BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second quarter 2026 financial results conference call. Our 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 Falada, 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 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 portal 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 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 Hemispheria. Glix1 is an oral, first-in-class small molecule with a novel mechanism of action designed to activate the TEN2 enzyme and drive tumor DNA damage. By restoring TEN2 activity, Glyx1 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 is 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 Glix-1'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 its hemazolamide-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 1-2A clinical trial of Mx1 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 Stoop and Dr. Dina Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Rogan, have also enrolled patients in the Phase 1 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 plant cohorts in Phase 1. 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. As a reminder, the phase one 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 We continue to anticipate Phase 1 data in the first half of 2027. The Phase 2A 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, in May, we were very encouraged to report new preclinical data demonstrating potent anti-tumor effect of Glix1 in GBM across multiple in vivo studies, including a temozolomide-resistant patient-derived xenograft model and three orthotopic cell-derived xenograft or CDX GBM models. Glyx-1 produced significant tumor growth inhibition and survival benefit across all doses tested with greater benefit at higher dose levels. Notably, we also completed the subcutaneous temozolomide resistant patient-derived xenograft or PDX-GBN model. In that model, Glyx-1 demonstrated a robust anti-tumor 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 gemozolomide. These results will also be presented at the ENO2026 and SNOW2026 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 six arms, cisplatin, Glix-1 monotherapy, and Olaparib monotherapy, each at their expected optimal doses, as well as a low-dose Glix-1 arm, a low-dose Glix-1 Olaparib combination arm, and a control arm. The low-dose Glix-1 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 Glyx1 and PARP inhibitors and support our plan to include an ovarian cancer arm in the phase 2a 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 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 improvement since. Median survival following diagnosis remains approximately 12 to 18 months. by 2030 annual GPM incidence is expected to reach over 18,000 patients in the US and over 13,000 across the EU 4 plus 1, representing a combined total addressable market of more than $3.7 billion in the US 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 GLCS program this quarter, both in the clinic and across our expanding pre-clinical 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 retain the rights to development to support the item PDAC as part of the air-mid-out licensing agreement, and we continue to support its ongoing development in the syndication. Columbia University, supported by both Regeneron and BioLineRx, is executing a randomized phase 2B clinical trial known as Chemo4MedPeg, and we are pleased to report that enrollment continues to track well. This trial is evaluating Quotixifortide in combination with the PD-1 inhibitor Planned for when 40% of progression-free survival events are observed, expected later this year. I'd now like to briefly touch on effects of this performance. The Airman team continues to make progress driving effects to 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 in equivalence of $13.1 million, which is sufficient to fund our operating plan as currently un-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 non-dilutive funding from the royalties and milestone-driven revenue from our license agreements with both Airman 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, non-operating expenses, net loss, and cash. I invite you to review the 6K 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 Airmid Gamida Cells product sales of Apexa. 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 GlixOne project, offset by lower expenses related to MotixSupportRate. 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. 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. Non-operating expenses for both periods primarily relate to fair value adjustment Net loss for the quarter ended June 30, 2026 with $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 Thank you Mali 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. To withdraw your question, please press star 2. If you are using speaker equipment, kindly lift 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 questions. The first question is from John Vandermosten of Zakt. Please go ahead.

Great.

Thank you. Taking my questions. I guess I'll start out with what the Glix-1 and PARP-I inhibitor synergies that you announced. So based on what you're seeing now, how would that be positioned in ovarian cancer? You know, what setting and line of therapy is appropriate for what you're seeing so far in this early stage?

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

Yes, hi John. Thank you for the question. So I think it's the model tested combination between Glyx and Pap inhibitor 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 similar to the effect of cisplatin. As you know, currently PARP inhibitors are yes, and this was in a HR proficient patient-derived paragraph model. Currently, PARP inhibitors are approved as maintenance therapy following a and then chemotherapy and then type inhibitor maintenance. So this gives us various options with regards to the clinical development plan for this combination, but I think at this stage it's a bit too premature, and we're having still discussions with the O'Brien key opinion leaders in order to better tailor the best way forward with this potential combination.

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. And then, you know, we saw an approval recently, Revolutions, and I'm wondering, does that change your approach on the chemo from that tank objectives at all?

Yeah, so I mean, I think we've spoken about this before. You know, we acknowledge that this is going to potentially change the, you know, the treatment landscape in pancreatic cancer. And I think that we still feel that there's a role for Metixin 4-Tidin for CXCR4 inhibition. and you know right now we're looking forward to seeing the interim futility analysis coming up and then we can you know continue to to push forward on the study and and once we see some of the results and we can make a decision you know we're best to go but we do believe that there will still be room for other treatments other combinations in BDAC it's not you know it's there's still a lot of room for a lot of unmet medical needs Understood, yeah, definitely.

And then, you know, final question on Afexta, you know, I know you're not on the ground there, you know, as Aramid is doing that work and they probably don't share all the details with you, but I'm just wondering, you know, larger picture, have they continued to penetrate into transplant centers and then, you know, the competitive environment, has that materially changed, I guess, with, you know, the generics out there for alternatives?

Well, you know, first of all, I think just overall, you know, we can't get much guidance on what's going on. You know, Aramid is doing the sales, but, you know, even in our, you know, even when we launched the product in 2024, there were already, you know, the generics were, many generics were on the market. We didn't find necessarily that the price was, you know, was the main, you know, 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, etc. I think even if you look at Plurixa 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, etc. at the TransMed Centers, but they're putting all their efforts into it, and, you know, I think that we're optimistic as we look down the road.

All right.

Thank you, Phil, and thanks, Ella and Mali, too. Take care, you guys. Well, have a great day.

If there are any additional questions, please press star 1. To withdraw your question, please press star 2. Please stand by when 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 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 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.

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