ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today reported financial results for the quarter ended
March 31, 2016, and provided a business update.
“We are grateful for the continuing support of the physicians,
clinical investigators and patients participating in the GENETIC-AF
trial evaluating GencaroTM as potentially the first
genetically-targeted treatment for atrial fibrillation,” commented
Dr. Michael Bristow, ARCA’s President and CEO. “Last month we
reached the halfway mark in enrollment to have a sufficient number
of patients for the DSMB Phase 2B interim efficacy analysis, the
outcome of which we expect in the second quarter of 2017. This
analysis will provide the foundation for the decision whether or
not to proceed to the Phase 3 portion of the GENETIC-AF trial. This
is an important step for the Gencaro development program, which, if
successful, may address an unmet medical need for new atrial
fibrillation treatments that have fewer side effects than currently
available therapies and are more effective in heart failure
patients with reduced ejection fraction.”
First Quarter 2016 Summary Financial Results
Cash, cash equivalents and marketable securities totaled
$35.9 million as of March 31, 2016, compared to $38.8 million as of
December 31, 2015. The Company believes that its current cash, cash
equivalents and marketable securities will be sufficient to fund
its operations, at its projected cost structure, through at least
the end of 2017. ARCA had approximately 9.1 million outstanding
shares of common stock as of March 31, 2016.
Research and development (R&D) expense for the three
months ended March 31, 2016 was $2.6 million compared to $1.7
million for the corresponding period of 2015. The increase in
R&D expense is due, primarily, to the increased clinical
expense of our GENETIC-AF clinical trial. The Company expects
R&D expense in 2016 to be higher than 2015 as it activates new
clinical sites and enrolls additional patients in the GENETIC-AF
clinical trial.
General and administrative (G&A) expense for the
three months ended March 31, 2016 was $1.1 million compared to $1.0
million for the corresponding period in 2015. The increase in
G&A expense is due, primarily, to increased franchise taxes and
outside services. The Company expects G&A expense in 2016 will
be higher than in 2015 as the Company increases administrative
activities to support the GENETIC-AF clinical trial.
Total operating expense for the three months ended March
31, 2016 was $3.7 million compared to $2.7 million for the
corresponding period in 2015.
Net loss was $3.6 million, or $0.40 per share, for the
first quarter of 2016, compared to $2.7 million, or $0.91 per
share, for the first quarter of 2015.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/Phase 3, multi-center, randomized,
double-blind, adaptive design clinical trial comparing the safety
and efficacy of Gencaro to Toprol-XL (metoprolol succinate) for the
treatment of atrial fibrillation (AF) in approximately 620
patients. Eligible patients will have heart failure with reduced
left ventricular ejection fraction (HFREF), a history of paroxysmal
AF (episodes lasting 7 days or less) or persistent AF (episodes
lasting more than 7 days and less than 1 year) in the past 6
months, and the beta-1 389 arginine homozygous genotype that the
Company believes responds most favorably to Gencaro. The primary
endpoint of the study is time to first event of symptomatic
AF/atrial flutter (AFL) or all-cause mortality. The combined Phase
2B/Phase 3 trial is designed for 90 percent power at a p-value of
less than 0.01 significance level to detect a 25 percent reduction
in the primary endpoint for patients in the Gencaro arm compared to
patients in the Toprol-XL arm. The trial is currently enrolling
patients in the United States and Canada.
Based on the current enrollment rate, the Company expects to
enroll at least 150 patients in the trial by the end of 2016. The
GENETIC-AF Data and Safety Monitoring Board (DSMB) will conduct a
pre-specified interim analysis of study endpoints for efficacy,
safety and futility to recommend whether or not the trial should
proceed to Phase 3. The DSMB will make its recommendation based on
a predictive probability analysis of certain trial data after at
least 150 patients have evaluable endpoint data. An enrolled
patient has evaluable endpoint data either when they experience
their first endpoint event, or after they complete the 24-week
follow up period. The DSMB interim analysis will focus on analyses
of the AF/AFL endpoints in the trial using both clinical-based
intermittent monitoring and device-based continuous monitoring
techniques. Should the DSMB interim analysis indicate that the data
are consistent with pre-trial statistical assumptions and the
potential for achieving statistical significance for the Phase 3
endpoint, the DSMB may recommend that the study continue to Phase
3. The DSMB may also recommend that the study be halted. The
Company expects the outcome of the interim analysis in the second
quarter of 2017.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted
therapies for cardiovascular diseases. The Company's lead product
candidate, GencaroTM (bucindolol hydrochloride), is an
investigational, pharmacologically unique beta-blocker and mild
vasodilator being developed for atrial fibrillation. 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 atrial fibrillation prevention
treatment. ARCA has a collaboration with Medtronic, Inc. for
support of the GENETIC-AF trial. For more information please visit
www.arcabiopharma.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, potential timing for patient
enrollment in the GENETIC-AF trial, potential timeline for
GENETIC-AF trial activities and related recommendations of the
DSMB, the sufficiency of the Company’s capital to support its
operations, the potential for genetic variations to predict
individual patient response to Gencaro, Gencaro’s potential to
treat atrial fibrillation, future treatment options for patients
with atrial fibrillation, and the potential for Gencaro to be the
first genetically-targeted atrial fibrillation 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:
the Company's financial resources and whether they will be
sufficient to meet the Company's business objectives and
operational requirements; results of earlier clinical trials may
not be confirmed in future trials, the protection and market
exclusivity provided by the Company’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 SEC, including without limitation the
Company’s annual report on Form 10-K for the year ended December
31, 2015, and subsequent filings. The Company disclaims any intent
or obligation to update these forward-looking statements.
ARCA BIOPHARMA, INC.BALANCE
SHEET DATA(in thousands)
March 31,
2016
December 31,
2015
Cash, cash equivalents and marketable securities $35,933 $38,802
Working capital $28,674 $37,412 Total assets $36,928 $39,574 Total
stockholders’ equity $34,584 $38,070
ARCA BIOPHARMA, INC.STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited)
Three Months Ended March 31, 2016
2015 (in thousands, except share
and per share amounts)
Costs and expenses: Research and development $ 2,594 $ 1,707
General and administrative 1,074 1,037
Total costs and expenses 3,668 2,744
Loss from operations (3,668 ) (2,744 )
Interest and other income 21 1 Interest expense —
(1 ) Net loss $ (3,647 ) $ (2,744 ) Change in
unrealized gain on marketable securities 6 —
Comprehensive loss $ (3,641 ) $ (2,744 ) Net loss per
share: Basic and diluted $ (0.40 ) $ (0.91 ) Weighted average
shares outstanding: Basic and diluted 9,053,186 3,023,932
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ARCA biopharma, Inc.Investor & Media
Contact:Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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