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Outcome of GENETIC-AF Clinical Trial Interim
Efficacy Analysis Anticipated in the Second Quarter of 2017
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GENETIC-AF Evaluating Gencaro as Potentially
First Genetically-Targeted Treatment for Atrial
Fibrillation
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today reported financial results for the quarter ended
June 30, 2016, and provided a business update.
“We believe that our precision medicine approach to drug
development, tailoring medical treatment to the genetic
characteristics of patient subpopulations, can enable more
effective therapies, improve patient outcomes and reduce healthcare
costs,” commented Dr. Michael Bristow, ARCA’s President and CEO.
“Our on-going GENETIC-AF Phase 2B/3 clinical trial is evaluating
GencaroTM as potentially the first genetically-targeted treatment
for atrial fibrillation. We believe enrollment is on track for
having a sufficient number of patients by the end of this year for
the DSMB Phase 2B interim efficacy analysis, the outcome of which
we expect in the second quarter of 2017. With our experienced team,
strong balance sheet, supportive collaborations with Medtronic and
LabCorp, and high quality investors, we feel ARCA is well
positioned as a late stage cardiovascular company dedicated to
serving patients with these chronic diseases.”
Second Quarter 2016 Summary Financial Results
Cash, cash equivalents and marketable securities totaled
$31.4 million as of June 30, 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 June 30, 2016.
Research and development (R&D) expense for the three
months ended June 30, 2016 was $2.9 million compared to $1.7
million for the corresponding period of 2015, an increase of
approximately $1.2 million. R&D expense for the six months
ended June 30, 2016 was $5.5 million compared to $3.5 million for
the corresponding period of 2015, an increase of approximately $2.1
million. The increase in R&D expense in the three and six month
periods ended June 30, 2016 is due, primarily, to the increased
clinical expense of the 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 June 30, 2016 was $1.0 million compared to $1.0
million for the corresponding period in 2015. G&A expense was
$2.1 million for the six months ended June 30, 2016 as compared to
$2.0 million for the corresponding period in 2015, an increase of
$93,000. The increase in G&A expense is due, primarily, to
increased franchise taxes. 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 June
30, 2016 was $3.9 million compared to $2.7 million for the
corresponding period in 2015. Total operating expense for the six
months ended June 30, 2016 was $7.6 million compared to $5.5
million for the corresponding period in 2015.
Net loss was $3.9 million, or $0.43 per share, for the
second quarter of 2016, compared to $2.7 million, or $0.69 per
share, for the second quarter of 2015. For the first half of 2016,
net loss was $7.5 million, or $0.83 per share, compared to $5.5
million, or $1.57 per share, for the first half 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.
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.
Based on the current enrollment rate, the Company expects to enroll
at least 150 patients in the trial by the end of 2016. 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 through a precision medicine
approach to drug development. 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)
June 30,
2016
December 31,
2015
Cash, cash equivalents and marketable securities $31,366 $38,802
Working capital $25,038 $37,412 Total assets $32,635 $39,574 Total
stockholders’ equity $30,891 $38,070
ARCA BIOPHARMA, INC.STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited)
Three months ended
Six months ended
June 30,
June 30, 2016 2015 2016
2015 (in thousands, except share and per share
amounts) Costs and expenses: Research and development $ 2,913 $
1,747 $ 5,507 $ 3,454 General and administrative 1,028
972 2,102 2,009 Total costs and expenses
3,941 2,719 7,609 5,463 Loss from
operations (3,941 ) (2,719 ) (7,609 )
(5,463 ) Interest and other income 47 2 68 3 Interest
expense — (2 ) — (3 ) Net loss $ (3,894
) $ (2,719 ) $ (7,541 ) $ (5,463 ) Change in unrealized gain
on marketable securities 7 — 13 —
Comprehensive loss $ (3,887 ) $ (2,719 ) $ (7,528 ) $ (5,463 )
Net loss per share: Basic and diluted $ (0.43 ) $ (0.69 ) $
(0.83 ) $ (1.57 ) Weighted average shares outstanding: Basic and
diluted 9,065,922 3,951,895 9,059,554 3,490,477
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ARCA biopharma, Inc.Investor & Media
Contact:Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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