ARCA biopharma Announces First Quarter 2021 Financial Results and Provides Corporate Update
12 May 2021 - 6:15AM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today reported
first quarter 2021 financial results and provided a corporate
update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “We are continuing to advance the
Phase 2b clinical trial evaluating rNAPc2 as a potential treatment
for patients hospitalized with COVID-19, actively enrolling
patients at 7 clinical trial sites in the United States. We look
forward to sharing the trial results early in the third quarter of
this year. We believe rNAPc2’s combination of anticoagulant,
anti-inflammatory and antiviral properties, give it the potential
to be effective in addressing the impact of COVID-19 from multiple
pathways. As a therapeutic aimed at a host response to a disease
syndrome, we believe rNAPc2 has therapeutic potential for future
viral outbreaks beyond the current pandemic, even after safe and
effective vaccines for SARS-CoV-2 are successfully deployed.”
Pipeline Update
rNAPc2 (AB201) – a small
recombinant protein being developed as a potential treatment for
RNA virus associated disease, initially focusing on COVID-19.
- Phase
2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential
treatment for patients hospitalized with COVID-19 initiated in
December 2020.
-
Currently enrolling patients in ASPEN-COVID-19 at 7 clinical trial
sites in the United States.
- Phase
2b topline data anticipated early in the third quarter of
2021.
- U.S.
Food and Drug Administration (FDA) designated the investigation of
rNAPc2 as a potential treatment for COVID-19 as a Fast Track
development program.
Gencaro™ (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).
- In
February 2021, ARCA was issued a new patent by the United States
Patent and Trademark Office (USPTO) for use of Gencaro in treating
AF in patients with HF. The Company believes this patent would
provide effective patent coverage in the United States into 2039.
ARCA has filed similar patent applications in other countries.
- The
Company continues to evaluate 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.
First Quarter 2021 Summary Financial
Results
Cash and cash equivalents were
$66.9 million as of March 31, 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 $2.9 million for the quarter ended March 31,
2021, compared to $0.4 million for the corresponding period in
2020. The $2.5 million increase in R&D expenses in the first
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 $1.2 million for the quarter ended March 31,
2021, compared to $1.0 million for the corresponding period in
2020. The $0.3 million increase in G&A expenses was primarily a
result of higher personnel costs in 2021. G&A expenses in 2021
are expected to be consistent with those in 2020 as the Company
maintains administrative activities to support its ongoing
operations.
Total operating expenses for
the quarter ended March 31, 2021 were $4.1 million compared to $1.3
million for the first quarter of 2020.
Net loss for the quarter ended
March 31, 2021 was $4.1 million, or $0.33 per basic and diluted
share, compared to $1.3 million, or $0.83 per basic and diluted
share for the first 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 diseases caused by RNA viruses, initially focusing on
COVID-19. The U.S. FDA has granted Fast Track designation to the
rNAPc2 development program, currently in Phase 2 clinical testing.
ARCA is also developing Gencaro™ (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) |
|
|
|
|
|
March 31, 2021 |
December 31, 2020 |
Cash and cash equivalents |
$66,933 |
$49,071 |
Working capital |
$65,850 |
$46,469 |
Total assets |
$69,183 |
$50,429 |
Total stockholders’ equity |
$65,909 |
$46,521 |
ARCA BIOPHARMA, INC. STATEMENTS OF
OPERATIONS(unaudited) |
|
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
(in thousands, except shareand per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
2,876 |
|
|
$ |
365 |
|
General and administrative |
|
1,226 |
|
|
|
975 |
|
Total costs and expenses |
|
4,102 |
|
|
|
1,340 |
|
Loss from operations |
|
(4,102 |
) |
|
|
(1,340 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
2 |
|
|
|
24 |
|
Interest expense |
|
— |
|
|
|
(4 |
) |
Net loss |
$ |
(4,100 |
) |
|
$ |
(1,320 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.83 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
12,356,928 |
|
|
|
1,594,070 |
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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