BioLineRx Q2 2026 Earnings Report

BioLineRx EPS Results

• Actual EPS: N/A
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

BioLineRx Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

BioLineRx Announcement Details

• Quarter: Q2 2026
• Date: 8/14/2026
• Time: Before Market Opens
• Conference Call Date: N/A
• Conference Call Time: N/A

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 Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: GLIX1 clinical trial progressing on plan: The Phase I/IIa study in glioblastoma began dosing its second of five planned cohorts, with the third expected to start in September; management reported encouraging safety and tolerability and still expects Phase I data in the first half of 2027.
• Positive Sentiment: New preclinical results showed strong GLIX1 activity in glioblastoma models, including a temozolomide-resistant model, while a low-dose GLIX1–olaparib combination produced substantially better results than either monotherapy in an HR-proficient ovarian cancer model. The company plans an ovarian cancer expansion cohort and has begun discussions with PARP inhibitor developers.
• Neutral Sentiment: The CheMo4METPANC Phase IIb pancreatic cancer trial of motixafortide, cemiplimab and chemotherapy continues to enroll well, with an interim futility analysis expected later this year. Management acknowledged that the recent approval of a competing KRAS-targeted therapy could affect the treatment landscape but said it still sees a role for CXCR4 inhibition.
• Negative Sentiment: BioLineRx ended the quarter with $13.1 million in cash, expected to fund operations into the first half of 2027, but reported a $4.3 million quarterly net loss and announced a $3.75 million registered direct offering, which adds near-term dilution risk. APHEXDA generated $1.6 million in quarterly sales and $0.3 million in royalty revenue, although adoption remains dependent on gradually changing transplant-center practices.

Presentation

[Operator]

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second 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 the call over to Chuck Padala, Investor Relations. 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 Form 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, and 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'd like to begin this morning with an update on GLIX1, our highly innovative molecule for the treatment of glioblastoma and other cancers, which we obtained through our collaboration with Hemispherian. GLIX1 is an oral first-in-class small molecule with a novel mechanism of action designed to activate the TET2 enzyme and drive tumor DNA damage. By restoring TET2 activity, GLIX1 selectively induces DNA damage in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors.

[Phil Serlin, CEO at BioLineRx]

Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. GBM remains one of the most aggressive and treatment-resistant cancers, and there is an urgent need for breakthrough innovation and more effective treatment options. We believe GLIX1's differentiation is reflected in its excellent blood-brain barrier penetration, its cytotoxicity to patient-derived neurospheres glioma stem cells, its efficaciousness in numerous orthotopic GBM models, and a temozolomide-resistant PDX model. The fact that it does not rely on the immune system and its very clean safety profile shown in animal toxicity studies, which should allow for longer treatment durations and combination treatment. We initiated our phase I/IIa clinical trial of GLIX1 in glioblastoma and other high-grade gliomas in March, and the first patient was dosed in April at NYU Langone Health under the supervision of Dr. Alexandra Miller.

[Phil Serlin, CEO at BioLineRx]

Two additional academic centers, Northwestern University, led by Dr. Roger Stupp and Dr. Dina Pryma, and Moffitt Cancer Center, led by Dr. Patrick Grogan, have also enrolled patients in the phase I part of this study. I am pleased to report that recruitment to the study is going extremely well and the trial continues to progress according to plan. Last month, dosing commenced in the second of five planned cohorts in phase I, and the third cohort is expected to commence dosing in September. To date, a little more than four months into the study, we have been very pleased with the drug safety and tolerability.

[Phil Serlin, CEO at BioLineRx]

As a reminder, 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, with the objective of establishing a maximum tolerated dose and/or recommended dose based on safety, PK/PD, and preliminary efficacy. We continue to anticipate phase I data in the first half of 2027. The phase IIa expansion part of the trial is planned to include additional cohorts, including GBM, newly diagnosed and/or recurrent, as well as additional cancers with or without standard of care, for example, PARP inhibitors. The study was accepted for presentation at the European Association of Neuro-Oncology, EANO 2026 Conference and at the Society for Neuro-Oncology, SNO 2026 Annual Meeting. In May, we were very encouraged to report new preclinical data demonstrating potent antitumor effect of GLIX1 in GBM across multiple in vivo studies, including a temozolomide-resistant patient-derived xenograft model.

[Phil Serlin, CEO at BioLineRx]

In three orthotopic cell-derived xenograft or CDX GBM models, GLIX1 produced significant tumor growth inhibition and survival benefit across all doses tested with greater benefit at higher dose levels. Notably, we also completed a subcutaneous temozolomide-resistant patient-derived xenograft or PDX GBM model. In that model, GLIX1 demonstrated a robust antitumor effect, while temozolomide, the current standard of care chemotherapy, showed no effect. These results further support GLIX1's potential to treat a broad range of patients with GBM, including those that do not respond to temozolomide. These results will also be presented at the EANO 2026 and SNO 2026 conferences. In July, we announced highly encouraging new preclinical data demonstrating strong synergy between GLIX1 and the PARP inhibitor olaparib in a patient-derived xenograft model of HR-proficient ovarian cancer, a setting where PARP inhibitors have historically shown limited efficacy.

[Phil Serlin, CEO at BioLineRx]

The study included six arms, cisplatin, GLIX1 monotherapy, and olaparib monotherapy, each at their expected optimal doses, as well as a low-dose GLIX1 arm, a low-dose GLIX1 olaparib combination arm, and a control arm. The low-dose GLIX1 olaparib combination arm showed substantially better efficacy than the control arm and versus either molecule as monotherapy, despite using lower doses of each agent in the combination. The combination also achieved tumor reduction comparable to cisplatin, the current chemotherapy benchmark in this setting. These results reinforce the synthetic lethality between GLIX1 and PARP inhibitors and support our plan to include an ovarian cancer arm in the phase IIa expansion part of our ongoing study.

[Phil Serlin, CEO at BioLineRx]

Looking ahead, we look forward to presenting our data on GLIX1 and PARP inhibitor synergy across HR-proficient ovarian cancer lines, as well as the PDX model at the ESMO Annual Conference in Madrid this October, where the abstract has been accepted for a presentation. Given these data on synergy, we have also commenced initial discussions with several leading developers of PARP inhibitors regarding potential collaborations leveraging GLIX1. As we have said before, but it bears repeating, the unmet need in glioblastoma remains significant. It is the most common and aggressive form of primary brain cancer, occurring at all ages, but peaking in patients in their 50s and 60s, with incidence increasing alongside an aging global population. The current standard of care was established more than 20 years ago, with only limited improvements since. Median survival following diagnosis remains approximately 12 to 18 months.

[Phil Serlin, CEO at BioLineRx]

By 2030, annual GBM incidence is expected to reach over 18,000 patients in the U.S. and over 13,000 across the EU4+UK, representing a combined total addressable market of more than $3.7 billion in the U.S. and Europe alone. We continue to view this as a wide-open market with few competitors. We remain very encouraged by the progress of the GLIX program this quarter, both in the clinic and across our expanding preclinical data set, and we look forward to keeping you apprised of our progress as we advance its development across a range of cancers. Turning now to pancreatic cancer or PDAC. Recall that we retained the rights to motixafortide in PDAC as part of the Ayrmid out-licensing agreement, and we continue to support its ongoing development in this indication.

[Phil Serlin, CEO at BioLineRx]

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. As noted previously, a pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, expected 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 $1.6 million in the second quarter of 2026, which resulted in $0.3 million of royalty revenue to BioLineRx. In terms of cash, we ended the quarter with cash and equivalents of $13.1 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027.

[Phil Serlin, CEO at BioLineRx]

This past Friday, we announced a $3.75 million offering, which is expected to close later today. We also have the benefit of non-dilutive funding from the royalties and milestone-driven revenue from our license agreements with both Ayrmid and Gloria Biosciences. Now, let me turn the call over to Mali to provide a 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 statements. Revenues, research and development expenses, general and administrative expenses, non-operating expenses, 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 June 30, 2026, were $0.3 million, similar to the three months ended June 30, 2025. Revenues in both periods primarily reflect royalties earned on Ayrmid Gamida Cell's product sales of APHEXDA. Research and development expenses for the three months ended June 30, 2026, were $2.9 million, an increase of $0.6 million compared to $2.3 million for the comparable 2025 period. The increase resulted primarily from expenses related to the new GLIX1 project, offset by lower expenses related to motixafortide.

[Mali Zeevi, CFO at BioLineRx]

General and administrative expenses for the three months ended June 30, 2026, were $0.9 million, an increase of $0.7 million compared to $0.2 million for the comparable 2025 period. The increase resulted from a reversal of a $0.8 million provision for a doubtful account in the 2025 period following receipt of an overdue milestone payment from Gloria Biosciences. Without regard to this reversal, G&A expenses were slightly lower in 2026 as compared to 2025. Non-operating expenses amounted to $0.7 million for the three months ended June 30, 2026, compared to non-operating expenses of $1.9 million for the same period in 2025.

[Mali Zeevi, CFO at BioLineRx]

Non-operating expenses for both periods primarily relates to fair value adjustment of warrant liabilities on the company's balance sheet. Net loss for the quarter ended June 30, 2026, was $4.3 million, compared to net loss of $3.9 million for the 2025 quarter. As of June 30, 2026, the company had cash equivalents, and short-term bank deposits of $13.1 million, sufficient to fund operations as currently planned into the first half of 2027. As mentioned, subsequent to the balance sheet date, the company raised an additional $3.75 million in a registered direct offering. 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. 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 one. To withdraw your question, please press star two. If you are using speaker equipment, kindly leave the handset before pressing the numbers. Your questions will be pulled in the order they are received. Please stand by while we pull for your question. The first question is from John Vandermosten of Zacks. Please go ahead.

[John Vandermosten, Analyst at Zacks]

Great. Thank you for taking my questions. I guess I'll start out with the GLIX1 and PARP inhibitor synergies that you announced. Based on what you're seeing now, how would that be positioned in ovarian cancer? What setting and line of therapy is appropriate for what you're seeing so far in this early stage?

[Phil Serlin, CEO at BioLineRx]

Hi, John. How are you? I'll let Ella take that question.

[Ella Sorani, Chief Development Officer at BioLineRx]

Yes. Hi, John. Thank you for the question. I think it's the model-tested combination between GLIX and PARP inhibitor at suboptimal concentration compared to monotherapy of each of the arms, and also compared to the chemotherapy monotherapy cisplatin. The combination was better than the control, better than the monotherapies at higher doses, and similar to the effect of cisplatin. As you know, currently, PARP inhibitors are Yes, and this was in HR-proficient patient-derived xenograft model. Currently, PARP inhibitors are approved as maintenance therapy following standard of care, which is resection and then chemotherapy, and then PARP inhibitor as maintenance. This gives us various options with regards to the clinical development plan for this combination.

[Ella Sorani, Chief Development Officer at BioLineRx]

But I think at this stage it's a bit too premature, and we're having still discussions with the ovarian key opinion leaders in order to better tailor the best way forward with this potential combination.

[John Vandermosten, Analyst at Zacks]

Okay. Thank you, Ella. I appreciate that insight. Yes, I know it's early, but it's good to hear your thoughts on how you're approaching that. Then we saw an approval recently, Revolution Medicines' daraxonrasib, and I'm wondering, does that change your approach on the CheMo4METPANC objectives at all?

[Phil Serlin, CEO at BioLineRx]

Yeah. So I think we've spoken about this before. We acknowledge this is going to potentially change the treatment landscape in pancreatic cancer. I think that we still feel that there's a role for motixafortide for CXCR4 inhibition. Right now, we're looking forward to seeing the interim futility analysis coming up, and then we can continue to push forward on the study, and once we see some of the results, then we can make a decision where best to go. But we do believe that there will still be room for other treatments, other combinations in PDAC. There's still a lot of room for a lot of unmet medical need.

[John Vandermosten, Analyst at Zacks]

Understood. Yeah, definitely. Then, final question on APHEXDA. I know you're not on the ground there. Ayrmid is doing that work, and they probably don't share all the details with you. But I'm just wondering, larger picture, have they continued to penetrate into transplant centers? Then the competitive environment, has that materially changed, I guess, with the generics out there for alternatives?

[Phil Serlin, CEO at BioLineRx]

Well, first of all, I think just overall, we cannot give much guidance on what is going on. Ayrmid is doing the sales. But even when we launched the product in 2024, many generics were on the market. We did not find necessarily that the price was the main impediment, so to speak. I think this is an area where it just takes a lot of work to change the treatment paradigm in general, et cetera. I think even if you look at Plerixafor for when it was first approved, it took them several years to accelerate their sales. This is an area where it takes a lot of work, like I said, to change the standard operating procedures, et cetera, at the transplant centers. But they are putting all their efforts into it, and I think that we are optimistic as we look down the road.

[John Vandermosten, Analyst at Zacks]

All right. Thank you, Phil. Thanks to Ella and Mali, too. Take care, you guys.

[Phil Serlin, CEO at BioLineRx]

John, have a great day.

[Operator]

If there are any additional questions, please press star one. To withdraw your question, please press star two. Please stand by while we pull for more questions. 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 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 9723-9255-904. Mr. Serlin, would you like to make a concluding statement?

[Phil Serlin, CEO at BioLineRx]

Yes. Thank you, operator. In closing, we remain very excited about our recent progress and believe we are well positioned 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 this year and beyond. Thank you all very much for your continued interest in BioLineRx. Be safe and have a great day.

[Operator]

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

Participants

Executives

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

Analysts

• Chuck Padala, Investor Relations Officer at LifeSci Advisors
• John Vandermosten, Analyst at Zacks