Gracell Biotechnologies Inc.

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

Good morning, and welcome to Graysol third quarter 2022 Corporate Update Conference call on the webcast. With me today are Grissel's founder and the Chief Executive Officer, Dr. William Stahl, and our Chief Medical Officer, Dr. Wendy Lee. We're excited to discuss the progress of our innovative technologies and the rich clinical pipeline of CAR-T therapies on today's call. We also look forward to sharing with you our recent business development and upcoming objectives for the remainder of 2022. After our formal remarks, we will conduct a question and answer session. This morning, Griselle issued a press release announcing an unaudited financial resource for the quarter ended September 30, 2022. We encourage everyone to read this press release and would like to remind you that this call is being recorded for replay. Please note that for certain information discussed on the call today, including financial data, clinical data, and future plans of our program, 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 Factors section of our latest 20S filing with the SEC for a full disclosure of these risks and the factors. The conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 14, 2022. RISA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except that may be required by security law. I will now turn the call over to Grisel's CEO, Dr. William Tau. William?

Thank you, Kevin. And again, welcome everyone to our third quarter 2022 corporate update conference call. I will begin today's call with a key corporate and pipeline update. I will then turn the call over to our CMO, Dr. Wendley, to provide insight on our first clinical data from ongoing RIT evaluating EC012F in newly diagnosed multiple myeloma, which was accepted for an oral session at ASH 2022. Thereafter, our CFO, Dr. Kevin Shea, we'll discuss our third quarter 2022 financial results. After our prepared remarks, we'll open the call to questions. I'm glad to open this call and announce that today, Grayscale's Fast Car Tee Next Day Manufacture Autologous Car Tee Platform was named the winner of the 2022 Fierce Life Sciences Innovation Awards. Fast Car Tee was developed with a deep understanding of the challenges faced by conventional CAR-T. And we firmly believe this technology, as well as the BCMA CD19 dual targeting CAR-T GC012F, developed on the FastCar platform, represent the innovation that could broaden the use and accessibility of CAR-T. The FIAS Life Sciences Innovation Award identified and showcase outstanding innovation that is driving improvements and transforming the industry. An expert panel of judges reviewed all the submissions and has determined that the fast car has the potential to make great impact for biotech and the pharma industry. Hence, I hope to thank the recognition by the judges, and I also thank the entire Grayscale team, especially our scientists, for their commitment and hard work. Currently, Brace-L continues to advance a robust clinical pipeline developed in our fast CAR autologous CAR-T platform and the true UCAR allogenetic CAR-T platform. First, on our lead candidate, GC012F, the autologous BCMA-CD19 dual-targeting fast CAR-T therapy. GC12F is currently being studied in three indications. relapsed refractory multiple myeloma, newly diagnosed multiple myeloma, and in relapsed refractory non-Hodgkin lymphoma. We completed enrollment in the Investigator Initiative Trial, IIT, study evaluating 12F for RRMM. In 2022, at both ESCO and EHA annual meetings, we presented updated clinical data that showcased the deep response achieved favorable safety profile, and a differentiated next stage of manufacturing. Specifically, as of June 8, 2022, data cutoff, date following enrollment completion of 29 patients, a single infusion of 12F has achieved 100% MRD negative rates in this group of heavily pre-treated patients, of which 90% were classified as high-risk 12F also consistently demonstrated a favorable safety profile. We are continuing to follow up these patients. Furthermore, we are on track to complete the R&D submission of 12F in RRMM in both the U.S. and China before year end. After having submitted a pre-R&D meeting request to the U.S. FDA, we received a written response in October 2022. Their response was encouraging, and we are currently preparing our IND filing in the U.S. Also in September 2022, we received a written response for our pre-IND submission from China and MPA. The IND submission is on track. Turning to the IAT that is underway to evaluate 12F in newly diagnosed high-risk multiple myeloma patients, we are thrilled This data was accepted for oral session and ASH annual meeting in December 2022. We started this IIT study over a year ago, and this will be the first time that we present the clinical data. Newly diagnosed high-risk patients usually respond less favorably to standard care and are associated with poor outcomes. and remain at high unmet medical needs, despite of novel agents being approved in recent years. We hope 12F could demonstrate its potential of providing a new, safe, highly efficacious first-line therapy. The data in this abstract shows an excellent safety profile and encouraging efficacy. Our CMO, Dr. Wendy Lee, will provide more details later in this call. At EHA in June 2022, we also unveiled the first data of 12F in relapse refractory NHL from ongoing RIT. This initial data set demonstrate potent and fast activity with 100% CR rate at month one, observing all three patients treated. As of cutoff date of February 22, 2020. To put this into perspective, All three patients have DL-BCL, a fast-growing aggressive form of NHL. We are continuing the enrollment and follow-up of this ongoing study. And we plan to share updated data at the medical conference in 2023. Moving on to the off-the-shelf 2UCAR platform, GC502 is our 2UCAR-enabled CD19-CD7 dual-directed allogenetic CAR-T therapy candidates. As we outlined previously, we presented updated data last June at IHA from a single-arm, open-labeled IIT with longer follow-up compared to the data that was shared in April at AACR. The data was encouraging as 75% of all three of the patients achieved MID-CR-CRI. The study is ongoing. Next, moving to our donor-derived CAR-T. In October, we announced the dosing of the first patient in China registration of Phase II trial evaluating GC007G, an allogenetic CD19-targeted CAR-T cell therapy. GC007G is derived from HLA-matched donor for the treatment of RRBL patients who failed transplant and may not be eligible for autologous CAR T therapy. This is an exciting milestone for GraceL team as it is our first pivotal trial. We have observed highly encouraging safety and efficacy data in the phase one portion, and we hope to share the data in 2023. Last but not the least, I'm happy to report we have those first patients with our smart CAR T candidate. GC503 for the treatment of metastatic positive solid tumors in a China RIT. Smart Car T is a second-generation technology for the treatment of solid tumors, and they utilize a novel construct to take advantage of the suppressive tumor microenvironment and effectively combat solid tumors. We are also preparing to bring the second Smart Car T candidate, GC506, targeting Claudine 18.2 to the clinical trial soon. For the past 10 and a half months in 2022, we have delivered all promised milestones, including starting several IIT studies, opening our first phase two trials, and providing clinical data updates at a major medical conferences. These clinical and operational developments further emphasize Grace Health's commitment to delivering accessible and highly efficacious treatments to the patients across the wide range of malignancies. Now, I'll hand the call over to our CMO, Dr. Wendy Li, to discuss our participation at ASH in December. Wendy, please go ahead.