Topline results expected in the first half of 2023 from INTERCEPT-AD, a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1 clinical trial of ACU193 in patients with early Alzheimer’s disease (AD)

Key methods and assay model developed to potentially standardize the study of soluble amyloid-beta oligomers (AßOs) presented in a poster at the recent Alzheimer’s Association International Conference (AAIC)

$209.9 million in cash, cash equivalents and marketable securities as of June 30, 2022, which is expected to provide cash runway through 2025

Company to host conference call and webcast today at 4:30 pm ET

INTERCEPT-AD enrollment remains ongoing. Patient screening and enrollment is continuing for INTERCEPT-AD. At present, we have 15 active clinical trial sites recruiting patients for INTERCEPT-AD. Acumen anticipates topline data from this trial in the first half of 2023.

Presentation of methodology for synthetic model assay to potentially standardize the study of soluble AßOs. Methodology was recently presented in a poster, “Preparation and qualification of soluble amyloid beta oligomers for use in bioanalytic assays supporting Alzheimer’s disease therapeutics” (P4-178), at the 2022 Alzheimer’s Association International Conference. This presentation discussed utilizing Aß-derived diffusible ligands (ADDLs) as a synthetic AßO model reagent to aid in standardization of AßO assays, including the use of ADDLs as a potential quantitative reference standard in potency and PK assays, and possibly to better understand the AßO specificity and selectivity of Aß-targeting antibodies.

Phase 2/3 clinical trial preparation activities progressing. Acumen anticipates initiating a Phase 2/3 trial for ACU193 following completion of INTERCEPT-AD, if successful, and subsequent consultation and feedback from the FDA. Chronic toxicology and chemistry manufacturing and controls (CMC) activities are ongoing to support readiness.

Acumen continues to expand its team with new appointments. In Q2 2022, we hired Liean Schenck, MS as our VP, Head of Chemistry, Manufacturing and Controls (CMC). Ms. Schenck brings over 25 years of pharmaceutical industry experience in biologics process development, manufacturing, and CMC program management and has been responsible for CMC delivery of three commercial products since 2016 in her prior experience with other companies. Ms. Schenck started her career at Lonza Biologics in fermentation development before spending more than 20 years at Eli Lilly and Company in various CMC roles. In her most recent position, she served as Head of CMC program management at Novavax.

Dr. Jeffrey Sevigny, the Chief Medical Officer of Prevail Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company, has departed from the Board effective August 12, 2022. Dr. Sevigny’s departure was due to requirements of his current employment and not due to any disagreement with the Company. Dr. Sevigny joined Acumen’s Board in 2019 and has made valuable contributions to the company. “We thank Jeff for his service and support of Acumen over the last three years,” said Dan O’Connell, Chief Executive Officer of Acumen. “His extensive experience and detailed knowledge of clinical translation and neuroscience have been highly valued at Acumen as we have grown, and his early commitment and support of our program and team are greatly appreciated.”

Cash Balance. As of June 30, 2022, cash, cash equivalents and marketable securities totaled $209.9 million, compared to cash, cash equivalents and marketable securities of $225.9 million as of December 31, 2021. The decrease in cash is related to funding ongoing operations.

Research and Development (R&D) Expenses. R&D expenses were $7.3 million for the three-month period ended June 30, 2022, compared to $2.3 million for the three-month period ended June 30, 2021. The increase in research and development expenses was due to increased costs related to our ongoing clinical trial, which was initiated in 2021 and started enrolling patients in the second half of 2021, as well as nonclinical research and development activity.

General and Administrative (G&A) Expenses. G&A expenses were $3.1 million for the three-month period ended June 30, 2022, compared to $1.2 million for the three-month period ended June 30, 2021. The increase in general and administrative expenses was primarily due to increased costs related to personnel, insurance, legal, marketing and recruiting expenses.

Loss from Operations. Losses from operations were $10.4 million for the three-month period ended June 30, 2022, compared to $3.4 million for the three-month period ended June 30, 2021. This increase was due to the increased R&D and G&A expenses over the prior year period.

Net Loss. Net loss was $10.2 million for the three-month period ended June 30, 2022, compared to $61.4 million for the three-month period ended June 30, 2021. Net losses in the 2021 period includes a $57.9 million non-cash expense that represents the changes in fair value of Acumen’s Series B tranche liability and Series A-1 warrant liability. The remaining increase relates to increased operating expenses.

ASSETS

Current assets

Cash and cash equivalents

Marketable securities, short-term

Prepaid expenses and other current assets

Total current assets

Marketable securities, long-term

Property and equipment, net

Deferred offering costs

Right-of-use asset

Other assets

Total assets

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

Accounts payable

Accrued expenses and other current liabilities

Operating lease liability, current portion

Total current liabilities

Operating lease liability, net of current portion

Total liabilities

Commitments and contingencies

Stockholders’ equity

Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding as of June 30, 2022 and December 31, 2021

Common stock, $0.0001 par value; 300,000,000 shares authorized and 40,501,258 shares and 40,473,270 issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

Additional paid-in capital

Accumulated deficit

Accumulated other comprehensive loss

Total stockholders’ equity

Total liabilities and stockholders’ equity

Operating expenses

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense)

Interest income, net

Change in fair value of preferred stock tranche rights liability and preferred stock

warrant liability

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Net loss

Other comprehensive loss

Unrealized loss on marketable securities

Comprehensive loss

Net loss per common share, basic and diluted

Weighted-average shares outstanding, basic and diluted

Cash flows from operating activities

Net loss

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation

Change in fair value of preferred stock tranche rights liability and preferred stock

warrant liability

Stock-based compensation expense

Amortization of premiums and accretion of discounts on marketable securities, net

Amortization of right-of-use asset

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

Other assets

Accounts payable

Operating lease liability

Accrued expenses and other current liabilities

Net cash used in operating activities

Cash flows from investing activities

Purchases of marketable securities

Proceeds from maturities and sales of marketable securities

Purchases of property and equipment

Net cash provided by (used in) investing activities

Cash flows from financing activities

Proceeds from issuance of Series B milestone shares, net of issuance costs

Proceeds from exercise of Series A-1 warant

Proceeds from exercise of common stock warrants

Payments for deferred offering costs

Proceeds from the exercise of stock options

Net cash provided by (used in) financing activities

Net change in cash and cash equivalents

Cash and cash equivalents at the beginning of the period

Cash and cash equivalents at the end of the period

Supplemental disclosure of cash flow information

Cash paid for income taxes

Cash paid for interest

Supplemental disclosure of noncash investing and financing activities

Right-of-use asset obtained in exchange for operating lease liabilities

Deferred offering costs in accrued expenses and other current liabilities

Purchases of property and equipment in accounts payable

Reclassification of preferred stock tranche rights liability upon share issuance

Reclassification of warrant liability upon exercise of preferred stock warrant

Deferred offering costs in accounts payable