Acumen Pharmaceuticals Reports First Quarter 2023 Financial Results and Business Highlights
May 09 2023 - 7:00AM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage
biopharmaceutical company developing a novel therapeutic that
targets toxic soluble amyloid beta oligomers (AβOs) for the
treatment of Alzheimer’s disease (AD), today reported
financial results for the first quarter of 2023 and provided a
business update.
“In the first quarter, we remained focused on executing the
Phase I INTERCEPT-AD trial of ACU193, our novel therapeutic for the
treatment of early Alzheimer’s disease. We are pleased to confirm
our expectation that we will share the first clinical data in the
field from a monoclonal antibody with high selectivity for toxic
amyloid beta oligomers in the upcoming third quarter,” said Daniel
O’Connell, President and Chief Executive Officer of Acumen. “Amid a
dynamic and evolving Alzheimer’s landscape, we look forward to
reporting clinical evidence of the overall safety profile,
pharmacokinetic data, including the potential for monthly dosing,
as well as target engagement. We expect that these topline data
will serve as the basis for an anticipated interaction with the FDA
in the fourth quarter to inform our next phase of development for
ACU193.”
Recent Business Highlights and Anticipated
Milestones
- In February 2023,
enrollment was completed in our Phase 1 INTERCEPT-AD trial,
investigating the safety, tolerability, pharmacokinetics and target
engagement of ACU193 in patients with early AD.
- Acumen continues to anticipate
reporting topline results from this trial in the third quarter of
2023.
- In March 2023, the
Company presented research at the International
Conference on Alzheimer’s and Parkinson’s Diseases (ADPD).
- The research demonstrated the
utility of a human in vitro model of induced pluripotent
stem cell (iPSC)-derived excitatory neurons for a better
understanding of which forms of amyloid beta oligomers contribute
to the pathogenesis of AD in the human brain. Utilizing human
iPSC-derived excitatory neurons as a model, a panel of Aβ detection
antibodies, and a panel of globular soluble AβOs plus monomers, the
current study found that soluble Aβ size may influence synaptic
binding. Read more here.
First Quarter 2023 Financial Results
- Cash
Balance. As of March 31, 2023, cash, cash equivalents and
marketable securities totaled $183.8 million, compared to cash,
cash equivalents and marketable securities of $193.4 million as of
December 31, 2022. The decrease in cash is related to funding
ongoing operations.
- Research and
Development (R&D) Expenses. R&D expenses
were $8.7 million for the three-month period ended March 31, 2023,
compared to $6.0 million for the three-month period ended March 31,
2022. The increase in R&D expenses was primarily due to
increased costs related to our ongoing clinical trial, as well as
nonclinical research and development activity.
- General and
Administrative (G&A) Expenses. G&A expenses
were $4.4 million for the three-month period ended March 31, 2023,
compared to $3.2 million for the three-month period ended March 31,
2022. The increase in G&A expenses was primarily due to
increased costs related to personnel, consulting and travel
expenses.
- Loss from
Operations. Losses from operations were $13.1 million
for the three-month period ended March 31, 2023, compared to $9.2
million for the three-month period ended March 31, 2022. This
increase was due to the increased R&D and G&A expenses over
the prior year period.
- Net Loss. Net loss was
$11.3 million for the three-month period ended March 31, 2023,
compared to $9.1 million for the three-month period ended March 31,
2022.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
May 9, 2023, at 8:00 a.m. ET.
To participate in the live conference call, please register
using this link. After registration, you will be informed of
the dial-in numbers including PIN.
The webcast audio will be available via this link.
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.
About ACU193ACU193 is a humanized 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 a growing body of evidence indicating that soluble
AβOs are a primary underlying cause of the neurodegenerative
process in Alzheimer’s disease. ACU193 has been granted Fast Track
designation for the treatment of early Alzheimer’s disease by the
U.S. Food and Drug Administration.
About INTERCEPT-AD
INTERCEPT-AD is a Phase 1, U.S.-based, multi-center, randomized,
double-blind, placebo-controlled clinical trial evaluating the
safety and tolerability, and establishing clinical proof of
mechanism, of ACU193 in patients with early Alzheimer’s disease
(AD). Sixty-five individuals with early AD (mild cognitive
impairment or mild dementia due to AD) enrolled in this
first-in-human study of ACU193. The INTERCEPT-AD study 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 has completed enrollment across all sites.
More information can be found on www.clinicaltrials.gov, NCT
identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with clinical
operations based in Carmel, IN, is a clinical-stage
biopharmaceutical company developing a novel therapeutic that
targets toxic soluble amyloid beta oligomers (AβOs) for the
treatment of Alzheimer’s disease (AD). Acumen’s scientific founders
pioneered research on AβOs, which a growing body of evidence
indicates are early and persistent 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
INTERCEPT-AD, 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,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,”
“will,” “milestone” 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 expected sufficiency of its cash
resources through 2025, and the therapeutic potential of Acumen’s
product candidate, ACU193, including against other antibodies, and
the anticipated timeline for reporting topline safety and proof of
mechanism data and results and for further engagement with the FDA.
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 geopolitical events and macroeconomic conditions, such
as rising inflation and interest rates, supply disruptions and
uncertainty of credit and financial markets. 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 most recent Annual Report on Form
10-K, and in subsequent filings with the SEC. 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.
Investors: Alex
Braunabraun@acumenpharm.com
Media: AcumenPR@westwicke.com
Acumen
Pharmaceuticals, Inc. |
Condensed
Balance Sheets |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
77,999 |
|
|
$ |
130,101 |
|
Marketable securities, short-term |
|
62,410 |
|
|
|
47,504 |
|
Prepaid expenses and other current assets |
|
3,623 |
|
|
|
2,724 |
|
Total
current assets |
|
144,032 |
|
|
|
180,329 |
|
Marketable
securities, long-term |
|
43,419 |
|
|
|
15,837 |
|
Property and
equipment, net |
|
151 |
|
|
|
165 |
|
Right-of-use
asset |
|
67 |
|
|
|
105 |
|
Other
assets |
|
195 |
|
|
|
151 |
|
Total
assets |
$ |
187,864 |
|
|
$ |
196,587 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
762 |
|
|
$ |
1,640 |
|
Accrued clinical trial expenses |
|
5,203 |
|
|
|
2,717 |
|
Accrued expenses and other current liabilities |
|
2,747 |
|
|
|
3,350 |
|
Operating lease liability |
|
67 |
|
|
|
105 |
|
Total
current liabilities |
|
8,779 |
|
|
|
7,812 |
|
Total
liabilities |
|
8,779 |
|
|
|
7,812 |
|
Commitments
and contingencies |
|
|
|
Stockholders' equity |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and no shares issued and outstanding as of March 31, 2023 and
December 31, 2022 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
41,025,062 shares issued and outstanding as of March 31, 2023 and
December 31, 2022 |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
361,339 |
|
|
|
359,949 |
|
Accumulated deficit |
|
(181,734 |
) |
|
|
(170,427 |
) |
Accumulated other comprehensive loss |
|
(524 |
) |
|
|
(751 |
) |
Total
stockholders' equity |
|
179,085 |
|
|
|
188,775 |
|
Total
liabilities and stockholders' equity |
$ |
187,864 |
|
|
$ |
196,587 |
|
|
|
|
|
Acumen
Pharmaceuticals, Inc. |
|
Condensed
Statements of Operations and Comprehensive Loss |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating
expenses |
|
|
|
|
Research and development |
$ |
8,713 |
|
|
$ |
5,985 |
|
|
General and administrative |
|
4,422 |
|
|
|
3,221 |
|
|
Total
operating expenses |
|
13,135 |
|
|
|
9,206 |
|
|
Loss from
operations |
|
(13,135 |
) |
|
|
(9,206 |
) |
|
Other income
(expense) |
|
|
|
|
Interest income, net |
|
1,832 |
|
|
|
76 |
|
|
Other income (expense), net |
|
(4 |
) |
|
|
1 |
|
|
Total other
income |
|
1,828 |
|
|
|
77 |
|
|
Net
loss |
|
(11,307 |
) |
|
|
(9,129 |
) |
|
Other
comprehensive gain (loss) |
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
227 |
|
|
|
(583 |
) |
|
Comprehensive loss |
$ |
(11,080 |
) |
|
$ |
(9,712 |
) |
|
Net loss per
common share, basic and diluted |
$ |
(0.28 |
) |
|
$ |
(0.23 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
41,025,062 |
|
|
|
40,473,270 |
|
|
|
|
|
|
|
Acumen Pharmaceuticals, Inc. |
Condensed Statements of Cash Flows |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
Cash flows from operating activities |
|
Net loss |
$ |
(11,307 |
) |
|
$ |
(9,129 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
14 |
|
|
|
4 |
|
Stock-based compensation expense |
|
1,390 |
|
|
|
618 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
(334 |
) |
|
|
216 |
|
Amortization of right-of-use asset |
|
38 |
|
|
|
33 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
(899 |
) |
|
|
1,416 |
|
Other assets |
|
(44 |
) |
|
|
(65 |
) |
Accounts payable |
|
(878 |
) |
|
|
121 |
|
Accrued clinical trial expenses |
|
2,486 |
|
|
|
281 |
|
Operating lease liability |
|
(38 |
) |
|
|
(32 |
) |
Accrued expenses and other current liabilities |
|
(603 |
) |
|
|
(1,762 |
) |
Net cash used in operating activities |
|
(10,175 |
) |
|
|
(8,299 |
) |
Cash flows from investing activities |
|
|
|
Purchases of marketable securities |
|
(52,131 |
) |
|
|
(9,090 |
) |
Proceeds from maturities and sales of marketable securities |
|
10,204 |
|
|
|
4,000 |
|
Purchases of property and equipment |
|
- |
|
|
|
(9 |
) |
Net cash used in investing activities |
|
(41,927 |
) |
|
|
(5,099 |
) |
Net change in cash and cash equivalents |
|
(52,102 |
) |
|
|
(13,398 |
) |
Cash and cash equivalents at the beginning of the period |
|
130,101 |
|
|
|
122,162 |
|
Cash and cash equivalents at the end of the period |
$ |
77,999 |
|
|
$ |
108,764 |
|
|
|
|
|
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