11/5/2021

speaker
Operator
Conference Operator

Greetings. Welcome to the Selectus Q3 2021 earnings call. At this time, all participants are in a listen-only mode. A 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. I will now turn the conference over to your host, Eric Dutang, Chief Financial Officer. Thank you. You may begin.

speaker
Eric Dutang
Chief Financial Officer

Thank you and welcome everyone to Selectives Third 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, and Dr. Carrie Bronstein, our Chief Medical Officer. Yesterday evening, Selectis filed its interim report and press release reporting our financial results for the third quarter and nine-month period ending September 30, 2021. This report and press release are available on our website at selectis.com. As a reminder, we'll make forward-looking statements regarding Selectis' financial outlook in addition to its manufacturing, regulatory, and product development statements. 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 in our most recent Form 20F file with the ECC for the year ending on December 31, 2020, and subsequent filings selected mixed with the ECC from time to time. I would like now to hand over the call over to André.

speaker
Dr. Andre Choulika
Chief Executive Officer

Thank you, Eric. Good morning and thank you everyone for joining us today. Over the course of the third quarter and the last nine months of 2021, Selectis 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. 2021 has been a productive year thus far for Selectis. who has made significant progress on all fronts that we're thrilled to share with you over the next half hour. Notably, yesterday Selectus announced that the release of two abstracts accepted for presentation at the 63rd American Society of Hematology Annual Meeting Selectives will present additional preliminary clinical data from its BALI-01 trial of Fucart T22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia and presentation of our first preclinical data of Talglobin-01 for the treatment of sickle cell disease. Additionally, With regard to our preclinical UCART-T pipeline focusing on solid tumors, we have made notable progress with UCART-Metho, our allogenic CAR-T cell product candidate targeting mesothelin-expressing solid tumors. We are excited to share that the first preclinical data demonstrating in vitro and in vivo anti-tumor activity will be presented at the Society for Immunotherapy of Cancer annual meeting later this month. In 2018, Selectis made a transformative decision to internalize the manufacturing of its therapeutic products. This decision revealed a crucial competitive advantage in today's world. This investment in our GMP manufacturing facility provides Selectis with independence and control over its gene and cell therapy processes from buffers to DNA, messenger RNA, vectors, and of course our cell therapies such as our eukaryotes. We create and own our processes, our developments, and our production. In the cell and gene therapy space, whoever owns the process, owns the product. Due to the success of completion of both of our GMP manufacturing facilities, we can move swiftly into an innovative ID at the R&D stage to clinical trials with potential to produce commercial level supplies in the future. We're proud to be one of the only companies of our size that are capable of moving into innovative new IDs From R&D to clinical trial to manufacturing and delivery directly to the patient, all in-house. We believe that bringing manufacturing 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 time are met, and adaptability. As each disease target by our advanced therapies may require cutting-edge innovation at the level of our manufacturing capabilities, we need to fully master the process. Importantly, having our manufacturing in-house means that we can rapidly version promising therapeutic candidates as we monitor clinical responses, leading to the best possible product at registration and filing. Our Paris GMP manufacturing facility is now fully operational for the production of starting material. On the other side of the pond, our Raleigh GMP manufacturing facility, qualification of the facility equipment and systems was completed successfully in Q3. Qualification of the second UCAR production suite equipment remains on track to enable start of Engineering Grants of the third UCART product in early 2022. Now, I would like to turn the call over to Dr. Carrie Brownstein, our Chief Medical Officer, to give an update of our three sponsored clinical trials and preclinical product pipeline. Carrie, please go ahead.

Disclaimer

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