ARCA Biopharma Announces Third Quarter 2019 Financial Results and Provides Corporate Update
07 November 2019 - 8:10AM
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 September 30, 2019
and provided a corporate update.
“There are currently no FDA approved drug
therapies indicated for treating patients with atrial fibrillation
and heart failure with left ventricular ejection fraction values
greater than 40%,” commented Dr. Michael Bristow, ARCA’s President
and Chief Executive Officer. “Approximately two-thirds of all
heart failure patients have LVEF values greater than 40% and about
half of these patients will develop atrial fibrillation. Based on
our Phase 2 data, we believe Gencaro has the potential to help
address this substantial unmet medical need. We look forward
to further evaluating Gencaro in the planned Phase 3 clinical
trial, PRECISION-AF, which we plan to initiate in the first quarter
of 2020.”
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 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.
- In September 2019, Gencaro AF
clinical data from the GENETIC-AF Phase 2B trial was presented at
the Heart Failure Society of America (HFSA) 2019 Annual Scientific
Meeting. The data indicate Gencaro response appears to be
greater in HF patients with less severe left ventricular
dysfunction, a patient population with no FDA approved drug
therapeutic options for AF prevention or heart failure.
AB171 – a thiol-substituted
isosorbide mononitrate being developed as a potential
genetically-targeted treatment for HF and peripheral arterial
disease (PAD).
- Chemistry, manufacturing and
controls (CMC) activities continued in the third quarter.
- Subject to securing additional
financing, Investigational New Drug (IND)-enabling non-clinical
studies are anticipated to begin in the first quarter of 2020, and
an IND submission is anticipated in the second half of 2020.
Third Quarter 2019 Summary Financial
ResultsCash and cash equivalents were
$9.6 million as of September 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, after giving effect to potential cost
reductions, through the third quarter of 2020.
Research and development (R&D)
expenses for the three months ended September 30, 2019
were $0.3 million compared to $0.7 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. The
Company does not anticipate having any material clinical trial
expense in 2019, consequently R&D expense in 2019 is expected
to be lower than in 2018.
General and administrative (G&A)
expenses were relatively unchanged at $0.9 million for
both the three months ended September 30, 2019 and 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 September 30, 2019 were $1.2 million
compared to $1.7 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 $1.2 million, or
$0.76 per share, for the third quarter of 2019 compared to $1.6
million, or $2.06 per share, for the third 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. 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 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)
|
September 30, 2019 |
December 31, 2018 |
Cash and cash equivalents |
$9,645 |
$6,608 |
Working capital |
$8,754 |
$5,984 |
Total assets |
$9,949 |
$6,825 |
Total stockholders’ equity |
$8,799 |
$6,032 |
|
|
|
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(unaudited)
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
(in thousands, except share and per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
347 |
|
|
$ |
740 |
|
|
$ |
1,449 |
|
|
$ |
3,614 |
|
General and administrative |
|
900 |
|
|
|
922 |
|
|
|
3,087 |
|
|
|
2,977 |
|
Total costs and expenses |
|
1,247 |
|
|
|
1,662 |
|
|
|
4,536 |
|
|
|
6,591 |
|
Loss from operations |
|
(1,247 |
) |
|
|
(1,662 |
) |
|
|
(4,536 |
) |
|
|
(6,591 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
50 |
|
|
|
40 |
|
|
|
136 |
|
|
|
124 |
|
Interest expense |
|
(1 |
) |
|
|
(2 |
) |
|
|
(7 |
) |
|
|
(8 |
) |
Loss before income taxes |
|
(1,198 |
) |
|
|
(1,624 |
) |
|
|
(4,407 |
) |
|
|
(6,475 |
) |
Income tax benefit |
|
42 |
|
|
|
31 |
|
|
|
151 |
|
|
|
31 |
|
Net loss |
$ |
(1,156 |
) |
|
$ |
(1,593 |
) |
|
$ |
(4,256 |
) |
|
$ |
(6,444 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2 |
|
Comprehensive loss |
$ |
(1,156 |
) |
|
$ |
(1,593 |
) |
|
$ |
(4,256 |
) |
|
$ |
(6,442 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.76 |
) |
|
$ |
(2.06 |
) |
|
$ |
(3.46 |
) |
|
$ |
(8.39 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
1,521,259 |
|
|
|
773,545 |
|
|
|
1,229,289 |
|
|
|
767,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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