Gamida Cell Ltd.

Thank you, Brandy, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the full year of 2020. Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website at www.communicell.com. Here with me on our call today are Julian Adams, Chief Executive Officer, Ronit Simantov, Chief Medical Officer, and Shai Lankri, Chief Financial Officer. Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Tracy Lodi, our Chief Scientific Officer, are also on hand for the Q&A portion of the call following our prepared remarks. During this call, we may make forward-looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies, and projected operating expenses and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factor section of our Form 20F and in other filings that Gameta Cell makes with the SEC from time to time. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events, or otherwise. Now I'd like to turn the call over to Julian.

Thank you, Josh, and thanks to everyone for joining us this morning. At GametaCell, we are at the forefront of developing and commercializing potentially curative medicines for patients by harnessing our proprietary NAM cell expansion technology. This platform provides us with an opportunity to create therapies that could redefine standards of care for patients with life-threatening diseases. 2020 was an important year for Gametacel as we made significant progress across our entire pipeline, including Omidubicel, which is poised to become the first FDA-approved cell therapy for bone marrow transplantation, and GDA201, and innate natural killer cell or NK cell therapy. Today, we'll review both programs and summarize our progress around plans to bring Omidubacill to patients in the commercial setting pending FDA review. Starting with our lead program, Omidubacill has completed a pivotal randomized phase three study. This global trial evaluated Omidubacill versus standard cord blood in patients with hematologic malignancies who needed a bone marrow transplant but did not have a suitable matched donor. The primary endpoint of the study was time to neutrophil engraftment, or the time it took for the white blood cells to recover following transplantation. In 2020, we reported the Omiduba cell phase three data, including primary and secondary endpoints, demonstrating its clinical benefit and made important advances to be launch ready upon FDA approval. Following our December Type B meeting with FDA, we now have a very clear understanding of the Omidubicel commercial manufacturing requirements. We are on track to fulfill these requirements to submit the full BLA by the end of 2021 and meet the commercial supply needs. As we continue to advance Omidubicel for a potential launch, and prepare to become a commercial organization, we are establishing key commercial capabilities, including the creation of Gameta Cell Assist, a program designed to support a positive patient and transplant center experience. With over 13,000 patients with hematologic malignancies eligible for transplant annually, and approximately 200 transplant centers in the U.S., we plan to focus on patient access and support of every individual and their caregivers at each step of the process. In addition, we have conducted extensive market research and have been encouraged by the feedback from physicians and payers indicating the opportunity for Omidubacil to improve safety and efficacy outcomes. Following FDA approval, the market research supports that Omidubacil will be an important therapy for all patients in need of an allogeneic stem cell transplant, who do not have access to an appropriate match-related donor. Omidubicel also has the opportunity to increase access for patients who are not currently able to find a match. Moving to the rest of our pipeline, we are also pleased to report significant progress for GDA201, our first NK cell-based product candidate. Natural killer cells are innate immune cells that hold tremendous promise for treating cancer, A challenge in the field includes the ability to expand NK cells in culture while preserving their functionality. Our NAM-based technology addresses this challenge and potentially improves their direct tumor-killing potential and antibody-dependent cellular cytotoxicity, known as ADCC. GDA201 has demonstrated impressive proof of concept in our Phase I study. which was designed to assess the safety of GDA201 in combination with a monoclonal antibody in non-Hodgkin lymphoma or multiple myeloma. The data from our ongoing phase one study has demonstrated striking early signs of efficacy with multiple durable complete responses while being very well tolerated in patients with advanced lymphoma. We have now developed a cryopreserved formulation in support of our vision to support a multicentered, off-the-shelf allogeneic cell therapy with durable, deep responses and a favorable safety profile. Furthermore, we are leveraging the NAM expansion platform to develop a pipeline of gene-edited NK cell product candidates with enhanced function for both hematologic malignancies and solid tumors. Based on the impressive clinical data generated by both Omidubacil and GDA201, we have significantly strengthened our financial position by raising approximately $220 million in the past year. These proceeds will support the development of both programs and provide sufficient capital through the potential Omidubicel product approval and launch by mid-2020. I want to conclude my introductory remarks by acknowledging the challenges of the past year as we navigated through the COVID-19 pandemic, and the resilience and dedication of the Gametacel team as we work to bring cures to patients. I'll now turn the call over to Ronit Simontov, our Chief Medical Officer, to provide further details on Omadubacil and GDA201. Ronit?

Thank you, Julian, and good morning, everyone. This morning, I'll review our clinical program, and highlight the data we presented throughout 2020 on both Omidubacil and GDA201. I'll start with the Phase III study of Omidubacil. In May of 2020, we were pleased to report that the study met its primary endpoint, time to neutrophil engraftment. In October, we reported that the Phase III study also met all three pre-specified secondary endpoints, platelet engraftment, infections, and hospitalization. These positive study outcomes, as well as additional exploratory endpoints, were presented in a peer-reviewed setting for the first time at the TCT meeting a few weeks ago. And there will be an encore presentation at the presidential session of the European bone marrow transplant annual meeting next week. The trial was a well-conducted and rigorously designed study, analyzed on an intent-to-treat basis. 125 patients were randomized, 52 to the omodubo cell arm and 63 to standard cord blood. Demographics and baseline disease characteristics were well-balanced and reflected a diverse population of patients with hematologic malignancies in need of allogeneic bone marrow transplants. Clinical outcomes supported the superior neutrophil engraftment demonstrated in the primary endpoint analysis. Specifically, patients randomized to omadubicel had fewer serious bacterial, fungal, and viral infections than the comparative group. Patients also spent significantly less time in the hospital in the first 100 days after transplant. Importantly, omodubacill was generally well tolerated, and in particular, the incidence of both acute and chronic graft-versus-host disease, which has been shown to be lower in patients transplanted with cord blood than in other modalities, was statistically similar in the two arms. While the study was not designed to detect a difference in relapse or mortality endpoints, We reported the results of these analyses, including non-relapse or transplant-related mortality, which was 11% for patients randomized to omodubacil and 24% for patients randomized to comparator, and overall survival, which was 73% in the omodubacil arm and 52% for control. The data we presented in 2020 continue to strengthen our confidence in the clinical potential of omodubacil. I want to thank the investigators, patients, and caregivers that participated in our study. We are grateful for their support as we move the field forward. With these data in hand, we anticipate submitting the BLA for omadubacil in the fourth quarter of this year. We believe that omadubacil also has potential to treat patients with diseases beyond hematologic malignancies and are currently investigating omadubacil in patients with severe aplastic anemia, a rare, life-threatening blood disorder. An investigator sponsored Phase 1-2 study being led by Dr. Richard Childs at the National Institutes of Health. At the recent American Society of Hematology Conference, we presented data from a total of eight patients, three who underwent stem cell transplant with omadubicel plus haploidentical stem cells, and five patients who received omadubicel as a standalone graft. The data showed that transplantation with omadubicel following reduced intensity conditioning was generally well tolerated and led to rapid engraftment. With a median follow-up of 10 months, seven of the eight patients had early and sustained engraftment and were no longer dependent on transfusion. Neutrophil and platelet recovery occurred at a median of 10 days and 31 days respectively. We are encouraged by these data in patients who are at high risk for graft failure with conventional cord blood transplants. The study is still ongoing. As Julian mentioned, in addition to Omadubacil, we are advancing our first MK cell therapy, GDA201, We have demonstrated impressive proof of concept in our phase one study, which is designed to assess the safety of GDA201 in combination with a monoclonal antibody in patients with non-Hodgkin lymphoma or multiple myeloma. The study is being conducted by Dr. Veronica Bacanova at the University of Minnesota. At ASH, we presented safety data from 35 patients with relapsed or refractory disease, 19 patients with non-Hodgkin lymphoma, and 16 with myeloma. GVA201 was generally well-tolerated with no dose-limiting toxicity, no GVHD, and importantly, no neurotoxicity observed. We were also very impressed with the promising clinical activity at all doses evaluated in patients with lymphoma. These patients were heavily pretreated with a meeting of three prior lines of chemotherapy. Of the 19 patients with lymphoma, 13 had complete responses and one had a partial response for an overall response rate of 74% and a complete response rate of 68%. Responses were observed in patients with both follicular and diffuse large B cell histologies. We're developing a cryopreserved formulation and will be submitting our IMD in the second half of this year. This will allow us to conduct a multicenter, multidose study to explore the potential of GDA201 as an off-the-shelf cell therapy in patients with lymphoma. I'm very proud of our team and their dedication to advancing our clinical studies during the global pandemic. I will now turn the call over to Shai to review our financial results.