UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________ FORM 10-K __________________________ x Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: December 31, 2022 or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-40551 __________________________ Acumen Pharmaceuticals, Inc. (Exact name of registrant ...

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Alex Braun - Head IR Daniel O'Connell - President and CEO Eric Siemers - CMO Matt Zuga - CFO and CBO Conference Call Participants Tom Shrader - BTIG Judah Frommer - Credit Suisse Charlie Yang - Bank of America Operator Good day. Thank you for standing by. Welcome to the Acumen Pharmaceuticals, Q3 2022 Conference Call and Webcast. At this time, all participants are in a listen-only mo ...

Table of Contents Title of each classTrading Symbol(s)Name of each exchange on which registered Common stock, par value $0.0001 per share ABOS The Nasdaq Global Select Market Emerging growth company ☒ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANG ...

Financial Data and Key Metrics Changes - As of June 30, the company had approximately $210 million in cash and marketable securities, with a cash runway expected to last through 2025 [28] - R&D expenses were approximately $7.3 million in Q2 2022, an increase compared to the prior year due to heightened activity in the INTERCEPT-AD trial [29] - The comprehensive loss for Q2 2022 was $10.3 million, significantly lower than the $61.4 million loss in the prior year, which was primarily driven by a non-cash expense related to changes in fair value of liabilities [31][32] Business Line Data and Key Metrics Changes - The INTERCEPT-AD trial is ongoing with enrollment at 15 active sites, up from 11 in the previous quarter, indicating progress in clinical trial site activation [9] - The company is preparing for a future Phase 2/3 trial of ACU193, with ongoing studies and expected finalization of drug production processes [10][11] Market Data and Key Metrics Changes - The company is positioned in the Alzheimer's disease treatment market, focusing on the development of ACU193, a monoclonal antibody targeting soluble amyloid-beta oligomers [8][21] - The upcoming clinical and regulatory developments in the Alzheimer's space include anticipated Phase III data readouts from competing products, which may influence market dynamics [16] Company Strategy and Development Direction - The company aims to demonstrate proof of mechanism in the INTERCEPT-AD study, which is crucial for advancing to a Phase 2/3 study [25] - The strategic imperative includes ensuring timely and economical clinical drug product development, with recent leadership appointments to strengthen capabilities [12][14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the potential impact of external factors such as the COVID-19 pandemic and geopolitical events on business operations [5][6] - The management expressed optimism about reporting top-line data from the INTERCEPT-AD trial in the first half of 2023, which is critical for future development plans [9][33] Other Important Information - The company has made a minor change in enrollment criteria for the INTERCEPT-AD trial, lowering the MMSE score cutoff to include more patients with mild dementia [70][71] - The company is exploring the potential for combination therapies in the future, which may enhance treatment efficacy [43] Q&A Session Summary Question: What are the assumptions underlying cash runway through 2025? - The company expects to start a Phase 2 study in early 2024, with a design involving approximately 550 patients [39] Question: How do late-stage abetamabs relate to ACU193? - Management indicated that while there may be some relevance, ACU193 was developed with a different purpose and methodology compared to other late-stage products [37] Question: What is the sensitivity of the antibody binding test? - The assay is being refined to measure antibody concentration binding to oligomers, with sufficient sensitivity expected to show target engagement [46][49] Question: What are the safety signals observed during trial enrollment? - The company conducts extensive safety reviews at the end of each cohort, with no specific results disclosed during the ongoing study [53] Question: How many dose arms will be taken into the Phase 2/3 study? - The plan is to launch the Phase 2 with two active dose arms and one placebo, with the final decision based on results from the INTERCEPT-AD study [55]

PART I. FINANCIAL INFORMATION This section presents the unaudited condensed financial statements and management's discussion and analysis for the company [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Acumen Pharmaceuticals' unaudited condensed financial statements and accompanying notes for specified interim periods [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) Provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of specific dates | ASSETS (in thousands) | June 30, 2022 (unaudited) | December 31, 2021 | | :-------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $111,067 | $122,162 | | Marketable securities, short-term | $78,844 | $72,075 | | Total current assets | $191,053 | $198,661 | | Total assets | $211,678 | $230,330 | | Total current liabilities | $5,134 | $5,147 | | Total liabilities | $5,159 | $5,147 | | Total stockholders' equity | $206,519 | $225,183 | | Total liabilities and stockholders' equity | $211,678 | $230,330 | [Condensed Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's financial performance, including operating expenses, net loss, and comprehensive loss over specific periods | Operating Expenses (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $7,321 | $2,254 | $13,306 | $4,832 | | General and administrative | $3,090 | $1,187 | $6,312 | $2,402 | | Total operating expenses | $10,411 | $3,441 | $19,618 | $7,234 | | Loss from operations | $(10,411) | $(3,441) | $(19,618) | $(7,234) | | Net loss | $(10,151) | $(61,358) | $(19,280) | $(88,355) | | Comprehensive loss | $(10,302) | $(61,358) | $(20,014) | $(88,355) | | Net loss per common share, basic and diluted | $(0.25) | $(141.93) | $(0.48) | $(207.52) | [Condensed Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20(Deficit)) Outlines changes in the company's equity, including preferred stock and stockholders' equity, over the reporting periods - For the three months ended June 30, **2022**, the Company's **total stockholders' equity** decreased from **$216,089 thousand** to **$206,519 thousand**, primarily due to a **net loss** of **$10,151 thousand** and an **unrealized loss** on marketable securities of **$151 thousand**, partially offset by **stock-based compensation** of **$715 thousand**[19](index=19&type=chunk) - For the six months ended June 30, **2022**, **total stockholders' equity** decreased from **$225,183 thousand** to **$206,519 thousand**, driven by a **net loss** of **$19,280 thousand** and an **unrealized loss** on marketable securities of **$734 thousand**, partially offset by **stock-based compensation** of **$1,333 thousand**[21](index=21&type=chunk) [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Summarizes the company's cash inflows and outflows from operating, investing, and financing activities for specified periods | Cash Flows (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(14,767) | $(6,634) | | Net cash provided by (used in) investing activities | $3,686 | $(6) | | Net cash provided by (used in) financing activities | $(14) | $31,675 | | Net change in cash and cash equivalents | $(11,095) | $25,035 | | Cash and cash equivalents at the end of the period | $111,067 | $68,812 | [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Provides detailed explanations and disclosures supporting the unaudited condensed financial statements [NOTE 1. DESCRIPTION OF ORGANIZATION AND BUSINESS OPERATIONS](index=11&type=section&id=NOTE%201.%20DESCRIPTION%20OF%20ORGANIZATION%20AND%20BUSINESS%20OPERATIONS) Describes Acumen Pharmaceuticals' business, its focus on Alzheimer's drug ACU193, IPO details, and financial outlook - **Acumen Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing ACU193, a humanized monoclonal antibody targeting amyloid-beta oligomers for Alzheimer's disease**[25](index=25&type=chunk) - The Company completed an IPO in July **2021**, issuing **11,499,998 shares** of common stock at **$16.00** per share, generating **$168.6 million** in **net proceeds**[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - The Company has incurred significant **operating losses** since inception, with an **accumulated deficit** of **$146.9 million** as of June 30, **2022**. Management believes existing cash and equivalents are **sufficient for over 12 months of operations**[31](index=31&type=chunk) - The INTERCEPT-AD **Phase 1 clinical trial** for ACU193, initiated in **2021**, experienced **delays in clinical trial site activation and patient enrollment** due to the COVID-19 pandemic, leading to an **expansion of trial sites**. Patient recruitment is ongoing, with **topline data anticipated in the first half of 2023**[34](index=34&type=chunk) [NOTE 2. BASIS OF PRESENTATION, SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND RECENT ACCOUNTING PRONOUNCEMENTS](index=12&type=section&id=NOTE%202.%20BASIS%20OF%20PRESENTATION%2C%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES%20AND%20RECENT%20ACCOUNTING%20PRONOUNCEMENTS) Outlines the basis of financial statement presentation, significant accounting policies, and recent accounting pronouncement adoptions - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP for interim financial information and reflect normal recurring adjustments[35](index=35&type=chunk) - The Company adopted ASC **842**, Leases, on January 1, **2022**, using the modified retrospective method, recognizing a right-of-use asset and lease liability of approximately **$0.2 million**[41](index=41&type=chunk) - The Company adopted ASU No. **2019-12**, Income Taxes, on January 1, **2022**, with **no material impact on financial statements**[42](index=42&type=chunk) - The Company expects **no material impact from the adoption of ASC 326**, Financial Instruments-Credit Losses, effective for periods beginning after December 15, **2022**, as its marketable securities are available-for-sale debt securities[43](index=43&type=chunk) [NOTE 3. MARKETABLE SECURITIES](index=14&type=section&id=NOTE%203.%20MARKETABLE%20SECURITIES) Details the composition and fair value of the company's marketable securities, including unrealized gains and losses | Marketable Securities (in thousands) | June 30, 2022 Fair Value | December 31, 2021 Fair Value | | :----------------------------------- | :----------------------- | :--------------------------- | | Commercial paper | $43,984 | $47,939 | | Corporate debt securities | $20,305 | $24,694 | | Asset-backed securities | $10,902 | $19,143 | | U.S. treasury securities | $23,654 | $11,918 | | Total available-for-sale securities | $98,845 | $103,694 | - **Unrealized losses on available-for-sale securities** as of June 30, **2022**, totaling **$965 thousand**, were **primarily due to changes in interest rates and not increased credit risks**, with **no other-than-temporary impairment recorded**[44](index=44&type=chunk)[45](index=45&type=chunk) [NOTE 4. FAIR VALUE MEASUREMENTS](index=15&type=section&id=NOTE%204.%20FAIR%20VALUE%20MEASUREMENTS) Explains the fair value hierarchy and valuation methods used for the company's financial instruments | Fair Value Measurements (in thousands) | Level 1 (June 30, 2022) | Level 2 (June 30, 2022) | Total Fair Value (June 30, 2022) | | :------------------------------------- | :---------------------- | :---------------------- | :------------------------------- | | Money market securities | $110,067 | — | $110,067 | | Commercial paper | — | $43,984 | $43,984 | | Corporate debt securities | — | $20,305 | $20,305 | | Asset-backed securities | — | $10,902 | $10,902 | | U.S. treasury securities | — | $23,654 | $23,654 | | Total fair value | $110,067 | $98,845 | $208,912 | - **Money market funds are valued using Level 1 inputs (quoted market prices)**, while **available-for-sale marketable securities are valued using Level 2 inputs (observable inputs like yield curves and credit spreads)**[49](index=49&type=chunk)[50](index=50&type=chunk) [NOTE 5. SUPPLEMENTAL FINANCIAL INFORMATION](index=16&type=section&id=NOTE%205.%20SUPPLEMENTAL%20FINANCIAL%20INFORMATION) Provides additional details on prepaid expenses, other current assets, accrued expenses, and other current liabilities | Prepaid Expenses and Other Current Assets (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------------------------- | :------------ | :---------------- | | Research and development service agreements | $650 | $2,591 | | Prepaid insurance | $21 | $1,514 | | Total prepaid expenses and other current assets | $1,142 | $4,424 | | Accrued Expenses and Other Current Liabilities (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------------------------------ | :------------ | :---------------- | | Research and development | $2,031 | $2,623 | | Bonuses and other employee liabilities | $934 | $1,102 | | Total accrued expenses and other current liabilities | $3,282 | $4,059 | [NOTE 6. STOCKHOLDERS' EQUITY](index=16&type=section&id=NOTE%206.%20STOCKHOLDERS%27%20EQUITY) Details the company's authorized capital stock, common stock, and recent shelf registration statement for securities offerings - The Company's **authorized capital stock includes 310,000,000 shares, with 10,000,000 preferred stock and 300,000,000 common stock, both with a par value of $0.0001**[53](index=53&type=chunk)[54](index=54&type=chunk) - On July 1, **2022**, the Company filed a **shelf registration statement (Form S-3) to offer up to $200.0 million in securities, including an at-the-market (ATM) offering program for up to $50.0 million in common stock**. **No shares have been sold under the ATM as of the report date**[55](index=55&type=chunk) [NOTE 7. STOCK-BASED COMPENSATION](index=17&type=section&id=NOTE%207.%20STOCK-BASED%20COMPENSATION) Describes the company's equity incentive plan, stock option activity, and recognized stock-based compensation expenses - The **2021 Equity Incentive Plan became effective on June 30, 2021, initially reserving 7,698,282 shares, with an automatic annual increase**. As of June 30, **2022**, **9,721,945 shares were authorized, and 4,460,737 shares remained available**[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) | Stock Options (Six Months Ended June 30) | 2022 | 2021 | | :--------------------------------------- | :--- | :--- | | Weighted average grant date fair value per share | $3.58 | $1.34 | | Stock Option Activity | Outstanding at Dec 31, 2021 | Granted | Exercised | Forfeited | Outstanding at Jun 30, 2022 | | :-------------------- | :-------------------------- | :------ | :-------- | :-------- | :-------------------------- | | Stock Options | 3,835,618 | 1,455,550 | (29,982) | (33,149) | 5,228,037 | | Weighted Average Exercise Price | $2.51 | $4.80 | $0.84 | $2.11 | $3.16 | - **Total unrecognized compensation costs for unvested stock options were approximately $8.5 million** as of June 30, **2022**, **expected to be recognized over a weighted-average period of 3.0 years**[64](index=64&type=chunk) | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $510 | $79 | $962 | $159 | | Research and development | $205 | $48 | $371 | $94 | | Total stock-based compensation | $715 | $127 | $1,333 | $253 | [NOTE 8. LEASES](index=18&type=section&id=NOTE%208.%20LEASES) Outlines the company's operating lease arrangements, associated costs, and key lease terms - The Company has an **operating sublease for space in Indiana, effective February 1, 2021, and expiring August 30, 2023**[67](index=67&type=chunk) | Operating Leases (in thousands) | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :------------------------------ | :------------------------------- | :----------------------------- | | Operating lease cost | $38 | $76 | | Less: sublease income | $(16) | $(32) | | Operating lease expense | $22 | $44 | | Short-term lease rent expense | $5 | $10 | | Total rent expense | $27 | $54 | - As of June 30, **2022**, the **weighted-average remaining lease term for operating leases is 1.2 years**, with a **weighted-average discount rate of 10.0%**[69](index=69&type=chunk) [NOTE 9. COMMITMENTS AND CONTINGENCIES](index=20&type=section&id=NOTE%209.%20COMMITMENTS%20AND%20CONTINGENCIES) Confirms the absence of material legal proceedings or claims that would adversely affect the company's business - **The Company is not a party to any material legal proceedings and is unaware of any pending or threatened claims that would materially adversely affect its business**[73](index=73&type=chunk) [NOTE 10. NET LOSS PER SHARE](index=20&type=section&id=NOTE%2010.%20NET%20LOSS%20PER%20SHARE) Explains the calculation of basic and diluted net loss per share and lists potentially dilutive securities - **Basic and diluted loss per share were the same for all periods presented because the inclusion of all potential common stock outstanding would have been anti-dilutive**[74](index=74&type=chunk) | Potentially Dilutive Securities (Anti-Dilutive) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Shares issuable upon exercise of stock options | 5,228,037 | 3,664,601 | | Shares issuable upon conversion of Series A Preferred Stock | — | 477,297 | | Shares issuable upon conversion of Series A-1 Preferred Stock | — | 7,985,305 | | Shares issuable upon conversion of Series B Preferred Stock | — | 19,770,070 | | Shares issuable upon exercise of common stock warrants | — | 248,247 | | Total | 5,228,037 | 32,145,520 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion of financial condition, operational results, liquidity, and future outlook, including COVID-19 and macroeconomic impacts [Overview](index=21&type=section&id=Overview) Provides a high-level summary of Acumen Pharmaceuticals' business, financial performance, and future funding requirements - **Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing ACU193, a targeted immunotherapy for early Alzheimer's Disease, currently in a Phase 1 INTERCEPT-AD clinical trial**[78](index=78&type=chunk) - The Company incurred **net losses of $19.3 million and $88.4 million for the six months ended June 30, 2022 and 2021, respectively**, and **expects increased operating losses as ACU193 advances in clinical trials**[79](index=79&type=chunk) - Future operations will require **substantial additional funding, likely through equity offerings, debt financings, or collaborations**, as the Company **does not anticipate product sales revenue until regulatory approval**[81](index=81&type=chunk) [COVID-19 and Macroeconomic Update](index=22&type=section&id=COVID-19%20and%20Macroeconomic%20Update) Discusses the impact of the COVID-19 pandemic and broader macroeconomic conditions on clinical trials and business operations - The **COVID-19 pandemic caused delays in clinical trial site activation and patient enrollment for the INTERCEPT-AD trial**, leading to an **expansion of trial sites**. **Topline data from the INTERCEPT-AD trial is now anticipated in the first half of 2023**[85](index=85&type=chunk) - Ongoing **geopolitical events (Russia-Ukraine conflict) and macroeconomic conditions (inflation, supply chain disruptions) introduce uncertainty and could materially adversely affect the Company's business**[86](index=86&type=chunk) [Components of Results of Operations](index=22&type=section&id=Components%20of%20Results%20of%20Operations) Explains the primary components of operating expenses, including R&D and G&A, and other income/expense categories - **Operating expenses consist of research and development (R&D) expenses and general and administrative (G&A) expenses**[87](index=87&type=chunk) - **R&D expenses include costs for third-party research, manufacturing, clinical trials, consulting, regulatory compliance, and personnel**. These are **expected to increase substantially with ACU193's clinical development**[88](index=88&type=chunk)[90](index=90&type=chunk) - **G&A expenses cover personnel, insurance, professional fees, investor relations, and public company costs**. These are **expected to increase due to organizational growth and public company requirements**[91](index=91&type=chunk)[92](index=92&type=chunk) - **Other income (expense) primarily includes interest income from marketable securities and, historically, changes in fair value of preferred stock tranche rights and warrant liabilities prior to the IPO**[93](index=93&type=chunk)[94](index=94&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Compares the company's financial performance for the three and six months ended June 30, 2022 and 2021 Comparison of Three Months Ended June 30, 2022 and 2021 (in thousands) | Metric | 2022 | 2021 | Change | | :-------------------------------- | :--- | :--- | :----- | | Research and Development Expenses | $7,321 | $2,254 | $5,067 | | General and Administrative Expenses | $3,090 | $1,187 | $1,903 | | Total Operating Expenses | $10,411 | $3,441 | $6,970 | | Net Loss | $(10,151) | $(61,358) | $51,207 | - **Research and development expenses increased by $5.1 million** (YoY) for the three months ended June 30, **2022**, **driven by increased costs for clinical trials, nonclinical R&D, CROs, materials, drug safety testing, consulting, and personnel**[97](index=97&type=chunk) - **General and administrative expenses increased by $1.9 million** (YoY) for the three months ended June 30, **2022**, **primarily due to higher personnel expenses, insurance costs, legal expenses, and marketing costs**[98](index=98&type=chunk) - **Other income was $0.3 million** for Q2 **2022** (**net interest income**), a **significant change from other expense of $57.9 million** in Q2 **2021**, which was **due to fair value increases in preferred stock tranche and warrant liabilities**[99](index=99&type=chunk) Comparison of Six Months Ended June 30, 2022 and 2021 (in thousands) | Metric | 2022 | 2021 | Change | | :-------------------------------- | :--- | :--- | :----- | | Research and Development Expenses | $13,306 | $4,832 | $8,474 | | General and Administrative Expenses | $6,312 | $2,402 | $3,910 | | Total Operating Expenses | $19,618 | $7,234 | $12,384 | | Net Loss | $(19,280) | $(88,355) | $69,075 | - **Research and development expenses increased by $8.5 million** (YoY) for the six months ended June 30, **2022**, **due to increased clinical trial and nonclinical R&D activities, including higher consulting, CRO, personnel, materials, and drug safety testing costs**[101](index=101&type=chunk) - **General and administrative expenses increased by $3.9 million** (YoY) for the six months ended June 30, **2022**, **primarily driven by increases in insurance, personnel costs, legal expenses, and marketing, largely due to added headcount and public company operating costs**[102](index=102&type=chunk) - **Other income was $0.3 million** for H1 **2022** (**net interest income**), **compared to other expense of $81.1 million** in H1 **2021**, which was **due to fair value increases in preferred stock tranche and warrant liabilities**[103](index=103&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) Details the company's cash, cash equivalents, marketable securities, and plans for future funding to support operations - As of June 30, **2022**, **cash, cash equivalents, and marketable securities totaled $209.9 million**. The Company **expects these resources to fund operating expenses and capital expenditures through 2025**[105](index=105&type=chunk) - The Company filed a **shelf registration statement (Form S-3) on July 1, 2022, to offer up to $200.0 million in securities, including an at-the-market (ATM) offering program for up to $50.0 million in common stock**[108](index=108&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) Analyzes the company's cash flows from operating, investing, and financing activities for the reported periods | Cash Flows (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(14,767) | $(6,634) | | Net cash provided by (used in) investing activities | $3,686 | $(6) | | Net cash provided by (used in) financing activities | $(14) | $31,675 | | Net change in cash and cash equivalents | $(11,095) | $25,035 | - **Net cash used in operating activities increased to $14.8 million for the six months ended June 30, 2022, from $6.6 million in the prior year**, **primarily due to a higher net loss, partially offset by non-cash adjustments and changes in operating assets and liabilities**[110](index=110&type=chunk)[111](index=111&type=chunk) - **Investing activities provided $3.7 million in cash for H1 2022, mainly from maturities and sales of marketable securities, a shift from de minimis cash used in H1 2021**[113](index=113&type=chunk) - **Financing activities used $14 thousand in cash for H1 2022, compared to $31.7 million provided in H1 2021, which included proceeds from Series B preferred stock and warrant exercises**[114](index=114&type=chunk)[115](index=115&type=chunk) [Funding Requirements](index=27&type=section&id=Funding%20Requirements) Outlines the company's anticipated future capital needs for R&D, clinical trials, and public company operations - The Company **expects increased expenses from ongoing R&D, clinical trials, and public company operations, necessitating substantial additional funding**[116](index=116&type=chunk) - **Future capital requirements depend on factors such as the scope and cost of product development, regulatory review, collaboration terms, commercialization activities, intellectual property costs, and headcount growth**[117](index=117&type=chunk) - **Funding may come from equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements, with potential for dilution or restrictive covenants**[118](index=118&type=chunk)[119](index=119&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) Addresses management's estimates and assumptions in financial reporting, noting no significant changes to critical accounting policies - The preparation of financial statements requires management to make estimates and assumptions affecting reported amounts, with **no significant changes to critical accounting policies from those disclosed in the Annual Report**[120](index=120&type=chunk)[121](index=121&type=chunk) [Recent Accounting Pronouncements](index=28&type=section&id=Recent%20Accounting%20Pronouncements) Refers to Note 2 for details on recently adopted and not-yet-adopted accounting standards and their financial impact - **Information on recent accounting pronouncements, both adopted and not yet adopted, is detailed in Note 2 to the unaudited condensed financial statements**[122](index=122&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=28&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Explains the company's status as an emerging growth and smaller reporting company, and associated disclosure exemptions - The Company **qualifies as an 'emerging growth company' under the JOBS Act, allowing it to delay adoption of certain accounting standards and benefit from reduced disclosure requirements**[123](index=123&type=chunk)[124](index=124&type=chunk) - The Company will **cease to be an emerging growth company by December 31, 2025, or earlier if it meets certain revenue or market value thresholds**[126](index=126&type=chunk) - The Company is **also a 'smaller reporting company,' which provides additional exemptions from disclosure requirements, such as presenting only two years of audited financial statements**[127](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Exempt from quantitative and qualitative market risk disclosures due to smaller reporting company status - **The Company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company'**[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the company's disclosure controls and procedures, management's evaluation, and changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=29&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2022, ensuring timely and accurate reporting - As of June 30, **2022**, **management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective in providing reasonable assurance that required information is recorded, processed, summarized, and reported timely**[129](index=129&type=chunk)[130](index=130&type=chunk) [Changes in Internal Control Over Financial Reporting](index=29&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) Confirms no material changes in the company's internal control over financial reporting during the fiscal quarter ended June 30, 2022 - **There have been no material changes in the Company's internal control over financial reporting during the fiscal quarter ended June 30, 2022**[131](index=131&type=chunk) [Inherent Limitations on Effectiveness of Internal Controls](index=30&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Internal%20Controls) Acknowledges that internal controls provide reasonable, not absolute, assurance due to inherent limitations and resource constraints - **Management acknowledges that internal controls, regardless of design, can only provide reasonable, not absolute, assurance of achieving control objectives due to inherent limitations and resource constraints**[133](index=133&type=chunk)[134](index=134&type=chunk) PART II. OTHER INFORMATION Presents other required information, including legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) Acumen Pharmaceuticals is not currently involved in any material legal proceedings or claims that would adversely affect its business - **The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims that would materially adversely affect its business**[136](index=136&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) Refers readers to the comprehensive discussion of risk factors detailed in the Company's Annual Report on Form 10-K - **Readers should refer to the 'Risk Factors' section in the Company's Annual Report on Form 10-K for a discussion of factors that could adversely affect financial condition and results of operations**[137](index=137&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Confirms no unregistered equity sales and details the use of proceeds from the company's initial public offering (IPO) - **There were no unregistered sales of equity securities during the period**[138](index=138&type=chunk) - The **IPO, which closed in July 2021, generated aggregate net proceeds of $168.6 million** after underwriting discounts and offering expenses. **There has been no material change in the planned use of these proceeds**[139](index=139&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the Company for the reporting period - **This item is not applicable**[140](index=140&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company for the reporting period - **This item is not applicable**[140](index=140&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) Indicates that there is no other information to report for the period - **No other information is reported under this item**[140](index=140&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) Lists the exhibits filed as part of the Form 10-Q, including corporate documents, sales agreements, and certifications - **Exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Sales Agreement, and various certifications from executive officers**[143](index=143&type=chunk) SIGNATURES Formal attestations by the company's executive officers confirming the accuracy and completeness of the report [Signatures](index=33&type=section&id=Signatures) The report is duly signed by the President and CEO, and CFO and CBO of Acumen Pharmaceuticals, Inc. on August 15, 2022 - The **report was signed by Daniel O'Connell, President and CEO, and Matthew Zuga, CFO and CBO, on August 15, 2022**[145](index=145&type=chunk)

Financial Data and Key Metrics Changes - As of March 31, 2022, the company had approximately $217 million in cash and marketable securities, providing a cash runway expected to last through 2025 [23][24] - R&D expenses were approximately $6 million in Q1 2022, an increase compared to the prior year due to heightened activity in the INTERCEPT-AD trial [25] - G&A expenses were $3.2 million in the quarter, reflecting increased headcount and costs associated with being a public company [26] - The loss from operations for the quarter was $9.2 million, with a comprehensive loss of $9.7 million, significantly lower than the $27 million loss in the prior year period [26][28] Business Line Data and Key Metrics Changes - The INTERCEPT-AD clinical trial is ongoing, with enrollment now at 11 active sites, an increase from eight sites previously [9][10] - The company is preparing for a future Phase 2/3 trial of ACU193, with significant progress in drug substance production and formulation [11] Market Data and Key Metrics Changes - The company anticipates growing interest in upcoming clinical and regulatory developments for other Alzheimer's disease programs, which could positively impact enthusiasm for ACU193 [13] Company Strategy and Development Direction - The company is focused on advancing ACU193 through multiple critical milestones, with a strong emphasis on the ongoing INTERCEPT-AD trial [8] - The strategy includes preparing for a Phase 2/3 trial rapidly after demonstrating proof-of-mechanism in the ongoing trial [11] - The company aims to operate efficiently to maintain its cash runway through 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of ACU193 and the broader Alzheimer's treatment landscape, despite recent setbacks in the industry [35] - The company is committed to developing ACU193 for patients and is closely monitoring the outcomes of other late-stage products [36] Other Important Information - A publication in Frontiers in Neuroscience supports the rationale for targeting soluble A oligomers in early Alzheimer's disease, highlighting ACU193's unique selectivity [14][15] - The trial design includes a focus on demonstrating target engagement and proof-of-mechanism, with safety and tolerability being key objectives [21] Q&A Session Summary Question: Can you remind us about the Phase 1 data readout and how you will assess percent change in oligomer levels? - Management clarified that the focus will be on measuring the concentration of ACU193 bound to oligomers, with a goal to demonstrate binding in spinal fluid after dosing [30][31] Question: Thoughts on recent moves for lecanemab and gantenerumab? - Management acknowledged the frustration in the Alzheimer's space regarding recent decisions but remains optimistic about the potential of ACU193 [35] Question: How does the plasma half-life of ACU193 compare to other anti-amyloid antibodies? - Management indicated that data on plasma half-life is still being gathered, and they do not anticipate a safety titration for ACU193 due to its selectivity for oligomers [36][37]

Financial Performance - For the three months ended March 31, 2022, the company reported net losses of $9.1 million, a decrease of 66.3% compared to net losses of $27.0 million for the same period in 2021[69]. - The total operating expenses for the three months ended March 31, 2022, were $9.2 million, an increase of $5.4 million from $3.8 million in the same period of 2021[86]. - Net cash used in operating activities for Q1 2022 was $8.3 million, compared to $2.4 million in Q1 2021, reflecting a significant increase in operational losses[93][94]. - The net loss for Q1 2022 was $9.1 million, which included non-cash adjustments of $0.6 million for stock-based compensation and $0.2 million for net accretion and amortization[93]. Expenses - Research and development expenses increased to $6.0 million for the three months ended March 31, 2022, up from $2.6 million in the same period of 2021, reflecting a $3.4 million increase primarily due to ongoing clinical trials[87]. - General and administrative expenses rose to $3.2 million for the three months ended March 31, 2022, compared to $1.2 million in the prior year, marking a $2.0 million increase[88]. - The company expects to incur significant expenses related to developing its commercialization capability if regulatory approval is obtained for its product candidates[70]. - The company expects to incur additional costs related to research and development, clinical trials, and public company operations following its IPO in July 2021[96]. Cash and Funding - The company had cash, cash equivalents, and marketable securities totaling $216.7 million as of March 31, 2022, which is expected to fund operations at least through 2025[73]. - The company plans to finance operations through public or private equity offerings and debt financings until significant revenue is generated from product sales[72]. - The company anticipates needing substantial additional funding for future operations, with potential financing through equity offerings, debt financings, and collaborations[100][101]. - The company has no committed external sources of funds and may face dilution of ownership interests if additional capital is raised through equity sales[100]. Investments - Cash used in investing activities for Q1 2022 was $5.1 million, primarily due to purchases and maturities of marketable securities totaling $9.1 million and $4.0 million, respectively[95]. Clinical Trials - The company initiated a Phase 1 clinical trial of its drug candidate ACU193 in 2021, with topline data anticipated in the first half of 2023[68]. - Future capital requirements will depend on various factors, including the progress of clinical trials and the costs of commercialization activities for product candidates like ACU193[99]. Other Information - The company reported other income of $0.1 million for the three months ended March 31, 2022, primarily from net interest income on marketable securities[89]. - The company issued 9,999,999 shares of common stock in its IPO on July 6, 2021, raising net proceeds of $168.6 million after expenses[90]. - As of March 31, 2022, the company reported a net change in cash and cash equivalents of $(13.4 million) for the quarter[98]. - The management evaluated the effectiveness of disclosure controls and procedures as of March 31, 2022, concluding they were effective[112]. - The company is not currently involved in any material legal proceedings that could adversely affect its business[117].

Financial Status - Acumen had approximately $225 million in cash, cash equivalents, and marketable securities as of December 31, 2021, which is expected to fund operations through 2025[5, 8, 93] - The company completed a Series B tranche with gross proceeds of $30 million and an IPO with gross proceeds of $184 million[7] - In FY 2021, R&D expenses were $123 million and G&A expenses were $73 million, resulting in a $196 million loss from operations[93] - The FY 2021 net loss was $101 million, including a non-cash expense of over $81 million[93] Clinical Development of ACU193 - ACU193 is a clinical-stage monoclonal antibody (mAb) designed to selectively target amyloid-beta oligomers (AβOs) for the treatment of early Alzheimer's disease (AD)[5, 38] - The INTERCEPT-AD trial, a Phase 1 clinical trial of ACU193 in patients with early AD, is ongoing, with topline results expected in 1H 2023[5, 9, 77, 88] - The primary outcomes of the INTERCEPT-AD trial are safety/ARIA-E, pharmacokinetics (PK), and target engagement[9, 88] - Acumen is developing a Phase 2/3 study design and planning for an FDA End of Phase 2 meeting[9] Alzheimer's Disease Market and Scientific Rationale - Alzheimer's disease (AD) represents a significant market driven by high unmet need, with direct healthcare costs estimated at $355 billion annually in 2021[5, 19] - Scientific consensus supports amyloid-beta oligomers (AβOs) as the most toxic form of amyloid-beta and a novel target for effective AD treatment[5, 11] - Recent anti-amyloid mAb results show a reduction in cognitive decline of approximately 11%-47% at ~18 months, with ARIA-E rates of approximately 10%-35%[25]