BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx third quarter 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 the call over to Timothy McCarthy of Lifestyle Advisors to read the Save Harbor theme. 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 third quarter earnings conference call today. Earlier this morning, we issued our Q3 results press release. A copy of which is available in the Investor Relations section of our website. It was also filed as a 6K. 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 Vice President, Clinical Development, and Ella Sorani, our Vice President, Research and Development. Our most important achievement since our last quarterly update, and probably one of the most significant achievements in the company's history, is about our Phase 3 Genesis study in stem cell mobilization. At the end of October, we received the results of a pre-planned interim analysis of the study. Recall that Genesis is a randomized, placebo-controlled, multicenter study evaluating our lead clinical candidate, Botoxifortide, in addition to the standard of care, GCSF, for the mobilization of hematopoietic stem cells for transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of metixifortide on top of GCSF is superior to GCSF alone in the ability to mobilize 6 million or more CD34 positive cells per kilogram in up to two apheresis sessions. This is an area of significant unmet need given that 50 to 70% of multiple myeloma patients are poor mobilizers and often require multiple apheresis sessions, leading to an extensive burden for the patients and their families, as well as increased costs for the payers. The interim analysis found statistically significant evidence favoring treatment with a motixifortide in the primary endpoint. As a result, the study's independent DMC issued a recommendation to the company Thank you very much. will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021. This is an extremely important milestone for our company, as stem cell mobilization is our most advanced program and our most efficient path to registration. We are thrilled that the first phase three data readout from our three ongoing development programs featuring rotixifortide came back overwhelmingly positive. We are optimistic that these results will position motixifortide as the foundation of a new treatment paradigm in stem cell mobilization. Now turning to AML. Recall that we have been evaluating motixifortide in a Phase IIb study known as BLAST in consolidation AML. The double-blind, multi-center, placebo-controlled BLAST study was evaluating motixifortide plus the standard of care, cytarabine, compared to cytarabine alone. Just a few days ago, our collaboration partners for this study, the German Leukemia Alliance, conducted an interim analysis on 128 out of 194 planned study subjects, all of whom have completed treatment in the study. Regrettably, upon review of the interim data, the DMC did not find a statistically significant effect in the study's primary endpoint of relapsary survival and recommended not to continue the study. As a result, our collaboration partners and we have made a decision to terminate this study. The results of this interim analysis are particularly disappointing in light of the positive data from the Phase I-IIa study that we previously completed in relapsed refractory AML. In that study, in 23 patients selected for the dose expansion phase, we observed a 39% composite complete response rate with patients receiving metixifortide in addition to cytarabine as compared to historical data of 19% for patients treated with cytarabine alone. Similarly, median overall survival was 10.7 months for the metixifortide plus cytarabine group as compared to historical median overall survival of 5.8 to 6.1 months for patients on cytarabine alone. It is important to note that, over the last few decades, other treatments which have been effective in induction and or relapse refractory AML have failed to show improvement in consolidation treatment. Indeed, despite advances in treatment options across different lines in AML, and specifically in certain AML mutations, high-dose Cytarabine and allogeneic transplantation remain the only effective post-induction treatment for more than 20 years. We continue to believe in the relevance of CXCR4 as a viable target in AML, particularly in the relapse or factory AML and induction treatment lines. We will decide on next steps once we've had a chance to review and analyze the unblinded data from this study, including detailed biomarker and subpopulation data. Moving on to late stage pancreatic cancer, or PDAC, Recall that we are currently evaluating metixifortide in a triple combination cohort in the ongoing phase 2A combat keynote 202 trial that we are running under our collaboration with Merck. This cohort is evaluating metixifortide in combination with Keytruda and chemotherapy as a second line therapy. PDAC is among the most difficult cancers to treat and patients with this diagnosis have a very poor prognosis. In addition, more than 50% of PDAC patients are initially diagnosed with advanced stage 4 disease, due mainly to the fact that this cancer is often relatively asymptomatic while it is metastasizing, and these patients have a particularly poor prognosis. The patient population in our combat keynote study are these extremely challenging patients initially diagnosed at stage 4. but we believe both the difficulty and the homogeneity of the patient population will emphasize the potential robustness of the upcoming data and increase the likelihood of repeatability in a phase three study. Recapping the highly encouraging data that we reported at the ESMO-IO conference in December of last year, at which time approximately half the patients in the study, 22 out of a total of 43 patients to be exact, were valuable for efficacy. As previously mentioned, all patients enrolled were originally diagnosed with Stage 4 PDAC and had progressed following first-line treatment with gemcitabine-based chemotherapy. The confirmed overall response rate at that time was 13.6%. The disease control rate was 77%, consisting of seven partial response and 10 stable disease patients. Median duration of clinical benefit until progression for the 17 patients with disease control was 7.8 months. We completed the full study enrollment of 43 patients in February of this year and we are looking forward and remain on track to reporting full data from this study including median overall survival, median progression-free survival, and the final overall response rate in the next few weeks before the end of this year. Also in PDAC, we recently announced the signing of a collaboration agreement with Columbia University for an investigator-initiated Phase II study led by Columbia to evaluate motixifortide in combination with the anti-PD-1 simiplimab, known by its brand name, Liptio, and standard-of-care chemotherapy, gemcitabine and nabpaclitaxel. 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. The open-label study will initially enroll 10 to 12 first-line 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. The primary endpoint of the study is the overall response rate. Secondary endpoints include safety and tolerability, progression-free survival, duration of clinical benefit, and overall survival. Data from the study is anticipated in mid-2022. Finally, we recently announced an investigator-initiated trial for motixifortide in patients with COVID-19-induced acute respiratory distress syndrome, or ARDS. The open-label, single-arm Phase 1b study is being conducted as an investigator-initiated study under a collaboration agreement with Wolfson Medical Center in Holon, Israel, and will enroll up to 25 patients hospitalized with severe ARDS, secondary to COVID-19 and other respiratory viral infections. The study will include patients with ARDS within 72 hours of initial ventilation. Study subjects will receive metixifortide via sub-Q injection for seven consecutive days. Patients who remain stable or improve, according to the investigator's assessment, may continue with a maintenance treatment of metixifortide every other day until recovery or clinical laboratory deterioration. Patients showing clinical laboratory deterioration after the seven days of treatment will be discontinued from the study. The primary endpoint of the study is to assess the safety of metixifortide in these patients. Exploratory endpoints include the change in ratio of arterial oxygen partial pressure to fractional-inspired oxygen, the change from baselines of inflammatory biomarkers, and the number of ventilation days. A preliminary analysis is planned after 10 patients have completed the initial treatment period. We project sometime in the first half of next year. Based on the preliminary evaluation, a decision to continue or not will be made. Prior research suggests that CXCR4 is the primary mediator of neutrophils, neutrophil extracellular traps or NETs, monocytes, and macrophages, all of which are implicated in the development of inflammatory lung symptoms from COVID-19 and other viral infections. As a best-in-class CXCR4 inhibitor, we believe motixifortide may be of use and is very difficult to treat patient population. Regarding our second clinical candidate, recall that we are evaluating the safety and tolerability of AGI-134 at the recommended dose in multiple solid tumor types in a phase one two-way study. The study is also 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. Recall that in September 2019, we announced positive safety data, and later that same month, we moved quickly to initiate part two, which is the dose expansion phase. Approximately seven months ago, a decision was made to temporarily suspend enrollment in this trial, since the trial sites are located in hard-hit COVID-19 areas, including the US, UK, and Israel. We anticipated that this would lead to a nine-month delay. We have recently restarted enrollment, but we are carefully monitoring the COVID situation given the recent surge in new cases in many parts of the world. At this point, however, we continue to expect to report data in the second half of 2021 unchanged from prior guidance. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key third quarter financial statement items. Mali, please go ahead.