Gracell Biotechnologies Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Griswold Biotechnologies first quarter 2022 conference call. At this time, all participants are in listen-only mode. After opening remarks, we will open the call for your questions. Instructions for queuing up will be given at that time. I would now like to turn the conference over to Dr. Kevin Shea, CFO. Please go ahead.

Good morning and welcome to GreenCell's first quarter 2022 Corporate Update conference call and webcast. With me today are GreenCell's founder and the chief executive officer Dr. William Cao and our chief medical officer Dr. Martina Serge. We're excited to discuss our innovative technologies and reach clinical pipelines of CAR T therapies on today's call. We also look forward to sharing with you our recent business development and upcoming objectives for 2022. After our formal remarks, we will conduct a question and answer session. This morning, Resell issued a price release announcing unaudited financial results for the quarter ended March 31st, 2022. We encourage everyone to read this price release and would like to remind you that this call is being recorded through replay. Please note that certain information discussed on the call today, including financial data, clinical data, and future plans of our programs, resource management will be making forward-looking statements. Actual results could differ materially from those stated or implied by those forward-looking statements as a result of various important factors. and please refer to the Risk Factor section of our latest 20S filing, Risk SEC, for a 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, May 16, 2022. RiskFile undertakes no obligation to revise or update any forward-looking statements to reflect events and circumstances at the date of this conference call, except as may be required by securities law. I will now turn the call over to Grayscale CEO, Dr. William Tao. William? Thank you, Kevin.

And again, welcome everyone to our first quarter 2022 Corporate Update Conference Call. Grayscale has made substantial progress over the past quarter and continues to deliver across corporate, clinical, and operational initiatives. I will elaborate on some of the key achievements so far and anticipated milestones over the next few quarters. Following this, I will turn the call over to our CMO, Dr. Martina Sesh, to discuss our clinical developments and then turn to our CFO, Dr. Kevin Shea, to discuss financial results. We are dedicated to developing our rich clinical pipeline with multiple clinical trials underway, including two IMD-approved trials and several investigator-initiated trials, or IIT for short. We continue to advance the IITs for GC012F, our autologous CAR T-therapy, therapeutic candidates based on our fast car next-day manufacturing platform. As announced, we will be providing updates from two out-of-the-IT studies at the medical meetings in June. Concurrently, we plan to file R&Ds in the U.S. and China for GC012F for the treatment of relapsed refractory multiple myeloma, or RRMM for short. during the second half of 2022. We are pleased to that updated data from ongoing IIT evaluating GC012F for the treatment of RMM was selected as oral presentations next month at both conference ESCO 2022 and EHA 2022. We look forward to sharing more details when the abstracts were posted on ASCO's and EHAR's websites on May 26th. At EHAR 2022, we also plan to present initial data from an ongoing IIT evaluating GC012F for the treatment of relapsed refractory B-cell non-Hodgkin's lymphoma, RRB-NHL. We are very excited about this data, as it is the first time that we'll be disclosing data for NHL. This is yet another demonstration of our unwavering commitment in developing breakthrough cell therapy. Turning to the off-the-shelf TrueU-CAR platform, GC502 is our TrueU-CAR-enabled CD19 CD7 dual-directed allogenetic CAR T-cell therapy candidate. Mid-April, at an AACR annual meeting, we presented early results of a first-in-human clinical study of GC502 for the treatment of relapsed refractory B-cell acute lymphoblastic leukemia, RRBALL. Dr. Sesh will expand upon GC502's progress shortly. In addition, we'll be presenting updated data from its IIT study in a poster presentation at IHA 2022 on June 10th. In the beginning of the year, I mentioned this will be an active and exciting year for Grayscale as we expect multiple advancements across our pipeline. Our lead asset, 12F, on the fast car platform has expanded into second indication, BNHL. The second candidate utilizing our allogenetic 2U car platform, GC502, which is also our first dual car allogenetic candidate, has presented promising early data at AACR. We are very pleased with the progress so far and look forward to presenting these three data sets at ESCO and IHA in June. It is worth highlighting that we plan to host the investor update call shortly after ESCO and IHA to share these data. On corporate side, we continue to invest in our R&D and manufacturing capabilities. In the first quarter, we expanded our U.S. presence with the opening of our San Diego Innovation Center. We are also continuing to actively expand our US teams. Next, I will provide a few updates regarding our operations in China, given the recent COVID-19 pandemic outbreak. Starting in late February 2022, due to the spread of the highly contagious Omicron variant in China, the Chinese government enclosed stricter restrictions, including lockdowns in certain cities and districts, which include Shanghai. As a result, we are experiencing disruptions to our operations in certain cities. For example, short-term logistic issues, as well as impacts on patient follow-up and treatment. We believe that the continued lockdown may temporarily impact our business. But at this point, our clinical development targets and timelines remain unchanged for the full year. Moreover, I would like to take a moment and sincerely thank our team and our primary investigators who continue to work relentlessly and help minimize the impact on patients. During the first five months of 2022, We demonstrate a continued advancement of our clinical programs. As we head into the spring, we are focused on following initiatives. We plan to file R&D in the US and China for GC012F for the treatment of relapsed refractory multiple myeloma during the second half 2022. We are seeking to establish partnership for one or more programs This is a key priority for 2022. Currently, we have two R&D trials and three IIT studies ongoing, and also two recently completed IIT studies. We expect to present clinical data updates from IITs for two of our product candidates in three indications at both ESCO and EHA in June. We anticipate additional updates at the major medical conferences in the second half of 2022. Meanwhile, we are advancing our early pipeline candidates and are on track to bring our first smart car candidate for solid tumors into clinical stage this year. We also plan to expand our manufactured capacity by developing a second facility in Suzhou, China. In addition to our state of art 6,000 square feet GMP manufacturing facility. The second facility will feature foreclosed production capabilities to reduce contamination risks and optimize cost efficiency. These clinical and operation developments will bring Gracell closer to delivering accessible and highly efficacious treatments for patients across a wide range of malignancies. Now, I will hand over the call to our CMO, Dr. Martina Sesh, to discuss the pipeline and our clinical programs. Martina, please go ahead.