BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2021 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 Tim McCarthy of LifeSci Advisors. 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 BioLineRx's business, financial condition and other operating results. These include but are not limited to the risk factors and other qualifications contained in BioLineRx's annual report on Form 20F, quarterly reports filed in the 6K and other reports filed by BioLineRx with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed Thank you, Tim, and good morning, everyone. And thank you for joining us on our first quarter earnings conference call today.

Earlier this morning we issued our Q1 results 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 custom, I will begin with some brief prepared remarks and then Mali Zeevi, our Chief Financial Officer, will provide a short discussion of our financial results. We will then open up the call to your questions. also joining the call for Q&A are Abby Weinstein, our Chief Medical Officer, and Ella Sorani, our Chief Development Officer. Our most meaningful achievement since our last quarterly update is our most recent. Just a few weeks ago, we announced extremely positive top-line results from our Phase III clinical trial, evaluating our lead clinical candidate, Motyxifortide, in stem cell mobilization for multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. Recapping the unmet need, patients undergoing autologous transplantation generally require multiple administrations of GCSF, the current standard of care, and up to four apheresis sessions in order to collect the target number of stem cells required for transplantation. In addition, it is estimated that between 30% and 50% of patients are poor mobilizers. not only necessitating multiple apheresis sessions, but requiring on top of GCSF one to four daily injections of Clorixifor. The main objectives of this study was to demonstrate that Motixifor type on top of GCSF provides superior mobilization relative to the current standard of care, resulting in more cells collected, fewer doses, and fewer apheresis sessions. This has significant clinical benefits to patients. Mali Zeevi, Ella Sorani, John Lacey, Philip Serlin, Raziel Fried Since apheresis sessions are costly, so the more days that can be eliminated, the stronger the pharmacoeconomic case to be made for motixifortide as the backbone of a new stem cell mobilization treatment paradigm. To that end, we are currently running a pharmacoeconomic study to support this cost-benefit analysis, which we hope that healthcare payers will ultimately find compelling. The data demonstrate that the study successfully met all primary and secondary endpoints, with an exceptionally high level of statistical significance with a p-value of less than 0.0001. Some of the key highlights are 88.3% of patients receiving motixifortide and GCSF underwent transplantation after only one administration of motixifortide and in only one apheresis session. This compares to 10.8% for GCSF alone. Patients receiving metixifortide plus GCSF showed a 54.6% treatment effect and a 4.9-fold increase in the primary endpoint, mobilization of over 6 million cells per kilogram following a single dose of metixifortide in up to two aporesis sessions, as compared to the control arm of GCSF alone. While not a head-to-head study, this compares very favorably with to results from the Registrational Study of Plurixifor, which demonstrated a 37.2% treatment effect and a 2.1 fold increase for the Plurixifor plus GCSF arm versus GCSF alone. So to emphasize, a 54.6% treatment effect and 4.9 fold increase in our study versus a 37.2% treatment effect and a 2.1 fold increase in the Plurixifor study in the primary endpoint. The study also achieved its main secondary endpoint, the percentage of patients who mobilized over 6 million cells per kilogram following a single dose of metixifortide on top of GCSF and in just one apheresis session, in an even more impressive manner. Patients in the treatment cohort of the Genesis trial demonstrated a 61.7% treatment effect and a 14.1 fold increase as compared to the control arm of GCSF alone. By comparison, the registrational study of Plurixa4 demonstrated a 36.9% treatment effect and a 3.1 fold increase for the Plurixa4 plus GCSF arm versus GCSF alone. Again, to emphasize, a 61.7% treatment effect and a 14.1 fold increase in our study versus a 36.9% treatment effect and a 3.1 fold increase in the Plurixa4 study in the main secondary endpoint. By any measure, we believe these data demonstrate a very significant clinical benefit from adding metixifortide to GCSF and support metixifortide on top of GCSF as the new standard of care mobilization agent in autologous bone marrow transplantation. As previously mentioned, this study represents our fastest track to registration. and to that end, we are very diligently working on activities in support of the US New Drug Application or NDA, which we plan to submit in the first half of next year. If ultimately approved in this indication, we would begin our transition to a commercial stage company, the most important and transformational milestone that we will have achieved to date. Turning now to our pancreatic cancer or PDAC program, Recall that in December, we announced positive final results from the Phase 2A Combat Keynote 202 study of Metixifortide in combination with Merck's Anti-PD-1 Keytruda and chemotherapy as a second-line therapy. A total of 43 patients initially diagnosed with unresectable Stage 4 metastatic PDAC who had progressed following first-line gemcitabine-based therapy were enrolled in the triple combination arm. Data from this 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. With regard to next steps, as we've previously indicated, we continue to engage in discussions with the potential biopharma partners to collaborate on a randomized controlled Phase 2-3 study. Regarding our second clinical candidate, AGI134, recall that we are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in a Phase I-IIa study. The study is designed to evaluate a wide array of biomarkers and assess both clinical and pharmacodynamic parameters. In September 2019, we announced positive safety data, and later that same month, we moved quickly to initiate Part II, the dose expansion phase. As we have discussed, the COVID-19 pandemic did impact enrollment for a period of time but has now resumed. We remain on track to report data in the second half of this year. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key first quarter financial statement items. Mali, please go ahead.