Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage
biopharmaceutical company focused on the development of novel
targeted therapeutics for Alzheimer’s disease, today reported
financial results for the quarter ended June 30, 2022 and provided
a business update.
“We continue to make progress advancing INTERCEPT-AD, our Phase
1 clinical trial investigating the safety, tolerability,
pharmacokinetics and target engagement of ACU193 in patients with
early AD. We remain on track to report topline results in the first
half of 2023,” said Daniel O’Connell, President and Chief Executive
Officer of Acumen. “Importantly, based on our current plans, we
expect our existing cash, cash equivalents and marketable
securities to be sufficient to fund our operating expenses and
capital expenditure requirements through 2025.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
- INTERCEPT-AD enrollment
remains ongoing. Patient screening and enrollment is
continuing for INTERCEPT-AD. At present, we have 15 active clinical
trial sites recruiting patients for INTERCEPT-AD. Acumen
anticipates topline data from this trial in the first half of
2023.
-
Presentation of methodology for synthetic model assay to
potentially standardize the study of soluble AβOs.
Methodology was recently presented in a poster, “Preparation and
qualification of soluble amyloid beta oligomers for use in
bioanalytic assays supporting Alzheimer’s disease therapeutics”
(P4-178), at the 2022 Alzheimer’s Association International
Conference. This presentation discussed utilizing Aβ-derived
diffusible ligands (ADDLs) as a synthetic AβO model reagent to aid
in standardization of AβO assays, including the use of ADDLs as a
potential quantitative reference standard in potency and PK assays,
and possibly to better understand the AβO specificity and
selectivity of Aβ-targeting antibodies.
- Phase 2/3
clinical trial preparation activities progressing. Acumen
anticipates initiating a Phase 2/3 trial for ACU193 following
completion of INTERCEPT-AD, if successful, and subsequent
consultation and feedback from the FDA. Chronic toxicology and
chemistry manufacturing and controls (CMC) activities are ongoing
to support readiness.
Corporate and Board
- Acumen
continues to expand its team with new appointments. In Q2
2022, we hired Liean Schenck, MS as our VP, Head of Chemistry,
Manufacturing and Controls (CMC). Ms. Schenck brings over 25 years
of pharmaceutical industry experience in biologics process
development, manufacturing, and CMC program management and has been
responsible for CMC delivery of three commercial products since
2016 in her prior experience with other companies. Ms. Schenck
started her career at Lonza Biologics in fermentation development
before spending more than 20 years at Eli Lilly and Company in
various CMC roles. In her most recent position, she served as Head
of CMC program management at Novavax.
-
Dr. Jeffrey Sevigny, the Chief Medical Officer of
Prevail Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly
and Company, has departed from the Board effective August 12, 2022.
Dr. Sevigny's departure was due to requirements of his current
employment and not due to any disagreement with the Company. Dr.
Sevigny joined Acumen’s Board in 2019 and has made valuable
contributions to the company. “We thank Jeff for his service and
support of Acumen over the last three years,” said Dan O’Connell,
Chief Executive Officer of Acumen. “His extensive experience and
detailed knowledge of clinical translation and neuroscience have
been highly valued at Acumen as we have grown, and his early
commitment and support of our program and team are greatly
appreciated.”
Second Quarter 2022 Financial Results
- Cash
Balance. As of June 30, 2022, cash, cash equivalents and
marketable securities totaled $209.9 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 $7.3
million for the three-month period ended June 30, 2022, compared to
$2.3 million for the three-month period ended June 30, 2021. The
increase in research and development expenses was 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 June 30, 2022,
compared to $1.2 million for the three-month period ended June 30,
2021. The increase in general and administrative
expenses was primarily due to increased costs related to personnel,
insurance, legal, marketing and recruiting expenses.
- Loss from
Operations. Losses from operations were $10.4 million for
the three-month period ended June 30, 2022, compared to $3.4
million for the three-month period ended June 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 $10.2 million for the three-month
period ended June 30, 2022, compared to $61.4 million for the
three-month period ended June 30, 2021. Net losses in the 2021
period includes a $57.9 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,
August 15, 2022, at 4:30 pm 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 presentation with 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.
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,” “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, 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, rate of site activation, rate of enrollment,
enrollment objectives and the expected timing of reporting data,
the potential utility of ADDLs as a synthetic AβO model reagent to
aid in standardization of AβO assays, including the use of ADDLs as
a potential quantitative reference standard in potency and PK
assays and the potential to better understand the AβO specificity
and selectivity of Aβ-targeting antibodies, and risks and
uncertainties relating to the progression and duration of the
COVID-19 pandemic and responsive measures , geopolitical events
such as the conflict between Russia and Ukraine and sanctions
related thereto, macroeconomic conditions such as rising inflation,
supply disruptions, and uncertainty of credit and financial
markets, 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, geopolitical events and macroeconomic
conditions. 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, Acumen’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2022, and future filings and reports by Acumen, including
Acumen’s Quarterly Report on Form 10-Q for the quarter ended and
June 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.
Investor & Media Contact:
investors@acumenpharm.com
Acumen
Pharmaceuticals, Inc. |
Condensed
Balance Sheets |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
111,067 |
|
|
$ |
122,162 |
|
Marketable securities, short-term |
|
78,844 |
|
|
|
72,075 |
|
Prepaid expenses and other current assets |
|
1,142 |
|
|
|
4,424 |
|
Total
current assets |
|
191,053 |
|
|
|
198,661 |
|
Marketable
securities, long-term |
|
20,001 |
|
|
|
31,619 |
|
Property and
equipment, net |
|
113 |
|
|
|
36 |
|
Deferred
offering costs |
|
238 |
|
|
|
- |
|
Right-of-use
asset |
|
167 |
|
|
|
- |
|
Other
assets |
|
106 |
|
|
|
14 |
|
Total
assets |
$ |
211,678 |
|
|
$ |
230,330 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,710 |
|
|
$ |
1,088 |
|
Accrued expenses and other current liabilities |
|
3,282 |
|
|
|
4,059 |
|
Operating lease liability, current portion |
|
142 |
|
|
|
- |
|
Total
current liabilities |
|
5,134 |
|
|
|
5,147 |
|
Operating
lease liability, net of current portion |
|
25 |
|
|
|
- |
|
Total
liabilities |
|
5,159 |
|
|
|
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 June 30, 2022 and
December 31, 2021 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
40,501,258 shares and 40,473,270 issued and outstanding as of June
30, 2022 and December 31, 2021, respectively |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
354,331 |
|
|
|
352,981 |
|
Accumulated deficit |
|
(146,851 |
) |
|
|
(127,571 |
) |
Accumulated other comprehensive loss |
|
(965 |
) |
|
|
(231 |
) |
Total
stockholders' equity |
|
206,519 |
|
|
|
225,183 |
|
Total
liabilities and stockholders' equity |
$ |
211,678 |
|
|
$ |
230,330 |
|
|
|
|
|
Acumen
Pharmaceuticals, Inc. |
|
Condensed
Statements of Operations and Comprehensive Loss |
|
(in
thousands, except share and per share data) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
Research and development |
$ |
7,321 |
|
|
$ |
2,254 |
|
|
$ |
13,306 |
|
|
$ |
4,832 |
|
|
General and administrative |
|
3,090 |
|
|
|
1,187 |
|
|
|
6,312 |
|
|
|
2,402 |
|
|
Total
operating expenses |
|
10,411 |
|
|
|
3,441 |
|
|
|
19,618 |
|
|
|
7,234 |
|
|
Loss from
operations |
|
(10,411 |
) |
|
|
(3,441 |
) |
|
|
(19,618 |
) |
|
|
(7,234 |
) |
|
Other income
(expense) |
|
|
|
|
|
|
|
|
Interest income, net |
|
260 |
|
|
|
4 |
|
|
|
337 |
|
|
|
8 |
|
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
(57,940 |
) |
|
|
- |
|
|
|
(81,157 |
) |
|
Other income, net |
|
- |
|
|
|
19 |
|
|
|
1 |
|
|
|
28 |
|
|
Total other
income (expense) |
|
260 |
|
|
|
(57,917 |
) |
|
|
338 |
|
|
|
(81,121 |
) |
|
Net
loss |
|
(10,151 |
) |
|
|
(61,358 |
) |
|
|
(19,280 |
) |
|
|
(88,355 |
) |
|
Other
comprehensive loss |
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
(151 |
) |
|
|
- |
|
|
|
(734 |
) |
|
|
- |
|
|
Comprehensive loss |
$ |
(10,302 |
) |
|
$ |
(61,358 |
) |
|
$ |
(20,014 |
) |
|
$ |
(88,355 |
) |
|
Net loss per
common share, basic and diluted |
$ |
(0.25 |
) |
|
$ |
(141.93 |
) |
|
$ |
(0.48 |
) |
|
$ |
(207.52 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
40,497,087 |
|
|
|
432,325 |
|
|
|
40,485,244 |
|
|
|
425,761 |
|
|
|
|
|
|
|
|
|
|
|
Acumen
Pharmaceuticals, Inc. |
Condensed
Statements of Cash Flows |
(in
thousands) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
Cash
flows from operating activities |
|
Net
loss |
$ |
(19,280 |
) |
|
$ |
(88,355 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation |
|
10 |
|
|
|
- |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
- |
|
|
|
81,157 |
|
Stock-based compensation expense |
|
1,333 |
|
|
|
253 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
384 |
|
|
|
- |
|
Amortization of right-of-use asset |
|
66 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and other current assets |
|
3,282 |
|
|
|
(1,108 |
) |
Other assets |
|
(92 |
) |
|
|
(13 |
) |
Accounts payable |
|
580 |
|
|
|
741 |
|
Operating lease liability |
|
(66 |
) |
|
|
- |
|
Accrued expenses and other current liabilities |
|
(984 |
) |
|
|
691 |
|
Net cash
used in operating activities |
|
(14,767 |
) |
|
|
(6,634 |
) |
Cash
flows from investing activities |
|
|
|
Purchases of
marketable securities |
|
(12,129 |
) |
|
|
- |
|
Proceeds
from maturities and sales of marketable securities |
|
15,860 |
|
|
|
- |
|
Purchases of
property and equipment |
|
(45 |
) |
|
|
(6 |
) |
Net cash
provided by (used in) investing activities |
|
3,686 |
|
|
|
(6 |
) |
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 |
|
(31 |
) |
|
|
(220 |
) |
Proceeds
from the exercise of stock options |
|
17 |
|
|
|
- |
|
Net cash
provided by (used in) financing activities |
|
(14 |
) |
|
|
31,675 |
|
Net change
in cash and cash equivalents |
|
(11,095 |
) |
|
|
25,035 |
|
Cash and
cash equivalents at the beginning of the period |
|
122,162 |
|
|
|
43,777 |
|
Cash and
cash equivalents at the end of the period |
$ |
111,067 |
|
|
$ |
68,812 |
|
Supplemental disclosure of cash flow
information |
|
|
|
Cash paid
for income taxes |
$ |
- |
|
|
$ |
- |
|
Cash paid
for interest |
$ |
- |
|
|
$ |
- |
|
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 |
$ |
207 |
|
|
$ |
497 |
|
Purchases of
property and equipment in accounts payable |
$ |
42 |
|
|
$ |
- |
|
Reclassification of preferred stock tranche rights liability upon
share issuance |
$ |
- |
|
|
$ |
81,190 |
|
Reclassification of warrant liability upon exercise of preferred
stock warrant |
$ |
- |
|
|
$ |
5,380 |
|
Deferred
offering costs in accounts payable |
$ |
- |
|
|
$ |
1,635 |
|
|
|
|
|
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