BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine Rx second 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 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 the 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 Mr. Phil Serlin, Chief Executive Officer of BioLine Rx.

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. As is our custom, I will begin with some brief prepared remarks, and then Molly Zebi, 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 Serrani, our chief development officer. I would like to begin this morning with a brief recap of the overwhelmingly positive results from our phase three Genesis clinical trial, which we announced in May. The Genesis study evaluated metixifortide on top of GCSF, the current standard of care, versus GCSF alone, in stem cell mobilization from multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. The main objective of this study was to demonstrate that motixifortide on top of GCSF provides superior mobilization relative to GCSF alone, resulting in more cells collected, fewer doses of GCSF administered, and fewer apheresis sessions required, all of which provide meaningful clinical benefit for patients, while saving potentially significant money for payers and the entire healthcare system. We covered the results in detail during our last quarterly update, but we believe a few key highlights are worth repeating. First, the study met all primary and secondary endpoints with an exceptionally high level of statistical significance, a p-value of less than 0.0001. Perhaps most notably, approximately 90% of patients who received motixifortide in GCSF underwent transplantation after only one administration of motixifortide and in only one aphoresis session. This compares to 10.8% for GCSF alone. In addition, while not a head-to-head study, this compares very favorably to results from the registrational study of plurixifor, which demonstrated that approximately 54% of patients who went to transplantation after one administration of Plurixifor on top of GCSF and in one apheresis session. Using the current standard of care with GCSF alone, several apheresis sessions are generally required to collect the optimal number of stem cells. However, somewhere between 30 and 50% of patients are unable to reach this optimal number of stem cells. Due to the ability of Motixifortide in the vast majority of cases to enable the collection of an exceptionally high number of stem cells following one administration, with only one aphoresis session, thereby lowering the number of GCSF administrations, aphoresis sessions, and related adverse events. We believe there is a compelling case to be made regarding the potentially significant clinical benefits, as well as health system cost benefits that can be achieved with metixifortide if approved. We also note that the higher number of cells collected allows for the transplant of an optimal number of cells, as well as enabling the storage of a sufficient amount of remaining cells for future transplantation without the need for additional mobilization and apheresis procedures. In this regard, we are running a pharmacoeconomic cost effectiveness study that we believe will demonstrate our case for the use of metixifortide as the backbone for all new stem cell mobilization procedures. The study is progressing as planned, and we look forward to reporting data by the end of this year. In addition, we continue to perform additional analyses that were predefined in the statistical analysis plan, as well as post hoc analyses of the Genesis data set, and look forward to presenting our additional findings from the study at future medical meetings. As previously mentioned, this program represents our fastest track to registration, and to that end, we are aggressively working on activities in support of the U.S. New Drug Application, or NDA, which we plan to submit in the first half of next year. We are making preparations now for a pre-NDA meeting with the agency that we anticipate will occur prior to the end of this year. If ultimately approved in this indication, we would begin our transition to a company with a commercial stage molecule, the most important and transformational milestone that we will have achieved as a company to this point. We would have a commercial stage molecule in one indication with significant potential utility in other cancer types as well, most notably pancreatic cancer, which we will discuss next. In addition, based on the strength of the GENESIS results, we are also exploring development of lentixoportide in other stem cell mobilization indications as part of its life cycle management program. Turning now to our Pancreatic Cancer Program, or PDAC, recall that in December we announced positive final results from the Phase 2A Combat Keynote 202 study of motixifortide 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 and consistent 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. As we've previously indicated, we continue to prepare the next development steps regarding this program, including continuing to engage in discussions with potential biopharma partners to collaborate on a randomized controlled Phase 2-3 study. In addition, we are actively engaged in productive discussions with potential commercialization partners for stem cell mobilization. The high level of interest we are receiving reflects the versatility of motixifortide as the potential backbone of innovative new cancer treatments, something that we have demonstrated in two high-need indications so far. Regarding our second innovative candidate, AGI134, we continue to advance our Phase I-II clinical study, evaluating the safety, tolerability, and proof of mechanism in multiple solid tumor types. 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 two, the dose expansion phase. As we have previously disclosed, in 2020, the COVID-19 pandemic impacted enrollment for a period of time, but enrollment did resume earlier this year. In order to improve enrollment and make up some of the time lost during the pandemic, we have worked diligently to open new sites across Spain, and these sites are already beginning to recruit patients. At this time, we still hope to report data in the second half of this year in line with our prior guidance, although due to the recent severe worsening of the COVID-19 pandemic throughout most of the world, there may be some delays. From a balance sheet perspective, we are on a very solid financial footing with approximately $66 million of cash, which we believe enables us to achieve multiple potentially value-creating milestones this year and next. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our key second quarter financial statement items. Molly, please go ahead.