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, 2025 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 ___________________________ Acumen Pharmaceuticals, Inc. (Exa ...

Acumen Pharmaceuticals (ABOS) Q2 2025 Earnings Call August 12, 2025 08:00 AM ET Speaker0Good day, and welcome to the Acumen Pharmaceuticals Second Quarter twenty twenty five Conference Call and Webcast. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, this call may be recorded. I would now like to turn the call over to Alex Braun, Head of Investor Relations.Please go ahead.Speaker1Thanks, Michelle. Good mo ...

Exhibit 99.1 Acumen Pharmaceuticals Reports Second Quarter 2025 Financial Results and Business Highlights NEWTON, Mass., August 12, 2025 – Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) ("Acumen" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD), today reported financial results for the second quarter of 2025 and provided a business update. "Our momentum in the second ...

NEWTON, Mass., July 10, 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), will present new findings at the upcoming Alzheimer's Association International Conference (AAIC®) 2025 in Toronto. The presentations include a cost savings analysis of the use of pTau217 as a screening tool in Acumen’s Phase 2 ALTITUDE-AD trial ...

Sabirnetug (ACU193) Overview - Sabirnetug (ACU193) is a monoclonal antibody (mAb) highly selective for toxic Amyloid Beta Oligomers (AβOs) for early Alzheimer's Disease (AD)[4, 9] - Phase 2 (IV) topline results expected in late 2026[5] - Acumen believes it has the expertise and resources to advance sabirnetug into early 2027[99] Alzheimer's Disease Market and Sabirnetug's Potential - Early AD patient population represents a significant and growing market, with approximately 5 million early Alzheimer's Disease cases in the U S[6, 7] - Sabirnetug has the opportunity to be a treatment of choice in the large early AD population due to potential clinical and safety benefits conferred by AO selectivity[37] - Sabirnetug is well-positioned to emerge as a potential next-generation treatment of choice, with recent approvals paving a new path for the treatment of AD[36] Clinical Trial Results and Development - INTERCEPT-AD Phase 1 data support the potential for Sabirnetug to offer next-generation efficacy and safety[73] - Phase 2 ALTITUDE-AD study enrollment completed in March 2025, with topline results expected in late 2026[19, 101] - Topline results announced in March 2025 show systemic exposure supports further clinical development of the subcutaneous formulation[85, 101] Sabirnetug's Selectivity and Target Engagement - Sabirnetug demonstrates high selectivity for AβOs versus monomeric Aβ, with 8750x higher binding affinity for Aβ oligomers compared to Aβ1-40 monomer[20, 25] - Nearly all Sabirnetug-treated patients in high-dose MAD cohorts showed reductions in plaque load after three doses at 63 or 70 days[49] - Mean reduction in amyloid plaque was 137 centiloids (206%) in the 25 mg/kg Q2W MAD cohort and 181 centiloids (256%) in the 60 mg/kg Q4W MAD cohort[50] Safety Profile - The Phase 1 trial showed a compelling overall safety profile, with a low incidence of ARIA-E, approximately 10% of total ARIA-E cases[72]

Summary of Acumen Pharmaceuticals (ABOS) Conference Call Company Overview - **Company**: Acumen Pharmaceuticals - **Focus**: Development of new treatment options for Alzheimer's disease, specifically targeting amyloid beta oligomers with their main program, sabrutinib [2][3] Key Points and Arguments - **Mechanism of Action**: - Sabrutinib is a monoclonal antibody selectively targeting amyloid beta oligomers, which are considered the most toxic species in Alzheimer's pathology [2] - The approach aims to neutralize the toxic effects of oligomers, which disrupt neuronal function and lead to Alzheimer's symptoms [2][3] - **Phase I Study (INTERCEPT AD)**: - Conducted exclusively in early Alzheimer's patients to assess safety, pharmacokinetics, and tolerability [4] - Results showed a favorable safety profile with a lower incidence of ARIA (Amyloid Related Imaging Abnormalities) compared to plaque-directed antibodies [5][12] - Demonstrated robust target engagement with a novel assay showing a dose-response relationship [5][6] - Imaging results indicated a 20-25% reduction in amyloid PET signal at high doses, comparable to other agents like Leukembi [6] - Biomarker assessments showed significant signals in CSF and plasma, indicating engagement with the target [7][8] - **Cognitive Impact**: - The study was not powered to detect cognitive benefits, and no significant clinical effects were observed [10][11] - Future studies, particularly the Phase II ALPITUDE AD study, are expected to provide more insights into cognitive outcomes over an 18-month period [11][14] - **Safety Profile**: - The incidence of ARIA was low, with only five cases reported, and none in the high-risk APOE4 homozygous population [12][13] - The mechanism of action is believed to contribute to a better safety profile by targeting soluble aggregates rather than plaque-bound amyloid [12][13] - **Future Studies**: - The ALPITUDE AD study aims to enroll 540 patients across multiple sites and is designed to assess the long-term effects of treatment [18][19] - The study's rapid enrollment reflects increased awareness and willingness to participate in Alzheimer's research [19] Competitive Landscape - The Alzheimer's treatment market is evolving, with several approved agents facing limitations, indicating room for improvement [22][24] - There is interest in enhancing drug delivery to the brain, potentially through combination therapies with other mechanisms of action [24][25][28] Additional Insights - Acumen is exploring subcutaneous formulations of sabrutinib alongside intravenous options, which could provide flexibility for patients and physicians [26][27] - Combination strategies with other therapeutic modalities are being considered to enhance treatment efficacy [28] This summary encapsulates the key discussions and findings from the conference call, highlighting Acumen Pharmaceuticals' strategic focus on Alzheimer's treatment and the promising results from their ongoing studies.

Financial Performance - The company reported a net loss of $28.8 million for the three months ended March 31, 2025, compared to a net loss of $14.9 million for the same period in 2024, representing a 94% increase in losses [126]. - The company has an accumulated deficit of $353.9 million as of March 31, 2025, reflecting ongoing financial challenges [116]. - Net cash used in operating activities increased by $16.2 million to $34.1 million for the three months ended March 31, 2025, compared to $17.9 million for the same period in 2024 [138]. - Interest income decreased by 38% to $2.5 million for the three months ended March 31, 2025, compared to $4.0 million in 2024 [126]. - Net cash provided by financing activities was immaterial and decreased by $7.1 million from $7.1 million in the same period of 2024, primarily due to the issuance of common stock [141]. Research and Development - Research and development expenses increased to $25.3 million for the three months ended March 31, 2025, up from $12.4 million in 2024, marking a 103% increase primarily due to costs associated with the ALTITUDE-AD clinical trial [127]. - The ALTITUDE-AD clinical trial for sabirnetug is designed to evaluate clinical efficacy with up to 540 participants, and top-line results are expected in late 2026 [110]. - The company expects expenses to increase significantly as it continues research and development and seeks marketing approval for product candidates [142]. - The company plans to seek third-party collaborators for the future commercialization of sabirnetug or any other approved product candidates [116]. Cash and Funding - The company has cash and cash equivalents of $197.9 million as of March 31, 2025, which is expected to fund operations into early 2027 [118]. - The company had cash and cash equivalents and marketable securities totaling $197.9 million as of March 31, 2025, expected to fund operations into early 2027 [135]. - The company entered into a loan agreement providing a term loan facility of up to $50 million, of which $30 million has been drawn down [114]. - The company anticipates that existing cash and marketable securities may be exhausted sooner than expected if additional clinical trials or programs are initiated [143]. - The company expects to incur additional costs associated with operating as a public company and ongoing research and development activities, indicating a need for substantial additional funding [142]. - The company may need to raise additional funds sooner than anticipated if it chooses to expand more rapidly than currently planned [143]. Operational Expenses - General and administrative expenses slightly decreased to $5.1 million for the three months ended March 31, 2025, from $5.3 million in 2024 [128]. - Cash provided by investing activities was $28.7 million for the three months ended March 31, 2025, an increase of $37.9 million from cash used in investing activities of $9.2 million in the same period of 2024 [139]. - The company issued 2,068,246 shares of common stock under the ATM in January 2024 for net proceeds of $7.9 million, or $3.84 per share [134]. Company Classification - The company is classified as a smaller reporting company, with the market value of shares held by non-affiliates being less than $700 million [152].

First Quarter 2025 Investor Presentation Quarterly Highlights Forward Looking Statement In this presentation, we have included statements that may constitute "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "estimate," "project," "plan," "believe," "anticipate," "intend," "planned," "potential" and similar expressions, or future or conditional verbs such as "will," "should," "would," "could," and "may," or th ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had $197.9 million in cash and marketable securities, which is expected to support current clinical and operational activities into early 2027 [12] - Research and Development (R&D) expenses were $25.3 million in the first quarter, an increase attributed to spending for the ALTITUDE AD trial [12] - General and Administrative (G&A) expenses were $5.1 million, roughly flat compared to the same period last year, leading to a loss from operations of $30.4 million and a net loss of $28.8 million for the quarter [13] Business Line Data and Key Metrics Changes - The company completed enrollment of its 542-participant Phase II study, ALTITUDE AD, designed to evaluate the clinical efficacy and safety of sabernatog in patients with early Alzheimer's disease [6][11] - The rapid enrollment was attributed to interest in sabernatog's therapeutic potential, innovative participant screening methods, and strong execution by the team [6][9] Market Data and Key Metrics Changes - The company presented at two major Alzheimer's medical conferences, highlighting the innovative use of plasma phospho tau217 screening in the ALTITUDE AD study [8] - The study aims to reduce the number of negative PET scans, improving enrollment efficiency and reducing costs [9] Company Strategy and Development Direction - The company aims to establish sabernatog as a next-generation treatment option for early Alzheimer's disease [6] - Future steps include ongoing formulation drug delivery assessments for subcutaneous administration of sabernatog, with plans to integrate this into ongoing or standalone studies [11][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sabernatog as an innovative treatment for Alzheimer's disease and is excited to share Phase II results expected in late 2026 [11] - The management noted that the enrollment rate for the ALTITUDE study was much higher than projected, indicating strong interest despite the presence of FDA-approved drugs in the market [36] Other Important Information - The company is focused on the use of biomarkers in clinical studies, emphasizing the importance of synaptic biomarkers in understanding Alzheimer's disease progression [29][30] - Management acknowledged the advancements in blood-based plasma biomarkers and their potential role in assessing drug effects and disease progression [39][41] Q&A Session Summary Question: Inquiry about the incorporation of subcutaneous administration into future development plans - Management indicated that options include incorporating subcutaneous administration into an ongoing Phase III study or conducting a standalone study [19] Question: Clarification on powering assumptions for ALTITUDE and interim analysis - Management confirmed there is no interim analysis in the study, and the powering is appropriate for a Phase II study with 542 participants [21][22] Question: Discussion on the impact of recent advancements in Alzheimer's biomarkers - Management noted that recent advances in biomarkers provide valuable insights and that their Phase II study will focus on clinical measures while also considering biomarker data [27][30] Question: Concerns about competition from newly approved drugs - Management reported that the enrollment rate for the ALTITUDE study was higher than expected and that discontinuation rates are currently low, indicating no significant impact from competing drugs [36][37] Question: Inquiry about the potential of pTau217 as a treatment biomarker - Management suggested that multiple biomarkers will likely be used to assess disease progression and treatment efficacy, rather than relying on a single marker [39][40]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company had $197.9 million in cash and marketable securities, expected to support operations into early 2027 [10] - Research and Development (R&D) expenses were $25.3 million in Q1 2025, an increase attributed to the ALPITUDE AD trial [10] - General and Administrative (G&A) expenses were $5.1 million, roughly flat compared to the same period last year, leading to a loss from operations of $30.4 million and a net loss of $28.8 million for the quarter [11] Business Line Data and Key Metrics Changes - The company completed enrollment of its 542-participant Phase II study, ALTITUDE AD, designed to evaluate the efficacy and safety of sabernatog in patients with early Alzheimer's disease [5][6] - The rapid enrollment was attributed to interest in sabernatog's therapeutic potential and innovative participant screening methods [6] Market Data and Key Metrics Changes - The company presented at two major Alzheimer's medical conferences, highlighting the use of plasma phospho tau217 as a sensitive indicator of amyloid pathology [6][8] - The study showed that screening for pTau217 improved enrollment efficiency and reduced screening costs [7] Company Strategy and Development Direction - The company aims to establish sabernatog as a next-generation treatment option for early Alzheimer's disease [5] - Future steps include ongoing formulation drug delivery assessments for subcutaneous administration of sabernatog [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sabernatog's potential as an innovative treatment for Alzheimer's disease and is excited to share Phase II results in late 2026 [9][11] - The management noted that the enrollment rate for the ALTITUDE study was higher than projected, and the discontinuation rate looks favorable [32] Other Important Information - The company completed a Phase I study comparing subcutaneous and intravenous administration of sabernatog, which was well tolerated [8] - Management emphasized the importance of biomarkers in understanding Alzheimer's disease progression and treatment efficacy [25][26] Q&A Session Summary Question: Incorporation of SubQ administration into future plans - Management discussed options for integrating subcutaneous administration into ongoing studies or conducting a standalone study [15][16] Question: Powering assumptions for ALPITUDE and interim analysis - Management confirmed no interim analysis is planned and that the powering is appropriate for a Phase II study with 542 participants [18][19] Question: Impact of recent advances in Alzheimer's biomarkers - Management acknowledged the rapid advancements in blood-based plasma biomarkers and their relevance to the development plan for sabernatog [21][22] Question: Risks posed by commercial antibodies to the trial - Management indicated that the presence of FDA-approved drugs has not negatively impacted the ALTITUDE study, with good enrollment and discontinuation rates [31][32] Question: Usefulness of pTau217 as a treatment biomarker - Management suggested that multiple biomarkers will likely be used to assess disease progression and treatment efficacy, rather than a single marker [35][36]