ARCA Biopharma Announces First Quarter 2020 Financial Results And Provides Corporate Update
May 06 2020 - 4:30PM
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 first quarter of 2020 and provided a
corporate update.
Dr. Michael Bristow, ARCA’s President and Chief
Executive Officer, commented, “During this time of national and
global health crisis, ARCA has acted to address uncertainty with a
focus on three key areas: protecting the health and well-being of
our employees, continuing effective operations to support advancing
the development of Gencaro as a potential genetically targeted
treatment for heart failure patients with atrial fibrillation, and
seeking additional funding, whether through direct financing or
on-going partnering discussions. Our planned Phase 3 clinical trial
addresses a patient population for which there are currently no FDA
approved drug therapies and we believe Gencaro has the potential to
help address this substantial unmet medical need.”
Pipeline Update
Gencaro™ (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).
- The U.S. Food and Drug Administration (FDA) issued a Special
Protocol Assessment (SPA) agreement for a single Phase 3 clinical
trial (PRECISION-AF) to examine Gencaro as a genetically targeted
therapy for the prevention of AF recurrence in certain heart
failure patients.
- PRECISION-AF is designed as a double-blind, active-controlled,
multicenter, international, adaptive study comparing Gencaro with
TOPROL-XL (metoprolol succinate) for the prevention of AF
recurrence or all-cause mortality in approximately 400 heart
failure patients who have left ventricular injection fraction
(LVEF) values ≥ 40% and ≤ 55% and the genotype which ARCA
believes responds best to Gencaro (ADRB1 Arg389Arg).
- Subject to securing additional financing, ARCA anticipates
initiating PRECISION-AF in the fourth quarter of 2020.
AB171 – a thiol-substituted
isosorbide mononitrate being developed as a potential genetically
targeted treatment for HF and peripheral arterial disease
(PAD).
§
Subject to securing additional financing, the Company anticipates
conducting non-clinical studies to support a potential IND
submission and initiation of clinical development in 2021.
First Quarter 2020 Summary Financial
ResultsCash and cash equivalents were
$6.7 million as of March 31, 2020, compared to $8.4 million as of
December 31, 2019. ARCA believes that its current cash and cash
equivalents will be sufficient to fund its operations, at its
current cost structure, after giving effect to potential cost
reductions, through the end of the third quarter of 2020.
Research and development (R&D)
expenses for the three months ended March 31, 2020 were
$0.4 million compared to $0.7 million for the corresponding period
in 2019, a decrease of approximately $0.3 million. The decrease was
primarily due to decreased R&D personnel costs and lower
outside services and consulting costs.
General and administrative (G&A)
expenses were $1.0 million for the three months ended
March 31, 2020 compared to $1.1 million for the corresponding
period in 2019. The Company expects G&A expenses in 2020 to be
consistent with those in 2019 as it maintains administrative
activities to support its ongoing operations.
Total operating expenses for
the three months ended March 31, 2020 were $1.3 million compared to
$1.8 million for the corresponding period in 2019.
Net loss for the three months
ended March 31, 2020 was $1.3 million, or $0.83 per basic and
diluted share, compared to $1.7 million, or $1.86 per basic and
diluted share, for the corresponding period in 2019.
The Company will need to raise additional
capital, and/or complete a partnership or other possible strategic
transaction, to fund future operations and develop Gencaro or any
other product candidates.
About ARCA biopharmaARCA
biopharma is dedicated to developing genetically targeted therapies
for cardiovascular diseases through a precision medicine approach
to drug development. ARCA’s lead product candidate,
Gencaro™ (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. 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 U.S. FDA has granted the
Gencaro development program Fast Track designation and a Special
Protocol Assessment (SPA) agreement for a single Phase 3 clinical
trial. ARCA is also developing AB171, a thiol-substituted
isosorbide mononitrate, as a potential genetically targeted
treatment for heart failure and peripheral arterial disease. For
more information, please visit www.arcabio.com or follow the
Company on LinkedIn.
Safe Harbor StatementThis 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 third quarter of
2020, 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 or PAD, 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,
2019, 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
ARCA BIOPHARMA, INC.
BALANCE SHEET DATA (in
thousands) (unaudited)
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
Cash and cash equivalents |
$ |
6,674 |
$ |
8,363 |
Working capital |
$ |
6,223 |
$ |
7,554 |
Total assets |
$ |
7,461 |
$ |
8,536 |
Total stockholders’ equity |
$ |
6,306 |
$ |
7,610 |
|
|
|
|
|
ARCA BIOPHARMA, INC.
STATEMENTS OF OPERATIONS
(unaudited)
|
Three Months Ended |
|
|
March 31, |
|
|
2020 |
|
|
2019 |
|
|
(in thousands, except shareand per share
amounts) |
|
Costs and expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
365 |
|
|
$ |
662 |
|
General and administrative |
|
975 |
|
|
|
1,119 |
|
Total costs and expenses |
|
1,340 |
|
|
|
1,781 |
|
Loss from operations |
|
(1,340 |
) |
|
|
(1,781 |
) |
|
|
|
|
|
|
|
|
Interest and other income |
|
24 |
|
|
|
38 |
|
Interest expense |
|
(4 |
) |
|
|
(3 |
) |
Loss before income taxes |
|
(1,320 |
) |
|
|
(1,746 |
) |
Income tax benefit |
|
— |
|
|
|
82 |
|
Net loss |
$ |
(1,320 |
) |
|
$ |
(1,664 |
) |
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.83 |
) |
|
$ |
(1.86 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic and diluted |
|
1,594,070 |
|
|
|
895,970 |
|
|
|
|
|
|
|
|
|
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/af496e97-20da-420a-bf93-e51b3a3ed740
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