ARCA biopharma Announces Second Quarter 2019 Financial Results and Provides Corporate Update
August 01 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 June 30, 2019 and
provided a corporate update.
“We continue to make important progress on our
lead development program Gencaro building on our GENETIC-AF Phase
2B clinical trial results, which were published in the Journal of
the American College of Cardiology: Heart Failure,” commented Dr.
Michael Bristow, ARCA’s President and Chief Executive
Officer. “The U.S. FDA recently agreed to amend the Special
Protocol Assessment agreement for our Phase 3 trial to include
heart failure patients with preserved ejection fraction (HFpEF) and
a left ventricular ejection fraction (LVEF) up to 55%, the upper
boundary of the LVEF range in GENETIC-AF for which Gencaro
exhibited effectiveness for preventing atrial fibrillation/flutter.
The revised PRECISION-AF target population, patients with recent
atrial fibrillation and heart failure with mid-range and preserved
ejection fractions, is an underserved population and we believe our
Phase 2B data indicates that Gencaro may have a positive impact for
these patients.”
Pipeline Update
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).
- 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”.
- In July 2019, the U.S. Food and Drug Administration (FDA)
agreed to amend ARCA’s Special Protocol Assessment (SPA) agreement
for the Phase 3 PRECISION-AF clinical trial to expand the target
trial population to include heart failure patients with left
ventricular injection fractions (LVEF) > 40% and < 55%.
Subject to securing additional financing, ARCA anticipates
initiating PRECISION-AF in the first quarter of 2020.
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 second quarter.
- Subject to securing additional financing, IND-enabling
non-clinical studies are anticipated to begin in the fourth quarter
of 2019, and an IND submission is anticipated in the second half of
2020.
Second Quarter 2019 Summary Financial
Results
Cash and cash equivalents were
$9.97 million as of June 30, 2019, compared to $6.6 million as of
December 31, 2018. ARCA believes that its current cash and cash
equivalents will be sufficient to fund its operations, at its
current cost structure, through the first quarter of 2020.
Research and development (R&D)
expenses for the three months ended June 30, 2019 were
$0.4 million compared to $1.2 million for the corresponding period
of 2018. The 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 June 30, 2019 were
$1.1 million, compared to $1.0 million in the second 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 its ongoing operations.
Total operating expenses for
the three months ended June 30, 2019 were $1.5 million compared to
$2.2 million for the corresponding period of 2018. The
decrease in total operating expenses was primarily attributable to
the decrease in R&D expense due to the completion of the
GENETIC-AF clinical trial in 2018.
Net loss was $1.4 million, or
$1.14 per share, for the second quarter of 2019 compared to $2.1
million, or $2.74 per share, for the second quarter of 2018.
The Company will need to raise additional
capital, and/or complete a partnership or other possible strategic
transaction, to fund future operations and develop Gencaro or any
other product candidates.
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, GencaroTM (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of 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 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 first quarter of 2020, 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)
|
|
June 30, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
$9,966 |
$6,608 |
Working capital |
$9,124 |
$5,984 |
Total assets |
$10,388 |
$6,825 |
Total stockholders’ equity |
$9,189 |
$6,032 |
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(unaudited)
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
440 |
|
|
$ |
1,154 |
|
|
$ |
1,102 |
|
|
$ |
2,874 |
|
General and administrative |
|
1,068 |
|
|
|
1,002 |
|
|
|
2,187 |
|
|
|
2,055 |
|
Total costs and expenses |
|
1,508 |
|
|
|
2,156 |
|
|
|
3,289 |
|
|
|
4,929 |
|
Loss from operations |
|
(1,508 |
) |
|
|
(2,156 |
) |
|
|
(3,289 |
) |
|
|
(4,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
48 |
|
|
|
43 |
|
|
|
86 |
|
|
|
84 |
|
Interest expense |
|
(3 |
) |
|
|
(3 |
) |
|
|
(6 |
) |
|
|
(6 |
) |
Loss before income taxes |
|
(1,463 |
) |
|
|
(2,116 |
) |
|
|
(3,209 |
) |
|
|
(4,851 |
) |
Income tax benefit |
|
27 |
|
|
|
— |
|
|
|
109 |
|
|
|
— |
|
Net loss |
$ |
(1,436 |
) |
|
$ |
(2,116 |
) |
|
$ |
(3,100 |
) |
|
$ |
(4,851 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2 |
|
Comprehensive loss |
$ |
(1,436 |
) |
|
$ |
(2,116 |
) |
|
$ |
(3,100 |
) |
|
$ |
(4,849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(1.14 |
) |
|
$ |
(2.74 |
) |
|
$ |
(2.87 |
) |
|
$ |
(6.34 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
1,263,768 |
|
|
|
773,528 |
|
|
|
1,080,885 |
|
|
|
765,164 |
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Aug 2024 to Sep 2024
ARCA Biopharma (NASDAQ:ABIO)
Historical Stock Chart
From Sep 2023 to Sep 2024