Cellectis Inc.

Greetings and welcome to the Selectives Q3 2020 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, Simon Harness, Senior Vice President, Strategy and Finance.

Thank you and welcome everyone to Selective Third Quarter 2020 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. Kerry Brownstein, our Chief Medical Officer, and Eric Dutton, our Chief Financial Officer. Yesterday evening, Selectis issued a press release reporting our financial results for the second quarter and the September 30th, 2020. The press release is available on our website at selectis.com. As a reminder, we will make forward-looking statements regarding financial outlook in addition to regulatory and product development plans. These statements 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 20F filed with the SEC and the financial report, including the management report for the year end of December 31st, 2019 and subsequent filing Selectus makes with the Securities Exchange Commission from time to time. I would now like to turn the call over to Andre. Andre, please go ahead.

Thank you, Simon. Good morning and thank you everyone for joining us today. Yesterday, Selectus as well as our sub-licensee Allogene announced a series of clinical updates in the form of abstracts selected for all presentations at the upcoming ASH Conference. These abstracts will be the main subject of today's call and our Chief Medical Officer, Dr. Kerry Brownstein, will summarize these data in detail, followed by an update on our financials from our Chief Financial Officer, and Eric Dutton. As a quick overview, SelectisYesterday announced an abstract on an early interim clinical data readout of Bally01 study investigating UCAR-T22, one of our wholly controlled allogenic CAR-T cell programs. This data set has been selected for an old presentation at the upcoming ASH conference in December. This abstract provides entering data on the first two dose cohorts of the BALI-01 dose escalation clinical trial of UCAR-T22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Already, at the first dose level of the 100,000 cell core karyogram with the standard fludarabine and cyclophosphamide lymphodepletion regimen, Without allanthuzumab, two out of three patients achieved a best response of complete remission, or CR, and a second patient with a CR with incomplete hematologic recovery. We also announced a second abstract selected for trial-in-progress poster presentation of our AMELI-01 Phase I Dose Escalation Study of UCAR T123 in relapsed refractory AML patients. We have cleared the first two dose levels and are progressing to DL3 and we are looking forward to presenting clinical update when available. Our strategy moving forward is to give regular updates on clinical milestones for our lead allogenic CAR T cell programs UCAR-T22 in the BALI-01 study in BALL and UCAR-T123 in the AMILY-01 study in ANA. We are about to start those cohorts for both studies with the addition of alamthusinab to the fludarabine plus cyclophosphamide lymphodepletion regimen. A patented invention of Selectif utilizing our gene editing platform to knock out the CD52 gene in allogenic CAR-T cells. Our third wholly controlled program, UCAR-T-CS1, is in its first dose cohort in patients with relapsed refractory multiple myeloma in the MELANIE-01 study. While the study is currently on clinical hold, who have responded to the questions of the FDA and are waiting for an agreement on the proposed path forward. We believe we have a straightforward plan to get this promising candidate back on track in clinical development and we will share any updates as soon as available. Our sub-licensee, Allergy and Therapeutics, yesterday announced and Mastrax selected for oral presentation at ASH under universal trial investigating Allo 715 in relapsed refractory multiple myeloma patients. Allo 715 is an allogenic CAR T cell product candidate targeting BCMA, which is exclusively licensed from Selectus to Allogene. The virtual presentation will include data on approximately 20 patients available for efficacy across Allo 715 cell dose cohorts and lower dose at 39 mg of Allo 647 as well as patients available for efficacy who are treated with higher doses of Allo 715 and higher doses of Allo 647. We are impressed with the initial response rate in this first-in-class allogenic CAR-T approach and are excited for the future of this program. A quick word on our alliance regarding the CD19-targeted allogenic CAR-T cell program. Allogene continues enrollment in the phase 1 alpha and alpha 2 trials, expecting a rich data set to emerge. Pending data, Allogene's current plan is to initiate the potential pivotal phase two trial of Allo 501A in 2021. Furthermore, Allogene announced its plan to submit three additional IND applications in the coming months, expanding clinical development of targets under our license agreement. This includes the first solid tumor target with Allo 316, targeting CD70 by the end of 2020, as well as the expansion of the BCMA franchise with Allo 715 in combination with Mirogestat by the end of 2020. and Allo6105, a new BCMA turbo CAR T in multiple myeloma will be filed in 2021. Although the year 2020 has created a challenging environment for virtually every aspect of professional and personal life, we have immediately adapted to this new environment. I'm excited to announce that our in-house manufacturing site in Europe and in the United States are on track to start production by year 2020 and year 2021 respectively. This is a major milestone for Selectis in becoming an independent gene and cell therapy manufacturing powerhouse. With that, I would like to hand the call over to Dr. Carrie Brownstein, our chief medical officer, who will go into more details on the ASH abstracts for our proprietary clinical program. Kerry, please go ahead.