Investment Rating - The report maintains a "Buy" rating for Acumen Pharmaceuticals Inc with a 12-month price target (PT) lowered to $6 from $14 [4][8]. Core Insights - The investment thesis has been updated following the 2Q24 earnings report, with a focus on the execution of Phase 2 (P2) trials for sabirnetug (ACU193) as a key driver for stock performance [2][6]. - The overall sentiment in the Alzheimer's disease (AD) market remains low, influenced by regulatory setbacks and slow commercial uptake of competing products [3][9]. - Despite the challenges, the report highlights that Acumen Pharmaceuticals has sufficient cash to fund operations into the first half of 2027, with P2 trial enrollment exceeding expectations [6][7]. Summary by Sections Investment Rating - 12-month rating: Buy - 12-month price target: $6.00 (previously $14.00) [4]. Financial Performance - Current stock price as of August 14, 2024: $2.46 - Market capitalization: $0.14 billion - Expected revenues for 12/24E: $21 million [5]. Market and Competitive Landscape - The AD market is sizable but has seen a decline in clinical trials and investigational drugs in 2024 compared to 2023 [3]. - Regulatory risks have increased following the EMA refusal of Leqembi, impacting overall market sentiment [3][9]. Company-Specific Developments - Acumen Pharmaceuticals reported a cash position of $281.4 million, sufficient to support ongoing trials [6]. - Management noted that the P2 ALTITUDE-AD study is progressing faster than expected, with positive feedback on the trial design [6][7]. Valuation Adjustments - Peak sales estimates for sabirnetug have been lowered from $6.8 billion to $2.4 billion due to anticipated lower commercial uptake [9][10]. - The probability of success (PoS) for sabirnetug has been increased from 15% to 20% based on evolving clinical data [9][10].

Financial Performance - The company reported a net loss of $35.4 million for the six months ended June 30, 2024, compared to a net loss of $22.9 million for the same period in 2023, representing a 55% increase in losses [110]. - The net loss for the six months ended June 30, 2024, was $35.41 million, a 55% increase from a net loss of $22.92 million in 2023 [128]. - Net cash used in operating activities increased to $34.40 million for the six months ended June 30, 2024, up from $21.85 million in 2023 [139]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $19.5 million, a 114% increase from $9.1 million in the same period in 2023 [122]. - Research and development expenses increased to $31.98 million for the six months ended June 30, 2024, up 79% from $17.85 million in 2023 [128]. - The first patient in the ALTITUDE-AD clinical trial was dosed in May 2024, with planned doses of 35 mg/kg and 50 mg/kg every four weeks [103]. - The company expects to complete enrollment in the ALTITUDE-AD clinical trial in the first half of 2025, with a total of up to 540 participants [103]. Operating Expenses - Total operating expenses increased by 81% to $24.4 million for the three months ended June 30, 2024, compared to $13.5 million for the same period in 2023 [122]. - General and administrative expenses rose to $10.17 million for the six months ended June 30, 2024, a 16% increase from $8.77 million in 2023 [130]. Cash and Liquidity - The company has cash and cash equivalents totaling $281.4 million as of June 30, 2024, which is expected to fund operations into the first half of 2027 [112]. - Cash and cash equivalents, along with marketable securities, totaled $281.4 million as of June 30, 2024, expected to fund operations into the first half of 2027 [135]. - Cash provided by investing activities was $28.50 million for the six months ended June 30, 2024, a significant increase from cash used of $30.86 million in 2023 [141]. - Cash provided by financing activities was $6.98 million for the six months ended June 30, 2024, compared to cash used of $0.15 million in 2023 [142]. - The company raised net proceeds of $121.9 million from a public offering in July 2023, which contributed to increased investments in marketable securities [125]. Funding and Capital - The company plans to seek third-party collaborators for future commercialization of its product candidates, indicating a need for substantial additional funding [143]. - The company may face challenges in obtaining additional funding on acceptable terms, which could lead to dilution for stockholders and affect business operations [147]. - The company may be forced to curtail operations if it cannot raise sufficient additional capital in a timely manner, which would adversely affect stock value [147]. - The company's ability to raise additional capital may be negatively impacted by worsening global economic conditions and volatility in financial markets [147]. Accounting and Reporting - The company has elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act, delaying adoption until they apply to private companies [150]. - As an emerging growth company, the company benefits from reduced disclosure requirements, including exemptions from certain auditor attestation requirements [151]. - The company qualifies as a "smaller reporting company," with a market value of shares held by non-affiliates below $700 million and annual revenue under $100 million [154]. - The company may continue to rely on exemptions from certain disclosure requirements as long as it remains a smaller reporting company [154]. - There have been no significant changes to the company's critical accounting policies that require significant judgments and estimates from those disclosed in the Annual Report [149]. - The company has taken advantage of certain reduced reporting requirements in its Quarterly Report on Form 10-Q [153]. - Actual results may differ from estimates and assumptions made by management, affecting reported amounts of assets and liabilities [148].

Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) Q2 2024 Earnings Conference Call August 13, 2024 8:00 AM ET Company Participants Dan O’Connell - Chief Executive Officer Matt Zuga - Chief Financial Officer, Chief Business Officer Dr. Jim Doherty - President, Chief Development Officer Dr. Eric Siemers - Chief Medical Officer. Alex Braun - Head of Investor Relations Conference Call Participants Tom Shrader - BTIG Cameron Bozdog - Bank of America Samantha Schaeffer - Cantor Fitzgerald Trung Huynh - UBS Ananda Ghos ...

Financial Performance - Loss from operations was $24.4 million for Q2 2024, compared to $13.5 million for Q2 2023, attributed to higher R&D and G&A expenses[6] - Net loss for Q2 2024 was $20.5 million, compared to $11.6 million for Q2 2023[6] - Total operating expenses for Q2 2024 reached $24,381,000, up 81% from $13,478,000 in Q2 2023[20] - Net loss for Q2 2024 was $20,537,000, compared to a net loss of $11,610,000 in Q2 2023, representing a 77% increase in losses[20] - Comprehensive loss for the first half of 2024 was $35,886,000, compared to $22,812,000 in the same period of 2023, a 57% increase[20] Research and Development - Research and Development (R&D) expenses increased to $19.5 million for Q2 2024, compared to $9.1 million for Q2 2023, primarily due to higher clinical trial costs related to ALTITUDE-AD[5] - The ALTITUDE-AD Phase 2 study is actively enrolling subjects, with over 50 sites activated across the U.S., Canada, U.K., and EU[2] - The first patient was dosed in the ALTITUDE-AD study in May 2024, which aims to evaluate the efficacy and safety of sabirnetug in early Alzheimer's disease[2] - A Phase 1 pharmacokinetic comparison study for subcutaneous administration of sabirnetug was initiated in July 2024, with topline results expected in Q1 2025[3] - Acumen plans to host a virtual R&D Day on October 2, 2024, to discuss the scientific rationale and clinical plans for sabirnetug[4] - Sabirnetug has received Fast Track designation from the FDA for the treatment of early Alzheimer's disease[8] Cash and Cash Equivalents - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled $281.4 million, down from $306.1 million as of December 31, 2023, with expected support for operations into the first half of 2027[5] - Cash and cash equivalents at the end of the period for Q2 2024 were $68,190,000, down from $77,248,000 at the end of Q2 2023[23] - Net cash used in operating activities for the first half of 2024 was $34,404,000, compared to $21,845,000 in the same period of 2023, reflecting a 57% increase[23] Other Financial Metrics - Interest income for Q2 2024 was $3,816,000, an increase of 102% from $1,884,000 in Q2 2023[20] - Total other income for Q2 2024 was $3,844,000, up from $1,868,000 in Q2 2023, marking a 105% increase[20] - Stock-based compensation expense for the first half of 2024 was $4,954,000, compared to $2,911,000 in the same period of 2023, reflecting a 70% increase[23] - Weighted-average shares outstanding for Q2 2024 were 60,079,778, compared to 41,025,062 in Q2 2023, indicating a 46% increase in shares[20]

Jonathan Kitchen Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) is a clinical-stage biopharmaceutical company that develops innovative treatments for AD, specifically targeting toxic soluble AβOs that accumulate in the brain, producing synapse deterioration, tau hyper-phosphorylation, and inflammation. These factors contribute to neuronal death, leading to cognitive and functional impairments. ABOS’s leading drug candidate, Sabirnetug, is a monoclonal antibody designed to neutralize AβOs to preserve neurona ...

Core Insights - Acumen Pharmaceuticals has initiated a Phase 1 pharmacokinetic study for its subcutaneous formulation of sabirnetug (ACU193), targeting soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment [1][2] - The subcutaneous formulation utilizes Halozyme's ENHANZE® technology, which enhances drug delivery by allowing larger volumes to be administered subcutaneously [1][6] - Sabirnetug is the first humanized monoclonal antibody to show selective engagement with AβOs in Alzheimer's patients, aiming to address early neurodegenerative processes [2][4] Company Overview - Acumen Pharmaceuticals is focused on developing therapies for Alzheimer's disease, specifically targeting toxic soluble AβOs, which are implicated in the disease's pathology [8] - The company is currently conducting the ALTITUDE-AD Phase 2 clinical trial to evaluate the efficacy and safety of intravenous sabirnetug in early Alzheimer's patients [2][8] Clinical Trial Insights - The Phase 1 INTERCEPT-AD trial demonstrated that intravenous sabirnetug is well tolerated, with a favorable safety profile and significant amyloid plaque reduction [3][5] - The INTERCEPT-AD trial involved 65 participants with early symptomatic Alzheimer's disease and aimed to establish safety, tolerability, and pharmacokinetics of the drug [5] Technology Utilization - Halozyme's ENHANZE® technology allows for rapid subcutaneous delivery of biologics, potentially reducing the need for multiple injections and improving patient convenience [6][7]

NEWTON, Mass., July 28, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD), today announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193). The research highlights the experiences of patients in the clinical trial to inform development of future trials, biomarker data to support sabirnetug's ...

Core Insights - Acumen Pharmaceuticals announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193), a novel therapeutic targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease treatment [1][2][3] Group 1: Study Findings - The Phase 1 study highlighted the strength of the study design and the potential of sabirnetug as a best-in-class treatment for early symptomatic Alzheimer's disease [3] - Sabirnetug demonstrated selective target engagement of AβOs, which are toxic forms of amyloid beta that contribute to neurodegeneration [2][6] - Three administrations of sabirnetug significantly lowered cerebrospinal fluid (CSF) levels of synaptic biomarkers, indicating its mechanism of action [4] Group 2: Patient Experience - Acumen incorporated patient feedback from exit interviews in the INTERCEPT-AD trial to understand their experiences and expectations for treatment [3] - Participants expressed a desire for treatments that would prevent disease progression and maintain cognitive functions, such as recognizing loved ones [3] Group 3: Ongoing Trials - The ongoing Phase 2 clinical trial, ALTITUDE-AD, aims to evaluate the efficacy and safety of sabirnetug in approximately 540 individuals with early Alzheimer's disease [5][8] - The trial is currently enrolling participants at multiple sites in the U.S., Canada, and plans to expand to Europe and the UK [5][8] Group 4: Assay Development - Acumen developed an ultra-sensitive assay to detect total levels of sabirnetug in CSF, which will aid in quantifying drug exposure in clinical trials [4]

Core Insights - Acumen Pharmaceuticals is set to present patient experience and biomarker data from its Phase 1 INTERCEPT-AD study of sabirnetug (ACU193) at the Alzheimer's Association International Conference (AAIC®) 2024, highlighting its focus on Alzheimer's disease treatment [1][2] Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing sabirnetug (ACU193), a humanized monoclonal antibody targeting toxic soluble amyloid beta oligomers (AβOs) for Alzheimer's disease [3][6] - The company has received Fast Track designation from the U.S. FDA for sabirnetug in treating early Alzheimer's disease [3] Product Details - Sabirnetug is the first humanized monoclonal antibody to selectively engage AβOs in patients with early symptomatic Alzheimer's disease, aiming to address synaptic dysfunction and neurodegeneration [2][3] - The INTERCEPT-AD study, completed in 2023, involved 65 participants and evaluated the safety, tolerability, and clinical proof of mechanism of sabirnetug [4][5] Upcoming Conference Presentations - Acumen will present several posters at the AAIC 2024, including: - A gender analysis of trial participants [2] - Development of a sensitive immunoassay for detecting sabirnetug in cerebrospinal fluid [2] - Analysis of synaptic biomarkers associated with sabirnetug [2] - Insights into patient experiences and expectations for treatment [2] Clinical Trial Information - The INTERCEPT-AD study was a multi-center, randomized, double-blind, placebo-controlled trial designed to assess the pharmacokinetics and target engagement of sabirnetug [4][5] - The study included both single-ascending-dose and multiple-ascending-dose cohorts [5] Future Directions - Acumen is advancing sabirnetug into a Phase 2 clinical trial, ALTITUDE-AD, following positive results from the Phase 1 trial [6]

PART I. FINANCIAL INFORMATION This section presents the unaudited financial statements and management's analysis for the reporting period [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Acumen Pharmaceuticals reported an increased net loss of $14.9 million in Q1 2024, driven by higher operating expenses, ending the quarter with $301.0 million in total assets [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, total assets were $301.0 million, slightly down from year-end 2023, with a decrease in cash and an increase in marketable securities Condensed Balance Sheets (in thousands) | Balance Sheet Items | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $46,930 | $66,886 | | Marketable securities | $249,690 | $239,189 | | Total assets | $300,967 | $310,125 | | **Liabilities & Equity** | | | | Total liabilities | $38,933 | $43,152 | | Total stockholders' equity | $262,034 | $266,973 | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $14.9 million for Q1 2024, an increase from the prior year, primarily due to higher R&D and G&A expenses, partially offset by increased interest income Condensed Statements of Operations and Comprehensive Loss (in thousands) | Statement of Operations | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Research and development | $12,449 | $8,713 | | General and administrative | $5,325 | $4,422 | | **Total operating expenses** | **$17,774** | **$13,135** | | Loss from operations | ($17,774) | ($13,135) | | Interest income | $4,005 | $1,832 | | Interest expense | ($1,000) | $0 | | **Net loss** | **($14,873)** | **($11,307)** | | Net loss per share | ($0.25) | ($0.28) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $17.9 million in Q1 2024, reflecting the higher net loss, with financing activities providing $7.1 million Condensed Statements of Cash Flows (in thousands) | Cash Flow Activity | Q1 2024 (in thousands) | Q1 2023 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,859) | ($10,175) | | Net cash used in investing activities | ($9,203) | ($41,927) | | Net cash provided by financing activities | $7,107 | $0 | | **Net change in cash** | **($19,955)** | **($52,102)** | | Cash at end of period | $47,164 | $77,999 | [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's focus on sabirnetug for Alzheimer's, its financial runway, and key financing and collaboration agreements - The company is focused on advancing its drug candidate, sabirnetug, in the Phase 2 portion of a Phase 2/3 clinical trial called "ALTITUDE-AD" for Alzheimer's disease[26](index=26&type=chunk) - Management believes the company has sufficient cash to continue operating activities for beyond 12 months from the issuance of the financial statements, despite an accumulated deficit of **$237.7 million** as of March 31, 2024[28](index=28&type=chunk) - In November 2023, the company entered into a Loan and Security Agreement for a term loan facility of up to **$50 million**, borrowing an initial **$30 million**, which includes a feature allowing lenders to convert up to **$2.5 million** of the loan into common stock[60](index=60&type=chunk)[63](index=63&type=chunk) - The company entered into a license agreement with Halozyme in November 2023 to develop a subcutaneous formulation of sabirnetug, involving an upfront payment and future milestone and royalty payments[94](index=94&type=chunk)[95](index=95&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the advancement of sabirnetug in clinical trials, increased operating expenses, and the company's financial runway extending into the first half of 2027 - The company's lead drug candidate, sabirnetug, is being advanced in the ALTITUDE-AD study, a Phase 2/3 clinical trial for early Alzheimer's disease, with the first patient dosed in May 2024[101](index=101&type=chunk)[103](index=103&type=chunk) - Based on the current operating plan, the company expects its existing cash, cash equivalents, and marketable securities of **$296.6 million** (as of March 31, 2024) to be sufficient to fund operations into the first half of 2027[111](index=111&type=chunk)[125](index=125&type=chunk) Operating Expenses (in thousands) | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $12,449 | $8,713 | 43% | | General and administrative | $5,325 | $4,422 | 20% | | **Total operating expenses** | **$17,774** | **$13,135** | **35%** | - In January 2024, the company raised net proceeds of **$7.9 million** by issuing 2,068,246 shares of common stock under its at-the-market (ATM) offering program[108](index=108&type=chunk)[124](index=124&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Disclosure is not required as the company is a smaller reporting company[145](index=145&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal controls - Management concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[147](index=147&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the fiscal quarter ended March 31, 2024[148](index=148&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and required exhibits [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not subject to any material legal proceedings[153](index=153&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have been made to the risk factors as described in the Annual Report on Form 10-K for the year ended December 31, 2023[154](index=154&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company reported no unregistered sales or issuer purchases of equity securities, with IPO proceeds used as planned - There has been no material change in the planned use of proceeds from the company's IPO[154](index=154&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents - The report includes standard exhibits such as CEO/CFO certifications (Sections 302 and 906) and XBRL data files[157](index=157&type=chunk)