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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) has reported promising preliminary data from its Phase 1 study on FasTCAR-T GC012F, a dual-targeting therapy for newly diagnosed multiple myeloma patients. The results show a 100% overall response rate (ORR) and all patients achieving minimal residual disease (MRD) negativity. The therapy demonstrated a strong safety profile, with only 23% experiencing mild cytokine release syndrome. The findings will be presented at the 64th ASH Annual Meeting on December 10, 2022, highlighting the potential of GC012F in the CAR-T therapy landscape.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will release its unaudited financial results for Q3 2022, ending September 30, on November 14, 2022, before U.S. market opens. The company will also provide updates on recent developments. A live audio webcast and conference call will be held at 8:00 AM ET on the same day. Investors can participate via domestic and international dial-ins. A recording of the event will be available for 90 days after the conclusion. Gracell focuses on developing affordable cell therapies for cancer treatment.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will participate in two investor conferences in November 2022. The Credit Suisse 31st Annual Healthcare Conference will include one-on-one meetings on November 8 in Rancho Palos Verdes, CA. The Jefferies London Healthcare Conference features a fireside chat on November 15 at 2:40 PM GMT and one-on-one meetings in London, UK. A webcast of the fireside chat will be available on Gracell's investor website for 30 days post-event. Gracell focuses on innovative cell therapies to treat cancer.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced the dosing of the first patient in the Phase 2 portion of its registrational Phase 1/2 clinical trial for GC007g, a donor-derived CAR-T therapy targeting Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL). Conducted in China, this trial aims to evaluate the safety and efficacy of GC007g, following encouraging Phase 1 results indicating a favorable safety profile. This milestone marks a significant step in Gracell's development of innovative treatments for patients with urgent medical needs.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its participation in three investor conferences in September 2022. The events include the Citi Hong Kong China Corporate Day on September 20-21, the Cantor Oncology, Hematology & HemeOnc Conference on September 28, and the Jefferies Cell & Genetic Medicine Summit on September 30. Gracell is focused on developing innovative cell therapies for cancer treatment, employing advanced technologies like FasTCAR and TruUCAR. A webcast of the fireside chat at the Jefferies Summit will be available on their investor website for 30 days post-event.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced participation in four investor conferences in September 2022. Key events include the Wells Fargo Healthcare Conference from September 7-9, featuring a fireside chat on September 7 at 9:45 a.m. ET, and the Citi's 17th Annual BioPharma Conference from September 6-8, with a panel presentation on September 8 at 11:20 a.m. ET. Other conferences include the H.C. Wainwright Conference and the Cantor Call on September 15. Webcasts will be available for 30 days after the events.
Gracell Biotechnologies (NASDAQ: GRCL) reported significant clinical progress and second-quarter financial results for 2022. Key highlights include a 100% MRD negativity rate in relapsed/refractory multiple myeloma patients treated with the FasTCAR GC012F. The company is on schedule for IND submissions for this therapy in both the U.S. and China by year-end. Financially, Gracell recorded a net loss of RMB146.3 million (US$21.8 million) and increased R&D expenses due to clinical trial investments. With cash reserves of RMB1,707.3 million (US$254.9 million), Gracell is well-funded into 2024.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will announce its unaudited financial results for Q2 2022, ending June 30, on August 15, 2022, before U.S. markets open. The company, focused on creating affordable cell therapies for cancer treatment, will provide a business update during a live audio webcast and conference call at 8:00 AM ET. Investors can join via domestic and international dial-ins, and a replay will be available for 90 days post-event. For more details, visit Gracell's website.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) appointed Dr. Wendy Li as Chief Medical Officer on August 1, 2022. With over 20 years of experience in oncology clinical development and regulatory affairs, Dr. Li's role will involve overseeing clinical operations and advancing Gracell's pipeline of cell therapies. Her past experience includes leadership positions at EXUMA Biotech, Pfizer, and Sanofi, where she contributed to multiple INDs and NDAs for successful therapies. Dr. Li aims to leverage her expertise to enhance Gracell's position in the biopharmaceutical sector.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will participate in the BTIG 2022 Hybrid Biotechnology Conference in August 2022. The management team will hold in-person one-on-one meetings on August 8 and virtual meetings on August 9. As a clinical-stage biopharmaceutical company, Gracell focuses on developing innovative cell therapies for cancer treatment using its advanced FasTCAR and TruUCAR technology platforms. These aim to address significant challenges in conventional CAR-T therapies, such as long manufacturing times and high costs.
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