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Cellectis Inc.
8/6/2021
Greetings. Welcome to Selectus' second quarter 2021 earnings call. At this time, all participants will be in listen-only mode. The 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. Please note this conference is being recorded. At this time, I'll now turn the conference over to Eric Dutang, Chief Financial Officer. Eric, you may now begin.
Thank you and welcome everyone to Selectis Second Quarter 2021 Corporate Update and Financial Results Conference Call. Joining me on the call today with prepared remarks is Dr. Andre Choulika, our Chief Executive Officer. Dr. Carrie Brunson, our Chief Medical Officer, and Steve D'Arrest, our Senior Vice President of U.S. Manufacturing, will be joining for the Q&A. Yesterday evening, Selectis filed its interim report and issued a press release Reporting our financial results for the second quarter and six-month period ending June 30, 2021. The report and press release are available on our website at selectis.com. As a reminder, we will make forward-looking statements regarding Selectis' financial outlook in addition to its manufacturing, 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 this risk can be found on our most recent Form 20F, Filing with ECC, and the financial report for the year ending on December 31st, 2020, and subsequent filing, Selectives Mixed with ECC from Time to Time. Now, I would like to turn the call over to André.
Thank you, Eric. Good morning, and thank you, everyone, for joining us today. Despite challenges the world is facing, Selectus has achieved a series of key milestones and we are incredibly grateful and proud of all the hard work achieved by our team, our partners, and our stakeholders. During the first half of 2021, we have made significant progress on all fronts that we're thrilled to share with you over the next half an hour. Today, we believe that Selectus is reaching a turning point and is entering into a new phase of its development, demonstrating excellence in clinical execution and acceleration of our internal product manufacturing of both new products and also new stock of existing products for expansion phases of our clinical program. Selectus has enrolled patients in parallel in the three sponsored phase one dose escalation trial for our three clinical stage wholly owned product candidate. UCAR22 in Bally01 for relapsed or refractory B-cell lymphoblastic leukemia. UCAR123 in Amelie01 for relapsed or refractory acute meal age leukemia. And UCARCS1 and Melanie 01 for relapsed or refractory multiple myeloma. During the second quarter, we presented preliminary translational data for the first group of patients enrolled for the Melanie 01 of FuCard CS1 at the Virtual American Society of Gene and Cell Therapy for the 24th annual meeting. Early preliminary data validate CS1 as a target for allogenic CAR T cells in multiple myeloma. UCART CS1 expansion and persistence was observed and correlated with the change in relevant serum cytokines and anti-myeloma activity. MELANIE-01 trial is currently enrolling patients at the dose level minus one The first of the three planned doses level. We organized a virtual event called Flectus Innovation Days that took place in May 2021. The event provides an inside look at Flectus and was a huge success with great attendance through the week. We presented a clear view into our pipeline of new product candidates, our gene editing platform, Our electroporation technologies as well as our end-to-end state-of-the-art internal manufacturing capabilities. These new immunology product candidates include UCAR 20x22, the first allergenic dual CAR T-cell candidate product for B-cell malignancy. The power of UCAR 20x22 is that it is not and yet another CD19 product. CD19 is an overcrowded target space and UCART 20x22 with the power of dual-CART can address all patients with B-cell malignancies including the one not responding to the numerous CD19 targeting treatments. In addition, we also presented UCART meso-targeted mesothelin expressing solid tumors. and Yukard Makwan targeted Mucin-1 expressing epithelial cancers. Finally, we presented Yukard FAP, a fairly innovative mechanism to pursue solid tumor through targeting cancer-associated fibroblasts, CAFs, in the tumor microenvironment, which has the potential to turn a cold tumor hot. We plan to file INDs of UCAR 20x22 and UCAR Mesothelin in 2022. During these innovation days, we also introduced the market to HEAL, our genome surgery platform for genetic diseases. The platform leveraged the power and the precision of tail and gene editing to perform therapeutic genome surgery of hematopoietic stem cells. We announced programs in sickle cell disease, liposomal storage disorders, and primary immunodeficiencies. HEAL's lead product candidate is Talglobin-01 for the treatment of sickle cell disease. Talglobin-01 is developed using both tail and technology to induce a double-stranded DNA break on the mutation at the sickle cell disease-causing hemoglobin subunit beta HBB gene, and an AEV that will be providing a DNA repair matrix designed to correct the faulty HBB gene via homologous recombination. Select this plan to file a 9D for Talglobin-01 in 2022. If you are interested in watching Selectus Innovation Days on-demand episodes, you can get more information on our website Selectis.com. In May 2021, Selectis and Sanofi entered into a partnership agreement and a supply agreement regarding alentuzumab, an anti-CD52 monoclonal antibody, to be used as part of the lymphodepleting regimen in certain Selectis-sponsored UCAR clinical trials. Sanofi will supply alentuzumab to support Selectis clinical trials and we agreed to enter into discussions to execute a commercial supply of allanthuzumab under pre-agreed financial conditions. In our Paris GMP manufacturing facility, manufacturing of plasmids, the starting material, its DNA matrixes, is now fully operational. One very critical element was the production of messenger RNA coding payments that are at the center of our gene editing approach. We are proud to announce that messenger RNA are now in production at Selectis. We finally remain on track for the manufacturing of viral vectors in the second half of 2021. In our RallyGMP manufacturing facility, We successfully completed two UCAR training runs from starting cells to vial drug product and we have started mid-year production of first batches. Manufacturing independence and execution in the cell and gene therapy space is a key success factor for all companies operating in this competitive arena. We believe that Slectis is a state-of-the-art biotechnology company with the product development process mastered from A to Z, including the construction of our proprietary electroversion devices to the production of buffers up to the vial final product ready to be injected. With that, I would like to hand the call over to Eric Dutton, Selectives Chief Financial Officer for an overview of the financials for the quarter. Eric, please go ahead.
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