Gracell Biotechnologies

Gracell Biotechnologies, Inc. engages in the research and development activities of biotechnological and pharmaceutical industries. The firm through its FasTCAR and TruUCAR platforms, it is developing a pipeline of autologous and allogeneic cell therapy candidates with the potential to treat both hematologic malignancies and solid tumors. The company was founded by William Wei Cao in 2017 and is headquartered in Suzhou, China.

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Gracell Biotechnologies reports solid financials and advances lead CAR-T therapy

Gracell Biotechnologies showcased strong financials and promising progress with their lead CAR-T therapy GC012F for multiple myeloma.
While facing challenges in trial optimization and enrollment, the company is well-positioned to leverage partnerships and drive future growth.
Opportunities lie in expanding partnerships, generating durability data, and prioritizing pipeline development to enhance market competitiveness and patient outcomes.

Gracell Biotechnologies reports Q1 loss, advances CAR-T therapy pipeline

Gracell Biotechnologies faces financial challenges with a net loss in Q1 2023 but maintains a strong cash position for future operations.
The company's focus on advancing CAR-T therapy, particularly GC012F, and venturing into autoimmune disease clinical development highlight strategic growth initiatives.

Gracell Biotechnologies excels in Q2 with promising trial results and funding success

Gracell Biotechnologies showcased strong performance in Q2 2023 with positive trial results and successful fundraising, underlining their commitment to innovation and growth.
While facing challenges in communication and sustaining trial outcomes, the company's strategic strengths and opportunities position them for future success in the biotech sector.
Investors should take note of Gracell's progress in advancing novel therapies like GC012F and their financial stability, signaling potential for long-term value creation.

Gracell Biotechnologies reports strong Q3 performance and advances CAR-T therapies

Gracell Biotechnologies reported positive financial performance and strong clinical data, positioning the company well for future growth and innovation.
While facing challenges such as limited information availability and regulatory complexities, the company remains focused on advancing its CAR-T therapies and addressing unmet medical needs.
Opportunities lie in leveraging financial strength to attract partners, showcasing research at industry events, and advancing clinical programs for myeloma and autoimmune diseases.
Overall, Gracell Biotechnologies' emphasis on safety, efficacy, and innovation underscores its commitment to developing transformative therapies for patients in need.

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Gracell Biotechnologies is a developer of cancer immune therapy designed to treat cancer. The company's therapy offers cellular therapeutics for the patients suffered from hematological malignancy, solid tumor or degenerative disease, enabling healthcare providers to cure their patients and improve their lives.

First disclosure of data from Phase 1 study of the donor-derived allogeneic CAR-T GC007g shows 100% overall response rate (ORR) and a favorable safety profile for treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) Longer-term GC012F data in relapsed/refractory multiple myeloma (RRMM) and B-cell non-Hodgkin's lymphoma (B-NHL) indications to be highlighted, with B-NHL data selected for oral presentation   SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , May 11, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that clinical data from three studies in B-NHL, RRMM and B-ALL will be presented at the 2023 European Hematology Association (EHA) Annual Meeting taking place June 8-15 in Frankfurt, Germany, and online.

Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-Targeting FasTCAR-T GC012F in RRMM and B-NHL and Donor-Derived CAR-T GC007g in B-ALL at EHA2023 Congress

SAN DIEGO and SUZHOU, China and SHANGHAI, China, May 02, 2023 (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 plans to release unaudited financial results for the first quarter ended March 31, 2023 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, May 15, 2023. The management team will host a live audio webcast and conference call at 8:00 AM Eastern Time.

Gracell Biotechnologies to Report First Quarter 2023 Financials on Monday, May 15, 2023

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , April 26, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), 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 present updated clinical data on GC012F, the Company's FasTCAR-enabled autologous CAR-T cell therapy dual-targeting B-cell maturation antigen (BCMA) and CD19, from ongoing investigator-initiated trials (IIT) in relapsed-refractory multiple myeloma (RRMM) and B-cell non-Hodgkin's lymphoma (B-NHL) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago and online.

Gracell Biotechnologies to Present Updated Clinical Data on BCMA/CD19 Dual-Targeting FasTCAR-T GC012F at 2023 ASCO Annual Meeting

SAN DIEGO and SUZHOU, China and SHANGHAI, China, April 25, 2023 (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, 2022 with the U.S. Securities and Exchange Commission (“SEC”) on April 25, 2023.

Gracell Biotechnologies Announces Filing of Its Annual Report on Form 20-F for Fiscal Year 2022

Fintel reports that Orbimed Advisors has filed a 13D form with the SEC disclosing ownership of 7.58MM shares of Gracell Biotechnologies Inc.

Orbimed Advisors Now Owns 11.2% of Gracell Biotechnologies

Gracell Biotechnologies Inc. (NASDAQ:GRCL ) Q4 2022 Earnings Conference Call March 13, 2023 8:00 AM ET Company Participants Kevin Yili Xie - Chief Financial Officer William Wei Cao - Founder, Chairman, and Chief Executive Officer Wendy Li - Chief Medical Officer Conference Call Participants Carly Kenselaar - Citi James Shin - Wells Fargo Justin Zelin - BTIG Emily Bodnar - H.C. Wainwright Operator [Operator Instructions] I would now like to turn the call over to Dr. Kevin Xie, CFO.

Gracell Biotechnologies Inc. (GRCL) Q4 2022 Earnings Call Transcript

SAN DIEGO and SUZHOU, China and SHANGHAI, China, March 13, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported fourth quarter and full year 2022 unaudited financial results for the period ended December 31, 2022, and provided corporate updates.

Gracell Biotechnologies Reports Fourth Quarter and Full Year 2022 Unaudited Financial Results, and Provides Corporate Update

SAN DIEGO Calif., and SUZHOU and SHANGHAI, China , Feb. 28, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell" or the "Company"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the management team will participate in the Oppenheimer 33rd Annual Healthcare Conference from March 13 th to 15th.

Gracell Biotechnologies to Participate in Oppenheimer 33rd Annual Healthcare Conference

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , Feb. 27, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell" or the "C om pany"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that it plans to release unaudited financial results for the fourth quarter ended December 31, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, March 13, 2023.

Gracell Biotechnologies to Report Fourth Quarter 2022 Financials on Monday, March 13, 2023

Approval follows U.S. FDA clearance of IND application for BCMA/CD19 dual-targeting FasTCAR-T GC012F Company plans to initiate Phase 1/2 clinical trial in China in third quarter of 2023 SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Feb. 13, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM).

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for Treatment of Relapsed/Refractory Multiple Myeloma

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BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies Company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023 SAN DIEGO Calif., and SUZHOU and SHANGHAI, China , Feb. 3, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell's Investigational New Drug (IND) application and the Company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM).

Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma

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BCMA/CD19 dual-targeting FasTCAR-T GC012F data from ongoing clinical trial presented at 64th American Society of Hematology Annual Meeting and Exposition SAN DIEGO and SUZHOU and SHANGHAI, China , Dec. 10, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the clinical data from its ongoing Phase 1, investigator-initiated trial (IIT) in China evaluating FasTCAR-enabled GC012F as first-line therapy in transplant-eligible, high-risk, newly diagnosed multiple myeloma (NDMM) patients. Data has been presented in an oral session at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, held Dec. 10-13 in New Orleans.

Gracell Biotechnologies Presents Clinical Data for FasTCAR-T GC012F for High Risk, Newly Diagnosed Multiple Myeloma Demonstrating 100% Overall Response Rate

FasTCAR next-day manufacturing autologous CAR-T platform recognized with prestigious biotech innovation award SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China , Nov. 16, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its FasTCAR Autologous CAR-T Platform was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards.

Gracell Biotechnologies Wins 2022 Fierce Life Sciences Innovation Award

Gracell Biotechnologies Inc. (NASDAQ:GRCL ) Q3 2022 Results Earnings Conference Call November 14, 2022 8:00 AM ET Company Participants Kevin Yili Xie - Chief Financial Officer William Wei Cao - Founder, Chairman, and Chief Executive Officer Wendy Li - Chief Medical Officer Conference Call Participants Carly Kenselaar - Citigroup Dev Prasad - Jefferies Joseph Catanzaro - Piper Sandler Justin Zelin - BTIG Suowei Wu - Cantor Fitzgerald James Shin - Wells Fargo Operator Ladies and gentlemen, thank you for standing by. Welcome to Gracell Biotechnologies Third Quarter 2022 Conference Call.

Gracell Biotechnologies Inc. (GRCL) Q3 2022 Results - Earnings Call Transcript

SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or “Company”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported third quarter unaudited financial results for the period ended September 30, 2022, and provided corporate updates.

Gracell Biotechnologies Reports Third Quarter 2022 Unaudited Financial Results and Provides Corporate Update

BCMA/CD19 dual-targeting FasTCAR-T GC012F demonstrated 100% ORR and 100% MRD negativity in the 13 patients treated SAN DIEGO, Calif., SUZHOU and SHANGHAI, China , Nov. 3, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the first clinical data of its ongoing Phase 1, investigator-initiated study in China evaluating FasTCAR-enabled GC012F in newly diagnosed, transplant-eligible, high-risk multiple myeloma (NDMM) patients.

Gracell Biotechnologies to Present First Clinical Data of FasTCAR-T GC012F for Newly Diagnosed Multiple Myeloma at 64th American Society of Hematology Annual Meeting & Exposition

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , Oct. 31, 2022 /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 it plans to release unaudited financial results for the third quarter ended September 30, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, November 14, 2022.

Gracell Biotechnologies to Report Third Quarter 2022 Financials on Monday, November 14, 2022

C linical trial  assessing allogeneic, HLA-matched, donor-derived allogeneic CAR-T therapy SAN DIEGO, Calif., SUZHOU and SHANGHAI, China , Oct. 17, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the first patient has been dosed in the Phase 2 portion of its registrational Phase 1/2 clinical trial evaluating GC007g for the treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) being conducted in China.

Gracell Biotechnologies Doses First Patient in Phase 2 Portion of Registrational Phase 1/2 Clinical Trial Evaluating GC007g for Treatment of B-cell Acute Lymphoblastic Leukemia

Gracell Biotechnologies Inc. (NASDAQ:GRCL ) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET Company Participants Dr. Kevin Xie - CFO Dr. William Cao - Founder and CEO Dr. Wendy Li - Chief Medical Officer Conference Call Participants Joe Catanzaro - Piper Sandler Justin Zelin - BTIG Kelly Shi - Jefferies James Shin - Wells Fargo Operator Ladies and gentlemen, thank you for standing by. Welcome to Gracell Biotechnologies Second Quarter 2022 Conference Call.

Gracell Biotechnologies Inc. (GRCL) CEO Dr. William Cao on Q2 2022 Results - Earnings Call Transcript

SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (“Gracell” or “Company”), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported second quarter unaudited financial results for the period ended June 30, 2022, and provided corporate updates.

Gracell Biotechnologies Reports Second Quarter 2022 Unaudited Financial Results and Provides Corporate Update

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , Aug. 2, 2022 /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 it plans to release unaudited financial results for the second quarter ended June 30, 2022 and provide an update on recent developments prior to the open of the U.S. financial markets on Monday, August 15, 2022.

Gracell Biotechnologies to Report Second Quarter 2022 Financial on Monday, August 15, 2022

Dr. Li brings deep oncology clinical development, medical affairs and U.S. regulatory experience SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China , Aug. 1, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), 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 Wendy Li, M.D.

Gracell Biotechnologies Appoints Accomplished Clinical Leader Dr. Wendy Li as Chief Medical Officer

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China , July 26, 2022 /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 management team will participate in BTIG 2022 Hybrid Biotechnology Conference in August 2022.

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