ARCA biopharma Announces Second Quarter 2021 Financial Results and Provides Corporate Update
August 04 2021 - 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
second quarter 2021 financial results and provided a corporate
update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “We continue to be encouraged with
the opportunities we see in our development pipeline compounds,
rNAPc2 and Gencaro. With the ASPEN-COVID-19 Phase 2b trial of
rNAPc2 expanding to South America, we look forward to completing
the trial and we anticipate sharing the results in the fourth
quarter. Given the rate of global vaccination and the continued
emergence of variants, along with rNAPc2’s combination of
anticoagulant, anti-inflammatory and antiviral properties, we
believe it has the potential to be effective in addressing COVID-19
impacts in hospitalized patients. For Gencaro, we believe that, if
approved, it may be a safe and effective therapy for the treatment
of higher ejection fraction heart failure patients with atrial
fibrillation and look forward to evaluating it in the planned
PRECISION-AF Phase 3 clinical study.”
Pipeline Update
rNAPc2 (AB201) – a small
recombinant protein being developed as a potential treatment for
RNA virus associated disease, initially focusing on COVID-19.
-
On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2
as a potential treatment for patients hospitalized with
COVID-19.
-
ASPEN-COVID-19 expanding to South America with regulatory clinical
trial commencement authorizations in Argentina and Brazil.
- Phase
2b topline data anticipated in the fourth quarter of 2021.
- In
July, the Company entered into a patent assignment agreement with
the University Medical Center of Johannes Gutenberg University
Mainz, Germany, under which ARCA received exclusive world-wide
patent rights related to the use of rNAPc2 as a potential treatment
for COVID-19, and other potential indications.
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).
- Gencaro
Phase 2b data on AF burden and rhythm control interventions was
published in Circulation: Arrhythmia and Electrophysiology, a
journal of the American Heart Association. In the Phase 2b
superiority clinical trial, although the prespecified primary
endpoint was not met, compared with metoprolol, Gencaro reduced AF
burden, delayed AF progression, increased maintenance of sinus
rhythm, and reduced the need for additional rhythm control
interventions in patients with HF and the genotype which responds
most favorably to Gencaro.
- 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.
Corporate
- The
Company added to its executive team with the hiring of Jeff Dekker
as Chief Financial Officer and Christopher Graybill as Vice
President, Clinical Development.
Second Quarter 2021 Summary Financial
Results
Cash and cash equivalents were
$63.2 million as of June 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 $3.6 million for the quarter ended June 30,
2021, compared to $0.4 million for the corresponding period in
2020. The $3.2 million increase in R&D expenses in the second
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 June 30,
2021, compared to $0.9 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 the
second half of 2021 are expected to be consistent with the first
half of 2021 as the Company maintains administrative activities to
support its ongoing operations.
Total operating expenses for
the quarter ended June 30, 2021 were $4.8 million compared to $1.3
million for the second quarter of 2020.
Net loss for the quarter ended
June 30, 2021 was $4.8 million, or $0.34 per basic and diluted
share, compared to $1.3 million, or $0.73 per basic and diluted
share for the second 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 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)
|
June 30, 2021 |
|
December 31, 2020 |
Cash and cash equivalents |
$63,197 |
|
$49,071 |
Working capital |
$61,098 |
|
$46,469 |
Total assets |
$65,338 |
|
$50,429 |
Total stockholders’ equity |
$61,208 |
|
$46,521 |
ARCA BIOPHARMA, INC.
STATEMENTS OF
OPERATIONS(unaudited)
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,577 |
|
|
$ |
372 |
|
|
$ |
6,453 |
|
|
$ |
737 |
|
General and administrative |
|
1,260 |
|
|
|
938 |
|
|
|
2,486 |
|
|
|
1,913 |
|
Total costs and expenses |
|
4,837 |
|
|
|
1,310 |
|
|
|
8,939 |
|
|
|
2,650 |
|
Loss from operations |
|
(4,837 |
) |
|
|
(1,310 |
) |
|
|
(8,939 |
) |
|
|
(2,650 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
3 |
|
|
|
2 |
|
|
|
5 |
|
|
|
26 |
|
Interest expense |
|
— |
|
|
|
(3 |
) |
|
|
— |
|
|
|
(7 |
) |
Loss before income taxes |
|
(4,834 |
) |
|
|
(1,311 |
) |
|
|
(8,934 |
) |
|
|
(2,631 |
) |
Income tax benefit |
|
— |
|
|
|
9 |
|
|
|
— |
|
|
|
9 |
|
Net loss |
$ |
(4,834 |
) |
|
$ |
(1,302 |
) |
|
$ |
(8,934 |
) |
|
$ |
(2,622 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.73 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.55 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
14,410,143 |
|
|
|
1,793,900 |
|
|
|
13,389,207 |
|
|
|
1,693,985 |
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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