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, today announced financial results for the three and six months ended June 30, 2016, and provided a corporate update.

Second Quarter Ended June 30, 2016 Financial Results:

  • Total operating expenses in the second quarter 2016 were $5.9 million, compared to $5.2 million in the second quarter 2015.
  • Net operating expenses, excluding non-cash stock based compensation of $0.6 million, in the second quarter 2016 were $5.3 million, compared with $4.8 million in the second quarter 2015.
  • Research and development (R&D) expenses in the second quarter 2016 were $4.2 million, compared with $3.7 million in the second quarter 2015. R&D expenses consist primarily of costs associated with the conduct of Alcobra’s Phase III Adult ADHD clinical study named MEASURE.
  • General and administrative (G&A) expenses in the second quarter 2016 were $1.4 million, compared with $1.2 million in the second quarter 2015.
  • Cash, marketable securities, and deposits totaled $61.1 million at June 30, 2016, compared with $65.2 million at March 31, 2016 and $69.7 million at the end of 2015.

Second Quarter and Recent Corporate Updates:

  • Alcobra is currently enrolling subjects into the MEASURE study (MDX Evaluation in Adults – Study of Response and Efficacy). The MEASURE study is Alcobra’s second Phase III study of Metadoxine Extended Release (MDX) in 750 adults with ADHD.
  • 718 subjects have been screened to date in the MEASURE study, with 474 subjects already enrolled or at a post-screening visit. With a current rate of close to 150 screenings per month, Alcobra expects to complete enrollment in this study in 2016 and release data in the first quarter of 2017.
  • Alcobra expects to begin enrollment in the first of two registration studies with MDX in pediatric ADHD in the fourth quarter of 2016.
  • Alcobra is continuing discussions with the FDA on a pivotal Phase III study in adolescents and adult subjects with Fragile X Syndrome. MDX has previously shown a benefit on Daily Living Skills in a placebo-controlled Phase II study in this population. The European Commission recently granted orphan drug designation to MDX for the treatment of Fragile X. The FDA previously granted orphan drug designation and Fast Track designation to MDX for the treatment of Fragile X Syndrome.

 

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 Syndrome. For more information, please visit the company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.

Alcobra Ltd.
Consolidated Statements of Comprehensive Loss
(In thousands, except share and per share amounts)
 
  Three Months Ended   Six Months Ended
  June 30,   June 30,
    2016       2015       2016       2015  
  (unaudited)   (unaudited)   (unaudited)    (unaudited)
               
Research and development $   4,182     $   3,683     $   7,544     $    7,273  
Pre commercialization expenses   334       288       746       637  
General and administrative   1,402       1,202       2,860       2,491  
               
Total operating expenses   5,918       5,173       11,150       10,401  
               
Financial income, net   (152 )     (64 )     (324 )     (128 )
               
Loss before taxes on income   5,766       5,109       10,826       10,273  
Tax on income   22       14       48       27  
               
Net loss attributable to holders of Ordinary shares     5,788         5,123         10,874         10,300  
               
Unrealized gain on available-for-sale marketable securities   5       -       5       -  
               
Total comprehensive loss $   5,783     $   5,123     $   10,869     $   10,300  
               
Net basic and diluted loss per share $   (0.21 )   $   (0.24 )   $   (0.39 )   $   (0.50 )
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share   27,562,795       21,179,233       27,562,517       20,677,364  
               
Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
 
ASSETS    
    June 30,
2016		   December 31,
2015
    (Unaudited)    
Current assets:        
Cash and cash equivalents   $   15,093     $   16,658  
Short-term bank deposits     24,000       34,022  
Available-for-sale marketable securities     13,989       -  
Prepaid expenses and other receivables       1,276       1,666  
         
Total current assets     54,358       52,346  
         
Long-term assets:        
Long-term bank deposits     8,000       19,000  
Other long-term assets     112       110  
Property and equipment, net     219       227  
         
Total long-term assets     8,331       19,337  
         
Total assets    $  62,689     $  71,683  
LIABILITIES AND
SHAREHOLDERS’ EQUITY		        
         
Current liabilities:        
Trade payables   $     138     $     57  
Accrued expenses and other liabilities     2,769           2,295  
 
Total current liabilities     2,907       2,352  
         
Shareholders’ equity:        
Ordinary shares     74       74  
Additional paid-in capital     141,594       140,274  
Accumulated other comprehensive income     5       -  
Accumulated deficit     (81,891 )     (71,017 )
         
Total shareholders’ equity     59,782       69,331  
         
Total liabilities and shareholders’ equity   $   62,689     $      71,683  
Alcobra Ltd.
Consolidated Cash Flow Data
(In thousands)
 
  Three Months Ended   Six Months Ended
  June 30,   June 30,
    2016       2015       2016       2015  
  (unaudited)   (unaudited)   (unaudited)   (unaudited)
Cash flow from operating activities:              
Net loss $  (5,788 )   $   (5,123 )   $    (10,874 )   $   (10,300 )
Adjustments to reconcile net loss to net cash used in operating activities:              
Depreciation   18       11       33       21  
Amortization of premium on marketable securities   41       -       41       -  
Stock based compensation   578       418       1,314       1,201  
Loss from sale of property, and equipment   -       (1 )     -       (1 )
Change in operating assets and liabilities:              
  Prepaid expenses and other receivables   261       (86 )     448       94  
  Other long-term assets   (13 )     22       (60 )     10  
  Trade payables   27       106       81       (144 )
  Accrued expenses and other liabilities   770       762       474       633  

Net cash used in operating activities		   (4,106 )     (3,891 )     (8,543 )     (8,486 )
               
Cash flow from investing activities:              
Purchase of property and equipment   (2 )     (24 )     (25 )     (36 )
Investment in marketable securities   (10,676 )     -       (14,415 )     -  
Proceeds from maturity of marketable securities   145       -       145       -  
Proceeds from call redemption of marketable securities   245       -       245       -  
Decrease in long-term deposit   -       -       -       -  
Proceeds from (investment in) short-term bank deposit   16,000       5,000       21,022       (13,000 )

Net cash provided by (used in) investing activities		   5,712       4,976       6,972      
 (13,036
)
               
Cash flow from financing activities:              
Issuance of share capital upon public offering, net   -       -       -       27,903  
Exercise of options   -       13       6       13  

Net cash provided by financing activities		  
 -		      
 13		       6       27,916  
               
Increase (decrease) in cash and cash equivalents   1,606       1,098       (1,565 )     6,394  
               
Cash and cash equivalents at the beginning of the period   13,487       7,472       16,658       2,176  
               
Cash and cash equivalents at the end of the period $   15,093     $   8,570     $   15,093     $   8,570