Gamida Cell Ltd.

And I'll be your operator for today's call. Please be advised that this call is being recorded at Gamita Sales Request. Now, I would like to introduce your host for today's conference, Heather DeBacchia, Gamita Sales Director of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Livia, 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 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.gomeda-cell.com. Here with me on the call today are Julian Adams, Chief Executive Officer, Ronit Simantoff, our Chief Medical Officer and Scientific Officer, Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Shai Linkreit, 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 preclinical and clinical trials of our product candidates, regulatory filings, including the review of the BLA for Amidubicel by the FDA, commercialization planning efforts, the potential life-saving or curative therapeutic and commercial potential of Gametacel's product candidates, including GDA-201 and Amidubicel, and our expectations regarding our projected cash, cash equivalents, and investments to be used for operating activities. 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 operation, the scope, progress, and expansion of our clinical trials and impacts to the cost thereof, clinical, scientific, regulatory, and technical developments, 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 factors section of our most recent quarterly report on Form 10-Q 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 or future events, except as required by applicable law. Now I'd like to turn the call over to Julian.

Thank you, Heather, and thanks to everyone for joining us this morning. This was an extraordinary quarter for GametaCell as we continue our momentum into the second half of 2022, focused on delivering on multiple milestones and accomplishments for all our stakeholders. All that we have accomplished this quarter continues to lay the groundwork for even larger inflection points, advancing towards the potential commercialization of our first NAM-enabled cell therapy candidate, Omidubacill. Continuing the development of our lead NAM-enabled cell therapy candidate, GDA201, for patients with lymphoma who need new treatment options. Developing our expanding pipeline of genetically modified NAM-enabled NK cell therapy candidates supported by robust preclinical data, and exploring future opportunities that leverage our proprietary nanotechnology across a broad range of innate and adaptive immune cells. Recently, we announced our Omidubacill Biologics License Application, or BLA, was accepted by the FDA and granted priority review with a PDUFA date of January 30th, 2023. We are pleased to have received priority review, which validates the importance of Omidubacill for patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. As a reminder, Omidubacill has breakthrough therapy designation as well as orphan drug status. With the U.S. review underway, we are continuing with our preparations to support a potential commercial launch. If approved, Omidubacill has the potential to achieve 20 to 25% of the addressable market at peak market share by improving outcomes for patients based on our encouraging clinical data and increasing access, especially for patients who are eligible for transplant but cannot find a match. This 20 to 25% equates to 2,000 to 2,500 patients treated in the U.S. each year. Michelle will provide additional detail on our launch strategy and plans later in this call. Beyond Omidubacill, we also announced the dosing of our first patient in our company-sponsored Phase 1-2 clinical study evaluating a cryopreserved, readily available formulation of GDA201, our lead program in our expanding NAM-enabled NK pipeline for the treatment of follicular and diffuse large B-cell lymphoma. We continue to be encouraged by the results observed in a Phase I investigator-sponsored study of the fresh formulation. Ronit will provide additional detail on the Phase I-II study supporting GDA201. Our continued focus on patients and our vision for advancing potentially curative cell therapies has never been more important. Prior to turning the call over to Ronit, I'd like to thank my colleagues at GametaCell for their dedication to our mission. Additionally, GametaCell would like to sincerely thank the clinical trials sites and the patients and their families that have been such important partners as we advance our pipeline of NAM-enabled cell therapies. With that, I'll turn the call over to Ronit.