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

公司创始人及团队情况 Acumen的科学创始团队来自西北大学、南加州大学，是早期可溶性Aβ寡聚体（AβOs）病理机制的奠基研究者，1996年公司依托两所高校Aβ衍生弥散配体（ADDLs）专利授权正式成立，核心科研根基围绕Aβ寡聚体神经毒性假说搭建。企业高管团队以礼来阿尔茨海默病药物开发核心班底为骨干，2018年完成核心临床团队组建，现任CEO Daniel O’Connell具备生物药企商业化运营经验，首席开发官Jim Doherty博士、首席医学官Eric Siemers MD均深耕AD抗体药物临床开发多年，CFO Matthew Zuga统筹资本运作与商务合作，首席运营官Russell Barton负责整体运营落地，监管、CMC、临床运营职能岗均配备大型药企资深人员，董事会主席George Golumbeski博士拥有头部药企管线管理履历，整体团队兼顾基础科研溯源与产业化临床落地能力。主要管线、产品与技术平台 公司核心资产为Sabirnetug（ACU193），全球首款特异性结合可溶性Aβ寡聚体的人源化单克隆抗体，区别于靶向淀粉样斑块的传统Aβ抗体，不结合单体Aβ与成熟斑块，精准清除突触毒性寡聚体，已经获得FDA早期AD快速通道资格认定。一期INTERCEPT-AD临床试验2023年完成，65例早期AD受试者给药后验证静脉输注安全性、靶点结合活性；二期ALTITUDE-AD随机双盲对照试验2024年启动，全球入组542例轻度认知障碍、轻度AD患者，设置35mg/kg、50mg/kg每4周静脉给药两组，2025年3月完成全部受试者入组，同年11月开启开放标签扩展试验，首位受试者顺利完成给药，关键疗效数据计划2026年末读出。同步布局皮下注射剂型，依托Halozyme ENHANZE给药技术完成一期健康人试验，2025年3月公布阳性药代数据，支持后续临床开发，降低患者静脉输注就医频次。 自研Enhanced Brain Delivery™（EBD）增强脑递送技术平台，和JCR制药合作基于转铁蛋白受体（TfR）介导血脑屏障穿透，将Sabirnetug改造后脑部药物暴露量较原型抗体提升14–40倍，非人灵长类动物试验提示TfR改造后贫血不良反应风险更低，2025年CTAD大会完整披露临床前数据包，后续计划推进EBD改造抗体的IND申报准备工作。公司无已上市药物，全部管线集中于AD寡聚体靶向抗体及递送技术开发，无其他适应症布局。按时间线梳理公司发展、研发、融资、团队变动 1996年，公司取得西北大学、南加州大学ADDLs全部独家专利授权，完成初创成立，锁定Aβ寡聚体核心知识产权壁垒。 2004年，和默克达成Aβ寡聚体靶点联合研发与授权合作，借助大厂资金推进早期候选分子筛选。 2012年，拿回ACU193项目全球独家开发权益，终止和默克的联合开发绑定，自主主导先导抗体优化。 2017年，获得美国老龄化研究所360万美元U01课题经费，专项支持ACU193临床前工艺与药理验证。 2018年，引入前礼来AD完整临床开发团队搭建临床部门，完成1500万美元A-1轮融资，补齐临床转化资金缺口。 2020年，完成7500万美元B轮大额融资，为一期临床启动储备现金流。 2021年，启动Sabirnetug一期INTERCEPT-AD人体临床试验，同年登陆纳斯达克（ABOS）完成IPO上市，初期员工规模14人，搭建完整职能部门框架。 2022年，公司人员扩张至34人，持续推进一期受试者入组，锁定2023年一期揭盲节点。 2023年，一期临床取得阳性安全性与药效学生物标志物结果，在AAIC会议公开数据；同年官宣和Halozyme合作开发皮下注射剂型。 2024年，正式启动二期ALTITUDE-AD关键性临床试验，推进全球多中心受试者招募。 2025年3月，二期试验完成全部542例受试者入组；一季度公布Sabirnetug皮下剂型一期临床顶线数据；11月启动二期开放标签扩展试验，首例患者完成给药；12月在CTAD 2025发布EBD增强脑递送平台临床前完整数据；年末账面现金约1.169亿美元，可支撑运营至2027年初。 2026年3月，完成3575万美元私募配售，由RA Capital领投，资金全部用于EBD管线推进与二期临床后续运营；核心高管团队自2018年定型后无重大人事更迭，仅补充临床、工艺中层技术人员扩充产能。 公司成立至今无对外收并购动作，全部管线为自主研发+外部技术合作模式搭建。简要评价 Acumen是AD抗体药物赛道差异化定位鲜明的临床阶段Biotech，依托源头Aβ寡聚体基础专利避开斑块型抗体的同质化竞争，Sabirnetug选择性靶向毒性寡聚体的作用机制，理论上可以减少斑块清除类抗体常见的ARIA水肿出血风险，一期安全性数据已经体现该优势。公司资本节奏稳健，IPO+两轮私募覆盖临床全周期现金流，二期临床完整入组、开放标签顺利推进，2026年末的疗效数据将直接决定公司价值拐点。EBD脑递送平台进一步放大核心抗体的脑部利用效率，形成“差异化靶点+优化递送”的双层技术壁垒，短板在于管线极度单一，全部价值绑定Sabirnetug二期临床结果，若关键终点未达预期，公司后续管线接续空间有限。 Acumen Pharmaceuticals. About Us[EB/OL].https://acumenpharm.com/about-us/#bodAcumen Pharmaceuticals. Our Team[EB/OL].https://acumenpharm.com/our-team/Acumen Pharmaceuticals. Announces $35.75 Million Private Placement to Advance Potential Best-in-Class Molecules from Amyloid Beta Oligomer-Selective Enhanced Brain Delivery Portfolio[EB/OL].https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-announces-3575-million-private-placement/Acumen Pharmaceuticals. Highlights Enhanced Brain Delivery™ Technology for Oligomer-Selective Antibodies at CTAD 2025[EB/OL].https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-highlights-enhanced-brain-deliverytm AD，AβOs（可溶性Aβ寡聚体），Sabirnetug（ACU193），Enhanced Brain Delivery（EBD，增强脑部递送），ALTITUDE-AD，INTERCEPT-AD 本文内容来自公开信息及研究文献，不代表临床建议。 如需投稿、转载、商务合作后台留言，回复有一定延迟敬请谅解。 辅助编辑：腾讯元宝or（GPT、Gemini、Claude等）