Full Press Release Details
Acumen Pharmaceuticals Reports Financial Results for Full Year Ended December 31, 2021 and Business
Charlottesville, Va. and Carmel, In., March 28, 2022 Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage
biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer s disease (AD), today reported financial results for the full year ended December 31, 2021, and provided recent business highlights.
After a transformational year in 2021, highlighted by multiple accomplishments, including our IPO, Acumen is completely focused on executing our
business strategy with a primary emphasis on INTERCEPT-AD, our Phase 1 clinical trial investigating the safety, tolerability, pharmacokinetics and target engagement of ACU193 in early Alzheimer s
patients. Based on current progress in the trial and our current plan to report a dataset inclusive of Cohort 7 Day 168 follow up, we now expect to report topline results in the first half of 2023. We have experienced slower than anticipated
enrollment due to the COVID-19 pandemic, however our strong cash position has provided us the ability to expand the study footprint to support recruitment and to include a longer
follow-up period prior to read out, said Daniel O Connell, President and Chief Executive Officer at Acumen. With the proceeds from our successful IPO last year, we estimate our existing cash,
cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital requirements through 2025 based on our current plans.
Recent Business Highlights and Anticipated Milestones
ACU193 Clinical Development
In the fourth quarter of 2021, Acumen expanded its team with several new appointments. The new team members include Julie Bockenstette, Head of Human
Relations; Siew Tin Gan, Head of Clinical Operations; and Stephen Reynolds, Corporate Controller and Treasurer.
Siew Tin and Stephen, who are joining Acumen at a critical time in our company s growth as we continue to pioneer a new approach to treating Alzheimer s disease, said Daniel O Connell. We believe their individual
experience and collective passion for improving the lives of patients with Alzheimer s disease will help us move closer to our ambitious goals.
In addition to these appointments, Kim Drapkin, CPA, has been appointed to the Board of Directors effective
April 1, 2022. Ms. Drapkin is currently the Chief Financial Officer of Jounce Therapeutics. Ms. Drapkin brings more than 25 years of experience working with private and publicly traded biotechnology and pharmaceutical companies,
including building and leading finance functions, raising capital, and leading strategic financial planning. Ms. Drapkin will also serve as the chair of the company s audit committee.
I m incredibly excited to join the Board of Directors of Acumen at this exciting time. We face a massive unmet need in Alzheimer s disease,
and I believe that Acumen s approach of targeting toxic amyloid-beta oligomers has the potential to transform the treatment of the disease. I look forward to working with the team and the rest of the Board to support the company s growth
and, in particular, the development of ACU193, said Ms. Drapkin.
2021 Financial Results
Conference Call Details
Acumen will host a conference
call and live audio webcast today, March 28th, at 4:30 pm ET. The live webcast may be accessed from the Investors section of the Company s website at www.acumenpharm.com. Please connect to the website prior to the start of the conference
call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 877 311-0573 in the U.S., or +1 470 495-9505 outside the U.S., and entering passcode 3629669.
An archived version of the webcast will be available for at
least 30 days in the Investors section of the Company s website at www.acumenpharm.com.
ACU193 is a monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble A Os, which Acumen believes are the most toxic and
pathogenic form of A , relative to A monomers and amyloid plaques. Soluble A Os have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting
toxic soluble A Os, ACU193 aims to directly address what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD.
Approximately 62 individuals with early AD (mild cognitive impairment or mild dementia due to AD) are expected to be randomized into this double-blind,
placebo-controlled, first-in-human study of ACU193. INTERCEPT-AD is designed to establish safety and proof of mechanism. It
consists of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and target engagement of intravenous doses of ACU193. The study is enrolling at multiple
investigative sites located in the United States. More information can be found on www.clinicaltrials.gov, NCT identifier NCT04931459.
Pharmaceuticals, Inc.
Acumen Pharmaceuticals, headquartered in Charlottesville, VA, with clinical operations based in Carmel, IN, is a clinical stage
biopharmaceutical company developing a novel disease-modifying approach to treat Alzheimer s disease. Acumen s scientific founders pioneered research on toxic soluble A Os, which a growing body of evidence indicates are primary
triggers of Alzheimer s disease pathology. Acumen is currently focused on advancing its investigational product candidate, ACU193, a humanized monoclonal antibody that selectively targets toxic soluble A Os, in a Phase 1 clinical trial
involving early Alzheimer s disease patients. For more information, visit www.acumenpharm.com.
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 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 expressions are intended to
identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning Acumen s business, Acumen s ability to achieve its strategic and
financial goals, including its projected use of cash, cash equivalents and marketable securities and the sufficiency of its cash resources, and the therapeutic potential of Acumen s product candidate, ACU193, including its potential for
improved safety and efficacy as compared to other monoclonal antibodies in development, as well as the expectations concerning the INTERCEPT-AD trial and Acumen s planned Phase 2/3 clinical trial,
including the expected timing of initiation, enrollment and reporting data, and risks and uncertainties relating to the progression and duration of the COVID-19 pandemic and responsive measures thereto and
related effects on Acumen. 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 Acumen s programs are described in
additional detail in Acumen s filings with the Securities and Exchange Commission ( SEC ), including in Acumen s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021,
and future filings and reports by Acumen, including Acumen s Annual Report on Form 10-K for the year ended December 31, 2021. Copies of these and other documents are available from
Acumen. Additional information will be made available in other filings that Acumen makes 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:
(in thousands, except share and per share data)
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 122,162 | $ | 43,777 | ||||
| Marketable securities, short-term | 72,075 | |||||||
| Grant receivable | 109 | |||||||
| Prepaid expenses and other current assets | 4,424 | 543 | ||||||
| Total current assets | 198,661 | 44,429 | ||||||
| Marketable securities, long-term | 31,619 | |||||||
| Property and equipment, net | 36 | |||||||
| Other assets | 14 | |||||||
| Total assets | $ | 230,330 | $ | 44,429 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,088 | $ | 531 | ||||
| Accrued expenses and other current liabilities | 4,059 | 423 | ||||||
| Preferred stock tranche rights liability | 5,033 | |||||||
| Preferred stock warrant liability | 380 | |||||||
| Total liabilities | 5,147 | 6,367 | ||||||
| Series A convertible preferred stock, $0.0001 par value; no shares authorized, issued and outstanding as of December 31, 2021; 711,203 shares authorized and 477,297 shares issued and outstanding as of December 31, 2020; liquidation preference of $1,067 as of December 31, 2020 | 1,067 | |||||||
| Series A-1 convertible preferred stock, $0.0001 par value; no shares authorized, issued and outstanding as of December 31, 2021; 11,898,177 shares authorized and 7,537,879 shares issued and outstanding as of December 31, 2020; liquidation preference of $16,847 as of December 31, 2020 | 16,333 | |||||||
| Series B convertible preferred stock, $0.0001 par value; no shares authorized, issued and outstanding as of December 31, 2021; 29,457,450 shares authorized and 11,862,043 shares issued and outstanding as of December 31, 2020; liquidation preference of $45,070 as of December 31, 2020 | 39,253 | |||||||
| Stockholders equity (deficit) | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding as of December 31, 2021; no shares authorized, issued and outstanding as of December 31, 2020 | ||||||||
| Common stock, $0.0001 par value; 300,000,000 shares authorized and 40,473,270 shares issued and outstanding as of December 31, 2021; 50,500,000 shares authorized and 419,124 shares issued and outstanding as of December 31, 2020 | 4 | |||||||
| Additional paid-in capital | 352,981 | 8,374 | ||||||
| Accumulated deficit | (127,571 | ) | (26,965 | ) | ||||
| Accumulated other comprehensive loss | (231 | ) | ||||||
| Total stockholders equity (deficit) | 225,183 | (18,591 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 230,330 | $ | 44,429 |
Statements of Operations
(in thousands, except share and per share data)
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Grant and other revenue | $ | $ | 1,436 | |||||
| Operating expenses | ||||||||
| Research and development | 12,305 | 7,997 | ||||||
| General and administrative | 7,279 | 1,351 | ||||||
| Total operating expenses | 19,584 | 9,348 | ||||||
| Loss from operations | (19,584 | ) | (7,912 | ) | ||||
| Other income (expense) | ||||||||
| Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | (81,157 | ) | 586 | |||||
| Interest income, net | 84 | 1 | ||||||
| Other income, net | 51 | |||||||
| Total other income (expense) | (81,022 | ) | 587 | |||||
| Net loss | (100,606 | ) | (7,325 | ) | ||||
| Other comprehensive loss | ||||||||
| Unrealized loss on marketable securities | (231 | ) | ||||||
| Comprehensive loss | $ | (100,837 | ) | $ | (7,325 | ) | ||
| Net loss per common share, basic and diluted | $ | (5.02 | ) | $ | (17.48 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 20,057,534 | 419,124 |
Statements of Cash Flows
| Year Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (100,606 | ) | $ | (7,325 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 4 | |||||||
| Change in fair value of preferred stock tranche rights liability and preferred stock warrant liability | 81,157 | (586 | ) | |||||
| Stock-based compensation expense | 922 | 154 | ||||||
| Amortization of premiums and accretion of discounts on marketable securities, net | 155 | |||||||
| Other non-cash expense | 109 | |||||||
| Changes in operating assets and liabilities: | ||||||||
| Grant receivable | (79 | ) | ||||||
| Prepaid expenses and other current assets | (3,881 | ) | 53 | |||||
| Other assets | (14 | ) | 144 | |||||
| Accounts payable | 557 | 308 | ||||||
| Accrued expenses and other current liabilities | 3,636 | (119 | ) | |||||
| Net cash used in operating activities | (17,961 | ) | (7,450 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of available-for-sale marketable securities | (104,080 | ) | ||||||
| Purchases of property and equipment | (40 | ) | ||||||
| Net cash used in investing activities | (104,120 | ) | ||||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of Series B milestone shares, net of issuance costs | 30,031 | |||||||
| Proceeds from issuance of convertible preferred stock, net of issuance costs | 44,675 | |||||||
| Proceeds from exercise of Series A-1 warrant | 1,250 | |||||||
| Proceeds from exercise of common stock warrants | 614 | |||||||
| Proceeds from issuance of common stock upon initial public offering, net of issuance costs | 168,556 | |||||||
| Proceeds from stock option exercises | 15 | |||||||
| Net cash provided by financing activities | 200,466 | 44,675 | ||||||
| Net change in cash and cash equivalents | 78,385 | 37,225 | ||||||
| Cash and cash equivalents at the beginning of the period | 43,777 | 6,552 | ||||||
| Cash and cash equivalents at the end of the period | $ | 122,162 | $ | 43,777 | ||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash paid for income taxes | $ | $ | ||||||
| Cash paid for interest | $ | $ | ||||||
| Supplemental disclosure of noncash financing activities | ||||||||
| Reclassification of preferred stock tranche rights liability upon share issuance | $ | 81,190 | $ | |||||
| Reclassification of warrant liability upon exercise of preferred stock warrant | $ | 5,380 | $ | |||||
| Conversion of convertible preferred stock into common stock upon IPO | $ | 174,504 | $ |