Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to the Gameta Sales Conference call for the full year 2022 financial results. My name is Catherine, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gameta Sales request. I would now like to introduce your host for today, Mike Koskowski of Gameta Sales Corporate Communications. Please go ahead.

Thank you, Catherine, 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 2022. Earlier this morning, we issued a press release summarizing our financial results and providing a business update, which is available on our website at www.cometacell.com. Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Ronit Simantov, Chief Medical Officer and Scientific Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Lankry, Chief Financial Officer. During this call, we may make forward-looking statements about our future expectations and plans, including with respect of the timing and 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 Amaduvacil by the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gametacel's product candidates, including GDA201 and Amadugacel, 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, the scope, progress, and expansion of our clinical trials and impacts to the cost thereof, scientific, clinical, 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 factor sections of our most recent quarterly report on Form 10Q 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'll turn the call over to our president and CEO, Abby Jenkins.

Thank you, Mike, and everyone who is joining us this morning. I want to start this call by grounding us in GametaCell's mission. When I joined the company last September, I was drawn to the commitment to discovering, developing, and delivering advanced cell therapies that offer patients with cancer hope for cures. In our industry, particularly when we are focused on talking about our earnings, we talk extensively about our science, potential indications, manufacturing, go-to-market plans, and projected revenues. As we do that, it's good to remember the North Star of unmet patient needs. Gametacel was founded to pursue those needs, and it elected to do so in one of the most challenging areas of medicine and science, stem cell transplants. We believe we have the opportunity to potentially save lives with our science, and so we aim to keep our focus squarely on that goal as we make decisions about how to move forward as a company. Our belief has been and remains that Gametacel represents a compelling investment thesis. We have a robust short-term catalyst in the pending FDA approval of Amidubacil, our lead product candidate, and great long-term potential in our pipeline of natural killer cell therapies, including clinical stage GDA201 and our three engineered preclinical NK cell therapy candidates. In recent weeks, we've had positive data presented on both OmniduvaCell and GDA201 at the Transplantation and Cellular Therapy or TCT meeting, showing why we believe we are on the right path to bring meaningful innovation to patients with hematologic malignancies. Our intrinsic NK cell therapies, which are derived from healthy human donors, are differentiated from other NK approaches and have data showing that they may not only stimulate direct cytotoxic effects, but may trigger a response from the adaptive immune system, which is very promising. Unfortunately, we are in an extremely challenging economic environment. In our last earnings call, we guided a cash runway to the middle of 2023 and thus need to ensure that while we continue to pursue fundraising in support of bringing AmiDubicel to patients if approved, we also reduce expenses to preserve our cash runway. Therefore, today, we are taking decisive action with a strategic restructuring to prioritize our organizational efforts and resources around the commercial launch of AmiDubicel. We are doing this because AmiDubicel has significant clinical evidence that it may increase access and improve outcomes for patients in need of an allogeneic stem cell transplant. If approved, amibibicel will be the first advanced cell therapy for stem cell transplant and may mark the only hope for the approximately 1,200 patients that go untransplanted each year, including those who are ethnically or racially diverse. The safety profile of Omidubacill in our Phase III clinical study was consistent with the expected toxicities of an allogeneic stem cell transplant following conditioning therapy, and there was no increase in adverse events, serious adverse events, or infusion reactions in the Omidubacill arm compared to control. We've had productive interactions with the FDA, including a recently completed late-cycle meeting earlier this quarter and a pre-licensing inspection of our manufacturing facility in the fourth quarter of 2022 with no 483 observations to date, significantly de-risking our path to approval. We've had positive interactions with patients, transplanters, and advocacy leaders in the stem cell transplant space encouraging us that they are looking forward to having the opportunity to have Amidubacil as a new alternate donor source. We believe Amidubacil can fulfill our mission of having a meaningful, potentially life-saving impact on patients. With today's announcement that we are strategically restructuring the organization to dedicate the vast majority of our resources to bring Amidubacil to patients in the U.S., we've made the difficult decision to discontinue development of our early pipeline candidates, GDA301, 501, and 601. We will, however, continue enrollment in our phase one clinical trial of GDA201. Let me be clear. We believe in the scientific and therapeutic potential of these candidates. In fact, now more than ever, based on the data presented at the recent medical meeting. These changes are being made solely for economic reasons. Further to these changes, we will implement a headcount reduction of 17% beginning this week and extending into the second quarter, with the majority of impacted headcount tied to the discontinuation of our NK preclinical pipeline development. We will also close our operations in Jerusalem and consolidate Israeli operations into our state-of-the-art manufacturing site in Kiryat Gat. Finally, we will slow our ramp of hiring and expenses related to the launch of Amidu Basel. These measures collectively will extend our cash runway through the third quarter. We believe these changes will make ComidaCell a more focused, prioritized, and attractive investment opportunity and create a path for near-term value creation with the potential approval and launch of Omidubacill. While we will be focused on bringing Omidubacill to patients in the U.S. if approved in May, We will also explore strategic options, including potential U.S. and global partnerships that may enable us to do so with a more significant level of investment than our current resources allow. This has been an extremely difficult decision. Our team has worked hard on the discovery work to support these NK programs and prepare for the launch of AmiDubasel in a more robust manner. We are encouraged by the initial clinical efficacy and safety profile of GDA201 and our preclinical pipeline. But we must take these steps to sustain the company and position ourselves to bring Omidubacill to the patients who need it. Finally, last week we announced the appointment of Shawn Klein Tomasello as chairwoman of our board of directors. Shawn, who has been on our board since 2019, is a highly respected and seasoned biotech executive with tremendous experience in all dimensions of our industry, including corporate strategy and commercialization of innovative hematology, oncology, and cell therapy products. On behalf of the board and the entire company, we thank Robert Blum, our previous chairman, for his dedicated service over the past five years and look forward to Sean's leadership as we approach our May 1st PDUFA date. These changes, both the strategic restructuring of the company and the evolution of the board support our transformation from a clinical stage to commercial stage company. Now I'll turn the call over to Ronit to take us through key data supporting Omidubacill as we prepare for approval and commercialization. Ronit?