Acumen Pharmaceuticals Reports Financial Results for Second Quarter 2021 and Business Highlights
August 16 2021 - 4:05PM
Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (Acumen), a clinical
stage biopharmaceutical company focused on the development of novel
targeted therapeutics for Alzheimer’s disease (AD), today reported
financial results for the quarter ended June 30, 2021 and provided
recent business highlights.
“We continue to execute on our corporate and clinical
development goals during this exciting time in the Alzheimer’s
field,” said Daniel O’Connell, President and Chief Executive
Officer at Acumen. “Our clinical trial, ACU-001, is investigating
the safety, tolerability, pharmacokinetics, and target engagement
of our product candidate ACU193 in a Phase 1 clinical trial
involving early Alzheimer’s patients. ACU193 is the first humanized
monoclonal antibody discovered and developed to selectively target
toxic amyloid-beta oligomers (AβOs) to enter a clinical trial. We
anticipate ACU-001 recruitment and cohort progression will allow us
to provide topline results with the goal of demonstrating ‘proof of
mechanism’ for ACU193 in early AD by year end 2022. With the recent
closing of our IPO, we believe we are well-funded to achieve
multiple corporate and clinical development milestones, as we
execute against our comprehensive strategic plan.”
Recent Business Highlights and Anticipated
Milestones
ACU193 Clinical Development
- ACU-001 trial is actively
recruiting and we expect to report top-line data by year end
2022. Patient screening and enrollment is proceeding for
the randomized, placebo-controlled Phase 1 clinical trial
evaluating ACU193.
Corporate
- Prefunding of Series B
Milestone Tranche - $30M. On June 17, 2021, the Milestone
Closing for the Series B convertible preferred stock occurred,
resulting in the sale of 7,908,027 shares of Series B convertible
preferred stock for gross proceeds of $30.0 million. The Series B
investors included RA Capital, PBM Capital, BlackRock, and Sands
Capital.
- Closing of
Initial Public Offering. In July 2021, Acumen issued an
aggregate of 11,499,998 shares of common stock, including shares
pursuant to the underwriters’ exercise of their full over-allotment
option, in an initial public offering (IPO), resulting in aggregate
net proceeds of $168.6 million.
Second Quarter 2021 Financial Results
- Cash Balance. Cash,
cash equivalents and marketable securities were $68.8 million as of
June 30, 2021, compared to $43.8 million as of December 31, 2020.
The net proceeds of the IPO resulted in total cash, cash
equivalents and marketable securities increasing to more than $235
million in early July 2021.
- Research and
Development (R&D) Expenses. R&D expenses were $2.3
million and $4.8 million for the three- and six-month periods
ending June 30, 2021, respectively, compared to $1.9 million and
$4.0 million for the three- and six-month periods ending June 30,
2020, respectively.
- General and
Administrative (G&A) Expenses. G&A expenses were
$1.2 million and $2.4 million for the three- and six-month periods
ending June 30, 2021, respectively, compared to $0.3 million and
$0.5 million for the three- and six-month periods ending June 30,
2020, respectively.
- Net
Operating Loss. Net Operating Losses were $3.4 million
and $7.2 million for the three- and six-month periods ending June
30, 2021, respectively, compared to $2.0 million and $4.1 million
for the three- and six-month periods ending June 30, 2020,
respectively.
- Net
Loss. Net Losses were $61.4 million and $88.4 million for
the three-and six-month periods ending June 30, 2021, respectively,
compared to $2.0 million and $4.1 million for the three- and
six-month periods ending June 30, 2020, respectively. Net losses in
2021 include a non-cash expense that represents the changes in fair
value of Acumen’s Series A-1 warrant liability and the Series B
tranche rights. The warrant liability and tranche rights were
initially recorded at fair value as a liability on the company’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.
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 drug, ACU193, a
humanized monoclonal antibody that selectively targets
toxic AbOs, in a Phase I clinical
trial involving early Alzheimer’s disease patients. We believe
that ACU193 represents a differentiated approach from current and
prior AD immunotherapies because it is highly selective for toxic
AβOs and because it is engineered to reduce immune signaling. As
such, ACU193 is expected to carry a reduced rate of amyloid-related
imaging abnormalities, or ARIA, a common, dose-limiting adverse
event observed with amyloid plaque-targeting immunotherapies.
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” 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, our ability to achieve our strategic and financial goals,
the therapeutic potential of Acumen’s product candidate, ACU193,
and the expected timing of reporting top line data from the Phase 1
clinical trial of ACU193. 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 our prospectus dated June
30, 2021, as filed with the SEC on July 2, 2021, pursuant to Rule
424(b) under the Securities Act of 1933, which is available on the
SEC’s website at www.sec.gov. Copies of these and other documents
are available from the Company. Additional information will be made
available in other filings that we make 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, 2021 |
|
December 31, 2020 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
68,812 |
|
|
$ |
43,777 |
|
Grant receivable |
|
109 |
|
|
|
109 |
|
Prepaid expenses and other current assets |
|
1,651 |
|
|
|
543 |
|
Total
current assets |
|
70,572 |
|
|
|
44,429 |
|
|
|
|
|
Property and
equipment, net |
|
6 |
|
|
|
- |
|
Deferred
offering costs |
|
2,352 |
|
|
|
- |
|
Other
assets |
|
13 |
|
|
|
- |
|
Total
assets |
$ |
72,943 |
|
|
$ |
44,429 |
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
DEFICIT |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
2,907 |
|
|
$ |
531 |
|
Accrued expenses and other current liabilities |
|
1,611 |
|
|
|
423 |
|
Preferred stock tranche rights liability |
|
- |
|
|
|
5,033 |
|
Preferred stock warrant liability |
|
- |
|
|
|
380 |
|
Total
liabilities |
|
4,518 |
|
|
|
6,367 |
|
|
|
|
|
Series A
convertible preferred stock, $0.0001 par value; 711,203 shares
authorized as of June 30, 2021 and December 31, 2020; 477,297
shares issued and outstanding as of June 30, 2021 and December 31,
2020; liquidation preference of $1,067 as of June 30, 2021 |
|
1,067 |
|
|
|
1,067 |
|
Series A-1
convertible preferred stock, $0.0001 par value; 11,898,177 shares
authorized as of June 30, 2021 and December 31, 2020; 7,985,305 and
7,537,879 shares issued and outstanding as of June 30, 2021 and
December 31, 2020, respectively; liquidation preference of $18,097
as of June 30, 2021 |
|
22,963 |
|
|
|
16,333 |
|
Series B
convertible preferred stock, $0.0001 par value; 29,457,450 shares
authorized as of June 30, 2021 and December 31, 2020; 19,770,070
and 11,862,043 shares issued and outstanding as of June 30, 2021
and December 31, 2020, respectively; liquidation preference of
$75,116 as of June 30, 2021 |
|
150,474 |
|
|
|
39,253 |
|
|
|
|
|
Stockholders' deficit |
|
|
|
Common stock, $0.0001 par value; 50,500,000 shares authorized as of
June 30, 2021 and December 31, 2020, respectively; 556,570 and
419,124 shares issued and outstanding as of June 30, 2021 and
December 31, 2020, respectively |
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
9,241 |
|
|
|
8,374 |
|
Accumulated deficit |
|
(115,320 |
) |
|
|
(26,965 |
) |
Total stockholders' deficit |
|
(106,079 |
) |
|
|
(18,591 |
) |
Total
liabilities, convertible preferred stock and stockholders'
deficit |
$ |
72,943 |
|
|
$ |
44,429 |
|
|
|
|
|
Acumen
Pharmaceuticals, Inc. |
Condensed
Statements of Operations |
(in
thousands, except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Grant and
other revenue |
$ |
- |
|
|
$ |
151 |
|
|
$ |
- |
|
|
$ |
377 |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
2,254 |
|
|
|
1,927 |
|
|
|
4,832 |
|
|
|
3,977 |
|
General and administrative |
|
1,187 |
|
|
|
259 |
|
|
|
2,402 |
|
|
|
481 |
|
Total
operating expenses |
|
3,441 |
|
|
|
2,186 |
|
|
|
7,234 |
|
|
|
4,458 |
|
Loss from
operations |
|
(3,441 |
) |
|
|
(2,035 |
) |
|
|
(7,234 |
) |
|
|
(4,081 |
) |
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
Interest income |
|
4 |
|
|
|
- |
|
|
|
8 |
|
|
|
1 |
|
Change in fair value of preferred stock tranche rights liability
and preferred stock warrant liability |
|
(57,940 |
) |
|
|
- |
|
|
|
(81,157 |
) |
|
|
- |
|
Other income |
|
19 |
|
|
|
- |
|
|
|
28 |
|
|
|
- |
|
Total other
income (expense) |
|
(57,917 |
) |
|
|
- |
|
|
|
(81,121 |
) |
|
|
1 |
|
Net loss
attributable to common stockholders |
$ |
(61,358 |
) |
|
$ |
(2,035 |
) |
|
$ |
(88,355 |
) |
|
$ |
(4,080 |
) |
|
|
|
|
|
|
|
|
Net loss per
common share, basic and diluted |
$ |
(141.93 |
) |
|
$ |
(4.86 |
) |
|
$ |
(207.52 |
) |
|
$ |
(9.73 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
432,325 |
|
|
|
419,124 |
|
|
|
425,761 |
|
|
|
419,124 |
|
|
|
|
|
|
|
|
|
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