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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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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Nevada
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20-5093315
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Large accelerated filer
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[ ]
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Accelerated filer
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[ ]
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Non-Accelerated filer
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[ ]
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Smaller reporting company
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[X]
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Page
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1
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2
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3
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4
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24
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36
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37
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37
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67
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68
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68
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69
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December 31,
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March 31,
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|||||||
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2015
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2015
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|||||||
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(Unaudited)
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(Note 2)
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|||||||
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ASSETS
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||||||||
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Current assets:
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||||||||
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Cash and cash equivalents
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$ | 1,158,400 | $ | 70,000 | ||||
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Prepaid expenses and other current assets
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728,300 | 35,700 | ||||||
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Total current assets
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1,886,700 | 105,700 | ||||||
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Property and equipment, net
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78,600 | 117,100 | ||||||
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Security deposits and other assets
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46,900 | 46,900 | ||||||
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Total assets
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$ | 2,012,200 | $ | 269,700 | ||||
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LIABILITIES AND STOCKHOLDERS’ DEFICIT
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||||||||
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Current liabilities:
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||||||||
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Accounts payable
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$ | 1,097,600 | $ | 2,251,100 | ||||
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Accrued expenses
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929,100 | 1,206,500 | ||||||
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Current maturities of senior secured convertible promissory notes and accrued interest
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- | 4,146,100 | ||||||
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Current portion of notes payable, net of discount of $0 at December 31, 2015 and $474,500 at March
31, 2015, and accrued interest
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73,800 | 4,117,000 | ||||||
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Current portion of notes payable to related parties, net of discount of $0 at December 31, 2015 and
$54,500 at March 31, 2015, and accrued interest
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- | 1,508,800 | ||||||
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Convertible promissory notes and accrued interest, net of discount of $0 at December 31, 2015 and
$180,000 at March 31, 2015, respectively
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- | 4,157,600 | ||||||
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Capital lease obligations
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1,100 | 1,000 | ||||||
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Total current liabilities
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2,101,600 | 17,388,100 | ||||||
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Non-current liabilities:
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||||||||
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Senior secured convertible promissory notes and accrued interest
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- | 296,200 | ||||||
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Notes payable
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29,300 | 35,600 | ||||||
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Warrant liability
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- | 3,008,500 | ||||||
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Accrued dividends on Series B Preferred Stock
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1,415,800 | - | ||||||
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Deferred rent liability
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63,500 | 83,000 | ||||||
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Capital lease obligations
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300 | 1,100 | ||||||
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Total non-current liabilities
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1,508,900 | 3,424,400 | ||||||
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Total liabilities
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3,610,500 | 20,812,500 | ||||||
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Commitments and contingencies
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||||||||
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Stockholders’ deficit:
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||||||||
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Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2015 and March 31, 2015:
|
||||||||
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Series A Preferred, 500,000 shares authorized and outstanding at December 31, 2015 and March 31, 2015
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500 | 500 | ||||||
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Series B Preferred, 4,000,000 shares and no shares authorized at December 31, 2015 and March 31, 2015,
respectively; 3,588,863 shares and no shares issued and outstanding at December 31, 2015 and
March 31, 2015, respectively
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3,600 | - | ||||||
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Common stock, $0.001 par value; 30,000,000 shares and 10,000,000 shares authorized at December 31, 2015
and March 31, 2015, respectively; 1,965,170 shares and 1,677,110 shares issued at December 31, 2015
and March 31, 2015 respectively
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2,000 | 1,700 | ||||||
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Additional paid-in capital
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125,605,200 | 67,945,800 | ||||||
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Treasury stock, at cost, 135,665 shares of common stock held at December 31, 2015 and March 31, 2015,
respectively
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(3,968,100 | ) | (3,968,100 | ) | ||||
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Accumulated deficit
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(123,241,500 | ) | (84,522,700 | ) | ||||
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Total stockholders’ deficit
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(1,598,300 | ) | (20,542,800 | ) | ||||
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Total liabilities and stockholders’ deficit
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$ | 2,012,200 | $ | 269,700 | ||||
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Three Months Ended
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Nine Months Ended
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|||||||||||||||
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December 31,
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December 31,
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|||||||||||||||
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2015
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2014
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2015
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2014
|
|||||||||||||
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Operating expenses:
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||||||||||||||||
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Research and development
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806,300 | 445,400 | $ | 2,835,000 | $ | 1,476,600 | ||||||||||
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General and administrative
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1,335,500 | 671,300 | 6,514,500 | 2,024,600 | ||||||||||||
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Total operating expenses
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2,141,800 | 1,116,700 | 9,349,500 | 3,501,200 | ||||||||||||
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Loss from operations
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(2,141,800 | ) | (1,116,700 | ) | (9,349,500 | ) | (3,501,200 | ) | ||||||||
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Other expenses, net:
|
||||||||||||||||
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Interest expense, net
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(2,500 | ) | (792,400 | ) | (769,800 | ) | (2,182,900 | ) | ||||||||
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Change in warrant liability
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- | 953,700 | (1,894,700 | ) | 528,300 | |||||||||||
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Loss on extinguishment of debt
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- | - | (26,700,200 | ) | (2,371,400 | ) | ||||||||||
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Other expense
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(2,300 | ) | (134,900 | ) | (2,300 | ) | (134,900 | ) | ||||||||
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Loss before income taxes
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(2,146,600 | ) | (1,090,300 | ) | (38,716,500 | ) | (7,662,100 | ) | ||||||||
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Income taxes
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- | - | (2,300 | ) | (2,400 | ) | ||||||||||
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Net loss and comprehensive loss
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$ | (2,146,600 | ) | $ | (1,090,300 | ) | $ | (38,718,800 | ) | $ | (7,664,500 | ) | ||||
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Accrued dividends on Series B Preferred stock
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(631,300 | ) | - | (1,459,300 | ) | - | ||||||||||
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Deemed dividend on Series B Preferred Units
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(668,700 | ) | - | (1,811,800 | ) | - | ||||||||||
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Net loss attributable to common stockholders
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$ | (3,446,600 | ) | $ | (1,090,300 | ) | $ | (41,989,900 | ) | $ | (7,664,500 | ) | ||||
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Basic net loss attributable to common stockholders
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||||||||||||||||
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per common share
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$ | (1.95 | ) | $ | (0.84 | ) | $ | (25.45 | ) | $ | (6.03 | ) | ||||
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Diluted net loss attributable to common stockholders
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||||||||||||||||
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per common share
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$ | (1.95 | ) | $ | (1.08 | ) | $ | (25.45 | ) | $ | (6.14 | ) | ||||
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Weighted average shares used in computing:
|
||||||||||||||||
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Basic net loss attributable to common stockholders
|
||||||||||||||||
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per common share
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1,765,641 | 1,302,300 | 1,650,160 | 1,270,495 | ||||||||||||
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Diluted net loss attributable to common stockholders
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||||||||||||||||
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per common share
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1,765,641 | 1,302,300 | 1,650,160 | 1,288,674 | ||||||||||||
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Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
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Cash flows from operating activities:
|
||||||||
|
Net loss
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$ | (38,718,800 | ) | $ | (7,664,500 | ) | ||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
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Depreciation and amortization
|
40,800 | 39,200 | ||||||
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Amortization of discounts on convertible and promissory notes
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564,800 | 1,294,700 | ||||||
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Change in warrant liability
|
1,894,700 | (528,300 | ) | |||||
|
Stock-based compensation
|
3,868,300 | 564,000 | ||||||
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Expense related to modification of warrants
|
614,900 | - | ||||||
|
Non-cash rent expense
|
(19,500 | ) | (9,700 | ) | ||||
|
Interest income on note receivable for common stock purchase
|
- | 2,800 | ||||||
|
Loss on settlement of note receivable for common stock purchase
|
- | 134,900 | ||||||
|
Fair value of common stock granted for services
|
606,300 | 134,000 | ||||||
|
Fair value of Series B Preferred stock granted for services
|
1,045,000 | - | ||||||
|
Fair value of warrants granted for services and interest
|
111,200 | 38,700 | ||||||
|
Foreign currency transaction gain
|
(6,400 | ) | (22,000 | ) | ||||
|
Loss on extinguishment of debt
|
26,700,200 | 2,371,400 | ||||||
|
Loss on disposition of fixed assets
|
2,300 | - | ||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Prepaid expenses and other current assets
|
61,800 | 74,300 | ||||||
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Accounts payable and accrued expenses, including accrued interest
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(264,500 | ) | 1,696,100 | |||||
|
Net cash used in operating activities
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(3,498,900 | ) | (1,874,400 | ) | ||||
|
Cash flows from investing activities:
|
||||||||
|
Purchases of equipment, net
|
(4,600 | ) | - | |||||
|
Net cash used in investing activities
|
(4,600 | ) | - | |||||
|
Cash flows from financing activities:
|
||||||||
|
Net proceeds from issuance of common stock and warrants, including Units
|
280,000 | 2,128,200 | ||||||
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Net proceeds from issuance of Series B Preferred Units
|
4,397,800 | - | ||||||
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Repayment of capital lease obligations
|
(700 | ) | (3,700 | ) | ||||
|
Repayment of notes
|
(85,200 | ) | (236,900 | ) | ||||
|
Net cash provided by financing activities
|
4,591,900 | 1,887,600 | ||||||
|
Net increase in cash and cash equivalents
|
1,088,400 | 13,200 | ||||||
|
Cash and cash equivalents at beginning of period
|
70,000 | - | ||||||
|
Cash and cash equivalents at end of period
|
$ | 1,158,400 | $ | 13,200 | ||||
|
Supplemental disclosure of noncash activities:
|
||||||||
|
Senior Secured Notes, 2014 Unit Notes, other promissory notes and related
accrued interest, and accounts payable, including conversion premiums,
converted into Series B Preferred stock
|
$ | 18,891,400 | $ | - | ||||
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
|
December 31,
|
December 31,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Research and development expense:
|
||||||||||||||||
|
Stock option grants
|
$ | 71,300 | $ | 30,000 | $ | 118,700 | $ | 156,100 | ||||||||
|
Warrants granted to officer in March 2014 and March 2013
|
2,800 | 36,300 | 8,500 | 108,900 | ||||||||||||
|
Warrants granted to officer in September 2015
|
- | - | 852,200 | - | ||||||||||||
| 74,100 | 66,300 | 979,400 | 265,000 | |||||||||||||
|
General and administrative expense:
|
||||||||||||||||
|
Stock option grants
|
20,400 | 18,600 | 36,500 | 86,700 | ||||||||||||
|
|
||||||||||||||||
|
Warrants granted to officers and directors in March 2014 and March 2013
|
3,900 | 70,700 | 11,700 | 212,300 | ||||||||||||
|
Warrants granted to officers, directors and
consultants in September 2015
|
- | - | 2,840,700 | - | ||||||||||||
| 24,300 | 89,300 | 2,888,900 | 299,000 | |||||||||||||
|
Total stock-based compensation expense
|
$ | 98,400 | $ | 155,600 | $ | 3,868,300 | $ | 564,000 | ||||||||
|
Assumption:
|
Warrants
|
Employee Options
|
Non-employee Options
|
|||||||
|
Market price per share at grant date
|
$
|
9.11
|
$
|
9.11
|
$
|
9.11
|
||||
|
Exercise price per share
|
$
|
9.25
|
$
|
9.25
|
$
|
9.25
|
||||
|
Risk-free interest rate
|
1.52
|
% |
2.02
|
% |
2.20
|
% | ||||
|
Contractual or estimated term in years
|
5.00
|
6.25
|
10.00
|
|||||||
|
Volatility
|
77.19
|
% |
79.48
|
% |
103.42
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0%
|
% |
0.0
|
% | ||||
|
Shares
|
650,000
|
60,000
|
30,000
|
|||||||
|
Fair Value per share
|
$
|
5.68
|
$
|
6.35
|
$
|
8.27
|
||||
|
Three Months Ended
December 31,
|
Nine Months Ended December 31,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
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Numerator:
|
||||||||||||||||
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Net loss attributable to common stockholders for basic earnings per share
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$ | (3,446,600 | ) | $ | (1,090,300 | ) | $ | (41,989,900 | ) | $ | (7,664,500 | ) | ||||
|
less: change in fair value of warrant liability attributable to outstanding
warrants issued to Platinum
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- | (314,900 | ) | - | (251,500 | ) | ||||||||||
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Net loss for diluted earnings per share attributable to common stockholders
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$ | (3,446,600 | ) | $ | (1,405,200 | ) | $ | (41,989,900 | ) | $ | (7,916,000 | ) | ||||
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Denominator:
|
||||||||||||||||
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Weighted average basic common shares outstanding
|
1,765,641 | 1,302,300 | 1,650,160 | 1,270,495 | ||||||||||||
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Assumed conversion of dilutive securities:
|
||||||||||||||||
|
Warrants to purchase common stock
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- | - | - | 18,179 | ||||||||||||
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Potentially dilutive common shares assumed converted
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- | - | - | 18,179 | ||||||||||||
|
Denominator for diluted earnings per share - adjusted
weighted average shares
|
1,765,641 | 1,302,300 | 1,650,160 | 1,288,674 | ||||||||||||
|
Basic net loss attributable to common stockholders per common share
|
$ | (1.95 | ) | $ | (0.84 | ) | $ | (25.45 | ) | $ | (6.03 | ) | ||||
|
Diluted net loss attributable to common stockholders per common share
|
$ | (1.95 | ) | $ | (1.08 | ) | $ | (25.45 | ) | $ | (6.14 | ) | ||||
|
As of December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Series A Preferred stock issued and outstanding
(1)
|
750,000 | 750,000 | ||||||
|
Series B Preferred stock issued and outstanding
(2)
|
3,588,863 | - | ||||||
|
Warrant shares issuable to Platinum upon exercise of common stock warrants by Platinum
upon exchange of Series A Preferred under the terms of the October 11, 2012 Note
Exchange and Purchase Agreement, as subsequently amended
|
535,715 | 375,000 | ||||||
|
Outstanding options under the 2008 and 1999 Stock Incentive Plans
|
296,738 | 207,768 | ||||||
|
Outstanding warrants to purchase common stock
|
4,971,497 | 999,840 | ||||||
|
10% Senior Secured Convertible Notes issued to Platinum between October 2012 and
July 2013, including accrued interest through December 31, 2014
|
- | 433,311 | ||||||
|
10% convertible notes issued as a component of Unit Private Placements, including
accrued interest through December 31, 2014
|
- | 322,091 | ||||||
|
Total
|
10,142,813 | 3,088,010 | ||||||
|
____________
|
||||||||
|
(1)
Assumes exchange under the terms of the October 11, 2012 Note Exchange and Purchase Agreement with Platinum, as amended
|
||||||||
|
(2)
Assumes exchange under the terms of the Certificate of Designation of the Relative Rights and Preferences of the Series B 10% Convertible Preferred Stock, effective May 5, 2015
|
||||||||
|
|
•
|
Level 1
— Quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
|
|
•
|
Level 2
— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
•
|
Level 3
— Unobservable inputs (
i.e.,
inputs that reflect the reporting entity’s own assumptions about the assumptions that market participants would use in estimating the fair value of an asset or liability) are used when little or no market data is available.
|
|
|
Fair Value Measurements at Reporting Date Using
|
|||||||||||||||
|
Total
Carrying
|
Quoted Prices inActive Markets for Identical
Assets
|
Significant Other
Observable Inputs
|
Significant
Unobservable
|
|||||||||||||
|
|
Value
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
||||||||||||
|
December 31, 2015:
|
||||||||||||||||
|
Warrant liability
|
$ | - | $ | - | $ | - | $ | - | ||||||||
|
March 31, 2015:
|
||||||||||||||||
|
Warrant liability
|
$ | 3,008,500 | $ | - | $ | - | $ | 3,008,500 | ||||||||
|
Fair Value Measurements
|
||||
|
Using Significant
|
||||
|
Unobservable Inputs
|
||||
|
(Level 3)
|
||||
|
Warrant Liability
|
||||
|
Balance at March 31, 2015
|
$ | 3,008,500 | ||
|
Mark to market loss included in net loss
|
1,894,700 | |||
|
Elimination of liability upon modification of warrants
|
(4,903,200 | ) | ||
|
Balance at December 31, 2015
|
$ | - | ||
|
December 31,
|
March 31,
|
|||||||
|
2015
|
2015
|
|||||||
|
Insurance
|
$ | 51,600 | $ | 27,300 | ||||
|
Prepaid compensation under financial advisory
and other consulting agreements
|
675,000 | - | ||||||
|
Legal fees
|
- | 3,400 | ||||||
|
Technology license fees and all other
|
1,700 | 5,000 | ||||||
| $ | 728,300 | $ | 35,700 | |||||
|
December 31,
|
March 31,
|
|||||||
|
2015
|
2015
|
|||||||
|
Accrued professional services
|
$ | 367,000 | $ | 213,800 | ||||
|
Accrued compensation
|
561,100 | 990,700 | ||||||
|
All other
|
1,000 | 2,000 | ||||||
| $ | 929,100 | $ | 1,206,500 | |||||
|
|
December 31, 2015
|
March 31, 2015
|
||||||||||||||||||||||
|
|
Principal
|
Accrued
|
Principal
|
Accrued
|
||||||||||||||||||||
|
Balance
|
Interest
|
Total
|
Balance
|
Interest
|
Total
|
|||||||||||||||||||
|
Senior Secured 10% Convertible Promissory Notes issued to Platinum:
|
||||||||||||||||||||||||
|
Total Senior notes issued between October 11, 2012
and July 23, 2013
|
$ | - | $ | - | $ | - | $ | 3,522,600 | $ | 919,700 | $ | 4,442,300 | ||||||||||||
|
less: current portion
|
- | - | - | (3,272,600 | ) | (873,500 | ) | (4,146,100 | ) | |||||||||||||||
|
Senior notes - non-current portion
|
$ | - | $ | - | $ | - | $ | 250,000 | $ | 46,200 | $ | 296,200 | ||||||||||||
|
10% Convertible Promissory Notes (Unit Notes)
|
||||||||||||||||||||||||
|
2014 Unit Notes, including amended notes, due 3/31/15
|
$ | - | $ | - | $ | - | $ | 4,066,900 | $ | 270,700 | $ | 4,337,600 | ||||||||||||
|
Note discounts
|
- | - | - | (180,000 | ) | - | (180,000 | ) | ||||||||||||||||
|
Net convertible notes (all current at March 31, 2015)
|
$ | - | $ | - | $ | - | $ | 3,886,900 | $ | 270,700 | $ | 4,157,600 | ||||||||||||
|
Notes Payable to unrelated parties:
|
||||||||||||||||||||||||
|
7.5% Notes payable to service providers for
accounts payable converted to notes payable:
|
||||||||||||||||||||||||
|
Burr, Pilger, Mayer
|
$ | - | $ | - | $ | - | $ | 90,400 | $ | 13,100 | $ | 103,500 | ||||||||||||
|
Desjardins
|
- | - | - | 156,300 | 24,100 | 180,400 | ||||||||||||||||||
|
McCarthy Tetrault
|
- | - | - | 319,700 | 46,000 | 365,700 | ||||||||||||||||||
|
August 2012 Morrison & Foerster Note A
|
- | - | - | 918,200 | 193,200 | 1,111,400 | ||||||||||||||||||
|
August 2012 Morrison & Foerster Note B
|
- | - | - | 1,379,400 | 333,100 | 1,712,500 | ||||||||||||||||||
|
University Health Network
|
- | - | - | 549,500 | 101,800 | 651,300 | ||||||||||||||||||
| - | - | - | 3,413,500 | 711,300 | 4,124,800 | |||||||||||||||||||
|
Note discount
|
- | - | - | (474,500 | ) | - | (474,500 | ) | ||||||||||||||||
| - | - | - | 2,939,000 | 711,300 | 3,650,300 | |||||||||||||||||||
|
less: current portion (and discount at March 31, 2015)
|
- | - | - | (2,939,000 | ) | (711,300 | ) | (3,650,300 | ) | |||||||||||||||
|
non-current portion and discount
|
$ | - | $ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||
|
5.67% and 10.25% Notes payable to insurance
premium financing company (current)
|
$ | - | $ | - | $ | - | $ | 5,800 | $ | - | $ | 5,800 | ||||||||||||
|
10% Notes payable to vendors for accounts
payable converted to notes payable
|
$ | 26,300 | $ | 7,000 | $ | 33,300 | $ | 378,300 | $ | 51,500 | $ | 429,800 | ||||||||||||
|
less: current portion
|
(26,300 | ) | (7,000 | ) | (33,300 | ) | (378,300 | ) | (51,500 | ) | (429,800 | ) | ||||||||||||
|
non-current portion
|
$ | - | $ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||
|
7.0% Note payable (August 2012)
|
$ | 58,800 | $ | 11,000 | $ | 69,800 | $ | 58,800 | $ | 7,900 | $ | 66,700 | ||||||||||||
|
less: current portion
|
(29,500 | ) | (11,000 | ) | (40,500 | ) | (23,200 | ) | (7,900 | ) | (31,100 | ) | ||||||||||||
|
7.0% Notes payable - non-current portion
|
$ | 29,300 | $ | - | $ | 29,300 | $ | 35,600 | $ | - | $ | 35,600 | ||||||||||||
|
Total notes payable to unrelated parties
|
$ | 85,100 | $ | 18,000 | $ | 103,100 | $ | 3,381,900 | $ | 770,700 | $ | 4,152,600 | ||||||||||||
|
less: current portion (and discount at March 31, 2015)
|
(55,800 | ) | (18,000 | ) | (73,800 | ) | (3,346,300 | ) | (770,700 | ) | (4,117,000 | ) | ||||||||||||
|
Net non-current portion
|
$ | 29,300 | $ | - | $ | 29,300 | $ | 35,600 | $ | - | $ | 35,600 | ||||||||||||
|
Notes payable to related parties:
|
||||||||||||||||||||||||
|
October 2012 7.5% Note to Cato Holding Co.
|
$ | - | $ | - | $ | - | $ | 293,600 | $ | 55,900 | $ | 349,500 | ||||||||||||
|
October 2012 7.5% Note to Cato Research Ltd.
|
- | - | - | 1,009,000 | 204,800 | 1,213,800 | ||||||||||||||||||
| - | - | - | 1,302,600 | 260,700 | 1,563,300 | |||||||||||||||||||
|
Note discount
|
- | - | - | (54,500 | ) | - | (54,500 | ) | ||||||||||||||||
|
Total notes payable to related parties
|
- | - | - | 1,248,100 | 260,700 | 1,508,800 | ||||||||||||||||||
|
less: current portion
|
- | - | - | (1,248,100 | ) | (260,700 | ) | (1,508,800 | ) | |||||||||||||||
|
non-current portion and discount
|
$ | - | $ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||||
|
Assumption:
|
Platinum Unit Notes and Acquired
Unit
Notes
|
Investor
Unit
Notes
|
||||||
|
Market price per share at conversion date
|
$
|
10.00
|
$
|
8.00
|
||||
|
Exercise price per share
|
$
|
7.00
|
$
|
7.00
|
||||
|
Risk-free interest rate
|
1.58
|
1.57
|
||||||
|
Contractual term in years
|
5.00
|
5.00
|
||||||
|
Volatility
|
76.5
|
% |
75.7
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Warrant shares
|
506,004
|
327,016
|
||||||
|
Fair Value per share
|
$
|
6.89
|
$
|
5.15
|
||||
|
Assumption:
|
Pre-
modification
|
Post-
modification
|
||||||
|
Market price per share at modification date
|
$
|
10.00
|
$
|
10.00
|
||||
|
Exercise price per share
|
$
|
20.00 and $30.00
|
$
|
7.00
|
||||
|
Risk-free interest rate
|
0.87
|
% |
0.87
|
% | ||||
|
Contractual term in years
|
2.31
|
2.31
|
||||||
|
Volatility
|
73.9
|
% |
73.9
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Weighted Average Fair Value per share
|
$
|
2.44 and $1.57
|
$
|
5.33
|
||||
|
Assumption:
|
Pre-
modification
|
Post-
modification
|
||||||
|
Market price per share at modification date
|
$
|
10.00
|
$
|
10.00
|
||||
|
Exercise price per share
|
$
|
20.00 and $40.00
|
$
|
20.00
|
||||
|
Risk-free interest rate
|
0.86
|
% |
1.57
|
% | ||||
|
Contractual term in years
|
2.27
|
4.27
|
||||||
|
Volatility
|
73.8
|
% |
76.7
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Weighted Average Fair Value per share
|
$
|
2.39 and $1.04
|
$
|
4.35
|
||||
|
Assumption:
|
Pre-
modification
|
Post-
modification
|
||||||
|
Market price per share at modification date
|
$
|
16.00
|
$
|
16.00
|
||||
|
Exercise price per share
|
$
|
10.00
|
$
|
7.00
|
||||
|
Risk-free interest rate
|
1.34
|
% |
1.34%
|
% | ||||
|
Contractual term in years
|
3.76
|
3.76
|
||||||
|
Volatility
|
76.3
|
% |
76.3
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Weighted Average Fair Value per share
|
$
|
10.48
|
$
|
11.60
|
||||
|
Unit Warrants
|
||||||||||||
|
Warrant
|
Weighted Average Issuance Date
Valuation Assumptions
|
Per Share
Fair
|
Aggregate
Fair Value
|
Aggregate
Proceeds
|
Aggregate Allocation of Proceeds
Based on Relative Fair Value of:
|
|||||||
|
Risk free
|
||||||||||||
|
Shares
|
Market
|
Exercise
|
Term
|
Interest
|
Dividend
|
Value of
|
of Unit
|
of Unit
|
Unit
|
|||
|
Issued
|
Price
|
Price
|
(Years)
|
Rate
|
Volatility
|
Rate
|
Warrant
|
Warrants
|
Sales
|
Unit Stock
|
Warrant
|
Unit Note
|
|
24,250
|
$ 10.00
|
$ 10.00
|
1.70
|
0.45%
|
73.19%
|
0.00%
|
$ 3.69
|
$ 89,600
|
$ 280,000
|
$ 128,900
|
$ 32,900
|
$ 118,200
|
|
|
·
|
Converted into 641,335 shares of Series B Preferred all of the approximately $4.5 million outstanding balance (principal and accrued but unpaid interest) of the Senior Secured Notes we had previously issued to Platinum, as described previously in Note 7,
Convertible Promissory Notes and Other Notes Payable
;
|
|
|
·
|
Released all of its security interests in our assets and those of our subsidiaries by terminating the Amended and Restated Security Agreement, IP Security Agreement and Negative Covenant, each dated October 11, 2012 between us and Platinum;
|
|
|
·
|
Converted into 240,305 shares of Series B Preferred and five-year warrants to purchase 240,305 shares of our common stock at a fixed exercise price of $7.00 per share (
Series B
Warrants
) all of the approximately $1.3 million outstanding balance (principal and accrued but unpaid interest) of the 2014 Unit Notes that we issued to Platinum, as described previously in Note 7,
Convertible Promissory Notes and Other Notes Payable
;
|
|
|
·
|
Purchased approximately $1.5 million (including accrued but unpaid interest thereon) of outstanding 2014 Unit Notes we had previously issued to various accredited investors from the respective holders thereof (
Acquired Unit Notes
) and converted the entire approximately $1.5 million outstanding balance of the Acquired Unit Notes into 265,699 shares of Series B Preferred and Series B Warrants to purchase 265,699 shares of our common stock, as described previously in Note 7,
Convertible Promissory Notes and Other Notes Payable
;
|
|
|
·
|
Entered into a Securities Purchase Agreement (
SPA
) to purchase from us, in our self-placed private placement, for $1.0 million, a total of 142,857 shares of Series B Preferred and a Series B Warrant to purchase 142,857 shares of our common stock, which shares of Series B Preferred and Series B Warrants have been purchased and issued;
|
|
|
·
|
Amended the Platinum Warrants previously issued by us to Platinum in connection with the Senior Secured Notes and the Series A Exchange Warrant to (i) fix the exercise price thereof, (ii) eliminate the exercise price reset features and (iii) fix the number of shares of our common stock issuable thereunder, and (iv) eliminate the cashless exercise provisions from the Platinum Warrants; and
|
|
|
·
|
Agreed to refrain from the sale of any shares of our common stock held by Platinum or its affiliates until the earlier to occur of an effective registration statement relating to resale of certain specified shares of common stock under the Securities Act of 1933, as amended, or the closing price of our common stock is at least $15.00 per share.
|
|
Unit Warrants
|
|||||||||||
|
Warrant
|
Weighted Average Issuance Date
Valuation Assumptions
|
Per Share
Fair
|
Aggregate
Fair Value
|
Aggregate
Proceeds
|
Aggregate Allocation of Proceeds
Based on Relative Fair Value of:
|
||||||
|
Risk free
|
|||||||||||
|
Shares
|
Market
|
Exercise
|
Term
|
Interest
|
Dividend
|
Value of
|
of Unit
|
of Unit
|
Unit
|
||
|
Issued
|
Price
|
Price
|
(Years)
|
Rate
|
Volatility
|
Rate
|
Warrant
|
Warrants
|
Sales
|
Unit Stock
|
Warrant
|
|
628,264
|
$ 10.86
|
$ 7.00
|
5.00
|
1.65%
|
77.16%
|
0.0%
|
$ 7.72
|
$ 4,849,100
|
$ 4,397,800
|
$ 2,585,900
|
$ 1,811,900
|
|
Assumption:
|
11/23/2015
|
12/11/2015
|
||||||
|
Market price per share
|
$
|
6.75
|
$
|
5.00
|
||||
|
Exercise price per share
|
$
|
7.00
|
$
|
7.00
|
||||
|
Risk-free interest rate
|
1.70
|
% |
1.16
|
% | ||||
|
Contractual term in years
|
5.0
|
3.0
|
||||||
|
Volatility
|
77.95
|
% |
77.88
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Fair Value per share
|
$
|
4.22
|
$
|
2.12
|
||||
|
Warrant shares granted
|
7,500
|
37,500
|
||||||
|
Expense recognized
|
$
|
31,700
|
$
|
79,600
|
||||
|
Assumption:
|
Pre-
modification
|
Post-
modification
|
||||||
|
Market price per share
|
$
|
10.00
|
$
|
10.00
|
||||
|
Exercise price per share (weighted average)
|
$
|
30.23
|
$
|
11.92
|
||||
|
Risk-free interest rate (weighted average)
|
0.8
|
% |
0.83
|
% | ||||
|
Remaining contractual term in years (weighted average)
|
2.26
|
2.26
|
||||||
|
Volatility (weighted average)
|
73.7
|
% |
73.7
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Fair Value per share (weighted average)
|
$
|
1.55
|
$
|
3.79
|
||||
|
Assumption:
|
Pre-
modification
|
Post-
modification
|
||||||
|
Market price per share
|
$
|
6.50
|
$
|
6.50
|
||||
|
Exercise price per share (weighted average)
|
$
|
9.97
|
$
|
7.00
|
||||
|
Risk-free interest rate (weighted average)
|
1.74
|
% |
1.75
|
% | ||||
|
Remaining contractual term in years (weighted average)
|
5.13
|
5.16
|
||||||
|
Volatility (weighted average)
|
78.8
|
% |
78.7
|
% | ||||
|
Dividend rate
|
0.0
|
% |
0.0
|
% | ||||
|
Fair Value per share (weighted average)
|
$
|
3.65
|
$
|
4.08
|
||||
|
Shares Subject
|
|||||||
|
Exercise
|
to Purchase at
|
||||||
|
Price
|
Expiration
|
December 31,
|
|||||
|
per Share
|
Date
|
2015
|
|||||
| $ | 7.00 |
9/30/2017 to 3/3/2023
|
4,169,645 | ||||
| $ | 9.25 |
9/2/2020
|
50,000 | ||||
| $ | 10.00 |
1/31/2016 to 1/11/2020
|
554,915 | ||||
| $ | 15.00 |
2/14/2018 to 3/4/2018
|
75,389 | ||||
| $ | 20.00 |
7/30/2016 to 9/15/2019
|
115,448 | ||||
| $ | 30.00 |
2/13/2016 to 11/20/2017
|
6,100 | ||||
| 4,971,497 | |||||||
|
Item 2
.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
|
Three Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
$ | 806 | $ | 445 | ||||
|
General and administrative
|
1,336 | 671 | ||||||
|
Total operating expenses
|
2,142 | 1,116 | ||||||
|
Loss from operations
|
(2,142 | ) | (1,116 | ) | ||||
|
Interest expense (net)
|
(3 | ) | (792 | ) | ||||
|
Change in warrant liabilities
|
- | 953 | ||||||
|
Loss on extinguishment of debt
|
- | - | ||||||
|
Other expense
|
(2 | ) | (135 | ) | ||||
|
Loss before income taxes
|
(2,147 | ) | (1,090 | ) | ||||
|
Income taxes
|
- | - | ||||||
|
Net loss
|
$ | (2,147 | ) | $ | (1,090 | ) | ||
|
Accrued dividend on Series B Preferred Stock
|
(631 | ) | - | |||||
|
Deemed dividend on Series B Preferred Stock
|
(669 | ) | - | |||||
|
Net loss attributable to common stockholders
|
$ | (3,447 | ) | $ | (1,090 | ) | ||
|
Three Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Salaries and benefits
|
$ | 214 | $ | 230 | ||||
|
Stock-based compensation
|
74 | 66 | ||||||
|
Consulting and other professional services
|
5 | 23 | ||||||
|
Technology licenses and royalties
|
159 | 43 | ||||||
|
Project-related research and supplies:
|
||||||||
|
AV-101
|
137 | 7 | ||||||
|
Stem cell and all other
|
19 | 10 | ||||||
| 156 | 17 | |||||||
|
Rent
|
55 | 55 | ||||||
|
Depreciation
|
8 | 11 | ||||||
|
Warrant modification expense
|
135 | - | ||||||
|
Total Research and Development Expense
|
$ | 806 | $ | 445 | ||||
|
Three Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Salaries and benefits
|
$ | 172 | $ | 254 | ||||
|
Stock-based compensation
|
24 | 89 | ||||||
|
Consulting Services
|
16 | 28 | ||||||
|
Legal, accounting and other professional fees
|
643 | 157 | ||||||
|
Investor relations
|
4 | 34 | ||||||
|
Insurance
|
33 | 32 | ||||||
|
Travel expenses
|
18 | 7 | ||||||
|
Rent and utilities
|
40 | 39 | ||||||
|
Warrant modification expense
|
358 | - | ||||||
|
All other expenses
|
28 | 31 | ||||||
|
Total General and Administrative Expense
|
$ | 1,336 | $ | 671 | ||||
|
Three Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Interest expense on promissory notes
|
$ | 2 | $ | 317 | ||||
|
Amortization of discount on promissory notes
|
- | 496 | ||||||
|
Other interest expense, including on capital leases and premium financing
|
1 | 1 | ||||||
| 3 | 814 | |||||||
|
Effect of foreign currency fluctuations on notes payable
|
- | (22 | ) | |||||
|
Interest income
|
- | - | ||||||
|
Interest expense, net
|
$ | 3 | $ | 792 | ||||
|
Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
$ | 2,835 | $ | 1,477 | ||||
|
General and administrative
|
6,515 | 2,024 | ||||||
|
Total operating expenses
|
9,350 | 3,501 | ||||||
|
Loss from operations
|
(9,350 | ) | (3,501 | ) | ||||
|
Interest expense (net)
|
(770 | ) | (2,183 | ) | ||||
|
Change in warrant liabilities
|
(1,895 | ) | 528 | |||||
|
Loss on extinguishment of debt
|
(26,700 | ) | (2,371 | ) | ||||
|
Other expense
|
(2 | ) | (135 | ) | ||||
|
Loss before income taxes
|
(38,717 | ) | (7,662 | ) | ||||
|
Income taxes
|
(2 | ) | (2 | ) | ||||
|
Net loss
|
$ | (38,719 | ) | $ | (7,664 | ) | ||
|
Accrued dividend on Series B Preferred Stock
|
(1,459 | ) | - | |||||
|
Deemed dividend on Series B Preferred Stock
|
(1,812 | ) | - | |||||
|
Net loss attributable to common stockholders
|
$ | (41,990 | ) | $ | (7,664 | ) | ||
|
Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Salaries and benefits
|
$ | 628 | $ | 680 | ||||
|
Stock-based compensation
|
979 | 265 | ||||||
|
Consulting and other professional services
|
51 | 85 | ||||||
|
Technology licenses and royalties
|
646 | 177 | ||||||
|
Project-related research and supplies:
|
||||||||
|
AV-101
|
161 | 23 | ||||||
|
Stem cell and all other
|
42 | 49 | ||||||
| 203 | 72 | |||||||
|
Rent
|
163 | 165 | ||||||
|
Depreciation
|
29 | 33 | ||||||
|
Warrant modification expense
|
135 | - | ||||||
|
All other
|
1 | - | ||||||
|
Total Research and Development Expense
|
$ | 2,835 | $ | 1,477 | ||||
|
Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Salaries and benefits
|
$ | 520 | $ | 530 | ||||
|
Stock-based compensation
|
2,889 | 299 | ||||||
|
Consulting Services
|
72 | 84 | ||||||
|
Legal, accounting and other professional fees
|
2,113 | 658 | ||||||
|
Investor relations
|
60 | 98 | ||||||
|
Insurance
|
105 | 103 | ||||||
|
Travel expenses
|
73 | 49 | ||||||
|
Rent and utilities
|
116 | 117 | ||||||
|
Warrant modification expense
|
480 | - | ||||||
|
All other expenses
|
87 | 86 | ||||||
|
Total General and Administrative Expense
|
$ | 6,515 | $ | 2,024 | ||||
|
Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Interest expense on promissory notes
|
$ | 208 | $ | 909 | ||||
|
Amortization of discount on promissory notes
|
565 | 1,295 | ||||||
|
Other interest expense, including on capital leases and premium financing
|
3 | 6 | ||||||
| 776 | 2,210 | |||||||
|
Effect of foreign currency fluctuations on notes payable
|
(6 | ) | (22 | ) | ||||
|
Interest income
|
- | (5 | ) | |||||
|
Interest expense, net
|
$ | 770 | $ | 2,183 | ||||
|
Nine Months Ended December 31,
|
||||||||
|
2015
|
2014
|
|||||||
|
Net cash used in operating activities
|
$ | (3,499 | ) | $ | (1,874 | ) | ||
|
Net cash used in investing activities
|
(5 | ) | - | |||||
|
Net cash provided by financing activities
|
4,592 | 1,887 | ||||||
|
Net increase in cash and cash equivalents
|
1,088 | 13 | ||||||
|
Cash and cash equivalents at beginning of period
|
70 | - | ||||||
|
Cash and cash equivalents at end of period
|
$ | 1,158 | $ | 13 | ||||
|
Ite
m
4.
|
CONTROLS AND PROCEDURES
|
|
·
|
we may not be able to demonstrate that our product candidate is safe and effective in treating a human disease or disorder, to the satisfaction of the FDA;
|
|
·
|
the results of our non-clinical studies and clinical trials may not meet the level of statistical or clinical significance required by the FDA for marketing approval;
|
|
·
|
the FDA may disagree with the number, design, size, conduct or implementation of our non-clinical studies and clinical trials;
|
|
·
|
the FDA may require that we conduct additional non-clinical studies and clinical trials;
|
|
·
|
the FDA or the applicable foreign regulatory agency may not approve the formulation, labeling or specifications of any of our product candidates;
|
|
·
|
the contract research organizations, or CROs, that we retain to conduct our non-clinical studies and clinical trials may take actions outside of our control that materially adversely impact our non-clinical studies and clinical trials;
|
|
·
|
the FDA may find the data from non-clinical studies and clinical trials insufficient to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;
|
|
·
|
the FDA may disagree with our interpretation of data from our non-clinical studies and clinical trials;
|
|
·
|
the FDA may not accept data generated at our non-clinical studies and clinical trial sites;
|
|
·
|
if our NDA, if and when submitted, is reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional non-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;
|
|
·
|
the FDA may require development of a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval or post-approval;
|
|
·
|
the FDA or the applicable foreign regulatory agency may determine that the manufacturing processes or facilities of third-party contract manufacturers with which we contract do not conform to applicable requirements, including current Good Manufacturing Practices, or cGMPs; or
|
|
·
|
the FDA or applicable foreign regulatory agency may change its approval policies or adopt new regulations.
|
|
·
|
the FDA may deny permission to proceed with our planned clinical trials or any other clinical trials we may initiate, or may place a clinical trial on hold;
|
|
·
|
delays in filing or receiving approvals of additional INDs that may be required;
|
|
·
|
negative results from our ongoing pre-clinical studies;
|
|
·
|
delays in reaching or failing to reach agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
|
·
|
inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical trials, for example delays in the manufacturing of sufficient supply of finished drug product;
|
|
·
|
difficulties obtaining Institutional Review Board, or IRB, approval to conduct a clinical trial at a prospective site or sites;
|
|
·
|
challenges in recruiting and enrolling patients to participate in clinical trials, including the proximity of patients to trial sites;
|
|
·
|
eligibility criteria for the clinical trial, the nature of the clinical trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications;
|
|
·
|
severe or unexpected drug-related side effects experienced by patients in a clinical trial;
|
|
·
|
delays in validating any endpoints utilized in a clinical trial;
|
|
·
|
the FDA may disagree with our clinical trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials;
|
|
·
|
reports from pre-clinical or clinical testing of other CNS therapies that raise safety or efficacy concerns; and
|
|
·
|
difficulties retaining patients who have enrolled in a clinical trial but may be prone to withdraw due to rigors of the clinical trials, lack of efficacy, side effects, personal issues or loss of interest.
|
|
·
|
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 that reveals deficiencies or violations that require us to undertake corrective action, including the imposition of a clinical hold;
|
|
·
|
unforeseen safety issues, including any that could be identified in our ongoing non-clinical carcinogenicity studies, adverse side effects or lack of effectiveness;
|
|
·
|
changes in government regulations or administrative actions;
|
|
·
|
problems with clinical supply materials; and
|
|
·
|
lack of adequate funding to continue clinical trials.
|
|
·
have staffing difficulties;
|
|
·
fail to comply with contractual obligations;
|
|
·
experience regulatory compliance issues;
|
|
·
undergo changes in priorities or become financially distressed; or
|
|
·
form relationships with other entities, some of which may be our competitors.
|
|
·
|
the efficacy of our product candidates as demonstrated in clinical trials, and, if required by any applicable regulatory authority in connection with the approval for the applicable indications, to provide patients with incremental health benefits, as compared with other available CNS therapies;
|
|
·
|
limitations or warnings contained in the labeling approved for our product candidates by the FDA or other applicable regulatory authorities;
|
|
·
|
the clinical indications for which our product candidates are approved;
|
|
·
|
availability of alternative treatments already approved or expected to be commercially launched in the near future;
|
|
·
|
the potential and perceived advantages of our product candidates over current treatment options or alternative treatments, including future alternative treatments;
|
|
·
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
|
·
|
the strength of marketing and distribution support and timing of market introduction of competitive products;
|
|
·
|
publicity concerning our products or competing products and treatments;
|
|
·
|
pricing and cost effectiveness;
|
|
·
|
the effectiveness of our sales and marketing strategies;
|
|
·
|
our ability to increase awareness of our product candidates through marketing efforts;
|
|
·
|
our ability to obtain sufficient third-party coverage or reimbursement; or
|
|
·
|
the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
|
|
·
|
regulatory authorities may withdraw or limit their approval of such product candidates;
|
|
·
|
regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;
|
|
·
|
we may be required to change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates;
|
|
·
|
we may be subject to regulatory investigations and government enforcement actions;
|
|
·
|
we may decide to remove such product candidates from the marketplace;
|
|
·
|
we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and
|
|
·
|
our reputation may suffer.
|
|
·
|
issue warning letters or untitled letters;
|
|
·
|
seek an injunction or impose civil or criminal penalties or monetary fines;
|
|
·
|
suspend or withdraw marketing approval;
|
|
·
|
suspend any ongoing clinical trials;
|
|
·
|
refuse to approve pending applications or supplements to applications submitted by us;
|
|
·
|
suspend or impose restrictions on operations, including costly new manufacturing requirements; or
|
|
·
|
seize or detain products, refuse to permit the import or export of products, or require that we initiate a product recall.
|
|
·
|
The federal anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid.
|
|
·
|
The federal False Claims Act imposes criminal and civil penalties, including those from civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.
|
|
·
|
The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.
|
|
·
|
The federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services.
|
|
·
|
The federal transparency requirements, sometimes referred to as the “Sunshine Act,” under the Patient Protection and Affordable Care Act, require manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests.
|
|
·
|
Analogous state laws and regulations, such as state anti-kickback and false claims laws and transparency laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance.
|
|
·
|
guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures and drug pricing.
|
|
·
|
our customers’ ability to obtain reimbursement for our product candidates in foreign markets;
|
|
·
|
our inability to directly control commercial activities because we are relying on third parties;
|
|
·
|
the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;
|
|
·
|
different medical practices and customs in foreign countries affecting acceptance in the marketplace;
|
|
·
|
import or export licensing requirements;
|
|
·
|
longer accounts receivable collection times;
|
|
·
|
longer lead times for shipping;
|
|
·
|
language barriers for technical training;
|
|
·
|
reduced protection of intellectual property rights in some foreign countries;
|
|
·
|
the existence of additional potentially relevant third party intellectual property rights;
|
|
·
|
foreign currency exchange rate fluctuations; and
|
|
·
|
the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.
|
|
·
|
produce product candidates;
|
|
·
|
develop and obtain required regulatory approvals for commercialization of products we produce;
|
|
·
|
maintain, leverage and expand our intellectual property portfolio;
|
|
·
|
establish and maintain sales, distribution and marketing capabilities, and/or enter into strategic partnering arrangements to access such capabilities;
|
|
·
|
gain market acceptance for our products; and
|
|
·
|
obtain adequate capital resources and manage our spending as costs and expenses increase due to research, production, development, regulatory approval and commercialization of product candidates.
|
|
·
|
our drug rescue research methodology may not be successful in identifying potential drug rescue NCEs;
|
|
·
|
competitors may develop alternatives that render our drug rescue NCEs obsolete;
|
|
·
|
a drug rescue NCE may, on further study, be shown to have harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
|
|
·
|
a drug rescue NCE may not be capable of being produced in commercial quantities at an acceptable cost, or at all; or
|
|
·
|
a drug rescue NCE may not be accepted as safe and effective by regulatory authorities, patients, the medical community or third-party payors.
|
|
·
|
our ability to identify potential drug rescue candidates in the public domain, obtain sufficient quantities of them, and assess them using our bioassay systems;
|
|
·
|
if we seek to rescue drug rescue candidates that are not available to us in the public domain, the extent to which third parties may be willing to out-license or sell certain drug rescue candidates to us on commercially reasonable terms;
|
|
·
|
our medicinal chemistry collaborator’s ability to design and produce proprietary drug rescue NCEs based on the novel biology and structure-function insight we provide using
CardioSafe
3D; and
|
|
·
|
financial resources available to us to develop and commercialize lead drug rescue NCEs internally, or, if we out-license them to strategic partners, the resources such partners choose to dedicate to development and commercialization of any drug rescue NCEs they license from us.
|
|
·
|
decreased demand for products that we may develop;
|
|
·
|
injury to our reputation;
|
|
·
|
withdrawal of clinical trial participants;
|
|
·
|
costs to defend the related litigation;
|
|
·
|
a diversion of management's time and our resources;
|
|
·
|
substantial monetary awards to trial participants or patients;
|
|
·
|
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
|
·
|
loss of revenue;
|
|
·
|
the inability to commercialize our product candidates; and
|
|
·
|
a decline in our stock price.
|
|
·
|
initiate and successfully complete clinical trials that meet their clinical endpoints;
|
|
·
|
initiate and successfully complete all safety studies required to obtain U.S. and foreign marketing approval for our product candidates;
|
|
·
|
commercialize our product candidates, if approved, by developing a sales force or entering into collaborations with third parties; and
|
|
·
|
achieve market acceptance of our product candidates in the medical community and with third-party payors.
|
|
·
|
the number and characteristics of the product candidates we pursue, including AV-101 and drug rescue NCEs;
|
|
·
|
the scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical and clinical studies;
|
|
·
|
the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;
|
|
·
|
the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs;
|
|
·
|
the cost of manufacturing our product candidates and any products we successfully commercialize;
|
|
·
|
our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements;
|
|
·
|
market acceptance of our products;
|
|
·
|
the effect of competing technological and market developments;
|
|
·
|
our ability to obtain government funding for our programs;
|
|
·
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims necessary to preserve our freedom to operate in the stem cell industry, including litigation costs associated with any claims that we infringe third-party patents or violate other intellectual property rights and the outcome of such litigation;
|
|
·
|
the timing, receipt and amount of potential future licensee fees, milestone payments, and sales of, or royalties on, our future products, if any; and
|
|
·
|
the extent to which we acquire or invest in businesses, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.
|
|
·
|
any of our AV-101 or other pending patent applications, if issued, will include claims having a scope sufficient to protect AV-101 or any other products or product candidates;
|
|
·
|
any of our pending patent applications will issue as patents at all;
|
|
·
|
we will be able to successfully commercialize our product candidates, if approved, before our relevant patents expire;
|
|
·
|
we were the first to make the inventions covered by each of our patents and pending patent applications;
|
|
·
|
we were the first to file patent applications for these inventions;
|
|
·
|
others will not develop similar or alternative technologies that do not infringe our patents;
|
|
·
|
others will not use pre-existing technology to effectively compete against us;
|
|
·
|
any of our patents, if issued, will be found to ultimately be valid and enforceable;
|
|
·
|
any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties;
|
|
·
|
we will develop additional proprietary technologies or product candidates that are separately patentable; or
|
|
·
|
that our commercial activities or products will not infringe upon the patents or proprietary rights of others.
|
|
·
|
cease developing, selling or otherwise commercializing our product candidates;
|
|
·
|
pay substantial damages for past use of the asserted intellectual property;
|
|
·
|
obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all; and
|
|
·
|
in the case of trademark claims, redesign, or rename, some or all of our product candidates to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming.
|
|
·
|
the scope of rights granted under the license agreement and other interpretation-related issues;
|
|
·
|
whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
|
|
·
|
our right to sublicense patent and other rights to third parties under collaborative development relationships;
|
|
·
|
our diligence obligations with respect to the use of the licensed technology in relation to our development and commercialization of our product candidates, and what activities satisfy those diligence obligations; and
|
|
·
|
the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.
|
|
·
|
others may be able to develop and/or practice technology that is similar to our technology or aspects of our technology but that is not covered by the claims of patents, should such patents issue from our patent applications;
|
|
|
·
|
we might not have been the first to make the inventions covered by a pending patent application that we own;
|
|
|
·
|
we might not have been the first to file patent applications covering an invention;
|
|
|
·
|
others may independently develop similar or alternative technologies without infringing our intellectual property rights;
|
|
|
·
|
pending patent applications that we own or license may not lead to issued patents;
|
|
|
·
|
patents, if issued, that we own or license may not provide us with any competitive advantages, or may be held invalid or unenforceable, as a result of legal challenges by our competitors;
|
|
|
·
|
third parties may compete with us in jurisdictions where we do not pursue and obtain patent protection;
|
|
|
·
|
we may not be able to obtain and/or maintain necessary or useful licenses on reasonable terms or at all;
|
|
|
·
|
the patents of others may have an adverse effect on our business.
|
|
·
|
plans for, progress of or results from non-clinical studies and clinical trials of our product candidates;
|
|
|
·
|
the failure of the FDA to approve our product candidates;
|
|
|
·
|
announcements of new products, technologies, commercial relationships, acquisitions or other events by us or our competitors;
|
|
|
·
|
the success or failure of other CNS therapies;
|
|
|
·
|
regulatory or legal developments in the United States and other countries;
|
|
|
·
|
failure of our product candidates, if approved, to achieve commercial success;
|
|
|
·
|
fluctuations in stock market prices and trading volumes of similar companies;
|
|
|
·
|
general market conditions and overall fluctuations in U.S. equity markets;
|
|
|
·
|
variations in our quarterly operating results;
|
|
|
·
|
changes in our financial guidance or securities analysts’ estimates of our financial performance;
|
|
|
·
|
changes in accounting principles;
|
|
|
·
|
our ability to raise additional capital and the terms on which we can raise it;
|
|
|
·
|
sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders;
|
|
|
·
|
additions or departures of key personnel;
|
|
|
·
|
discussion of us or our stock price by the press and by online investor communities; and
|
|
|
·
|
other risks and uncertainties described in these risk factors.
|
|
Exhibit
|
||
|
Number
|
Description
|
|
| 3.1 |
Certificate of Designation of the Relative Rights and Preferences of the Series C Convertible Preferred Stock of VistaGen Therapeutics, Inc., dated January 25, 2016, incorporated by reference from Exhibit 3.1 to the Companys Current Report on Form 8-K filed on January 29, 2016
|
|
| 10.1 |
Exchange Agreement, by and between VistaGen Therapeutics, Inc., and Platinum Long Term Growth VII, LLC and Montsant Partners, LLC, dated January 25, 2016, incorporated by reference from Exhibit 10.1 to the Companys Current Report on Form 8-K filed on January 29, 2016
|
|
| 10.2 | Form of Warrant Exchange Agreement | |
|
31.1
|
Certification of the Principal Executive Officer required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
31.2
|
Certification of the Principal Financial Officer required by Rule 13a-14(a) under the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
32
|
Certification of the Principal Executive and Financial Officers required by Rule 13a-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
101.INS
|
XBRL Instance Document
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase
|
|
VISTAGEN THERAPEUTICS, INC.
/s/ Shawn K. Singh
Shawn K. Singh
Chief Executive Officer (Principal Executive Officer)
|
|
| /s/ Jerrold D. Dotson | |
|
Jerrold D. Dotson
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer)
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|