GlobeNewswire Inc | Aug 16, 2021 04:05PM EDT

August 16, 2021

-- Acumens investigational drug, ACU193, is the first humanized monoclonal antibody discovered and developed to selectively target toxic amyloid-beta oligomers (AOs) to enter clinical trials -- Initiated ACU-001, a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 clinical trial of ACU193 in patients with early Alzheimers Disease -- Closed initial public offering in July 2021, with aggregate net proceeds of $169 million

CHARLOTTESVILLE, Va. and CARMEL, Ind., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (Acumen), a clinical stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimers disease (AD), today reported financial results for the quarter ended June 30, 2021 and provided recent business highlights.

We continue to execute on our corporate and clinical development goals during this exciting time in the Alzheimers field, said Daniel OConnell, President and Chief Executive Officer at Acumen. Our clinical trial, ACU-001, is investigating the safety, tolerability, pharmacokinetics, and target engagement of our product candidate ACU193 in a Phase 1 clinical trial involving early Alzheimers patients. ACU193 is the first humanized monoclonal antibody discovered and developed to selectively target toxic amyloid-beta oligomers (AOs) to enter a clinical trial. We anticipate ACU-001 recruitment and cohort progression will allow us to provide topline results with the goal of demonstrating proof of mechanism for ACU193 in early AD by year end 2022. With the recent closing of our IPO, we believe we are well-funded to achieve multiple corporate and clinical development milestones, as we execute against our comprehensive strategic plan.

Recent Business Highlights and Anticipated Milestones

ACU193 Clinical Development

-- ACU-001 trial is actively recruiting and we expect to report top-line data by year end 2022. Patient screening and enrollment is proceeding for the randomized, placebo-controlled Phase 1 clinical trial evaluating ACU193.

Corporate

-- Prefunding of Series B Milestone Tranche - $30M. On June 17, 2021, the Milestone Closing for the Series B convertible preferred stock occurred, resulting in the sale of 7,908,027 shares of Series B convertible preferred stock for gross proceeds of $30.0 million. The Series B investors included RA Capital, PBM Capital, BlackRock, and Sands Capital. -- Closing of Initial Public Offering. In July 2021, Acumen issued an aggregate of 11,499,998 shares of common stock, including shares pursuant to the underwriters exercise of their full over-allotment option, in an initial public offering (IPO), resulting in aggregate net proceeds of $168.6 million.

Second Quarter 2021 Financial Results

-- Cash Balance. Cash, cash equivalents and marketable securities were $68.8 million as of June 30, 2021, compared to $43.8 million as of December 31, 2020. The net proceeds of the IPO resulted in total cash, cash equivalents and marketable securities increasing to more than $235 million in early July 2021. -- Research and Development (R&D) Expenses. R&D expenses were $2.3 million and $4.8 million for the three- and six-month periods ending June 30, 2021, respectively, compared to $1.9 million and $4.0 million for the three- and six-month periods ending June 30, 2020, respectively. -- General and Administrative (G&A) Expenses.G&A expenses were $1.2 million and $2.4 million for the three- and six-month periods ending June 30, 2021, respectively, compared to $0.3 million and $0.5 million for the three- and six-month periods ending June 30, 2020, respectively. -- Net Operating Loss.Net Operating Losses were $3.4 million and $7.2 million for the three- and six-month periods ending June 30, 2021, respectively, compared to $2.0 million and $4.1 million for the three- and six-month periods ending June 30, 2020, respectively. Net Loss. Net Losses were $61.4 million and $88.4 million for the three-and six-month periods ending June 30, 2021, respectively, compared to $2.0 million and $4.1 million for the three- and six-month periods ending June 30, 2020, respectively. Net losses in 2021 include a non-cash expense that represents the changes in fair value of Acumens Series A-1 warrant liability and the Series B tranche rights. The warrant liability and tranche rights were initially recorded at fair value as a liability on the companys balance sheet and were subsequently re-measured at fair value at the end of each reporting period. The increases in the fair value of these instruments were recognized as a component of other expense.

About Acumen Pharmaceuticals, Inc. Acumen, headquartered inCharlottesville,VAwith clinical operations based in Carmel, IN,isaclinical stagebiopharmaceuticalcompanydeveloping a novel disease-modifying approach totreatAlzheimers disease.Acumensscientific founders pioneered research onAOs,whicha growing body of evidence indicatesareprimary triggers of Alzheimersdiseasepathology.Acumen is currentlyfocused onadvancing its investigational drug, ACU193, a humanized monoclonal antibodythatselectively targets toxicAbOs,inaPhase I clinical trialinvolvingearlyAlzheimersdiseasepatients. We believe that ACU193 represents a differentiated approach from current and prior AD immunotherapies because it is highly selective for toxic AOs and because it is engineered to reduce immune signaling. As such, ACU193 is expected to carry a reduced rate of amyloid-related imaging abnormalities, or ARIA, a common, dose-limiting adverse event observed with amyloid plaque-targeting immunotherapies.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statement describing Acumens 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 and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning Acumens business, our ability to achieve our strategic and financial goals, the therapeutic potential of Acumens product candidate, ACU193, and the expected timing of reporting top line data from the Phase 1 clinical trial of ACU193. These statements are based upon the current beliefs and expectations of Acumen management, and are subject to certain factors, risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of the COVID-19 pandemic. These and other risks concerning Acumens programs are described in additional detail in Acumens filings with the Securities and Exchange Commission (SEC), including in our prospectus dated June 30, 2021, as filed with the SEC on July 2, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, which is available on the SECs website at www.sec.gov. Copies of these and other documents are available from the Company. Additional information will be made available in other filings that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether as a result of new information, future events or otherwise.

Investor & Media Contact: investors@acumenpharm.com

Acumen Pharmaceuticals, Inc.Condensed Balance Sheets(in thousands, except share and per share data) June 30, 2021 December 31, 2020 (Unaudited) ASSETS Current assets Cash and cash equivalents $ 68,812 $ 43,777 Grant receivable 109 109 Prepaid expenses and other current assets 1,651 543 Total current assets 70,572 44,429 Property and equipment, net 6 - Deferred offering costs 2,352 - Other assets 13 - Total assets $ 72,943 $ 44,429 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICITCurrent liabilities Accounts payable $ 2,907 $ 531 Accrued expenses and other current liabilities 1,611 423 Preferred stock tranche rights liability - 5,033 Preferred stock warrant liability - 380 Total liabilities 4,518 6,367 Series A convertible preferred stock, $0.0001par value; 711,203 shares authorized as of June30, 2021 and December 31, 2020; 477,297 shares 1,067 1,067 issued and outstanding as of June 30, 2021 andDecember 31, 2020; liquidation preference of$1,067 as of June 30, 2021Series A-1 convertible preferred stock, $0.0001par value; 11,898,177 shares authorized as ofJune 30, 2021 and December 31, 2020; 7,985,305and 7,537,879 shares issued and outstanding as 22,963 16,333 of June 30, 2021 and December 31, 2020,respectively; liquidation preference of $18,097as of June 30, 2021Series B convertible preferred stock, $0.0001par value; 29,457,450 shares authorized as ofJune 30, 2021 and December 31, 2020; 19,770,070and 11,862,043 shares issued and outstanding as 150,474 39,253 of June 30, 2021 and December 31, 2020,respectively; liquidation preference of $75,116as of June 30, 2021 Stockholders' deficit Common stock, $0.0001 par value; 50,500,000shares authorized as of June 30, 2021 andDecember 31, 2020, respectively; 556,570 and - - 419,124 shares issued and outstanding as ofJune 30, 2021 and December 31, 2020,respectivelyAdditional paid-in capital 9,241 8,374 Accumulated deficit (115,320 ) (26,965 )Total stockholders' deficit (106,079 ) (18,591 )Total liabilities, convertible preferred stock $ 72,943 $ 44,429 and stockholders' deficit

Acumen Pharmaceuticals, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Grant and other $ - $ 151 $ - $ 377 revenue Operating expensesResearch and 2,254 1,927 4,832 3,977 developmentGeneral and 1,187 259 2,402 481 administrativeTotal operating 3,441 2,186 7,234 4,458 expensesLoss from (3,441 ) (2,035 ) (7,234 ) (4,081 )operations Other income (expense)Interest income 4 - 8 1 Change in fairvalue ofpreferred stocktranche rights (57,940 ) - (81,157 ) - liability andpreferred stockwarrantliabilityOther income 19 - 28 - Total other (57,917 ) - (81,121 ) 1 income (expense)Net lossattributable to $ (61,358 ) $ (2,035 ) $ (88,355 ) $ (4,080 )commonstockholders Net loss percommon share, $ (141.93 ) $ (4.86 ) $ (207.52 ) $ (9.73 )basic anddiluted Weighted-averagesharesoutstanding, 432,325 419,124 425,761 419,124 basic anddiluted