Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to GametaSales conference call for the fourth quarter and full year 2021 financial results. My name is Howard, and I'll be your operator for today's call. Please be advised that this call is being recorded at GametaSales request. Now I would like to introduce your host for today's conference, Heather DeVecchia, GametaSales Chief of Staff. Please go ahead.

Thank you, Howard, 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 fourth quarter and full year 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.gamedacel.com. Here with me on our call today are Julian Adams, Chief Executive Officer, Ronit Simantoff, our Chief Medical Officer and Chief Scientific Officer, Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Shai Langrey, Chief Financial Officer. During this call, we may make forward-looking statements about our future expectations and plans, including in respect of the timing of 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 Amidubicel to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Amidubicel, 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 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 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 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. Now I'd like to turn the call over to Julian.

Thank you, Heather, and thanks to everyone for joining us this morning. Before I begin, I want to take a moment to acknowledge the major events in the Ukraine that are impacting the world globally over the past few weeks. While we don't have any operations in the Ukraine or Russia and expect minimal impact to our operations, as global citizens, our thoughts are with all those affected. At GametaCell, we are incredibly proud to be part of the significant advancements occurring in the field of cell therapy. as it continues to grow and progress towards cures for patients in need. 2021 was an important year for us as we progressed our two clinical stage NAM-enabled cell therapy programs, Omadubacil and GDA201, both of which hold significant potential to benefit patients suffering from hematologic malignancies and serious blood disorders. We further expanded our NAM-enabled platform with the addition of genetically modified NAM-enabled NK cell constructs, allowing us to leverage our expertise in NK cells to potentially treat various hematologic malignancies and solid tumors. I will start today's call by commenting on our lead program, Omadubacil, which has breakthrough therapy designation and the potential to be the first FDA-approved cell therapy for stem cell transplant. Throughout 2021, we announced several data presentations which contribute to the evidence for Omidubacil's potential efficacy, and also the positive health economic impact of Omidubacil, with data demonstrating a reduction in healthcare resource utilization. As Ronit will describe later on in this call, This reduction in healthcare resource utilization is very important for patients, hospitals, and payers. The robust data that we have generated in support of the potential for Omidubacill led us to our most recent and exciting milestone last month, namely the initiation of the rolling BLA for Omidubacill with the submission of our non-clinical module following the receipt the recent receipt of positive CMC-focused type B meeting correspondence from the FDA. In this correspondence, the FDA confirmed analytical comparability between our wholly-owned commercial manufacturing facility in Israel to the Omiduba cell batches that were produced at the clinical manufacturing sites for the Phase III study. This month, we also submitted our clinical module to the FDA We are on track to submit the remaining modules and complete the full BLA submission by the end of the second quarter. We are thrilled to have reached this inflection point and look forward to working with the FDA to bring Omidubacill to patients as soon as possible. Beyond Omidubacill, we are also developing our NAM-enabled NK cell pipeline, which is led by GDA201, GDA201 leverages our proprietary NAMM technology platform to expand natural killer cells to enhance their functionality, direct tumor cell killing properties, and antibody-dependent cellular cytotoxicity, or ADCC. We are highly encouraged by the potential of GDA201, which has produced truly remarkable results in a Phase I investigator-sponsored study, where we have seen very high and complete durable responses in both follicular lymphoma and diffuse large B-cell lymphoma. In September 2021, we submitted an IND application to the FDA for a phase 1-2 trial with a cryopreserved formulation of GDA201 in patients with diffuse large B-cell lymphoma and follicular lymphoma. Following this submission, we were placed on clinical hold in November of 21 prior to patients being dosed since the FDA had questions about donor eligibility procedures and assay qualification. We are actively working with the FDA to address their comments to enable an IND acceptance and study initiation. This year, we plan to initiate dosing in this Phase I-II study. Moving to our newest product candidates, our genetically modified NAMNK-enabled cell therapy programs. Last year, we were excited to establish a broad pipeline of NK product candidates that utilize CAR and CRISPR-mediated strategies to increase targeting potency and persistence against hematologic malignancies and solid tumors. Robust preclinical evidence gives us the confidence that these new NAM-enabled NK product candidates hold promise as potentially curative therapies for both hematologic cancers and solid tumors. Furthermore, we announced a research collaboration with the Dana-Farber Cancer Institute for GDA601, a CD38 CRISPR knockout combined with a CD38 CAR-NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines. We are excited to leverage the expertise of researchers at Dana-Farber to study the in vitro NK cell killing activity of GD8601 in multiple myeloma. Throughout 2022, we plan to execute preclinical proof of concept studies for these genetically modified NK therapeutic targets. And by the end of 2022, select a pipeline candidate for IND enabling studies. With the progress we achieved in 2021, we are encouraged about what the future holds for Gametacel in 22. And of course, this wouldn't be possible without our employees whose dedication is focused on advancing therapies to help address unmet needs for patients. I am grateful for and proud of their continued determination and focus on patients, which has brought us to where we are today. Before turning the call over to Ronit, I would like to take a moment to congratulate her on her recent promotion, now assuming the role of not only Chief Medical Officer, but also Chief Scientific Officer. We at Gameta thank you all for your contributions thus far, and look forward to your continued work towards division with your expanded role. Ronit?