Acumen Pharmaceuticals Reports Financial Results for Third Quarter 2021 and Business Highlights
16 November 2021 - 12:00AM
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 quarter ended September 30, 2021 and
provided recent business highlights.
“Starting with our successful IPO in early July, the third
quarter of 2021 marked the beginning of the next phase of life for
our company. In October 2021, we announced the screening and
initial dosing of our first patient in INTERCEPT-AD,” said Daniel
O’Connell, President and Chief Executive Officer at Acumen.
“INTERCEPT-AD is investigating the safety, tolerability,
pharmacokinetics and target engagement of our product candidate
ACU193 in a Phase 1 clinical trial involving early Alzheimer’s
patients. ACU193 is differentiated as the first humanized
monoclonal antibody discovered and developed to selectively target
toxic amyloid-beta oligomers (AβOs) to enter a clinical trial. We
have cleared our sentinel safety review and are continuing to
recruit patients in INTERCEPT-AD. We believe we have the resources
to execute against our current strategic plan with our existing
cash and cash equivalents and marketable securities, which we
believe will be sufficient to enable us to fund our operating
expenses and capital expenditure requirements at least through
2024.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
-
INTERCEPT-AD is recruiting; sentinel safety review complete
and Cohort 1 is enrolling. Patient screening and
enrollment is ongoing for INTERCEPT-AD. Although Acumen has
experienced delays in clinical site activation and patient
enrollment in INTERCEPT-AD, which Acumen believes is a result of
the rise of the Delta variant of COVID-19 early in the third
quarter of 2021, Acumen continues to anticipate topline data from
this trial by the end of 2022, subject to the rate of site
activation and patient recruitment.
Corporate
- 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, resulting in aggregate net
proceeds of $168.6 million.
Third Quarter 2021 Financial Results
- Cash Balance. As of
September 30, 2021, our cash and cash equivalents totaled $135.8
million and our marketable securities totaled $94.1 million,
compared to cash and cash equivalents of $43.8 million and no
marketable securities as of December 31, 2020.
- Research and
Development (R&D) Expenses. R&D expenses were $1.8
million and $6.6 million for the three- and nine-month periods
ended September 30, 2021, respectively, compared to $3.0 million
and $7.0 million for the three- and nine-month periods ended
September 30, 2020, respectively.
- General and
Administrative (G&A) Expenses. G&A expenses were
$2.1 million and $4.5 million for the three- and nine-month periods
ended September 30, 2021, respectively, compared to $0.2 million
and $0.7 million for the three- and nine-month periods ended
September 30, 2020, respectively.
- Loss from
Operations. Losses from Operations were $3.9 million and
$11.2 million for the three- and nine-month periods ended September
30, 2021, respectively, compared to $2.5 million and $6.6 million
for the three- and nine-month periods ended September 30, 2020,
respectively.
- Net
Loss. Net Losses were $3.9 million and $92.3 million for
the three- and nine-month periods ended September 30, 2021,
respectively, compared to $2.5 million and $6.6 million for the
three- and nine-month periods ended September 30, 2020,
respectively. Net losses in 2021 include a non-cash expense that
represents the changes in fair value of Acumen’s Series B tranche
liability and Series A-1 warrant liability. The tranche liability
and warrant liability were initially recorded at fair value as a
liability on Acumen’s 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. The second tranche of the Series B
Preferred Stock financing round closed in June 2021 and, as a
result, the remaining value of the tranche liability was
reclassified to convertible preferred stock on Acumen’s condensed
balance sheet. Additionally, the Series A-1 warrant was exercised
in June 2021, and the remaining value of the warrant liability was
reclassified to convertible preferred stock on Acumen’s condensed
balance sheet. Upon the closing of the initial public offering, all
outstanding share of convertible preferred stock converted into
equivalent shares of common stock.
About ACU193
ACU193 is a monoclonal antibody (mAb) discovered and developed
based on its selectivity for soluble AβOs, which Acumen believes
are the most toxic and pathogenic form of Aβ, relative to Aβ
monomers and amyloid plaques. Soluble AβOs have been observed to be
potent neurotoxins that bind to neurons, inhibit synaptic function
and induce neurodegeneration. By selectively targeting toxic
soluble AβOs, ACU193 aims to directly address what a growing body
of evidence indicates is a primary underlying cause of the
neurodegenerative process in AD.
About INTERCEPT-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.
About Acumen 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 AβOs, 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 AβOs 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, including the expected timing of 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 June 30, 2021, and future
filings and reports by Acumen, including Acumen’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 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:
investors@acumenpharm.com
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