Sabirnetug

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 pro 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. ACU301 and ACU401 were nominated in the EBD program as part of the exercise of Acumen’s option under its license agreement with JCR Pharmaceuticals. Acumen’s EBD candidates are designed to achieve higher brain penetration with potential for improved safety compared to native antibodies and delivered in a stable, low volume subcutaneous administration format. In July 2026, the Company announced EBD program data and early AD insights at the Alzheimer’s Association International Conference (AAIC ® ) 2026. EBD bispecific antibodies targeting both AβOs and hTfR (human transferrin receptor) showed improved brain penetration compared to the native anti-AβO antibodies, which may enable administration with a low-volume delivery device and reduce the delivered dose required for efficacy. EBD candidate ACU401 achieves up to 40-fold greater frontal cortex exposure in non-human primates and significant increase in exposures in deep brain regions. No hematological safety signals, including no effects on reticulocytes, were observed in non-human primates, demonstrating low potential for anemia. ALTITUDE-AD patient experience data highlight unmet need in early Alzheimer's disease. To access the material, please visit the Publications section of the Acumen website . Anticipated Milestones ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); 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. ALTITUDE-AD includes two active doses (35 mg/kg, 50 mg/kg, IV Q4W) vs. placebo over an 18-month double-blinded period. Topline results are expected to include 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. 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 . 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 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 . 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 abraun@acumenpharm.com Media: ICR Healthcare AcumenPR@icrhealthcare.com Acumen Pharmaceuticals, Inc. Condensed Balance Sheets (in thousands, except share and per share data) June 30, December 31, 2026 2025 (unaudited) ASSETS Current assets Cash and cash equivalents $ 59,443 $ 53,989 Marketable securities, short-term 50,754 62,876 Prepaid expenses and other current assets 5,316 5,387 Total current assets 115,513 122,252 Restricted cash 231 231 Other assets, long-term 263 350 Total assets $ 116,007 $ 122,833 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 13,379 $ 554 Accrued clinical trial expenses 6,263 10,616 Accrued expenses and other current liabilities 7,533 10,072 Debt, short-term 19,673 8,765 Total current liabilities 46,848 30,007 Debt, long-term 11,896 22,396 Total liabilities 58,744 52,403 Commitments and contingencies Stockholders' equity Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding as of June 30, 2026 and December 31, 2025 - - Common stock, $0.0001 par value; 300,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 72,314,714 and 60,575,369 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 7 6 Additional paid-in capital 557,186 516,803 Accumulated deficit (499,917 ) (446,462 ) Accumulated other comprehensive (loss) income (13 ) 83 Total stockholders' equity 57,263 70,430 Total liabilities and stockholders' equity $ 116,007 $ 122,833 Acumen Pharmaceuticals, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses Research and development $ 27,809 $ 37,125 $ 44,293 $ 62,391 General and administrative 4,747 4,625 9,412 9,729 Total operating expenses 32,556 41,750 53,705 72,120 Loss from operations (32,556 ) (41,750 ) (53,705 ) (72,120 ) Other income (expense) Interest income 1,111 2,015 2,175 4,486 Interest expense (1,094 ) (1,046 ) (2,163 ) (2,069 ) Change in fair value of embedded derivatives (160 ) (40 ) 300 150 Other expense, net (19 ) (129 ) (62 ) (193 ) Total other (expense) income (162 ) 800 250 2,374 Net loss (32,718 ) (40,950 ) (53,455 ) (69,746 ) Other comprehensive gain (loss) Unrealized (loss) gain on marketable securities (34 ) 8 (96 ) 71 Comprehensive loss $ (32,752 ) $ (40,942 ) $ (53,551 ) $ (69,675 ) Net loss per common share, basic and diluted $ (0.45 ) $ (0.68 ) $ (0.79 ) $ (1.15 ) Weighted-average shares outstanding, basic and diluted 72,250,694 60,573,425 67,759,940 60,549,658 Acumen Pharmaceuticals, Inc. Statements of Cash Flows (in thousands) (unaudited) Six Months Ended June 30, 2026 2025 Cash flows from operating activities Net loss $ (53,455 ) $ (69,746 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 23 31 Stock-based compensation expense 4,920 4,972 Amortization of premiums and accretion of discounts on marketable securities, net (161 ) (644 ) Change in fair value of embedded derivatives (300 ) (150 ) Amortization of right-of-use asset 68 61 Realized gain on marketable securities (6 ) (3 ) Noncash interest expense 708 613 Changes in operating assets and liabilities: Prepaid expenses and other current assets 71 1,714 Other long-term assets (4 ) 18 Accounts payable 12,825 (3,545 ) Accrued clinical trial expenses (4,353 ) (4,236 ) Accrued expenses and other liabilities (2,539 ) 4,962 Net cash used in operating activities (42,203 ) (65,953 ) Cash flows from investing activities Purchases of marketable securities (40,823 ) (38,056 ) Proceeds from maturities and sales of marketable securities 53,016 105,316 Purchases of property and equipment - (88 ) Net cash provided by investing activities 12,193 67,172 Cash flows from financing activities Proceeds from private placement, net of offering costs 35,441 - Proceeds from exercise of stock options 172 37 Repurchase of common shares to pay employee withholding taxes (149 ) (73 ) Net cash provided by (used in) financing activities 35,464 (36 ) Net change in cash and cash equivalents and restricted cash 5,454 1,183 Cash and cash equivalents and restricted cash at the beginning of the period 54,220 35,859 Cash and cash equivalents and restricted cash at the end of the period $ 59,674 $ 37,042

NEWTON, Mass., Aug. 05, 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 for the treatment of Alzheimer’s disease, today announced that the Company will report second quarter financial results on Wednesday, Aug. 12, 2026. The Company will host a conference call and live audio webcast at 8:00 a.m. ET to provide a business and financial update. 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 Acumen Pharmaceuticals, Inc. Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets 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 investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets synaptotoxic 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. Investors: Alex Braun abraun@acumenpharm.com Media:  ICR Healthcare AcumenPR@icrhealthcare.com