Alcobra Announces Third Quarter 2016 Financial Results And Provides Corporate Update

  • Conference Call & Webcast November 15th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time

TEL AVIV, Israel, Nov. 15, 2016 (GLOBE NEWSWIRE) -- 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 nine months ended September 30, 2016, and provided a corporate update.

Third Quarter Ended September 30, 2016 Financial Results:
  • 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.

Third Quarter and Recent Corporate Updates:
  • 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
Domestic:  855-469-0611
International: 484-756-4341
Passcode: 9001229
Webcast: http://www.alcobra-pharma.com/events.cfm
Replays available through November 29, 2016
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 9001229
   

About Alcobra Ltd.   Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX (Metadoxine Extended Release), 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.

Forward Looking Statements This press release as well as the content of the Alcobra conference call scheduled for today contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the MEASURE study, the removal of any safety concerns and any basis thereto, the potential clinical benefit of MDX, expected expenses and sufficiency of capital resources, timing and design of future preclinical and clinical studies and content and timing of discussions with the U.S. Food and Drug Administration and possible positive outcomes of such discussions.  In addition, historic results of scientific research do not guarantee that the conclusions of future research would suggest similar conclusions or that historic results referred to in this press release would be interpreted similarly in light of additional research or otherwise. Also, while Alcobra has received Fast Track designation for MDX for the treatment of Fragile X Syndrome, the company cannot guarantee that it will be able to maintain such designation due to reasons within or outside of its control. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2015, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. 
 
Alcobra Ltd.
Consolidated Statements of Comprehensive Loss
(In thousands, except per share amounts)
 
  Three Months Ended         Nine Months Ended
  September 30,         September 30,
    2016       2015           2016        2015  
  (unaudited)     (unaudited)          (unaudited)     (unaudited)  
               
Research and development $ 6,400     $ 2,853     $ 13,944     $ 10,126  
Pre commercialization expenses   313       294       1,059       931  
General and administrative   1,211       1,176       4,071       3,667  
                                         
Total operating expenses   7,924       4,323       19,074       14,724  
                                         
Financial income, net   (137 )     (68 )     (461 )     (196 )
                                         
Loss before taxes on income   7,787       4,255       18,613       14,528  
Tax on income   15       7       63       34  
                                         
Net loss attributable to holders of Ordinary shares $ 7,802     $ 4,262     $ 18,676     $ 14,562  
                                         
Unrealized loss on available-for-sale marketable securities   (8 )     -       (3 )     -  
                                         
Total comprehensive loss $ 7,810     $ 4,262         $   18,679     $ 14,562  
                                         
Net basic and diluted loss per share $ (0.28 )   $ (0.20 )   $ (0.68 )   $ (0.70 )
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share   27,562,795       21,181,722       27,562,610       20,796,235  
               

Alcobra Ltd.
Consolidated Balance Sheet Data
(In thousands)
         
ASSETS
 
    September 30,   December 31,
      2016       2015  
    (Unaudited)    
Current assets:        
Cash and cash equivalents   $ 4,375     $ 16,658  
Short-term bank deposits     32,000       34,022  
Available-for-sale marketable securities     14,972       -  
Prepaid expenses and other receivables     1,279       1,666  
         
Total current assets     52,626       52,346  
         
Long-term assets:        
Long-term bank deposits     3,000       19,000  
Other long-term assets     74       110  
Property and equipment, net     212       227  
         
Total long-term assets     3,286       19,337  
         
Total assets   $ 55,912     $ 71,683  
                 
LIABILITIES AND
SHAREHOLDERS' EQUITY
 
Current liabilities:        
Trade payables   $ 152     $ 57  
Accrued expenses and other liabilities     3,143       2,295  
                 
Total current liabilities     3,295       2,352  
         
Shareholders' equity:        
Ordinary shares     74       74  
Additional paid-in capital     142,239       140,274  
Accumulated other comprehensive loss     (3 )     -  
Accumulated deficit     (89,693 )     (71,017 )
         
Total shareholders' equity     52,617       69,331  
         
Total liabilities and shareholders' equity   $ 55,912     $ 71,683  
                 

Alcobra Ltd.
Consolidated Cash Flow Data
(In thousands)
 
  Three Months Ended   Nine Months Ended
  September 30,   September 30,
    2016       2015       2016       2015  
  (unaudited)   (unaudited)   (unaudited)   (unaudited)
Cash flow from operating activities:              
Net loss $ (7,802 )   $ (4,262 )   $ (18,676 )   $ (14,562 )
Adjustments to reconcile net loss to net cash used in operating activities:              
Depreciation   14       16       47       37  
Amortization of premium on marketable securities   45       -       86       -  
Stock-based compensation   645       585       1,959       1,786  
Loss from sale of property and equipment   -       3       -       2  
Change in operating assets and liabilities:              
Prepaid expenses and other receivables   (3 )     (1,376 )     445       (1,282 )
Other long-term assets   38       (2 )     (22 )     8  
Trade payables   14       366       95       222  
Accrued expenses and other liabilities   374       (713 )     848       (80 )
                               
Net cash used in operating activities   (6,675 )     (5,383 )     (15,218 )     (13,869 )
               
Cash flow from investing activities:              
Purchase of property and equipment, net   (7 )     (56 )     (32 )     (92 )
Change in restricted cash   -       (146 )     -       (146 )
Investment in marketable securities   (1,912 )     -       (16,327 )     -  
Proceeds from maturity of marketable securities   876           1,021      
Proceeds from call redemption of marketable securities   -           245      
Proceeds from (investment in) short-term bank deposit   (3,000 )     6,985       18,022       (6,015 )
                               
Net cash provided by (used in) investing activities   (4,043 )     6,783       2,929       (6,253 )
               
Cash flow from financing activities:              
Issuance of share capital upon public offering, net   -       -       -       27,903  
Exercise of options   -       -       6       13  
                               
Net cash provided by financing activities   -       -       6       27,916  
               
Increase (decrease) in cash and cash equivalents   (10,718 )     1,400       (12,283 )     7,794  
               
Cash and cash equivalents at the beginning of the period   15,093       8,570       16,658       2,176  
               
Cash and cash equivalents at the end of the period   4,375       9,970       4,375       9,970  
               
Non-cash transactions:              
Purchase of property and equipment   -       47       -       47  
               

 
U.S. Investor ContactsLifeSci Advisors, LLCMichael Rice646-597-6979mrice@lifesciadvisors.com Media InquiriesSam Brown, Inc.Mike Beyer312-961-2502mikebeyer@sambrown.com Israel Investor Contact:Alcobra Investor RelationsDebbie Kaye+972-72 2204661debbie@alcobra-pharma.com

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