BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to BioLineRx first quarter 2025 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 Irena Koffler, investor relations.

Irena, please go ahead. Thank you operator and welcome everyone. Thank you for joining us on our quarterly 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. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Irina, and good morning, everyone. And thank you for joining us on today's call. As has been our practice, I will begin with a few prepared remarks before turning the call over to Molly Zebi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Serrani, our chief development officer, is also available for Q&A. In November of last year, we announced a transformational exclusive out-licensing agreement with Aramid Pharma Limited. The agreement gives Aramid the rights to commercialize effects that our FDA-approved stem cell mobilization agent indicated in combination with GCSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. The agreement covers all indications, excluding solid tumor indications, and in all territories other than Asia. In exchange, we received an upfront payment as well as potentially significant commercial milestones and royalties. Recall that we successfully shepherded Afexta, also known as Metixoportide, through clinical development and FDA approval in September 2023. We believe AirMid is the ideal partner for Afexta, given that team's track record of success. As a reminder, the current Aramid team established Amrit Bio in 2015 to focus on rare diseases, and in less than eight years, they grew Amrit revenue to an annual run rate of several hundred million dollars, ultimately selling the company for approximately $1.5 billion. In addition, the Aramid commercial portfolio also includes AmiSearch, the first and only FDA-approved nicotinamide NAM-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. So the addition of Afexa is very complimentary. And while it has taken a few months to complete the transition, Afexa has returned to growth and is performing well under Aramid's stewardship. And I believe it will contribute incremental long-term value to our company through the potential milestones and royalties just mentioned. This transaction enabled us to return to our roots as a highly innovative company in complex drug development. with a very experienced team and a validated track record of clinical and regulatory success. Since that announcement, we have been laser focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare disease that will allow us to leverage our expertise in drug development and expand our pipeline. I am pleased to report that we continue to evaluate several promising candidates that fit our criteria. Importantly, the subsequent development of any candidates that we identify will have efficient and clearly defined clinical development paths and will be partly funded through milestones and royalties from our license agreements with Aramid as well as our previously announced agreement with Gloria Bio. We continue to conduct due diligence and advance discussions with a number of parties and I am optimistic that we'll make a definitive announcement later this year. The ARAMID agreement also covers ongoing development of effects in patients with sickle cell disease undergoing gene therapy. Stem cell mobilization is a challenge for many sickle cell disease patients, as currently available gene therapies for sickle cell disease rely on the collection of significant quantities of CD34 positive hematopoietic stem cells. And this collection process often requires multiple aphoresis sessions, which adds cost and complicates the patient journey. In addition, many patients are ineligible for stem cell transplantation because they are unable to mobilize the required numbers of cells for successful transplants. Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with sickle cell disease, and we eagerly await results from two phase one investigator-initiated trials that are ongoing. The first sickle cell disease trial is being sponsored by Washington University in St. Louis. An abstract detailing the initial results from this proof of concept study was presented at the 66th Annual American Society of Hematology Annual Meeting last December. The findings suggest that patients with sickle cell disease given metixifortide alone or in combination with natalizumab can mobilize and potentially collect the number of stem cells required for approved gene therapies in a single aporesis cycle. The second sickle cell disease trial is being sponsored by St. Jude Children's Research Hospital in Memphis and is being executed by some of the leading sickle cell disease researchers in the world. As a result of the AIRMID agreement and the transition of several members of the Form BioLine RX commercial team to AIRMID, late last year we announced the shutdown of our U.S. operations and we also implemented a headcount reduction in Israel where BioLine RX continues to be based. Together, these actions have allowed us to reduce our ongoing operating cash burn by over 70%, from over $40 million annually to less than $12 million as we entered 2025. Including a $10 million financing that we completed in January, we ended the first quarter on a firm financial footing with cash of $26.4 million and a cash runway projected to fund our operations through the second half of 2026. Turning now to pancreatic cancer, or PDAC, we are continuing to support the development of metixifortide in this indication. Recall that metixifortide 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 PD-L1 inhibitors have demonstrated significant efficacy in multiple solid tumor types, but no survival benefit in PDAC. In contrast, we previously completed a phase two trial in second line PDAC patients with metixivortide plus a PD-1 inhibitor plus standard of care chemotherapy that demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific rationale for continued development by us in this area. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLine RX, known as Chemo4MetPank, continues to enroll patients. To further accelerate enrollment, last quarter, Columbia activated additional trial sites, and the trial is planned to be fully enrolled in 2027. A pre-specified interim analysis is planned for when 40% of PFS events are observed, which is planned for 2026. Results from this trial, if positive, could be a significant value inflection point for our company and signal new hope for patients suffering from this very challenging tumor type. We look forward to keeping you up to date on our progress with this important program. And staying on the topic of the Columbia University PDAC study for a moment, We were very pleased to announce that an abstract detailing new data from the pilot phase of the Chemo for MedPank trial has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO. The presentation will take place at 9 a.m. Central Daylight Time on Saturday, May 31st. Recall that in data previously presented, seven of the 11 patients in the pilot study experienced a partial response with six of those responses confirmed. That equates to a partial response rate of 64%, which compares very favorably to the historical partial response rate of 23%. 10 of 11 patients, or 91%, exhibited disease control, which also compares very favorably to a historic disease control rate of 48%. Additionally, median PFS progression pre-survival was 9.6 months compared to historic median PFS of 5.5 months. Notably, an analysis of the biopsy samples demonstrated a significant increase in CD8-positive T-cell density in tumors from all 11 patients treated, suggesting the ability of the Metixaportec combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data to be presented at ASCO on Saturday, four patients have now been progression-free for over a year. Two patients underwent definitive treatment for metastatic PDAC. One had complete resolution of all radiologically-detected liver lesions and underwent definitive radiations of the primary pancreatic tumor, while the other had a sustained partial response and underwent pancreatic coduodenectomy with pathology demonstrating a complete response Recall that it was due to these exceptional results from the pilot phase that the chemo for MedPank phase two trial was amended to become the current ongoing randomized study with planned enrollment increasing from 30 patients to 108 patients. Suffice it to say that we continue to be very excited about the data emerging from this program. In summary, with potential revenue from AirMid, together with a significantly streamlined organization and a strengthened balance sheet, We believe we are very well positioned to advance metixoportide in solid tumor indications such as pancreatic cancer while evaluating and licensing additional assets in oncology and rare disease. Our goal continues to be to help as many patients as possible while creating enduring value for our shareholders. Before turning the call over to Molly to review our financials in more detail, I'd like to briefly touch on Apexis performance in the first quarter. After a brief transition period in late 2024 and early 2025, the Aramid team has made very encouraging progress in driving effects to sales, generating sales of $1.4 million in Q1 2025, which resulted in $0.3 million of royalty revenues to BioLine RX. We anticipated some modest and temporary softness in effects to sales in the first part of Q1 as a result of the transition to Aramid. However, we have now seen it return to growth in late Q1 and early Q2. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statement. Revenues, cost of revenues, research and development expenses, sales and marketing expenses, net loss, and cash. I invite you to review the 6K filing we made this morning, which contains our financials and press release. Total revenues for the quarter ended March 31st, 2025, were $0.3 million as compared to $6.9 million for the comparable period in 2024. The revenues in 2025 reflect the royalties paid by AIRMID from the commercialization of Afexta in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect the portion of the upfront payment received under the Gloria License Agreement and the milestone payment achieved under the Gloria License Agreement, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of Effecta in the U.S. Cost of revenues for the quarter ended March 31st, 2025, was immaterial, compared to cost of revenues of $1.5 million for the comparable period in 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by AIRMID from the commercialization of Afeksta in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a maximum payment received under the Gloria Biosciences License Agreement and royalties on net product sales of Apexta in the US, as well as amortization of intangible assets and cost of goods sold on product sales. Research and development expenses for the quarter ended March 31st, 2025, were $1.6 million compared to $2.5 million for the comparable period in 2024. The decrease resulted primarily from lower expenses related to MOTIC support due to the out-licensing of U.S. rights to EIRMID, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the quarter ended March 31, 2025, compared to $6.3 million for the comparable period in 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024, following the Airmid out-licensing transaction. Net income for the quarter ended March 31st, 2025, were $5.1 million, compared to a net loss of $0.7 million for the comparable period in 2024. The increase in net income stems primarily from non-operating income, associated with the re-evaluation of warrants on our balance sheet. As of March 31st, 2025, the company had cash, cash equivalents, and short-term bank deposits of $26.4 million. And with that, I'll turn the call back over to Phil.

Thank you, Molly, and thank you to everyone joining this call. We will continue to update you on our progress identifying new assets over the course of the year. 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, good afternoon. Can you hear me? Yes, we can. Great, thank you. So first a couple questions on the balance sheet and the P&L, if you don't mind. So first, wanted to check on the cash runway stated. Does this include any new asset coming in for projected development costs on your end which you also stated these costs could also be offset by potential milestones and effects to royalties. Yes, it does. Okay. I could elaborate, but I think it's... No, no, no, that's fine. Look, I mean, I know there's a bit of vagary there because we don't know what the asset is yet. You know, you have better visibility, but that's definitely good to know. So, no, that's helpful. And then regarding overall P&L costs, have the costs from the November restructuring worked their way through the P&L already?

Yeah, absolutely. Actually, those costs were fully accrued already by the end of 2024, and so there were no more anticipated costs at all in 2025.

Great. We're wanting to make sure. And then for chemo for MedPank, I guess first some anecdotal and then some specific questions. add or provide with regard to the sites that have been added that might be linked to say excitement to join the study and you know the underlying unmet needs

Yeah, I'm trying to think if we gave that information. It's probably in clinicaltrials.org, I imagine. I mean, the sites in the study originally were Columbia and Brown University, and two more sites have been added, Beth Israel and Wisconsin.

Yes, and Fred Hutch is also about to participate.

Correct, and Fred Hutch as well. Yeah, no more of like, you know, the excitement that these sites wanted. out there, and that sort of links to my, you know, amended question to that of, you know, any competition for enrollment, you know, with regard to pancreatic studies out there.

Yes, okay. So, yes, the sites definitely are excited to join. You know, I think the poster that is going to be presented at ASH will show some of the data at ASCO, sorry. We'll show some of the exciting data from the pilot phase. There is a great figure where you can see one tumor completely disappearing. There's a beautiful figure there. Also, there is one, in that poster, there is one patient where his liver met also disappeared. So these are things, you know, although as you said, anecdotal, or not in all the patients, but these are definitely things that are very exceptional and exciting.

Got it. And then I guess a couple looking forward questions. I guess part one is, you know, when you talked about the interim analysis at 40% PFS events, was just curious about the communication strategy around this. Is this a canonical, you know, continuous plan type of announcement to the public, or will more data provided? And then the second part of the question is, you know, any views on the potential regulatory strategy going forward, you know, looking at a breakthrough designation or even the potential to file on the chemo for MedPank data based on potential strength?

Okay, so I can start, take the first part of that question. As you know, we're not running the study, right? It's a collaboration with Columbia University and Columbia is leading it. And so we are somewhat limited vis-a-vis their communication strategy. So we certainly in our collaboration agreement were allowed to put out data once it's published by Columbia, but it initially has to be published by Columbia and so we're limited about as to what we can say right now and how much control we have over it, but of course we will be putting out that data as soon as it comes out.

With regard to the second part of your question, if based on this study one could consider going for regulatory approval, You know, to be fair, usually those studies, in order to get approval, require a primary endpoint of overall survival, and this study, as you know, has PFS as the primary endpoint. So, of course, everything will depend, you know, if the results will be completely outstanding, but I think that that's really more, you know, the chances are not very high that based on this study one could get regulatory approval.

No, understood. Thanks for all the details, guys. All right. Have a good day, Joe.

The next question is from Justin Walsh of Dillon's Trading. Please go ahead.

Hi, thanks. This is Justin from Jones Trading. Now that Afexta is returning to growth but out of your hands, I'm wondering if you can provide any color on what your expectations are and sort of the long-term opportunity for the asset there. I mean, obviously, you can't speak for Amirate, of course.

Yeah, I mean... You're so right. We can't speak grammar, but I will say that you know we we thought all along I mean you know we talked a little bit about the size of the market that you know this was we estimated when it was in our hands and it hasn't changed materially that this is overall about a 300 million dollar market not that our product would take that whole market but overall it was a 300 million dollar market and that we would be able to take a substantial portion of that market and so you know if you just look at the entire opportunity you know I think you know I think that you could infer from that that this is an opportunity you know in the you know 100 plus a million dollar range and so I think that's more or less what you could you know say as far as you know how you see the revenues of this product you know going up Aramid, I can't speak for Aramid, but those are sort of our estimations throughout. And, you know, if you take that sort of curve going up over the next, you know, number of years, I think that you can, you know, sort of extrapolate from that how we see this asset, you know, if we're getting an 18% to 23% royalty on it as we move forward. I hope that helps. That's about as much as I can say.

Yeah, no, it does. And maybe one quick follow-up. I'm curious what your thoughts are on the current trajectory of the cell and gene therapy fields. I think there's been a lot of kind of headwinds from a funding perspective and maybe some of the initial commercial opportunities haven't been quite as high as people have hoped, but of course there's still potentially curative opportunities out there for a lot of these. So curious as you guys follow the space what your thoughts are from a high level.

Yeah, I mean, I think that I think that, you know, we just do the same. But, you know, this is a long-term play. We didn't expect that effect that would, you know, immediately, you know, enter, you know, the market as far as, you know, from a sickle cell disease perspective. We see it long-term, as you know.

I think the headwinds have got to the gene therapy.

That's what I'm saying, yeah, the gene therapy, absolutely. So because, obviously, there are headwinds in the gene therapy, the use of mobilization agents is obviously, you know, going to be limited as well. I think that we always saw this as a longer-term play, and we have composition of matter coverage well into 2041, and so I think that we did see this as sort of a very significant upside to the asset over the next number of years, maybe not initially, but because this therefore affects as well moving in because it, you know, we see it as a superior mobilization agent and allowing the gene therapy companies to, you know, to reduce their costs of goods sold. We see that as far as the patients being able to mobilize many more cells in, you know, many fewer sessions, et cetera. So for all of those reasons, we do see this as a potential significant upside for the asset.

Great. Thanks for taking the question.

The next question is from John van der Mosten of Zax.

Please go ahead. Great. Thank you, and good morning and afternoon to you guys. Do we expect a proportion of license revenues for effects to continue at the rate that we saw in the first quarter? Was it 255 to, like, 1.4 million? Do we expect that to go on?

You're saying the ratio of royalty revenues to effects to revenues? I just want to make sure I understand your question.

Yes. Yeah, the license revenues to product revenues, about 18% or so, I guess, which is on the low end of your – Yeah, well, yeah.

I mean, you know, this is very typical. certain level of revenues, it will stay at 80%, then it will go up, you know, to the next tier and then to the next tier, the next tier. I mean, we also have, you know, milestone-based payments as well. I think that it's a total of up to $87 million in milestone payments. So those payments as well could potentially, you know, inert to us over the next number of years. So we're expecting both royalty revenues on a regular basis and milestone payments if we reach the milestones that are set forth in the agreement.

Okay. And then what's the visibility on the milestones? And, you know, I know you've got a couple different sources, Gloria, give me the cell for that. You may not be able to tell me the timing, but maybe just the milestone type or, you know, whatever kind of visibility you can provide us as we forecast out. on that, on future milestones?

Yeah, so because this is a commercial stage asset, the milestones are primarily commercial-based, right? Not development-based and not regulatory-based, but commercial-based. But that's about as much as I could tell you.

Okay. I mean, are there any, like, geographic-related milestones if it expands? You know, and I'm talking about also on Gloria as well.

Yeah, I mean, there are some, yeah, I mean, are you talking about the Aramid Agreement or the Gloria Agreement?

Oh, well, either one, really, just, you know, in terms of the potential geographic expansion.

Right. So the Gloria Agreement has both commercial milestones and development and regulatory milestones because there are a number of additional territories, China, Japan, Korea, that require some development work and also some regulatory work. as commercial milestones. I believe the agreement also has both indication-based milestones as well as some geographic milestones.

Okay. And a question on your search. You know, again, I know you're keeping things pretty close to the vest on that, but I wanted to see what your thought process was. And I guess one of the aspects would be looking for either well-validated mechanisms or novel molecules. Do you take a stand on either one of those sides of things? I mean, obviously there's benefits to each one.

We're looking at everything. I think that we're doing a large and comprehensive search with the help of consultants. And we've identified a number of potential assets. And, you know, we're working to diligence. smaller company, we need to be opportunistic, so we do have obviously a set of principles that are guiding us as far as the search, but we're also trying to be nimble and opportunistic as well, and so I can't give you a clear answer to that.

Okay. And just one more question on that aspect. And, you know, again, you're probably not going to share the whole thing with me, but, you know, there's also looking at small markets with little to no competition or deep markets where there's an unmet need that you think you can address. Is that, you know, when you talk about your principles, is that something that you look at as well on those two axes?

We're looking at everything. I do want to add, I mean, I think that we're looking for programs that have a relatively short So I think that that's sort of something that, you know, could help you understand what we're looking at. You know, I think we're not looking at, you know, massive educations that require an enormous, you know, a large phase two or, you know, phase three or anything like that. We're looking at, you know, more modest programs, again, that have a short pathway, a short clinical development pathway, and a lean clinical development program. I think that's our ideal type of asset that we're looking at.

Okay, great. Thank you, Phil. I appreciate it.

Okay. Have a great day.

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 in two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 03-9255-904. Internationally, please call 972-39255-904. Mr. Thurland, would you like to make your concluding statement?

Yes, thank you, Operator. In closing, we are excited about this new vision for BioLine RX, and we are working diligently to identify new assets for in-licensing and development that would expand our pipeline and give us additional opportunities for value creation. 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 disease. We look forward to providing our next comprehensive quarterly update in August. Be safe and have a great day.

Thank you. This concludes the BioLineRx first quarter 2025 conference call. Thank you for your participation. You may go ahead and disconnect.