BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLine RX third quarter 2021 results conference call. All participants are present 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 the call over 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 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 Molly Zevi, 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 recap of our most recent news, the statistically significant positive results from the pharmacoeconomic study comparing Motixifortide and GCSF to GCSF alone, which supports the use of metixifortide as the standard of care on top of GCSF for the mobilization of stem cells in multiple myeloma patients undergoing autologous stem cell transplantation. This study, which was pre-planned, was conducted as a part of the Genesis Phase III study, for which we reported highly statistically significant positive results back in May. At this point, it may be useful to review the Genesis results again. The study enrolled a total of 122 patients, of which 80 were randomized into the motixifortide arm and 42 into the placebo arm. The main objectives of the study were to demonstrate that motixifortide on top of GCSF provides superior mobilization relative to the current standard of care, GCSF, resulting in more cells collected, fewer doses, and fewer apheresis sessions. The key highlights are worth repeating. 89% of patients receiving motixifortide and GCSF mobilized the optimal number of cells and subsequently underwent transplantation after only one administration of motixifortide and in only one apheresis session. This compares to 10% for GCSF alone. The median number of cells collected in one apheresis session in the motixifortide GCSF arm was 11 million. This would allow transplant of the optimal number of cells or more after one apheresis session, and still leave over enough cells to freeze for future transplantation purposes, a huge advantage. For comparative purposes, GCSF alone mobilized a median number of two million cells. While not a head-to-head study, this compares very favorably to results from the registrational study of Plurixifor, which demonstrated that 54% of patients receiving plurixifor and GCSF mobilized the optimal number of cells and subsequently underwent transplantation after only one administration of plurixifor and in only one aporesis session. As a reminder, all primary and secondary endpoints in the Genesis study were achieved with an exceptionally high level of statistical significance, a p-value of less than 0.0001. We are not aware of any other mobilization therapy, either currently available or in development, that has been able to achieve results as strong as these. Now turning to the pharmacoeconomic analysis. First a little background to help in better understanding the results and significant clinical benefits. Autologous stem cell transplantation is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma, non-Hodgkin's lymphoma, and other lymphomas. In eligible patients, autologous transplantation is performed after initial induction therapy, and in most cases requires consecutive day clinic visits for the mobilization and apheresis or harvesting phases. It also generally requires costly inpatient hospitalization for the conditioning, chemotherapy, and transplantation phases until engraftment, a process that typically takes two to four weeks. The associated burden is therefore significant. patients experience clinically relevant deteriorations in their quality of life during autologous transplantation, and healthcare resource use throughout the autologous transplantation phases is particularly intense. Therefore, new interventions impacting the autologous transplantation process have the potential to relieve some of the clinical and logistical burdens for transplanted patients, the logistical burden for the apheresis units, and the financial burden for healthcare providers and payers. Described simply, autologous transplantation consists of, first, mobilizing the patient's own stem cells from his or her bone marrow to the peripheral blood for removing or harvesting via an aporesis procedure. Second, freezing and storing the harvested cells until they are needed for transplantation. Third, providing a conditioning treatment such as high-dose chemotherapy or radiation to kill the remaining cancer cells the day before transplant. And finally, infusing the stored stem cells back to the patient intravenously via a catheter. To mobilize the patient's stem cells from the bone marrow to the peripheral blood for harvesting, the current standard of care includes the administration of five to eight daily doses of GCSF and the performance of one to four apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out consisting of one to four doses of plurixifor on top of GCSF and the performance of an additional number of apheresis sessions is necessary. In light of this, an agent with superior mobilization activity like motixifortide may significantly reduce the mobilization and harvesting burden and associated risks of the autologous transplantation process and lead to significant clinical and resource benefits. and it is this hypothesis that was tested in the pharmacoeconomic study. The study was performed by the Global Health Economics and Outcomes Research, the HEOR team of IQVIA, one of the leading global data and technology firms focusing on the healthcare sector. The pharmacoeconomic study analyzed healthcare resource utilization observed during the GENESIS trial in each of the two randomized arms. Motixifluorotide in combination with GCSF with a patient number of 80 or placebo in combination with GCSF with a patient number of 42. Health resource use known as HRU data points collected included the number of metixifortide and GCSF doses as well as the number of apheresis sessions performed in the primary mobilization phase. The percentage of patients needing rescue mobilization due to poor primary mobilization including the number of apheresis sessions needed and the number of GCSF and plurixifor doses required. And three, hospitalization costs related to conditioning and transplantation, including length of stay. Quality adjusted life years gained from published literature were also incorporated into the model. Metixifortide plus GCSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to standard of care GCSF alone. Given the higher number of mobilized cells and the lower number of aphoresis sessions, Lifetime estimates showed quality adjusted life year benefits and net cost savings of approximately $17,000, not including the cost of metixifortide versus the current standard of care. We believe that the compelling cost savings identified by this rigorously designed study strongly support our view that metixifortide in combination with GCSF can become the new standard of care as an upfront or primary therapy for all multiple myeloma patients undergoing autologous stem cell transplantation. Together with the data from the Genesis trial showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of metixivortide and in only one apheresis session, versus less than 10% for GCSF alone, The $17,000 cost savings demonstrated by the pharmacoeconomic study should leave substantial room in the future to optimize our pricing strategy for motixifortide at product launch and thereafter, if approved. I would also like to point out that fewer administrations and apheresis sessions confirm meaningful safety and time benefits to patients. In addition, the significantly higher median number of cells collected in one apheresis session, 11 million using motixifortide on top of GCSF, versus 2 million for GCSF alone, not only enables transplantation of an optimal number of cells with the potential to significantly accelerate the time to engraftment, it also permits the retention of enough cells for cryopreservation in the event that an additional transplantation is required in the future. Also, we believe that higher levels of certainty regarding the number of apheresis sessions required for mobilization will enable more efficient use of apheresis units at transplantation institutions. where there is often a shortage of available machines. The potential to position motixifortide plus GCSF as a new standard of care primary mobilization agent versus part of a rescue therapy regimen is significant. There are more than 45,000 autologous stem cell transplantation procedures in the U.S. and Europe annually. The global estimated market is approximately $500 million. For reference, the current first generation CXCR4 inhibitor, Plurixifor, generates annual sales in excess of $250 million in the two indications for which it is approved, multiple myeloma and non-Hodgkin's lymphoma, and it is primarily used as a rescue therapy treatment. In terms of next steps, in mid-December, we will attend a pre-NDA meeting with the FDA, and we hope to receive the formal minutes from the meeting by the first half of January. Assuming our meeting with the FDA is successful, we plan to submit an NDA to the FDA in the first half of next year. Our future plans also include evaluating lifecycle management potential in other autologous stem cell mobilization indications, for example, other lymphomas, sickle cell anemia, et cetera, as well as in allogeneic transmutation indications and neutropenia and others. So, in summary, we believe the data from the Genesis study, together with the results from this pharmacoeconomic study, set metixifortide apart from all other mobilization agents either currently available or in development, if approved. It will represent a significant advancement in stem cell mobilization to the benefit of patients and payers alike. As we have stated before, stem cell mobilization represents our fastest path to registration and we look forward to transitioning to a company with a commercial stage asset if ultimately approved in 2023. 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 triple combination 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 four metastatic PDAC who had progressed following first-line gemcitabine-based therapy were enrolled. 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 for our PDAC program, as we've previously indicated, we continue to engage in discussions with potential biopharma partners with the goal of collaborating on a randomized controlled Phase 2-3 study. Taken together, the positive results that we have seen in trials to date across both Stencil Mobilization and PDAC reflect the underlying versatility of metixifortide as the potential backbone of improved treatments for both hematological and solid tumor cancers. We have an opportunity to highlight this fact at this year's American Society of Hematology Annual Meeting and Exposition, or ASH, which is taking place December 11th to December 14th. We had a total of four abstracts accepted, one as an oral presentation and three as posters. The oral presentation will describe the positive results from the Genesis study, which I touched on earlier. In addition, the three poster presentations will describe, first, findings from a pooled analysis of the Genesis trial demonstrating the correlation of higher numbers of stem cells infused with shorter time to engraftment, Second, findings from a correlative study of the Genesis trial demonstrating that motixifortide plus GCSF mobilized higher numbers of specific cells, enabling broad multilineage hematopoietic reconstitution. And third, findings from preclinical studies demonstrating that motixifortide affects the biology of regulatory T cells, resulting in a reduction of infiltrating Treg cells into the tumors. Needless to say, we are very pleased to have a notable presence at such an important and prestigious medical meeting, and we believe this reflects the significant progress we have made across these two core clinical programs. Regarding our second clinical candidate, AGI-134, recall that we are evaluating safety, tolerability, and proof of mechanism in multiple solid tumor types in a Phase I two-way 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 two, the dose expansion phase. As we have discussed, the COVID-19 pandemic did impact enrollment for a period of time, but has now resumed. At this stage, it looks like we will complete recruitment by the end of this year, and be in a position to announce results from the trial in the first half of next year. I would now like to turn the call over to Molly Zevi, our CFO, who will give a brief overview of our key third quarter financial statement items. Molly, please go ahead.