Ladies and gentlemen, thank you for standing by. Welcome to the Gracell Biotechnologies' Third Quarter 2022 Conference C all. 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 Xie, CFO. Please go ahead. Good morning, and welcome to Gracell's third quarter 2022 corporate update conference call and webcast. With me today are Gracell's Founder and Chief Executive Officer, William Cao, and our Chief Medical Officer, Wendy Li. 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, Gracell issued a press release announcing unaudited financial results 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 programs, Gracell's 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. Please refer to the Risk Factors section of our latest 20-F filing with the SEC for a full disclosure of these risks and factors. The conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 14, 2022. Gracell undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by securities law. I will now turn the call over to Gracell CEO, Dr. William Cao. William? Thank you, Kevin. 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. Wendy Li, to provide insight on our first clinical data from ongoing IIT evaluating GC012F in newly diagnosed multiple myeloma, which was accepted for an oral session at ASH 2022. Thereafter, our CFO, Dr. Kevin Xie, will 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, Gracell's FasTCAR next day manufacture autologous CAR- T platform was named the winner of the 2022 Fierce Life Sciences Innovation Awards. FasTCAR 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 Fierce Life Sciences Innovation Awards identify 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 FasTCAR has the potential to make great impact for biotech and pharma industry. Hence, I hope to thank the recognition by the judges, and I also thank the entire Gracell team, especially our scientists, for their commitment and hard work. Currently, Gracell continues to advance a robust clinical pipeline developed in our FasTCAR autologous CAR-T platform and the TruUCAR allogeneic CAR-T platform. First, on our lead candidate, GC012F, the autologous BCMA/CD19 dual-targeting FasTCAR therapy. GC012F is currently being studied in three indications: relapsed/refractory multiple myeloma, newly diagnosed multiple myeloma, and relapsed/refractory non-Hodgkin lymphoma. We completed enrollment in the investigator-initiated trial, IIT, study evaluating GC012F for RRMM. In 2022, at both ASCO and EHA annual meetings, we presented updated clinical data that showcased the deep response achieved, favorable safety profile, and a differentiated next-day stage of manufacturing. Specifically, as of June 8, 2022 data cutoff date, following enrollment completion of 29 patients, a single infusion of GC012F has achieved 100% MRD-negative rates. In this group of heavily pre-treated patients, of which 90% were classified as high risk. GC012F also consistently demonstrate a favorable safety profile. We are continuing follow-up these patients. Furthermore, we are on track to complete the IND submission of GC012F in RRMM in both the U.S. and China before year-end. After having submitted a pre-IND 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 NMPA. The IND submission is on track. Turning to IIT that is underway to validate GC012F in newly diagnosed high-risk multiple myeloma patients. We are thrilled that this data was accepted for oral session at 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 a poor outcome, and remain a high unmet medical need, despite of novel agents being approved in recent years. We hope GC012F 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 Li, will provide more details later in this call. At EHA in June 2022, we also unveiled the first data of GC012F in relapsed refractory NHL from the ongoing IIT. This initial data set demonstrate potent and fast activity with 100% CR rate at month one, observed in all three patients treated as of cutoff date of February 22, 2020. To put this into perspective, all three patients have DLBCL, a fast-growing aggressive form of NHL. We are continuing enrollment and follow-up of this ongoing study, and we plan to share updated data at a medical conference in 2023. Moving on to the off-the-shelf TruUCAR platform. GC502 is our TruUCAR-enabled CD19/CD7 dual-directed allogeneic CAR- T therapy candidate. As we outlined previously, we presented updated data last June at EHA from a single-arm open label IIT with longer follow-up compared to the data was shared in April at AACR. The data was encouraging, as 75% of all treated patients achieved MRD-negative 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 registrational phase II trial evaluating GC007G, an allogeneic CD19-targeted CAR- T cell therapy. GC007G is derived from HLA-matched donor for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR- T therapy. This is exciting milestone for Gracell team as it is our first pivotal trial. We have observed highly encouraging safety and efficacy data in the phase I portion, and we hope to share the data in 2023. Last but not the least, I'm happy to report we have dosed first patients with our SMART CAR- T candidate, GC503, for the treatment of mesothelin-positive solid tumors in a China IIT. SMART CAR- T is a second-generation technology for the treatment of solid tumors and 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 Claudin 18.2, to the clinical trial soon. For the past ten and a half months in 2022, we have delivered all promised milestones, including starting several IIT studies, opening our first phase II trials, and providing clinical data updates at major medical conferences. These clinical and operational developments further emphasize Gracell'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. Thank you, William. As William mentioned, the abstract for first-in-human data from ongoing phase I open label IIT evaluating GC012F in newly diagnosed transplant-eligible high-risk multiple myeloma patients was accepted for an oral session at ASH 2022. As a reminder, GC012F is an autologous CAR-T therapeutic candidate dual targeting BCMA and CD19, developed on our FasTCAR next-day manufacturing platform. As outlined in our accepted abstract that is now available online, a total of 13 newly diagnosed multiple myeloma patients were treated as of the July 25, 2022 abstract data cutoff. The preliminary data shows an excellent safety profile, with only 23% of patients experiencing grade 1-2 CRS, no high grade CRS, and no neurotoxicity of any grade was observed. The data shows a 100% ORR and a 100% MRD negativity in all treated patients. We are very encouraged by this data and look forward to share more details in December. Given GC012F clean safety profile, paired with its potential for faster administration time, leveraging our next day manufacturing and attractive efficacy profile given the younger T-cells with enhanced fitness, we believe that GC012F could potentially provide a safe and effective treatment option to the newly diagnosed multiple myeloma patients. We are very encouraged by this first clinical data and very much look forward to sharing more details at the ASH annual meeting and exposition in December of this year. I will now hand the call over to our CFO, Dr. Kevin Xie. Kevin? Thank you, Wendy. Turning to our financials, I'd like to touch on a few financial trends. As of September 30, 2022, the company had RMB 1,629.6 million, or $229.1 million in cash and cash equivalents and short-term investments. In addition, the company had short-term borrowings and the current portion of long-term borrowings of RMB 125.1 million or $17.6 million, and long-term borrowings of RMB 48.1 million, or $6.8 million. We are very well funded with cash runway for the next 24 months. We expect cash use for this year to be approximately $100 million, primarily to fund our R&D and the clinical programs in the U.S. and China. Net loss attributable to ordinary shareholders for the third quarter was RMB 171.9 million or $24.2 million, compared to RMB 129.3 million for the third quarter of 2021. Research and development expenses for the past quarter were RMB 133.4 million or $18.7 million, compared to RMB 88.6 million in the third quarter of 2021. The increase was primarily due to the increase in spending on research and development and the clinical trials, as well as higher payroll and personnel expenses attributable to the increased headcount and higher facility related costs. With that, I'd like to turn it back to the operator to open the session for your questions. Operator? At this time, I would like to remind everyone, in order to ask a question, please press star then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from Yigal Nochomovitz from Citi. Please go ahead. Hi, this is Carly on for Yigal. Thanks so much for taking our questions. We have a couple on the newly diagnosed multiple myeloma ASH abstract. First, are you aware of any other published data for a BCMA CAR- T in a similar newly diagnosed population? Our more general question is if you can just talk about any early feedback you've gotten from KOLs on the abstract data so far. Thank you. Okay. Wendy, I'm going to take this one, and, Go ahead. Please feel free to chip in. This is William Cao, CEO of the company. I think we heard there are a few trials ongoing for newly diagnosed patients. I believe you can also find in ClinicalTrials.gov, probably there are two registered. But we haven't heard any data. We haven't seen the data, obviously. So this conference probably is the first event you're gonna see, you know, serious studies in this field. What was the other question? Please. Yeah. The other question was just on any, you know, early feedback you've gotten from KOLs. We're also curious if you can comment on how much more data we'll see at ASH beyond what's included in the abstract. I think, Wendy, this is probably, you know, more probably for you to answer if you have talked to KOL regarding newly diagnosed patients and any feedback. Yes. We do have a discussion with the PIs, actually from the leading medical centers, and the reactions have been very positive, and they're very interested in our product and the clinical data. Right. Since this study is ongoing, we plan to provide updated data on the ASH presentation December. Thank you. Okay, great. Thanks very much. Your next question comes from Kelly Shi from Jefferies. Please go ahead. Hi, this is Dave on for Kelly Shi from Jefferies. Thank you for taking our question, and, congrats on the new data. I have couple. First is, you mentioned that company received a written response from FDA. Could you provide any colors on the steps that are needed from now 'til filing the IND, and, at what steps you are? Also, you mentioned IND will be in, RRMM. However, since the data in newly diagnosed is available, any color or any guidance on IND in a newly diagnosed patient? Let me take this. Good question. The FDA's feedback is encouraging, it's constructive, it's somewhat expected. It's good. We move forward based on the feedback and now being preparing for the package as the last part. Everything moving accordingly. China as well. We received a response from China CDE, and we are in the process submitting the package. Yeah, that's how it goes. Everything seems smooth. Now, regarding the trial design, I think it's too early to talk about details. For this IND, again, we'll be focusing on RMM. Newly diagnosed, it is a very interesting area, and we're very encouraged by the results, preliminary results. Again, this is a very new field. How do we, you know, navigate forward, what specific indications? I think it remains to be studied and discussed with the KOL, although data looks really encouraging, especially safety and efficacy both are really outstanding. I'm sure you're gonna hear more details at the presentation. We will definitely not in this IND filing, that's for sure. How much, you know, how, what is the plan? I think you need to wait to see. We'll keep you updated. Great. Thank you. Can I ask one more? Last time you mentioned you are looking for some collaboration. Any color on collaboration to develop GC012F in the U.S.? Yes. It's ongoing. It just takes longer than we, you know, thought would be. Yeah, it's still dialogue is ongoing. There are interesting several products, but GC012F is probably the most popular one. All right. Okay. Thank you. Thanks. Your next question comes from Joe Catanzaro from Piper Sandler. Please go ahead. Hey, guys. Thanks for taking my question. Maybe two quick ones from me. Maybe updated thoughts around any potential, you know, IND filing strategy for GC012F as it relates to B-cell lymphomas. I know you said you expected to provide some updated data in 2023. And maybe similarly, is the strategy for the SMART CAR-T solid tumor programs to generate some initial clinical data out of those IITs in China before you think about pursuing formal INDs in the U.S. and within China? Thanks. Thanks, Joe. For NHL, I don't think we have decided to you know, to share the detailed plan with public, but certainly it's ongoing. I think you know, I can't say when we're gonna file, but the direction is right because the preliminary IIT data looks really encouraging. You know, since EHA this year, we have enrolled more patients and you know, the data continue looks very encouraging. So it's probably you know, straightforward. This will be considered you know, a U.S. program. But again, I can't be you know, firm at this moment. But you know, give a couple of months and we'll firm up the plan. The what was the other? Newly diagnosed or- No, no. The second question was around the SMART CAR-T strategy and whether that's gonna be- Oh, SMART CAR-T, yeah. Generate- Yes. Clinical data and then go from there. Correct. Thank you. We have dosed SMART CAR-T with dose 503 in mesothelin-positive ovarian cancer. As you know, to evaluate solid tumor, it probably takes a couple more months to have a reasonable evaluation. We are right now at the dose escalation, starting from very low. Since we have a enhancer embedded, we wanna make sure, you know, safety is well taken care of. The 506, we haven't started those patients yet. We haven't decided to file IND in the United States or not in China, because we need to see more clinical evidence, and that's how we wanna de-risk the new products. So far, you know, I can say it looks good, but it's very early. Okay, great. Thanks for taking my questions. Sure. Your next question comes from Justin Zelin from BTIG. Please go ahead. Hi. Thanks for taking the questions and congrats on all the progress. My first question is, with the encouraging newly diagnosed data that you have here, I'm curious how you envision GC012F being used eventually in a myeloma treatment algorithm, if you could see it being used ahead of transplant or antibody-based therapies. Wendy, let me crack this first, okay? Sure. Mm-hmm. You know, Justin, this is a newly diagnosed is new arena. I'm sure, you know, everybody understand this is a very big pie. You know, to our understanding, safety is more important than anything for newly diagnosed patients. You know, as these patients are relatively healthy, and the tolerance level to safety would be much lower. We are very encouraged by the confirmation of the safety profile of GC012F. You know, we will continue generate more evidence, especially durability of the response and the response is deepening. We definitely take time to collect all these evidence. I know we need to definitely talk to medical community, see how they feel. As you're aware, for this IIT study, the design and it was pretty, I would say, bold, encouraging. We have enrolled almost all the patients, high-risk and transplant-eligible patients, which shows support from, you know, the hospital, the authority that these transplant-eligible patients, you know, become our first targeted group. This is just but whether we're gonna, for future extended study, are we gonna continue target transplant-eligible or ineligible, high-risk or non-refractory. You know, we just need to see more data evidence to further stratify the groups. For now, I think that this group is approved by the hospital for the justification quote quote. These patients are high-risk, whether they transplant plus quadruplets or triplets. The prognosis is not very bright. This is a good start. We're very excited about the data. Got it. That's helpful. Just on the IND filing, I was just wondering if you had any thoughts on when the first patient might be dosed in the U.S., if that could take place sometime next year or if you get the go ahead as expected. Yeah. Wendy, you wanna take this? Yeah. For the U.S. and actually right now it's premature to discuss this. Yeah. We plan to wait until we have received IND acceptance. We're looking forward to providing the update along the way. Great. Got it. Thanks so much for taking the questions. Your next question comes from Louise Chen from Cantor Fitzgerald. Please go ahead. Hi, this is Wayne on for Louise Chen. Congrats on the new data, and thanks for taking our question. The first question is on the GC012F. I think the safety data is so much better on the newly diagnosed multiple myeloma patients compared to the relapsed patients. Can you maybe give us more color on why you think it's much better? The second question is if there's any updates you can share with us on the partnership discussion as well as the Suzhou GMP facility expansion. Thank you. Thanks, Justin. The safety profile appears better in newly diagnosed patients. You know, this is not a big surprise. We kind of expect because these patients might be healthier. However, the response, I mean, the CRS rate is so low, you know, it's about 23% with grade 1-2 CRS and the 77% has no CRS. That is kind of surprise. I can't, you know, comment too much without much evidence. It is new field. We hope that continue that way, and I hope other team studies, when they come up with data, will be interesting to compare. Yeah, that's all I can comment. Now, regarding the manufacturing capacity, we have sort of made a justification. We made an internal sort of redesign, adjust our space. The capacity for the pipelines that we want to develop into clinical, even the first phase of commercial, it's all set. In Suzhou we're, you know, given the circumstances, we'll not aggressively expand our capacity for commercialization, since we think for up to year 2025, 2026, we have sufficient capacity. Got it. Thank you so much. You're welcome. Your next question comes from James Shin from Wells Fargo. Please go ahead. Hi. Good morning. Thanks for taking my question. For William or Wendy, can you say if or how many of 12S newly diagnosed patients achieved molecular remission after induction? Secondly, this one's on transplant. There were two trials, the FORTE trial and the IFM trials. They both seem to suggest that MRD negative patients receiving transplant had improved PFS and sustained MRD negativity. That said, can you say how many of the newly diagnosed patients have gone on to receive transplant? Can you Well- The second question? Sure, sure. Sorry. William, the second question was, there's two trials, I think FORTE and IFM. The data there seems to suggest that like patients with MRD negative status that go on to receive transplant, the PFS and MRD negativity improved. Do you know how many or if any of the newly diagnosed patients in 12S trial have gone on to receive transplant? Let me take the first, Wendy. Sure, go ahead. I'm not aware about these studies, so, but, you know, we can only comment our study. Although, you know, the study is still under embargo for ASH, so we can't really elaborate details. For your second part of question, how many patients gone in our study gone to transplant? No, we don't have that detail at this moment. Hopefully, you know, just in couple weeks, we'll have more details. The first question, Wendy, maybe you can do it. Actually, yes, for all the details that, you know, we have to, I think, respect the ASH embargo policy, so, I think we cannot share too much details beyond the abstract at this point. We welcome, yeah, you to join our ASH presentation in December, and we're looking forward to discussing more at that time. Thank you. Thanks, William and Wendy. Appreciate it. Sure. There are no further questions at this time. I would like to turn the call back over to Dr. William Cao. Thank you again to everyone for joining us on the call. Gracell is well-positioned to deliver breakthrough CAR- T therapies capable of overcoming major industrial challenges by leveraging our proprietary FasT CAR and TruUCAR technology platforms. We are proud of the progress Gracell has made over the third quarter of 2022. We are focused on preparing the IND applications for the U.S. and China agencies and look forward to presenting this first clinical data from the newly diagnosed multiple myeloma IIT at ASH next month. Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.