1. SUZHOU, China and PALO ALTO, Calif., Aug. 26, 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 announced that it will participate in the following upcoming virtual conferences:

    Citi 16th Annual BioPharma Conference

    One-on-one and small group meetings: September 8 - 10, 2021

    Panel - Exploring the State of Play in Cell Therapy: September 9, 2021, 10:40-11:25 am ET

    For more information, please contact your Citi representative.

    2021 Wells Fargo Healthcare Conference

    One-on-one and small group meetings: September 9 - 10, 2021

    Fireside…

    SUZHOU, China and PALO ALTO, Calif., Aug. 26, 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 announced that it will participate in the following upcoming virtual conferences:

    Citi 16th Annual BioPharma Conference

    One-on-one and small group meetings: September 8 - 10, 2021

    Panel - Exploring the State of Play in Cell Therapy: September 9, 2021, 10:40-11:25 am ET

    For more information, please contact your Citi representative.

    2021 Wells Fargo Healthcare Conference

    One-on-one and small group meetings: September 9 - 10, 2021

    Fireside Chat: September 10, 2021, 8:40-9:10 am ET

    For more information, please contact your Wells Fargo representative.

    The live webcast and replay of the panel and fireside chat can also be accessed through the "Events and Presentations" section of the Gracell Investor website.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  2. 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…

    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 GC027, 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 January 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 highest dose level (n=9) obtained MRD- sCR.
    • Favorable safety profile. The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome (CRS) (84% Grade 1/2, 11% (n=2) patients Grade 3). No Grade 4 or 5 CRS and no ICANS (immune effector cell-associated neurotoxicity) were observed in any of the 19 patients. Treatment-emergent adverse events (TEAEs) presented predominantly as cytopenias and AST increase. All TEAEs resolved with standard therapy. Patients are continued to be followed for efficacy and safety.
    • IND in 1H2022. IND application submission in both the US and China planned within the first half of 2022.

    GC007g for the treatment of B-cell acute lymphoblastic leukemia (B-ALL):

    GC007g is a donor-derived CD19-targeted allogeneic CAR-T cell therapy for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy. The allogeneic approach, utilizing T-cells from a human leukocyte antigen (HLA)-matched healthy donor, has the potential to provide a novel treatment approach to patients not eligible for standard of care.

    • First patient enrolled. Enrolled first patient in the pivotal seamless Phase 1/2 clinical trial to evaluate the safety and efficacy of GC007g in r/r B-ALL patients. (Press Release March 2021).
    • First dosing cohort completed. Successful enrollment of first dosing cohort in the phase 1/2 seamless design study was completed.

    GC027 for the treatment of adult relapsed/refractory T cell acute lymphoblastic leukemia (r/r T-ALL): GC027 is a TruUCAR-enabled CD7-targeted allogeneic CAR-T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult r/r T-ALL. GC027 is manufactured from T cells of non-HLA-matched healthy donors.

    • Longer-term follow-up data presented AACR. Updated long-term follow-up data (data cut-off as of February 4, 2021) for GC027 was presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting (Press Release April 2021). Patients had received a median of six prior lines of therapy and received a single infusion of TruUCAR GC027 in one of three dose levels with the highest dose level at 1.5x107 cells/kg. 
    • Longest ongoing DOR 16.8 months. Six patients (100%) treated achieved a complete remission with or without complete blood count recovery (CR/CRi) and five of the six patients (83%) achieved MRD- CR. At 6 months post treatment, three out of five patients (60%) had maintained MRD- CR. After 18.5 months of follow up for the initial patients treated, one patient continued to be MRD- CR at 16.8 months. One patient maintained MRD- CR until 9 months and one patient with primary refractory disease (no response to VDP regimen) maintained his MRD- CR status until month 7. One additional patient treated presented initially with a high tumor burden and extensive extramedullary (EM) disease. After treatment with GC027 and as confirmed by PET CT scan, all EM lesions resolved. The patient achieved MRD- CR at day 28.
    • No ICANS or aGvHD. All six patients tolerated a single infusion of TruUCAR GC027. No neurotoxicity events (ICANS) or acute graft-versus-host disease (aGvHD) were observed. CRS occurred in all patients and was managed with standard of care including tocilizumab. Overall safety findings were consistent with previous observations.
    • IND in 2022. IND application submission in both the US and China planned in 2022.

    Corporate Highlights:

    • Expanded executive leadership. Expanded executive leadership team with the appointment of Dr. Jenny (Yajin) Ni, as Chief Technology Officer. Dr. Ni will strategically lead CAR-T process development, CMC and supply chain management activities at Gracell (Press Release May 2021)
    • Exclusive License Agreement with FutureGen Biopharmaceutical Co., Ltd. On May 11, 2021, we entered into an exclusive license agreement with FutureGen Biopharmaceutical Co., Ltd. ("FutureGen") under which FutureGen grants to Gracell an exclusive, worldwide, sublicensable license under FutureGen's patent rights to research, develop, manufacture, commercialize, and otherwise exploit the patent rights in the field of engineered or modified immune cell therapies for solid tumors. (Press Release August 2021)

    Financial Results for the Second Quarter Ended June 30, 2021

    Research and development expenses for the three months ended June 30, 2021 were RMB65.3 million (US$10.1 million), as compared to RMB40.8 million in the corresponding prior year period. This increase was primarily driven by increases of RMB8.2 million (US$1.3 million) in labor costs due to the further expansion in business as well as an increases of RMB6.9 million (US$1.1 million) and RMB5.1 million (US$0.8 million) in depreciation expenses of research and development facilities and in costs incurred to advance preclinical and clinical pipeline, an increase of RMB2.8 million (US$0.4 million) in professional service expenses and an increase of RMB1.8 million (US$0.3 million) in recognition of share-based compensation expenses upon the completion of initial public offering, respectively.

    Administrative expenses for the three months ended June 30, 2021 were RMB30.4 million (US$4.7 million), compared to RMB7.0 million for the corresponding prior year period. This increase was primarily related to an increase of RMB7.7 million (US$1.2 million) in recognition of share-based compensation expenses upon the completion of initial public offering, an increase of RMB6.3 million (US$1.0 million) attributable to labor costs due to expansion of administrative functions, an increase of RMB5.2 million (US$0.8 million) in financial and legal consulting fee, an increase of RMB2.3 million (US$0.4 million) of insurance expense for the employees and also an increase of RMB0.7 million (US$0.1 million) in lease-related expense.

    Interest income for the second quarter of 2021 was RMB1.7 million (US$0.3 million) as compared to RMB1.0 million for the corresponding prior year period.

    Foreign exchange loss for the three months ended June 30, 2021 was RMB0.8 million (US$0.1 million), compared to a foreign exchange loss of RMB0.1 million for the corresponding prior year period. This increase in the foreign exchange loss of RMB0.7 million was primarily attributable to unfavorable foreign exchange rate fluctuating during the quarter ended June 31, 2021.

    Net loss attributable to ordinary shareholders for the three months ended June 30, 2021 was RMB96.2 million (US$14.9 million), compared to RMB63.1 million for the corresponding prior year period.

    Balance Sheet Highlights

    As of June 30, 2021, we had RMB2,053.6 million (US$318.1 million) in cash and cash equivalents and short-term investments. During the first half of the year, we completed an initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of $19.00 per ADS. In connection with the initial public offering, we granted the underwriters an option to purchase up to an additional 1,650,000 ADSs at the initial public offering price, which was exercised in full by the underwriters. The net proceeds from these transactions were approximately US$220 million.

    We early adopted ASU 2016-02, Lease (Topic 842), in the first quarter of 2021. As of June 30, 2021, we had operating lease liabilities of RMB39.5 million (US$6.1 million) and operating lease right-of-use assets of RMB39.2 million (US$6.1 million).

    In the first quarter of 2021, we received a payment from the depositary bank of RMB14.5 million (US$2.2 million) mostly to reimburse the expenses related to the establishment of ADS facility. The payment is initially recognized as a liability and is being amortized over the facility arrangement period. As of June 30, 2021, we had the related other current liabilities of RMB2.9 million (US$0.44 million) and other non-current liabilities of RMB10.1 million (US$1.6 million).

    In addition, as of June 30, 2021, we had short-term borrowings and current portion of long-term borrowings of RMB58.1 million (US$9.0 million) and long-term borrowings of RMB55.6 million (US$8.6 million).

    As of June 30, 2021, 336,217,511 ordinary shares, par value of US$0.0001 per share, were issued and outstanding. As of June 30, 2021, 11,707,435 options were granted and 10,946,710 options were outstanding, and 303,030 restricted share units ("RSUs") were granted under our employee stock option plan. Each of our ADS represents five ordinary shares.

    Conference Call Details

    Tuesday, August 17, 2021 at 8:00 am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: +1 201-689-8560

    Conference ID: 13722146

    Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    The webcast replay will be available on the Gracell website at ir.gracellbio.com for 90 days following the completion of the call.

    Exchange Rate Information

    This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.4566 to US$1.00, the rate in effect as of June 30, 2021 published by the Federal Reserve Board.

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

    About TruUCAR

    TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft vs host disease (GvHD) without the need of being co-administered with additional immunosuppressive drugs.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "look forward to," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com 

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com 

     
     
    Unaudited Condensed Consolidated Balance Sheets
     
    (All amounts in thousands, except for share and per share data)
     
      As of

    December 31,
     As of June 30,
      2020

     2021

      RMB RMB US$
    ASSETS      
    Current assets:      
    Cash and cash equivalents 754,308  2,049,897  317,489 
    Short-term investments 18,743  3,733  578 
    Prepayments and other current assets 42,418  62,938  9,747 
    Total current assets 815,469  2,116,568  327,814 
    Property, equipment and software 119,083  122,439  18,963 
    Operating lease right-of-use assets   39,239  6,077 
    Other non-current assets 30,398  13,532  2,096 
    TOTAL ASSETS 964,950  2,291,778  354,950 
    LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT      
    Current liabilities:      
    Short-term borrowings 49,990  56,090  8,687 
    Operating lease liabilities, current   18,184  2,816 
    Current portion of long-term borrowings 970  1,978  306 
    Accruals and other current liabilities 42,401  55,616  8,614 
    Total current liabilities 93,361  131,868  20,423 
    Long-term borrowings 51,926  55,646  8,619 
    Operating lease liabilities, non-current   21,288  3,297 
    Other non-current liabilities   10,104  1,565 
    TOTAL LIABILITIES 145,287  218,906  33,904 
    Commitments and contingencies      
    Mezzanine equity:      
    Series A convertible redeemable preferred shares 110,468     
    Series B-1 convertible redeemable preferred shares 142,481     
    Series B-2 convertible redeemable preferred shares 495,799     
    Series C convertible redeemable preferred shares 658,788     
    Total mezzanine equity 1,407,536     
    Shareholders' deficit:      
    Ordinary shares 68  222  34 
    Additional paid-in capital   2,867,603  444,135 
    Accumulated other comprehensive loss (23,912) (35,051) (5,429)
    Accumulated deficit (564,029) (759,902) (117,694)
    Total shareholders' deficit (587,873) 2,072,872  321,046 
    TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT 964,950  2,291,778  354,950 
           



    Unaudited Condensed Consolidated Statements of Comprehensive Loss
     
    (All amounts in thousands, except for share and per share data)
     
      For the three months ended June 30, For the six months ended June 30,
      2020  2021  2020  2021 
      RMB RMB US$ RMB RMB US$
    Expenses            
    Research and development expenses (40,796) (65,267) (10,108) (68,151) (130,700) (20,243)
    Administrative expenses (6,972) (30,423) (4,712) (12,597) (62,182) (9,631)
    Loss from operations (47,768) (95,690) (14,820) (80,748) (192,882) (29,874)
    Interest income 1,003  1,734  269  2,166  2,666  413 
    Interest expense (490) (1,412) (219) (696) (2,647) (410)
    Other income 2,069  5  1  2,074  133  21 
    Foreign exchange loss, net (99) (803) (124) (20) (1,101) (170)
    Others, net (500) (53) (8) (515) (53) (8)
    Loss before income tax (45,785) (96,219) (14,901) (77,739) (193,884) (30,028)
    Income tax expense            
    Net loss (45,785) (96,219) (14,901) (77,739) (193,884) (30,028)
    Accretion of convertible redeemable preferred shares to redemption value (17,311)     (28,050) (1,989) (308)
    Net loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders (63,096) (96,219) (14,901) (105,789) (195,873) (30,336)
    Other comprehensive loss            
    Foreign currency translation adjustments, net of nil tax (26) (34,767) (5,385) 3,498  (11,138) (1,725)
    Total comprehensive loss attributable to Gracell

    Biotechnologies Inc.'s ordinary shareholders
     (63,122) (130,986) (20,286) (102,291) (207,011) (32,061)
    Weighted average number of ordinary shares used in per share calculation:            
    —Basic 99,044,776  336,167,006  336,167,006  99,044,776  320,415,223  320,415,223 
    —Diluted 99,044,776  336,167,006  336,167,006  99,044,776  320,415,223  320,415,223 
    Net loss per share attributable to Gracell Biotechnologies Inc.'s ordinary shareholders            
    —Basic (0.64) (0.29) (0.04) (1.07) (0.61) (0.09)
    —Diluted (0.64) (0.29) (0.04) (1.07) (0.61) (0.09)


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  3. SUZHOU and SHANGHAI, China, and PALO ALTO, Calif., Aug. 16, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced an exclusive license agreement with FutureGen Biopharm ("FutureGen"), an innovative biopharmaceutical company, to develop engineered immune cell therapies targeting Claudin 18.2 ("CLDN18.2") in solid tumors.

    The collaboration aims to leverage Gracell's extensive experience in immune cell therapy in synergy with FutureGen's fully human CLDN18.2 antibodies to develop, manufacture and commercialize novel immune cell therapies for the treatment of patients with CLDN18.2 positive cancers.

    CLDN18.2 is a tumor-specific marker that is overexpressed in a variety of tumor tissues, including in gastric or gastroesophageal junction cancers, pancreatic cancers and esophageal cancers, but rarely expressed in normal human tissues. This feature supports the therapeutic potential of CLDN18.2 as a key target for immune cell therapies. In particular, gastric cancer (around 70%[1] CLDN18.2 expression) is among the most frequently diagnosed malignancies worldwide and the second leading cause of cancer-related death. An estimated 1,033,701 new cases and 782,685 deaths occurred in 2018[2], representing a highly unmet medical need in treating gastric cancer.

    "Gracell has been making significant progress in developing innovative CAR-T therapies for solid tumors as well as hematological malignancies," Dr. William (Wei) Cao, Founder, Chairman and Chief Executive Officer of Gracell said. "This partnership with FutureGen marks another key milestone in our persistent efforts for treating solid tumors. Moving forward, we expect to explore more strategic alliances to identify additional targets that maximize the value of our highly differentiated technology platforms and eventually benefit cancer patients worldwide."

    "Gracell has been optimizing its proprietary Enhanced CAR technology to improve CAR-T cell persistence and efficacy in solid tumors. The preliminary clinical investigator-initiated trial data of our first generation Enhanced CAR-T for solid tumors has shown tolerability and preliminary efficacy. These initial results have been accepted to be published soon in Cellular & Molecular Immunology," said Dr. Lianjun Shen, Senior Vice President, Head of Research and Development at Gracell. "We are very excited to partner with FutureGen to develop next generation immune cell therapies against CLDN18.2-expressing malignancies, and hope to unlock significant potential of our next generation Enhanced CAR-T therapies for solid tumors, one of our founding missions."

    Dr. Zhaoyu Jin, the Founder and Chief Executive Officer of FutureGen said, "The specific CLDN18.2 antibody has been developed through our innovative STEP and CAP technology platforms. The fine-tuned affinity of antibody for CAR-T application may eliminate CLDN18.2 positive tumor cells more specifically with better safety profile. We are very excited to collaborate with Gracell, a lead company in the cell and gene therapy industry, to leverage their innovative Enhanced CAR-T technology platform and experience in the field and our proprietary cutting-edge technologies to develop advanced treatments across solid tumors."

    Under the terms of the agreement, FutureGen will receive an upfront payment and will be eligible to receive additional payments based on the achievement of non-clinical validation, clinical development and commercialization milestones, as well as low single-digit royalties.

    About CLDN18.2

    CLDN18.2, a small transmembrane protein with four transmembrane domains and two extracellular loops, is overexpressed in a significant proportion of gastric cancers and esophageal adenocarcinomas. The restricted expression makes it a promising target for the treatment of gastric or gastroesophageal junction cancers, pancreatic cancers, etc. Overall, CLDN18.2 is prevalently expressed in the cancer tissues of approximately 70% of gastric cancer patients and approximately 60% of pancreatic cancer patients. CLDN18.2-specific antibodies developed to target CLDN18.2 have exhibited anti-tumor activity in preclinical studies.[3]

    About Enhanced CAR

    Enhanced CAR is Gracell's proprietary technology that further strengthens the functionality of CAR-T cells, for example by overcoming the immunosuppressive tumor micro-environment (TME) and/or increasing cytokine signaling. Gracell utilizes gene editing technologies to edit some check point inhibitor(s) or/and cytokine(s) or cytokine receptor(s) on CAR-T cells to release potential suppression from tumor cells and other suppressive immune cells in tumor tissue to enhance CAR-T cells' functionality. Our second generation Enhanced CAR technology can be implemented to many other targets in several types of solid tumors.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.

    About FutureGen

    FutureGen Biopharm ("FutureGen") focuses on precise cancer immunotherapy and drives the development of novel therapeutics through the world's leading antibody engineering technology. The company has developed a Structure-based Targeted Evolution Platform ("STEP") and Cell-based Antibody Panning ("CAP") for antibody discovery and engineering with proprietary intellectual property rights, which can quickly and efficiently screen and optimize a series of candidate drugs that have the potential to be best-in-class antibodies with specific epitopes, ideal affinity and activity, and finest developability. Currently, the ADCC enhanced CLDN18.2 antibody for gastric cancer and pancreatic cancer is at the clinical trial stage, and multiple bispecific therapeutic antibodies are at pre-clinical stage. For more information on FutureGen Biopharm, please visit http://www.futuregen.com.cn/.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    [1] Clinical Implications of Claudin18.2 Expression in Patients With Gastric Cancer

    [2] Hsu A, Chudasama R, Almhanna K, Raufi A. Targeted therapies for gastroesophageal cancers. Ann. Transl. Med. (2020) 8:1104. doi: 10.21037/atm-20-3265

    [3] The full-length Claudin 18.2 to accelerate antibody drug development

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/gracell-biotechnologies-signs-exclusive-license-agreement-with-futuregen-biopharm-to-develop-engineered-immune-cell-therapies-targeting-claudin-18-2-in-solid-tumors-301355538.html

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  4. SUZHOU, China and PALO ALTO, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that it will release financial results for the second quarter ended June 30, 2021, prior to the open of the U.S. financial markets on Tuesday, August 17. Gracell's management team will host a corresponding conference call beginning at 8:00 a.m. Eastern Time to discuss the financial results and recent business developments. A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

    Conference

    SUZHOU, China and PALO ALTO, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that it will release financial results for the second quarter ended June 30, 2021, prior to the open of the U.S. financial markets on Tuesday, August 17. Gracell's management team will host a corresponding conference call beginning at 8:00 a.m. Eastern Time to discuss the financial results and recent business developments. A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

    Conference call and webcast details:

    Tuesday, August 17, 2021 @ 8:00am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: +1 201-689-8560

    Conference ID: 13722146

    Live webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  5. SUZHOU, China and PALO ALTO, Calif., July 26, 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 announced that it will participate in the BTIG Virtual Biotechnology Conference 2021 (details below).

    BTIG Virtual Biotechnology Conference 2021

    One-on-one and small group meetings: August 9-10, 2021

    Fireside chat: Tuesday, August 10, 2021, 9:30 – 9:55am ET

    For more information, please contact your BTIG representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to…

    SUZHOU, China and PALO ALTO, Calif., July 26, 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 announced that it will participate in the BTIG Virtual Biotechnology Conference 2021 (details below).

    BTIG Virtual Biotechnology Conference 2021

    One-on-one and small group meetings: August 9-10, 2021

    Fireside chat: Tuesday, August 10, 2021, 9:30 – 9:55am ET

    For more information, please contact your BTIG representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  6. SUZHOU, China and PALO ALTO, Calif., June 02, 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 announced that it has rescheduled its conference call and webcast to present an update on the results of a Phase 1 first-in-human multicenter investigator-initiated study of the FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy, GC012F, in relapsed/refractory multiple myeloma. This data was accepted for poster presentations at the 2021 American Society of Clinical Oncology Annual Meeting and the European Hematology Association (EHA) 2021…

    SUZHOU, China and PALO ALTO, Calif., June 02, 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 announced that it has rescheduled its conference call and webcast to present an update on the results of a Phase 1 first-in-human multicenter investigator-initiated study of the FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy, GC012F, in relapsed/refractory multiple myeloma. This data was accepted for poster presentations at the 2021 American Society of Clinical Oncology Annual Meeting and the European Hematology Association (EHA) 2021 Virtual Congress. The conference call and webcast have been rescheduled to a time after the release of the e-poster presentation at the EHA 2021 Virtual Congress. Details for the rescheduled conference call are as follows:

    Conference call and webcast details:

    Monday, June 14, 2021 @ 8:00 am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: +1 201-689-8560

    Conference ID: 13719675

    Live webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  7. SUZHOU, China and PALO ALTO, Calif., May 26, 2021 /PRNewswire/ -- 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 announced that it will host a key opinion leader (KOL) webinar on the challenges of treating High Risk Multiple Myeloma and a potential novel approach on Friday, June 11, 2021 at 8:00am Eastern Time.

    (PRNewsfoto/Gracell)

    The call will feature a presentation by Dr. Andrzej Jakubowiak, University of Chicago Medicine, who will give an overview on the current treatment landscape and unmet medical need in treating patients with high-risk multiple myeloma. Dr. Martina Sersch

    SUZHOU, China and PALO ALTO, Calif., May 26, 2021 /PRNewswire/ -- 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 announced that it will host a key opinion leader (KOL) webinar on the challenges of treating High Risk Multiple Myeloma and a potential novel approach on Friday, June 11, 2021 at 8:00am Eastern Time.

    (PRNewsfoto/Gracell)

    The call will feature a presentation by Dr. Andrzej Jakubowiak, University of Chicago Medicine, who will give an overview on the current treatment landscape and unmet medical need in treating patients with high-risk multiple myeloma. Dr. Martina Sersch, Chief Medical Officer of Gracell, will present clinical data of GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma manufactured on Gracell's proprietary FasTCAR overnight manufacturing platform.

    Following the formal presentations, there will be a fireside chat moderated by Neil Canavan of LifeSci Advisors and Author of "The Cure Within" with Dr. Jakubowiak and members of the Gracell management team who will discuss various topics related to the FasTCAR technology platform and the lead clinical program GC012F, a BCMA/CD19 dual-targeting CAR-T therapy. FasTCAR is Gracell's autologous CAR-T platform that tackles the most pressing challenges associated with autologous therapies, including lengthy manufacturing time, suboptimal manufacturing quality, high therapy cost, and poor T cell fitness.

    A live Q&A session will follow the formal presentations and fireside chat.

    To register for the event, please click here.

    About the KOL

    Andrzej Jakubowiak, M.D., Ph.D., is an internationally known expert on multiple myeloma, a cancer of the plasma cells in a patient's bone marrow. He works closely with the Multiple Myeloma Research Consortium (MMRC) to bring the latest treatments to the patient's bedside as quickly as possible.

    Dr. Jakubowiak's primary research focus is in the development of new drugs for the treatment of multiple myeloma. He is currently the lead investigator on a number of multi-site clinical trials for patients who are newly diagnosed, have relapsed, or have refractory (resistant to treatment) disease. Dr. Jakubowiak has received research funding and several grants from the MMRC. He is also the recipient of many honors, including the Myeloma Center of the Year award by the MMRC in 2008 and 2010.

    A frequently invited lecturer, Dr. Jakubowiak has presented his research findings at medical meetings around the world. He has published more than 50 peer-reviewed articles as well as 14 book chapters. Additionally, he serves as an ad hoc reviewer for several scientific journals, including the Journal of Clinical Oncology, Blood and Leukemia and Lymphoma.

    About GC012F

    GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being studied in an ongoing investigator-initiated Phase 1 trial across multiple centers in China for the treatment of MM. GC012F tackles MM by simultaneously targeting both malignant plasma cells expressing BCMA and early progenitor cells expressing CD19 in order to drive fast, deep and durable responses in MM patients.

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With overnight manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-hosting-key-opinion-leader-webinar-on-high-risk-multiple-myeloma-treatment-challenges-and-dual-targeting-car-t-with-overnight-manufacturing--a-novel-approach-for-treatment-of-multiple-myeloma-301299911.html

    SOURCE Gracell Biotechnologies Inc.

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  8. SUZHOU, China and PALO ALTO, Calif., May 25, 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 announced that it will participate in the following upcoming virtual conferences:

    Jefferies Virtual Healthcare Conference
    One-on-one and small group meetings: June 1-4, 2021
    Fireside chat: June 4, 2021, 8:00 – 8:25 am ET
    Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations
    The replay of the fireside chat can be accessed through the "News and Events" section of the Gracell Investor website.
    For more information, please contact…

    SUZHOU, China and PALO ALTO, Calif., May 25, 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 announced that it will participate in the following upcoming virtual conferences:

    Jefferies Virtual Healthcare Conference

    One-on-one and small group meetings: June 1-4, 2021

    Fireside chat: June 4, 2021, 8:00 – 8:25 am ET

    Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    The replay of the fireside chat can be accessed through the "News and Events" section of the Gracell Investor website.

    For more information, please contact your Jefferies representative.

    Citi Pan-Asia Regional Investor Conference

    One-on-one and small group meetings: June 2-4, 2021

    For more information, please contact your Citi representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  9. SUZHOU, China and PALO ALTO, Calif., May 21, 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 announced that it will host a conference call and webcast to present an update on the results of a Phase 1 first-in-human multicenter investigator-initiated study of the FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy GC012F in relapsed/refractory multiple myeloma. This data was accepted as poster presentation at the 2021 American Society of Clinical Oncology Annual Meeting.

    Conference call and webcast details:
    Friday, June 4, 2021…

    SUZHOU, China and PALO ALTO, Calif., May 21, 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 announced that it will host a conference call and webcast to present an update on the results of a Phase 1 first-in-human multicenter investigator-initiated study of the FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy GC012F in relapsed/refractory multiple myeloma. This data was accepted as poster presentation at the 2021 American Society of Clinical Oncology Annual Meeting.

    Conference call and webcast details:

    Friday, June 4, 2021 @ 11:00 am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: +1 201-689-8560

    Conference ID: 13719675

    Live webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  10. SUZHOU, China and PALO ALTO, Calif., May 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, is presenting updated results of their first-in-human multicenter study of GC012F for the treatment of relapsed and/or refractory multiple myeloma, a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy currently in development for the treatment of multiple myeloma, at the 2021 American Society of Clinical Oncology ("ASCO") Annual Meeting and the European Hematology Association 2021 ("EHA2021") Congress.

    SUZHOU, China and PALO ALTO, Calif., May 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, is presenting updated results of their first-in-human multicenter study of GC012F for the treatment of relapsed and/or refractory multiple myeloma, a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy currently in development for the treatment of multiple myeloma, at the 2021 American Society of Clinical Oncology ("ASCO") Annual Meeting and the European Hematology Association 2021 ("EHA2021") Congress.

    GC012F is a BCMA/CD19 dual-targeting CAR-T cell therapy developed on Gracell's proprietary FasTCAR next-day manufacturing technology platform and is being evaluated in a Phase 1 investigator-initiated trial study.

    • As of January 12, 2021, the study had enrolled and treated 19 patients at three dose levels with the highest dose level of 3x105 cells per kg. Additional patients were treated since last update (reported at ASH 2020) in the highest dose level.
    • Early Overall Response Rate (ORR) shows a promising 94.7% (18/19) with all responses being VGPR or better (sCR), demonstrating fast, deep and durable responses in all dose levels.
    • 100% of the patients treated at the highest dose level (n=9) obtained MRD negative sCR.
    • 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.
    • The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome (CRS) (84% Grade 1/2, 11% (n=2) patients Grade 3). No Grade 4 or 5 CRS and no ICANS (immune effector cell-associated neurotoxicity) were observed in any of the 19 patients. Treatment-emergent adverse events (TEAEs) presented predominantly as cytopenias and AST increase. All TEAEs resolved with standard therapy.
    • Patients are continued to be followed for efficacy and safety.

    "The longer-term follow-up and additional patients treated with GC012F confirm the previous findings presented at ASH 2020 and are an additional confirmation for the impressive safety and efficacy shown with our dual-targeting CAR-T therapy, including in high risk patients," said Dr. Martina Sersch, MD, Chief Medical Officer of Gracell. "High-risk patients are difficult to treat. All patients in the highest dose level showed an initial 100% MRD negative sCR, and these deep responses were maintained at month six post-infusion after treatment with GC012F and beyond. These are very encouraging data and they hold a promise for multiple myeloma patients with high risk features and beyond, including those who have failed or are no longer responding to standard treatment options. We are planning to expand our program globally including earlier lines of therapy and are looking forward to sharing updates as we advance our programs."

    Details on the poster presentations are shown below:

    2021 ASCO Annual Meeting

    Abstract 8014: Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 targeted FasTCAR-T GC012F for patients with relapsed/refractory multiple myeloma

    Poster Release Date: June 4, 2021                           

    EHA2021 Virtual Congress

    Abstract EP962: Long-term follow-up results of a multicenter first-in-human study of the dual BCMA/CD19 targeted FasTCAR-T GC012F for patients with relapsed/refractory multiple myeloma

    Poster Release Date: June 11, 2021

    About Multiple Myeloma

    Multiple myeloma (MM) is the third most common type of blood cancer in the United States, originating from plasma cells, a type of immune cell that is typically responsible for secreting antibodies to fight infection. Globally, approximately 160,000 patients are diagnosed with MM every year with over 32,000 expected to be diagnosed in the United States in 2020. In recent years, many advances have been made to treat MM, however, the disease is still considered incurable. Multiple myeloma patients with certain cytogenetic and other abnormalities are classified by the International Myeloma Working Group, or IMWG, and Mayo Stratification for Myeloma and Risk-Adapted Therapy, or mSMART, criteria as high-risk patients. They represent 20-30% of the overall MM patient population. High-risk patients have a much higher risk of early relapse and shorter progression free and overall survival. These patients are considered the most difficult to treat MM patients, typically with a poor prognosis.

    About GC012F

    GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being studied in an ongoing investigator-initiated Phase 1 trial across multiple centers in China for the treatment of MM. GC012F tackles MM by simultaneously targeting both malignant plasma cells expressing BCMA and early progenitor cells expressing CD19 in order to drive fast, deep and durable responses in MM patients.

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com.

    Follow @GracellBio on
    LinkedIn.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

     

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    SOURCE Gracell Biotechnologies Inc.

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  11. Reported updated long-term follow-up data for TruUCAR-enabled CD7-targeted CAR-T product candidate GC027 for the treatment of T-ALL at AACR 2021 Annual Meeting

    Signed agreement with Lonza to manufacture FasTCAR-enabled product candidates in the U.S.

    Completed initial public offering of ADSs for net proceeds of US$220 million; US$331.1 million in cash as of March 31, 2021

    SUZHOU, China and PALO ALTO, Calif., May 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 first quarter and recent…

    Reported updated long-term follow-up data for TruUCAR-enabled CD7-targeted CAR-T product candidate GC027 for the treatment of T-ALL at AACR 2021 Annual Meeting

    Signed agreement with Lonza to manufacture FasTCAR-enabled product candidates in the U.S.

    Completed initial public offering of ADSs for net proceeds of US$220 million; US$331.1 million in cash as of March 31, 2021

    SUZHOU, China and PALO ALTO, Calif., May 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 first quarter and recent business highlights.

    "We are thrilled to have ushered in the new year as a public company following a successful initial public offering that was supported by top-tier institutional investors," commented Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. "We have made significant advancements during the first quarter regarding our pipeline of innovative autologous and allogeneic CAR-T cell therapies. Recently, we announced dosing the first patient in the Phase 1/2 registrational study of GC007g, an allogeneic CAR-T cell therapy derived from HLA-matched donors for the treatment of r/r B-ALL. At the AACR 2021 Annual Meeting last month, we presented follow-up data on our off-the-shelf stand-alone allogeneic CAR-T cell therapy GC027 for the treatment of r/r T-ALL. With a patient maintaining minimal residual disease negative complete remission (MRD- CR) through 16.8 months, we are very encouraged by the potential of GC027 in this hard-to-treat indication."

    Dr. Cao continued, "We are pleased to announce that we are expanding our leadership team with Jenny (Yajin) Ni, Ph.D., M.D., as Chief Technology Officer. Dr. Ni brings extensive experience in developing CAR-T cell therapies, including having successfully lead process development at both Pfizer and Allogene Therapeutics. We look forward to her contributions, including leading our technical operations teams including Chemistry, Manufacturing and Control (CMC) and manufacturing to ensure a smooth technology transfer to Lonza for our FasTCAR-enabled product candidate GC012F."

    "We plan to build on the momentum achieved during the first quarter with several near-term catalysts expected during 2021. As we continue to ramp up clinical development efforts, we continue to expand our team in the U.S. and preparing to expand our GMP manufacturing facility in China. We also look forward to providing updates at the ASCO and EHA 2021 annual meetings on the FasTCAR-enabled BCMA/CD19 dual-targeting candidate GC012F for the treatment of r/r multiple myeloma, which has demonstrated fast, deep, and durable responses in a predominantly high-risk multiple myeloma patient population. We are excited to begin collaborating with Lonza to manufacture our FasTCAR-enabled product candidate GC012F as we work towards the U.S. IND filing in the first half of 2022. We believe the potential of our proprietary FasTCAR and TruUCAR platforms is vast, and we are working expeditiously to bring new product candidates into clinical development," Dr. Cao concluded.

    First Quarter 2021 and Subsequent Highlights

    GC027 for the treatment of adult relapsed/refractory T cell acute lymphoblastic leukemia (r/r T-ALL):

    GC027 is a TruUCAR-enabled CD7-targeted allogeneic CAR-T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult r/r T-ALL. GC027 is manufactured from T cells of non-HLA (human leukocyte antigen)-matched healthy donors.

    • Updated long-term follow-up data (data cut-off as of February 4, 2021) for GC027 was presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting (Press Release April 2021)
      • Patients had received a median of six prior lines of therapy and received a single infusion of TruUCAR GC027 in one of three dose levels with the highest dose level at 1.5x107 cells/kg. Six patients (100%) treated achieved a complete remission with or without complete blood count recovery (CR/CRi) and five of the six patients (83%) achieved MRD- CR. At 6 months post treatment, three out of five patients (60%) had maintained MRD- CR. After 18.5 months of follow up for the initial patients treated, one patient continued to be MRD- CR at 16.8 months. One patient maintained MRD- CR until 9 months and one patient with primary refractory disease (no response to VDP) maintained his MRD- CR status until month 7. One additional patient treated presented initially with a high tumor burden and extensive extramedullary (EM) disease. After treatment with GC027 and as confirmed by PET CT scan, all EM lesions resolved. The patient achieved MRD- CR at day 28. All six patients tolerated a single infusion of TruUCAR GC027. No events of neurotoxicity (ICANS) or acute graft-versus-host disease (aGvHD) were observed. Cytokine release syndrome (CRS) occurred in all patients and was managed with standard of care including Tocilizumab.

    GC007g for the treatment of B-cell acute lymphoblastic leukemia (B-ALL):

    GC007g is a donor-derived CD19-targeted allogeneic CAR-T cell therapy for the treatment of r/r B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy. The allogeneic approach, utilizing T-cells from an HLA-matched healthy donor, has the potential to provide a novel treatment approach to patients not eligible for standard of care.

    • Enrolled first patient in the pivotal seamless Phase 1/2 clinical trial to evaluate the safety and efficacy of GC007g in r/r B-ALL patients. (Press Release March 2021) We received IND approval for the pivotal seamless Phase 1/2 trial of GC007g from China's NMPA in December 2020. (Press Release Jan 2021) The study is ongoing and accruing patients.

    GC019F for the treatment of B-ALL:

    GC019F is a FasTCAR-enabled CD19-targeted autologous CAR-T cell therapy for the treatment of r/r B-ALL.

    • China's National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for the Phase I study of GC019F (Press Release Jan 2021)

    Corporate Highlights:

    • Completed a successful initial public offering of American Depositary Shares (ADSs), raising net proceeds of approximately US$220 million, and commenced trading on the NASDAQ Global Select Market under the ticker symbol "GRCL" (Press Release Jan 2021)
    • Gracell's manufacturing site in Suzhou has been granted the Medical Products Manufacturing Certificate from the Jiangsu Medical Products Administration (Jiangsu is a province/state in China) for the production of CAR-T cell therapy products (Press Release Jan 2021)
    • Entered into a Manufacturing Service Agreement with Lonza (SIX:LONN) for clinical manufacturing of Gracell's FasTCAR-enabled CAR-T cell product candidates in the U.S. (Press Release March 2021)
    • Expanded executive leadership team with appointment of Jenny (Yajin) Ni, Ph.D., M.D., as Chief Technology Officer. Dr. Ni will strategically lead CAR-T process development, CMC and supply chain management activities at Gracell (Press Release May 2021)

    Financial Results for the First Quarter Ended March 31, 2021

    Research and development expenses for the three months ended March 31, 2021 were RMB65.4 million (US$10.0 million), as compared to RMB27.4 million in the corresponding prior year period. This increase was primarily driven by increases of RMB15.7 million (US$2.4 million) in costs incurred to advance preclinical and clinical pipeline as well as increases of RMB10.5 million (US$1.6 million) and RMB5.7 million (US$0.9 million) in depreciation expenses of manufacturing facilities and labor costs due to the further expansion in business, and an increase of RMB6.0 million (US$0.9 million) in recognition of share-based compensation expenses upon the completion of initial public offering, respectively.

    Administrative expenses for the three months ended March 31, 2021 were RMB31.8 million (US$4.8 million), compared to RMB5.6 million for the corresponding prior year period. This increase was primarily related to an increase of RMB11.5 million (US$1.8 million) in recognition of share-based compensation expenses upon the completion of initial public offering, an increase of RMB5.8 million (US$0.9 million) in professional service fee, an increase of RMB3.6 million (US$0.5 million) attributable to labor costs due to expansion of administrative functions, an increase of RMB1.9 million (US$0.3 million) of insurance expense for the employees and also an increase of RMB1.0 million (US$0.1 million) in lease-related expense.

    Interest income for the first quarter of 2021 was RMB0.9 million (US$0.1 million) as compared to RMB1.2 million for the corresponding prior year period. Other income for the first quarter of 2021 was RMB0.1 million (US$0.02 million) as compared to RMB0.005 million for the corresponding prior year period.

    Foreign exchange loss for the three months ended March 31, 2021 was RMB0.3 million (US$0.05 million), compared to a foreign exchange gain of RMB0.08 million for the corresponding prior year period. This decline in the foreign exchange gain of RMB0.4 million was primarily attributable to unfavorable foreign exchange rate fluctuation during the quarter ended March 31, 2021.

    Net loss attributable to ordinary shareholders for the three months ended March 31, 2021 was RMB99.7 million (US$15.2 million), compared to RMB42.7 million for the corresponding prior year period.

    Balance Sheet Highlights

    As of March 31, 2021, we had RMB2,169.4 million (US$331.1 million) in cash and cash equivalents and short-term investments. During the first quarter, we completed an initial public offering of 11,000,000 ADSs, each representing five ordinary shares, at a public offering price of $19.00 per ADS. In connection with the initial public offering, we granted the underwriters an option to purchase up to an additional 1,650,000 ADSs at the initial public offering price, which was exercised in full by the underwriters. The net proceeds from these transactions were approximately US$220 million.

    We early adopted ASU 2016-02, Lease (Topic 842), in the first quarter of 2021. As of March 31, 2021, we had operating lease liabilities of RMB25.8 million (US$3.9 million) and operating lease right-of-use assets of RMB26.1 million (US$4.0 million).

    In the first quarter of 2021, we received a payment from the depositary bank of RMB14.5 million (US$2.2 million) mostly to reimburse the expenses related to the establishment of ADS facility. The payment is initially recognized as a liability and is being amortized over the facility arrangement period. As of March 31, 2021, we had the related other current liabilities of RMB2.9 million (US$0.44 million) and other non-current liabilities of RMB11.1 million (US$1.7 million).

    In addition, as of March 31, 2021, we had short-term borrowings and current portion of long-term borrowings of RMB60.9 million (US$9.3 million) and long-term borrowings of RMB51.9 million (US$7.9 million).

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

    About TruUCAR

    TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft vs host disease (GvHD) without the need of being co-administered with additional immunosuppressive drugs.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Exchange Rate Information

    This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.5518 to US$1.00, the rate in effect as of March 31, 2021 published by the Federal Reserve Board.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "look forward to," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

    Unaudited Consolidated Balance Sheets

    (All amounts in thousands, except for share and per share data)

     As of December 31,As of March 31,
     2020

     2021 
     RMBRMBUS$
    ASSETS   
    Current assets:   
    Cash and cash equivalents        754,308 2,157,833 329,350 
    Short-term investments        18,743 11,614 1,773 
    Prepayments and other current assets        42,418 54,899 8,379 
           
        
    Total current assets        815,469 2,224,346  339,502  
    Property, equipment and software        119,083 117,732 17,969 
    Operating lease right-of-use assets                — 26,077 3,980 
    Other non-current assets        30,398 19,902 3,037 
           
        
    TOTAL ASSETS        964,950 2,388,057 364,488 
           
        
    LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT   
    Current liabilities:   
    Short-term borrowings        49,990 59,990 9,156 
    Operating lease liabilities, current                — 16,244 2,479 
    Current portion of long-term borrowings        970 874 133 
    Accruals and other current liabilities        42,401 43,912 6,702 
           
        
    Total current liabilities        93,361 121,020 18,470 
    Long-term borrowings        51,926 51,926 7,925 
    Operating lease liabilities, non-current                — 9,597 1,465 
    Other non-current liabilities                — 11,078 1,691 
           
    TOTAL LIABILITIES        145,287 193,621 29,551 
           
        
    Commitments and contingencies           
    Mezzanine equity:   
    Series A convertible redeemable preferred shares        110,468         —         — 
    Series B-1 convertible redeemable preferred shares        142,481         —         — 
    Series B-2 convertible redeemable preferred shares        495,799         —         — 
    Series C convertible redeemable preferred shares        658,788         —         — 
           
        
    Total mezzanine equity        1,407,536         —         — 
           
        
    Shareholders' equity (deficit):   
    Ordinary shares        68 222 34 
    Additional paid-in capital                — 2,858,181 436,244 
    Accumulated other comprehensive loss        (23,912)(284)(43)
    Accumulated deficit        (564,029)(663,683)(101,298)
           
        
    Total shareholders' equity (deficit)        (587,873)2,194,436 334,937 
           
        
    TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' EQUITY (DEFICIT)        964,950 2,388,057 364,488 
           
        



    Unaudited Consolidated Statements of Comprehensive Loss

    (All amounts in thousands, except for share and per share data)

     For the three months ended March 31,
     2020 2021 
     RMBRMBUS$
    Expenses   
    Research and development expenses        (27,355)(65,433)(9,987)
    Administrative expenses        (5,625)(31,759)(4,847)
           
        
    Loss from operations        (32,980)(97,192)(14,834)
    Interest income        1,163 932 142 
    Interest expense        (206)(1,235)(188)
    Other income        5 128 20 
    Foreign exchange gain (loss), net        79 (298)(45)
    Others, net        (15)        —         — 
           
        
    Loss before income tax        (31,954)(97,665)(14,905)
    Income tax expense           
           
        
    Net loss        (31,954)(97,665)(14,905)
    Accretion of convertible redeemable preferred shares to redemption value        (10,739)(1,989)(304)
           
        
    Net loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders                

    (42,693




    )
    (99,654)(15,209)
           
        
    Other comprehensive income   
    Foreign currency translation adjustments, net of nil tax        3,524 23,629 3,607 
           
        
    Total comprehensive loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders        (39,169)(76,025)(11,602)
           
        
    Weighted average number of ordinary shares used in per

    share calculation:
       
    —Basic        99,044,776 304,488,419 304,488,419 
    —Diluted        99,044,776 304,488,419 304,488,419 
    Net loss per share attributable to Gracell Biotechnologies Inc.'s ordinary shareholders   
    —Basic        (0.43)(0.33)(0.05)
    —Diluted        (0.43)(0.33)(0.05)

     



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  12. SUZHOU and SHANGHAI, China, May 10, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the appointment of Dr. Jenny (Yajin) Ni as its Chief Technology Officer (CTO). In her role, Dr. Ni will be responsible for strategically leading CAR-T product development, Chemistry, Manufacturing, and Control (CMC), and supply chain management activities. Dr. Ni will lead the efforts to ensure the smooth technology transfer to Gracell's strategic collaborator, Lonza, for manufacturing of FasTCAR-enabled product candidates in the U.S.

    SUZHOU and SHANGHAI, China, May 10, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the appointment of Dr. Jenny (Yajin) Ni as its Chief Technology Officer (CTO). In her role, Dr. Ni will be responsible for strategically leading CAR-T product development, Chemistry, Manufacturing, and Control (CMC), and supply chain management activities. Dr. Ni will lead the efforts to ensure the smooth technology transfer to Gracell's strategic collaborator, Lonza, for manufacturing of FasTCAR-enabled product candidates in the U.S.

    Dr. Ni brings over 25 years of experience in process and product development for gene & cell therapies and vaccines to Gracell. Prior to joining Gracell, Dr. Ni served as Head of Process Development at both Pfizer and Allogene Therapeutics, where she served in senior leadership roles in technical development and operation functions, led allogeneic CAR-T product development, and advanced multiple first-in-human allogeneic CAR-T pipeline programs through preclinical to clinical development, including five IND approvals for hematological malignancy and solid tumor indications. Prior to that, Dr. Ni also served as Director of Tech Operations at VIRxSYS Inc., where she held roles of increasing responsibility across process and analytical development, technology transfer, as well as technical support for GMP manufacturing and QC testing. While at VIRxSYS, Dr. Ni was instrumental in bringing the first-ever lentiviral vector-modified autologous T cell product for HIV infection into clinical development. Dr. Ni holds a Ph.D. in Molecular Virology from Kyoto University in Japan and an M.D. in Internal Medicine from Kunming Medical University in China.

    "We are delighted that Dr. Ni has joined Gracell as CTO," said Dr. William (Wei) Cao. "Manufacturing is often a critical bottleneck in developing and commercializing CAR-T therapies. With the establishment of an internal GMP-compliant manufacturing facility in Suzhou and a process development center in Shanghai, we are well-positioned to support our extensive pipeline. A key component of our manufacturing strategy is a fully-closed system that enables us to substantially reduce costs, improve productivity, and scale-up production of our autologous FasTCAR product candidates. With Dr. Ni's extensive knowledge and experience, I am confident that Gracell will further accelerate the expansion of its global manufacturing capability and enhance our leadership position within the cell and gene therapy field."

    "Gracell has successfully built a GMP-compliant manufacturing facility and an R&D center in China, as well as started establishing a state-of-the-art cGMP process in the U.S. in collaboration with Lonza. Gracell's comprehensive manufacturing strategy serves as a great foundation for its preclinical and clinical development initiatives," said Dr. Jenny (Yajin) Ni. "As CTO, I am excited to lead our efforts to ensure the smooth transfer of our pioneering FasTCAR technology to Lonza, and continuously broaden our proprietary genetic engineering and cell manufacturing capabilities and advance the next generation of CAR-T cell therapies for the treatment of cancer."

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com.

    Follow @GracellBio on LinkedIn.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-appoints-seasoned-gene--cell-therapy-executive-dr-jenny-yajin-ni-as-chief-technology-officer-301287843.html

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  13. SUZHOU and SHANGHAI, China, April 30, 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 announced that it will participate in the following upcoming virtual conferences:

    Morgan Stanley Virtual Asia Healthcare Conference
    One-on-one and small group meetings: May 13-14, 2021
    For more information, please contact your Morgan Stanley representative.

    ICA China Healthcare Corporate Day
    One-on-one and small group meetings: May 18, 2021
    For more information, please contact your ICA representative.

    Sachs Associates 7th Annual Immuno-Oncology Innovation

    SUZHOU and SHANGHAI, China, April 30, 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 announced that it will participate in the following upcoming virtual conferences:

    Morgan Stanley Virtual Asia Healthcare Conference

    One-on-one and small group meetings: May 13-14, 2021

    For more information, please contact your Morgan Stanley representative.

    ICA China Healthcare Corporate Day

    One-on-one and small group meetings: May 18, 2021

    For more information, please contact your ICA representative.

    Sachs Associates 7th Annual Immuno-Oncology Innovation Forum

    Chinese Innovation in IO Panel: 10:10am EDT, May 20, 2021

    For more information, please contact your Sachs Associates representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Media Contact

    Marvin Tang

    Marvin.tang@gracellbio.com

    Investor Contact

    Gracie Tong

    Gracie.tong@gracellbio.com



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  14. SUZHOU and SHANGHAI, China, April 23, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the company has filed its annual report on Form 20-F for the full year ended December 31, 2020 with the U.S. Securities and Exchange Commission ("SEC") on April 23, 2021.

    The annual report is available on the company's investor relations website at ir.gracellbio.com and on the SEC's website at www.sec.gov. The company will provide hard copies of the annual report, free of charge, to its shareholders and ADS holders upon written request. Requests should…

    SUZHOU and SHANGHAI, China, April 23, 2021 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the company has filed its annual report on Form 20-F for the full year ended December 31, 2020 with the U.S. Securities and Exchange Commission ("SEC") on April 23, 2021.

    The annual report is available on the company's investor relations website at ir.gracellbio.com and on the SEC's website at www.sec.gov. The company will provide hard copies of the annual report, free of charge, to its shareholders and ADS holders upon written request. Requests should be directed to Investor Relations, Gracell Biotechnologies, Building 3, 418 Guilin Road, XuHui District, Shanghai, 200233, People's Republic of China.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com



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  15. SUZHOU and SHANGHAI, China, April 10, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today presented updated long-term follow-up data on their TruUCAR-enabled allogeneic product candidate GC027 for the treatment of adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL) in an e-poster presentation at the 2021 American Association for Cancer Research (AACR) Annual Meeting on April 10.

    TruUCAR-enabled GC027 is a first-in-human, off-the-shelf allogeneic CAR-T stand-alone therapy targeting CD7. An ongoing, multi-center investigator-initiated Phase 1 trial in China is evaluating the safety and efficacy of GC027 for the treatment of adults with r/r T-ALL. We first reported results as oral presentation at the AACR 2020 Annual Meeting.

    The updated data with a February 4, 2021 data cut-off represents long-term follow-up as well as additional patients treated. Patients had received a median of six prior lines of therapy and received a single infusion of TruUCAR GC027 in one of three dose levels: 0.6x107cells/kg, 1.0x107cells/kg or 1.5x107cells/kg. Six patients (100%) treated achieved a complete remission with or without complete blood count recovery (CR/CRi) and five of the six patients (83%) achieved minimum residual disease negative complete remission (MRD- CR). At 6 months post treatment, three out of five patients (60%) had maintained MRD- CR. After 18.5 months of follow up for the initial patients treated, one patient continued to be MRD- CR at 16.8 months. One patient maintained MRD- CR until 9 months and one patient with primary refractory disease (no response to VDP) maintained his MRD- CR status until month 7. One additional patient treated presented initially with a high tumor burden and extensive extramedullary (EM) disease. After treatment with GC027 and as confirmed by PET CT scan, all EM lesions resolved. The patient achieved MRD- CR at day 28.

    All six patients tolerated a single infusion of TruUCAR GC027. No neurotoxicity events (ICANS) or acute graft-versus-host disease (aGvHD) were observed. Cytokine release syndrome (CRS) occurred in all patients and was managed with standard of care including Tocilizumab. Overall safety findings were consistent with previous observations.

    "These data show promising long-term follow-up results in r/r T-ALL patients who have very limited treatment options available," commented Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell. "With these findings, GC027 may have the potential to be developed as a single-infusion stand-alone allogeneic CAR-T therapy. We are looking forward to expediting the clinical development of our TruUCAR-enabled GC027 globally, as well as expanding into additional indications beyond T-ALL."

    Presentation link: https://cattendee.abstractsonline.com/meeting/9325/Presentation/4633

    Abstract link: https://www.abstractsonline.com/pp8/#!/9325/presentation/4633

    About GC027

    TruUCAR-enabled GC027 is a first-in-human, off-the-shelf allogeneic CAR-T therapy targeting CD7, currently being developed for the treatment of T-ALL in adults. GC027 is manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors. Developed on our proprietary TruUCAR platform, GC027 utilizes dual-function CAR to specifically target a patient's own T cells and natural killer (NK) cells that would otherwise be directed against the foreign, or allogeneic, CAR-T cells resulting in rejection by the patients. This novel design allows this allogeneic cell therapy to survive a patient's immune system without the need for combination treatment with additional potent immunosuppressant and represents a differentiated monotherapy approach.

    About T-ALL

    T cell malignancies are a group of cancers involving T lymphocytes, including acute T cell lymphoblastic leukemia or T-ALL. Standard of care treatment for T-ALL includes chemotherapy, radiation therapy and stem cell transplantation. Standard chemotherapy regimens only result in 30% - 40% response rate with 6 months median Overall Survival among responders. Patients with T cell malignancies usually have high relapse and mortality rates. Relapsed patients have dismal prognosis with very limited treatment options and <10% of patients surviving beyond 5 years. Due to shared common surface antigens and potential contamination by malignant cells, development of CAR-T cell therapies for T-ALL is lagged behind. In addition, no new therapies have been approved for the treatment of T-ALL since the approval of Nelarabine (marketed by GlaxoSmithKline) by the FDA in 2005. Globally, approximately 64,000 patients are diagnosed with ALL every year with over approximately 6,000 expected to be diagnosed in the United States in 2020. T-ALL accounts for approximately 25% of ALL diagnoses in adults. 1

    About TruUCAR

    TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs graft rejection (HvG) as well as graft vs host disease (GvHD) without the need of being co-administered with immunosuppressive drugs.

    The lead program of TruUCAR platform, GC027, is manufactured using T cells from non-HLA matched healthy donors. The TruUCAR platform utilizes novel designs of a dual-function CAR or dual-CAR to reduce HvG, eliminating the need of combination therapy with additional potent immunosuppressant to induce deeper immune suppression and enabling stand-alone allogeneic CAR-T cell therapy.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com 

    1 D.I. Marks, C. Rowntree, Management of adults with T-cell lymphoblastic leukemia, Blood 2017

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  16. SUZHOU, China and SHANGHAI, China, April 05, 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, today announced that it will present at the 20th Annual Needham Virtual Healthcare Conference (details below).

    Corporate Presentation: 8:45 – 9:25 am ET, Monday, April 12, 2021
    Presenter: Dr. William (Wei) Cao, Founder and CEO
    Webcast: https://wsw.com/webcast/needham107/grcl/2238544
    The webcast and replay of the presentation can also be accessed through the "News and Events" section of the Gracell Investor website.

    One-on-one meetings: April 12-15, 2021
    Management participants: Dr…

    SUZHOU, China and SHANGHAI, China, April 05, 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, today announced that it will present at the 20th Annual Needham Virtual Healthcare Conference (details below).

    Corporate Presentation: 8:45 – 9:25 am ET, Monday, April 12, 2021

    Presenter: Dr. William (Wei) Cao, Founder and CEO

    Webcast: https://wsw.com/webcast/needham107/grcl/2238544

    The webcast and replay of the presentation can also be accessed through the "News and Events" section of the Gracell Investor website.

    One-on-one meetings: April 12-15, 2021

    Management participants: Dr. William (Wei) Cao, Founder and CEO; Dr. Kevin Xie, CFO

    For more information, please contact your Needham representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Media Contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor Contact

    Gracie Tong

    Gracie.tong@gracellbio.com



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  17. SUZHOU, China and PALO ALTO, Calif., March 31, 2021 /PRNewswire/ -- 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 announced that the company has entered into a Manufacturing Service Agreement (MSA) with Lonza (SIX:LONN) for clinical manufacturing of Gracell's FasTCAR-enabled CAR-T cell product candidates in the U.S.

    (PRNewsfoto/Gracell)

    Gracell is advancing its innovative CAR-T pipeline globally for difficult-to-treat cancers, including its lead program for GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma. This autologous CAR-T product candidate is manufactured…

    SUZHOU, China and PALO ALTO, Calif., March 31, 2021 /PRNewswire/ -- 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 announced that the company has entered into a Manufacturing Service Agreement (MSA) with Lonza (SIX:LONN) for clinical manufacturing of Gracell's FasTCAR-enabled CAR-T cell product candidates in the U.S.

    (PRNewsfoto/Gracell)

    Gracell is advancing its innovative CAR-T pipeline globally for difficult-to-treat cancers, including its lead program for GC012F, a BCMA/CD19 dual-targeting CAR-T therapy for multiple myeloma. This autologous CAR-T product candidate is manufactured on Gracell's proprietary FasTCAR technology platform, which significantly reduces the manufacturing time from an industry norm of two to six weeks down to next day. Gracell will leverage Lonza's integrated services in CAR-T manufacturing and establish state of the art cGMP process, a critical component of Gracell's IND enabling clinical development programs.

    "Gracell has developed some highly innovative CAR-T manufacturing platforms, including our FasTCAR platform enabling next day manufacturing of autologous CAR-T products. With Lonza's experience in CAR-T therapy manufacturing and excellent reputation, they are an ideal strategic collaborator for advancing our pioneering, proprietary FasTCAR platform globally," stated Dr. William Wei Cao, Chief Executive Officer of Gracell. Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, added, "We are pleased to enter into this collaboration with Lonza and are currently building our international presence, including clinical operations to advance our product candidates and bring them to more patients globally. We are hoping to expand our programs in close collaboration with Lonza's capabilities. In addition, we look forward to a strategic relationship with Lonza to support IND-filing and clinical manufacturing in the U.S."

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients. 

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com

    Follow @GracellBio on LinkedIn

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the clinical results of our product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of our clinical trials and marketing approval, our ability to achieve commercial success if any of our product candidates is approved, our ability to obtain and maintain protection of intellectual property for our product candidates and technology platforms, the future developments of the COVID-19 outbreaks, and other factors more fully discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission (the "SEC") and in any subsequent filings made by the Company with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Contacts

    Gracell Biotechnologies

    Media contact:

    Marvin Tang

    Marvin.tang@gracellbio.com

    Investor contact:

    Gracie Tong

    Gracie.tong@gracellbio.com

    +86 021 64031522

     

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  18. SUZHOU and SHANGHAI, China, March 31, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, announced that they have enrolled the first patient in their pivotal Phase 1/2 clinical study of GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia (B-ALL).

    GC007g is an allogeneic HLA (human leukocyte antigen)-matched donor-derived CAR-T therapy. Gracell obtained IND approval for GC007g for the treatment of B-ALL from China's National Medical Products Administration (NMPA) and the approval for the pivotal Phase 1/2 clinical study in December 2020. The open-label, single-arm Phase 1/2 study is evaluating the safety and efficacy of GC007g in r/r B-ALL patients.

    "We are thrilled to announce the enrollment of the first patient into our registrational Phase 1/2 trial for the allogeneic donor-derived CD19-targeted CAR-T therapy, GC007g, for the treatment of patients with B-ALL," said Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell. "GC007g is a unique treatment approach for B-ALL patients who relapse after allogeneic stem cell transplantation and are not eligible for standard-of-care. With Gracell's innovative portfolio, we are excited to bring novel CAR-T therapies to more patients with high unmet medical need."

    About GC007g

    GC007g is a donor-derived CD19-directed allogeneic CAR-T cell therapy that has been studied for the treatment of r/r B-ALL in a completed investigator-initiated Phase 1 trial in China, where CAR-T cells were manufactured using T cells from an HLA-matched healthy donor.

    About B-ALL

    B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Marvin Tang

    marvin.tang@gracellbio.com

    +86 21 64031522

    Investor contact

    Gracie Tong

    gracie.tong@gracellbio.com

    [1] https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html

    [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055577  

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  19. SUZHOU and SHANGHAI, China, March 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, today announced that it will participate in the upcoming 2021 Virtual Wells Fargo Biotech Corporate Access Day. Details of the event are as follows:

    2021 Virtual Wells Fargo Biotech Corporate Access Day

    One-on-one and small group meetings: April 6, 2021

    Management participants: Dr. William (Wei) Cao, Founder and CEO; Dr. Martina Sersch, M.D., CMO; Dr. Kevin Xie, CFO

    For more information, please contact your Wells Fargo representative.

    About Gracell
    Gracell Biotechnologies Inc. ("Gracell…

    SUZHOU and SHANGHAI, China, March 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, today announced that it will participate in the upcoming 2021 Virtual Wells Fargo Biotech Corporate Access Day. Details of the event are as follows:

    2021 Virtual Wells Fargo Biotech Corporate Access Day

    One-on-one and small group meetings: April 6, 2021

    Management participants: Dr. William (Wei) Cao, Founder and CEO; Dr. Martina Sersch, M.D., CMO; Dr. Kevin Xie, CFO

    For more information, please contact your Wells Fargo representative.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Media Contact

    Marvin Tang


    Marvin.tang@gracellbio.com

    Investor Contact

    Gracie Tong

    Gracie.tong@gracellbio.com



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  20. Reported interim readouts for lead CAR-T product candidates: FasTCAR-enabled dual-targeting BCMA/CD19 autologous CAR-T product candidate GC012F for the treatment of multiple myeloma and TruUCAR-enabled CD7-directed CAR-T product candidate GC027 for the treatment of T-ALL

    Completed initial public offering of ADSs for net proceeds of $220 million (USD); approximately $338 million* in cash as of January 31, 2021

    Conference call tomorrow, March 10, 2021 at 8:00 am ET

    SUZHOU and SHANGHAI, China, March 09, 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, today reported its…

    Reported interim readouts for lead CAR-T product candidates: FasTCAR-enabled dual-targeting BCMA/CD19 autologous CAR-T product candidate GC012F for the treatment of multiple myeloma and TruUCAR-enabled CD7-directed CAR-T product candidate GC027 for the treatment of T-ALL

    Completed initial public offering of ADSs for net proceeds of $220 million (USD); approximately $338 million* in cash as of January 31, 2021

    Conference call tomorrow, March 10, 2021 at 8:00 am ET

    SUZHOU and SHANGHAI, China, March 09, 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, today reported its unaudited financial results for the fourth quarter and fiscal year ended December 31, 2020 and recent business highlights. Gracell will host a conference call tomorrow, Wednesday, March 10, at 8:00 am Eastern Time.

    "We are very pleased with the substantial progress made thus far in 2021 and over the course of 2020. We recently closed a successful initial public offering that was supported by top-tier institutional investors. We believe their support reflects confidence in our proprietary FasTCAR and TruUCAR platforms that enable highly differentiated autologous and allogeneic CAR-T therapies," commented Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. "Our lead asset GC012F, a FasTCAR-enabled dual-targeting BCMA/CD19 CAR-T cell therapy, currently being studied in multiple myeloma, has shown promising results including high risk patients. We were thrilled to present results from an interim analysis at last year's American Society of Hematology (ASH) Annual Meeting. We look forward to providing further updates at upcoming scientific meetings."

    "Following the success of our recent business developments, the Gracell team continues to feel energized as we work towards accomplishing our operational goals for 2021. Looking ahead, we are well-positioned to continue to fund our R&D programs and expansion of operations in China and the U.S. We have just recently received IND approval in China for GC019F, a FasTCAR-enabled CD19-targeted CAR-T therapy for the treatment of B-ALL, and we believe this is a validation of our next-day manufacturing FasTCAR platform. We look forward to sharing updates of our lead programs at major medical conferences. To support our clinical operations, we plan to establish R&D capabilities in the U.S. and to significantly expand our GMP manufacturing facility in China during 2021 and beyond. With tremendous energy and dedication, we will continue to strive towards advancing our innovative CAR-T pipeline for difficult to treat cancers while driving further value for our shareholders," concluded Dr. Cao.

    * Translation from Renminbi to U.S. dollars of cash balance on January 31, 2021 is for the convenience of the reader and made at a rate of RMB6.4709 to US$1.00, the rate in effect as of January 31, 2021.

    2020 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.

    • An interim data readout was presented as an oral presentation at the ASH's 2020 Annual Meeting (Press Release Dec 2020)

      • As of July 17, 2020, the study had enrolled and treated 16 patients at three dose levels with the highest dose level at 3x105 cells/kg. Notably, the vast majority of this study population (93.8%) belong to a subgroup of MM patients with high-risk features, a difficult to treat patient population. Overall Response Rate (ORR) at time of data cut off was 93.8% with responses being VGPR or better. 100% of the patients treated at the highest dose level (n=6) achieved minimal residual disease negative stringent complete response (MRD- sCR) that was maintained through a landmark analysis at six months (n=4). GC012F showed a favorable safety profile with primarily low grade cytokine release syndrome (CRS) (14 out of 16 patients (87.5%) Grade 1/2, 2 (12.5%) patients Grade 3, no Grade 4 or 5) and no patients experienced any immune effector cell-associated neurotoxicity syndrome (ICANS)

    GC019F for the treatment of with B-cell acute lymphoblastic leukemia (B-ALL):

    GC019F is a FasTCAR-enabled CD19-targeted autologous CAR-T cell therapy for the treatment of R/R B-ALL.

    • China's National Medical Products Administration (NMPA) has approved an investigational new drug (IND) application for the Phase I study of GC019F (Press Release Jan 2021)

    GC027 for the treatment of adult T cell acute lymphoblastic leukemia (T-ALL):

    GC027 is a TruUCAR-enabled allogeneic CD7-targeted CAR-T cell therapy being studied in an ongoing Phase 1 IIT in China for the treatment of adult R/R T-ALL. GC027 is manufactured from T cells of non-HLA (human leukocyte antigen)-matched healthy donors.

    • Preliminary efficacy and safety data were presented as oral presentations at AACR (the American Association for Cancer Research) Virtual Annual Meeting 2020 (Press Release April 2020) and EHA (European Hematology Association) 25th Annual Congress 2020.

      • As of February 2020, the study had enrolled and treated five patients who had failed a median of five prior-lines of therapy. All five evaluable patients achieved a response, CR or CRi, including four patients, or 80%, achieving MRD- CR on Day 28 after treatment. Four out of five patients experienced CRS of Grade 3 and one out of five patients experienced CRS of Grade 4. No patients developed ICANS or graft-versus-host-disease (GvHD)

    GC007g for the treatment of B-ALL:

    GC007g is a donor-derived allogeneic CD19-targeted CAR-T cell therapy for the treatment of R/R B-ALL patients who failed transplant and may not be eligible for autologous CAR-T therapy. The allogeneic approach, utilizing T-cells from an HLA-matched healthy donor, has the potential to provide a novel treatment approach to patients not eligible for standard of care.

    • China's NMPA approved a pivotal seamless Phase 1/2 clinical trial for GC007g. (Press Release Jan 2021) The study is ongoing and accruing patients

    Corporate Highlights:

    • Expanded executive leadership team with appointments of Chief Medical Officer Dr. Martina Sersch, M.D., and Chief Financial Officer Dr. Kevin Xie, both bringing extensive knowledge and leadership experience to Gracell (Press Release July 2020)
    • Secured $100 million in Series C funding in a round led by Wellington Management Company, OrbiMed and Morningside Ventures, and joined by Vivo Capital. Existing investors Temasek Holdings, Lilly Asia Ventures, and King Star Med LP also participated (Press Release Oct 2020)
    • Completed a successful initial public offering of American Depositary Shares (ADSs), raising net proceeds of approximately $220 million, and commenced trading on the NASDAQ Global Select Market under the ticker symbol "GRCL" (Press Release Jan 2021)
    • Gracell's manufacturing site in Suzhou has been granted the Medical Products Manufacturing Certificate from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for the production of CAR-T cell therapy products (Press Release Jan 2021)

    Financial Results for the Fourth Quarter Ended December 31, 2020

    Research and development expenses for the three months ended December 31, 2020 were RMB60.7 million (US$9.3 million), as compared to RMB38.0 million in the corresponding prior year period. This increase was primarily driven by increases of RMB10.4 million (US$1.6 million) in costs incurred to advance preclinical and clinical pipeline as well as increases of RMB7.4 million (US$1.1 million) and RMB 1.4 million (US$0.2 million) in depreciation expenses of manufacturing facilities and labor costs, respectively.

    Administrative expenses for the three months ended December 31, 2020 were RMB24.8 million (US$3.8 million), compared to RMB7.9 million for the corresponding prior year period. This increase was primarily related to an increase of RMB11.4 million (US$ 1.7 million) of professional service fees and also an increase of RMB4.9 million (US$0.8 million) attributable to the expansion of administrative functions to support research and development activities.

    Interest income for the fourth quarter of 2020 was RMB0.5 million (US$0.07 million) as compared to RMB1.4 million for the corresponding prior year period. Other income for the fourth quarter of 2020 was RMB2.9 million (US$0.4 million) as compared to RMB1.3 million for the corresponding prior year period.

    Foreign exchange loss for the three months ended December 31, 2020 was RMB0.7 million (US$0.1 million), compared to a foreign exchange gain of RMB0.4 million for the corresponding prior year period. This change in the foreign exchange gain of RMB1.1 million was primarily attributable to increase in United States dollars received along with the issuance of Series C convertible redeemable preferred shares and less favorable foreign exchange rate fluctuation during the quarter ended December 31, 2020.

    Net loss attributable to ordinary shareholders for the three months ended December 31, 2020 was RMB99.9 million (US$15.3 million), compared to RMB53.4 million for the corresponding prior year period.

    Financial Results for the Fiscal Year Ended December 31, 2020

    Research and development expenses for the year ended December 31, 2020 were RMB168.8 million (US$25.9 million) compared to RMB119.2 million for the year ended December 31, 2019. This increase was primarily due to increases of RMB21.9 million (US$3.4 million) in manufacturing and other costs to support the progression of our preclinical studies and clinical trials, an increase of RMB5.3 million (US$0.8 million) in payroll and other personnel expenses related to expanded research and development headcount, and an increase of RMB17.1 million (US$2.6 million) in depreciation expenses of manufacturing facilities.

    Administrative expenses for the year ended December 31, 2020 were RMB45.6 million (US$7.0 million) as compared to RMB27.4 million for the year ended December 31, 2019. This increase was primarily due to an increase of RMB12.2million (US$1.9 million) in professional service fees and an increase of RMB4.5 million (US$0.7 million) in personnel costs attributable to the expansion of administrative functions.

    Interest income for the year ended December 31, 2020 was RMB2.9 million (US$0.4 million) as compared to RMB3.9 million for the year ended December 31, 2019. Other income for the year ended December 31, 2020 was RMB4.7 million (US$0.7 million), compared to RMB1.4 million for the year ended December 31, 2019.

    Foreign exchange loss for the year ended December 31, 2020 was RMB2.9 million (US$0.4 million), compared to a foreign exchange gain of RMB2.6 million for the year ended December 31, 2019. This decrease in the foreign exchange gain of RMB5.5 million was primarily attributable to increase in United States dollars received along with the issuance of Series C convertible redeemable preferred shares and less favorable foreign exchange rate fluctuation during the year ended December 31, 2020.

    Net loss attributable to ordinary shareholders for the year ended December 31, 2020 was RMB274.6 million (US$42.1 million), compared to RMB200.9 million for the year ended December 31, 2019.

    Balance Sheet Highlights

    As of December 31, 2020, we had RMB773.1 million (US$118.5 million) in cash and cash equivalents and short-term investments. Subsequent to December 31, 2020, we completed an initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of $19.00 per ADS. In connection with the initial public offering, we granted the underwriters an option to purchase up to an additional 1,650,000 ADSs at the initial public offering price. The net proceeds to the Company were approximately US$220 million (including in connection with the underwriters' exercise of their option to purchase additional ADSs in full).

    In addition, as of December 31, 2020, the Company had short-term borrowings and current portion of long-term borrowings of RMB50.0 million (US$7.7 million) and long-term borrowings of RMB51.9 million (US$8.0 million).

    Conference Call Details

    Wednesday, March 10, 2021 at 8:00 am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: 201-689-8560

    Conference ID: 13716516

    Webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    The webcast replay will be available on the Gracell website at ir.gracellbio.com for 90 days following the completion of the call.

    About FasTCAR

    CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing (22 to 36 hours), FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients. 

    About TruUCAR

    TruUCAR is Gracell's proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host vs. graft rejection as well as graft vs host disease (GvHD) without the need of being co-ministered with immunosuppressive antibody drugs.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Exchange Rate Information

    This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from Renminbi to U.S. dollars are made at a rate of RMB6.5250 to US$1.00, the rate in effect as of December 31, 2020 published by the Federal Reserve Board.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the clinical results of our product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of our clinical trials and marketing approval, our ability to achieve commercial success if any of our product candidates is approved, our ability to obtain and maintain protection of intellectual property for our product candidates and technology platforms, the future developments of the COVID-19 outbreaks, and other factors more fully discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission (the "SEC") and in any subsequent filings made by the Company with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media Contact

    Marvin Tang

    marvin.tang@gracellbio.com

    Investor Contact

    Gracie Tong

    Gracie.tong@gracellbio.com

    GRACELL BIOTECHNOLOGIES INC.

    CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2019 AND 2020

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     As of December 31,

     201920202020
     RMBRMBUS$RMBUS$
        (Pro forma) (Note 1)



    ASSETS     
    Current assets:     
    Cash and cash equivalents312,058 754,308 115,603 754,308 115,603 
    Short-term investments4,200 18,743 2,872 18,743 2,872 
    Prepayments and other current assets24,095 42,418 6,501 42,418 6,501 
    Total current assets340,353 815,469 124,976 815,469 124,976 
    Property, equipment and software48,323 119,083 18,250 119,083 18,250 
    Other non-current assets23,541 30,398 4,658 30,398 4,658 
    TOTAL ASSETS412,217 964,950 147,884 964,950 147,884 
          
    LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT     
    Current liabilities:     
    Short-term borrowings 49,990 7,661 49,990 7,661 
    Current portion of long-term borrowings 970 149 970 149 
    Accruals and other current liabilities18,166 42,401 6,498 42,401 6,498 
    Total current liabilities18,166 93,361 14,308 93,361 14,308 
    Long-term borrowings 51,926 7,958 51,926 7,958 
    Convertible loans138,695     
    TOTAL LIABILITIES156,861 145,287 22,266 145,287 22,266 
          
    Commitments and contingencies     
    Mezzanine equity:     
    Series A convertible redeemable preferred shares (US$ 0.0001 par value; 31,343,284 shares authorized, issued and outstanding as of December 31, 2019 and 2020; and nil outstanding on a pro forma basis as of December 31, 2020)82,334 110,468 16,930   
    Series B-1 convertible redeemable preferred shares (US$ 0.0001 par value; nil and 21,735,721 shares authorized, issued and outstanding as of December 31, 2019 and 2020 respectively; and nil outstanding on a pro forma basis as of December 31, 2020) 142,481 21,836   
    Series B-2 convertible redeemable preferred shares (US$ 0.0001 par value; 59,327,653 shares authorized, issued and outstanding as of December 31, 2019 and 2020; and nil outstanding on a pro forma basis as of December 31, 2020)465,509 495,799 75,985   
    Series C convertible redeemable preferred shares (US$ 0.0001 par value; nil and 61,364,562 shares authorized, issued and outstanding as of December 31, 2019 and 2020 respectively; and nil outstanding on a pro forma basis as of December 31, 2020) 658,788 100,963   
    Total mezzanine equity547,843 1,407,536 215,714   
    Shareholders' deficit:     
    Ordinary shares(par value of US$0.0001 per share; 500,000,000 and 500,000,000 shares authorized; 99,044,776 shares issued and outstanding as of December 31, 2019 and 2020; 272,815,996 shares issued and outstanding on a pro forma basis as of December 31, 2019 (unaudited))68 68 10 181 28 
    Additional paid-in capital   1,407,423 215,696 
    Accumulated other comprehensive loss(3,159)(23,912)(3,665)(23,912)(3,665)
    Accumulated deficit(289,396)(564,029)(86,441)(564,029)(86,441)
    Total shareholders' deficit(292,487)(587,873)(90,096)819,663 125,618 
    TOTAL LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS' DEFICIT412,217 964,950 147,884 964,950 147,884 
          

    Note 1: The unaudited pro forma balance sheet information as of December 31, 2020 assumes the automatic conversion of all of the outstanding convertible preferred shares into ordinary shares at a conversion ratio of 1:1, as if the conversion had occurred as of December 31, 2020.

    GRACELL BIOTECHNOLOGIES INC.

    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

    FOR THE YEARS ENDED DECEMBER 31, 2018, 2019 AND 2020

    (All amounts in thousands, except for share and per share data, unless otherwise noted)

     For the years ended December 31,
     201820192020
     RMBRMBRMBUS$
    Expenses    
    Research and development expenses(52,243)(119,218)(168,830)(25,874)
    Administrative expenses(10,261)(27,362)(45,566)(6,983)
    Loss from operations(62,504)(146,580)(214,396)(32,857)
    Interest income1,435 3,932 2,870 440 
    Interest expense  (2,155)(330)
    Other income256 1,449 4,707 721 
    Foreign exchange gain, net 2,556 (2,914)(447)
    Others, net20 (21)(12)(2)
    Loss before income tax(60,793)(138,664)(211,900)(32,475)
    Income tax expense    
    Net loss(60,793)(138,664)(211,900)(32,475)
    Deemed dividend to convertible redeemable preferred shareholders (25,390)  
    Accretion of convertible redeemable preferred shares to redemption value(12,199)(36,802)(62,733)(9,614)
    Net loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders(72,992)(200,856)(274,633)(42,089)
    Other comprehensive loss    
    Foreign currency translation adjustments, net of nil tax (3,159)(20,754)(3,181)
    Total comprehensive loss attributable to Gracell Biotechnologies Inc.'s ordinary shareholders(72,992)(204,015)(295,387)(45,270)
    Weighted average number of ordinary shares used in per share calculation:    
    —Basic100,089,552 99,053,363 99,044,776 99,044,776 
    —Diluted100,089,552 99,053,363 99,044,776 99,044,776 
    Net loss per share attributable to Gracell Biotechnologies Inc.'s ordinary shareholders    
    —Basic(0.73)(2.03)(2.77)(0.42)
    —Diluted(0.73)(2.03)(2.77)(0.42)
             


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  21. SUZHOU and SHANGHAI, China, Feb. 23, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies, today announced that it plans to release financial results for the fourth quarter and year ended December 31, 2020 after the close of the U.S. financial markets on Tuesday, March 9. Gracell's management team plans to host a corresponding conference call beginning at 8:00 a.m. Eastern Time on Wednesday, March 10, to discuss the financial results and recent business developments. A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days…

    SUZHOU and SHANGHAI, China, Feb. 23, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies, today announced that it plans to release financial results for the fourth quarter and year ended December 31, 2020 after the close of the U.S. financial markets on Tuesday, March 9. Gracell's management team plans to host a corresponding conference call beginning at 8:00 a.m. Eastern Time on Wednesday, March 10, to discuss the financial results and recent business developments. A replay of the webcast will be available on ir.gracellbio.com shortly after the conclusion of the event for 90 days.

    Conference call and webcast details:

    Wednesday, March 10, 2021 @ 8:00am ET

    Investor domestic dial-in: 877-407-0784

    Investor international dial-in: +1 201-689-8560

    Conference ID: 13716516

    Live webcast link: https://ir.gracellbio.com/news-events/events-and-presentations

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Media contact

    Linc He

    Linc.he@gracellbio.com

    +86 021 64031522

    Investor contact

    Gracie Tong

    Gracie.tong@gracellbio.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-to-report-fourth-quarter-and-fiscal-2020-financial-results-on-tuesday-march-9-2021-301232997.html

    SOURCE Gracell Biotechnologies

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  22. SUZHOU and SHANGHAI, China, Jan. 19, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the National Medical Products Administration (NMPA) in China has approved an investigational new drug (IND) application to study GC019F, a FasTCAR-enabled chimeric antigen receptor (CAR)-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL).

    GC019F is an autologous CAR-T therapy currently in development for adult B-ALL patients who are relapsed from or refractory to prior therapies. With the therapy, a patient's own T cells are genetically modified to express CD19-specific CAR. GC019F is manufactured on Gracell's FasTCAR technology platform, which significantly reduces manufacturing time from an industry norm of two to six weeks down to 22 to 36 hours.

    "This marks the first IND approval for a product candidate manufactured on Gracell 's FasTCAR platform and sets an important milestone for furthering therapies manufactured on this platform. We are excited to bring this new therapy to adult B-ALL patients, who - once relapsed from or refractory to therapy - remain a high unmet medical need with limited treatment options in China," commented Dr. Martina Sersch, M.D., Ph.D., Chief Medical Officer of Gracell.

    About GC019F

    GC019F is an autologous investigational CD19-targeted CAR-T cell therapy, directed to eradicate CD19 positive leukemia cells.

    About FasTCAR

    FasTCAR-manufactured CAR-T cells appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing (22 to 36 hours), FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients. 

    About B-ALL

    B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the further advancement of, and anticipated clinical development and regulatory milestones of GC019F.The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He

    Linc.he@gracellbio.com

    +86 021 64031522

    Investor contact

    Gracie Tong

    Gracie.tong@gracellbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-receives-ind-approval-from-china-nmpa-for-gc019f-a-fastcar-enabled-car-t-therapy-for-the-treatment-of-relapsed-or-refractory-adult-b-all-301209901.html

    SOURCE Gracell Biotechnologies Inc.

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  23. SUZHOU, China, Jan. 15, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products. The certification was granted on January 4, 2021, and indicates that Gracell's site in Suzhou Industrial Park (SIP) has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment.

    SUZHOU, China, Jan. 15, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration (JSMPA, Jiangsu is a province/state in China) for its CAR-T cell therapy products. The certification was granted on January 4, 2021, and indicates that Gracell's site in Suzhou Industrial Park (SIP) has fully met the compliance requirements for Good Manufacturing Practice (GMP) in relation to the production of CAR-T cell therapy for cancer treatment.

    Since the new Pharmaceutical Administration Law of the People's Republic of China took effect on December 1, 2019, GMP certification has been abolished in China and applications for GMP certification are no longer accepted by the National Medical Products Administration (NMPA). Instead, the "Measures for Supervision and Management of Medical Products Manufacturing", which came into effect on July 1, 2020, clearly outlines strict and detailed requirements regarding permissions and relevant supervisions for the manufacture of medical products. Only manufacturing sites that fully satisfy these stringent requirements can successfully pass an on-site inspection to obtain the "Medical Products Manufacturing Certificate".

    As of March 2020, Gracell has implemented a comprehensive Quality Management System that fully complies with the U.S. FDA cGMP, EU GMP, China GMP, and relevant global guidelines for cell therapy products.

    Gracell's Suzhou site underwent and successfully passed an on-site inspection conducted by JSMPA inspectors in November, 2020, and received its official "Medical Products Manufacturing Certificate" on January 4, making it one of five CAR-T cell therapy manufacturers nationwide to receive the license.

    "Our passion is to change the way conventional CAR-T therapies have been manufactured, and provide effective, low cost manufacturing of cellular gene therapeutics with fast turnaround time," said Dr. William (Wei) Cao, founder, Chairman, and CEO of Gracell. "We are thrilled to receive this certificate from JSMPA, which will enable us to further advance our current clinical programs including our FasTCAR-T programs and bring transformative CAR-T cell therapies to a broader group of patients."

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He

    Linc.he@gracellbio.com

    +86-21-6403-1375

    Investor contact

    Gracie Tong

    Gracie.tong@gracellbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-receives-medical-products-manufacturing-certificate-for-car-t-cell-therapy-products-301206090.html

    SOURCE Gracell Biotechnologies

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  24. SUZHOU and SHANGHAI, China, Jan. 13, 2021 /PRNewswire/ --  Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China's National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China. 

    SUZHOU and SHANGHAI, China, Jan. 13, 2021 /PRNewswire/ --  Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy, for the treatment of B-cell acute lymphoblastic leukemia (B-ALL), by China's National Medical Products Administration (NMPA) on December 24, 2020. The seamless Phase 1/2 pivotal clinical trial of GC007g will enable Gracell to potentially substantially accelerate the clinical development of GC007g in China. 

    GC007g is an allogeneic CAR-T therapy under development for the treatment of a subset of B-ALL patients who relapsed after receiving an allogeneic transplant. The allogeneic therapy is derived from human leukocyte antigen (HLA)-matched donor T cells. This allogeneic approach has the potential to resolve the T cell fitness issue associated with autologous CAR-T cell therapies. The donor-derived CAR-T cell therapy, GC007g, is designed for relaspsed/refractory B-ALL patients who may not be eligible for autologous CAR-T therapy due to poor cell fitness, infections, and other conditions.

    "The approval of the pivotal study for GC007g is an exciting milestone for the program, and more importanty, the approval of the new study design by the Chinese regulatory agency expedites the process of delivering a potential new treatment option to eligible patients in need," Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell, commented. "As we continue to explore the potential  of GC007g, Gracell remains focused on developing innovative cell therapies for patients with high unmet medical needs."

    About GC007g

    GC007g is an investigational CD19-targeted CAR-T cell therapy, where HLA-matched donors' T cells were employed to be redirected to eradicate CD19 positive leukemia cells.

    About B-ALL

    B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1] In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2] It is also the most common cause of cancer and death from cancer among children.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He

    Linc.he@gracellbio.com

    +86-21-6403-1375

    Investor contact

    Gracie Tong

    Gracie.tong@gracellbio.com

     

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  25. SUZHOU and SHANGHAI, China, Jan. 8, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer, today announced the pricing of its initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of US$19.00 per ADS. The gross proceeds to Gracell from the offering are expected to be US$209.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Gracell has granted the underwriters a 30-day…

    SUZHOU and SHANGHAI, China, Jan. 8, 2021 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ:GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer, today announced the pricing of its initial public offering of 11,000,000 American Depositary Shares ("ADSs"), each representing five ordinary shares, at a public offering price of US$19.00 per ADS. The gross proceeds to Gracell from the offering are expected to be US$209.0 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Gracell has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 ADSs at the initial public offering price, less underwriting discounts and commissions. All of the ordinary shares represented by ADSs are being offered by Gracell.

    The ADSs have been approved for listing on The Nasdaq Global Market and are expected to begin trading on January 8, 2021 under the ticker symbol "GRCL". The offering is expected to close on January 12, 2021 subject to the satisfaction of customary closing conditions.

    Citigroup, Jefferies, Piper Sandler & Co. and Wells Fargo Securities are acting as joint book-running managers for the offering.

    The offering of the securities is made only by means of a prospectus forming a part of the effective registration statement. A copy of the prospectus relating to the offering may be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146 or by email at prospectus@citi.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at prospectus_department@jefferies.com; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at prospectus@psc.com; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897 or by email at cmclientsupport@wellsfargo.com.

    Gracell's registration statement relating to the offering has been filed with, and declared effective by the U.S. Securities and Exchange Commission. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Gracell

    Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

    Cautionary Noted Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the preliminary prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

    Media contact

    Linc He

    Linc.he@gracellbio.com

    +86-21-6403-1375

    Investor contact

    Gracie Tong

    Gracie.tong@gracellbio.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-biotechnologies-announces-pricing-of-initial-public-offering-301203264.html

    SOURCE Gracell Biotechnologies

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