Earnings Call Transcript - BLRX Q3 2023

Operator, Operator

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. I would now like to turn the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.

John Lacey, Head of Investor Relations and Corporate Communications

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. It was also filed as a 6-K. I'd like to remind you that certain statements we make during the call will be forward-looking. If we make such statements, they are subject to risks and uncertainties. Actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly report on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Phil Serlin, CEO

Thank you, John, and good morning, everyone. Thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with an overview of our Stem Cell Mobilization program, then Holly will provide an update on the efforts to launch activities and progress. I will then provide an update on our other clinical programs, notably the Motixafortide program in PDAC and Sickle Cell Disease. Finally, Mali will provide a discussion of our financial results. 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 U.S. FDA approval of Motixafortide, known commercially as APHEXDA, in combination with G-CSF to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma. The approval of APHEXDA is the culmination of tireless work by the entire BioLineRx team and transitions us to a commercial-stage company that is bringing patients, physicians, and caregivers the 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 APHEXDA. Feedback from our initial outreach to top-tier transplant centers across the U.S. suggests that APHEXDA 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 about the long-term opportunity that is in front of us. There are many factors driving the need for improved stem cell mobilization regimens, 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 aged 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 natalizumab, which are often given in combination. As a result, many patients may require multiple apheresis sessions. Recall that the approval of APHEXDA was based on results from the highly successful GENESIS Phase 3 clinical trial. In this contemporary trial, most patients received a lenalidomide-containing induction regimen, and the median age in the Motixafortide treatment arm was approximately 64 years old. Particularly relevant to the transplant centers in the GENESIS trial, the addition of G-CSF enabled almost 90% of patients to proceed to transplantation after only one apheresis 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. Historically, depending on treatment regimens, up to 47% of patients have faced challenges mobilizing the target number of stem cells after one session. With APHEXDA as a 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 BioLineRx USA for a review of our launch activities. Holly, please go ahead.

Holly May, President of BioLineRx USA

Thank you, Phil. As Phil indicated, the approval of APHEXDA for stem cell mobilization in multiple myeloma patients marks a significant advancement in this field for the first time in over a decade. Our choice to commercialize APHEXDA independently in the U.S. is crucial for making this new mobilization agent available to transplant centers and patients promptly. I would like to provide a brief update on our activities supporting the commercial launch, which began immediately after APHEXDA was approved. Firstly, some statistics highlight the significant opportunity before us, not only in terms of potential sales but also in our ability to assist thousands of patients who struggle to mobilize enough stem cells for transplantation. Approximately 35,000 patients are diagnosed with multiple myeloma each year in the U.S., with an estimated 18,000 eligible for autologous stem cell transplantation. Among these patients, about 8,000 procedures are performed annually, a number that has nearly doubled since 2010. Autologous stem cell transplantation remains the preferred treatment for these patients. However, due to various factors, including an aging population and the increased use of multi-drug induction therapies, up to 47% of patients experience difficulties collecting the required number of stem cells in one apheresis session. As we will discuss in more detail shortly, the need for multiple apheresis sessions can lead to more adverse events, higher costs, and significant inconvenience and emotional strain for patients. With the efficacy demonstrated in the Phase 3 GENESIS trial that supported APHEXDA's approval, we believe we can address these challenges. We feel that we offer a significantly differentiated second-generation mobilization agent, presenting a compelling value proposition for transplant centers, patients, and payers alike. Regarding differentiation, we have conducted comprehensive market research and understand the evolving landscape. Since our last earnings call, multiple abbreviated new drug applications for generic plerixafor have been approved, resulting in considerable price erosion for this first-generation mobilization agent, which we anticipated and included in our model. Although we consider plerixafor to be in the same market as APHEXDA, they are not equivalent. Our product profile is highly differentiated due to better and more consistent mobilization outcomes. Initial conversations with customers indicate that transplant centers recognize the innovation we bring in addressing their need for a superior mobilizer. As we mentioned before, we have priced APHEXDA at approximately [indiscernible] per vial, which we believe fairly reflects the value it adds to the autologous stem cell transplant landscape. Moreover, despite the presence of lower-priced generic plerixafor, we are confident that APHEXDA's differentiated clinical attributes will foster long-term adoption and set a new standard of care for mobilization. We strongly believe that in the long run, differentiation will be more significant than price as centers seek the best treatment options for their patients. Our primary focus has been to educate transplant centers on the unmet needs of roughly 8,000 patients who qualify for autologous stem cell transplant each year. We estimate that the top 80 centers, out of 212 nationally, conduct around 85% of all stem cell transplant procedures. Since our approval, we have reached out to all of our top-tier centers, and our engagement has been very active. As apheresis supplies can be limited at many transplant centers, APHEXDA's potential to collect the necessary number of stem cells often in a single session should enable more efficient scheduling and resource use, which is valuable for centers that perform numerous procedures. We are in ongoing discussions with pharmacy and therapeutics committees at these centers that need to approve formulary decisions before they can trial our product and integrate APHEXDA into their protocols. Our progress is steady and consistent. A critical aspect influencing APHEXDA’s future success is its inclusion in clinical treatment guidelines. Shortly after its approval, APHEXDA was included in the national clinical practice guidelines in oncology, known as NCCN, for stem cell mobilization, including multiple myeloma. The American Society for Transplantation and Cellular Therapy, or ASTCT, is also updating its guidelines, which we anticipate to be released next year. Currently, ASTCT recommends a collection target of 3 million to 5 million cells per program, doubling that target for multiple transplants. In the GENESIS trial, the median number of CD34 stem cells collected on the first apheresis day was 8.5 million in the treatment group compared to 1.5 million in the control group. As Phil mentioned earlier, adding Motixafortide to G-CSF allowed 88.3% of patients to undergo transplantation after just one apheresis session, compared to 10.8% in the G-CSF group. Given APHEXDA's demonstrated performance against current guidelines, we are confident of eventual inclusion. Now turning to payers, the successful launch of any new therapeutic hinges on securing broad, affordable access regarding coverage and reimbursement. This involves both national and regional commercial health plans and the Centers for Medicare and Medicaid Services, particularly since many multiple myeloma patients are older and receive care through Medicare. The immediate upfront cost of stem cell collection, excluding drug costs, is $13,850 per patient, varying from $6,300 to $48,500. Each apheresis session costs between $6,200 and $6,600, again not counting drug costs. The ability to reliably achieve the target number of stem cells needed for transplantation in fewer sessions can result in significant savings for payers over time. Payers view APHEXDA's clinical data positively, leading us to establish unrestricted access to over 90% of covered lives, including a mix of commercial and government payers. We continue to enhance this access to ensure that APHEXDA is available to as many patients as possible. In summary, I am very pleased with our launch progress thus far. Our commercial and medical affairs teams, which include many seasoned professionals in both stem cell mobilization and multiple myeloma, are generating promising results early in this launch as we engage with major transplant centers, physician leaders, and payers regarding this exciting new treatment option. I will now turn the call back to Phil for an update on our other programs.

Phil Serlin, CEO

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 Motixafortide 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 APHEXDA for Stem Cell Mobilization in multiple myeloma. They 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. In China, autologous stem cell transplantation for multiple myeloma is already included in medical insurance reimbursement. We continue to evaluate additional commercialization partnership opportunities in significant markets for APHEXDA in stem cell mobilization. Turning now to our second developmental indication for Motixafortide, 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, zimberelimab, which is approved in the region for relapsed or refractory classical Hodgkin lymphoma and recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimberelimab in its first indication in China in only four years. So we believe they are uniquely positioned to explore the potential utility of Motixafortide in combination trials against this difficult-to-treat cancer. Recapping the terms of the agreement, we received $15 million upfront 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 Motixafortide in any indication in the Asia region. In addition, the transaction included an equity investment of $14.6 million in BioLineRx, with the purchase of newly issued American Depositary Shares priced at $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 2 combination clinical trial of Motixafortide in first-line pancreatic cancer. The trial, known as CheMo4METPANC, is sponsored by Columbia University and was recommended to proceed to the randomized phase based on the very compelling preliminary data in 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 partial responses per the RECIST 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, with five confirming PRs, and one patient even experiencing resolution of the metastatic lesion in the liver. Along with the three patients who experienced stable disease, this resulted in a disease control rate of 91%. These findings compare very favorably to the 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 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. Neuro immunotherapies have shown promise in other tumor types, with 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 Motixafortide, KEYTRUDA, and chemotherapy as a second-line therapy. Substantial improvement was observed across all study endpoints, including overall survival, progression-free survival, and overall response in the most challenging PDAC patients, those initially diagnosed with stage four 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 Motixafortide to form the backbone of new PDAC treatment regimens, giving new hope to patients suffering from this very difficult-to-treat tumor type, while also demonstrating the versatility of Motixafortide 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 Motixafortide 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 Motixafortide is in 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 School of Medicine to evaluate Motixafortide in this indication. Unlike multiple myeloma patients, the current standard of care mobilization G-CSF carries 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 numbers 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 Motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ motixafortide 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 Mali Zeevi, our CFO, who will give a brief overview of our main financial results. Mali, please go ahead.

Mali Zeevi, CFO

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 statements: 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, 20-F, 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 Motixafortide 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 Motixafortide, as well as lower expenses associated with the completed AGI-134 clinical trials. 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 the revaluation of outstanding warrants due to an increase in the company's share price during the 2023 period. Let me now turn to net loss. The net loss for the three months ended September 30, 2023, was $16 million compared to $6.8 million for the corresponding period last year. The 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 nine-month periods in 2023 were primarily due to the significant non-operating expenses related to the revaluation 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 that the non-cash expenses associated with the warrant revaluation did not impact its cash position as of September 30, 2023. Note that 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 Kreos 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.

Phil Serlin, CEO

Thank you, Mali. In closing, as is our custom, I would like to take a few moments to summarize our key upcoming milestones. Commercial ramp-up of APHEXDA U.S. sales and ongoing evaluation of commercial partnership opportunities for APHEXDA in additional markets. Recruitment in the CheMo4METPANC Phase 2 randomized clinical trial in first-line PDAC sponsored by Columbia University. Recruitment in the Phase I pilot study of Motixafortide 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 the approval of APHEXDA and stem cell mobilization for multiple myeloma in China in preparation activities with Gloria Biosciences on a randomized Phase II/III clinical trial evaluating Motixafortide in combination with the PD-1 inhibitor zimberelimab and standard 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.

Operator, Operator

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. The first question is from Joe Pantginis of H.C. Wainright. Please go ahead.

Joe Pantginis, Analyst

Hi, everybody. Good morning. Thank you for taking the questions. And first, I just wanted to extend my well wishes to everybody, both for these difficult and turbulent times, but also for the holidays. I'd like to focus on two things regarding stem cell transplantation and then one on PDAC, if you don't mind. So first, Holly, I really appreciate all the details; it is definitely 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, when you're early in the launch, I'm considering what places or areas that you feel the company has had to pivot according to the plans that you had, saying, okay, we learned we might need more emphasis in a particular geography or anything of that nature.

Phil Serlin, CEO

Holly, go ahead.

Holly May, President of BioLineRx USA

Thanks, Joe. Much of what we're doing is proceeding as anticipated. We previously mentioned that transplant centers account for about 85% of all transplantations in the U.S. Hence, we have a deployment strategy that includes both sales and medical affairs personnel. I believe we've executed that well. Our plans for reaching these institutions and ensuring the right frequency of engagement are effective. One intriguing aspect has been our discussions with decision-makers about our three pillars of value. We're noticing significant interest in the efficiency of our product, particularly regarding planning and logistics at the centers as well as pharmacokinetics. We are dedicating more time to this area than we initially expected. Our strong clinical data, specifically the Phase 3 GENESIS data, is also making a positive impact. However, we are focusing more on the efficiency aspect and its implications. Additionally, while you didn't ask, I want to emphasize that the patient experience is another crucial element of our value proposition. We are actively conveying all these messages, but the efficiency component is generating more inquiry than we had anticipated.

Joe Pantginis, Analyst

That's really, really helpful. Thank you for that. I guess the thing that I'm curious about is, because it's intriguing, the fact that it's significant that you're on the NCCN guidelines. You said for SCM broadly, so I wanted to get a sense of how that impacts your potential development plan. And I know you can't really talk to off-label use in 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.

Phil Serlin, CEO

Holly, do you want to take that?

Holly May, President of BioLineRx USA

I can. Yes. 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 study that is open and available for various institutions or physicians that have an area of interest in stem cell mobilization. We are constantly looking at the data that is required for making sure that we augment our label and that. But I'm certainly not going to speak at all to any kind of off-label utilization that the guidelines may or may not afford. Did that answer your question?

Joe Pantginis, Analyst

It does. I'd like to add something.

Phil Serlin, CEO

Joe, I’d like to add something. I just I'm sorry; I didn't mean to interrupt you. I just wanted to add, first of all, hi, good to speak to you. But I do want to add that we mentioned the gene therapy in sickle cell disease area. Obviously, that's an area that we're putting a lot of focus on in a big way. We see that as a very key life cycle management opportunity for the company.

Joe Pantginis, Analyst

Great. And then just the last question. It's a short question, but it may require a more detailed answer. The Phase II pilot study being conducted with Columbia is obviously expanding to a larger group of patients. My question is: How do the data from this study influence or pose limitations for potential business development?

Phil Serlin, CEO

Let me ensure that I understand correctly. We are indeed focused on generating data to advance our efforts. We have entered into an agreement with Gloria Biosciences, which includes a significant component for them to produce Phase IIb data through a randomized study. We are collaborating with Columbia University on this IST trial. Based on the results, we aim to leverage this data for business development discussions with large pharmaceutical companies. However, we are also considering the possibility of pursuing this on our own, depending on the circumstances. Given the significance of this indication, especially regarding PDAC, we view this as a proof of concept that could extend to other solid tumors. This could lead to a larger firm conducting numerous Phase III studies to secure broad approvals across various indications. I trust that clarifies your question. We see this as a potential launch point for business development with larger companies in the solid tumor space.

Joe Pantginis, Analyst

It certainly answered 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.

Phil Serlin, CEO

Thank you.

Holly May, President of BioLineRx USA

Thank you.

Operator, Operator

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

John Vandermosten, Analyst

Thank you and hello, Phil, Holly, and Mali. As Joe mentioned, APHEXDA was added to the NCCN guidelines. How quickly is a change like that incorporated into practice?

Phil Serlin, CEO

Holly, do you want to take that?

Holly May, President of BioLineRx USA

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, it happens pretty much immediately.

John Vandermosten, Analyst

That’s great. And then looking at gene therapy, I mean, personally, I think that's one of the greater options you guys have out there. You've got quite a few. But there was recently a sickle cell disease drug approved by Vertex, I think, in the UK. I think they also applied in the EU and the U.S. as well. What are the bottlenecks 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 in as well? I mean you're doing work there. Maybe you can help me understand how that drug that just got approved in the UK might be something you could take advantage of.

Phil Serlin, CEO

Holly, do you want to take that?

Holly May, President of BioLineRx USA

Why don't I begin, and then you can add if I miss anything. 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 PDUFA dates in December here in the U.S., which could be significant. The thing that gene therapy companies are always looking to solve for is the entire patient journey and what kind of improvements can be made. This can happen on several different fronts: conditioning is one area, but also mobilization is another area. I think this is especially true with sickle cell disease because the standard for mobilization we see in our multiple myeloma indication is G-CSF plus a mobilizer such as APHEXDA. With sickle cell patients, they cannot use G-CSF, and therefore, it produces an appendage situation. That’s not to say that stem cell mobilization isn’t also something looked at for some of these other applications. For the moment, our efforts are focused on the high unmet need in sickle cell disease. As announced, we do have the study at Washington University, which is looking at some of those issues.

Phil Serlin, CEO

I think we've mentioned this previously, but we regard this area as something that we can really, really find a real place for it. 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 million to 20 million CD34+ positive cells per kilogram. Just for example, in multiple myeloma, we're talking about 6 million cells per kilogram. This is a significantly higher number of cells that need to be mobilized to move forward in gene therapy. As Holly mentioned, these patients cannot receive G-CSF, making it that much more difficult to mobilize their stem cells. The current mobilization regimen requires these patients to go through multiple cycles of apheresis and mobilization and collection with usually a 30-day period between each cycle. The collection of the cells could take two to three months or even longer in some circumstances. We hope and think that we may be able to show better mobilization and perhaps even reduce the number of mobilization cycles to a bare minimum, thus saving a significant amount of time and discomfort for sickle cell patients, as that’s the idea driving our value proposition in this area.

Holly May, President of BioLineRx USA

There’s one other thing I thought I would add on that is very unique about these approaches to gene therapy that you mentioned, especially the Vertex product. That is 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; there’s always the need for backup in case something happens. This is personalized medicine and gene therapy, and it’s manufactured for the individual. Thus, there is always a need for backup through the manufacturing process, which just again drives the need for a very high number of stem cells.

John Vandermosten, Analyst

Okay. Great. Yeah. It would be exciting to see how this turns out with that product, and maybe you guys will be involved. A couple of questions on cash flow movements and share movements recently. 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 year.

Phil Serlin, CEO

Yes. So I think we discussed our cash. Including the almost $30 million that we received from the agreements, 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 Mali mentioned, have a $30 million debt facility available to us. We feel quite comfortable from a cash perspective in meeting all necessary operational plans within the near future. Regarding the number of shares, I think we have about 70 million outstanding ADS.

John Vandermosten, Analyst

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

Phil Serlin, CEO

Yes. I mean, John, we’re happy. As Holly mentioned, we’re pleased with how things are progressing. There’s a lot of activity on all fronts: hospitals, KOLs, P&T committees, etc. But as I’m sure you’re aware, we can’t get into sales forecasts, and companies usually don’t provide forecasts on commercial launches. That’s about all we can say at this point.

John Vandermosten, Analyst

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

Phil Serlin, CEO

Thanks so much.

Operator, Operator

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 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 925-5904. Internationally, please call +9723-9255-904. Mr. Serlin, would you like to make your concluding statements?

Phil Serlin, CEO

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 in raising awareness of the many benefits APHEXDA can bring to payers and transplant centers. We completed our first ex-U.S. partnership agreement for APHEXDA and are evaluating the potential of commercial partnerships in other significant markets. We have made important additional life cycle management steps through both our PDAC program and 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.

Operator, Operator

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