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 full year ended December 31, 2021, and
provided recent business highlights.
“After a transformational year in 2021, highlighted by multiple
accomplishments, including our IPO, Acumen is completely focused on
executing our business strategy with a primary emphasis on
INTERCEPT-AD, our Phase 1 clinical trial investigating the safety,
tolerability, pharmacokinetics and target engagement of ACU193 in
early Alzheimer’s patients. Based on current progress in the trial
and our current plan to report a dataset inclusive of Cohort 7 Day
168 follow up, we now expect to report topline results in the first
half of 2023. We have experienced slower than anticipated
enrollment due to the COVID-19 pandemic, however our strong cash
position has provided us the ability to expand the study footprint
to support recruitment and to include a longer follow-up period
prior to read out,” said Daniel O’Connell, President and Chief
Executive Officer at Acumen. “With the proceeds from our successful
IPO last year, we estimate our existing cash, cash equivalents and
marketable securities will be sufficient to fund our operating
expenses and capital requirements through 2025 based on our current
plans.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
-
INTERCEPT-AD enrollment continues to
progress. Patient screening and enrollment is ongoing
for INTERCEPT-AD at eight active sites, with six additional sites
selected for potential activation. Acumen anticipates topline
results from this trial in the first half of 2023, subject to the
rate of site activation and patient recruitment.
- Clinical
trial design for INTERCEPT-AD presented at 2021 Clinical Trials on
Alzheimer’s Disease (CTAD) Conference. The presentation
included the scientific rationale for targeting toxic AβOs, the
clinical trial design of the Phase 1 INTERCEPT-AD study of ACU193,
and how the study is designed to establish Proof of Mechanism for
ACU193 and serve as the basis for moving to a Phase 2/3 trial.
- Phase 2/3 clinical trial
preparation activities progressing. Given the continued
advancement of necessary actions for the planned Phase 2/3 trial,
including chronic toxicology and chemistry manufacturing and
controls (CMC) activities, Acumen plans to be ready to initiate a
Phase 2/3 trial on the success of INTERCEPT-AD results.
Corporate
In the fourth quarter of 2021, Acumen expanded its team with
several new appointments. The new team members include
Julie Bockenstette, Head of Human Relations;
Siew Tin Gan, Head of Clinical Operations; and
Stephen Reynolds, Corporate Controller and
Treasurer.
“We welcome Julie, Siew Tin and Stephen, who are joining Acumen
at a critical time in our company’s growth as we continue to
pioneer a new approach to treating Alzheimer’s disease,” said
Daniel O’Connell. “We believe their individual experience and
collective passion for improving the lives of patients with
Alzheimer’s disease will help us move closer to our ambitious
goals.”
- Ms. Bockenstette has more than 20
years of experience in human resources and sales at high-growth
companies. Prior to this role, Bockenstette was Vice President of
HR and Head of HR at the Diabetes Care Europe and North America
division of Roche Diabetes Care. She has also held several key
human resources and leadership roles at Elanco Animal Health and
Eli Lilly and Co., both in Indiana.
- Ms. Gan has more than 20 years of
experience in clinical research with a history of working in the
pharmaceuticals and nutrition industries. Prior to this role, Gan
was Senior Clinical Operations Program Leader in Neuroscience at
Takeda, in addition to senior research and leadership positions at
Danone Nutricia Research (Singapore), Lundbeck (Singapore), and
Novo Nordisk (New Jersey).
- Mr. Reynolds has more than 25 years
of finance experience in the healthcare industry. Prior to this
role, Reynolds was Global Controller and Treasurer at Envigo RMS in
Indianapolis, in addition to several other financial management
positions at Roche Diagnostics, LDI and FinishMaster, Eli Lilly and
Co., Memry Corporation, Roche Health Solutions, and Assembly
Biosciences.
In addition to these appointments, Kim Drapkin,
CPA, has been appointed to the Board of Directors effective April
1, 2022. Ms. Drapkin is currently the Chief Financial Officer of
Jounce Therapeutics. Ms. Drapkin brings more than 25 years of
experience working with private and publicly traded biotechnology
and pharmaceutical companies, including building and leading
finance functions, raising capital, and leading strategic financial
planning. Ms. Drapkin will also serve as the chair of the company’s
audit committee.
“I’m incredibly excited to join the Board of Directors of Acumen
at this exciting time. We face a massive unmet need in Alzheimer’s
disease, and I believe that Acumen’s approach of targeting toxic
amyloid-beta oligomers has the potential to transform the treatment
of the disease. I look forward to working with the team and the
rest of the Board to support the company’s growth and, in
particular, the development of ACU193,” said Ms. Drapkin.
2021 Financial Results
- Cash
Balance. As of December 31, 2021, our cash, cash
equivalents and marketable securities totaled $225.9 million,
compared to cash and cash equivalents of $43.8 million and no
marketable securities as of December 31, 2020.
- Research and
Development (R&D) Expenses. R&D expenses were
$12.3 million for the twelve-month period ended December 31, 2021,
compared to $8.0 million for the twelve-month period ended December
31, 2020. The net increase in research and development expenses in
2021 from 2020 was primarily due to increased costs related to
initiating our clinical trial in 2021.
- General and
Administrative (G&A) Expenses. G&A expenses were
$7.3 million for the twelve-month period ended December 31, 2021,
compared to $1.4 million for the twelve-month period ended December
31, 2020. Following the initial public offering, we added a number
of new personnel and a large portion of the other increase is a
direct result of our transition from a private to a public
company.
- Loss from
Operations. Losses from operations were $19.6 million for
the twelve-month period ended December 31, 2021, compared to $7.9
million for the twelve-month period ended December 31, 2020.
- Net
Loss. Net losses were $100.6 million for the twelve-month
period ended December 31, 2021, compared to $7.3 million for the
twelve-month period ended December 31, 2020. Net losses in 2021
include a non-cash expense of $81.2 million that represents the
changes in fair value of Acumen’s Series B tranche liability and
Series A-1 warrant liability. The tranche liability and warrant
liability were initially recorded at fair value as liabilities on
Acumen’s balance sheet and were subsequently re-measured at fair
value at the end of each reporting period. The increases in the
fair value of these instruments were recognized as a component of
other expense. The second tranche of the Series B Preferred Stock
financing round closed in June 2021 and, as a result, the remaining
value of the tranche liability was reclassified to convertible
preferred stock on Acumen’s condensed balance sheet. Additionally,
the Series A-1 warrant was exercised in June 2021, and the
remaining value of the warrant liability was reclassified to
convertible preferred stock on Acumen’s condensed balance sheet.
Upon the closing of the initial public offering, all outstanding
shares of convertible preferred stock converted into equivalent
shares of common stock.
Conference Call Details
Acumen will host a conference call and live audio webcast today,
March 28th, 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
3629669.
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 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 AβOs, 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 expected timing of initiation, enrollment and
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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, and future filings and reports by Acumen,
including Acumen’s Annual Report on Form 10-K for the year ended
December 31, 2021. 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
Balance Sheets(in
thousands, except share and per share data)
|
December 31, |
|
2021 |
|
2020 |
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
122,162 |
|
|
$ |
43,777 |
|
Marketable securities, short-term |
|
72,075 |
|
|
|
- |
|
Grant receivable |
|
- |
|
|
|
109 |
|
Prepaid expenses and other current assets |
|
4,424 |
|
|
|
543 |
|
Total current assets |
|
198,661 |
|
|
|
44,429 |
|
Marketable securities, long-term |
|
31,619 |
|
|
|
- |
|
Property and equipment, net |
|
36 |
|
|
|
- |
|
Other assets |
|
14 |
|
|
|
- |
|
Total assets |
$ |
230,330 |
|
|
$ |
44,429 |
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
EQUITY (DEFICIT) |
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
1,088 |
|
|
$ |
531 |
|
Accrued expenses and other current liabilities |
|
4,059 |
|
|
|
423 |
|
Preferred stock tranche rights liability |
|
- |
|
|
|
5,033 |
|
Preferred stock warrant liability |
|
- |
|
|
|
380 |
|
Total liabilities |
|
5,147 |
|
|
|
6,367 |
|
Series A convertible preferred stock, $0.0001 par value; no shares
authorized, issued and outstanding as of December 31, 2021; 711,203
shares authorized and 477,297 shares issued and outstanding as of
December 31, 2020; liquidation preference of $1,067 as of December
31, 2020 |
|
- |
|
|
|
1,067 |
|
Series A-1 convertible preferred stock, $0.0001 par value; no
shares authorized, issued and outstanding as of December 31, 2021;
11,898,177 shares authorized and 7,537,879 shares issued and
outstanding as of December 31, 2020; liquidation preference of
$16,847 as of December 31, 2020 |
|
- |
|
|
|
16,333 |
|
Series B convertible preferred stock, $0.0001 par value; no shares
authorized, issued and outstanding as of December 31, 2021;
29,457,450 shares authorized and 11,862,043 shares issued and
outstanding as of December 31, 2020; liquidation preference of
$45,070 as of December 31, 2020 |
|
- |
|
|
|
39,253 |
|
Stockholders' equity (deficit) |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and no shares issued and outstanding as of December 31, 2021; no
shares authorized, issued and outstanding as of December 31,
2020 |
|
- |
|
|
|
- |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized and
40,473,270 shares issued and outstanding as of December 31, 2021;
50,500,000 shares authorized and 419,124 shares issued and
outstanding as of December 31, 2020 |
|
4 |
|
|
|
- |
|
Additional paid-in capital |
|
352,981 |
|
|
|
8,374 |
|
Accumulated deficit |
|
(127,571 |
) |
|
|
(26,965 |
) |
Accumulated other comprehensive loss |
|
(231 |
) |
|
|
- |
|
Total stockholders' equity (deficit) |
|
225,183 |
|
|
|
(18,591 |
) |
Total liabilities, convertible preferred stock and stockholders'
equity (deficit) |
$ |
230,330 |
|
|
$ |
44,429 |
|
Statements of
Operations(in thousands, except share and per
share data)
|
Year Ended December 31, |
|
2021 |
|
2020 |
Grant and other revenue |
$ |
- |
|
|
$ |
1,436 |
|
|
|
|
|
Operating expenses |
|
|
|
Research and development |
|
12,305 |
|
|
|
7,997 |
|
General and administrative |
|
7,279 |
|
|
|
1,351 |
|
Total operating expenses |
|
19,584 |
|
|
|
9,348 |
|
Loss from operations |
|
(19,584 |
) |
|
|
(7,912 |
) |
|
|
|
|
Other income (expense) |
|
|
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
(81,157 |
) |
|
|
586 |
|
Interest income, net |
|
84 |
|
|
|
1 |
|
Other income, net |
|
51 |
|
|
|
- |
|
Total other income (expense) |
|
(81,022 |
) |
|
|
587 |
|
Net loss |
|
(100,606 |
) |
|
|
(7,325 |
) |
|
|
|
|
Other comprehensive loss |
|
|
|
Unrealized loss on marketable securities |
|
(231 |
) |
|
|
- |
|
Comprehensive loss |
$ |
(100,837 |
) |
|
$ |
(7,325 |
) |
|
|
|
|
Net loss per common share, basic and diluted |
$ |
(5.02 |
) |
|
$ |
(17.48 |
) |
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
20,057,534 |
|
|
|
419,124 |
|
Statements of Cash
Flows(in thousands)
|
Year Ended December 31, |
|
2021 |
|
2020 |
|
|
Cash flows from operating activities |
|
Net loss |
$ |
(100,606 |
) |
|
$ |
(7,325 |
) |
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 |
|
81,157 |
|
|
|
(586 |
) |
Stock-based compensation expense |
|
922 |
|
|
|
154 |
|
Amortization of premiums and accretion of discounts on marketable
securities, net |
|
155 |
|
|
|
- |
|
Other non-cash expense |
|
109 |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
Grant receivable |
|
- |
|
|
|
(79 |
) |
Prepaid expenses and other current assets |
|
(3,881 |
) |
|
|
53 |
|
Other assets |
|
(14 |
) |
|
|
144 |
|
Accounts payable |
|
557 |
|
|
|
308 |
|
Accrued expenses and other current liabilities |
|
3,636 |
|
|
|
(119 |
) |
Net cash used in operating activities |
|
(17,961 |
) |
|
|
(7,450 |
) |
|
|
|
|
Cash flows from investing activities |
|
|
|
Purchases of available-for-sale marketable securities |
|
(104,080 |
) |
|
|
- |
|
Purchases of property and equipment |
|
(40 |
) |
|
|
- |
|
Net cash used in investing activities |
|
(104,120 |
) |
|
|
- |
|
|
|
|
|
Cash flows from financing activities |
|
|
|
Proceeds from issuance of Series B milestone shares, net of
issuance costs |
|
30,031 |
|
|
|
- |
|
Proceeds from issuance of convertible preferred stock, net of
issuance costs |
|
- |
|
|
|
44,675 |
|
Proceeds from exercise of Series A-1 warrant |
|
1,250 |
|
|
|
- |
|
Proceeds from exercise of common stock warrants |
|
614 |
|
|
|
- |
|
Proceeds from issuance of common stock upon initial public
offering, net of issuance costs |
|
168,556 |
|
|
|
- |
|
Proceeds from stock option exercises |
|
15 |
|
|
|
- |
|
Net cash provided by financing activities |
|
200,466 |
|
|
|
44,675 |
|
|
|
|
|
Net change in cash and cash equivalents |
|
78,385 |
|
|
|
37,225 |
|
Cash and cash equivalents at the beginning of the period |
|
43,777 |
|
|
|
6,552 |
|
Cash and cash equivalents at the end of the period |
$ |
122,162 |
|
|
$ |
43,777 |
|
|
|
|
|
Supplemental disclosure of cash flow
information |
|
|
|
Cash paid for income taxes |
$ |
- |
|
|
$ |
- |
|
Cash paid for interest |
$ |
- |
|
|
$ |
- |
|
|
|
|
|
Supplemental disclosure of noncash financing
activities |
|
|
|
Reclassification of preferred stock tranche rights liability upon
share issuance |
$ |
81,190 |
|
|
$ |
- |
|
Reclassification of warrant liability upon exercise of preferred
stock warrant |
$ |
5,380 |
|
|
$ |
- |
|
Conversion of convertible preferred stock into common stock upon
IPO |
$ |
174,504 |
|
|
$ |
- |
|
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