BioLineRx Ltd.

First Quarter 2026 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management's call and presentation, instructions will be given for the question and answer session. For operator assistance during the conference, please press star zero. I would now like to turn over the call to Chuck Pallada, 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 6K. 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 20F and our quarterly reports on Form 6K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BylineRx.

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 Molly Zeffi, our chief financial officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Surani, our chief development officer, is also available for Q&A. I would like to begin this morning with an update on GLIX-1, a highly innovative molecule for the treatment of glioblastoma, or GBM, and other cancers that we obtained through our collaboration with Hemispherium. In March, we were pleased to announce the initiation of a Phase 1-2A first-in-human trial of GLIPS-1 for the treatment of GBM. And a few weeks later, the first patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center, Perlmutter Cancer Center at Langone Health. A total of three renowned academic centers will participate in this clinical trial. In addition to Langone Health, Northwestern University, led by Dr. Roger Stoop and Dr. Dita Creamdahl, and Moffitt 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 one part of the trial is expected to recruit up to 30 patients with recurrent GBMs and other high-grade gliomas. The objective is to establish a maximum tolerated dose and or recommended dose based on safety, PKPD, 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 2A expansion part of the trial is planned to include additional indications, including newly diagnosed GBM as well as select cancers, which one is monotherapy or in combination with standard of care, including in combination with 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 plan. As a reminder, GLIX-1 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 two orthotopic cell-derived xenograms, or CDX, models in GBM. In addition, in a newly completed subcutaneous temozolomide-resistant patient-derived xenograft, or PDX, model in GBM, GLIX-1 demonstrated a robust anti-tumor effect while no effect was observed with temozolomide. These results are very encouraging, highlighting the potential to address the high unmet need in GBM, especially since more than half of GBM patients are resistant to temozolomide, which is the current standard of care chemotherapy. We also look forward to engaging with the broader oncology community over the next few days at this year's ASCO meeting with two abstracts featuring Glix1 that have been accepted for online publication. The abstracts highlight the wealth of preclinical data that support Glix1's novel mechanism of action designed to induce tumor-selected 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 Glix-1 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 Glix-1 strongly support its continued advancement in the ongoing phase 128 person-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 keeps the 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 EU4 plus 1, France, Germany, Italy, Spain, and the United Kingdom. This translates into total addressable markets across both the newly diagnosed and recurrent settings of more than $3.7 billion in the U.S. and Europe alone. We view this as a wide open market with few competitors. We are incredibly pleased to have brought this highly innovative molecule into our pipeline, and we look forward to keeping reprise 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 Muxoxyxoportide in PDAC as part of the Aramid Out Licensing Agreement, and we continue to support its ongoing development in this indication. Columbia University, supported by both Regeneron and BioLine RX, is executing a randomized Phase IIb clinical trial known as Chemo4MedPank, and we are pleased to report that enrollment continues to track well. This trial is evaluating rituxifluortide in combination with the PD-1 inhibitor simiplimab and standard chemotherapies gemcitabine and napaclitaxel. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, which is still anticipated later this year. I'd now like to briefly touch on effects of this performance. The AirMed team continues to make progress driving effects to 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 BioLine Rx. We remain optimistic about the role that Effecsta 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 AIRMID Outlicensing Agreement last year, they obtained not only the rights to commercialize Effecsta in stem cell mobilization for multiple myeloma, but also the rights to develop metixifortide across all other indications, excluding solid tumor indications, and in all territories other than Asia. This includes the evaluation of metixifortide in sickle cell disease. Indeed, ARAMID are continuing development of metixifortide 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, GCSF, 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 its indication, more than 20 million CD34 positive cells per kilogram, without further burdening already constrained aporesis capacities. Now let me turn the call over to Molly to provide a more detailed financial update. Molly, please go ahead.

Thank you, Phil. As is our practice, I will only go over the most significant items in our financial statement. Revenues, research and development expenses, general and administrative expenses, non-operating income, net loss, and cash. I invite you to review the 6K that we found this morning that contains our financials and press release. Revenues for the three months ended March 31st, 2026 were $0.5 million, an increase of $0.2 million, compared to revenues of $0.3 million for the three months ended March 31st, 2025. The increase in revenues from 2025 to 2026 reflects an increase in royalties paid by EIRMIT from the commercialization of APEXTA. Research and development expenses for the three months ended March 31st, 2026, were $2.5 million, an increase of $0.9 million, compared to $1.6 million for the three months ended March 31st, 2025. The increase resulted primarily from expenses related to the new GLIX-1 project. General administrative expenses for the three months ended March 31st, 2026 were $0.9 million, an increase of $0.1 million compared to $1 million for the three months ended March 31st, 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 non-operating income amounted to $0.5 million for the three months ended March 31st, 2026, compared to net non-operating income of $7.6 million for the three months ended March 31st, 2025. Non-operating income for the period remotely relates to non-cash carry value adjustments of warranted liabilities as a result of changes in the company's share price, offset by warranted operating expenses. Net loss for the quarter ended March 31st, 2026, was $2.6 million, compared to net income of $5.1 million for the quarter ended March 31st, 2025. In terms of cash, we ended the quarter with cash and equivalents of $17.4 million, which is sufficient to fund our operating plan and currently conjugated into the first half of 2027. And with that, I'll turn the curls back over to Phil.

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

Thank you. Ladies and gentlemen, at this time we will begin the question and answer session. If you would like to ask a question, please press star 1. If you would like to draw your question, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the numbers. Your questions will be pulled in the order they are received. Please stand by while we pull for your questions. The first question is from Justin Walsh of Jones Trading. Please go ahead.

Hi. Thanks for taking the question. Now that dosing is underway for the phase 1 to 8 trial, it would be great to hear your thoughts on the current development landscape in GDM and how challenging or competitive it is to involve patients in this population.

Yeah, hi, good morning. So, I mean, this is a, you know, sort of a wide open, you know, area right now. There are, you know, a number of, you know, 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, you know, the TT Fields device, but in GBM, if you're not a biological area, biologics or pharmaceuticals, therapeutics, they're just not that much. So we're not seeing any significant problem with recruitment at this point, and we don't expect any. Ella, would you like to add anything?

Yes, I would. Hi, Justin. It's Ella. Just to elaborate on what Phil is saying, you know that the current study is being performed in recurrent and progressive GBM patients. 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, you know, in terms of the recruitment for this study with this patient population, we don't see any issue with recruitment.

Great. Thank you for taking questions.

The next question is from Joe Pantinis of HC Waveridge. Please go ahead.

Good morning. This is Josh on for Joe. Thanks for taking our questions. So for our first one, could you provide an update on activation status at Northwestern and Moffitt? Are all three centers now open and screening and enrolling patients? And now that the first patient's been dosed with Glix1, are there any initial safety observations you're able to share with us?

Hi, 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, you know, 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 cannot be on the same.

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

Okay.

Thank you so much. Okay.

The next question is from John Van Der Moorten of Zaxi. Please go ahead.

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

Yeah, so hi, John. It's good to hear your voice as well. So, you know, we've already indicated that we expect to have an interim futility analysis sometime later this year when 40% of the and that's still on track, et cetera. As far as next steps, I think that we can't ignore the fact that there was new data from Revolution Medicine that has come out that may have a significant effect on the PDAC landscape at this point. And so, you know, obviously that's good news for the patients, but we are, you know, looking at what the signals, what signal we would like to see and what would support, you know, CXC bar 4 inhibition, you know, as sort of a backbone agnostic adjunct strategy across, you know, various treatment platforms because we expect, you know, probably the treatment platform, the treatment paradigm will be changing in the next couple of years. And so I think that we have to look at, you know, 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 FECSTA efforts, I was wondering if you could provide any metrics or just kind perhaps your discussions with Aramid because, you know, they're a private company and they don't really provide data, but just in terms of, you know, regions covered, sales professionals allocated to the product, also I have listed here peer coverage, marketing budget, digital strategies used, you know, kind of the general topics that, you know, one would think about when launching a product and, in the first few years of commercialization?

Yeah, I mean, those are really good questions. And, you know, I mean, there's very little I can give you any detail about. You know, we're not giving guidance on what AirMid is doing. But I will say I can point out to the fact that, as I mentioned on the call, the sales have affected in this E1 2021. significantly increased from I think $1.3 or $1.4 million last year to $2.5 million this year. So this, you know, is I think at least from our perspective is good news because we're seeing, you know, after sort of the year that we did the initial launch and then they took over for us and then sort of, you know, it took them a while to get things moving. And so I think from our perspective this is very good news because it shows you know, a significant increase from last year and we hope that this will sort of be the, you know, sort of be the new, you know, the new line, so to speak, or the new curve going up, you know, for the future. That's really all, you know, I can say at this point, you know, regarding effects of sales.

Okay. Thanks, Phil. And then last question on GLICS 1, you know, you put out some discussions on the preclinical data that's going to be presented later. and one of the metrics was I think up to 2,000 milligrams per gig were used in rats. What dose level do you think would be the absolute maximum in the clinical trials?

We haven't disclosed the doses yet.

Yeah, I'm sorry. We haven't disclosed the doses at this point. So there's not much that we can tell you. There are, I think, you know, 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, you know, primarily from, you know, a trade secret perspective at this point.

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

Just to elaborate on that, you referred to dose of 2,000 milligrams in red in terms of the safety, so this gives us, In any case, a huge safety margin with regards to those that's expected to be given in the clinic.

So we have... Right, and that was my thought. I mean, maybe it's, you know, 100 or 1,000 times what it might be. I guess that's what I was trying to get a sense for.

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

Okay. Thank you, Ella. Appreciate it.

Thank you.

If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. There are no further questions at this time. Before I ask Mr. Phil Sterling to go ahead with his closing statement, I would like to remind participants that a paper of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 03-9255-904. Internationally, please call 972-3925-5904. Mr. Sterling, would you like to make a 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.