BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter and full year 2025 financial results conference call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will begin for the question and answer session. I would now like to turn over the call to Irina Koffler, investor relations. Irina, please go ahead.

Thank you, Operator, and welcome, everyone. Thank you for joining us on our annual 2025 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 to 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 Mali Zevi, 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. I would like to begin this morning with an update on GLICS 1, a highly innovative molecule for the treatment of glioblastoma and other cancers that we brought into our pipeline through our collaboration with Hemispherion. As a reminder, GLIX-1 is a first-in-class oral small molecule with a novel mechanism of action applicable to a broad range of cancers. By restoring TET2 activity, GLIX-1 selectively targets DNA damage repair in cancer cells only. GBM was selected as the first indication for GLIX1 due to the low level of TET2 activity in this aggressive brain cancer, for which there remains a high unmet medical need for novel and more effective treatments. In extensive preclinical studies, including in vivo GBM models, GLIX1 demonstrated potent anti-tumor activity and excellent blood-brain barrier penetration, combined with a favorable safety profile in toxicology studies. The FDA approved hemispherian investigational new drug, or IMD, application last August, and I am pleased to report that we are on track to initiate the first in human Phase 1-2A glioblastoma trial by the end of this month, and we anticipate that patient treatment will commence shortly thereafter. I'd also note that GLICS-1 has also been granted orphan drug designation by both the FDA and the European Medicines Agency. which is accompanied by an expedited review process and other financial and market exclusivity benefits. The phase one part of the trial is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose and or recommended dose based on safety, PKPV, and preliminary efficacy. Data from the phase one part of the trial are anticipated in the first half of next year. The Phase 2A expansion part of the trial is planned to include various population cohorts, including GBM, both newly diagnosed and or recurrent, as well as additional cancers with or without standard of care, for example, PARP inhibitors. These cohorts are expected to identify preliminary efficacy, PD assessment, and dose optimization data, serving as the basis for a rapid and effective advanced clinical development program. Three renowned academic centers will ultimately participate in this clinical trial. The first center ready to start enrolling patients is NYU Langone Health, led by Dr. Alexandra Miller. This will be followed by Northwestern University, led by Dr. Roger Stoop and Dr. Dita Primdahl, and by Moffitt Cancer Center, led by Dr. Patrick Grogan. In parallel, we will continue to conduct preclinical activities in support of further development of Glix1 in additional cancer indications with high unmet needs. And separately, we're also conducting studies to further investigate and affirm the potential synergistic effect of Glix1 in combination with PARP inhibitors as we work to maximize the value of the Glix1 opportunity. As we have stated previously, the unmet need in glioblastoma is significant. GBM is the most common and aggressive form of primary brain cancer. The current standard of care treatment was established in 2005, with only limited further advancement since. Treatment includes surgical resection, followed by radiotherapy and concomitant and adjuvant chemotherapy, temozolomide. Yet most patients will succumb to their disease within less than 18 months. The median overall survival is between 12 and 18 months. GBM occurs at all ages but peaks with individuals in their 50s and 60s with an increased incidence driven by an aging global population. New and better treatments are desperately needed that can improve survival, maintain quality of life, and delay tumor progression. By 2030, the annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and approximately 13,500 patients across the EU4 plus 1. France, Germany, Italy, Spain, and the United Kingdom. This translates into total addressable markets across both the newly diagnosed and recurrent settings of more than $3.7 billion in the U.S. and Europe alone. We view this as a wide open market with few competitors. We already talked about Glix1's unique mechanism of action as well as the fact that we believe this novel molecule has potential clinical utility across a range of cancers. To that end, we were very pleased to announce in November that we received a notice of allowance from the USPTO for a key patent covering the use of Glix1 for the treatment of all cancers in which cytidine deaminase, or CDA, is not overexpressed beyond a specific threshold. This new patent provides patent protection through 2040, not including a possible patent term extension of up to five years. It is estimated that as many as 90% of all cancers, Both solid tumor and hematologic cancers fall into this category, and we have already seen encouraging preclinical results in other cancers in which GLIX1 has been evaluated. So while glioblastoma is our initial indication, as previously mentioned, we are planning to expand the development of GLIX1 into additional planned cancer indications once safety and dosing are successfully established in patients. In this regard, we will continue to advance preclinical work in other cancers in parallel with our glioblastoma study. We believe the versatility of GLTS-1 provides us with multiple opportunities to advance patient care while creating value for our company and its shareholders. In addition to the pending U.S. patent just referenced, GLTS-1 is covered by two additional key patent families covering its use alone and in combination with established anti-cancer agents. both of which provide patent protection to at least 2040, not including potential patent term extensions. We are very pleased to have brought this highly innovative molecule into our pipeline, and we look forward to keeping you apprised of our progress as we pursue its development in a range of high unmet need cancers. Turning now to pancreatic cancer, or PDAC, recall that we retained the rights to develop a tixoportide in PDAC as part of the Aramid Out Licensing Agreement, and we continue to support its ongoing development in this indication. Recall that Columbia University, supported by both Regeneron and BioLineRx, is executing a randomized Phase IIb clinical trial known as Chemo4MedPANC, and we are pleased to report that enrollment in this trial has accelerated. This trial is evaluating metixoportide in combination with the PD-1 inhibitor zimiplumab and standard chemotherapies, gemcitabine and napaclitaxel. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, and we anticipate this analysis will occur this year. 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. In terms of cash, our balance sheet remains strong. We ended the year with cash in equivalence of approximately $21 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. We also have the potential benefit of royalties and milestone-driven revenue from our license agreements with both Airmint and Gloria Biosciences. We remain a very lean organization following the shutdown of our commercialization operations in the U.S. and our focus on development. I'd now like to briefly touch on Fexted's performance. The Airmint team continues to push a Fexted option, generating sales of $6.5 million in 2025. which resulted in $1.2 million of royalty revenue to BioLine Rx. We remain hopeful about the role that Effecsta can play in the new multiple myeloma treatment paradigm, and we look forward to growth in the future. Turning now to sickle cell disease, recall that when we executed the Aramid Outlicensing Agreement, they obtained not only the rights to commercialize Effecsta in stem cell mobilization for multiple myeloma, but also the rights to develop Metixifortide across all other indications. excluding solid tumor indications, and in territories other than Asia. This includes the evaluation of a tixoportide in sickle cell disease, specifically as a mobilization agent for gene therapies in this indication. The current standard of care mobilization agent, GCSF, is contraindicated in patients with sickle cell disease, so there is an urgent need for an agent that can reliably produce the very large quantities of stem cells that manufacturing and transplantation require in this indication, around 20 million CD34 positive cells per kilogram, without further burdening already constrained aporesis capacity. A phase one investigator-initiated trial sponsored by Washington University School of Medicine recently concluded, and we were very pleased to announce that a poster detailing final positive results from this proof of concept study was presented at the most recent ASH annual meeting in December. The trial, which enrolled 10 patients, evaluated metixiportide both as monotherapy and in combination with natalizumab for the mobilization of hematopoietic stem cells for gene therapies in sickle cell disease. The study demonstrated that metixiportide alone and in combination with natalizumab was safe and well-tolerated, and that metixiportide alone and in combination with natalizumab demonstrated robust hematopoietic stem cell mobilization to the poor full blood, resulting in high collection yields. Furthermore, in two subjects who had previously undergone mobilization with plurixifor, motixifortide alone and in combination with natalizumab resulted in nearly 3x greater mobilization and subsequent collection yields of stem cells compared to plurixifor. In conclusion, this trial demonstrated the potential of motixifortide alone and in combination with natalizumab as a novel GCSF-free regimen to safely optimize hematopoietic stem cell mobilization in sickle cell disease. A second sickle cell disease study hematic support site sponsored by St. Jude's Children's Research Hospital continues to enroll patients. Before turning the call over to Molly to review the financials, I would like to provide a very positive update on a legal matter. In June of 2024, BioKind Therapeutics, from whom we licensed the rights to metixoportide, filed a complaint against us in the District Court of Jerusalem alleging breach of contract and a purported failure to make certain payments to Biokine under our licensing agreement. The complaint, as amended, sought $7.2 million and a declaratory judgment in favor of Biokine. In November 2024, we and Biokine entered into an agreement to refer the dispute to binding arbitration. Last month, the arbitrator issued a final award in favor of BioLine Rx, denying any and all claims asserted against us by BioKind and awarding reimbursement of all expenses, including legal fees, to BioLine Rx. Needless to say, we are very pleased with this resolution, which removes a financial overhang and allows us to concentrate our resources fully on the ongoing development of GLICS 1. 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 go over the most significant items in our financial statement. Revenues, research and development expenses, general and administrative expenses, net loss, and cash. I invite you to review the 20F that we filed this morning that contains our financials and press release. Revenues for the year ended December 31st, 2025 were $1.2 million as compared to $28.9 million for the full year 2024. Revenues in 2025 primarily reflect royalties earned on Airmid Gamida cells product sales of Afexa. The revenues in 2024 primarily reflect a portion of the upfront payment received and the milestone payment achieved under the Gloria license, which collectively amounted to $15 million, as well as a $10 million upfront payment received under the EIRMID license and $6 million of net revenues from product sales of Afexsta in the U.S. Research and development expenses for the year ended December 31, 2025, were $8.1 million as compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from lower expenses related to MOTIX afforded due to the out-licensing of U.S. rights to EIRMIT, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX-1 project. General and administrative expenses for the year ended December 31, 2025, were $3.1 million, as compared to $6.3 million for the year ended December 31, 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount and a decrease in a number of general and administrative expenses. Net loss for the year ended December 31, 2025 was $2 million compared to $9.2 million for the year ended December 31, 2024. As of December 31, 2025, the company had cash, cash equivalents, and short-term bank deposits of $20.9 million sufficient to fund operations as currently planned into the first half of 2027. And with that, I'll turn the call back over to Phil.

Thank you, Molly, and thank you to everyone for joining this call. Operator, we will now open the call up to questions.

Thank you. Ladies and gentlemen, at this time we will begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the number. Your questions will be pulled in the order they are received. Please stand by while we call for your questions. The first question is from Joe Pangenis of H.D. Wainwright. Please go ahead.

Thanks for the update. So one question, Carol. So in the upcoming Phase I study in GDM, what is the potential for more interim data regarding overall responses since this is such a rapidly progressing belief? Thanks a lot. Did you hear that?

I'm having difficulty a little bit to hear. Can you repeat the question?

It's a little choppy. I'm sorry. I'm sorry.

So the potential for interim data before the first F2027 data in the GPM study since this is such a rapidly progressing belief.

Okay. So yeah. So thanks for the question. Generally speaking, it's a dose escalation study, so the major objective of this study is to determine the safety and recommend the dose for the continued development. The study is not necessarily designed and in order to assess efficacy. Also, this is, you know, in patient population with high-grade reumat, and again, the major objective is safety and recommended dose. Of course, we will also, as a secondary influence, look at efficacy, but, you know, I just want to be transparent with expectations. That's not the major objective of the dose escalation.

Okay. Thank you. Thanks, Jo. Have a good day.

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

Hi. Thanks for taking the question. As you're looking to initiate the GLICS1 trial, it would be great to hear what you've heard from the PIs at these centers. I'm just curious about the level of enthusiasm for the trial and what aspects of the drug's profile are most intriguing to these physicians.

Yeah, yeah, for sure. What I can tell you is that there's really... I'm sorry, we have some kind of... We have some kind of... Okay.

Go ahead, Ella.

Okay, so there's real enthusiasm from the investigators participating in the study. They're very excited. You know, they are... because of the novelty of the mechanism of action, the results from the preclinical in vivo studies. They are really engaged. We are having discussions with them almost, you know, on a very frequent basis. The enthusiasm is very high. They are eager to initiate a study, try to, you know, initiate the study and hopefully bring new hope to the patient.

If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. The next question is from John Vandermusten of Varset. Please go ahead.

Great. Thank you. And so I wanted to see if you could give us an update on the status of Gloria's phase 3 bridging trial and also their PDAC trial. perhaps also the next milestones that we should expect to see from them.

Yeah, so thanks. Thanks, John. So I think we had reported previously that Gloria, some of the things had been delayed because Gloria was in the process of raising money and had some financial difficulties. They have, you know, sort of worked out most of their difficulties. They paid us, as we reported, they repaid us our first milestone that had been delayed for, you know, for over a year. And we understand that they have started the bridging study in stem cell mobilization, which is required for approval in China. And so that is moving along. We're still having discussions with them about the solid tumor indications and trying to put together a development plan for that. So I still don't have any news on the solid tumor indications, but I do have some positive news on the stem cell mobilization. Like I said, they're moving forward with the bridging study, and they've already recruited a number of patients.

Great. Will we see any data interim readouts or anything from that for the remainder of this year?

It's a blinded study. You know, it's for registration, so we're not going to see any interim readouts. But hopefully we should have some data. I believe they should be putting out data sometime next year, if I'm not mistaken, sometime by like the middle or so of next year.

Okay. And then for the GLICS1 GBM study, are these patients that are new and old, are they pretty much all eligible for investigational therapies? They've kind of run out of standard care, is that correct?

Yes, there are recurrent or progressed GBM patients, yes.

Okay. That's usually the case in, you know, in first demand studies, obviously of this nature.

Right. And I guess, you know, will you be able to measure blood brain barrier penetration in the study? Because I know that was one of the big features of the product.

So this is a complicated question. So we are taking biopsies. However, it's not mandatory. You know, these are not newly diagnosed and this is not a zero or window of opportunity study. So it's not designed to assess these measures. there will be biopsies in these patients, then we will be able to take samples. So it's possible we will, but there's no guarantee that it will happen.

Okay. Thanks, Ellen. And last question, Phil, for you is, well, do you know Airbit's position on providing guidance for effects to sales? I mean, I know generally in the early stages that's kind of held back on, but, you know, it's in the third year now, I think. Do you anticipate them providing any? guidance either to you or to the broader market on what they expect going forward?

Yes. They've just had it for over a year. They're just ramping up themselves. They're a private company. It's maybe fortunately for them but unfortunately for us. They don't have a need necessarily to put out guidance or data of that sort. We do have discussions with them. have not yet provided us with any, you know, long-term guidance. We have our own obvious, you know, thoughts about what the molecule will be doing and et cetera, but they haven't provided us with anything as of yet. It might be too early still.

Okay, great. Thank you, Phil. Appreciate it. All right, thank you.

There are no further questions at this time. I will turn the call over to Mr. Phil Selling for concluding statements. Mr. Selling, please go ahead.

Thank you, operator. In closing, we remain very excited about this new vision for BioLineRx, including our new lead development asset, Glix1, and believe we are well positioned to drive meaningful innovation for patients with some of the most challenging cancer types. I am very excited about what the future holds for BioLineRx this year and beyond. Thank you all very much for your continued interest in BioLineRx. Be safe and have a great day.