Gamida Cell Ltd.

Ladies and gentlemen, thank you for standing by. Welcome to Gameta Sales conference call for the third quarter 2022 financial results. My name is Shannon, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gameta Sales requests. Now I would like to introduce your host for today's conference, Heather DeVecchia, Gameta Sales Director, Investor Relations and Corporate Communications. Please go ahead.

Thank you, Shannon, 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 third 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.gometafil.com. Here with me on our call today are Abby Jenkins, President and Chief Executive Officer, Ronit Simintop, Chief Medical Officer and Scientific Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, and Shai Langree, Chief Financial Officer. During this call, we may make forward-looking statements about our future expectations and plans, including in respect to 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 Amadubicel 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 Amadubacel, 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 operations, 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 factor section 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'd like to turn the call over to our recently appointed President and CEO, Abby Jenkins.

Thank you, Heather, and thanks to everyone for joining us this morning. It is an exhilarating time for GametaCell as we mark another quarter of meaningful progress and prepare to shift from clinical to commercial stage with the potential approval of our transformative stem cell therapy candidate, Amidubucel. I would like to start off by saying how excited I am to speak with everyone today on my first earnings call as GametaCell's president and CEO, a role that I assumed in September. I was drawn to GametaCell for three reasons, the mission, the science, and the team. I've worked to bring innovative therapies with the promise of addressing diseases of high unmet need for over 25 years. While many of those products made an impact through treatment or disease prevention, none had the potential to be truly curative. Our mission of developing curative therapies for people with cancer or other serious diseases is incredibly inspiring and is made possible because of our remarkable science. Our NAMM technology both increases the number of stem cells and immune cells and enhances their functionality, enabling us to create potentially transformative cell therapies that go beyond what is possible with the existing approaches. NAM is the power behind AmidubaCell, our lead product candidate, which has breakthrough status and is currently under priority review with the FDA with a PDUFA date of January 30th, 2023. Amidubacil has the potential to transform the treatment landscape for patients in need of a stem cell transplant. Our Phase III clinical data demonstrate Amidubacil significantly reduced the time to neutrophil engraftment from 22 to 12 days versus standard cord blood transplant. Neutrophil engraftment is a key predictor of patient outcomes. Earlier this month, we further showed that in real-world data, Amidubicel produced the shortest median time for neutrophil engraftment of any hematopoietic stem cell transplant option, including that of a match-related donor source. Amidubicel achieved neutrophil engraftment in 10 days as compared with 15 to 20 days for other donor sources. We believe that Amidubicel offers a meaningful new transplant option as the data support that neutrophil engraftment occurs rapidly and is durable maintaining an effect for up to 10 years based on clinical studies. In addition, Omidubacill reduces total days hospitalized post-transplant, which improves outcomes while reducing costs to the healthcare system. If approved, Omidubacill will be the first FDA-approved allogeneic hematopoietic stem cell therapy to address an expanding unmet need for patients with blood cancers in need of a stem cell transplant. NAM is also the power behind our pipeline of allogeneic NK cell therapies, including our clinical stage therapy, GDA201. Ronit will be going into more details in this regard following my remarks. Speaking of, and bringing us to the third reason I was drawn to GametaCell, the team. The advancement of our NAM-enabled cell therapies is possible as a result of our talented team of experienced leaders like Ronit and Michelle, who have successfully developed and launched multiple life-enhancing treatments in hematology and oncology, including cell therapies. We have many experienced and talented team members across GametaCell discovering, developing, and preparing to deliver our advanced cell therapies to patients in need. Let's turn now to Q3 results. This was an important quarter marked by continued progress toward larger inflection points. Our BLA for amidubicel was accepted by the FDA and granted priority review. Beyond amidubicel, we progressed our Phase I-II clinical study, evaluating a cryopreserved, readily available formulation of GDA201, our lead NAM-enabled NK cell therapy, for the treatment of follicular and diffuse large B-cell lymphomas. GDA201 holds tremendous promise, and we look forward to its continued progression in the clinic. Beyond GDA201, we continue to be excited by our NK pipeline of cell therapy candidates, and we believe our NAM technology increases targeting, potency, and persistence of a broad range of innate and adaptive cell types, including NK cells. However, we are going to hold on selecting the next IND candidate from the NK pipeline at this time to both prioritize resources to the commercialization of Amidubicel and advancement of GDA201, as well as enable development activities on these canned visits to further progress. Next, we highlighted promising preclinical and clinical results across our pipeline at multiple medical and scientific meetings, including CoreBlood Connect, the Society of Hematologic Oncology, and the Society for Immunotherapies of Cancers. Additionally, we strengthened our financial position with a public offering in September 2022, raising $20 million as well as obtaining a commitment letter from Highbridge Capital for a $25 million senior secured convertible term loan. With this capital raise and with our FDA review of Amidu Bissell progressing on track, we are accelerating into launch mode. Michelle will provide more details on this very important initiative later on the call. I believe Gimita Cell is a company that is poised for long-term success. And I want to thank my predecessor, Julian Adams, for his vision and leadership in bringing the company to where it is today. Julian leaves us an incredible legacy of scientific innovation, which enabled us to develop assets like Ami Dubassell and GDA 201. We are grateful to continue to benefit from his guidance on our board of directors and wish him well in his retirement. I would also like to take an opportunity to commend my new colleagues. I am continually inspired by your teamwork and dedication with our important work every day, and that you're putting patients first in all we do as we advance on our mission. Additionally, I would like to sincerely thank all of the clinical trial sites and the patients and their families that have been such important partners as we advance our pipeline of NAM-enabled cell therapies. We believe we have a truly transformative therapy with Omidubacill, and we are motivated every day by the meaningful impact it can have on patients' lives. With that, I will now turn the call over to Roni to take us through key data supporting our NAM-enabled cell therapies. Roni?