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QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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36-3898269
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(State or other jurisdiction of
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(I.R.S. Employer Identification No.)
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incorporation or organization)
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Large accelerated filer
¨
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Accelerated filer
¨
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Non-accelerated filer
¨
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Smaller reporting company
x
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Page
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PART I
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FINANCIAL INFORMATION
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Item 1.
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Unaudited Condensed Consolidated Financial Statements:
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Unaudited Condensed Consolidated Balance Sheets
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4
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Unaudited Condensed Consolidated Statements of Operations
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5
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Unaudited Condensed Consolidated Statements of Stockholders’ Equity (Deficiency)
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6
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Unaudited Condensed Consolidated Statements of Cash Flows
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8
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Notes to Unaudited Condensed Consolidated Financial Statements
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10
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Item 2.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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26
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Item 3.
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Quantitative and Qualitative Disclosure About Market Risk
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36
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Item 4.
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Controls and Procedures
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36
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PART II
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OTHER INFORMATION
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Item 1.
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Legal Proceedings
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37
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Item 1A.
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Risk Factors
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37
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Item 6.
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Exhibits
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37
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Signatures
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38
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·
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the development of our drug candidates;
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·
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the regulatory approval of our drug candidates;
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·
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our use of clinical research centers and other contractors;
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·
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our ability to find collaborative partners for research, development and commercialization of potential products;
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·
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acceptance of our products by doctors, patients or payers;
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·
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our ability to market any of our products;
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·
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our history of operating losses;
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·
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our ability to compete against other companies and research institutions;
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·
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our ability to secure adequate protection for our intellectual property;
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·
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our ability to attract and retain key personnel;
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·
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availability of reimbursement for our product candidates;
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·
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the effect of potential strategic transactions on our business;
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·
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our ability to obtain adequate financing; and
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·
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the volatility of our stock price.
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September 30,
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December 31,
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|||||||
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2011
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2010
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||||||
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(unaudited)
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(See Note 1)
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|||||||
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Assets
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||||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$ | 212,280 | $ | 478,668 | ||||
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Grant receivable
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- | 244,479 | ||||||
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Debt issue costs
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- | 4,408 | ||||||
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Other current assets
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100,759 | 141,622 | ||||||
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Total current assets
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313,039 | 869,177 | ||||||
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In-process research and development
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17,742,110 | 17,742,110 | ||||||
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Property and equipment, net
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1,580 | 2,984 | ||||||
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Other assets
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7,750 | 21,370 | ||||||
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Total assets
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$ | 18,064,479 | $ | 18,635,641 | ||||
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Liabilities and Stockholders' Deficiency
|
||||||||
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Current Liabilities:
|
||||||||
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Notes payable, current portion, net of discount
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$ | 761,314 | $ | 2,054,246 | ||||
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Accounts payable and accrued expenses
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167,719 | 223,516 | ||||||
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Interest payable, current portion, net of beneficial conversion
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47,223 | 480,890 | ||||||
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Derivative liability
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538,830 | 534,846 | ||||||
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Total current liabilities
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1,515,086 | 3,293,498 | ||||||
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Notes payable, noncurrent portion, net of discount
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16,388,797 | 16,130,571 | ||||||
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Interest payable, noncurrent portion
|
455,214 | 626,697 | ||||||
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Exchange obligation
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- | 3,949,176 | ||||||
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Total liabilities
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18,359,097 | 23,999,942 | ||||||
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Commitments and contingencies
|
||||||||
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Stockholders’ deficiency:
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||||||||
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Preferred stock, $.001 par value. Authorized 1,500,000 shares; no shares issued and outstanding at September 30, 2011 and December 31, 2010
|
- | - | ||||||
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Common stock, $.001 par value. Authorized 500,000,000 shares; 7,398,316 shares issued and outstanding at September 30, 2011 and 2,419,305 shares issued and outstanding at December 31, 2010
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7,398 | 2,419 | ||||||
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Contingently issuable shares
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15,890 | 15,890 | ||||||
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Additional paid-in capital
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60,693,779 | 55,927,180 | ||||||
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Deficit accumulated during the development stage
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(61,011,685 | ) | (61,309,790 | ) | ||||
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Total stockholders’ deficiency
|
(294,618 | ) | (5,364,301 | ) | ||||
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Total liabilities and stockholders' deficiency
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$ | 18,064,479 | $ | 18,635,641 | ||||
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Three months ended
September 30,
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Nine months ended
September 30,
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Cumulative
period from
August 6, 2001
(inception) to
September 30,
|
||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
2011
|
||||||||||||||||
|
Revenue
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
|
Costs and expenses:
|
||||||||||||||||||||
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Research and development
|
95,897 | 236,734 | 541,292 | 305,500 | 29,369,296 | |||||||||||||||
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General and administrative
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165,946 | 278,897 | 609,542 | 1,264,666 | 20,323,939 | |||||||||||||||
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In-process research and development charge
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- | - | - | - | 11,887,807 | |||||||||||||||
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Impairment of intangible assets
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- | - | - | - | 1,248,230 | |||||||||||||||
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Loss on disposition of intangible assets
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- | - | - | - | 1,213,878 | |||||||||||||||
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Total operating expenses
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261,843 | 515,631 | 1,150,834 | 1,570,166 | 64,043,150 | |||||||||||||||
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Operating loss
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(261,843 | ) | (515,631 | ) | (1,150,834 | ) | (1,570,166 | ) | (64,043,150 | ) | ||||||||||
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Other (income) expense:
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||||||||||||||||||||
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Equity in losses of Hedrin JV
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- | - | - | - | 750,000 | |||||||||||||||
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Change in fair value of derivative liability
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(2,100,898 | ) | (830,165 | ) | (39,587 | ) | (2,696,900 | ) | (2,455,261 | ) | ||||||||||
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Interest and other income
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(196 | ) | (76,275 | ) | (4,518,150 | ) | (228,305 | ) | (7,610,133 | ) | ||||||||||
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Interest expense
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1,165,078 | 349,562 | 1,882,886 | 937,555 | 3,795,334 | |||||||||||||||
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Loss on early extinguishment of debt
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1,225,912 | - | 1,225,912 | 159,070 | 1,384,982 | |||||||||||||||
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Realized gain on sale of marketable equity securities
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- | - | - | - | (76,032 | ) | ||||||||||||||
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Total other (income) expense
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289,896 | (556,878 | ) | (1,448,939 | ) | (1,828,580 | ) | (4,211,110 | ) | |||||||||||
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Net income (loss)
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(551,739 | ) | 41,247 | 298,105 | 258,414 | (59,832,040 | ) | |||||||||||||
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Preferred stock dividends (including imputed amounts)
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- | - | - | - | (1,179,645 | ) | ||||||||||||||
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Net income (loss) applicable to common shares
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$ | (551,739 | ) | $ | 41,247 | $ | 298,105 | $ | 258,414 | $ | (61,011,685 | ) | ||||||||
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Net income (loss) per common share:
|
||||||||||||||||||||
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Basic and diluted
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$ | (0.16 | ) | $ | 0.02 | $ | 0.10 | $ | 0.12 | |||||||||||
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Weighted average shares of common stock outstanding:
|
||||||||||||||||||||
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Basic and diluted
|
3,431,031 | 2,419,305 | 2,861,792 | 2,176,257 | ||||||||||||||||
|
Common stock
shares
|
Common stock
amount
|
Additional
paid-
in capital
|
Deficit
accumulated
during
development
stage
|
Other
|
Total
stockholders'
equity
(deficiency)
|
|||||||||||||||||||
|
Stock issued at $0.02 per share for subscription receivable
|
203,355 | $ | 203 | $ | 3,797 | $ | - | $ | (4,000 | ) | $ | (0 | ) | |||||||||||
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Net loss
|
- | - | - | (56,796 | ) | - | (56,796 | ) | ||||||||||||||||
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Balance at December 31, 2001
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203,355 | 203 | 3,797 | (56,796 | ) | (4,000 | ) | (56,796 | ) | |||||||||||||||
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Proceeds from subscription receivable
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- | - | - | - | 4,000 | 4,000 | ||||||||||||||||||
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Stock issued at $0.02 per share for license rights
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50,839 | 51 | 949 | - | - | 1,000 | ||||||||||||||||||
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Stock options issued for consulting services
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- | - | 60,589 | - | (60,589 | ) | - | |||||||||||||||||
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Common stock issued at $31.50 per share, net of expenses
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60,866 | 61 | 1,704,257 | - | - | 1,704,318 | ||||||||||||||||||
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Amortization of unearned consulting services
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- | - | - | - | 22,721 | 22,721 | ||||||||||||||||||
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Net loss
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- | - | - | (1,037,320 | ) | - | (1,037,320 | ) | ||||||||||||||||
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Balance at December 31, 2002
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315,060 | 315 | 1,769,592 | (1,094,116 | ) | (37,868 | ) | 637,923 | ||||||||||||||||
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Common stock issued at $31.50 per share, net of expenses
|
26,436 | 26 | 743,665 | - | - | 743,691 | ||||||||||||||||||
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Effect of reverse acquisition
|
125,752 | 126 | 2,336,115 | - | - | 2,336,241 | ||||||||||||||||||
|
Payment for fraction shares for stock combination
|
- | - | (300 | ) | - | - | (300 | ) | ||||||||||||||||
|
Preferred stock issued at $10 per share, net of expenses
|
- | - | 9,045,176 | - | 1,000 | 9,046,176 | ||||||||||||||||||
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Imputed preferred stock dividend
|
- | - | 418,182 | (418,182 | ) | - | - | |||||||||||||||||
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Amortization of unearned consulting services
|
- | - | - | - | 37,868 | 37,868 | ||||||||||||||||||
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Unrealized loss on short-term investments
|
- | - | - | - | (7,760 | ) | (7,760 | ) | ||||||||||||||||
|
Net loss
|
- | - | - | (5,960,907 | ) | - | (5,960,907 | ) | ||||||||||||||||
|
Balance at December 31, 2003
|
467,248 | 467 | 14,312,430 | (7,473,205 | ) | (6,760 | ) | 6,832,932 | ||||||||||||||||
|
Exercise of stock options
|
552 | 1 | 30,099 | - | - | 30,100 | ||||||||||||||||||
|
Common stock issued at $55.00 per share, net of expenses
|
67,379 | 67 | 3,361,651 | - | - | 3,361,718 | ||||||||||||||||||
|
Preferred stock dividend accrued
|
- | - | - | (585,799 | ) | - | (585,799 | ) | ||||||||||||||||
|
Preferred stock dividend paid by issuance of preferred shares
|
- | - | 281,073 | - | 25 | 281,098 | ||||||||||||||||||
|
Conversion of preferred stock to common stock at $55.00 per share
|
31,005 | 31 | 140 | - | (171 | ) | - | |||||||||||||||||
|
Warrants issued for consulting services
|
- | - | 125,558 | - | (120,968 | ) | 4,590 | |||||||||||||||||
|
Amortization of unearned consulting services
|
- | - | - | - | 100,800 | 100,800 | ||||||||||||||||||
|
Unrealized gain and reversal of unrealized loss on short-term investments
|
- | - | - | - | 20,997 | 20,997 | ||||||||||||||||||
|
Net loss
|
- | - | - | (5,896,031 | ) | - | (5,896,031 | ) | ||||||||||||||||
|
Balance at December 31, 2004
|
566,184 | 566 | 18,110,951 | (13,955,035 | ) | (6,077 | ) | 4,150,405 | ||||||||||||||||
|
Common stock issued at $55.50 and $57.50 per share, net of expenses
|
238,354 | 238 | 12,249,971 | - | - | 12,250,209 | ||||||||||||||||||
|
Common stock issued at $55.50 in satisfaction of accounts payable
|
13,513 | 13 | 749,987 | - | - | 750,000 | ||||||||||||||||||
|
Exercise of stock options
|
648 | 1 | 32,399 | - | - | 32,400 | ||||||||||||||||||
|
Exercise of warrants
|
5,597 | 6 | 68,485 | - | - | 68,491 | ||||||||||||||||||
|
Preferred stock dividend accrued
|
- | - | - | (175,663 | ) | - | (175,663 | ) | ||||||||||||||||
|
Preferred stock dividend paid by issuance of preferred shares
|
- | - | 477,736 | - | 42 | 477,778 | ||||||||||||||||||
|
Conversion of preferred stock to common stock at $55.00 per share
|
162,937 | 163 | 733 | - | (896 | ) | - | |||||||||||||||||
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Stock issued in connection with acquisition of Tarpan Therapeutics, Inc.
|
214,621 | 215 | 11,052,769 | - | - | 11,052,984 | ||||||||||||||||||
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Reversal of unrealized gain on short-term investments
|
- | - | - | - | (12,250 | ) | (12,250 | ) | ||||||||||||||||
|
Share-based compensation
|
- | - | 66,971 | - | 20,168 | 87,139 | ||||||||||||||||||
|
Net loss
|
- | - | - | (19,140,997 | ) | - | (19,140,997 | ) | ||||||||||||||||
|
Balance at December 31, 2005
|
1,201,854 | 1,202 | 42,810,002 | (33,271,695 | ) | 987 | 9,540,496 | |||||||||||||||||
|
Cashless exercise of warrants
|
547 | - | - | - | - | - | ||||||||||||||||||
|
Costs associated with private placement
|
- | - | (15,257 | ) | - | - | (15,257 | ) | ||||||||||||||||
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Unrealized loss on short-term investments
|
- | - | - | - | (987 | ) | (987 | ) | ||||||||||||||||
|
Share-based compensation
|
- | - | 1,675,499 | - | - | 1,675,499 | ||||||||||||||||||
|
Net loss
|
- | - | - | (9,695,123 | ) | - | (9,695,123 | ) | ||||||||||||||||
|
Balance at December 31, 2006
|
1,202,401 | 1,202 | 44,470,244 | (42,966,818 | ) | - | 1,504,628 | |||||||||||||||||
|
Common stock
shares
|
Common stock
amount
|
Additional paid-
in capital
|
Deficit
accumulated
during
development
stage
|
Other
|
Total
stockholders'
equity
(deficiency)
|
|||||||||||||||||||
|
Common stock issued at $42.00 and $45.00 per share, net of expenses
|
203,710 | $ | 204 | $ | 7,851,981 | $ | - | $ | - | $ | 7,852,185 | |||||||||||||
|
Common stock issued at $36.00 per share in satisfaction of accounts payable
|
556 | 1 | 19,999 | - | - | 20,000 | ||||||||||||||||||
|
Common stock issued with in-licensing agreement at $45.00 per share
|
2,500 | 2 | 112,498 | - | - | 112,500 | ||||||||||||||||||
|
Common stock issued with in-licensing agreement at $40.00per share
|
3,000 | 3 | 119,997 | - | - | 120,000 | ||||||||||||||||||
|
Warrants issued for consulting services
|
- | - | 83,670 | - | - | 83,670 | ||||||||||||||||||
|
Exercise of warrants
|
206 | - | 7,233 | - | - | 7,233 | ||||||||||||||||||
|
Cashless exercise of warrants
|
112 | - | (6 | ) | - | - | (6 | ) | ||||||||||||||||
|
Share-based compensation
|
- | - | 1,440,956 | - | - | 1,440,956 | ||||||||||||||||||
|
Net loss
|
- | - | - | (12,032,252 | ) | - | (12,032,252 | ) | ||||||||||||||||
|
Balance at December 31, 2007
|
1,412,485 | 1,412 | 54,106,572 | (54,999,070 | ) | - | (891,086 | ) | ||||||||||||||||
|
Sale of warrant
|
- | - | 150,000 | - | - | 150,000 | ||||||||||||||||||
|
Warrants issued with 12% notes
|
- | - | 170,128 | - | - | 170,128 | ||||||||||||||||||
|
Share-based compensation
|
- | - | 463,890 | - | - | 463,890 | ||||||||||||||||||
|
Net loss
|
- | - | - | (4,268,858 | ) | - | (4,268,858 | ) | ||||||||||||||||
|
Balance at December 31, 2008
|
1,412,485 | 1,412 | 54,890,590 | (59,267,928 | ) | - | (4,375,926 | ) | ||||||||||||||||
|
Cumulative effect of a change in accounting principle
|
- | - | (150,000 | ) | 127,778 | - | (22,222 | ) | ||||||||||||||||
|
Balance at January 1, 2009, as adjusted
|
1,412,485 | 1,412 | 54,740,590 | (59,140,150 | ) | - | (4,398,148 | ) | ||||||||||||||||
|
Warrants issued with secured 12% notes
|
- | - | 53,044 | - | - | 53,044 | ||||||||||||||||||
|
Share-based compensation
|
- | - | 353,438 | - | - | 353,438 | ||||||||||||||||||
|
Net loss
|
- | - | - | (2,793,285 | ) | - | (2,793,285 | ) | ||||||||||||||||
|
Balance at December 31, 2009
|
1,412,485 | 1,412 | 55,147,072 | (61,933,435 | ) | - | (6,784,951 | ) | ||||||||||||||||
|
Common stock issued at $3.50 per share, net of expenses
|
865,572 | 866 | 2,584,621 | - | - | 2,585,487 | ||||||||||||||||||
|
Derivative liability associated with warrants issued with common stock
|
- | - | (3,497,898 | ) | - | - | (3,497,898 | ) | ||||||||||||||||
|
Shares issued and issuable in Merger with Ariston
|
141,248 | 141 | 1,475,906 | - | 15,890 | 1,491,937 | ||||||||||||||||||
|
Share-based compensation
|
- | - | 217,479 | - | - | 217,479 | ||||||||||||||||||
|
Net income
|
- | - | - | 623,645 | - | 623,645 | ||||||||||||||||||
|
Balance at December 31, 2010
|
2,419,305 | 2,419 | 55,927,180 | (61,309,790 | ) | 15,890 | (5,364,301 | ) | ||||||||||||||||
|
Share-based compensation
|
- | - | 19,210 | - | - | 19,210 | ||||||||||||||||||
|
Shares issued on achievement of Ariston milestone
|
176,561 | 177 | 220,524 | - | - | 220,701 | ||||||||||||||||||
|
Roundup adjustment for 1 for 50 reverse stock split
|
251 | - | - | - | - | - | ||||||||||||||||||
|
Derivative liability associated with warrant amendment
|
- | - | (115,000 | ) | - | - | (115,000 | ) | ||||||||||||||||
|
Beneficial conversion feature of Secured 12% Notes Payable and interest
|
- | - | 2,245,596 | - | - | 2,245,596 | ||||||||||||||||||
|
Conversion of Secured 12% Notes Payable and interest into common stock (see Note 1)
|
4,802,199 | 4,802 | 2,396,269 | 2,401,071 | ||||||||||||||||||||
|
Net income
|
- | - | - | 298,105 | - | 298,105 | ||||||||||||||||||
|
Balance at September 30, 2011
|
7,398,316 | $ | 7,398 | $ | 60,693,779 | $ | (61,011,685 | ) | $ | 15,890 | $ | (294,618 | ) | |||||||||||
|
Nine months ended September 30,
|
Cumulative period
from August 6, 2001
(inception) to
|
|||||||||||
|
2011
|
2010
|
September 30, 2011
|
||||||||||
|
Cash flows from operating activities:
|
||||||||||||
|
Net income/(loss)
|
$ | 298,105 | $ | 258,414 | $ | (59,832,040 | ) | |||||
|
Adjustments to reconcile net income/(loss) to net cash used in operating activities:
|
||||||||||||
|
Equity in losses of Hedrin JV
|
- | - | 750,000 | |||||||||
|
Non cash gain on Nordic settlement
|
(4,017,488 | ) | - | (4,017,488 | ) | |||||||
|
Share-based compensation
|
19,210 | 211,771 | 4,419,000 | |||||||||
|
Amortization of OID, issue costs and beneficial conversion feature
|
1,041,745 | 288,772 | 1,978,376 | |||||||||
|
Change in fair value of derivative liability
|
(39,587 | ) | (2,696,900 | ) | (3,131,569 | ) | ||||||
|
Loss on early extinguishment of debt
|
1,225,912 | 159,070 | 1,384,982 | |||||||||
|
Shares issued in connection with in-licensing agreement
|
- | - | 232,500 | |||||||||
|
Shares issued in connection with Ariston milestone
|
220,701 | - | 220,701 | |||||||||
|
Warrants issued to consultant
|
- | - | 83,670 | |||||||||
|
Amortization of intangible assets
|
- | - | 145,162 | |||||||||
|
Gain on sale of marketable equity securities
|
- | - | (76,032 | ) | ||||||||
|
Depreciation
|
1,404 | 2,644 | 232,267 | |||||||||
|
Noncash portion of in-process research and development charge
|
- | - | 11,721,623 | |||||||||
|
Loss on impairment and disposition of intangible assets
|
- | - | 2,462,108 | |||||||||
|
Other
|
- | - | 23,917 | |||||||||
|
Changes in operating assets and liabilities, net of acquisitions:
|
||||||||||||
|
Decrease in grant receivable
|
244,479 | - | - | |||||||||
|
Decrease in prepaid expenses and other current assets
|
40,508 | 60,612 | 77,999 | |||||||||
|
Decrease/(increase) in other assets
|
10,859 | - | (25,511 | ) | ||||||||
|
Decrease in accounts payable and accrued expenses
|
(55,797 | ) | (332,972 | ) | (178,104 | ) | ||||||
|
Increase in interest payable
|
843,561 | 620,219 | 1,722,574 | |||||||||
|
Net cash used in operating activities
|
(166,388 | ) | (1,428,370 | ) | (41,805,865 | ) | ||||||
|
Cash flows from investing activities:
|
||||||||||||
|
Purchase of property and equipment
|
- | (2,844 | ) | (242,452 | ) | |||||||
|
Cash acquired in connection with acquisitions
|
- | 519,365 | 493,334 | |||||||||
|
Net cash provided from the purchase and sale of short-term investments
|
- | - | 435,938 | |||||||||
|
Proceeds from sale of license
|
- | - | 200,001 | |||||||||
|
Net cash provided by investing activities
|
- | 516,521 | 886,821 | |||||||||
|
Cash flows from financing activities:
|
||||||||||||
|
Proceeds related to sale of common stock, net
|
- | 2,163,486 | 28,059,748 | |||||||||
|
Proceeds from sale of preferred stock, net
|
- | - | 9,046,176 | |||||||||
|
Proceeds from the Hedrin JV agreement
|
- | - | 3,199,176 | |||||||||
|
Proceeds from sale of notes payable
|
- | - | 1,509,915 | |||||||||
|
Sale of warrant
|
- | - | 150,000 | |||||||||
|
Net repayments of notes payable
|
(100,000 | ) | (193,667 | ) | (1,207,124 | ) | ||||||
|
Other, net
|
- | - | 373,433 | |||||||||
|
Net cash provided by/(used in) financing activities
|
(100,000 | ) | 1,969,819 | 41,131,324 | ||||||||
|
Net increase (decrease) in cash and cash equivalents
|
(266,388 | ) | 1,057,970 | 212,280 | ||||||||
|
Cash and cash equivalents at beginning of period
|
478,668 | 17,996 | - | |||||||||
|
Cash and cash equivalents at end of period
|
$ | 212,280 | $ | 1,075,966 | $ | 212,280 | ||||||
|
Nine months ended September 30,
|
Cumulative period
from
August 6, 2001
(inception) to September 30,
|
|||||||||||
|
2011
|
2010
|
2011
|
||||||||||
|
Supplemental disclosure of cash flow information:
|
||||||||||||
|
Interest paid
|
$ | 882 | $ | 28,212 | $ | 68,387 | ||||||
|
Supplemental disclosure of noncash investing and financing activities:
|
||||||||||||
|
Issuance of common stock for acquisitions
|
$ | - | $ | 1,491,937 | $ | 14,881,163 | ||||||
|
Conversion of debt to common stock and warrants
|
2,401,071 | 422,000 | 2,823,071 | |||||||||
|
In-process research and development acquired
|
- | 17,742,110 | 17,742,110 | |||||||||
|
Investment in Hedrin JV
|
- | 500,000 | 1,250,000 | |||||||||
|
Beneficial conversion feature
|
2,245,596 | - | 2,245,596 | |||||||||
|
Warrants issued with notes payable
|
- | - | 250,562 | |||||||||
|
Note issued to settle accrued expenses
|
- | - | 211,900 | |||||||||
|
Common stock issued in satisfaction of accounts payable
|
- | - | 770,000 | |||||||||
|
Imputed and accrued preferred stock dividend
|
- | - | 1,179,644 | |||||||||
|
Conversion of preferred stock to common stock
|
- | - | 1,067 | |||||||||
|
Preferred stock dividends paid by issuance of shares
|
- | - | 759,134 | |||||||||
|
Issuance of common stock in connection with in-licensing agreement
|
- | - | 232,500 | |||||||||
|
Marketable equity securities received in connection with sale of license
|
- | - | 359,907 | |||||||||
|
Warrants issued to consultant
|
- | - | 83,670 | |||||||||
|
Net liabilities assumed over assets acquired in business combination
|
- | - | (675,416 | ) | ||||||||
|
Cashless exercise of warrants
|
- | - | 33 | |||||||||
|
September 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Fair value
|
$ | 0.052 - $0.084 | $ | 0.695 - $0.835 | ||||
|
Expected volatility
|
89 | % | 88 | % | ||||
|
Dividend yield
|
- | - | ||||||
|
Expected term (in years)
|
2.14 - 3.52 | 2.51 - 4.52 | ||||||
|
Risk-free interest rate
|
0.69 | % | 0.96 | % | ||||
|
September 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Fair value at January 1
|
$ | 534,846 | $ | 784,777 | ||||
|
Purchases, sales, issuances and settlements
|
43,571 | 3,272,121 | ||||||
|
Net unrealized (gain)/loss
|
(39,587 | ) | (2,696,900 | ) | ||||
|
Fair value at September 30
|
$ | 538,830 | $ | 1,359,998 | ||||
|
2.
|
LIQUIDITY
|
|
3.
|
REVERSE STOCK SPLIT
|
|
|
·
|
At June 20, 2011, immediately and without further action by the Company’s stockholders, every fifty (50) shares of the Company’s pre-split Common Stock, par value $0.001 per share, was automatically converted into one (1) share of post-split Common Stock, par value $0.001 per share. Accordingly, the Company’s approximately 129.8 million pre-split shares of common stock outstanding will be combined into approximately 2.6 million post-split shares outstanding. The reverse stock split affects all issued and outstanding shares of the Company’s Common Stock immediately prior to June 20, 2011. In addition, proportional adjustments will be made to the Company’s equity awards, outstanding warrants and convertible notes.
|
|
|
·
|
Continental Stock Transfer and Trust Company, Manhattan’s transfer agent, will act as exchange agent for the exchange. Stockholders will receive forms and notices to exchange their existing shares for new shares from the exchange agent or their broker. No fractional shares will be issued. Stockholders who otherwise would be entitled to receive fractional shares because they hold a number of shares not evenly divisible by 50, will automatically receive one whole share of Common Stock in lieu of the fractional share.
|
|
Pre-Reverse
Split
|
Anti-dilution
Effect
|
Reverse Split
Effect
|
Conversion of
12% Secured
Notes and
Interest
|
As of September
30, 2011, Post-
Reverse Split,
Anti-dilution and
Conversion
|
||||||||||||||||
|
Shares outstanding:
|
||||||||||||||||||||
|
Before conversion of 12% Secured Notes
|
129,793,289 | (127,197,423 | ) | 2,595,866 | ||||||||||||||||
|
Conversion of 12% Secured Notes
|
4,802,199 | 4,802,199 | ||||||||||||||||||
|
After conversion
|
129,793,289 | - | (127,197,423 | ) | 4,802,199 | 7,398,065 | ||||||||||||||
|
Shares issuable:
|
||||||||||||||||||||
|
Warrants with antidilution rights
|
129,911,363 | 963,038,387 | (1,071,090,755 | ) | 21,858,995 | |||||||||||||||
|
Warrants without antidilution rights
|
12,989,189 | (12,729,405 | ) | 259,784 | ||||||||||||||||
|
Options
|
11,564,936 | (11,333,637 | ) | 231,299 | ||||||||||||||||
|
Ariston milestone shares
|
15,890,452 | (15,572,643 | ) | 317,809 | ||||||||||||||||
|
12% Secured Notes and interest
|
240,107,200 | (235,305,001 | ) | (4,802,199 | ) | - | ||||||||||||||
|
Other Convertible debt
|
45,776,620 | (44,861,088 | ) | 915,532 | ||||||||||||||||
|
Total shares issued and issuable
|
586,033,049 | 963,038,387 | (1,518,089,952 | ) | - | 30,981,484 | ||||||||||||||
|
4.
|
COMPUTATION OF NET INCOME (LOSS) PER COMMON SHARE
|
|
5.
|
SHARE-BASED COMPENSATION
|
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
General and administrative expense:
|
||||||||||||||||
|
Share-based employee compensation cost
|
$ | 5,597 | $ | 5,597 | $ | 19,210 | $ | 211,664 | ||||||||
|
Share-based consultant and non-employee cost
|
- | 3 | - | 11 | ||||||||||||
|
Total general and administrative expense
|
5,597 | 5,600 | 19,210 | 211,675 | ||||||||||||
|
Research and development expense:
|
||||||||||||||||
|
Share-based employee compensation cost
|
- | - | - | - | ||||||||||||
|
Share-based consultant and non-employee cost
|
- | 30 | - | 96 | ||||||||||||
|
Total research and development expense
|
- | 30 | - | 96 | ||||||||||||
|
Total share-based cost
|
$ | 5,597 | $ | 5,630 | $ | 19,210 | $ | 211,771 | ||||||||
|
Nine months ended September 30,
|
||||||||
|
2011
|
2010
|
|||||||
|
Expected volatility
|
- | 88 | % | |||||
|
Dividend yield
|
- | - | ||||||
|
Expected term (in years)
|
- | 5.7 | ||||||
|
Risk-free interest rate
|
- | 2.46 | % | |||||
|
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at December 31, 2010
|
231,499 | $ | 24.37 | 6.72 | ||||||||||||
|
Granted
|
- | |||||||||||||||
|
Exercised
|
- | |||||||||||||||
|
Cancelled
|
(200 | ) | $ | 14.00 | ||||||||||||
|
Outstanding at September 30, 2011
|
231,299 | $ | 24.37 | 5.19 | $ | - | ||||||||||
|
Exercisable at September 30, 2011
|
210,303 | $ | 26.45 | 4.86 | $ | - | ||||||||||
|
Vested and expected to vest at September 30, 2011
|
229,404 | $ | 24.54 | 5.16 | $ | - | ||||||||||
|
|
·
|
The Nordic Put has been terminated. The Company believed the Nordic Put permitted Nordic to become the owner, upon exercise of the Nordic Put, of 1,428,571 shares of the Company’s common stock. Nordic asserted that the Nordic Put would have permitted Nordic to become the owner of 3,666,666 shares of the Company’s common stock.
|
|
|
·
|
The Nordic Warrant has been terminated. The Company believed the Nordic Warrant covered 285,714 shares of the Company’s common stock. Nordic asserted that the Nordic Warrant covered 666,666 shares of the Company’s common stock.
|
|
|
·
|
Nordic was required to make an additional, non-dilutive capital contribution to the Hedrin JV of $1,500,000, which includes $300,000 contributed to the Hedrin JV by Nordic on December 15, 2010.
|
|
|
·
|
The Hedrin JV has paid to the Company a settlement amount of $500,000, less any "Excess Payment" (defined below). An "Excess Payment" is the amount by which Nordic’s and the Hedrin JV’s reasonable out-of-pocket legal and other costs incurred with respect to the Settlement and Release Agreement exceed $70,000. To date there have been no Excess Payments.
|
|
|
·
|
Our equity interest in the Hedrin JV was reduced to 15%, and further reductions in our equity interest are possible if and when Nordic makes additional capital contributions to the Hedrin JV. In no event shall the capital contributions by Nordic reduce our ownership in the Hedrin JV below 5%.
|
|
|
·
|
The Hedrin JV has paid $75,000 to the Company under the Services Agreement, dated February 21, 2008, and that Services Agreement is terminated as of December 31, 2010.
|
|
|
·
|
The Hedrin JV Agreement, dated January 31, 2008, as amended on February 18, 2008, and as further amended by an Omnibus Amendment on June 9, 2008, between the Company and Nordic; the Shareholders’ Agreement, dated February 21, 2008, as amended by an Omnibus Amendment on June 9, 2008, with respect to the Hedrin JV, and the Registration Rights Agreement, dated February 25, 2009, are terminated.
|
|
Total
|
Cash portion
|
Non cash
portion
|
||||||||||
|
Exchange obligation, termination of the Nordic Put
|
$ | 3,949,176 | $ | - | $ | 3,949,176 | ||||||
|
Termination of the Nordic Warrant
|
71,429 | - | 71,429 | |||||||||
|
Payment of settlement amount
|
500,000 | 500,000 | - | |||||||||
|
Other
|
(3,117 | ) | - | (3,117 | ) | |||||||
|
Totals
|
$ | 4,517,488 | $ | 500,000 | $ | 4,017,488 | ||||||
|
|
·
|
Upon the affirmative decision of Manhattan’s Board of Directors, provided that such decision is made prior to March 8, 2011, to further develop the AST-915, either internally or through a corporate partnership, Manhattan would issue 176,561 of the Milestone Shares. This milestone was attained in January 2011 and the shares were issued in March 2011. The Company recognized approximately $220,000 of research and development expense during the nine months ended September 30, 2011 from the issuance of these shares.
|
|
|
·
|
Upon the acceptance by the FDA of the Ariston’s filing of the first New Drug Application for the AST-726 product candidate, Manhattan would issue 141,248 of the Milestone Shares.
|
|
|
·
|
Upon the Company receiving FDA approval to market the AST-726 product candidate in the United States of America, Manhattan would issue 176,561 of the Milestone Shares.
|
|
|
·
|
Timothy McInerney, a former director of Manhattan, owned 333 shares of Ariston common stock which represented less than 1% of Ariston’s outstanding common stock as of the closing of the Merger.
|
|
|
·
|
Neil Herskowitz, a director of Manhattan, indirectly owned convertible promissory notes of Ariston with interest and principal in the amount of $192,739.
|
|
|
·
|
Michael Weiser, a former director of Manhattan, owned 2,347 shares of Ariston common stock, which represented approximately 2.1% of Ariston’s outstanding common stock as of the closing of the Merger.
|
|
|
·
|
Lindsay Rosenwald, a more than 5% beneficial owner of Manhattan common stock, in his individual capacity and indirectly through trusts and companies he controls, owned 9,958 shares of Ariston common stock, which represented approximately 8.9% of Ariston’s outstanding common stock as of the closing of the Merger and indirectly owned convertible promissory notes of Ariston in the amount of $141,438.
|
|
Cash and cash equivalents
|
$ | 519,365 | ||
|
Other assets
|
120,870 | |||
|
Total identifiable assets
|
640,235 | |||
|
Accounts payable and accrued expenses
|
437,615 | |||
|
ICON convertible note payable
|
1,000,000 | |||
|
5% convertible notes payable
|
15,452,793 | |||
|
Total identifiable liabilities
|
16,890,408 | |||
|
Net identifiable assets (liabilities)
|
(16,250,173 | ) | ||
|
In-process research and development acquired
|
17,742,110 | |||
|
Net assets acquired
|
$ | 1,491,937 |
|
Pro forma consolidated
results:
|
Three Month
Period
Ended
September 30,
2010
|
Nine Month
Period
Ended
September 30,
2010
|
||||||
|
Revenue
|
$ | - | $ | - | ||||
|
Net income
|
$ | 41,247 | $ | 104,411 | ||||
|
Basic and diluted income per share
|
$ | 0.02 | $ | 0.05 | ||||
|
At September 30, 2011
|
At December 31, 2010
|
|||||||||||||||||||||||
|
Current
portion, net
|
Non-current
portion, net
|
Total
|
Current
portion, net
|
Non-current
portion, net
|
Total
|
|||||||||||||||||||
|
Secured 12% Note Payable, Net
|
$ | - | $ | - | $ | - | $ | 1,722,346 | $ | - | $ | 1,722,346 | ||||||||||||
|
Non-interest Bearing Note Payable, Net
|
246,900 | - | 246,900 | 231,900 | - | 231,900 | ||||||||||||||||||
|
Convertible 5% Notes Payable
|
- | 16,225,433 | 16,225,433 | - | 15,452,793 | 15,452,793 | ||||||||||||||||||
|
ICON Convertible Note
|
514,414 | 163,364 | 677,778 | 100,000 | 677,778 | 777,778 | ||||||||||||||||||
|
Total
|
$ | 761,314 | $ | 16,388,797 | $ | 17,150,111 | $ | 2,054,246 | $ | 16,130,571 | $ | 18,184,817 | ||||||||||||
|
December 31,
2010
|
Purchases,
sales,
issuances
and
settlements
|
Change in Fair
Value During
Nine
Months
Ended
September 30,
2011
|
September 30,
2011
|
|||||||||||||
|
Nordic Warrant
|
$ | 71,429 | $ | (71,429 | ) | $ | - | $ | - | |||||||
|
Warrants issued with Convertible 12% Notes
|
15,644 | - | (1,125 | ) | 14,519 | |||||||||||
|
Warrants issued in 2010 Equity Financing
|
447,773 | - | (106,012 | ) | 341,761 | |||||||||||
|
Amended warrants associated with the 12% Secured Notes
|
- | 115,000 | 67,550 | 182,550 | ||||||||||||
|
Total
|
$ | 534,846 | $ | 43,571 | $ | (39,587 | ) | $ | 538,830 | |||||||
|
Nine months ended September 30,
|
Increase/
|
% Increase/
|
||||||||||||||
|
2011
|
2010
|
(decrease)
|
(decrease)
|
|||||||||||||
|
Costs and expenses:
|
||||||||||||||||
|
Research and development:
|
||||||||||||||||
|
Share-based compensation
|
$ | - | $ | - | $ | - | N/A | |||||||||
|
Other research and development expenses
|
541,000 | 305,000 | 236,000 | 77.38 | % | |||||||||||
|
Total research and development expenses
|
541,000 | 305,000 | 236,000 | 77.38 | % | |||||||||||
|
General and administrative:
|
||||||||||||||||
|
Share-based compensation
|
19,000 | 212,000 | (193,000 | ) | -91.04 | % | ||||||||||
|
Other general and administrative expenses
|
591,000 | 1,053,000 | (462,000 | ) | -43.87 | % | ||||||||||
|
Total general and administrative expenses
|
610,000 | 1,265,000 | (655,000 | ) | -51.78 | % | ||||||||||
|
Other (income)/expense:
|
||||||||||||||||
|
Gain on Nordic Settlement
|
(4,517,000 | ) | - | (4,517,000 | ) | N/A | ||||||||||
|
Change in fair value of derivative liabilities
|
(40,000 | ) | (2,697,000 | ) | 2,657,000 | -98.52 | % | |||||||||
|
Loss on early extinguishment of debt
|
1,226,000 | 159,000 | 1,067,000 | 671.07 | % | |||||||||||
|
Interest expense
|
1,882,000 | 938,000 | 944,000 | 100.64 | % | |||||||||||
|
Interest and other (income)/expense
|
- | (228,000 | ) | 228,000 | -100.00 | % | ||||||||||
|
Total other (income)/expense
|
(1,449,000 | ) | (1,828,000 | ) | 379,000 | -20.73 | % | |||||||||
|
Net income/(loss)
|
$ | 298,000 | $ | 258,000 | $ | 40,000 | 15.50 | % | ||||||||
|
Three months ended September 30,
|
Increase/
|
% Increase/
|
||||||||||||||
|
2011
|
2010
|
(decrease)
|
(decrease)
|
|||||||||||||
|
Costs and expenses:
|
||||||||||||||||
|
Research and development:
|
||||||||||||||||
|
Share-based compensation
|
$ | - | $ | - | $ | - | N/A | |||||||||
|
Other research and development expenses
|
96,000 | 236,000 | (140,000 | ) | -59.32 | % | ||||||||||
|
Total research and development expenses
|
96,000 | 236,000 | (140,000 | ) | -59.32 | % | ||||||||||
|
General and administrative:
|
||||||||||||||||
|
Share-based compensation
|
5,000 | 6,000 | (1,000 | ) | -16.67 | % | ||||||||||
|
Other general and administrative expenses
|
161,000 | 273,000 | (112,000 | ) | -41.03 | % | ||||||||||
|
Total general and administrative expenses
|
166,000 | 279,000 | (113,000 | ) | -40.50 | % | ||||||||||
|
Other (income)/expense:
|
||||||||||||||||
|
Change in fair value of derivative liabilities
|
(2,101,000 | ) | (830,000 | ) | (1,271,000 | ) | 153.13 | % | ||||||||
|
Loss on early extinguishment of debt
|
1,226,000 | - | 1,226,000 | N/A | ||||||||||||
|
Interest expense
|
1,164,000 | 350,000 | 814,000 | 232.57 | % | |||||||||||
|
Interest and other (income)/expense
|
1,000 | (76,000 | ) | 77,000 | -101.32 | % | ||||||||||
|
Total other (income)/expense
|
290,000 | (556,000 | ) | 846,000 | -152.16 | % | ||||||||||
|
Net income/(loss)
|
$ | (552,000 | ) | $ | 41,000 | $ | (593,000 | ) | -1446.34 | % | ||||||
|
|
·
|
The Nordic Put has been terminated. The Company believed the Nordic Put permitted Nordic to become the owner, upon exercise of the Nordic Put, of 71,428,571 shares (pre-Reverse Split basis) of the Company’s common stock. Nordic asserted that the Nordic Put would have permitted Nordic to become the owner of 183,333,333 (pre-Reverse Split basis) shares of the Company’s common stock.
|
|
|
·
|
The Nordic Warrant has been terminated. The Company believed the Nordic Warrant covered 14,285,714 (pre-Reverse Split basis) shares of the Company’s common stock. Nordic asserted that the Nordic Warrant covered 33,333,333 (pre-Reverse Split basis) shares of the Company’s common stock.
|
|
|
·
|
Nordic was required to make an additional, non-dilutive capital contribution to the Hedrin JV of $1,500,000, which includes $300,000 contributed to the Hedrin JV by Nordic on December 15, 2010.
|
|
|
·
|
The Hedrin JV has paid to the Company a settlement amount of $500,000, less any "Excess Payment" (defined below). An "Excess Payment" is the amount by which Nordic’s and the Hedrin JV’s reasonable out-of-pocket legal and other costs incurred with respect to the Settlement and Release Agreement exceed $70,000. To date there have been no Excess Payments.
|
|
|
·
|
Our equity interest in the Hedrin JV was reduced to 15%, and further reductions in our equity interest are possible if and when Nordic makes additional capital contributions to the Hedrin JV. In no event shall the capital contributions by Nordic reduce our ownership in the Hedrin JV below 5%.
|
|
|
·
|
The Hedrin JV has paid $75,000 to the Company under the Services Agreement, dated February 21, 2008, and that Services Agreement is terminated as of December 31, 2010.
|
|
|
·
|
The Hedrin JV Agreement, dated January 31, 2008, as amended on February 18, 2008, and as further amended by an Omnibus Amendment on June 9, 2008, between the Company and Nordic; the Shareholders’ Agreement, dated February 21, 2008, as amended by an Omnibus Amendment on June 9, 2008, with respect to the Hedrin JV, and the Registration Rights Agreement, dated February 25, 2009, are terminated.
|
|
Total
|
Cash portion
|
Non cash
portion
|
||||||||||
|
Exchange obligation, termination of the Nordic Put
|
$ | 3,949,176 | $ | - | $ | 3,949,176 | ||||||
|
Termination of the Nordic Warrant
|
71,429 | - | 71,429 | |||||||||
|
Payment of settlement amount
|
500,000 | 500,000 | - | |||||||||
|
Other
|
(3,117 | ) | - | (3,117 | ) | |||||||
|
Totals
|
$ | 4,517,488 | $ | 500,000 | $ | 4,017,488 | ||||||
|
Exhibit
No.
|
Description
|
|
|
31.1
|
Certification of Principal Executive and Financial Officer
|
|
|
32.1
|
|
Certifications of Principal Executive and Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101
|
XBRL
|
|
MANHATTAN PHARMACEUTICALS, INC.
|
|||
|
Date: November 14, 2011
|
By:
|
/s/ Michael G. McGuinness
|
|
|
Michael G. McGuinness
|
|||
|
Principal Executive Officer
|
|||
|
Exhibit No.
|
Description
|
|
|
31.1
|
Certification of Principal Executive and Financial Officer.
|
|
|
32.1
|
Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
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 |
|---|