Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the
“Company”), 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 third quarter of 2023 and
provided a business update.
“My excitement for Acumen’s future is centered on the strength
of our ACU193 development strategy for the treatment of early
Alzheimer’s disease, and the deep expertise of our team to execute
on that strategy. We continue to make significant operational,
regulatory and strategic progress. Following our positive Phase 1
data in the third quarter, we recently had a positive interaction
with the FDA and plan to initiate a Phase 2 study in the first half
of 2024. On a strategic front, I am excited about our recent
collaboration and licensing agreement with Halozyme for the
development of a subcutaneous formulation of ACU193, to broaden
potential treatment optionality and increase convenience for
patients. To help finance this important workstream, we are pleased
to announce today that we have entered into an agreement with K2
HealthVentures for a debt facility of up to $50 million,” said
Daniel O’Connell, President and Chief Executive Officer of Acumen.
“We have also observed encouraging trends in CSF biomarker data
from our Phase 1 study, further solidifying the pharmacology of
ACU193. Our talented team is committed to pursuing the full
potential of targeting amyloid beta oligomers for this patient
population, and I am proud of our progress as we continue to
execute at the highest level and work to generate strong and
sustainable value, today and into the future.”
Recent Highlights and Anticipated
Milestones
ACU193 Clinical Development
- In October 2023, the
Company presented additional detail from first-in-human Phase 1
study of ACU193 for early AD at the Clinical Trials on Alzheimer’s
Disease (CTAD) conference.
- Announced dose selection of 50
mg/kg and 35 mg/kg every 4 weeks for ACU193 treatment arms in
upcoming placebo-controlled Phase 2 trial based on significant
target engagement of AβOs approaching maximal effect.
- Presented data exploring target
engagement modeling of ACU193 to inform dose selection, plus
further analyses of dose-related amyloid plaque reduction and
clinical characteristics of ARIA-E, confirming proof-of-mechanism
for ACU193.
- In October 2023, the
Company met with the FDA to discuss the next clinical trial in the
development program for ACU193.
- The agency indicated they are
aligned in principle with the Phase 2/3 study design.
- In the first half of 2024, the
Company expects to initiate a Phase 2 study, ALTITUDE-AD, as the
next phase of development for ACU193.
- Today, the Company
announced encouraging results from INTERCEPT-AD Phase 1
cerebrospinal fluid (CSF) biomarker data, further supporting the
pharmacologic activity of ACU193.
- Observed dose dependent trend in
the multiple ascending dose cohorts on CSF levels of p-tau181,
total tau, neurogranin and Aβ 42/40 ratio.
- P-tau181 (p=0.049) and neurogranin
(p=0.037) showed statistically significant improvement at 60 mg/kg
Q4W as compared to the placebo group after three administrations of
ACU193.
- Nominally significant correlation
between target engagement of AβOs and change in
neurogranin observed across all doses.
- Trend between target engagement of
AβOs and change in p-tau181 observed across all doses.
- Plasma biomarker analysis in
progress.
“We have observed a dose-dependent trend toward
drug effect of ACU193 on CSF levels of p-tau181, total tau,
neurogranin and the Aβ 42/40 ratio after only three
administrations. The fact that we are observing changes in CSF
biomarkers is highly supportive of ACU193’s downstream pharmacology
as determined in our Phase 1 study,” said Eric Siemers, Chief
Medical Officer of Acumen. “Changes in neurogranin and p-tau181
were statistically significant at the highest dose level studied,
and correlated with target engagement of AβOs, consistent with the
mechanism of action of ACU193. These data increase our confidence
that ACU193 has potential for the treatment of early Alzheimer’s
disease, which we will investigate in our Phase 2 study that is
expected to initiate in the first half of 2024.”
Corporate Updates
- In November 2023, announced
a global collaboration and licensing agreement with Halozyme for
the development of a subcutaneous formulation of ACU193, to
potentially offer additional flexibility and convenience for
patients and caregivers.
- Expect to initiate a Phase 1 trial
investigating a subcutaneous dosing option of ACU193 in
mid-2024.
- Today, announced a credit
facility for up to $50 million provided by K2 HealthVentures, for
capital to support subcutaneous clinical work as well as general
corporate purposes.
Third Quarter 2023 Financial
Results
- Cash Balance. As of
September 30, 2023, cash, cash equivalents and marketable
securities totaled $282.7 million, compared to cash, cash
equivalents and marketable securities of $172.2 million as of June
30, 2023. This increase is due to the net proceeds from the
Company’s public offering of approximately $122 million on July 21,
2023. Altogether, this runway is expected to be sufficient to
support current clinical and operational activities into the second
half of 2026.
- Research and Development (R&D) Expenses.
R&D expenses were $11.2 million for the three-month period
ended September 30, 2023, compared to $8.3 million for the
three-month period ended September 30, 2022. The increase in
R&D expenses was primarily due to increased costs related to
materials, consulting, personnel and other costs.
- General and Administrative (G&A) Expenses.
G&A expenses were $4.9 million for the three-month period ended
September 30, 2023, compared to $3.1 million for the three-month
period ended September 30, 2022. The increase in G&A expenses
was primarily due to increased costs related to personnel,
consulting and legal/patent services.
- Loss from Operations. Losses from operations
were $16.0 million for the three-month period ended September 30,
2023, compared to $11.4 million for the three-month period ended
September 30, 2022. This increase was due to the increased R&D
and G&A expenses over the prior year period.
- Net Loss. Net loss was $13.0 million for the
three-month period ended September 30, 2023, compared to $10.7
million for the three-month period ended September 30, 2022.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
Nov. 13, 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 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 was 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 consisted of
single-ascending-dose (SAD) and multiple-ascending-dose (MAD)
cohorts and was designed to evaluate the safety, tolerability,
pharmacokinetics (PK), and target engagement of intravenous doses
of ACU193. More information can be found on www.clinicaltrials.gov,
NCT identifier NCT04931459.
About Acumen Pharmaceuticals, Inc.
Acumen, headquartered in Charlottesville, VA, with offices in
Indianapolis, IN, and Newton, MA, 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, following
positive topline results 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 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 into the second half of 2026, the therapeutic
potential of Acumen’s product candidate, ACU193, including against
other antibodies, the anticipated timeline for initiating a Phase 2
clinical trial of ACU193 and a Phase 1 trial to support a
subcutaneous dosing option of ACU 193, and the expected use of
proceeds from a credit facility. 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.
CONTACTS:
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, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
94,917 |
|
|
$ |
130,101 |
|
Marketable securities, short-term |
|
120,517 |
|
|
|
47,504 |
|
Prepaid expenses and other current assets |
|
3,164 |
|
|
|
2,724 |
|
Total current assets |
|
218,598 |
|
|
|
180,329 |
|
Marketable securities,
long-term |
|
67,270 |
|
|
|
15,837 |
|
Restricted cash |
|
189 |
|
|
|
— |
|
Property and equipment,
net |
|
123 |
|
|
|
165 |
|
Right-of-use asset |
|
2 |
|
|
|
105 |
|
Other assets |
|
189 |
|
|
|
151 |
|
Total assets |
$ |
286,371 |
|
|
$ |
196,587 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,362 |
|
|
$ |
1,640 |
|
Accrued clinical trial expenses |
|
1,566 |
|
|
|
2,717 |
|
Accrued expenses and other current liabilities |
|
3,168 |
|
|
|
3,350 |
|
Operating lease liability |
|
2 |
|
|
|
105 |
|
Total current liabilities |
|
6,098 |
|
|
|
7,812 |
|
Total liabilities |
|
6,098 |
|
|
|
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 September 30, 2023 and
December 31, 2022 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized as
of September 30, 2023 and December 31, 2022; 57,910,461 and
41,025,062 shares issued and outstanding as of September 30, 2023
and December 31, 2022 |
|
6 |
|
|
|
4 |
|
Additional paid-in capital |
|
487,077 |
|
|
|
359,949 |
|
Accumulated deficit |
|
(206,301 |
) |
|
|
(170,427 |
) |
Accumulated other comprehensive loss |
|
(509 |
) |
|
|
(751 |
) |
Total stockholders’
equity |
|
280,273 |
|
|
|
188,775 |
|
Total liabilities and
stockholders’ equity |
$ |
286,371 |
|
|
$ |
196,587 |
|
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, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
Research and development |
$ |
11,179 |
|
|
$ |
8,309 |
|
|
$ |
29,025 |
|
|
$ |
21,615 |
|
General and administrative |
|
4,860 |
|
|
|
3,062 |
|
|
|
13,627 |
|
|
|
9,374 |
|
Total operating expenses |
|
16,039 |
|
|
|
11,371 |
|
|
|
42,652 |
|
|
|
30,989 |
|
Loss from operations |
|
(16,039 |
) |
|
|
(11,371 |
) |
|
|
(42,652 |
) |
|
|
(30,989 |
) |
Other income (expense) |
|
|
|
|
|
|
|
Interest income, net |
|
3,124 |
|
|
|
663 |
|
|
|
6,840 |
|
|
|
1,000 |
|
Other expense, net |
|
(42 |
) |
|
|
(2 |
) |
|
|
(62 |
) |
|
|
(1 |
) |
Total other income |
|
3,082 |
|
|
|
661 |
|
|
|
6,778 |
|
|
|
999 |
|
Net loss |
|
(12,957 |
) |
|
|
(10,710 |
) |
|
|
(35,874 |
) |
|
|
(29,990 |
) |
Other comprehensive gain
(loss) |
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
137 |
|
|
|
— |
|
|
|
242 |
|
|
|
(734 |
) |
Comprehensive loss |
$ |
(12,820 |
) |
|
$ |
(10,710 |
) |
|
$ |
(35,632 |
) |
|
$ |
(30,724 |
) |
Net loss per common share,
basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.74 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
54,229,630 |
|
|
|
40,502,860 |
|
|
|
45,474,953 |
|
|
|
40,491,181 |
|
Acumen Pharmaceuticals, Inc.Condensed
Statements of Cash Flows(in
thousands)(unaudited) |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
Cash flows from
operating activities |
|
|
|
Net loss |
$ |
(35,874 |
) |
|
$ |
(29,990 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
Depreciation |
|
42 |
|
|
|
20 |
|
Stock-based compensation expense |
|
4,511 |
|
|
|
2,173 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
(1,344 |
) |
|
|
575 |
|
Amortization of right-of-use asset |
|
103 |
|
|
|
100 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
(436 |
) |
|
|
2,058 |
|
Other assets |
|
(38 |
) |
|
|
(78 |
) |
Accounts payable |
|
(278 |
) |
|
|
996 |
|
Accrued clinical trial expenses |
|
(1,151 |
) |
|
|
1,358 |
|
Operating lease liability |
|
(103 |
) |
|
|
(100 |
) |
Accrued expenses and other current liabilities |
|
(182 |
) |
|
|
(1,062 |
) |
Net cash used in operating
activities |
|
(34,750 |
) |
|
|
(23,950 |
) |
Cash flows from
investing activities |
|
|
|
Purchases of marketable
securities |
|
(178,857 |
) |
|
|
(12,129 |
) |
Proceeds from maturities and
sales of marketable securities |
|
55,997 |
|
|
|
71,860 |
|
Proceeds from sale of property
and equipment |
|
3 |
|
|
|
— |
|
Purchases of property and
equipment |
|
(7 |
) |
|
|
(126 |
) |
Net cash provided by (used in)
investing activities |
|
(122,864 |
) |
|
|
59,605 |
|
Cash flows from
financing activities |
|
|
|
Proceeds from issuance of
common stock, net of issuance costs |
|
122,294 |
|
|
|
— |
|
Proceeds from exercise of
stock options |
|
325 |
|
|
|
19 |
|
Payments for deferred offering
costs |
|
— |
|
|
|
(296 |
) |
Net cash provided by (used in)
financing activities |
|
122,619 |
|
|
|
(277 |
) |
Net change in cash and cash
equivalents and restricted cash |
|
(34,995 |
) |
|
|
35,378 |
|
Cash and cash equivalents and
restricted cash at the beginning of the period |
|
130,101 |
|
|
|
122,162 |
|
Cash and cash equivalents and
restricted cash at the end of the period |
$ |
95,106 |
|
|
$ |
157,540 |
|
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