On March 14, 2022 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported 2021 financial results and provided a corporate update (Press release, Arca biopharma, MAR 14, 2022, View Source [SID1234610037]).

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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "We have completed blinded data collection from the Phase 2b clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 and look forward to unblinding and subsequently reporting results of the study in the last week of this month. We believe rNAPc2 has the potential to be effective in addressing the impact of COVID-19 from multiple pathways due to its combination of anticoagulant, anti-inflammatory and antiviral properties. We look forward to sharing the data with the FDA at an end of Phase 2 meeting."

Pipeline Update

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

Topline data from Phase 2b ASPEN-COVID-19 clinical trial evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19 anticipated in the last week of March 2022.
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 January 2022, ARCA announced that the paper entitled "Dose Limiting, Adverse Event Associated Bradycardia with β-blocker Treatment of Atrial Fibrillation in the GENETIC-AF Trial" (William Abraham, et al) was published in Heart Rhythm O2, a publication of the Hearth Rhythm Society. The paper details an analysis that examined the prevalence of bradycardia and its association with adverse events (AEs) and failure to achieve target dose in the GENETIC-AF Phase 2b clinical trial. In the genetically defined population of GENETIC-AF (all ADRB1 Arg389Arg genotype), the prevalence of clinically important bradycardia was lower for Gencaro compared to metoprolol.
The Company continues to evaluate the feasibility and potential timing for initiation of PRECISION-AF relative to the COVID-19 pandemic and the ability to recruit patients for a cardiovascular clinical trial.
Full Year 2021 Summary Financial Results

Cash and cash equivalents were $53.4 million as of December 31, 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 the middle of 2023.

Research and development (R&D) expenses were $13.8 million for the year ended December 31, 2021, compared to $5.0 million for 2020. The $8.8 million increase in R&D expenses in 2021 as compared to 2020 was primarily related to the conduct of the rNAPc2 clinical trial. R&D expenses in 2022 are expected to be consistent with 2021.

General and administrative (G&A) expenses were $5.5 million for the year ended December 31, 2021, compared to $4.8 million for 2020, an increase of approximately $0.7 million. The increase in expenses during 2021 was comprised primarily of increased personnel and insurance costs, offset by lower legal costs in 2021, as compared to 2020. G&A expenses in 2022 are expected to be consistent with those in 2021 as the Company maintains administrative activities to support our ongoing operations.

Total operating expenses for the year ended December 31, 2021 were $19.3 million compared to $9.8 million in 2020.

Net loss for the year ended December 31, 2021 was $19.3 million, or $1.39 per basic and diluted share, compared to $9.7 million, or $2.07 per basic and diluted share in 2020.