Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to GamidaCell's conference call for the first quarter 2022 financial results. My name is Carmen, and I'll be your operator for today's call. Please be advised that this call is being recorded at GamidaCell's request. Now I would like to introduce your host for today's conference, Heather DiBecchia, GamidaCell's chief of staff. Please go ahead.

Thank you, Carmen, 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 first quarter of 2022. 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. Please note that unfortunately, our Chief Executive Officer, Julian Adams, is unable to join us this morning due to contracting COVID-19. Company operations are unaffected, and Julian has advised us that his symptoms are improving and he expects to recover shortly. With that, here with me on our call today are Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, Ronit Simontov, our Chief Medical Officer and Chief Scientific Officer, and Shai Langree, our 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 Amidubacil to the FDA, commercialization planning efforts, the potential life-saving or curative therapeutic and commercial potential of Gametacel's product candidates, including GDA201 and Amidubacil, 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 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 reports on Form 10-K 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 Michelle.

Thank you, Heather, and thank you to everyone for joining us this morning. GametaCell had a productive quarter as we made important progress across all areas of our company. We continue to build momentum as we head into several inflection points expected this year, most near-term being the full BLA submission from AmadupaCell, which we are on track to complete in the second quarter of this year. Additionally, our GDA 201 program advanced, marked by the recent clearance by FDA of our IND and removal of the clinical hold for the cryopreserved formulation. We are excited to have reached this milestone and are now moving forward with our plans to initiate a company-sponsored Phase 1-2 study in patients with follicular and diffuse large B-cell lymphomas, which Roni will provide additional detail on. Beyond GDA201, which is our lead program in our expanding NAM-enabled NK cell pipeline, We are also looking forward to announcing a new product candidate from our genetically engineered NAM-enabled NK cell constructs later this year. We recently announced preclinical data at the ISCT conference supporting the development of GDA301 and GDA601. It's an exciting time in gametocel development, and we are focused on advancing our pipeline of potentially curative cell therapies. Our continued commitment is demonstrated by the new and recent data on Amaduba Cell that we presented this quarter, focused on Amaduba Cell's encouraging clinical data and our health economic efforts, which we will comment on later on in the call. With all we have accomplished only this past quarter, but also in the last few months, we are poised to be a leader in the development of NAM-enabled cell therapies with two promising and important clinical programs, and a robust pipeline of genetically modified NK cell product candidates in preclinical development. The progress we achieved this quarter continues to add to the important foundation that we have established. This strong foundation is due to our dedicated employees and their continued focus on patients and our vision of advancing therapies to help address unmet needs. With this, I will now turn the call over to Ronit.