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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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26-2593535
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(State of incorporation)
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(I.R.S. Employer Identification No.)
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| Large accelerated filer | o | Accelerated filer | þ |
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Non-accelerated filer
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o |
Smaller reporting company
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þ |
| (Do not check if a smaller reporting company) |
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PAGE
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|||||
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PART I. FINANCIAL INFORMATION
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|||||
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Item 1.
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3 | ||||
| 3 | |||||
| 4 | |||||
| 5 | |||||
| 7 | |||||
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Item 2.
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21 | ||||
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Item 3.
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35 | ||||
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Item 4.
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35 | ||||
| Item 4.T | Controls and Procedures | ||||
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PART II. OTHER INFORMATION
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|||||
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Item 1.
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36 | ||||
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Item 1A.
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36 | ||||
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Item 2.
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43 | ||||
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Item 3.
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43 | ||||
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Item 4.
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43 | ||||
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Item 5.
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43 | ||||
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Item 6.
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44 | ||||
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January 31, 2011
(Unaudited) |
April 30, 2010
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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
|
$ | 522,340 | $ | 632,706 | ||||
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Accounts receivable
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7,812 | 72,055 | ||||||
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Inventory
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409,430 | 535,090 | ||||||
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Prepaid expenses
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340,065 | 249,780 | ||||||
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Other current assets
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36,607 | 695,195 | ||||||
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Total current assets
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1,316,254 | 2,184,826 | ||||||
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Property and equipment, net
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439,627 | 383,959 | ||||||
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Intangible assets, net
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967,612 | 907,710 | ||||||
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Other assets
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129,740 | 52,651 | ||||||
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Total assets
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$ | 2,853,233 | $ | 3,529,146 | ||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||||||
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Current liabilities
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||||||||
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Accounts payable
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$ | 724,114 | $ | 499,044 | ||||
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Accrued liabilities
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910,758 | 843,903 | ||||||
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Notes payable
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69,825 | 56,394 | ||||||
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Total current liabilities
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1,704,697 | 1,399,341 | ||||||
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Long-term notes payable, net
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2,041,694 | - | ||||||
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Long-term portion of convertible debt, net
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- | 2,767 | ||||||
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Total liabilities
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3,746,391 | 1,402,108 | ||||||
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Stockholders' equity
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||||||||
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Preferred stock, undesignated, authorized 10,000,000 shares; none issued or outstanding
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- | - | ||||||
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Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 23,391,714 and 21,457,265, respectively
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2,339 | 2,146 | ||||||
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Stock subscripton receivable
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- | 500,000 | ||||||
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Additional paid-in capital
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88,170,504 | 83,092,470 | ||||||
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Deficit accumulated during the development stage
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(89,066,001 | ) | (81,467,578 | ) | ||||
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Total stockholders’ (deficit) equity
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(893,158 | ) | 2,127,038 | |||||
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Total liabilities and stockholders' equity
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$ | 2,853,233 | $ | 3,529,146 | ||||
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Period from
May 26, 1967 (Inception) to January 31, 2011 |
Three months ended January 31,
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Nine months ended January 31,
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||||||||||||||||||
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2011
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2010
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2011
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2010
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|||||||||||||||||
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(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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(Unaudited)
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||||||||||||||||
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Revenue
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$ | 167,179 | $ | 52,562 | $ | 30,768 | $ | 95,543 | $ | 37,329 | ||||||||||
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Cost of sales
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87,022 | 25,973 | 18,603 | 36,718 | 18,603 | |||||||||||||||
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Net revenue
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80,157 | 26,589 | 12,165 | 58,825 | 18,726 | |||||||||||||||
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Operating expenses
|
||||||||||||||||||||
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Selling, general, and administrative
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38,812,279 | 2,282,823 | 1,753,715 | 5,677,105 | 5,478,927 | |||||||||||||||
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Research and development
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19,090,353 | 498,521 | 1,011,061 | 2,216,413 | 2,169,435 | |||||||||||||||
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Loss on impairment of long-lived assets
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32,113 | - | - | - | - | |||||||||||||||
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Total operating expenses
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57,934,745 | 2,781,344 | 2,764,776 | 7,893,518 | 7,648,362 | |||||||||||||||
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Net operating loss
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57,854,588 | 2,754,755 | 2,752,611 | 7,834,693 | 7,629,636 | |||||||||||||||
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Interest expense
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32,189,628 | 43,093 | 2,612 | 49,682 | 153,311 | |||||||||||||||
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Loss on extinguishment of debt
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250,097 | - | - | - | - | |||||||||||||||
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Other income
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(1,228,312 | ) | (253,661 | ) | (1,511 | ) | (285,952 | ) | (43,345 | ) | ||||||||||
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Net loss
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$ | 89,066,001 | $ | 2,544,187 | $ | 2,753,712 | $ | 7,598,423 | $ | 7,739,602 | ||||||||||
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Net loss per share, basic and diluted
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$ | (0.11 | ) | $ | (0.13 | ) | $ | (0.33 | ) | $ | (0.41 | ) | ||||||||
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Weighted average number of common shares outstanding, basic and diluted
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23,391,155 | 20,614,082 | 23,331,614 | 18,845,881 | ||||||||||||||||
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Period from
May 26, 1967 |
||||||||||||
| (Inception) to |
Nine months ended January 31,
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|||||||||||
| January 31, 2011 | 2011 |
2010
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||||||||||
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(Unaudited)
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(Unaudited)
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(Unaudited)
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||||||||||
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CASH FLOWS FROM OPERATING ACTIVITIES
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||||||||||||
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Net Loss
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$ | (89,066,001 | ) | $ | (7,598,423 | ) | $ | (7,739,602 | ) | |||
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Adjustments to reconcile net loss to net cash used in operating activities
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||||||||||||
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Depreciation and amortization
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1,808,162 | 255,057 | 91,273 | |||||||||
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Amortization of deferred compensation
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336,750 | - | - | |||||||||
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Interest on debt instruments
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31,796,755 | 49,681 | 151,723 | |||||||||
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Loss (gain) on debt settlement and extinguishment
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163,097 | - | - | |||||||||
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Loss on impairment, disposal and write down of long-lived assets
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365,611 | - | - | |||||||||
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Issuance and vesting of compensatory stock options and warrants
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8,209,870 | 111,802 | 1,037,476 | |||||||||
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Issuance of common stock below market value
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695,248 | - | - | |||||||||
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Issuance of common stock as compensation
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551,910 | 56,318 | 138,798 | |||||||||
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Issuance of common stock for services rendered
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1,265,279 | - | - | |||||||||
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Issuance of note payable for services rendered
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120,000 | - | - | |||||||||
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Contributions of capital through services rendered by stockholders
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216,851 | - | - | |||||||||
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Changes in operating assets and liabilities
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||||||||||||
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Accounts receivable, prepaid expenses and other assets
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(662,508 | ) | 95,139 | (647,368 | ) | |||||||
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Inventory
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85,978 | 85,978 | - | |||||||||
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Accounts payable and accrued liabilities
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1,841,426 | 291,920 | 673,663 | |||||||||
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Net cash used in operating activities
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(42,271,572 | ) | (6,652,528 | ) | (6,294,037 | ) | ||||||
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CASH FLOWS FROM INVESTING ACTIVITIES
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||||||||||||
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Purchase of property and equipment
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(1,690,776 | ) | (187,509 | ) | (174,549 | ) | ||||||
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Capitalization of patent costs and license rights
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(1,474,342 | ) | (183,118 | ) | (208,122 | ) | ||||||
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Net cash used in investing activities
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(3,165,118 | ) | (370,627 | ) | (382,671 | ) | ||||||
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CASH FLOWS FROM FINANCING ACTIVITIES
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||||||||||||
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Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
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35,744,664 | 4,901,400 | 9,792,725 | |||||||||
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Repurchase of outstanding warrants
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(2,836,520 | ) | - | (2,836,520 | ) | |||||||
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Proceeds from stockholder notes payable
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977,692 | - | - | |||||||||
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Proceeds from issuance of notes payable, net of issuance costs
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4,379,829 | 2,088,701 | 96,563 | |||||||||
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Proceeds from convertible notes, net of issuance costs
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8,807,285 | - | - | |||||||||
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Payments on notes - short-term
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(1,113,920 | ) | (77,312 | ) | (55,531 | ) | ||||||
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Net cash provided by financing activities
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45,959,030 | 6,912,789 | 6,997,237 | |||||||||
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Net change in cash and cash equivalents
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522,340 | (110,366 | ) | 320,529 | ||||||||
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Cash and cash equivalents, beginning of period
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- | 632,706 | 2,555,872 | |||||||||
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Cash and cash equivalents, end of period
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$ | 522,340 | $ | 522,340 | $ | 2,876,401 | ||||||
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Cash paid for:
|
||||||||||||
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Interest
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$ | 249,665 | $ | 2,262 | $ | 1,588 | ||||||
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Income taxes
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$ | 27,528 | $ | - | $ | - | ||||||
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(1)
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The Company issued 90,472 shares of common stock for the conversion of notes payable with a gross carrying value of $335,199, at a conversion price of $3.705 per share. These notes included a discount totaling $117,488, and thus had a net carrying value of $217,711. The unamortized discount of $117,488 was recognized as interest expense upon conversion.
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(2)
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The Company issued 2,363,767 shares of common stock and paid $2,836,520 in cash to repurchase 4,727,564 outstanding warrants.
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(3)
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The Company initiated a 1-for-15 reverse stock split of the Company’s common stock. The effect of this split resulted in a transfer of $27,681 from common stock to additional paid in capital to account for the reduction of shares outstanding at par value.
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Three months ended January 31,
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Nine months ended January 31,
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|||||||||||||||
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2011
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2010
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2011
|
2010
|
|||||||||||||
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Historical net loss per share:
|
||||||||||||||||
|
Numerator
|
||||||||||||||||
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Net loss, as reported
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$ | (2,544,187 | ) | $ | (2,753,712 | ) | $ | (7,598,423 | ) | $ | (7,739,602 | ) | ||||
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Less: Effect of amortization of interest expense on convertible notes
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- | - | - | - | ||||||||||||
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Net loss attributed to common stockholders (diluted)
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(2,544,187 | ) | (2,753,712 | ) | (7,598,423 | ) | (7,739,602 | ) | ||||||||
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Denominator
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||||||||||||||||
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Weighted-average common shares outstanding
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23,391,155 | 20,614,082 | 23,331,614 | 18,845,881 | ||||||||||||
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Effect of dilutive securities
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- | - | - | - | ||||||||||||
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Denominator for diluted net loss per share
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23,391,155 | 20,614,082 | 23,331,614 | 18,845,881 | ||||||||||||
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Basic and diluted net loss per share
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$ | (0.11 | ) | $ | (0.13 | ) | $ | (0.33 | ) | $ | (0.41 | ) | ||||
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Nine months ended January 31,
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Nine months ended January 31,
|
|||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
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Options to purchase common stock
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855,181 | 1,070,038 | 855,181 | 1,070,038 | ||||||||||||
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Convertible note shares outstanding
|
1,942 | 4,502 | 1,942 | 4,502 | ||||||||||||
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Warrants to purchase common stock
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4,026,352 | 3,342,024 | 4,026,352 | 3,342,024 | ||||||||||||
| January 31, 2011 | April 30, 2010 | |||||||
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Raw materials
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$ | 163,743 | $ | 310,315 | ||||
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Work in process
|
33,635 | - | ||||||
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Finished goods
|
212,052 | 224,775 | ||||||
| 409,430 | $ | 535,090 | ||||||
|
January 31, 2011
|
April 30, 2010
|
|||||||
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Laboratory equipment
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$ | 999,735 | $ | 980,025 | ||||
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Office furniture and fixtures
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118,370 | 32,900 | ||||||
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Computer equipment and software
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129,662 | 53,921 | ||||||
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Leasehold improvements
|
4,810 | 4,810 | ||||||
| 1,252,577 | 1,071,656 | |||||||
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Less: Accumulated depreciation and amortization
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(812,950 | ) | (687,697 | ) | ||||
| $ | 439,627 | $ | 383,959 | |||||
| January 31, 2011 | April 30, 2010 | |||||||
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Reimbursable patent expenses- Glucometrics
|
$ | 77,089 | $ | |||||
|
Prepaid royalty fee
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50,000 | 50,000 | ||||||
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Other
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2,651 | 2,651 | ||||||
| 129,740 | $ | 52,651 | ||||||
|
January 31, 2011
|
April 30, 2010
|
|||||||
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Clinical trial related
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$ | 75,000 | $ | 135,276 | ||||
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Employee related
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215,617 | 254,485 | ||||||
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Professional services
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31,007 | 391,210 | ||||||
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Other
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589,134 | 62,932 | ||||||
| $ | 910,758 | $ | 843,903 | |||||
|
January 31, 2011
|
April 30, 2010
|
|||||||
|
Note payable
|
$ | 3,262,630 | $ | 48,983 | ||||
|
Convertible notes payable
|
7,195 | 15,903 | ||||||
| 3,269,825 | 64,886 | |||||||
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Less: Unamortized discount
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(1,158,306 | ) | (5,725 | ) | ||||
| $ | 2,111,519 | $ | 59,161 | |||||
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Date issued
|
Note principal
|
Final payment premium
|
Effective interest rate
|
|||||||||
|
November 10, 2010
|
$ | 600,000 | $ | 360,000 | 15.68 | % | ||||||
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December 20, 2010
|
1,000,000 | 600,000 | 16.29 | % | ||||||||
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January 26, 2011
|
400,000 | 240,000 | 16.89 | % | ||||||||
| $ | 2,000,000 | $ | 1,200,000 | |||||||||
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Asset Category
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Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
|||||||||||||||
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Patents
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$ | 532,499 | 12.4 | $ | - | $ | (214,360 | ) | $ | 318,139 | ||||||||||
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License Rights
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551,425 | 17.9 | - | (58,262 | ) | 493,163 | ||||||||||||||
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Trademarks
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156,310 | N/A | - | - | 156,310 | |||||||||||||||
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Total
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$ | 1,240,234 | $ | - | $ | (272,622 | ) | $ | 967,612 | |||||||||||
|
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
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|||||||||||||||
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Patents
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$ | 434,612 | 12.6 | $ | - | $ | (111,363 | ) | $ | 323,249 | ||||||||||
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License Rights
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519,353 | 18.6 | - | (38,042 | ) | 481,311 | ||||||||||||||
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Trademarks
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103,150 | N/A | - | - | 103,150 | |||||||||||||||
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Total
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$ | 1,057,115 | $ | - | $ | (149,405 | ) | $ | 907,710 | |||||||||||
|
Three months ended January 31,
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Nine months ended January 31,
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|||||||||||||||
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2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
Net revenue
|
||||||||||||||||
|
United States
|
$ | 26,712 | $ | 30,768 | $ | 69,693 | $ | 37,329 | ||||||||
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Europe
|
25,850 | - | 25,850 | - | ||||||||||||
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Total net revenue
|
$ | 52,562 | $ | 30,768 | $ | 95,543 | $ | 37,329 | ||||||||
|
Segment loss
|
||||||||||||||||
|
United States
|
$ | 283,888 | $ | 106,715 | $ | 466,154 | $ | 100,154 | ||||||||
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Europe
|
9,771 | - | 9,771 | - | ||||||||||||
|
Unallocated expenses
|
||||||||||||||||
|
General and administrative
|
1,962,575 | 1,634,835 | 5,142,355 | 5,360,047 | ||||||||||||
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Research and development
|
498,521 | 1,011,061 | 2,216,413 | 2,169,435 | ||||||||||||
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Net interest and other income
|
(210,568 | ) | 1,101 | (236,270 | ) | 109,966 | ||||||||||
|
Net loss
|
$ | 2,544,187 | $ | 2,753,712 | $ | 7,598,423 | $ | 7,739,602 | ||||||||
|
(1)
|
The Company received $4,401,400 (net of closing costs) from the issuance of 1,724,138 shares of common stock as part of the registered direct offering (the "Offering") described below.
|
|
(2)
|
The Company received $500,000 (net of closing costs), from the issuance of 133,334 shares of restricted common stock in accordance with the Securities Purchase Agreement with Vatea Fund described below. An additional 53,334 shares of common stock were issued as compensation for services provided in closing the Securities Purchase Agreement.
|
|
(3)
|
The Company issued 2,018 shares of common stock from the cashless exercise of 6,333 stock options.
|
|
(4)
|
The Company issued 2,350 shares of common stock for the conversion of notes payable with a gross carrying value of $8,707, at a conversion price of $3.705 per share. These notes included a discount totaling $868, and thus had a net carrying value of $7,839. The unamortized discount of $868 was recognized as interest expense upon conversion.
|
|
(5)
|
The Company issued 19,275 shares of its common stock as compensation to its officers. These shares had a fair value at the grant date of $56,318.
|
|
(6)
|
As further discussed below, the Company recorded $111,802 for the computed fair value of options issued to employees, nonemployee directors, and consultants.
|
|
(1)
|
The Company received $9,735,000 (net of closing costs) from the issuance of 2,933,333 shares of common stock as part of the Securities Purchase Agreement with Vatea Fund. An additional 146,667 shares of common stock were issued as compensation for services provided in closing the Securities Purchase Agreement.
|
|
(2)
|
The Company received $57,625 from the exercise of 29,001 option shares of common stock.
|
|
(3)
|
The Company issued 90,472 shares of common stock for the conversion of notes payable with a gross carrying value of $335,199, at a conversion price of $3.705 per share. These notes included a discount totaling $117,488, and thus had a net carrying value of $217,711. The unamortized discount of $117,488 was recognized as interest expense upon conversion.
|
|
(4)
|
The Company issued 6,197 shares of its common stock as compensation to its Chief Executive Officer. These shares had a fair value at grant date of $31,663.
|
|
(5)
|
The Company issued 867 shares of common stock to its employees as bonus compensation. The Company recognized $5,135 in additional compensation expense for the fair value of the issued shares.
|
|
(6)
|
The company recorded $743,956 for the computed fair value of options issued to employees, nonemployee directors, and consultants.
|
|
(7)
|
The company recorded $37,339 for the computed fair value of 7,408 warrants issued to a consultant.
|
|
(8)
|
The Company extended the term for 151,111 outstanding warrants. The Company recorded $256,181 as additional compensation cost for the computed fair value of the modification.
|
|
(9)
|
The Company issued 2,363,767 shares of restricted common stock and paid $2,836,520 in cash to warrant holders in exchange for 4,727,564 outstanding warrants. The warrants were returned to the Company and cancelled
|
|
●
|
On April 26, 2010, in accordance with the second amendment of the agreement, the Company received $500,000 and issued 133,334 shares to Vatea Fund.
|
|
●
|
On May 27, 2010, in accordance with the second amendment of the agreement, the Company received $500,000 and issued 133,334 shares to Vatea Fund.
|
|
Warrants
|
Weighted Average Exercise Price
|
|||||||
|
Outstanding at April 30, 2010
|
3,322,154 | $ | 3.89 | |||||
|
Granted
|
732,758 | 5.32 | ||||||
|
Forfeited
|
(173,114 | ) | 7.05 | |||||
|
Other
|
144,554 | ( 1) | 2.90 | (1) | ||||
|
Outstanding at January 31, 2011
|
4,026,352 | $ | 3.88 | |||||
|
(1)
|
Pursant to the provisions of
Subsequent Equity Sales
anti dilution clause, the exercise price has been reduced to the base share price of the registered direct offereing on May 7, 2010. The number of warrant shares associated with these warrants have been increased so that the aggregate price of the outstanding warrants stay the same.
|
|||||
|
Outstanding Options
|
||||||||||||
|
Shares Available for Grant
|
Number of Shares
|
Weighted Average Exercise Price
|
||||||||||
|
Balances, at April 30, 2010
|
182,424 | 585,172 | $ | 4.67 | ||||||||
|
Options granted
|
(10,670 | ) | 10,670 | $ | 3.27 | |||||||
|
Restricted stock granted
|
(7,500 | ) | ||||||||||
|
Options exercised
|
(1,193 | ) | $ | 1.69 | ||||||||
|
Options cancelled
|
31,142 | (31,142 | ) | $ | 7.17 | |||||||
|
Balances, at July 31, 2010
|
195,396 | 563,507 | $ | 4.51 | ||||||||
|
Options granted
|
(22,503 | ) | 22,503 | $ | 2.63 | |||||||
|
Options cancelled
|
3,111 | (3,111 | ) | $ | 6.31 | |||||||
|
Balances, at October 31, 2010
|
176,004 | 582,899 | $ | 4.43 | ||||||||
|
Options granted
|
(21,503 | ) | 21,503 | $ | 2.11 | |||||||
|
Options cancelled
|
75,888 | (75,888 | ) | $ | 3.18 | |||||||
|
Balances, at January 31, 2011
|
230,389 | 528,514 | $ | 4.52 | ||||||||
|
For the nine months ended January 31,
|
||||||||
|
2011
|
2010
|
|||||||
|
General and administrative
|
$ | 19,428 | $ | 783,243 | ||||
|
Research and development
|
81,331 | 32,188 | ||||||
| $ | 100,759 | $ | 815,431 | |||||
|
For the nine months ended January 31,
|
||||||||
| 2011 | 2010 | |||||||
|
Risk-free interest rate (weighted average)
|
2.00 | % | 1.73 | % | ||||
|
Expected volatility (weighted average)
|
84.46 | % | 101.23 | % | ||||
|
Expected term (in years)
|
6 | 3-10 | ||||||
|
Expected dividend yield
|
0.00 | % | 0.00 | % | ||||
|
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
|
|
|
Expected Volatility
|
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
|
|
Expected Term
|
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the historical experience with the Company’s stock option grants.
|
|
Expected Dividend Yield
|
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and do not anticipate paying any dividends in the near future.
|
|
Forfeitures
|
As stock-based compensation expense recognized in the statement of operations for the nine months ended January 31, 2011 and 2010 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
|
|
Date issued
|
Note principal
|
Final payment premium
|
Effective interest rate
|
|||||||||
|
March 2, 2011
|
$ | 100,000 | $ | 60,000 | 17.50 | % | ||||||
|
March 4, 2011
|
650,000 | 390,000 | 17.54 | % | ||||||||
|
March 11, 2011
|
111,000 | 66,600 | 17.66 | % | ||||||||
| $ | 861,000 | $ | 516,600 | |||||||||
|
ITEM 2
.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
Three months ended January 31,
|
Nine months ended January 31,
|
|||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||
|
Product revenue
|
$ | 52,562 | $ | 30,768 | $ | 95,543 | $ | 37,329 | ||||||||
|
Cost of sales
|
25,973 | 18,603 | 36,718 | 18,603 | ||||||||||||
|
Gross profit
|
26,589 | 12,165 | 58,825 | 18,726 | ||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Sales and Marketing
|
320,248 | 118,880 | 534,750 | 118,880 | ||||||||||||
|
General and administrative
|
1,962,575 | 1,634,835 | 5,142,355 | 5,360,047 | ||||||||||||
|
Research and development
|
498,521 | 1,011,061 | 2,216,413 | 2,169,435 | ||||||||||||
|
Total Operating expenses
|
2,781,344 | 2,764,776 | 7,893,518 | 7,648,362 | ||||||||||||
|
Net operating loss
|
2,754,755 | 2,752,611 | 7,834,693 | 7,629,636 | ||||||||||||
|
Interest expense
|
43,093 | 2,612 | 49,682 | 153,311 | ||||||||||||
|
Other income
|
(253,661 | ) | (1,511 | ) | (285,952 | ) | (43,345 | ) | ||||||||
|
Net loss
|
$ | 2,544,187 | $ | 2,753,712 | $ | 7,598,423 | $ | 7,739,602 | ||||||||
|
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
|
Product revenue
|
$ | 52,562 | $ | 30,768 | $ | 21,794 | 71 | % | $ | 95,543 | $ | 37,329 | $ | 58,214 | 156 | % | ||||||||||||||||
|
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
|
Marketing and sales expense
|
$ | 320,248 | $ | 118,880 | $ | 201,368 | 169 | % | $ | 534,750 | $ | 118,880 | $ | 415,870 | 350 | % | ||||||||||||||||
|
-
|
We incurred approximately $70,000 and $119,000 in compensation costs related to marketing and selling the cosmetic topical product line Dermacyte for the three and nine months ended January 31, 2011, respectively, that were not incurred in the same periods in 2010. These costs include salaries, commissions, and employee benefits.
|
|
-
|
We incurred an increase of approximately $132,000 and $297,000 in costs related to direct marketing and advertising for the three and nine months ended January 31, 2011, respectively, as compared to the same period in 2010. These costs include attendace at trade shows and conferences, fees paid to a third party PR firm, the costs of product samples distributed to potential customers, and the costs of direct print and online advertisements.
|
|
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
|
General and administrative expense
|
$ | 1,962,575 | $ | 1,634,835 | $ | 327,740 | 20 | % | $ | 5,142,355 | $ | 5,360,047 | $ | (217,692 | ) | -4 | % | |||||||||||||||
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, we incurred a decrease of approximately $45,000 for investment banking fees and $160,000 in investor relation costs.
|
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, compensation costs decreased approximately $225,000 due to a decrease in share-based compensation of approximately $275,000 and a decrease of approximately $130,000 in bonuses paid; offset by an increase of approximately $15,000 for salaries and a $170,000 severance payment that we made to a former executive officer.
|
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, travel costs decreased approximately $96,000 due to a reduction in international travel to Switzerland and Israel, road shows, and costs related to Board meetings and investor presentations.
|
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, consultant costs increased by approximately $273,000. This increase was due to a prior year reclassification of $495,000 in cost incurred for financing activities offset by a $220,000 reduction in costs incurred for recruiting, fees paid to third parties for Dermacyte marketing, and public relations firms.
|
|
-
|
For the three months ended January 31, 2011, the Company accrued approximately $550,000 for the contingent tax liabilities resulting from the ongoing stock option review.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, we incurred an increase of approximately $165,000 in legal and accounting fees associated with our public filings, and listing fees for the NASDAQ Capital Market and Swiss Exchange.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, compensation costs decreased approximately $203,000 due to a decrease in share-based compensation of approximately $700,000 and a decrease of approximately $70,000 in bonuses paid; offset by an increase of approximately $395,000 for salaries and a $170,000 severance payment due to a former executive officer.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, rent expense increased approximately $50,000 due to expansion of our corporate offices in North Carolina.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, travel costs increased approximately $65,000 due to international travel to Switzerland and Israel, road shows, and costs related to Board meetings and investor presentations.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, consultant costs were reduced by approximately $690,000 due to a reduction in recruiting costs and fees paid to third parties for Dermacyte marketing, public relations firms, and financing activities.
|
|
-
|
For the nine months ended January 31, 2011, the Company accrued approximately $550,000 for the contingent tax liabilities resulting from the ongoing stock option review.
|
|
Three months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
Nine months ended January 31,
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
|||||||||||||||||||||||||||||
|
Research and development expense
|
$ | 498,521 | $ | 1,011,061 | $ | (512,540 | ) | -51 | % | $ | 2,216,413 | $ | 2,169,435 | $ | 46,978 | 2 | % | |||||||||||||||
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, we reported a decrease of approximately $530,000 in costs associated with the development and manufacture of Oxycyte and Dermacyte; including the costs of preclinical research.
|
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, the costs associated with the ongoing Phase II-b clinical trials for Oxycyte increased approximately $76,000. Included in these costs are site set-up fees, CRO costs, and supplying all of the sites with equipment and Oxycyte.
|
|
-
|
Also included in the increase in research and development costs for the three months ended January 31, 2011, as compared to the same period in 2010 were increases in payroll costs of approximately $25,000 as headcount was increased to manage the growth and development of the topical indications for Oxycyte and Dermacyte.
|
|
-
|
For the three months ended January 31, 2011, as compared to the same period in 2010, costs incurred for consultants and contract labor were reduced by approximately $85,000.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, we reported a decrease of approximately $432,000 in costs associated with the development and manufacture of Oxycyte and Dermacyte; including the costs of preclinical research.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, the costs associated with the ongoing Phase II-b clinical trials for Oxycyte increased approximately $507,000. Included in these costs are site set-up fees, CRO costs, and supplying all of the sites with equipment and Oxycyte.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, we incurred an increase in payroll costs of approximately $198,000 as headcount was increased to manage the growth and development of the topical indications for Oxycyte and Dermacyte.
|
|
-
|
For the nine months ended January 31, 2011, as compared to the same period in 2010, costs incurred for consultants and contract labor were reduced by approximately $255,000.
|
|
Date issued
|
Note principal
|
Final payment premium
|
Effective interest rate
|
|||||||||
|
November 10, 2010
|
$ | 600,000 | $ | 360,000 | 15.68 | % | ||||||
|
December 20, 2010
|
1,000,000 | 600,000 | 16.29 | % | ||||||||
|
January 26, 2011
|
400,000 | 240,000 | 16.89 | % | ||||||||
|
March 2, 2011
|
100,000 | 60,000 | 17.50 | % | ||||||||
|
March 4, 2011
|
650,000 | 390,000 | 17.54 | % | ||||||||
|
March 11, 2011
|
111,000 | 66,600 | 17.66 | % | ||||||||
| $ | 2,861,000 | $ | 1,716,600 | |||||||||
|
For the nine months ended January 31,
|
||||||||
|
2011
|
2010
|
|||||||
|
Net cash used in operating activities
|
(6,652,528 | ) | (6,294,037 | ) | ||||
|
Net cash used in investing activities
|
(370,627 | ) | (382,671 | ) | ||||
|
Net cash provided by financing activities
|
6,912,789 | 6,997,237 | ||||||
|
-
|
the costs of conducting our Phase IIb clinical trials for TBI;
|
|
-
|
increased payroll costs associated with our expansion in North Carolina; and
|
|
-
|
increased costs associated with marketing and selling our cosmetic products.
|
|
●
|
the initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
|
|
●
|
the outcome, timing and cost of regulatory approvals and the regulatory approval process;
|
|
●
|
delays that may be caused by changing regulatory requirements;
|
|
●
|
the number of product candidates that we pursue;
|
|
●
|
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
|
|
●
|
the timing and terms of future in-licensing and out-licensing transactions;
|
|
●
|
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
|
|
●
|
the cost of procuring clinical and commercial supplies for our product candidates;
|
|
●
|
the extent to which we acquire or invest in businesses, products or technologies; and
|
|
●
|
the possible costs of litigation.
|
|
ITEM 3
.
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
|
ITEM 4
.
|
CONTROLS AND PROCEDURES
|
|
LEGAL
PROCEEDINGS
|
|
●
|
we may not be able to control the amount and timing of resources that our partners may devote to the development or commercialization of product candidates or to their marketing and distribution;
|
|
●
|
partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
|
|
●
|
disputes may arise between us and our partners that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management’s attention and resources;
|
|
●
|
partners may experience financial difficulties;
|
|
●
|
partners may not properly maintain or defend our intellectual property rights, or may use our proprietary information, in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or proprietary information or expose us to potential litigation;
|
|
●
|
business combinations or significant changes in a partner’s business strategy may adversely affect a partner’s willingness or ability to meet its obligations under any arrangement;
|
|
●
|
a partner could independently move forward with a competing product candidate developed either independently or in collaboration with others, including our competitors; and
|
|
●
|
the collaborations with our partners may be terminated or allowed to expire, which would delay the development and may increase the cost of developing our product candidates.
|
|
●
|
|
●
|
obtaining regulatory approval to commence a clinical trial;
|
|
●
|
obtaining institutional review board, or IRB, approval to conduct a clinical trial at numerous prospective sites;
|
|
●
|
recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including meeting the enrollment criteria for our study and competition from other clinical trial programs for the same indication as our product candidates;
|
|
●
|
retaining patients who have initiated a clinical trial but may be prone to withdraw due to the treatment protocol, lack of efficacy, personal issues or side effects from the therapy or who are lost to further follow-up;
|
|
●
|
maintaining and supplying clinical trial material on a timely basis; and
|
|
●
|
collecting, analyzing and reporting final data from the clinical trials.
|
|
●
|
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
|
●
|
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
|
●
|
unforeseen safety issues or any determination that a trial presents unacceptable health risks; and
|
|
●
|
lack of adequate funding to continue the clinical trial, including unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties.
|
|
●
|
capital resources;
|
|
●
|
research and development resources, including personnel and technology;
|
|
●
|
expertise in prosecution of intellectual property rights;
|
|
●
|
manufacturing and distribution experience; and
|
|
●
|
sales and marketing resources and experience.
|
|
●
|
others may be able to make compositions or formulations that are similar to our product candidates but that are not covered by the claims of our patents;
|
|
●
|
we might not have been the first to make the inventions covered by our issued patents or pending patent applications;
|
|
●
|
we might not have been the first to file patent applications for these inventions;
|
|
●
|
others may independently develop similar or alternative technologies or duplicate any of our technologies;
|
|
●
|
it is possible that our pending patent applications will not result in issued patents;
|
|
●
|
our issued patents may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
|
|
●
|
we may not develop additional proprietary technologies that are patentable; or
|
|
●
|
the patents of others may have an adverse effect on our business.
|
|
●
|
actual or anticipated fluctuations in our financial condition and operating results;
|
|
●
|
status and/or results of our clinical trials;
|
|
●
|
results of clinical trials of our competitors’ products;
|
|
●
|
regulatory actions with respect to our products or our competitors’ products;
|
|
●
|
actions and decisions by our collaborators or partners;
|
|
●
|
actual or anticipated changes in our growth rate relative to our competitors;
|
|
●
|
actual or anticipated fluctuations in our competitors’ operating results or changes in their growth rate;
|
|
●
|
competition from existing products or new products that may emerge;
|
|
●
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
|
●
|
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
|
|
●
|
market conditions for biopharmaceutical stocks in general; and
|
|
●
|
general economic and market conditions.
|
|
|
|
|
|
|
|
|
|
|
|
Description
|
||
|
10.1
|
Severance Agreement with Kirk Harrington dated December 6, 2010 (1)
|
|
|
10.2
|
Employment Agreement with Michael B. Jebsen dated December 7, 2010 (1)
|
|
|
10.3
|
First Amendment to Note Purchase Agreement, dated December 29, 2010, between Oxygen Biotherapeutics, Inc. and JP SPC 1 Vatea, Segregated Portfolio (2)
|
|
| 10.4 | Master Agreement with Dermacyte Switzerland dated December 15, 2010 | |
| 10.5 | Amendment no. 1 to Master Agreement with Dermacyte Switzerland dated December 16, 2010 | |
|
10.6
|
Lease Agreement for North Carolina corporate office dated January 27, 2011
|
|
|
31.1
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
|
|
|
31.2
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
|
|
|
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
(1)
|
These documents were filed as exhibits to the quarterly report on Form 10-Q filed by Oxygen Biotherapeutics with the SEC on December 9, 2010, and are incorporated herein by reference.
|
|
(2)
|
This document was filed as an exhibit to the current report on Form 8-K filed by Oxygen Biotherapeutics with the SEC on December 30, 2010, and is incorporated herein by reference.
|
|
OXYGEN BIOTHERAPEUTICS, INC.
|
|||
|
Date: March 21, 2011
|
By:
|
/s/ Chris J. Stern | |
| Chris J. Stern | |||
|
Chairman and Chief Executive Officer
(Principal Executive Officer)
|
|||
|
|
By:
|
/s/ Michael B. Jebsen | |
| Michael B. Jebsen | |||
|
Secretary and Chief Financial Officer
(Principal 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 |
|---|