On November 14, 2018 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 September 30, 2018 and provided a corporate update (Press release, Arca biopharma, NOV 14, 2018, View Source [SID1234531458]).

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"We remain focused on advancing the development of our pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "FDA is currently giving further consideration to our SPA application for the Phase 3 clinical trial of Gencaro following our provision of supporting information in response to an initial No Agreement letter. We have requested a meeting with the FDA and look forward to meeting with them in December to discuss any remaining issues in the application."

Pipeline Update

GencaroTM (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed as a potential genetically-targeted treatment for heart failure (HF) patients at risk for atrial fibrillation (AF).

At the end of October, the Company received a No 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. After further correspondence with the FDA and the provision of information supporting the SPA application, the FDA has agreed to reconsider the SPA request. ARCA has requested a meeting with the FDA to review the SPA application, which the Company anticipates will occur in December.
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 third quarter.
IND-enabling non-clinical studies are anticipated to begin in the first half of 2019.
Third Quarter 2018 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $8.1 million as of September 30, 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 first quarter of 2019.

Research and development (R&D) expenses for the quarter ended September 30, 2018 totaled $0.7 million compared to $3.5 million for the corresponding period of 2017. The $2.7 million decrease in R&D expenses in the third quarter of 2018 as compared to the third quarter 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the quarter ended September 30, 2018 were $0.9 million, relatively unchanged compared to the $1.0 million in the third quarter of 2017. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the quarter ended September 30, 2018 were $1.7 million compared to $4.5 million for the third quarter of 2017. The decrease in total operating expenses for the second quarter of 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $1.6 million, or $0.11 per share, for the third quarter of 2018 compared to $4.4 million, or $0.39 per share, for the third quarter of 2017.