Gracell Biotechnologies Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Gray Cell Biotechnologies second quarter and half year 2021 conference call. At this time, all participants are in a listen-only mode. After opening remarks, we will open the call for your questions. Instructions for Q&Up will be given at that time. I will now turn the conference call over to Dr. Kevin Shiet, CFO. Please go ahead.

Good morning, and welcome to Greasell's second quarter earnings conference call and webcast. This is our second earnings call as a publicly treated company. With me today are Greasell's founder and chief executive officer, Dr. William Tao, and our chief medical officer, Dr. Martina Serge. We're excited to discuss our innovative technologies and the breakthrough clinical pipeline of CAR-T therapies on today's call. We also look forward to sharing with you our recent business development and upcoming targets for 2021. After our formal remarks, we will conduct a question and answer session and instruction will follow at that time. This morning, we shall issue a press release announcing an audit financial results for the quarter ended June 30th, 2021. We encourage everyone to read this press release and would like to remind you that this call is being reported to replay. Please note that for certain information discussed on the call today, including financial data, clinical data, and the future plans of our program, resource management will be making forward-looking statements. As a result, may differ materially from those stated or implied by those forward-looking statements as a result of various factors, and please refer to risk factor section of our latest 20F filings with SEC for full disclosure of these risks and factors. This conference call contains time sensitive information that is accurate only as of the date of this live broadcast, August 17, 2021. Bristol undertakes no obligation to revise or update any forward-looking statement to recite events or circumstances after the date of this conference call, except as may be required by security law. I will now turn the call over to Bristol CEO, Dr. William Tung. William?

Thank you, Kevin. And again, welcome everyone to our second quarter earnings call. GraceL has made substantial progress during the first half of this year, and it continues to deliver across corporate, clinical, and operational initiatives. I will elaborate on some of the key achievements so far and expected milestones for the remainder of year 2021. Following this, I will turn the call over to our CMO, Dr. Martina Sush, to discuss our pipeline development and then to our CFO, Dr. Kevin Shea, to discuss financial results. Over the first half of the year, our innovative portfolio of autologous and allogeneic CAR-T cell therapies built upon our rich cell therapy and gene editing expertise and proprietary FASTCAR and TrueUCAR technology platforms continues to meet key milestones and demonstrate encouraging and competitive therapeutic potential across multiple difficult to treat pathological malignancies and solid tumors. We presented exciting longer-term follow-up data for GC012F, our BCMA-CD19 dual-target CAR-T therapy. GC012F is a novel dual-targeting product specific for two different antigens, BCMA and CD19. which we believe has the potential to be highly efficacious. Dr. Sech will expand on this shortly. Our plans for R&D application submission remain on track in both U.S. and China within the first half year 2022. At AACI annual meeting in April, we presented updates on longer-term follow-up for our study in TALL for GC027. our lead true UCAR candidate, an off-the-shelf standalone UCAR-T therapy. Data continues to be very promising, and Dr. Sech will further elaborate. On the leadership team side, we're very happy to announce the timely expansion of our U.S. team. Last spring, we appointed Dr. Jenny Nee as Chief Technology Officer She is seasoned in CAR T-cell therapy CMC development and having successfully led process development at both Pfizer and Allergen Therapeutics. Dr. Ni's focus will be supporting smooth technology transfer to Lonza for our fast CAR-enabled product candidate, DC012F. In addition, we're excited about Dr. Grace Jiang's joining Gracell as our head of U.S. regulatory affairs, reporting to our chief medical officer. Dr. Jiang brings nearly 20 years of experience in biotechnology companies, including at Amgen in regulatory affairs, with filing experience in multiple myeloma. Dr. Ni and Dr. Jiang's contribution will be instrumental as we continue to advance our product development And these key appointments also mark an important step to advance our presence in the United States. As we enter the second half year 2021, we will continue to build on our solid progress achieved so far. In the coming months of this year, we are planning on advancing exciting early pipeline candidates into clinical studies in China. We will enhance our R&D capabilities in the U.S. with our ongoing manufacturing collaboration with Lonza supporting the U.S. R&D submission for the fast car candidate GC012F in the first half of year 2022. We also plan to expand our manufacturing capacity by developing a second, much larger facility in Suzhou, China. in addition to our state-of-the-art 66,000 square feet GMP manufacturing facility designed for fully closed production capabilities to reduce contamination risks and optimize cost efficiency. These clinical and operational developments will bring us closer to delivering accessible and highly efficacious treatments for patients across a wide range of malignancies. Now, I will hand it over the call to our CMO, Dr. Martina Serge, to discuss the pipeline and our clinical programs. Martina, please.