At this time, all participants are in a 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 call over to Dr. Kevin Xie, CFO. Please go ahead. Good morning, and welcome to Gracell's fourth quarter 2022 corporate update conference call and the webcast. With me today are Gracell's founder and Chief Executive Officer, Dr. William Cao, and our Chief Medical Officer, Dr. Wendy Li. We're excited to discuss the progress of our differentiated clinical pipeline of CAR-T therapies on today's call. We also look forward to sharing with you our recent business developments and upcoming objectives as we head into 2023. 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 and the full year ended December 31st, 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 the future plans of our program, Gracell 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 SEC for a full disclosure of these risks and factors. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, March 13, 2023. Gracell undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities laws. I will now turn the call over to Gracell CEO, Dr. William Cao. William? Thank you, Kevin, and again, welcome everyone to our fourth quarter 2022 corporate update conference call. It has been a very productive few months for us. I will begin today's call with key pipeline updates. I will then turn the call over to our CMO, Dr. Wendy Li, to provide insight into the two company-sponsored trials for GC012F in relapsed/refractory multiple myeloma that we plan to commence in 2023. Thereafter, our CFO, Dr. Kevin Xie, will discuss our fourth quarter and the full year 2022 financial results. After our prepared remarks, we'll open the call to questions. Let me start by emphasizing the high level of conviction that we have in the therapeutics and the commercial potential of our lead autologous CAR-T candidate, GC012F, in hematology and potentially in immunology indications. Autologous CAR-T therapy has now established itself as the most potent treatment for several hematologic malignancies. Significant unmet needs continue to exist for patients and physicians who are facing supply limits, long wait times, and high costs, as well as calling for improved safety and durable efficacy. These needs have been propelling the CAR-T industry to move forward and innovate. At Gracell, we believe GC012F represents a next generation of autologous CAR-T therapy candidate and has the potential to push the boundary of autologous CAR-T on many fronts, such as manufacturing speed, safety, cost, and even durability of efficacy. Utilizing our proprietary FasTCAR manufacturing process, GC012F is comprised of younger, more fit T-cells that are manufactured within 24-36 hours. FasTCAR not only helps to shorten patient wait time to weeks from months, but also provides key advantages in advanced cell quality and cost saving. GC012F features novel BCMA and CD19 dual targeting. This is designed to enable the deepest response and durable efficacy based on the dual mechanism action. Our clinical data generated from 45 multiple myeloma patients has shown a consistent 100% MRD-negative rate in all patients treated with GC012F, which represents the deepest level of eliminating malignant cells in bone marrow. On the durability side, we plan to provide an important data update from our relapsed/refractory multiple myeloma investigator-initiated trial study around mid-year, and hopefully that will add to the expanding body of evidence supporting GC012F's significant potential. I also hope to point it out that the dual targeting mechanism action provides GC012F with wide applicability across diseases, where either BCMA or, and CD19 could be antigen targets, including multiple myeloma, NHL, and beyond, for example, in certain immunology indications. Lastly, but very importantly, GC012F has demonstrated a highly differentiated safety profile in IIT studies. No neurotoxicity was observed in the 48 patients dosed in 3 studies underway in RRMM, newly diagnosed high-risk multiple myeloma, and in relapsed refractory non-Hodgkin lymphoma. While the cytokine release syndrome, or CRS, observed in the studies has been mostly low grade, it is also worthwhile highlighting that the median onset of CRS is around 6 days across our MM studies. These safety features could potentially provide critical differentiation and benefits in earlier lines or outpatient settings. Last month, we have announced that the U.S. FDA and China NMPA cleared our IND applications, which included our China IIT data. Gracell has reached a very exciting juncture in its development life cycle as two company-sponsored studies evaluating GC012F and RRMM are on track to commence soon. Advancing our lead BiSCAR-T candidate towards a U.S. phase I b/II clinical trial is a major milestone, and we plan to initiate enrollment in the second quarter. The phase I/II clinical trial in China is expected to commence in the third quarter of 2023. Our CMO, Dr. Li, will provide additional details shortly. We remain very excited about the data we have gathered so far in IIT studies. It is underway to evaluate GC012F in a newly diagnosed high-risk multiple myeloma patients. The first in-patient data from this trial was presented at an oral session of the ASH annual meeting in December 2022. We were overwhelmed by the very positive reception from the medical community on the data. KOLs are optimistic about our candidate's potential in frontline settings. We continue to follow up this study and anticipate sharing additional data later this year. As a reminder, we also unveiled the first data from an ongoing IIT of GC012F in relapsed/refractory NHL at EHA in June 2022. We are continuing the enrollment and the follow-up of these patients in ongoing study. A plan to share the updated data at a medical meeting 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 being evaluated as a treatment for r/r B-ALL. At last year's EHA, we presented updated IIT data which shows 3 out of 4 treated patients achieved MRD-negative CR, CRi. This study is ongoing. Next, moving on to our donor-derived CAR-T. In October, we announced the dosing of the first patient in China registrational phase II trial evaluating GC007g in an allogeneic CD19-targeted CAR-T 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. We have observed highly encouraging safety and efficacy data in the phase I portion, and we hope to share the data later 2023. Lastly, SMART CAR-T is our second-generation technology for the treatment of solid tumors and utilizing a novel construct to take advantage of the suppressive tumor microenvironment and effectively combat solid tumors. Preparations are underway for an IIT trial for the second SMART CAR-T candidate. GC506 targeting Claudin 18.2, enrollment is on track to commence in the coming months. As we're heading to 2023, we're very optimistic about continued advancement of our highly differentiated CAR-T platforms as we are on track to commence 2 company-sponsored trials, advance enrollment in ongoing studies, and push forward other initiatives. We look forward to providing several clinical data updates at upcoming medical meetings throughout 2023. Now, I will 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. In the U.S., we plan to initiate a company-sponsored phase Ib and II clinical trial evaluating GC012F for the treatment of relapsed and refractory multiple myeloma during the second quarter of 2023. We received clearance from the U.S. FDA for IND application in January 2023. The phase Ib portion of the trial is designed to evaluate the safety and the tolerability of GC012F in 2 dose levels and to determine the recommended phase II dose. We plan to enroll approximately 12 patients who have received three or more prior lines of therapy in the phase Ib portion at 2 dose levels. We plan to activate up to five to 10 sites that are very experienced in conducting CAR-T trials. We currently anticipate completing the phase I portion during the first quarter of 2024, and then holding an end of the phase I meeting with FDA shortly thereafter in 2024 to align on the next steps. Turning to the company's sponsored trial in China. We plan to initiate enrollment in the phase I/II trial evaluating GC012F in RRMM during the third quarter of 2023. The phase I portion of the trial is designed to evaluate the safety and the tolerability of GC012F across 2 dose levels and to determine the RP2D. We plan to enroll approximately 9 patients at 1 clinical site in China and anticipate completing enrollment in the phase I portion during the first half of 2024. Last December, an oral presentation on the first clinical data from ongoing IIT evaluating GC012F in newly diagnosed multiple myeloma patients was conducted at the ASH annual meeting. The data demonstrated that GC012F achieved a 100% overall response rate and a 100% MRD negativity in all 16 transplant-eligible high-risk NDMM patients across all dose levels. The safety profile was excellent, as 75% of the treated patients did not experience any cytokine release syndrome. No immune effector cell-associated neurotoxicity syndrome or other neurotoxicity of any grade has been observed. We have received significant enthusiasm from the medical community since the ASH presentation. The data highlighted an impressive 100% ORR and 100% MRD-negative in first-line patients that have multiple high-risk features and regardless of whether they have responded to the short induction therapy of two rounds of RVD before the infusion of GC012F. In contrast, the current standard of care for newly diagnosed multiple myeloma usually includes as many as 4 to 8 rounds of induction therapy, which can be triplets such as RVD, or quadruplets such as daratumumab plus RVD, followed by autologous stem cell transplant, and then a few years of maintenance therapy. At the end of the transplant, sCR is typically 30%-40%, and MRD-negative rate could be between 20%-50%. It's also worthwhile to mention that typically with the standard of care, it can take 1 year or more between diagnosis and completing the transplant, while with CAR-T, the median time from diagnosis to infusion of GC012F in the ongoing trial was less than 5 months. Our data is among the first to demonstrate the material benefits CAR-T can bring to the newly diagnosed multiple myeloma patients, including shortening the diagnosis to treatment time, deepening the response, and maximizing the response rate, all achieved with a good safety profile. We continue to follow the patients in our study to further evaluate the long-term benefits. We are very encouraged by this initial data and currently evaluating the path forward for this indication. 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 December 31, 2022, the company had RMB 1,458.2 million, or $211.4 million in cash and cash equivalents and short-term investments. We expect the cash use for this year to be approximately $100 million. Primarily to fund our R&D and clinical programs in the U.S. and China. We expect our current cash position to be sufficient to cover our operation plan and R&D activities towards the end of 2024. Net loss attributable to ordinary shareholders for the three months ended December 31st, 2022 was RMB 130.7 million, or $18.9 million, compared to RMB 128.6 million for the same period in 2021. Net loss attributable to ordinary shareholders for the full year ended December 31st, 2022 was RMB 607.5 million, or $88.1 million, compared to RMB 453.7 million for the same period in 2021. Research and development expenses for the three months ended December 31st, 2022 were RMB 113.1 million, or $16.4 million, as compared to RMB 107.6 million for the same period in 2021. For the full year ended December thirty-first, 2022, research and development expenses were RMB 485.4 million or $70.4 million, compared to RMB 326.9 million for the same period in 2021. Increases was primarily due to the increased spending on research development and the clinical trial, as well as higher payroll and the personnel expenses attributable to increased headcount, and higher facility-related costs in support of continued expansion of research and development activities. With that, I'd like to turn it back to the operator to open the session for your questions. Operator? The floor is now open for your questions. To ask a question at this time, please press star one on your telephone keypad. If at any point you'd like to withdraw from the queue, please press star one again. You will be provided the opportunity to ask one question and one further follow-up question. We'll now take a moment to render our roster. Our first question comes from the line of Carly Kenselaar from Citi. Please proceed. Hi, team. This is Carly on for Yigal. Thanks so much for taking our questions. Can you comment on the vein-to-vein time you are anticipating for GC012F in the U.S. phase I with the current process and quality control procedures that you have in place? I guess, how much further do you believe that can be optimized as you move into later stage development and eventually the commercial setting? Hi, Carly. Very good question. The first part is very good. Second part is better. Let me sort of put together pieces so that you understand, you know, because we're probably using different definition. Let's say at the delivery time, meaning we receive the sample and then, and return the cells to the hospital. That's about that's supposed to be 7 days. However, you add on logistics, and then QC everything, it's about 12 days. Now, before I get to lymphodepletion, okay, the release in tests in our hand is 5 days, 7 days. However, we in the U.S., the test is being done by third-party laboratory, so that will add on a few more days. It's not gonna be 7 days release of tests. It's been probably 9 days, 10 days, and perhaps even longer. That part I can't give you definitive answer yet. Basically it's 3 days manufacture from, you know, from receiving and by having the cells ready, plus 1 week to 7 or some days to 10 days of testing days. Vein-to-vein time, including lymphodepletion, that will add on 3 days plus. Total together, I would say about probably up to 3 weeks. The second part of the question is: Is any possibility to optimize? Yes, of course. Moving forward, we will establish in-house quote, the test can be done within CDMO. It will shorten the time of logistics shipping in and out. Okay, great. That's super helpful. We just had one follow-up. I guess we've heard from some companies that... No, sorry, Carly. Oh, yeah. Carly, there is one minor point I would like to add on here. Oh, sure. Sure. If we could further optimize the releasing test, let's say shorten from 7 days to 5 days, for example, then it is some area we can optimize as well. Okay, perfect. Then our follow-up was just on enrollment. I guess we've heard from some companies that enrolling late line myeloma patients in the U.S. is becoming increasingly difficult given the availability of the BCMA bispecific. Just curious any feedback you're hearing from KOLs around this and what steps you could take to facilitate enrollment in the phase I/II. Thank you so much. Sure. Wendy, do you want me to try first and then you can. Yeah, go ahead. Okay. Yeah, go ahead. Yeah. My signal is not very good. Okay. Yeah. Please go ahead. Carly, that's why we, what we hear is slightly different. Perhaps the PIs, the carriers we have been working with are very enthusiastic, and seems to us that phase Ib, 12 patients enrollment is not going to be an issue. Now, hopefully, you know, our sites we select are very experienced, that we know. Hopefully the patients, that enroll in that site, you know, also looking for the fast delivery products like GC012F. Anyhow, so far we don't have any special concern about the speed of enrollment. Does that answer your question? Or, Wendy, do you have anything to add on? Yeah, your answer is perfect. Thanks. Thanks. Carly, did we answer your question? Our next question comes from the line of James Shin from Wells Fargo. Please proceed. Good morning, guys. Thanks for taking my question. Just wanted to touch base on comments regarding a partnership, it didn't seem mentioned in the press release. I have a follow-up. Yeah. You haven't seen a press release. You're right. I would wish, you know, it come to material. We, you know, since our ASH presentation of newly diagnosed multiple myeloma study and the, you know, immediate news about IND filing, we do receive positive response and interest. I can't reveal more details, you know, on, in that direction. Please be ensured that's on top of our priority. This is the right way to go. We'll continue to pursue that. Got it. Okay. Then for the Claudin program, what sort of would you expect to see responses this early or is this sort of like a proof of concept? Can you say anything on your expectations for solid tumors for cell therapy? Claudin program, you mean SMART CAR-T for solid tumor? Yes. GC506. Okay. Yeah. The target is Claudin 18.2. We will initiate clinical IIT first, which will commence very soon, I believe. Yeah, very soon. We'll have, you know, reasonable time to assess solid tumor response. This will take, you know, I don't know, six months, to evaluate the new product. Okay. All right. Thank you. Yeah. Right. We haven't published any data, including the clinical data, mechanism of studies, so I can't really comment on the details. The purpose of this whole program or the objective of the new design on Claudin 18.2+ the SMART device is to enhance the efficacy. We believe for solid tumor you do need a strong push of the CAR-T cell into tumor tissue to combat the suppressive environment. Hopefully with the additional SMA design, plus this, you know, widely recognized target 18.2, we're going to see some signal. We just have to wait for that. Thank you, Brian. Our next question comes from the line of Justin Zelin from BTIG. Please proceed. Hi. Good morning, guys. Thanks for taking the question, and congrats on the progress here. I had a question just on the IIT durability data that we're expecting later this year. You know, are you targeting a medical meeting for disclosure of that data, or could that come as kind of a company event here? I have a follow-up. Yeah. Wendy, I think that that's for you. That's right. We're going to explore the data in the later this year for the meetings or the managed practice. We're looking forward to public this information later but within this year. Okay. Great. You know, may I add on? May I add on, you know, you hear from Dr. Li that the both paper and presentation conference are planned, so whichever come out first. You know, it's possible end of the year, if, you know, ask for any high of these, we can get in on time and if the paper publish earlier than that. It's all ballpark. It's in ballpark within this year. Got it. Okay, that makes sense to me. For the 29 patients, I think the last update we got last year, the median duration of follow-up was approaching a year. You know, for this next update, do you think we could potentially see, like, a 2-year median duration of follow-up or, you know, a year and a half, like, in that kinda range? Yes. That's true. Okay. Okay, excellent. All right. Thanks for taking my question. Thank you. Thank you. Thank you, Justin. Our next question comes from the line of Kelly Shi from Jefferies. Please proceed. Hi. Thank you for taking my question. This is Dave for Kelly Shi. Actually, I have a question on GC007g in B-ALL in China. You said data will be in 2023. Can you add some color on when the submission to NMPA is planned and maybe some color on market opportunity of GC007g in B-ALL in China? Thank you. Thanks. Do you want to take that one? Yeah. This is 77, right? It's GC007g? GC007g. Yeah. Right. The phase II portion is ongoing right now, the clinical trial. We have observed very improved data in the phase I. We're going to share the data again, later this year. We have more add on, William? No, I think that's about it. That's good. Yes. All right. Thank you. Our next question comes from Emily Bodnar from H.C. Wainwright. Please proceed. Hi. Thanks for taking the question. I guess since you said you expect to finish the phase Ib portion of the U.S. study in the first quarter of 2024, should we not expect any data updates from the phase I this year? I guess kind of a follow-up on the durability questions. Maybe just tell us how you're thinking about what would be considered positive. I know previously you said 15.7 months was an estimate, are you looking to see something around that range, or could we potentially see something higher? Maybe now that you're advancing GC012F into later stage studies, how are you kind of thinking about prioritizing the rest of your pipeline for development? Is there any other indications besides B-ALL that we could see data this year? Thanks. There are about three questions. First one, will we have any data release for phase Ib of GC012F prior to first quarter of next year? The second question is the durability of the 29 patients IIT study. What's the third part? Just prioritization of the rest of the pipeline. Oh. Got it. Got it. For this year. Right. That's right. That's right. Wendy, do you wanna take the first one, the GC012F 1b study? Actually, I think just like you just mentioned about the, you know, the completion will be the first one, phase Ib enrollment will be, you know, like, 2024 first quarter. I think the data, you know, we're just looking for that timing, timeframe. Now it's early and premature yet. The second question. The GC012F durability. The durability actually we're very confident from our 29, you know, our patients from the IIT already. We got very good, you know, data, right? Also durability. We're going to explore the data, I think we just mentioned about a couple people asking for in this year later on. Right. either one, the meeting or manuscript. Right. Yeah. Yeah, you know, we can provide more details about the durability, but, you know, you hear from us, we're very encouraged, very confident. Let's look forward. Now, the third part, which is prioritization, the GC012F has been demonstrated such, you know, safe, very outstanding safety profile as well as efficacy across about now total, what, 50 patients. you know, across three indications, MM, NDMM, NHL. We believe this dual targeting compound has very unique applicability. In addition to hematological cancers, there will be a possibility to cross the line to immunology indications, because of BCMA CD19 or CD19 or and the CD19. We, we reprioritize our resources, and we like to focus on expansion of application of this product. All right. Okay, thank you very much. You're welcome. With that, our final question comes from the line of Louise Chen from Cantor Fitzgerald. Please proceed. Hi, this is Wayne. I'm for Louise. Congrats on all the progress, and thanks for squeezing us in. My first question is, do you think the phase II portion of the U.S. study for the GC012F, that could serve as a basis for accelerated approval? I also wanted to ask, you have a lot going on this year, very, very busy. What are your key, most important readouts that you're looking forward to this year? Thank you. Yeah, two questions. Wendy, do you want me to take that one? Yeah, go ahead. Okay, the phase II, after the phase II 50 patients enrollment, are we, you know, looking at a breakthrough? It's very possible, of course. You know, let's see from phase Ib data, and we'll certainly look forward to apply for that. Now, we do have lots going on this year, particularly this year. Lots going on. on. IND study in the U.S. and new programs entering clinical IIT. We are moving on filing, some of these new products, IND filing in the U.S. as well as in China. It's all been laid out nicely. They're, they all stack out with all the resources aligned. Of course, the focus has continued to be, without hesitation, pushing forward with the GC012F on MM, because that's gonna demonstrate a lot of features of this product. Additional application of this compound is sort of being laid out, newly diagnosed NHL and potentially, immunology indication. These are sort of key focus. We're, you know, also very excited about a solid tumor program, where Claudin 18.2 is sort of proven target. Our logic is very simple. If we add SMART CAR-T device, would the efficacy be better? Which is so much needed for solid tumor. Now, for the TruUCAR platform, we're continuing refinement of the UCAR-T technology as well as the product, and with the goal of extending the persistence, which is the key to off-the-shelf CAR-T product. We do see very encouraging preclinical data in both solid tumor program as well as the UCAR-T program. Then we'll see now what's gonna happen in preclinical model, and we would like to see in human model, in human studies. It's a very exciting year, and we're looking forward to see data coming out mid of the year and end of the year. Got it. Thank you very much. Thank you. Thanks, congrats again. You're welcome, Louis. I would now like to turn the call back to Dr. William Cao. Thank you again to everyone for joining us on the call. We are proud of the progress the Gracell team made over the past year. 2023 will be a critical year for us, as we are on track to initiate our RRMM IND studies in the U.S. and China. We believe Gracell is well-positioned to deliver CAR-T-cell therapy that it can potentially transform the treatment landscape. We look forward to providing clinical data updates and sharing key pipeline and technology updates throughout the year. Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect.