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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
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
þ
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(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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Consolidated Financial Statements
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3
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Consolidated Balance Sheets (Unaudited) as of January 31, 2015 and April 30, 2014
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3
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||
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Consolidated Statements of Comprehensive Loss (Unaudited) for the Three and Nine months Ended January 31, 2015 and 2014
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4
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||
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Consolidated Statements of Cash Flows (Unaudited) for the Nine months Ended January 31, 2015 and 2014
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5
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||
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Notes to Consolidated Financial Statements
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7
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||
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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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20
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Item 3.
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Quantitative and Qualitative Disclosures About Market Risk
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30
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Item 4.
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Controls and Procedures
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31
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PART II. OTHER INFORMATION
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|||
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Item 1.
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Legal Proceedings
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32
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Item 1A.
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Risk Factors
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32
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Item 2.
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Unregistered Sales of Equity Securities and Use of Proceeds
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32
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Item 3.
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Defaults Upon Senior Securities
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32
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Item 4.
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Mine Safety Disclosures
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32
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Item 5.
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Other Information
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32
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Item 6.
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Exhibits
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32
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ITEM 1.
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CONSOLIDATED FINANCIAL STATEMENTS
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January 31,
2015
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April 30,
2014
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|||||||
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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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$ | 9,915,479 | $ | 58,320,555 | ||||
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Marketable securities
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7,159,176 | - | ||||||
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Accounts receivable
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64,662 | 36,358 | ||||||
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Government grant receivable
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- | 29,750 | ||||||
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Prepaid expenses
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348,151 | 401,964 | ||||||
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Other current assets
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181,834 | 177,406 | ||||||
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Total current assets
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17,669,302 | 58,966,033 | ||||||
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Marketable securities
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32,995,677 | - | ||||||
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Property and equipment, net
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67,460 | 124,374 | ||||||
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Debt issuance costs, net
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- | 21,427 | ||||||
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Intangible assets, net
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23,038,469 | 22,999,744 | ||||||
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Goodwill
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11,265,100 | 11,265,100 | ||||||
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Other assets
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1,156,785 | 52,762 | ||||||
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Total assets
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$ | 86,192,793 | $ | 93,429,440 | ||||
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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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$ | 425,231 | $ | 411,145 | ||||
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Accrued liabilities
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1,711,012 | 858,136 | ||||||
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Warrant liabilities
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579,660 | 954,876 | ||||||
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Notes payable, net
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151,255 | 346,890 | ||||||
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Total current liabilities
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2,867,158 | 2,571,047 | ||||||
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Other liabilities
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- | 10,932 | ||||||
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Deferred tax liability
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7,962,100 | 7,962,100 | ||||||
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Total liabilities
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10,829,258 | 10,544,079 | ||||||
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Commitments and contingencies; see Note 7
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||||||||
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Stockholders' equity
|
||||||||
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Preferred stock, undesignated, authorized 9,947,439; See Note 8
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- | - | ||||||
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Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,119,436 and 27,858,000, respectively
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2,812 | 2,786 | ||||||
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Additional paid-in capital
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220,987,935 | 219,468,498 | ||||||
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Accumulated other comprehensive gain
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53,432 | - | ||||||
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Accumulated deficit
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(145,680,644 | ) | (136,585,923 | ) | ||||
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Total stockholders’ equity
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75,363,535 | 82,885,361 | ||||||
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Total liabilities and stockholders' equity
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$ | 86,192,793 | $ | 93,429,440 | ||||
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Three months ended January 31,
|
Nine months ended January 31,
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|||||||||||||||
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2015
|
2014
|
2015
|
2014
|
|||||||||||||
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(Unaudited)
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(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||
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Product revenue
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$ | - | $ | 590 | $ | - | $ | 60,669 | ||||||||
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Cost of sales
|
- | 410 | - | 31,275 | ||||||||||||
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Net product revenue
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- | 180 | - | 29,394 | ||||||||||||
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Government grant revenue
|
- | 41,684 | - | 233,981 | ||||||||||||
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Total net revenue
|
- | 41,864 | - | 263,375 | ||||||||||||
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Operating expenses
|
||||||||||||||||
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General and administrative
|
1,907,482 | 1,783,596 | 4,943,683 | 4,187,522 | ||||||||||||
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Research and development
|
1,227,190 | 689,666 | 4,750,556 | 2,211,124 | ||||||||||||
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Total operating expenses
|
3,134,672 | 2,473,262 | 9,694,239 | 6,398,646 | ||||||||||||
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Net operating loss
|
3,134,672 | 2,431,398 | 9,694,239 | 6,135,271 | ||||||||||||
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Interest expense
|
968 | 69,967 | 47,288 | 2,142,627 | ||||||||||||
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Other (income) expense
|
(267,294 | ) | 849,556 | (646,806 | ) | 849,782 | ||||||||||
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Net loss
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$ | 2,868,346 | $ | 3,350,921 | $ | 9,094,721 | $ | 9,127,680 | ||||||||
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Unrealized (gain) loss on marketable securities
|
(95,738 | ) | - | (53,432 | ) | - | ||||||||||
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Total comprehensive loss
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$ | 2,772,608 | $ | 3,350,921 | $ | 9,041,289 | $ | 9,127,680 | ||||||||
|
Reconciliation of net loss to net loss attributable to common stockholders
|
||||||||||||||||
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Net loss
|
$ | 2,868,346 | $ | 3,350,921 | $ | 9,094,721 | $ | 9,127,680 | ||||||||
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Preferred stock dividend
|
- | 1,095,822 | - | 5,742,162 | ||||||||||||
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Net loss attributable to common stockholders
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$ | 2,868,346 | $ | 4,446,743 | $ | 9,094,721 | $ | 14,869,842 | ||||||||
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Net loss per share, basic
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$ | (0.10 | ) | $ | (0.43 | ) | $ | (0.32 | ) | $ | (2.56 | ) | ||||
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Weighted average number of common shares outstanding, basic
|
28,119,360 | 10,260,021 | 28,064,589 | 5,811,162 | ||||||||||||
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Net loss per share, diluted
|
$ | (0.10 | ) | $ | (0.44 | ) | $ | (0.32 | ) | $ | (2.58 | ) | ||||
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Weighted average number of common shares outstanding, diluted
|
28,119,360 | 10,266,601 | 28,064,589 | 5,817,819 | ||||||||||||
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Nine months ended January 31,
|
||||||||
|
2015
|
2014
|
|||||||
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(Unaudited)
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(Unaudited)
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||
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Net Loss
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$ | (9,094,721 | ) | $ | (9,127,680 | ) | ||
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Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
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Depreciation and amortization
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112,377 | 111,232 | ||||||
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Interest on debt instruments
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45,606 | 2,113,677 | ||||||
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Loss on disposal of property and equipment
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450 | - | ||||||
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Issuance and vesting of compensatory stock options and warrants
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691,069 | 101,053 | ||||||
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Issuance of common stock as compensation
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75,162 | 253,502 | ||||||
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Issuance of note payable for services rendered
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- | 175,000 | ||||||
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Change in the fair value of warrants
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(375,216 | ) | 849,905 | |||||
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Amortization of premium on marketable securities
|
419,319 | - | ||||||
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Changes in operating assets and liabilities
|
||||||||
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Accounts receivable, prepaid expenses and other assets
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(1,011,526 | ) | 370,096 | |||||
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Inventory
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- | 1,767 | ||||||
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Accounts payable and accrued liabilities
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1,016,098 | (1,130,205 | ) | |||||
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Net cash used in operating activities
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(8,121,382 | ) | (6,281,653 | ) | ||||
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CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
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Purchase of marketable securities
|
(44,805,044 | ) | - | |||||
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Sale of marketable securities
|
4,284,304 | - | ||||||
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Purchase of property and equipment
|
(4,234 | ) | (9,804 | ) | ||||
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Capitalization of patent costs and license rights
|
(90,405 | ) | (103,240 | ) | ||||
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Net cash used in investing activities
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(40,615,379 | ) | (113,044 | ) | ||||
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CASH FLOWS FROM FINANCING ACTIVITIES
|
||||||||
|
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
|
543,998 | 7,002,733 | ||||||
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Proceeds from convertible notes, net of issuance costs
|
172,025 | 141,320 | ||||||
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Proceeds for issuance of convertible preferred stock, net of issuance costs
|
- | 4,895,188 | ||||||
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Payments on notes - short-term
|
(384,338 | ) | (88,415 | ) | ||||
|
Net cash provided by financing activities
|
331,685 | 11,950,826 | ||||||
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Net change in cash and cash equivalents
|
(48,405,076 | ) | 5,556,129 | |||||
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Cash and cash equivalents, beginning of period
|
58,320,555 | 783,528 | ||||||
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Cash and cash equivalents, end of period
|
$ | 9,915,479 | $ | 6,339,657 | ||||
|
Cash paid for:
|
||||||||
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Interest
|
$ | 1,682 | $ | 28,949 | ||||
| (1) | The Company issued 255 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.10 per share for the payment of $11,500 interest payable on convertible notes with a gross carrying value of $300,000. |
| (1) | The Company issued 4,631 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.10 for the payment of $208,792 interest payable on convertible notes with a gross carrying value of $4,900,000. | |
| (2) | The Company issued 804,661 shares of its common stock for the payment of $1,227,360 as dividends on the Series C 8% Convertible Preferred stock. | |
| (3) | The Company issued 4,600 shares of Series D 8% Convertible Preferred Stock as consideration for cancellation of $4.6 million in outstanding principal amount of a convertible promissory note issued by the Company on July 1, 2011. | |
| (4) | The Company issued 576,084 shares of its common stock for the payment of $1,104,000 as dividends on the Series D 8% Convertible Preferred stock. | |
| (5) | The Company issued 1,366,844 shares of its common stock that had a fair value of approximately $8.7 million and 32,992 shares of its Series E Convertible Preferred Stock, which are convertible into an aggregate of 3,299,200 shares of common stock that had a fair value of approximately $15.3 million in exchange for the assets of Phyxius Pharma, Inc. The Company recorded Goodwill of $3,303,000 as a result of this issuance. |
|
Three months ended January 31,
|
Nine months ended January 31,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Historical net loss per share:
|
||||||||||||||||
|
Numerator
|
||||||||||||||||
|
Net loss attributable to common stockholders
|
$ | (2,868,346 | ) | $ | (4,446,743 | ) | $ | (9,094,721 | ) | $ | (14,869,842 | ) | ||||
|
Less: Effect of amortization of interest expense on convertible notes
|
- | (38,105 | ) | - | (133,363 | ) | ||||||||||
|
Net loss attributable to common stockholders (diluted)
|
(2,868,346 | ) | (4,484,848 | ) | (9,094,721 | ) | (15,003,205 | ) | ||||||||
|
Denominator
|
||||||||||||||||
|
Weighted-average common shares outstanding
|
28,119,360 | 10,260,021 | 28,064,589 | 5,811,162 | ||||||||||||
|
Effect of dilutive securities
|
- | 6,580 | - | 6,657 | ||||||||||||
|
Denominator for diluted net loss per share
|
28,119,360 | 10,266,601 | 28,064,589 | 5,817,819 | ||||||||||||
|
Basic net loss per share
|
$ | (0.10 | ) | $ | (0.43 | ) | $ | (0.32 | ) | $ | (2.56 | ) | ||||
|
Diluted net loss per share
|
$ | (0.10 | ) | $ | (0.44 | ) | $ | (0.32 | ) | $ | (2.58 | ) | ||||
|
Nine months ended January 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Options to purchase common stock
|
3,693,407 | 50,728 | ||||||
|
Warrants to purchase common stock
|
2,728,236 | 2,813,749 | ||||||
|
Restricted stock grants
|
256 | 42,629 | ||||||
|
Convertible preferred shares outstanding
|
- | 3,429,969 | ||||||
|
Level one
|
Quoted market prices in active markets for identical assets or liabilities;
|
|
|
Level two
|
Inputs other than level one inputs that are either directly or indirectly observable, and
|
|
|
Level three
|
Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.
|
|
January 31, 2015
|
||||||||||||||||||||
|
Amortized Cost
|
Accrued Interest
|
Gross Unrealized Gains
|
Gross Unrealized losses
|
Estimated Fair Value
|
||||||||||||||||
|
Obligations of U.S. Government and its agencies
|
$ | 3,749,188 | $ | 6,322 | $ | 6,315 | $ | - | $ | 3,761,825 | ||||||||||
|
Corporate debt securities
|
35,470,614 | 332,041 | 76,980 | (33,290 | ) | 35,846,345 | ||||||||||||||
|
Municipal bonds
|
541,243 | 2,013 | 3,427 | - | 546,683 | |||||||||||||||
|
Total investments
|
$ | 39,761,045 | $ | 340,376 | $ | 86,722 | $ | (33,290 | ) | $ | 40,154,853 | |||||||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
Maturing in one year or less
|
$ | 7,159,176 | $ | - | ||||
|
Maturing after one year through two years
|
32,995,677 | - | ||||||
|
Total investments
|
$ | 40,154,853 | $ | - | ||||
|
Series C Warrants
|
January 31,
2015
|
April 30,
2014
|
||||||
|
Closing stock price
|
$ | 3.40 | $ | 4.88 | ||||
|
Expected dividend rate
|
0 | % | 0 | % | ||||
|
Expected stock price volatility
|
84.24 | % | 90.32 | % | ||||
|
Risk-free interest rate
|
1.07 | % | 1.75 | % | ||||
|
Expected life (years)
|
4.47 | 5.23 | ||||||
|
Three months ended January 31,
2015
|
||||
|
Balance, at October 31, 2014
|
$ | 716,759 | ||
|
Issuance of warrants
|
- | |||
|
Exercise of warrants
|
- | |||
|
Gain included in income from change in fair value of warrants for the period
|
(137,099 | ) | ||
|
Balance, at January 31, 2015
|
$ | 579,660 | ||
|
Nine months ended January 31,
2015
|
||||
|
Balance, at April 30 2014
|
$ | 954,876 | ||
|
Issuance of warrants
|
- | |||
|
Exercise of warrants
|
- | |||
|
Gain included in income from change in fair value of warrants for the period
|
(375,216 | ) | ||
|
Balance, at January 31, 2015
|
$ | 579,660 | ||
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
|
Balance as of January 31, 2015
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
|
Current Assets
|
||||||||||||||||
|
Cash and cash equivalents
|
$ | 9,915,479 | $ | 9,915,479 | $ | - | $ | - | ||||||||
|
Marketable securities
|
$ | 7,159,176 | $ | - | $ | 7,159,176 | $ | - | ||||||||
|
Long-term Assets
|
||||||||||||||||
|
Marketable securities
|
$ | 32,995,677 | $ | - | $ | 32,995,677 | $ | - | ||||||||
|
Current Liabilities
|
||||||||||||||||
|
Warrant liabilities
|
$ | 579,660 | $ | - | $ | - | $ | 579,660 | ||||||||
|
Fair Value Measurements at Reporting Date Using
|
||||||||||||||||
|
Balance as of April 30, 2014
|
Quoted prices in Active Markets for Identical Securities (Level 1)
|
Significant Other Observable Inputs (Level 2)
|
Significant Unobservable Inputs (Level 3)
|
|||||||||||||
|
Current Assets
|
||||||||||||||||
|
Cash and cash equivalents
|
$ | 58,320,555 | $ | 58,320,555 | $ | - | $ | - | ||||||||
|
Current Liabilities
|
||||||||||||||||
|
Warrant liabilities
|
$ | 954,876 | $ | - | $ | - | $ | 954,876 | ||||||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
R&D materials
|
$ | 164,334 | $ | 177,406 | ||||
|
Deferred cost of sales
|
17,500 | - | ||||||
| $ | 181,834 | $ | 177,406 | |||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
Laboratory equipment
|
$ | 683,084 | $ | 683,632 | ||||
|
Computer equipment and software
|
123,295 | 142,380 | ||||||
|
Office furniture and fixtures
|
130,192 | 130,192 | ||||||
| 936,571 | 956,204 | |||||||
|
Less: Accumulated depreciation
|
(869,111 | ) | (831,830 | ) | ||||
| $ | 67,460 | $ | 124,374 | |||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
Operating costs
|
$ | 1,512,810 | $ | 76,632 | ||||
|
Deferred revenue
|
129,945 | 124,521 | ||||||
|
Employee related
|
46,393 | 609,130 | ||||||
|
Restructuring liability
|
21,864 | 43,728 | ||||||
|
Convertible note interest payable
|
- | 4,125 | ||||||
| $ | 1,711,012 | $ | 858,136 | |||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
Net non-cancelable operating lease obligation
|
$ | 21,864 | $ | 54,660 | ||||
|
Less: current portion
|
(21,864 | ) | (43,728 | ) | ||||
|
Long-term portion of net non-cancelable operating lease obligation
|
$ | - | $ | 10,932 | ||||
|
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
||||||||||||||
|
IPR&D
|
$ | 22,000,000 | N/A | $ | - | $ | - | $ | 22,000,000 | ||||||||||
|
Patents
|
795,769 | 10.7 | - | (317,275 | ) | 478,494 | |||||||||||||
|
License Rights
|
625,005 | 14.4 | - | (173,061 | ) | 451,944 | |||||||||||||
|
Trademarks
|
108,031 | N/A | - | - | 108,031 | ||||||||||||||
|
Total
|
$ | 23,528,805 | $ | - | $ | (490,336 | ) | $ | 23,038,469 | ||||||||||
|
Asset Category
|
Value Assigned
|
Weighted Average Amortization Period (in Years)
|
Impairments
|
Accumulated Amortization
|
Carrying Value (Net of Impairments and Accumulated Amortization)
|
||||||||||||||
|
IPR&D
|
$ | 22,000,000 | N/A | $ | - | $ | - | $ | 22,000,000 | ||||||||||
|
Patents
|
724,067 | 10.8 | - | (289,943 | ) | 434,124 | |||||||||||||
|
License Rights
|
607,947 | 14.6 | - | (148,713 | ) | 459,234 | |||||||||||||
|
Trademarks
|
106,386 | N/A | - | - | 106,386 | ||||||||||||||
|
Total
|
$ | 23,438,400 | $ | - | $ | (438,656 | ) | $ | 22,999,744 | ||||||||||
|
January 31,
2015
|
April 30,
2014
|
|||||||
|
Current portion of notes payable, net
|
$ | 151,255 | $ | 63,568 | ||||
|
Current portion of convertible notes payable
|
- | 300,000 | ||||||
|
Less: Unamortized discount
|
- | (16,678 | ) | |||||
|
Current portion of notes payable, net
|
$ | 151,255 | $ | 346,890 | ||||
|
Warrants
|
Weighted Average Exercise Price
|
|||||||
|
Outstanding at April 30, 2014
|
2,762,466 | $ | 4.28 | |||||
|
Issued
|
175,000 | $ | 4.00 | |||||
|
Exercised
|
(209,230 | ) | $ | 2.60 | ||||
|
Outstanding at January 31, 2015
|
2,728,236 | $ | 4.39 | |||||
|
Shares Available for Grant
|
||||
|
Balances, at April 30, 2014
|
155,408 | |||
|
Options granted
|
(50,225 | ) | ||
|
Options cancelled/forfeited
|
4,676 | |||
|
Restricted stock granted
|
(2,624 | ) | ||
|
Restricted stock cancelled/forfeited
|
14,973 | |||
|
Balances, at January 31, 2015
|
122,208 | |||
|
Outstanding Options
|
||||||||
|
Number of Shares
|
Weighted Average Exercise Price
|
|||||||
|
Balances, at April 30, 2014
|
3,647,858 | $ | 5.79 | |||||
|
Options granted
|
50,225 | $ | 4.82 | |||||
|
Options cancelled
|
(4,676 | ) | $ | 63.83 | ||||
|
Balances, at January 31, 2015
|
3,693,407 | $ | 5.70 | |||||
|
For the nine months ended January
|
||||||||
|
2015
|
2014
|
|||||||
|
Risk-free interest rate (weighted average)
|
2.23 | % | 1.12 | % | ||||
|
Expected volatility (weighted average)
|
98.43 | % | 86.24 | % | ||||
|
Expected term (in years)
|
7 | 7 | ||||||
|
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 Company’s historical experience with its 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 does not anticipate paying any dividends in the near future.
|
|
Forfeitures
|
Stock compensation expense recognized in the statements of operations for the nine months ended January 31, 2015 and 2014 is based on awards ultimately expected to vest, and 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.
|
|
Outstanding Restricted Stock Grants
|
||||||||
|
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
|
Balances, at April 30, 2014
|
42,478 | $ | 6.39 | |||||
|
Restricted stock granted
|
2,624 | $ | 4.89 | |||||
|
Restricted stock vested
|
(29,873 | ) | $ | 5.99 | ||||
|
Restricted stock cancelled
|
(14,973 | ) | $ | 6.96 | ||||
|
Balances, at January 31, 2015
|
256 | $ | 4.40 | |||||
|
Charges Incurred During the Nine Months Ended January 31, 2015
|
Amounts Paid Through January 31, 2015
|
Amounts Accrued at January 31, 2015
|
||||||||||
|
Future lease obligations, net of sublease revenue
|
$ | - | $ | 120,020 | $ | 21,864 | ||||||
|
●
|
Efficiently conduct clinical development to establish clinical proof of concept with our lead product candidates;
|
|
●
|
Efficiently explore new high-potential therapeutic applications, leveraging third-party research collaborations and our results from related areas;
|
|
●
|
Continue to expand our intellectual property portfolio; and
|
|
●
|
Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas.
|
|
●
|
Cash and cash equivalents, including the fair value of our available for sale securities, were $50.1 million at January 31, 2015.
|
|
●
|
Our loss from operations was $2.9 million for the third quarter of fiscal 2015 compared to $2.4 million for the three months ended January 31, 2014.
|
|
●
|
Net cash used in operating activities was $8.1 million and $6.3 million for the nine months ended January 31, 2015 and 2014, respectively.
|
|
●
|
Conducting well-designed studies early in the clinical development process to establish a robust foundation for subsequent development, partnership and expansion into complementary areas;
|
|
●
|
Working with collaborators and partners to accelerate product development, reduce our development costs, and broaden our commercialization capabilities;
|
|
●
|
Gaining regulatory approval for the continued development and commercialization of our products in the United States; and,
|
|
●
|
Developing new intellectual property to enable us to file patent applications that cover new applications of our existing technologies and product candidates.
|
|
Three months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease) | % Increase/ (Decrease) | |||||||||||||
|
Product revenue
|
$ | - | $ | 590 | $ | (590 | ) | (100 | ) % | |||||||
|
Cost of sales
|
- | 410 | (410 | ) | (100 | ) % | ||||||||||
|
Gross profit
|
$ | - | $ | 180 | $ | (180 | ) | (100 | ) % | |||||||
|
Three months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/(Decrease)
|
% Increase/(Decrease)
|
|||||||||||||
|
Government grant revenue
|
$ | - | $ | 41,684 | $ | (41,684 | ) | (100 | ) % | |||||||
|
Three months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Legal and professional fees
|
$ | 1,060,606 | $ | 710,793 | $ | 349,813 | 49 | % | ||||||||
|
Personnel costs
|
565,593 | 922,356 | (356,763 | ) | (39 | ) % | ||||||||||
|
Other costs
|
214,935 | 83,945 | 130,990 | 156 | % | |||||||||||
|
Facilities
|
38,468 | 39,055 | (587 | ) | (2 | ) % | ||||||||||
|
Depreciation and amortization
|
27,880 | 27,447 | 433 | 2 | % | |||||||||||
|
●
|
Costs associated with investor relations and communication increased approximately $376,000 during the current period. This increase was due primarily to the issue of 175,000 warrants with a calculated fair value of approximately $475,000, partially offset by a reduction of approximately $100,000 in fees paid to outsourced corporate communications firms.
|
|
●
|
Board of Directors fees increased in the current period by approximately $104,000 due to the addition of a director and restructuring of directors’ fees.
|
|
●
|
Consulting costs increased approximately $70,000 in the current period due primarily to fees paid to recruiting firms for placement services and contract labor.
|
|
●
|
Legal, accounting and capital market fees decreased in the current period by approximately $200,000 due primarily to costs incurred in the prior year related to the acquisition of the rights to develop levosimendan.
|
|
●
|
Stock based compensation and the vested value of issued stock options decreased approximately $205,000 in the current period due primarily to equity-based bonuses paid in the prior year related to the acquisition of the rights to develop levosimendan.
|
|
●
|
Salaries and benefits decreased approximately $150,000 in the current period due primarily to bonuses paid in the prior year related to the acquisition of the rights to develop levosimendan.
|
|
Three months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Clinical and preclinical development
|
$ | 1,126,171 | $ | 511,426 | $ | 614,745 | 120 | % | ||||||||
|
Personnel costs
|
76,806 | 156,110 | (79,304 | ) | (51 | ) % | ||||||||||
|
Consulting
|
13,515 | 4,369 | 9,146 | 209 | % | |||||||||||
|
Depreciation
|
8,118 | 12,256 | (4,138 | ) | (34 | ) % | ||||||||||
|
Other costs
|
2,225 | 3,100 | (875 | ) | (28 | ) % | ||||||||||
|
Facilities
|
355 | 2,405 | (2,050 | ) | (85 | ) % | ||||||||||
|
Three months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Interest expense
|
$ | 968 | $ | 69,967 | $ | (68,999 | ) | (99 | ) % | |||||||
|
Three months ended January 31,
|
||||||||||||
|
2015
|
2014
|
(Increase)/ Decrease
|
||||||||||
|
Other (income) expense, net
|
$ | (267,294 | ) | $ | 849,556 | $ | (1,116,850 | ) | ||||
|
Nine months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Product revenue
|
$ | - | $ | 60,669 | $ | (60,669 | ) | (100 | ) % | |||||||
|
Cost of sales
|
- | 31,275 | (31,275 | ) | (100 | ) % | ||||||||||
|
Gross profit
|
$ | - | $ | 29,394 | $ | (29,394 | ) | (100 | ) % | |||||||
|
Nine months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease) |
% Increase/ (Decrease)
|
|||||||||||||
|
Government grant revenue
|
$ | - | $ | 233,981 | $ | (233,981 | ) | (100 | ) % | |||||||
|
Nine months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Legal and professional fees
|
$ | 2,349,304 | $ | 1,872,365 | $ | 476,939 | 25 | % | ||||||||
|
Personnel costs
|
1,884,105 | 1,875,786 | 8,319 | 0 | % | |||||||||||
|
Other costs
|
501,891 | 240,497 | 261,394 | 109 | % | |||||||||||
|
Facilities
|
121,285 | 114,136 | 7,149 | 6 | % | |||||||||||
|
Depreciation and amortization
|
87,098 | 84,636 | 2,462 | 3 | % | |||||||||||
|
●
|
Costs associated with investor relations and communication increased approximately $680,000 in the current period. This increase was due primarily to the issue of 175,000 warrants with a calculated fair value of approximately $475,000 and an increase of approximately $205,000 in fees paid to outsourced corporate communication firms for investor relations services and website development.
|
|
●
|
Board of Directors fees increased in the current period by approximately $317,000. This increase was due primarily to approximately $210,000 in recognized expense for the vesting of stock options awarded and an increase of approximately $107,000 in fees paid due to the addition of a director and the restructuring of directors’ fees in the current period.
|
|
●
|
Consulting costs increased approximately $43,000 in the current period due primarily to fees paid for recruiting firms for placement services and contract labor in the current period.
|
|
●
|
Legal, accounting and capital market fees decreased in the current period by approximately $564,000. This decrease was due primarily to a reduction of approximately $501,000 in accounting and legal fees incurred in the prior year related to the acquisition of the rights to develop levosimendan and the issuance of our Series C and Series D Preferred Stock and a reduction of approximately $63,000 in fees paid for the listing of additional shares with Nasdaq and SEC filings made during the same period in the prior year.
|
|
●
|
Salaries and benefits increased approximately $382,000 in the current period. This increase was due primarily to headcount additions in the current year, including the Chief Executive Officer and two additional management positions and severance payments related to the stoppage of Oxycyte development programs, partially offset by bonuses paid in the prior year related to the acquisition of the rights to develop levosimendan.
|
|
●
|
Stock based compensation and the vested value of issued stock options decreased approximately $375,000 in the current period due primarily to equity-based bonuses paid in the prior year related to the acquisition of the rights to develop levosimendan.
|
|
Nine months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease)
|
% Increase/ (Decrease)
|
|||||||||||||
|
Clinical and preclinical development
|
$ | 4,287,897 | $ | 1,397,583 | $ | 2,890,314 | 207 | % | ||||||||
|
Personnel costs
|
384,981 | 610,793 | (225,812 | ) | (37 | ) % | ||||||||||
|
Consulting
|
28,446 | 140,548 | (112,102 | ) | (80 | ) % | ||||||||||
|
Depreciation
|
25,279 | 31,643 | (6,364 | ) | (20 | ) % | ||||||||||
|
Other costs
|
19,809 | 22,698 | (2,889 | ) | (13 | ) % | ||||||||||
|
Facilities
|
4,144 | 7,859 | (3,715 | ) | (47 | ) % | ||||||||||
|
Nine months ended January 31,
|
||||||||||||||||
|
2015
|
2014
|
Increase/ (Decrease) |
% Increase/ (Decrease)
|
|||||||||||||
|
Interest expense
|
$ | 47,288 | $ | 2,142,627 | $ | (2,095,339 | ) | (98 | ) % | |||||||
|
Nine months ended January 31,
|
||||||||||||
|
2015
|
2014
|
(Increase)/ Decrease | ||||||||||
|
Other (income) expense, net
|
$ | (646,806 | ) | $ | 849,782 | $ | (1,496,588 | ) | ||||
|
Nine months ended January 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Net cash used in operating activities
|
$ | (8,121,382 | ) | $ | (6,281,653 | ) | ||
|
Net cash used in investing activities
|
(40,615,379 | ) | (113,044 | ) | ||||
|
Net cash provided by financing activities
|
331,685 | 11,950,826 | ||||||
|
●
|
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 of our product candidates;
|
|
●
|
the extent to which we acquire or invest in businesses, products or technologies; and
|
|
●
|
the possible costs of litigation.
|
|
Period
|
Total Number of Shares Purchased (1)
|
Average Price Paid per Share (2)
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs
|
||||||||||||
|
|
||||||||||||||||
|
November 1, 2014 - November 30, 2014
|
- | $ | - | - | $ | - | ||||||||||
|
December 1, 2014 - December 31, 2014
|
- | $ | - | - | $ | - | ||||||||||
|
January 1, 2015 - January 31, 2015
|
52 | $ | 3.28 | - | $ | - | ||||||||||
|
Total
|
52 | $ | 3.28 | - | $ | - | ||||||||||
|
(1)
|
Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
|
|
(2)
|
Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
|
|
TENAX THERAPEUTICS, INC.
|
|||
|
Date: March 17, 2015
|
By:
|
/s/ Michael B. Jebsen | |
|
Michael B. Jebsen
|
|||
|
Chief Financial Officer
|
|||
|
(On behalf of the Registrant and as Principal Financial Officer)
|
|||
|
No.
|
Description
|
|
|
3.1
|
Certificate of Incorporation (1)
|
|
|
3.2
|
Certificate of Amendment of the Certificate of Incorporation (2)
|
|
|
3.3
|
Certificate of Amendment of the Certificate of Incorporation (3)
|
|
|
3.4
|
Certificate of Amendment of the Certificate of Incorporation (4)
|
|
|
3.5
|
Amended and Restated Bylaws (5)
|
|
|
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.*
|
|
|
101.INS
|
XBRL Instance Document *
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document *
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document *
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document *
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document *
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document *
|
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 |
|---|