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Delaware
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11-3516358
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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Large Accelerated Filer
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¨
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Accelerated Filer
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¨
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Non-Accelerated Filer
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¨
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Smaller reporting company
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þ
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(Do not check if a smaller reporting company)
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Page
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PART I
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FINANCIAL INFORMATION
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3
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Item 1
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Financial Statements (Unaudited)
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3
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3
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4
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5
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7
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Item 2
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29
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Item 3
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38
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Item 4
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38
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PART II
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OTHER INFORMATION
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39
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Item 1
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39
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Item 1A
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39
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Item 2
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39
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Item 3
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39
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Item 4
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39
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Item 5
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39
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Item 6
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40
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41
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March 31, 2014
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December 31, 2013
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||||||
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ASSETS
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||||||||
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Current Assets:
|
|
|
||||||
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Cash and cash equivalents
|
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$40,073,018
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|
$18,688,031
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||||
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Marketable securities (note 2)
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100,000
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100,000
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||||||
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Prepaid expenses and other current assets (note 3)
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725,469
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507,165
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||||||
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Total Current Assets
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40,898,487
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19,295,196
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||||||
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Restricted Cash Equivalents
(note 13)
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163,530
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196,130
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||||||
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Equipment, Net
(note 4)
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59,899
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65,172
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||||||
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Total Assets
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$41,121,916
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$19,556,498
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||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
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Current Liabilities:
|
||||||||
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Accounts payable and accrued expenses (note 5)
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$878,500
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$933,758
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||||
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||||||||
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Deferred Research and Development Arrangements
(note 6)
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782,280
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833,630
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||||||
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||||||||
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Other Liabilities
(note 7)
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138,278
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129,564
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||||||
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||||||||
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Warrant Liabilities
(note 11)
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11,290,566
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5,034,058
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||||||
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|
||||||||
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Total Liabilities
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13,089,624
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6,931,010
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||||||
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Commitments and Contingencies
(note 13)
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||||||||
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Stockholders’ Equity
(note 9):
|
||||||||
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Preferred stock, par value $0.0001, 100,000,000 authorized shares, none issued and outstanding
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-
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-
|
||||||
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Common stock, par value $0.0001, 500,000,000 authorized shares, 176,655,340 and 146,732,000 issued and 176,641,135 and 146,717,795 outstanding
|
17,665
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14,673
|
||||||
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Additional paid-in capital
|
115,454,243
|
85,449,932
|
||||||
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Accumulated deficit during the development stage
|
(87,411,206
|
)
|
(72,810,707
|
)
|
||||
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Treasury stock, 14,205 shares, at cost
|
(28,410
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)
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(28,410
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)
|
||||
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|
||||||||
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Total Stockholders’ Equity
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28,032,292
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12,625,488
|
||||||
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|
||||||||
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Total Liabilities and Stockholders’ Equity
|
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$41,121,916
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$19,556,498
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||||
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Cumulative
|
|||||||||
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from March 19,
|
|||||||||
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2001
|
|||||||||
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For the Three Months Ended
March 31,
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(Inception) to
March 31,
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||||||||||
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2014
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2013
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2014
|
|||||||||
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Revenues:
|
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|
|||||||||
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Research
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$
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-
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$
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-
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$
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-
|
||||||
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||||||||||||
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Expenses:
|
||||||||||||
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General and administrative
|
1,413,456
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1,210,752
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35,733,963
|
|||||||||
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Research and development
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1,271,574
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552,466
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39,803,212
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|||||||||
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Patent fees
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72,020
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136,491
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3,032,327
|
|||||||||
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Depreciation and amortization
|
9,044
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9,316
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729,100
|
|||||||||
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||||||||||||
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Total Expenses
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2,766,094
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1,909,025
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79,298,602
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|||||||||
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||||||||||||
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Loss from Operations
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(2,766,094
|
)
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(1,909,025
|
)
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(79,298,602
|
)
|
||||||
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||||||||||||
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Other Income (Expense)
|
||||||||||||
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Realized loss on marketable securities
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-
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-
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(13,301
|
)
|
||||||||
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Interest income
|
32,291
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10,018
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1,523,970
|
|||||||||
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Interest expense
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-
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-
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(301,147
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)
|
||||||||
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Other income
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-
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-
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56,047
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|||||||||
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Unrealized (loss)/gain on fair value of warrants
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(11,660,524
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)
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368,902
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(8,686,197
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)
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|||||||
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Unrealized gain on fair value of put feature on common stock
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-
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-
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2,315,539
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|||||||||
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Financing expense
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(206,172
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)
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-
|
(1,382,515
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)
|
|||||||
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Beneficial conversion feature
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-
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-
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(1,625,000
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)
|
||||||||
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Total Other Income (Expense)
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(11,834,405
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)
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378,920
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(8,112,604
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)
|
|||||||
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||||||||||||
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Loss Before Provision for Income Taxes
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(14,600,499
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)
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(1,530,105
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)
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(87,411,206
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)
|
||||||
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Provision for income taxes
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-
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-
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-
|
|||||||||
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Net Loss
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$
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(14,600,499
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)
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$
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(1,530,105
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)
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$
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(87,411,206
|
)
|
|||
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|
||||||||||||
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Net loss per share, basic and diluted
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$
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(0.09
|
)
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$
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(0.01
|
)
|
||||||
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|
||||||||||||
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Weighted average number of shares outstanding, basic and diluted
|
170,112,570
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119,428,989
|
||||||||||
|
|
|
|
Cumulative
|
|||||||||
|
|
|
|
From March 19, 2001
|
|||||||||
|
|
For the Three Months Ended
|
(Inception) to
|
||||||||||
|
|
March 31,
|
March 31,
|
||||||||||
|
|
2014
|
2013
|
2014
|
|||||||||
|
Cash Flows from Operating Activities:
|
|
|
|
|||||||||
|
Net loss
|
$
|
(14,600,499
|
)
|
$
|
(1,530,105
|
)
|
$
|
(87,411,206
|
)
|
|||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
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Beneficial conversion feature
|
-
|
-
|
1,625,000
|
|||||||||
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Compensatory stock
|
336,000
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-
|
2,772,677
|
|||||||||
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Depreciation and amortization
|
9,044
|
9,316
|
729,100
|
|||||||||
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Stock-based compensation
|
128,350
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371,951
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6,502,394
|
|||||||||
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Amortization of deferred research and development arrangements
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(51,350
|
)
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(153,371
|
)
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(1,643,720
|
)
|
||||||
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Realized losses on marketable securities
|
-
|
-
|
13,301
|
|||||||||
|
Unrealized loss/(gain) on fair value of warrants
|
11,660,524
|
(368,902
|
)
|
8,686,197
|
||||||||
|
Unrealized gain on fair value of put feature on common stock
|
-
|
-
|
(2,315,539
|
)
|
||||||||
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Financing expense
|
206,172
|
-
|
1,382,515
|
|||||||||
|
Amortization of deferred lease incentive
|
(3,111
|
)
|
(5,000
|
)
|
(89,333
|
)
|
||||||
|
Deferred lease expenses
|
11,825
|
(5,233
|
)
|
72,951
|
||||||||
|
Loss on impairment of intangible assets
|
-
|
-
|
286,132
|
|||||||||
|
Changes in assets and liabilities:
|
||||||||||||
|
Prepaid expenses and other current assets
|
(218,304
|
)
|
5,488
|
(670,809
|
)
|
|||||||
|
Accounts payable and accrued expenses
|
(55,258
|
)
|
124,329
|
878,500
|
||||||||
|
Net Cash Used in Operating Activities
|
(2,576,607
|
)
|
(1,551,527
|
)
|
(69,181,840
|
)
|
||||||
|
Cash Flows from Investing Activities:
|
||||||||||||
|
Restricted cash equivalents
|
32,600
|
134,621
|
(163,530
|
)
|
||||||||
|
Purchase of equipment
|
(3,771
|
)
|
(609
|
)
|
(618,915
|
)
|
||||||
|
Purchase of marketable securities
|
-
|
-
|
(21,123,960
|
)
|
||||||||
|
Proceeds from sales of marketable securities
|
-
|
-
|
21,010,659
|
|||||||||
|
Payment of licensing fees
|
-
|
-
|
(356,216
|
)
|
||||||||
|
Net Cash Provided by (Used In) Investing Activities
|
28,829
|
134,012
|
(1,251,962
|
)
|
||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||
|
Issuance of common stock and units, net of issuance costs
|
18,634,247
|
-
|
91,609,626
|
|||||||||
|
Proceeds from exercise of stock options
|
70,000
|
-
|
330,082
|
|||||||||
|
Proceeds from exercise of stock warrants
|
5,228,518
|
-
|
11,019,522
|
|||||||||
|
Proceeds from long-term debt
|
-
|
-
|
5,150,000
|
|||||||||
|
Proceeds from research and development arrangements
|
-
|
-
|
2,426,000
|
|||||||||
|
Purchase of treasury stock
|
-
|
-
|
(28,410
|
)
|
||||||||
|
Net Cash Provided by Financing Activities
|
23,932,765
|
-
|
110,506,820
|
|||||||||
|
Net Increase (Decrease) in Cash and Cash Equivalents
|
21,384,987
|
(1,417,515
|
)
|
40,073,018
|
||||||||
|
Cash and Cash Equivalents – beginning of period
|
18,688,031
|
13,486,543
|
-
|
|||||||||
|
Cash and Cash Equivalents - end of period
|
$
|
40,073,018
|
$
|
12,069,028
|
$
|
40,073,018
|
||||||
|
|
|
|
Cumulative
|
|||||||||
|
|
|
|
From March 19, 2001
|
|||||||||
|
|
For the Three Months Ended
|
(Inception) to
|
||||||||||
|
|
March 31,
|
March 31,
|
||||||||||
|
|
2014
|
2013
|
2014
|
|||||||||
|
Supplemental Cash Flow Information
|
|
|
|
|||||||||
|
Interest paid
|
$
|
-
|
$
|
-
|
$
|
301,147
|
||||||
|
Non-cash financing and investing activities:
|
||||||||||||
|
Warrants issued
|
$
|
3,691,429
|
$
|
-
|
$
|
19,947,074
|
||||||
|
Put feature on common stock issued
|
$
|
-
|
$
|
-
|
$
|
4,954,738
|
||||||
|
Dilutive issuances of common stock
|
$
|
-
|
$
|
-
|
$
|
2,639,199
|
||||||
|
Warrant liability extinguishment from exercise of warrants
|
$
|
9,095,445
|
$
|
-
|
$
|
17,013,768
|
||||||
|
Leasehold improvement incentive
|
$
|
-
|
$
|
-
|
$
|
154,660
|
||||||
|
Settlement of lawsuit
|
$
|
-
|
$
|
-
|
$
|
43,953
|
||||||
|
1.
|
Operations and Organization
|
| 2. | Marketable Securities |
|
|
|
|
|
|||||||||
|
|
|
|
|
|||||||||
|
|
Cost
|
Gross Unrealized
|
Fair
|
|||||||||
|
Securities available-for-sale
|
Basis
|
Gains/(Losses)
|
Value
|
|||||||||
|
March 31, 2014:
|
|
|
|
|||||||||
|
State and municipal obligations
|
$
|
100,000
|
$
|
-
|
$
|
100,000
|
||||||
|
|
||||||||||||
|
December 31, 2013:
|
||||||||||||
|
State and municipal obligations
|
$
|
100,000
|
$
|
-
|
$
|
100,000
|
||||||
|
|
Cost
|
Fair
|
||||||
|
Maturity
|
Basis
|
Value
|
||||||
|
10 years or more
|
$
|
100,000
|
$
|
100,000
|
||||
| 3. | Prepaid Expenses and Other Current Assets |
|
|
March 31,
|
December 31,
|
||||||
|
|
2014
|
2013
|
||||||
|
|
|
|
||||||
|
Deposits on contracts
|
$
|
86,694
|
$
|
37,760
|
||||
|
Prepaid expenses and other assets
|
638,775
|
469,405
|
||||||
|
|
||||||||
|
|
$
|
725,469
|
$
|
507,165
|
||||
| 4 | Equipment, Net |
|
|
March 31,
|
December 31,
|
||||||
|
|
2014
|
2013
|
||||||
|
|
|
|
||||||
|
Furniture and fixtures
|
$
|
62,071
|
$
|
59,133
|
||||
|
Office equipment
|
42,585
|
41,752
|
||||||
|
Lab and computer equipment
|
425,195
|
425,195
|
||||||
|
Leasehold improvements
|
119,841
|
119,841
|
||||||
|
|
||||||||
|
Total equipment
|
649,692
|
645,921
|
||||||
|
Less: Accumulated depreciation
|
(589,793
|
)
|
(580,749
|
)
|
||||
|
|
||||||||
|
Net carrying amount
|
$
|
59,899
|
$
|
65,172
|
||||
| 5. | Accounts Payable and Accrued Expenses |
|
|
March 31,
|
December 31,
|
||||||
|
|
2014
|
2013
|
||||||
|
|
|
|
||||||
|
Trade payables
|
$
|
322,338
|
$
|
251,687
|
||||
|
Accrued expenses
|
88,960
|
25,367
|
||||||
|
Accrued research and development contract costs
|
305,980
|
215,211
|
||||||
|
Payroll liabilities
|
161,222
|
441,493
|
||||||
|
|
||||||||
|
|
$
|
878,500
|
$
|
933,758
|
||||
| 6. | Deferred Research and Development Arrangements |
| 7. | Other Liabilities |
|
|
March 31,
|
December 31,
|
||||||
|
|
2014
|
2013
|
||||||
|
|
|
|
||||||
|
Deferred lease incentive
|
$
|
154,660
|
$
|
154,660
|
||||
|
Less accumulated amortization
|
(89,333
|
)
|
(86,222
|
)
|
||||
|
|
||||||||
|
Balance
|
$
|
65,327
|
$
|
68,438
|
||||
| 8. | Net Loss per Common Share |
| 9. | Common Stock |
|
a)
|
On January 21, 2014 the Company closed on a registered direct public offering to issue and sell 19,047,620 shares of common stock and warrants to purchase up to 4,761,905 shares of common stock. The common stock and warrants were sold in units, consisting of common stock and a warrant to purchase 0.25 shares of common stock, at a price of $1.05 per share, and the warrants have an exercise price of $1.28 per share. The total gross proceeds of the offering were $20,000,001. The warrants issued are exercisable beginning six months and one day after the closing date until the five-year anniversary of the closing date and were recorded as liabilities at fair value.
|
|
Gross Proceeds:
|
$
|
20,000,001
|
||
|
|
||||
|
Allocated to liabilities:
|
||||
|
Warrant liabilities
|
3,691,429
|
|||
|
|
||||
|
|
||||
|
Allocated to equity:
|
||||
|
Common stock and additional paid-in capital
|
16,308,572
|
|||
|
|
||||
|
Total allocated gross proceeds:
|
$
|
20,000,001
|
|
b)
|
On February 10, 2014, the Company issued 300,000 shares of stock to two vendors in exchange for investor relations and financial advisory services. The market value of the stock issued was $1.12, and the total market value of the issuance was $336,000.
|
|
c)
|
During the three months ended March 31, 2014, warrant holders exercised warrants to purchase shares of the Company’s common stock for cash of $5,228,518, and the Company issued 10,488,220 shares.
|
|
d)
|
During the three months ended March 31, 2014, an option holder exercised stock options to purchase shares of the Company’s common stock for cash of $70,000, and the Company issued 87,500 shares.
|
| 10. | Stock-Based Compensation |
|
|
|
|
Cumulative from
|
|||||||||
|
|
Three Months Ended March 31,
|
March 19, 2001 (Inception)
to
|
||||||||||
|
|
2014
|
2013
|
March 31, 2014
|
|||||||||
|
Statement of operations line item:
|
|
|
|
|||||||||
|
General and administrative:
|
|
|
|
|||||||||
|
Payroll
|
$
|
80,911
|
$
|
350,379
|
3,201,523
|
|||||||
|
Consulting and other professional fees
|
-
|
3,893
|
814,348
|
|||||||||
|
Research and development:
|
||||||||||||
|
Payroll
|
28,531
|
15,732
|
1,130,568
|
|||||||||
|
Consulting and other professional fees
|
18,908
|
1,947
|
1,355,955
|
|||||||||
|
|
||||||||||||
|
Total
|
$
|
128,350
|
$
|
371,951
|
6,502,394
|
|||||||
|
|
Three Months Ended March 31,
|
|||||||
|
|
2014
|
2013
|
||||||
|
Black-Scholes weighted average assumptions
|
|
|
||||||
|
Expected dividend yield
|
0
|
%
|
0
|
%
|
||||
|
Expected volatility
|
92-97
|
%
|
95-96
|
%
|
||||
|
Risk free interest rate
|
1.5-1.7
|
%
|
0.75-0.85
|
%
|
||||
|
Expected term (in years)
|
5 years
|
5 years
|
||||||
|
|
2014
|
2013
|
||||||||||||||
|
|
Number of Options
|
Weighted
Average Exercise
Price
|
Number of Options
|
Weighted Average
Exercise Price
|
||||||||||||
|
Outstanding at
|
|
|
|
|
||||||||||||
|
January 1
|
9,356,795
|
$
|
0.92
|
7,741,795
|
$
|
1.03
|
||||||||||
|
Granted
|
975,999
|
1.14
|
1,750,000
|
0.35
|
||||||||||||
|
Exercised
|
(87,500
|
)
|
0.80
|
-
|
-
|
|||||||||||
|
Expired
|
-
|
-
|
-
|
-
|
||||||||||||
|
Cancelled
|
-
|
-
|
-
|
-
|
||||||||||||
|
|
||||||||||||||||
|
Outstanding at March 31
|
10,245,294
|
$
|
0.94
|
9,491,795
|
$
|
0.90
|
||||||||||
|
|
Number of Options
|
Weighted Average Exercise Price
|
Weighted
Average
Remaining
Contractual
Term
|
Aggregate
Intrinsic Value
|
|||||||||
|
Outstanding at
|
|
|
|
|
|||||||||
|
March 31, 2014
|
10,245,294
|
$
|
0.94
|
5.1 years
|
$
|
2,859,168
|
|||||||
|
|
|
||||||||||||
|
Exercisable at
|
|
||||||||||||
|
March 31, 2014
|
8,089,295
|
$
|
0.99
|
3.9 years
|
$
|
2,104,218
|
|||||||
|
|
|
||||||||||||
|
Outstanding at
|
|
||||||||||||
|
December 31, 2013
|
9,356,795
|
$
|
0.92
|
4.8 years
|
$
|
350,865
|
|||||||
|
|
|
||||||||||||
|
Exercisable at
|
|
||||||||||||
|
December 31, 2013
|
7,956,795
|
$
|
0.99
|
4.0 years
|
$
|
199,795
|
|||||||
|
|
2014
|
|||||||
|
|
Number of Options
|
Weighted Average Fair Value at
Grant Date
|
||||||
|
Unvested at January 1, 2014
|
1,400,000
|
$
|
0.34
|
|||||
|
Granted
|
975,999
|
$
|
0.81
|
|||||
|
Vested
|
(220,000
|
)
|
$
|
0.44
|
||||
|
Cancelled
|
-
|
$
|
-
|
|||||
|
|
||||||||
|
Unvested at March 31, 2014
|
2,155,999
|
$
|
0.55
|
|||||
| 11. | Warrants |
|
|
2014
|
2013
|
||||||||||||||
|
|
Number of warrants
|
Weighted average
exercise price
|
Number of warrants
|
Weighted average
exercise price
|
||||||||||||
|
Balance, January 1
|
24,968,868
|
$
|
0.86
|
21,656,142
|
$
|
0.89
|
||||||||||
|
Issued during the period
|
4,761,905
|
$
|
1.28
|
-
|
$
|
-
|
||||||||||
|
Exercised during the period
|
(10,808,871
|
)
|
$
|
0.52
|
-
|
$
|
-
|
|||||||||
|
Expired during the period
|
-
|
$
|
-
|
-
|
$
|
-
|
||||||||||
|
|
||||||||||||||||
|
Balance, March 31
|
18,921,902
|
$
|
1.16
|
21,656,142
|
$
|
0.89
|
||||||||||
|
|
Fair Value as of:
|
|||||||||||
|
Warrant Issuance:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Exercised and Expired Warrants
|
$
|
-
|
$
|
-
|
$
|
3,985,570
|
||||||
|
June 5, 2009 financing:
|
||||||||||||
|
Series III warrants
|
80,889
|
11
|
1,306,200
|
|||||||||
|
Warrants to placement agent
|
8,484
|
1
|
122,257
|
|||||||||
|
October 23, 2009 financing:
|
||||||||||||
|
Warrants to institutional investors
|
316,159
|
19,689
|
1,012,934
|
|||||||||
|
June 30, 2010 financing
|
||||||||||||
|
Warrants to institutional investors
|
61,000
|
10
|
1,800,800
|
|||||||||
|
March 31, 2011 financing:
|
||||||||||||
|
Warrants to institutional investors
|
1,785,333
|
311,360
|
2,826,666
|
|||||||||
|
December 4, 2012 financing:
|
||||||||||||
|
Warrants to institutional investors
|
195,651
|
2,124,444
|
2,474,120
|
|||||||||
|
Warrants to placement agent
|
32,964
|
222,286
|
163,096
|
|||||||||
|
July 26, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
1,716,200
|
1,148,390
|
1,295,952
|
|||||||||
|
Warrants to placement agent
|
89,253
|
83,808
|
110,489
|
|||||||||
|
October 16, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
3,091,430
|
1,051,454
|
1,070,193
|
|||||||||
|
Warrants to placement agent
|
289,869
|
72,605
|
87,368
|
|||||||||
|
January 21, 2014 financing:
|
||||||||||||
|
Warrants to institutional investors
|
3,623,334
|
-
|
3,691,429
|
|||||||||
|
Total:
|
$
|
11,290,566
|
$
|
5,034,058
|
$
|
19,947,074
|
||||||
|
|
Number of Shares indexed as of:
|
|||||||||||
|
Warrant Issuance
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Exercised and Expired Warrants
|
-
|
-
|
5,950,304
|
|||||||||
|
June 5, 2009 financing:
|
||||||||||||
|
Series III warrants
|
1,555,555
|
1,555,555
|
1,555,555
|
|||||||||
|
Warrants to placement agent
|
132,143
|
132,143
|
142,857
|
|||||||||
|
October 23, 2009 financing:
|
||||||||||||
|
Warrants to institutional investors
|
778,333
|
1,228,333
|
2,125,334
|
|||||||||
|
June 30, 2010 financing
|
||||||||||||
|
Warrants to institutional investors
|
2,000,000
|
2,000,000
|
2,000,000
|
|||||||||
|
March 31, 2011 financing:
|
||||||||||||
|
Warrants to institutional investors
|
3,333,333
|
3,333,333
|
3,333,333
|
|||||||||
|
December 4, 2012 financing:
|
||||||||||||
|
Warrants to institutional investors
|
221,600
|
7,418,503
|
12,100,000
|
|||||||||
|
Warrants to placement agent
|
40,000
|
880,000
|
880,000
|
|||||||||
|
July 26, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
2,000,000
|
3,990,000
|
3,990,000
|
|||||||||
|
Warrants to placement agent
|
124,032
|
456,000
|
456,000
|
|||||||||
|
October 16, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
3,567,309
|
3,567,309
|
3,567,308
|
|||||||||
|
Warrants to placement agent
|
407,692
|
407,692
|
407,692
|
|||||||||
|
January 21, 2014 financing:
|
||||||||||||
|
Warrants to institutional investors
|
4,761,905
|
-
|
4,761,905
|
|||||||||
|
Total:
|
18,921,902
|
24,968,868
|
41,270,288
|
|||||||||
|
Exercised and Expired Warrants
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
-
|
$
|
-
|
$
|
1.75-2.14
|
||||||
|
Estimated future volatility
|
-
|
-
|
142-143
|
%
|
||||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
-
|
-
|
1.95-3.27
|
%
|
||||||||
|
Equivalent volatility
|
-
|
-
|
97-106
|
%
|
||||||||
|
Equivalent risk-free rate
|
-
|
-
|
1.31-3.26
|
%
|
||||||||
|
Estimated additional shares to be issued upon dilutive event
|
-
|
-
|
7,479-98,838
|
|||||||||
|
June 5, 2009 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
$
|
0.51
|
$
|
1.14
|
||||||
|
Estimated future volatility
|
110
|
%
|
109
|
%
|
100
|
%
|
||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
0.13
|
%
|
0.13
|
%
|
0.63-4.31
|
%
|
||||||
|
Equivalent volatility
|
89-90
|
%
|
43-45
|
%
|
103-117
|
%
|
||||||
|
Equivalent risk-free rate
|
0.02
|
%
|
0.05-0.06
|
%
|
0.20-1.44
|
%
|
||||||
|
October 23, 2009 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
$
|
0.51
|
$
|
0.69
|
||||||
|
Estimated future volatility
|
110
|
%
|
109
|
%
|
100
|
%
|
||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
0.13
|
%
|
0.13
|
%
|
2.63-3.80
|
%
|
||||||
|
Equivalent volatility
|
119
|
%
|
57
|
%
|
98-99
|
%
|
||||||
|
Equivalent risk-free rate
|
0.05
|
%
|
0.07
|
%
|
0.93-1.16
|
%
|
||||||
|
June 30, 2010 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
$
|
0.51
|
$
|
1.43
|
||||||
|
Estimated future volatility
|
110
|
%
|
109
|
%
|
100
|
%
|
||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
0.13
|
%
|
0.13
|
%
|
1.78
|
%
|
||||||
|
Equivalent volatility
|
89
|
%
|
49
|
%
|
98
|
%
|
||||||
|
Equivalent risk-free rate
|
0.03
|
%
|
0.06
|
%
|
0.59
|
%
|
||||||
|
March 31, 2011 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
$
|
0.51
|
$
|
1.18
|
||||||
|
Estimated future volatility
|
110
|
%
|
109
|
%
|
100
|
%
|
||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
1.82
|
%
|
1.58
|
%
|
1.32-3.64
|
%
|
||||||
|
Equivalent volatility
|
98
|
%
|
71
|
%
|
79-96
|
%
|
||||||
|
Equivalent risk-free rate
|
0.23
|
%
|
0.27
|
%
|
0.39-1.09
|
%
|
||||||
|
December 4, 2012 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
$
|
0.51
|
$
|
0.30-0.33
|
||||||
|
Estimated future volatility
|
110
|
%
|
109
|
%
|
100
|
%
|
||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Estimated future risk-free rate
|
1.82-2.56
|
%
|
1.58-2.72
|
%
|
0.52-1.065
|
%
|
||||||
|
Equivalent volatility
|
100-106
|
%
|
69-73
|
%
|
88-90
|
%
|
||||||
|
Equivalent risk-free rate
|
0.20-0.43
|
%
|
0.22-0.40
|
%
|
0.22-0.31
|
%
|
||||||
|
July 26, 2013 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
0.51
|
$
|
0.53
|
|||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Equivalent volatility
|
100-102
|
%
|
69-77
|
%
|
78-80
|
%
|
||||||
|
Equivalent risk-free rate
|
0.20-0.54
|
%
|
0.22-0.62
|
%
|
0.20-0.48
|
%
|
||||||
|
October 16, 2013 financing:
|
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
0.51
|
$
|
0.49
|
|||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Equivalent volatility
|
100-101
|
%
|
69-76
|
%
|
81-83
|
%
|
||||||
|
Equivalent risk-free rate
|
0.20-0.58
|
%
|
0.20-0.52
|
%
|
0.21-0.55
|
%
|
||||||
| January 21, 2014 financing: |
March 31, 2014
|
December 31, 2013
|
Transaction Date
|
|||||||||
|
Trading market prices
|
$
|
1.08
|
-
|
$
|
1.09
|
|||||||
|
Dividend
|
-
|
-
|
-
|
|||||||||
|
Equivalent volatility
|
99
|
%
|
-
|
98
|
%
|
|||||||
|
Equivalent risk-free rate
|
0.63
|
%
|
-
|
0.62
|
%
|
|||||||
|
|
Three Months
Ended March 31,
2014
|
Three Months
Ended March 31,
2013
|
Cumulative from
March 19, 2001
(Inception) to
March 31, 2014
|
|||||||||
|
Exercised and Expired Warrants
|
$
|
-
|
$
|
144
|
$
|
(1,460,407
|
)
|
|||||
|
June 5, 2009 financing:
|
||||||||||||
|
Series III warrants
|
(80,878
|
)
|
30,022
|
1,225,311
|
||||||||
|
Warrants to placement agent
|
(8,483
|
)
|
2,855
|
99,393
|
||||||||
|
October 23, 2009 financing:
|
||||||||||||
|
Warrants to institutional investors
|
(593,950
|
)
|
41,395
|
(649,945
|
)
|
|||||||
|
June 30, 2010 financing
|
||||||||||||
|
Warrants to institutional investors
|
(60,990
|
)
|
8,800
|
1,739,800
|
||||||||
|
March 31, 2011 financing:
|
||||||||||||
|
Warrants to institutional investors
|
(1,473,973
|
)
|
96,666
|
1,041,333
|
||||||||
|
December 4, 2012 financing:
|
||||||||||||
|
Warrants to institutional investors
|
(4,225,702
|
)
|
166,980
|
(5,613,687
|
)
|
|||||||
|
Warrants to placement agent
|
(533,250
|
)
|
22,040
|
(592,440
|
)
|
|||||||
|
July 26, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
(2,200,617
|
)
|
-
|
(2,053,055
|
)
|
|||||||
|
Warrants to placement agent
|
(293,538
|
)
|
-
|
(266,857
|
)
|
|||||||
|
October 16, 2013 financing:
|
||||||||||||
|
Warrants to institutional investors
|
(2,039,976
|
)
|
-
|
(2,021,237
|
)
|
|||||||
|
Warrants to placement agent
|
(217,262
|
)
|
-
|
(202,501
|
)
|
|||||||
|
January 21, 2014 financing:
|
||||||||||||
|
Warrants to institutional investors
|
68,095
|
-
|
68,095
|
|||||||||
|
Total:
|
$
|
(11,660,524
|
)
|
$
|
368,902
|
$
|
(8,686,197
|
)
|
||||
| 12. | Income Taxes |
|
|
March 31,
|
December 31,
|
||||||
|
|
2014
|
2013
|
||||||
|
|
|
|
||||||
|
Net Operating Loss Carryforwards
|
$
|
27,963,000
|
26,924,000
|
|||||
|
Stock Compensation Expense
|
2,059,500
|
2,028,200
|
||||||
|
Book tax differences on assets and liabilities
|
321,000
|
424,000
|
||||||
|
Valuation Allowance
|
(30,343,500
|
)
|
(29,376,200
|
)
|
||||
|
|
||||||||
|
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
||||
| 13. | Commitments and Contingencies |
|
a)
|
The Company has contracted with various vendors for research and development services. The terms of these agreements usually require an initial fee and monthly or periodic payments over the term of the agreement, ranging from two months to 36 months. The costs to be incurred are estimated and are subject to revision. As of March 31, 2014, the total estimated cost to be incurred under these agreements was approximately $2
6,212,772,
and the Company had made payments totaling $20,
934,687
since inception under the terms of the agreements. All of these agreements may be terminated by either party upon appropriate notice as stipulated in the respective agreements.
|
|
b)
|
The Company and four of its key executives currently have outstanding employment agreements. The agreements result in annual commitments for each key executive of $330,000, $285,000, $250,000
and
$250,000, respectively.
|
|
c)
|
On June 22, 2009, the Company entered into a License Agreement with Korea Research Institute of Chemical Technology (“KRICT”) to acquire the rights to all intellectual properties related to Quinoxaline-Piperazine derivatives that were synthesized under a Joint Research Agreement. The initial license fee was $100,000, all of which was paid as of December 31, 2009. The agreement with KRICT calls for a one-time milestone payment of $1,000,000 within 30 days after the first achievement of marketing approval of the first commercial product arising out of or in connection with the use of KRICT’s intellectual properties. As of March 31, 2014, the milestone has not occurred.
|
|
d)
|
On June 29, 2009, the Company signed a five-year commercial lease agreement for 5,466 square feet of office space in Rockville, Maryland commencing on June 29, 2009. The lease agreement required annual base rent with increases over the next five years. Under the lease agreement, the Company pays its allocable portion of real estate taxes and common area operating charges. Rent paid under the Company’s lease during the three months ended March 31, 2014 and 2013, including the amendment terms described below, was $
25,053
and $40,199, respectively.
|
|
For the remaining nine months ending December 31:
|
2014
|
114,622
|
|||
|
For the year ending December 31:
|
2015
|
156,000
|
|||
|
2016
|
159,881
|
||||
|
2017
|
163,871
|
||||
|
2018
|
167,970
|
||||
|
2019
|
85,024
|
||||
|
|
|||||
|
Total
|
$
|
847,368
|
|
e)
|
On September 21, 2009, the Company closed on the Purchase Agreement with Teva, and contemporaneous with the execution and delivery of this agreement, the parties executed the RELO Agreement, pursuant to which the Company agreed to use proceeds from the issuance and sale of shares to Teva to fund a research and development program for the pre-clinical development of RX-3117. On December 27, 2012, the Company received $926,000 from Teva in accordance with a second amendment to the RELO Agreement, entered into on November 27, 2012. The Company did not issue equity for this transaction. On August 28, 2013, the Company announced that Teva had decided not to exercise its option to license RX-3117, and as a result the RELO Agreement was terminated. The remaining proceeds of $1
26,030,
which is included in restricted cash equivalents at March 31, 2014 will be used to pay for unbilled expenses.
|
|
f)
|
The Company has established a 401(k) plan for its employees. The Company has elected to match 100% of the first 3% of an employee’s compensation plus 50% of an additional 2% of the employee’s deferral. Expense related to this matching contribution aggregated to $20,700 and $
17,716
for the three months ended March 31, 2014 and 2013, respectively.
|
|
g)
|
On June 24, 2013 and May 30, 2012, the Company signed a one-year renewal to use laboratory space commencing on July 1, 2013 and 2012, respectively. The lease requires monthly rental payments of $4,554. Rent paid under the Company’s lease during the three months ended March 31, 2014 and 2013 was $
13,662.
|
|
h)
|
In July 2013, the Company entered into an exclusive license agreement with the University of Maryland, Baltimore for a novel drug delivery platform, Nano-Polymer Drug Conjugate Systems. RX-21101 is the Company’s first drug candidate utilizing this platform. The agreement requires the Company to make payments to the University of Maryland if RX-21101 or any products from the licensed delivery platform achieve development milestones. As of March 31, 2014, no development milestones have occurred.
|
|
i)
|
In October 2013, the Company signed an exclusive license agreement with the Ohio State Innovation Foundation, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (“LCAN”). The agreement requires the Company to make payments to the Ohio State Innovation Foundation or any products from the licensed delivery platform achieve development milestones. As of March 31, 2014, no development milestones have occurred.
|
| 14. | Fair Value Measurements |
|
Level 1 Inputs
|
—
|
|
Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible by the Company;
|
|
|
Level 2 Inputs
|
—
|
|
Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly;
|
|
|
Level 3 Inputs
|
—
|
|
Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.
|
|
|
Fair Value Measurements at March 31, 2014
|
|||||||||||||||
|
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
|
Assets:
|
|
|
|
|
||||||||||||
|
Restricted Cash Equivalents
|
$
|
163,530
|
$
|
126,030
|
$
|
37,500
|
$
|
-
|
||||||||
|
Marketable Securities
|
100,000
|
100,000
|
-
|
-
|
||||||||||||
|
Total Assets:
|
$
|
263,530
|
$
|
226,030
|
$
|
37,500
|
$
|
-
|
||||||||
|
|
||||||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Warrant Liabilities
|
$
|
11,290,566
|
-
|
-
|
$
|
11,290,566
|
||||||||||
|
|
Fair Value Measurements at December 31, 2013
|
|||||||||||||||
|
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||
|
Assets:
|
|
|
|
|
||||||||||||
|
Restricted Cash Equivalents
|
$
|
196,130
|
$
|
158,630
|
$
|
37,500
|
$
|
-
|
||||||||
|
Marketable Securities
|
100,000
|
100,000
|
-
|
-
|
||||||||||||
|
Total Assets:
|
$
|
296,130
|
$
|
258,630
|
$
|
37,500
|
$
|
-
|
||||||||
|
|
||||||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Warrant Liabilities
|
$
|
5,034,058
|
-
|
-
|
$
|
5,034,058
|
||||||||||
| a) | Money market funds valued at the net asset value of shares held by the Company and classified within level 1 of the fair value hierarchy; |
| b) | Certificate of deposit valued based upon the underlying terms of a letter of credit, as disclosed in Note 13 and classified within level 2 of the fair value hierarchy. |
|
|
Warrant Liabilities
|
|||
|
Balance at January 1, 2014
|
$
|
5,034,058
|
||
|
Additions
|
3,691,429
|
|||
|
Unrealized losses, net
|
11,660,524
|
|||
|
Unrealized gains on expiration
|
-
|
|||
|
Transfers out of level 3
|
(9,095,445
|
)
|
||
|
Balance at March 31, 2014
|
$
|
11,290,566
|
||
|
|
Warrant Liabilities
|
|||
|
Balance at January 1, 2013
|
$
|
2,842,065
|
||
|
Additions
|
-
|
|||
|
Unrealized gains, net
|
(368,902
|
)
|
||
|
Unrealized gains on expiration
|
-
|
|||
|
Transfers out of level 3
|
-
|
|||
|
Balance at March 31, 2013
|
$
|
2,473,163
|
||
| 15. | Subsequent Events |
| · | our lack of profitability and the need for additional capital to operate our business; |
| · | our drug candidates being in early stages of development, including pre-clinical development |
| · | our ability to obtain the necessary U.S. and worldwide regulatory approvals for our drug candidates; |
| · | successful and timely completion of clinical trials for our drug candidates; |
| · | demand for and market acceptance of our drug candidates; |
| · | our ability to identify partners and collaborators for the development of certain of our drug candidates and, if identified, to enter into mutually agreeable relationships with those partners and collaborators; |
| · | the availability of qualified third-party researchers and manufacturers for our drug development programs; |
| · | our ability to develop and obtain protection of our intellectual property; and |
| · | other risks and uncertainties, including those detailed from time to time in our filings with the Securities and Exchange Commission (the “SEC”). |
| · | the progress of our product development activities; |
| · | the number and scope of our product development programs; |
| · | the progress of our pre-clinical and clinical trial activities; |
| · | the progress of the development efforts of parties with whom we have entered into collaboration agreements; |
| · | our ability to maintain current collaboration programs and to establish new collaboration arrangements; |
| · | the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and |
| · | the costs and timing of regulatory approvals. |
|
Exhibit No
|
Description
|
|
|
|
|
31.1
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
|
|
|
|
31.2
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
|
|
|
|
32.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
32.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
101
|
The following materials from Rexahn Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q, formatted in Extensible Business Reporting Language (“XBRL”): i) Condensed Balance Sheet, ii) Condensed Statement of Operations, iii) Condensed Statement of Cash Flows and (iv) Notes to the Financial Statements.
|
|
|
|
REXAHN PHARMACEUTICALS, INC.
|
|
|
|
(Registrant)
|
|
|
|
|
|
|
By:
|
/s/ Peter D. Suzdak
|
|
Date: May 14, 2014
|
|
Peter D. Suzdak
|
|
|
|
Chief Executive Officer
(principal executive officer)
|
|
|
|
|
|
|
By:
|
/s/ Tae Heum Jeong
|
|
Date: May 14, 2014
|
|
Tae Heum Jeong
|
|
|
|
Chief Financial Officer and Secretary
(principal financial and accounting officer)
|
|
Exhibit No
|
|
Description
|
|
Location
|
|
|
|
|
|
|
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
|
Filed herewith
|
|
|
|
|
|
|
|
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) / 15d-14(a)
|
|
Filed herewith
|
|
|
|
|
|
|
|
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
Filed herewith
|
|
|
|
|
|
|
|
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
Filed herewith
|
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
Filed herewith
|
|
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema
|
|
Filed herewith
|
|
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
Filed herewith
|
|
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
|
|
Filed herewith
|
|
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase
|
|
Filed herewith
|
|
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase
|
|
Filed herewith
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|