Acumen Pharmaceuticals(ABOS) - 2025 Q2 - Quarterly Results

Executive Summary & Business Highlights Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company, provides an overview of its Alzheimer's disease therapeutics, recent operational innovations, and upcoming milestones Company Overview Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease. The CEO highlighted strong operational execution and the expansion of the portfolio with the Enhanced Brain Delivery (EBD) program - 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[2] - CEO Daniel O'Connell emphasized strong operational execution and the broadening portfolio with the addition of the Enhanced Brain Delivery (EBD) program[3] Recent Business Highlights Recent highlights include presenting operational innovations in the ALTITUDE-AD Phase 2 trial, which reduced screening costs by approximately 40% using a two-step plasma pTau217 biomarker assay. The company also presented data on sabirnetug's high selectivity for toxic AβOs and announced a collaboration with JCR Pharmaceuticals for an oligomer-targeted Enhanced Brain Delivery (EBD) therapy - Operational innovations in the ALTITUDE-AD Phase 2 clinical trial, using a two-step plasma pTau217 biomarker assay, reduced total screening costs by approximately 40% across U.S. and Canadian sites[6][7] - Sabirnetug demonstrated 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, supporting its mechanism of action and selectivity for AβOs[10] - In July 2025, Acumen announced a collaboration, option, and license agreement with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery (EBD) therapy for Alzheimer's disease[10] Anticipated Milestones Acumen anticipates reporting topline results for its Phase 2 ALTITUDE-AD study in late 2026 and expects a decision to advance an oligomer-targeted Enhanced Brain Delivery product candidate in early 2026, following non-clinical data - Expect to report topline results for ALTITUDE-AD, a Phase 2 study investigating sabirnetug for early Alzheimer's disease, in late 2026[5][10] - Expect a decision to advance an oligomer-targeted Enhanced Brain Delivery product candidate in early 2026, supported by non-clinical data[5][10] Second Quarter 2025 Financial Results Acumen Pharmaceuticals reports a net loss increase in Q2 2025, primarily driven by higher research and development expenses, with cash reserves expected to fund operations into early 2027 Overview of Financial Performance Acumen reported a net loss of $41.0 million for Q2 2025, an increase from $20.5 million in Q2 2024, primarily driven by higher research and development expenses. The company's cash, cash equivalents, and marketable securities totaled $166.2 million as of June 30, 2025, expected to fund operations into early 2027 | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(40,950) | $(20,537) | $(20,413) | | Loss from Operations | $(41,750) | $(24,381) | $(17,369) | | Metric | As of June 30, 2025 (in millions) | As of March 31, 2025 (in millions) | | :----- | :-------------------------------- | :--------------------------------- | | Cash, cash equivalents and marketable securities | $166.2 | $197.9 | - Cash, cash equivalents and marketable securities of $166.2 million as of June 30, 2025, are expected to support current clinical and operational activities into early 2027[5][10] Operating Expenses Research and Development (R&D) expenses significantly increased to $37.1 million in Q2 2025 from $19.5 million in Q2 2024, mainly due to higher manufacturing, materials, and CRO costs for the ALTITUDE-AD trial. General and Administrative (G&A) expenses slightly decreased to $4.6 million from $4.8 million due to minor reductions in insurance and recruiting costs | Expense Category | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :--------------- | :--------------------- | :--------------------- | :----------- | | Research and Development | $37,125 | $19,533 | +$17,592 | | General and Administrative | $4,625 | $4,848 | $(223) | - The increase in R&D expenses was primarily due to increased costs for manufacturing and materials, as well as CRO costs associated with the ALTITUDE-AD clinical trial[10] - The decrease in G&A expenses was primarily due to immaterial decreases in insurance and recruiting costs[15] Product & Pipeline Information Acumen details its lead product candidate, sabirnetug (ACU193), its ongoing Phase 2 ALTITUDE-AD study, and the Enhanced Brain Delivery (EBD) program collaboration About Sabirnetug (ACU193) Sabirnetug (ACU193) is a humanized monoclonal antibody specifically designed to target soluble amyloid beta oligomers (AβOs), which are considered highly toxic and pathogenic in Alzheimer's disease. It has received Fast Track designation from the U.S. FDA for early AD treatment - Sabirnetug (ACU193) is a humanized monoclonal antibody developed for its selectivity for soluble amyloid beta oligomers (AβOs), a highly toxic and pathogenic form of Aβ[13] - Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration[13] About ALTITUDE-AD (Phase 2 Study) ALTITUDE-AD is an ongoing Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial initiated in 2024. It evaluates the efficacy and safety of sabirnetug in slowing cognitive and functional decline in 542 participants with early Alzheimer's disease across sites in the U.S., Canada, EU, and UK - 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) in slowing cognitive and functional decline[14] - The study has enrolled 542 individuals with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD)[14] - Investigative sites are located in the United States, Canada, the European Union, and the United Kingdom[14][16] Enhanced Brain Delivery (EBD) Program The EBD program is a collaboration with JCR Pharmaceuticals to develop an oligomer-targeted therapy for Alzheimer's disease, utilizing JCR's proprietary J-Brain Cargo® blood-brain barrier-penetrating technology combined with Acumen's AβO-targeting antibodies - Acumen is collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD) therapy for Alzheimer's disease[3][10][17] - The EBD program utilizes JCR's blood-brain barrier-penetrating technology (J-Brain Cargo®) combined with Acumen's AβO-selective antibodies[10][17] Corporate Information Acumen Pharmaceuticals provides an overview of its corporate structure, details of its Q2 2025 conference call, disclaimers regarding forward-looking statements, and investor/media contacts About Acumen Pharmaceuticals, Inc. Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company headquartered in Newton, Mass., focused on developing therapeutics targeting toxic soluble AβOs for AD. Its pipeline includes sabirnetug (ACU193) in Phase 2, a subcutaneous formulation of sabirnetug, and the EBD therapy collaboration with JCR - 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[17] - The company is advancing its investigational product candidate, sabirnetug (ACU193), in its ongoing Phase 2 clinical trial ALTITUDE-AD and investigating a subcutaneous formulation of sabirnetug[17] - Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD™) therapy for Alzheimer's disease[17] Conference Call Details Acumen hosted a conference call and live audio webcast on August 12, 2025, at 8:00 a.m. ET to discuss the financial results and business update. An archived version of the webcast is available on the company's website - Acumen hosted a conference call and live audio webcast on August 12, 2025, at 8:00 a.m. ET[5][11] - An archived version of the webcast will be available for at least 30 days in the Investors section of the Company's website[12] Forward-Looking Statements The press release contains forward-looking statements regarding Acumen's goals, expectations, financial projections, and pipeline development, which are subject to risks and uncertainties inherent in drug development and macroeconomic conditions. The company disclaims any obligation to update these statements - The press release contains forward-looking statements concerning Acumen's business, strategic and financial goals, therapeutic potential of sabirnetug, timing of ALTITUDE-AD results, and EBD technology development[18] - These statements are based upon current beliefs and expectations and are subject to certain factors, risks, and uncertainties inherent in the process of discovering, developing, and commercializing human therapeutics, amplified by geopolitical events and macroeconomic conditions[18] Contacts Contact information for investor relations and media inquiries is provided - Investor contact: Alex Braun (abraun@acumenpharm.com)[19] - Media contact: AcumenPR@westwicke.com[19] Financial Statements Acumen presents its balance sheets, statements of operations, and cash flows, detailing assets, liabilities, equity, and financial performance for the periods ended June 30, 2025 Balance Sheets The balance sheets present Acumen's assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, showing a decrease in total assets and stockholders' equity over the period | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $36,810 | $35,627 | | Marketable securities, short-term | $106,559 | $135,930 | | Prepaid expenses and other current assets | $5,035 | $6,749 | | Total current assets | $148,404 | $178,306 | | Marketable securities, long-term | $22,797 | $59,968 | | Restricted cash | $232 | $232 | | Other assets, long-term | $464 | $486 | | Total assets | $171,897 | $238,992 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Accounts payable | $2,103 | $5,648 | | Accrued clinical trial expenses | $11,108 | $15,344 | | Accrued expenses and other current liabilities | $11,650 | $6,615 | | Total current liabilities | $24,861 | $27,607 | | Debt, long-term | $29,882 | $29,419 | | Other liabilities, long-term | $77 | $150 | | Total liabilities | $54,820 | $57,176 | | Total stockholders' equity | $117,077 | $181,816 | Statements of Operations and Comprehensive Loss The statements detail the company's operating expenses, loss from operations, and net loss for the three and six months ended June 30, 2025, and 2024, indicating a significant increase in net loss year-over-year due to higher R&D expenses | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $37,125 | $19,533 | $62,391 | $31,982 | | General and administrative | $4,625 | $4,848 | $9,729 | $10,173 | | Total operating expenses | $41,750 | $24,381 | $72,120 | $42,155 | | Loss from operations | $(41,750) | $(24,381) | $(72,120) | $(42,155) | | Interest income | $2,015 | $3,816 | $4,486 | $7,821 | | Interest expense | $(1,046) | $(1,004) | $(2,069) | $(2,004) | | Change in fair value of embedded derivatives | $(40) | $1,100 | $150 | $1,050 | | Other expense, net | $(129) | $(68) | $(193) | $(122) | | Total other income | $800 | $3,844 | $2,374 | $6,745 | | Net loss | $(40,950) | $(20,537) | $(69,746) | $(35,410) | | Unrealized gain (loss) on marketable securities | $8 | $(20) | $71 | $(476) | | Comprehensive loss | $(40,942) | $(20,557) | $(69,675) | $(35,886) | | Net loss per common share, basic and diluted | $(0.68) | $(0.34) | $(1.15) | $(0.59) | | Weighted-average shares outstanding, basic and diluted | 60,573,425 | 60,079,778 | 60,549,658 | 59,945,889 | Statements of Cash Flows The cash flow statements show that for the six months ended June 30, 2025, net cash used in operating activities increased significantly, while net cash provided by investing activities also increased, primarily from marketable securities. Net cash used in financing activities was minimal | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(69,746) | $(35,410) | | Depreciation | $31 | $33 | | Stock-based compensation expense | $4,972 | $4,954 | | Amortization of premiums and accretion of discounts on marketable securities, net | $(644) | $(3,222) | | Change in fair value of embedded derivatives | $(150) | $(1,050) | | Amortization of right-of-use asset | $61 | $56 | | Realized gain on marketable securities | $(3) | $(2) | | Non-cash interest expense | $613 | $539 | | Changes in operating assets and liabilities: Prepaid expenses and other current assets | $1,714 | $(3,350) | | Other long-term assets | $18 | $(7) | | Accounts payable | $(3,545) | $2,823 | | Accrued clinical trial expenses | $(4,236) | $2,640 | | Accrued expenses and other liabilities | $4,962 | $(2,385) | | Finance lease liability | $— | $(23) | | Net cash used in operating activities | $(65,953) | $(34,404) | | Purchases of marketable securities | $(38,056) | $(57,093) | | Proceeds from maturities and sales of marketable securities | $105,316 | $85,605 | | Purchases of property and equipment | $(88) | $(16) | | Net cash provided by investing activities | $67,172 | $28,496 | | 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 | $— | $(188) | | Repurchase of common shares to pay employee withholding taxes | $(73) | $(32) | | Net cash provided by (used in) financing activities | $(36) | $6,979 | | Net change in cash and cash equivalents and restricted cash | $1,183 | $1,071 | | 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 | $37,042 | $68,190 |