ARCA Biopharma Announces First Quarter 2019 Financial Results and Provides Corporate Update
May 08 2019 - 4:30PM
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
applying a precision medicine approach to developing
genetically-targeted therapies for cardiovascular diseases, today
reported financial results for the quarter ended March 31, 2019 and
provided a corporate update.
“In the first part of this year, we continued to
make progress on our lead development program Gencaro, achieving an
agreement with the FDA on our Special Protocol Assessment for the
PRECISION-AF Phase 3 clinical trial evaluating Gencaro as
potentially the first genetically-targeted treatment for atrial
fibrillation,” commented Dr. Michael Bristow, ARCA’s President and
Chief Executive Officer. “Importantly, the GENETIC-AF Phase
2B clinical trial results, which are guiding our Phase 3
development, were accepted and published in JACC: Heart
Failure.”
Pipeline Update
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 2019, ARCA received a Special Protocol – Agreement
Letter from the U.S. Food and Drug Administration (FDA) on its
Special Protocol Assessment (SPA) application for the Phase 3
PRECISION-AF clinical trial. Subject to securing additional
financing, ARCA anticipates initiating PRECISION-AF by the end of
2019.
- In April 2019, GENETIC-AF Phase 2B clinical trial results were
published in the Journal of the American College of Cardiology:
Heart Failure in the paper “GENETIC-AF: Bucindolol for the
Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure
Population”.
AB171 – a thiol-substituted
isosorbide mononitrate being developed as a potential
genetically-targeted treatment for heart failure (HF) and
peripheral arterial disease (PAD).
- Chemistry, manufacturing and controls (CMC) activities
continued in the first quarter.
- Subject to securing additional financing, IND-enabling
non-clinical studies are anticipated to begin in the second half of
2019, and an IND submission is anticipated in the first half of
2020.
First Quarter 2019 Summary Financial
Results
Cash, cash equivalents and marketable
securities were $8.0 million as of March 31, 2019,
compared to $6.6 million as of December 31, 2018. ARCA believes
that its current cash, cash equivalents and marketable securities
will be sufficient to fund its operations, at its projected cost
structure, through the end of the third quarter of 2019.
Research and development (R&D)
expenses for the three months ended March 31, 2019 were
$0.7 million compared to $1.7 million for the corresponding period
of 2018. The $1.1 million decrease in R&D expenses was
primarily due to decreased clinical expenses following the
completion of the GENETIC-AF clinical trial in 2018.
General and administrative (G&A)
expenses for the three months ended March 31, 2019 were
$1.1 million similar to $1.1 million in the first quarter of
2018. The Company expects G&A expenses in 2019 to be
consistent with those in 2018 as it maintains administrative
activities to support our ongoing operations.
Total operating expenses for
the three months ended March 31, 2019 were $1.8 million compared to
$2.8 million for the corresponding period of 2018. The
decrease in total operating expenses was primarily due to the
decrease in R&D expense due to the completion of the GENETIC-AF
clinical trial.
Net loss was $1.7 million, or
$1.86 per share, for the first quarter of 2019 compared to $2.7
million, or $3.61 per share, for the first quarter of 2018.
The Company will need to raise additional
capital to fund future operations and develop Gencaro or any other
product candidates, complete a partnership or other possible
strategic transactions.
About ARCA biopharma
ARCA biopharma is dedicated to developing
genetically-targeted therapies for cardiovascular diseases through
a precision medicine approach to drug development. ARCA’s lead
product candidate, Gencaro™ (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of atrial
fibrillation in patients with heart failure. 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 Gencaro
development program has been granted Fast Track designation by FDA.
ARCA is also developing AB171, a thiol-substituted isosorbide
mononitrate, as a potential genetically-targeted treatment for
heart failure and peripheral arterial disease (PAD). For more
information, please visit www.arcabio.com or follow the Company on
LinkedIn.
Safe Harbor Statement
This 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 ability of ARCA’s
financial resources to support its operations through the end of
the third quarter of 2019, potential future development plans for
Gencaro, the expected features and characteristics of Gencaro or
AB171, including the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat AF, AB171’s potential to treat HF or PAD, future treatment
options for patients with AF, and the potential for Gencaro to be
the first genetically-targeted AF prevention treatment. 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 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, 2018, 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, 2019 |
|
December 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$8,006 |
|
$6,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
$7,231 |
|
$5,984 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
$8,606 |
|
$6,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
$7,318 |
|
$6,032 |
|
|
|
|
ARCA BIOPHARMA,
INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(unaudited)
|
Three Months Ended |
|
|
March 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
(in thousands, except share |
|
and per share amounts) |
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
662 |
|
|
$ |
1,720 |
|
General and administrative |
|
1,119 |
|
|
|
1,053 |
|
Total costs and expenses |
|
1,781 |
|
|
|
2,773 |
|
Loss from operations |
|
(1,781 |
) |
|
|
(2,773 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
38 |
|
|
|
41 |
|
Interest expense |
|
(3 |
) |
|
|
(3 |
) |
Loss before income taxes |
|
(1,746 |
) |
|
|
(2,735 |
) |
Income tax benefit |
|
82 |
|
|
|
— |
|
Net loss |
$ |
(1,664 |
) |
|
$ |
(2,735 |
) |
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
— |
|
|
|
2 |
|
Comprehensive loss |
$ |
(1,664 |
) |
|
$ |
(2,733 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.86 |
) |
|
$ |
(3.61 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
895,970 |
|
|
|
756,706 |
|
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