BioLineRx Ltd. ($BLRX)

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 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 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 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 and set 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 -- 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 Varseec (sic) [ 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-man 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 it's possible, we will, but there is no guarantee that it will...

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.