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Alcobra Announces Third Quarter 2015 Financial Results And Provides Corporate Update

The following excerpt is from the company's SEC filing.

Conference Call & Webcast November 17th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time

The company provides an update on its Fragile X Syndrome development program

Alcobra Ltd. (NasdaqGM: ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome (Fragile X), today announced financial results for the three and nine month s ended September 30, 2015, and provided a corporate update.

Third Quarter Ended September 30, 2015 Financial Results:

Total operating expenses were $4.3 million, compared with $5.2 million in the second quarter of 2015 and $10.6 million in the third quarter of 2014. Operating expenses included non-cash stock based compensation of $0.6 million in the third quarter of 2015 and $1.0 million in the same quarter of 2014.

Research and development (R&D) expenses were $2.9 million, compared with $8.8 million in the third quarter of 2014. R&D expenses in the third quarter of 2015 consisted primarily of costs associated with the Phase III pivotal study in adult ADHD.

General and administrative (G&A) expenses were $1.2 million in the third quarter of 2015, compared with $1.3 million in the same quarter of 2014. Pre-commercialization expenses were $0.3 million, compared with $0.6 million in the third quarter of 2014.

Cash, cash equivalents and bank deposits totaled $35.5 million at September 30, 2015, compared with $41.1 million at June 30, 2015. Net cash used in operating activities was $5.4 million in the third quarter of 2015, compared with $9.5 million in the third quarter of 2014.

Third Quarter and Recent Corporate Updates:

In October 2015, the company held a meeting with the U.S. Food and Drug Administration (FDA) to discuss the results of the company’s Phase II study in Fragile X and the requirements for new drug application (NDA) submission of MDX in this therapeutic indication.

The FDA concurred that results from a single short-term, adequate and well-controlled, efficacy study in adolescents and adult patients with Fragile X may be sufficient to support a claim of efficacy for approval of MDX in this indication. The FDA further confirmed that the Vineland-II Daily Living Skills Assessment, which was statistically significant in Alcobra’s Phase II study on the intent-to-treat population, could serve as the primary endpoint in the pivotal trial. The study is scheduled to begin in 2016.

company announced that the FDA has granted Fast Track designation to MDX for the treatment of Fragile X on September 21, 2015.

In the second quarter of 2015, we launched the MEASURE study (MDX...


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