Acumen Pharmaceuticals(ABOS) - 2025 Q2 - Quarterly Report

Cover Page This section provides an overview of Acumen Pharmaceuticals, Inc.'s Quarterly Report on Form 10-Q, including filing details and company classification - Acumen Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025[1][2] - The company's common stock (ABOS) is registered on The Nasdaq Global Select Market[5] - Acumen Pharmaceuticals is classified as a Non-accelerated filer, a Smaller reporting company, and an Emerging growth company[8] - As of August 8, 2025, the company had 60,573,425 shares of common stock outstanding[8] Special Note Regarding Forward-Looking Statements This section highlights the inherent risks and uncertainties associated with forward-looking statements regarding the company's future operations and financial condition - This report contains forward-looking statements about the company's future results of operations, financial condition, business strategy, and plans, which involve substantial risks and uncertainties[13] - Key areas of forward-looking statements include the sufficiency of existing cash, ability to obtain funding, clinical trial safety and efficacy of sabirnetug, therapeutic potential of sabirnetug, development activities, commercialization plans, intellectual property rights, regulatory approval, and financial performance[14] - The company operates in a competitive and rapidly changing environment, and actual results may differ materially from those described in forward-looking statements due to various risks and uncertainties[15] PART I. FINANCIAL INFORMATION This part presents the company's unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements (Unaudited) This section presents Acumen Pharmaceuticals, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows, along with their accompanying notes, for the periods ended June 30, 2025 Condensed Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific points in time Key Balance Sheet Data (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $36,810 | $35,627 | $1,183 | 3.32% | | Marketable securities, short-term | $106,559 | $135,930 | $(29,371) | -21.61% | | Total current assets | $148,404 | $178,306 | $(29,902) | -16.77% | | Marketable securities, long-term | $22,797 | $59,968 | $(37,171) | -62.00% | | Total assets | $171,897 | $238,992 | $(67,095) | -28.07% | | Accounts payable | $2,103 | $5,648 | $(3,545) | -62.77% | | Accrued clinical trial expenses | $11,108 | $15,344 | $(4,236) | -27.61% | | Accrued expenses and other current liabilities | $11,650 | $6,615 | $5,035 | 76.12% | | Total current liabilities | $24,861 | $27,607 | $(2,746) | -9.95% | | Total liabilities | $54,820 | $57,176 | $(2,356) | -4.12% | | Total stockholders' equity | $117,077 | $181,816 | $(64,739) | -35.61% | Condensed Statements of Operations and Comprehensive Loss This section outlines the company's financial performance over specific periods, reporting revenues, expenses, and net loss Operating Results (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | Change (%) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | :------------------------------ | :------------------------------ | :--------- | :--------- | | Research and development | $37,125 | $19,533 | $17,592 | 90% | $62,391 | $31,982 | $30,409 | 95% | | General and administrative | $4,625 | $4,848 | $(223) | -5% | $9,729 | $10,173 | $(444) | -4% | | Total operating expenses | $41,750 | $24,381 | $17,369 | 71% | $72,120 | $42,155 | $29,965 | 71% | | Net loss | $(40,950) | $(20,537) | $(20,413) | -99% | $(69,746) | $(35,410) | $(34,336) | -97% | | Net loss per common share, basic and diluted | $(0.68) | $(0.34) | $(0.34) | -100% | $(1.15) | $(0.59) | $(0.56) | -95% | Condensed Statements of Changes in Stockholders' Equity This section details the changes in the company's equity accounts, including net loss, stock-based compensation, and stock issuances, over specific periods Changes in Stockholders' Equity (in thousands) for Six Months Ended June 30, 2025 | Item | Amount | | :------------------------------------ | :------- | | Balance as of December 31, 2024 | $181,816 | | Issuance of common stock for RSUs, net | $(73) | | Stock options exercised for cash | $37 | | Unrealized gain on marketable securities | $71 | | Stock-based compensation | $4,972 | | Net loss | $(69,746) | | Balance as of June 30, 2025 | $117,077 | Changes in Stockholders' Equity (in thousands) for Six Months Ended June 30, 2024 | Item | Amount | | :------------------------------------ | :------- | | Balance as of December 31, 2023 | $266,973 | | Issuance of common stock for cash, net | $7,938 | | Issuance of common stock for RSUs, net | $(32) | | Unrealized loss on marketable securities | $(476) | | Stock-based compensation | $4,954 | | Net loss | $(35,410) | | Balance as of June 30, 2024 | $243,947 | Condensed Statements of Cash Flows This section summarizes the inflows and outflows of cash from operating, investing, and financing activities over specific periods Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | :--------- | | Net cash used in operating activities | $(65,953) | $(34,404) | $(31,549) | | Net cash provided by investing activities | $67,172 | $28,496 | $38,676 | | Net cash provided by (used in) financing activities | $(36) | $6,979 | $(7,015) | | Net change in cash and cash equivalents | $1,183 | $1,071 | $112 | Notes to Condensed Financial Statements This section provides additional information and explanations for the figures presented in the condensed financial statements NOTE 1. Description of Organization and Business Operations This note describes Acumen Pharmaceuticals as a clinical-stage biopharmaceutical company focused on Alzheimer's disease and its financial position - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing a novel disease-modifying approach for Alzheimer's disease (AD), targeting soluble amyloid-beta oligomers (AßOs)[37] - The company is advancing its drug candidate, sabirnetug, in a Phase 2 ALTITUDE-AD clinical trial, having completed enrollment in March 2025, following positive Phase 1 INTERCEPT-AD results reported in July 2023[37][41] - As of June 30, 2025, the company had an accumulated deficit of $394.9 million and working capital of $123.5 million, and expects existing cash to fund operations for over 12 months[38] NOTE 2. Basis of Presentation and Summary of Significant Accounting Policies This note outlines the accounting principles used in preparing the financial statements and discusses the impact of new accounting standards - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP for interim financial information, with no material changes to significant accounting policies previously disclosed in the Annual Report[43][44] - The Company is evaluating the disclosure impact of recently issued ASUs, including ASU 2023-09 (Income Taxes), ASU 2024-03 (Expense Disaggregation), and ASU 2024-04 (Convertible Debt), none of which are expected to materially impact financial position, results of operations, or cash flows[58][59][60] NOTE 3. Marketable Securities This note provides details on the company's marketable securities, including their fair value and unrealized gains or losses Marketable Securities Fair Value (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total available-for-sale securities | $129,356 | $195,898 | | Gross Unrealized Gains | $100 | $163 | | Gross Unrealized Losses | $(77) | $(211) | - As of June 30, 2025, none of the available-for-sale marketable securities have been in a continuous unrealized loss position for more than 12 months[63] NOTE 4. Fair Value Measurements This note describes the valuation techniques and inputs used to measure the fair value of certain assets and liabilities Fair Value Measurements (in thousands) as of June 30, 2025 | Asset/Liability | Level 1 | Level 2 | Level 3 | Total Fair Value | | :-------------------------- | :------ | :-------- | :------ | :--------------- | | Money market securities | $36,578 | — | — | $36,578 | | Corporate debt securities | — | $111,331 | — | $111,331 | | Government and agency - U.S. | — | $18,025 | — | $18,025 | | Embedded derivatives liability | — | — | $820 | $820 | - The fair value of the embedded derivatives liability decreased by $150 thousand during the six months ended June 30, 2025, from $970 thousand to $820 thousand[70] NOTE 5. Supplemental Financial Information This note provides additional detail on prepaid expenses, other assets, accrued expenses, and other liabilities Prepaid Expenses and Other Assets (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid Expenses and Other Current Assets | $5,035 | $6,749 | | Other Long-Term Assets | $464 | $486 | | Total Prepaid Expenses and Other Assets | $5,499 | $7,235 | Accrued Expenses and Other Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued Expenses and Other Current Liabilities | $11,650 | $6,615 | | Other Long-Term Liabilities | $77 | $150 | | Total Accrued Expenses and Other Liabilities | $11,727 | $6,765 | NOTE 6. Debt This note details the company's debt obligations, including the Term Loan facility, its terms, and principal payment schedule - The company has a Term Loan facility of $50.0 million, with $30.0 million borrowed in the first tranche, maturing on November 1, 2027 (extendable to 2028)[76] - The effective interest rate for the Term Loan was 14.1% for the three months ended June 30, 2025, and 14.0% for the six months ended June 30, 2025[82] Aggregate Principal Payments Due for Term Loan (in thousands) | Year | Amount | | :------------------------- | :------- | | Year ended December 31, 2026 | $10,104 | | Year ended December 31, 2027 | $21,531 | | Total | $31,635 | NOTE 7. Stockholders' Equity This note provides information on the company's common stock, authorized shares, and equity transactions, including ATM offerings and warrants - The company has 300,000,000 shares of common stock authorized[84] - No shares of common stock were sold under the at-the-market (ATM) offering program during the six months ended June 30, 2025, compared to 2,068,246 shares sold for $7.9 million net proceeds in the same period of 2024[87] - A Loan Warrant to purchase 730,769 shares of common stock at an exercise price of $1.95 remains outstanding as of June 30, 2025[91] NOTE 8. Stock-Based Compensation This note details the stock-based compensation expense recognized and the unrecognized compensation costs for options and RSUs Total Stock-Based Compensation Expense (in thousands) | Period | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :----- | :----- | :--------- | :--------- | | Three Months Ended June 30, | $2,498 | $2,470 | $28 | 1.13% | | Six Months Ended June 30, | $4,972 | $4,954 | $18 | 0.36% | - As of June 30, 2025, total unrecognized compensation costs were approximately $12.8 million for stock options (expected to be recognized over 2.5 years) and $4.3 million for unvested RSUs (expected over 2.0 years)[98][101] NOTE 9. Segment Reporting This note clarifies that the company operates as a single segment focused on research and development for Alzheimer's disease - The company manages its operations as a single operating segment focused on the research and development of sabirnetug for Alzheimer's disease[103][114] Segment Net Loss (in thousands) | Period | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------- | :----- | :----- | :--------- | :--------- | | Three Months Ended June 30, | $40,950 | $20,537 | $20,413 | 99.4% | | Six Months Ended June 30, | $69,746 | $35,410 | $34,336 | 97.0% | NOTE 10. Commitments and Contingencies This note discloses the company's material legal proceedings, collaboration agreements, and manufacturing commitments - The company is not a party to any material legal proceedings[107] - Entered into a Non-exclusive Collaboration and License Agreement with Halozyme in November 2023 for a subcutaneous formulation of sabirnetug, involving an upfront payment and potential milestone and royalty payments[108] - Entered into a License Agreement with Lonza in November 2022 for manufacturing sabirnetug, involving an upfront fee and future royalty and annual payments[109] NOTE 11. Subsequent Events This note reports significant events that occurred after the balance sheet date, including a new collaboration agreement with JCR Pharmaceuticals - In July 2025, the company entered into a collaboration, option, and license agreement with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery (EBD) therapy for AD[110] - JCR is eligible for future milestone payments of up to $40 million for development and up to $515 million for sales, plus single-digit royalties, if the company exercises its option to develop candidates[112] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, results of operations, and liquidity for the periods presented, highlighting key business developments, financial performance drivers, and future outlook Overview This section provides a high-level summary of the company's business, strategic focus, recent financial performance, and liquidity position - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing sabirnetug for Alzheimer's disease, with Phase 2 ALTITUDE-AD trial enrollment completed in March 2025 and topline results expected in late 2026[114] - The company reported net losses of $69.7 million for the six months ended June 30, 2025, and an accumulated deficit of $394.9 million, primarily driven by increased research and development spending[120] - A collaboration with JCR Pharmaceuticals was initiated in July 2025 to develop an oligomer-targeted Enhanced Brain Delivery (EBD) therapy for AD, strengthening Acumen's portfolio[116] - As of June 30, 2025, the company had $166.2 million in cash, cash equivalents, and marketable securities, which are expected to fund operations into early 2027[122] Components of Results of Operations This section explains the primary drivers of the company's financial results, including research and development, general and administrative expenses, and other income/expense - Research and development expenses primarily include direct costs for consultants, materials, CROs, CMOs, license agreements, and personnel, with a substantial increase expected due to ongoing clinical development of sabirnetug[124] - General and administrative expenses cover employee-related costs, professional fees (legal, accounting, patent), and public company operating expenses, which are anticipated to rise with organizational growth and compliance requirements[125][126] - Other income (expense) comprises interest income from marketable securities, interest expense from the Term Loan, and changes in the fair value of embedded derivatives[127] Results of Operations This section analyzes the company's financial performance by comparing key operating metrics across different reporting periods Comparison of the Three Months Ended June 30, 2025 and 2024 This section compares the company's financial performance for the three-month periods ended June 30, 2025, and 2024 - Net loss increased by 99% to $41.0 million for the three months ended June 30, 2025, compared to $20.5 million in the prior year[129] - Research and development expenses surged by 90% ($17.6 million increase) to $37.1 million, mainly due to higher manufacturing, materials, and CRO costs for the ALTITUDE-AD clinical trial[130] - Other income decreased by 79% ($3.0 million decrease) to $0.8 million, primarily due to lower interest income from marketable securities and a decrease in the fair value of embedded derivatives[132] Comparison of the Six Months Ended June 30, 2025 and 2024 This section compares the company's financial performance for the six-month periods ended June 30, 2025, and 2024 - Net loss increased by 97% to $69.7 million for the six months ended June 30, 2025, compared to $35.4 million in the prior year[133] - Research and development expenses rose by 95% ($30.4 million increase) to $62.4 million, driven by increased manufacturing, materials, and CRO costs related to the ALTITUDE-AD clinical trial[134] - Other income decreased by 65% ($4.3 million decrease) to $2.4 million, mainly due to reduced interest income from marketable securities and a decrease in the fair value of embedded derivatives[136] Liquidity and Capital Resources This section assesses the company's ability to meet its short-term and long-term financial obligations and its sources of funding Cash Flows This section analyzes the changes in cash from operating, investing, and financing activities for the reporting periods - Net cash used in operating activities increased by $31.6 million to $66.0 million for the six months ended June 30, 2025, primarily due to the increased net loss[145] - Net cash provided by investing activities increased by $38.7 million to $67.2 million, driven by higher proceeds from marketable securities maturities and reduced purchases[146] - Net cash provided by financing activities was immaterial for the six months ended June 30, 2025, a $7.0 million decrease from the prior year, which included proceeds from common stock issuance under the ATM[147] Funding Requirements This section discusses the company's anticipated capital needs and the factors influencing future funding requirements - The company expects its existing cash, cash equivalents, and marketable securities to be sufficient to fund operating expenses and capital expenditure requirements into early 2027[149] - Future funding requirements are highly dependent on the progress, costs, and timing of clinical trials (ALTITUDE-AD), regulatory approvals, expansion of product candidates, commercialization efforts, intellectual property, and personnel needs[150] - Additional funding may be required sooner than anticipated if spending increases or if the company expands more rapidly, with potential impacts including dilution to stockholders or debt covenants[149][151] Critical Accounting Policies, Significant Judgments and Use of Estimates This section highlights the accounting policies that require management's most difficult, subjective, or complex judgments and estimates - The preparation of financial statements requires management to make estimates and assumptions, which are based on historical experience and other reasonable factors[152] - There have been no significant changes to the company's critical accounting policies that require significant judgments and estimates from those disclosed in its Annual Report on Form 10-K[154] Emerging Growth Company and Smaller Reporting Company Status This section explains the company's classification as an emerging growth company and smaller reporting company and the associated regulatory benefits - Acumen Pharmaceuticals qualifies as both an 'emerging growth company' (EGC) and a 'smaller reporting company' (SRC)[155][159] - As an EGC, the company has elected to use the extended transition period for complying with new or revised accounting standards and benefits from reduced disclosure requirements, including exemptions from auditor attestation and certain executive compensation disclosures[155][156] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that market risk disclosures are not applicable to the company due to its status as a smaller reporting company - Quantitative and qualitative disclosures about market risk are not applicable to the company as it qualifies as a smaller reporting company[160] Item 4. Controls and Procedures This section details the management's evaluation of the effectiveness of the company's disclosure controls and procedures and confirms no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[162] - There were no changes in internal control over financial reporting during the fiscal quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[163] PART II. OTHER INFORMATION This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures Item 1. Legal Proceedings This section confirms that the company is not currently involved in any material legal proceedings or aware of any pending or threatened claims that would have a material adverse effect on its business - The company is not subject to any material legal proceedings and is not currently a party to any legal proceedings likely to have a material adverse effect on its business[168] Item 1A. Risk Factors This section refers readers to the company's Annual Report on Form 10-K for a comprehensive discussion of risk factors and states that there have been no material changes to these risks - There have been no material changes to the risk factors described in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024[169] Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities This section reports that there were no unregistered sales of equity securities or issuer purchases, and the planned use of proceeds from the initial public offering remains unchanged - There were no unregistered sales of equity securities or issuer purchases of equity securities during the reporting period[170][172] - There has been no material change in the planned use of proceeds from the company's initial public offering (IPO)[171] Item 3. Defaults Upon Senior Securities This section states that there are no defaults upon senior securities to report - This item is not applicable[173] Item 4. Mine Safety Disclosures This section indicates that mine safety disclosures are not applicable to the company - This item is not applicable[174] Item 5. Other Information This section discloses that certain officers entered into Rule 10b5-1 trading plans during the quarter to facilitate the sale of common stock for tax and fee coverage related to RSU vesting - In June 2025, the Chief Operating Officer, Chief Executive Officer, and Chief Financial Officer/Chief Business Officer each entered into Rule 10b5-1 trading plans[175][176][177] - These plans allow for the sale of common stock to cover taxes, commissions, and fees associated with the vesting of RSU awards, with sales scheduled between January 2026 and December 2028[175][176][177] Item 6. Exhibits This section provides a list of exhibits filed as part of the Quarterly Report on Form 10-Q, including organizational documents, agreements, and certifications - The report includes various exhibits such as the Amended and Restated Certificate of Incorporation, Bylaws, a Collaboration, Option, and License Agreement with JCR Pharmaceuticals, and certifications from the Principal Executive and Financial Officers[178] Signatures This section contains the official signatures of the company's authorized officers, certifying the accuracy of the report - The report was signed on August 12, 2025, by Daniel O'Connell, Chief Executive Officer, and Matthew Zuga, Chief Financial Officer and Chief Business Officer[182]