ARCA biopharma Announces Fiscal Year 2018 Financial Results and Provides Corporate Update
February 27 2019 - 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 financial results for the year ended December 31, 2018 and
provided a corporate update.
“During 2018, we continued to make progress on
our lead development program as we: reported Phase 2B results for
the GENETIC-AF trial; designed a Phase 3 development plan based on
learnings from those results; identified a clear regulatory path;
and, began discussions with the FDA to confirm agreement on future
development of Gencaro, potentially the first genetically-targeted
cardiovascular therapeutic,” commented Dr. Michael Bristow, ARCA’s
President and Chief Executive Officer. “With the Gencaro FDA
SPA agreement now in place, 2019 will be an important year for ARCA
as we work towards the initiation of the Phase 3 clinical trial and
expand development activities for AB171, a potential
genetically-targeted treatment for heart failure and peripheral
arterial disease.”
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 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.- PRECISION-AF is designed as a
double-blind, active-controlled, multicenter, international study
comparing Gencaro with Toprol-XL (metoprolol succinate) for the
prevention of AF recurrence or all-cause mortality (ACM) in HF
patients with mid-range ejection fraction (HFmrEF).- Subject to
securing additional financing, ARCA anticipates initiating
PRECISION-AF in the fourth quarter of 2019.
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 were
continued in the fourth quarter.
- IND-enabling non-clinical studies are anticipated to begin in
the second half of 2019.
- IND submission anticipated in the first quarter of 2020.
2018 Summary Financial
ResultsCash, cash equivalents and marketable
securities were $6.6 million as of December 31, 2018,
compared to $11.8 million as of December 31, 2017. 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 year ended December 31, 2018 were $4.2
million compared to $14.1 million for 2017. The $9.8 million
decrease in R&D expenses in 2018 as compared to 2017 was
primarily due to decreased clinical expenses following the
completion of the GENETIC-AF clinical trial in 2017.
General and administrative (G&A)
expenses for the year ended December 31, 2018 were
$3.9 million compared to $4.6 million in 2017. 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
2018 were $8.1 million compared to $18.7 million during 2017.
The decrease in total operating expenses in 2018 was primarily due
to the decrease in R&D expense due to the completion of the
GENETIC-AF clinical trial.
Net loss was $7.9 million, or
$0.57 per share, for 2018 compared to $18.5 million, or $1.77 per
share, for 2017.
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 with mid-range ejection
fraction. 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.
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 second 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, 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
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
(Tables follow) ARCA BIOPHARMA,
INC.
BALANCE SHEET DATA (in
thousands)
(unaudited)
|
December 31, 2018 |
|
December 31, 2017 |
Cash, cash
equivalents & marketable securities |
$6,608 |
|
$11,752 |
Working
capital |
$5,984 |
|
$10,229 |
Total
assets |
$6,825 |
|
$12,365 |
Total
stockholders’ equity |
$6,032 |
|
$10,275 |
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(unaudited)
|
Years Ended December 31, |
|
|
2018 |
|
|
2017 |
|
|
(in thousands, except share and per share
amounts) |
|
Costs and
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
4,239 |
|
|
$ |
14,076 |
|
General and administrative |
|
3,879 |
|
|
|
4,636 |
|
Total costs and expenses |
|
8,118 |
|
|
|
18,712 |
|
Loss from operations |
|
(8,118 |
) |
|
|
(18,712 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
162 |
|
|
|
167 |
|
Interest expense |
|
(8 |
) |
|
|
(6 |
) |
Loss before income taxes |
|
(7,964 |
) |
|
|
(18,551 |
) |
Income tax benefit |
|
31 |
|
|
|
61 |
|
Net loss |
$ |
(7,933 |
) |
|
$ |
(18,490 |
) |
|
|
|
|
|
|
|
|
Change in unrealized loss on marketable securities |
|
2 |
|
|
|
17 |
|
Comprehensive loss |
$ |
(7,931 |
) |
|
$ |
(18,473 |
) |
|
|
|
|
|
|
|
|
Net
loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.57 |
) |
|
$ |
(1.77 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
13,849,055 |
|
|
|
10,431,391 |
|
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