Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2024 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 over the call 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 third 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 6-K. 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 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 Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, John, and good morning, everyone. And thank you for joining us on today's call. I'll begin this morning with a recap of the significant licensing agreement that we announced last week with Ayrmid Limited, followed by a review of our third quarter performance, and then Mali Zeevi, our Chief Financial Officer will briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer is also available for Q&A. Last week, we announced that we executed an exclusive license agreement with Ayrmid Limited, the parent company of Gamida Cell Limited for motixafortide, which is sold in the U.S. under the brand name, APHEXDA. Recall that APHEXDA is our FDA-approved and commercially available stem cell mobilization agent indicated in combination with G-CSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. The agreement covers all indications with the notable exception of solid tumors like pancreatic ductal adenocarcinoma or PDAC and all territories with the exception of Asia, where we previously entered into a license agreement with Gloria Biosciences for motixafortide in that region. This transaction is very beneficial for BioLineRx with a $10 million upfront payment, $87 million in potential commercial milestones, and very healthy royalties of between 18% and 23%. In addition, we received another $9 million in the form of an equity investment from Highbridge Capital. This aggregate cash influx has enabled the company to finalize an agreement with BlackRock to repay a significant portion of its outstanding debt and restructure the remaining debt on favorable terms. With the transfer of our commercial program to Ayrmid, Gamida Cell, we have also reduced our cash burn in a very substantial manner, with our cash runway now extending into 2026. And I will provide more financial details about this shortly. Lastly, the agreement allows us to return to our drug development roots with a streamlined organization that has a proven track record in clinical development and regulatory affairs. To that end, we will continue to support the development of motixafortide in metastatic pancreatic cancer through our existing collaborations, which have the potential to create near-term value for shareholders. Over the next year, we also plan to evaluate early-stage clinical assets in the areas of oncology and rare disease, where we think we can leverage our expertise in complex drug development and create long-term shareholder value. We believe the choice of Gamida Cell as our commercial partner is a fortuitous one. Gamida Cell adds a highly differentiated mobilization agent in APHEXDA to its commercial portfolio that already includes omni-search, the first and only FDA-approved NAM-modified cell therapy for patients with hematologic malignancies in need of an allogeneic hematopoietic cell transplant. We envision Gamida Cell meaningfully growing APHEXDA sales by leveraging its portfolio for improved access to its transplant center customers. As part of this transaction, Gamida Cell is seeking to transition a significant number of former members of the BioLineRx commercial team, who have been instrumental in the early commercial success of APHEXDA driving penetration to over 40% of our target centers and capturing 10% of the market at the end of Q3. In addition, recall that APHEXDA is also being evaluated in patients with sickle cell disease undergoing gene therapy with two Phase 1 investigator-initiated trials ongoing. One at Washington University in St. Louis and the other at St. Jude Children's Research Hospital. We view this as another opportunity for long-term value creation. Quickly reviewing the terms of the agreement in exchange for the license, we received a $10 million upfront payment. We also are eligible to receive up to an additional $87 million of potential commercial milestones, plus royalties on net sales of APHEXDA ranging from 18% to 23%. We will also supply motixafortide on a cost-plus basis both for commercial and development supply. In addition, certain funds managed by Highbridge Capital management have made a $9 million equity investment in BioLineRx. This equity investment and the combined future potential commercial milestones from licensing agreements with Ayrmid and Gloria Biosciences as well as royalties on net sales are expected to provide a strong foundation for our company. Looking now at the new BioLineRx. Concurrent with the partnering transaction, we are shutting down our U.S. commercial operations. I would like to thank Holly May, who headed our U.S. commercial operations for her tireless commitment to building a world-class team and ensuring a successful launch. It is largely due to her efforts that we are experiencing strong momentum for APHEXDA, particularly among top-tier transplant centers that are leaders with respect to installing new therapies on formulary and into daily clinical practice. This transformation along with additional cost reductions will allow us to reduce our annual cash burn by more than 70% effective January 1, 2025, and refocus our efforts on clinical development in Israel. With the proceeds from this transaction, we entered into an agreement with BlackRock to repay $16.5 million of the approximately $29 million in outstanding debt with the remaining balance restructured at terms very favorable to our company including the pre-existing annual interest rate of 9.5%. With potential revenue from two licensing agreements, combined with a significantly streamlined organization, a greatly reduced cost structure, and restructured debt, we are very well positioned to advance our near and long-term value creation strategy for investors. At this point, I'd like to review our PDAC program, which we continue to advance through our existing collaborations that require minimal investment. Recall that motixafortide is an inhibitor of CXCR4, which plays a critical role in establishing and maintaining tumors. It is highly expressed in over 20 different tumor types, and it is estimated that greater than 70% of PDAC patients show an overexpression of CXCR4. PD-1 and PDL-1 inhibitors have demonstrated significant efficacy in multiple solid tumor types but no survival benefit in a large randomized PDAC trial comparing combination immunotherapy and standard-of-care chemotherapy versus standard-of-care chemotherapy alone. In contrast, a Phase 2 trial in second-line patients with the motixafortide plus PD-1 inhibitor plus standard-of-care chemotherapy demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific and clinical rationale for continued development. Motixafortide is being evaluated in an active Phase 2b study led by Columbia University, known as CheMo4METPANC, which is supported equally by BioLineRx and Regeneron. Recall that this trial had an initial pilot phase, and based on the results of this pilot phase, an assessment would be made on advancing to an expansion phase of the study. Seven of 11 patients in the pilot phase, or 64%, experienced a partial response, of which five were confirmed PRs as of the July 2023 cut-off date with one patient experiencing complete resolution of the metastatic lesion in the liver. Along with the three patients or 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48%, respectively, reported with the current standard of care. Based on these compelling data, we, along with Columbia and Regeneron, agreed to amend the original expansion phase of the study from a single-arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase 2b study of 108 patients with two arms: motixafortide plus Regeneron's PD-1 inhibitor cemiplimab and standard-of-care chemotherapy versus standard-of-care chemotherapy alone. The trial's primary endpoint is progression-free survival. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival. To further accelerate enrollment, Columbia plans to activate an additional three trial sites over the next two quarters. In addition to the two that are currently enrolling, we anticipate that the trial should be fully enrolled by 2027. Motixafortide is also planned to be evaluated in a Phase 2b PDAC study in China led by Gloria Biosciences pursuant to the license agreement that we signed with Gloria in October of last year. That study will evaluate motixafortide in combination with Gloria's commercially approved PD-1 inhibitor zimberelimab and standard-of-care combination chemotherapy in first-line pancreatic cancer. The opportunity for us to help patients in dire need of effective new treatment options while addressing a multi-billion dollar market opportunity is significant. PDAC is a very difficult cancer to treat given that it is often asymptomatic until Stage IV. It has the highest mortality rate among solid tumor malignancies. Globally, nearly 0.5 million people were diagnosed with PDAC in 2020 alone. We look forward to keeping you up-to-date on our progress in this important program. Now I'd like to briefly review some key performance indicators for APHEXDA during the third quarter, as I believe they reflect the many benefits to transplant centers and patients that key decision-makers are increasingly realizing, particularly as they pertain to center efficiency and economics. As we've noticed previously, transplant centers, the end users of APHEXDA, are a well-defined group in the U.S. Approximately 80 of the 212 centers in the U.S. performed roughly 85% of all transplant procedures. Among those 80 centers, by the end of the third quarter, we secured formulary placement at institutions managing over 40% of transplant procedures. We also continue to see steady growth in the number of centers reordering product. Furthermore, we saw an approximate 40% increase in the number of institutions ordering APHEXDA during the third quarter as compared to the second quarter. As the third quarter was only the third full quarter since launch, we are very pleased with the traction that we've seen, especially with the availability of plerixafor or generic Mozobil, which entered the market shortly before our launch. In fact, during the third quarter, we achieved a 10% market share milestone of total CXCR4 inhibitor usage in the U.S., which compares APHEXDA to branded Mozobil and generic plerixafor across all indications. We believe that this strong growth trajectory will continue to Gamida Cell's commercial program, building on the strong foundation in place. As we have discussed on prior conference calls, there are a number of factors that are driving the need for more effective mobilization regimens. First, multiple myeloma patients are getting older, and these patients are more challenged to achieve the required stem cell yields for transplantation. In addition, the growing use of quad induction therapies, while beneficial to patients, can negatively impact stem cell yields. Last quarter, we cited the PERSEUS trial, in which a recent FDA approved quad therapy was shown to reduce the risk of disease progression or death in multiple myeloma patients by 60%, pointing to the trend towards quad therapies as a new standard of care induction therapy. It is against this backdrop of a rapidly changing sensor mobilization treatment landscape that we believe APHEXDA can address significant unmet needs in the market. We are pleased to have entrusted its future success to an ideal partner like Gamida Cell with the expertise and infrastructure to maximize APHEXDA's commercial potential. Now let me turn the call over to Mali to provide a financial update. Mali, please go ahead.

Thank you, Phil. As is our practice, I will go over the most significant items in our financial statements, revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss, and cash. I invite you to review the 6-K filing we made this morning that contains our financials and press release. Total revenue for the three months ended September 30, 2024 was $4.9 million. The company did not record any revenue during the third quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.2 million as well as $1.7 million for the net revenue from product sales of APHEXDA in the U.S. Cost of revenue for the three months ended September 30, 2024 was $0.8 million. The company did not record any cost of revenue during the third quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales. Research and development expenses for the three months ended September 30, 2024 were $2.6 million, compared to $2.7 million for the same period in 2023. The decrease resulted primarily from lower expenses related to the termination of the development of AGI-134 and the decrease in payroll and share-based compensation. Sales and marketing expenses for the three months ended September 30, 2024 were $5.5 million compared to $8.1 million for the same period in 2023. The decrease resulted primarily from lower expenses of commercialization activities related to motixafortide. The higher expenses in the corresponding period of 2023 reflect the ramp-up of pre-commercialization activities related to motixafortide. General and administrative expenses for the three months ended September 30, 2024 were $1.4 million compared to $1.5 million for the same period in 2023. The decrease resulted primarily from small decreases in a number of G&A items. Net loss for the three months ended September 30, 2024 was $5.8 million compared to a net loss of $16 million for the same period in 2023. The net loss for the 2024 period included $0.8 million in non-operating income compared to non-operating expenses of $3.1 million for the same period in 2023, both primarily related to non-cash reevaluation of warrants. As of September 30, 2024, the company had cash, cash equivalents, and short-term bank deposits of $29.2 million. Following the out-licensing to Ayrmid, the equity investment from Highbridge, and the debt prepayment from BlackRock, the company's cash, cash equivalents, and short-term bank deposits are expected to be approximately $20 million, which we believe will be sufficient to fund operations into ’26 as currently planned. And with that, I'll turn the call over to Phil.

Thank you, Mali. In closing, I would like to take a moment to summarize our revised milestones. Over the next two quarters, we anticipate adding three new clinical trial sites to the ongoing CheMo4METPANC Phase 2b randomized clinical trial in first-line PDAC sponsored by Columbia University, and anticipate interim data in 2026. Working with Gloria Bio, we look forward to continued progress with the planned stem cell mobilization bridging study and the Phase 2b combination study evaluating motixafortide in first-line pancreatic cancer. Finally, in 2025, we will evaluate additional early-stage clinical assets for in-licensing and further development, seeking to add one new asset in 2025 and an additional one in 2026. 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, we will now begin the question-and-answer session. The first question is from Joe Pantginis of H.C. Wainwright. Please go ahead.

Hey, everybody. Good morning. Good afternoon. Got a few questions, if you don't mind. So first, Phil, I just wanted to make sure I heard you correctly with regard to pipeline growth. Did you say potential in-licensing of one asset in '25 and one in '26?

Yeah. I think that's what our plan is. We have a number of assets that we're already looking at. It's hard to say; business development things don't always go exactly according to plan. But I think overall, that's our plan.

No, of course. Okay. So then going to your current announcements, and thank you for all the details today that were very helpful. With regard to, say, the pancreatic program. I guess, how do we mix that with the potential for motixafortide in additional solid tumor indications, plus the ability to potentially have business development discussions around that? Can you discuss the level of maturity of these discussions?

We view the PDAC program as a prototype for other solid tumors. At this time, we are not planning to invest significantly more into PDAC. We have two ongoing collaborations that require minimal funding from us, primarily just for drug supply. We believe the best use of our current resources is to introduce new assets into our pipeline while these programs continue. We expect to have some initial data from the Columbia study in 2026, which could serve as a starting point for potential business development discussions.

That's very helpful. And then, with regards to the APHEXDA sale, a couple of things here. So just from a logistical standpoint, do they have any potential option on the solid tumor program?

They do not.

They do not. Okay. That's simple enough. And I guess two things here. So with regard to the company restructuring, it sounds like that it's mostly or largely the field force that they'll be assimilating?

Not necessarily. I mean, I don't think we're going to be at liberty to tell you to speak for them. But they are taking a piece of our organization or a number of our personnel. And I don't think it's only limited to field or customer-facing employees.

Okay. And then my last question is, I guess, from a financial standpoint and the important details you shared with regard to the drug launch to date. How should we sort of view, to the level of detail you can, the integration time within their program of APHEXDA and how that might impact any potential lags or dips in sales, especially as we go into the first quarter and insurance resets, etc.?

Yeah. So, I mean, I'm hoping that there won't be too much of a lag in anything. I mean they're taking, like I said, a significant number of employees with them. We're also according to the agreement, we're providing them with transition services for the next number of months. And so we think we're going to ASH. We’ll probably go to Tandem as well. So I think we believe that the transition period should be quite seamless. And I don’t believe there will be a significant lag in sales or in the uptick of sales.

Thank you very much.

All right, Joe. Have a great day.

The next question is from Justin Walsh of Jones Trading. Please go ahead.

Hi. Thanks for taking questions. I wonder if you can provide some color on where you view the company's core competencies as we wait to hear more about the addition of potential assets to your pipeline?

Thanks, Justin. Good morning. As we noted, we are returning to our roots as an Israeli-based development company, and I believe we possess several positive attributes that set us apart from other companies. Our highly experienced development team has proven capabilities from early-stage projects to approval and commercialization, though I will focus on the approval stage for now. Our Israeli team covers all necessary areas, including regulatory affairs, CMC, quality assurance, clinical operations, and preclinical development. We have a complete set of disciplines needed to advance our projects. Additionally, we benefit from cash flows generated by two partnerships that yield ongoing commercial milestones and royalty revenues, which may not be available to other development companies. Furthermore, we are conducting significant trials in PDAC through meaningful collaborations, incurring minimal costs for the company. Overall, we believe we are well positioned for the future. As I mentioned earlier, we aim to introduce at least two new assets in the 2025-2026 timeframe, and we have a list of potential candidates that align with our criteria of low upfront payments in oncology and rare diseases, with manageable clinical development programs. This is how we envision our path forward. I hope this provides a thorough answer to your question.

Yeah, definitely. Thanks for taking the question.

Great.

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

Thank you, Phil and Mali. Regarding the expenses for 2025, I believe you mentioned there would be a 70% reduction in spending next year. If we examine the projections, it seems we've eliminated sales and marketing expenses while keeping R&D and G&A unchanged. Is that an accurate interpretation? Additionally, we are also excluding the cost of goods sold.

I believe the expenses will be slightly higher than anticipated. As a company with operations in the U.S., there were additional expenditures stemming from our active U.S. subsidiary, which impacted our overall costs. However, you can expect a reduction in general and administrative expenses as we aim to streamline operations. Moving forward, we're committed to focusing solely on development in Israel, which is a cost-effective location for such efforts. Overall, we are targeting a reduction of over 70% in our expenses.

Okay. And then on the R&D side, should we think of that kind of continuing on at the same level? And what are those obligations going to be? I mean, I think there's PDAC in there. Is there anything else in there that's ongoing?

We have some minor obligations related to five-year commitments and post-marketing commitments with the FDA, but they are not very significant. Our PDAC commitments involve drug supply and a few small grants, which are also not substantial. We expect to conduct two Phase 2b studies at nearly no cost to the company, and our post-marketing commitment will be minimal. The majority of our expenditure will be focused on new projects as they come in.

And as we look at potentially a pivotal or registrational trial in PDAC, I guess you seem to indicate that that would be taken over by partners and that you would probably have limited contribution there?

Yeah. I mean, listen, everything is possible, but I think we believe that something of this size in solid tumors in general, it would make sense to partner, especially if we have very robust data from the Phase 2b. So I think our probably main path moving forward would be to look to partner it out, and this being such a blockbuster indication, we don't really think that it would be difficult depending, of course, on the data.

Okay. That seems to focus your attention more on earlier stage products. How would you consider adding a new product? What stage of development would it be in? I think oncology is an area where you have some experience. How do you view the time to commercialization, stage development indication? What factors are you considering when evaluating something to add?

Yeah. So, I mean, I said I think we're looking at oncology rare disease, we're looking at early-stage clinical assets. I can't say that that's the only thing that we'd look at, maybe something very, very late-stage, pre-clinical but I think our focus is primarily on early-stage clinical assets with best-in-class potential. And with small molecules, peptides, things that we have a lot of experience with previously and to sort of leverage our capabilities going forward.

Okay. And then on China, it seemed like you had mentioned that there's a clearance there, I guess, in some areas that don’t require the bridging study. When would you expect the first revenues to show up from that region?

It's difficult to determine right now, and we haven't provided any guidance on that. We are optimistic that 2025 will bring in some revenues, although we have limited control over the situation and what Gloria is doing. We are meeting with them regularly, and I anticipate that the first sale will happen sometime in 2025.

Thank you so much.

All right. Great. Thanks so much.

A follow-up question from John Vandermosten of Zacks. Please go ahead.

Great. Thanks for one more. On Gamida Cell, obviously, the only other product that they're commercializing the omni-search product or do they have something else to be I think.

I think right now, that's what they have. I think they may have plans to bring in some additional products. But right now, they have omni-search. Of course, now they have APHEXDA.

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 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 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we are very pleased to have entered into this license agreement with Ayrmid and Gamida Cell, which allows us to return to our drug development roots while simultaneously benefiting from APHEXDA’s long-term commercial potential in stem cell mobilization, sickle cell disease, and other non-solid tumor indications. We believe this path forward best positions us to create value for our shareholders while developing novel new therapies for patients with cancer and serious rare diseases. 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 2024 conference call. Thank you for your participation. You may go ahead and disconnect.