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 ...

NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer's disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison study. The study plans to compare the PK between subcutaneous and intravenous ad ...

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 ...

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’ ...

NEWTON, Mass., July 11, 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 that the Company will 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 taking place in Philadelphia ...

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)

Financial Data and Key Metrics Changes - As of March 31, 2024, the company had approximately $297 million in cash and marketable securities, with an expected cash runway lasting into the first half of 2027 [10] - R&D expenses for Q1 2024 were $12.4 million, an increase attributed to spending for the ALTITUDE-AD trial [11] - G&A expenses were $5.3 million for the quarter, reflecting an increase due to higher headcount, leading to a loss from operations of $17.8 million [11] Business Line Data and Key Metrics Changes - The ALTITUDE-AD Phase II study has commenced, with the first patient dosed, aiming to evaluate the efficacy and safety of sabirnetug in approximately 540 participants [7][8] - The company is also on track to initiate a Phase I study for a subcutaneous formulation of sabirnetug in mid-2024, which is expected to provide additional flexibility for patients [9] Market Data and Key Metrics Changes - The company is encouraged by the early engagement and interest from trial sites for the ALTITUDE study, which may be positively influenced by the Phase I INTERCEPT results [7][27] Company Strategy and Development Direction - The company aims to establish sabirnetug as a best-in-class treatment for early Alzheimer's patients, focusing on advancing clinical development efficiently [9] - A collaboration agreement with Lonza for manufacturing sabirnetug has been established, leveraging Lonza's expertise for clinical development and commercialization [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the ALTITUDE study's early progress and the potential for sabirnetug to provide significant value to patients and shareholders [9][27] - The company is closely monitoring the implications of competing products like lecanemab and donanemab on enrollment expectations for the ALTITUDE study [26][27] Other Important Information - The company is committed to delivering updates throughout the year as it advances the sabirnetug program [11] Q&A Session Summary Question: Is R&D about stable now, or are we expecting it to go up significantly? - R&D is expected to trend up for the next couple of quarters before flattening out and then decreasing [12][13] Question: Do you have a sense of what you're looking for in the subcutaneous formulation? - The focus is on getting the healthy volunteer study up and evaluating pharmacokinetics, with considerable optionality for future steps [14][15] Question: Can you ultimately get to a plaque-busting dose with the subcutaneous formulation? - The goal remains consistent with the INTERCEPT study, focusing on oligomer target engagement and some plaque reduction [18][19] Question: What are the implications of the upcoming donanemab AdComm? - The AdComm will focus on treatment duration and stratification concerns, which may have implications for market development [20] Question: Can the subcutaneous formulation be used within ALTITUDE if the healthy volunteer study goes well? - While theoretically possible, it would be logistically challenging to insert the subcutaneous formulation into the already designed ALTITUDE study [28][29]

Exhibit 99.1 Acumen Pharmaceuticals Reports First Quarter 2024 Financial Results and Business Highlights • Announced initiation of ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in May 2024 • Initiation of a Phase 1 study to support a subcutaneous dosing option of sabirnetug expected in mid- 2024 • Cash, cash equivalents and marketable securities of $296.6 million as of Mar. 31, 2024, expected to support current clinical and operational activi ...

Announced initiation of ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer's disease, in May 2024Initiation of a Phase 1 study to support a subcutaneous dosing option of sabirnetug expected in mid-2024Cash, cash equivalents and marketable securities of $296.6 million as of Mar. 31, 2024, expected to support current clinical and operational activities into the first half of 2027Company to host conference call and webcast today at 8:00 a.m. ET CHARLOTTESVILLE, ...

CHARLOTTESVILLE, Va., May 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers for the treatment of Alzheimer's disease, announced today that management will participate in a fireside chat at the 2024 Bank of America Healthcare Conference on Wednesday, May 15, 2024, at 8:55 a.m. PT (11:55 a.m. ET). The live webcast may be accessed under the Investors tab on www.acum ...