ARCA biopharma Announces 2021 Financial Results and Provides Corporate Update
March 14 2022 - 4:15PM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing genetically
targeted therapies for cardiovascular diseases, today reported 2021
financial results and provided a corporate update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “We have completed blinded data
collection from the Phase 2b clinical trial evaluating rNAPc2 as a
potential treatment for patients hospitalized with COVID-19 and
look forward to unblinding and subsequently reporting results of
the study in the last week of this month. We believe rNAPc2 has the
potential to be effective in addressing the impact of COVID-19 from
multiple pathways due to its combination of anticoagulant,
anti-inflammatory and antiviral properties. We look forward to
sharing the data with the FDA at an end of Phase 2 meeting.”
Pipeline Update
rNAPc2 (AB201) – a small
recombinant protein being developed as a potential treatment for
COVID-19 and potentially other viral diseases.
- Topline
data from Phase 2b ASPEN-COVID-19 clinical trial evaluating rNAPc2
as a potential treatment for patients hospitalized with COVID-19
anticipated in the last week of March 2022.
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
January 2022, ARCA announced that the paper entitled “Dose
Limiting, Adverse Event Associated Bradycardia with β-blocker
Treatment of Atrial Fibrillation in the GENETIC-AF Trial” (William
Abraham, et al) was published in Heart Rhythm O2, a publication of
the Hearth Rhythm Society. The paper details an analysis that
examined the prevalence of bradycardia and its association with
adverse events (AEs) and failure to achieve target dose in the
GENETIC-AF Phase 2b clinical trial. In the genetically defined
population of GENETIC-AF (all ADRB1 Arg389Arg genotype), the
prevalence of clinically important bradycardia was lower for
Gencaro compared to metoprolol.
- The
Company continues to evaluate the feasibility and potential timing
for initiation of PRECISION-AF relative to the COVID-19 pandemic
and the ability to recruit patients for a cardiovascular clinical
trial.
Full Year 2021 Summary Financial
Results
Cash and cash equivalents were
$53.4 million as of December 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 the middle of 2023.
Research and development (R&D)
expenses were $13.8 million for the year ended December
31, 2021, compared to $5.0 million for 2020. The $8.8 million
increase in R&D expenses in 2021 as compared to 2020 was
primarily related to the conduct of the rNAPc2 clinical trial.
R&D expenses in 2022 are expected to be consistent with
2021.
General and administrative (G&A)
expenses were $5.5 million for the year ended December 31,
2021, compared to $4.8 million for 2020, an increase of
approximately $0.7 million. The increase in expenses during 2021
was comprised primarily of increased personnel and insurance costs,
offset by lower legal costs in 2021, as compared to 2020. G&A
expenses in 2022 are expected to be consistent with those in 2021
as the Company maintains administrative activities to support our
ongoing operations.
Total operating expenses for
the year ended December 31, 2021 were $19.3 million compared to
$9.8 million in 2020.
Net loss for the year ended
December 31, 2021 was $19.3 million, or $1.39 per basic and diluted
share, compared to $9.7 million, or $2.07 per basic and diluted
share in 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 the middle of fiscal
year 2023. 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, 2021, 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)
|
|
December 31, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
$ |
53,359 |
$ |
49,071 |
Working capital |
$ |
50,923 |
$ |
46,469 |
Total assets |
$ |
54,924 |
$ |
50,429 |
Total stockholders’ equity |
$ |
51,043 |
$ |
46,521 |
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
|
Years Ended December 31, |
|
|
2021 |
|
|
2020 |
|
|
(in thousands, except shareand per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
13,832 |
|
|
$ |
4,992 |
|
General and administrative |
|
5,503 |
|
|
|
4,774 |
|
Total costs and expenses |
|
19,335 |
|
|
|
9,766 |
|
Loss from operations |
|
(19,335 |
) |
|
|
(9,766 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
13 |
|
|
|
28 |
|
Interest expense |
|
— |
|
|
|
(9 |
) |
Loss before income taxes |
|
(19,322 |
) |
|
|
(9,747 |
) |
Income tax benefit |
|
— |
|
|
|
9 |
|
Net loss |
$ |
(19,322 |
) |
|
$ |
(9,738 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.39 |
) |
|
$ |
(2.07 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
13,903,871 |
|
|
|
4,710,237 |
|
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