BioLineRx Q1 2026 Earnings Report

BioLineRx EPS Results

• Actual EPS: -$0.36
• Consensus EPS: -$1.04
• Beat/Miss: Beat by +$0.68
• One Year Ago EPS: N/A

BioLineRx Revenue Results

• Actual Revenue: $0.48 million
• Expected Revenue: $0.34 million
• Beat/Miss: Beat by +$134.00 thousand
• YoY Revenue Growth: N/A

BioLineRx Announcement Details

• Quarter: Q1 2026
• Date: 5/27/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, May 27, 2026
• Conference Call Time: 8:30AM ET

BioLineRx (NASDAQ:BLRX) (NASDAQ: BLRX) is a clinical-stage biopharmaceutical company that discovers and develops novel small-molecule therapies to address unmet medical needs. The company focuses on identifying promising drug candidates through licensing and collaboration agreements with academic institutions and biotech innovators, then advancing these candidates through preclinical and clinical development stages. BioLineRx’s pipeline spans oncology, immunology and inflammatory diseases, central nervous system disorders and pain management.

Among its clinical programs, BioLineRx is advancing targeted cancer therapies designed to improve outcomes for patients with difficult-to-treat tumors. In immunology and inflammatory diseases, the company is developing novel agents that modulate key biological pathways to reduce disease activity with minimal side effects. BioLineRx also explores treatments for neuropathic pain and other central nervous system conditions, seeking to offer new therapeutic options where few effective treatments exist.

Headquartered in Modi’in, Israel, BioLineRx maintains strategic partnerships and licensing arrangements across North America, Europe and Asia to support its global development efforts. By leveraging a business model that combines in-licensing, co-development and out-licensing of assets, the company aims to maximize the value of its pipeline while managing development risk. BioLineRx collaborates with contract research organizations and clinical centers worldwide to conduct multi-site trials and accelerate the advancement of its drug candidates.

BioLineRx Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: BioLineRx highlighted continued progress for GLIX1, including the start of its first-in-human Phase I/IIa trial in GBM and the first patient already dosed at NYU Langone. The company said additional sites at Northwestern and Moffitt will join the study soon.
• Positive Sentiment: Management emphasized encouraging preclinical GLIX1 data, including dose-dependent tumor growth inhibition, survival benefit, and activity in temozolomide-resistant GBM models. They also noted a strong safety margin from tox studies and a rationale for combining GLIX1 with PARP inhibitors.
• Neutral Sentiment: The company expects to provide periodic GLIX1 clinical updates in the second half of 2026, with full dose-escalation results expected in 2027. The Phase IIa expansion is planned to explore additional cancers and combination regimens.
• Positive Sentiment: APHEXDA royalties and sales improved, with Q1 2026 sales of $2.5 million versus $1.4 million a year ago, generating $0.5 million in royalty revenue for BioLineRx. Management said it views the uptick as evidence of stronger commercial momentum.
• Neutral Sentiment: BioLineRx’s cash and equivalents totaled $17.4 million at quarter-end, which it said should fund the current operating plan into the first half of 2027. The company also noted the pancreatic cancer trial’s interim futility readout remains expected later this year.

Presentation

[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 Officer at LifeSci Advisors]

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, CEO at 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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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.

[Phil Serlin, CEO at BioLineRx]

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, CFO at 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.

[Mali Zeevi, CFO at BioLineRx]

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.

[Mali Zeevi, CFO at BioLineRx]

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, CEO at 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 at 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, CEO at 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 at 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 at JonesTrading]

Great. Thanks for taking the question.

[Operator]

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

[Analyst at 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, CEO at 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 at BioLineRx]

If you can update on the sales.

[Phil Serlin, CEO at 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.

[Analyst at H.C. Wainwright]

Okay. Thank you so much.

[Phil Serlin, CEO at BioLineRx]

Okay.

[Operator]

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

[John Vandermosten, Analyst at Zacks]

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, CEO at 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.

[Phil Serlin, CEO at BioLineRx]

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 at Zacks]

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, CEO at 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.

[Phil Serlin, CEO at BioLineRx]

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 at Zacks]

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 at BioLineRx]

We haven't disclosed the doses yet.

[Phil Serlin, CEO at 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 at Zacks]

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

[Ella Sorani, Chief Development Officer at 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 at Zacks]

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 at 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 at Zacks]

Okay. Thank you, Ella. Appreciate it.

[Ella Sorani, Chief Development Officer at 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, CEO at 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.

Participants

Executives

• Ella Sorani, Chief Development Officer
• Mali Zeevi, CFO
• Phil Serlin, CEO

Analysts

• Chuck Padala, Investor Relations Officer at LifeSci Advisors
• John Vandermosten, Analyst at Zacks
• Justin Walsh, Analyst at JonesTrading
• Analyst at H.C. Wainwright