11/4/2022

speaker
Conference Operator
Call Facilitator

Greetings and welcome to Selecta's third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce your host, Arthur Strill, Chief Business Officer. Thank you, sir. You may begin.

speaker
Arthur Strill
Chief Business Officer

Good morning, and welcome everyone to Selectus' third quarter 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 Frittini, our Chief Medical Officer. Yesterday evening, Selectus filed a tintering report and issued a press release reporting its financial results for the third quarter and nine-month period ended September 30th, 2022. The report and press release are available on our website at Selectus.com. 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 our 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 SEC and the financial report, including the management report, for the year ending on December 31st, 2021, and subsequent filing Selectus makes with the Securities Exchange Commission from time to time. I would now like to turn the call over to André.

speaker
Dr. André Choulika
Chief Executive Officer

Thank you, Arthur. Good morning and thank you everyone for joining us today. 2022 has been a productive year thus far for Selectus. We have made progress on all fronts that we're thrilled to share with you today. Yesterday, We've announced that our UCART 1-2-3 abstract was accepted for an oral presentation at the American Society of Anthropology's annual meeting. We're excited to share preliminary data from our AMELI-01 trial, which is a dose escalation and dose expansion study evaluating the safety, expansion, persistence, and clinical activity of UCAR T123 in patients with relapsed or refractory acute myeloid leukemia. Acute myeloid leukemia is a huge unmet medical need with a lack of cell therapy options, and these encouraging clinical data are a great step forward for patients. We're also proud that the Amsterdam University Medical Center will present preclinical data at ASH on our product candidate, UCAR-T CS1, which reinforces the validation of CS1 as a relevant target for relapsed and refractory multiple myeloma patients. Selectus continues to make progress enrolling patients in its four sponsored allogenic CAR-T trials. We will soon initiate dosing patients with our product candidate, UCAR T22 and UCAR T20x22 that have been fully manufactured in-house. This will be a significant milestone for Selectis, highlighting how our investment in building our GMP manufacturing facilities has now provided the company with independence and control over our gene and cell therapy processes. We believe that bringing manufacturing fully in-house could contribute to eliminating some of the barriers competitors are facing. Our goal is to provide consistency and safety in our production, ensure lead times are met, and adaptability. Importantly, having our manufacturing in-house means that we can rapidly optimize promising therapeutic candidates as we monitor clinical responses leading to the best possible product at registration no filing. This quarter, our partnership continued to be a highlight for Selectis as several of our partners disclosed exciting milestones. Allogene announced that it was starting the first allogenic CAR-T potentially pivotal phase two trial for patients with large B-cell lymphoma. We share Allogene's excitement for this accomplishment as it paves the road for both Allo501A and our broader pipeline of allogenic candidate products to greatly increase patient access to cell therapy. Our licensed partner, Iovance, announced that the first patient was dosed and completed the safety observation period in the IOV-GM1-201 clinical trial for Iovansper genetically modified palin-edited tumor infiltrating lymphocytes, or TILT therapy, for the treatment of previously treated metastatic non-small cell lung cancer and advanced melanoma. Our partner, Cytovia, announced that it will present new preclinical data on tailing gene-edited induced pyropotent stem cells derived natural killer cells at the Society of Immunotherapy of Cancer's annual meeting that will take place in November. These achievements showcase once more that selectives, along with this gene-editing technology such as tailings, is a partner of choice for cell and gene therapy applications across a wide range of cell types and that we're continuing to deliver on our promises of constant innovation in order to advance the efforts of both our and our partners' clinical trials. With that, I'd like to turn the call over to Mark Fratini, our newly appointed chief medical officer. Most of you know Mark as he has been serving as a core member of the senior clinical team over the past two years. Previously, as a senior vice president of clinical science, Mark will give an overview of our sponsored clinical trials and preclinical product pipeline. Mark, please go ahead.

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