Core Viewpoint - Cognition Therapeutics, Inc. has announced that the Phase 2 'START' Study has surpassed 50% enrollment, indicating strong interest in their investigational drug zervimesine for treating early Alzheimer's disease [1][2][3] Company Overview - Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics for age-related degenerative disorders of the central nervous system [9][10] - The company is currently advancing zervimesine (CT1812), an oral treatment for Alzheimer's disease and dementia with Lewy bodies [5][9] Study Details - The START Study aims to enroll up to 540 individuals with mild Alzheimer's disease, who will receive either zervimesine or a placebo for 18 months [3][7] - The study is supported by an $81 million grant from the National Institute of Aging (NIA) and is conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) [1][8] Treatment Mechanism - Zervimesine is designed to target the toxic effects of protein buildup in the brain, specifically Aβ and ɑ-synuclein, which are associated with neurodegenerative diseases [5][10] - The treatment has shown promise in previous studies, with the Phase 2 'SHINE' Study indicating a 38% slowing of cognitive decline compared to placebo, and a 95% slowing in participants with lower levels of p-tau217 [4][10] Clinical Significance - The START Study is significant as it targets participants who are just beginning to show signs of cognitive loss, potentially allowing for earlier intervention [4][7] - The study will assess cognitive function and safety using validated tools, contributing to the understanding of zervimesine's efficacy in early Alzheimer's disease [7][8]

Core Insights - Acumen Pharmaceuticals is focused on developing sabirnetug (ACU193), a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [2][12][14] - The company reported a net loss of $28.8 million for Q1 2025, an increase from $14.9 million in Q1 2024, primarily due to rising R&D expenses [9][21] - Acumen's cash, cash equivalents, and marketable securities totaled $197.9 million as of March 31, 2025, expected to support operations into early 2027 [6][8] Business Update - The Phase 2 study, ALTITUDE-AD, is fully enrolled with 542 participants, and topline results are anticipated in late 2026 [2][4][13] - The company presented at the International Conference on Alzheimer's and Parkinson's Diseases, showcasing the effectiveness of the plasma pTau217 assay in screening participants for ALTITUDE-AD [7] Financial Performance - R&D expenses for Q1 2025 were $25.3 million, up from $12.4 million in Q1 2024, reflecting increased clinical trial costs [8][21] - General and administrative expenses slightly decreased to $5.1 million in Q1 2025 from $5.3 million in Q1 2024 [8][21] - The total operating expenses for Q1 2025 were $30.4 million, compared to $17.8 million in Q1 2024 [8][21] Cash Flow and Balance Sheet - The company reported a net cash used in operating activities of $34.1 million for Q1 2025 [24] - Cash and cash equivalents at the end of Q1 2025 were $30.4 million, down from $47.2 million at the end of Q1 2024 [24]

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is headquartered in Newton, Massachusetts [3] Product Development - Acumen is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers [3] - The company is currently conducting a Phase 2 clinical trial named ALTITUDE-AD for early symptomatic Alzheimer's disease patients, following positive results from its Phase 1 trial INTERCEPT-AD [3] Upcoming Events - Management will participate in a fireside chat at the Bank of America Healthcare Conference on May 14, 2025, at 8:15 a.m. PT/11:15 a.m. ET [1] - The live webcasts of the event will be accessible under the Investors tab on the company's website and archived for 90 days [2]

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is headquartered in Newton, Massachusetts [3] Product Development - Acumen is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers [3] - The company is currently conducting a Phase 2 clinical trial named ALTITUDE-AD for early symptomatic Alzheimer's disease patients, following positive results from its Phase 1 trial INTERCEPT-AD [3] Financial Reporting - Acumen Pharmaceuticals will report its first quarter 2025 financial results on May 13, 2025, and will host a conference call and live audio webcast at 8:00 a.m. ET for a business and financial update [1]

Core Insights - Acumen Pharmaceuticals is advancing its clinical development of sabirnetug, a treatment for early Alzheimer's disease, with significant progress reported in 2024 [2][5][12] - The company completed enrollment in its Phase 2 study, ALTITUDE-AD, ahead of schedule and anticipates topline results in late 2026 [5][7] - Financial results for 2024 show a net loss of $102.3 million, an increase from $52.4 million in 2023, primarily due to rising research and development expenses [14][22] Recent Highlights - Enrollment for the Phase 2 ALTITUDE-AD study was completed with 542 participants randomized to receive either sabirnetug or placebo [5][12] - The Phase 1 study results for a subcutaneous formulation of sabirnetug were announced, indicating it is well-tolerated and supports further development [6][11] - Cash, cash equivalents, and marketable securities totaled $231.5 million as of December 31, 2024, expected to fund operations into the first half of 2027 [5][14] Anticipated Milestones - Topline results from the ALTITUDE-AD study are expected in late 2026, focusing on the efficacy and safety of sabirnetug in early Alzheimer's disease [5][7] - The primary endpoint of the ALTITUDE-AD study is the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [6][12] Financial Overview - Research and development expenses increased to $93.8 million in 2024 from $42.3 million in 2023, driven by clinical trial costs and personnel expenses [14][22] - General and administrative expenses rose to $20.2 million in 2024, compared to $18.8 million in 2023 [14][22] - The company reported a loss from operations of $114.0 million in 2024, up from $61.1 million in 2023 [14][22]

Core Insights - Acumen Pharmaceuticals has completed enrollment in its ALTITUDE-AD Phase 2 trial for sabirnetug (ACU193), targeting early Alzheimer's disease, ahead of schedule and plans to report topline results in late 2026 [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [6][7] - The company’s investigational product, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease [4][6] Clinical Trial Details - The ALTITUDE-AD trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study that enrolled 542 patients with early Alzheimer's disease across the U.S., Canada, the EU, and the UK [3][5] - Participants were randomized to receive either 35mg/kg or 50mg/kg of sabirnetug or a placebo, with the primary endpoint being the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [3][5] - Secondary endpoints include various cognitive and functional assessments, as well as safety measures [3][5] Previous Trial Results - The Phase 1 INTERCEPT-AD trial indicated that sabirnetug was generally well-tolerated with low rates of ARIA-E and showed significant amyloid plaque reduction compared to placebo at higher doses [2][4]

Core Insights - Acumen Pharmaceuticals has completed enrollment in its ALTITUDE-AD Phase 2 trial for sabirnetug (ACU193), targeting early Alzheimer's disease, ahead of schedule and plans to report topline results in late 2026 [1][2][3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [6][7] - The company’s investigational product, sabirnetug (ACU193), is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease [4][6] Clinical Trial Details - The ALTITUDE-AD trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study that enrolled 542 patients with early Alzheimer's disease across the U.S., Canada, EU, and the UK [3][5] - Participants were randomized to receive either 35mg/kg or 50mg/kg of sabirnetug or a placebo, with the primary endpoint being the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) at 18 months [3][5] - Secondary endpoints include various cognitive and functional assessments, as well as safety measures [3][5] Previous Trial Results - The Phase 1 INTERCEPT-AD trial indicated that sabirnetug was generally well-tolerated with low rates of ARIA-E and showed significant amyloid plaque reduction compared to placebo [2][4]

Core Viewpoint - Acumen Pharmaceuticals is set to report its fourth quarter and year-end 2024 financial results on March 27, 2025, and will host a conference call for updates [1]. Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3]. - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, currently in a Phase 2 clinical trial (ALTITUDE-AD) after positive Phase 1 trial results [3]. - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are recognized as early triggers of Alzheimer's disease pathology [3].