BLRX

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2026 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. For operator assistance during the conference, please press star zero. I would now like to turn over the call to Chuck Padala, investor relations. Chuck, please go ahead.

Thank you, operator, and welcome everyone, and 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 6-K. I'd like to remind everyone 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 Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Chuck Padala. Good morning, everyone. 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 Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with an update on GLIX1, a highly innovative molecule for the treatment of glioblastoma, or GBM, and other cancers that we obtained through our collaboration with Hemispherian.

In March, we were pleased to announce the initiation of a phase I/IIa first-in-human trial of GLIX1 for the treatment of GBM, and a few weeks later, the first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-director of the Brain and Spine Tumor Center, Perlmutter Cancer Center at Langone Health. A total of three renowned academic centers will participate in this clinical trial. In addition to Langone Health, Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Hwu, will also be recruiting and treating patients. Additional sites may be added to the study at a later date as well. The phase I part of the trial is expected to recruit up to 30 patients with recurrent GBM and other high-grade gliomas.

The objective is to establish a maximum tolerated dose and/or recommended dose based on safety, PK/PD, and preliminary efficacy. We expect to provide periodic updates on the trial during the second half of 2026, with full results on the dose escalation part in 2027. The phase IIa expansion part of the trial is planned to include additional indications, including newly diagnosed GBM as well as select cancers with GLIX1 as monotherapy or in combination with standard of care, including in combination with PARP inhibitors. These cohorts are expected to identify preliminary efficacy, PD assessments, and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan. As a reminder, GLIX1 is an oral small molecule with a novel mechanism of action applicable to a broad range of cancers. By restoring TET2 activity, GLIX1 selectively targets DNA damage repair in cancer cells only.

Glioblastoma 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. GLIX1 has demonstrated its ability to cross the blood-brain barrier, which is a highly significant differentiator for treating GBM and gives us hope that it may show effect where others have failed in this exceedingly difficult indication. Expanding upon our extensive preclinical work, we were very excited to announce just last week new data demonstrating that GLIX1 achieved robust dose-dependent tumor growth inhibition and survival benefit in several studies in two orthotopic cell-derived xenograft, or CDX, models in GBM. In a newly completed subcutaneous temozolomide-resistant patient-derived xenograft, or PDX, model in GBM, GLIX1 demonstrated a robust anti-tumor effect, while no effect was observed with temozolomide.

These results are very encouraging, highlighting the potential to address the high unmet need in GBM, especially since more than half of GBM patients are resistant to temozolomide, which is the current standard of care chemotherapy. We also look forward to engaging with the broader oncology community over the next few days at this year's ASCO meeting, with two abstracts featuring GLIX1 that have been accepted for online publication. The abstracts highlight the wealth of preclinical data that support GLIX1's novel mechanism of action, designed to induce tumor-selective DNA damage in a broad range of cancers, thus providing rationale for the development of GLIX1 in GBM and in additional cancers as well.

They also highlight the compelling mechanistic rationale for combining GLIX1 with PARP inhibitors, supported by a synergistic effect in cell lines across diverse cancers, including tumor types typically less responsive to PARP inhibition. Taken together, the results of our extensive preclinical program for GLIX1 strongly support its continued advancement in the ongoing Phase I/II-A first-in-human study, both in GBM and in other cancer indications. The unmet need in glioblastoma is significant. It is the most common and aggressive form of primary brain cancer. GBM occurs at all ages, but peaks with individuals in their 50s and 60s, with an increasing 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. The current standard of care was established more than 20 years ago, with only limited improvements since that time.

Treatment includes surgical resection followed by radiotherapy and concomitant and adjuvant chemotherapy, as-mentioned temozolomide. The prognosis for patients is poor, with median survival of approximately 12 to 18 months following diagnosis. 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 +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 are incredibly 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 wide range of cancers. Turning now to pancreatic cancer or PDAC.

Recall that we retained the rights to develop motixafortide in PDAC as part of the Ayrmid out-licensing agreement, and we continue to support its ongoing development in this indication. Columbia University, supported by both Regeneron and BioLineRx, is executing a randomized Phase II-B clinical trial known as CheMo4METPANC, and we are pleased to report that enrollment continues to track well. This trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapies gemcitabine and nab-paclitaxel. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, which is still anticipated later this year. I'd now like to briefly touch on APHEXDA's performance.

The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $2.5 million in the first quarter of 2026, compared with $1.4 million of sales in Q1 2025, resulting in $0.5 million of royalty revenue to BioLineRx. We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm and look forward to continued growth in the future. Furthermore, recall that when we executed the Ayrmid out-licensing agreement last year, they obtained not only the rights to commercialize APHEXDA in stem cell mobilization for multiple myeloma, but also the rights to develop motixafortide across all other indications, excluding solid tumor indications and in all territories other than Asia. This includes the evaluation of motixafortide in sickle cell disease.

Indeed, Ayrmid are continuing the development of motixafortide in this indication and have previously reported encouraging results, and we are optimistic that this might contribute to future revenues given the high unmet need for better mobilization agents in this indication. The current standard of care mobilization agent, G-CSF, is contraindicated in patients with sickle cell disease, so there is an urgent need for an agent that can reliably produce the exceptionally large quantities of stem cells that manufacturing and transplantation require in this indication. More than 20 million CD34 positive cells per kilogram without further burdening already constrained apheresis capacity. Let me turn the call over to Mali to provide a more detailed financial update. Mali, please go ahead.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statement. Revenues, research and development expenses, general and administrative expenses, non-operating income, net loss, and cash. I invite you to review the 6-K that we filed this morning that contains our financials and press release. Revenues for the three months ended March 31, 2026, were $0.5 million, an increase of $0.2 million, compared to revenues of $0.3 million for the three months ended March 31, 2025. The increase in revenues from 2025 to 2026 reflects an increase in royalties paid by Ayrmid from the commercialization of APHEXDA. Research and development expenses for the three months ended March 31, 2026, were $2.5 million, an increase of $0.9 million, compared to $1.6 million for the three months ended March 31, 2025. The increase resulted primarily from expenses related to the new GLIX1 project.

General and administrative expenses for the three months ended March 31, 2026, were $0.9 million, an increase of $0.1 million, compared to $1 million for the three months ended March 31, 2025. The decrease resulted primarily from a decrease in legal expenses as well as a decrease in the number of other general and administrative expenses. Net non-operating income amounted to $0.5 million for the three months ended March 31st, 2026, compared to net non-operating income of $7.6 million for the three months ended March 31st, 2025. Non-operating income for the period primarily relates to non-cash fair value adjustment of warrant liabilities as a result of changes in the company's share price, offset by warrant offering expenses. Net loss for the quarter ended March 31st, 2026, was $2.6 million compared to net income of $5.1 million for the quarter ended March 31st, 2025.

In terms of cash, we ended the quarter with cash and equivalents of $17.4 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. With that, I'll turn the call back over to Phil.

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

Thank you. The first question is from Justin Walsh of JonesTrading. Please go ahead.

Hi. Thanks for taking the question. Now that dosing is underway for the phase I-IIA trial, it would be great to hear your thoughts on the current development landscape in GBM and how challenging or competitive it is to enroll patients in this population.

Yeah. Hi, good morning. This is sort of a wide open area right now. There are a number of drugs in development, but it's still there really nothing is really working at this point. There are some medical devices, for example, the TTFields device, but in GBM, in our biological area, the biologics or pharmaceuticals therapeutics, there just is not that much. We are not seeing any significant problem with recruitment at this point, and we don't expect any. Ella, would you like to add anything?

Yes, I would. Hi, Justin, it's Ella. Just to elaborate on what Phil is saying, you know that the current study is being performed in recurrent and progressive GBM patients. For this patient population, currently there is no real competition in terms of recruitment. We expect recruitment, unfortunately of course for the patients, but in terms of the recruitment for this study with this patient population, we don't see any issue with recruitment.

Great. Thanks for taking the question.

The next question is from Joseph Pantginis of H.C. Wainwright. Please go ahead.

Morning. This is Josh on for Joe. Thanks for taking our questions. For our first one, could you provide an update on activation status at Northwestern and Moffitt? Are all three centers now open and screening and enrolling patients? Now that the first patient's been dosed with GLIX1, are there any initial safety observations you're able to share with us?

Hi. We haven't really given disclosure about the status of each one of the sites. Obviously, NYU is up and recruiting. We are working with the other sites, but that's really all I can say about now, but they will be open very shortly. As far as, what was the second part of the question?

If you can update on the sales.

Yeah, we can't really do that, I'm sorry. We do plan to give periodic updates and not wait until the very end, but right now there's nothing really we can say.

Okay. Thank you so much.

Okay.

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

Thank you, and good to hear you guys' voices, Phil, Molly, and Ella. I thought I'd start with a question on the chemo from that PANC trial and just try to get a sense. I want to get a sense of anticipated next steps if it's successful and anticipated conclusion of it. Thinking about modeling purposes just in timing and what might be coming up in the next few quarters, years.

Yeah. Hi, John. It's good to hear your voice as well. We've already indicated that we expect to have an interim utility analysis sometime later this year when 40% of the PFS events occur, and that's still on track, et cetera. As far as next steps, I think that we can't ignore the fact that there was new data from Revolution Medicines that has come out that may have a significant effect on the PDAC landscape at this point. Obviously that's good news for the patients, but we are looking at what signal we would like to see and what would support CXCR4 inhibition as sort of a backbone agnostic adjunctive strategy across platforms because we expect probably the treatment platform or the treatment paradigm will be changing in the next couple of years.

I think that we have to look at the data that we see and then make some decisions later on about how best to proceed.

Got it. Shifting over to the APHEXDA efforts. I was wondering if you could provide any metrics or just perhaps your discussions with Ayrmid, because they're a private company and they don't really provide data. Just in terms of regions covered, sales professionals allocated to the product, I also had listed here payer coverage, marketing budget, digital strategies used, just kind of the general topics that one would think about when launching a product and in the first few years of commercialization.

Yeah. Those are really good questions. There is very little I can give you any detail about. We're not giving guidance on what Ayrmid is doing. I will say, I can point out to the fact that, as I mentioned on the call, their sales, the sales of APHEXDA in this Q1 2026 versus 2025 have significantly increased from I think $1.3 or $1.4 million last year to $2.5 million this year. This is, I think, at least from our perspective, is good news because we're seeing after sort of the year that we did the initial launch, and then they took over for us, and then it took them a while to get things moving.

I think from our perspective, this is very good news because it shows a significant increase from last year, and we hope that this will sort of be the new line so to speak, or the new curve going up for the future. That's really all I can say at this point regarding APHEXDA sales.

Okay. Thanks, Phil. Last question on GLIX1. You'd put out some discussions of the preclinical data that's going to be presented later, and one of the metrics was, I think, up to 2,000 milligrams per kg were used in rats. What dose level do you think would be the absolute maximum in the clinical trials?

We haven't disclosed the doses yet.

Yeah. I'm sorry. We haven't disclosed the doses at this point. There's not much that we can tell you. I think there are a number of dose levels in this particular trial, I don't think that we can give you that information. It's primarily from a trade secret perspective at this point.

Okay. Well, we'll keep our eyes open for updates on the GLIX1 trial.

Just to elaborate on that, you referred to the dose of 2,000 milligrams in rats in terms of the safety. This gives us- in any case, a huge safety margin with regards to doses expected to be given in the clinic.

Right. That was my thought. Maybe it's 100 or 1,000 times what it might be. I guess that's what I was trying to get a sense for.

We haven't disclosed the doses to be used, but we have a huge safety margin with regards to based on the excellent safety we had in the tox study, as compared to the doses we are going to give in the clinic.

Okay. Thank you, Ella. Appreciate it.

Thank you.

Before I ask Mr. Philip 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 remain very excited about our recent progress, and we believe that we are well-positioned to drive meaningful innovation for patients with some of the most challenging cancer types. I remain very optimistic 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.

This concludes the BioLineRx investors call. Thank you for your participation. You may go ahead and disconnect.

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 forward presentation, instructions will be given 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 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 Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Irina, and good morning, everyone. 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 Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with an update on GLIX1, a highly innovative molecule for the treatment of glioblastoma and other cancers that we brought into our pipeline through our collaboration with Hemispherian. As a reminder, GLIX1 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, GLIX1 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 antitumor activity and excellent blood-brain barrier penetration, combined with a favorable safety profile in toxicology studies. The FDA approved Hemispherian Investigational New Drug, or IND, application last August, and I am pleased to report that we are on track to initiate the first-in-human phase I/II-A glioblastoma trial by the end of this month, and we anticipate that patient treatment will commence shortly thereafter.

I also note that GLIX1 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 I 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, PK/PD, and preliminary efficacy. Data from the phase I part of the trial are anticipated in the first half of next year. The phase II-A 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 Stupp and Dr. Dieter 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. 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 EU 4 + 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. While glioblastoma is our initial indication, as previously mentioned, we are planning to expand the development of GLIX1 into additional 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 GLIX1 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, GLIX1 is covered by two additional key patent families covering its use alone and in combination with established anticancer 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 development motixafortide in PDAC as part of the Ayrmid 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 Chemo4METPANC, and we are pleased to report that enrollment in this trial has accelerated. This trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapies gemcitabine and nab-paclitaxel. 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 and equivalents 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 Ayrmid 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 APHEXDA's performance. The Ayrmid team continues to push APHEXDA adoption, generating sales of $6.5 million in 2025, which resulted in $1.2 million of royalty revenue to BioLineRx.

We remain hopeful about the role that APHEXDA 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 Ayrmid out-licensing agreement, they obtained not only the rights to commercialize APHEXDA in stem cell mobilization for multiple myeloma, but also the rights to develop motixafortide across all other indications, excluding solid tumor indications, and in territories other than Asia. This includes the evaluation of motixafortide 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 apheresis capacity. A phase I 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 motixafortide 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 motixafortide alone and in combination with natalizumab was safe and well-tolerated, and that motixafortide alone and in combination with natalizumab demonstrated robust hematopoietic stem cell mobilization to the peripheral blood, resulting in high collection yields. Furthermore, in two subjects who had previously undergone mobilization with plerixafor, motixafortide alone and in combination with natalizumab resulted in nearly 3x greater mobilization and subsequent collection yields of stem cells compared to plerixafor. In conclusion, this trial demonstrated the potential of motixafortide 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 of motixafortide sponsored by St. Jude 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, Biokine Therapeutics, from whom we licensed the rights to motixafortide, filed a complaint against us in the Jerusalem District Court, 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 BioLineRx, denying any and all claims asserted against us by Biokine and awarding reimbursement of all expenses, including legal fees, to BioLineRx. Needless to say, we are very pleased with this resolution, which removes the financial overhang and allows us to concentrate our resources fully on the ongoing development of GLIX1.

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 statement, revenues, research and development expenses, general and administrative expenses, net loss, and cash. I invite you to review the Form 20-F that we filed this morning that contains our financials and press release. Revenues for the year ended December 31, 2025 were $1.2 million as compared to $28.9 million for the full year 2024. Revenues in 2025 primarily reflect royalties earned on Ayrmid Gamida Cell's product sales of APHEXDA.

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 Ayrmid license and $6 million of net revenues from product sales of APHEXDA in the US. 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 motixafortide due to the out licensing of US rights to Ayrmid, 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 GLIX1 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 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 equivalents and short-term bank deposits of $20.9 million sufficient to fund operations as currently planned into the first half of 2027.

With that, I'll turn the call back over to Phil.

Thank you, Mali, 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 one. If you wish to cancel your request, please press star two. If you are using speaker equipment, kindly lift the handset before pressing the number. Your questions will be pulled in the order they are received. Please stand by while we pull for your question. The first question is from Joe Pantginis of H.C. Wainwright. Please go ahead.

Thanks for the update. One question. For the upcoming phase I study in GBM, what is the potential for more interim data regarding overall responses since this is such a rapidly progressing disease? Thanks a lot.

Ella, did you hear that?

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

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

Yeah. All right. The potential for interim data before the first half 2027 data in the GBM study since this is such a rapidly progressing disease.

Okay. Yeah. Thanks for the question. Generally speaking, it's a dose escalation study. The major objective of this study is to determine the safety and the recommended dose for the continued development. The study is not necessarily designed and for sure not powered in order to assess efficacy. Also this is, you know, a patient population with high-grade gliomas. Again, the major objective is safety and recommended dose.

Of course, we will also, as a secondary endpoint, look at efficacy, but, you know, I just want to be transparent and set expectations. That's not the major objective of the dose escalation. Okay. Thank you.

Thanks, Joe. Have a good day.

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

Hi. Thanks for taking the question. As you're looking to initiate the GLIX1 trial, it'd be great to hear what you've heard from the PIs at these centers. Just curious about the level of enthusiasm for the trial and what aspects of the drug's profile are most intriguing to these physicians.

Ella, do you want to take that?

Yeah. Yeah, for sure. What I can tell you is that there's really,

I'm sorry we have some kind of.

Bye. Bye.

We have some kind of disturbance on the line.

Okay.

Okay, go ahead. Go ahead, Ella.

Okay. There is real enthusiasm from the investigators participating in the study. They're very excited. You know, they are excited 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 the study and hopefully bring a new hope to the patient.

If there are any additional.

Okay, go ahead. I'm sorry. Go ahead.

If there are any additional questions, please press star one. If you wish to cancel your request, please press star two. The next question is from John Vandermosten of Zacks. Please go ahead.

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

Yeah. Thanks. Thanks, John. I think we had reported previously that Gloria, some of the things have 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 now had been delayed for, you know, for over a year. We understand that they have started the bridging study in stem cell mobilization, which is required for approval in China. 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.

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 so for the remainder of this year?

It's a blinded study, you know. It's for registration, so we're not gonna see any interim readouts. 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. Then for the GLIX1 GBM study, are these patients that are being enrolled, are they pretty much all eligible for investigational therapies? They've kind of run out of standard care. Is that correct or?

Yes. They are recurrent or progressed GBM patients. Yes.

Okay.

That's usually, you know, the case in first-in-man studies of IRC of this nature.

Right. 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.

This is a complicated question. We are taking biopsies. However, it's not mandatory and these are not newly diagnosed and this is not a phase zero or a window of opportunity studies, so it's not designed to assess this measure. However, if there will be a biopsy in this patient, then we will be able to take samples. If possible, we will, but there is no guarantee that it will indeed happen.

Okay. Thanks, Ella. Last question, Phil, for you is, do you know Ayrmid's position on providing guidance for expected sales? I mean, I know generally early stages that's kinda 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, you know, the broader market on what they expect going forward?

Yeah. They just had it for over a year. You know, they're just sort of ramping up themselves. They're a private company, you know. It, you know, maybe fortunately for them, but unfortunately for us. There's not much. You know, they don't have a need necessarily to put out, you know, guidance or data of that sort. We do have discussions with them, but they 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 etcetera, 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. Philip Serlin for concluding statements. Mr. Serlin, 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.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. 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 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 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 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 Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with a recap of our very significant and transformational announcement that we established a JV with Hemispherian, a Norwegian privately held biotech company to develop GLIX1, a highly innovative molecule for the treatment of glioblastoma and other cancers. The JV combines our proven track record of clinical and regulatory success, having advanced APHEXDA through clinical development and FDA approval with Hemispherian's expertise in small molecule cancer drug discovery, specifically in the area of DNA damage response research that leverages a unique mechanism of action and targets cancer cells. With these complementary capabilities, I believe we are very well positioned to bring much needed innovation to the most challenging cancer types while creating long-term value for our respective shareholders. GLIX1 is a first-in-class oral small molecule. As mentioned, GLIX1 is a very innovative molecule with a unique mechanism of action that targets DNA damage response in cancer cells while sparing healthy cells. Based on this unique MOA, the fact that it crosses the blood-brain barrier as well as highly impressive preclinical results, the first indication to be investigated will be glioblastoma or GBM, both newly diagnosed and recurrent. The FDA cleared Hemispherian's IND in August. And with the JV now up and running, we are planning to initiate a first-in-human Phase I/IIa glioblastoma trial in the first quarter of next year. At the same time, GLIX1 is a versatile molecule that has shown compelling antitumor activity in a large variety of cancer cell lines and other cancer models as well, and we will continue to advance preclinical activities in support of potential trials in other high unmet need cancer indications. Briefly recapping the terms of the JV agreement, Hemispherian contributed the global rights of GLIX1 to the JV, and we are responsible for managing, performing and funding all JV clinical development activities. In consideration for our respective contributions as of the JV's inception, Hemispherian holds 60% of the JV's share and BioLine holds 40%. We will continue to increase our stake over time up to a 70% stake as we continue to invest additional capital into the program. The unmet need in glioblastoma is significant. It is the most common and aggressive form of primary brain cancer. The current standard of care treatment was established more than 20 years ago with only limited improvements since that time. Treatment includes surgical resection followed by radiotherapy and concomitant and adjuvant chemotherapy, but the prognosis for patients is poor with median survival of approximately 12 to 18 months following diagnosis. GBM occurs at all ages, but peaks with individuals in their 50s and 60s with an increasing 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 13,400 across the EU 4+1, France, Germany, Italy, Spain and the U.K. 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. In terms of next steps, as mentioned, GLIX1's IND was cleared by the FDA this past August, and we are planning to initiate a Phase I/IIa study in the first quarter of next year. Data from the Phase I part of the trial is anticipated in the first half of 2027, but we may provide periodic updates earlier. Notably, 2 renowned experts in the area of glioblastoma, Dr. Roger Stupp and Dr. Ditte Primdahl of the Malnati Brain Tumor Institute at Northwestern University will serve as principal investigators for the study. 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 just a few days ago 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. It is estimated that as many as 90% of all cancers, both solid tumor and hematological cancers fall into this category, and we have already seen potent antitumor activity in other cancer models in which GLIX1 has been evaluated. So while glioblastoma is our lead indication, as previously mentioned, we are planning to expand the development of GLIX1 into additional cancer indications once safety and dosing are successfully established. In this regard, we will continue to advance preclinical work in other cancers in parallel with our glioblastoma study. We believe the versatility of GLIX1 provides us with multiple opportunities to advance cancer patient care while creating value for our company. Importantly, this new patent broadens and strengthens GLIX1's patent protection until 2040 with a possible patent term extension of up to 5 years. In addition to the recently allowed U.S. patent just referenced, GLIX1 is covered by 2 additional key patent families covering its use alone and in combination with established anticancer agents. GLIX1 for use in treating cancer in the central nervous system, such as glioblastoma is covered by patents issued in the U.S., Europe and 13 other countries. The patents are valid until at least 2040 with a possible patent term extension of up to 5 years. And then GLIX1 in combination with PARP inhibitors for use in treating homologous recombination proficient cancers, which represent the majority of cancers is covered by a pending international patent application. Corresponding national-based patents if granted will be valid until at least 2044 with a possible patent term extension of up to 5 years. So 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 very challenging cancers. Turning now to pancreatic cancer, or PDAC. Recall that we retained the rights to develop motixafortide in PDAC as part of the Ayrmid out-licensing agreement, and we continue to support its ongoing development in this indication. A randomized Phase IIb clinical trial sponsored by Columbia University and supported by both Regeneron and BioLineRx, known as CheMo4METPANC continues to enroll patients. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor, cemiplimab and standard chemotherapies, gemcitabine and nab-paclitaxel. A prespecified interim analysis is planned for when 40% of progression-free survival events are observed. Results for 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 third quarter with cash and equivalents of approximately $25.2 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 Ayrmid and Gloria Biosciences. 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 Mali to review our financials in more detail, I'd like to briefly touch on APHEXDA's performance in the third quarter. The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $2.4 million in Q3 2025, which resulted in $0.4 million of royalty revenue to BioLineRx. We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm and look forward to meaningful growth from this next-generation stem cell mobilization agent. Recall that when we executed the Ayrmid out-licensing agreement last year, we obtained not only the rights to commercialize APHEXDA in stem cell mobilization for multiple myeloma, but also the rights to develop motixafortide across all other indications, excluding solid tumor indications and in all territories other than Asia. This includes the evaluation of motixafortide in sickle cell disease. A Phase I investigator-initiated trial sponsored by Washington University School of Medicine recently concluded, and we are very pleased to announce that an abstract detailing final positive results for this proof-of-concept study has been accepted for presentation at this year's ASH Annual Meeting, which is taking place December 6 to December 9. Hitting a few of the highlights, the trial, which enrolled 10 subjects evaluated motixafortide 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 motixafortide alone and in combination with natalizumab was safe and well tolerated. In addition, motixafortide alone and in combination with natalizumab demonstrated robust hematopoietic stem cell mobilization in the peripheral blood, resulting in high collection yields. Furthermore, in 2 subjects who had previously undergone mobilization with plerixafor, motixafortide alone and in combination with natalizumab resulted in nearly 3x greater mobilization and subsequent collection yield of stem cells as compared to plerixafor. In conclusion, this trial demonstrated the potential of motixafortide alone and in combination with natalizumab as a novel G-CSF-free regimen to safely optimize hematopoietic stem cell mobilization in sickle cell disease. These results strongly support continued development in this indication. The current standard of care mobilization agent, G-CSF 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+ cells per kilogram without further burdening already constrained apheresis capacity. We believe motixafortide has the potential to expand access to stem cell mobilization and transplantation in sickle cell disease, which is potentially curative for these patients. 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 only 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 that we filed this morning, which contains our financials and press release. Total revenues for the third quarter of 2025 were $0.4 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Cost of revenues for the third quarter of 2025 was immaterial. Both revenues and cost of revenues in 2025 are not comparable to the same period in 2024, which primarily reflect a portion of the upfront payments received by us under the Gloria license agreement as well as direct commercial sales of APHEXDA by BioLineRx prior to the Ayrmid transaction in November 2024. Research and development expenses for the third quarter of 2025 were $1.7 million compared to $2.6 million for the third quarter of 2024. The decrease resulted primarily from lower expenses related to motixafortide following the out-licensing of U.S. rights to Ayrmid 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 third quarter of 2025 compared to $5.5 million for the third quarter of 2024. The decrease resulted primarily from the shutdown of our U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction. General and administrative expenses for the third quarter of 2025 were $0.8 million compared to $1.4 million for the third quarter of 2024. The decrease resulted primarily from lower payroll and share-based compensation, primarily due to a decrease in headcount as well as small decreases in a number of general and administrative expenses. Net loss for the third quarter of 2025 was $1 million compared to net loss of $5.8 million for the third quarter of 2024. As of September 30, 2025, the company had cash, cash equivalents and short-term bank deposits of $25.2 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, Mali, and thank you to everyone joining this call. Operator, we will now open the call to questions.

[Operator Instructions] The first question is from Joe Pantginis of H.C. Wainwright.

If you don't mind, I'm going to ask all 3 of my questions at the same time because there is some background noise. So please bear with me. So first, I wanted to get a sense as we look towards the upcoming clinical study for GLIX1, as you look early on for PK and PD markers, are there any potential PD markers that you look to release that might be correlated with clinical activity as people look to tease out any additional information from the study, number one. Number two, what would you say your intermediate or longer-term needs are for manufacturing capacity for GLIX1? And number three, thank you for taking these as you look towards additional tumor indications, when do you think we might see some preclinical data readouts and what those indications might be?

Thanks, Joe. So first of all, thanks for joining the call. Ella, do you want to take the question?

Yes, sure. Joe, thanks for your question. So the first question with regards to PK and PD markers during the clinical trial of GLIX. PK is an easy one. Of course, we are planning to take extensive PK data during this trial. With regards to pharmacodynamic markers, we do have pharmacodynamic markers for GLIX1. However, they are from biopsies. And since we are talking in the first part at least of the study, about recurrent GBM -- biopsies during or following treatment will not be easy to be obtained. Having said that, if there are going to be surgeries along the trial, then we are planning to use those in order to get some input with regards to these biomarkers. I hope this answers the question.

Yes.

And as far as the immediate needs for manufacturing, I can say that we're manufacturing at a world-class CDMO. We don't anticipate any need to change manufacturers or whatever. I think the current manufacturer has more than enough capacity and the batch size is correct for us to move forward all the way to Phase IIa.

And regarding your third question on results of preclinical models. So we are performing then with regards to when we will be able to present results probably in -- well, the plan would be in one of the conferences next year.

The next question is from John Vandermosten of Zacks.

So why the activities to commercialize APHEXDA are responsible at Ayrmid, I wanted to see if you can help me think about like a medium-term target for market penetration based on today's vantage point. Is that something you can help me with, Phil?

We can't really help you with it. We're not -- we're no longer the owner, so to speak, of the asset in the territories that Ayrmid holds. And so we're not really giving guidance at this time since it's no longer our product. I wish I could give you a better answer than that, but I'm really not able to.

Okay. And then shifting on to GBM. What would be a reasonable target for an improvement in overall survival for GBM that would get established pharma interested and get the FDA to be on board with approval? I know, again, that's well down the road, but I was wondering what you had in mind in terms of what would be material enough to get all parties, all stakeholders interested?

Yes. So with regards to that, I think it depends, of course, if you're talking recurrent GBM or newly diagnosed GBM. I think for the newly diagnosed, the benchmark would be -- I mean, temozolomide was approved based on improvement of median overall survival of approximately 2.5 months. So that would probably be sufficient for -- in terms of improvement of overall survival for newly diagnosed GBM. For recurrent GBM, I think the bar would even be lower in terms of improved efficacy.

Okay. That's very helpful. And then just a question on the financial statements. So your investments in the JV, how will they appear on your financial statements? Is that considered R&D expense? Or will it end up somewhere else? And I know there's a few different components there, like a periodic piece and then the investments in the JV itself.

Yes. So we ultimately control the JV. We have control of the Board of Directors, and we also have control of the joint development committees, et cetera. So we're actually consolidating the JV in our financial statements. And so therefore, all of the expenses in the JV will be reflected in the specific financial statement line items as if we were -- as if it was just being done directly at BioLine.

Okay. So those are all considered R&D expense, including that, I think that $80,000 amount.

Yes, of course. Yes. That $80,000 amount is actually -- is for specific services, transition services and what have you. So it will all be reflected in R&D expenses, I believe you're correct.

[Operator Instructions] There are no further questions at this time. Mr. Serlin, would you like to make your concluding statement?

Yes, I would. Thank you, operator. In closing, we remain very excited about this new vision for BioLineRx and believe we have the expertise and resources 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 in 2026 and beyond. Thank you all very much for your continued interest in BioLineRx. Be safe, and have a great day.