On February 27, 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 year ended December 31, 2018 and provided a corporate update (Press release, Arca biopharma, FEB 27, 2019, View Source [SID1234533785]).

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"During 2018, we continued to make progress on our lead development program as we: reported Phase 2B results for the GENETIC-AF trial; designed a Phase 3 development plan based on learnings from those results; identified a clear regulatory path; and, began discussions with the FDA to confirm agreement on future development of Gencaro, potentially the first genetically-targeted cardiovascular therapeutic," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "With the Gencaro FDA SPA agreement now in place, 2019 will be an important year for ARCA as we work towards the initiation of the Phase 3 clinical trial and expand development activities for AB171, a potential genetically-targeted treatment for heart failure and peripheral arterial disease."

Pipeline Update

GencaroTM (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.

– PRECISION-AF is designed as a double-blind, active-controlled, multicenter, international study comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of AF recurrence or all-cause mortality (ACM) in HF patients with mid-range ejection fraction (HFmrEF).

– Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in the fourth quarter of 2019.
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 were continued in the fourth quarter.
IND-enabling non-clinical studies are anticipated to begin in the second half of 2019.
IND submission anticipated in the first quarter of 2020.
2018 Summary Financial Results

Cash, cash equivalents and marketable securities were $6.6 million as of December 31, 2018, compared to $11.8 million as of December 31, 2017. 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 year ended December 31, 2018 were $4.2 million compared to $14.1 million for 2017. The $9.8 million decrease in R&D expenses in 2018 as compared to 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2017.

General and administrative (G&A) expenses for the year ended December 31, 2018 were $3.9 million compared to $4.6 million in 2017. 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 2018 were $8.1 million compared to $18.7 million during 2017. The decrease in total operating expenses in 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $7.9 million, or $0.57 per share, for 2018 compared to $18.5 million, or $1.77 per share, for 2017.