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 March 31, 2022 and provided
a business update.
“During the first quarter, we made significant progress in
advancing INTERCEPT-AD, our Phase 1 clinical trial investigating
the safety, tolerability, pharmacokinetics and target engagement of
ACU193 in patients with early AD. We expect to report topline
results in the first half of 2023,” said Daniel O’Connell,
President and Chief Executive Officer of Acumen. “Further, we
expect our existing cash, cash equivalents and marketable
securities will be sufficient to fund our operating expenses and
capital expenditure requirements through 2025 based on our current
plans.”
The Acumen team is pleased with the recent publication of the
Frontiers in Neuroscience article in which preclinical evidence
characterizing ACU193’s selectivity and differentiated profile is
reviewed with the rationale for targeting soluble amyloid-beta
oligomers in early AD. “The Frontiers article is timely, as we and
others in the field look at upcoming clinical and regulatory events
and as we continue to position ACU193 as potentially having a
best-in-class treatment profile based on its potential safety,
including anticipated limited to no ARIA-E, and clinical benefits
on cognitive measures,” said Eric Siemers, Acumen’s Chief Medical
Officer. “Each other monoclonal antibody which is approved or is in
development has a different profile targeting various forms of A
or amyloid. We believe the differences in these profiles are likely
to lead to meaningful differences in the benefit-to-risk ratios of
other products and product candidates and ACU193. The potential
clinical significance of ACU193’s ability to selectively target
toxic soluble AOs is something we are excited to address in the
clinic.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
-
INTERCEPT-AD enrollment remains
ongoing. Patient screening and enrollment is ongoing
for INTERCEPT-AD. Acumen anticipates topline data from this trial
in the first half of 2023, subject to the rate of site activation
and patient recruitment.
- Frontiers
in Neuroscience recently published a comprehensive summary of
preclinical evidence supporting ACU193 for the potential treatment
of early Alzheimer’s disease. The article is titled
“ACU193: An immunotherapeutic poised to test the amyloid β oligomer
hypothesis of Alzheimer’s disease” and can be accessed here.
- Phase 2/3
clinical trial preparation activities progressing. Acumen
plans to be ready to initiate a Phase 2/3 trial if INTERCEPT-AD
results are positive. Chronic toxicology and chemistry
manufacturing and controls (CMC) activities are ongoing to support
readiness.
First Quarter 2022 Financial Results
- Cash
Balance. As of March 31, 2022, cash, cash equivalents and
marketable securities totaled $216.7 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 $6.0
million for the three-month period ended March 31, 2022, compared
to $2.6 million for the three-month period ended March 31, 2021.
The increase in research and development expenses was primarily due
to increased costs related to our ongoing clinical trial which was
initiated in 2021.
- General and
Administrative (G&A) Expenses. G&A expenses were
$3.2 million for the three-month period ended March 31, 2022,
compared to $1.2 million for the three-month period ended March 31,
2021. The increase in general and administrative
expenses was primarily due to increased costs related to being a
public company.
- Loss from
Operations. Losses from operations were $9.2 million for
the three-month period ended March 31, 2022, compared to $3.8
million for the three-month period ended March 31, 2021.
- Net
Loss. Net loss was $9.1 million for the three-month period
ended March 31, 2022, compared to $27.0 million for the three-month
period ended March 31, 2021. Net losses in the 2021 period includes
a $23.2 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.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
May 16, 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 2586595.
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 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 AOs 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 anticipated number of trial sites, enrollment
objectives and 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 Annual Report on
Form 10-K for the fiscal year ended December 31, 2021, and future
filings and reports by Acumen, including Acumen’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022. 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
Acumen Pharmaceuticals,
Inc.Condensed Balance Sheets(in
thousands, except share and per share data)
|
March 31, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
108,764 |
|
|
$ |
122,162 |
|
Marketable securities, short-term |
|
80,326 |
|
|
|
72,075 |
|
Prepaid expenses and other current assets |
|
3,008 |
|
|
|
4,424 |
|
Total current assets |
|
192,098 |
|
|
|
198,661 |
|
Marketable securities,
long-term |
|
27,658 |
|
|
|
31,619 |
|
Property and equipment,
net |
|
51 |
|
|
|
36 |
|
Right-of-use asset |
|
201 |
|
|
|
- |
|
Other assets |
|
79 |
|
|
|
14 |
|
Total assets |
$ |
220,087 |
|
|
$ |
230,330 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,219 |
|
|
$ |
1,088 |
|
Accrued expenses and other current liabilities |
|
2,578 |
|
|
|
4,059 |
|
Operating lease liability, current portion |
|
139 |
|
|
|
- |
|
Total current liabilities |
|
3,936 |
|
|
|
5,147 |
|
Operating lease liability, net
of current portion |
|
62 |
|
|
|
- |
|
Total liabilities |
|
3,998 |
|
|
|
5,147 |
|
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, 2022 and
December 31, 2021 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
40,473,270 shares issued and outstanding as of March 31, 2022 and
December 31, 2021 |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
353,599 |
|
|
|
352,981 |
|
Accumulated deficit |
|
(136,700 |
) |
|
|
(127,571 |
) |
Accumulated other comprehensive loss |
|
(814 |
) |
|
|
(231 |
) |
Total stockholders’
equity |
|
216,089 |
|
|
|
225,183 |
|
Total liabilities and
stockholders’ equity |
$ |
220,087 |
|
|
$ |
230,330 |
|
|
|
|
|
|
|
|
|
Acumen Pharmaceuticals, Inc.
Condensed Statements of Operations and Comprehensive
Loss (in thousands, except share and per share
data) (unaudited)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
5,985 |
|
|
$ |
2,578 |
|
General and administrative |
|
3,221 |
|
|
|
1,215 |
|
Total operating expenses |
|
9,206 |
|
|
|
3,793 |
|
Loss from operations |
|
(9,206 |
) |
|
|
(3,793 |
) |
Other income (expense) |
|
|
|
|
|
|
|
Interest income, net |
|
76 |
|
|
|
4 |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
— |
|
|
|
(23,217 |
) |
Other income, net |
|
1 |
|
|
|
9 |
|
Total other income
(expense) |
|
77 |
|
|
|
(23,204 |
) |
Net loss |
|
(9,129 |
) |
|
|
(26,997 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
(583 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(9,712 |
) |
|
$ |
(26,997 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.23 |
) |
|
$ |
(64.41 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
40,473,270 |
|
|
|
419,124 |
|
|
|
|
|
|
|
|
|
Acumen Pharmaceuticals, Inc.
Condensed Statements of Cash Flows (in
thousands) (unaudited)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Cash flows from
operating activities |
|
|
|
|
|
|
|
Net loss |
$ |
(9,129 |
) |
|
$ |
(26,997 |
) |
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 |
|
— |
|
|
|
23,217 |
|
Stock-based compensation expense |
|
618 |
|
|
|
126 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
216 |
|
|
|
— |
|
Amortization of right-of-use asset |
|
33 |
|
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
1,416 |
|
|
|
(44 |
) |
Other assets |
|
(65 |
) |
|
|
(13 |
) |
Accounts payable |
|
121 |
|
|
|
387 |
|
Operating lease liability |
|
(32 |
) |
|
|
— |
|
Accrued expenses and other current liabilities |
|
(1,481 |
) |
|
|
954 |
|
Net cash used in operating
activities |
|
(8,299 |
) |
|
|
(2,370 |
) |
Cash flows from
investing activities |
|
|
|
|
|
|
|
Purchases of marketable
securities |
|
(9,090 |
) |
|
|
— |
|
Proceeds from maturities and
sales of marketable securities |
|
4,000 |
|
|
|
— |
|
Purchases of property and
equipment |
|
(9 |
) |
|
|
— |
|
Net cash used in investing
activities |
|
(5,099 |
) |
|
|
— |
|
Net change in cash and cash
equivalents |
|
(13,398 |
) |
|
|
(2,370 |
) |
Cash and cash equivalents at
the beginning of the period |
|
122,162 |
|
|
|
43,777 |
|
Cash and cash equivalents at
the end of the period |
$ |
108,764 |
|
|
$ |
41,407 |
|
Supplemental
disclosure of cash flow information |
|
|
|
|
|
|
|
Cash paid for income
taxes |
$ |
— |
|
|
$ |
— |
|
Cash paid for interest |
$ |
— |
|
|
$ |
— |
|
Supplemental
disclosure of noncash investing and financing
activities |
|
|
|
|
|
|
|
Purchases of property and
equipment in accounts payable |
$ |
10 |
|
|
$ |
— |
|
Deferred offering costs in
accrued expenses and other current liabilities |
$ |
— |
|
|
$ |
257 |
|
|
|
|
|
|
|
|
|
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