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Gracell Biotechnologies Inc. - GRCL STOCK NEWS

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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.

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Gracell Biotechnologies to participate in two investor conferences
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Gracell Biotechnologies Inc. (GRCL) reported second quarter unaudited financial results for the period ended June 30, 2023, and provided corporate updates. The company commenced Phase 1b/2 clinical trial in the U.S. evaluating FasTCAR-T GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM), and patient screening is underway. They also closed a private placement of ordinary shares and warrants to generate $100 million upfront and up to $50 million tied to exercise of warrants, extending cash runway into the second half of 2026.
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Gracell Biotechnologies announces oversubscribed $100 million financing with potential for an additional $50 million tied to exercise of warrants. The financing is expected to extend cash runway into the second half of 2026. Gracell intends to use the funds for research and development of its clinical-stage product candidates and other corporate purposes.
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Gracell Biotechnologies Inc. will participate in the Truist Securities Cell Therapy Symposium: Symposia-cel on June 27, 2023, in New York, NY.
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Gracell Biotechnologies presented data on their CD19/BCMA dual-targeting FasTCAR-T GC012F therapy for the treatment of B-cell non-Hodgkin’s Lymphoma (B-NHL) at the EHA2023 Congress. The data showed a 100% overall response rate (ORR) and a 66.7% complete response (CR) rate at 6 months among treated patients. GC012F also demonstrated a favorable safety profile. Gracell is also evaluating GC012F in other indications such as relapsed/refractory multiple myeloma (RRMM) and systemic lupus erythematosus (SLE).
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Gracell Biotechnologies presented long-term follow-up data on their GC012F therapy for the treatment of multiple myeloma at the ASCO Annual Meeting. The data showed impressive clinical outcomes, including a 93.1% overall response rate and 82.8% achieving minimal residual disease negativity. The therapy demonstrated durable responses with a median duration of response of 37.0 months and a median progression-free survival of 38.0 months. No new safety findings were reported.
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FAQ

What is the market cap of Gracell Biotechnologies (GRCL)?

The market cap of Gracell Biotechnologies (GRCL) is approximately 989.9M.

What does Gracell Biotechnologies Inc. specialize in?

Gracell Biotechnologies Inc. specializes in the discovery and development of breakthrough cell therapies for cancer and autoimmune diseases.

What are the key technologies developed by Gracell?

Gracell has developed pioneering technologies such as FasTCAR and TruUCAR platforms to address significant challenges in conventional CAR-T therapies.

What is GC012F?

GC012F is an autologous CAR-T therapeutic candidate dual-targeting BCMA and CD19, utilizing Gracell's FasTCAR next-day manufacturing platform.

What recent achievements has Gracell announced?

Gracell recently received its third U.S. IND clearance for GC012F and announced plans to delist from Nasdaq following a shareholder-approved merger.

What is the FasTCAR platform?

FasTCAR is a revolutionary next-day autologous CAR-T cell manufacturing platform designed to enhance treatment effectiveness and reduce costs.

What clinical trials are currently underway for GC012F?

GC012F is being evaluated in various clinical trials, including a Phase 1b/2 U.S. IND study for relapsed/refractory multiple myeloma and upcoming trials for systemic lupus erythematosus.

How does Gracell's FasTCAR technology improve CAR-T therapies?

FasTCAR technology reduces cell production times from weeks to overnight, enhancing cell effectiveness and proliferation in killing cancer cells.

What awards has Gracell’s FasTCAR platform received?

The FasTCAR platform has received the Biotech Innovation category award at the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards.

What is the significance of the recent merger agreement for Gracell?

The merger agreement enables Gracell to delist from Nasdaq and suspend SEC reporting obligations, aligning with its strategic corporate development goals.

Where can I find more information about Gracell Biotechnologies?

More information about Gracell Biotechnologies can be found on their website at www.gracellbio.com or by following @GracellBio on LinkedIn.

Gracell Biotechnologies Inc.

Nasdaq:GRCL

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GRCL Stock Data

989.87M
71.55M
16.39%
63.11%
1.23%
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