BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx fourth quarter and full year 2020 results conference call. All participants are present in a listen-only mode. Following the 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 and Timothy McCarthy of LifeSci Advisors to read the Saints Harbor Statement. Tim, 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 or implied by these forward-looking statements. BioLineRx 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 Mr. Phil Serlin, Chief Executive Officer of BioLineRx.

Thank you, Tim, and good morning, everyone. And thank you for joining us on our fourth quarter earnings conference call today. Earlier this morning, we issued our Q4 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. The fourth quarter 2020 was our most significant yet as we produced positive data sets from two key programs, stem cell mobilization and metastatic pancreatic cancer, or PDAC. I would like to begin with a brief discussion of stem cell mobilization. In October, we announced positive results from pre-planned interim analysis of our Genesis Phase 3 study evaluating our lead clinical candidate, Motixifortide, in stem cell mobilization for patients undergoing autologous hematopoietic stem cell transplantation. Stem cell mobilization is an area of significant unmet need, as 50-70% of patients are poor mobilizers, necessitating multiple apheresis sessions. In addition, a portion of these patients require 1-4 daily injections of Mozabil on top of GCSF. and the rest of the team. were overwhelmingly positive, as the interim analysis found highly statistically significant evidence for the primary endpoint favoring treatment with Mutaxifortide. Upon the recommendation of the Independent Data Monitoring Committee, study recruitment was terminated early at 122 out of a planned 177 patients. We are planning to announce top-line data in early Q2 of this year, including full primary and secondary efficacy endpoints. These data are exciting for two very important reasons. First, we hope that the data will show that the combination of metixifortide and GCSF is well positioned to become the new standard of care in autologous stem cell transplantation. And second, stem cell mobilization is our most expedient path to registration. It goes without saying that if metixifortide is ultimately approved for this indication, it would be a transformational event for our company. To that end, we are already proceeding with all activities in support of an NDA submission in this indication, which we are targeting for the first half of 2022, including a pre-NDA meeting with the FDA in the second half of this year. Now turning to our PDAC program. In December, we announced final results from the Phase 2A Combat Keynote 202 study of latixifortide in combination with Merck's PD-1 inhibitor, Contruda, and chemotherapy as a second-line therapy in stage 4 metastatic PDEC. A total of 43 patients initially diagnosed with unresectable stage 4 metastatic PDEC who had progressed following first-line gemcitabine-based therapy were enrolled in the triple combination arm. Patients received motixifortide monotherapy priming treatment for five days. Mali Zeevi, Ella Sorani, John Lacey, Philip Serlin Many patients are first diagnosed with advanced stage 4 disease due mainly to the fact that this cancer is asymptomatic while it is metastasizing. And as mentioned, the patients in our combat keynote study were initially diagnosed at stage 4, so this was a patient population with an extremely poor prognosis, and perhaps worse than the patient populations evaluated in previous PDAC studies to date. It is against this backdrop that the data that we announced in December are all the more encouraging. The data demonstrated substantial improvement across all study endpoints as compared to historical data, including overall survival, median progression-free survival, confirmed overall response rate, and disease control rate. This is a big differentiation factor from other studies in this indication, which showed improvement in only one specific endpoint. Let's recap the results. Median overall survival in months was 6.5 months in our combat keynote study versus 4.7 months of historical data. Median progression-free survival was 4.0 months in our combat keynote study versus 2.7 to 3.1 months of historical data. Our confirmed overall response rate in the combat keynote study was 13.2% versus 7.7% in the historical data. Our overall response rate was 21.2% versus 16% relating to historical data. And finally, our disease control rate in this study was 63.2% versus between 30 and 50% relating to historical data. As you can see, again, the data demonstrated a substantial improvement across all study endpoints. We refer you to our press release dated December 16th for more detail, as well as important references to accompany the historical data. We are currently planning the next development steps for this program, including discussions with potential collaboration partners and development of a protocol for a randomized control study. At this point, I'd like to very briefly recap two investigator-initiated trials that are also evaluating Otixifortide. Also in PDAC, Columbia University is leading a Phase II study evaluating motixifortide in combination with the anti-PD-1 simiplimab known by its brand name, Liptio, and standard of care chemotherapy, gemcitabine and napaclitaxel. Notably, this is an entirely new study that is evaluating this combination as a first-line treatment as compared to the combat study, which is second-line. This investigator-initiated Phase II study will initially enroll 10 to 12 PDAC patients. and will be expanded to a total of 40 patients following an evaluation of the initial 10 to 12 patients based on predefined criteria. Data from this study is anticipated in mid-2022, although since this trial is not a company-sponsored trial, the timelines are ultimately driven by the independent investigators and therefore could be subject to change. A second investigator-initiated trial of metixoporotide is ongoing in patients with COVID-induced acute respiratory distress syndrome, or ARDS. The open-label single-arm Phase 1B study is being conducted at Wolfson Medical Center in Holon, Israel, and will enroll up to 25 hospitalized COVID patients. An interim analysis is planned after 10 patients have completed the initial treatment period, after which a decision to continue or not will be conducted. These preliminary results could be announced as early as the second half of this year, or Although as with the Columbia University study, the timelines are driven by the independent investigators and could be subject to change. Regarding our second clinical candidate, AGI-134, recall that we are evaluating safety and tolerability at the recommended dose in multiple solid tumor types in a Phase I-IIA study. The study is designed to evaluate a wide array of biomarkers and to validate AGI-134's mechanism of action. We will also assess clinical and pharmacodynamic parameters. In September 2019, we announced positive safety data, and later that same month, we moved quickly to initiate Part 2, which is the dose expansion phase. We previously talked about enrollment delays caused by COVID-19, particularly as the pandemic impacted the UK and Israel particularly hard. And while this has caused delays, enrollment has now resumed and new sites and countries have been added and we remain on track to report data in the back half of this year. This is unchanged from the guidance that was provided last quarter. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key fourth quarter financial statement items. Mali, please go ahead.