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ARCA BIOPHARMA, INC. Reports Operating Results (10-Q)

August 13, 2012 | About:
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10qk

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ARCA BIOPHARMA, INC. (ABIO) filed Quarterly Report for the period ended 2012-06-30.

Arca Biopharma Inc has a market cap of $4.1 million; its shares were traded at around $0.34 .

Highlight of Business Operations:

The planned AF clinical trial is designed to be a multi-center, randomized, double-blind clinical trial to assess the safety and efficacy of Gencaro in AF patients with HF and/or left ventricular dysfunction, with the primary endpoint being time to recurrent symptomatic AF after direct current cardioversion. This AF trial is designed to compare Gencaro to the beta-blocker metoprolol CR/XL in the patient genotype we believe responds most favorably to Gencaro. The therapeutic benefit of metoprolol CR/XL does not appear to be enhanced in patients with this genotype. We believe data from the BEST HF trial indicate that Gencaro may have a potentially significant effect in reducing or preventing AF, and this effect may be one that is genetically regulated. The entire cohort of patients in the BEST HF trial that were treated with Gencaro had a 41% reduction in the risk of new onset AF (time-to-event) compared to placebo (p = 0.0004), although because there was not a predetermined AF clinical endpoint in the BEST HF trial, the data is based on subsequent analysis of adverse events and surveillance electrocardiograms (ECGs). In the DNA sub-study, patients with the most favorable genotype for Gencaro experienced a 74% (p = 0.0003) reduction in risk of AF, based on the same analysis. This most favorable genotype was present in about 47% of the patients in the sub-study, and we estimate it is present in about 50% of the US general population. We believe the AF study would take approximately two and one half years from enrollment of the first patient through completion.

Research and development, or R&D, expense is comprised of research & development, regulatory and manufacturing process development activities and costs. Our R&D expense continues to be almost entirely generated by our activities relating to the development of Gencaro. Research and Development expense for the three months ended June 30, 2012 was $322,000 compared to $497,000 for the corresponding period of 2011, a decrease of approximately $175,000. R&D expense was $744,000 for the six months ended June 30, 2012 as compared to $1,187,000 for the corresponding period of 2011, a decrease of $443,000.

SG&A expense was $823,000 for the three months ended June 30, 2012 as compared to $1.2 million for the corresponding period in 2011, a decrease of $384,000. For the six months ended June 30, 2012, SG&A expense was $1.8 million as compared to $2.7 million in the corresponding period in 2011, a decrease of $912,000. The decreases in the three month and six month periods are comprised of reduced personnel, consulting, legal and accounting expenses, as a result of our reduced operations.

Interest and other income was less than $1,000 in the three months ended June 30, 2012 and approximately $1,000 in the six months ended June 30, 2012 as compared to less than $1,000 and approximately $1,000, respectively, in the three months and six months ended June 30, 2011. The amounts and related change between years are nominal to our overall operations. We expect interest income to continue to be nominal in 2012 due to low investment yields and declining cash and cash equivalent investment balances.

Interest and other expense was $1,000 in the three months ended June 30, 2012 and $3,000 in the six months ended June 30, 2012 as compared to $2,000 and $7,000, respectively, in the three months and six months ended June 30, 2012. Based on our current capital structure, interest expense for 2012 is expected to be minimal.

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