Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Core Insights - The company has achieved progress with two approved traditional disease-modifying treatment options available for patients [1] - The development of Sabirnetug as an A-beta oligomer-directed antibody is seen as a distinct approach to address disease pathology, potentially offering better efficacy and safety [1] - Sabirnetug has been intentionally developed to neutralize toxic species, indicating a unique position in the treatment landscape [1] - The company envisions that the field will continue to evolve, with oligomer-directed treatment approaches like Sabirnetug being the best option for patients [1]

Acumen Pharmaceuticals (ABOS) Conference Summary Company Overview - **Company**: Acumen Pharmaceuticals (ABOS) - **Industry**: Alzheimer's Disease Treatment Key Points and Arguments Alzheimer's Treatment Landscape - The launch of Leukembi and Kisanla marks a significant milestone with two approved disease-modifying treatment options available for Alzheimer's patients [3][3] - Acumen is developing Sabranatug, an A-beta oligomer directed antibody, which aims to provide a distinct treatment option focusing on efficacy and safety [3][3] Scientific Basis and Research - There is a growing body of evidence supporting the hypothesis that A-beta oligomers are toxic species contributing to Alzheimer's pathology [4][4] - Acumen believes that the A-beta oligomer hypothesis has yet to be fully clinically validated, but they are well-positioned to provide conclusive evidence through their ongoing studies [5][5] Treatment Mechanisms - The complexity of Alzheimer's disease suggests that no single therapy will be effective for all patients; thus, a differentiated mechanism targeting toxic soluble oligomers is essential [8][8] - The company is optimistic about the combinability of Sabranatug with other treatments, anticipating that future treatment will likely involve multiple agents targeting various disease mechanisms [12][12] Biomarkers and Diagnosis - Fluid biomarkers are enhancing the ability to diagnose Alzheimer's disease, allowing for better patient staging and treatment targeting [19][19] - The phospho-tau 217 plasma biomarker has significantly improved the speed and efficiency of patient enrollment in clinical studies [15][15] AI and Machine Learning - There is interest in utilizing AI and machine learning to analyze diverse datasets, including EEG, biomarkers, and clinical assessments, to improve treatment outcomes [23][23] - The quality and scale of datasets remain a challenge, with a shift towards proprietary data management among companies in the field [42][42] Subcutaneous Formulation Development - Acumen is developing a subcutaneous formulation of Sabranatug, which could offer greater flexibility and ease of use for patients [55][55] - The collaboration with JCR Pharmaceuticals aims to enhance brain delivery of the drug, potentially allowing for lower dosing requirements while maintaining efficacy [57][57] Future Directions - The company is optimistic about the potential for Sabranatug to demonstrate a favorable risk-benefit profile in upcoming studies, particularly the ALTITUDE AD study [45][45] - There is ongoing exploration of other therapeutic targets, including tau and inflammatory pathways, which may complement existing A-beta and tau strategies [67][67][70][70] Market Dynamics - The Alzheimer's treatment landscape is characterized by high unmet needs and ongoing challenges, with Acumen positioning itself to address these through innovative approaches [65][65] - The potential for GLP-1 therapies to complement existing strategies is being closely monitored, with upcoming readouts expected to influence market sentiment [67][67] Additional Important Insights - The cost differential between blood tests and PET scans is significant, with blood tests being ten times cheaper, indicating a shift towards more efficient diagnostic methods [31][31] - The complexity of tau biology presents challenges, but ongoing studies may provide insights into effective tau-targeted interventions [37][37] This summary encapsulates the key discussions and insights from the Acumen Pharmaceuticals conference, highlighting the company's strategic focus on innovative Alzheimer's treatments and the evolving landscape of the industry.

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 ...

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had $166.2 million in cash and marketable securities, expected to support operations into early 2027 [19] - R&D expenses for Q2 2025 were $37.1 million, an increase attributed to manufacturing materials for the ALPITUDE AD clinical trial and increased clinical expenses due to full enrollment [19] - G&A expenses were $4.6 million, roughly flat compared to the same period last year, leading to a loss from operations of $41.7 million and a net loss of $41 million for the quarter [19] Business Line Data and Key Metrics Changes - The ALPITUDE AD study is progressing well, with positive feedback from site investigators regarding study design and patient retention [7] - The company expects top-line results from the ALPITUDE AD study in late 2026, focusing on efficacy and safety measures [7][21] Market Data and Key Metrics Changes - The company noted an increase in clinical infrastructure for diagnosing and treating Alzheimer's disease, with positive feedback from key opinion leaders (KOLs) [8][9] - The approval of the first blood-based biomarker by the FDA is expected to revolutionize early diagnosis and expand demand for anti-amyloid treatments [10] Company Strategy and Development Direction - The company announced a strategic collaboration with JCR Pharmaceuticals to develop an Alzheimer's disease product that combines its antibody expertise with JCR's blood-brain barrier technology [11][12] - The partnership aims to enhance the delivery of oligomer-targeted therapeutics to the brain, with development decisions for up to two product candidates expected in early 2026 [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing clinical infrastructure and blood-based diagnostic options, which could benefit patients and expand treatment demand [11] - The company remains dedicated to delivering next-generation treatment options for Alzheimer's disease, with a focus on the potential of its products to provide differentiated benefits [21] Other Important Information - The collaboration with JCR Pharmaceuticals is seen as a capital-efficient way to expand the portfolio of oligomer-targeted candidates, with potential milestone payments and royalties outlined [20] - The company is excited about the optionality and potential value provided by the collaboration, awaiting preclinical candidate data in early 2026 [20] Q&A Session Summary Question: Discussion on AIC and Roche's brain shuttling technology - Management acknowledged the opportunity to enhance therapeutic delivery to the brain and emphasized the importance of targeting toxic synaptotoxic oligomers [25][26] Question: Feedback on PTL-217 testing and its utility - Management reported positive feedback from clinicians regarding the utility of the blood test used in the ALPITUDE study, which reduced costs and patient burden [33][34] Question: Differentiation of TCR technology and safety - Management highlighted the potential for better safety profiles and lower delivered doses with the JCR collaboration, aiming to reduce risks associated with amyloid-targeting therapies [39][43] Question: Integration of blood-based markers and payer coverage - Management indicated that payers are currently reimbursing for the FDA-approved blood test and expressed optimism about future coverage as clinical studies demonstrate efficacy [56] Question: Updates on biomarkers and ARIA rates - Management confirmed ongoing blinded phase two study results are consistent with previous findings, and they are monitoring various biomarkers for disease progression [62][63]

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 ...

Core Viewpoint - Acumen Pharmaceuticals is advancing its clinical-stage biopharmaceutical efforts focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment, with significant operational progress and financial updates reported for Q2 2025 [1][2]. Recent Highlights - The company expects to report topline results for the ALTITUDE-AD Phase 2 study investigating sabirnetug (ACU193) for early Alzheimer's disease in late 2026 [4]. - A decision to advance an oligomer-targeted Enhanced Brain Delivery (EBDTM) product candidate is anticipated in early 2026 [4]. - As of June 30, 2025, Acumen had cash, cash equivalents, and marketable securities totaling $166.2 million, projected to support operations into early 2027 [4]. Financial Results - Research and Development (R&D) expenses for Q2 2025 were $37.1 million, up from $19.5 million in Q2 2024, primarily due to increased manufacturing and clinical trial costs [10]. - General and Administrative (G&A) expenses decreased slightly to $4.6 million in Q2 2025 from $4.8 million in Q2 2024 [10]. - The net loss for Q2 2025 was $41.0 million, compared to a net loss of $20.5 million in Q2 2024 [10]. Operational Innovations - Acumen implemented a two-step screening process in the ALTITUDE-AD trial using plasma pTau217 biomarker assay testing, achieving approximately 40% reduction in total screening costs across U.S. and Canadian sites [5]. - Sabirnetug demonstrated an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, supporting its mechanism of action [5]. Collaboration and Development - Acumen entered a collaboration with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery therapy, combining sabirnetug with JCR's blood-brain barrier-penetrating technology [5].

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 advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, currently in Phase 2 clinical trial ALTITUDE-AD for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are recognized as early triggers of Alzheimer's disease pathology [3] Recent Developments - Acumen Pharmaceuticals will report its second quarter 2025 financial results on August 12, 2025, and will host a conference call and live audio webcast at 8:00 a.m. ET for a business and financial update [1] - The company is also investigating a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE® drug delivery technology [3] - Acumen is collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery therapy for Alzheimer's disease utilizing a transferrin-receptor-targeting technology [3]

Core Insights - Acumen Pharmaceuticals has reported a 40% reduction in clinical trial screening costs through the implementation of a blood-based pTau217 screening assay in its Phase 2 ALTITUDE-AD study for early Alzheimer's disease [1][3][4] - The company’s investigational product, sabirnetug, has demonstrated superior selectivity for soluble amyloid beta oligomers (AβOs) compared to other treatments, indicating a differentiated mechanism of action [5][6] Company Overview - Acumen Pharmaceuticals is focused on developing therapies targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease, with its lead candidate being sabirnetug (ACU193) [10] - The company has received Fast Track designation from the U.S. FDA for sabirnetug, which is currently in a Phase 2 clinical trial [7][10] Clinical Trial Details - The ALTITUDE-AD trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sabirnetug in slowing cognitive decline in early Alzheimer's disease patients [9] - The trial has enrolled 542 participants across the U.S., Canada, the EU, and the UK, with a focus on improving patient-centric and cost-effective trial execution strategies [9][2] Screening Process Efficiency - The two-step screening process using plasma pTau217 biomarker testing resulted in 48% of participants meeting the threshold for confirmatory testing, with 81% of those passing the initial screening meeting amyloid positivity eligibility [4][3] - This innovative approach has led to strong enrollment rates and reduced the need for unnecessary amyloid PET scans and lumbar punctures [4][3] Mechanism of Action - Sabirnetug targets soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease, potentially slowing neurodegeneration and preventing synapse loss [5][7] - The product has shown an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, highlighting its targeted action [6]