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Delaware
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88-0378336
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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501 Fifth Avenue, 3rd Floor
New York, NY
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10017
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|
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
(Do not check if a smaller reporting company)
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Smaller reporting company
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x
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| PART I-- FINANCIAL INFORMATION | |||||
| 3 | |||||
| 18 | |||||
| 25 | |||||
| 25 | |||||
|
Item 1.
|
Legal Proceedings
|
||||
| 26 | |||||
| 26 | |||||
| 26 | |||||
| 26 | |||||
| 26 | |||||
| 26 | |||||
| SIGNATURES | 27 | ||||
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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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$
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5,877,781
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$
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5,533,366
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||||
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Prepaid expenses and other current assets
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667,911
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218,389
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||||||
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Total Current Assets
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6,545,692
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5,751,755
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||||||
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Property and equipment, net of accumulated depreciation
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14,214
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13,920
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||||||
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Total Assets
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$
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6,559,906
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$
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5,765,675
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||||
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Liabilities and Stockholders' Deficit
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||||||||
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Current Liabilities:
|
||||||||
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Accounts payable and accrued expenses
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$
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615,272
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$
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378,955
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||||
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Accounts payable and accrued expenses - related party
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189,537
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81,185
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||||||
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Notes payable
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94,481
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157,825
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||||||
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Derivative liabilities
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19,128,761
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6,707,255
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||||||
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Total Current Liabilities
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20,028,051
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7,325,220
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||||||
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Commitments and contingencies
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||||||||
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Stockholders' Deficit:
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||||||||
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Preferred stock, $0.01 par value; 50,000,000 authorized
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||||||||
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-0- issued and outstanding
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-
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-
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||||||
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Common stock, $0.01 par value; 200,000,000 shares authorized;
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||||||||
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25,562,346 and 24,565,447 shares issued and outstanding, respectively
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25,562
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24,565
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||||||
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Additional paid-in capital
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69,723,045
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64,933,145
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||||||
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Deficit accumulated during the development stage
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(83,216,752
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)
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(66,517,255
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)
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||||
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Total Stockholders' Deficit
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(13,468,145
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)
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(1,559,545
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) | ||||
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Total Liabilities and Stockholders' Deficit
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$
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6,559,906
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$
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5,765,675
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||||
| For the Period | ||||||||||||
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from June 13,
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||||||||||||
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For the Three
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For the Three
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2000 | ||||||||||
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Months Ended
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Months Ended
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(Inception) to
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||||||||||
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March 31,
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March 31,
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March 31,
|
||||||||||
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2014
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2013
|
2014
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||||||||||
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Revenue
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$
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-
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$
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-
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$
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-
|
||||||
|
Operating Expenses:
|
||||||||||||
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Research and development, net of reimbursements
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2,460,968
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1,085,707
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31,548,346
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|||||||||
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General and administrative
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1,676,053
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933,135
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30,100,379
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|||||||||
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Depreciation and amortization
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1,405
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-
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3,265,427
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|||||||||
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Loss on disposition of equipment
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-
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4,122
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554,308
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|||||||||
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Total Operating Expenses
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4,138,426
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2,022,964
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65,468,460
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|||||||||
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Loss From Operations
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(4,138,426
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)
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(2,022,964
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)
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(65,468,460
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)
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||||||
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Other Income and (Expense):
|
||||||||||||
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Interest expense
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-
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(575
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)
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(1,967,215
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)
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|||||||
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Gain on extinguishment of liability
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-
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-
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260,000
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|||||||||
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Gain (loss) on change in fair value of derivative liabilities
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(12,561,071
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)
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1,334,512
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(16,041,077
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)
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||||||
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Total Other Income and (Expense)
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(12,561,071
|
)
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1,333,937
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(17,748,292
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)
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|||||||
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Net Loss
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$
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(16,699,497
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)
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$
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(689,027
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)
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$
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(83,216,752
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)
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|||
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Net Loss Per Common Share - Basic and Diluted
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$
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(0.66
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)
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$
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(0.03
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)
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||||||
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Weighted Average Number of Common Shares Outstanding
|
||||||||||||
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- Basic and Diluted
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25,228,299
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21,391,665
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||||||||||
| For the Period | ||||||||||||
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For the Three
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For the Three
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from June 13, | ||||||||||
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Months
Ended
|
Months
Ended
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2000
(Inception) to
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||||||||||
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March 31,
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March 31,
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March 31,
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||||||||||
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2014
|
2013
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2014
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||||||||||
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Cash Flows From Operating Activities:
|
||||||||||||
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Net loss
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$ | (16,699,497 | ) | $ | (689,027 | ) | $ | (83,216,752 | ) | |||
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Adjustments to reconcile net loss to net cash used in
|
||||||||||||
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operating activities:
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||||||||||||
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Stock-based compensation expense
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1,750,926 | 94,200 | 8,460,774 | |||||||||
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Depreciation expense
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1,405 | - | 3,265,427 | |||||||||
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Loss on disposition of equipment
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- | 4,122 | 554,308 | |||||||||
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Amortization of debt discount
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- | - | 900,000 | |||||||||
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Amortization of deferred financing costs
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- | - | 292,692 | |||||||||
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Gain on extinguishment of liability
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- | - | (260,000 | ) | ||||||||
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Loss (gain) on change in fair value of derivative liabilities
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12,561,071 | (1,334,512 | ) | 16,041,077 | ||||||||
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Changes in operating assets and liabilities:
|
||||||||||||
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(Increase) decrease in:
|
||||||||||||
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Prepaid expenses and other current assets
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(449,522 | ) | (50,000 | ) | (370,086 | ) | ||||||
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Increase (decrease) in:
|
||||||||||||
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Accounts payable and accrued expenses
|
236,317 | (437,121 | ) | 957,001 | ||||||||
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Accounts payable and accrued expenses - related party
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108,352 | - | 189,537 | |||||||||
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Net Cash Used In Operating Activities
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(2,490,948 | ) | (2,312,338 | ) | (53,186,022 | ) | ||||||
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Cash Flows From Investing Activities:
|
||||||||||||
|
Payment made for patent rights
|
- | - | (3,000,000 | ) | ||||||||
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Purchase of property and equipment
|
(1,699 | ) | (1,112 | ) | (833,950 | ) | ||||||
|
Net Cash Used In Investing Activities
|
(1,699 | ) | (1,112 | ) | (3,833,950 | ) | ||||||
|
Cash Flows From Financing Activities:
|
||||||||||||
|
Borrowings on convertible debt, net of offering costs
|
- | - | 645,888 | |||||||||
|
Sales of stock, net of offering costs
|
2,871,477 | - | 58,945,832 | |||||||||
|
Proceeds from the exercise of options
|
5,220 | - | 18,273 | |||||||||
|
Proceeds from the exercise of warrants
|
23,709 | - | 3,491,104 | |||||||||
|
Payments on note payable
|
(63,344 | ) | (65,333 | ) | (203,344 | ) | ||||||
|
Net Cash Provided By (Used in) Financing Activities
|
2,837,062 | (65,333 | ) | 62,897,753 | ||||||||
|
Net change in cash
|
344,415 | (2,378,783 | ) | 5,877,781 | ||||||||
|
Cash at beginning of period
|
5,533,366 | 5,618,669 | - | |||||||||
|
Cash at end of period
|
$ | 5,877,781 | $ | 3,239,886 | $ | 5,877,781 | ||||||
|
Supplemental disclosures of cash flows information:
|
||||||||||||
|
Cash paid for interest
|
$ | - | $ | 561 | $ | 1,243 | ||||||
|
Cash paid for taxes
|
$ | - | $ | - | $ | - | ||||||
|
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||||||
|
Beneficial conversion feature discount
|
$ | - | $ | - | $ | 372,850 | ||||||
|
Insurance prepaid through premium finance
|
$ | - | $ | - | $ | 297,825 | ||||||
|
Fair value of warrants issued with debt
|
$ | - | $ | - | $ | 377,150 | ||||||
|
Fair value of warrants issued with stock
|
$ | - | $ | - | $ | 5,985,238 | ||||||
|
Fair value of warrants issued to the placement agent
|
$ | - | $ | - | $ | 2,170,282 | ||||||
|
Conversion of notes payable and accrued interest to stock
|
$ | - | $ | - | $ | 981,729 | ||||||
|
Transfer warrant derivatives from liability to equity classification
|
$ | 139,565 | $ | - | $ | 5,417,984 | ||||||
|
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
|
Derivative liabilities:
|
||||||||||||||||
|
At March 31, 2014
|
-
|
-
|
$
|
19,128,761
|
$
|
19,128,761
|
||||||||||
|
At December 31, 2013
|
-
|
-
|
6,707,255
|
6,707,255
|
||||||||||||
|
Milestones
|
Payments
|
|||
|
(1) filing of an New Drug Application (“NDA”) or regulatory approval for each licensed product
|
$
|
750,000
|
||
|
(2) upon the receipt of regulatory approval from the U.S. FDA for each licensed product
|
1,750,000
|
|||
|
Lives
|
2014
|
2013
|
|||||||
|
Office equipment
|
3 years
|
$
|
17,179
|
$
|
15,480
|
||||
|
Less: accumulated depreciation
|
(2,965
|
)
|
(1,560
|
)
|
|||||
|
Property and equipment, net
|
$
|
14,214
|
$
|
13,920
|
|||||
|
Units
|
Fair Value
|
|||||||
|
Balance, December 31, 2013
|
1,968,623
|
$
|
6,707,255
|
|||||
|
Transfer from liability classification to equity classification
|
(46,025
|
)
|
(139,565
|
)
|
||||
|
Change in fair value
|
-
|
12,561,071
|
||||||
|
Balance, March 31, 2014
|
1,922,598
|
$
|
19,128,761
|
|||||
|
March 31,
|
December 31,
|
|||||||
|
2014
|
2013
|
|||||||
|
Market value of common stock on measurement date (1)
|
$ | 12.45 | $ | 5.89 | ||||
|
Adjusted exercise price
|
$ | 9.95 | $ | 2.48 | ||||
|
Risk free interest rate (2)
|
1.32 | % | 1.27 | % | ||||
|
Warrant lives in years
|
0.5 years
|
0.5 years
|
||||||
|
Expected volatility (3)
|
71 | % | 73 | % | ||||
|
Expected dividend yield (4)
|
- | - | ||||||
|
Probability of stock offering in any period over 5 years (5)
|
- | 25 | % | |||||
|
Range of percentage of existing shares offered (6)
|
- | 35 | % | |||||
|
Offering price range (7)
|
$ | 9 | $ | 9 | ||||
|
(1)
|
The market value of common stock at the above measurement dates is based on the Company’s trading price quoted on the OTC Markets for December 31, 2013 and on the NYSE MKT for March 31, 2014.
|
|
(2)
|
The risk-free interest rate was determined by management using the Treasury Bill as of the respective measurement date.
|
|
(3)
|
Because the Company does not have adequate trading history to determine its historical trading volatility, the volatility factor was estimated by management using the historical volatilities of comparable companies in the same industry and region.
|
|
(4)
|
Management determined the dividend yield to be 0% based upon its expectation that it will not pay dividends for the foreseeable future.
|
|
(5)
|
Management determines the probability of future stock offering at each evaluation date.
|
|
(6)
|
Management estimates that the range of percentages of existing shares offered in each stock offering will be 0% and 35% of the shares outstanding at March 31, 2014 and December 31, 2013, respectively.
|
|
(7)
|
Represents the estimated offering price range in future offerings as determined by management.
|
|
a.
|
Abbott Biotherapeutics Corp – The Company entered into a Product Development and Patent License Agreement with Abbott Biotherapeutics Corp. (formerly Facet Biotech formerly known as Protein Design Labs) in 2003 to secure exclusive rights to a specific antibody when conjugated with alpha emitting radioisotopes. Upon execution of the agreement, the Company made a license fee payment of $3,000,000.
|
|
Milestones
|
Payments
|
|||
|
(1) when Company initiates a Phase I Clinical Trial of a licensed product
|
$
|
750,000
|
||
|
(2) when Company initiates a Phase II Clinical Trial of a licensed product
|
750,000
|
|||
|
(3) when Company initiates a Phase III Clinical Trial of a licensed product
|
1,500,000
|
|||
|
(4) Biological License Application filing with U.S. FDA
|
1,750,000
|
|||
|
(5) First commercial sale
|
1,500,000
|
|||
|
(6) after the first $10,000,000 in net sales
|
1,500,000
|
|||
|
b.
|
Memorial Sloan Kettering Cancer Center (MSKCC) – see related party disclosure.
|
|
|
c.
|
Oak Ridge National Laboratory (ORNL) – API is contracted to purchase $233,100 of radioactive material to be used for research and development, with a renewal option at the contract end. For 2013, the Company was obligated and paid approximately $0.3 million to purchase of radioactive material with ORNL. For 2014, the Company signed a contract with ORNL to purchase $0.4 million of radioactive material.
|
|
|
d.
|
AptivSolutions provides project management services for the study of the drug Ac-225-HuM195 (Actimab-A) used in the Company clinical trials, Phase 1 and Phase 2. The total project is estimated to cost approximately $1.9 million and requires a 12.5% down payment of the total estimated project cost. The down payment totaling $239,000 was paid in 2007 and 2012. On August 6, 2012, October 22, 2012 and May 16, 2013, the agreement was amended to provide for additional services. The total project is now estimated at approximately $2.2 million. As of March 31, 2014, approximately $1.0 million has been expensed to date. AptivSolutions bills the Company when services are rendered and the Company records the related expense to research and development costs.
|
|
e.
|
On June 15, 2012, the Company entered into a license and sponsored research agreement of BC8, a novel murine monoclonal antibody, with Fred Hutchinson Cancer Research Center (FHCRC). The Company will build upon previous and ongoing clinical trials, with BC8 (licensed antibody). FHCRC has currently completed Phase 1 and Phase 2 of the clinical trial and the Company intends to start preparation for a pivotal trial leading to an FDA approval. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC. The cost to develop the trial will range from $13.2 million to $23.5 million, depending on the trial design as required by the FDA. Under the terms of the sponsored research agreement, the Company will fund the FHCRC lab with $150,000 per year for the first two years and $250,000 thereafter. Payments made toward funding the lab will be credited toward royalty payments owed to FHCRC in the given year. A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.
During the quarters ended March 31, 2014 and 2013, the Company recorded fees of $37,500 and $37,500, respectively, related to this agreement.
|
|
f.
|
On July 19, 2012, the Company entered into a clinical trial agreement with FHCRC for
Actimab-A
. The Company will pay $31,366 for each patient that has completed the clinical trial. The Company paid a start-up fee of $19,749 in 2013. During the clinical trial additional fees apply and will be invoiced when applicable. For the three months ended March 31, 2014, the Company paid approximately $16,000 for patient enrollment.
|
|
|
g.
|
On August 28, 2012, the Company entered into a clinical trial agreement with The University of Texas M.D. Anderson Cancer Center for
Actimab-A
. The total estimated cost of conducting the clinical trial is approximately $500,000, which includes a non- refundable institutional fee of $14,500. The estimated cost is based on treating 24 patients through 2013. Upon execution of the agreement, the Company paid $33,946. During 2013, there was one patient treated and the Company paid $34,383 in July 2013. There have been no patients treated in 2014.
|
|
h.
|
On September 26, 2012, the Company entered into a clinical trial agreement with Johns Hopkins University. The Phase 1/2 clinical trial will be conducted with Actinium 225. The clinical trial will be conducted under the protocols established by the Company and pursuant to an Investigational New Drug Exemption (IND 10807) held by the Company. The Company will pay $38,501 per patient, who has completed the clinical trial. The Company is required to pay a start-up fee of $22,847, an annual pharmacy fee of $2,025 and an amendment processing fee of $500, when applicable. The Company paid the $22,847 start-up fee in February 2013. There were no payments made during the three months ended March 31, 2014 for this agreement.
|
|
|
i.
|
On November 21, 2012, the Company entered into a clinical trial agreement with the University of Pennsylvania. The Phase 1/2 clinical trial will be conducted with Actinium 225. The clinical trial will be conducted under the protocols established by the Company and pursuant to an Investigational New Drug Exemption (IND 10807) held by the Company. The Company will pay $31,771 per patient, who has completed the clinical trial. The Company will be required to pay a start-up fee of $16,000 and additional administrative fees, when applicable. The Company accrued $16,000 fee at December 31, 2013 and paid the fee in January 2014.
|
|
|
j.
|
On January 27, 2014, the Company entered into a manufacturing agreement with Goodwin Biotechnology Inc. (“Goodwin”). Goodwin will oversee the current Good Manufacturing Practices (cGMP) production of a monoclonal antibody anticipated to be used in an upcoming phase 3 clinical trial of Iomab™-B. Total cost of the agreement is $2,813,960. The Company paid a non-refundable payment of $562,790 upon execution of the agreement. Periodic payments will be made upon reaching certain milestones. As of March 31, 2014, the remaining cost of the agreement is $2,077,000.
|
|
Weighted
|
||||||||||||||||
|
Average
|
||||||||||||||||
|
Weighted
|
Remaining
|
Aggregate
|
||||||||||||||
|
Number of
|
Average
|
Contractual
|
Intrinsic
|
|||||||||||||
|
Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
|
Outstanding, December 31, 2013
|
1,985,384
|
$
|
3.23
|
8.34
|
$
|
5,908,696
|
||||||||||
|
Issued
|
291,500
|
7.86
|
10
|
|||||||||||||
|
Exercised
|
(11,655)
|
0.78
|
-
|
-
|
||||||||||||
|
Outstanding, March 31, 2014
|
2,265,229
|
$
|
3.84
|
8.34
|
$
|
19,514,362
|
||||||||||
|
Weighted
|
||||||||||||||||
|
Average
|
||||||||||||||||
|
Weighted
|
Remaining
|
Aggregate
|
||||||||||||||
|
Number of
|
Average
|
Contractual
|
Intrinsic
|
|||||||||||||
|
Units
|
Exercise Price
|
Term (in years)
|
Value
|
|||||||||||||
|
Outstanding, December 31, 2013
|
9,673,290
|
1.06
|
4.89
|
47,396,307
|
||||||||||||
|
Granted
|
306,928
|
7.88
|
6.63
|
|||||||||||||
|
Exercised
|
(299,885
|
)
|
1.04
|
|||||||||||||
|
Outstanding, March 31, 2014
|
9,680,333
|
$
|
1.28
|
4.71
|
$
|
107,268,785
|
||||||||||
|
For the three months ended
March 31,
|
||||||||
|
2014
|
2013
|
|||||||
|
Revenues
|
$ | - | $ | - | ||||
|
Operating expenses:
|
||||||||
|
Research and development, net of reimbursements
|
2,460,968 | 1,085,707 | ||||||
|
General and administrative
|
1,676,053 | 933,135 | ||||||
|
Depreciation and amortization
|
1,405 | - | ||||||
|
Other expenses
|
- | 4,122 | ||||||
|
Total operating expenses
|
4,138,426 | 2,022,964 | ||||||
|
Other (income) expense:
|
||||||||
|
Interest expense
|
- | 575 | ||||||
|
Loss (gain) on change in fair value of derivative liabilities
|
12,561,071 | (1,334,512 | ) | |||||
|
Total other (income) expense
|
12,561,071 | (1,333,937 | ) | |||||
|
Net loss
|
$ | (16,699,497 | ) | $ | (689,027 | ) | ||
|
For the three months ended
March 31,
|
||||||||
|
2014
|
2013
|
|||||||
|
Cash provided by (used in) operating activities
|
$ | (2,490,948 | ) | $ | (2,312,338 | ) | ||
|
Cash provided by (used in) investing activities
|
(1,699 | ) | (1,112 | ) | ||||
|
Cash provided by (used in) financing activities
|
2,837,062 | (65,333 | ) | |||||
|
Net change in cash
|
$ | 344,415 | $ | (2,378,783 | ) | |||
|
Exhibit No.
|
Title of Document
|
Location
|
||
| 10.1 |
Sublease Agreement, effective May 12, 2014, by and between Actinium Pharmaceuticals, In. and Corporate Technologies, Inc.
|
Attached
|
||
|
31
|
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
Attached
|
||
|
32
|
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
|
Attached
|
||
|
101.INS
|
XBRL Instance Document
|
Attached
|
||
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
Attached
|
||
|
101.CAL
|
XBRL Taxonomy Calculation Linkbase Document
|
Attached
|
||
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
Attached
|
||
|
101.LAB
|
XBRL Taxonomy Label Linkbase Document
|
Attached
|
||
|
101.PRE
|
XBRL Taxonomy Presentation Linkbase Document
|
Attached
|
|
ACTINIUM PHARMACEUTICALS, INC.
|
|||
|
Date: May 12, 2014
|
|||
|
By:
|
/s/ Kaushik J. Dave
|
||
|
Kaushik J. Dave
|
|||
|
President and Chief Executive Officer,
and Interim Chief Financial Officer
(Duly Authorized Officer, Principal
Executive Officer and Principal Financial and Accounting Officer)
|
|||
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 |
|---|