Gracell Biotechnologies Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Grace Health Biotechnology's fourth quarter and full year 2021 conference call. 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 for questions will be given at that time. I will now turn the conference call over to Dr. Kevin Shea, CFO. Please go ahead.

Good morning, and welcome to Green Cell's fourth quarter and full year 2021 earnings conference call and webcast. With me today are Green Cell's founder and chief executive officer, Dr. William Tau, and our chief medical officer, Dr. Martina Serge. We're excited to discuss our innovative technologies and the breakthrough clinical pipeline of CAR T therapies on today's call. We also look forward to share with you our recent business development and upcoming targets for 2022. After our formal remarks, we'll conduct a question and answer session. This morning, Resell issued a press release announcing unaudited financial results for the quarter ended December 31st, 2021. 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, future plans of our programs, resource management will be making forward-looking statements. Actual results could differ materially from the stated or implied by this forward-looking statement as a result of various important factors. And please refer to Risk Factor section of our latest 20S filing is SEC for full disclosure of these risks and factors. The conference call contains time-sensitive information that's accurate only as of date of this live forecast, March 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 as may be required by securities law. I will now turn the call over to GraceL's CEO, Dr. William Tsao. William?

Thank you, Kevin. And again, welcome everyone to our fourth quarter and full year 2021 earnings conference call. GraceL has made substantial progress over the last year, and it continues to deliver across corporate, clinical, and operational initiatives. I will elaborate on some of the key achievements and updates. Following this, I will turn the call over to our Chief Medical Officer, Dr. Martina Serge, to discuss our pipeline developments and regulatory advancements in the U.S., and then to our Chief Financial Officer, Dr. Kevin Shear, to discuss financial results. In the end, I will share our anticipated milestones for the year to come. Since our last corporate update call on August 27, 2021, we have continued to make progress across our innovative portfolio of autologous and allogeneic CAR-T cell therapies. Built upon our rich cell therapy and gene editing expertise and proprietary fast CAR, true CAR, and smart CAR-T technology platforms across multiple difficult-to-treat hematological malignancies and solid tumors. We are continuing to advance our fast autologous CAR T platform, which is designed to overcome challenges of conventional CAR T therapies by significantly shortening cell manufacture time from weeks down to next day. Importantly, this also contributes to enhanced T cell fitness. This is supported by the vast data from our preclinical studies. Because our process manages to preserve T cell fitness, our cells are very potent, and the therapy only needs a small number of cells in comparison to others, eliminating the need of ex vivo expansion, which could result in cell exhaustion. If you dose to other CAR T therapies, our dose ranges from one-third to 100 to other dose. And because our cells are more potent, and expansion happens in vivo, the optimal environment for T cell proliferation. So the peak of expansion of our CAR T cells reaches three times that of certain marketed CAR T cell products. And our AUC area under the curve is about 2.5 times of others. In November of 2021, our lead fast CAR T candidate, GC012F, was granted orphan drug designation by the U.S. FDA for the treatment of multiple myeloma. COFF-F is a novel dual-targeting product candidate specific for two different antigens, BCMA and CD19, which we believe has potential to be highly efficacious. COFF-F has demonstrated fast, deep, and durable responses in patients with relapsed refractory multiple myeloma. In an ongoing IIT study in China, with most patients on study being high risk, according to MSMAR 3.0 criteria, are difficult to treat the patient population. We're very excited about it being granted often drug designation for the treatment of multiple myeloma by the US FDA, as it qualifies Gracell as the sponsor of the therapy for certain development incentives. Dr. Sush? will share more about 12F and expand on its progress shortly. We have extended our timeline for R&D submission in the U.S. for GC012F for RRMM to the second half 2022. While we have made significant progress with our tech transfer from our Suzhou GMP manufacturing facility to the U.S. CDMO, this revised timeline reflects the impact to the industry-wide high demand of cell therapy manufacturing capacity. The verification runs are producing quality cells, and we continue to work closely with our CDMO to move forward. For the IND filing in the U.S., we are on track to submit by the end of the year. The IND filings and further clinical developments of 12F are a priority of gray cell. Our exciting advancement of 12F candidates is that we have dosed multiple patients in China, phase one IIT study, evaluating 12F in a new indication, relapsed endofractory B-cell non-Hodgkin-informer, NHL. 12F is the first BCMA-CD19 dual-targeting CAR-T in human trials for B-NHL. We have a strong rationale and preclinical data to support this novel design. This is consistent with Gracell's goal of innovation and a focus on pioneering best-in-class candidates. Turning to our allogenetic 2U CAR platform, we have an IIT study underway for CD19-CD7 dual-directed CC502 in adult patients with B-cell malignancies, including and a plan to present early first-in-human data from this study at AACR in April. We're very excited about this new candidate as it is the first of its kind as of CD19-CD7 dual-car allogenetic CAR-T and exemplify the TrueU car platform's broad applicability enabled by the novel dual-direct-to-the-car design. As a reminder, we share data from the preclinical studies of GC502 last year at ASH. GC502 displayed strong anti-tumor potency and suppression of host versus graft response. For example, GC502 showed superior CAR T-cell expansion and also cytotoxicity, including in very demanding tumor re-challenge model. It demonstrated robust activity in killing allogenetic T and NK cells to help suppress host versus graft rejection. We also compared it with CD19 CAR-T control. The results showed very strong potency in annual models. We look forward to sharing the exciting early first in human data next month. As 2022 unfolds, We will continue to build on our solid progress achieved so far. Towards the end of the prepared remarks, I will share our anticipated milestones for this year. Now, I will hand over the call to our Chief Medical Officer, Dr. Martina Serge, to discuss the pipeline and our clinical programs. Martina, please.