OREANDA-NEWS. Alcobra Ltd. (Nasdaq: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 months ended March 31, 2016, and provided a corporate update.

First Quarter Ended March 31, 2016 Financial Results:

  • Total operating expenses in the first quarter 2016 were $5.2 million, in line with the first quarter 2015.
  • Net operating expenses, excluding non-cash stock based compensation of $0.7 million, in the first quarter 2016 were $4.5 million, compared with $4.4 million in the first quarter 2015
  • Research and development (R&D) expenses in the first quarter 2016 were $3.4 million, compared with $3.6 million in the first quarter 2015. R&D expenses consist primarily of costs associated with the conduct of our Phase III Adult ADHD clinical study.
  • General and administrative (G&A) expenses in the first quarter 2016 were $1.5 million, compared with $1.3 million in the first quarter 2015. Pre-commercialization expenses in the first quarter 2016 were $0.4 million, compared with $0.3 million in the first quarter 2015.
  • Cash, marketable securities, and deposits totaled $65.2 million at March 31, 2016, compared with $69.7 million at December 31, 2015 and $45.0 million at March 31, 2015.

First Quarter and Recent Corporate Updates:

  • The company is currently enrolling patients into the MEASURE study (MDX Evaluation in Adults – Study of Response and Efficacy). The MEASURE study is the company’s second Phase III study of Metadoxine Extended Release (MDX) in adults with ADHD. The company continues to expect data from the study by year-end 2016.
  • The company is advancing discussions with the U.S. Food and Drug Administration (FDA) on its pediatric ADHD development plan, including the launch of the first of two registration studies with MDX in pediatric ADHD.
  • The company continues its preparations and discussions with FDA on the design of its planned Phase III study in adolescents and adult patients with Fragile X. The FDA has previously granted an orphan drug designation and Fast Track designation to MDX for the treatment of Fragile X.
  • About Alcobra Ltd. 

Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX, a proprietary drug candidate, to treat cognitive disorders including ADHD and Fragile X.

Alcobra Ltd.
Consolidated Statements of Operation
 (In thousands, except share and per share amounts)		  
   
  Three Months Ended  
  March 31,  
    2016       2015    
  (Unaudited)   (Unaudited)  
         
Research and development $ 3,362     $ 3,590    
Pre commercialization expenses   412       349    
General and administrative   1,458       1,289    
         
Total operating expenses   5,232       5,228    
         
Financial income, net   (172 )     (64 )  
         
Loss before taxes on income   5,060       5,164    
Taxes on income   26       13    
         
Net loss attributable to holders of Ordinary shares $ 5,086     $ 5,177    
         
Net basic and diluted loss per share $ (0.18 )   $ (0.26 )  
                 
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share   27,562,239       20,158,404    
         

  

Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
 
ASSETS 
 
    March 31,
2016		   December 31,
2015
    (Unaudited)    
Current assets:        
Cash and cash equivalents   $ 13,487     $ 16,658  
Short-term bank deposits     36,000       34,022  
Marketable securities     3,739       -  
Prepaid expenses and other receivables     1,538       1,666  
         
Total current assets     54,764       52,346  
         
Long-term assets:        
Long-term bank deposits     12,000       19,000  
Other long-term assets     98       110  
Property and equipment, net     235       227  
         
Total long-term assets     12,333       19,337  
         
Total assets   $ 67,097     $ 71,683  
         
LIABILITIES AND 
SHAREHOLDERS’ EQUITY
         
Current liabilities:        
Trade payables   $ 111     $ 57  
Accrued expenses and other liabilities     1,999       2,295  

Total current liabilities

     2,110       2,352  
         
Shareholders’ equity:        
Ordinary shares     74       74  
Additional paid-in capital     141,016       140,274  
Accumulated deficit     (76,103 )     (71,017 )
         
Total shareholders’ equity     64,987       69,331  
         
Total liabilities and shareholders’ equity   $ 67,097     $ 71,683  
Alcobra Ltd.
Consolidated Cash Flow Data
 (In thousands)		  
   
  Three Months Ended  
  March 31,  
    2016       2015    
  (Unaudited)   (Unaudited)  
Cash flow from operating activities:        
Net loss $ (5,086 )   $ (5,177 )  
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation   15       10    
Stock based compensation   736       783    
Change in operating assets and liabilities:        
Prepaid expenses and other receivables   187       180    
Other long-term assets   (47 )     (12 )  
Trade payables   54       (250 )  
Accrued expenses and other liabilities   (296 )     (129 )  
Net cash used in operating activities   (4,437 )     (4,595 )  
         
Cash flow from investing activities:        
         
Purchase of property and equipment, net   (23 )     (12 )  
Investment in marketable securities   (3,739 )     -    
Proceeds from (investment in) bank deposits, net   5,022       (18,000 )  
Net cash provided (used in) by investing activities   1,260       (18,012 )  
         
Cash flow from financing activities:        
         
Issuance of share capital upon public offering, net   -       27,903    
Exercise of options   6       -    
Net cash provided by financing activities   6       27,903    
         
Increase (decrease) in cash and cash equivalents   (3,171 )     5,296    
         
Cash and cash equivalents at the beginning of the period   16,658       2,176    
         
Cash and cash equivalents at the end of the period $ 13,487     $ 7,472