BioLineRx Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx first quarter 2020 results conference call. All participants at present will 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 LifeSci Advisors 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 first quarter earnings conference call today. Earlier this morning, we issued our Q1 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. Before turning to the results, I would like to make a comment about the humanitarian and economic crisis brought on by COVID-19. We, like many companies, have quickly adapted to a remote working environment that puts our employees in the best position to remain safe while continuing to work toward our collective goals as a company. The pandemic has caused unprecedented disruptions in day-to-day activities and has resulted in delays to drug development pipelines around the world given the difficulty of advancing ongoing trials and recruiting patients for new trials. Recall that our lead clinical candidate, Motixifortide, formerly BL8040, is currently being evaluated in several studies across multiple cancer indications, including advanced metastatic pancreatic cancer, stem cell mobilization, and AML. We also have a second clinical candidate, the anti-cancer vaccine, AGI134, that is being evaluated in solid tumors. We believe that having multiple clinical trials at various stages of completion will help us navigate through this crisis, even while some of our programs may experience COVID-related delays. As currently contemplated, notwithstanding the pandemic, we believe we remain on track for three meaningful data readouts by the end of this year. That will be quite an accomplishment and a testament to the dedication of not only our team, but also the principal investigators that believe strongly in the potential of Metixa Fortide and are eager to see these trials through to completion. Our broad development pipeline together with recent decisive actions that we have taken internally to reduce cash burn best position us to navigate through these challenging times and I believe we will emerge even stronger than before. And while COVID-19 has clearly created challenges for us in the industry, it also may present an opportunity for BioLineRx to potentially play a role in the fight against this dangerous pathogen. We are in the initial stages of evaluating motixifortide as a potential therapy 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 lung. 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. Now, recapping our programs. Recall that during the fourth quarter, we announced preliminary Phase IIa data from the triple combination arm of our ongoing combat Keynote 202 clinical trial that we are running in collaboration with Merck. This trial is evaluating metixifortide in combination with Merck's Keytruda and chemotherapy as a second-line treatment for pancreatic ductal adenocarcinoma, or PDEC. Of 22 evaluable patients at the time, the combination demonstrated a 32% overall response rate, a 13.6% confirmed overall response rate, and a 77% disease control rate, disease control being defined as patients with partial responses or stable disease. By comparison, the ORR, confirmed ORR, and DCR for the current chemotherapy standard of care in a similar patient population are 17%, 7.7%, and 52% respectively. Out of the seven partial responders at that time in our trial, five were still on treatment with a maximum treatment time of over 330 days, and four responders showed a tumor reduction and tumor burden of over 50%. In addition, the median duration of clinical benefit for the 17 patients exhibiting disease control was 7.8 months versus approximately 3 to 4 months for the current standard of care. These are clearly very exciting results, particularly since PDAC is among the most difficult cancers to treat and also due to its late stage at the time of diagnosis. In January, we completed enrollment of the 43 patients in this study. As mentioned earlier, since the emergence of the pandemic, we have remained in close contact with the principal investigators of all our studies, and we are pleased to report that as of today, we remain on track to report progression-free survival data and overall survival data from the triple combination arm of this study mid-year. This is consistent with our prior guidance and is poised to be a very significant milestone for our company, given the promising data to date and the urgent need for new effective options to treat PDEC. As a CXCR4 inhibitor, we believe Motixifortide has potential to be combined with a number of therapeutic agents to attack different cancers and at different stages. Reflecting this versatility, we are also evaluating Motixifortide in acute myeloid leukemia as well as stem cell mobilization for multiple myeloma patients. The FDA has granted Motixifortide orphan drug designation in all three indications, and this past January we received Orphan Drug Designation in Pancreatic Cancer from the European Medicines Agency. Now speaking about AML. Regarding AML, our large randomized controlled Phase IIb study of notixifortide in consolidation therapy for patients in first remission, known as the BLAST study, is continuing. We currently expect to conduct an interim analysis on this study during the second half of this year. We will certainly keep you updated as we continue to progress toward this important data milestone. If positive, these results, together with the meaningful proof-of-concept data announced on 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 regulators to discuss the optimal development path forward in the relapsed refractory setting after the results. Now turning to stem cell mobilization, which is our most advanced indication, the Phase 3 Genesis trial continues to recruit as planned. This study is a double-blind, placebo-controlled trial comparing metixofortide in combination with GCSF to GCSF alone for the mobilization of stem cells used for autologous transplantation in multiple myeloma patients. The randomized portion of the trial is ongoing, and we remain on track to report results from this study by the end of this year. As our most advanced indication, stem cell mobilization remains our most efficient pathway to registration, and we believe it has potential to be a game changer in autologous bone marrow transplantation for multiple myeloma and other indications such as non-Hodgkin's lymphoma. Recall that the results that we observed from 11 patients in the lean-in portion of this study showed an ability of the combination to reduce the number of administrations and apheresis sessions, as well as hospitalization costs. Related to the preparation of multiple myeloma patients for autologous hemopoietic stem cell transplantation. Nine of 11 patients reached the primary endpoint threshold of 6 million CD34 cells per kilogram with only one dose of BL8040 and in up to two aporesis sessions. And seven out of 11 patients reached the threshold in a single aporesis session only. Now turning to our second clinical asset, our novel cancer immunotherapy, AGI134. which we are evaluating in a multi-center, open-label Phase 1-2A 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 array of biomarkers and to validate AGI-134's mechanism of action. We will also assess efficacy by clinical and pharmacodynamic parameters. Following the results of Part 1 of the study, we moved quickly to initiate Part 2, which is the dose expansion phase. In Part 2, we are assessing the efficacy of AGI-134 using clinical and pharmacodynamic parameters. The trial is being carried out in the UK and Israel, both of which saw significant impact from the COVID-19 pandemic. The decision was made to temporarily suspend enrollment in this trial, which we project will lead to an approximate nine-month delay. So whereas we previously guided the top-line data from this trial in the back half of this year, we now expect to report data in the second half of 2021. 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. Before turning the call over to Mali, I want to wrap up with an update on intellectual property. In February, we announced that a Notice of Allowance has been issued by the U.S. Patent and Trademark Office, USPTO, for a patent application claiming the use of metixoportide combined with any PD-1 inhibitor for the treatment of any type of cancer. This patent, when issued, will be valid until July 2036, with a possibility of up to five years patent term extension. Additional corresponding patent applications are pending in Europe, Japan, China, Canada, Australia, India, Korea, Mexico, Brazil, and Israel. This patent is an important addition to our intellectual property state, and we will continue to file additional patent applications both in the U.S. and globally that further protect our proprietary technology. I would now like to turn the call over to Mali Zeevi, our CFO. will give a brief overview of our key first quarter financial statement items. Mali, please go ahead.