Greetings. Welcome to Gracell Biotechnologies' clinical update conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. At this time, I'll turn the conference over to Kevin Xie, Chief Financial Officer. Kevin, you may now begin. Good morning, welcome to Gracell's clinical update conference call and webcast. There is a slide presentation accompanying today's call. This slide presentation can be accessed on the investor relations section of Gracell website at gracellbio.com. I would also like to remind you that this call is being recorded for replay. Please note that for certain information discussed on the call today, including clinical data and future plans of our programs, Gracell management will be making forward-looking statements. Actual results could differ materially from those stated or implied by the forward-looking statements as a result of various important factors. Please refer to the Risk Factors section of our latest 20F filing with SEC for 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, June 14, 2021. 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. With me today are Gracell's Founder and Chief Executive Officer, Dr. William Wei Cao, and our Chief Medical Officer, Dr. Martina Sersch. We're excited to discuss our innovative technologies and the clinical pipeline of CAR-T therapy in today's call. We also look forward to sharing with you the results we have presented at ASCO and EHA 2021 annual meeting, as well as key events we foresee in the near future. With that said, I'd like to turn the call over to Gracell CEO, Dr. William Wei Cao. Thanks, Kevin. As an introduction to Gracell, we are a global clinical stage biopharmaceutical company dedicated to discovering and developing breakthrough CAR-T cell therapies for the treatment of cancer. CAR-T cells can be classified as either autologous, derived from T-cells of a cancer patient, or allogeneic, derived from T-cells of a healthy donor. We have developed proprietary technology platform, FasTCAR and TruUCAR, which we believe represents game-changing advances in CAR-T industry. FasTCAR is Gracell's autologous CAR-T platform designed to overcome challenges of conventional CAR-T therapies by significantly shortening cell manufacturing time from weeks down to next day, which importantly also contributes to enhanced T-cell fitness and potency. TruUCAR is Gracell platform of allogeneic CAR-T therapy that can be administered off the shelf at a lower cost, offering hope for accessibility to a broader patient population. TruUCAR is highly differentiated with a novel design enabling single infusion standalone therapy. We have also developed proprietary technology enhancements, Dual CAR and Enhanced CAR, that can be leveraged with our FasTCAR and TruUCAR platforms to potentially further enhance the therapeutic effect and the safety profile of our CAR-T product candidates. Our lead asset and focus of today's call, GC012F, has Dual CAR design. We believe this offers an effective strategy to control relapse in patients by reducing likelihood of antigen escape, as well as eliminating cancer cells with heterogeneity. By leveraging these proprietary technology platforms, Gracell is developing a rich clinical stage pipeline of multiple autologous allogeneic product candidates to overcome major industrial challenges and address the high medical needs in the treatment of cancer. Our leader program is BCMA CD19 dual-targeting CAR-T product for treatment of multiple myeloma, GC012F, which is manufactured using the FasTCAR next-day manufacturing platform and is the focus of the data that we presented at the year 2021 ASCO. Dr. Martina Sersch will discuss the updated results for the first-in-human multi-center study of GC012F in today's call. GC012F has a highly differentiated BCMA CD19 dual-targeting design, which we believe has the potential of offering enhanced treatment outcomes. We are planning on submitting an IND application in both the U.S. and China within the first half of the year 2022. We are also applying the FasTCAR platform to other indications, including but not limited to B-cell malignancies. We also have multiple candidates developed with our second proprietary platform, TruUCAR, which offers allogeneic off-the-shelf solution for the treatment of cancer. Recently, at AACR year 2021 annual meeting, we were excited to present promising long-term follow-up results of GC027 in r/r T-ALL patients. T-ALL is a unique indication, a highly aggressive form of cancer, and with very limited treatment options, representing a meaningful unmet medical need. With these findings, we believe GC027 may have the potential to be developed as a single infusion standalone allogeneic CAR-T therapy, and we are looking forward to expediting the clinical development of GC027 globally, as well as expanding the TruUCAR platform into additional indications beyond T-ALL. Last but not least, is our allogeneic donor-derived CAR-T, GC007g, for the treatment of B-ALL, where we already obtained IND approval, including approval of a seamless phase I/II registrational study for GC007g in China. We have dosed the first patient in this phase I, II study, which is currently ongoing at a multiple center in China. On slide five, you see how our Autologous FasTCAR platform has distinguished itself from conventional CAR-T approaches by significantly shortening the manufacture time from an industry norm of two to six weeks, to the next day. We have developed a proprietary system of concurrently activating and transducing resting T cells in a single step, where we have many of our proprietary elements working together to ensure high transduction efficiency while also avoiding aging cells. Because our process greatly preserves T cell fitness, our therapy only needs a small number of cells in comparison to others, eliminating the need of ex vivo expansion. This is a contrast to lengthy, laborious, and costly steps in conventional CAR-T manufacturing to activate, transduce, and expand T cells. The time saved is critical for patients with rapidly progressing disease. Together with substantial cost savings, we believe FasTCAR can increase accessibility of cell therapy for cancer patients. Importantly, the benefits of our FasTCAR platform go beyond shortening the manufacture time and increasing the speed in which therapies can be delivered to patients. The platform is designed to overcome several other key challenges with conventional CAR-T therapies. The most notable benefit is the enhanced T cell fitness. CAR-T cell manufacture on this platform appears younger, less exhausted, and show enhanced proliferation, persistence, bone marrow migration, and antitumoral cell clearance activities as demonstrated in our preclinical studies. Based on clinical data today, our lead FasTCAR therapy on FasTCAR platform, GC012F, has demonstrated promises of fast, deep, and durable responses. On the cost side, the shortened manufacturing time reduces the direct cost of consumables, labor, and facility in a linear fashion. While shortened wait time for patients also helps to generate substantial cost savings to the healthcare system. Now, let's come back to our lead clinical program, GC012F, developed on the FasTCAR platform. GC012F is our FasTCAR-enabled CAR-T candidate for the treatment of multiple myeloma patients who aren't relapsed and/or refractory to prior therapies. GC012F is a novel dual targeting product, targeting two different antigens, BCMA and CD19. On slide eight, it is shown that BCMA is universally expressed on malignant plasma cells, while CD19 is expressed on both multiple myeloma cells and myeloid progenitor cells. Preclinical work performed by Gracell has shown that targeting both BCMA and CD19 is a highly efficacious approach. Now, I will hand over the call to our CMO, Dr. Martina Sersch, to discuss the latest data of GC012F presented at ASCO and EHA. Martina, please go ahead. Welcome, everyone, to today's call discussing the data update for GC012F in relapsed/refractory multiple myeloma. It is my pleasure to present updated clinical results of the multi-center first-in-human study of the dual BCMA and CD19 targeted novel platform, FasTCAR T-cell therapy, GC012F, for patients with relapsed and/or refractory multiple myeloma. GC012F is a dual targeting BCMA CD19 CAR-T therapy currently in development for the treatment of relapsed or refractory multiple myeloma. Targeting both antigens is designed to drive deep, fast, and durable responses. Early clinical data we generated show that targeting CD19 can trigger elimination of malignant cells by CAR-T. At the data cutoff of January 12th, 2021, with a median time to follow-up of 13.8 months, 19 relapsed refractory multiple myeloma patients were enrolled and have been treated in three different dose levels, ranging from one to 10 to the 6th to three to 10 to the 6th per kilogram with a single infusion of GC012F after standard lymphodepletion regimen over three days within our single arm open label multi-center IIT study in China. Primary endpoint of the study is safety. Secondary endpoints are overall response rate, MRD negativity rate at six time points, duration of response, and PK, amongst others. GC012F is being manufactured on the FasTCAR platform, enabling 22 to 36-hour manufacturing. Baseline characteristics show a median age of 55. Patients enrolled on study were primarily high-risk patients, 95% as defined by mSMART criteria. Among those patients, 16% were double hit and had received a median of five prior lines of therapy. 79% of the patients were refractory to last therapy, 95% were triple exposed to PI, IMiDs, and other treatment modalities, and 95% of the patients were refractory to PI. Four patients had received and were refractory to anti-CD38 therapy. The safety profile of GC012F showed TEAE of mostly cytopenias and were all reversible. Cytokine release syndrome, or CRS, a common safety finding in CAR-T therapy, occurred mostly low at grade one or two, with a median time to onset of six days, ranging from 2-10 days. Median duration of CRS was four days, ranging from one to eight days. No grade four or grade five CRS were observed. CRS were treated with standard of care, including tocilizumab, steroids, and vasopressors, and resolved in all patients within one week. We did not observe any ICANS of any grade. Overall response rate at time of data cutoffs was 94.7%, with all responses being VGPR or better. 84.2% out of the total 19 treated patients achieved stringent complete response, sCR, the deepest response possible. In dose level three, our recommended phase II dose, 100% of the patients achieved stringent complete CR. Median duration of response is not yet reached. Time to earliest response was 28 days. All patients on study were assessed for MRD at six time points. All patients had one post-baseline bone marrow sample by NGS at month one. Out of 16 evaluable patients, 81.3% had achieved MRD negativity by flow at month six. 100% of all evaluable patients had achieved MRD negativity in all dose levels. All patients on study received a reduction in paraprotein, with 95% of the patients achieved a 100% reduction of paraprotein. GC012F dual targeting BCMA CD19 CAR-T showed a very promising activity in relapsed and/or refractory multiple myeloma patients. In mostly high-risk patients, 94.7%, and in patients who were heavily pretreated, including anti-CD38 antibodies, PIs, and IMiDs, with a median of five prior lines of therapy. We observed a favorable safety profile consistent with previous findings, with mostly low-grade CRS and no ICANS. No grade four or grade five CRS was observed. GC012F dual targeting BCMA CD19 CAR-T showed an impressive high overall response rate of 100% MRD negative sCR in the highest dose level, dose level three, the recommended phase II dose, RP2D. GC012F Dual CAR-T may present a new treatment approach for relapsed refractory multiple myeloma patients, including those with high-risk features, and may provide exceptional deep responses that are durable in a specifically hard-to-treat patient population. Slide 17. In March, we announced that we have entered into MSA with the CDMO Lonza to support clinical manufacturing of GC012F in the U.S. On slide 17, you can see the milestones we have achieved so far in the Lonza collaboration. We have already made good progress toward manufacturing GC012F in the U.S. for planned IND filing in studies by completing SOW and initiating tech transfer. Moving forward, we plan to leverage Lonza integrated service in CAR-T manufacturing and to establish a state-of-art GMP process, which will be a critical component of our IND filing. For GC012F, we are targeting an IND application in the U.S. and China in the first half year of year 2022. I will now hand it back to Kevin to touch on some additional near-term targets for our programs. As shown on slide 18, we have already made great progress on our operational goals for 2021. Earlier this year, we announced the enrollment and dosing of the first patient in the pivotal phase I/II clinical study of GC007g, the allogeneic donor-derived anti-CD19 CAR-T therapy for B-ALL. As discussed today, we have recently provided clinical data updates for GC012F and GC027 at major medical conferences. For both of these candidates, we're working towards filing an IND application in both the U.S. and China next year. In the second half of this year, we expect to initiate enrollment in the GC012F phase I study in China, advance new candidates from the discovery into clinical studies, and to present additional data updates for our lead clinical programs at major medical conferences. To support our clinical operations, we're planning to extend our state-of-the-art GMP facility in China and establish R&D facilities in the U.S. In conclusion, in 2020, we continued to make significant progress in developing breakthrough CAR-T cell therapies by leveraging our proprietary technology platforms, FasTCAR and TruUCAR, to overcome major industry challenges. We were very pleased to present updated, highly competitive data of our lead clinical programs and continue to develop and extend our rich clinical-stage pipeline of oncologic and allogeneic product candidates. Central to our progress is a highly experienced leadership team with a proven track record of success, including our recent key addition of Dr. Jenny Ni as our Chief Technology Officer. Dr. Ni brings over 25 years of experience in process and CMC development for gene and cell therapy with work at Pfizer and Allogene Therapeutics. We look forward to building on the momentum achieved thus far as we continue to advance our innovative CAR-T pipeline for difficult to treat cancers. With that, I'd like to turn it back to the operator to open the session for your questions. Operator? Our first question is coming from the line of Mohit Bansal with Citigroup. Please proceed with your questions. Great. Thanks for taking my question and congrats on the data. A couple of questions. I'll ask first question. In terms of you being able to file a U.S. IND in first half of 2022, could you please remind us and walk us through what steps need to be taken or what work needs to be done before you can file a U.S. IND in the timeframe you're talking about? Sure, Mohit. Yeah. Oh. No, go ahead. Thanks. Sure. Thanks, William. Mohit, the steps we need to take is the tech transfer, which is currently ongoing from China to Lonza, U.S., and then we would be generating data with the manufacturing conducted in the United States. That data will have to be submitted together with our IND application. Got it. The other question I have is, I was listening to another Chinese company, Junshi, and they have generated some data in China. They are looking at a possibility of using those data to file a U.S. IND. I understand this is a different kind of product, so it may not be suitable, but how do you think about the Chinese data becoming a key part of not just IND, eventually the filing when you do that? Yeah, sure. As you know, in an IND, there's different modules. Besides the tech data, manufacturing data, and others that we would want to submit, we're also planning on using the data generated in China, absolutely. I think there's a gateway opening up right now to having that data even more acceptable than before to be able to help the submission is not only for safety, even for efficacy. Got it. Very helpful. Thank you very much, Martina. Sure, yeah. Welcome. Our next question is coming from the line of Nick Abbott with Wells Fargo. Please proceed with your questions. Good morning. Thanks for taking my question. The first one would be, Martina, you've talked about a frontline myeloma IIT, high-risk IIT trial study in China. What do you think a study would look like, how big it is, and what are the key endpoints there? I have a follow-up. Sure. We want to keep this confidential until we actually started the study, Nick. In general, what we would be looking at would be a study in frontline, basically looking at patients with high-risk criteria who may be transplant eligible or transplant ineligible. We want to tackle the entire breadth of patient population that would be available that could benefit from GC012F. Great. Thanks. I look forward to seeing that one being listed. My second question is, recently there was listed a lymphoma trial, China IIT lymphoma trial, for what appears to be a different CD19 BCMA Dual CAR than 12. Can you talk about what the rationale there is for having a BCMA CAR for lymphoma? Sure. The dual targeting may provide benefits in extended other indications as well. As we have been talking about, we want to expand the indication for our dual targeting agent, BCMA CD19, into other indications. There is data in lymphoma showing that dual targeting may be substantially beneficial in B-NHL as well. That is why we want to expand in those different indications in an IIT setting in China. Maybe William would like to add here as well. Yeah. First of all, these markers are expressed on lymphoma. It's similar to multiple myeloma. CD19 expression is there, it's neglected. People focus on CD38, BCMA, and even other markers. We have studied pre-clinically, and now we believe this product, with dual targeting, does provide a rationale that will target two antigens on lymphoma. Also because of safety profile, these are the rationales we want to choose that expand to the different indications. Just follow up, William, the goal here would be showing improved durability of response, I guess, and/or depth of response? It would be both. Yeah, exactly. Yes. If you look at landscape, the multiple myeloma field is still much I would say the upside is as clearly as there. Unlike multiple myeloma, it's very, very competitive regarding, especially the efficacy. For lymphoma, generally, the CCR rate is around 60%, but then 50% will relapse in 12 months or 24 months. The gap is still there, and we believe by dual targeting could bring up to a higher response while keep safety profile in check. Okay, fair enough. Thank you. Thank you. Our next question is from the line of Kelly Shi with Jefferies. Please proceed with your questions. Hey, this is Hao calling in for Kelly Shi. My first question is also regarding the GC012F regulatory path. Could you talk maybe more specifically for the high-risk patients? For example, maybe some of the criteria to define this subpopulation, and what maybe other things will be required regarding the regulatory path for both in the U.S. and China? That's a great question. I want to say very clearly here that while we have this very strong data in high-risk patients, our regulatory pathway is targeting all comers. One kind of paradigm that is true, if you work in high risk, usually you work even better in normal risk, and that has been shown for many different modalities in its PIs as well as probably CAR-T, as we've just seen the update in the KarMMa study. Our regulatory pathway would not just be high-risk patients, it would be all comers relapsed/refractory multiple myeloma. That's the first part. The second step, of course, would be early lines of therapy, but that's something we wouldn't be discussing at this point in time. Okay, thanks. My second one is, again, for the high-risk patient, this good high activity of the GC012F, could you maybe talk about what do you think in terms of mechanism, why GC012F shows this high activity fundamentally? One part would be the dual targeting, as William mentioned, and we also reiterated that the target is expressed on myeloid progenitor cells as well as BCMA is universally expressed on malignant plasma cells. Targeting both, per se, with our hypothesis as well as the preclinical data we were able to generate, shows a much deeper and more durable response than targeting BCMA alone. That is also what we've been seeing in our study, in our clinical study, having those very fast and extremely deep responses up to stringent MRD negative, stringent CR, MRD negative stringent CR, which in the way, if you look at the percentage of those deep responses, is unheard of with BCMA alone. Okay, great. Thank you so much and congrats on the good progress. Yeah. Thank you very much. Appreciate it. Thank you. Our next question is from the line of Joseph Catanzaro with Piper Sandler. Please proceed with your questions. Hey, guys. Thanks for hosting this call. Thanks for taking my question. Maybe just one quick one from me. I'm wondering with regards to the U.S. trial, if you could speak a little bit towards the sort of dose level that you expect to move forward with, whether you take simply dose level three or is there some dose escalation work that you suspect will be required from the FDA and whether you could go higher than dose level three? Thanks. Sure. Great question. We are hoping to use our data generated in China to provide to the FDA in regards to a safety assessment. We are hoping that we do not have to do dose escalation study, but could go in right away with our recommended phase II dose, which would be dose level three. We are not planning on dose escalating because dose level three already provides all benefits that we are hoping to achieve, meaning the deepest response the fastest possible, as well as a very favorable safety profile. Okay, perfect. Thanks so much. That's all from me. Thank you. At this time, I'll turn the floor back to management for further remarks. Thank you. At this time, I'll be handing the floor back to management for closing remarks. Thank you. At this time, ladies and gentlemen, this will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.