- Conference Call & Webcast November 15th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
- Total operating expenses in the third quarter 2016 were $7.9 million, compared to $4.3 million in the third quarter 2015.
- Net operating expenses, excluding non-cash stock based compensation of $0.6 million, in the third quarter 2016 were $7.3 million, compared with $3.7 million in the third quarter 2015.
- Research and development (R&D) expenses in the third quarter 2016 were $6.4 million, compared with $2.9 million in the third quarter 2015. R&D expenses consisted primarily of costs associated with the conduct of our Phase III Adult ADHD clinical study named MEASURE.
- General and administrative (G&A) expenses in the third quarter 2016 were $1.2 million, similar to the third quarter 2015.
- Cash, marketable securities, and deposits totaled $54.3 million at September 30, 2016 compared with $61.1 million at June 30, 2016 and $69.7 million at the end of 2015.
- Alcobra paused enrollment and treatment in its MEASURE study following the placement of a full clinical hold by the Division of Psychiatry Products (DPP) of the U.S. Food and Drug Administration. The DPP stated concerns over adverse neurophysiological findings in animal studies and recommended the scheduling of a meeting to discuss human safety data collection in the MDX development program. The DPP did not cite any clinical safety data observed in the MEASURE study or previous clinical studies involving MDX as the basis for their action.
- Alcobra will hold a meeting with the DPP next month to present its proposals to collect additional safety data in its previously planned long-term clinical safety study as well as the MEASURE study.
- Alcobra will also seek guidance on the possibility of conducting certain analyses of the efficacy data already collected in the MEASURE study. The number of evaluable subjects (n=281) in the MEASURE dataset is comparable to other Phase III adult ADHD studies with approved medications.
|Conference Call & Webcast|
|Tuesday, November 15, 2016 @ 8:30a.m. Eastern Time|
|Replays available through November 29, 2016|