Presentation and poster include deeper data insights on sabirnetug safety profile, target engagement and fluid biomarker changesPresentation to be featured during AAN Emerging Science SessionCompany on track to initiate Phase 2 trial evaluating sabirnetug in first half of 2024 CHARLOTTESVILLE, Va., April 16, 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) fo ...

Core Viewpoint - Acumen Pharmaceuticals has partnered with Lonza to manufacture its monoclonal antibody candidate, sabirnetug (ACU193), aimed at treating Alzheimer's disease by targeting toxic soluble amyloid beta oligomers [1][2]. Company Overview - Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for Alzheimer's disease, specifically targeting toxic soluble amyloid beta oligomers (AβOs) [4]. - The company is headquartered in Charlottesville, Virginia, with additional offices in Indianapolis, Indiana, and Newton, Massachusetts [4]. - Acumen's scientific founders have pioneered research on AβOs, which are believed to be early triggers of Alzheimer's disease pathology [4]. Product Development - Sabirnetug (ACU193) is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs in a Phase 1 clinical study [2]. - The drug aims to prevent toxic AβOs from binding to dendritic spines, thereby preserving neuronal function and addressing an underlying cause of Alzheimer's disease [2]. - Acumen plans to initiate a Phase 2 clinical trial for sabirnetug in the first half of 2024 [1]. Manufacturing Collaboration - Under the agreement, Lonza will manufacture sabirnetug at its next-generation facility in Portsmouth, New Hampshire, utilizing 2,000L single-use bioreactors [2]. - Lonza's expertise in regulatory compliance and antibody manufacturing will support Acumen in advancing its clinical development [2][3]. - The collaboration is seen as a critical step for Acumen to ensure broader access to next-generation Alzheimer's therapies [3]. Lonza Overview - Lonza is a leading global healthcare manufacturing organization with a workforce of around 18,000 employees [5]. - The company generated sales of CHF 6.7 billion and a CORE EBITDA of CHF 2.0 billion in the full year 2023 [5]. - Lonza operates across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients, providing comprehensive support to pharmaceutical and biotech companies [5].

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Corporate Presentation March 2024 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen's goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as "believes," "expects," "anticipates," "could," "would," "seeks," "aims," "plans," "potential," "will" and similar expr ...

Financial Performance - The net loss for the year ended December 31, 2023, was $52,371 thousand, compared to a net loss of $42,856 thousand in 2022, indicating a 22.5% increase in losses [500]. - The comprehensive loss for 2023 was $51,308 thousand, compared to $43,376 thousand in 2022, reflecting an 18.4% increase [500]. - The company reported a net loss of $52.4 million for the year ended December 31, 2023, compared to a net loss of $42.9 million for the previous year, reflecting an increase in losses of approximately 22% [506]. - The company incurred $6.1 million in stock-based compensation expense in 2023, compared to $3.1 million in 2022, reflecting a 99% increase year-over-year [506]. - The company reported net cash used in operating activities of $43.1 million for 2023, compared to $35.2 million for 2022, indicating a 22% increase in cash outflows [506]. Assets and Liabilities - As of December 31, 2023, total assets were $310,125 thousand, an increase from $196,587 thousand in 2022, representing a 57.7% growth [498]. - The company’s balance sheet shows a cash position of $66,886 thousand as of December 31, 2023, down from $130,101 thousand in 2022, a decrease of 48.5% [498]. - As of December 31, 2023, the company had an accumulated deficit of $222.8 million, up from $170.4 million at the end of 2022, indicating a significant increase in accumulated losses [510]. - The company had working capital of $233.6 million as of December 31, 2023, compared to $172.5 million at the end of 2022, showing an increase of approximately 35% [510]. Revenue and Income - The company reported interest income of $10,791 thousand in 2023, significantly higher than $2,392 thousand in 2022, representing a 350.5% increase [500]. Research and Development - Research and development expenses increased to $42,318 thousand in 2023 from $32,361 thousand in 2022, marking a 30.9% rise [500]. - Research and development expenses primarily consist of costs related to consultants, materials, and clinical trials, which are expensed as incurred [539]. - The company expects to initiate a Phase 2 clinical trial of its drug candidate sabirnetug in the first half of 2024, following successful Phase 1 results reported in July 2023 [513]. - The Phase 1 clinical trial, named INTERCEPT-AD, enrolled 65 patients with early Alzheimer's disease, with 62 participants receiving at least one dose of the study drug [512]. - The Company recorded R&D expenses related to the Halozyme License Agreement, including a seven-figure upfront payment, as the Halozyme Product is still in the development stage [614]. Stock and Equity - The weighted-average shares outstanding increased to 48,609,383 in 2023 from 40,601,936 in 2022, a growth of 19.8% [500]. - The Company has a total of 310 million authorized shares, with 300 million designated as Common Stock [584]. - The maximum number of shares that may be issued under the 2021 Equity Incentive Plan is 12 million, with 11,773,198 shares authorized for issuance and 3,674,730 shares remaining available as of December 31, 2023 [591]. - The intrinsic value of stock options exercised in 2023 was approximately $0.5 million, while the total unrecognized compensation costs related to unvested stock options was about $12.3 million [600]. - The Company granted 328,500 Restricted Stock Units (RSUs) in January 2023, with a weighted average fair value of $6.11 per share, and total unrecognized compensation costs related to unvested RSUs was approximately $1.4 million [602]. Financing and Capital Structure - The company raised $121.9 million in a public offering on July 21, 2023, issuing 16,774,193 shares at a price of $7.75 per share [509]. - The Company entered into a Term Loan Agreement for a principal amount of $50 million, borrowing $30 million in the first tranche, with an interest rate of 9.65% or the prime rate plus 1.15% [568]. - The effective interest rate for the Term Loan was reported at 14.3% for the year ended December 31, 2023 [573]. - The Company plans to finance its operations through a combination of equity offerings, debt financings, and collaborations, indicating ongoing reliance on external funding sources [511]. Tax and Deferred Tax Assets - The Company has not recorded any tax provision or benefit for federal income taxes for the years ended December 31, 2023 and 2022, with a statutory federal income tax rate of 21% [605]. - The total deferred tax assets as of December 31, 2023 amounted to $34.098 million, with a valuation allowance of $33.661 million recorded [608]. - The Company has not adjusted any of its deferred tax assets, including NOLs or R&D credits, pending a formal analysis of the potential impact of Section 382 on its deferred tax assets as of December 31, 2023 [610]. Marketable Securities - The company's total available-for-sale securities amounted to $239,189,000 as of December 31, 2023, with gross unrealized losses of $212,000 [554]. - The fair value of the company's total financial assets was $305,396,000 as of December 31, 2023, with significant contributions from corporate debt and U.S. treasury securities [559]. - The company's marketable securities portfolio consists entirely of available-for-sale debt securities, with short-term securities maturing within one year and long-term securities within two years [557]. - The fair value of embedded derivatives in the Term Loan increased from $1.2 million at issuance to $2.56 million by December 31, 2023, reflecting a change of $1.36 million [563]. Other Financial Information - The Company recorded no liabilities related to uncertain tax positions as of December 31, 2023 and 2022, indicating no significant tax-related risks [545]. - The Company has recorded a full valuation allowance to reduce its net deferred income tax assets to zero, reflecting uncertainty in realizing these assets [544]. - The Company did not require an allowance for credit losses for available-for-sale securities as of December 31, 2023, as the aggregate amount of credit loss was immaterial [525]. - The Company maintains deposits in financial institutions in excess of government insured limits but believes it is not exposed to significant credit risk [526]. - The Company recorded a non-cash expense of $0.7 million related to the right-of-use assets for a computer equipment lease used in R&D [578].

Corporate Presentation March 2024 1 Forward-Looking Statements 2 This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “would,” “seeks,” “aims,” “plans,” “potential,” “will” and similar ex ...

Group 1 - Acumen Pharmaceuticals, Inc. (ABOS) is currently ranked 4 in the Zacks Sector Rank within the Medical group, which consists of 1063 companies [1] - The Zacks Rank for Acumen Pharmaceuticals is 2 (Buy), indicating a favorable outlook based on earnings estimate revisions [2] - Year-to-date, Acumen Pharmaceuticals has returned 8.1%, outperforming the Medical sector's average return of 6.8% [2] Group 2 - Acumen Pharmaceuticals is part of the Medical - Biomedical and Genetics industry, which includes 512 companies and is currently ranked 80 in the Zacks Industry Rank [3] - The Medical - Biomedical and Genetics industry has shown an average gain of 0% year-to-date, indicating that Acumen Pharmaceuticals is performing better than its industry peers [3] - Ayr Wellness Inc. (AYRWF) is another Medical stock that has outperformed the sector with a year-to-date return of 12% and a Zacks Rank of 2 (Buy) [3]

- Company on track to initiate Phase 2 trial evaluating sabirnetug in first half of 2024 CHARLOTTESVILLE, Va., March 21, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer's disease (AD), today announced that the Company will present data from its Phase 1 INTERCEPT-AD study evaluating sabirnetug (ACU193) in early AD during an Emerging S ...

CHARLOTTESVILLE, Va., March 19, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers for the treatment of Alzheimer’s disease, today announced that the Company will report fourth quarter and year-end 2023 financial results on Tuesday, March 26, 2024. The Company will host a conference call and live audio webcast at 8:00 a.m. ET to provide a ...

CHARLOTTESVILLE, Va., March 19, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ:ABOS) ("Acumen" or the "Company"), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers for the treatment of Alzheimer's disease, today announced that the Company will report fourth quarter and year-end 2023 financial results on Tuesday, March 26, 2024. The Company will host a conference call and live audio webcast at 8:00 a.m. ET to provide a b ...