BioLineRx Q1 2026 Earnings Call - GLIX1 First Patient Dosed in Glioblastoma Trial as Cash Runs Dry

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2026 financial results conference call. All participants are presently in a listen-only mode. Following management’s formal presentation, instructions will be given for the question and answer session. For operator assistance during the conference, please press star zero. I would now like to turn over the call to Chuck Padala, investor relations. Chuck, please go ahead.

Chuck Padala, Investor Relations, BioLineRx: 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.

Phil Serlin, Chief Executive Officer, BioLineRx: Thank you, Chuck Padala. Good morning, everyone. Thank you for joining us on today’s call. As has been our practice, I will begin with a few prepared remarks before turning the call over to Mali Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with an update on GLIX1, a highly innovative molecule for the treatment of glioblastoma, or GBM, and other cancers that we obtained through our collaboration with Hemispherian.

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

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

Glioblastoma was selected as the first indication for GLIX1 due to the low level of TET2 activity in this aggressive brain cancer, for which there remains a high unmet medical need for novel and more effective treatments. GLIX1 has demonstrated its ability to cross the blood-brain barrier, which is a highly significant differentiator for treating GBM and gives us hope that it may show effect where others have failed in this exceedingly difficult indication. Expanding upon our extensive preclinical work, we were very excited to announce just last week new data demonstrating that GLIX1 achieved robust dose-dependent tumor growth inhibition and survival benefit in several studies in two orthotopic cell-derived xenograft, or CDX, models in GBM. In a newly completed subcutaneous temozolomide-resistant patient-derived xenograft, or PDX, model in GBM, GLIX1 demonstrated a robust anti-tumor effect, while no effect was observed with temozolomide.

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

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

Treatment includes surgical resection followed by radiotherapy and concomitant and adjuvant chemotherapy, as-mentioned temozolomide. The prognosis for patients is poor, with median survival of approximately 12 to 18 months following diagnosis. By 2030, the annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and approximately 13,500 patients across the EU4 +1; France, Germany, Italy, Spain, and the United Kingdom. This translates into total addressable markets across both the newly diagnosed and recurrent settings of more than $3.7 billion in the U.S. and Europe alone. We view this as a wide-open market with few competitors. We are incredibly pleased to have brought this highly innovative molecule into our pipeline, and we look forward to keeping you apprised of our progress as we pursue its development in a wide range of cancers. Turning now to pancreatic cancer or PDAC.

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

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

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

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

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

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

Phil Serlin, Chief Executive Officer, BioLineRx: Thank you, Mali, and thank you to everyone joining this call. Operator, we will now open the call to questions.

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

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

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

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

Justin Walsh, Analyst, JonesTrading: Great. Thanks for taking the question.

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

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

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

Ella Sorani, Chief Development Officer, BioLineRx: If you can update on the sales.

Phil Serlin, Chief Executive Officer, BioLineRx: Yeah, we can’t really do that, I’m sorry. We do plan to give periodic updates and not wait until the very end, but right now there’s nothing really we can say.

Josh Pantginis, Analyst, H.C. Wainwright: Okay. Thank you so much.

Phil Serlin, Chief Executive Officer, BioLineRx: Okay.

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

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

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

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

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

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

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

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

Ella Sorani, Chief Development Officer, BioLineRx: We haven’t disclosed the doses yet.

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

John Vandermosten, Analyst, Lux: Okay. Well, we’ll keep our eyes open for updates on the GLIX1 trial.

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

John Vandermosten, Analyst, Lux: Right. That was my thought. Maybe it’s 100 or 1,000 times what it might be. I guess that’s what I was trying to get a sense for.

Ella Sorani, Chief Development Officer, BioLineRx: 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.

John Vandermosten, Analyst, Lux: Okay. Thank you, Ella. Appreciate it.

Ella Sorani, Chief Development Officer, BioLineRx: Thank you.

Operator: Before I ask Mr. Philip Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin 2 hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 03-925-5904. Internationally, please call 972-3-925-5904. Mr. Serlin, would you like to make your concluding statement?

Phil Serlin, Chief Executive Officer, BioLineRx: 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.

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