Core Insights - The interview features Acumen Pharmaceuticals' CEO Daniel O'Connell and Dr. Jessica Clark discussing the challenges and advancements in Alzheimer's disease treatment [1][5] - There are over six million diagnosed cases of Alzheimer's in the U.S. and approximately 55 million worldwide, with treatment and long-term care costs estimated at $360 billion [2] Company Focus - Acumen Pharmaceuticals is dedicated to developing targeted therapies for Alzheimer's, specifically a monoclonal antibody named sabirnetug, which targets amyloid beta oligomers (AβOs) [3][6] - The company is advancing sabirnetug into a Phase II study involving around 540 patients across the U.S., North America, and Europe, with enrollment expected to complete in the first half of the year [4] Industry Context - The economic impact of Alzheimer's disease is significant, affecting not only healthcare costs but also caregiver productivity and time investment [2] - The advancements in pharmaceuticals are crucial for improving patient care and reshaping healthcare delivery models [5]

Oral presentations will highlight the implementation of a validated research-use plasma pTau217 assay in the participant screening process for the Phase 2 ALTITUDE-AD study of sabirnetugNEWTON, Mass., March 12, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced upcoming scientific presentations at the In ...

NEWTON, Mass., March 12, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD), today announced upcoming scientific presentations at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD) in Vienna, Austria from April 1-5, 2025, and the American Academy of Neurology (A ...

Core Insights - 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 [2] - The company is advancing its investigational product candidate, sabirnetug (ACU193), which is currently in a Phase 2 clinical trial named ALTITUDE-AD, following positive results from its Phase 1 trial INTERCEPT-AD [2] Company Overview - Acumen Pharmaceuticals is headquartered in Newton, Massachusetts, and is dedicated to addressing Alzheimer's disease through innovative research on amyloid beta oligomers [2] - The scientific founders of Acumen have pioneered research indicating that amyloid beta oligomers are significant early triggers of Alzheimer's disease pathology [2] Upcoming Events - Management will participate in webcast fireside chats at two investor conferences: UBS Virtual CNS Day on March 17, 2025, and Stifel Virtual CNS Days on March 18, 2025 [3]

Core Insights - The Phase 1 INTERCEPT-AD trial results support the continued development of sabirnetug (ACU193) for early Alzheimer's disease treatment, showing selective target engagement and significant amyloid plaque reduction [1][3][4] - Acumen Pharmaceuticals is advancing sabirnetug as a next-generation antibody treatment, targeting toxic soluble amyloid beta oligomers (AβOs) that contribute to Alzheimer's disease pathology [2][8] - The ongoing Phase 2 ALTITUDE-AD trial aims to evaluate the efficacy and safety of sabirnetug in approximately 540 adults with early Alzheimer's disease, with enrollment expected to complete in the first half of 2025 [6][10] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting toxic soluble AβOs for Alzheimer's disease [11] - The company has received Fast Track designation from the U.S. FDA for sabirnetug, indicating its potential as a treatment for early Alzheimer's disease [8] - The INTERCEPT-AD trial involved 65 participants and demonstrated a favorable safety profile, with low levels of amyloid-related imaging abnormalities [3][9] Clinical Trials - The INTERCEPT-AD trial was a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of sabirnetug in early Alzheimer's disease patients [3][9] - The ALTITUDE-AD trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating sabirnetug's efficacy in slowing cognitive decline, with the first patient dosed in May 2024 [6][10]

Core Viewpoint - The publication of Phase 1 INTERCEPT-AD data supports the continued development of sabirnetug (ACU193) for early Alzheimer's disease treatment, demonstrating its safety, target engagement, and efficacy in reducing amyloid plaques [1][4]. Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing sabirnetug, a humanized monoclonal antibody targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment [10]. - The company is headquartered in Newton, Massachusetts, and aims to advance its investigational product candidate through ongoing clinical trials [10]. Clinical Trials - The Phase 1 INTERCEPT-AD trial involved 65 participants with early Alzheimer's disease, showing dose-dependent target engagement and significant amyloid plaque reduction [3][8]. - The ongoing Phase 2 ALTITUDE-AD trial aims to evaluate the efficacy and safety of sabirnetug in approximately 540 adults aged 50 to 90 years, with enrollment expected to complete in the first half of 2025 [6][9]. Drug Mechanism and Development - Sabirnetug is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in early symptomatic Alzheimer's disease patients [2]. - The drug targets soluble AβOs, which are believed to be a significant early trigger of neurodegeneration in Alzheimer's disease [7]. Safety and Efficacy Findings - The INTERCEPT-AD trial results indicated a low incidence of amyloid-related imaging abnormalities (ARIA), with only one participant experiencing mild ARIA-E that resolved within four weeks [3][8]. - The study confirmed the safety profile of sabirnetug and established a foundation for the ongoing Phase 2 trial [3][4].

Financial Performance and Expenses - Net loss for the nine months ended September 30, 2024 was $65.2 million, with 91% ($59.2 million) attributed to research and development spending[102] - Research and development expenses increased by 144% to $27.2 million in Q3 2024 compared to Q3 2023[112] - General and administrative expenses increased by 3% to $5.0 million in Q3 2024 compared to Q3 2023[112] - Research and development expenses increased by $16.0 million to $27.2 million for the three months ended September 30, 2024, primarily due to a $13.4 million increase in costs associated with the Phase 2 ALTITUDE-AD clinical trial[113] - General and administrative expenses increased by $0.1 million to $5.0 million for the three months ended September 30, 2024, primarily due to higher personnel costs[114] - Other income decreased by $0.6 million to $2.5 million for the three months ended September 30, 2024, due to an increase in interest expense related to borrowings[115] - Research and development expenses increased by $30.2 million to $59.2 million for the nine months ended September 30, 2024, primarily due to a $20.9 million increase in costs associated with the Phase 2 ALTITUDE-AD clinical trial[118] - General and administrative expenses increased by $1.6 million to $15.2 million for the nine months ended September 30, 2024, primarily due to higher personnel costs[119] - Other income increased by $2.4 million to $9.2 million for the nine months ended September 30, 2024, primarily due to a $4.5 million increase in interest income[120] - Net cash used in operating activities increased by $24.2 million to $59.0 million for the nine months ended September 30, 2024, primarily due to an increase in net loss[129] Cash and Funding - Cash and cash equivalents and marketable securities totaled $258.9 million as of September 30, 2024, including $30.0 million from the first tranche of the K2HV loan[104] - The company expects its existing cash and cash equivalents to fund operations into the first half of 2027[104] - The company entered into a $50 million loan agreement with K2HV in November 2023, with $30 million already drawn[100] - In Q3 2024, the company issued 2,068,246 shares of common stock under its ATM program for net proceeds of $7.9 million ($3.84 per share)[101] - Cash provided by investing activities increased by $141.2 million to $18.4 million for the nine months ended September 30, 2024, primarily due to proceeds from maturities of marketable securities[132] - Cash provided by financing activities decreased by $115.7 million to $6.9 million for the nine months ended September 30, 2024, primarily due to lower net proceeds from the issuance of common stock[133] - The company expects its existing cash and cash equivalents and marketable securities totaling $258.9 million to fund operating expenses and capital expenditure requirements into the first half of 2027[127] - Additional funding may result in dilution to stockholders, imposition of debt covenants, and repayment obligations, potentially affecting the company's business[138] - The company's ability to raise capital may be adversely impacted by worsening global economic conditions, disruptions in credit markets, and rising interest rates[138] Clinical Trials and Drug Development - The Phase 2 ALTITUDE-AD clinical trial for sabirnetug is expected to complete enrollment in the first half of 2025 with approximately 540 participants[96] - Sabirnetug demonstrated a 10.4% overall rate of ARIA-E in the INTERCEPT-AD trial, with dose-dependent rates of 7% (10/25 mg/kg) and 21% (60 mg/kg)[95] Financial Position and Deficits - The company has an accumulated deficit of $288.0 million and working capital of $187.7 million as of September 30, 2024[102] Accounting and Reporting - Financial statements preparation requires significant estimates and assumptions, which may differ under different conditions[139] - The company has elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act[142] - The company qualifies as an "emerging growth company" and may take advantage of reduced disclosure requirements until December 31, 2026, or until specific financial thresholds are met[144] - The company is also a "smaller reporting company" with a market value of shares held by non-affiliates less than $700 million and annual revenue below $100 million[145] - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[145] - The company may continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[145] - Quantitative and qualitative disclosures about market risk are not applicable to the company as a smaller reporting company[146]

Financial Data and Key Metrics Changes - As of September 30, the company had approximately $259 million in cash and marketable securities, with an expected cash runway lasting into the first half of 2027 [18] - R&D expenses for Q3 2024 were $27.2 million, primarily due to increased spending for the ALTITUDE-AD trial, representing an increase compared to the prior year [18] - The company reported a loss from operations of $32.3 million and a net loss of $29.8 million for the quarter, with a net cash burn of approximately $23 million [19] Business Line Data and Key Metrics Changes - The ALTITUDE-AD Phase II study is currently enrolling over 540 patients with mild cognitive impairment or mild dementia due to Alzheimer’s, with more than 75 sites active across North America, the U.K., and the EU [7][8] - Enrollment in the ALTITUDE-AD trial has progressed faster than expected, with completion anticipated in the first half of 2025 [8] Market Data and Key Metrics Changes - The company is positioned to capitalize on advancements in the Alzheimer’s field, particularly with anti-A-beta disease-modifying treatments [10] - Blood-based biomarkers are becoming increasingly important in clinical research and drug development, with the company utilizing a plasma phospho-tau 217 assay for participant screening in the ALTITUDE-AD trial [11] Company Strategy and Development Direction - The company aims to advance the clinical development of sabirnetug efficiently, with a focus on its mechanism of action targeting toxic A-beta oligomers [17] - The appointment of Dr. Amy Schacterle as Chief Regulatory Officer is expected to enhance the company’s regulatory strategy and product development efforts [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing execution of clinical trials and the potential of sabirnetug as a next-generation treatment option for Alzheimer’s [19] - The company is committed to exploring subcutaneous formulations of sabirnetug to provide a more convenient treatment option [27] Other Important Information - The company reported a significant reduction in the incidence of negative amyloid PET scans by about 50% compared to the Phase I study, contributing to rapid enrollment in the ALTITUDE-AD trial [12] - The company hosted a virtual R&D Day to discuss the scientific rationale supporting sabirnetug and its clinical plans [14] Q&A Session Summary Question: What kind of data can be expected from the subcutaneous study? - The Phase I study is evaluating pharmacokinetics and bioavailability of subcutaneous sabirnetug compared to IV, with specific next steps to be determined after data analysis [21] Question: Thoughts on taking an interim look at 6 months for ALTITUDE-AD? - Management clarified that there are no plans for interim results; the study is designed to preserve statistical power and integrity [23][24] Question: Confidence in having enough data for pivotal studies with subcutaneous formulation? - Management indicated that they need to see Phase I data before predicting the next steps for subcutaneous formulation [26] Question: What indicators will suggest that ALTITUDE-AD remains on track? - The rapid enrollment rate in the ALTITUDE-AD trial is a positive indicator, with expectations to complete enrollment in the first half of 2025 [30] Question: How is the patient population for ALTITUDE-AD being targeted? - The study targets patients with mild cognitive impairment or mild dementia, focusing on those with demonstrated Alzheimer’s pathology [35] Question: Why has ARIA burden been less with sabirnetug? - The company anticipated lower ARIA rates due to sabirnetug's specific targeting of oligomers, and the Phase I study confirmed this expectation [41]

Financial Performance - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $258.9 million, down from $306.1 million as of December 31, 2023, with the decrease attributed to funding ongoing operations[8]. - Loss from operations for Q3 2024 was $32.3 million, compared to $16.0 million in Q3 2023, driven by higher R&D and G&A expenses[11]. - Net loss for Q3 2024 was $29.8 million, compared to $13.0 million in Q3 2023[11]. - Total operating expenses for the nine months ended September 30, 2024, were $74,420,000, compared to $42,652,000 for the same period in 2023, reflecting a 74% increase[24]. - The net loss for the nine months ended September 30, 2024, was $65,175,000, compared to a net loss of $35,874,000 for the same period in 2023, indicating an 81% increase in losses[25]. - Cash used in operating activities for the nine months ended September 30, 2024, was $59,000,000, up from $34,750,000 in the same period of 2023, marking a 70% increase[25]. - The company reported total other income of $2,500,000 for Q3 2024, down from $3,082,000 in Q3 2023, a decrease of 19%[24]. - The company reported a comprehensive loss of $29,083,000 for Q3 2024, compared to a comprehensive loss of $12,820,000 in Q3 2023, indicating a 127% increase in comprehensive losses[24]. Research and Development - Research and Development (R&D) expenses for Q3 2024 were $27.2 million, compared to $11.2 million in Q3 2023, reflecting increased clinical trial costs related to the ALTITUDE-AD study[9]. - Research and development expenses for Q3 2024 were $27,247,000, a significant increase from $11,179,000 in Q3 2023, representing a 143% rise[24]. - The ALTITUDE-AD Phase 2 study is expected to complete enrollment in the first half of 2025, with approximately 540 individuals targeted for enrollment[6]. - Topline results from the Phase 1 study supporting subcutaneous administration of sabirnetug are anticipated in the first quarter of 2025[7]. - The company presented insights from its participant screening approach for the ALTITUDE-AD trial at the 17th Annual Clinical Trials on Alzheimer's Disease conference[5]. Administrative Expenses - General and Administrative (G&A) expenses were $5.0 million for Q3 2024, slightly up from $4.9 million in Q3 2023, primarily due to increased personnel costs[10]. - The company incurred stock-based compensation expense of $7,292,000 for the nine months ended September 30, 2024, compared to $4,511,000 for the same period in 2023, an increase of 62%[25]. Collaboration and Appointments - The company extended its collaboration with Lonza for the commercial launch of sabirnetug, enhancing drug substance manufacturing capabilities for ongoing and future clinical phases[3]. - The company appointed Amy Schacterle, PhD, as Chief Regulatory Officer & Head of Quality, bringing over 30 years of experience in regulatory affairs and therapeutic development[6]. Share Information - The weighted-average shares outstanding for basic and diluted net loss per share increased to 60,079,778 in Q3 2024 from 54,229,630 in Q3 2023, a rise of 11%[24]. - Cash and cash equivalents at the end of the period were $33,420,000, down from $95,106,000 at the end of Q3 2023, a decrease of 65%[25]. - Interest income for Q3 2024 was $3,504,000, compared to $3,124,000 in Q3 2023, reflecting a 12% increase[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 product is currently in an ongoing Phase 2 clinical trial named ALTITUDE-AD, which involves early symptomatic Alzheimer's disease patients [3] - Positive results were reported from the previous Phase 1 trial, INTERCEPT-AD [3] Upcoming Events - Management will participate in a fireside chat at the Stifel Healthcare Conference on November 18, 2024, at 11:30 a.m. ET [1] - The live webcast of the event will be accessible under the Investors tab on the company's website and will be archived for 90 days [2]