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 ...

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q2 2022 Earnings Conference Call August 15, 2022 4:30 PM ET Company Participants John Woolford - Investor Relations, Westwicke Daniel O'Connell - President & Chief Executive Officer Eric Siemers - Chief Medical Officer Matt Zuga - Chief Financial Officer & Chief Business Officer Conference Call Participants Judah Frommer - Credit Suisse Tom Shrader - BTIG Ting Liu - UBS Operator Good day. Thank you for standing by, and welcome to the Acumen Pharmaceuticals, Second ...

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 ☒ Table of Contents 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 June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECUR ...

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) ```