On May 8, 2019 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the quarter ended March 31, 2019 and provided a corporate update (Press release, Arca biopharma, MAY 8, 2019, View Source [SID1234535934]).

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"In the first part of this year, we continued to make progress on our lead development program Gencaro, achieving an agreement with the FDA on our Special Protocol Assessment for the PRECISION-AF Phase 3 clinical trial evaluating Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "Importantly, the GENETIC-AF Phase 2B clinical trial results, which are guiding our Phase 3 development, were accepted and published in JACC: Heart Failure."

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).

In February 2019, ARCA received a Special Protocol – Agreement Letter from the U.S. Food and Drug Administration (FDA) on its Special Protocol Assessment (SPA) application for the Phase 3 PRECISION-AF clinical trial. Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF by the end of 2019.

In April 2019, GENETIC-AF Phase 2B clinical trial results were published in the Journal of the American College of Cardiology: Heart Failure in the paper "GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population".
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 continued in the first quarter.

Subject to securing additional financing, IND-enabling non-clinical studies are anticipated to begin in the second half of 2019, and an IND submission is anticipated in the first half of 2020.
First Quarter 2019 Summary Financial Results

Cash, cash equivalents and marketable securities were $8.0 million as of March 31, 2019, compared to $6.6 million as of December 31, 2018. 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 third quarter of 2019.

Research and development (R&D) expenses for the three months ended March 31, 2019 were $0.7 million compared to $1.7 million for the corresponding period of 2018. The $1.1 million decrease in R&D expenses was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2018.

General and administrative (G&A) expenses for the three months ended March 31, 2019 were $1.1 million similar to $1.1 million in the first quarter of 2018. The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support our ongoing operations.

Total operating expenses for the three months ended March 31, 2019 were $1.8 million compared to $2.8 million for the corresponding period of 2018. The decrease in total operating expenses was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $1.7 million, or $1.86 per share, for the first quarter of 2019 compared to $2.7 million, or $3.61 per share, for the first quarter of 2018.

The Company will need to raise additional capital to fund future operations and develop Gencaro or any other product candidates, complete a partnership or other possible strategic transactions.