Bioline RX Ltd Sponsored ADR Aktie

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2026 Financial Results Conference. [Operator Instructions] 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, 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 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 3 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 Moffit Cancer Center led, by Dr. Patrick Grogan 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.

In addition, 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 2 orthotopic cell-derived xenograft or CDx models in GBM.

In addition, in a newly completed subcutaneous temozolamide-resistant patient-derived xenograft or PDX model in GBM, GLIX1 demonstrated a robust antitumor 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 2 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 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/IIa 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 improvement since that time. Treatment includes surgical resection, followed by radiotherapy and concomitant and adjuvant chemotherapy, as mentioned, temozolomide. But 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 EU 4 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 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 IIb 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 prespecified 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.

Now 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 statements, revenues, research and development expenses, general and administrative expenses, nonoperating 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 3 months ended March 31, 2026, were $0.5 million, an increase of $0.2 million compared to revenues of $0.3 million for the 3 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 3 months ended March 31, 2026, were $2.5 million, an increase of $0.9 million compared to $1.6 million for the 3 months ended March 31, 2025. The increase resulted primarily from expenses related to the new GLIX1 project. General and administrative expenses for the 3 months ended March 31, 2026, were $0.9 million, an increase of $0.1 million compared to $1 million for the 3 months ended March 31, 2025. The decrease resulted primarily from a decrease in legal expenses as well as a decrease in a number of other general and administrative expenses.

Net nonoperating income amounted to $0.5 million for the 3 months ended March 31, 2026, compared to net nonoperating income of $7.6 million for the 3 months ended March 31, 2025. Nonoperating income for the period primarily relates to noncash 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 31, 2026, was $2.6 million compared to net income of $5.1 million for the quarter ended March 31, 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.

And with that, I'll turn the call back over to Philip.

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 Justin Walsh of JonesTrading.

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?

Yes. So I mean, 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. I mean there are some medical devices, for example, the TT fields device. But in GBM, in biological area, the biologics or pharmaceuticals therapeutics, there just is not that much. And so 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. 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. So for this patient population, currently, there is no real competition in terms of recruitment. So 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.

The next question is from Joe Pantginis of H.C. Wainwright.

This is Josh on for Joe. So for our first one, could you provide an update on activation status at Northwestern and Moffit? Are all 3 centers now open and screening and enrolling patients? And now that the first patient has been dosed with GLIX1, are there any initial safety observations you're able to share with us?

So we can't really -- 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.

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

The next question is from John Vandermosten of Zacks.

And good to hear you guys' voices, Phil, Mali and Ella. I thought I'd start with a question on the CheMo4METPANC trial. And just trying 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?

Yes. John, it's good to hear your voice as well. So we've already indicated that we expect to have an interim futility 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 mean, I think that we can't ignore the fact that there was new data from Revolution Medicine that has come out that may have a significant effect on the PDAC landscape at this point.

And so obviously, that's good news for the patients. But we are looking at what the signals -- what signal we would like to see and what would support CXCR4 inhibition as sort of a backbone agnostic adjunctive strategy across various treatment platforms because we expect probably the treatment platform and the treatment paradigm will be changing in the next couple of years. And so 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. And shifting over to the APHEXDA efforts. I was wondering if you could provide any metrics or just kind of perhaps your discussions with Ayrmid because they're a private company and they don't really provide data. But just in terms of regions covered, sales professionals allocated to the product, I also had listed your payer coverage, marketing budget, digital strategies used, just kind of the general topics that one would think about when launching a product in the first few years of commercialization?

Yes. I mean those are really good questions. And I mean, there's very little I can give you any detail about. We're not giving guidance on what Ayrmid is doing. But 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 million or $1.4 million last year to $2.5 million this year. So 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 sort of it took them a while to get things moving. And so 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. And then last question on GLIX1. You had 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.

Yes. I'm sorry, we haven't disclosed the doses at this point. So there's not much that we can tell you. There are -- I think there are a number of dose levels in this particular trial, but 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 milligram in rats in terms of the safety. So this gives us, in any case, a huge safety margin with regards to doses expected to be given in the clinic. So we have...

Right. And that was my thought. I mean maybe it's 100 or 1,000x 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.

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 9723-9255-904.

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. [Operator Instructions]

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, 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 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/IIa 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 IIa 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. Ditte Primdahl and by Moffit 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 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 5 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 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 2 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 develop 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 prespecified 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 is 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, 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.

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 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 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 G-CSF-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 Mali 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 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 BioLineRx denying all and -- 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 statements, revenues, research and development expenses, general and administrative expenses, net loss and cash. I invite you to review the 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 reflects royalties earned on Ayrmid, Gamida Cell 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 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 motixafortide due to 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, 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 account 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, Mali, and thank you to everyone for joining this call. Operator, we will now open the call up to questions.

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

So first question, so 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?

Ella 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 half 2027 data in the GBM study since this is such a rapidly progressing disease.

Okay. So yes, 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 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 patient population with high-grade gliomas. And again, the major objective is safety and recommended dose. Of course, we will also, as a secondary endpoints look at efficacy, but I just want to be transparent at expectations. That's not the major objective of the dose escalation.

The next question is from Justin Walsh of JonesTrading.

As you're looking to initiate the GLIX1 trial, it would 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?

Yes, yes, for sure. So what I can tell you is that there is really...

I'm sorry, we have some kind of disturbance -- go ahead, Ella.

Okay. So there is real enthusiasm from the investigators participating in the study. They're very excited. 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 on a very frequent basis. The enthusiasm is very high. They are eager to initiate the study and try to initiate the study and hopefully bring new hope to the patient.

[Operator Instructions] The next question is from John Vandermosten of Zacks.

Great. And so 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.

Yes. So thanks, John. So 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 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 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. And like I said, they're moving forward with the bridging study, and they've already recruited a number of patients.

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

It's a blinded study. 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 GLIX1 GBM study, are these patients that are being enrolled, are they pretty much all eligible for investigational therapies as they've kind of run out of standard of care. Is that correct? Or...

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

And that's usually the case in first-in-human studies, obviously, of this nature.

Right. And I guess, 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 -- it's a complicated question. So we are taking biopsies. However, it's not mandatory. And 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. However, if there will be biopsies in these patients, then we will be able to take samples. So if possible, we will, but there is no guarantee that it will happen.

Okay. And last question, Phil, for you is, will Ayrmid -- do you know Ayrmid'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 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 how -- on what they expect going forward?

Yes. So they've just had it for over a year. So they're just sort of ramping up themselves. They're a private company. It's maybe fortunately for them, but unfortunately for us. So there's not much -- they don't have a need necessarily to put out guidance or data of that sort. We do have discussions with them, but they have not yet provided us with any long-term guidance. We have our own obvious 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.

There are no further questions at this time. I will turn the call over to Mr. Phil 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'm 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.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Update Conference Call. [Operator Instructions] I would now like to turn over the call to Irina Koffler, Head of Investor Relations and Corporate Communications, BioLineRx. Please go ahead.

Thank you, operator, and welcome, everyone. Thank you for joining us as we discuss this morning's announcement that BioLineRx and Hemispherian have established a joint venture. 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. Philip Serlin, Chief Executive Officer of BioLineRx.

Thank you, Irina, and good morning, everyone, and thank you for joining us on today's call for this significant announcement. Earlier this morning, we announced that we have entered into an agreement with Hemispherian AS, a Norwegian privately held biotech company focused on small molecule cancer therapeutics to establish a joint venture to develop GLIX1, a highly innovative molecule for the treatment of glioblastoma and other cancers.

I will begin with a few prepared remarks before turning the call over to Dr. Ella Sorani, our Chief Development Officer, to provide more information on GLIX1. I will then provide an overview of the JV structure and discuss next steps, after which we will take your questions. Mali Zeevi, our Chief Financial Officer; as well as Zeno Albisser, CEO of Hemispherian; and Dr. Adam Robertson, CSO of Hemispherian, are also available for Q&A.

Since November of 2024, when we entered into an exclusive out-licensing agreement with Ayrmid Ltd. for our FDA-approved stem cell mobilization agent, APHEXDA, we have been focused on four things: First, evaluating early clinical stage assets in the areas of oncology and rare disease to regenerate our development pipeline where we can fully leverage our clinical and regulatory expertise and successful track record of drug development. Second, operating a very lean organization to preserve our cash runway that extends into the first half of 2027. Third, supporting our clinical trial partner, Columbia University under the collaboration supported by both us and Regeneron to advance the Phase IIb trial of motixafortide in pancreatic ductal adenocarcinoma, or PDAC, for which we retain the development rights globally other than Asia. And four, supporting our out-licensing partners, Ayrmid and Gloria in order to fully realize future royalties and potential future milestone payments under our collaboration agreements with them.

Today, I'm very pleased to announce that following a relatively lengthy process of scouting and reviewing literally hundreds of potential projects since the beginning of the year as well as performing substantial due diligence on a number of very promising candidates that fit our search criteria, most notably a highly innovative asset with a clear unmet need as well as a clear and efficient path forward. We have entered into an agreement with Hemispherian AS to establish a joint venture to develop GLIX1, a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers. This joint venture combines our proven track record of clinical and regulatory success with Hemispherian's expertise in small molecule cancer drug discovery, specifically in the area of DNA damage response research, leveraging a unique mechanism of action that targets cancer cells.

We are also very pleased with the deal structure in the form of a joint venture, which we believe is the optimal way for BioLine to bring in a new program and invest gradually in its development while maximizing synergies and sharing the development risk with our collaboration partner. Hemispherian's lead candidate, GLIX1 is being developed as a potential treatment for many types of cancers. Based on its mechanism as well as the highly impressive preclinical results, the first indication to be investigated will be glioblastoma or GBM, both newly diagnosed and recurrent.

GBM is an extremely aggressive type of primary brain tumor with few effective treatment options. In a number of preclinical studies, GLIX1 demonstrated potent antitumor activity in multiple glioblastoma models, excellent blood-brain barrier penetration and a favorable safety profile. In August of this year, Hemispherian announced the U.S. Food and Drug Administration had cleared its IND. And with the joint venture now established, we are planning to initiate a Phase I/IIa clinical trial in the first quarter of 2026. We will provide more details on the trial in a moment.

Glioblastoma is the most common and most aggressive form of primary brain cancer. Prognosis of patients is extremely poor with median survival of approximately 12 to 18 months following diagnosis. The current standard of care treatment, which was established in 2005, includes surgical resection followed by radiotherapy, and concomitant and adjuvant chemotherapy, temozolomide. Importantly, 50% to 75% of patients do not benefit from treatment with temozolomide and those who do see a modest increase of approximately 2.5 months in overall survival. So this is among the most challenging cancer types where new therapeutic approaches are sorely needed.

Glioblastoma occurs at all ages, peaking in the fifth and sixth decades of life with increasing incidents in light of the aging global population. New and better treatments are desperately needed that can improve survival, maintain quality of life and delay tumor symptoms and progression. The annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and approximately 13,400 across the EU5, the U.K., France, Germany, Italy and Spain by 2030. This translates to addressable markets across both the newly diagnosed and recurrent settings of approximately $2.5 billion in the U.S. and approximately $1.3 billion across the 5EU.

This is a very open and uncrowded market with few competitors and represents a significant opportunity to bring innovation to patients while creating significant and enduring value for the JV and our respective shareholders, and we are truly excited by this opportunity. I would also like to emphasize the potential of GLIX1 in other cancers, both as monotherapy and in combination with PARP inhibitors. In addition, the JV also has a first look at other molecules in Hemispherian's pipeline, all focusing on DNA repair, although the initial focus of the JV will be GLIX1.

Finally, in terms of intellectual property, GLIX1 for use in treating cancer of the central nervous system, such as glioblastoma is covered by patents granted in the U.S., Europe and 13 other countries. The patents will be valid until at least 2040 with a possible patent term extension of up to 5 years. GLIX1 for use in treating any cancer in which CD8 is not overexpressed, which is the majority of cancers, is covered by patents granted or pending in the U.S., Europe and other countries, which will be valid until at least 2040 with a possible patent term extension as well of up to 5 years.

GLIX1, combined with a PARP inhibitor for use in treating HR-proficient cancers, also the majority of cancers, is covered by a pending international patent application. Corresponding national phase patents, if granted, will be valid until at least 2044, again, with a possible patent term extension of up to 5 years. So while glioblastoma will be our initial indication, GLIX1 is covered by a global portfolio of patents, both issued and pending that preserve our ability to evaluate it in the vast majority of cancer types, both as monotherapy and also in combination with standard-of-care therapies, including with PARP inhibitors. I'd now like to turn the call over to Ella to provide a bit more detail on GLIX1.

Thank you, Phil. GLIX1 has a unique mechanism of action that targets DNA repair vulnerabilities in cancer cells while sparing healthy tissue. It targets TET2, an enzyme that has a central role in DNA demethylation, a key process in the regulation of gene expression, cell differentiation and development. TET2 is responsible for initiating the DNA demethylation cycle, which downstream leads to single-stranded DNA breaks. In normal cells, this demethylation cycle occurs constantly and has no negative effect on the cell. Accordingly, stimulation of this cycle by GLIX1 in normal cells has no negative effect on the cell.

In cancers, however, alteration in DNA methylation are common and TET2 activity is inhibited by oncometabolites, giving rise to increased DNA methylation in close genomic proximity. This is applicable in hematological as well as solid tumors and is particularly pronounced in glioblastoma. In cancer, the restoration of TET2 activity by GLIX1 generates large amounts of single-stranded DNA breaks in close proximity to one another, resulting in double-stranded DNA breaks, which overwhelm the repair capacity of the cell killing the cancer cells. As expected from this mechanism of action, toxicology studies demonstrated that GLIX1 is safe and well tolerated up to the highest feasible doses tested. GLIX1 has been tested in multiple glioblastoma mouse models, including two orthotopic xenograft models. In both of the orthotopic GBM models, GLIX1 completely prevented tumor growth compared to an approximate 20-fold increase in tumor size in the control groups. This also translated into a substantial improvement in survival of the GLIX1 treated animals.

GLIX1 is a small molecule that effectively crosses the blood brain barrier. It is produced through a robust, straightforward synthesis method formulated as a capsule and demonstrates an excellent stability profile. In summary, its preclinical profile strongly supports the initiation of first-in-human studies. In addition to IND clearance by the FDA, GLIX1 has also been granted Orphan Drug Designation by both the FDA and the European Medicine Agency, the EMA, which is accompanied by an expedited review process and other financial benefits and may provide additional market exclusivity following approval.

As mentioned, we are planning to initiate a Phase I/IIa trial in the first quarter of 2026. The Phase I part of the trial is expected to recruit up to 30 recurrent GBM patients. The objective of this dose escalation part of the study is to establish a maximum tolerated dose and/or a recommended dose based on safety, PK/PD and available preliminary efficacy. Data from Phase I part of the trial is anticipated in the first half of 2027. The Phase IIa expansion part of the trial is planned to include three patient cohorts: GLIX1 as monotherapy in recurrent glioblastoma, GLIX1 on top of standard of care in newly diagnosed GBM patients and GLIX1 in combination with PARP inhibitors in other solid tumors. It is worth noting that PARP inhibitors are only efficacious in HR-deficient cancer, which represents just 6% of all cancers.

Early data suggests the potential for strong synergy of GLIX1 with PARP inhibitors by sensitizing HR proficient cancers representing 94% of all malignancies to PARP inhibitors. In addition, GLIX1 has shown antitumor activity in other cancer models. So, while glioblastoma remains our initial indication for the GLIX1 clinical program, we believe there is significant potential opportunity in other cancers as well. I now turn the call back to Phil.

Thank you, Ella. Reviewing the structure of the JV, Hemispherian will contribute the global rights of GLIX1 to the JV, and BioLineRx will be responsible for managing, performing and funding all JV development activities in accordance with an agreed development plan and budget. In consideration of our respective contributions, as of the JV's inception, Hemispherian will hold 60% of the JV's share capital, and we will hold a 40% stake with our stake increasing incrementally to a potential maximum of 70% in parallel with our continued investment in the program. There was no initial upfront payment associated with the transaction. Both parties agreed that all funding would go strictly to development in order to expedite this high potential program.

The JV also has a first look at other molecules in Hemispherian's pipeline. Incorporating the contemplated investment in GLIX1, BioLineRx currently has a cash runway into the first half of 2027. So we are well positioned financially to support start-up activities and subsequent initiation of the GLIX1 development program. It is also worth noting that some funding for our programs will come from royalties and potential milestone payments from our development partners, Ayrmid and Gloria Biosciences, pursuant to the aforementioned previously announced license agreements with those companies. In terms of next steps, as mentioned, we are planning to initiate the first-in-man Phase I/IIa trial of GLIX1 in the first quarter of 2026.

We are very pleased that the study will be conducted by world-leading investigators in the field of glioblastoma. Dr. Roger Stupp and Dr. Ditte Primdahl, of the Malnati Brain Tumor Institute of the Lurie Comprehensive Cancer Center at Northwestern University will serve as principal investigators for the study. Hemispherian has been working to build strong relationships with leading patient advocacy groups, which the JV intends to maintain and expand. And given that patients are actively looking to join clinical trials for promising new therapies, we anticipate that enrollment will proceed efficiently. We also note that the trial is open label, so we will be able to see the data on an ongoing basis and plan to provide updates wherever possible. This concludes our prepared remarks.

We will now ask the operator to open up the call to your questions.

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

Very intriguing announcement and looking forward to how the clinical program plays out. So a few questions first, Phil. So when you talk about your current runway, how does this play into -- how far does it get you into data catalysts, especially when you have some of the expenses offset by some royalties?

Yes. So we had -- first of all, it's a pleasure speaking to you, Joe, as usual. We had $28 million in cash as of our last financial date as well as royalties and potential milestones from our existing partners. So we definitely have enough resources to initiate and fund a significant portion of the trial. So that's sort of what I can say at this point.

I understand. And I guess if I just stand with the terms and the financials of the arrangement, would you disclose what the triggers are to get to your option to move to 70% ownership?

Everything is disclosed in the 6-K. There's basically a formula as we invest more, we acquire a larger percentage in the JV. But it's very well laid out in the 6-K that we filed.

Okay. Sorry, forgive me, I'm just processing...

No, no. it's early in the morning, I understand. I do want to say -- again, you mentioned something about the milestones. I just want to say that since -- as we mentioned, since this is an open-label trial, we will be seeing the data, and we will try to utilize every potential opportunity to provide that data to the public, to our shareholders.

Got it. And from the drug itself side, just curious, and I know it's a small molecule, but anything we need to consider with regard to manufacturing and supply of the drug, number one. And then with regard to the actual targeting of the drug and clinical -- potential clinical profile, is there anything to consider with regard to underlying MGMT status of the patients? Or is this drug agnostic to that?

Okay. On the CMC side, I'll just say that the CMC is very well established. It's manufactured at a well-known, reputable international CDMO. We have enough drug product to initiate the study as planned, and we're planning to carry out a manufacturing run sometime next year in order to complete the study. But it's very stable. And as Ella said, there are no issues at all whatsoever with CMC. The second part is for...

Yes, I can take that one. With regards to MGMT status, so generally speaking, based on its mechanism, GLIX1 should work in all cancers that express TET2. So it means it potentially should work also in -- either MGMT status should work. And actually, we also have seen data where in vitro, it works in temozolomide-resistant cells.

The next question is from Justin Walsh of JonesTrading.

Maybe to start off, wondering what you're looking to see in Phase I part of the trial that would give you confidence moving into Phase II, especially since you mentioned it's open label.

Ella, go ahead.

Yes. With regards to the first part of the trial, as I said before, we are looking into safety, PK/PD, potential efficacy. So it's a standard first-in-human trial, where we will assess all these parameters in order to proceed to the expansion part of the study.

Got it. And in terms of the safety and tolerability, are there any specific signals that you're expecting based on the preclinical studies?

Yes. So with regards to the safety, this is actually an excellent question. Based on the mechanism of action of GLIX1, that's the beauty of the molecule, I would say, because it's completely safe. It's specific to cancer cells, but does not negatively affect normal cells. And indeed, in the GLP tox study, we had excellent safety results shown with this molecule. It was completely safe up to the highest feasible tested doses in both species tested. So in terms of safety, we expect actually -- hopefully, we will be able to show also in humans that it's safe. But what we saw so far is completely aligned with the mechanism, and it was extremely safe.

Got it. One more for me. I'm wondering if there's a sort of specific rationale. I know you mentioned you did preclinical studies, but beyond just seeing some synergy between GLIX1 and the PARP inhibitors versus other DNA damage repair inhibitors or other antitumor therapies. And related to that, I'm curious if there are certain solid tumor indications outside of GBM that you guys are -- think you might see more benefit in?

Adam, would you like to take that question?

Yes. So with regards to the PARP inhibitors, the mechanism of action of PARP inhibitors overlaps with that of the GLIX molecule. So that's why we predicted that we would see good synergy, and that's actually -- and we did indeed see that good synergy. So GLIX causes the formation of single-stranded breaks and PARP inhibitors prevents the repair of the single-stranded breaks. So that's why we'd expect to see synergy, and we then indeed did see synergy.

To the second part of the question, which was, did we see other combination with other DNA damage response agents. So far, we haven't seen any synergy with GLIX1 and any of the other DNA damaging agents. So with that, that's kind of the status of it right now, but I think the PARP inhibitors are the way to go. In terms of other indications, we're looking towards blood cancers, but we do see good efficacy in many other cancer types. So we'll start with glioblastoma and then other blood cancers, but then we have a lot of options there.

The next question is from John Vandermosten of Zacks SCR.

I had a question on just other molecules in this class that may have been investigated for similar molecules. Is there anything else like that, that sets a precedent?

Adam, do you want to take that?

Yes. So we have -- so GLIX1 is 1 of 6 molecules that we found were good at targeting the TET2 enzyme. GLIX5 also has a similar effect. We found that -- of the 6 that we found, GLIX1 and GLIX5 were by far the best and GLIX1 had superior pharmacological properties. So that's why we decided to advance that first. I will mention that the JV has the option to advance GLIX5 as well. So that's potentially interesting, although that's not. We're not -- we don't have plans at this moment to advance GLIX5.

Okay. And I'm sorry, go ahead.

Yes. I'm not sure that if you meant other drugs from Hemispherian or generally speaking, because actually, the mechanism of GLIX1 is a first-in-class molecule. And although there are other studies that validated TET2 as a drug using genetics, but it's the first pharmaceutical to be advanced clinically, if that was your question.

Actually, yes, that was part of the question. So -- and then looking at GLIX1, I guess it's initially intended to be used after a failed standard of care in GBM. Is that the intention?

After what? Sorry.

After failed standard of care in GBM. Is that the initial question?

Well, the first -- yes, in the dose escalation, we are aiming -- we are starting with the current GBM because in order to gather safety, but the plan is in the expansion also to test it on top of standard of care in newly diagnosed GBM patients.

The next question is from Joe Pantginis of H.C. Wainwright.

So Phil, I just wanted to have a strategic question. So as of today, you have motixafortide royalties, you have CheMo4METPANC and then you have the new GLIX1 asset. Is there anything we can consider in the sort of near to intermediate term for any potential pipeline expansion?

We're always looking for interesting opportunities, but I have to tell you right now, we're fully focused on what we have. I can't say that we won't see some other opportunities out there. But I think with our budget and with the cash on hand and with our capabilities, this is sort of going to keep us busy for quite a while. I will say though that -- I also want to point out that we also plan to perform and investigate or do perform a number of preclinical studies as well in this molecule to see other indications, et cetera, et cetera. So between everything, I think we're pretty well engaged at this point.

[Operator Instructions] There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make a concluding statement?

Yes, I would. Thank you, operator. In closing, we are very pleased and excited to establish this joint venture, which allows us to expand our pipeline with a highly innovative asset such as GLIX1, with the potential to become an effective and safe treatment option for cancer patients with high unmet needs. Recall that our other molecule, the CXCR4 inhibitor, motixafortide, is currently being evaluated in the Phase IIb CheMo4METPANC study in combination with the PD-1 inhibitor, cemiplimab and standard of care chemotherapies in first-line metastatic pancreatic cancer.

That study is sponsored by Columbia University with equal support by Regeneron and BioLineRx. Enrollment continues to progress, and we're planning for a prespecified interim analysis when 40% of progression-free survival events are observed. We are excited to apply our clinical and regulatory experience to the development of GLIX1 and look forward to keeping you apprised of our progress. Thank you all very much for your continued interest in BioLineRx as we embark on this exciting new endeavor. Be safe, and have a great day.

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

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2025 Financial Results Conference Call. [Operator Instructions]

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 were 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'd like to begin this morning with an update on our search for additional early-stage assets, both clinical and preclinical in the areas of oncology and rare diseases to support our pipeline expansion. I am pleased to report today that we are making excellent progress in our evaluation of promising assets, and we continue to target the execution of a transaction this year, giving us an additional opportunity to deliver innovation to patients while creating long-term value for our shareholders.

For those who may be new to our story, in November of last year, we announced a transformational exclusive out-licensing agreement with Ayrmid Pharma Limited, which gave them the rights to commercialize APHEXDA, our FDA-approved stem cell mobilization agent indicated in combination with G-CSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. That agreement covers all indications, excluding solid tumor indications such as pancreatic ductal adenocarcinoma, or PDAC, for which we retain the rights and in all territories other than Asia.

In exchange, we received an upfront payment as well as commercial milestones and royalties. In addition to being approved for stem cel mobilization, APHEXDA is also being studied in 2 investigator-sponsored Phase I trials, evaluating it for the mobilization of CD34-positive hematopoietic stem cells used in the development of gene therapies for patients with sickle cell disease.

The first study is evaluating motixafortide as monotherapy and in combination with natalizumab and is sponsored by Washington University School of Medicine in St. Louis. Data from this program are expected in the second half of this year. The second study is evaluating motixafortide as monotherapy and is sponsored by St. Jude's Children's Research Hospital. So while it is early, the potential broad clinical utility of motixafortide, including in sickle cell disease represents an additional potential source of long-term milestones and royalties for our company.

As previously mentioned, as part of the Ayrmid agreement, we retained the rights to motixafortide in pancreatic cancer, and we continue to support its ongoing development in this indication. To that end, a randomized Phase IIb PDAC 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 of care chemotherapy, gemcitabine and nab-paclitaxel. A prespecified interim analysis is planned for when 40% of progression-free survival events are observed. 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 this trial was presented at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO, in May.

Recall that in previous presented data, 7 of the 11 patients in the pilot study experienced a partial response, with 6 of those 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 was 9.6 months compared to historic median PFS of 5.5 months. Notably, an analysis of biopsy samples demonstrated a significant increase in CD8-positive T cell density in tumors from all 11 patients treated suggesting the ability of motixafortide combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective.

In the updated data that was presented at ASCO, 4 patients have now been progression-free for over a year. Two patients underwent definitive treatment for metastatic PDAC, one had a complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, while the other had a sustained partial response and a pancreatic duodenectomy better known as a Whipple procedure, with pathology demonstrating a complete response.

We are very excited about the data that continue to emerge from this program. While motixafortide represents an unequivocal demonstration of our ability to develop and launch a new therapeutic agent, the Ayrmid 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.

Recall that we successfully advanced motixafortide known commercially as APHEXDA through clinical development and FDA approval in September 2023, giving new hope to the increasing number of multiple myeloma patients who may benefit from an autologous stem cell transplant, yet who have difficulty mobilizing the significant quantities of stem cells required for successful transplantation. Since the Ayrmid agreement, we have been laser-focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare diseases that will allow us to leverage this proven 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 an efficient and clearly defined clinical development path and will be partly funded through milestones and royalties from our license agreement with Ayrmid as well as from our previously announced agreement with Gloria Bio.

The current pace of due diligence is actively progressing. And as I said, we are targeting a definitive announcement this year. I want to underscore that our diligence process is lengthy and intensive and includes deep verification of preclinical data, intellectual property and drug manufacturing processes. This thorough process is expected to generate the best results for our shareholders. Our whole team has been engaged in these activities since the beginning of the year. In this regard, we are pleased to be well financed as we undertake this endeavor.

We ended the second quarter with cash and equivalents of approximately $28.2 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. Note that this represents an extension of our cash runway as compared to our previous guidance, which was through the second half of 2026.

Following the announcement of the Ayrmid out-licensing agreement, several BioLineRx commercial team members transitioned to Ayrmid, and we also implemented a broad restructuring of our company, including the shutdown of our U.S. operation that resulted in more than a 70% reduction in our operating cash burn as we entered this year.

These decisions, while difficult, have transformed us into a lean and nimble organization capable of quickly seizing on new opportunities that are consistent with our go-forward strategy for the company.

In summary, with potential revenue from Ayrmid and Gloria Biosciences, together with a significantly streamlined organization and strengthened balance sheet, we believe we are very well positioned to advance motixafortide in solid tumor indications such as pancreatic cancer, while evaluating and in-licensing additional assets in oncology and rare diseases.

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 second quarter.

The Ayrmid team continues to make progress driving APHEXDA adoption, generating sales of $1.7 million in Q2 2025, which resulted in $0.3 million of royalty revenues to BioLineRx.

We remain optimistic about the role that APHEXDA can play in the new multiple myeloma treatment paradigm as well as in sickle cell disease and look forward to meaningful growth as treatment protocols are updated to reflect the commercial availability of this next-generation stem cell mobilization agent.

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 filing we made this morning, which contains our financial and press release. Total revenues for the second quarter of 2025 were $0.3 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 second quarter of 2025 was immaterial compared to cost of revenues of $0.9 million for the second quarter of 2024. Both revenues and cost of revenues in 2025 are not comparable to the same period in 2024, which primarily related to direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.

Research and development expenses for the second quarter of 2025 were $2.3 million compared to $2.2 million for the second quarter of 2024. The small increase related primarily from certain onetime costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to 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 second quarter of 2025 compared to $6.4 million for the second quarter of 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024, following the Ayrmid transaction.

General and administrative expenses for the second quarter of 2025 were $0.2 million compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in 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 second quarter of 2025 was $3.9 million compared to net income of $0.5 million for the second quarter of 2024. As of June 30, 2025, the company had cash, cash equivalents and short-term bank deposits of $28.2 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.

A few, if you don't mind. So first, Phil, can you remind us with regard to the CheMo4METPANC study, does Regeneron have any options or right of first looks or refusals?

No, they do not. This is a clinical -- for both sides, it's just a clinical collaboration. We have access to the data, down the road, but there's no option for -- as far as I know for -- on our part for sure. And as far as I know, there's no option on the Regeneron side either.

Got it. And then with regard to the conduct of the study and the data, you obviously stated and we all knew this anyway that you need a 40% PFS event rate to be able to trigger an interim there. Do you anticipate that, that would release data or be sort of a continuous plan type of announcement? And then overall, when the study is completed based on the unmet medical need, do you believe there's any potential for filing on this study for an accelerated standpoint?

Mali, would you like to take that?

Yes, I can take that. So with regard to the interim analysis, it's a prespecified interim analysis in the protocol. So it will be performed with regards to the publication. It's in -- Phil, I'll leave it to you, it's an investigor-initiated study. I don't know if...

Yes. I would like to -- I think that we have every -- we would like to publish that data or at least that the study is continuing, et cetera, et cetera. I think that that's our goal. I think we have to close that issue with Columbia. And also, I believe that they have the rights to publish that data first. So the timing of it might be -- we will have to discuss it with them to understand the timing.

Understood. Go ahead, sorry.

With regard to your second, if based on this interim analysis, it would be a way forward with regards to accelerated approval. I doubt it because it's -- 40% of the events in this 108% patient study will probably not be sufficient in order to result in accelerated approvals in terms of this. And also, it's based on PFS, while, as you know, the standard primary endpoint for approval will be overall survival. So I don't see it result in accelerated approval based on interim analysis of following 40% of the events.

Okay. Understood. And then you guys are obviously busy with your academic collaboration. So I want to focus specifically on the sickle cell study. If you could sort of give us what should we and the Street be looking for out of the study with regard to key metrics and end points, the overall expectations?

I mean, generally, we'll be looking at the mobilization. There will be mobilization data coming out of these studies, both at the WashU, for example, the WashU study is both motixafortide as a monotherapy and also motixafortide together with natalizumab. And so there should be -- again, these are investigator-initiated studies, but there should be data relating to the mobilization of both of those arms. Any other data...

Yes, I can add to that. So of course, one of the most important endpoints of this study is safety because it's the first time that sickle cell disease patients have been mobilized with motixafortide. The second aspect is, of course, the mobilization into peripheral blood.

So cells per microliter in the peripheral blood, which is correlative to the collection yield. And the third would be collection yield in sickle cell disease patients. As you remember, there was a preliminary results presented in last year's ASCO as an oral presentation, results from 7 patients, which showed very promising results in all these parameters, especially if you compare it to the historical control of plerixafor.

For example, just to remind you, the mobilization to peripheral blood, the mean and median values with motixafortide where the median was around 200 cells per microliter. The mean was 300 cells per microliter. If you compare this to the benchmark of mobilization with plerixafor, it's less than 100 cells per microliter, just as a high-level comparison. And also the collection yields, the very high and promising. And so this, I think, will be the outcomes from this study. What you will not get from this study, of course, is data on manufacturing.

Understood. And then my last question, if you will. Obviously, you've had -- you've been very busy in the background with regard to all the due diligence in looking at new assets. So if I heard you correctly, Phil, correct me if I'm wrong, it seemed like there were sort of 2 that were sort of at the forefront right now. Are you able to share at least -- I mean you provided some timing of potential consummation of the deals, but sort of the stages of these assets? Is it potential to be accretive or late stage? How should we sort of view this for near to intermediate-term impact on the P&L?

Yes. So we're targeting closing a transaction this year. I can't promise that it will happen, but we're targeting closing a transaction this year. We're looking for early stage. We're looking in our sweet spot, our wheelhouse, which is early clinical stage assets from IND through Phase I.

That's sort of where we're looking. These are -- we're also looking for assets that have a very clear and well-defined development plan, something that we can afford. Also transactability is important for us, right? So we're not looking at assets that require a significant upfront payment, et cetera, et cetera.

So we have a lot of experience in bringing in assets over the years. We've brought in over 50 assets over the 20-year life of the company. And so this is sort of these assets that we're looking for are very much in our wheelhouse, both from a development perspective, a cost perspective, a transactability perspective and also in the areas that we have expertise in oncology, et cetera.

The next question is from Justin Walsh of Jones Trading.

Can you provide any additional color on how your ASCO data was received? I don't know if you had an interesting feedback from physicians or potential partners at the conference.

ASCO data.

ASCO data from the pancreatic study, you mean?

Yes. Yes.

Okay. Yes. So what I can tell you that there was excitement. There are some aspects in the results that are very promising, in particular the results on the liver mets, which is something that is very unusual to see a reduction in liver mets. So we received very exciting feedback with that regard in particular to that finding.

The next question is from John Vandermosten of Zacks.

And just some more questions on your progress in finding new assets. What are the most attractive sources that you've identified for some of the pipeline candidates? I generally think of there's universities, public private companies, big pharma that has something that they don't have time for maybe it's too small for them. What are some of the sources that you're looking at?

Yes, that's a good question. I -- We're looking at all of those sources, of course. I'd have to say generally, and these are broad generalizations. Academic institutions are less of a source from our perspective for clinical stage projects. They usually are at earlier stages of development.

So we are looking at them also, of course, but we're finding that there's -- that they're a much better source of interesting and innovative early-stage projects. On the other hand, if you look -- and if I go to the other extreme, so to speak, and that's the pharma companies, there are very interesting assets available. I think that from our perspective, we're finding that from a transactability perspective, it's difficult for us to compete in those areas.

Those usually require a significant upfront payment and early-stage milestones, et cetera, et cetera. And we're trying as much as possible to spend very little to nothing upfront and enable us to spend all of the spend on development, et cetera, and back end and have a back-ended type of deal.

So I have to say -- in conclusion, I have to say that overall, the best source that we're finding are the smaller companies both private and public mostly private because it's very difficult to raise money right now.

And so we are finding interesting assets at smaller companies that have brought the assets to a certain milestone, so to speak, but don't have the capital or the development expertise necessarily to move those assets further. And so this is exactly our wheelhouse, again, sort of early clinical stages we have -- this is what we've been doing for the last 20 years. And so this is probably the best source of assets for our pipeline expansion activities.

Okay. Yes, that makes perfect sense. And then given the funding environment, which you mentioned, how -- do you feel like you have the upper hand in negotiating? You've got a long history of doing this. And I guess compared to previous periods, does it seem like you're in a little bit stronger position now than you were in the last 20 years -- other periods in the last 20 years?

That's a very good question. I think we are in a better position as far as that we have a validated development history. I think when we were looking for assets 10 years ago because we really haven't done much in-licensing activities, we've spent the last 10 years or so primarily on motixafortide, right? So I think that before we had the validation from our entire clinical development capabilities that we've shown in -- with motixafortide, I think that there was maybe -- again, years ago, there was skepticism about when we came and said that we can really do everything and bring this forward.

I think that we -- I think we're finding that with the validation that we have from having FDA approval and even is -- really resonates. And so therefore, it is somewhat easier now versus in the past for us to make the case that if you give us the asset maybe we can't compete financially with someone else, but we can bring it forward in the quickest, most efficient manner all the way through potential approval. And so that is resonating better.

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 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 9723-9255-904.

Mr. Serlin, would you like to make your concluding statement?

Yes. Thank you, operator. In closing, we remain very excited about this new vision for BioLineRx, and we are making excellent progress in our due diligence as we work to identify new assets for in-licensing and development that would expand our pipeline and give us additional opportunities for value creation.

As mentioned, we are targeting a potential announcement this year. Thank you all very much for your continued interest in BioLineRx. We look forward to providing our next comprehensive quarterly update in November. Be safe and have a great day.

Thank you. This concludes the BioLineRx Second Quarter 2025 Conference Call. Thank you for your participation. You may go ahead and disconnect.