GRCL Gracell Biotechnologies Inc.

10.29
-1.43  -12%
Previous Close 11.72
Open 11.43
52 Week Low 9.75
52 Week High 33.6999
Market Cap $691,935,636
Shares 67,243,502
Float 67,243,502
Enterprise Value $491,903,831
Volume 108,023
Av. Daily Volume 63,477
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Drug Pipeline

Drug Stage Notes
GC027
B cell acute lymphoblastic leukemia
Phase 1
Phase 1
U.S. IND filing due 2022.
GC012F
Multiple myeloma
Phase 1
Phase 1
Phase 1 data presented. 19 pts were evaluated for response. Overall response rate (ORR) was 94.7%.
GC007g
B-cell acute lymphoblastic leukemia (B-ALL)
Phase 1/2
Phase 1/2
Phase 1/2 commencement of enrollment announced March 31, 2021.

Latest News

  1. Humanigen, Inc. (NASDAQ:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,' announced today that the Company's Board of Directors (the "Board") has elected John Hohneker, MD, and Kevin Xie, PhD, to serve as independent directors of the Company, effective October 19, 2021.

    "We are excited about the depth and breadth of experience John and Kevin will add to our Board at this important time as we continue our efforts seeking regulatory authorization to commercialize lenzilumab for the treatment of hospitalized COVID-19 patients, while furthering our development of lenzilumab in CAR-T and other indications," said Cameron Durrant, Chairman and CEO of…

    Humanigen, Inc. (NASDAQ:HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,' announced today that the Company's Board of Directors (the "Board") has elected John Hohneker, MD, and Kevin Xie, PhD, to serve as independent directors of the Company, effective October 19, 2021.

    "We are excited about the depth and breadth of experience John and Kevin will add to our Board at this important time as we continue our efforts seeking regulatory authorization to commercialize lenzilumab for the treatment of hospitalized COVID-19 patients, while furthering our development of lenzilumab in CAR-T and other indications," said Cameron Durrant, Chairman and CEO of Humanigen.

    John Hohneker, MD, has more than 30 years of experience as an executive in the biopharmaceutical industry and he now serves as a member of the Board for five other biotechnology companies including: BioTheryX, Inc. (private); Cygnal Therapeutics, Inc. (private); Aravive, Inc. (NASDAQ:ARAV); Evelo Biosciences (NASDAQ:EVLO); and Trishula Therapeutics (private). As an executive he has advanced several programs from pre-clinical evaluation through Phase IV, including products in oncology and immunology. He played a critical role in the development and commercialization of many blockbuster products including Cosentyx®, Gleevec®, Zometa®, Tasigna®, and Afinitor®. His experience includes 15 years at Novartis AG, from 2001 to 2015, where he was most recently Senior Vice President and Global Head of Development, Immunology and Dermatology. Prior to Novartis, he held several positions of increasing responsibility over a nearly 11-year period beginning at Burroughs Wellcome and then with its successor Glaxo Wellcome. Dr. Hohneker received a bachelor's degree in chemistry from Gettysburg College and a medical degree from the University of Medicine and Dentistry of New Jersey at Rutgers Medical School. He completed his internship and residency in internal medicine and his fellowship in medical oncology, all at the University of North Carolina at Chapel Hill. In addition to his operational experience, Dr. Hohneker has direct experience leading business development and licensing deals, raising capital, and serving on corporate boards through acquisitions.

    Kevin Xie, PhD, has nearly twenty years of experience evaluating and investing in companies across an array of healthcare-related industries, first for 13 years on the buy-side and then for six years in industry where he also demonstrated the ability to add value through operational improvements. He is the Chief Financial Officer of Gracell Biotechnologies (NASDAQ:GRCL), a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies intended to disrupt conventional approaches to CAR-T cell therapies. As CFO at Gracell since July 2020, Dr. Xie has completed a cross-over round and IPO that raised $340 million. Prior to Gracell, as President of Healthcare Holdings for Fosun Group, he built and managed a team of 20 investment professionals, which invested more than $2 billion in 30+ projects in biotechnology, pharmaceutical, healthcare information technology, and healthcare services industries. Dr. Xie co-founded and served as Portfolio Manager of Locust Walk Capital. Dr. Xie had previously served as Healthcare Sector Head at Scopia Capital, and as a Managing Director at Great Point Partners. He currently serves on the Board of Directors for ViewRay (NASDAQ:VRAY). Dr. Xie has a Bachelor of Science in Material Science and Engineering from Tianjin University, an MBA in Finance from The Wharton School of the University of Pennsylvania, and a PhD in Chemistry from The City University of New York.

    About Humanigen

    Humanigen, Inc. (NASDAQ:HGEN) ("Humanigen"), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm'. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen's Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.

    Forward-Looking Statements

    All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our plans relating to lenzilumab.

    Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.

    All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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  2. SUZHOU, China and PALO ALTO, Calif., Oct. 15, 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 China Biotech Summit

    One-on-one and small group meetings: October 26, 2021

    Fireside Chat: October 26, 2021, 10:30-11:00 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…

    SUZHOU, China and PALO ALTO, Calif., Oct. 15, 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 China Biotech Summit

    One-on-one and small group meetings: October 26, 2021

    Fireside Chat: October 26, 2021, 10:30-11:00 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 China Investor Conference 2021

    One-on-one and small group meetings: November 1 - 3, 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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  3. 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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    View Full Article Hide Full Article
  4. 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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  5. 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

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