BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to BioLineRx first quarter 2025 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. I would now like to turn over the call to Irena Koffler, investor relations.

Irena, please go ahead. Thank you operator and welcome everyone. 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 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 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, 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 Molly Zebi, 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. In November of last year, we announced a transformational exclusive out-licensing agreement with Aramid Pharma Limited. The agreement gives Aramid the rights to commercialize effects that our FDA-approved stem cell mobilization agent indicated in combination with GCSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. The agreement covers all indications, excluding solid tumor indications, and in all territories other than Asia. In exchange, we received an upfront payment as well as potentially significant commercial milestones and royalties. Recall that we successfully shepherded Afexta, also known as Metixoportide, through clinical development and FDA approval in September 2023. We believe AirMid is the ideal partner for Afexta, given that team's track record of success. As a reminder, the current Aramid team established Amrit Bio in 2015 to focus on rare diseases, and in less than eight years, they grew Amrit revenue to an annual run rate of several hundred million dollars, ultimately selling the company for approximately $1.5 billion. In addition, the Aramid commercial portfolio also includes AmiSearch, the first and only FDA-approved nicotinamide NAM-modified cell therapy for patients with hematologic malignancies in need of a stem cell transplant. So the addition of Afexa is very complimentary. And while it has taken a few months to complete the transition, Afexa has returned to growth and is performing well under Aramid's stewardship. And I believe it will contribute incremental long-term value to our company through the potential milestones and royalties just mentioned. This transaction enabled us to return to our roots as a highly innovative company in complex drug development. with a very experienced team and a validated track record of clinical and regulatory success. Since that announcement, we have been laser focused on evaluating early clinical stage and late preclinical stage therapeutic assets in oncology and rare disease that will allow us to leverage our expertise in drug development and expand our pipeline. I am pleased to report that we continue to evaluate several promising candidates that fit our criteria. Importantly, the subsequent development of any candidates that we identify will have efficient and clearly defined clinical development paths and will be partly funded through milestones and royalties from our license agreements with Aramid as well as our previously announced agreement with Gloria Bio. We continue to conduct due diligence and advance discussions with a number of parties and I am optimistic that we'll make a definitive announcement later this year. The ARAMID agreement also covers ongoing development of effects in patients with sickle cell disease undergoing gene therapy. Stem cell mobilization is a challenge for many sickle cell disease patients, as currently available gene therapies for sickle cell disease rely on the collection of significant quantities of CD34 positive hematopoietic stem cells. And this collection process often requires multiple aphoresis sessions, which adds cost and complicates the patient journey. In addition, many patients are ineligible for stem cell transplantation because they are unable to mobilize the required numbers of cells for successful transplants. Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with sickle cell disease, and we eagerly await results from two phase one investigator-initiated trials that are ongoing. The first sickle cell disease trial is being sponsored by Washington University in St. Louis. An abstract detailing the initial results from this proof of concept study was presented at the 66th Annual American Society of Hematology Annual Meeting last December. The findings suggest that patients with sickle cell disease given metixifortide alone or in combination with natalizumab can mobilize and potentially collect the number of stem cells required for approved gene therapies in a single aporesis cycle. The second sickle cell disease trial is being sponsored by St. Jude Children's Research Hospital in Memphis and is being executed by some of the leading sickle cell disease researchers in the world. As a result of the AIRMID agreement and the transition of several members of the Form BioLine RX commercial team to AIRMID, late last year we announced the shutdown of our U.S. operations and we also implemented a headcount reduction in Israel where BioLine RX continues to be based. Together, these actions have allowed us to reduce our ongoing operating cash burn by over 70%, from over $40 million annually to less than $12 million as we entered 2025. Including a $10 million financing that we completed in January, we ended the first quarter on a firm financial footing with cash of $26.4 million and a cash runway projected to fund our operations through the second half of 2026. Turning now to pancreatic cancer, or PDAC, we are continuing to support the development of metixifortide in this indication. Recall that metixifortide is an inhibitor of CXCR4, which plays a critical role in establishing and maintaining tumors. It is highly expressed in over 20 different tumor types, and it is estimated that greater than 70% of PDAC patients show an overexpression of CXCR4. PD-1 and PD-L1 inhibitors have demonstrated significant efficacy in multiple solid tumor types, but no survival benefit in PDAC. In contrast, we previously completed a phase two trial in second line PDAC patients with metixivortide plus a PD-1 inhibitor plus standard of care chemotherapy that demonstrated improvements across all study endpoints. So while PDAC is an inherently challenging cancer to treat, there is very strong scientific rationale for continued development by us in this area. To that end, a randomized Phase IIb PDAC trial sponsored by Columbia University and supported by both Regeneron and BioLine RX, known as Chemo4MetPank, continues to enroll patients. To further accelerate enrollment, last quarter, Columbia activated additional trial sites, and the trial is planned to be fully enrolled in 2027. A pre-specified interim analysis is planned for when 40% of PFS events are observed, which is planned for 2026. 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. And staying on the topic of the Columbia University PDAC study for a moment, We were very pleased to announce that an abstract detailing new data from the pilot phase of the Chemo for MedPank trial has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology, or ASCO. The presentation will take place at 9 a.m. Central Daylight Time on Saturday, May 31st. Recall that in data previously presented, seven of the 11 patients in the pilot study experienced a partial response with six of those responses confirmed. That equates to a partial response rate of 64%, which compares very favorably to the historical partial response rate of 23%. 10 of 11 patients, or 91%, exhibited disease control, which also compares very favorably to a historic disease control rate of 48%. Additionally, median PFS progression pre-survival was 9.6 months compared to historic median PFS of 5.5 months. Notably, an analysis of the biopsy samples demonstrated a significant increase in CD8-positive T-cell density in tumors from all 11 patients treated, suggesting the ability of the Metixaportec combination to overcome the immunosuppressive mechanisms within the tumor microenvironment that render other treatments ineffective. In the updated data to be presented at ASCO on Saturday, four patients have now been progression-free for over a year. Two patients underwent definitive treatment for metastatic PDAC. One had complete resolution of all radiologically-detected liver lesions and underwent definitive radiations of the primary pancreatic tumor, while the other had a sustained partial response and underwent pancreatic coduodenectomy with pathology demonstrating a complete response Recall that it was due to these exceptional results from the pilot phase that the chemo for MedPank phase two trial was amended to become the current ongoing randomized study with planned enrollment increasing from 30 patients to 108 patients. Suffice it to say that we continue to be very excited about the data emerging from this program. In summary, with potential revenue from AirMid, together with a significantly streamlined organization and a strengthened balance sheet, We believe we are very well positioned to advance metixoportide in solid tumor indications such as pancreatic cancer while evaluating and licensing additional assets in oncology and rare disease. Our goal continues to be to help as many patients as possible while creating enduring value for our shareholders. Before turning the call over to Molly to review our financials in more detail, I'd like to briefly touch on Apexis performance in the first quarter. After a brief transition period in late 2024 and early 2025, the Aramid team has made very encouraging progress in driving effects to sales, generating sales of $1.4 million in Q1 2025, which resulted in $0.3 million of royalty revenues to BioLine RX. We anticipated some modest and temporary softness in effects to sales in the first part of Q1 as a result of the transition to Aramid. However, we have now seen it return to growth in late Q1 and early Q2. Now let me turn the call over to Molly to provide a financial update. Molly, please go ahead.