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Cellectis Inc.
5/5/2023
Good morning, everyone, and welcome to Selective's first quarter 2023 earnings 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 the first speaker, Arthur Strill, Chief Business Officer. Please go ahead, sir.
Good morning, and welcome, everyone, to Selectus' first quarter 2023 corporate update and financial results conference call. Joining me on the call today with prepared remarks are Dr. André Choulicat, our Chief Executive Officer, Dr. Bing Wang, our Chief Financial Officer, and Dr. Mark Trottini, our Chief Medical Officer. Yesterday evening, Selectus issued a press release reporting its financial results for the three-month period ended March 31, 2023. The report and press release are available on our website at selectives.com. As a reminder, we will make statements regarding Selectives Financial Outlook, in addition to its manufacturing, regulatory, and product development standards and plans, and product development of its licensed partners. These forward statements, which are based on our management's current expectations and assumptions, and the 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 20F filed with the Security Exchange Commission, SEC, and the financial report, including the management report, for the year ended on December 31st, 2022, and subsequent filing selected makes with the SEC from time to time. I would now like to turn the call over to André.
Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Lectus made significant progress with its pipeline this quarter. We took a notable step forward with the first patient being dosed in France with our in-house manufacturer product candidate, UCAR T22, evaluated in the Bally01 clinical study. This is an important advancement for the selective team who has worked tirelessly to expand the Bally01 clinical study to Europe. UCAR-T22 is currently the most advanced allogenic CAR-T cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia. We believe that our off-the-shelf treatment approach, coupled with our ability to manufacture UCAR-T product candidates, give us a competitive advantage on the market. It potentially maximizes the chances for eligible patients to be treated without delay. On the business development front, our partnerships proved to be an exciting highlight for Selective. Last month, we announced that we have implemented the use of Sanofi's Alentuzumab as the Selective's investigational medicine product. coded as ELLS-52 as part of the lymphodepletion regimen for UCAR-T22 in the Bally-01 clinical trial, for UCAR-T123 in the Amelie-01 clinical trial, and for UCAR-T20-by-22, the Natalie clinical trial. This follows the partnership and supplies agreement that we entered with Central Care regarding allanthuzanab. This quarter, we were proud to present encouraging preclinical data at the American Association for Cancer Research annual meeting on TALEN-edited MUC1 CAR T-cell to enhance efficacy in targeting triple-negative breast cancer. The data showed the capability of armored allogenic MUC1 CAR T-cell with sophisticated gene edits to excel in the immune-suppressive tumor microenvironment, suggesting that they could be an effective option in treating patients with limited therapeutic options. We're proud of these results that reinforces the performance of our technologies and our commitment to treat cancer patients. We also announced that two abstracts have been accepted at the upcoming American Society of Cell and Gene Therapy annual meeting. Selectives will present clinical data on the Amelie-01 clinical trial in evaluating UCAR-T123 that were already showcased in an oral presentation at the 2022 ASH annual meeting, as well as preclinical data on multiplex engineering for superior generation of CAR-T cells. Those presentations will take place on May 17th in Los Angeles. This quarter, Selectus announced the closing of the global offering of $25 million of its depository shares, launched in February. The net proceeds of the global offering is approximately $22.8 million. Finally, in April, we announced that the drawdown of the first tranche of the 20 million euros under the finance contract for up to 40 million euros credit facility made with the European Investment Bank in December 2022, selected this plan to use the net proceeds of the funds to focus on the development of its pipeline of allergenic CAR T cell prologue candidates, UCAR T22, UCAR T20x22, and UCAR T123, and decided to stop enrollment of treatment of patients with UCAR TCS1. To accelerate the speed of enrollment of patients in the MELANIE-01 study evaluating UCAR-PCS1, the company would have had to invest a meaningful amount of resources. Therefore, to optimize its resources, Selectus decided to focus its development efforts on the BALI-01, AMOE-01, and NATALI-01 studies and stop MELANIE-01. Lastly, based on our current plan, we anticipate our cash runway to take us into the third quarter of 2024. We are excited about the drive in our clinical trials, building on the momentum of our lead product candidates in our pipeline and the upcoming milestones for 2023. With that, I would like to turn the call over to Dr. Mark Frettini, our Chief Medical Officer, who will give us an overview of these clinical trials. Mark, please go ahead.
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