- Conference Call & Webcast February 15th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time
TEL AVIV, Israel, Feb. 15, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat CNS and cognitive disorders, today announced financial results for the three and twelve months ended December 31, 2016 and provided a corporate update.
Recent Corporate Updates:
- In January 2017, Alcobra held a Pre-IND meeting with the U.S. Food & Drug Administration (FDA) regarding the company’s new proprietary Abuse-Deterrent, Amphetamine Immediate Release (ADAIR) product candidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ADAIR could be the first FDA-approved proprietary Abuse Deterrent immediate-release dextro-amphetamine drug.
- As a result of this meeting, Alcobra plans to develop ADAIR to deter abuse by snorting or injecting, a significant unmet need in the growing ADHD market which includes over 24 million annual U.S. prescriptions of immediate-release stimulants. Recent studies show that 40% or more of the people who misuse stimulants do so by snorting or injecting them.
- Alcobra has been developing ADAIR’s patent-pending formulation, specifically designed to deter abuse by snorting or injecting, for over a year. Development was conducted in association with Capsugel®, a global leader in delivering high-quality, innovative dosage forms and solutions.
- ADAIR will be developed through a 505(b)(2) development path, targeting a 2H 2018 New Drug Application (NDA) submission. Management expects that all development activities to NDA filing can be supported by Alcobra’s existing cash resources.
- Extensive analyses and commissioned surveys suggest a potential of $300+ million in ADAIR annual sales within four years of launch, if approved.
- Alcobra is exploring various strategic alternatives for Metadoxine Extended Release (MDX) while minimizing any additional investment of Alcobra’s existing resources on this drug candidate.
Fourth-Quarter and Fiscal-Year Ended December 31, 2016 Financial Results:
- Total operating expenses in the fourth quarter and fiscal year 2016 were $6.1 million and $25.2 million, respectively, compared with $5.0 million and $19.7 million in the fourth quarter and fiscal year 2015.
- Net operating expenses, excluding non-cash stock based compensation of $0.5 million and $2.5 million, respectively, in the fourth quarter and fiscal year 2016 were $5.6 million and $22.7 million, respectively, compared with $4.4 million and $17.3 million in the fourth quarter and fiscal year 2015.
- Research and development (R&D) expenses in the fourth quarter and fiscal year 2016 were $4.4 million and $18.4 million, respectively, compared with $3.3 million and $13.5 million in the fourth quarter and fiscal year 2015. R&D expenses consisted primarily of costs associated with the conduct of the MEASURE study.
- General and administrative (G&A) expenses in the fourth quarter and fiscal year 2016 were $1.3 million and $5.4 million, respectively, compared with $1.3 million and $5.0 million in the fourth quarter and fiscal year 2015. Pre-commercialization expenses in the fourth quarter and fiscal year 2016 were $0.4 million and $1.4 million, respectively, compared with $0.3 million and $1.2 million in the fourth quarter and fiscal year 2015.
- Cash, marketable securities, and deposits totaled $50.2 million at December 31, 2016, compared with $54.3 million at September 30, 2016 and $69.7 million at December 31, 2015.
- Total estimated clinical development cost of the ADAIR product to NDA filing is approximately $13 million. The investment to date in the project (2015 and 2016) has been less than $1 million.
Conference Call & Webcast
Wednesday, February 15, 2017 @ 8:30a.m. Eastern Time
