NEWTON, Mass., Nov. 18, 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 that it will present new findings at the upcoming 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place in San Diego. The presentations include Acumen’s recruitment strategies for its Phase 2 ALTITUDE-A ...

NEWTON, Mass., Nov. 17, 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 that the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in people with early Alzheimer's disease. The open-label extension provid ...

Financial Performance - The company reported a net loss of $96.2 million for the nine months ended September 30, 2025, compared to a net loss of $65.2 million for the same period in 2024, with approximately 88% of the loss attributed to research and development spending [120]. - Net loss increased by $31.0 million, or 48%, to $96.2 million for the nine months ended September 30, 2025 [133]. - Other income decreased by $6.8 million to $2.4 million for the nine months ended September 30, 2025, primarily due to a $5.2 million decrease in interest income [136]. - Interest income decreased by 53% to $1.64 million for the three months ended September 30, 2025, compared to $3.50 million in 2024 [129]. - Cash provided by financing activities decreased by $7.0 million to $(36) thousand for the nine months ended September 30, 2025 [148]. Research and Development - Research and development expenses decreased by 19% to $21.97 million for the three months ended September 30, 2025, down from $27.25 million in 2024, primarily due to reduced costs associated with the ALTITUDE-AD clinical trial [129][130]. - The company expects to continue increasing research and development expenses as it advances sabirnetug in clinical development and expands its product candidate portfolio [120]. - Research and development expenses increased by $25.1 million, or 42%, to $84.4 million for the nine months ended September 30, 2025, driven mainly by costs associated with the ALTITUDE-AD clinical trial [134]. - The company completed enrollment in the Phase 2 ALTITUDE-AD clinical trial in March 2025, with a total of 542 participants expected to be evaluated for the efficacy of the drug candidate sabirnetug [114]. Cash and Funding - The company has cash and cash equivalents of $136.1 million as of September 30, 2025, which is expected to fund operations into early 2027 [122]. - Cash and cash equivalents and marketable securities totaled $136.1 million as of September 30, 2025, expected to fund operations into early 2027 [142]. - The company has borrowed $30 million under a loan agreement with K2 HealthVentures, with an additional $20 million available upon request [118]. - The company anticipates needing substantial additional funding for future operations and may seek third-party collaborators for commercialization [149]. Operating Expenses - The company incurred total operating expenses of $26.51 million for the three months ended September 30, 2025, an 18% decrease from $32.27 million in the same period of 2024 [129]. - Total operating expenses rose by $24.2 million, or 33%, to $98.6 million for the nine months ended September 30, 2025 [133]. - Net cash used in operating activities increased by $37.4 million to $96.4 million for the nine months ended September 30, 2025 [145]. Company Status and Compliance - The company has not generated any revenue from product sales and relies on funding through equity offerings and debt financings [117]. - The company has not generated revenue from product sales and does not expect to do so for several years [137]. - The company may cease to qualify as an emerging growth company by December 31, 2026, or if total annual gross revenues exceed $1.235 billion [158]. - The market value of the company's shares held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [159]. - The company’s annual revenue was less than $100 million during the most recently completed fiscal year [159]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company [159]. - The company has taken advantage of reduced reporting requirements in its Quarterly Report on Form 10-Q [158]. Intellectual Property and Competition - The company needs to maintain, expand, and defend its intellectual property portfolio, which may involve payments related to licensing and enforcement [157]. - The company faces competition from other drugs and product candidates in the market [157]. - The company may enter into collaborations, licensing, or other arrangements for product commercialization [157]. - The company may need to retain management and hire scientific and clinical personnel to support its operations [157]. Collaborations - A collaboration agreement with JCR Pharmaceuticals was established in July 2025, which includes potential milestone payments of up to $555 million and royalties on sales of products developed from the partnership [116].

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had $136.1 million in cash and marketable securities, expected to support clinical and operational activities into early 2027 [10] - R&D expenses for Q3 2025 were $22 million, a decrease from the prior year primarily due to reduced CRO costs associated with the ALTITUDE-AD clinical trial [10] - G&A expenses were $4.5 million in Q3 2025, down due to reductions in legal fees, audit, and recruiting expenses [10] - The company reported a loss from operations and a net loss of $26.5 million for the quarter [11] Business Line Data and Key Metrics Changes - The ALTITUDE-AD trial is progressing with 542 participants enrolled, and some are beginning to complete the placebo-controlled phase [4][5] - The open-label extension of the trial allows participants to receive sabirnetug at 35 mg per kg every four weeks for up to 52 weeks, aimed at gathering long-term safety and efficacy data [5] Market Data and Key Metrics Changes - The company is exploring a strategic collaboration with JCR Pharmaceuticals to develop an Alzheimer's disease product that combines A-beta oligomer selective antibody expertise with blood-brain barrier technology [6][8] Company Strategy and Development Direction - The company is focused on advancing the ALTITUDE-AD trial and the Enhanced Brain Delivery (EBD) program, targeting synaptotoxic A-beta oligomers for Alzheimer's treatment [4][11] - The addition of Dr. George Golembeski to the board is expected to enhance strategic initiatives and business development efforts [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the ALTITUDE-AD trial and anticipates sharing top-line results in late 2026 [11] - The EBD program is seen as a potential next-generation product opportunity in Alzheimer's treatment [5][11] Other Important Information - The company plans to present data at upcoming medical conferences related to the EBD program [7] - A non-clinical data package, including a non-human primate study, is expected in early 2026 to inform decisions on advancing development candidates [8] Q&A Session Summary Question: What are the criteria for the early transferrin data for a go/no-go decision? - Management indicated that they are looking for a meaningful increase in overall exposure of sabirnetug in the brain, which could enhance efficacy and safety [15][16] Question: How does the Evoke trials impact the company's approach? - Management is monitoring the GLP-1 studies closely and believes that improved metabolic profiles could positively affect Alzheimer's patients [18] Question: Will both candidates in the shuttle program be advanced simultaneously? - It is too early to determine if one or both candidates will advance, as it will be data-dependent in early 2026 [36] Question: What biomarkers will be included in the non-clinical data package? - The data package will include preclinical studies on pharmacokinetics and biomarker profiles, including A-beta levels and synaptic markers [32][33] Question: What is the minimum expectation from the ALTITUDE-AD study? - The primary outcome will be assessed using the iADRS scale, and management is looking for a clear and demonstrable effect on clinical scales [40][42]

Exhibit 99.1 Acumen Pharmaceuticals Reports Third Quarter 2025 Financial Results and Business Highlights NEWTON, Mass., Nov. 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 third quarter of 2025 and provided a business update. "We continued our strong operati ...

Core Insights - Acumen Pharmaceuticals reported strong operational progress in Q3 2025, focusing on its Phase 2 trial of sabirnetug and the Enhanced Brain Delivery program [2][5] - The company aims to translate advanced science into innovative medicines for Alzheimer's disease while maximizing shareholder value [2] - Anticipated non-clinical data in early 2026 and topline results from the ALTITUDE-AD Phase 2 study in late 2026 are expected to provide insights into the role of amyloid beta oligomers in Alzheimer's disease [2][5] Recent Highlights - The first patient is expected to be dosed in the open-label extension of the ALTITUDE-AD trial in November 2025 [6] - George Golumbeski, Ph.D., was appointed as Chairman of the Board, bringing over 30 years of biotechnology experience [6] - Acumen has exclusive rights to develop up to two candidates in partnership with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [6] Financial Results - As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $136.1 million, down from $166.2 million as of June 30, 2025, expected to support operations into early 2027 [5][14] - Research and Development (R&D) expenses decreased to $22.0 million in Q3 2025 from $27.2 million in Q3 2024, primarily due to reduced costs associated with the ALTITUDE-AD trial [6][14] - General and Administrative (G&A) expenses were $4.5 million for Q3 2025, down from $5.0 million in Q3 2024, attributed to lower legal and recruiting expenses [6][7] Loss and Equity - Loss from operations was $26.5 million for Q3 2025, compared to $32.3 million for Q3 2024, reflecting decreased R&D expenses [14] - Net loss for Q3 2025 was $26.5 million, down from $29.8 million in Q3 2024 [14] - Total stockholders' equity as of September 30, 2025, was $93.2 million, a decrease from $181.8 million as of December 31, 2024 [18]

Acumen Pharmaceuticals Conference Call Summary Company Overview - **Company**: Acumen Pharmaceuticals (NasdaqGS:ABOS) - **Focus**: Development of new treatment options for Alzheimer's disease, specifically targeting synaptotoxic A oligomers with their lead program, sabirnetug [2][3] Key Points Product Development - **Lead Product**: Sabirnetug, a monoclonal antibody targeting A oligomers, currently in a robust phase two study expected to read out late next year [2][3] - **Formulations**: Both intravenous (IV) and subcutaneous (sub-Q) formulations are being developed, with the subcutaneous formulation having completed a phase one study [2] - **Collaboration**: Partnership with JCR Pharmaceuticals to combine transferrin-directed carrier technology with Acumen's antibody cargoes [2][29] Scientific Basis - **Oligomer Hypothesis**: Acumen's research is based on the hypothesis that soluble aggregates of the A peptide, particularly A oligomers, are a distinct target for slowing Alzheimer's progression [3][5] - **Toxicity Evidence**: Historical research indicates that A oligomers disrupt synaptic function and contribute to neurodegenerative processes [5][6] Clinical Data - **Phase One Study (Intercept AD)**: Conducted with 48 Alzheimer's patients, showing a safety profile with only five cases of ARIA (Amyloid-related imaging abnormalities) [9][10] - **Biomarker Effects**: - 20%-25% reduction in amyloid PET signal observed [11] - Normalization of A 40 to 42 ratio in cerebrospinal fluid (CSF) [11] - Positive trends in synaptic markers (neurogranin and VAMP2) [12] Phase Two Strategy - **Dosing Strategy**: Two doses are being tested in phase two, with one targeting oligomers and the other focusing on plaque interactions [13][14] - **Efficacy Expectations**: Aiming for a clinically significant efficacy difference of 25%-30% in early Alzheimer's patients over 18 months [34] Competitive Landscape - **Market Positioning**: Acumen aims to establish sabirnetug as a treatment of choice in the evolving Alzheimer's treatment landscape, emphasizing its unique targeting of toxic oligomers [20][21] - **Future Developments**: Anticipation of multiple subcutaneous therapies entering the market, with Acumen's products expected to play a significant role [20] Collaboration and Innovation - **JCR Partnership**: Focused on enhancing brain delivery through transferrin-mediated transport, which is seen as a critical advancement in the field [29][32] - **Future Constructs**: Plans to explore multiple carrier configurations for improved delivery of therapeutic agents [33] Financial and Operational Considerations - **Phase Three Plans**: Acumen envisions partnering for phase three trials to expedite development, given the scale and complexity of such studies [38][39] - **CMC Investments**: Ongoing collaboration with Lonza for drug substance and product development, ensuring efficient resource allocation [39] Conclusion - **Outlook**: Acumen expresses optimism about the future of Alzheimer's treatments, with ongoing studies expected to provide critical data to support their unique therapeutic approach [40]

Results Presentation 3Q2 5 The ecosystem of solutions created to simplify Brazil's healthcare market Opening Remarks CEO: Leonardo Byrro Priorities Established for 2025 Working Capital Quality x Quantity Operational Excellence Operational Excellence: Expected Improvements 4 ▪ Adjustment of operations with a focus on efficiency and cash generation, reducing the pace of growth. ▪ Discontinuation of businesses with below-expected returns (ROIC) and margin expansion across all business lines. ▪ Reduction of exp ...

Core Insights - Acumen Pharmaceuticals has appointed Dr. George Golumbeski as Chairman of its Board of Directors, bringing over 30 years of biopharmaceutical experience to the company [1][2] - The company is focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment, with ongoing Phase 2 trials for its product candidate, sabirnetug (ACU193) [3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing treatments for Alzheimer's disease, specifically targeting AβOs, which are implicated in the disease's pathology [3] - The company is advancing its investigational product candidate, sabirnetug, in the ALTITUDE-AD Phase 2 clinical trial, following positive results from its Phase 1 trial [3] - Acumen is also exploring a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE® drug delivery technology and collaborating with JCR Pharmaceuticals on an Enhanced Brain Delivery therapy [3] Leadership and Strategic Direction - Dr. Golumbeski's experience includes significant roles in business development at Celgene, Novartis, and Elan Pharmaceuticals, with a focus on neurology and neurodegeneration [2] - The addition of Dr. Golumbeski expands Acumen's Board to eight members, aligning with the company's growth objectives and upcoming catalysts in its clinical programs [1][2]

Core Insights - Acumen Pharmaceuticals is set to report its third quarter 2025 financial results on November 12, 2025, and will host a conference call for updates [1] - The company is focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease [3] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Newton, Massachusetts [3] - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, in a Phase 2 clinical trial for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are believed to be early triggers of Alzheimer's disease pathology [3] - The company is also exploring a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE drug delivery technology and collaborating with JCR Pharmaceuticals for Enhanced Brain Delivery therapy [3]