On August 4, 2021 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported second quarter 2021 financial results and provided a corporate update (Press release, Arca biopharma, AUG 4, 2021, View Source [SID1234585843]).
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Dr. Michael Bristow, ARCA’s President and Chief Executive Officer, commented, "We continue to be encouraged with the opportunities we see in our development pipeline compounds, rNAPc2 and Gencaro. With the ASPEN-COVID-19 Phase 2b trial of rNAPc2 expanding to South America, we look forward to completing the trial and we anticipate sharing the results in the fourth quarter. Given the rate of global vaccination and the continued emergence of variants, along with rNAPc2’s combination of anticoagulant, anti-inflammatory and antiviral properties, we believe it has the potential to be effective in addressing COVID-19 impacts in hospitalized patients. For Gencaro, we believe that, if approved, it may be a safe and effective therapy for the treatment of higher ejection fraction heart failure patients with atrial fibrillation and look forward to evaluating it in the planned PRECISION-AF Phase 3 clinical study."
Pipeline Update
rNAPc2 (AB201) – a small recombinant protein being developed as a potential treatment for RNA virus associated disease, initially focusing on COVID-19.
On-going Phase 2b clinical trial (ASPEN-COVID-19) evaluating rNAPc2 as a potential treatment for patients hospitalized with COVID-19.
ASPEN-COVID-19 expanding to South America with regulatory clinical trial commencement authorizations in Argentina and Brazil.
Phase 2b topline data anticipated in the fourth quarter of 2021.
In July, the Company entered into a patent assignment agreement with the University Medical Center of Johannes Gutenberg University Mainz, Germany, under which ARCA received exclusive world-wide patent rights related to the use of rNAPc2 as a potential treatment for COVID-19, and other potential indications.
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).
Gencaro Phase 2b data on AF burden and rhythm control interventions was published in Circulation: Arrhythmia and Electrophysiology, a journal of the American Heart Association. In the Phase 2b superiority clinical trial, although the prespecified primary endpoint was not met, compared with metoprolol, Gencaro reduced AF burden, delayed AF progression, increased maintenance of sinus rhythm, and reduced the need for additional rhythm control interventions in patients with HF and the genotype which responds most favorably to Gencaro.
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.
Corporate
The Company added to its executive team with the hiring of Jeff Dekker as Chief Financial Officer and Christopher Graybill as Vice President, Clinical Development.
Second Quarter 2021 Summary Financial Results
Cash and cash equivalents were $63.2 million as of June 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 $3.6 million for the quarter ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. The $3.2 million increase in R&D expenses in the second 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 June 30, 2021, compared to $0.9 million for the corresponding period in 2020. The $0.3 million increase in G&A expenses was primarily a result of higher personnel costs in 2021. G&A expenses in the second half of 2021 are expected to be consistent with the first half of 2021 as the Company maintains administrative activities to support its ongoing operations.
Total operating expenses for the quarter ended June 30, 2021 were $4.8 million compared to $1.3 million for the second quarter of 2020.
Net loss for the quarter ended June 30, 2021 was $4.8 million, or $0.34 per basic and diluted share, compared to $1.3 million, or $0.73 per basic and diluted share for the second quarter of 2020.