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Gracell Biotechnologies Inc. (GRCL) is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies. The company leverages its pioneering FasTCAR and TruUCAR technology platforms to create a robust clinical-stage pipeline of autologous and allogeneic product candidates. These innovations aim to address significant challenges in conventional CAR-T therapies such as lengthy manufacturing times, suboptimal production quality, high costs, and the lack of effective CAR-T therapies for solid tumors.
One of Gracell's leading developments is GC012F, an autologous CAR-T candidate that dual-targets B cell maturation antigen (BCMA) and CD19. Utilizing the proprietary FasTCAR next-day manufacturing platform, GC012F has shown promise in treating multiple myeloma and other hematological cancers. The candidate is currently undergoing various clinical trials, including a Phase 1b/2 U.S. IND study for relapsed/refractory multiple myeloma and a Phase 1/2 trial for refractory systemic lupus erythematosus set to initiate in 2024.
Gracell’s FasTCAR platform, introduced in 2017, has revolutionized CAR-T cell manufacturing by drastically shortening cell production times from weeks to overnight, reducing patient wait times and the likelihood of disease progression. FasTCAR T-cells appear younger and more proliferative, enhancing their effectiveness in killing cancer cells. The platform has garnered multiple accolades, including the Biotech Innovation category award at the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards.
As part of its ongoing efforts, Gracell is also expanding the clinical development of GC012F in early-line multiple myeloma therapies and other indications. The company's recent milestone achievements include receiving its third U.S. IND clearance for GC012F, marking its entry into early-line multiple myeloma treatment. This strategic move aims to address unmet needs and drive improved patient outcomes through GC012F's unique dual-targeting approach and FasTCAR manufacturing capabilities.
Moreover, Gracell recently announced a merger agreement approved by its shareholders, making significant strides in its corporate development. The company intends to delist from the Nasdaq Global Select Market and suspend its SEC reporting obligations, following the merger's effective date on February 22, 2024. For more information, visit www.gracellbio.com or follow @GracellBio on LinkedIn.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its plan to release unaudited financial results for Q1 2022 on May 16, 2022, before U.S. market opening. The company will also provide updates on recent developments during a live conference call at 8:00 AM ET. Gracell focuses on developing affordable cell therapies to treat cancer, utilizing its innovative technology platforms, including FasTCAR and TruUCAR. The company aims to address challenges in conventional CAR-T therapies.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its upcoming presentation of long-term clinical data for GC012F, a dual-targeting CAR-T candidate for relapsed/refractory multiple myeloma, at the 2022 ASCO Annual Meeting in Chicago from June 3-7. GC012F targets both BCMA and CD19 and has received Orphan Drug Designation from the FDA. The presentation will take place on June 5 at 9:36 AM CT, with the full abstract released on May 26. Gracell aims to enhance the efficacy and affordability of cancer therapies through its innovative FasTCAR platform.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) has filed its annual report on Form 20-F for the year ended December 31, 2021, with the SEC on April 22, 2022. This report demonstrates Gracell's commitment to transparency with stakeholders, offering insights into its financial performance and plans. The report is accessible on both the company’s investor relations website and the SEC’s site. Gracell focuses on innovative cell therapies to address the limitations of traditional CAR-T therapies, aiming to improve affordability and efficacy in cancer treatment.
Gracell Biotechnologies (NASDAQ: GRCL) has announced its abstract on GC012F for treating relapsed/refractory multiple myeloma has been selected for oral presentation at the 2022 ASCO Annual Meeting. GC012F, a dual-targeting CAR-T therapy using the FasTCAR platform, aims to enhance treatment efficacy and reduce relapse rates. This candidate received Orphan Drug Designation from the FDA in November 2021. The abstract title will be available on April 27, 2022, with the meeting set for June 3-7, 2022, in Chicago.
Gracell Biotechnologies announced promising early results of its clinical study for GC502, a dual-directed CAR-T therapy targeting CD19/CD7 for relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). The findings, to be presented on April 12, 2022, at the AACR Annual Meeting, show that three out of four patients achieved minimal residual disease negative complete response. Conducted in China, the Phase I trial indicates GC502’s potential for patients who can't receive autologous CAR-T therapies. The trial continues under ClinicalTrials.gov Identifier: NCT05105867.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in upcoming investor conferences in April 2022, focusing on advancing its innovative cell therapies for cancer treatment. Key events include the Wells Fargo Biotech Forum on April 12-13 in Palm Beach Gardens, Florida; the Needham Virtual Healthcare Conference on April 14, featuring a presentation at 9:30 am ET; and the UBS Asia Healthcare Virtual Conference on April 27-29. Gracell aims to tackle significant challenges in CAR-T therapies using its advanced technology platforms.
Gracell Biotechnologies (NASDAQ: GRCL) reported its Q4 and full-year 2021 financial results, highlighting a cash balance of RMB1,832.6 million (US$287.6 million) as of December 31, 2021.
Net losses for Q4 reached RMB128.6 million (US$20.2 million), increasing from RMB99.9 million year-over-year. For the full year, losses totaled RMB453.7 million (US$71.2 million), up from RMB274.6 million in 2020.
R&D expenses surged to RMB107.6 million (US$16.9 million) in Q4, driven by clinical trial activities. The company plans to file a U.S. IND for its lead therapy, GC012F, in late 2022.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in the Oppenheimer 32nd Annual Healthcare Conference from March 15-17, 2022. The management team will present on March 15 from 11:20 AM to 11:50 AM ET and host virtual investor meetings. A webcast of the presentation will be available on the company's website for 90 days post-event. Gracell specializes in developing innovative cell therapies to treat cancer, utilizing technology platforms like FasTCAR and TruUCAR to address challenges in conventional CAR-T therapies.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its upcoming presentation on GC502, a novel dual-directed CAR-T cell therapy for B-cell malignancies, at the AACR Annual Meeting 2022. Taking place on April 12 in New Orleans, the presentation will highlight early clinical data from a Phase 1 trial for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). GC502, leveraging Gracell's TruUCAR platform, aims to enhance safety and efficacy while minimizing host-versus-graft rejection risks.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will release its unaudited financial results for Q4 and full year 2021 on March 14, 2022. A live audio webcast and conference call will occur at 8:00 AM ET, where management will discuss these results and recent business developments. Gracell focuses on developing innovative and cost-effective cell therapies for cancer treatment, utilizing its advanced technology platforms to address industry challenges.
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