Gamida Cell Ltd.

Gentlemen, thank you for standing by. Welcome to the Gameta Sales Conference call for the third quarter, 2021 financial results. My name is Henry, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gameta Sales Request. Now I would like to introduce your host for today's conference, Mr. Josh Hammermesh, Chief Business Officer. Sir, please go ahead.

Thank you, Henry, 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 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 Simontov, our Chief Medical Officer, Michelle Corfin, Chief Operating Officer and Chief Commercial Officer, Shai Lankrey, Chief Financial Officer, and additionally, Jazz Uppel, our Chief Regulatory and Quality Officer, will join for the Q&A session following our prepared remarks. 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 Omidubacil to the FDA, commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Omidubacil, and our expectations regarding our projected cash to be used for operating activities and cash runways. our actual results may differ materially from what we project today due to a number of important factors, including the impact of COVID-19 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 products, 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 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, Josh. And thanks to everyone for joining us this morning. This was an important quarter for GametaCell as we continue to advance our mission of bringing potentially curative cell therapies to cancer patients. We are at a crucial inflection point in the field of cell therapy, where we are starting to see multiple development programs that offer the potential for clinical benefit for patients with hematologic malignancies and serious blood disorders. I am proud that GametaCell is at the forefront of this research with our two advanced clinical stage NAM-enabled cell therapy programs, Omidubacill and GDA201. We also recently expanded our pipeline of genetically modified NAM-enabled NK cell constructs and we are excited about sharing new data and developments on our cell therapy pipeline at multiple major international medical meetings this quarter. Let me start today's call with an update on our lead program, Omidubicel, which has breakthrough therapy designation and the potential to be the first FDA-approved cell therapy for hematopoietic stem cell transplants. Omidubacil is supported by a robust body of evidence, including positive Phase III results, demonstrating strong efficacy and important benefit to patients in need of a bone marrow transplant. We recently had a pre-BLA meeting during which the FDA requested that Gametacel provide revised analysis of the analytical data generated by at GametaCell's wholly-owned commercial manufacturing facility in Israel to demonstrate comparability to the Omidubacill batches that were produced at the clinical manufacturing sites for the Phase III study. We are confident that we can execute the analytical comparability that the FDA has requested in a timely manner to enable a BLA submission in the first half of 22. It is also important to note that the FDA did not request additional clinical data to initiate the BLA submission once analytical comparability is demonstrated. In collaboration with the FDA, we will work towards our BLA submission to bring Omidubacill to patients as soon as possible. Moving to our NK cell pipeline, it is extremely exciting to be at the front at the forefront of the cutting edge research that is being conducted in the emerging field of NK cell therapy. NK cells have tremendous promise for treating cancer. NK cells are the body's first line of defense, providing innate immunity and have immune privileged properties that obviate the requirement for donor matching, which can lead to a cryopreserved off-the-shelf product for patients. The most advanced candidate in our NAM-enabled NK pipeline, GDA201, leverages our proprietary NAM technology platform in the expansion of NK cells to enhance their functionality, direct tumor cell killing properties, and antibody-dependent cellular cytotoxicity, or ADCC. GDA201 has produced truly remarkable results in a phase one investigator-sponsored study where we have seen very high and durable responses in both follicular lymphoma and diffuse large B-cell lymphoma. As we have previously reported, the phase one study had an overall response rate of 74% and 68% complete response rates. And an impressive duration with several patients maintaining their complete responses for over two years after treatment. During the third quarter, we submitted an IMD application to the FDA for a Phase I-II trial with cryopreserved formulation in patients with diffuse large B-cell lymphoma and follicular lymphoma. Before initiating our clinical study, we must address the clinical hold by responding to the FDA's questions about donor eligibility procedures and sterility assay qualification. We believe these questions are addressable, and we plan to respond expeditiously to enable IND acceptance and patient enrollment. Due to the clinical hold, the initiation of the Phase I-II trial will occur in 2022. We will provide an update and additional guidance on timing when we have further clarity from the FDA. This quarter, we made progress advancing our genetically modified NAM-enabled NK cell therapy programs, which utilize CAR and CRISPR-mediated strategies to increase targeting, potency, and the persistence against hematologic malignancies and solid tumors. We were excited to highlight these new programs at an R&D day in October. Importantly, we are pleased to announce a research collaboration with the Dana-Farber Cancer Institute for our GDA601 cell therapy, which is a CD38 CRISPR knockout combined with a CD38 CAR-NK cell construct that has demonstrated promising preclinical results against multiple myeloma cell lines. Together with Dana-Farber, we will be studying the great potential of GDA601 in multiple myeloma. Our NAM-enabled NK product candidates hold tremendous promise for both hematologic cancers and solid tumors, and we look forward to advancing our work in this very important field. I want to conclude my introductory remarks by expressing my gratitude to our employees for their dedication and hard work towards driving forward our important mission. Their continued determination and focus on patients have brought us to where we are today. And with that, I will turn the call over to Ronit Simintel, our Chief Medical Officer.