Gamida Cell Ltd.

Again, ladies and gentlemen, this is the operator speaking. Today's conference is scheduled to begin shortly. Please continue to stand by, and we thank you for your patience. Thank you. Thank you. Ladies and gentlemen, thank you for standing by. Welcome to the Media Cells conference call for the first quarter 2021 financial results. My name is Ludi, and I'll be your operator for today's call. Please be advised that today's call is being recorded at the Media Cells request. Now I would like to introduce your host for today's conference, Mr. Josh Hammermesh, Chief Business Officer. Please go ahead.

Thank you, Ludi, 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 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.gomitacel.com. Here with me on the call today are Julian Adams, Chief Executive Officer, Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, and Shai Lankri, Chief Commercial Officer. Ronit Simantav, our Chief Medical Officer, and Tracy Lodi, Chief Scientific Officer, are also on hand for the question and answer portion of the call following our prepared remarks. During this call, we may make forward-looking statements about our future expectations and plans, including clinical development and commercial objectives, the therapeutic potential of our product candidates, our operational plans and strategies, and projected operating expenses and cash runway. Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factor section of our Form 20F and in other filings that give me the cell makes 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. Those of you who have been following our progress know that Gametacel is approaching a major inflection point in the company's history as we approach a BLA submission later this year and prepare for the potential product launch of what could be the first ever FDA-approved bone marrow transplant graft product for blood cancer patients in need of a stem cell transplant. At GametaCell, we are dedicated to advancing two cell therapy programs that leverage our proprietary NAM cell expansion platform with the potential to redefine standards of care for patients with blood cancers and serious immunologic disorders. This platform continues to demonstrate compelling results in clinical trials based on critical features such as cell expansion, functionality, and safety, all leading to improved patient outcomes. 2021 has gotten off to a strong start, marked by continued progress across our pipeline towards key milestones. We continue to be encouraged by the clinical profile of our product candidates, Omidubicel and GDA201. Omidubicel has the potential to transform medical practice for patients with hematologic malignancies and be the first FDA-approved cell therapy for bone marrow transplant. Commercial preparations are ongoing as we work towards submitting the BLA in the fourth quarter of 2021. Our second candidate in clinical development is GDA201. an advanced cell therapy that utilizes our NAM cell expansion technology to harness the power of the innate immune system and has demonstrated remarkable results in patients with non-Hodgkin lymphoma, specifically follicular lymphoma and diffuse large B-cell lymphoma histologies. This past quarter, we continued to make progress toward the production of a cryopreserved product to support a multicentered Phase I-II trial later this year. Additionally, we are excited about the progress we are making in our R&D activities to pursue the development of genetically modified NAM expanded NK cells. This morning, we will review both programs and summarize our progress around plans to bring Omadugazel to patients in the commercial setting pending FDA approval. Let me share More details with you starting with our lead program, Omadubacil, which as a reminder has FDA breakthrough therapy designation as well as orphan drug status. Our successful phase three trial demonstrated, meeting both primary and secondary endpoints, that Omadubacil addresses a key unmet need for patients in need of a bone marrow transplant. by expanding the CD34 positive stem cells and creating a suitable dose of highly functional cells. We are on track to submit the BLA for Omidubacil to the FDA in the fourth quarter of this year and meet the anticipated commercial supply needs. As we continue to advance Omidubacil for a potential launch and prepare to become a commercial organization, we have taken important steps to establish key commercial capabilities including the creation of Gameta Cell Assist, a program designed to support a positive patient and transplant center experience. And Michelle will elaborate further on this effort. Moving to the rest of our pipeline, we are thrilled by the emerging profile of GD8201, our first lead candidate from our NAM expanded NK cell program. Natural killer cells are innate immune cells that hold tremendous promise as an approach for treating cancer. By leveraging our NAM technology to expand NK cells derived from healthy adult donors while enhancing their functionality, we believe GDA201 improves NK cells' direct tumor cell killing as well as antibody-dependent cellular cytotoxicity, known as ADCC. In a Phase I trial, GDA201 demonstrated impressive proof-of-concept and striking early signs of efficacy with multiple durable complete responses while being very well tolerated in heavily pretreated patients with relapsed or refractory lymphoma. The study was designed to assess the safety of GDA201 in combination with rituxan in non-Hodgkin lymphoma. As a result of these encouraging data, we developed a GMP cryopreserved formulation and have initiated manufacturing runs in preparation for a multicentered study with an off-the-shelf allogeneic cell therapy in patients with lymphoma. Based on the significant clinical activity we've seen so far in the Phase I trial, we plan to submit an IND for GDA201 in the second half of this year to enable our Phase I-II study in lymphoma patients with follicular lymphoma, or diffuse large B-cell lymphoma. Additionally, we are maximizing the potential of our NAMM technology platform to develop a pipeline of gene-edited NK cell therapies with enhanced function for both hematological malignancies and solid tumors. I want to conclude my introductory remarks by thanking our employees for their hard work and dedication, and I continue to be impressed by the progress we are making bring potentially life-saving therapies to patients. I'll now turn the call over to Michelle Corfin, our Chief Operating Officer and Chief Commercial Officer, who will talk more about our launch readiness for Omidubacil. Michelle?