-- 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.
(MORE TO FOLLOW) Dow Jones Newswires
March 26, 2026 07:00 ET (11:00 GMT)