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ARCA BIOPHARMA, INC. (ABIO) filed Quarterly Report for the period ended 2011-09-30.
Arca Biopharma Inc. has a market cap of $12.6 million; its shares were traded at around $1.2 with and P/S ratio of 0.8.
This is the annual revenues and earnings per share of ABIO over the last 10 years. For detailed 10-year financial data and charts, go to 10-Year Financials of ABIO.
Highlight of Business Operations:
The 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 left ventricular dysfunction/HF, with the primary endpoint being time to recurrent symptomatic AF after direct current cardioversion. The planned AF trial is designed to compare Gencaro to the beta-blocker metoprolol CR/XL in the genotype (homozygous arginine position 389 of the beta-1 adrenergic receptor), or the genotype the Company believes responds most favorably to Gencaro. Metoprolol CR/XL does not appear to be enhanced in patients with this genotype. Data from the BEST trial indicate that Gencaro may have a potentially significant effect in reducing andor preventing AF, and this effect may be one that is regulated genetically, similar to the effect we believe Gencaro has on HF. The entire cohort of patients in the BEST 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), based on an analysis of adverse events and surveillance ECGs. In the DNA sub study, patients with the most favorable genotype for Gencaro experienced a 74% (p = 0.0003) reduction in risk of atrial fibrillation, 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. We believe there is an unmet medical need for new AF treatments that have fewer side effects than currently available therapies and are more effective, particularly in patients with HF where most of the approved drugs are contra-indicated or have warnings in their prescribing information.Research and development, or R&D, expense was $533,000 for the three months ended September 30, 2011 as compared to $726,000 for the corresponding period in 2010, a decrease of approximately $193,000. R&D expense was $1,720,000 for the nine months ended September 30, 2011 as compared to $2,246,000 for the corresponding period of 2010, a decrease of $526,000. R&D expense decreased $145,000 for the three months and $336,000 for the nine months ended September 30, 2011 due to reduced personnel costs and the conclusion of certain pre-clinical studies in process during the comparative periods of 2010 with no similar studies or costs in 2011. Regulatory and manufacturing process costs decreased by $49,000 for the three months and $191,000 for the nine months ended September 30, 2011 compared to the corresponding period in 2010 due to reduced personnel costs and the conclusion of certain Gencaro related regulatory activities in the 2010 period.
SG&A expense was $1.3 million for the three months ended September 30, 2011 as compared to $1.4 million for the corresponding period in 2010, a decrease of $92,000. For the nine months ended September 30, 2011, SG&A expense was $4.0 million as compared to $4.6 million in the corresponding period of 2010, a decrease of $570,000. The decreases in the three month and nine month periods is comprised of reduced personnel, consulting, legal and accounting expenses, as a result of our reduced operations. SG&A expenses for the remainder of 2011 are expected to decrease from 2010 levels as a result of our reduction in workforce completed during the first quarter, but are contingent upon our ability to
As of September 30, 2011, we had total cash and cash equivalents of approximately $5.7 million, as compared to $7.0 million as of December 31, 2010. The net decrease of $1.2 million in the nine month period reflects cash from investing activities of $2.0 million and net proceeds from financing activities of $2.5 million, less cash used to fund operating activities of approximately $5.7 million.
Net cash provided by financing activities of $2.5 million for the nine months ended September 30, 2011 is the net proceeds from the sale of our common stock completed in April 2011. In the nine months ended September 30, 2010, the $7.3 million of cash provided by financing activities is comprised of $7.2 million of net proceeds from the sale of our common stock and $138,000 of proceeds received upon exercise of stock options.
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