BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter and full year 2024 financial results conference call. All participants are at present in 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 Irina Koffler, Investor Relations. Irina, please go ahead.

Thank you, operator. Welcome, everyone. Thank you for joining us on our fourth quarter and full year 2024 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 Mali Zeevi, our Chief Financial Officer, to briefly recap our financials. Afterwards, we will take your questions. Ella Sorani, our Chief Development Officer, will also be available for Q&A. It has been a little over four months since we announced a major strategy shift highlighted by the Transformational Licensing Agreement with Aramid Pharma Limited that we announced in November. That 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 diseases that would allow us to leverage our expertise in drug development and expand our pipeline. Today, I am pleased to report that we are evaluating several promising candidates that fit our criteria. Importantly, the subsequent development of any candidates that we identify will be partly funded through milestones and royalties from our license agreements. We continue to conduct due diligence and advance discussions with a number of parties and I am optimistic that we will be in a position to make a definitive announcement this year. In the meantime, I would like to once again express my thanks to our shareholders who have been so supportive as we work to make this vision of the company a reality. At this point, I'd like to take a step back and briefly review the salient terms of the Airmint Agreement. In November, we executed an exclusive license agreement with Airmint Pharma Limited for Motixifortide, which you may recall is sold in the U.S. under the brand name Afexta. Afexta is our commercially available indicated in combination with GCSF for the collection and subsequent autologous transplantation in patients with multiple myeloma. As we previously indicated, the management team of AirMid is very experienced and has a successful track record. The team established Amrit Bio in 2015 to focus on rare diseases. In less than eight years, they grew Amrit revenue to an annual run rate of several hundred million dollars ultimately selling Amrit in 2023 for approximately $1.5 billion. Additionally, AirMid markets AmiSurge, a cell therapy for patients with blood cancers who are in need of a stem cell transplant. This product is extremely complementary to Afexta and we believe the team's entrenchment in the transplant space should create a tailwind for Afexta We are very pleased to have been able to entrust Aphexta to an ideal partner in order to maximize its full commercial potential. In addition, recall that Aphexta is also being evaluated in patients with sickle cell disease undergoing gene therapy with two Phase I investigator-initiated trials ongoing. Hematopoietic stem cell transplantation after genetic modification is potentially curative for patients with sickle cell disease. 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 American Society of Hematology, or ASH, annual meeting this past December. The findings suggest that patients with sickle cell disease given motixifortide alone or in combination with natalizumab can mobilize and potentially collect the The second sickle cell disease trial is being sponsored by St. Jude's Children's Research Hospital in Memphis and is being executed by some of the leading sickle cell disease researchers in the world. Earlier this quarter, the first patient was dosed in this important trial. 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 also often requires multiple apheresis 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 number of cells for successful transplant. The Airman Agreement covers all indications, stem cell mobilization, sickle cell disease, and others, with a notable exception of solid tumors like pancreatic ductal carcinoma or PDAC, and all territories with the exception of Asia. This transaction is very beneficial for BioLineRx. First, it generated $10 million in upfront payments. In addition, we are eligible to earn $87 million in potential milestones and very healthy double-digit sales royalties in the range of 18% to 23%. In parallel, we will continue to support the development of Metixifortide in PDAC, where randomized Phase 2B clinical trial sponsored by Columbia University and supported by both Regeneron and BioLineRx is currently enrolling. Results of this trial could be a significant milestone for the company in the future. Looking now at the new BioLineRx, concurrent with the closing of the AirMid agreement in November, we shut down our U.S. operations with a substantial portion of our BioLineRx commercial team transitioning to AirMid. In addition to the shutdown of our U.S. operations, we also implemented a headcount reduction in Israel, where BioLineRx continues to be based. Together, these actions have allowed us to reduce our ongoing operating cash burn by approximately 70%, from over $40 million annually to approximately $12 million annually. With the proceeds from this transaction and a portion of our cash on hand, we repaid a significant portion of our debt and Jr., and John Lacey. With potential revenue from AIRMED together with a significantly streamlined organization and a strengthened balance sheet, we believe we are very well positioned to advance Metixifortide in solid-term indications such as pancreatic cancer. While evaluating and in-licensing additional assets in oncology and rare diseases, our goal continues to be to help as many patients as possible while creating enduring value for our shareholders. At this point, I'd like to briefly review our PDAC program, since we are continuing to support 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 but no real survival benefit in a large randomized PDAC trial comparing combination immunotherapy and standard of care chemotherapy versus standard of care chemotherapy alone. In contrast, a phase two trial in second line patients with mitoxifluorotide plus a PD1 inhibitor plus standard of care chemotherapy demonstrated improvement 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. At present, Metixifortide is being evaluated in an active phase-to-be study led by Columbia University known as Chemo4MetPank, which is supported equally by BioLineRx and Regeneron. Recall that this trial had an initial pilot phase, and based on the results of this pilot phase, an assessment was to be made on advancing to an expansion phase of the study. I'm not going to recap the pilot results in detail again, but suffice it to say that based along with Columbia and Regeneron agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized phase 2b study of 108 patients with two arms. Metixifortide, the PD-1 inhibitor Simiplimab and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression-free survival. Secondary objectives include safety, response rate, disease control rate, duration of clinical benefit, and overall survival. To further accelerate enrollment, Columbia recently activated additional trial sites, and the trial is planned for full enrollment by 2027. A pre-specified interim futility analysis is planned for when 40% of progression-free survival events are observed. The opportunity for us to help patients in dire need of effective new treatment options while addressing a multi-billion dollar market opportunity is significant. PDAC is a very difficult cancer to treat given that it is often asymptomatic until stage four and it has the highest mortality rate among solid tumor malignancies. We look forward to keeping you up to date on our progress with this important program. Now I'd like to briefly touch on Afexta's performance in 2024. Last quarter we indicated that Effexa had achieved a 10% market share of total CXCR4 inhibitor usage in the U.S., which compares Effexa to branded Mozaville and generic Plurixifor across all indications. This is a significant milestone given that Effexa had only been on the market since Q4 of 2023. On a year-to-date basis through the closing of the Airmid transaction on November 21st, i.e. less than 11 months, we generated more than $6 million of net effects of product revenue in the U.S. The BioLineRx commercial team was able to build a solid foundation from which to drive future growth and demand. It is largely due to their efforts that we have a high degree of confidence that Affecta will maintain a robust growth trajectory under the stewardship of Airmint once it has fully transitioned the asset. Now let me turn the call over to Mali to provide a financial update. Mali, please go ahead.