On November 6, 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 September 30, 2019 and provided a corporate update (Press release, Arca biopharma, NOV 6, 2019, View Source [SID1234552349]).

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"There are currently no FDA approved drug therapies indicated for treating patients with atrial fibrillation and heart failure with left ventricular ejection fraction values greater than 40%," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "Approximately two-thirds of all heart failure patients have LVEF values greater than 40% and about half of these patients will develop atrial fibrillation. Based on our Phase 2 data, we believe Gencaro has the potential to help address this substantial unmet medical need. We look forward to further evaluating Gencaro in the planned Phase 3 clinical trial, PRECISION-AF, which we plan to initiate in the first quarter of 2020."

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 July 2019, the U.S. Food and Drug Administration (FDA) agreed to amend ARCA’s Special Protocol Assessment (SPA) agreement for the Phase 3 PRECISION-AF clinical trial to expand the target trial population to include heart failure patients with left ventricular injection fractions (LVEF) > 40% and < 55%. Subject to securing additional financing, ARCA anticipates initiating PRECISION-AF in the first quarter of 2020.

In September 2019, Gencaro AF clinical data from the GENETIC-AF Phase 2B trial was presented at the Heart Failure Society of America (HFSA) 2019 Annual Scientific Meeting. The data indicate Gencaro response appears to be greater in HF patients with less severe left ventricular dysfunction, a patient population with no FDA approved drug therapeutic options for AF prevention or heart failure.
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for HF and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities continued in the third quarter.

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

Cash and cash equivalents were $9.6 million as of September 30, 2019, compared to $6.6 million as of December 31, 2018. 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 third quarter of 2020.

Research and development (R&D) expenses for the three months ended September 30, 2019 were $0.3 million compared to $0.7 million for the corresponding period of 2018. The decrease in R&D expenses was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial in 2018. The Company does not anticipate having any material clinical trial expense in 2019, consequently R&D expense in 2019 is expected to be lower than in 2018.

General and administrative (G&A) expenses were relatively unchanged at $0.9 million for both the three months ended September 30, 2019 and 2018. The Company expects G&A expenses in 2019 to be consistent with those in 2018 as it maintains administrative activities to support its ongoing operations.

Total operating expenses for the three months ended September 30, 2019 were $1.2 million compared to $1.7 million for the corresponding period of 2018. The decrease in total operating expenses was primarily attributable to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial in 2018.

Net loss was $1.2 million, or $0.76 per share, for the third quarter of 2019 compared to $1.6 million, or $2.06 per share, for the third quarter of 2018.

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.