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 third quarter of 2022 and provided a
business update.
“During the third quarter, we remained focused on executing
INTERCEPT-AD, our Phase 1 clinical trial of ACU193 in patients with
early AD. We are pleased with the rate of progress in the study in
the quarter, which is a testament to our team’s efforts and the
therapeutic promise of ACU193. We believe that our recent receipt
of Fast Track designation from the FDA also reflects the clinical
potential of ACU193 and underscores the high unmet need for
additional disease-modifying treatments in the Alzheimer’s patient
community,” said Daniel O’Connell, President and Chief Executive
Officer of Acumen. “We remain well capitalized through 2025 based
on our current business plans and anticipate achieving the
completion of study enrollment in INTERCEPT-AD in the first quarter
of 2023 and topline results in the second half of 2023.”
Dr. Eric Siemers, M.D., Chief Medical Officer of Acumen said,
“ACU193 is the first clinical-stage monoclonal antibody designed to
selectively target toxic soluble amyloid beta oligomers. Many
studies have shown these soluble species disrupt neuronal function
and initiate the process of neurodegeneration leading to AD.
Underscoring our goal to expeditiously advance ACU193, the recent
publication of our clinical development plan in the Journal for
Prevention of Alzheimer’s Disease details incorporation of several
advancements in AD research methodology, including an adaptive
Phase 2/3 trial design. Our recent Fast Track designation should
also allow for close engagement with the FDA as we seek the most
efficient path to develop ACU193 as a potential better and
differentiated therapeutic option for patients living with AD.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
-
INTERCEPT-AD enrollment remains
ongoing. Patient screening and enrollment is
continuing for INTERCEPT-AD, with 17 active clinical trial sites
currently recruiting patients.
- The study has progressed as planned
in the protocol and blinded safety data for ACU193 are consistent
with our expectations.
- Acumen anticipates completing
enrollment in the first quarter of 2023 and reporting topline data
from this trial in the second half of 2023.
- In October 2022, Fast Track designation was granted by
the U.S. Food and Drug Administration (FDA) for ACU193 for the
treatment of early Alzheimer’s disease. Fast Track
Designation is granted to drugs being developed for the treatment
of serious or life-threatening conditions where there is an unmet
medical need. A drug candidate that receives Fast Track designation
is eligible for more frequent communication with the FDA throughout
the drug development process for the purpose of expediting the
drug's development, review, and potential approval.
- In October 2022, the development rationale and clinical
development plan for ACU193 was published in the
Journal for Prevention of Alzheimer’s Disease
(JPAD). It outlines the design of the ongoing
Phase 1 INTERCEPT-AD trial for ACU193 and planned criteria for
advancing to a Phase 2/3 clinical trial based on recent
advancements in clinical research on Alzheimer’s disease.
Corporate
- In
September 2022, Derek Meisner joined Acumen as Chief Legal
Officer. Mr. Meisner brings more than two decades of
experience providing counsel to public and private companies across
key legal and operational functions, including regulatory
compliance, debt and equity financings, mergers and acquisitions,
strategic partnerships, and corporate governance. Mr. Meisner
previously served in a similar capacity at two other
publicly-traded biotechnology companies. He also served as the
General Counsel of RA Capital Management and as a Branch Chief in
the Division of Enforcement of the U.S. Securities and Exchange
Commission.
Third Quarter 2022 Financial Results
- Cash
Balance. As of September 30, 2022, cash, cash equivalents
and marketable securities totaled $200.2 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 $8.3
million for the three-month period ended September 30, 2022,
compared to $1.8 million for the three-month period ended September
30, 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 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 September 30, 2022,
compared to $2.1 million for the three-month period ended September
30, 2021. The increase in general and administrative expenses was
primarily due to increased costs related to personnel, accounting,
marketing, recruiting and travel expenses.
- Loss from
Operations. Losses from operations were $11.4 million for
the three-month period ended September 30, 2022, compared to $3.9
million for the three-month period ended September 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 $10.7 million for the three-month
period ended September 30, 2022, compared to $3.9 million for the
three-month period ended September 30, 2021. The increase was due
to the increased R&D and G&A expenses over the prior year
period.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
Nov. 14, 2022, at 4:30 p.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 what a growing body of evidence indicates is a
primary underlying cause of the neurodegenerative process in AD.
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
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, 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 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 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 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 and
expectations with respect to blinded safety data and the potential
of soluble amyloid beta (Ab) species to be more effective or safer
disease-modifying therapeutic targets, as well as the expectations
concerning the INTERCEPT-AD trial and criteria for Acumen’s planned
Phase 2/3 clinical trial, and the potential benefits of receiving
Fast Track designation from 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 the
COVID-19 pandemic, 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 Annual Report on
Form 10-K for the fiscal year ended December 31, 2021, and future
filings with the SEC, including Acumen’s Quarterly Report on Form
10-Q for the quarter ended and September 30, 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.
Investors: Alex Braunabraun@acumenpharm.com
Media: AcumenPR@westwicke.com
Acumen Pharmaceuticals, Inc. |
Condensed Balance Sheets |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
September 30, 2022 |
December 31, 2021 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
157,540 |
|
|
$ |
122,162 |
|
Marketable securities, short-term |
|
42,654 |
|
|
|
72,075 |
|
Prepaid expenses and other current assets |
|
2,366 |
|
|
|
4,424 |
|
Total current assets |
|
202,560 |
|
|
|
198,661 |
|
Marketable securities, long-term |
|
- |
|
|
|
31,619 |
|
Property and equipment, net |
|
142 |
|
|
|
36 |
|
Deferred offering costs |
|
337 |
|
|
|
- |
|
Right-of-use asset |
|
133 |
|
|
|
- |
|
Other assets |
|
92 |
|
|
|
14 |
|
Total assets |
$ |
203,264 |
|
|
$ |
230,330 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,084 |
|
|
$ |
1,088 |
|
Accrued expenses and other current liabilities |
|
4,396 |
|
|
|
4,059 |
|
Operating lease liability, current portion |
|
133 |
|
|
|
- |
|
Total current liabilities |
|
6,613 |
|
|
|
5,147 |
|
Total liabilities |
|
6,613 |
|
|
|
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 September 30, 2022 and
December 31, 2021 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
40,503,124 and 40,473,270 shares issued and outstanding as of
September 30, 2022 and December 31, 2021, respectively |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
355,173 |
|
|
|
352,981 |
|
Accumulated deficit |
|
(157,561 |
) |
|
|
(127,571 |
) |
Accumulated other comprehensive loss |
|
(965 |
) |
|
|
(231 |
) |
Total stockholders' equity |
|
196,651 |
|
|
|
225,183 |
|
Total liabilities and stockholders' equity |
$ |
203,264 |
|
|
$ |
230,330 |
|
Acumen Pharmaceuticals, Inc. |
Condensed Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
8,309 |
|
|
$ |
1,800 |
|
|
$ |
21,615 |
|
|
$ |
6,632 |
|
General and administrative |
|
3,062 |
|
|
|
2,135 |
|
|
|
9,374 |
|
|
|
4,537 |
|
Total operating expenses |
|
11,371 |
|
|
|
3,935 |
|
|
|
30,989 |
|
|
|
11,169 |
|
Loss from operations |
|
(11,371 |
) |
|
|
(3,935 |
) |
|
|
(30,989 |
) |
|
|
(11,169 |
) |
Other income (expense) |
|
|
|
|
|
|
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(81,157 |
) |
Interest income, net |
|
663 |
|
|
|
14 |
|
|
|
1,000 |
|
|
|
22 |
|
Other income, net |
|
(2 |
) |
|
|
19 |
|
|
|
(1 |
) |
|
|
47 |
|
Total other income (expense) |
|
661 |
|
|
|
33 |
|
|
|
999 |
|
|
|
(81,088 |
) |
Net loss |
|
(10,710 |
) |
|
|
(3,902 |
) |
|
|
(29,990 |
) |
|
|
(92,257 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
- |
|
|
|
(28 |
) |
|
|
(734 |
) |
|
|
(28 |
) |
Comprehensive loss |
$ |
(10,710 |
) |
|
$ |
(3,930 |
) |
|
$ |
(30,724 |
) |
|
$ |
(92,285 |
) |
Net loss per common share, basic and diluted |
$ |
(0.26 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.74 |
) |
|
$ |
(7.00 |
) |
Weighted-average shares outstanding, basic and diluted |
|
40,502,860 |
|
|
|
38,266,593 |
|
|
|
40,491,181 |
|
|
|
13,177,983 |
|
Acumen Pharmaceuticals, Inc. |
Condensed Statements of Cash Flows |
(in thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
Cash flows from operating activities |
|
Net loss |
$ |
(29,990 |
) |
|
$ |
(92,257 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
20 |
|
|
|
1 |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
81,157 |
|
Stock-based compensation expense |
|
2,173 |
|
|
|
557 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
575 |
|
|
|
(6 |
) |
Amortization of right-of-use asset |
|
100 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
2,058 |
|
|
|
(4,297 |
) |
Other assets |
|
(78 |
) |
|
|
(13 |
) |
Accounts payable |
|
996 |
|
|
|
(149 |
) |
Operating lease liability |
|
(100 |
) |
|
|
- |
|
Accrued expenses and other current liabilities |
|
296 |
|
|
|
685 |
|
Net cash used in operating activities |
|
(23,950 |
) |
|
|
(14,322 |
) |
Cash flows from investing activities |
|
|
|
Purchases of marketable securities |
|
(12,129 |
) |
|
|
(94,095 |
) |
Proceeds from maturities and sales of marketable securities |
|
71,860 |
|
|
|
- |
|
Purchases of property and equipment |
|
(126 |
) |
|
|
(14 |
) |
Net cash provided by (used in) investing activities |
|
59,605 |
|
|
|
(94,109 |
) |
Cash flows from financing activities |
|
|
|
Proceeds from issuance of Series B milestone shares, net of
issuance costs |
|
- |
|
|
|
30,031 |
|
Proceeds from exercise of Series A-1 warrant |
|
- |
|
|
|
1,250 |
|
Proceeds from exercise of common stock warrants |
|
- |
|
|
|
614 |
|
Payments for deferred offering costs |
|
(296 |
) |
|
|
168,559 |
|
Proceeds from the exercise of stock options |
|
19 |
|
|
|
2 |
|
Net cash provided by (used in) financing activities |
|
(277 |
) |
|
|
200,456 |
|
Net change in cash and cash equivalents |
|
35,378 |
|
|
|
92,025 |
|
Cash and cash equivalents at the beginning of the period |
|
122,162 |
|
|
|
43,777 |
|
Cash and cash equivalents at the end of the period |
$ |
157,540 |
|
|
$ |
135,802 |
|
Supplemental disclosure of noncash investing and financing
activities |
|
|
|
Right-of-use asset obtained in exchange for operating lease
liabilities |
$ |
233 |
|
|
$ |
- |
|
Deferred offering costs in accrued expenses and other current
liabilities |
$ |
41 |
|
|
$ |
- |
|
Conversion of convertible preferred stock into common stock upon
initial public offering |
$ |
- |
|
|
$ |
174,504 |
|
Reclassification of preferred stock tranche rights liability upon
share issuance |
$ |
- |
|
|
$ |
81,190 |
|
Reclassification of warrant liability upon exercise of preferred
stock warrant |
$ |
- |
|
|
$ |
5,380 |
|
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