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O Gracell Biotechnologies Reports Second Quarter 2021 Unaudited Financial Results and Provides Corporate Update PRESS RELEASE GRACELL SUZHOU , China and PALO ALTO , Calif . , Aug. 17 , 2021 ( GLOBE NEWSWIRE ) . Gracell Biotechnologies Inc. ( NASDAQ : GRCL ) ( " Gracell " ) , a global clinical - stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer , today reported its unaudited financial results for the second quarter of the year and recent business highlights . Gracell will host a conference call today , Tuesday , August 17 , at 8:00 am Eastern Time . " We are very pleased with the significant progress we have made in 2021 across our key clinical , manufacturing and corporate objectives , " commented Dr. William ( Wei ) Cao , founder , Chairman , and CEO of Gracell . " Our innovative portfolio of autologous and allogeneic CAR - T cell therapies , built upon our rich cell therapy and gene editing expertise and proprietary FasTCAR and TruUCAR technology platforms , continues to meet key milestones and demonstrate encouraging and competitive therapeutic potential across multiple difficult to treat hematologic malignancies and solid tumors . " " Longer - term follow - up data for GC012F , our BCMA / CD19 dual - targeting CAR - T therapy for multiple myeloma designed on the next - day manufacturing FasTCAR platform , was presented at the ASCO 2021 Annual Meeting and the EHA 2021 Congress in June . We continue to see fast , deep and durable responses in a difficult to treat , predominantly high - risk patient population . Updates on longer - term follow - up for our study in T - ALL for GC 027 , our lead TruUCAR candidate , an off - the - shelf , stand - alone allogeneic CAR - T cell therapy , was presented at the AACR 2021 Annual Meeting this April . Data continues to be encouraging and we are planning on enrolling additional patients to expand the indication to AML . In March , we announced enrollment of the first patient in our pivotal Phase 1/2 clinical study of GC007g in China , an allogeneic donor - derived anti - CD19 CAR - T cell therapy for the treatment of r / r B - ALL and we are pleased to announce completion of the first dosing cohort for GC007g . " Dr. Cao continued , " We are very happy to announce the timely expansion of our US team . In spring , we appointed Dr. Jenny ( Yajin ) Ni as Chief Technology Officer . Seasoned in CAR - T cell therapy CMC development and having successfully lead process development at both Pfizer and Allogene Therapeutics , Dr. Ni's focus is supporting a smooth technology transfer to Lonza for our FasTCAR - enabled product candidate GC012F . In addition , we are excited about Dr. Grace Jiang joining Gracell as our Head of U.S. Regulatory Affairs reporting to our Chief Medical Officer Dr. Sersch . Dr. Jiang brings nearly 20 years of experience in biotechnology companies , including at Amgen , in regulatory affairs with filing experience in Multiple Myeloma . Dr. Ni and Dr. Jiang will be instrumental as we continue to advance our product development , and these key appointments also mark an important step to advance our presence in the U.S. " " As we enter the second half of 2021 , we will continue to build on our solid progress achieved so far . In the coming months of this year , we are planning on advancing exciting early pipeline candidates into clinical studies in China . We will enhance our R & D capabilities in the U.S. , with our ongoing manufacturing collaboration with Lonza supporting a U.S. IND submission for the FasTCAR candidate GC012F in the first half of 2022. We also plan to expand our manufacturing capacity by developing a second facility in Suzhou , China in addition to our state - of - the - art , 66,000 sq . ft . GMP manufacturing facility , designed for fully - closed production capabilities to reduce contamination risks and optimize cost - efficiency . These clinical and operational developments will bring Gracell closer to delivering accessible and highly efficacious treatments for patients across a wider range of malignancies , " Dr. Cao concluded . Second Quarter 2021 and Subsequent Highlights GC012F for the treatment of multiple myeloma ( MM ) : GC012F is a FasTCAR - enabled dual - targeting BCMA / CD19 autologous chimeric antigen receptor ( CAR ) -T cell therapy that is currently being studied in an ongoing Phase 1 investigator - initiated trial ( IIT ) in China for the treatment of MM patients who are relapsed from or refractory to ( r / r ) prior therapies . • Interim data presented at ASCO & EHA . Interim data presented at the ASCO 2021 Annual Meeting and the EHA 2021 Congress ( Press Release May 2021 ) . As of J anuary 12 , 2021 , the study had enrolled and treated 19 patients at three dose levels with the highest dose level of 3x105 cells / kg . Since the last update ( reported at ASH 2020 ) , additional patients were treated at the highest dose level . • High risk patient population . Notably , 18 of the 19 patients ( 94.7 % ) treated were classified as high - risk according to mSMART 3.0 guidelines and patients had received a median of 5 prior lines of therapy . 94.7 % ( 18/19 ) of the patients were triple exposed to a PI , IMID , and at least a third treatment modality , including anti - CD38 targeted therapy . • 100 % MRD - SCR at dose level 3. Early Overall Response Rate ( ORR ) shows a promising 94.7 % ( 18/19 ) with all responses being VGPR or better ( SCR ) , highlighting fast , deep and durable responses in all dose levels . 100 % of the patients treated at the