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DELAWARE
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51-0407811
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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
o
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Non-accelerated filer
x
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Accelerated filer
o
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Smaller reporting entity
o
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PART I
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FINANCIAL INFORMATION
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Page
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Item 1:
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Financial Statements (Unaudited)
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|
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Consolidated Balance Sheets as of September 30, 2010 and June 30, 2010
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3
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Consolidated Statements of Operations for the three months ended September 30, 2010 and 2009 and for the period from December 1, 2000 (inception) through September 30, 2010
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4
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Consolidated Statements of Cash Flows for the three months ended September 30, 2010 and 2009 and for the period from December 1, 2000 (inception) through September 30, 2010
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5
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Consolidated Statement of Stockholders’ Equity
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6
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Notes to Consolidated Financial Statements
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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 Operation
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19
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Item 3:
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Quantitative and Qualitative Disclosures about Market Risk
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28
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Item 4T:
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Controls and Procedures
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29
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PART II
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OTHER INFORMATION
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Item 6:
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Exhibits
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30
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SIGNATURES
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31
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|
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September 30,
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June 30,
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|||||||
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2010
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2010
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|||||||
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(unaudited)
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(Note 1)
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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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$ | 7,479 | $ | 9,031 | ||||
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Prepaid expenses and other current assets
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91 | 102 | ||||||
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Total current assets
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7,570 | 9,133 | ||||||
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Plant and equipment, net
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48 | 3 | ||||||
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Total assets
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$ | 7,618 | $ | 9,136 | ||||
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
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Current liabilities
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||||||||
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Accounts payable
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$ | 765 | $ | 529 | ||||
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Accrued expenses
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837 | 925 | ||||||
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Amount due to related company
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274 | 301 | ||||||
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Total current liabilities
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1,876 | 1,755 | ||||||
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Stockholders' equity:
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||||||||
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Preferred stock, $0.01 par value, authorized 100,000 shares,
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||||||||
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none outstanding
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- | - | ||||||
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Common stock, $ 0.00000002 par value, 113,000,000 authorized
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||||||||
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shares; shares issued and outstanding: 7,346,324 at
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||||||||
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September 30, 2010 and 7,346,324 at June 30, 2010
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- | - | ||||||
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Additional paid-in capital
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78,308 | 78,188 | ||||||
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Deficit accumulated during development stage
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(72,566 | ) | (70,807 | ) | ||||
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Total stockholders' equity
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5,742 | 7,381 | ||||||
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Total liabilities and stockholders' equity
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$ | 7,618 | $ | 9,136 | ||||
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Three Months Ended
September 30,
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Period from
December 1, 2000 (Inception)
through
September 30,
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|||||||||||
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2010
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2009
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2010
|
||||||||||
|
Revenues:
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||||||||||||
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Dividends received
|
$ | 57 | $ | - | $ | 57 | ||||||
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Interest and other income
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14 | 26 | 2,744 | |||||||||
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Total revenues
|
71 | 26 | 2,801 | |||||||||
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Operating expenses:
|
||||||||||||
|
Research and development
|
(685 | ) | (503 | ) | (37,759 | ) | ||||||
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License fees
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- | (1,500 | ) | (21,500 | ) | |||||||
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Selling, general and administrative
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(1,145 | ) | (431 | ) | (16,100 | ) | ||||||
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Total operating expenses
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(1,830 | ) | (2,434 | ) | (75,359 | ) | ||||||
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Loss from operations
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(1,759 | ) | (2,408 | ) | (72,558 | ) | ||||||
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Income tax expense
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- | - | (8 | ) | ||||||||
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Net loss arising during development stage
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$ | (1,759 | ) | $ | (2,408 | ) | $ | (72,566 | ) | |||
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Net loss per common share:
|
||||||||||||
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Basic and diluted
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$ | (0.24 | ) | $ | (0.33 | ) | ||||||
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Weighted average number of common shares outstanding
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7,346,324 | 7,346,324 | ||||||||||
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Three Months Ended
September 30,
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Period from
December 1, 2000 (Inception)
through
September 30,
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|||||||||||
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2010
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2009
|
2010
|
||||||||||
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Operating activities
|
||||||||||||
|
Net loss arising during development stage
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$ | (1,759 | ) | $ | (2,408 | ) | $ | (72,566 | ) | |||
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Adjustments to reconcile net loss to net cash
|
||||||||||||
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(used in) provided by operating activities:
|
||||||||||||
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Share based payments
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120 | - | 1,916 | |||||||||
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Depreciation
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3 | - | 3 | |||||||||
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Changes in operating assets and liabilities:
|
||||||||||||
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Prepaid expenses and other current assets
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11 | 235 | (91 | ) | ||||||||
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Accounts payable
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236 | 534 | 765 | |||||||||
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Accrued expenses
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(88 | ) | (2,256 | ) | 837 | |||||||
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Amounts due to related company
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(27 | ) | 61 | 274 | ||||||||
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Net cash used in operating activities
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(1,504 | ) | (3,834 | ) | (68,862 | ) | ||||||
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Investing activities
|
||||||||||||
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Purchases of plant and equipment
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(48 | ) | - | (51 | ) | |||||||
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Net cash used in investing activities
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(48 | ) | - | (51 | ) | |||||||
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Financing activities
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||||||||||||
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Net proceeds from issuance of common stock
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- | - | 76,392 | |||||||||
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Net cash provided by financing activities
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- | - | 76,392 | |||||||||
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Net (decrease)/increase in cash and cash equivalents
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(1,552 | ) | (3,834 | ) | 7,479 | |||||||
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Cash and cash equivalents at beginning of period
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9,031 | 19,067 | - | |||||||||
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Cash and cash equivalents at end of period
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$ | 7,479 | $ | 15,233 | $ | 7,479 | ||||||
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Common Stock
|
Additional paid in capital
|
Deficit
accumulated
during
development
stage
|
Total
|
|||||||||||||
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(shares)
|
||||||||||||||||
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Balance at June 30, 2010
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7,346,324 | $ | 78,188 | $ | (70,807 | ) | $ | 7,381 | ||||||||
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Net loss arising during development stage
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- | - | (1,759 | ) | (1,759 | ) | ||||||||||
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Comprehensive Loss
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(1,759 | ) | ||||||||||||||
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Share-based payments (refer Note 6)
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- | 120 | - | 120 | ||||||||||||
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Balance at September 30, 2010
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7,346,324 | $ | 78,308 | $ | (72,566 | ) | $ | 5,742 | ||||||||
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Three Months Ended
September 30,
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||||
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2010
|
2009
|
|||
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(In Thousands, except share and per share data)
|
||||
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Numerator
|
||||
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Net loss arising during development stage
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(1,759)
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(2,408)
|
||
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Numerator for diluted earnings per share
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$ (1,759)
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$ (2,408)
|
||
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Denominator
|
||||
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Denominator for basic earnings per share:
|
||||
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Weighted average number of shares used in computing net loss per share, basic and diluted
|
7,346,324
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7,346,324
|
||
|
Dilutive potential common shares
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7,346,324
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7,346,324
|
||
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Basic and diluted earnings per share
|
$ (0.24)
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$ (0.33)
|
||
|
As at September 30,
|
||||
|
2010
|
2009
|
|||
|
(Number of shares redeemable under warrants or options)
|
||||
|
Warrants exercisable prior to July 11, 2010 at an exercise price of $43.50
|
-
|
281,525
|
||
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Warrants exercisable prior to August 6, 2012 at an exercise price of $36.00
|
218,559
|
218,559
|
||
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Warrants exercisable prior to August 6, 2012 at an exercise price of $30.00
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24,836
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24,836
|
||
|
Warrants exercisable prior to July 30, 2013 at an exercise price of $21.70
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4,608
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4,608
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||
|
Options exercisable prior to January 28, 2014 at an exercise price of $6.30
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5,000
|
5,000
|
||
|
Options exercisable prior to April 23, 2015 at an exercise price of $5.05
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110,195
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-
|
||
|
Options exercisable prior to June 7, 2015 at an exercise price of $1.86
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110,195
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-
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||
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Options exercisable prior to June 18, 2015 at an exercise price of $1.52
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73,463
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-
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||
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Options exercisable prior to September 1, 2015 at an exercise price of $0.77
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82,232
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|||
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Common shares issuable upon exercise of outstanding warrants or options
|
629,088
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534,528
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||
|
(In thousands)
|
Payment due by period
|
|||||||||||||||||||
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Contractual Obligations
|
Total
|
Less than 1 Year
|
1 - 3 Years
|
3 - 5 Years
|
More than 5 Years
|
|||||||||||||||
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Operating Lease Obligations
|
$ | 306 | $ | 121 | $ | 120 | $ | 65 | $ | - | ||||||||||
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Purchase Obligations
|
$ | 560 | $ | 560 | $ | - | $ | - | $ | - | ||||||||||
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Total
|
$ | 866 | $ | 681 | $ | 120 | $ | 65 | $ | - | ||||||||||
|
Three Months Ended September 30, 2010
|
Three Months Ended September 30, 2009
|
|||
|
(In Thousands)
|
||||
|
USA
|
Australia
|
USA
|
Australia
|
|
|
Loss from operations
|
$ (772)
|
$ (987)
|
$ (20)
|
$ (2,388)
|
|
Segment assets
|
6,695
|
923
|
11,689
|
3,598
|
|
(a)
|
the date of expiration or lapsing of the last patent right in the patents and patent applications set out in the license agreement with Novogen; or
|
|
(b)
|
the date of expiration or lapsing of the last licensed patent right which MEPL would, but for the license granted in the license agreement, infringe in any country in the geographical territory covered by the license agreement by doing in that country any of the things set out in the license agreement.
|
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(i)
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approval by the U.S. Food and Drug Administration (the “FDA”) of a New Drug Application (“NDA”) for phenoxodiol;
|
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(ii)
|
approval or authorization of any kind to market phenoxodiol in the U.S.; or
|
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(iii)
|
approval or authorization of any kind by a government agency in any other country to market phenoxodiol,
|
|
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i)
|
$1,000,000 on the date an investigational new drug application (“IND”) for the licensed product goes into effect or the equivalent approval of a government agency is obtained in another country. If this event does not occur before March 31, 2008 then this amount will be due on this date. The amount of $1,000,000 was paid to Novogen on March 31, 2008 under the terms of this agreement;
|
|
|
ii)
|
$2,000,000 on the date of enrollment of the first clinical trial subject in a Phase II clinical trial of the licensed product. If this event does not occur before June 30, 2009, then this amount will be due on this date. The amount of $2,000,000 was paid to Novogen on June 30, 2009 under the terms of this agreement;
|
|
|
iii)
|
$3,000,000 on the date of enrollment of the first clinical trial subject in a Phase III clinical trial of the licensed product. If this event does not occur before December 31, 2011, then this amount will be due on this date; and
|
|
|
iv)
|
$8,000,000 on the date of first receipt of a NDA for the licensed product from the FDA or equivalent approval from a government agency in another country. If this event does not occur before December 31, 2013, then this amount will be due on this date.
|
|
|
i)
|
$1,000,000 on the date an investigational new drug application (“IND”) for the licensed product goes into effect or the equivalent approval of a government agency is obtained in another country. If this event does not occur before March 31, 2008 then this amount will be due on this date. The amount of $1,000,000 was paid to Novogen on March 31, 2008 under the terms of this agreement;
|
|
|
ii)
|
$2,000,000 on the date of enrollment of the first clinical trial subject in a Phase II clinical trial of the licensed product. If this event does not occur before June 30, 2009, then this amount will be due on this date. The amount of $2,000,000 was paid to Novogen on June 30, 2009 under the terms of this agreement;
|
|
|
iii)
|
$3,000,000 on the date of enrollment of the first clinical trial subject in a Phase III clinical trial of the licensed product. If this event does not occur before December 31, 2011, then this amount will be due on this date; and
|
|
|
iv)
|
$8,000,000 on the date of first receipt of a NDA for the licensed product from the FDA or equivalent approval from a government agency in another country. If this event does not occur before December 31, 2013, then this amount will be due on this date.
|
|
·
our inability to obtain required additional financing or financing available to us on acceptable terms,
|
|
·
our inability to maintain or enter into, and our dependence upon, collaboration or contractual arrangements necessary for the clinical development of phenoxodiol, triphendiol, NV-143 and NV-128;
|
|
·
our failure to successfully commercialize our product candidates;
|
|
·
costs and delays in the clinical development program and/or receipt of U.S. Food and Drug Administration (the “FDA”) or other required governmental approvals, or the failure to obtain such approvals, for our product candidates;
|
|
·
uncertainties in clinical trial results;
|
|
·
our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products;
|
|
·
our inability to control the costs of manufacturing our products;
|
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·
competition and competitive factors;
|
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·
our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business;
|
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·
our inability to operate our business without infringing the patents and proprietary rights of others;
|
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·
costs stemming from our defense against third party intellectual property infringement claims;
|
|
·
general economic conditions;
|
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·
the failure of any products to gain market acceptance;
|
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·
technological changes;
|
|
·
government regulation generally and the receipt of regulatory approvals;
|
|
·
changes in industry practice; and
|
|
·
one-time events.
|
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Grant date
|
January 28, 2009
|
April 23, 2010
|
June 7, 2010
|
June 18, 2010
|
September 1, 2010
|
|
Dividend yield
|
0%
|
0%
|
0%
|
0%
|
0%
|
|
Expected volatility
|
111%
|
132%
|
135%
|
136%
|
136%
|
|
Historical volatility
|
111%
|
132%
|
135%
|
136%
|
136%
|
|
Risk-free interest rate
|
1.70%
|
2.61%
|
1.95%
|
2.04%
|
1.41%
|
|
Expected life
|
5 years
|
5 years
|
5 years
|
5 years
|
5 years
|
|
Fair value
|
$5.00
|
$4.38
|
$1.63
|
$1.33
|
$0.67
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•
|
Commence the clinical development of the drug candidate NV-143;
|
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•
|
Continue the pre-clinical development of NV-128 and its next-generation candidates necessary to file an IND with the FDA.
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31.1
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
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31.2
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
|
32.1
|
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C 1350).
|
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|
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards, Inc.;
|
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2.
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Based on my knowledge, this Quarterly Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Quarterly Report;
|
|
3.
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Based on my knowledge, the financial statements, and other financial information included in this Quarterly Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within the entities, particularly during the period in which this Quarterly Report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in the Quarterly Report our conclusions about the effectiveness of this disclosure controls and procedures, as of the end of the period covered by this Quarterly Report based on such evaluation; and
|
|
(d)
|
Disclosed in this Quarterly Report any change in the registrant’s internal control over financial reporting that occurred during the registrants first fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards, Inc.;
|
|
2.
|
Based on my knowledge, this Quarterly Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Quarterly Report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this Quarterly Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Quarterly Report;
|
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within the entities, particularly during the period in which this Quarterly Report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
(c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in the Quarterly Report our conclusions about the effectiveness of this disclosure controls and procedures, as of the end of the period covered by this Quarterly Report based on such evaluation; and
|
|
(d)
|
Disclosed in this Quarterly Report any change in the registrant’s internal control over financial reporting that occurred during the registrants first fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
|
5.
|
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
|
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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1.
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The Registrant’s Quarterly Report on Form 10-Q for the period ended September 30, 2010, (the “Form 10-Q”) to which this Certification is attached as Exhibit 32.1, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and
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2.
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The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition of the Registrant at the end of the period covered by the Form 10-Q and results of operations of the registrant for the period covered by the Form 10-Q.
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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 |
|---|