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Cellectis Inc.
5/13/2022
Greetings and welcome to the Selectus first quarter 2022 corporate update and earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Arthur Stril, Chief Business Officer for Selectus. Please go ahead, sir.
Good morning and welcome everyone to Selective First Quarter 2022 Corporate Update and Financial Results Conference Call. Joining me on the call today with prepared remarks are Dr. Andre Choulika, our Chief Executive Officer, Dr. Carrie Brownstein, our Chief Medical Officer, and Dr. Bing Wang, our Chief Financial Officer. Yesterday evening, Selectis filed its entering report and issued a press release reporting its financial results for the first quarter and three-month period ended March 31, 2022. The report and press release are available on our website at selectis.com. As a reminder, we will make statements regarding Selectis' financial outlook in addition to its manufacturing, regulatory, and product development plan. These forward statements which are based on our management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent Form 20-F filed with the SEC and the financial report, including the management report, for the year ending on December 31, 2021, and subsequent filing Selectis makes with the Securities Exchange Commission from time to time. I would now like to turn the call over to Andre.
Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Selectis made progress with our pipeline this quarter. We took a notable step forward with the first preclinical data on UCAR-T 20 by 22, the allogenic dual CAR-T cell product candidate being developed for patients with relapsed or refractory non-Hodgkin's lymphoma or NHL. We are proud to see that the data demonstrated a robust preclinical proof of concept with strong activity against tumor cell lines expressing either a single antigen CD20 or CD22, or both simultaneously. We remain on track to file an investigational new drug for UCAR-T 20x22 this year. UCAR-T 20x22 is expected to be Selectiv's first product candidate with fully integrated in-house development. This showcases our transformation into an end-to-end cell and gene therapy company from discovery and Preclinical Development to Product Development and Transfer into GMP Manufacture and to Clinical Development. We were proud to announce two back-to-back publications in Nature Communications, providing strong validation of UCRT123 to treat acute myeloid leukemia, or AML, and plastic plasmacydoid dendritic cell neoplasma, or BPDTN. This is the first preclinical data published on UCAR T123 that supports our rationale for evaluating these allergenic UCAR T123 in the clinic. While the few CD123 T-cell therapy evaluated to date rely on autologous approaches with complex clinical and logistical challenges, this set of preclinical data strongly support the potential benefits of the allogenic CAR T approach in AML and BPDCN. We are proud of these results that reinforce our commitment to cancer patients, specifically in very hard to treat diseases like AML and our mission to address unmet medical needs. Our partnerships provide to be an exciting highlight for Selective. In January, Allogene announced that the U.S. Food and Drug Administration removed the clinical hold on their clinical trials, which was announced on October 2021. Allogene reported that after investigation, it was determined that the chromosomal abnormality detected in some CAR-T cells of the single patient treated with Allo501A was unrelated to tailline gene editing in these cells. Allogene is now focused on initiating their pivotal trial of Allo501A in third-line large B cell lymphoma around middle of this year, pending SDA discussion, and continue to enroll in the phase one portion of the study to offer Allo501 to patients in need. Enrollment has previously resumed in trial targeting BCMA for patients with relapsed or refractory multiple myeloma and targeting CD70 for patients with advanced or metastatic clear cell renal carcinoma. This quarter, our partner, Iovan, announced that the U.S. FDA allowed an IND to proceed for its first tailline-edited tumor infiltrating lymphocyte, or TILT, therapy using selective technology to develop next-generation TILT therapy. This provides a significant opportunity to deliver the combination of TIL and immune checkpoint inhibition within single genome-edited TIL therapy in multiple solid tumor types. We look forward to continuing our collaboration with Ioban. In April, we also received $20 million of convertible note in payment of the upfront collaboration consideration for our partner, Cytovia Therapeutics. The nodes will be converted into common stock upon completion of the announced business combination between Cytovia and Isleworth Healthcare Acquisition Corp., a special purpose acquisition company, or SPAC. Electis is developing custom tailings for Cytovia to develop gene-edited introduced pluripotent stem cells or IPS-derived natural killer cells. These announcements reiterate once more that Palin is a technology of choice for gene editing, which continues to provide the company with expanded business opportunities. As I stated in our last earning call, Selectis made a meaningful leap toward becoming one of the few end-to-end cell and gene therapy companies. With our two manufacturing sites fully operational in Raleigh, North Carolina, and in Paris, Select this plan to initiate dosing of patients in the Bally 01 trial with clinical supplies of UCAR T22 manufactured in-house in Raleigh and UCAR T20 x 22 in North Hodgkin lymphoma trial during the second half of 2022. At Milestone, our entire company has been working towards this year. Based on our current plan, we anticipate our cash runway takes us into early 2024. Now, I would like to turn the call over to Dr. Carrie Brownstein, our Chief Medical Officer, to give an overview of our three sponsored clinical trials and preclinical product pipeline. Carrie, please go ahead.
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