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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
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OF THE SECURITIES EXCHANGE ACT OF 1934
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TEXAS
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75-1974352
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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4134 Business Park Drive, Amarillo, Texas 79110
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(Address of principal executive offices) (Zip Code)
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(806) 376-1741
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(Issuer’s telephone number, including area code)
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Large accelerated filer [ ]
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Accelerated filer [ ]
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Non-accelerated filer [ ] (do not check if smaller reporting company)
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Smaller reporting company [√]
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PAGE NO.
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PART I:
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FINANCIAL INFORMATION
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ITEM 1.
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Financial Statements
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Balance Sheets– September 30, 2010 (unaudited) and December 31, 2009
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3
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Statements of Operations – Three and Nine Months Ended September 30, 2010 and 2009 (unaudited)
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4
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Condensed Statements of Cash Flows – Nine Months Ended September 30, 2010 and 2009 (unaudited)
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5
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Notes to Financial Statements (unaudited)
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6
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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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9
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ITEM 3.
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Quantitative and Qualitative Disclosures About Market Risk.
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16
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ITEM 4.
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Controls and Procedures
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19
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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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20
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ITEM 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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20
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ITEM 3.
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Defaults Upon Senior Securities
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22
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ITEM 4.
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Submission of Matters to a Vote of Security Holders
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22
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ITEM 5.
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Other Information
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22
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ITEM 6.
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Exhibits……………………………………………………………
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22
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Signatures
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23
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ITEM 1.
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Financial Statements
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September 30, 2010
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December 31, 2009
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||||||||
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Assets
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(unaudited)
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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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$ | 1,399 | $ | 24,216 | |||||
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Other current assets
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78,635 | 87,208 | |||||||
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Total current assets
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80,034 | 111,424 | |||||||
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Property, equipment, and software, net
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2,064 | 4,321 | |||||||
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Patents, net
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117,373 | 123,184 | |||||||
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Total assets
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$ | 199,471 | $ | 238,929 | |||||
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Liabilities and Stockholders' Deficit
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|||||||||
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Current liabilities:
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|||||||||
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Accounts payable and accrued expenses
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$ | 568,790 | $ | 318,550 | |||||
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Accrued interest - related party
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728,609 | 661,294 | |||||||
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Accrued expenses – related party
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78,360 | 78,360 | |||||||
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Derivative liabilities
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931,775 | 1,928,120 | |||||||
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Notes payable - related party
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2,000,000 | 2,000,000 | |||||||
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Total current liabilities
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4,307,534 | 4,986,324 | |||||||
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Total liabilities
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4,307,534 | 4,986,324 | |||||||
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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:
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|||||||||
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Authorized shares - 10,000,000
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|||||||||
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Series 2010-A, 10,000 shares authorized
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Issued and outstanding shares – 950 at September 30, 2010 and December 31, 2009
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10 | - | |||||||
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Common stock, $0.01par value:
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|||||||||
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Authorized shares - 100,000,000
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|||||||||
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Issued and outstanding shares – 54,646,272 at September 30, 2010 and 52,041,001 at December 31, 2009
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546,463 | 520,410 | |||||||
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Additional paid-in capital
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30,545,354 | 30,051,134 | |||||||
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Accumulated deficit
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( 35,199,890 | ) | ( 35,318,939 | ) |
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Total stockholders' deficit
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(4,108,063 | ) | ( 4,747,395 | ) |
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Total liabilities and stockholders’ deficit
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$ | 199,471 | $ | 238,929 | |||||
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Three months ended September 30,
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Nine months ended September 30,
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|||||||||||||||
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2010
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2009
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2010
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2009
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|||||||||||||
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Revenues:
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||||||||||||||||
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Dietary supplement sales
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$ | 1,375 | $ | 36 | $ | 4,495 | $ | 264 | ||||||||
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Sublicense fee revenue
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- | 48,000 | - | 48,795 | ||||||||||||
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Total revenues
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1,375 | 48,036 | 4,495 | 49,059 | ||||||||||||
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Cost of revenues:
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||||||||||||||||
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Product
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600 | 21 | 2,695 | 75 | ||||||||||||
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Sublicense fees
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- | 24,009 | - | 24,407 | ||||||||||||
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Total cost of revenues
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600 | 24,030 | 2,695 | 24,482 | ||||||||||||
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Gross Margin
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775 | 24,006 | 1,800 | 24,577 | ||||||||||||
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Operating expenses:
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Research and development
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102,268 | 110,032 | 301,386 | 389,969 | ||||||||||||
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Selling, general and administrative
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193,538 | 235,484 | 506,105 | 917,572 | ||||||||||||
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Total operating expenses
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295,806 | 345,516 | 807,491 | 1,307,541 | ||||||||||||
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Operating loss
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( 295,031 | ) | ( 321,510 | ) | ( 805,691 | ) | ( 1,282,964 | ) | ||||||||
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Other income (expense)
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||||||||||||||||
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Change in fair value of derivative
Instruments
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148,555 | ( 744,913 | ) | 996,345 | ( 2,736,649 | ) | ||||||||||
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Interest expense
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( 24,173 | ) | ( 23,697 | ) | ( 70,517 | ) | ( 69,406 | ) | ||||||||
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Interest and other income
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- | - | 140 | 3,391 | ||||||||||||
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Net income (loss)
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( 170,649 | ) | ( 1,090,120 | ) | 120,277 | (4,085,628 | ) | |||||||||
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Dividend on preferred stock
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( 1,228 | ) | - | ( 1,228 | ) | - | ||||||||||
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Net income (loss) applicable to common shareholders
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$ | ( 171,877 | ) | $ | ( 1,090,120 | ) | $ | 119,049 | $ | (4,085,628 | ) | |||||
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Basic net income (loss) per share
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$ | ( 0.00 | ) | $ | ( 0.02 | ) | $ | 0.00 | $ | ( 0.10 | ) | |||||
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Diluted net income (loss) per share
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$ | ( 0.00 | ) | $ | ( 0.02 | ) | $ | 0.00 | $ | ( 0.10 | ) | |||||
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Basic weighted average shares outstanding
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54,600,497 | 45,689,709 | 53,775,893 | 42,508,318 | ||||||||||||
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Diluted weighted average shares outstanding
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54,600,497 | 45,689,709 | 55,082,699 | 42,508,318 | ||||||||||||
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Nine months ended September 30,
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|||||||
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2010
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2009
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||||||
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Net cash used in operating activities
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$
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( 312,162
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)
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$
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( 660,471
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)
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Cash from investing activities:
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|||||||
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Patent expenditures
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( 6,555
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)
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( 10,142
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)
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Net cash used in investing activities
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( 6,555
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)
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( 10,142
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)
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Cash from financing activities:
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Proceeds from exercise of options
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8,200
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-
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Convertible preferred stock issued for cash
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85,500
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-
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Proceeds from sale of common stock
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202,200
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699,735
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Net cash provided by financing activities
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295,900
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699,735
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Net increase (decrease) in cash
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(22,817
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) |
29,122
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Cash and cash equivalents at beginning of period
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24,216
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10,853
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Cash and cash equivalents at end of period
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$
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1,399
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$
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39,975
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Supplemental disclosure of cash flow information
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|||||||
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Cash paid for interest
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$
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3,202
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$
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1,393
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Cash paid for income taxes
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-
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-
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|||||
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1.
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Basis of presentation. The accompanying financial statements, which should be read in conjunction with the financial statements and footnotes included in the Company's Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission, are unaudited, but have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the nine months ended September 30, 2010 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2010.
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2.
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Financial Condition. Our viability as a company is dependent upon successful commercialization of products resulting from its research and product development activities. We plan on working with commercial development partners in the United States and in other parts of the world to provide the necessary sales, marketing and distribution infrastructure to successfully commercialize the interferon alpha product for both human and animal applications. Our products will require significant additional development, laboratory and clinical testing and investment prior to obtaining regulatory approval to commercially market our product(s). Accordingly, for at least the next few years, we will continue to incur research and development and general and administrative expenses and may not generate sufficient revenues from product sales or license fees to support its operations.
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The Company continues to pursue a broad range of financing alternatives to improve its financial condition. These alternatives may include the sale or issuance of a substantial amount of common stock, common stock warrants or stock options. These financing alternatives could require an increase in the number of authorized shares of the Company’s common stock and result in significant dilution to existing shareholders and, possibly, a change of control of the Company.
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3.
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Common Stock. The shareholders have authorized 100,000,000 shares of voting common shares for issuance. On September 30, 2010, a total of 80,640,368 shares of common stock were either outstanding (54,646,272) or reserved for issuance upon exercise of options and warrants or conversion of convertible preferred stock (25,994,096). Common stock issuances in the first, second and third quarters of 2010 are as follows:
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Common Stock Issued in Q1 2010
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Shares
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Issue Price
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Net Price
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|||||||||
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Private placements – cash
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1,060,000 | $ | 0.10 | $ | 103,000 | |||||||
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Directors, officers, consultants plan – services
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145,814 | 0.105-0.16 | 19,130 | |||||||||
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Options exercised – cash
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82,000 | 0.10 | 8,200 | |||||||||
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Options exercised – cashless
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70,258 | 0.10 | - | |||||||||
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Total Common Stock Issued in Q1 2010
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1,358,072 | $ | 0.105-0.16 | $ | 130,330 | |||||||
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Common Stock Issued in Q2 2010
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Shares
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Issue Price
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Net Price
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|||||||||
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Private placements – cash
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1,075,000 | $ | 0.10 | $ | 99,000 | |||||||
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Directors, officers, consultants plan – services
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90,343 | 0.08-0.105 | 8,630 | |||||||||
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Total Common Stock Issued in Q2 2010
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1,165,343 | $ | 0.08-0.105 | $ | 107,630 | |||||||
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Brokerage commissions totaled $8,500 during the second quarter of 2010. Net price above reflects net proceeds after commissions are deducted. Private placement stock issued during the second quarter of 2010 included 100% warrant coverage (1,075,000 warrants) with $0.10 exercise price and 3-year term.
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Common Stock Issued in Q3 2010
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Shares
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Issue Price
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Net Price
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|||||||||
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Private placements – cash
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2,000 | $ | 0.10 | $ | 200 | |||||||
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Directors, officers, consultants plan – services
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79,856 | 0.06-0.065 | 4,916 | |||||||||
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Total Common Stock Issued in Q3 2010
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81,856 | $ | 0.06-0.10 | $ | 5,116 | |||||||
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No brokerage commissions were paid for the sale of common stock during the third quarter of 2010. Private placement stock issued during the third quarter of 2010 included 100% warrant coverage (2,000 warrants) with $0.10 exercise price and 3-year term.
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The common stock issuances above do not trigger any reset provisions of previously issued securities. The issuances of common stock with prices below $0.10 per share that are issued to employees, directors or consultants pursuant to stock plans approved by a majority of the non-employee directors are exempt issuances.
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4.
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Convertible Preferred Stock. The shareholders have authorized 10,000,000 shares of preferred stock shares for issuance. The Board of directors authorized the issuance of up to 10,000 shares of Series 2010-A 10% Convertible Preferred Stock on July 29, 2010. Each preferred share is convertible into 1,000 common shares ($100 stated value per share divided by $0.10). Dividends are payable quarterly at 10% per annum in cash or stock at the option of the preferred stock Holder. Stock dividend payments are valued at the higher of $0.10 per share of common stock or the average of the two highest volume weighted average closing prices for the 5 consecutive trading days ending on the trading day that is immediately prior to the dividend payment date. During the third quarter of 2010, a total of 950 shares of Series 2010-A 10% Convertible Preferred Stock were issued. Net proceeds totaled $85,500 after $9,500 of brokerage commissions. The preferred stock is convertible into 950,000 shares of restricted common stock.
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5.
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Common Stock Options. We recognized $112,874 of employee options expense, related to previously issued options during the nine months ended September 30, 2010. No more costs remain to be recognized for these options. The Board granted 100,000 options with 2-year term and $0.11 exercise price to a consultant on March 8, 2010 with a fair value of $8,852. One quarter of the options (fair value $2,213) vest each quarter during 2010. An officer and a consultant exercised 245,000 options in 2010. See “7. Stock Option and Warrant Exercise Incentive
”
below for more details about 2010 stock option exercises. On July 29, 2010, the Board of Directors authorized the issuance of 1,050,000 options with 5-
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6.
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Common Stock Warrants. Private placement stock (1,060,000 shares) issued at $0.10 per share during the first quarter of 2010 included 1,060,000 warrants with $0.10 exercise price and 3-year term. We received $103,000 of net proceeds. Private placement stock (1,075,000 shares) issued at $0.10 per share during the second quarter of 2010 included 1,075,000 warrants with $0.10 exercise price and 3-year term. We received $99,000 of net proceeds. Private placement stock (2,000 shares) issued at $0.10 per share during the third quarter of 2010 included 2,000 warrants with $0.10 exercise price and 3-year term.
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Options/Warrants Exercised Q1 2010
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Common Stock Issued
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Release of Reserved into Available Shares
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Net Cash to Company
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Options
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245,000 | 152,258 | 92,742 | $ | 8,200 | |||||||||||
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Warrants
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- | - | - | - | ||||||||||||
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Total
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245,000 | 152,258 | 92,742 | $ | 8,200 | |||||||||||
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8.
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Notes Payable – Related Party. Two $1,000,000 notes are payable under an unsecured loan agreement with Hayashibara Biochemical Laboratories, Inc. (“HBL”), a major stockholder, dated July 22, 1999. Although we are currently in repayment default on the notes, HBL has not demanded payment.
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9.
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Line of Credit. We have a line of credit with Wells Fargo for $20,000, with an interest rate of prime rate plus 6.75 percent. There was an outstanding balance on September 30, 2010 of $20,047 which is included in accounts payable.
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10.
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License and Sublicense Agreements. During the first nine months of 2010 no license fees were received.
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11.
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Related Party Transactions. The Company engaged the law firm of Underwood, Wilson, Berry, Stein and Johnson P.C. of which Mr. Morris is a shareholder. Mr. Morris is also the Secretary of the Company. During the nine months ended September 30, 2010 the Company incurred $24,829 of legal fees from this law firm.
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12.
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Subsequent Events. On October 15 and 20, 2010 two consultants purchased 50,000 shares and 2,857,143 shares of common stock respectively at $0.035 per share under a stock plan for officers, directors and consultants. Net proceeds totaled $101,750.
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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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·
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announcements of technological innovation or improved or new diagnostic products by others;
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·
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general market conditions;
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·
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changes in government regulation or patent decisions;
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·
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changes in insurance reimbursement practices or policies for diagnostic products.
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·
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net tangible assets in excess of $2,000,000, if such issuer has been in continuous operation for three years;
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·
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net tangible assets in excess of $5,000,000, if such issuer has been in continuous operation for less than three years; or
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·
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average revenue of at least $6,000,000, for the last three years.
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ITEM 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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Date (2010)
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Shares of Common Stock
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Purchaser
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Discount
1
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||||||
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Issue Price
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Number
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Per Share
|
Total
|
||||||
|
1
|
January 7
2
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$
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.10
|
100,000
|
Dan Mascarenhas
|
$
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0.08
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$
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8,000
|
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2
|
January 11
3
|
.10
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30,000
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Dr. Joseph Cummins
|
0.071
|
2,130
|
|||
|
3
|
January 11
4
|
.175
|
25,714
|
Dr. Joseph Cummins
|
0
|
0
|
|||
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4
|
January 18
5
|
.10
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500,000
|
Thomas Ulie
|
.07
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35,000
|
|||
|
5
|
January 19
6
|
.10
|
10,000
|
Dr. Kimball Miller
|
.0763
|
7,630
|
|||
|
6
|
January 22
7
|
.10
|
52,000
|
Dr. Gary Coy
|
.07
|
3,640
|
|||
|
7
|
January 22
8
|
.1762
|
44,544
|
Dr. Gary Coy
|
0
|
0
|
|||
|
8
|
February 9
9
|
.10
|
50,000
|
David Min
|
.0329
|
1,645
|
|||
|
9
|
March 12
10
|
.10
|
150,000
|
Marian Tibbits
|
.005
|
750
|
|||
|
10
|
March 12
10
|
.10
|
150,000
|
Paul Tibbits
|
.005
|
750
|
|||
|
11
|
March 12
|
.105
|
10,000
|
George Bergleitner, Jr.
|
0
|
0
|
|||
|
12
|
March 29
11
|
.10
|
50,000
|
Robert Costes
|
.025
|
1,250
|
|||
|
13
|
March 29
11
|
.10
|
50,000
|
Joanna Costes
|
.025
|
1,250
|
|||
|
14
|
April 15
12
|
.10
|
100,000
|
Marian Tibbits
|
.02
|
2,000
|
|||
|
15
|
April 15
12
|
.10
|
100,000
|
Paul Tibbits
|
.02
|
2,000
|
|||
|
16
|
April 26
13
|
.10
|
25,000
|
David Minn
|
.0198
|
495
|
|||
|
17
|
May 7
14
|
.10
|
150,000
|
Marian Tibbits
|
.0089
|
1,335
|
|||
|
18
|
May 7
14
|
.10
|
150,000
|
Paul Tibbits
|
.0089
|
1,335
|
|||
|
19
|
June 4
15
|
.10
|
350,000
|
Paul Tibbits
|
0
|
0
|
|||
|
20
|
June 29
16
|
.10
|
200,000
|
Virginia Sumner, Trustee
|
0
|
0
|
|||
|
21
|
July 15
17
|
.10
|
2,000
|
Stephen H. Gens
|
0
|
0
|
|||
|
2.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.20 per share. The stock closing price on January 7, 2010 was $0.18 per share.
|
|
3.
|
Options were exercised for cash. The stock closing price on January 11, 2010 was $0.1701 per share.
|
|
4.
|
A total of 60,000 cashless options were exercised at $0.10 per share. 25,714 shares of common stock were issued and 34,286 shares of common stock held in reserve for options were returned to Treasury. The stock closing price on January 11, 2010 was $.1701 per share.
|
|
5.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on Friday, January 15, 2010 was $0.17 per share. No shares traded on January 18, 2010.
|
|
6.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on January 19, 2010 was $0.1763 per share.
|
|
7.
|
Options were exercised for cash. The stock closing price on January 22, 2010 was $0.17 per share.
|
|
8.
|
103,000 cashless options were exercised at $0.10 per share. 44,544 shares of common stock were issued and 58,456 shares of common stock held in reserve for options were returned to Treasury. The stock closing price on January 22, 2010 was $0.17 per share.
|
|
9.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on February 9, 2010 was $0.1329 per share.
|
|
10.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on March 6, 2010 was $0.105 per share.
|
|
11.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on March 29, 2010 was $0.125 per share.
|
|
12.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on April 15, 2010 was $0.12 per share.
|
|
13.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on April 26, 2010 was $0.1198 per share.
|
|
14.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on May 7, 2010 was $0.1089 per share.
|
|
15.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on June 4, 2010 was $0.076 per share.
|
|
16.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on June 29, 2010 was $0.08 per share.
|
|
17.
|
The price was $0.10 for each share of common stock and one warrant with three year term and exercisable at $0.10 per share. The stock closing price on July 15, 2010 was $0.07 per share.
|
|
Date (2010)
|
Shares of Convertible Preferred Stock*
|
Purchaser
|
Discount
|
|||
|
Issue Price
|
Number
|
Per Share
|
Total
|
|||
|
1
|
July 22
|
$ 100
|
300
|
Paul Tibbits
|
$ .00
|
0
|
|
2
|
August 11
|
100
|
350
|
Paul Tibbits
|
.00
|
0
|
|
3
|
August 31
|
100
|
100
|
Paul Tibbits
|
.00
|
0
|
|
4
|
September15
|
100
|
200
|
Paul Tibbits
|
.00
|
0
|
|
|
* Each preferred share is convertible into 1,000 common shares ($100 stated value per share divided by $0.10). Dividends are payable quarterly at 10% per annum in cash or stock at the option of the preferred stock Holder. Stock dividend payments are valued at the higher of $0.10 per share of common stock or the average of the two highest volume weighted average closing prices for the 5 consecutive trading days ending on the trading day that is immediately prior to the dividend payment date. The stock closing price was $0.07, $0.053, $0.05 and $0.055 per share on July 22, August 11, August 31 and September 15, 2010, respectively.
|
|
ITEM 3.
|
Defaults Upon Senior Securities.
|
|
|
None, other than set forth in Note 6 to Financial Statements, “Notes Payable”, under Part I, Item 1, above, regarding non-payment of the HBL Notes.
|
|
ITEM 4.
|
Submission of Matters to a Vote of Security Holders.
|
|
ITEM.5.
|
Other Information
|
|
ITEM 6.
|
Exhibits.
|
|
|
None
|
|
|
Date: November 19, 2010
|
By:
/s/ Joseph M. Cummins
|
|
|
Joseph M. Cummins
|
|
|
President and Chief Executive Officer
|
|
|
Date: November 19, 2010
|
By:
/s/ Bernard Cohen
|
|
|
Bernard Cohen
|
|
|
Vice President and Chief Financial Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | 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 |
|---|