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Delaware
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58-1959440
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(State or other jurisdiction of
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(I.R.S. Employer Identification No.)
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incorporation or organization)
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Large accelerated filer
¨
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Accelerated filer
¨
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Non-accelerated filer
þ
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Smaller reporting
company
¨
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Class
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Outstanding at May 12, 2011
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Common Stock $.01 Par Value
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11,578,973
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PAGE
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||
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PART I.
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FINANCIAL INFORMATION
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Item 1 —
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Consolidated Financial Statements
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Consolidated Balance Sheets as of March 31, 2011 (unaudited) and December 31, 2010
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4
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Consolidated Statements of Operations for the
Three Months Ended March 31, 2011 and 2010 (unaudited)
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5
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Consolidated Statements of Cash Flows for the
Three Months Ended March 31, 2011 and 2010 (unaudited)
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6
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Notes to Consolidated Financial Statements (unaudited)
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7
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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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14
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Item 3 —
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Quantitative and Qualitative Disclosures
About Market Risk
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23
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Item 4 —
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Controls and Procedures
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23
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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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24
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Item 1A –
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Risk Factors
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24
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Item 2 —
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Unregistered Sales of Equity Securities and Use of Proceeds
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24
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Item 3 —
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Defaults upon Senior Securities
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24
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Item 4 —
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Removed and Reserved
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24
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Item 5 —
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Other Information
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24
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Item 6 —
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Exhibits
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24
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SIGNATURES
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25
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March 31, 2011
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December 31, 2010
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|||||||
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(Unaudited)
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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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$ | 4,800,690 | $ | 4,885,972 | ||||
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Short-term investments
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28,203 | 25,816 | ||||||
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Accounts receivable, net of allowance for doubtful accounts of
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||||||||
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$72,145 at March 31, 2011 and December 31, 2010
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- | 2,750,447 | ||||||
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Prepaid expenses and other
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171,689 | 265,683 | ||||||
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Total current assets
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5,000,582 | 7,927,918 | ||||||
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Property and equipment, net
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96,850 | 104,729 | ||||||
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Other assets
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4,584 | 4,584 | ||||||
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Total assets
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$ | 5,102,016 | $ | 8,037,231 | ||||
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
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Current liabilities:
|
||||||||
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Accounts payable
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$ | 1,397,949 | $ | 1,351,004 | ||||
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Accrued liabilities
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314,002 | 595,341 | ||||||
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Current portion of loan payable
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- | 757,471 | ||||||
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Total current liabilities
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1,711,951 | 2,703,816 | ||||||
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Commitments and contingencies
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- | - | ||||||
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Stockholders' equity :
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||||||||
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Convertible preferred stock, $1.00 par value;
|
||||||||
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5,000,000 shares authorized and 3,350,000 shares issued and
|
||||||||
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outstanding at March 31, 2011 and December 31, 2010
|
||||||||
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(liquidation value - $33,500,000 at March 31, 2011 and December 31, 2010)
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3,350,000 | 3,350,000 | ||||||
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Common stock, $.01 par value:
|
||||||||
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170,000,000 shares authorized at March 31, 2011 and December 31, 2010:
|
||||||||
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11,578,576 and 11,517,566 shares issued and outstanding
|
||||||||
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at March 31, 2011 and December 31, 2010, respectively
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115,786 | 115,176 | ||||||
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Additional paid-in capital
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384,780,043 | 384,130,011 | ||||||
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Treasury stock, at cost: 79,545 shares held at March 31, 2011 and December 31, 2010
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(8,034,244 | ) | (8,034,244 | ) | ||||
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Accumulated other comprehensive income
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2,387 | - | ||||||
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Accumulated deficit
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(376,823,907 | ) | (374,227,528 | ) | ||||
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Total stockholders' equity
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3,390,065 | 5,333,415 | ||||||
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Total liabilities and stockholders' equity
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$ | 5,102,016 | $ | 8,037,231 | ||||
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Three Months Ended
|
||||||||
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March 31, 2011
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March 31, 2010
|
|||||||
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Revenues:
|
||||||||
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Royalties
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- | - | ||||||
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Other
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- | - | ||||||
| - | - | |||||||
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Costs and expenses:
|
||||||||
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Research and development
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1,398,274 | 843,953 | ||||||
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General and administrative
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1,253,105 | 1,051,225 | ||||||
| 2,651,379 | 1,895,178 | |||||||
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Interest expense
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- | (220,965 | ) | |||||
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Other income
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55,000 | - | ||||||
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Other expense
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- | (10,001 | ) | |||||
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Net loss
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(2,596,379 | ) | (2,126,144 | ) | ||||
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Dividends on Series A convertible preferred stock
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(251,250 | ) | (251,250 | ) | ||||
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Net loss attributable to common shareholders
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$ | (2,847,629 | ) | $ | (2,377,394 | ) | ||
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Net loss per share (basic and diluted)
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$ | (0.25 | ) | $ | (0.28 | ) | ||
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Weighted average number of common shares
|
||||||||
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outstanding (basic and diluted)
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11,444,711 | 8,540,812 | ||||||
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THREE MONTH PERIOD ENDED
MARCH 31,
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||||||||
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2011
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2010
|
|||||||
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CASH FLOWS FROM OPERATING ACTIVITIES
|
||||||||
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Net loss
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$ | (2,596,379 | ) | $ | (2,126,144 | ) | ||
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Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
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||||||||
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Depreciation and amortization
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12,088 | 19,557 | ||||||
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Stock-based compensation expense
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491,988 | 211,890 | ||||||
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Gain on sale of assets
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(55,000 | ) | - | |||||
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Non-cash interest
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- | 20,471 | ||||||
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Investment impairment loss
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- | 10,001 | ||||||
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Changes in operating assets and liabilities:
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||||||||
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Accounts receivable
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2,750,447 | 3,284,786 | ||||||
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Prepaid expenses and other
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93,995 | 61,062 | ||||||
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Accounts payable
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46,945 | (340,107 | ) | |||||
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Accrued liabilities
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(281,340 | ) | (408,157 | ) | ||||
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Net cash provided by operating activities
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462,744 | 733,359 | ||||||
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CASH FLOWS FROM INVESTING ACTIVITIES
|
||||||||
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Purchases of furniture and equipment
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(4,209 | ) | - | |||||
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Proceeds from sale of assets
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55,000 | - | ||||||
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Net cash provided by investing activities
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50,791 | - | ||||||
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CASH FLOWS FROM FINANCING ACTIVITIES
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||||||||
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Repayment of loan
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(757,471 | ) | (2,055,268 | ) | ||||
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Net proceeds from sale of common stock or exercise of options and warrants
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158,654 | 4,657,491 | ||||||
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Net cash provided by (used in) financing activities
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(598,817 | ) | 2,602,223 | |||||
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Net increase (decrease) in cash and cash equivalents
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(85,282 | ) | 3,335,582 | |||||
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Cash and cash equivalents at beginning of period
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4,885,972 | 6,312,182 | ||||||
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Cash and cash equivalents at end of period
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$ | 4,800,690 | $ | 9,647,764 | ||||
|
Supplemental disclosure of cash flow information:
|
||||||||
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Cash paid during the period for interest
|
$ | 7,145 | $ | 200,494 | ||||
|
1.
|
Basis of Presentation
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2.
|
Revenue Recognition
|
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3.
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Comprehensive Loss
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THREE MONTHS ENDED
MARCH 31,
|
||||||||
|
2011
|
2010
|
|||||||
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Net loss
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$ | (2,596,379 | ) | $ | (2,126,144 | ) | ||
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Other comprehensive income
|
2,387 | - | ||||||
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Comprehensive loss
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$ | (2,593,992 | ) | $ | (2,126,144 | ) | ||
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4.
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New Accounting Pronouncements
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5.
|
Short-Term Investments
|
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Available-for-Sale Securities
|
||||||||||||||||
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Amortized
|
Gross
Unrealized
|
Gross
Realized
|
Estimated Fair
Value (Net
Carrying
|
|||||||||||||
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Cost
|
Gains
|
Losses
|
Amount)
|
|||||||||||||
|
Equity Securities
|
$ | 125,000 | $ | 2,387 | $ | (99,184 | ) | $ | 28,203 | |||||||
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Total
|
$ | 125,000 | $ | 2,387 | $ | (99,184 | ) | $ | 28,203 | |||||||
|
Available-for-Sale Securities
|
||||||||||||||||
|
Amortized
|
Gross
Unrealized
|
Gross
Realized
|
Estimated Fair
Value (Net
Carrying
|
|||||||||||||
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Cost
|
Gains
|
Losses
|
Amount)
|
|||||||||||||
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Equity Securities
|
$ | 125,000 | $ | - | $ | (99,184 | ) | $ | 25,816 | |||||||
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Total
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$ | 125,000 | $ | - | $ | (99,184 | ) | $ | 25,816 | |||||||
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6.
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Loan Payable
|
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7.
|
Fair Value Measurement
|
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·
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Level 1 – Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date.
|
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·
|
Level 2 – Inputs are quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted pries that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
|
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·
|
Level 3 – Unobservable inputs that reflect our own assumptions, based on the best information available, including our own data.
|
|
Fair Value Measurements at March 31, 2011
|
||||||||||||||||
|
Total Carrying
Value at
|
Quoted prices in
active markets
|
Significant other
observable inputs
|
Significant
unobservable
inputs
|
|||||||||||||
|
March 31, 2011
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
|
Cash equivalents
|
$ | 105,868 | $ | 105,868 | $ | — | $ | — | ||||||||
|
Available for sale securities*
|
28,203 | 28,203 | — | — | ||||||||||||
|
Fair Value Measurements at December 31, 2010
|
||||||||||||||||
|
Total Carrying
Value at
|
Quoted prices in
active markets
|
Significant other
observable inputs
|
Significant
unobservable
inputs
|
|||||||||||||
|
December 31, 2010
|
(Level 1)
|
(Level 2)
|
(Level 3)
|
|||||||||||||
|
Cash equivalents
|
$ | 1,105,868 | $ | 105,868 | $ | — | $ | — | ||||||||
|
Available for sale securities*
|
25,816 | 25,816 | — | — | ||||||||||||
|
8.
|
Share-Based Compensation
|
|
THREE MONTHS ENDED
MARCH 31,
|
||||||||
|
2011
|
2010
|
|||||||
|
Research and development
|
$ | 76,526 | $ | 9,766 | ||||
|
General and administrative
|
415,462 | 202,124 | ||||||
|
Share-based compensation expense
|
$ | 491,988 | $ | 211,890 | ||||
|
Net share-based compensation expense, per common share:
|
||||||||
|
Basic and diluted
|
$ | 0.04 | $ | 0.02 | ||||
|
THREE MONTH PERIOD ENDED
MARCH 31,
|
||||||||
|
2011
|
2010
|
|||||||
|
Expected volatility
|
94.09 | % | 97.50 | % | ||||
|
Risk-free interest rate
|
2.04 | % | 2.38 | % | ||||
|
Expected term of option
|
5.49 years
|
5 years
|
||||||
|
Forfeiture rate*
|
5.00 | % | 5.00 | % | ||||
|
Expected dividend yield
|
0.00 | % | 0.00 | % | ||||
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
|||||||
|
Outstanding at January 1, 2011
|
590,009 | $ | 38.94 | |||||
|
Granted
|
181,750 | $ | 6.22 | |||||
|
Exercised
|
(12,863 | ) | $ | 1.76 | ||||
|
Expired
|
(6,502 | ) | $ | 170.54 | ||||
|
Forfeited
|
(519 | ) | $ | 8.31 | ||||
|
Outstanding at March 31, 2011
|
751,875 | $ | 30.55 | |||||
|
Vested and expected to vest at March 31, 2011
|
747,203 | $ | 30.71 | |||||
|
Exercisable at March 31, 2011
|
658,463 | $ | 34.11 | |||||
|
9.
|
Income Taxes
|
|
|
-
|
Going Concern - A fundamental principle of the preparation of financial statements in accordance with GAAP is the assumption that an entity will continue in existence as a going concern, which contemplates continuity of operations and the realization of assets and settlement of liabilities occurring in the ordinary course of business. This principle is applicable to all entities except for entities in liquidation or entities for which liquidation appears imminent. In accordance with this requirement, our policy is to prepare our consolidated financial statements on a going concern basis unless we intend to liquidate or have no other alternative but to liquidate. As a result of our operational losses and the potential that we may be unable to meet our cash requirements for the next twelve months, there is substantial doubt about our ability to continue as a going concern. While we have prepared our consolidated financial statements on a going concern basis, if we do not receive additional funding, our ability to continue as a going concern may be impacted. Our consolidated financial statements included in this Quarterly Report on Form 10-Q do not reflect any adjustments that might specifically result from the outcome of this uncertainty.
|
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-
|
Revenue Recognition - We recognize revenue in accordance with the provisions of authoritative guidance issued, whereby revenue is not recognized until it is realized or realizable and earned. Revenue is recognized when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price to the buyer is fixed and determinable and collectibility is reasonably assured.
|
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-
|
Royalty Revenue – Royalties from licenses are based on third-party sales and recorded as earned in accordance with contract terms, when third-party results are reliably measured and collectibility is reasonably assured. We expect that the majority of our 2011 revenues will be from royalties on the sale of Thalomid
®
, which we will recognize when earned. In 2004, certain provisions of a purchase agreement dated June 14, 2001 by and between Bioventure Investments kft (“Bioventure”) and the Company were satisfied and, as a result, beginning in 2005 we became entitled to share in the royalty payments received by Royalty Pharma Finance Trust, successor to Bioventure, on annual Thalomid
®
sales above a certain threshold. Based on the licensing agreement royalty formula, annual royalty sharing commences when net royalties received by Royalty Pharma exceeds $15,375,000, which equates to approximately $225 million in Thalomid
®
annual sales.
|
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-
|
The Company is also eligible to receive royalties from Oxford Biomedica, PLC based on a portion of the net sales of products developed for the treatment of ophthalmic (eye) diseases based in part on Endostatin. We received our first royalty in the amount of $368,000 under this agreement in 2009, a portion of which was paid to Children’s Medical Center Corporation under the Company’s original Endostatin license agreement with Children’s. We did not receive any additional payment from Oxford Biomedica, PLC in 2010. We do not expect to receive additional payments from Oxford Biomedica, PLC in 2011.
|
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-
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Royalty payments, if any, are recorded as revenue when received and/or when collectibility is reasonably assured.
|
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-
|
Research and Development - Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with preclinical testing and clinical trials of our product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses. Research and development costs are expensed as incurred.
|
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-
|
Expenses for Clinical Trials – Expenses for clinical trials are incurred from planning through patient enrollment to reporting of the data. We estimate expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs that are associated with patient enrollment are recognized as each patient in the clinical trial completes the enrollment process. Estimated clinical trial costs related to enrollment can vary based on numerous factors, including expected number of patients in trials, the number of patients that do not complete participation in a trial, and when a patient drops out of a trial. Costs that are based on clinical data collection and management are recognized in the reporting period in which services are provided. In the event of early termination of a clinical trial, we would accrue an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial.
|
|
|
-
|
Stock-Based Compensation – All share-based payment transactions are recognized in the financial statements at their fair values. Using the straight-line expense attribution method over the requisite service period, which is generally the option vesting term of three years, share-based compensation expense recognized for the three months ended March 31, 2011 and 2010 totaled approximately $492,000 and $212,000, respectively.
|
|
CLINICAL
PHASE
|
ESTIMATED
COMPLETION
PERIOD
|
|
|
Phase I
|
1-2 Years
|
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Phase II
|
2-3 Years
|
|
|
Phase III
|
|
2-4 Years
|
|
-
|
the number of patients that ultimately participate in the trial;
|
|
-
|
the duration of patient follow-up that seems appropriate in view of the results;
|
|
-
|
the number of clinical sites included in the trials; and
|
|
-
|
the length of time required to enroll suitable patient subjects.
|
|
|
-
|
Outside Services – In the three-month period ended March 31, 2011, we expended $36,000 on outside service activities versus $5,000 in the same 2010 period. The increase in 2011 as compared to 2010 reflects an increase in outsourced services related to the development of ENMD-2076.
|
|
|
-
|
Clinical Trial Costs – Clinical trial costs, which include clinical site fees, monitoring costs and data management costs, increased to $435,000 in the three months ended March 31, 2011 from $21,000 in the three-month period ended March 31, 2010. The increase relates primarily to our focus on the increase in clinical development of ENMD-2076 in the 2011 period, in addition to the reduction of patient costs for cycles of treatment that were not completed in trials that have wound down in discontinued programs in the 2010 period.
|
|
|
-
|
Contract Manufacturing Costs – The costs of manufacturing the material used in clinical trials for our product candidates is reflected in contract manufacturing. These costs include bulk manufacturing, encapsulation and fill and finish services, product release costs and storage fees. Contract manufacturing costs for the three months ended March 31, 2011 increased to $202,000 from $169,000 during the same period in 2010.
|
|
|
-
|
Personnel Costs — Personnel costs increased to $391,000 in the three months ended March 31, 2011 from $345,000 in the three-month period ended March 31, 2010. The increase is primarily attributed to the $67,000 increase in non-cash stock-based compensation expense related to stock options granted in 2011
.
|
|
|
-
|
Also reflected in our 2011 research and development expenses for the three-month period ended March 31, 2011 are patent costs of $161,000 and facility and related expenses of $53,000. In the corresponding 2010 period, these expenses totaled $103,000 and $57,000, respectively.
|
|
|
·
|
selling additional equity securities;
|
|
|
·
|
out-licensing product candidates to one or more corporate partners;
|
|
|
·
|
monetizing our Thalomid
®
royalty payment stream;
|
|
|
·
|
completing an outright sale of non-priority assets; and/or
|
|
|
·
|
engaging in one or more strategic transactions.
|
|
ENTREMED, INC.
|
|
|
(Registrant)
|
|
|
Date: May 16, 2011
|
/s/ Michael M. Tarnow
|
|
Michael M. Tarnow
|
|
|
Executive Chairman
|
|
|
Date: May 16, 2011
|
/s/ Sara B. Capitelli
|
|
Sara B. Capitelli
|
|
|
Principal Accounting Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | 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 |
|---|