-- Expect decision regarding the advancement of an A<BETA> oligomer-targeted
Enhanced Brain DeliveryTM product candidate in early 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
-- Cash, cash equivalents and marketable securities of $136.1 million as of
Sept. 30, 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., Nov. 12, 2025 (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 third quarter of 2025 and provided a business update.
"We continued our strong operational progress throughout the third quarter, both clinically, with our ongoing Phase 2 trial of sabirnetug, and non-clinically, with the advancement of our Enhanced Brain Delivery (EBD$(TM)$ ) program. Our goal remains clear: to deliver meaningful innovation for patients," said Daniel O'Connell, Chief Executive Officer of Acumen. "We remain focused on translating cutting-edge science into novel medicines with the greatest potential to benefit patients, while deploying capital with the goal of maximizing shareholder value. We anticipate non-clinical data in early 2026 will inform the direction of our EBD strategy and ALTITUDE-AD Phase 2 topline results in late 2026 will provide true insight into the role A<BETA>Os play in Alzheimer's disease."
Recent Highlights
-- In November 2025, the Company expects the first patient to be dosed 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 with the
opportunity to receive sabirnetug at 35 mg/kg administered
intravenously once every four weeks for up to 52 weeks.
-- In November 2025, the Company announced the addition of biopharma veteran
George Golumbeski, Ph.D., to its Board of Directors in the role of
Chairman.
-- Dr. Golumbeski brings more than 30 years of experience in the
biotechnology industry, with expertise in business and portfolio
strategy, business development strategic collaborations and
licensing, and M&A.
-- With the addition of Dr. Golumbeski, the Acumen Board increases
to eight members.
Anticipated Milestones
-- The Company expects non-clinical data to support the development of an
EBD therapy in early 2026, at which point Acumen has an exclusive right
to exercise its option to develop up to two development candidates as
part of its partnership with JCR Pharmaceuticals.
-- 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.
Third Quarter 2025 Financial Results
-- Cash Balance. As of Sept. 30, 2025, cash, cash equivalents and marketable
securities totaled $136.1 million compared to cash, cash equivalents and
marketable securities of $166.2 million as of June 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 $22.0 million
for the three-month period ended Sept. 30, 2025, compared to $27.2
million for the three-month period ended Sept. 30, 2024. The decrease was
primarily due to a reduction of CRO costs associated with the ALTITUDE-AD
clinical trial, for which we completed enrollment in March 2025 following
dosing of the first patient in May 2024.
-- General and Administrative (G&A) Expenses. G&A expenses were $4.5 million
for the three-month period ended Sept. 30, 2025, compared to $5.0 million
for the three-month period ended Sept. 30, 2024. The decrease was
primarily due to reductions in legal fees, audit and other accounting
services expenses, and recruiting expenses.
-- Loss from Operations. Loss from operations was $26.5 million for the
three-month period ended Sept. 30, 2025, compared to $32.3 million for
the three-month period ended Sept. 30, 2024. This decrease was due to the
decreased R&D expenses over the prior year period.
-- Net Loss. Net loss was $26.5 million for the three-month period ended
Sept. 30, 2025, compared to $29.8 million for the three-month period
ended Sept. 30, 2024.
Conference Call Details
Acumen will host a conference call and live audio webcast today, Nov. 12, 2025, 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. 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.
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, the potential for additional development to support a subcutaneous dosing option of sabirnetug, and the potential to develop a candidate to treat Alzheimer's Disease utilizing EBD technology. 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
abraun@acumenpharm.com
Media: AcumenPR@westwicke.com
Acumen Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
September 30, December 31,
2025 2024
(unaudited)
ASSETS
Current assets
Cash and cash equivalents $ 46,832 $ 35,627
Marketable securities, short-term 79,777 135,930
Prepaid expenses and other current
assets 5,544 6,749
Total current assets 132,153 178,306
Marketable securities, long-term 9,443 59,968
Restricted cash 232 232
Other assets, long-term 393 486
Total assets $ 142,221 $ 238,992
========== =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 682 $ 5,648
Accrued clinical trial expenses 9,884 15,344
Accrued expenses and other current
liabilities 7,792 6,615
Debt, short-term 3,598 -
---------- ---------
Total current liabilities 21,956 27,607
Debt, long-term 27,053 29,419
Other liabilities, long-term 39 150
Total liabilities 49,048 57,176
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.0001 par value;
10,000,000 shares authorized and no
shares issued and outstanding as of
September 30, 2025 and December 31,
2024 - -
Common stock, $0.0001 par value;
300,000,000 shares authorized as
of September 30, 2025 and December
31, 2024; 60,573,425 and
60,094,083 shares issued and
outstanding as of September 30,
2025 and December 31, 2024,
respectively 6 6
Additional paid-in capital 514,382 506,985
Accumulated deficit (421,324) (325,127)
Accumulated other comprehensive
income (loss) 109 (48)
Total stockholders' equity 93,173 181,816
---------- ---------
Total liabilities and stockholders'
equity $ 142,221 $ 238,992
========== =========
Acumen Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share data)
(unaudited)
Three Months Ended Nine Months Ended September
September 30, 30,
-------------------------- ----------------------------
2025 2024 2025 2024
---------- ---------- ---------- ----------
Operating expenses
Research and
development $ 21,968 $ 27,247 $ 84,359 $ 59,229
General and
administrative 4,545 5,018 14,274 15,191
Total operating
expenses 26,513 32,265 98,633 74,420
---------- ---------- ---------- ----------
Loss from
operations (26,513) (32,265) (98,633) (74,420)
Other income
(expense)
Interest income 1,639 3,504 6,125 11,325
Interest
expense (1,068) (1,027) (3,137) (3,031)
Change in fair
value of
embedded
derivatives (440) (10) (290) 1,040
Other income
(expense),
net (69) 33 (262) (89)
Total other income 62 2,500 2,436 9,245
---------- ---------- ---------- ----------
Net loss (26,451) (29,765) (96,197) (65,175)
---------- ---------- ---------- ----------
Other comprehensive
gain (loss)
Unrealized gain
on marketable
securities 86 682 157 206
Comprehensive loss $ (26,365) $ (29,083) $ (96,040) $ (64,969)
========== ========== ========== ==========
Net loss per common
share, basic and
diluted $ (0.44) $ (0.50) $ (1.59) $ (1.09)
========== ========== ========== ==========
Weighted-average
shares
outstanding, basic
and diluted 60,573,425 60,079,778 60,557,668 59,990,844
========== ========== ========== ==========
Acumen Pharmaceuticals, Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
Nine Months Ended September 30,
---------------------------------------
2025 2024
Cash flows from operating
activities
Net loss $ (96,197) $ (65,175)
Adjustments to reconcile net loss
to net cash used in operating
activities:
Depreciation 46 49
Stock-based compensation
expense 7,433 7,292
Amortization of premiums and
accretion of discounts on
marketable securities, net (919) (4,599)
Change in fair value of
embedded derivatives 290 (1,040)
Amortization of right-of-use
asset 93 85
Realized gain on marketable
securities (17) (97)
Non-cash interest expense 942 823
Other non-cash expense - 230
Changes in operating assets
and liabilities:
Prepaid expenses and other
current assets 1,205 (4,196)
Other long-term assets 42 51
Accounts payable (4,966) 963
Accrued clinical trial
expenses (5,460) 8,130
Accrued expenses and other
liabilities 1,066 (1,493)
Finance lease liability - (23)
Net cash used in operating
activities (96,442) (59,000)
------------ -------------
Cash flows from investing
activities
Purchases of marketable
securities (38,056) (155,631)
Proceeds from maturities and
sales of marketable securities 145,827 174,011
Purchases of property and
equipment (88) (16)
------------ -------------
Net cash provided by investing
activities 107,683 18,364
------------ -------------
Cash flows from financing
activities
Proceeds from issuance of common
stock, net of issuance costs - 7,938
Proceeds from exercise of stock
options 37 -
Payment for financing lease - (739)
Payments for deferred offering
costs - (230)
Repurchase of common shares to
pay employee withholding taxes (73) (32)
Net cash provided by (used in)
financing activities (36) 6,937
------------ -------------
Net change in cash and cash
equivalents and restricted cash 11,205 (33,699)
Cash and cash equivalents and
restricted cash at the beginning
of the period 35,859 67,119
Cash and cash equivalents and
restricted cash at the end of
the period $ 47,064 $ 33,420
============ =============
(END) Dow Jones Newswires
November 12, 2025 07:00 ET (12:00 GMT)