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)

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q1 2022 Earnings Conference Call May 16, 2022 4:30 PM ET Company Participants John Woolford - IR, Westwicke Daniel O'Connell - President & CEO Eric Siemers - Chief Medical Officer Matt Zuga - CFO & Chief Business Officer Conference Call Participants Operator Operator Thank you for standing by, and welcome to the Acumen Pharmaceuticals, First Quarter 2022 Update Call. At this time, all participants are in a listen-only mode. There'll be a brief overview followed by ...

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 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 March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q4 2021 Earnings Conference Call March 28, 2022 4:30 AM ET Company Participants John Woolford - IR, Westwicke Daniel O'Connell - President & CEO Eric Siemers - Chief Medical Officer Matt Zuga - CFO & Chief Business Officer Conference Call Participants Alex Park - Stifel Jason Zemansky - Bank of America Judah Frommer - Credit Suisse Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the ...

```markdown Part I [Business](index=7&type=section&id=Item%201.%20Business) Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing ACU193 for Alzheimer's disease [Our Product Candidate and Strategy](index=9&type=section&id=Our%20Product%20Candidate%20and%20Strategy) ACU193 is a humanized monoclonal antibody targeting AßOs for early AD, with a strategy to advance clinical trials - ACU193 is designed to selectively target AßOs with **over 500-fold greater selectivity** for AßOs over Aß monomers and limited binding to amyloid plaques, which may lead to a better safety profile, particularly a lower rate of ARIA[23](index=23&type=chunk)[49](index=49&type=chunk) - The company's strategy includes rapidly advancing ACU193, evaluating it in combination with other drugs (e.g., those targeting tau or inflammation), exploring its use in other indications like Down Syndrome-associated dementia, and expanding the portfolio[28](index=28&type=chunk) [Clinical Development Plan](index=29&type=section&id=Clinical%20Development%20Plan) The INTERCEPT-AD Phase 1 trial evaluates ACU193's safety and pharmacokinetics in early AD patients INTERCEPT-AD Trial Design | Part | Type | Participants | Dosing Cohorts | | :--- | :--- | :--- | :--- | | Part A | Single Ascending Dose (SAD) | 32 | Single IV doses of 2, 10, 25, or 60 mg/kg vs. placebo. | | Part B | Multiple Ascending Dose (MAD) | 30 | Three doses of 10 mg/kg Q4W, 60 mg/kg Q4W, or 60 mg/kg Q2W vs. placebo. | - Due to COVID-19 related delays in site activation and enrollment, the company is expanding the number of trial sites and now anticipates reporting topline data in the **first half of 2023**[113](index=113&type=chunk) [Competition](index=32&type=section&id=Competition) Acumen faces significant competition from approved and late-stage Alzheimer's disease therapies - ACU193 will compete with Biogen's approved drug Aduhelm and late-stage candidates from major pharmaceutical companies including Eisai (lecenamab), Eli Lilly (donanemab), and Roche (gantenerumab), all of which target amyloid plaques and are anticipated to complete Phase 3 studies in 2022-2023[121](index=121&type=chunk) - Numerous other companies are developing therapies with Aß, AßO, and amyloid plaque-related targets, as well as therapies targeting other underlying causes of AD[122](index=122&type=chunk) [Government Regulation](index=34&type=section&id=Government%20Regulation) The company's operations are subject to extensive FDA regulations for drug development, approval, and compliance - The development and approval of biologics like ACU193 is a lengthy process requiring submission of an Investigational New Drug (IND) application before clinical trials and a Biologics License Application (BLA) for marketing approval[139](index=139&type=chunk)[149](index=149&type=chunk) - The FDA offers expedited programs such as Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval for drugs treating serious conditions, which could potentially apply to ACU193[155](index=155&type=chunk)[161](index=161&type=chunk) - Upon approval, a biologic product like ACU193 is granted **12 years of data exclusivity** in the U.S. under the BPCIA, protecting it from biosimilar competition during that period[172](index=172&type=chunk) - The company's sole product candidate, ACU193, is a humanized monoclonal antibody that selectively targets soluble amyloid-beta oligomers (AßOs), a key underlying cause of Alzheimer's disease[12](index=12&type=chunk) - A Phase 1 clinical trial, INTERCEPT-AD, was initiated in the second quarter of 2021 to evaluate the safety, tolerability, and proof of mechanism of ACU193 in early AD patients. Topline data is anticipated in the **first half of 2023**[15](index=15&type=chunk)[16](index=16&type=chunk) - Acumen holds an exclusive, perpetual, irrevocable, royalty-free, worldwide license from Merck for the research, development, and commercialization of ACU193, which originated from a collaboration between 2003 and 2011[53](index=53&type=chunk)[125](index=125&type=chunk) - The company's intellectual property portfolio for ACU193, licensed from Merck, includes one issued U.S. patent and 18 issued foreign patents, which are projected to expire in **July 2031**[129](index=129&type=chunk) [Risk Factors](index=45&type=page&id=Item%201A.%20Risk%20Factors) The company faces substantial financial, development, and operational risks, including dependence on ACU193 and funding needs - The company is a clinical-stage entity with a limited operating history, no approved products, no revenue, and a net loss of **$100.6 million in 2021**. It will require substantial additional funding to continue operations[194](index=194&type=chunk)[195](index=195&type=chunk)[200](index=200&type=chunk) - The company is substantially dependent on the success of its sole product candidate, ACU193, and has concentrated its efforts in the high-risk field of Alzheimer's disease drug development, which has seen very limited success[205](index=205&type=chunk)[208](index=208&type=chunk) - The COVID-19 pandemic has caused delays in clinical site activation and patient enrollment for the INTERCEPT-AD trial and may continue to adversely affect operations[246](index=246&type=chunk)[247](index=247&type=chunk) - The company relies on contract manufacturing organizations (CMOs) for the supply of ACU193 and contract research organizations (CROs) to conduct its clinical trials, creating dependence on third-party performance[296](index=296&type=chunk)[302](index=302&type=chunk) - Intellectual property for ACU193 is licensed from Merck, and the primary patents are predicted to expire in **2031**, making the company reliant on maintaining this license and potential regulatory exclusivity[326](index=326&type=chunk)[342](index=342&type=chunk)[348](index=348&type=chunk) [Unresolved Staff Comments](index=106&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[493](index=493&type=chunk) [Properties](index=106&type=section&id=Item%202.%20Properties) The company leases corporate headquarters in Charlottesville, VA, and additional office space in Carmel, IN - The company's corporate headquarters are in a leased office in Charlottesville, VA, with the lease expiring in **December 2022**. It also leases office space in Carmel, IN, with a lease expiring in **August 2023**[494](index=494&type=chunk) [Legal Proceedings](index=106&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not subject to any material legal proceedings[495](index=495&type=chunk) [Mine Safety Disclosures](index=106&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[496](index=496&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=107&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'ABOS', with IPO proceeds used for business development and no dividends paid - The company's common stock is listed on The Nasdaq Global Select Market under the symbol '**ABOS**'[498](index=498&type=chunk) - The company raised net proceeds of **$168.6 million** from its Initial Public Offering, which closed in **July 2021**[501](index=501&type=chunk) - No cash dividends have ever been paid, and the company does not intend to pay any in the foreseeable future[499](index=499&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=108&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a significant net loss in 2021 due to non-cash charges and increased operating expenses, with IPO proceeds providing liquidity through 2025 [Results of Operations](index=111&type=section&id=Results%20of%20Operations) The company's net loss significantly increased in 2021 due to a non-cash charge and higher operating expenses Results of Operations (in thousands) | | Year Ended December 31, | Change | | :--- | :--- | :--- | | | **2021** | **2020** | **$** | | **Grant and other revenue** | **$ —** | **$ 1,436** | **$ (1,436)** | | **Operating expenses** | | | | | Research and development | 12,305 | 7,997 | 4,308 | | General and administrative | 7,279 | 1,351 | 5,928 | | **Total operating expenses** | **19,584** | **9,348** | **10,236** | | **Loss from operations** | **(19,584)** | **(7,912)** | **(11,672)** | | **Total other income (expense)** | **(81,022)** | **587** | **(81,609)** | | **Net loss** | **(100,606)** | **(7,325)** | **(93,281)** | - Research and development expenses increased by **$4.3 million**, from **$8.0 million** in 2020 to **$12.3 million** in 2021, primarily due to increased costs for personnel, materials, and CRO services related to the initiation of the clinical trial[530](index=530&type=chunk) - General and administrative expenses increased by **$5.9 million**, from **$1.4 million** in 2020 to **$7.3 million** in 2021, mainly due to higher personnel, insurance, accounting, and legal expenses following the transition to a public company[531](index=531&type=chunk) [Liquidity and Capital Resources](index=113&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity from its 2021 IPO is projected to fund operations through 2025, with future funding from equity, debt, or collaborations - As of December 31, 2021, the company had cash and cash equivalents of **$122.2 million** and marketable securities of **$103.7 million**[536](index=536&type=chunk) - The company received net proceeds of **$168.6 million** from its IPO in **July 2021**[535](index=535&type=chunk) - Based on the current operating plan, existing cash and marketable securities are expected to fund operations at least through **2025**[544](index=544&type=chunk) [Critical Accounting Policies, Significant Judgments and Use of Estimates](index=115&type=section&id=Critical%20Accounting%20Policies%2C%20Significant%20Judgments%20and%20Use%20of%20Estimates) Critical accounting policies involve significant judgments and estimates for stock-based compensation, pre-IPO valuations, and accrued R&D expenses - Stock-based compensation is calculated using the Black-Scholes model, with key subjective inputs including expected volatility (based on a peer group) and expected term (using the 'simplified method')[551](index=551&type=chunk) - Prior to the IPO, the fair value of common stock was determined using complex valuation methods such as the Option Pricing Method (OPM) and a hybrid of the OPM and Probability-Weighted Expected Return Method (PWERM)[555](index=555&type=chunk)[556](index=556&type=chunk) - The company is an 'emerging growth company' and has elected to use the extended transition period for complying with new or revised accounting standards[563](index=563&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=119&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Acumen is not required to provide this information - The company is not required to provide this information as it qualifies as a "smaller reporting company"[568](index=568&type=chunk) [Financial Statements and Supplementary Data](index=119&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited financial statements and notes for 2021 and 2020 Key Balance Sheet Data (in thousands) | | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $122,162 | $43,777 | | Marketable securities | $103,694 | $— | | **Total Assets** | **$230,330** | **$44,429** | | **Total Liabilities** | **$5,147** | **$6,367** | | **Total Stockholders' Equity (Deficit)** | **$225,183** | **$(18,591)** | Key Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Grant and other revenue | $— | $1,436 | | Research and development | $12,305 | $7,997 | | General and administrative | $7,279 | $1,351 | | **Loss from operations** | **$(19,584)** | **$(7,912)** | | **Net loss** | **$(100,606)** | **$(7,325)** | | **Net loss per share** | **$(5.02)** | **$(17.48)** | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=151&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no disagreements with its accountants on accounting principles, disclosures, or auditing procedures - None reported[702](index=702&type=chunk) [Controls and Procedures](index=151&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of December 31, 2021, remediating a prior material weakness - Disclosure controls and procedures were deemed effective as of **December 31, 2021**[704](index=704&type=chunk) - A previously identified material weakness in internal controls related to segregation of duties was remediated in the **second half of 2021**[706](index=706&type=chunk) [Other Information](index=152&type=section&id=Item%209B.%20Other%20Information) The board amended director compensation policy and appointed Kim C Drapkin to the board and as audit committee chair - On **March 24, 2022**, the board amended the non-employee director compensation policy to increase the initial stock option grant to **50,000 shares** and the annual grant to **25,000 shares**[711](index=711&type=chunk) - Kim C. Drapkin was appointed to the board of directors and as chair of the audit committee, effective **April 1, 2022**[712](index=712&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=153&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2022 Proxy Statement - Information is incorporated by reference from the **2022 Proxy Statement**[716](index=716&type=chunk) [Executive Compensation](index=154&type=section&id=Item%2011.%20Executive%20Compensation) Information on executive and director compensation is incorporated by reference from the 2022 Proxy Statement - Information is incorporated by reference from the **2022 Proxy Statement**[717](index=717&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=154&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information on security ownership and equity compensation plans is incorporated by reference from the 2022 Proxy Statement - Information is incorporated by reference from the **2022 Proxy Statement**[718](index=718&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=154&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2022 Proxy Statement - Information is incorporated by reference from the **2022 Proxy Statement**[719](index=719&type=chunk) [Principal Accountant Fees and Services](index=154&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information on principal accountant fees and services is incorporated by reference from the 2022 Proxy Statement - Information is incorporated by reference from the **2022 Proxy Statement**[720](index=720&type=chunk) Part IV [Exhibit and Financial Statement Schedules](index=154&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists exhibits filed with the Form 10-K and notes the omission of financial statement schedules - The financial statements are included in Item 8, and all related schedules are omitted as inapplicable or otherwise included[720](index=720&type=chunk)[721](index=721&type=chunk) - A list of exhibits filed with the report is provided, including key corporate and compensatory agreements[721](index=721&type=chunk)[722](index=722&type=chunk) [Form 10–K Summary](index=156&type=section&id=Item%2016.%20Form%2010%E2%80%93K%20Summary) The company reports no Form 10-K summary - None[723](index=723&type=chunk) ```