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]

Core Insights - Acumen Pharmaceuticals presented updated data on the pTau217 assay, highlighting its effectiveness in screening participants for the ALTITUDE-AD clinical trial, which reduces unnecessary amyloid PET scans and lumbar punctures for ineligible individuals [1][2][4] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [9] - The company is headquartered in Newton, Massachusetts, and is advancing its investigational product candidate, sabirnetug (ACU193), in the ongoing Phase 2 clinical trial ALTITUDE-AD [9] Clinical Trial Details - ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of sabirnetug in approximately 540 adults aged 50 to 90 years [2][8] - The trial is currently enrolling participants at 75 sites across the U.S., Canada, EU, and U.K., with expected completion of enrollment in the first half of 2025 [2][8] pTau217 Assay Insights - The pTau217 assay serves as an enrichment tool, classifying participants most likely to be eligible for the ALTITUDE-AD study, with a threshold established at ≥0.15 pg/mL [4] - More than half of potential participants have been excluded due to pTau217 results below this threshold, while 74% of those with results ≥0.15 pg/mL met eligibility requirements following confirmatory assessments [4] Clinical Trial Process Improvement - The pTau217 screening assay is designed to reduce the burden on patients by minimizing invasive procedures and unnecessary radiation exposure, thus streamlining the trial enrollment process [2][3] - The study's design aims to enhance the patient experience while advancing next-generation treatments for Alzheimer's disease [5]

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease (AD) treatment [5] - The company is headquartered in Newton, Massachusetts, and is advancing its investigational product candidate, sabirnetug (ACU193), in the ongoing Phase 2 clinical trial ALTITUDE-AD [5] Product Information - Sabirnetug (ACU193) is a humanized monoclonal antibody that selectively targets toxic soluble AβOs, which are believed to be early triggers of Alzheimer's disease pathology [3][5] - The drug has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of early AD [3] Clinical Trial Details - The ALTITUDE-AD study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial initiated in 2024, designed to evaluate the efficacy and safety of sabirnetug infusions administered every four weeks [4] - The trial aims to enroll approximately 540 individuals with early Alzheimer's disease, including those with mild cognitive impairment or mild dementia due to AD [4] - The study is currently ongoing at multiple investigative sites across the United States, Canada, the UK, and the European Union [4] Biomarker Utilization - Acumen will present updated data on the use of a validated plasma pTau217 assay as a screening tool for potential participants in the ALTITUDE-AD trial [2] - The pTau217 biomarker indicates AD pathology and is used to identify individuals who qualify for additional amyloid testing [2] Upcoming Presentation - A late-breaking presentation will be held on October 31, 2024, at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference, focusing on the participant screening process in the ALTITUDE-AD study [1][3]

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease (AD) treatment [4] - The company is headquartered in Newton, Massachusetts and is advancing its investigational product candidate, sabirnetug (ACU193), in an ongoing Phase 2 clinical trial named ALTITUDE-AD [4] Upcoming Event - Acumen will host a virtual R&D Day on October 2, 2024, at 10:00 a.m. ET, to present its strategic vision and discuss the mechanistic rationale, pre-clinical, and clinical data supporting the development of sabirnetug for early AD [1] - The event will feature discussions from Acumen's management and scientific leadership, along with external key opinion leaders on the current treatment paradigm and unmet needs in early Alzheimer's disease [2] Clinical Development - Sabirnetug is a humanized monoclonal antibody that selectively targets toxic soluble AβOs and is currently in Phase 2 clinical trials after positive results in its Phase 1 trial, INTERCEPT-AD [4] - The ongoing Phase 2 ALTITUDE-AD trial is investigating sabirnetug in early symptomatic Alzheimer's disease patients [4]

Investment Rating - The report maintains a "Buy" rating for Acumen Pharmaceuticals Inc with a 12-month price target (PT) lowered to $6 from $14 [4][8]. Core Insights - The investment thesis has been updated following the 2Q24 earnings report, with a focus on the execution of Phase 2 (P2) trials for sabirnetug (ACU193) as a key driver for stock performance [2][6]. - The overall sentiment in the Alzheimer's disease (AD) market remains low, influenced by regulatory setbacks and slow commercial uptake of competing products [3][9]. - Despite the challenges, the report highlights that Acumen Pharmaceuticals has sufficient cash to fund operations into the first half of 2027, with P2 trial enrollment exceeding expectations [6][7]. Summary by Sections Investment Rating - 12-month rating: Buy - 12-month price target: $6.00 (previously $14.00) [4]. Financial Performance - Current stock price as of August 14, 2024: $2.46 - Market capitalization: $0.14 billion - Expected revenues for 12/24E: $21 million [5]. Market and Competitive Landscape - The AD market is sizable but has seen a decline in clinical trials and investigational drugs in 2024 compared to 2023 [3]. - Regulatory risks have increased following the EMA refusal of Leqembi, impacting overall market sentiment [3][9]. Company-Specific Developments - Acumen Pharmaceuticals reported a cash position of $281.4 million, sufficient to support ongoing trials [6]. - Management noted that the P2 ALTITUDE-AD study is progressing faster than expected, with positive feedback on the trial design [6][7]. Valuation Adjustments - Peak sales estimates for sabirnetug have been lowered from $6.8 billion to $2.4 billion due to anticipated lower commercial uptake [9][10]. - The probability of success (PoS) for sabirnetug has been increased from 15% to 20% based on evolving clinical data [9][10].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ___________________________ FORM 10-Q ___________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-40551 ___________________________ Acume ...

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q2 2024 Earnings Conference Call August 13, 2024 8:00 AM ET Company Participants Dan O’Connell - Chief Executive Officer Matt Zuga - Chief Financial Officer, Chief Business Officer Dr. Jim Doherty - President, Chief Development Officer Dr. Eric Siemers - Chief Medical Officer. Alex Braun - Head of Investor Relations Conference Call Participants Tom Shrader - BTIG Cameron Bozdog - Bank of America Samantha Schaeffer - Cantor Fitzgerald Trung Huynh - UBS Ananda Ghos ...