Acumen Pharmaceuticals Reports Financial Results for Full Year Ended December 31, 2022 and Business Highlights
March 27 2023 - 7:00AM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage
biopharmaceutical company focused on developing a novel therapeutic
that targets toxic soluble amyloid beta oligomers (AβOs) and is
designed for the treatment of Alzheimer’s disease (AD), today
reported financial results for the full year ended December 31,
2022 and provided a business update.
“2022 was a year of significant accomplishment as we advanced
the clinical development of ACU193, our novel therapeutic targeting
toxic amyloid beta oligomers for the treatment of Alzheimer’s
Disease. We recently completed enrollment in our Phase I
INTERCEPT-AD trial and are encouraged by preliminary
pharmacokinetic and safety data that support ACU193’s
differentiated product profile,” said Daniel O’Connell, President
and Chief Executive Officer of Acumen. “We believe that our
continued execution will drive Acumen’s momentum during 2023. Our
Phase 1 topline results expected in the third quarter and
anticipated interaction with FDA in the fourth quarter of 2023 will
help inform our next phase of clinical development. With cash
runway expected through 2025, a strong scientific foundation, and
an increasingly attractive market environment, we believe we are
well positioned to achieve our near-term milestones and to advance
our mission of delivering a novel treatment option for patients
with Alzheimer’s Disease.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
- 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. Fast Track
designation does not change the standard for approval, but 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 January 2023, a protocol
amendment was submitted to the FDA with respect to Cohort 7 of
the Company’s Phase 1 INTERCEPT-AD clinical trial to reduce
the dose to 25 mg/kg every two weeks (updated from 60 mg/kg every
two weeks). The change was based in part on a blinded
review of preliminary pharmacokinetic data in the trial, inclusive
of levels of ACU193 in plasma and cerebrospinal fluid, which
indicated a dose of 60 mg/kg every two weeks should not be needed
to attain central target engagement, and preliminary safety
data, including two asymptomatic cases of ARIA-E (one in
Cohort 4 after a single 60 mg/kg dose and one in Cohort 5 after the
third 10 mg/kg dose).
- In February 2023, enrollment was completed in the
Company’s Phase 1 INTERCEPT-AD trial of ACU193 in patients with
early Alzheimer’s disease.
- Acumen anticipates reporting
topline results from this trial, including safety and
proof-of-mechanism data, in the third quarter of 2023.
Corporate
- In 2022,
we continued to expand our team with talent necessary to advance
our mission to develop a novel treatment for AD. These
appointments included Liean Schenck, MS as our VP, Head of
Chemistry, Manufacturing and Controls (CMC) and Derek Meisner, JD
as our Chief Legal Officer.
- In January
2023, Derrell Porter, M.D. joined Acumen’s Board of
Directors. Dr. Porter is a physician-entrepreneur with
more than 20 years of experience in drug development. He is
currently the Founder and CEO of Cellevolve, a development and
commercialization company focused on cell therapy, and
previously served in commercial and corporate development roles at
Atara Biotherapeutics, Inc., Gilead, AbbVie and Amgen.
2022 Financial Results
- Cash
Balance. As of December 31, 2022, cash, cash equivalents
and marketable securities totaled $193.4 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 for
2022 were $32.4 million compared to $12.3 million in 2021. The
increase in R&D expenses in 2022 compared to 2021 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
for 2022 were $12.9 million, compared to $7.3 million in
2021. The increase in G&A expenses in 2022 compared to
2021 was primarily due to increased expenses as a public
company and additions to its financial and administrative
infrastructure, such as costs related to personnel, accounting,
marketing, recruiting and travel and entertainment
expenses.
- Loss from
Operations. Losses from operations for 2022 were
$45.2 million, compared with $19.6 million in 2021. This increase
was due to the increased R&D and G&A expenses over the
prior year period.
- Net Loss. Net loss for
the year ended December 31, 2022 was $42.9 million, compared to a
net loss of $100.6 million for the year ended December 31, 2021.
Net loss in 2021 includes a $81.2 million non-cash expense that
represents the changes in fair value of Acumen’s Series B tranche
liability and Series A-1 warrant liability.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
March 27, 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. Please register at least one day in
advance.
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 ACU193
ACU193 is a recombinant humanized immunoglobin gamma 2
(IgG2) 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
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 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 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 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 and continued momentum, 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 through 2025, and the therapeutic potential of
Acumen’s product candidate, ACU193, including the anticipated
timeline for reporting topline safety and proof-of-mechanism data
and results, ACU193’sits differentiated product profile, as
supported by preliminary pharmacokinetic and safety data, as
compared to other monoclonal antibodies in development, and the
potential benefits and outcomes of receiving Fast Track designation
from and anticipated upcoming interactions 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
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 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. |
Balance Sheets |
(in thousands, except share and per share
data) |
|
|
|
December 31, 2022 |
|
December 31, 2021 |
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
130,101 |
|
|
$ |
122,162 |
|
Marketable securities, short-term |
|
47,504 |
|
|
|
72,075 |
|
Prepaid expenses and other current assets |
|
2,724 |
|
|
|
4,424 |
|
Total current assets |
|
180,329 |
|
|
|
198,661 |
|
Marketable securities, long-term |
|
15,837 |
|
|
|
31,619 |
|
Property and equipment, net |
|
165 |
|
|
|
36 |
|
Right-of-use asset |
|
105 |
|
|
|
- |
|
Other assets |
|
151 |
|
|
|
14 |
|
Total assets |
$ |
196,587 |
|
|
$ |
230,330 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,640 |
|
|
$ |
1,088 |
|
Accrued clinical trial expenses |
|
2,717 |
|
|
|
147 |
|
Accrued expenses and other current liabilities |
|
3,350 |
|
|
|
3,912 |
|
Operating lease liability, current portion |
|
105 |
|
|
|
- |
|
Total current liabilities |
|
7,812 |
|
|
|
5,147 |
|
Total liabilities |
|
7,812 |
|
|
|
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 December 31, 2022 and
2021 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
41,025,062 and 40,473,270 shares issued and outstanding as of
December 31, 2022 and 2021, respectively |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
359,949 |
|
|
|
352,981 |
|
Accumulated deficit |
|
(170,427 |
) |
|
|
(127,571 |
) |
Accumulated other comprehensive loss |
|
(751 |
) |
|
|
(231 |
) |
Total stockholders' equity |
|
188,775 |
|
|
|
225,183 |
|
Total liabilities and stockholders' equity |
$ |
196,587 |
|
|
$ |
230,330 |
|
|
|
|
|
Statements of Operations and Comprehensive
Loss |
(in thousands, except share and per share
data) |
|
|
|
|
|
Year Ended December 31, |
|
|
2022 |
|
|
|
2021 |
|
Operating expenses |
|
|
|
Research and development |
$ |
32,361 |
|
|
$ |
12,305 |
|
General and administrative |
|
12,876 |
|
|
|
7,279 |
|
Total operating expenses |
|
45,237 |
|
|
|
19,584 |
|
Loss from operations |
|
(45,237 |
) |
|
|
(19,584 |
) |
Other income (expense) |
|
|
|
Interest income, net |
|
2,392 |
|
|
|
84 |
|
Other income (expense), net |
|
(11 |
) |
|
|
51 |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
(81,157 |
) |
Total other income (expense) |
|
2,381 |
|
|
|
(81,022 |
) |
Net loss |
|
(42,856 |
) |
|
|
(100,606 |
) |
Other comprehensive loss |
|
|
|
Unrealized loss on marketable securities |
|
(520 |
) |
|
|
(231 |
) |
Comprehensive loss |
$ |
(43,376 |
) |
|
$ |
(100,837 |
) |
Net loss per common share, basic and diluted |
$ |
(1.06 |
) |
|
$ |
(5.02 |
) |
Weighted-average shares outstanding, basic and diluted |
|
40,601,936 |
|
|
|
20,057,534 |
|
|
|
|
|
Statements of Cash Flows |
(in thousands) |
|
|
|
|
|
Year Ended December 31, |
|
|
2022 |
|
|
|
2021 |
|
Cash flows from operating activities |
|
Net loss |
$ |
(42,856 |
) |
|
$ |
(100,606 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
32 |
|
|
|
4 |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
81,157 |
|
Stock-based compensation expense |
|
3,061 |
|
|
|
922 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
487 |
|
|
|
155 |
|
Amortization of right-of-use asset |
|
137 |
|
|
|
- |
|
Other non-cash expense |
|
- |
|
|
|
109 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
1,700 |
|
|
|
(3,881 |
) |
Other assets |
|
(137 |
) |
|
|
(14 |
) |
Accounts payable |
|
552 |
|
|
|
557 |
|
Accrued clinical trial expenses |
|
2,570 |
|
|
|
147 |
|
Operating lease liability |
|
(137 |
) |
|
|
- |
|
Accrued expenses and other current liabilities |
|
(562 |
) |
|
|
3,489 |
|
Net cash used in operating activities |
|
(35,153 |
) |
|
|
(17,961 |
) |
Cash flows from investing activities |
|
|
|
Purchases of marketable securities |
|
(41,514 |
) |
|
|
(104,080 |
) |
Proceeds from maturities and sales of marketable securities |
|
80,860 |
|
|
|
- |
|
Purchases of property and equipment |
|
(161 |
) |
|
|
(40 |
) |
Net cash provided by (used in) investing activities |
|
39,185 |
|
|
|
(104,120 |
) |
Cash flows from financing activities |
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
3,792 |
|
|
|
168,556 |
|
Proceeds from exercise of stock options |
|
115 |
|
|
|
15 |
|
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 |
|
Net cash provided by financing activities |
|
3,907 |
|
|
|
200,466 |
|
Net change in cash and cash equivalents |
|
7,939 |
|
|
|
78,385 |
|
Cash and cash equivalents at the beginning of the period |
|
122,162 |
|
|
|
43,777 |
|
Cash and cash equivalents at the end of the period |
$ |
130,101 |
|
|
$ |
122,162 |
|
|
|
|
|
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