Cellectis Inc.

Good morning, everyone, and welcome to Selective's fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. Please be aware that today's conference call is being recorded. I'd now like to introduce you to the first speaker, Arthur Strill, Chief Business Officer. You may begin.

Good morning and welcome everyone to select this fourth quarter and full year 2022 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Dr. André Choulika, our Chief Executive Officer, Dr. Bing Wang, our Chief Financial Officer, and Dr. Mark Fratini, our Chief Medical Officer. Yesterday evening, Selectus issued a press release reporting its financial results for the fourth quarter and full year 2022, ended December 31st, 2022. The press release is available on our website at selectus.com. We expect to file the annual reports in the coming days. As a reminder, we will make statements regarding Selectus Financial Outlook, in addition to its manufacturing, regulatory, and product development status, and plans and product development of its licensed partners. 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 Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31st, 2021, and subsequent filing Selectus makes with the SEC 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. 2022 has been a milestone year for Selectus. We have reached key milestones for our clinical trials that we're thrilled to share with you today. In December 2022, selectives presented positive preliminary clinical data from five additional patients from our BALI-01 trial evaluating UCAR22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia, or ALL. In this Phase I-IIa study, the five additional patients received UCAR22 at dose level three after lymphodepletion with fludarabine, cyclophosphamide, and alentuzumab, or FCA pre-conditioning regimen. These results showed evidence of FucRT22 anti-tumor activity observed in three of the five, or 60% of the patients. Overall, these preliminary data support the continued administration of FucRT22 after SCA lymphodepletion in patients with relapsed or refractory B-cell ALL. We're excited by these preliminary clinical responses for ALL patients who have limited, if any, treatment options, especially for those who have failed prior CD19-directed CAR T-cell therapy and allogenic stem cell transplant. UCAR T22 is currently the most advanced allogenic CAR T cell product in development for B cell ALL. We believe that our off-the-shelf treatment approach coupled with our ability to manufacture our UCAR T22 product candidate completely in-house give us a main advantage on market. It potentially maximizes the chances for eligible patients to be treated without delay. In December 2022, we also presented encouraging preliminary clinical data from our AMLE01 study evaluating UCAR T123 in patients with relapsed or refractory acute myeloid leukemia, or AML. The normal session at the American Society of Hematology, the preliminary data showed that adding alimtuzumab to the fludarabine and cyclophosphamide lymphodepletion regimen was associated with sustained lymphodepletion and significantly higher URCAR-T123 cell expansion, which correlated with improved antitumor activity. 25% of patients at dose level 2 in the FCA arm achieved a meaningful response, Exemplary activity was seen in a 64-year-old female with AML who had relapsed after allergenic stem cell transplantation and had maintained a durable minimal residual disease negative complete responses for over one year without salvaged donor lymphocyte infusion. Or second allergenic stem cell transplantation. We're excited by these encouraging clinical data, which are a meaningful step forward for patients and support further enrollment into phase one study. On the business development front, Plectus gene editing system continued to provide the company with expanded opportunities. Plectus has announced a collaboration agreement with Primera Therapeutics to edit mutations in the mitochondrial DNA in vivo to treat the root cause of associated diseases. Primera, together with Selectis, will be co-developing a mitochondrial DNA engineering toolbox that could enable effective therapies for mitochondrial diseases. Our partnership with Primera further showcases and expands the application of our gene editing capabilities into a previously unexplored space. This partnership is very much in line with Selecta's mission to leverage its gene editing technologies to develop potentially life-saving prologue candidates to address unmet medical needs. In October 2022, our licensed partner, iOVAN, announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial of Iovance's first genetically modified tail-in-edited tumor infiltrating lymphocyte, or TIL therapy, for the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma. In December 2022, Selective signed a 40 million credit facility with the European Investment Bank and in the same month received a milestone payment from our licensed partners survey in connection with the phase two trial of Allo501A for patients with relapsed or refractory large B-cell lymphoma. Finally, in February 2023, we were proud to announce the closing of a $25 million equity offering. All the selectives team and I would like to warmly thank the European Investment Bank and our investors for the strong support, and we know now have cash runway into the third quarter 2024. This year, Selectus remains deeply focused on the patient recruitment on our four ongoing phase one clinical trials, Bally 01, Amelie 01, Melanie 01, and Nathalie 01, evaluating UCAR T22, UCAR T123, UCAR TCS1, and UCAR T20 by 22, respectively. With that, I would like to turn the call over to Dr. Mark Frattini, our Chief Medical Officer, who will give an overview of these clinical trials. Mark, please go ahead.