BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx second quarter 2024 financial results conference call. All participants are presently in listen-only mode. Following management's formal presentation, instructions will be given for the question and answer session. I would now like to hand the call over to John Lacey, head of investor relations and corporate communications. John, please go ahead.

Thank you, operator. Welcome, everyone. Thank you for joining us on our second quarter 2024 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 6K. 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 forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20F and our quarterly reports on Form 6K that are filed with the U.S. Securities and Exchange Commission. On the call today, we will have Phil Serlin, Chief Executive Officer of BioLineRx, Holly May, President of BioLineRxUSA, and Molly Zevi, our Chief Financial Officer. In addition, Ella Cerani, our Chief Development Officer, will be joining the call for Q&A. At this time, it is now my pleasure to turn the call over to Phil.

Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Following our strong second quarter 2024 performance and the encouraging progress of our FEXTA launch to date, I wanted to highlight that today's BioLineRx is a fully integrated leader in stem cell mobilization with promising label expansion opportunities. This is a stark change from last year, and we are well-positioned deliver value to all of our stakeholders. I will begin with a brief update on the important progress that we are making on our effects to launch, then turn the call over to Holly. We'll go into our commercialization and lifecycle management progress in more detail. Molly will review our financial results, and then I will give a brief summary of our upcoming milestones. We will then open up the call for your questions. Let me begin with an effects to commercialization update. Last quarter, we set an important goal. We said that among our targeted top 80 transplant centers, by the end of the second quarter, we would secure formulary placement at institutions managing 35% of stem cell transplant procedures. And I'm happy to say that we surpassed this goal by June 30th, with formulary placement at institutions managing 37% of transplant procedures. We continue to make steady progress on this most important launch metric and remain on track to achieve our year-end target of 60%. Additionally, last quarter we achieved formulary status at two of the largest transplant centers in the U.S., and we also doubled the number of centers ordering product. We are pleased with this continued positive momentum in only the second full quarter of our commercialization program. Each week we learn about patients who have failed to collect enough stem cells on other mobilization agents, putting their path to transplant at risk. These patients were then given Afexa, and they achieved their stem cell mobilization goals, many in a single aporesis session. Transplant centers are seeing the tremendous efficacy that Afexa can provide in this new era for multiple myeloma patients, where patients more often are older and increasingly receive quad induction therapy, which can increase mobilization risk. In July, the FDA granted approval of an important quad therapy approach for transplant-eligible patients newly diagnosed multiple myeloma patients, including daratumumab and lenalidomide, which can negatively impact stem cell yield. The approval was based on the tremendous efficacy results seen in the Perseus trial, which compared the quad therapy to the leading triple therapy. The quad therapy lowered the risk of disease progression or death by 60%. Physicians have been treating patients with quad therapies prior to this approval. However, we believe that the data from this trial and the subsequent FDA approval will accelerate the process of quad therapy becoming the new standard of care, which, while beneficial to patients, has the potential to further increase the need for effect stuff. Our team is excited to be introducing a new standard of care for the mobilization of stem cells for multiple myeloma in this new era of care for patients. At this point, I'd like to turn the call over to Holly May, president of BioLine RxUS. to discuss our commercialization efforts and some of our lifecycle management initiatives. Holly, please go ahead.

Thank you, Phil. Last quarter, I discussed effective benefits on center efficiency and economics. And in conversations with transplant center key decision makers, including physicians, pharmacists, and apheresis unit managing directors, these two factors continue to be a significant determinant in transplant center formulary adoption. We launched Effexa into a mobilization agent market that included generic cloroxifor, which had just entered generic status a few months before our approval. At the same time, transplant centers were realizing the impact that new induction therapy approaches have on stem cell collection yields. These factors, quite naturally, created many questions for centers. Centers that have, for many years, had long-standing protocols. It is within this changing landscape that institutions have also come to understand Afexa's innovative benefits for patients and are actively studying how our product can benefit their center and members of our field force are supporting them in this effort with our efficiency modeling tools. Additionally, we are publishing important health economics data and continue to work on additional research. Our health economics presentations in April at the American Society for Apheresis Annual Meeting and at the International Society for Pharmaco-Economics and Outcomes Research demonstrated the economic advantages for centers using GCSF plus Effexa over GCSF alone or GCSF plus Cloroxifor. Given the efficacy, efficiency, and economic benefits that Effexa provides, we believe that key decision makers will continue to move towards our best-in-class mobilizer. Let me transition now to our lifecycle management efforts. Our vision is to maximize the potential of Afexta in its current indication and to expand into key areas with high unmet need. There is significant interest by independent investigators to evaluate Afexta across a number of areas associated with myeloma. including mobilization studies in patients treated with quad therapies or for post-CAR-T cytopenia management. We are also actively speaking with physician researchers across a number of additional disease states that have a high unmet need in the area of stem cell mobilization. One critical area that continues to make progress is evaluating effects as stem cell mobilization potential in patients with sickle cell disease undergoing gene therapy. This type of gene therapy is an area where I have significant experience based on my prior roles. The two currently approved gene therapies for sickle cell disease require significant quantities of stem cells to produce the therapies. And in speaking with leaders in the field, using a mobilization agent that could speed the collection process would be a great advantage for patients. Our two ongoing sickle cell disease phase one investigator-initiated studies with Washington University in St. Louis and St. Jude's Children Research Hospital in Memphis were designed by significant key opinion leaders in this research area. We anticipate early data from the WashU collaboration in the second half of this year and the first patient dosed in the St. Jude's study in September. Overall, in the next 12 months, we anticipate several independent investigators to initiate studies that will provide BioLine with critical data and insights to aid our ongoing lifecycle management efforts. Now, let me turn the call over to Molly to provide a financial update.

Thank you, Holly. As is our practice, I will only go over the most significant items in our financial statements. Revenues, cost of revenues, research and development expenses, sales and marketing expenses, net profit, and cash. I invite you to review the filings we made this morning, which contain our financials and press release. Total revenue for the three months ended June 30, 2024, was $5.4 million. We did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of Afexa in the U.S. Cost of revenue for the three months ended June 30, 2024, was $0.9 million. We did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets royalties on net product sales of Afexa in the U.S., and cost of goods sold on product sales. Research and development expenses for the three months ended June 30, 2024, were $2.2 million compared to $3 million for the same period in 2023. The decrease resulted primarily from lower expenses related to MOTIC-supported NTA supporting activities, the termination of the development of AGI-134, and a decrease in share-based compensation. Sales and marketing expenses for the three months ended June 30, 2024, were $6.4 million compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with fully hired field team. Net income for the three months ended June 30, 2024, was $0.5 million compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income compared to non-operating expenses of $7.7 million for the same period in 2023, both mainly related to the non-cash revaluation of warrants. As of June 30, 2024, the company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The company anticipates that this amount will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call over to Phil.

Thank you, Molly. In closing, as is our custom, I would like to take a few moments to summarize our upcoming milestones. We anticipate first patient dose in the St. Jude Sickle Cell Disease Gene Therapy Phase 1 trial in September. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent lortexaportide for the mobilization and collection of CD34-positive hematopoietic stem cells in 12 patients aged 18 and older with sickle cell disease. We anticipate the initiation of the bridging study by collaboration partner Gloria Biosciences to support approval of Apexa in stem cell mobilization for multiple myeloma in China in the second half of this year. Also in the second half of this year, as Holly mentioned, we anticipate a presentation on early data from the WashU Sickle Cell Disease Gene Therapy Phase 1 trial, evaluating metixifortide as monotherapy and in combination with natalizumab for stem cell mobilization. Additionally, working with Gloria Bio, we completed the study design of the Phase IIb combination study, evaluating metixifortide in first-line pancreatic cancer. We anticipate that Gloria will submit the study design for regulatory review in 2024, with the study initiating in 2025. Finally, we continue recruitment in the Chem4MetPANC Phase IIb randomized clinical trial in first-line metastatic pancreatic cancer, sponsored by Columbia University, and in partnership with Regeneron. We anticipate that this trial, which had very encouraging pilot-based data published at ASCO this quarter, will be fully enrolled by 2027. With that, we have now concluded the formal part of our presentation. Operator, we will now open the call up for 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 one. To withdraw your questions, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be pulled in the order that they are received. Please stand by while we pull for your questions. The first question is from John Vandermusen of SACS. Please go ahead.

Great. Thank you. So the summer is usually known to have kind of negative seasonal effects for both, I guess, therapy use and with hospital staff, especially in academic settings. And I just wonder if you could comment on how you expect seasonally the effort to go with sales of Effecsta. Do you anticipate a strong pickup activity in September? And was the summer – I guess it's not over yet, but I guess was the summer as you had expected –

Yeah, so hi, John. So good morning, and thanks for the question and joining the call. So I'll turn it over to Holly in a moment, but our results are through June 30th, so we're talking now about the second quarter, which is really the spring. I would like to again mention that we doubled our sales in Q2 from Q1, and so I'm not sure the results at this point really reflect any kind of slowdown, you know, seasonal slowdown in the summer, we're looking, you know, things are looking very, very good at the moment. But I'll let Holly expand on that if she'd like.

Yeah, thanks, Bill, and good morning, John. So we have actually analyzed some of the seasonality on a month-to-month basis because this is indicated for multiple myeloma, and it's very dependent on patients needing to get timely transplants. We don't necessarily see those same kind of seasonality effects with a product like Afexta, as you may with others. That's a very general answer. But that is not something that we are terribly concerned about and have, you know, huge downturns built into any kind of forecasting for that reason. Does that answer your question?

Yes, it does. And how would you characterize the reorder rate? It seems like, you know, based on kind of a top-down view that it's fairly good. Would you characterize it that way as well?

Holly, you want to take that?

Yeah, I would love to. So, yes. So once a – I think we've spoken about this before – Once a product is on formulary, that's the biggest hurdle to begin adoption and utilization and an uptake in sales. And so our field teams are continuing to do both things to onboard institutions that have approved us for formulary through their P&T. So that is a significant step. part of future growth, as well as then working on institutions where we already have formulary acceptance and continuing to do selling efforts in those hospitals to increase the quantities where we are in formulary. So the team very early on, the field teams very early on, were singularly focused on assuring the readiness of P&T committees to put us on formulary. That work continues, but now we are also looking at selling efforts in those institutions that have us on formulary to increase there. So we see revenues from both sources, new accounts and existing accounts as we move throughout the year.

Okay. And final question on sickle cell and gene therapy. You know, I guess I'm surprised to see, you know, two studies in the same gene therapy indication. And I guess that's because, well, maybe you can tell me why that is. And then are there any other gene therapy indications that would also be kind of the next place to go for using mitoxifortide to collect the proper number of cells?

Yes. So let me ask Ellen, maybe you can talk about the differences between the two studies a little bit.

Yes. So, I'm sorry, but the design of the Sanjot study is not, I don't think that we have disclosed it yet. The design, there is a difference between the two studies in terms of... Yeah, I guess you're right. Yeah, perhaps.

We haven't disclosed that yet. I mean, they are different. I'm wondering if... I just don't remember whether we've disclosed that. You're sure we haven't disclosed it? Yeah, so John, I'm sorry about that. There are differences in the studies based on whether they're single administrations or multiple administrations. and the size of the studies, but I don't think, like as Ella said, I don't think that we've spoken about the design yet. There are, you know, possible publication and embargoes and those kind of things, so we can't really discuss it at this point. I apologize.

Okay. And then I guess, you know, are there any other kind of gene therapy indications that would be, you know, equally of interest from sponsors to use metixifortide to collect, you know, enough cells? Because I assume that's why the sickle cell was chosen, because compared to others, they just need more cells.

Yeah, well, it's more complicated than that. I mean, I'll turn it over to Holly, but I'll just say one of the reasons why mobilization is so difficult. in sickle cell patients is because the underlying mobilization agent, GCSF, is contraindicated in sickle cell patients. And therefore, they can only get what you'd call in, you know, in air quotes, a booster like Plurixifor or like Effexa. So they can't get the underlying GCSF, which is given to patients like multiple myeloma patients. before they're given a booster agent, so to speak. So that's one of the main reasons why this is an area that has a clear medical need in mobilization. But Holly, if you'd like to expand on that, please feel free.

Yeah, I'm happy to talk about that a little bit. So there are different types of gene therapy, some like AAV therapy that do not require hemopoietic stem cells. and others like the sickle cell approved therapies right now by Bluebird and Vertex that do require stem cells in order to complete the gene therapy. And so, certainly sickle cell based on the things that Phil just said is the ideal place to begin using a product like Effecsta for the mobilization of stem cells to complete that type of gene therapy. But we do see that there could be other types of gene therapies that do require CD34 stem cells, which could very easily benefit from Effecsta in the future. But currently, we are focused on generating the data in sickle cell because of the high unmet need.

Understood. Thank you, Holly.

Yeah.

Thanks, John. If there are any additional questions, please press star 1. To withdraw your question, please press star 2. Please stand by while we poll for more questions. The next question is from John Vandermussen. of SACS. Please go ahead.

Great. Thanks for allowing me to follow up. Have there been any inquiries from investigators for use that affects the outside of multiple myeloma, you know, extending more into some other leukemias?

As Holly mentioned, and I think I'll let her expand on it a little bit, we have a number of requests from investigators to perform investigator-initiated studies in, you know, in potentially different indications, et cetera. Holly, do you maybe want to expand on that a little bit?

Yeah, I guess I'm looking for some guidance here as to what I can and can't say. Some, we are in the process of, these ISS's, we are in the process of signing for what I would call, you know, kind of indication enhancing data. And other investigators are, yes, very interested in other areas of study and investigation where mobilization of stem cells is required. So I think the easiest way to say this is we have a very active ISS program that we have launched here since, that we have initiated since launch. And we continue to review all of those programs. proposals, but there does seem to be a lot of interest in Metixifor tied to be studied in areas to improve on things like multiple myeloma and then in other indications as well.

Okay, great. Thank you. Thanks, John. There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call all three, 925-5904. Internationally, please call 972-39-55904. Mr. Serling, would you like to make your concluding statement? Yes, I would. Thank you, Operator.

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

Thank you. This concludes BioLine RX second quarter 2024 conference call. Thank you for your participation. You may now go ahead and disconnect.