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GENETIC-AF Trial Evaluating Gencaro as a
Potential Treatment for Atrial Fibrillation
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Interim Analysis of Phase 2B Efficacy Data
Planned for the First Half of 2017
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company
developing genetically-targeted therapies for cardiovascular
diseases, today reported financial results for the quarter ended
September 30, 2015, and provided a business update.
“This has been a productive quarter as we continue enrollment in
the GENETIC-AF trial evaluating Gencaro as a potential treatment
for atrial fibrillation,” commented Dr. Michael Bristow, ARCA’s
President and CEO. “We currently have 58 sites in the United States
and Canada recruiting patients for the trial, with all of the sites
now operating under the revised trial protocol, which expanded the
target patient population. We expect the DSMB interim analysis of
Phase 2B efficacy data to occur in the first half of 2017.”
Third Quarter 2015 Summary Financial Results
Cash and cash equivalents totaled $41.5 million as of
September 30, 2015, compared to $15.4 million as of December 31,
2014. The Company believes that its current cash and cash
equivalents will be sufficient to fund its operations, at its
projected cost structure, through at least the end of 2017. ARCA
had approximately 9.0 million outstanding shares of common stock as
of September 30, 2015.
Research and development (R&D) expense for the three
months ended September 30, 2015 was $1.7 million compared to $1.3
million for the corresponding period of 2014, an increase of
approximately $0.4 million. R&D expense for the nine months
ended September 30, 2015 was $5.2 million compared to $4.0 million
for the corresponding period of 2014, an increase of approximately
$1.1 million. The increase in R&D expense in the three and nine
month periods ended September 30, 2015 is primarily due to the
increased clinical expense of the GENETIC-AF clinical trial. The
Company expects R&D expense in 2015 to be higher than 2014 as
it activates new clinical sites and enrolls additional patients in
the GENETIC-AF clinical trial and incurs incremental costs
associated with transitioning to the protocol amended in the first
quarter of 2015.
General and administrative (G&A) expense for the
three months ended September 30, 2015 was $1.1 million compared to
$1.0 million for the corresponding period in 2014. G&A expense
for the nine months ended September 30, 2015 was $3.1 million
compared to $3.0 million for the corresponding period in 2014. ARCA
expects that G&A expense in 2015 will be higher than in 2014 as
the Company increases administrative activities to support our
GENETIC-AF clinical trial.
Total operating expense for the three months ended
September 30, 2015 was $2.8 million compared to $2.3 million for
the corresponding period in 2014. Total operating expense for the
nine months ended September 30, 2015 was $8.3 million compared to
$7.1 million for the corresponding period in 2014. The increase in
total operating expense for three and nine month periods ended
September 30, 2015 is primarily due to the increase in R&D
expense due to the increased clinical expense of the GENETIC-AF
clinical trial.
Net loss was $2.8 million, or $0.31 per share, for the
third quarter of 2015 and $8.3 million, or $1.54, for the nine
months ended September 30, 2015, compared to $2.3 million, or $0.76
per share, for the third quarter of 2014 and $7.1 million, or $2.44
per share, for the nine months ended September 30, 2014.
Key Accomplishments
- Continued implementation of a
previously announced protocol amendment for GENETIC-AF, which
expanded the trial’s target population.
- Additional investigative clinical sites
were approved, trained and began adopting the revised protocol,
with all of the clinical sites now operating under the revised
protocol.
There are currently 58 clinical trial sites in the United States
and Canada. The Company anticipates that the trial will enroll
patients at approximately 65 sites for the Phase 2B portion of
GENETIC-AF. The Company believes the DSMB interim analysis could be
finished in the first half of 2017. Although all of the clinical
sites are now operating under the revised protocol, the Company
does not yet know how the protocol changes will impact enrollment
or if its enrollment projections will prove to be accurate.
GENETIC-AF Trial Phase 2B Projected Timeline
-- Revised protocol distributed to participating clinical trial
sites March 2015 -- GENETIC-AF Trial
Investigators meeting and training May -- First trial sites
operating under revised protocol May -- Approximately 65 clinical
trial sites active in U.S. & Canada Q4 -- Completion of
Enrollment for Phase 2B DSMB Interim Analysis YE 2016 -- DSMB
Interim Analysis Decision 1H 2017
The Company’s forecast of the time periods to achieve these
milestones is a forward-looking statement and involves risks and
uncertainties, and actual results are likely to vary as a result of
a number of factors, including the factors discussed in “Risk
Factors” in the Company’s periodic SEC filings.
GENETIC-AF Clinical Trial
GENETIC-AF is a Phase 2B/3, multi-center, randomized,
double-blind clinical trial comparing the safety and efficacy of
Gencaro to Toprol-XL (metoprolol succinate) for the treatment of
atrial fibrillation (AF) in patients with heart failure and left
ventricular systolic dysfunction (HFREF patients). The primary
endpoint of GENETIC-AF is time to symptomatic AF/atrial flutter
(AFL). ARCA is enrolling only HFREF patients with the genetic
variant of the cardiac beta-1 adrenergic receptor, which the
Company believes responds most favorably to Gencaro, the 389
arginine homozygous genotype (ADRB1 Arg389Arg). GENETIC-AF has an
adaptive design, under which the Company initiated the trial as a
Phase 2B trial seeking to enroll approximately 200 patients. The
GENETIC-AF Data Safety Monitoring Board (DSMB) will analyze certain
data from the Phase 2B portion of the trial and recommend, based on
a comparison to the pre-trial statistical assumptions, whether the
trial should proceed to Phase 3 and seek to enroll an additional
420 patients.
Atrial Fibrillation (AF)
Atrial fibrillation, the most common sustained cardiac
arrhythmia, is considered an epidemic cardiovascular disease and a
major public health burden. The estimated number of individuals
with AF globally in 2010 was 33.5 million. According to the 2015
American Heart Association report on Heart Disease and Stroke
Statistics, the estimated number of individuals with AF in the
United States in 2010 ranged from 2.7 million to
6.1 million people. Hospitalization rates for AF increased by
23% among U.S. adults from 2000 to 2010 and hospitalizations
account for the majority of the economic cost burden associated
with AF.
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, 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, 2014, and subsequent
filings. The Company disclaims any intent or obligation to update
these forward-looking statements.
ARCA BIOPHARMA, INC.BALANCE
SHEET DATA(in thousands)
September 30,
2015
December 31,
2014
Cash and cash equivalents $ 41,482 $ 15,354 Working capital
$ 40,383 $ 14,100 Total assets $ 42,397 $ 16,132 Total
stockholders’ equity $ 41,093 $ 14,741
ARCA BIOPHARMA, INC.STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30, 2015
2014 2015
2014 (in thousands, except share and per share
amounts) Costs and expenses: Research and development $ 1,716 $
1,335 $ 5,170 $ 4,043 General and administrative 1,101
950 3,110 3,038
Total costs and expenses 2,817 2,285
8,280 7,081 Loss from operations
(2,817 ) (2,285 ) (8,280 ) (7,081 )
Interest and other income 4 2 7 6 Interest expense (1 )
(1 ) (4 ) (3 ) Net loss and comprehensive loss
$ (2,814 ) $ (2,284 ) $ (8,277 ) $ (7,078 ) Net loss per
share: Basic and diluted $ (0.31 ) $ (0.76 ) $ (1.54 ) $ (2.44 )
Weighted average shares outstanding: Basic and diluted 9,034,016
3,004,163 5,358,629 2,897,568
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version on businesswire.com: http://www.businesswire.com/news/home/20151112006439/en/
ARCA biopharma, Inc.Investor & Media
Contact:Derek Cole,
720-940-2163derek.cole@arcabiopharma.com
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