Press Release: Acumen Pharmaceuticals Reports Financial Results for the Year Ended December 31, 2025 and Business Highlights

Dow Jones
Mar 26
   -- 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 Enhanced Brain Delivery 
      (EBDTM) program targeted for mid-2027, following strong preclinical data 
      and $35.75 million private placement to advance candidates in 
      A<BETA>O-selective EBD portfolio 
 
   -- Cash, cash equivalents and marketable securities of $116.9 million as of 
      Dec. 31, 2025, 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., March 26, 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 (A<BETA>Os) for the treatment of Alzheimer's disease $(AD)$, today reported financial results for the full year ended December 31, 2025 and provided a business update.

"2025 was defined by significant clinical progress supporting our Phase 2 ALTITUDE-AD study investigating our lead therapeutic candidate, sabirnetug, and the expansion of our pipeline via a notable Enhanced Brain Delivery (EBD$(TM)$ ) partnership to develop a transferrin-receptor-targeting blood-brain barrier-penetrating therapy," said Daniel O'Connell, Chief Executive Officer of Acumen. "2026 is poised to be transformative for Acumen. Topline results for ALTITUDE-AD are expected late in the year and are anticipated to provide important insights into the role of A<BETA>Os in Alzheimer's disease. Supported by our recent financing, we are also advancing toward clinical candidate nomination in our EBD program, with an IND filing targeted for mid-2027. Pairing a commitment to scientific innovation with a track record of strong execution, we believe that we are well-positioned to deliver differentiated treatment options for Alzheimer's patients."

Recent Highlights

   -- In March 2026, the Company announced a $35.75 million private placement 
      to advance candidates in its A<BETA>O-selective EBD portfolio, following 
      strong preclinical data, including in vitro, in vivo and non-human 
      primate study results. 
 
          -- Candidates exceeded key preclinical criteria, demonstrating 
             elevated brain exposure in non-human primates up to 40-fold over 
             native antibodies, low risk of anemia, and robust stability 
             profiles to enable subcutaneous administration. 
 
          -- Lead clinical candidate Investigational New Drug $(IND)$ filing 
             targeted for mid-2027. 
 
   -- In March 2026 and in November 2025, the Company presented one oral and 
      four poster presentations at the International Conference on Alzheimer's 
      and Parkinson's Diseases and Related Neurological Disorders (AD/PD) and 
      the 18th Annual Clinical Trials on Alzheimer's Disease (CTAD) conference. 
 
          -- At AD/PD, the presentations highlighted new data regarding the EBD 
             program, sabirnetug biomarker treatment responses, and the 
             development of new A<BETA>O-targeting antibodies. 
 
          -- At CTAD, results presented from a collaborative study with JCR 
             Pharmaceuticals demonstrated that bispecific antibodies that 
             target transferrin (TfR) as well as the A<BETA>O-targeting 
             antibody sabirnetug achieved increased brain penetration in mice 
             while preserving target binding. Results presented on clinical 
             trial recruitment from the Phase 2 ALTITUDE-AD clinical trial 
             showed that site databases and physician referrals were the most 
             reliable recruitment methods overall. 
 
          -- Presentations are available on the Company's website here. 
   -- In November 2025, the Company dosed the first patient in the open-label 
      extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial 
      evaluating sabirnetug (ACU193) in patients with early Alzheimer's 
      disease. 
 
          -- The OLE provides all participants who completed the 18-month 
             placebo-controlled double-blind portion of ALTITUDE-AD, including 
             patients previously treated with placebo, with the opportunity to 
             receive sabirnetug at 35 mg/kg administered intravenously once 
             every four weeks for up to 52 weeks. 

Anticipated Milestones

   -- The Company expects topline results from ALTITUDE-AD, a Phase 2 study to 
      investigate sabirnetug for the treatment of early Alzheimer's disease, in 
      late 2026. 
 
   -- The Company is targeting the submission of an IND filing with respect to 
      a lead clinical candidate in its EBD program in mid-2027. 

2025 Financial Results

   -- Cash Balance. As of Dec. 31, 2025, cash, cash equivalents and marketable 
      securities totaled $116.9 million compared to cash, cash equivalents and 
      marketable securities of $136.1 million as of Sept. 30, 2025. The 
      decrease in cash is related to funding ongoing operations. Cash is 
      expected to support current clinical and operational activities into 
      early 2027. 
   -- Research and Development (R&D) Expenses.  R&D expenses were $104.9 
      million for the year ended Dec. 31, 2025, compared to $93.8 million for 
      the year ended Dec. 31, 2024. The increase was primarily due to an 
      increase in manufacturing and materials mainly associated with our 
      ALTITUDE-AD clinical trial, as well as personnel-related costs and 
      research expenses, including EBD research. 
   -- General and Administrative (G&A) Expenses. G&A expenses were $18.9 
      million for the year ended Dec. 31, 2025, compared to $20.2 million for 
      the year ended Dec. 31, 2024. The decrease was primarily due to 
      reductions in recruiting expenses, corporate insurance expenses and 
      consulting costs. 
   -- Loss from Operations. Loss from operations was $123.8 million for the 
      year ended Dec. 31, 2025, compared to $114.0 million for the year ended 
      Dec. 31, 2024. This increase was due to the increased R&D expenses over 
      the prior year period. 
   -- Net Loss.  Net loss was $121.3 million for the year ended Dec. 31, 2025, 
      compared to $102.3 million for the year ended Dec. 31, 2024. 

Conference Call Details

Acumen will host a conference call and live audio webcast today, Mar. 26, 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 (A<BETA>Os), which are a highly toxic and pathogenic form of A<BETA>, relative to A<BETA> monomers and amyloid plaques. Soluble A<BETA>Os have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble A<BETA>Os, sabirnetug aims to address the hypothesis that soluble A<BETA>Os 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 a novel therapeutic that targets toxic soluble amyloid beta oligomers (A<BETA>Os) for the treatment of Alzheimer's disease (AD). Acumen's scientific founders pioneered research on A<BETA>Os, 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 A<BETA>Os, 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$(R)$ drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD(TM)) 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.

About JCR Pharmaceuticals Co., Ltd.

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