ARCA biopharma Announces Third Quarter 2021 Financial Results and Provides Corporate Update
03 November 2021 - 7:15AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today reported
third quarter 2021 financial results and provided a corporate
update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “The continuing pandemic and the
emergence of multiple variants that have led to a resurgence of
infections and hospitalizations, highlight the need for additional
safe and effective therapeutic tools to treat patients that develop
severe COVID-19. With rNAPc2’s combination of anticoagulant,
anti-inflammatory and potential antiviral properties, we believe it
has the potential to be effective in addressing COVID-19 impacts in
hospitalized patients. Our international Phase 2b clinical trial is
nearing completion and we look forward to sharing its results in
the first quarter.”
Pipeline Update
rNAPc2 (AB201) – a small
recombinant protein being developed as a potential treatment for
COVID-19 and potentially other viral diseases.
-
On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2
as a potential treatment for patients hospitalized with COVID-19,
enrolling patients at investigative sites in United States,
Argentina and Brazil.
-
Clinical trial Data and Safety Monitoring Committee (DSMC)
completed a pre-specified interim analysis and, based on the DSMC’s
review of approximately 75% of the projected final efficacy and
safety data, recommended completion of the clinical trial with no
modifications to the clinical trial design.
- Phase
2b topline data anticipated in first quarter of 2022.
GencaroTM
(bucindolol hydrochloride) - a pharmacologically unique
beta-blocker and mild vasodilator being developed as a potential
genetically-targeted treatment for atrial fibrillation (AF) in
patients with heart failure (HF).
- ARCA
currently has an agreement with the U.S. FDA, known as a Special
Protocol Assessment, or SPA, for the requirements of a Gencaro
Phase 3 clinical trial, PRECISION-AF, that would support potential
approval of Gencaro if successful. The Company is currently
evaluating the potential timing for initiation of PRECISION-AF
relative to the COVID-19 pandemic and the ability to recruit
patients for a cardiovascular clinical trial, and based on an
improving clinical trial ecosystem, has begun organizing necessary
trial logistics.
Third Quarter 2021 Summary Financial
Results
Cash and cash equivalents were
$58.3 million as of September 30, 2021, compared to
$49.1 million as of December 31, 2020. ARCA believes that its
current cash and cash equivalents will be sufficient to fund its
operations through 2022.
Research and development (R&D)
expenses were $3.4 million for the quarter ended September
30, 2021, compared to $1.1 million for the corresponding period in
2020. The $2.3 million increase in R&D expenses in the
third quarter was primarily related to the initiation of the rNAPc2
clinical trial in the second half of 2020. R&D expenses in 2021
are expected to be higher than 2020 as the Company continues the
rNAPc2 Phase 2b clinical trial.
General and administrative (G&A)
expenses were $1.3 million for the quarter ended September
30, 2021, compared to $0.9 million for the corresponding period in
2020. The $0.4 million increase in G&A expenses was
primarily a result of higher personnel costs in 2021. G&A
expenses in the last quarter of 2021 are expected to be consistent
with the third quarter of 2021 as the Company maintains
administrative activities to support its ongoing operations.
Total operating expenses for
the quarter ended September 30, 2021 were $4.7 million compared to
$2.0 million for the third quarter of 2020.
Net loss for the quarter ended
September 30, 2021 was $4.7 million, or $0.33 per basic and diluted
share, compared to $2.0 million, or $0.33 per basic and diluted
share for the third quarter of 2020.
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA is developing rNAPc2 as a potential
treatment for COVID-19 and potentially other viral diseases. The
U.S. FDA has granted Fast Track designation to the rNAPc2
development program, currently in Phase 2 clinical testing.
ARCA is also developing GencaroTM (bucindolol hydrochloride), an
investigational, pharmacologically unique beta-blocker and mild
vasodilator, as a potential treatment for atrial fibrillation in
heart failure patients. ARCA has identified common genetic
variations that it believes predict individual patient response to
Gencaro, giving it the potential to be the first genetically
targeted AF prevention treatment. The U.S. FDA has granted the
Gencaro development program Fast Track designation and a Special
Protocol Assessment (SPA) agreement. For more information, please
visit www.arcabio.com or follow the Company on LinkedIn.
Safe Harbor StatementThis press
release contains "forward-looking statements" for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. These statements include, but are not limited to,
statements regarding the potential future development plans for
rNAPc2 and Gencaro, the expected features and characteristics of
rNAPc2 and Gencaro, including the potential for genetic variations
to predict individual patient response to Gencaro, Gencaro’s
potential to treat atrial fibrillation, rNAPc2’s potential to treat
COVID-19, future treatment options for patients with COVID-19 or
AF, the potential for Gencaro to be the first genetically targeted
AF prevention treatment and the ability of ARCA’s financial
resources to support its operations through 2022. Such statements
are based on management's current expectations and involve risks
and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, the
risks and uncertainties associated with: ARCA’s financial resources
and whether they will be sufficient to meet its business objectives
and operational requirements; ARCA may not be able to raise
sufficient capital on acceptable terms, or at all, to continue
development of rNAPc2 or Gencaro or to otherwise continue
operations in the future; results of earlier clinical trials may
not be confirmed in future trials; the protection and market
exclusivity provided by ARCA’s intellectual property; risks related
to the drug discovery and the regulatory approval process; and, the
impact of competitive products and technological changes. These and
other factors are identified and described in more detail in ARCA’s
filings with the Securities and Exchange Commission, including
without limitation ARCA’s annual report on Form 10-K for the year
ended December 31, 2020, and subsequent filings. ARCA
disclaims any intent or obligation to update these forward-looking
statements.
Investor & Media
Contact:Derek Cole720.940.2163derek.cole@arcabio.com
(Tables follow)
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA (in
thousands) (unaudited)
|
September 30, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
$58,313 |
|
$49,071 |
Working capital |
$56,484 |
|
$46,469 |
Total assets |
$60,192 |
|
$50,429 |
Total stockholders’ equity |
$56,600 |
|
$46,521 |
|
|
|
|
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(unaudited)
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,438 |
|
|
$ |
1,051 |
|
|
$ |
9,891 |
|
|
$ |
1,788 |
|
General and administrative |
|
1,278 |
|
|
|
939 |
|
|
|
3,764 |
|
|
|
2,852 |
|
Total costs and expenses |
|
4,716 |
|
|
|
1,990 |
|
|
|
13,655 |
|
|
|
4,640 |
|
Loss from operations |
|
(4,716 |
) |
|
|
(1,990 |
) |
|
|
(13,655 |
) |
|
|
(4,640 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
4 |
|
|
|
1 |
|
|
|
9 |
|
|
|
27 |
|
Interest expense |
|
— |
|
|
|
(2 |
) |
|
|
— |
|
|
|
(9 |
) |
Loss before income taxes |
|
(4,712 |
) |
|
|
(1,991 |
) |
|
|
(13,646 |
) |
|
|
(4,622 |
) |
Income tax benefit |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9 |
|
Net loss |
$ |
(4,712 |
) |
|
$ |
(1,991 |
) |
|
$ |
(13,646 |
) |
|
$ |
(4,613 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.46 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
14,410,143 |
|
|
|
6,044,315 |
|
|
|
13,733,259 |
|
|
|
3,154,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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