Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Core Insights - The company has achieved progress with two approved traditional disease-modifying treatment options available for patients [1] - The development of Sabirnetug as an A-beta oligomer-directed antibody is seen as a distinct approach to address disease pathology, potentially offering better efficacy and safety [1] - Sabirnetug has been intentionally developed to neutralize toxic species, indicating a unique position in the treatment landscape [1] - The company envisions that the field will continue to evolve, with oligomer-directed treatment approaches like Sabirnetug being the best option for patients [1]

Acumen Pharmaceuticals (ABOS) Conference Summary Company Overview - **Company**: Acumen Pharmaceuticals (ABOS) - **Industry**: Alzheimer's Disease Treatment Key Points and Arguments Alzheimer's Treatment Landscape - The launch of Leukembi and Kisanla marks a significant milestone with two approved disease-modifying treatment options available for Alzheimer's patients [3][3] - Acumen is developing Sabranatug, an A-beta oligomer directed antibody, which aims to provide a distinct treatment option focusing on efficacy and safety [3][3] Scientific Basis and Research - There is a growing body of evidence supporting the hypothesis that A-beta oligomers are toxic species contributing to Alzheimer's pathology [4][4] - Acumen believes that the A-beta oligomer hypothesis has yet to be fully clinically validated, but they are well-positioned to provide conclusive evidence through their ongoing studies [5][5] Treatment Mechanisms - The complexity of Alzheimer's disease suggests that no single therapy will be effective for all patients; thus, a differentiated mechanism targeting toxic soluble oligomers is essential [8][8] - The company is optimistic about the combinability of Sabranatug with other treatments, anticipating that future treatment will likely involve multiple agents targeting various disease mechanisms [12][12] Biomarkers and Diagnosis - Fluid biomarkers are enhancing the ability to diagnose Alzheimer's disease, allowing for better patient staging and treatment targeting [19][19] - The phospho-tau 217 plasma biomarker has significantly improved the speed and efficiency of patient enrollment in clinical studies [15][15] AI and Machine Learning - There is interest in utilizing AI and machine learning to analyze diverse datasets, including EEG, biomarkers, and clinical assessments, to improve treatment outcomes [23][23] - The quality and scale of datasets remain a challenge, with a shift towards proprietary data management among companies in the field [42][42] Subcutaneous Formulation Development - Acumen is developing a subcutaneous formulation of Sabranatug, which could offer greater flexibility and ease of use for patients [55][55] - The collaboration with JCR Pharmaceuticals aims to enhance brain delivery of the drug, potentially allowing for lower dosing requirements while maintaining efficacy [57][57] Future Directions - The company is optimistic about the potential for Sabranatug to demonstrate a favorable risk-benefit profile in upcoming studies, particularly the ALTITUDE AD study [45][45] - There is ongoing exploration of other therapeutic targets, including tau and inflammatory pathways, which may complement existing A-beta and tau strategies [67][67][70][70] Market Dynamics - The Alzheimer's treatment landscape is characterized by high unmet needs and ongoing challenges, with Acumen positioning itself to address these through innovative approaches [65][65] - The potential for GLP-1 therapies to complement existing strategies is being closely monitored, with upcoming readouts expected to influence market sentiment [67][67] Additional Important Insights - The cost differential between blood tests and PET scans is significant, with blood tests being ten times cheaper, indicating a shift towards more efficient diagnostic methods [31][31] - The complexity of tau biology presents challenges, but ongoing studies may provide insights into effective tau-targeted interventions [37][37] This summary encapsulates the key discussions and insights from the Acumen Pharmaceuticals conference, highlighting the company's strategic focus on innovative Alzheimer's treatments and the evolving landscape of the industry.

[Cover Page](index=1&type=section&id=Cover%20Page) 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](index=1&type=chunk)[2](index=2&type=chunk) - The company's common stock (ABOS) is registered on The Nasdaq Global Select Market[5](index=5&type=chunk) - Acumen Pharmaceuticals is classified as a Non-accelerated filer, a Smaller reporting company, and an Emerging growth company[8](index=8&type=chunk) - As of August 8, 2025, the company had **60,573,425 shares of common stock outstanding**[8](index=8&type=chunk) [Special Note Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) 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](index=13&type=chunk) - 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](index=14&type=chunk) - 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](index=15&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) 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)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(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](index=6&type=section&id=Condensed%20Balance%20Sheets) 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 | $(64,739) | -35.61% | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance over specific periods, reporting revenues, expenses, and net loss Operating Results (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change ($) | 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](index=8&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) 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 | $243,947 | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section summarizes the inflows and outflows of cash from operating, investing, and financing activities over specific periods Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | :--------- | | 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](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides additional information and explanations for the figures presented in the condensed financial statements [NOTE 1. Description of Organization and Business Operations](index=11&type=section&id=NOTE%201.%20DESCRIPTION%20OF%20ORGANIZATION%20AND%20BUSINESS%20OPERATIONS) 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](index=37&type=chunk) - 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](index=37&type=chunk)[41](index=41&type=chunk) - 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](index=38&type=chunk) [NOTE 2. Basis of Presentation and Summary of Significant Accounting Policies](index=12&type=section&id=NOTE%202.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) 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](index=43&type=chunk)[44](index=44&type=chunk) - 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](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) [NOTE 3. Marketable Securities](index=14&type=section&id=NOTE%203.%20MARKETABLE%20SECURITIES) 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](index=63&type=chunk) [NOTE 4. Fair Value Measurements](index=15&type=section&id=NOTE%204.%20FAIR%20VALUE%20MEASUREMENTS) 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](index=70&type=chunk) [NOTE 5. Supplemental Financial Information](index=17&type=section&id=NOTE%205.%20SUPPLEMENTAL%20FINANCIAL%20INFORMATION) 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](index=18&type=section&id=NOTE%206.%20DEBT) 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](index=76&type=chunk) - 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](index=82&type=chunk) 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](index=19&type=section&id=NOTE%207.%20STOCKHOLDERS'%20EQUITY) 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](index=84&type=chunk) - 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](index=87&type=chunk) - A Loan Warrant to purchase **730,769 shares of common stock** at an exercise price of **$1.95** remains outstanding as of June 30, 2025[91](index=91&type=chunk) [NOTE 8. Stock-Based Compensation](index=20&type=section&id=NOTE%208.%20STOCK-BASED%20COMPENSATION) This note details the stock-based compensation expense recognized and the unrecognized compensation costs for options and RSUs Total Stock-Based Compensation Expense (in thousands) | Period | 2025 | 2024 | Change ($) | 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 **$4.3 million** for unvested RSUs (expected over 2.0 years)[98](index=98&type=chunk)[101](index=101&type=chunk) [NOTE 9. Segment Reporting](index=22&type=section&id=NOTE%209.%20SEGMENT%20REPORTING) This note clarifies that the company operates as a single segment focused on research and development for Alzheimer's disease - The company manages its operations as a single operating segment focused on the research and development of sabirnetug for Alzheimer's disease[103](index=103&type=chunk)[114](index=114&type=chunk) Segment Net Loss (in thousands) | Period | 2025 | 2024 | Change ($) | 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](index=23&type=section&id=NOTE%2010.%20COMMITMENTS%20AND%20CONTINGENCIES) 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](index=107&type=chunk) - 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](index=108&type=chunk) - Entered into a License Agreement with Lonza in November 2022 for manufacturing sabirnetug, involving an upfront fee and future royalty and annual payments[109](index=109&type=chunk) [NOTE 11. Subsequent Events](index=23&type=section&id=NOTE%2011.%20SUBSEQUENT%20EVENTS) 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](index=110&type=chunk) - 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](index=112&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=25&type=section&id=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](index=114&type=chunk) - 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](index=120&type=chunk) - 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](index=116&type=chunk) - 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](index=122&type=chunk) [Components of Results of Operations](index=27&type=section&id=Components%20of%20Results%20of%20Operations) 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](index=124&type=chunk) - 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](index=125&type=chunk)[126](index=126&type=chunk) - 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](index=127&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) 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](index=28&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) 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](index=129&type=chunk) - 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](index=130&type=chunk) - 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](index=132&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) 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](index=133&type=chunk) - 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](index=134&type=chunk) - 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](index=136&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations and its sources of funding [Cash Flows](index=30&type=section&id=Cash%20Flows) 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](index=145&type=chunk) - 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](index=146&type=chunk) - 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](index=147&type=chunk) [Funding Requirements](index=31&type=section&id=Funding%20Requirements) 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](index=149&type=chunk) - 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](index=150&type=chunk) - 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](index=149&type=chunk)[151](index=151&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) 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](index=152&type=chunk) - 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](index=154&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=32&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) 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](index=155&type=chunk)[159](index=159&type=chunk) - 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](index=155&type=chunk)[156](index=156&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=160&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=162&type=chunk) - 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](index=163&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=168&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) 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](index=169&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=170&type=chunk)[172](index=172&type=chunk) - There has been no material change in the planned use of proceeds from the company's initial public offering (IPO)[171](index=171&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there are no defaults upon senior securities to report - This item is not applicable[173](index=173&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - This item is not applicable[174](index=174&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) 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](index=175&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk) - 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](index=175&type=chunk)[176](index=176&type=chunk)[177](index=177&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) 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](index=178&type=chunk) [Signatures](index=37&type=section&id=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](index=182&type=chunk)

Financial Data and Key Metrics Changes - As of June 30, 2025, the company had $166.2 million in cash and marketable securities, expected to support operations into early 2027 [19] - R&D expenses for Q2 2025 were $37.1 million, an increase attributed to manufacturing materials for the ALPITUDE AD clinical trial and increased clinical expenses due to full enrollment [19] - G&A expenses were $4.6 million, roughly flat compared to the same period last year, leading to a loss from operations of $41.7 million and a net loss of $41 million for the quarter [19] Business Line Data and Key Metrics Changes - The ALPITUDE AD study is progressing well, with positive feedback from site investigators regarding study design and patient retention [7] - The company expects top-line results from the ALPITUDE AD study in late 2026, focusing on efficacy and safety measures [7][21] Market Data and Key Metrics Changes - The company noted an increase in clinical infrastructure for diagnosing and treating Alzheimer's disease, with positive feedback from key opinion leaders (KOLs) [8][9] - The approval of the first blood-based biomarker by the FDA is expected to revolutionize early diagnosis and expand demand for anti-amyloid treatments [10] Company Strategy and Development Direction - The company announced a strategic collaboration with JCR Pharmaceuticals to develop an Alzheimer's disease product that combines its antibody expertise with JCR's blood-brain barrier technology [11][12] - The partnership aims to enhance the delivery of oligomer-targeted therapeutics to the brain, with development decisions for up to two product candidates expected in early 2026 [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing clinical infrastructure and blood-based diagnostic options, which could benefit patients and expand treatment demand [11] - The company remains dedicated to delivering next-generation treatment options for Alzheimer's disease, with a focus on the potential of its products to provide differentiated benefits [21] Other Important Information - The collaboration with JCR Pharmaceuticals is seen as a capital-efficient way to expand the portfolio of oligomer-targeted candidates, with potential milestone payments and royalties outlined [20] - The company is excited about the optionality and potential value provided by the collaboration, awaiting preclinical candidate data in early 2026 [20] Q&A Session Summary Question: Discussion on AIC and Roche's brain shuttling technology - Management acknowledged the opportunity to enhance therapeutic delivery to the brain and emphasized the importance of targeting toxic synaptotoxic oligomers [25][26] Question: Feedback on PTL-217 testing and its utility - Management reported positive feedback from clinicians regarding the utility of the blood test used in the ALPITUDE study, which reduced costs and patient burden [33][34] Question: Differentiation of TCR technology and safety - Management highlighted the potential for better safety profiles and lower delivered doses with the JCR collaboration, aiming to reduce risks associated with amyloid-targeting therapies [39][43] Question: Integration of blood-based markers and payer coverage - Management indicated that payers are currently reimbursing for the FDA-approved blood test and expressed optimism about future coverage as clinical studies demonstrate efficacy [56] Question: Updates on biomarkers and ARIA rates - Management confirmed ongoing blinded phase two study results are consistent with previous findings, and they are monitoring various biomarkers for disease progression [62][63]

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company, provides an overview of its Alzheimer's disease therapeutics, recent operational innovations, and upcoming milestones [Company Overview](index=1&type=section&id=Company%20Overview) 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](index=2&type=chunk) - CEO Daniel O'Connell emphasized **strong operational execution** and the broadening portfolio with the addition of the Enhanced Brain Delivery (EBD) program[3](index=3&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) 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](index=6&type=chunk)[7](index=7&type=chunk) - 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](index=10&type=chunk) - 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](index=10&type=chunk) [Anticipated Milestones](index=1&type=section&id=Anticipated%20Milestones) 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](index=5&type=chunk)[10](index=10&type=chunk) - Expect a decision to advance an oligomer-targeted Enhanced Brain Delivery product candidate in **early 2026**, supported by non-clinical data[5](index=5&type=chunk)[10](index=10&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) 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](index=2&type=section&id=Overview%20of%20Financial%20Performance) 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](index=5&type=chunk)[10](index=10&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) 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](index=10&type=chunk) - The decrease in G&A expenses was primarily due to immaterial decreases in insurance and recruiting costs[15](index=15&type=chunk) [Product & Pipeline Information](index=3&type=section&id=Product%20%26%20Pipeline%20Information) 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)](index=3&type=section&id=About%20Sabirnetug%20(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](index=13&type=chunk) - Sabirnetug has been granted **Fast Track designation** for the treatment of early AD by the U.S. Food and Drug Administration[13](index=13&type=chunk) [About ALTITUDE-AD (Phase 2 Study)](index=3&type=section&id=About%20ALTITUDE-AD%20(Phase%202%20Study)) 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](index=14&type=chunk) - The study has enrolled **542 individuals** with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD)[14](index=14&type=chunk) - Investigative sites are located in the United States, Canada, the European Union, and the United Kingdom[14](index=14&type=chunk)[16](index=16&type=chunk) [Enhanced Brain Delivery (EBD) Program](index=1&type=section&id=Enhanced%20Brain%20Delivery%20(EBD)%20Program) 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](index=3&type=chunk)[10](index=10&type=chunk)[17](index=17&type=chunk) - The EBD program utilizes JCR's blood-brain barrier-penetrating technology (J-Brain Cargo®) combined with Acumen's AβO-selective antibodies[10](index=10&type=chunk)[17](index=17&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) 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.](index=4&type=section&id=About%20Acumen%20Pharmaceuticals%2C%20Inc.) 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](index=17&type=chunk) - 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](index=17&type=chunk) - Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery (EBD™) therapy for Alzheimer's disease[17](index=17&type=chunk) [Conference Call Details](index=3&type=section&id=Conference%20Call%20Details) 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](index=5&type=chunk)[11](index=11&type=chunk) - An archived version of the webcast will be available for at least **30 days** in the Investors section of the Company's website[12](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=18&type=chunk) - 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](index=18&type=chunk) [Contacts](index=5&type=section&id=Contacts) Contact information for investor relations and media inquiries is provided - Investor contact: Alex Braun (abraun@acumenpharm.com)[19](index=19&type=chunk) - Media contact: AcumenPR@westwicke.com[19](index=19&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) 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](index=6&type=section&id=Balance%20Sheets) 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](index=7&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=8&type=section&id=Statements%20of%20Cash%20Flows) 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 |

Core Viewpoint - Acumen Pharmaceuticals is advancing its clinical-stage biopharmaceutical efforts focused on developing novel therapeutics targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment, with significant operational progress and financial updates reported for Q2 2025 [1][2]. Recent Highlights - The company expects to report topline results for the ALTITUDE-AD Phase 2 study investigating sabirnetug (ACU193) for early Alzheimer's disease in late 2026 [4]. - A decision to advance an oligomer-targeted Enhanced Brain Delivery (EBDTM) product candidate is anticipated in early 2026 [4]. - As of June 30, 2025, Acumen had cash, cash equivalents, and marketable securities totaling $166.2 million, projected to support operations into early 2027 [4]. Financial Results - Research and Development (R&D) expenses for Q2 2025 were $37.1 million, up from $19.5 million in Q2 2024, primarily due to increased manufacturing and clinical trial costs [10]. - General and Administrative (G&A) expenses decreased slightly to $4.6 million in Q2 2025 from $4.8 million in Q2 2024 [10]. - The net loss for Q2 2025 was $41.0 million, compared to a net loss of $20.5 million in Q2 2024 [10]. Operational Innovations - Acumen implemented a two-step screening process in the ALTITUDE-AD trial using plasma pTau217 biomarker assay testing, achieving approximately 40% reduction in total screening costs across U.S. and Canadian sites [5]. - Sabirnetug demonstrated an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, supporting its mechanism of action [5]. Collaboration and Development - Acumen entered a collaboration with JCR Pharmaceuticals to develop an oligomer-targeted Enhanced Brain Delivery therapy, combining sabirnetug with JCR's blood-brain barrier-penetrating technology [5].

Company Overview - Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel therapeutic targeting toxic soluble amyloid beta oligomers for Alzheimer's disease treatment [3] - The company is advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody, currently in Phase 2 clinical trial ALTITUDE-AD for early symptomatic Alzheimer's disease patients [3] - Acumen's scientific founders have pioneered research on amyloid beta oligomers, which are recognized as early triggers of Alzheimer's disease pathology [3] Recent Developments - Acumen Pharmaceuticals will report its second quarter 2025 financial results on August 12, 2025, and will host a conference call and live audio webcast at 8:00 a.m. ET for a business and financial update [1] - The company is also investigating a subcutaneous formulation of sabirnetug using Halozyme's ENHANZE® drug delivery technology [3] - Acumen is collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery therapy for Alzheimer's disease utilizing a transferrin-receptor-targeting technology [3]

Core Insights - Acumen Pharmaceuticals has reported a 40% reduction in clinical trial screening costs through the implementation of a blood-based pTau217 screening assay in its Phase 2 ALTITUDE-AD study for early Alzheimer's disease [1][3][4] - The company’s investigational product, sabirnetug, has demonstrated superior selectivity for soluble amyloid beta oligomers (AβOs) compared to other treatments, indicating a differentiated mechanism of action [5][6] Company Overview - Acumen Pharmaceuticals is focused on developing therapies targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease, with its lead candidate being sabirnetug (ACU193) [10] - The company has received Fast Track designation from the U.S. FDA for sabirnetug, which is currently in a Phase 2 clinical trial [7][10] Clinical Trial Details - The ALTITUDE-AD trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sabirnetug in slowing cognitive decline in early Alzheimer's disease patients [9] - The trial has enrolled 542 participants across the U.S., Canada, the EU, and the UK, with a focus on improving patient-centric and cost-effective trial execution strategies [9][2] Screening Process Efficiency - The two-step screening process using plasma pTau217 biomarker testing resulted in 48% of participants meeting the threshold for confirmatory testing, with 81% of those passing the initial screening meeting amyloid positivity eligibility [4][3] - This innovative approach has led to strong enrollment rates and reduced the need for unnecessary amyloid PET scans and lumbar punctures [4][3] Mechanism of Action - Sabirnetug targets soluble AβOs, which are believed to be a significant factor in the neurodegenerative process of Alzheimer's disease, potentially slowing neurodegeneration and preventing synapse loss [5][7] - The product has shown an 8,750-fold selectivity for Aβ1-42 stabilized oligomers over Aβ1-40 monomers, highlighting its targeted action [6]