BioLineRx Ltd. (BLRX) Q2 2026 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] I would now like to turn the call over to Chuck Padala, Investor Relations. 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 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.

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 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. 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, and 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. Two additional academic centers, Northwestern University led by Dr. Roger Stupp and Dr. Ditte Primdahl 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 5 planned cohorts in Phase I, and the third cohort is expected to commence dosing in September. To date, a little more than 4 months into the study, we have been very pleased with the drug's safety and tolerability. 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. In 3 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. The study included 6 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. 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 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 incidents increasing alongside an aging global population. The current standard of care was established more than 20 years ago with only limited improvement since. Median survival following diagnosis remains approximately 12 to 18 months. By 2030, annual GBM incidence is expected to reach over 18,000 patients in the U.S. and over 13,000 across the EU 4+1, 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 GLIX1 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 this development across a 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 IIb clinical trial known as chemo for 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 prespecified 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 royal revenue -- 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. And this past Friday, we announced a $3.75 million offering, which is expected to close later today. We also have the benefit of nondilutive 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.

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, nonoperating 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 3 months ended June 30, 2026, were $0.3 million, similar to the 3 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 3 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. General and administrative expenses for the 3 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 doubtful account in the 2025 period following receipt of an overdue milestone payment from Gloria. Without regard to this reversal, G&A expenses were slightly lower in 2026 as compared to 2025. Nonoperating expenses amounted to $0.7 million for the 3 months ended June 30, 2026, compared to nonoperating expenses of $1.9 million for the same period in 2025. Nonoperating expenses for both periods primarily related 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, 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. And with that, I'll turn the call back over to Phil.

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

[Operator Instructions] The first question is from John Vandermosten of Zacks.

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

I'll let Ella take that question.

John, thank you for the question. So I think it's -- the model tested combination between GLIX1 and PARP inhibitors at suboptimal concentration compared to monotherapy of each of the arms and also compared to the chemotherapy monotherapy cisplatin. And 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 an 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. So this gives us various options with regards to the clinical development plan with -- for this combination. 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.

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

Yes. So I mean, we've -- I think we've spoken about this before. We acknowledge this is going to potentially change the treatment landscape in pancreatic cancer. And I think that we still feel that there's a role for motixafortide and for CXCR4 inhibition. And 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. It's not -- it's -- there's still a lot of room -- a lot of unmet medical need.

Understood. Yes, definitely. And 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? And then the competitive environment, has that materially changed, I guess, with the generics out there for alternatives?

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

[Operator Instructions] 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 2 hours after the conference. In the U.S., please call 1 (888) 295-2634. In Israel, please call (03) 9255-904. Internationally, please call 972-3-9255-904. Mr. Serlin, would you like to make a concluding statement?

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'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.

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