BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter and full year 2025 financial results conference call. All participants are presently in a listen-only mode. Following management's formal presentation, instructions will begin for the question and answer session. I would now like to turn over the call to Irina Koffler, investor relations. Irina, please go ahead.

Thank you, Operator, and welcome, everyone. Thank you for joining us on our annual 2025 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 you 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 quarterly reports on Form 6K that are filed to 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, Irina, 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 Zevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Serrani, our Chief Development Officer, is also available for Q&A. I would like to begin this morning with an update on GLICS 1, a highly innovative molecule for the treatment of glioblastoma and other cancers that we brought into our pipeline through our collaboration with Hemispherion. As a reminder, GLIX-1 is a first-in-class oral small molecule with a novel mechanism of action applicable to a broad range of cancers. By restoring TET2 activity, GLIX-1 selectively targets DNA damage repair in cancer cells only. GBM 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. In extensive preclinical studies, including in vivo GBM models, GLIX1 demonstrated potent anti-tumor activity and excellent blood-brain barrier penetration, combined with a favorable safety profile in toxicology studies. The FDA approved hemispherian investigational new drug, or IMD, application last August, and I am pleased to report that we are on track to initiate the first in human Phase 1-2A glioblastoma trial by the end of this month, and we anticipate that patient treatment will commence shortly thereafter. I'd also note that GLICS-1 has also been granted orphan drug designation by both the FDA and the European Medicines Agency. which is accompanied by an expedited review process and other financial and market exclusivity benefits. 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. The objective is to establish a maximum tolerated dose and or recommended dose based on safety, PKPV, and preliminary efficacy. Data from the phase one part of the trial are anticipated in the first half of next year. The Phase 2A expansion part of the trial is planned to include various population cohorts, including GBM, both newly diagnosed and or recurrent, as well as additional cancers with or without standard of care, for example, PARP inhibitors. These cohorts are expected to identify preliminary efficacy, PD assessment, and dose optimization data, serving as the basis for a rapid and effective advanced clinical development program. Three renowned academic centers will ultimately participate in this clinical trial. The first center ready to start enrolling patients is NYU Langone Health, led by Dr. Alexandra Miller. This will be followed by Northwestern University, led by Dr. Roger Stoop and Dr. Dita Primdahl, and by Moffitt Cancer Center, led by Dr. Patrick Grogan. In parallel, we will continue to conduct preclinical activities in support of further development of Glix1 in additional cancer indications with high unmet needs. And separately, we're also conducting studies to further investigate and affirm the potential synergistic effect of Glix1 in combination with PARP inhibitors as we work to maximize the value of the Glix1 opportunity. As we have stated previously, the unmet need in glioblastoma is significant. GBM is the most common and aggressive form of primary brain cancer. The current standard of care treatment was established in 2005, with only limited further advancement since. Treatment includes surgical resection, followed by radiotherapy and concomitant and adjuvant chemotherapy, temozolomide. Yet most patients will succumb to their disease within less than 18 months. The median overall survival is between 12 and 18 months. GBM occurs at all ages but peaks with individuals in their 50s and 60s with an increased 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. 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 plus 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 already talked about Glix1's unique mechanism of action as well as the fact that we believe this novel molecule has potential clinical utility across a range of cancers. To that end, we were very pleased to announce in November that we received a notice of allowance from the USPTO for a key patent covering the use of Glix1 for the treatment of all cancers in which cytidine deaminase, or CDA, is not overexpressed beyond a specific threshold. This new patent provides patent protection through 2040, not including a possible patent term extension of up to five years. It is estimated that as many as 90% of all cancers, Both solid tumor and hematologic cancers fall into this category, and we have already seen encouraging preclinical results in other cancers in which GLIX1 has been evaluated. So while glioblastoma is our initial indication, as previously mentioned, we are planning to expand the development of GLIX1 into additional planned cancer indications once safety and dosing are successfully established in patients. In this regard, we will continue to advance preclinical work in other cancers in parallel with our glioblastoma study. We believe the versatility of GLTS-1 provides us with multiple opportunities to advance patient care while creating value for our company and its shareholders. In addition to the pending U.S. patent just referenced, GLTS-1 is covered by two additional key patent families covering its use alone and in combination with established anti-cancer agents. both of which provide patent protection to at least 2040, not including potential patent term extensions. We are very 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 range of high unmet need cancers. Turning now to pancreatic cancer, or PDAC, recall that we retained the rights to develop a tixoportide in PDAC as part of the Aramid Out Licensing Agreement, and we continue to support its ongoing development in this indication. Recall that Columbia University, supported by both Regeneron and BioLineRx, is executing a randomized Phase IIb clinical trial known as Chemo4MedPANC, and we are pleased to report that enrollment in this trial has accelerated. This trial is evaluating metixoportide in combination with the PD-1 inhibitor zimiplumab and standard chemotherapies, gemcitabine and napaclitaxel. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed, and we anticipate this analysis will occur this year. Results from this trial, if positive, could be a significant value inflection point for our company and signal new hope for patients suffering from this very challenging tumor type. We look forward to keeping you up to date on our progress with this important program. In terms of cash, our balance sheet remains strong. We ended the year with cash in equivalence of approximately $21 million, which is sufficient to fund our operating plan as currently contemplated into the first half of 2027. We also have the potential benefit of royalties and milestone-driven revenue from our license agreements with both Airmint and Gloria Biosciences. We remain a very lean organization following the shutdown of our commercialization operations in the U.S. and our focus on development. I'd now like to briefly touch on Fexted's performance. The Airmint team continues to push a Fexted option, generating sales of $6.5 million in 2025. which resulted in $1.2 million of royalty revenue to BioLine Rx. We remain hopeful about the role that Effecsta can play in the new multiple myeloma treatment paradigm, and we look forward to growth in the future. Turning now to sickle cell disease, recall that when we executed the Aramid Outlicensing Agreement, they obtained not only the rights to commercialize Effecsta in stem cell mobilization for multiple myeloma, but also the rights to develop Metixifortide across all other indications. excluding solid tumor indications, and in territories other than Asia. This includes the evaluation of a tixoportide in sickle cell disease, specifically as a mobilization agent for gene therapies in this indication. The current standard of care mobilization agent, GCSF, is contraindicated in patients with sickle cell disease, so there is an urgent need for an agent that can reliably produce the very large quantities of stem cells that manufacturing and transplantation require in this indication, around 20 million CD34 positive cells per kilogram, without further burdening already constrained aporesis capacity. A phase one investigator-initiated trial sponsored by Washington University School of Medicine recently concluded, and we were very pleased to announce that a poster detailing final positive results from this proof of concept study was presented at the most recent ASH annual meeting in December. The trial, which enrolled 10 patients, evaluated metixiportide both as monotherapy and in combination with natalizumab for the mobilization of hematopoietic stem cells for gene therapies in sickle cell disease. The study demonstrated that metixiportide alone and in combination with natalizumab was safe and well-tolerated, and that metixiportide alone and in combination with natalizumab demonstrated robust hematopoietic stem cell mobilization to the poor full blood, resulting in high collection yields. Furthermore, in two subjects who had previously undergone mobilization with plurixifor, motixifortide alone and in combination with natalizumab resulted in nearly 3x greater mobilization and subsequent collection yields of stem cells compared to plurixifor. In conclusion, this trial demonstrated the potential of motixifortide alone and in combination with natalizumab as a novel GCSF-free regimen to safely optimize hematopoietic stem cell mobilization in sickle cell disease. A second sickle cell disease study hematic support site sponsored by St. Jude's Children's Research Hospital continues to enroll patients. Before turning the call over to Molly to review the financials, I would like to provide a very positive update on a legal matter. In June of 2024, BioKind Therapeutics, from whom we licensed the rights to metixoportide, filed a complaint against us in the District Court of Jerusalem alleging breach of contract and a purported failure to make certain payments to Biokine under our licensing agreement. The complaint, as amended, sought $7.2 million and a declaratory judgment in favor of Biokine. In November 2024, we and Biokine entered into an agreement to refer the dispute to binding arbitration. Last month, the arbitrator issued a final award in favor of BioLine Rx, denying any and all claims asserted against us by BioKind and awarding reimbursement of all expenses, including legal fees, to BioLine Rx. Needless to say, we are very pleased with this resolution, which removes a financial overhang and allows us to concentrate our resources fully on the ongoing development of GLICS 1. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.