreciate the innovation as they look to address their need for a better mobilizer. As such, we have indicated previously that we have priced Afexa at $5,900 per vial. We believe this price adequately reflects the value that Afexa adds to the autologous stem cell transplant treatment landscape. Further, notwithstanding the existence of lower-priced generic Cloroxifor, we believe the differentiated clinical attributes of Afexa will drive long-term adoption and allow it to evolve into the new standard of care for mobilization. Over time, we strongly believe that differentiation will outweigh drug price as centers adopt the best treatment paradigm for their patients. As we indicated previously, our first priority has been to educate transplant centers on the unmet need of roughly 8,000 patients who progress to autologous stem cell transplant each year. We estimate the top 80 centers out of about 212 nationally, perform approximately 85% of all stem cell transplant procedures. Since approval, we have established initial contact with all of our top tier centers, and receptivity has been extremely high. Apheresis chairs can be in short supply at many transplant centers, and the potential for Afexa to allow for the collection of the targeted number of stem cells quite often in a single apheresis session, should allow for the more efficient scheduling and utilization of those chairs. This is of significant value to transplant centers, particularly those that perform a high number of procedures. We are in ongoing discussions with pharmacy and therapeutics committees at those centers that require positive TNT formulary decision prior to trialing the product and including Effecsta in their protocols. We are making consistent and steady progress. We believe an important factor driving the patient success of AFEXTA is inclusion in clinical treatment guidelines. Shortly after approval, AFEXTA was included in the National Clinical Practice Guidelines in Oncology, otherwise known as NCCN, for stem cell mobilization broadly, including multiple myeloma. The American Society for Transplantation and Cellular Therapy, or AFTCT, is also working on updated guidelines, which we anticipate next year. Currently, AFTCT consensus recommendations call for a recommended collection target of 3 to 5 million cells per kilogram and double that target if multiple transplants are planned. Recall that in the Genesis trial, the median number of CD34 stem cells collected on the first day of apheresis was 8.5 million in the treatment arm versus 1.5 million in the control arm. As Phil indicated earlier, the addition of metixifortad to GCSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the GCSF arm. Given the demonstrated performance of Mefexta relative to the current treatment guidelines, we are confident that we will ultimately gain inclusion. Turning now to payers, the success of any new therapeutic launch is contingent upon establishing broad, affordable access from a coverage and reimbursement perspective. This includes not only national and regional commercial health plans, but also the Centers for Medicare and Medicaid Services, since a significant number of multiple myeloma patients are older and therefore receive their health care through Medicare. The median upfront cost of stem cell collection, independent of drug costs, is 13,850 per patient and can range from 6,300 to 48,500. The cost of one additional session is 6,200 to 6,600, again, independent of drug costs. So the ability to more predictably and reliably achieve their targeted number of stem cells required for transplantation in fewer apheresis sessions can result in significant savings to payers over time. Payers view the FXDA clinical data very favorably, and as a result, we have already established unrestricted access to over 90% of covered lives. This represents a mix of both commercial and government payers, and we continue to work to increase this number so that FXDA is as broadly accessible to patients as possible. In summary, I am very pleased with our launch progress to date. Both our commercial and medical affairs teams which include many individuals with decades of experience in both stem cell mobilization and multiple myeloma, 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. At this point, I'll turn the call back to Phil to provide an update on our other programs.

Thank you, Holly. At this point, I would like to provide an update on opportunities that we are pursuing in stem cell mobilization for multiple myeloma outside of the United States. Just a few weeks ago, we closed an exclusive license agreement for the development and commercialization of lemmatixifluorotide in Asia across multiple indications. As part of the agreement in stem cell mobilization, our partner, Gloria Biosciences, plans to execute a 30 to 50 patient bridging study in China to support approval and commercialization of Afexa for stem cell mobilization in multiple myeloma, and will also seek approval in other Asian countries. In prior clinical trials, Gloria Biosciences has demonstrated an ability to enroll patients quickly, and we believe they will be able to complete this trial with similar efficiency. In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma, the largest number of multiple myeloma cases globally. So this is an area of great unmet need in those territories as well. And in China, autologous stem cell transportation for multiple myeloma is already included in medical insurance reimbursement. We continue to evaluate additional commercialization partnership opportunities in significant markets for effects in stem cell mobilization. Turning now to our second development indication for metixifortide, pancreatic cancer. Our license agreement with Gloria Biosciences covers this indication as well. Gloria Biosciences is a leader in the development of cancer immunotherapies in Greater China, having developed and commercially launched the anti-PD-1 monoclonal antibody, zimburimumab, which is approved in the region for relapsed or refractory classical Hodgkin's lymphoma and recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimburimumab in its first indication in China in only four years. So we believe they are uniquely positioned to explore the potential utility of metixifortide in combination trials against this difficult-to-treat cancer. Recapping the terms of the agreement, we received $15 million up front and are eligible to receive up to approximately $50 million in development milestones based on the achievement of specific development milestones in China and Japan. Additionally, we are eligible to receive up to approximately $200 million in potential commercial milestones and royalties ranging from 10% to 20% of net sales following the approval of MATIC support in any indication in the Asia region. In addition, the transaction included an equity investment of $14.6 million in BioLine RX through the purchase of newly issued American depository shares at a price of $2.14 per ADS. No warrants were issued in the transaction. In other PDAC developments in July, we announced the initiation of a randomized Phase II combination clinical trial of metixoportide in first-line pancreatic cancer. The trial, known as Chemo for MedPank, is sponsored by Columbia University, and it was recommended to proceed to the randomized phase of the study based on the very compelling preliminary data from the single-arm pilot phase of the study. Recall that the original pilot study was to enroll approximately 10 patients and was to be expanded to 30 patients if data from the first 10 patients were encouraging, which was defined as three or more patients showing a partial response per the resist criteria. As we recently presented at the AACR Special Conference on Pancreatic Cancer in September, seven of 11 patients, or 64%, experienced a partial response, of which five were confirmed PRs, with one patient even experiencing resolution of the metastatic lesion in the liver. Along with the three patients were 27% experiencing stable disease, This resulted in a disease control rate of 91%. These findings compare very 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 original trial design was amended from a single-arm study with a target enrollment of 30 patients as mentioned to a much larger randomized study of 108 patients. The trial's primary endpoint is progression-free survival, PFS. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival. Enrollment in the study is expected to begin in the next few months. As is well known, PDAC is a tumor type in dire need of new effective treatment options. Newer immunotherapies have shown promise in other tumor types. but limited efficacy in PDAC due to immunosuppressive pathways. Our optimism for this trial is also based on the success of our COMBAT Keynote 202 Triple Combination Phase 2a study for which we announced results in December 2020. Recall that the COMBAT Keynote study evaluated the combination of metixifortide, Keytruda, and chemotherapy as a second-line therapy. Substantial improvement was observed across all study endpoints, including overall survival, progression pre-survival, and overall response rate in the most challenging PDAC patients, those initially diagnosed with stage 4 cancer. The combination also appeared to be well-tolerated with a low incidence of neutropenia and infections in treated patients. Needless to say, we are excited about the potential of metixifortide to form the backbone of new PDAC treatment regimens. giving new hope to patients suffering from this very difficult to treat tumor type while demonstrating the versatility of metixifortide across both hematological and solid tumor cancers. It is also worth mentioning that based on the promising data to date in PDAC, we see opportunities to explore metixifortide as part of exciting new combination therapies to treat other solid tumor types. This only adds to our optimism for the long-term potential of this molecule. Another area where we are exploring the potential utility of metixifortide is autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease, one of the most common genetic diseases globally. To that end, in March, we announced a clinical trial collaboration with Washington University's School of Medicine to evaluate metixifortide in this indication. Unlike multiple myeloma patients, the current standard of care mobilization agent, GCSF, carry significant risks and potential severe side effects for patients suffering from sickle cell disease. Furthermore, in many cases, current mobilization treatments fail to reliably yield optimal number of stem cells to facilitate gene therapy. As such, this patient population is in need of an effective new mobilization regimen. Through this collaboration, we are conducting a proof-of-concept trial to study metixoportide 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 positive hematopoietic stem cells in patients with sickle cell disease. Study enrollment has recently begun, and we anticipate data in the second half of 2024. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our main financial results. Molly, please go ahead.

Thank you, Phil. As is our practice, in our financial discussion on this call, we will only go over the most significant items in our financial statement. Sales and marketing expenses, research and development expenses, non-operating expenses, net loss, and cash. Therefore, let me invite you to review the filings we made this morning, which contain our financials, 20F, and press release for additional information. Sales and marketing expenses for the three months ended September 30, 2023, were $8.1 million, an increase of $6.8 million, or 517.4% compared to $1.3 million, for the corresponding period last year. The increase resulted from the significant launch-related activities for Motexa forti in the U.S. Research and development expenses for the three months ended September 30, 2023, were $2.7 million, a decrease of $1.6 million, or 37.6% compared to $4.3 million for the corresponding period last year. The decrease resulted primarily from lower expenses for NDA-supporting activities related to MOTIC-supported, as well as lower expenses associated with a completed AGI-134 clinical trial. Non-operating expenses for the three months ended September 30, 2023, were $3.1 million, an increase of $3.5 million, compared to non-operating income of $0.4 million for the corresponding period last year. The increase relates primarily to a non-cash expense from reevaluation of outstanding warrants due to an increase in the company's share price during the 2023 period. Let me now turn to net loss. Net loss for the three months ended September 30, 2023, was $16 million compared to $6.8 million for the corresponding period last year. Net loss for the nine months ended September 30, 2023, amounted to $46.7 million compared to $19.2 million for the corresponding period last year. The increases in net loss for both the three and the nine-month period in 2023 were primarily due to the significant non-operating expenses related to reevaluation of outstanding warrants, as well as the significant increases in sales and marketing expenses related to launch activities, which were partially offset by a decrease in research and development expenses. The company emphasizes the non-cash expenses associated with the warrant reevaluation did not impact its cash position as of September 30, 2023, nor did they affect the company's projected cash runway going forward. Turning to cash, the company held $26 million of cash, cash equivalents, and short-term bank deposits as of September 30, 2023. This does not include the roughly $30 million consideration from the license agreement and the equity investment in the deal with Gloria Biosciences, nor does it include the $30 million available to us under our debt agreement with Krios Capital, which is tied to the attainment of certain milestones. We believe we are well-financed to fund our operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.

Thank you, Molly. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. Commercial ramp-up of Effecsta U.S. sales and ongoing evaluation of commercial partnership opportunities for Effecsta in additional markets. Recruitment in the Chemo for MedTank Phase II Randomized Clinical Trial in Firstline PDAC sponsored by Columbia University. Recruitment in the phase one pilot study of metixoportype 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 2024. Initiation by Gloria BioSciences of a 30 to 50 patient bridging study in 2024 to support approval of Afexa in stem cell mobilization for multiple myeloma in China. and preparation activities with Gloria Biosciences on a randomized Phase 2-3 clinical trial, evaluating mitoxifortide in combination with the PD-1 inhibitor, Zinberulimab, and standards of care combination chemotherapy in first-line pancreatic cancer. With that, we have now concluded the formal part of our presentation. Operator, we will now open the call to questions.

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you would like to ask a question, please press star 1. To withdraw your question, please press star 2. If you're using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be polled in the order they are received. Please stand by while we poll for your questions. The first question is from Joe Pangenis of H.C. Wainwright. Please go ahead.

Hi, everybody. Good morning. Thank you for taking the questions. And first, I just wanted to extend my well wishes to everybody, not only for these difficult and turbulent times, but also for the holidays. So you have all of our best. So I'd like to focus on two things for stem cell transplantation and then one on PANC, if you don't mind. So first, Holly, I really appreciate all the details. It definitely is encouraging to hear all the details that you shared. about the launch, so hopefully I'm not getting too much into the weeds because it is early. I guess, you know, when you're early in the launch, I'm just considering, you know, what places or areas that you feel the company have had to be nimble in, you know, according to the plans that you had and saying, okay, we learned we might need more emphasis in a particular geography or, you know, anything of that such, of those details. Holly, go ahead.

Yeah. Yeah, sure. Thanks, Joe. So much of what we're doing right now is as expected and as in planned. We have said this previously. I spoke again in my comments this morning about the fact that 80 transplant centers make up about 85% of all of the transplantations in the U.S. And therefore, you know, we are – we have a deployment plan with – field individuals, both sales account type people as well as medical affairs type people. I think we kind of got that one right. The deployment plans and our ability to reach and hit the right frequency within those institutions is spot on. I think one of the things that's been interesting for us, I don't know if it's a huge shift, but it's been interesting to speak to some of these decision makers within the centers about what we would – we have three pillars of our value proposition. And the one I think that maybe not surprising but we're finding a lot of interest in is the efficiency of this product. And that has to do really around the planning and logistics at the centers as well as the pharmacoeconomics. So that's an area I think that we – are spending perhaps a little bit more time than maybe we had originally. The strong clinical data, which is our efficacy pillar, the phase three genesis data is resonating quite well, but I think the thing that we're spending some more time on is probably the efficiency and what that means. I do want to add though, you didn't ask this, but the third I've spoken about the efficacy and the efficiency But the other really important part of our value proposition is the experience, that patient experience as well. So we are out there with all of that messaging, but the one I think that we're really finding to resonate or maybe a few more questions than we initially thought was that efficiency pillar.

That's really, really helpful. Thank you for that. And I guess the thing that I'm curious about is, because it's pretty intriguing, is the fact that it's huge that you're on the NCCN guidelines, and you said for SCM broadly. So I wanted to get a sense of how that impacts your potential development plans. And I know you can't really talk to off-label use and other indications, but I think this could help drive, I guess, how you develop for other indications. I don't know if you have any comments on that. Holly, you want to take that?

I can, yes. So, we are very much staying the course on thinking about what we want to do for add-on indications, either things that would be driven within our own clinical planning. We do have an active independent sponsored studies that is open and available for various institutions or physicians that have an area of interest for metixifortide in stem cell mobilization. We are constantly looking at the data that's required for making sure that we shore up our label and that, but I'm certainly not going to speak at all to any kind of off-label utilization that, you know, the guidelines may or may not afford. I don't know. Did that answer your question?

No, it does. No, thank you.

Joe, I'd like to add something. I'm sorry to interrupt you. I just wanted to add, first of all, hi. It's good to speak to you. But I do want to add, you know, we mentioned the gene therapy in the sickle cell disease area, and obviously... that's an area that we're putting a lot of focus on in a big way. And so, you know, we see that as a very key, you know, lifecycle management upside for the company.

Great, great. And then just the last question. I mean, short question, but maybe more elaborate answer, maybe. The Phase II pilot study being run with Columbia, obviously you're having a nice expansion into a larger set of patients. I guess I'll ask the question this way. to what extent do data from this study impact or serve as a rate-limiting step for potential business development?

Wow, okay, so let me just make sure that I understand. So, I mean, I think I do understand. I think when we are obviously looking to generate data, I think that we've made it clear that we are looking to generate data to move this forward. We were, you know, we entered into agreement with Gloria Biosciences in Asia. Part of that deal, a significant part of that deal is for them to generate, you know, Phase 2b data in a randomized study, Phase 2-3 data in a randomized study in PDAC. And we're running this trial or we're cooperating or collaborating with Columbia University in this IST. trial. Depending on the data, we are hoping to be able to take this data and move forward from a business development perspective. And, you know, speaking with, you know, large pharma companies, that would be the idea. Of course, I'm not ruling out us, you know, potentially taking this forward ourselves, depending on the situation, but it's likely in a very significant indication like this. And when we're talking about PDAC, we're not only talking about PDAC, we look at this as a sort of as a proof of concept for other solid tumors as well. And so obviously that would speak to, you know, a larger company conducting many studies, many phase three studies across the board in order to get, you know, broad approval in a number of indications. So I hope that answered your question. You know, I think that we're looking at this as a potential launching pad, so to speak, for business development with larger companies in this particular, you know, area of solid tumors?

It certainly answers the question. I appreciate the color. And as usual, what I'm hearing personally is that you continue to have a lot of optionality going forward. Thanks a lot, guys. Thank you.

Thank you.

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

All right, thank you, and hello, Phil, Holly, and Molly. As Joe mentioned, IFECSA was added to the NCCN guidelines. How quickly is a change like that incorporated into practice? Holly, you want to take that?

Sure. I mean, from a market access perspective, that's what many of these payers will lean on for decisions about reimbursability, et cetera. So from an NCCN perspective, pretty much immediately.

Okay. Well, that's great news. And then, you know, looking at gene therapy, I mean, personally, I think that's one of the greater options that you guys have out there. You've got quite a few. But there was recently a sickle cell disease drug-approved vertex, I think, in the U.K., and I think they're also – applied in the EU and the US as well. What are the bottlenecks there in terms of gene therapy for sickle cell disease? Is stem cell mobilization part of the bottleneck there? Is that approval and potentially two others somewhere where you can get into as well? I mean, you're doing work there. Maybe you can help me understand kind of how that drug that just got approved in the UK might be something that you could take advantage of.

Holly, do you want to take that?

Yeah, I can. You know what? Why don't I begin, and then you can add on if I've got some gaps. And I may be a good one to ask just because it's a world I came from. So prior to this, I was the chief commercial officer at a gene therapy company, so I certainly understand the challenges. We also know that both Vertex and Bluebird are looking at caducidates in December here in the U.S., so that could be significant changes. I think the thing that is that, you know, gene therapy companies or these ex vivo gene therapy companies are always looking to solve for is that entire patient journey and what kind of improvements can be made. And that can happen on several different fronts. Conditioning is one area that, of course, they're always looking at, but also stem cell mobilization is another area. And I think this is especially true with sickle cell disease because the standard for stem cell mobilization, we see it with our multiple myeloma indication, is GCSF plus a mobilizer such as Effecsta. And with that, we know that sickle cell patients are unable to use GCSF in sickle cell patients. So I think it produces an attenuated situation in sickle cell That's not to say that stem cell mobilization isn't also something that's looked at for some of these other applications. And, you know, in the future as these come to market, we could also be looking at those. But right now, of course, our efforts are focused on the high unmet need in sickle cell. And as has been announced, we do have the study at WashU, which is looking at some of that. Phil, did I forget anything? Was there anything that you wanted to add to that?

I think I might want to add, I think we've mentioned this previously, but we look at this area as something that we can really, really find a real place for. There is an unmet need. There's a huge amount of cells that are required to be mobilized for gene therapy. We're talking about 15 to 20 million CD34 positive cells per kilogram. And just to, for example... In multiple myeloma, our phase three, we were talking about six million cells per kilogram. And so a significantly higher number of cells need to be mobilized in order to move forward in gene therapy. And in addition, as Holly mentioned, these patients cannot receive GCSF, and therefore it's that much more difficult to mobilize. The current mobilization regimens require these patients to go through multiple cycles of aphoresis sessions and mobilization and collection with usually a 30-day period between each cycle. So therefore, the collection of the cells could be something that takes two to three months or even longer in some circumstances. And therefore, we hope and we think that that we may be able to show better mobilization and perhaps even reduce the number of mobilization cycles to a bare minimum and therefore save a significant amount of time and discomfort for the sickle cell patients. And so that's the idea behind our value proposition there.

There's one other thing that you were speaking that I thought I would add on that is fascinating. you know, very unique abound to these approaches to gene therapy. You mentioned in particular, John, the Vertex product. And that is the manufacturing and the manufacturing of the cells that go into that. That's another reason why a very high number of CD34 stem cells are required for these types of therapies just because there's always the need for backup in case something... This is personalized medicine and gene therapy, obviously, that is manufactured for the individual. And so there is always the need for backup through the manufacturing processes, which just, again, drives the need for a very, very high number of stem cells.

Okay, great. Yeah, it'll be exciting to see how this turns out with that product and maybe how you guys will be involved. A couple other questions on... You know, there's been a lot of, I guess, you know, cash flow movements and share movements recently. And I'm wondering if you can give me some kind of sense of where cash and share balance might be at the beginning of the, you know, at the end of the year, beginning of the year, December 31st. Can you help me with that at all?

Yeah. So, I mean, I think we discussed our, you know, our cash. We, you know, including the almost $30 million that we received from the deals or the agreements, the license and the equity agreement. We have in excess of $50 million in cash on a pro forma basis, which, as we mentioned, is enough to take us into 2025. We also, as Molly mentioned, we have a $30 million debt facility that's available to us. And so we feel quite comfortable from a cash perspective that we can meet everything that we need to do from a launch perspective in the near future. And so as a – you also asked about the number of shares. Is that what you asked? Did you want – Yeah, exactly. I think we have – Molly, do you recall? No, but in ADSs, I think we have about 70. We have somewhere – the exact number isn't in front of me. I apologize. I think it's somewhere around 70 million outstanding ADSs.

Okay, great. And then the last one for me is just any kind of revenue guidance that you can provide us for fourth quarter?

Yeah, I mean, that's the question. So, listen, John, I mean, we're happy, as Holly mentioned, we're happy with the way things are progressing. And, you know, there's a lot of activity that we're doing on all fronts, you know, hospitals, KOLs, the committees, P&T committees. You know, as you know, we also, you know, got on the NCCN guidelines, etc., But as I'm sure you're aware, we can't, of course, get into sales forecasts, and companies usually don't give, you know, forecasts on, you know, commercial launches. And so that's about all we can say at this point.

Right. I mean, lots of volatility there. Well, thank you. You guys are in a great place, and I appreciate you taking my questions. Thanks so much.

This concludes the question and answer session. 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 039255904. Internationally, please call 972-39255904. Mr. Serlin. Would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we are progressing through 2023 with significant momentum. We are launching our first therapy in stem cell mobilization and are making significant progress, raising awareness of the many benefits Afexta can bring to payers and transplant centers. We completed our first ex-US partnership agreement for Afexta and are evaluating the potential of commercial partnerships in other significant markets. We have made important additional lifecycle management steps through both our PDAC program as well as our program for stem cell mobilization for gene therapies. I am very pleased with our progress during the third quarter, and I'm excited about what we are in the process of achieving. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in March. Be safe and have a great day.

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