ABOS

Interested in Acumen Pharmaceuticals, Inc.? Here are five stocks we like better. Acumen remains on track to report late-2026 Phase II results from the ALTITUDE-AD study of sabirnetug in early Alzheimer’s disease, with efficacy, safety, ARIA and biomarker data expected. The company is preparing manufacturing and clinical plans for a potential Phase III program, while advancing brain-delivery candidates ACU301 and ACU401. Acumen expects to select a lead candidate and file an IND application in mid-2027. Acumen ended the second quarter with $110.2 million in cash and marketable securities, which it expects to fund operations into early 2027; quarterly net loss was $32.7 million. MarketBeat Week in Review – 7/17 - 7/21 Acumen Pharmaceuticals (NASDAQ:ABOS) said it remains on track to report top-line results late in 2026 from its Phase II ALTITUDE-AD study of sabirnetug, an investigational antibody designed to selectively target synaptotoxic amyloid-beta oligomers in early Alzheimer’s disease. Chief Executive Officer Dan O’Connell said the readout will be a key test of the company’s scientific premise that targeting amyloid-beta oligomers could provide a differentiated approach to Alzheimer’s treatment. He said the randomized study is designed to assess clinically meaningful outcomes after 18 months of treatment and is evaluating sabirnetug at 35 milligrams per kilogram and 50 milligrams per kilogram against placebo. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Acumen Soars on Alzheimer's Study...Street Sees It Doubling O’Connell said Acumen expects the top-line dataset to include clinical efficacy measures, safety findings including adverse events and amyloid-related imaging abnormalities, or ARIA, as well as fluid and imaging biomarker results. During prepared remarks, he described ADAS-Cog as the study’s primary clinical efficacy endpoint. Later in the question-and-answer session, he referred to iADRS, a composite of cognitive and functional measures, as the primary outcome, alongside the Clinical Dementia Rating-Sum of Boxes, or CDR-SB. O’Connell said prior Phase I findings showed amyloid-beta oligomer target engagement and biomarker changes as early as three months of treatment. He said Acumen believes the Phase II study, which he characterized as well powered, could expand on those earlier findings. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company also presented patient-experience data at the Alzheimer’s Association International Conference in London last month. O’Connell said the data, collected from ALTITUDE-AD participants and their study partners before treatment, illustrated the differing ways people with early Alzheimer’s experience and respond to cognitive and functional changes. When asked about another company’s blinded interim assessment involving an oligomer-specific approach, O’Connell said Acumen did not believe much could be concluded from the early-stage disclosure. He pointed instead to Acumen’s own Phase I results and said the company saw effects on fluid and imaging biomarkers after three doses. → First Solar’s Profit Engine Faces a New Policy Test in Washington Acumen is preparing activities intended to reduce the time between a potentially favorable Phase II outcome and a Phase III program. O’Connell said work is ongoing across manufacturing, clinical-site planning and other areas, though he noted that regulatory discussions regarding a Phase III design would follow the data. The company hopes a successful ALTITUDE-AD outcome could support moving sabirnetug into a single pivotal Phase III study. Chief Medical Officer Eric Siemers said sabirnetug may have safety and tolerability distinctions from other anti-amyloid antibodies because it targets oligomers rather than plaque and is an IgG2 antibody. He said IgG2 antibodies have less effector function than IgG1 antibodies, meaning they have less immune-system activation. According to Siemers, that could be relevant to risks such as ARIA, though he said the ALTITUDE-AD results will determine the treatment’s profile. Siemers said Acumen uses p-tau217 as part of its screening process for ALTITUDE-AD and will also evaluate it as an outcome measure after the study is unblinded. The company did not include MTBR-tau243 in the original study design because the biomarker was less established at that time, he said. However, Acumen has stored plasma samples from a large patient population and may evaluate MTBR and other emerging blood-based biomarkers after the study. President and Chief Development Officer James Doherty said the company’s July collaboration with Unlearn.AI will use “digital twins” as an exploratory endpoint. The models use data from previously studied patients to estimate an individual’s likely disease progression based on baseline characteristics. Doherty said the technology could potentially assist with patient selection or serve as a prognostic covariate, but Acumen is initially evaluating how useful the approach may be. Acumen also highlighted two enhanced brain delivery, or EBD, candidates: ACU301 and ACU401. The company exercised an option with JCR Pharmaceuticals to advance the programs, which combine blood-brain barrier-penetrating technology with antibodies targeting amyloid-beta oligomers. ACU301 is a bispecific antibody incorporating sabirnetug, while ACU401 includes ACU234, a next-generation amyloid-beta oligomer-selective antibody. O’Connell said Acumen intends to select one candidate for clinical development after continuing work on both molecules. The company anticipates filing an investigational new drug application for its lead EBD candidate in mid-2027. At AAIC, Acumen presented non-human primate findings showing that all three EBD bispecific antibodies tested achieved greater brain exposure after intravenous administration than unmodified ACU234. O’Connell said ACU401 achieved up to 40-fold greater frontal-cortex exposure in cynomolgus monkeys and increased exposure in deep brain regions. Doherty said the candidate-selection process evaluated factors including transferrin receptor affinity, antibody valency and potential anemia risk. The company is still determining its initial clinical study design and has not made a final decision on whether to begin in healthy volunteers or move directly to patients. Chief Financial Officer and Chief Business Officer Matt Zuga said Acumen ended the second quarter with $110.2 million in cash and marketable securities, which the company expects will fund current clinical and operational activities into early 2027. Research and development expense was $27.8 million, down from the prior-year period primarily due to lower manufacturing, materials and contract research organization costs. General and administrative expense was $4.7 million, roughly unchanged from a year earlier. Loss from operations totaled $32.6 million. Net loss was $32.7 million for the second quarter. Acumen plans to hold a virtual investor relations day on Sept. 16, which Head of Investor Relations Alex Braun said will provide an overview of the company’s investment thesis, sabirnetug and the EBD program ahead of the Phase II data release. Acumen Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of oral small molecule therapies for neurodegenerative diseases. Leveraging a proprietary drug discovery platform that integrates chemoproteomics, high-throughput screening and computational chemistry, the company seeks to identify and optimize compounds that selectively modulate pathological protein aggregation. Its approach is designed to address the underlying biology of conditions such as Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and related proteinopathies. The company's pipeline comprises multiple lead candidates at various stages of preclinical and early clinical development. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Acumen Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Expect to report topline results for ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in late 2026 Two candidates nominated for development in Acumen’s Enhanced Brain Delivery™ (EBD™) program; lead clinical candidate IND filing for the EBD program targeted for mid-2027 Cash, cash equivalents and marketable securities of $110.2 million as of June 30, 2026, expected to support current clinical and operational activities into early 2027 Company to host conference call and webcast today at 8:00 a.m. ET NEWTON, Mass., Aug. 12, 2026 (GLOBE NEWSWIRE) -- 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 2026 and provided a business update. “This quarter we have been laser-focused on the readout preparations for our ALTITUDE-AD Phase 2 study investigating the efficacy, safety and tolerability of sabirnetug for the treatment of early AD, with topline results expected later this year. We are excited about the potential for sabirnetug to emerge as a potential treatment of choice with a differentiated benefit-to-risk profile given its unique product attributes as an anti-AβO, IgG2 monoclonal,” said Daniel O’Connell, Chief Executive Officer of Acumen. “In the second quarter, we also announced the nomination of two Enhanced Brain Delivery™ candidates for the treatment of Alzheimer’s Disease, representing the only program combining a validated blood-brain barrier-penetrating technology with an AβO-selective therapeutic antibody. We continue to advance IND-enabling activities toward a mid-2027 IND submission for a lead candidate, and are excited about the optionality this innovative product approach adds to our pipeline and the potential it holds to deliver a next-generation treatment for AD.” Recent Highlights In June 2026, the Company announced the nomination of two EBD™ development candidates for the treatment of AD. In July 2026, the Company announced EBD program data and early AD insights at the Alzheimer’s Association International Conference (AAIC®) 2026. Anticipated Milestones The Company expects topline results from ALTITUDE-AD in late 2026. ALTITUDE-AD is a Phase 2 study investigating sabirnetug in 542 participants (N=180 per cohort) for the treatment of early Alzheimer’s disease. The Company is targeting the submission of an IND filing with respect to a lead clinical candidate in its EBD program in mid-2027. Second Quarter 2026 Financial Results Cash Balance. As of June 30, 2026, cash, cash equivalents and marketable securities totaled $110.2 million compared to cash, cash equivalents and marketable securities of $128.4 million as of March 31, 2026. Cash is expected to support current clinical and operational activities into early 2027. Research and Development (R&D) Expenses. R&D expenses were $27.8 million for the quarter ended June 30, 2026, compared to $37.1 million for the quarter ended June 30, 2025. The decrease was primarily due to reductions in manufacturing and materials costs, and CRO costs, which are both associated with our ALTITUDE-AD clinical trial. General and Administrative (G&A) Expenses. G&A expenses were $4.7 million for the quarter ended June 30, 2026, compared to $4.6 million for the quarter ended June 30, 2025. Loss from Operations. Loss from operations was $32.6 million for the quarter ended June 30, 2026, compared to $41.8 million for the quarter ended June 30, 2025. This decrease was due to the decreased R&D expenses over the prior year period. Net Loss. Net loss was $32.7 million for the quarter ended June 30, 2026, compared to $41.0 million for the quarter ended June 30, 2025. Conference Call Details Acumen will host a conference call and live audio webcast today, August 12, 2026, at 8:00 a.m. ET. To participate in the live conference call, please register using this link. After registration, you will be informed of the dial-in numbers including PIN. Please register at least one day in advance. The webcast audio will be available via this link. An archived version of the webcast will be available for at least 30 days in the Investors section of the Company's website at www.acumenpharm.com. About Sabirnetug (ACU193) Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD. About ALTITUDE-AD (Phase 2) Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study has enrolled 542 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. Topline results are expected in late 2026. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173. About Acumen Pharmaceuticals, Inc. Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its lead investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. Acumen is also investigating a subcutaneous formulation of sabirnetug using Halozyme’s proprietary ENHANZE® drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery™ (EBD™) therapy for Alzheimer’s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning Acumen’s business, and Acumen’s ability to achieve its strategic and financial goals, including its projected use of cash, cash equivalents and marketable securities and the expected sufficiency of its cash resources into early 2027, the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193), including against other antibodies, the timing of anticipated topline results of ALTITUDE-AD, Acumen’s plans to develop a candidate to treat Alzheimer's Disease utilizing EBD technology, including its expectations with respect to timing for the submission of an IND, the potential of its EBD candidates and the potential for developing a best-in-class therapeutic candidate for people living with Alzheimer’s Disease. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen.  Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise. CONTACTS: Investors:Alex Braun [email protected] Media: ICR [email protected]

This article first appeared on GuruFocus. Cash and Marketable Securities: $110.2 million at end of Q2 2026, expected to fund operations into early 2027. R&D Expenses: $27.8 million in Q2 2026, down from prior year due to lower manufacturing, materials, and CRO costs. G&A Expenses: $4.7 million in Q2 2026, roughly flat year-over-year. Loss from Operations: $32.6 million in Q2 2026. Net Loss: $32.7 million in Q2 2026. Warning! GuruFocus has detected 3 Warning Signs with ABOS. Is ABOS fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Acumen Pharmaceuticals Inc (NASDAQ:ABOS) is on track to report top-line Phase 2 ALTITUDE-AD data for sabirnetug late this year, a key catalyst that could validate its oligomer-targeting approach. The company has nominated two Enhanced Brain Delivery (EBD) candidates, ACU301 and ACU401, with ACU401 showing up to 40-fold greater brain exposure in non-human primates, demonstrating strong preclinical potential. Sabirnetug's unique IgG2 antibody design and selective targeting of A-beta oligomers may offer a differentiated safety profile with reduced ARIA risk compared to existing treatments. The company is actively preparing for a potential Phase 3 trial, with ongoing CMC, site planning, and regulatory discussions to minimize the gap between Phase 2 results and Phase 3 initiation. Acumen is leveraging innovative tools like digital twins from Unlearn AI and exploring new biomarkers (e.g., MTBR-tau243) to enhance trial design and patient selection, showing a forward-thinking approach. Acumen Pharmaceuticals Inc (NASDAQ:ABOS) has limited cash runway, with $110.2 million expected to fund operations only into early 2027, which may be insufficient if Phase 3 costs are needed. The company has not provided detailed powering or statistical analysis plans for the two-dose ALTITUDE-AD study, leaving uncertainty about the criteria for a positive result. The EBD program is still in early stages, with an IND filing not expected until mid-2027, and no final decision on which candidate will advance, adding pipeline risk. The recent competitor's blinded interim data (likely from another oligomer approach) provides limited read-through, and the company acknowledges it cannot draw conclusions, highlighting competitive uncertainty. The company plans to go radio silent before the Phase 2 readout, which may limit investor visibility and increase uncertainty during a critical period. Q: How should we set expectations on safety and tolerability for sabirnetug compared to existing Alzheimer's treatments like Kisunla and Leqembi, especially given real-world experience with those agents?A: Eric Siemers, Chief Medical Officer, highlighted two key differentiators for sabirnetug's safety profile. First, its target is highly selective for amyloid beta oligomers rather than plaque, which may offer safety benefits. Second, sabirnetug is an IgG2 antibody, unlike the IgG1 antibodies used by competitors. IgG2 antibodies have less effector function, meaning they are less likely to call in immune cells that can lead to issues like ARIA. This mechanism doesn't require that immune activation, providing two reasons to expect a favorable safety and tolerability profile. Q: Can you clarify the statistical framework for the ALTITUDE-AD trial? Is each dose independently powered against placebo, and what would constitute a positive study if only one dose succeeds?A: CEO Dan O'Connell stated that the company has not provided specific details on the powering and analysis of the two active doses. He reiterated that both the 35 mg/kg and 50 mg/kg doses have demonstrated target engagement and could emerge as efficacious. The company will provide more information as the data readout approaches later this year. Q: What are the next steps for the EBD franchise? Do you plan to take both candidates into humans, and will you start with healthy volunteers?A: President and Chief Development Officer Jim Doherty explained that while two candidates (ACU301 and ACU401) have been nominated, the company intends to select one lead molecule with the best overall profile for clinical development. They are actively working on CMC and tox studies to support an IND filing in mid-2027. The decision on whether to start in healthy volunteers or patients is still under discussion, but the goal is to transition to patients as quickly as practical to gather valuable information, as was done in the INTERCEPT study. Q: Will the biomarker data be included in the top-line release for ALTITUDE-AD, or will it be released later?A: CEO Dan O'Connell confirmed that the top-line results will be a robust readout, including the primary endpoint (iADRS), key secondary measures like CDR-SB, and both fluid and imaging biomarkers. The company intentionally plans to include this comprehensive data set in the top-line release late this year to fully determine sabirnetug's safety and clinical efficacy. Q: What are the differences between your oligomer-specific approach and the recent blinded data from another company using a similar approach? How much can we read through on their clean safety to your upcoming data?A: CEO Dan O'Connell noted that the other company's announcement was an early-stage blinded interim assessment, from which little can be concluded. He emphasized that Acumen's Phase 1 results from 2023 established robust clinical target engagement of A-beta oligomers, with effects on fluid and imaging biomarkers that exceeded expectations after just three doses. This underpins confidence in the larger, efficacy-based ALTITUDE-AD study. Q: Can you speak to the work being done now to minimize the interval between Phase 2 results and the initiation of a Phase 3? What activities are gated until the data?A: CEO Dan O'Connell stated that many activities are already underway to minimize the "white space" between the readout and a potential Phase 3, including CMC and site planning. However, regulatory interactions to establish the Phase 3 design are gated until the data. The company is hopeful that a successful ALTITUDE readout will facilitate and accelerate the move into a single pivotal Phase 3. Q: Do you plan to look at newer biomarkers like MTBR-tau243 in the ALTITUDE study, and how could it be incorporated into a Phase 3?A: Chief Medical Officer Eric Siemers explained that while p-tau217 is used for screening and as an outcome measure, MTBR is a newer biomarker that wasn't widely discussed when ALTITUDE was designed. However, the study has a large number of stored plasma samples, providing the opportunity to analyze MTBR and other emerging blood-based biomarkers post-hoc after the study is unblinded. Jim Doherty added that these tools could eventually help identify patients at different disease stages or better candidates for treatment. Q: What should we expect from the September 16 Investor Relations Day? Will it include new EBD data or a preview of the ALTITUDE analysis plan?A: Head of Investor Relations Alex Braun clarified that the IR Day will be a comprehensive review of the Acumen investment thesis, designed to get investors up to speed on both the sabirnetug program and the EBD program prior to the Phase 2 data readout. It is intended as an educational event rather than a venue for new data or a detailed preview of the analysis plan. Q: In selecting the EBD candidates, what parameters were optimized, and where might the second molecule (ACU401) be better than the bispecific sabirnetug (ACU301)?A: CEO Dan O'Connell stated the goal is a product profile with convenient subcutaneous administration, preserved or enhanced oligomer selectivity, and efficient blood-brain barrier transport using JCR's technology. Jim Doherty added that the selection process involved optimizing a range of parameters, including affinity for TfR, valency (monovalent vs. divalent), and potential risks like anemia. The chosen candidates represent the culmination of a campaign to find the best fit for delivering oligomer-targeting antibodies into the CNS. Q: Given the recent competitor tau data, is there a way to fast-track a combination proof-of-concept after the ALTITUDE data?A: CEO Dan O'Connell acknowledged the Biogen BIIB080 tau data as potentially the first clinical validation of a tau-directed approach. He expressed the view that Alzheimer's will ultimately be addressed with combination strategies. Acumen will continue to evaluate ways to leverage its portfolio of A-beta oligomer-directed treatments with potentially synergistic combinations, including tau or anti-inflammatory approaches, as the field moves toward more robust treatment options. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is focused on the late 2026 topline readout of the Phase II ALTITUDE-AD trial, which serves as the primary test for their thesis that selectively targeting amyloid-beta oligomers provides a differentiated treatment approach. The company nominated two enhanced brain delivery (EBD) candidates, ACU301 and ACU401, leveraging JCR Pharmaceuticals' blood-brain barrier technology to potentially improve therapeutic exposure and patient convenience. Preclinical data for the EBD program showed up to 40-fold greater frontal cortex exposure in non-human primates compared to unmodified antibodies, exceeding management's internal expectations for brain penetration. Acumen is utilizing a patient-centric approach, incorporating patient experience data and digital twin modeling to better understand cognitive changes and refine future clinical trial designs. The choice of an IgG2 monoclonal antibody for sabirnetug is a strategic decision to minimize immune effector function, which management believes may lead to a superior safety profile regarding ARIA compared to IgG1 competitors. Operational discipline resulted in a cash position of $110.2 million, which management expects will fund activities into early 2027, covering the critical Phase II data inflection point. Topline Phase II ALTITUDE-AD results expected in late 2026 will include primary iADRS efficacy data, secondary CDR-SB measures, and comprehensive fluid and imaging biomarkers. Management plans to file an Investigational New Drug (IND) application for the lead EBD candidate in mid-2027, following ongoing optimization of CMC and toxicology studies. The company intends to minimize the 'white space' between Phase II results and the start of a potential Phase III study by advancing preparatory work in manufacturing and site planning. Future clinical designs for the EBD program are being evaluated for efficiency, with a goal to transition from healthy volunteers to patient populations as quickly as practical. Management anticipates a period of reduced public engagement in the fourth quarter of 2026 as they prepare for the unblinding and analysis of the ALTITUDE-AD dataset. R&D expenses decreased year-over-year to $27.8 million, primarily due to lower manufacturing and CRO costs as the ALTITUDE-AD trial enters its final stages. The collaboration with Unlearn.AI to use 'digital twins' is currently an exploratory effort to evaluate if prognostic models can improve patient selection or serve as covariates in future analyses. Management noted that while other oligomer-specific approaches have reported blinded interim data, those results are too early to provide meaningful read-through for Acumen's program. The EBD program's success is dependent on confirming mouse and non-human primate data in human trials, specifically regarding the risk of anemia associated with transferrin receptor targeting. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that sabirnetug uses an IgG2 framework, which has less 'effector function' than the IgG1 framework used by competitors like Leqembi. This design choice aims to reduce the immune system activation that typically leads to ARIA (brain swelling/bleeding) while still effectively targeting toxic oligomers. Management declined to provide specific details on the powering for each individual dose (35 mg/kg and 50 mg/kg) against placebo. They confirmed both doses showed target engagement in Phase I and expressed confidence that either or both could emerge as efficacious in the Phase II readout. Acumen is using p-tau217 for patient screening and as an outcome measure, but is also monitoring newer markers like MTBR-tau243. Management highlighted the ability to perform post-hoc analysis on stored plasma samples to stay aligned with the rapidly evolving biomarker landscape. The EBD program aims to enable subcutaneous dosing, which would be more convenient for patients than current intravenous infusions. The selection process optimized for the 'right fit' between the antibody cargo and the transferrin carrier to maximize brain penetration while minimizing hematological risks like anemia.

This article first appeared on GuruFocus. Cash and Marketable Securities: $128.4 million as of March 31, 2026. Private Placement: Grossed $35.75 million in support of the EBD program. R&D Expenses: $16.5 million in the first quarter, decreased due to reduced manufacturing and CRO costs. G&A Expenses: $4.7 million in the first quarter, decreased due to reductions in legal, accounting, consulting, and insurance expenses. Loss from Operations: $21.1 million in the first quarter. Net Loss: $20.7 million in the first quarter. Warning! GuruFocus has detected 3 Warning Signs with ABOS. Is ABOS fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Acumen Pharmaceuticals Inc (NASDAQ:ABOS) is advancing its Phase 2 ALTITUDE-ad trial for sabirnetug, targeting synaptotoxic Abeta oligomers, which could offer a differentiated treatment for Alzheimer's. The company has successfully transitioned participants into a 12-month open label extension study with a high conversion rate, indicating strong participant retention. Acumen Pharmaceuticals Inc (NASDAQ:ABOS) has a robust financial position with $128.4 million in cash and marketable securities, supporting operations into early 2027. The Enhanced Brain Delivery (EBD) program is progressing well, with plans to license two compounds developed with JCR Pharma, aiming for an IND filing in mid-2027. The company has reduced R&D and G&A expenses, reflecting efficient cost management and a focus on strategic priorities. Acumen Pharmaceuticals Inc (NASDAQ:ABOS) reported a net loss of $20.7 million in the first quarter, highlighting ongoing financial challenges. The ALTITUDE-ad trial is designed as a low-powered study, which may limit the ability to detect statistically significant differences. There is significant competition in the Alzheimer's treatment space, which could impact the market potential for sabirnetug. The company's EBD program, while promising, is still in preclinical stages, with an IND filing not expected until mid-2027, indicating a long timeline to potential commercialization. The success of the ALTITUDE-ad trial is critical for future development plans, and any setbacks could significantly impact the company's strategic direction. Q: Could you give us your current thoughts on which populations or patient types you would target in Phase 3 studies, assuming that ALTITUDE-ad is positive and you move forward with sabirnetug? A: Daniel O'Connell, CEO: We remain focused on the early Alzheimer's disease (AD) population, similar to those enrolled in ALTITUDE-ad, as the path forward for sabirnetug in a future registration study. Our interest in the preclinical population is high, potentially for a future EBD candidate, though it's not part of our immediate plans. Q: What are the key properties and preclinical data that will drive the decision on candidate selection for the EBD program? A: Daniel O'Connell, CEO: We've explored diversity in the EBD program and are down to a shortlist. We anticipate exercising our option for two candidates in Q2 and filing an IND by mid-2027. Key properties include broad brain distribution, a wider safety margin, and subcutaneous dosing convenience. Q: Could you walk us through the early physician interest and feedback on sabirnetug, especially given the unmet need in early Alzheimer's? A: James Doherty, President & Chief Development Officer: There's significant interest in sabirnetug's differentiated approach. KOLs are looking forward to seeing the data from the ALTITUDE trial in late 2026, anticipating a differentiated response compared to current therapies. Q: What would be a clear win in the upcoming Phase 2 readout to prove sabirnetug as a unique alternative to existing treatments? A: Daniel O'Connell, CEO: A clear win would be an efficacy signal of at least a 30% slowing, which is the upper end for current agents. We are hopeful that targeting toxic species directly will unlock greater efficacy and a better safety profile. Q: How are the blinded operational metrics tracking for the ALTITUDE-ad study? A: W. Matthew Zuga, CFO: We are pleased with the study's progress, which has been tracking to our assumptions. Eric Siemers, Chief Medical Officer, added that the use of a plasma PTL 217 test improved the screening process, reducing negative PET scans significantly. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Acumen Pharmaceuticals, Inc.? Here are five stocks we like better. Acumen’s Phase 2 ALTITUDE-AD trial of sabirnetug remains on schedule, with top-line results expected in late 2026. Management said the study is a key test of its amyloid beta oligomer-targeting approach in early Alzheimer’s disease. The company highlighted promising clinician interest in sabirnetug and said it will judge success by both efficacy and safety, especially ARIA risk. Executives said a “clear win” would be about 30% slowing on the iADRS measure, while also looking for differentiation versus approved Alzheimer’s antibodies. Acumen’s cash position of $128.4 million at March 31 is expected to fund operations into early 2027. The company is also advancing its enhanced brain delivery program with JCR Pharmaceuticals, with a license decision planned for Q2 2026 and an IND filing targeted for mid-2027. MarketBeat Week in Review – 7/17 - 7/21 Acumen Pharmaceuticals (NASDAQ:ABOS) said its Phase 2 ALTITUDE-AD trial of sabirnetug remains on track, with top-line results expected late in 2026, as the company continues to advance its broader Alzheimer’s disease pipeline. On the company’s first-quarter 2026 earnings call, Chief Executive Officer Daniel O’Connell said Acumen continued to build on clinical momentum for sabirnetug, an investigational antibody designed to selectively target synaptotoxic amyloid beta oligomers rather than amyloid plaques. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum Acumen Soars on Alzheimer's Study...Street Sees It Doubling “Execution has stayed on track,” O’Connell said, adding that participants have been transitioning smoothly into the 12-month open-label extension study and that the conversion rate remains high. O’Connell described ALTITUDE-AD as a “critical proving ground” for Acumen’s thesis that targeting amyloid beta oligomers could offer a more effective and/or safer approach in Alzheimer’s disease. The study is evaluating two dose levels, 35 milligrams per kilogram and 50 milligrams per kilogram, against placebo. → MercadoLibre Boldly Invests in Growth: Discount Deepens O’Connell said the Phase 2 ALTITUDE-AD trial is designed as a “low-powered study” to detect a statistically significant difference after 18 months on its primary clinical efficacy endpoint, the amount of slowing measured by the integrated Alzheimer’s Disease Rating Scale, or iADRS. The company also expects to report key secondary endpoints in the top-line data, including the Clinical Dementia Rating-Sum of Boxes, safety measures such as adverse event rates and amyloid-related imaging abnormality, or ARIA, rates, along with fluid and imaging biomarkers. → 3 Ways to Target the Resources Powering AI and Data Centers During the question-and-answer session, O’Connell said a “clear win” for ALTITUDE-AD would include an efficacy signal of at least 30% slowing, which he described as the upper end of the range for currently approved agents. He said Acumen will evaluate the totality of the data, including efficacy and safety, to determine how sabirnetug may be differentiated from existing therapies. Chief Medical Officer Dr. Eric Siemers said the company will look closely at ARIA data, particularly symptomatic ARIA and serious adverse events. Siemers also noted that sabirnetug is an IgG2 antibody, while the two approved antibodies are IgG1s, which he said have more effector function and potential for more ARIA. President and Chief Development Officer Dr. Jim Doherty said the two doses in ALTITUDE-AD were chosen to bracket the range of oligomer clearance observed in Acumen’s Phase 1 INTERCEPT-AD study. Doherty said the company will assess whether the doses show differences in efficacy or tolerability and use the results to inform future development. Asked about physician feedback, Doherty said Acumen has spoken with a number of key opinion leaders about the sabirnetug program. He said there is interest in the company’s differentiated hypothesis compared with currently approved therapies. “Everyone’s very much looking forward to seeing the data as we release the results for the ALTITUDE trial in late 2026,” Doherty said. Siemers said he recently attended the American Academy of Neurology meeting in Chicago, where he observed “a great deal of interest and enthusiasm” among practicing neurologists regarding information on the approved drugs lecanemab and donanemab. He said infrastructure has been a limiting factor for commercial uptake, but that it is expected to continue improving. O’Connell said Acumen remains focused on early Alzheimer’s disease for sabirnetug in a potential future registration study. He said the company continues to have interest in preclinical Alzheimer’s disease, but that any such approach is not part of immediate plans and could be more relevant to a future enhanced brain delivery candidate. Acumen also highlighted progress in its enhanced brain delivery, or EBD, program, which is being developed in collaboration with JCR Pharmaceuticals. O’Connell said the company intends to submit a notice in the second quarter of 2026 to exercise its option to license two compounds developed through the collaboration. He said Acumen expects to discuss the candidate profiles in greater detail at a future medical meeting and continues to anticipate filing an investigational new drug application in mid-2027. O’Connell said the EBD approach is intended to enhance Acumen’s antibodies by increasing penetration and distribution in the brain, while maintaining a favorable safety profile and allowing for patient-friendly subcutaneous dosing. He said Acumen sees differentiation because no competitor in the space has an amyloid beta oligomer-targeted therapeutic cargo. Doherty said the company has explored multiple candidates, varying both the carrier technology from JCR and modifications on the antibody cargo side. He said Acumen has observed substantial improvements in brain exposure in rodent studies using humanized transferrin receptors and in primate studies, including improvements in the range of approximately 15-fold to 40-fold across multiple brain regions. Chief Financial Officer and Chief Business Officer Matt Zuga said Acumen ended March 31 with $128.4 million in cash and marketable securities. The company expects that balance to support current clinical and operational activities into early 2027. Zuga said the increase from the prior quarter was due to a private placement completed in support of the EBD program, which grossed $35.75 million and was announced in March. Research and development expenses were $16.5 million in the first quarter. Zuga said the year-over-year decrease was primarily due to lower manufacturing and material costs, as well as reduced contract research organization costs tied to ALTITUDE-AD, which completed enrollment in March 2025. General and administrative expenses were $4.7 million, down primarily because of reductions in legal fees, accounting, consulting and insurance expenses. Acumen reported a loss from operations of $21.1 million and a net loss of $20.7 million for the quarter. Zuga said the company remains focused on its Phase 2 readout later this year and advancing its EBD program as it works to build value around its portfolio of amyloid beta oligomer-targeted antibodies for Alzheimer’s patients, caregivers and stakeholders. Acumen Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of oral small molecule therapies for neurodegenerative diseases. Leveraging a proprietary drug discovery platform that integrates chemoproteomics, high-throughput screening and computational chemistry, the company seeks to identify and optimize compounds that selectively modulate pathological protein aggregation. Its approach is designed to address the underlying biology of conditions such as Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis and related proteinopathies. The company's pipeline comprises multiple lead candidates at various stages of preclinical and early clinical development. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Acumen Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Expect to report topline results for ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in late 2026 Lead clinical candidate IND filing in Acumen’s EBDTM (enhanced brain delivery) program targeted for mid-2027 Cash, cash equivalents and marketable securities of $128.4 million as of Mar. 31, 2026, expected to support current clinical and operational activities into early 2027 Company to host conference call and webcast today at 8:00 a.m. ET NEWTON, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- 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 first quarter of 2026 and provided a business update. “In the first quarter of 2026 Acumen remained steadfast in the execution of our ALTITUDE-AD Phase 2 study investigating the efficacy, safety and tolerability of sabirnetug for the treatment of early AD. Topline results are expected late this year and are anticipated to provide important evidence in support of the amyloid beta oligomer hypothesis within the broader field of anti-amyloid antibodies,” said Daniel O’Connell, Chief Executive Officer of Acumen. “In the near term, we expect to execute our option to license as many as two candidates in our EBD program. We are excited about the optionality this innovative blood-brain barrier technology affords our pipeline and the potential it holds to deliver a next-generation treatment for Alzheimer’s patients.” Anticipated Milestones The Company currently expects to exercise its option to license two compounds developed as part of its collaboration with JCR Pharmaceuticals during the second quarter of 2026. The Company expects topline results from ALTITUDE-AD in late 2026. ALTITUDE-AD is a Phase 2 study to investigate sabirnetug for the treatment of early Alzheimer’s disease. Topline results are expected to include the difference after 18 months as measured by iADRS (Integrated Alzheimer’s Disease Rating Scale), our primary clinical efficacy endpoint, as well as key secondary endpoints, such as CDR-SB (Clinical Dementia Rating – Sum of the Boxes), certain safety measures such as adverse event rates, including ARIA rates, and key biomarkers. The Company is targeting the submission of an IND filing with respect to a lead clinical candidate in its EBD program in mid-2027. First Quarter 2026 Financial Results Cash Balance. As of Mar. 31, 2026, cash, cash equivalents and marketable securities totaled $128.4 million compared to cash, cash equivalents and marketable securities of $116.9 million as of Dec. 31, 2025. The increase in cash is related to the private placement announced in March 2026 that resulted in gross proceeds of $35.75 million. Cash is expected to support current clinical and operational activities into early 2027. Research and Development (R&D) Expenses. R&D expenses were $16.5 million for the quarter ended Mar. 31, 2026, compared to $25.3 million for the quarter ended Mar. 31, 2025. The decrease was primarily due to a reduction in manufacturing and materials costs as well as a reduction in CRO costs associated with our ALTITUDE-AD clinical trial which completed enrollment in March 2025. General and Administrative (G&A) Expenses. G&A expenses were $4.7 million for the quarter ended Mar. 31, 2026, compared to $5.1 million for the quarter ended Mar. 31, 2025. The decrease was primarily due to reductions in legal fees, as well as reductions in accounting, consulting and insurance expenses. Loss from Operations. Loss from operations was $21.1 million for the quarter ended Mar. 31, 2026, compared to $30.4 million for the quarter ended Mar. 31, 2025. This decrease was due to the decreased R&D expenses over the prior year period. Net Loss. Net loss was $20.7 million for the quarter ended Mar. 31, 2026, compared to $28.8 million for the quarter ended Mar. 31, 2025. Conference Call Details Acumen will host a conference call and live audio webcast today, May 12, 2026, at 8:00 a.m. ET. To participate in the live conference call, please register using this link. After registration, you will be informed of the dial-in numbers including PIN. Please register at least one day in advance. The webcast audio will be available via this link. An archived version of the webcast will be available for at least 30 days in the Investors section of the Company's website at www.acumenpharm.com. About Sabirnetug (ACU193) Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AβOs), which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD. About ALTITUDE-AD (Phase 2) Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease. The study has enrolled 542 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. Topline results are expected in late 2026. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173. About Acumen Pharmaceuticals, Inc. Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its lead investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. Acumen is also investigating a subcutaneous formulation of sabirnetug using Halozyme’s proprietary ENHANZE® drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an EBD™ (enhanced brain delivery) therapy for Alzheimer’s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” “milestone” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning Acumen’s business, and Acumen’s ability to achieve its strategic and financial goals, including its projected use of cash, cash equivalents and marketable securities and the expected sufficiency of its cash resources into early 2027, the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193), including against other antibodies, the timing of the exercise of its option to license up to two candidates in its EBD program, the timing of anticipated topline results of ALTITUDE-AD, Acumen’s plans to develop a candidate to treat Alzheimer's Disease utilizing EBD technology, including its expectations with respect to timing for the submission of an IND, as well as its potential for developing a best-in-class therapeutic candidate for people living with Alzheimer’s Disease. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions, such as rising inflation and interest rates, supply disruptions and uncertainty of credit and financial markets. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen. Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise. CONTACTS: Investors: Alex Braun [email protected] Media: ICR Healthcare [email protected]

Management attributes 2025 performance to the successful enrollment and transition of patients into the Phase II ALTITUDE-AD trial, testing the core hypothesis that toxic amyloid beta oligomers drive Alzheimer's progression. The company emphasizes sabirnetug's selectivity for oligomers over plaque, which is intended to provide superior clinical efficacy and a safer profile compared to existing plaque-directed antibodies. Strategic expansion into the Enhanced Brain Delivery (EBD) program via a JCR Pharmaceuticals partnership aims to 'supercharge' antibodies by increasing brain penetration 14- to 40-fold in preclinical models. Management views the EBD platform as a gateway to treating presymptomatic Alzheimer's populations, a significant future market opportunity beyond their current clinical focus. Optimism for the upcoming Phase II readout is supported by Phase Ib INTERCEPT-AD data, which showed positive effects on pTau181 and neurogranin biomarkers after only three doses. The competitive landscape is described as evolving, with management positioning their IgG2 antibody framework as a potentially safer alternative to the IgG1 frameworks used in currently marketed therapies. The Phase II ALTITUDE-AD trial is expected to provide a top-line readout in late 2026, covering both clinical efficacy and safety measures over 18 months of treatment. Management anticipates that a single additional Phase III study may be sufficient for a BLA filing, based on preliminary interactions with the FDA and precedents set by other Alzheimer's therapies. The EBD program is targeting an Investigational New Drug (IND) filing in mid-2027, following the recent identification of multiple candidates that exceeded target product profiles. Current cash reserves of $116.9 million are projected to fund operations into early 2027, while a separate $35.75 million private placement will primarily support the next-generation EBD program. Future development for the EBD platform will prioritize subcutaneous dosing formats to improve patient convenience and distribution compared to intravenous alternatives. R&D expenses increased to $104.9 million in 2025, driven by manufacturing costs for the ALTITUDE-AD trial and expanded EBD research activities. A $35.75 million private placement was closed in March 2026 specifically to accelerate the EBD program following positive preclinical data in non-human primates. Management explicitly noted the risk of ARIA (Amyloid-Related Imaging Abnormalities), though they highlighted that most cases are asymptomatic and their IgG2 approach may mitigate severe events. The company flagged the species-specific nature of transferrin receptors as a challenge in preclinical modeling, requiring specialized humanized mouse models for validation. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management reported that retention and rollover rates are 'well in line' with other major Alzheimer's trials like CLARITY-AD. High rollover rates into the OLE are interpreted by management as a positive indicator of patient satisfaction and the perceived safety profile of sabirnetug. Non-human primate studies showed 14- to 40-fold higher brain levels of the antibody compared to native controls 24 hours post-dosing. Management noted no observed changes in red blood cell counts or hemoglobin, suggesting the JCR technology avoids the anemia risks seen in some other transferrin-targeting programs. The 35 mg/kg dose was selected based on modeling that showed full target saturation (Emax) at both peak and trough levels. The 50 mg/kg dose serves as an 'insurance policy' to ensure maximum possible impact on both oligomers and potentially plaque reduction. Management explained that their use of an IgG2 framework provides less 'effector function' (immune response) than the IgG1 used in lecanemab or donanemab. This structural difference is hypothesized to lead to lower rates of serious symptomatic ARIA and other inflammatory adverse events. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.