On November 2, 2021 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported third quarter 2021 financial results and provided a corporate update (Press release, Arca biopharma, NOV 2, 2021, View Source [SID1234594189]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "The continuing pandemic and the emergence of multiple variants that have led to a resurgence of infections and hospitalizations, highlight the need for additional safe and effective therapeutic tools to treat patients that develop severe COVID-19. With rNAPc2’s combination of anticoagulant, anti-inflammatory and potential antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. Our international Phase 2b clinical trial is nearing completion and we look forward to sharing its results in the first quarter."

Pipeline Update

rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for COVID-19 and potentially other viral diseases.

On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19, enrolling patients at investigative sites in United States, Argentina and Brazil.
Clinical trial Data and Safety Monitoring Committee (DSMC) completed a pre-specified interim analysis and, based on the DSMC’s review of approximately 75% of the projected final efficacy and safety data, recommended completion of the clinical trial with no modifications to the clinical trial design.
Phase 2b topline data anticipated in first quarter of 2022.
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).

ARCA currently has an agreement with the U.S. FDA, known as a Special Protocol Assessment, or SPA, for the requirements of a Gencaro Phase 3 clinical trial, PRECISION-AF, that would support potential approval of Gencaro if successful. The Company is currently evaluating the potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial, and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
Third Quarter 2021 Summary Financial Results

Cash and cash equivalents were $58.3 million as of September 30, 2021, compared to $49.1 million as of December 31, 2020. ARCA believes that its current cash and cash equivalents will be sufficient to fund its operations through 2022.

Research and development (R&D) expenses were $3.4 million for the quarter ended September 30, 2021, compared to $1.1 million for the corresponding period in 2020. The $2.3 million increase in R&D expenses in the third quarter was primarily related to the initiation of the rNAPc2 clinical trial in the second half of 2020. R&D expenses in 2021 are expected to be higher than 2020 as the Company continues the rNAPc2 Phase 2b clinical trial.

General and administrative (G&A) expenses were $1.3 million for the quarter ended September 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.4 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the last quarter of 2021 are expected to be consistent with the third quarter of 2021 as the Company maintains administrative activities to support its ongoing operations.

Total operating expenses for the quarter ended September 30, 2021 were $4.7 million compared to $2.0 million for the third quarter of 2020.

Net loss for the quarter ended September 30, 2021 was $4.7 million, or $0.33 per basic and diluted share, compared to $2.0 million, or $0.33 per basic and diluted share for the third quarter of 2020.