BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx second 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 LifeSciAdvisors to read the Safe 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 second quarter earnings conference call today. Earlier this morning, we issued our Q2 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, 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. During the second quarter, we continue to advance our clinical programs towards important and meaningful data readouts that are anticipated over the next few months. And while some timelines have changed very modestly as a result of COVID-19 and other factors, we look forward to a catalyst-rich second half of the year from Metixa Fortide, formerly known as BL8040, our lead clinical candidate. Recall that Metixa Fortide is currently being evaluated in multiple late-stage trials across a range of cancer indications. At this point, I will provide an update on our motixifortide development programs as well as our second clinical candidate, the anti-cancer vaccine, AGI-134. Beginning with late-stage pancreatic cancer, or PDAC, recall that we are currently evaluating motixifortide in combination with Keytruda and chemotherapy in a Phase IIa clinical trial known as the COMBAT-Kino-202 trial, under a clinical trial collaboration with Merck. As you probably know, PDAC is among the most difficult cancers to treat, and patients with this diagnosis have historically had very poor prognoses. More than 50% of PDAC patients are first diagnosed with advanced stage four disease, due mainly to the fact that this cancer is asymptomatic while it is metastasizing. In addition, immunotherapy has had a very limited effect in PDAC, both alone and in combination. So this is clearly a cancer indication with a substantial unmet medical need. During the fourth quarter of 2019, we announced encouraging preliminary data from this triple combination arm. Briefly recapping the results of 22 evaluable patients at that time, the combination demonstrated a 32% overall response rate, a 13.6 confirmed overall response rate, and a 77% disease control rate. disease control defined as patients with partial responses or stable disease. Out of the seven partial responders at that time, five were still on treatment with a maximum treatment time of over 330 days, and four responders showed a reduction in tumor burden of greater than 50%. In addition, the median duration of clinical benefit for the 17 patients exhibiting disease control was 7.8 months. This data was later published in Nature Medicine. In February, we completed enrollment of a total of 43 patients in the study and had previously guided to providing survival data in the middle of this year. However, as this is an event-driven study, the requisite number of events has not yet been reached. The data is still maturing, and we now expect to report full results, including overall survival, progression-free survival, and final overall response rate later in the second half of this year. We are pleased that as of today, there are still patients on study, and we hope this is an encouraging sign. We look forward to announcing this important data as soon as we were able to do so. Turning now to stem cell mobilization, we continue to advance our Genesis Phase III study, and this continues to represent our most efficient path to registration. This study is a double-blind, placebo-controlled trial comparing metixifortide in combination with GCSF to GCSF alone. for the mobilization of stem cells used for autologous transplantation in multiple myeloma patients. The primary endpoint is the proportion of subjects mobilizing over six million CD34 positive cells per kilogram in up to two apheresis sessions. Recall that in the lead-in portion of the study, our analysis of the first 11 patients found that nine out of 11, 82% of the patients received the primary endpoint with one administration of BL8040 and up to two apheresis sessions, while eight out of 11 or 73% reached the threshold after only one apheresis session. These are very compelling results and hold great promise for the 50 to 70% of multiple myeloma patients who are poor mobilizers. Based on those lead-in results in the first 11 patients, the DMC recommended that we move directly into the randomized portion of the study without the need for completing the full 30 patients in the lead-in period. The COVID-19 pandemic has had an effect on recruitment. On the other hand, we have seen a significantly lower dropout rate than we had anticipated when calculating the original sample size. As a result of these factors, we have made the decision to conduct an interim analysis on approximately 65% of the original trial sample size later in the second half of this year, for which the recruitment is nearly complete. Should the interim analysis demonstrate that the primary endpoint has been reached, we expect to announce the immediate termination of further enrollment. In order to maintain study blinding, top line results, including 100 days of patient follow-up subsequent to transplantation, will be announced in the first half of next year. If the interim analysis demonstrates that the primary endpoint has not yet been reached, study recruitment will continue to completion of the full target enrollment of 177 patients. Should this be the case as mentioned, we anticipate that the ongoing COVID-19 pandemic will have some impact on patient recruitment and taking this into consideration, we would expect to report top line data under this scenario in the second half of next year. Moving on to the Phase IIb BLAST study of metixifluorotide consolidation AML. This study is a randomized, one-to-one, double-blind, placebo-controlled study with two arms, BL8040 plus cytarabine and placebo plus cytarabine. The primary endpoint is relapse-free survival. Our collaboration partners for this study, the German Leukemia Alliance, will be conducting an interim analysis on 128 out of 194 planned study subjects, all of whom have completed the full 18 months of follow-up in the study. The interim analysis will also include a futility analysis, and accordingly, the study will stop in the event of overwhelming superiority or futility. Otherwise, the DMC will make a recommendation regarding study continuation. Consistent with our prior guidance, we anticipate reporting results from the interim analysis in the back half of this year as well. If positive, these results together with the meaningful proof of concept data announced in our previously conducted Phase 2A study in relapsed refractory AML would provide strong rationale for continued development in this indication, and we plan to meet with the regulators to discuss the optimal development path forward in the AML setting. If the study is not terminated due to futility or overwhelming superiority as mentioned, the DMC will make a recommendation recording study continuation in which case the number of subjects will be increased by eight patients to 202 patients. And in that scenario, the estimated completion date will be in 2023 at the earliest. Before turning to our second clinical candidate, AGI-134, I would like to briefly comment on COVID-19 and the opportunity that it presents us. As we previously disclosed last quarter, but it is worth reiterating, we are currently evaluating motixifortide as a potential therapy for for COVID-19 induced inflammatory lung disorders, including acute respiratory distress syndrome, or ARDS. In this regard, substantial data is emerging regarding the involvement of neutrophils and macrophages in the development of COVID-19 lung symptoms, including severe complications such as ARDS, as well as the key involvement of CXCR4 as the primary mediator of those cells in the inflamed alveolar tissue of the lungs. Our hypothesis is that motixifortide may succeed in modulating neutrophils and macrophages via CXCR4 inhibition, thus reducing their retention in the lungs, potentially resulting in improved morbidity and mortality. We are currently evaluating the optimal pathway to obtain initial clinical data in the shortest time possible, and we will, of course, keep you apprised of our progress. Now turning to AGI134. Our second clinical candidate, AGI-134, is a synthetic alpha-gal glycolipid immunotherapy in development for solid tumors. AGI-134 harnesses the body's preexisting, highly abundant anti-alpha-gal antibodies to induce a hyperacute, systemic, specific anti-tumor response to the patient's own tumor neoantigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable follow-on anti-metastatic immune response. We are evaluating AGI-134 in an open-label Phase I-IIa study in patients with unresectable solid tumors. The study is designed to evaluate the safety and tolerability of AGI-134 at the recommended dose in multiple solid tumor types, to evaluate a wide range 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 a dose expansion phase. In part two, we are assessing the efficacy of AGI-134 using clinical and pharmacodynamic parameters. The trial is being carried out in the UK, US, and Israel, all of which have been hard hit by the COVID-19 pandemic. Approximately four months ago, the decision was made to temporarily suspend enrollment in this trial, which we continue to expect will lead to an approximate nine-month delay. We are now gradually resuming enrollment activities and we expect to report data in the second half of 2021. This is unchanged from the revised timing that we introduced last quarter. This delay does not dampen our enthusiasm for the molecule, which in preclinical studies has demonstrated an ability to drive primary tumor regression while preventing the growth of untreated distal secondary tumors. It also triggers a vaccine effect that may prevent the development of future metastases. I would now like to turn the call over to Mali Zeevi, our CFO, who will give a brief overview of our key second quarter financial statement items. Mali, please go ahead.