- 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 AßO-selective EBD portfolio - Cash, cash equivalents and marketable securities of
$116.9 million as ofDec. 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
“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 (EBDTM) partnership to develop a transferrin-receptor-targeting blood-brain barrier-penetrating therapy,” said Daniel O’Connell, Chief Executive Officer of
Recent Highlights
- In
March 2026 , the Company announced a$35.75 million private placement to advance candidates in its AßO-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 inNovember 2025 , the Company presented one oral and four poster presentations at theInternational 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 AßO-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 AßO-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 ofSept. 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 endedDec. 31, 2025 , compared to$93.8 million for the year endedDec. 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 endedDec. 31, 2025 , compared to$20.2 million for the year endedDec. 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 endedDec. 31, 2025 , compared to$114.0 million for the year endedDec. 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 endedDec. 31, 2025 , compared to$102.3 million for the year endedDec. 31, 2024 .
Conference Call Details
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 (AßOs), which are a highly toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, sabirnetug aims to address the hypothesis that soluble AßOs 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
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
About
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About JCR Pharmaceuticals Co., Ltd.
JCR Pharmaceuticals Co., Ltd. is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world’s most complex healthcare challenges. JCR continues to build upon our 50-year legacy in
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, 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
CONTACTS:
Investors:
Alex Braun
abraun@acumenpharm.com
Media:
AcumenPR@icrhealthcare.com
| Balance Sheets | ||||||||
| (in thousands, except share and per share data) | ||||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 53,989 | $ | 35,627 | ||||
| Marketable securities, short-term | 62,876 | 135,930 | ||||||
| Prepaid expenses and other current assets | 5,387 | 6,749 | ||||||
| Total current assets | 122,252 | 178,306 | ||||||
| Marketable securities, long-term | - | 59,968 | ||||||
| Restricted cash | 231 | 232 | ||||||
| Other assets, long-term | 350 | 486 | ||||||
| Total assets | $ | 122,833 | $ | 238,992 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 554 | $ | 5,648 | ||||
| Accrued clinical trial expenses | 10,616 | 15,344 | ||||||
| Accrued expenses and other current liabilities | 10,072 | 6,615 | ||||||
| Debt, short-term | 8,765 | - | ||||||
| Total current liabilities | 30,007 | 27,607 | ||||||
| Debt, long-term | 22,396 | 29,419 | ||||||
| Other liabilities, long-term | - | 150 | ||||||
| Total liabilities | 52,403 | 57,176 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 6 | 6 | ||||||
| Additional paid-in capital | 516,803 | 506,985 | ||||||
| Accumulated deficit | (446,462 | ) | (325,127 | ) | ||||
| Accumulated other comprehensive income (loss) | 83 | (48 | ) | |||||
| Total stockholders' equity | 70,430 | 181,816 | ||||||
| Total liabilities and stockholders' equity | $ | 122,833 | $ | 238,992 | ||||
| Statements of Operations and Comprehensive Loss | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 104,885 | $ | 93,798 | ||||
| General and administrative | 18,947 | 20,219 | ||||||
| Total operating expenses | 123,832 | 114,017 | ||||||
| Loss from operations | (123,832 | ) | (114,017 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 7,447 | 14,317 | ||||||
| Interest expense | (4,224 | ) | (4,068 | ) | ||||
| Change in fair value of embedded derivatives | (460 | ) | 1,590 | |||||
| Other expense, net | (266 | ) | (151 | ) | ||||
| Total other income | 2,497 | 11,688 | ||||||
| Net loss | (121,335 | ) | (102,329 | ) | ||||
| Other comprehensive gain (loss) | ||||||||
| Unrealized gain (loss) on marketable securities | 131 | (360 | ) | |||||
| Comprehensive loss | $ | (121,204 | ) | $ | (102,689 | ) | ||
| Net loss per common share, basic and diluted | $ | (2.00 | ) | $ | (1.71 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 60,561,836 | 60,013,277 | ||||||
| Statements of Cash Flows | ||||||||
| (in thousands) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (121,335 | ) | $ | (102,329 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 58 | 63 | ||||||
| Stock-based compensation expense | 9,852 | 9,635 | ||||||
| Amortization of premiums and accretion of discounts on marketable securities, net | (809 | ) | (5,015 | ) | ||||
| Change in fair value of embedded derivatives | 460 | (1,590 | ) | |||||
| Amortization of right-of-use asset | 126 | 115 | ||||||
| Realized gain on marketable securities | (59 | ) | (97 | ) | ||||
| Noncash interest expense | 1,288 | 1,118 | ||||||
| Other noncash expense | - | 232 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | 1,362 | (3,656 | ) | |||||
| Other long-term assets | 40 | 74 | ||||||
| Accounts payable | (5,094 | ) | 4,269 | |||||
| Accrued clinical trial expenses | (4,728 | ) | 10,957 | |||||
| Accrued expenses and other liabilities | 3,301 | 32 | ||||||
| Finance lease liability | - | (23 | ) | |||||
| Net cash used in operating activities | (115,538 | ) | (86,215 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of marketable securities | (38,056 | ) | (170,731 | ) | ||||
| Proceeds from maturities and sales of marketable securities | 172,077 | 218,774 | ||||||
| Purchases of property and equipment | (88 | ) | (16 | ) | ||||
| Net cash provided by investing activities | 133,933 | 48,027 | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, net of issuance costs | - | 7,938 | ||||||
| Proceeds from exercise of stock options | 39 | - | ||||||
| Payment for financing lease | - | (739 | ) | |||||
| Payments for deferred offering costs | - | (230 | ) | |||||
| Repurchase of common shares to pay employee withholding taxes | (73 | ) | (41 | ) | ||||
| Net cash (used in) provided by financing activities | (34 | ) | 6,928 | |||||
| Net change in cash and cash equivalents and restricted cash | 18,361 | (31,260 | ) | |||||
| 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 | $ | 54,220 | $ | 35,859 | ||||
