Gamida Cell Ltd.

Thank you, Crystal, 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 second quarter of 2021. 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.gametacell.com. Here with me on our call today are Julian Adams, Chief Executive Officer, Ronit Simintov, Chief Medical Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Lankre, Chief Financial Officer. There will also be a Q&A session following our prepared remarks. During this call, we may make forward-looking statements about our future expectations and plans, including in respect of the timing and initiation and progress of and data reported from the clinical trials of our product candidates. anticipated regulatory filings, including the submission of the BLA for Omidubacil to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Omidubacil, and our expectations regarding our projected cash to be used for operating activities and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the impact of the COVID-19 pandemic on our operations, the scope, progress, and expansion of our clinical trials and cost impact thereof, clinical, scientific, regulatory, and technical developments, and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates, as well as those considerations described in the risk factor section of our most recent annual report, on Form 20F and other filings that we make 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. And now I'd like to turn the call over to Julian.

Thank you, Josh, and thanks to everyone for joining us this morning. This was a productive quarter for GametaCell. we continue to execute on our plan to launch the first allogeneic stem cell therapy, Omidubacil, for cancer patients in need of a stem cell transplant. In addition, based on promising preliminary studies, we have accelerated our plans to develop a unique NAM-enabled natural killer, or NK cell, GDA201, for patients with follicular lymphoma and diffuse large B-cell lymphoma. and we are very excited about the expansion of our cell therapy pipeline with four new NAM-enabled genetically modified NK cells targeting cancers. Patients are at the forefront of our work, and we are committed to turning our NAM-enabled NK product candidates into curative therapies. I'll start with our most advanced program, Hormoduga Cell. potentially life-saving treatment for patients with blood cancers who are in need of a stem cell transplant. This quarter, we announced the results of a Phase III clinical study of omadubacil, which were published in Blood, the official journal of the American Society for Hematology. The published results demonstrate that transplantation with omadubacil leads to faster neutrophil and platelet recovery compared with the standard of care. Additionally, The data demonstrate that omadugasel results in fewer bacterial, fungal, and viral infections and less time in the hospital. These results add to the compelling body of evidence for the potential of omadugasel as a life-saving therapy that can benefit patients in need of a bone marrow transplant and help reduce the burden on our healthcare system. We continue to execute our plan of action to toward becoming a commercial company in 2022 as we prepare for our BLA submission for Omidugacel by the end of this year, subject to a pre-BLA meeting with the agency in the fourth quarter. Omidugacel has the potential to be the first FDA-approved cell therapy for stem cell transplants. Michelle will provide an update on launch readiness later on in the call. Moving to our NK pipeline, we believe that NK cells hold tremendous potential as a best-in-class next-generation immunotherapy. NK cells are the body's first line of defense in providing innate immunity. They also have immune-privileged properties which obviate the requirement for HLA matching. Given that any healthy adult donor can provide an apheresis unit, from which we apply our proprietary NAM technology to expand and produce a cryopreserved, off-the-shelf, allogeneic natural killer cell treatment for cancer patients. Our NAM-enabled NK cells display several important cell surface markers, including high expression of CD16, the FC gamma R3 receptor for antibodies, which allows the combination with monochromal antibodies to target tumors through enhanced antibody-dependent cellular cytotoxicity, or ADCC. Importantly, NAM also increases CD62L, or L-selectin expression, which leads to in vivo homing and retention in lymphoid tissues. Furthermore, NAM increases secretion of inflammatory cytokines for activation of host adaptive immune cells. The culmination of these activities results in increased cytotoxicity for more efficient tumor cell killing and durable responses. The combination of NK cells with therapeutic antibodies increased GDA201's potency of killing and enhanced ADCC, both in vitro and in vivo, supporting clinical treatment with GDA201 in parallel with selected antibodies for specific malignancies. We are advancing the power of NK cells to the next level with our second candidate in clinical development, GDA201, which has demonstrated remarkable results in preliminary studies as a potential treatment for patients with follicular and diffuse large B cell lymphomas. We have completed the GMP batches with our cryopreserved formulation of GDA201 and are on track to submit an IMD in this quarter to support a multi-centered Phase I-II study by the end of the year. Today, we announced that we are expanding the reach of both the NAMM technology and the power of NK cells through the growth of our NK pipeline to now include genetically modified variants and proprietary therapies using CRISPR-Cas9 and CAR technologies. Ronit will give more detail on this exciting new development shortly. and we look forward to providing a more detailed update at an R&D day later this year. I'm extremely proud of the progress our team has made with this expansion, and I believe that our technology combined with our expertise in NK biology holds great promise to further our vision of bringing curative therapies to patients. I want to conclude my introductory remarks by really thanking our employees for their continued dedication to our mission and hard work. And with that, I will turn the call over to Roni.

Thank you, Julian. I'm very excited to provide more detail on our NK pipeline expansion, which we announced this morning. We're confident in the potential to leverage our NAMM technology for these newly announced targets based on the encouraging clinical data we've demonstrated with GDA201, for patients with lymphoma. These new programs will involve genetic modifications intended to direct NK cells against cancer cells, enhancing targeting and persistence, and improving cytotoxicity against both hematologic malignancies and solid tumors. This pipeline expansion stems from research that we've been conducting here at GametaCell and in collaboration with key academic researchers. and represents important progress in the development of NK therapies for patients. Our new product candidates include GDA301, a knockout of SISH, or cytokine-inducible SH2-containing protein in NK cells using CRISPR-Cas9, with concomitant insertion of membrane-bound interleukin-15, or IL-15. SISH is a regulator of IL-15 signaling, And FISH deletion increases NK sensitivity to IL-15 by lowering the NK activation threshold. NK cells equipped with membrane-bound IL-15 are designed for enhanced persistence and improved antitumor effects. In preclinical studies, we've demonstrated elevation of pro-inflammatory cytokines and enhanced potency and cytotoxic activity in these cells. We believe that the CISH target coupled with membrane-bound IL-15 has potential across multiple tumor types. Additionally, today, we announced the development of GDA-401, which is genetically engineered towards an undisclosed target designed to enhance NK cell survival in a solid tumor microenvironment. As with GDA-301, we believe that GDA-401 has potential application across a broad range of solid tumors. The third development candidate in our NK pipeline is GDA501, a chimeric antigen receptor, or CAR, engineered NK cell designed to target HER2-positive solid tumors. This candidate has the potential to enhance HOM2 and activity against tumors overexpressing HER2, such as breast cancer, ovarian, lung, bladder, and gastric cancers. The NK-CAR is based on a single-chain variable fragment of the widely used immunized monoclonal antibody trastuzumab. GDA501-CAR was selected out of several constructs that are primarily focused on optimizing the intracellular signaling domain. These were further validated in preclinical studies, showing increase in cytotoxicity and enhanced potency. The fourth development candidate in our NK pipeline is GDA601, which is designed to target multiple myeloma. There is strong biological rationale for the augmentation of allogeneic NK cells with a CAR to enhance myeloma targeting. And CD38 is an established immunotherapy to target multiple myeloma. However, CD38 expression on NK cells, which is increased during NK expansion, represents a barrier to the development of a CD38 CAR NK cell therapy. To overcome anticipated targeting or fracture site of NK cells by anti-CD38, we applied CRISPR-Cas9 genome editing to disrupt CD38 protein expression in NK. We combined this with a CD38 targeting CAR designed to enhance killing of CD38 positive myeloma cells, and we have demonstrated this in preclinical studies. We believe that NK cells are a very promising new approach to the treatment of cancers. and we are proud to be at the forefront of the research to advance this powerful technology. I'll now turn the call over to Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our launch readiness for Omidubatel. Michelle?