Cellectis Inc.

Good morning everyone and welcome to Selective's fourth quarter 2021 and year end conference call. At this time all participants are in a listen only mode. Later we will conduct a question and answer session. Instructions will follow at that time. Please be aware that today's conference call is being recorded. I would now like to introduce the first speaker, Arthur Shrill, Chief Business Officer. You may begin.

Good morning and welcome everyone to SELECTIS Fourth Quarter 2021 Year-End 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. Carrie Brownstein, our Chief Medical Officer, and our new Chief Financial Officer, Dr. Bing Wang. Yesterday evening, Selective filed its annual report and issued a press release reporting its financial results for the fourth quarter and year ended December 31st, 2021. The report and press release are available on our website at selective.com. As a reminder, we will make statements regarding Selective's financial outlook in addition to its manufacturing, regulatory, and product development plans. These forward-looking 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 31st, 2021, and subsequent filings Selectus 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. 2021 was a productive year for Selectus. We are proud of the progress we've made as it relates to our corporate milestones as we evolve to become full end-to-end cell and gene therapy by a pharmaceutical company. We have progressed on the clinical front with escalating doses of our product candidates. We completed our manufacturing plans, and that gives us control of product's quality and supply line. We continue to innovate. We have been working on our first dual-targeted UCART product. your CAR T20 by 22, and plan to bring it to the clinic in 2022. We have been able to leverage our valuable talent platform to provide selectives with business opportunities in the future cell therapy field outside of our core allogenic CAR T area. Regulatory issues that had posed some of our partner programs have been resolved, It is clear that none of these issues are due to select this Palin technology. And our financial position is secure. Based on our current plans, our cash takes us not just through 2023, but to early 2024. First, I will touch on some of the clinical progress. Kerry Brownstein, our Chief Medical Officer We'll give additional details later. We have trials running in three different forms of hematological cancers. At the annual meeting of the American Society of Hematology held in December 2021, we released encouraging preliminary efficacy and safety data from our BALI-01 trial evaluating UCAR-T22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. These patients received fludarabine, cyclophosphamide, and alemtuzumab as lymphodepletion regimen and provides us strong confidence that we are moving into the right direction. These results showed that our preconditioning regimen that includes alemtuzumab was well tolerated. and promoted the expansion of clinical activity of our UCAR-T22 in patients with relapsed or refractory B-cell lymphoblastic leukemia. Currently, in the BALI-01 trial, we are enrolling patients at the highest dose so far, dose level three. We also added alimtuzumab to the preconditioning regimen in another blood cancer clinical trial Amelie 01 in acute myeloid leukemia. So in the clinic, we're moving into 2022, confident in our ability to execute our ambitious new program focused on product development and patient recruitment into our three ongoing multicenter dose escalation clinical trial, Valley 01, Amelie 01, and Melanie 01. We also plan to file a new IND for our new product candidate, UCAR T20 by 22, for patients with relapsed refractory, not Hodgkin's lymphoma. With this roadmap, our cash runway takes us into Q1 2024. Let's turn now to the progress we have made in manufacturing. In 2021, Selectus made a meaningfully powered becoming one of the few end-to-end cell and gene therapy companies. Back in 2018, Selectis made the decision to internalize the manufacturing of its therapeutics product candidates, providing the company with independence and a stronghold over its cell and gene therapy processes. We are thrilled to say that this goal has been achieved in 2021. Our two manufacturing sites in Raleigh, North Carolina, and Paris, France, are both now fully operational. We produce our own cell libraries, our own plasmid DNA, our own messenger RNA. We produce two types of vectors, AAVs and recombinant lentiviruses. We are set up to produce our own clinical-grade allogenic CAR-T cell product. In fact, In the second half of 2022, we plan to initiate dosing patients in the Bally 01 trial with clinical supplies of UCAR T22 manufactured in-house in Raleigh and UCAR T20 by 22 in non-Hodgkin-linked format trial. We're becoming self-sufficient in clinical supplies. This reduces our dependence on outside suppliers. These de-risk suppliers our path to the market. This removes bumps into the road Selectus is positioned to capitalize on clinical and commercial success of its product candidates. I already mentioned our plan to file an IND of a new product candidate, Trucar T20x22, in Mount Hodgkin's lymphoma. This is a very exciting product for at least two reasons. First, UCAR-T 20 by 22 will potentially be our first dual allogenic CAR-T to enter clinical trial. It is designed to hit two validated targets in B-cell malignancy. The product candidate is also the first product candidate Selectus has designed in-house, developed in-house, and manufactured in-house. In addition, the power of UCAR-T 20 by 22 is that it goes beyond overcrowded CD19 antigen on B cells. We believe it's a real allogenic CAR-T alternative to the crowded CD19 targeting protocol. I want to say a word now about our partner product pipeline, which remains important to selectives as a validation of our technology-based source of future revenues. In January this year, Allogene announced that the United States Food and Drug Administration has removed the clinical hold on all of the Allogene's clinical trials, which was announced on October the 7th, 2021. Allogene reported that after investigation, it was determined that the chromosomal abnormality detected in some UCAR cells of a single patient treated with allo501A was unrelated to talon gene editing in these cells. Allogene has announced that it has resumed clinical studies activities on talon gene edited product candidate allo715 and allo605 targeting BCMA for relapsed or refractory multiple myeloma. Allogene has resumed clinical studies activities on tail and gene-edited Allo316 targeting CD70 for advanced or metastatic clear cell renal cell carcinoma and began enrolling patients earlier this month. Allogene also announced that it and its partner, Servier, will resume their clinical activities on CD19, During the 2021 annual meeting of the American Society of Hematology in December 2021, Allogene, in collaboration with Servia, reported that the results from Alpha and Alpha-2 clinical data continue to support the promises Allo 501 and Allo 501a to be safe and durable alternatives to approved autologous CAR-T therapy in patients with relapse or refractory not Hodgkin's lymphoma. Allogene announced its intent to initiate a Phase II pivotal trial on Allo501A in relapsed or refractory large B-cell lymphoma is on track to commence mid-year 2022 pending FDA discussion. On the business development front, The utility of Selectus Taillin gene editing system continued to provide the company with expanded opportunity. In February 2021, we entered into strategic research and development collaboration with Cytovia Therapeutics to develop Taillin gene-edited products in new type of cells, IPSNK and CAR-TNK, for a series of different types of tumors. In November 2021, That collaboration with Cytovia expanded to include a new car target and development in China by Cytovia's joint venture entity, CytoLynx Therapeutics. Financial terms include either cash payment and or equity stake totaling $20 million, depending on the satisfaction of certain conditions by December the 31st, 2021. Delictus is in discussion with Cytovia regarding a potential extension of the deadline for such conditions to be met. The agreement also provides us up to $805 million of development, regulatory, and sales milestone, and a single-digit royalty payment on the net sales of all partner products commercialized by Cytovia. After Allogene and IOVENT's biotherapeutics, partnerships that we have signed. The collaboration with Cytovia in another cell therapy modality highlights TALEN as a gene editing technology of choice for cell therapy application. We have also expanded our general management team and board committee with top talent. Firstly, Selectus recently appointed Dr. Beng Wang, our new chief financial officers. I would like to take this moment to welcome Bing to our executive committee and to select this. Bing is a highly accomplished executive who brings extensive global finance experience in the biotechnology industry, including a background with global public companies in corporate finance. He comes to us from Refuge Biotechnologies, a cell therapy immunology biotechnology company leveraging synthetic biology and gene engineering, where he was co-founder and the chief executive officer. Bing's extensive experience in financing clinical stage biotech companies will be critical as we enter our next stage of development of our clinical trials. Welcome to Selectus team, Bing. Secondly, Selectus appointed Dr. Donald Bergstrom, as an observer on the company's board of director in November 2021. Dr. Bergstrom brings with him 15 years of experience in the biopharmaceutical and medical industry and serves as head of research and development at Relay Therapeutics, the clinical stage precision medicine company. They join a team executive clear plan to transform opportunities in cellular biology to the production of multiple focus clinical candidates. We already have a place of many of the elements that select these needs as if products prove themselves. We have invested in the future, and we have the resources to continue to push forward that future. 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 pre-clinic product pipeline. Carrie, please go ahead.