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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 (NASDAQ: GRCL) announced preclinical data for GC502, an allogeneic CAR-T cell therapy targeting B-cell malignancies. This data will be presented at the 63rd American Society of Hematology Annual Meeting on December 11, 2021. GC502 utilizes Gracell's TruUCAR technology, showing strong anti-tumor efficacy and potential to suppress host versus graft rejection without the need for additional immunosuppressive drugs. The company is optimistic about further clinical development for this therapy aimed at improving treatment options for patients with B-cell malignancies.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in several upcoming healthcare conferences. The events include the Goldman Sachs Asia Pacific Healthcare Forum (November 15-17, 2021), the BioCentury-BayHelix China Healthcare Summit (November 17, 2021), and the Jefferies London Healthcare Conference (November 18-19, 2021). Gracell aims to showcase its innovative cell therapies designed to treat cancer. The company utilizes its advanced FasTCAR and TruUCAR technology platforms to create effective and affordable solutions for patients.
Gracell Biotechnologies (NASDAQ: GRCL) aims to advance cancer treatment through innovative cell therapies. On October 15, 2021, the company announced its participation in two upcoming virtual conferences. The Jefferies China Biotech Summit is set for October 26, featuring one-on-one meetings and a fireside chat at 10:30 AM ET. Additionally, Gracell will engage in the Citi China Investor Conference from November 1-3. Investors can access details and replays via Gracell's website.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announces participation in virtual conferences including the Citi 16th Annual BioPharma Conference from September 8-10, 2021, featuring a panel on cell therapy on September 9. Additionally, Gracell will participate in the 2021 Wells Fargo Healthcare Conference from September 9-10, with a fireside chat on September 10. These events aim to showcase Gracell's advancements in cell therapies aimed at enhancing cancer treatment. Live webcasts will be available on the Gracell Investor website.
Gracell Biotechnologies (NASDAQ: GRCL) announced its second quarter 2021 financial results. The company reported a net loss of RMB 96.2 million (US$14.9 million), increasing from RMB 63.1 million in Q2 2020. R&D expenses rose to RMB 65.3 million (US$10.1 million), attributed to business expansion. Cash and equivalents stood at RMB 2,053.6 million (US$318.1 million). Gracell's lead CAR-T therapies, GC012F for multiple myeloma and GC007g for B-ALL, showed promising interim results. The company continues to expand its U.S. presence with new executive appointments.
Gracell Biotechnologies (NASDAQ: GRCL) has signed an exclusive license with FutureGen Biopharm to develop innovative immune cell therapies targeting the tumor-specific marker Claudin 18.2 in solid tumors. This collaboration aims to leverage Gracell's expertise in CAR-T therapies alongside FutureGen's human antibodies for CLDN18.2, essential for treating cancers like gastric and pancreatic. The agreement includes upfront payments and royalties based on development milestones. Given that 70% of gastric cancer cases express CLDN18.2, this partnership could address significant unmet medical needs in oncology.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will release its second-quarter financial results on August 17, 2021, before U.S. markets open. A conference call is scheduled for 8:00 a.m. ET to discuss these results alongside recent business developments. Gracell focuses on developing innovative cell therapies for cancer, addressing major challenges in CAR-T treatments. The company utilizes its FasTCAR and TruUCAR technology platforms to enhance production quality and reduce costs.
Gracell Biotechnologies (NASDAQ: GRCL) will participate in the BTIG Virtual Biotechnology Conference 2021 on August 9-10, 2021. This includes one-on-one meetings and a fireside chat scheduled for August 10 at 9:30 AM ET. Gracell is a clinical-stage biopharmaceutical company focused on developing innovative cell therapies for cancer using its FasTCAR and TruUCAR technology platforms. These advancements aim to address challenges like lengthy manufacturing times and high costs associated with traditional CAR-T therapies.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced the rescheduling of its conference call to update on the results of a Phase 1 study of GC012F, a dual-targeting CAR-T cell therapy for relapsed/refractory multiple myeloma. The presentation data will be showcased at the 2021 American Society of Clinical Oncology Annual Meeting and the EHA 2021 Virtual Congress. The conference call is set for June 14, 2021, at 8:00 am ET. This event aims to discuss findings from the multicenter study, underscoring Gracell's commitment to developing innovative cancer treatments.
Gracell Biotechnologies (NASDAQ: GRCL) announced a webinar on June 11, 2021, focused on treating High-Risk Multiple Myeloma. The event will feature Dr. Andrzej Jakubowiak from the University of Chicago, discussing treatment challenges and introducing GC012F, a dual-targeting CAR-T therapy, which leverages Gracell's FasTCAR platform for improved efficiency and cost-effectiveness. The session will include a fireside chat with Dr. Jakubowiak and Gracell’s leadership, followed by a live Q&A. This initiative aims to address significant unmet medical needs in Multiple Myeloma treatment.
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