ARCA biopharma Announces Second Quarter 2018 Financial Results and Provides Corporate Update
August 09 2018 - 04:15PM
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 quarter ended June 30, 2018.
“The second quarter of this year saw an
important milestone for the Gencaro development program with the
completion of an End-of-Phase 2 FDA meeting that provided important
guidance for the next steps in our development of Gencaro as
potentially the first genetically-targeted treatment for atrial
fibrillation,” commented Dr. Michael Bristow, ARCA’s President and
Chief Executive Officer. “With work underway on completing
the Gencaro Phase 3 trial protocol and continued progress with IND
enabling activities for AB171 in PAD and HF, we believe ARCA is
advancing our pipeline of genetically-targeted therapeutics to
address the unmet medical needs of patients with cardiovascular
disease.”
Pipeline Update
Gencaro (bucindolol
hydrochloride) - a pharmacologically unique beta-blocker and mild
vasodilator being developed for the potential treatment of patients
with atrial fibrillation (AF) and chronic heart failure with
reduced left ventricular ejection fraction (HFrEF).
- In April 2018, Medtronic, Inc. and ARCA agreed to extend their
current U.S., Canadian and European Clinical Trial Collaboration
Agreement for one additional year.
- In May 2018, results from ARCA’s GENETIC-AF Phase 2B clinical
trial were presented in a “Late Breaking Clinical Trials” oral
presentation at the European Society of Cardiology (ESC) Heart
Failure 2018 World Congress.
- In June 2018, ARCA held an End-of-Phase 2 meeting with the U.S.
Food and Drug Administration (FDA) to review the GENETIC-AF data
and potential future Gencaro development plans.
- FDA concurrence to proceed into Phase 3 was reached. ARCA
anticipates submitting a Special Protocol Assessment (SPA)
application for the proposed Gencaro Phase 3 clinical trial in the
third quarter of 2018. Progress to Phase 3 is dependent on the
Company receiving additional funding.
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 second quarter.
- IND-enabling non-clinical studies are anticipated to begin in
the first half of 2019.
Second Quarter 2018 Summary Financial
Results
Cash, cash equivalents and marketable
securities totaled $9.6 million as of June 30, 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 first quarter of 2019.
Research and development (R&D)
expenses for the quarter ended June 30, 2018 totaled $1.2
million compared to $4.5 million for the corresponding period of
2017. The $3.3 million decrease in research and development
expenses in the second quarter of 2018 as compared to the second
quarter 2017 was primarily due to decreased clinical expenses
following the completion of the GENETIC-AF clinical trial.
The Company expects R&D expenses in 2018 to be lower than 2017
as the GENETIC-AF clinical trial has been completed.
General and administrative (G&A)
expenses for the quarter ended June 30, 2018 were
$1.0 million, relatively unchanged compared to the $1.1
million in the second quarter of 2017. ARCA expects G&A
expenses in 2018 to be consistent with those in 2017 as it
maintains administrative activities to support ongoing
operations.
Total operating expenses for
the quarter ended June 30, 2018 were $2.2 million compared to $5.6
million for the second quarter of 2017. The decrease in total
operating expenses for the second quarter of 2018 was primarily due
to the decrease in R&D expense due to the completion of the
GENETIC-AF clinical trial.
Net loss was $2.1 million, or
$0.15 per share, for the second quarter of 2018 compared to $5.5
million, or $0.59 per share, for the second quarter of 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 patients
with atrial fibrillation (AF) and chronic heart failure with
reduced left ventricular ejection fraction (HFrEF) which recently
completed a Phase 2B clinical trial. 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. ARCA has a
collaboration with Medtronic, Inc. for support of the GENETIC-AF
trial. 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 peripheral arterial disease
(PAD) and for heart failure (HF). 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 first 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, 2017, 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, 2018 |
|
December 31, 2017 |
Cash,
cash equivalents & marketable securities |
$9,635 |
|
$11,752 |
Working
capital |
$8,950 |
|
$10,229 |
Total
assets |
$10,067 |
|
$12,365 |
Total
stockholders’ equity |
$8,998 |
|
$10,275 |
|
|
|
|
|
|
ARCA BIOPHARMA, INC. |
|
|
|
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
|
(unaudited) |
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except share and per share
amounts) |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
1,154 |
|
|
$ |
4,508 |
|
|
$ |
2,874 |
|
|
$ |
7,754 |
|
General
and administrative |
|
1,002 |
|
|
|
1,051 |
|
|
|
2,055 |
|
|
|
2,186 |
|
Total
costs and expenses |
|
2,156 |
|
|
|
5,559 |
|
|
|
4,929 |
|
|
|
9,940 |
|
Loss from
operations |
|
(2,156 |
) |
|
|
(5,559 |
) |
|
|
(4,929 |
) |
|
|
(9,940 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and
other income |
|
43 |
|
|
|
39 |
|
|
|
84 |
|
|
|
84 |
|
Interest
expense |
|
(3 |
) |
|
|
(2 |
) |
|
|
(6 |
) |
|
|
(4 |
) |
Net
loss |
$ |
(2,116 |
) |
|
$ |
(5,522 |
) |
|
$ |
(4,851 |
) |
|
$ |
(9,860 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in
unrealized loss on marketable securities |
|
— |
|
|
|
4 |
|
|
|
2 |
|
|
|
14 |
|
Comprehensive
loss |
$ |
(2,116 |
) |
|
$ |
(5,518 |
) |
|
$ |
(4,849 |
) |
|
$ |
(9,846 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
$ |
(0.15 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.07 |
) |
Weighted
average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
13,923,512 |
|
|
|
9,324,822 |
|
|
|
13,772,947 |
|
|
|
9,210,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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