BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2023 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. For operator assistance during the conference, please press star zero. I would now like to turn over the call to John Lacey, Head of Investor Relations and Corporate Communications, BioLineRx. Please go ahead.

Thank you, Operator. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements in this conference call, other than historical facts, are indeed forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are used typically to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other factors that may affect BioLine RX's business, financial condition, and other operating results. These include, but are not limited to, the risk factors, and other qualifications contained in BioLine RX's annual report on Form 20F, quarterly reports filed in a 6K, and other reports filed by BioLine RX with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. BioLine RX expressly disclaims any intent or obligation to update these forward-looking statements. At this time, it is now my pleasure to turn the call over to Phil Serwin, Chief Executive Officer of Byline RA.

Thank you, John, and good morning, everyone. Thank you for joining us on our first quarter 2023 results conference call today. Earlier this morning, 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. As is our practice, I will begin with an overview, then Molly Zevi, our Chief Financial Officer, will provide a discussion of our financial results. We will then open the call and are looking forward to your questions. Also joining the call for Q&A are Ella Serrani, our Chief Development Officer, Holly May, President of BioLine Rx USA, and Tommy Rachmilevich, MD, our Chief Medical Officer. Beginning with our lead program, Motixifortide for stem cell mobilization in patients with multiple myeloma, we announced in November of last year that the FDA accepted our new drug application and assigned a PDUFA target action date of September 9th, 2023. We continue to be on track. In anticipation of potential FDA approval, we have had a very productive quarter across each of our commercial readiness activities, including completing the hiring of an experienced sales force most of whom have particular expertise in relevant transplant centers across the U.S. We have also substantially advanced supply chain, market access, and medical affairs activities. We previously talked about our U.S. leadership, including Holly May, who heads all of our U.S. activities and has led 14 product launches throughout her career, and Kevin Campbell, our new head of U.S. sales and market development, whose prior experience includes serving as head of transplant at Sanofi, where he led a 23-person commercial team whose portfolio included Plurixifor, known by its brand name Mozabil, for stem cell mobilization. Kevin helped to grow and expand the use of Mozabil, and we believe he is the ideal person to help make Motixifortide the new standard of care mobilization agent. As we have said several times in the past, but it is worth repeating, Based on proprietary market research that we commissioned, the stem cell mobilization market continues to grow and is worth some $360 million in the US and more than $500 million globally. With the team that we have assembled, I believe we are very well positioned to capture a significant share of this market over time. Further validating the potential benefits of metixifortide in stem cell mobilization, we were pleased during the quarter to announce the publication of our Genesis Phase III clinical trial data, which supports our pending new drug application in the highly regarded peer-reviewed journal Nature Medicine. Of particular note, the publication describes how the Genesis trial included patients representative of the current multiple myeloma population undergoing autologous stem cell mobilization, including older patients and those who received lenalidomide-containing induction therapies, both factors associated with impaired mobilization. Multiple myeloma is the second most common hematologic malignancy, and stem cell transplantation has been shown to improve survival, and as such, plays a central role in the treatment of these patients. A meaningful number of patients, however, are unable to collect the target number of peripheral blood CD34 positive hematopoietic stem and progenitor cells with the current standard of care in stem cell mobilization. The primary objective of the study was to demonstrate that one dose of metixifortide with GCSF compared to placebo with GCSF allowed more patients to mobilize six million CD34 positive cells or more per kilogram of body weight in up to two apheresis sessions. A secondary objective of the study was to demonstrate that one dose of metixifortide with GCSF was superior to placebo with GCSF in its ability to mobilize six million CD34 positive cells or more per kilogram of body weight in just one apheresis session. the clinical trial found that all primary and secondary endpoints were achieved with statistical significance p-value of less than 0.0001. If approved, metixifortide would be the first true advancement in stem cell mobilization in over a decade. In parallel with our development work in stem cell mobilization for multiple myeloma, we believe there are additional therapeutic areas where the demonstrated benefits of metixifortide can be beneficial. One of these is autologous hematopoietic stem cell-based gene therapy for patients suffering from sickle cell disease, one of the most common genetic diseases globally. To that end, in March, we announced a clinical trial collaboration with Washington University School of Medicine to evaluate metixifortide in this indication. Unlike multiple myeloma patients, one of the current standard of care mobilization agents, GCSF, carry significant risks and potential severe side effects for patients suffering from sickle cell disease. Furthermore, in many cases, the other current mobilization treatments fail to reliably yield optimal numbers of stem cells to facilitate gene therapy. As such, this patient population is in urgent need of an effective new mobilization regimen. Through this collaboration, we plan to conduct a proof of concept trial that will study metixifortide as both a single agent and in combination with the immunomodulator natalizumab. This study will assess the safety and tolerability of the two regimens as mobilization agents of CD34-positive hematopoietic stem cells in patients with sickle cell disease and is anticipated to begin enrollment in the second half of 2023. Let's turn now to our clinical programs in metastatic pancreatic cancer. Recall that metixifortide is being evaluated in an investigator-initiated metastatic pancreatic cancer trial in collaboration with Columbia University. This Phase II study is evaluating metixifortide in combination with the anti-PD-1 simiplimab and standard of care chemotherapy in first-line metastatic pancreatic cancer patients. This study continues to progress, and we anticipate data from the first cohort of patients this year. We also previously announced a collaboration with GenFleet Therapeutics pursuant to which GenFleet will execute a rigorously designed randomized phase 2B clinical study assessing metoxifortide in combination with a PD-1 inhibitor and standard of care chemotherapy in approximately 200 first-line metastatic pancreatic cancer patients in China. This collaboration follows the positive results that we reported from our phase 2A combat keynote 202 triple combination study of metixifluortide in combination with the anti-PD1 prembolizumab and chemotherapy in second-line patients. As a reminder, data from that phase 2A study demonstrated a substantial improvement across all study endpoints as compared to historical data, including median overall survival, median progression-free survival, confirmed overall response rate, overall response rate, and disease control rate. We anticipate that the GenFleet Phase 2b trial will initiate by the end of this year. Turning now to our second clinical candidate, the Investigational Intratumoral Anti-Cancer Vaccine, AGI134. We believe AGI134 coats tumor cells with alpha-gal to make them look like foreign tissue in order to evoke an immune response that both destroys existing tumors and also provides a vaccine-like effect. In December, we announced results from a phase one two-way study of AGI-134 in metastatic solid tumors. The first in human single agent study met its primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. At this time, we are evaluating potential development program pathways in consultation with the program scientific advisory board. and we will provide further updates as appropriate. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our main financial results. Molly, please go ahead.