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Arcellx, Inc. (NASDAQ: ACLX) is a clinical-stage biotechnology company dedicated to transforming cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. By harnessing advanced scientific techniques, Arcellx is reimagining cell therapy to be safer, more effective, and widely accessible.
Arcellx's flagship product candidate, CART-ddBCMA, now known as anitocabtagene autoleucel (anito-cel), is a BCMA-specific CAR-modified T-cell therapy aimed at treating relapsed or refractory multiple myeloma (rrMM). The innovative D-Domain binding technology used in anito-cel is designed to enhance target specificity and binding affinity, potentially improving therapeutic outcomes. In ongoing clinical studies, anito-cel has demonstrated remarkable efficacy, achieving a 100% overall response rate and a 76% complete response rate in patients with poor prognostic factors.
Arcellx is also making strides with its ARC-SparX platform, which includes two clinical-stage programs: ACLX-001 for rrMM and ACLX-002 for relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. These programs highlight Arcellx's commitment to developing dosable and controllable CAR-T therapies that address unmet medical needs.
In collaboration with Kite, a Gilead Company, Arcellx is co-developing and co-commercializing anito-cel for the treatment of multiple myeloma. This partnership not only strengthens their financial footing but also accelerates the clinical development and potential commercial launch of anito-cel. Kite's extensive experience in CAR T-cell therapy manufacturing and commercialization complements Arcellx's cutting-edge research, creating a synergistic force in the cell therapy landscape.
Arcellx has a robust pipeline and a solid financial position, with cash, equivalents, and marketable securities expected to fund operations into 2027. The company is on track to initiate the global Phase 3 trial iMMagine-3 in the second half of 2024, aimed at further validating anito-cel's efficacy and safety compared to standard of care treatments in a diverse patient population.
For more detailed information, visit www.arcellx.com and follow Arcellx on X (formerly Twitter, @arcellx) and LinkedIn.
Arcellx, Inc. (ACLX) announced significant developments in its Q2 2022 financial results and business highlights. The company completed a public offering raising $128.8 million and presented promising data from its CART-ddBCMA Phase 1 trial at the ASCO Annual Meeting, reporting a 100% overall response rate. Cash reserves as of June 30, 2022, stood at $307 million. However, the company incurred a net loss of $32.1 million, up from $15.9 million a year earlier, driven largely by increased R&D expenses.
Arcellx, Inc. (NASDAQ: ACLX) has appointed Maryam Abdul-Kareem, J.D., as General Counsel, bringing extensive experience in the biopharmaceutical industry from her previous roles at Kinnate Biopharma and AstraZeneca. Abdul-Kareem's responsibilities will include overseeing legal, contracts, and compliance matters as the company scales its operations. CEO Rami Elghandour emphasized her leadership skills and commitment to diversity as vital for the company’s growth.
Arcellx is focused on developing innovative immunotherapies for cancer and related diseases, including its lead candidate CART-ddBCMA.
Arcellx, Inc. (NASDAQ: ACLX) has successfully closed its upsized public offering, raising $128.8 million through the sale of 8,050,000 shares of common stock at $16.00 per share. This includes the full exercise of an option by underwriters to purchase an additional 1,050,000 shares. The offering, which was registered with the SEC and became effective on June 15, 2022, aims to advance Arcellx's innovative immunotherapies, including CART-ddBCMA for multiple myeloma and ARC-SparX for various cancers.
Arcellx, Inc. (NASDAQ: ACLX) announced a follow-on public offering of 7,000,000 shares at $16.00 per share, raising $112 million in gross proceeds. This offering is an increase from the initial size of 4,000,000 shares. Underwriters have a 30-day option to purchase an additional 1,050,000 shares. The offering is set to close on June 21, 2022. BofA Securities, SVB Securities, William Blair, and Canaccord Genuity are acting as joint book-running managers.
Arcellx, Inc. (NASDAQ: ACLX) presented promising Phase 1 results for its CART-ddBCMA therapy targeting relapsed or refractory multiple myeloma. Among 31 evaluable patients, a 100% overall response rate was observed, with 71% achieving complete (CR) or stringent complete (sCR) responses. Notably, long-term data showed that 81% of patients dosed over 12 months reached CR/sCR. The treatment was well-tolerated, with no severe toxicities reported. A pivotal Phase 2 study is expected to initiate by the end of 2022. These findings highlight the therapy's potential as a leading treatment option.
Arcellx, Inc. (NASDAQ: ACLX) has appointed Michelle Gilson as the new Chief Financial Officer. Gilson previously served as a Managing Director and Senior Equity Research Analyst at Canaccord Genuity, specializing in biotechnology. Her extensive background in capital markets will enhance Arcellx's financial strategy as they advance their innovative cell therapies aimed at treating cancer. The lead product candidate, CART-ddBCMA, is in an ongoing Phase 1 study and has received multiple FDA designations, underscoring the company's commitment to developing effective treatment options.
Arcellx, Inc. (NASDAQ: ACLX) announced the appointment of Olivia Ware to its Board of Directors, replacing Lewis T. "Rusty" Williams, M.D. Ware brings over 20 years of experience in biotech and pharmaceutical drug development, having played key roles in launching major oncology drugs such as Rituxan and Herceptin. Her expertise is expected to enhance the company's strategic direction, especially as it prepares for a Phase 2 study of CART-ddBCMA for relapsed or refractory multiple myeloma. The company is focused on advancing innovative immunotherapies and has received multiple FDA designations for its lead product.
Arcellx, Inc. (NASDAQ: ACLX) initiated a Phase 1 clinical trial for ACLX-001 utilizing its innovative ARC-SparX technology to treat relapsed or refractory multiple myeloma (r/r MM). The company raised $142 million in its IPO and reported cash reserves of $210.9 million as of March 31, 2022, sufficient to fund operations into late 2023. Unfortunately, they posted a net loss of $32.4 million with R&D expenses increasing to $24.4 million. Upcoming presentations at the ASCO Annual Meeting are anticipated to provide further insights into their clinical data.
Arcellx, Inc. (NASDAQ: ACLX) has initiated its Phase 1 clinical trial for ACLX-001, targeting relapsed or refractory multiple myeloma (r/r MM). The trial, utilizing the innovative ARC-SparX platform, aims to evaluate safety and tolerability while addressing challenges like dose-limiting toxicities and tumor heterogeneity. The first patient has been dosed, and initial data is expected in 2023. The ARC-SparX technology combines SparX proteins and ARC-T cells to enable controlled and adaptable treatment options, potentially enhancing patient access to CAR-T therapies.
On May 9, 2022, Arcellx, Inc. (ACLX) announced key clinical data for CART-ddBCMA from its ongoing Phase 1 study aimed at treating relapsed or refractory multiple myeloma. Published in Blood Advances, the findings show a 100% overall response rate (ORR) and a 75% complete response/sustained complete response (CR/sCR) in 12 patients. The trial reported no significant adverse effects, solidifying CART-ddBCMA's safety profile. Following these results, Arcellx plans to expand the study and present new data at ASCO on June 5, with a pivotal Phase 2 study expected later in 2022.
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