ANAVEX LIFE SCIENCES CORP. - Quarter Report: 2009 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2009 or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to _____
Commission File Number: 000-51652
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
Nevada | 20-8365999 |
(State or other jurisdiction of incorporation or | (IRS Employer Identification No.) |
organization) |
27 Marathonos Ave., 15351 Athens,
Greece
(Address of principal executive offices) (Zip Code)
30 210 603 4026
(Registrants telephone
number, including area code)
Not Applicable
(Former name, former
address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of
the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes
[X] No [ ]
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if
any, every
Interactive Data File required to be submitted and posted pursuant to Rule 405
of Regulation S-T
(§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required
to submit and
post such files). [ ] Yes [ ] No
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
or a
smaller reporting company. See the definitions of large accelerated filer,
accelerated filer and smaller reporting
company in Rule 12b-2 of the
Exchange Act.
Large accelerated filer [ ] | Accelerated filer [ ] | |
Non-accelerated filer [ ] | (Do not check if a smaller reporting company) | Smaller reporting company [X] |
ii
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes [ ] No [X]
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the
issuers classes of common stock, as of the latest
practicable date:
20,746,761 shares of common stock outstanding as of August 14,
2009.
iii
TABLE OF CONTENTS
1
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements.
ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
INTERIM FINANCIAL STATEMENTS
June 30, 2009
(Stated in US Dollars)
(Unaudited)
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
INTERIM BALANCE SHEETS |
June 30, 2009 and September 30, 2008 |
(Stated in US Dollars) |
(Unaudited) |
June 30, | September 30, | |||||
ASSETS | 2009 | 2008 | ||||
Current | ||||||
Cash | $ | 742,577 | $ | 6,357 | ||
Deferred financing charge Note 4 | 55,777 | - | ||||
Equipment | 602 | 862 | ||||
$ | 798,956 | $ | 7,219 | |||
LIABILITIES | ||||||
Current | ||||||
Accounts payable and accrued liabilities | $ | 980,263 | $ | 749,389 | ||
- | ||||||
Promissory notes payable Note 3 | 2,523,693 | 1,550,000 | ||||
3,503,956 | 2,299,389 | |||||
CAPITAL DEFICIT | ||||||
Capital stock Notes 4 and 6 | ||||||
Authorized: | ||||||
150,000,000 common shares, par value $0.001 per share | ||||||
Issued and outstanding: | ||||||
20,617,873 common shares (September 30, 2008: 19,957,420) | 20,618 | 19,957 | ||||
Shares to be issued | - | 125,849 | ||||
Additional paid-in capital | 7,846,248 | 4,624,838 | ||||
Deficit accumulated during the development stage | (10,571,866 | ) | (7,062,814 | ) | ||
(2,705,000 | ) | (2,292,170 | ) | |||
$ | 798,956 | $ | 7,219 |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
INTERIM STATEMENTS OF OPERATIONS |
for the three and nine months ended June 30, 2009 and 2008 and |
for the period from January 23, 2004 (Date of Inception) to June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
January 23, | |||||||||||||||
2004 (Date of | |||||||||||||||
Three Months Ended | Nine Months Ended | Inception) to | |||||||||||||
June 30, | June 30, | June 30, | |||||||||||||
2009 | 2008 | 2009 | 2008 | 2009 | |||||||||||
Restated | Restated | ||||||||||||||
Note 9 | Note 9 | ||||||||||||||
Expenses | |||||||||||||||
Accounting and audit fees | $ | 36,957 | $ | 22,538 | $ | 71,217 | $ | 59,267 | $ | 194,633 | |||||
Amortization | 80 | 130 | 260 | 130 | 480 | ||||||||||
Bank charges and interest | 632 | 9,871 | 2,427 | 14,440 | 17,533 | ||||||||||
Consulting Notes 5 and 6 | 653,306 | 1,359,582 | 1,624,837 | 2,267,160 | 5,525,533 | ||||||||||
Legal fees (recovery) | 68,783 | (24,385 | ) | 74,304 | 32,460 | 192,633 | |||||||||
Management fees Note 5 | - | - | - | - | 14,625 | ||||||||||
Office and miscellaneous | 35,989 | 27,973 | 81,345 | 90,520 | 265,673 | ||||||||||
Registration and filing fees | 4,673 | 1,883 | 10,718 | 6,602 | 35,048 | ||||||||||
Rent | - | 15,000 | - | 75,000 | 148,750 | ||||||||||
Research and development | 455,683 | 275,115 | 1,068,646 | 799,543 | 3,507,826 | ||||||||||
Website design and maintenance | 1,455 | 1,424 | 1,455 | 1,424 | 26,725 | ||||||||||
Loss before other items | (1,257,558 | ) | (1,689,131 | ) | (2,935,209 | ) | (3,346,546 | ) | (9,929,459 | ) | |||||
Loss on extinguishment of debt | - | - | (487,469 | ) | - | (487,469 | ) | ||||||||
Accretion of debt discount-Note 3 | (11,550 | ) | - | (19,331 | ) | - | (19,331 | ) | |||||||
Interest | (5,206 | ) | (13,057 | ) | (40,696 | ) | (22,109 | ) | (100,980 | ) | |||||
Loss on foreign exchange | (65,340 | ) | (323 | ) | (26,347 | ) | (10,881 | ) | (34,627 | ) | |||||
Net loss for the period | $ | (1,339,654 | ) | $ | (1,702,511 | ) | $ | (3,509,052 | ) | $ | (3,379,536 | ) | $ | (10,571,866 | ) |
Basic and diluted loss per share | $ | (0.07 | ) | $ | (0.09 | ) | $ | (0.18 | ) | $ | (0.17 | ) | |||
Weighted average shares | 20,145,630 | 19,757,579 | 20,042,999 | 19,679,466 | |||||||||||
outstanding |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
INTERIM STATEMENTS OF CASH FLOWS |
for the nine months ended June 30, 2009 and 2008 and |
for the period from January 23, 2004 (Date of Inception) to June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
January 23, | |||||||||
2004 | |||||||||
(Date of | |||||||||
Nine months ended | Inception) to | ||||||||
June 30, | June 30, | ||||||||
2009 | 2008 | 2009 | |||||||
Restated | |||||||||
Note 9 | |||||||||
Cash Flows used in Operating Activities | |||||||||
Net loss for the period | $ | (3,509,052 | ) | $ | (3,379,536 | ) | $ | (10,571,866 | ) |
Add items not involving cash: | |||||||||
Amortization | 260 | 130 | 480 | ||||||
Accretion of debt discount | 19,331 | - | 19,331 | ||||||
Stock-based compensation | 555,790 | 959,349 | 2,240,576 | ||||||
Common shares issued for consulting expenses | 307,097 | - | 626,847 | ||||||
Common shares issued for research and development | |||||||||
expenses | - | 533,600 | 800,000 | ||||||
Common shares issued for severance | - | - | 340,600 | ||||||
Interest accrued on promissory notes | 30,489 | 30,489 | |||||||
Loss on extinguishment of debt | 487,469 | - | 487,469 | ||||||
Promissory note issued for severance | - | - | 71,500 | ||||||
Management fees contributed | - | - | 14,625 | ||||||
Rent contributed | - | - | 3,750 | ||||||
Adjustments to reconcile net loss to net cash used | |||||||||
in operating activities: | |||||||||
Prepaid expenses | - | (5,000 | ) | - | |||||
Accounts payable and accrued liabilities | 285,303 | 77,261 | 1,208,193 | ||||||
Net cash used in operating activities | (1,823,313 | ) | (1,814,196 | ) | (4,728,006 | ) | |||
Cash Flows from Financing Activities | |||||||||
Promissory note proceeds | 1,202,500 | 1,296,052 | 2,652,500 | ||||||
Promissory note repayments | - | - | (100,000 | ) | |||||
Issuance of common shares | 1,357,033 | 525,000 | 2,552,500 | ||||||
Due to related parties | - | - | 33,665 | ||||||
Shareholder advances | - | - | 333,000 | ||||||
Net cash provided by financing activities | 2,559,533 | 1,821,052 | 5,471,665 | ||||||
Cash Flows from Investing Activities | |||||||||
Acquisition of equipment | - | (1,082 | ) | (1,082 | ) | ||||
Increase in cash during the period | 736,220 | 5,774 | 742,577 | ||||||
Cash, beginning of period | 6,357 | 25 | - | ||||||
Cash, end of period | $ | 742,577 | $ | 5,799 | $ | 742,577 | |||
Non cash transactions Note 7 |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
STATEMENT OF CHANGES IN CAPITAL DEFICIT |
for the period January 23, 2004 (Date of Inception) to June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
Deficit | ||||||||||||||||||
Common Stock | Accumulated | |||||||||||||||||
Additional | Common | During the | ||||||||||||||||
Paid-in | Shares to | Development | ||||||||||||||||
Shares | Par Value | Capital | Be Issued | Stage | Total | |||||||||||||
Capital stock issued for cash - at $0.0033 | 12,000,000 | $ | 12,000 | $ | 28,000 | $ | - | $ | - | $ | 40,000 | |||||||
Net loss from January 23, 2004 to September 30, | - | - | - | - | (14,395 | ) | (14,395 | ) | ||||||||||
2004 | ||||||||||||||||||
Balance, September 30, 2004 | 12,000,000 | 12,000 | 28,000 | - | (14,395 | ) | 25,605 | |||||||||||
Capital stock issued for cash - at $0.0033 | 7,200,000 | 7,200 | 16,800 | - | - | 24,000 | ||||||||||||
Management fees contributed | - | - | 13,000 | - | - | 13,000 | ||||||||||||
Rent contributed | - | - | 3,000 | - | - | 3,000 | ||||||||||||
Net loss for the year | - | - | - | - | (91,625 | ) | (91,625 | ) | ||||||||||
Balance, September 30, 2005 | 19,200,000 | 19,200 | 60,800 | - | (106,020 | ) | (26,020 | ) | ||||||||||
Management fees contributed - Note 5 | - | - | 1,625 | - | - | 1,625 | ||||||||||||
Rent contributed Note 5 | - | - | 750 | - | - | 750 | ||||||||||||
Debt forgiven by directors Note 5 | - | - | 33,666 | - | - | 33,666 | ||||||||||||
Net (loss) for the period | - | - | - | - | (25,532 | ) | (25,532 | ) | ||||||||||
Balance, September 30, 2006 | 19,200,000 | 19,200 | 96,841 | - | (131,552 | ) | (15,511 | ) | ||||||||||
Capital stock issued for research and development | 222,222 | 222 | 799,788 | - | - | 800,000 | ||||||||||||
services, on September 24, 2007 at $3.60 | ||||||||||||||||||
Capital stock issued for research and development | 92,500 | 93 | 332,907 | - | - | 333,000 | ||||||||||||
services, on September 25, 2007 at $3.60 | ||||||||||||||||||
Net loss for the period | - | - | - | - | (1,579,993 | ) | (1,5779,993 | ) | ||||||||||
Balance, September 30, 2007 Carried forward | 19,514,722 | $ | 19,515 | $ | 1,229,526 | - | $ | (1,711,545 | ) | $ | (462,504 | ) |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
STATEMENT OF CHANGES IN CAPITAL DEFICIT |
for the period January 23, 2004 (Date of Inception) to June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
Deficit | ||||||||||||||||||
Common Stock | Accumulated | |||||||||||||||||
Additional | Common | During the | ||||||||||||||||
Paid-in | Shares to | Development | ||||||||||||||||
Shares | Par Value | Capital | Be Issued | Stage | Total | |||||||||||||
Balance, September 30, 2007 - brought forward | 19,514,722 | 19,515 | 1,229,526 | - | (1,711,545 | ) | (462,504 | ) | ||||||||||
Capital stock issued for cash on December 10, 2007 - | 150,000 | 150 | 524,850 | - | - | 525,000 | ||||||||||||
at $3.50 | ||||||||||||||||||
Capital stock issued for consulting services on | 50,000 | 50 | 192,950 | - | - | 193,000 | ||||||||||||
December 18, 2007 - $3.86 | ||||||||||||||||||
Capital stock issued in settlement of debt on | 10,000 | 10 | 44,990 | - | - | 45,000 | ||||||||||||
December 18, 2007 - $4.50 | ||||||||||||||||||
Stock-based compensation for stock issued at a | - | - | 65,000 | - | - | 65,000 | ||||||||||||
discount | ||||||||||||||||||
Capital stock issued for severance on May 15, 2008 - | 65,000 | 65 | 340,535 | - | - | 340,600 | ||||||||||||
at $5.24 | ||||||||||||||||||
Common stock to be issued for consulting services | - | - | - | 252,599 | - | 252,599 | ||||||||||||
Capital stock issued for consulting services on | 25,000 | 25 | 126,725 | (126,750 | ) | - | - | |||||||||||
August 19, 2008 - at $5.00 | ||||||||||||||||||
Capital stock issued for cash on August 19, 2008 - at | 142,698 | 142 | 606,325 | - | - | 606,467 | ||||||||||||
$4.25 | ||||||||||||||||||
Stock-based compensation Note 6 | - | - | 1,493,937 | - | - | 1,493,937 | ||||||||||||
Net loss for the year | - | - | - | - | (5,351,269 | ) | (5,351,269 | ) | ||||||||||
Balance, September 30, 2008 | 19,957,420 | $ | 19,957 | $ | 4,624,838 | 125,849 | $ | (7,062,814 | ) | $ | (2,292,170 | ) |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
STATEMENT OF CHANGES IN CAPITAL DEFICIT |
for the period January 23, 2004 (Date of Inception) to June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
Deficit | ||||||||||||||||||
Common Stock | Accumulated | |||||||||||||||||
Additional | Common | During the | ||||||||||||||||
Paid-in | Shares to | Development | ||||||||||||||||
Shares | Par Value | Capital | Be Issued | Stage | Total | |||||||||||||
Balance, September 30, 2008 brought forward | 19,957,420 | $ | 19,957 | $ | 4,624,838 | $ | 125,849 | $ | (7,062,814 | ) | $ | (2,292,170 | ) | |||||
Stock-based compensation Note 7 | - | - | 555,790 | - | - | 555,790 | ||||||||||||
Capital stock issued for consulting services on | 25,000 | 25 | 65,725 | (65,750 | ) | - | - | |||||||||||
November 20, 2008 - $2.63 | ||||||||||||||||||
Capital stock issued for consulting services on | 25,000 | 25 | 62,475 | (62,500 | ) | - | - | |||||||||||
February 20, 2009 - $2.50 | ||||||||||||||||||
Capital stock issued for cash on March 6, 2009 - at | 89,148 | 89 | 200,494 | - | - | 200,583 | ||||||||||||
$2.25 | ||||||||||||||||||
Capital stock issued for consulting services on March | 2,500 | 3 | 4,997 | - | - | 5,000 | ||||||||||||
20, 2009 - at $2.50 | ||||||||||||||||||
Capital stock issued for cash on March 20, 2009 - at | 10,800 | 11 | 24,289 | - | - | 24,300 | ||||||||||||
$2.25 | ||||||||||||||||||
Capital stock issued for cash on June 11, 2009 - at | 36,000 | 36 | 72,864 | - | - | 72,900 | ||||||||||||
$2.25, net of finders fees of $8,100 | ||||||||||||||||||
Capital stock issued for services on June 11, 2009 - at | 29,227 | 29 | 65,731 | - | - | 65,760 | ||||||||||||
$2.25 | ||||||||||||||||||
Capital stock issued for cash on June 19, 2009 - at | 495,556 | 496 | 1,058,754 | - | - | 1,059,250 | ||||||||||||
$2.25, net of finders fees of $55,750 | ||||||||||||||||||
Capital stock issued for finders fees on June 26, | 22,222 | 22 | 55,755 | - | - | 55,777 | ||||||||||||
2009 at $2.51 | ||||||||||||||||||
Shares to be issued for consulting services | - | - | - | 236,337 | - | 236,337 | ||||||||||||
-Note 5 | ||||||||||||||||||
Beneficial conversion features on convertible debt | ||||||||||||||||||
issuances - Note 4 | - | - | 333,056 | - | - | 333,056 | ||||||||||||
Extinguishment of debt - Note 3 | - | - | 487,469 | - | - | 487,469 | ||||||||||||
Cancellation of common shares Note 5 | (75,000 | ) | (75 | ) | 234,011 | (233,936 | ) | - | - | |||||||||
Net loss for the period | - | - | - | - | (3,509,052 | ) | (3,509,052 | ) | ||||||||||
Balance, June 30, 2009 | 20,617,873 | $ | 20,618 | $ | 7,846,248 | $ | - | $ | (10,571,866 | ) | $ | (2,705,000 | ) |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. |
(A Development Stage Company) |
NOTES TO THE INTERIM FINANCIAL STATEMENTS |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) |
Note 1 | Nature of Operations |
The Company is in the development stage as defined by Statement of Financial Accounting Standard (SFAS) No. 7 Accounting and Reporting by Development Stage Enterprises and has not yet realized any revenues from its planned operations. The Company is seeking to develop and market proprietary drug targets for the treatment of cancer and diseases of the central nervous system. |
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These financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America on a going concern basis, which assumes that the Company will continue to realize its assets and discharge its obligations and commitments in the normal course of operations. Realization values may be substantially different from carrying values as shown and these financial statements do not give effect to adjustments that would be necessary to the carrying values and classification of assets and liabilities should the Company be unable to continue as a going concern. At June 30, 2009, the Company had an accumulated deficit of $10,571,866 (September 30, 2008 - $7,062,814) since its inception, has a working capital deficit of $2,761,379 (September 30, 2008 - $2,293,032) and expects to incur further losses in the development of its business, all of which casts substantial doubt about the Companys ability to continue as a going concern. The Companys ability to continue as a going concern is dependent upon its ability to generate future profitable operations and/or to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. Management has no formal plan in place to address this concern but is considering obtaining additional funds by debt financing to the extent there is a shortfall from operations. While the Company is expending its best efforts to achieve the above plans, there is no assurance that any such activity will generate funds for operations. |
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The Company was incorporated in the State of Nevada, United States of America on January 23, 2004 as Thrifty Printing Inc. On January 25, 2007, the Company changed its business from developing online photofinishing services to its current business and changed its name to Anavex Life Sciences Corp. |
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These statements reflect all adjustments, consisting of normal recurring adjustments, which in the opinion of management are necessary for fair presentation of the information contained therein. It is suggested that these interim financial statements be read in conjunction with the audited financial statements of the Company for the year ended September 30, 2008. The interim results are not necessarily indicative of the operating results expected for the fiscal year ending on September 30, 2009. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations, although the Company believes that the disclosures herein are adequate to make the information presented not misleading. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 2 |
Note 2 | Recent Accounting Pronouncements |
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Recently Adopted Accounting Pronouncements |
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In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. This Statement defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosure related to the use of fair value measures in financial statements. The Company adopted SFAS 157 effective October 1, 2008. The adoption of SFAS 157 did not have a material effect on the Companys financial position, results of operations or cash flows. |
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In February, 2007, the FASB issued SFAS No. 159 The Fair Value Option for Financial Assets and Financial Liabilities. This Statement establishes presentation and disclosure requirements designed to facilitate comparisons between companies that choose different measurement attributes for similar types of assets and liabilities. The Company adopted SFAS 159 effective October 1, 2008. The adoption of SFAS 159 did not have a material effect on the Companys financial position, results of operations or cash flows. |
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Recent Accounting Pronouncements Not Yet Adopted |
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In December 2007, the Emerging Issues Task Force (EITF) reached a consensus on EITF No. 07-01, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property (EITF 07-01). EITF 07-01 discusses the appropriate income statement presentation and classification for the activities and payments between the participants in arrangements related to the development and commercialization of intellectual property. The sufficiency of disclosure related to these arrangements is also specified. EITF 07-01 was effective for fiscal years beginning after December 15, 2008. As a result, EITF 07-01 is effective for the Company for the fiscal year beginning October 1, 2009. The adoption of EITF 07-01 is expected to have minimal, if any, impact on its financial position and results of operations. However, based upon the nature of the Companys business, EITF 07-01 could have a material impact on its financial position and results of operations in future years. |
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In December 2007, FASB issued Statement No. 141 (Revised 2007), Business Combinations (SFAS 141(R)) and SFAS No. 160, Accounting and Reporting of Non- controlling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (SFAS 160). SFAS 141(R) requires companies to: (i) recognize, with certain exceptions, 100% of the fair values of assets acquired, liabilities assumed, and non-controlling interests in acquisitions of less than a 100% controlling interest when the acquisition constitutes a change in control of the acquired entity; (ii) measure acquirer shares issued in consideration for a business combination at fair value on the acquisition date; (iii) recognize contingent consideration arrangements at their acquisition-date fair values, with subsequent changes in fair value generally reflected in earnings; (iv) with certain exceptions, recognize pre- acquisition loss and gain contingencies at their acquisition-date fair values; (v) capitalize in- process research and development (IPR&D) assets acquired; (vi) expense, as incurred, acquisition-related transaction costs; (vii) capitalize acquisition- related restructuring costs only if the criteria in SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities , are met as of the acquisition date; and (viii) recognize changes that result from a business combination transaction in an acquirers existing income tax valuation allowances and tax uncertainty accruals as adjustments to income tax expense. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 3 |
Note 2 | Recent Accounting Pronouncements (contd) |
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Recent Accounting Pronouncements Not Yet Adopted (contd) |
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SFAS 141(R) is required to be adopted concurrently with SFAS 160 and is effective for business combination transactions for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. The adoption of these statements is not expected to have a material impact on significant acquisitions completed after October 1, 2009. |
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In April 2008, the FASB issued FSP 142-3, Determination of the Useful Life of Intangible Assets. This FSP amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FASB Statement No. 142, Goodwill and Other Intangible Assets. The intent of this FSP is to improve the consistency between the useful life of a recognized intangible asset under Statement 142 and the period of expected cash flows used to measure the fair value of the asset under FASB Statement No. 141 (Revised 2007), Business Combinations, and other U.S. generally accepted accounting principles (GAAP). This FSP is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited. The Company is in the process of evaluating the impact, if any, of FSP 142-3 on its financial statements. |
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In May 2008, the FASB issued FSP No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP APB 14-1). FSP APB 14-1 applies to convertible debt instruments that, by their stated terms, may be settled in cash (or other assets) upon conversion, including partial cash settlement, unless the embedded conversion option is required to be separately accounted for as a derivative under SFAS 133. Convertible debt instruments within the scope of FSP APB 14-1 are not addressed by the existing APB 14. FSP APB 14-1 requires that the liability and equity components of convertible debt instruments within the scope of FSP APB 14-1 be separately accounted for in a manner that reflects the entitys nonconvertible debt borrowing rate. This requires an allocation of the convertible debt proceeds between the liability component and the embedded conversion option (i.e., the equity component). The difference between the principal amount of the debt and the amount of the proceeds allocated to the liability component will be reported as a debt discount and subsequently amortized to earnings over the instruments expected life using the effective interest method. FSP APB 14- 1 is effective for the Companys fiscal year beginning October 1, 2009 and will be applied retrospectively to all periods presented. The Company is currently evaluating the effects of adopting FSP APB 14-1. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 4 |
Note 2 | Recent Accounting Pronouncements (contd) |
Recent Accounting Pronouncements Not Yet Adopted (contd) | |
In June 2008, the FASB ratified EITF Issue No. 07-05, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entitys Own Stock, or EITF 07-05. Equity-linked instruments (or embedded features) that otherwise meet the definition of a derivative as outlined in SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, or SFAS 133, are not accounted for as derivatives if certain criteria are met, one of which is that the instrument (or embedded feature) must be indexed to the entitys own stock. EITF 07-05 provides guidance on how to determine if equity-linked instruments (or embedded features) such as warrants and convertible notes are considered indexed to our stock. The Company will adopt EITF 07-05, beginning October 1, 2009. Under EITF 07-05, equity- linked instruments that are not indexed to the Companys own stock and thus classified as liabilities are carried at fair value and adjusted quarterly. The Company is currently evaluating the effect of adopting EITF 07-5. |
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In May 2009, the FASB issued SFAS No. 165, Subsequent Events. This statement establishes guidance related to accounting for and disclosure of events that happen after the date of the balance sheet but before the release of the financial statements. SFAS No. 165 is effective for reporting periods ending after June 15, 2009. We do not expect the adoption of this statement to have a material effect on our results of operations or financial position. |
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In June 2009, the FASB issued SFAS No.168, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 establishes the FASB Accounting Standards Codification (Codification), which officially launched July 1, 2009, to become the source of authoritative U.S. generally accepted accounting principles (GAAP) recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. The subsequent issuances of new standards will be in the form of Accounting Standards Updates that will be included in the Codification. Generally, the Codification is not expected to change U.S. GAAP. All other accounting literature excluded from the Codification will be considered non- authoritative. SFAS 168 is effective for financial statements issued for interim and annual periods ending after September 15, 2009. We will adopt SFAS 168 for our quarter ending September 30, 2009. We are currently evaluating the effect on our financial statement disclosures as all future references to authoritative accounting literature will be references in accordance with the Codification. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 5 |
Note 3 | Promissory Notes Payable |
June 30, | September 30, | ||||||
2009 | 2008 | ||||||
Promissory notes | $ | 100,000 | $ | 1,650,000 | |||
Convertible promissory notes payable | 2,737,418 | ||||||
Less: beneficial conversion features | (333,056 | ) | |||||
Add: accretion | 19,331 | ||||||
Less: Repayment | - | (100,000 | ) | ||||
$ | 2,523,693 | $ | 1,550,000 |
The Company has issued unsecured promissory notes totaling $1,919,418 in exchange for funds received from several parties. These notes have no terms of interest and are due on demand but not before January 13, 2010 as to $150,000, February 2, 2010 as to $1,669,418 and March 16, 2010 as to $100,000. The promissory notes are convertible into units at $2.50 per unit as to $1,819,418 of the notes and at $2.25 as to $100,000. Each unit is comprised of one common share and one common share purchase warrant exercisable at $3.00 per share for a period of two years from the conversion date. The promissory note of $1,669,418 was issued in exchange for a promissory note of the same amount that had matured as a result of the Company renegotiating this debt. The Company recorded the transaction as a debt extinguishment in accordance with EITF 96-19, Debtors Accounting for a Modification or Exchange of Debt Instruments with the Company incurring a loss on extinguishment of $487,469 as a result of recording the new promissory note at its fair value of $2,156,887. The premium of the fair value of the note over its principal balance in the amount of $487,469 has been recorded as additional paid-in capital. The Company recorded a beneficial conversion feature totaling $41,995 in respect of the promissory note issued in the amount of $150,000 based on the comparison of the proceeds of the note allocated to the common stock portion of the conversion feature and the fair value of the common stock at the commitment date of the note in accordance with EITF 00-27 Application of Issue 98-5 to Certain Convertible Instruments. This amount is being accreted using the effective interest rate method as a charge to income and included in accretion expense in the financial statements over the term of the note. During the nine months ended June 30, 2009, the Company recorded accretion expense of $19,331 (2008: $Nil) in respect of the accretion of this note discount.
During the three months ended June 30, 2009, the Company has issued additional promissory notes totalling $668,000 bearing interest at 8% and maturing June 3, 2014, as to $500,000 and June 19, 2011, as to $168,000. The holders of these notes may demand repayment of the balance outstanding at any time commencing 180 days from the issuance of the note to its maturity date. The promissory notes are convertible into units at $2.25 per unit. Each unit is comprised of one common share and one common share purchase warrant exercisable at $3.00 per share for a period of two years from the conversion date, as to $500,000 and one common share and one-half of one common share purchase warrant exercisable at $3.50 per share for a period of one year from the conversion date, as to $168,000.
The Company has also issued a promissory note in the amount of $150,000 bearing interest at 8% and maturing on December 31, 2009.
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 6 |
Note 3 | Promissory Notes Payable (contd) |
The Company has recorded a beneficial conversion feature in the amount of $232,581 on the promissory note totaling $500,000 and a beneficial conversion feature in the amount of $58,480 on the promissory notes totaling $168,000 for total beneficial conversion features on these note issuances of $291,061. These beneficial conversion features are calculated based on the comparison of the proceeds of the note allocated to the common stock portion of the conversion feature and the fair value of the common stock at the commitment date of the note in accordance with EITF 00-27 Application of Issue 98-5 to Certain Convertible Instruments. These amounts will be accreted using the effective interest rate method as a charge to income and included in accretion expense in the financial statements over the term of the note. During the nine months ended June 30, 2009, there was no material accretion expense to record in respect of these note discounts. |
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Pursuant to a termination agreement the Company has issued one promissory note to a former officer of the Company, in the amount of $200,000. The note is without interest and had specified repayment terms. The Company repaid $100,000 in accordance with the repayment terms. As at June 30, 2009 the Company is in default of the payment terms for the entire $100,000 balance owing. |
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Note 4 | Capital Stock |
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On May 24, 2006, the board of directors approved a six (6) for one (1) forward split of the authorized issued and outstanding common stock. The Companys authorized capital increased from 25,000,000 shares of common stock to 150,000,000 shares of common stock. |
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On September 24, 2007, the Company issued 222,222 common shares common shares at $3.60 per share for a total of $800,000 for research and development expenses. The common shares were recorded based upon the quoted market price of the Companys common stock on the agreement date. | |
On September 25, 2007, the Company settled a loan payable in the amount of $333,000 by issuing 92,500 common shares at $3.60 per share, being the quoted market price of the Companys common stock on the settlement date. |
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On December 10, 2007, the Company issued 150,000 units at $3.50 per unit for proceeds of $525,000. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $5.00 per share until December 10, 2009. | |
On December 18, 2007, the Company issued 10,000 shares at $4.50 per share for a total of $45,000 pursuant to an agreement to settle a debt and issued 50,000 shares at $3.86 per share for a total of $193,000 pursuant to a consulting agreement. The Company recorded compensation expense of $65,000 in respect of these issuances based on the excess of the fair value of these shares over the balances at which they were recorded by the Company. |
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On May 15, 2008, the Company issued 65,000 common shares at $5.24 per share for a total of $340,600 to its former CEO in accordance with the terms of a severance agreement upon the termination of his services. (Notes 5 and 9) The common shares were recorded based upon the quoted market price of the Companys common stock on the agreement date. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 7 |
Note 4 | Capital Stock (contd) |
On August 19, 2008, the Company issued 25,000 common shares at $5.07 per share for a total of $126,750 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Companys common stock on the issuance date |
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On August 19, 2008, the Company issued 142,698 units at $4.25 per unit for proceeds of $606,467 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $5.00 per share until August 19, 2009. |
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On November 20, 2008, the Company issued 25,000 common shares at $2.63 per share for a total of $65,750 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Companys common stock on the issuance date. |
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On February 20, 2009, the Company issued 25,000 common shares at $2.50 per share for a total of $62,500 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Companys common stock on the issuance date. |
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On March 6, 2009, the Company issued 89,148 units at $2.25 per unit for proceeds of $200,583 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until March 6, 2010. |
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On March 20, 2009, the Company issued 10,800 units at $2.25 per unit for proceeds of $24,300 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until March 20, 2010. |
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On March 20, 2009, the Company issued 2,500 common shares at $2.00 per share for a total of $5,000 to a public relations consultant pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Companys common stock on the issuance date. |
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On May 14, 2009, the Company entered into a revised consulting agreement with a director whereby the consultant returned 75,000 common shares to the Company for cancellation. The return of shares was recorded in the same amount at which they were originally issued. |
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On June 11, 2009 the Company issued 36,000 units at $2.25 per unit for proceeds of $81,000 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until June 11, 2010. The Company paid finders fees in the amount of $8,100 in relation to this private placement. |
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On June 11, 2009 the Company issued 29,227 common shares at $2.25 per share for service rendered by consultants. The common shares were recorded based upon the quoted market price of the Company’s common stock on the issuance date. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 8 |
Note 4 | Capital Stock (contd) |
On June 19, 2009 the Company issued 495,556 units at $2.25 per unit for proceeds of $1,115,000 pursuant to private placement agreements. Each unit consisted of one common share and one and one-eighth common share purchase warrant entitling the holder to purchase an additional common share at $2.25 per share until June 19, 2011. The Company paid finders fees in the amount of $55,750 in relation to this private placement. |
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On June 26, 2009 the Company issued 22,222 common shares at $2.51 for a total value of $55,777 for finders’ fees related to the issuance of the $500,000 promissory note (Note 3). The common shares were recorded based upon the quoted market price of the Company’s common stock on the issuance date. Such amount has been deferred and will be amortized over the term of the debt. |
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Note 5 | Related Party Transactions |
During the three and nine months ended June 30, 2009 and 2008 the Company was charged consulting fees from officers and a private company owned by a director as follows: |
Three months ended | Nine months ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2009 | 2008 | 2009 | 2008 | ||||||||||
Consulting | $ | 65,690 | $ | 151,961 | $ | 198,516 | $ | 332,461 |
The following amounts were contributed to the Company by the directors and officers of the Company:
January 23, | ||||||||||||||||
2004 (Date of | ||||||||||||||||
Three months ended | Nine months ended | Inception) to | ||||||||||||||
June 30, | June 30, | June 30, | ||||||||||||||
2009 | 2008 | 2009 | 2008 | 2009 | ||||||||||||
Management fees | $ | - | $ | - | $ | - | $ | - | 14,625 | |||||||
Rent | - | - | - | - | 3,750 | |||||||||||
Debt forgiven by directors | - | - | - | - | 33,666 | |||||||||||
$ | - | $ | - | $ | - | $ | - | $ | 52,041 |
On May 20, 2008, the Company executed an agreement with a director of the Company to provide consulting services for consideration consisting of 200,000 common shares to be issued every quarter at the rate of 25,000 per quarter commencing August 20, 2008 and by granting 400,000 share purchase options which vest at the rate of 100,000 per quarter commencing August 20, 2008. On May 14, 2009, the agreement was amended whereby the director was granted 400,000 share purchase options in exchange for rescinding the portion of the agreement that called for compensation of 200,000 common shares. Consequently, as a result of this amendment, the director returned 75,000 common shares to the Company for cancellation that had previously been issued.
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 9 |
Note 5 | Related Party Transactions (contd) | |
During the nine months ended June 30, 2009, the Company calculated compensation expense associated with this agreement as follows: |
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a) |
At September 30, 2008, the value of the shares to be issued under this agreement was $125,849. During the nine months ended June 30, 2009, as a result of re-measuring the remaining shares to be issued, the Company recognized a compensation expense of $236,337 up to the date of the agreement being amended and the director returning the previously issued common shares to the Company for cancellation. As a result of the agreement being amended, there are no remaining common shares to be issued. |
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b) |
In accordance with the agreement being amended on May 14, 2009, the director was granted 400,000 additional share purchase options having a fair value of $335,389. In accordance with the provisions of SFAS 123(R) Share-Based Payment, the Company recorded an incremental share-based compensation charge of $101,453 in respect of these options after giving effect to the director receiving these options in exchange for surrendering the right to receive common shares, having a fair value of $233,936 as at the date of the amendment, for future consulting services to be performed. |
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c) |
At December 31, 2008, the remaining 200,000 unvested options pertaining to the original agreement were re-measured with their fair value determined to be $142,000 for which the Company recognized compensation expense of $45,906. At March 31, 2009, the remaining 100,000 unvested options were re-measured with their fair value determined to be $38,000 for which the Company recognized as compensation expense included in consulting fees for the period ended June 30, 2009. |
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d) |
Included in accounts payable and accrued liabilities at June 30, 2009 is $ Nil (September 30, 2008 - $ 10,114) owing to directors and officers of the Company. |
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Note 6 | Commitments | |
a) | Share Purchase Warrants | |
A summary of the Companys share purchase warrants outstanding is presented below: |
Number of | Exercise | ||||
Shares | Price | ||||
Outstanding, September 30, 2008 | 292,698 | $5.00 | |||
Issued | 693,449 | $2.63 | |||
Balance, June 30, 2009 | 986,147 |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 10 |
Note 6 | Commitments - Continued | |
a) | Share Purchase Warrants - continued | |
At June 30, 2009, the Company has 986,147 share purchase warrants outstanding entitling the holder thereof the right to purchase one common share for each warrant held as summarized below: |
Weighted | |||||
Average | |||||
Number of | Exercise | ||||
Expiry Date | Shares | Price | |||
August 2009 | 142,698 | $5.00 | |||
December 2009 | 150,000 | $5.00 | |||
March 2010 | 89,148 | $4.00 | |||
March 2010 | 10,800 | $4.00 | |||
June 2010 | 36,000 | $4.00 | |||
June 2011 | 557,501 | $2.25 | |||
Balance, June 30, 2009 | 986,147 | $3.38 |
b) | Stock-based compensation plan |
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At June 30, 2009, the Company has stock purchase options outstanding entitling directors of the Company and consultants to purchase a total of 3,075,000 common shares of the Company. A summary of the outstanding stock purchase options is presented below: |
Number of | Weighted Average |
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Shares | Exercise Price | ||||
Outstanding at September 30, 2008 | 1,420,000 | $4.44 | |||
Granted | 1,655,000 | 2.50 | |||
Outstanding at June 30, 2008 | 3,075,000 | $3.40 |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 11 |
Note 6 | Commitments - Continued | |
b) | Stock-based compensation plan - continued | |
At June 30, 2009, the following stock options were outstanding and exercisable: |
Number of Shares | Exercise | Expiry | Aggregate | Remaining | |||||||||||
Price | Date | Intrinsic | contractual | ||||||||||||
Total | Number | Value | life (yrs) | ||||||||||||
Number | Vested | ||||||||||||||
100,000 (1) | - | $ 3.86 | December 1, 2010 | $ | - | 1.45 | |||||||||
400,000 (2) | 400,000 | $ 5.25 | May 20, 2011 | - | 1.89 | ||||||||||
50,000 (3) | 50,000 | $ 3.75 | November 1, 2012 | - | 3.34 | ||||||||||
150,000 (4) | 150,000 | $ 3.85 | December 3, 2012 | - | 3.43 | ||||||||||
450,000 (5) | 450,000 | $ 5.00 | June 3, 2013 | - | 3.93 | ||||||||||
50,000 (6) | 25,000 | $ 2.75 | January 14, 2014 | - | 4.55 | ||||||||||
5,000 (7) | 5,000 | $ 2.50 | March 2, 2014 | - | 4.67 | ||||||||||
400,000 (8) | 200,000 | $ 2.50 | May 12, 2014 | - | 4.87 | ||||||||||
500,000 (9) | - | $ 2.50 | June 11, 2014 | - | 4.95 | ||||||||||
700,000 (10) | - | $ 2.50 | June 12, 2014 | - | 4.95 | ||||||||||
270,000 (11) | - | $ 3.00 | February 8, 2017 | - | 7.62 | ||||||||||
3,075,000 | 1,280,000 | $ | - |
1. | As at June 30, 2009, these options have not vested. The options vest upon the Company listing its shares on the American Stock Exchange or any other nationally recognized stock exchange by December 1, 2012 or in the event of a change of control and a listing on a nationally recognized stock exchange is not required. No stock-based compensation has been recorded in the financial statements as the performance conditions have not yet been met. |
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2. | As at June 30, 2009 these options have fully vested. The fair value of the options on the grant date was calculated to be $1,031,800, of which the Company recognized $257,950 stock-based compensation for the options vested in the year ended September 30, 2008. At September 30, 2008, the remaining 300,000 unvested options were re-measured with their fair value determined to be $172,350, of which the Company recognized $62,802 stock- based compensation in the year ended September 30, 2008. At December 31, 2008, the remaining 200,000 unvested options were re-measured, with their fair value determined to be $142,000, of which the Company recognized $45,906 stock-based compensation included in consulting fees for the three months ended December 31, 2008. At March 31, 2009 the remaining 100,000 unvested options were re-measured, with their fair value determined to be $38,000 of which the Company reversed $11,092 stock based compensation recorded in previous periods and which amount is included in consulting fees for the three-month period ended March 31, 2009 and recognized $5,206 included in consulting fees in the three month period ended June 30, 2009. |
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3. | As at June 30, 2009 these options were fully vested. The fair value of these options was calculated to be $122,150 which amount has been recognized as stock-based compensation and included with investor relations expense in the financial statements for the year ended September 30, 2008. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 12 |
Note 6 | Commitments - Continued | |
b) | Stock-based compensation plan continued |
4. | As at June 30, 2009 all of these options had vested. The fair value of the options on the grant date was calculated to be $269,910 of which the Company has recognized stock-based compensation in the amount $12,960 for the nine month period ended June 30, 2009, included with consulting fees in the financial statements. |
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5. | As at June 30, 2009, all of these options have vested. The fair value of the options on the grant date was calculated to be $1,136,025 of which the Company has recognized stock- based compensation in the amount of $141,750 for the three-month period ended December 31, 2008, $141,750 for the three-month period ended March 31, 2009 and $57,854 for the three month period ended June 30, 2009, included with consulting fees in the financial statements. |
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6. | As at June 30, 2009 25,000 of these options have vested. The remaining 25,000 options vest on January 13, 2010. The fair value of these options was calculated to be $79,000 of which the Company has recognized stock-based compensation in the amount of $16,669 for the three-month period ended March 31, 2009 and $19,750 for the three-month period ended June 30, 2009 included with consulting fees in the financial statements. |
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7. | As at June 30, 2009 all of these options had vested. The fair value of the options on the grant date was calculated to be $6,000 of which the Company has recognized stock-based compensation in that amount for the three-month period ended March 31, 2009, included with consulting fees in the financial statements. |
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8. | As at June 30, 2009 200,000 of these options have vested. The remaining 200,000 options vest on 50,000 on each of August 14, 2009, November 14, 2009, February 14, 2010 and May 14, 2010. The fair value of these options was calculated to be $544,000 of which the Company has recognized stock-based compensation in the amount of $101,453 for the three-month period ended June 30, 2009 included with consulting fees in the financial statements. |
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9. | As at June 30, 2009 none of these options have vested. The options vest on commencement of Phase 3 trial of a specific compound. The fair value of these options was calculated to be $740,000, which the Company has not yet recognized in the financial statements as the performance conditions have not yet been met. |
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10. | As at June 30, 2009 none of these options have vested. The options vest 233,333 on each of June 10, 2010, one compound commencing Phase 2 trials and one compound commencing Phase 3 trial. The fair value of these options was calculated to be $1,099,000 of which the Company has recognized stock-based compensation in the amount of $17,584 for the three- month period ended June 30, 2009 included with consulting fees in the financial statements. |
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11. | As at June 30, 2009, these options have not vested. The options vest upon one or more compounds: entering Phase 2 Trial 90,000 options; entering Phase 3 Trial 90,000 options; and receiving FDA approval 90,000 options. No stock-based compensation has been recorded in the financial statements as none of the performance conditions have yet been met. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 13 |
Note 6 | Commitments - Continued | |
b) | Stock-based Compensation Plan (contd) | |
The fair value of stock options granted has been determined using the Black-Scholes option pricing model using the following weighted average assumptions applied to stock options granted or re-priced during the periods: |
Nine Months | Nine Months | ||||||
Ended June 30, | Ended June 30, | ||||||
2009 | 2008 | ||||||
Risk-free interest rate | 0.69% - 2.87% | 2.37% | |||||
Expected life of options | 2.14 - 5 years | 5.00 years | |||||
Annualized volatility | 77.82% | 82.93% | |||||
Dividend rate | 0 | 0 |
The volatility was determined based on an index of volatility from comparable companies. The expected term of the options granted is derived from the simplified method as prescribed by SEC Staff Accounting Bulletin No. 110 given that the Company has no historical experience of options for which to base an estimate of the expected term of options granted. The Company anticipates it will discontinue the use of the simplified method of SAB 110 once sufficient historical option exercise behavior become apparent. The expected term of options granted to non-employees was determined to be the option term.
At June 30, 2009, the following summarizes the unvested stock options:
Number of | Weighted | Weighted | ||||||
Shares | Average | Average | ||||||
Exercise | Grant-date | |||||||
Price | Fair Value | |||||||
Unvested options at September 30, 2008 | 970,000 | $4.31 | $2.42 | |||||
Granted | 1,655,000 | $2.50 | $3.19 | |||||
Vested | (830,000 | ) | $4.30 | $3.69 | ||||
Unvested options at June 30, 2009 | 1,795,000 | $2.65 | $2.94 |
As at June 30, 2009, there was a total of $391,330 of unrecognized compensation cost associated with unvested share-based compensation awards that will become vested exclusive of achieving any performance milestones. This unrecognized compensation cost is expected to be recognized $111,333 during the quarter ended September 30, 2009 and $279,997 during the year ended September 30, 2010. There has been no stock-based compensation recognized in the financial statements for the period ended June 30, 2009 for options that vest upon the achievement of performance milestones because the Company has determined that satisfaction of the performance milestones was not probable. Compensation relating to stock options exercisable upon achieving performance milestones will be recognized in the period the milestones are achieved.
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 14 |
Note 6 | Commitments - Continued | |
b) | Stock-based Compensation Plan (contd) | |
Stock-based compensation amounts, including those relating to shares issued for non-cash consideration during the nine month period, are classified in the Companys Statements of Operations and Comprehensive Loss as follows: |
June 30, | June 30, | ||||||
2009 | 2008 | ||||||
Consulting | $ | 792,127 | $ | 959,349 |
Note 7 | Supplemental Cash Flow Information |
Investing and financing activities that do not have an impact on current cash flows are excluded from the statements of cash flows. The following non-cash investing and financing activities occurred during the nine months ended June 30, 2009: |
a) | The Company issued 25,000 shares at $2.63 per share, 25,000 common shares at $2.50 per share, 2,500 common shares at $2.50 per share, 29,227 at $2.25 per share and 22,222 common shares at $2.51 for a total of $254,787 as consideration for consulting services; and |
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b) | As a result of re-measuring remaining shares to be issued pursuant to a consulting agreement, the Company recorded compensation expense of $236,337 as consideration for consulting services; and |
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c) | The Company issued 22,222 common shares at $2.51 per share for a total of $55,777 pursuant to a deferred financing charge on an issuance of a convertible promissory note. |
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d) | The Company paid cash interest and income taxes of $nil (2008: $nil). |
Note 8 | Comparative Figures |
Certain of the comparative figures have been reclassified to conform with the presentation in the current year. |
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Note 9 | Prior Period Correction |
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In its prior fiscal year, during the nine months ended June 30, 2008, the Company acquired intellectual property consisting of patents for consideration of $104,595 and for which it had recorded amortization costs of $4,686. At the time, the Company capitalized these costs as an intangible asset. Subsequent to June 30, 2008, in its fourth quarter ended September 30, 2008, the Company changed its accounting policy in respect of patent costs whereby the Company determined to expense the costs of its acquired patents. This change was made because the probability of success and length of time to develop commercial applications of the drugs subject to the patents acquired was too difficult to determine and there was no assurance that the acquired patents would ever be successfully commercialized. |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 15 |
Note 9 | Prior Period Correction (contd) |
The effects of the change in accounting policy on the financial statements for the three and nine months ended June 30, 2008 is as follows: |
Three months | Nine months | ||||||
ended | ended | ||||||
June 30, 2008 | June 30, 2008 | ||||||
Statement of operations and comprehensive loss | |||||||
Research and development | |||||||
As previously reported | $ | 248,232 | $ | 694,948 | |||
Patent costs expensed | 26,883 | 104,595 | |||||
As restated | $ | 275,115 | $ | 799,543 | |||
Amortization | |||||||
As previously reported | $ | 4,816 | $ | 4,816 | |||
Elimination of amortization of patent costs previously | (4,686 | ) | (4,686 | ) | |||
capitalized |
|||||||
As restated |
$ | 130 | $ | 130 | |||
|
|||||||
Net loss and comprehensive loss for the period |
|||||||
As previously reported |
$ | (1,680,314 | ) | $ | (3,279,627 | ) | |
Patent costs expensed |
(26,883 | ) | (104,595 | ) | |||
Elimination of amortization of patent costs previously |
4,686 | 4,686 | |||||
capitalized |
|||||||
|
|||||||
As restated | $ | (1,702,511 | ) | $ | (3,379,536 | ) | |
Basic and diluted loss per share | |||||||
As previously reported | $ | (0.09 | ) | $ | (0.17 | ) | |
Patent costs expensed and elimination of amortization of | (0.00 | ) | (0.00 | ) | |||
patent costs | |||||||
As restated | $ | (0.09 | ) | $ | (0.17 | ) | |
Statement of cash flows | |||||||
Net cash used in operating activities | |||||||
As previously reported | $ | (1,709,601 | ) | ||||
Patent costs expensed | (104,595 | ) | |||||
Patent costs expensed and elimination of amortization of | (4,686 | ) | |||||
patent costs | |||||||
Items not involving cash: Amortization | 4,686 | ||||||
As restated | $ | (1,814,196 | ) | ||||
Net cash used in investing activities | |||||||
As previously reported | |||||||
Patent costs expensed | $ | (105,677 | ) | ||||
104,595 | |||||||
As restated | $ | (1,082 | ) |
Anavex Life Sciences Corp. |
(A Development Stage Company) |
Notes to the Interim Financial Statements |
June 30, 2009 |
(Stated in US Dollars) |
(Unaudited) Page 16 |
Note 10 | Subsequent Events |
Subsequent to June 30, 2009, pursuant to two private placements, the Company has issued 128,888 Units at $2.25 per Unit for total proceeds of $290,000. Of these placements, 40,000 Units consisted of one common share and one share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until July 10, 2010 and 88,888 Units consisted on one common share and one and one-eighth share purchase warrant entitling the holder to purchase an additional common shares at $2.25 per share until August 4, 2011. The Company paid finders fees totalling $19,000 in respect of these private placements. |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Statements
This quarterly report contains forward-looking statements. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as may, should, expect, plan, anticipate, believe, estimate, predict, potential or continue or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled Risk Factors that may cause our companys or our industrys actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Our financial statements are stated in United States dollars and are prepared in accordance with United States generally accepted accounting principles.
In this quarterly report, unless otherwise specified, all dollar amounts are expressed in United States dollars and all references to common shares refer to the shares of our common stock.
As used in this quarterly report, the terms we, us, our, and Anavex mean Anavex Life Sciences Corp., unless the context clearly requires otherwise.
Our Business
We are a biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases. Our proprietary SIGMACEPTOR™ discovery Platform has resulted in and continues to generate small molecule drug candidates with unique modes of action. Presently we several lead drug candidates at the late preclinical stage and an additional 50+ compounds at various early stages of the discovery process and a library of over 500 compounds.
Our SIGMACEPTOR™-N program involves the development of novel and original drug candidates, targeting neurological and neurodegenerative diseases (Alzheimer’s disease, epilepsy, depression, etc.). Our lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. We believe that oxidative stress, not amyloid-beta, is the cause of Alzheimer’s. Our two lead drug candidates modulate sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. Based on recent data, we now know that sigma receptors are implicated in oxidative stress, through modulation of calcium signaling via the mitochondria, providing an etiological pathway in Alzheimer's disease. In preclinical studies the compounds have performed well in well-recognized animal models of Alzheimer’s disease, underscoring the promise of our new alternative approach to the disease.
Our SIGMACEPTOR™-C program involves the development of novel and original drug candidates targeting deadly forms of the disease such as metastatic melanoma, pancreatic, breast, lung, colon and prostate cancer. These are diseases with significant unmet medical needs and any improvement in survival and quality of life for these patients would fill a large medical need. Our research leverages the unique properties of sigma-1 and /or sigma-2 receptor ligands which allows our company to create a potent class of drug candidates which exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties.
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We intend to begin clinical phase trials on one or more of our most advanced compounds in early 2010 which is dependand on sufficient funding being obtained. We also intend to continue to work on other compounds, which are currently at different stages of pre-clinical development.
Research and Development Activities
Anavexs SIGMACEPTOR(TM)-N program pipeline is focused on moving our lead drug candidates ANAVEX 2-73 and ANAVEX 1-41 to clinical trials.
ANAVEX 2-73 is expected to enter clinical trials in early 2010 for Alzheimers disease. Regulatory pre-clinical work has already begun. Scaleup manufacturing of ANAVEX 2-73, our lead drug candidate for the treatment of Alzheimers disease, has been completed by organic chemistry services provider Syntagon AB in Sweden.
Moreover, ANAVEX 2-73 or its optimized derivative ANAVEX 19-144 is intended to enter clinical trials for epilepsy treatment in 2010. Results from animal models reveal that these compounds have significant anti-amnesic, neuroprotective and anti-convulsant properties. These activities involve muscarinic and sigma-1 receptor components, which is significant because it indicates a unique synergistic mode of action that may help provide disease modifying potential for Alzheimer’s and protect the neurons from oxidative stress. Additionally, such potential can provide control for epilepsy and prevent the process that causes long-term damage to tissue and cells as well as biochemical and physiological alterations to the brain. Published results were presented at the Neuroscience 2007 conference in San Diego. Ongoing pre-clinical studies are being conducted in collaboration with Universite Montpellier.
Promising developments have also been made with ANAVEX 1-41. In recent pre-clinical animal studies, the compound demonstrated significant neuroprotective benefits through the prevention of oxidative stress, which damages and destroys cells and is believed to be a primary cause of Alzheimers disease. The novel mechanism of action of ANAVEX 1-41 demonstrates that the compound may influence the course of Alzheimers disease and prevent or limit the creation of plaques that destroy brain cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. Published results were presented at the Neuroscience 2007 conference in San Diego, California. Most recent results were presented in the ICAD 2008 conference in Chicago, where the neuroprotective profile of the candidate drug was highlighted with accompanying results. Testing on ANAVEX 1-41 is being conducted in cooperation with Universite Montpellier in France. Phase 1 trials of ANAVEX 1-41 on humans are expected to commence in 2010.
Anavex’s SIGMACEPTOR(TM)-C program pipeline involves the development of novel and original drug candidates targeting cancer. To date we have considerably advanced our cancer projects and have identified over 50 compounds that have exhibited growth inhibiting activity at a low micromolar concentration and two of them even lower at a nanomolar range concentration.
ANAVEX 7-1037, our lead drug candidate for the treatment of colorectal, prostate and or other types of solid tumors, has revealed chemotherapeutic potential without toxic side effects in advanced pre-clinical studies. The compound has been shown to kill human colon cancer cells and also significantly suppress tumor growth in immune-deficient mice. ANAVEX 7-1037 as well as ANAVEX 22-1068, targeting pancreatic cancer, have both demonstrated outstanding efficacy in grafted mice (xenografts) wil little toxicity. Preparations are currrently underway to move both compounds to Phase 1 in 2010. Testing on ANAVEX 7-1037 is being conducted in cooperation with the Academy of Athens’ Institute of Biomedical Research.
Published results for ANAVEX 1-41, ANAVEX 2-73 and ANAVEX 7-1037 are available at www.anavex.com/publications.html.
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Results of Operations
Revenue
We have not earned any revenues since our inception on January 23, 2004. We are still in the development stage and do not anticipate earning any revenues until we can establish an alliance with targeted companies to market or distribute the results of our research projects.
Expenses
Our expenses for the three and nine months ended June 30, 2009 and 2008 were as follows:
Three Months Ended | Nine months ended | |||||||||||
June 30 | June 30 | |||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||
Accounting and audit fees | $ | 36,957 | $ | 22,538 | $ | 71,217 | $ | 59,267 | ||||
Accretion | 11,550 | - | 19,331 | - | ||||||||
Amortization | 80 | 130 | 260 | 130 | ||||||||
Bank charges and interest | 632 | 9,871 | 2,427 | 14,440 | ||||||||
Consulting fees | 653,306 | 1,359,582 | 1,624,837 | 2,267,160 | ||||||||
Legal fees (recovery) | 68,783 | (24,385 | ) | 74,304 | 32,460 | |||||||
Office and miscellaneous | 35,989 | 27,973 | 81,345 | 90,520 | ||||||||
Registration and filing fees | 4,673 | 1,883 | 10,718 | 6,602 | ||||||||
Rent and administration | - | 15,000 | - | 75,000 | ||||||||
Research and development | 455,683 | 275,115 | 1,068,646 | 799,543 | ||||||||
Website design and maintenance | 1,455 | 1,424 | 1,455 | 1,424 | ||||||||
Total expenses | $ | 1,269,108 | $ | 1,689,131 | $ | 2,954,540 | $ | 3,346,546 |
Three Months Ended June 30, 2009 and 2008
Expenses for the three months ended June 30, 2009 decreased by $420,023 over the same period in 2008. Accretion charges of $11,550 for the three months ended June 30, 2009 increased from $0 for the same period in 2008 as a result of the issued promissory notes. Bank charges and Interest decreased to $632 for the three months ended June 30, 2009 from $9,871 for the same period in 2008 due to the maturity of interest bearing promissory notes. Consulting fees decreased from $1,359,582 for the three months ended June 30, 2008 to $653,306 for the same period in 2009 primarily as a result of decreased stock based compensation charges. Legal fees increased to $68,783 for the three months ended June 30, 2009 from $(24,385) for the same period in 2008 primarily as a result of increased patent and corporate activity fees. Research and Development charges increased to $455,683 for the three months ended June 30, 2009 from $275,115 for the same period in 2008 resulting from increased research activities.
Nine months ended June 30, 2009 and 2008
Expenses for the nine months ended June 30, 2009 decreased by $392,006 over the same period in 2008. Accounting and audit fees have increased to $71,217 for the nine months ended June 30, 2009 from $59,267 for the nine months ended June 30, 2008 primarily as a result of our company having to address complex accounting matters resulting from our various agreements thus requiring increased scrutiny by our external auditors. Consulting fees have decreased by $642,323 from $2,267,160 for the nine months ended June 30, 2008 to $1,624,837 for the nine months ended June 30, 2009 as a result of lower stock-based compensation charges. Rent and administration fees decreased to $Nil for the nine months ended June 30, 2009 from $75,000 in the nine months ended June 30, 2009 as a result of the lease for our rented premises in Europe expiring in the period ended June 30, 2008 and which was not renewed.
Liquidity and Capital Resources
Working Capital
June 30, 2009 | September 30, 2008 | |||||
Cash | $ | 742,577 | $ | 6,357 | ||
Current Assets | 742,577 | 6,357 | ||||
Current Liabilities | 3,503,956 | 2,299,389 | ||||
Working Capital (Deficit) | $ | (2,761,379 | ) | $ | (2,293,032 | ) |
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As of June 30, 2009, we had $742,577 in cash, an increase of $736,220 from September 30, 2008. The principal component of this increase in cash was contributed from a number of recently closed private placements and convertible notes issued by our company. As of June 30, 2009, we had a working capital deficit of $2,761,379, an increase of $468,347 from September 30, 2008. The principal component of this increase in working capital deficit was an increase in promissory notes payable by our company.
We anticipate that we will require up to $10 million for the 12 months ending June 30, 2010 to implement our plan of operation of researching and developing our patents, the related compounds and further intellectual property we may acquire or develop. The majority of our capital resource requirement is needed to enter ANAVEX 2-73, ANAVEX 1-41 and ANAVEX 7-1037 into clinical trials. If we are not able to secure additional financing, we will not be able to implement and fund these trials.
Going Concern
At June 30, 2009, we had an accumulated deficit of $10,571,866 since our inception and expect to incur further losses in the development of our business, all of which casts substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate future profitable operations and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due. Our independent auditors included an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern in their report on our annual financial statements for the year ended September 30, 2008.
Future Financing
We will require additional financing to fund our planned operations, including researching and developing our patents, the related compounds and any further intellectual property that we may acquire and entering some of our current compounds into clinical trials. We currently do not have committed sources of additional financing and may not be able to obtain additional financing, particularly, if the volatile conditions in the stock and financial markets, and more particularly the market for early development stage biotechnology research and development company stocks persist.
There can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain the additional financing on a timely basis, if and when it is needed, we will be forced to delay or scale down some or all of our research and development activities or perhaps even cease the operation of our business.
Since inception we have funded our operations primarily through equity and debt financings and we expect that we will continue to fund our operations through other equity and debt financings. If we raise additional financing by issuing equity securities, our existing stockholders’ ownership will be diluted. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.
There is no assurance that we will be able to maintain operations at a level sufficient for an investor to obtain a return on his, her, or its investment in our common stock. Further, we may continue to be unprofitable.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to our stockholders.
Application of Critical Accounting Policies
Our financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles in the United States. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. These estimates and assumptions are affected by managements application of accounting policies. We believe that understanding the
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basis and nature of the estimates and assumptions involved with the following aspects of our financial statements is critical to an understanding of our financials.
We base our assumptions and estimates on historical experience and other sources that we believe to be reasonable at the time. Actual results may vary from our estimates due to changes in circumstances, weather, politics, global economics, mechanical problems, general business conditions and other factors. Our significant estimates are related to the valuation of warrants and options.
There are accounting policies that we believe are significant to the presentation of our financial statements. The most significant of these accounting policies relates to the accounting for our research and development expenses and stock-based compensation expense.
Research and Development Expenses
Research and developments costs are expensed as incurred. These expenses are comprised of the costs of our proprietary research and development efforts, including salaries, facilities costs, overhead costs and other related expenses as well as costs incurred in connection with third-party collaboration efforts. Milestone payments to third parties are expensed when the specific milestone has been achieved.
In addition, we incur expenses in respect of the acquisition of intellectual property relating to patents and trademarks. The probability of success and length of time to developing commercial applications of the drugs subject to the acquired patents and trademarks is difficult to determine and numerous risks and uncertainties exist with respect to the timely completion of the development projects. There is no assurance the acquired patents and trademarks will ever be successfully commercialized. Due to these risks and uncertainties, we expense the acquisition of patents and trademarks.
Stock-based Compensation
We account for all of our stock-based payments and awards under the fair value based method.
Stock-based payments to non-employees are measured at the fair value of the consideration received, or the fair value of the equity instruments issued, or liabilities incurred, whichever is more reliably measurable. The fair value of stock-based payments to non-employees is periodically re-measured until the counterparty performance is complete, and any change therein is recognized over the vesting period of the award and in the same manner as if we had paid cash instead of paying with or using equity based instruments. The cost of the stock-based payments to non-employees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless there is a contractual term for services in which case such compensation would be amortized over the contractual term.
We account for the granting of share purchase options to employees using the fair value method whereby all awards to employees will be recorded at fair value on the date of the grant. The fair value of all share purchase options are expensed over their vesting period with a corresponding increase to additional capital surplus. Upon exercise of share purchase options, the consideration paid by the option holder, together with the amount previously recognized in additional capital surplus, is recorded as an increase to share capital.
We use the Black-Scholes option valuation model to calculate the fair value of share purchase options at the date of the grant. Option pricing models require the input of highly subjective assumptions, including the expected price volatility. Changes in assumptions can materially affect the fair value estimate and therefore the Black-Scholes model does not necessarily provide a reliable single measure of the fair value of our share purchase options.
The summary of significant accounting policies should be read in conjunction with our consolidated financial statements and related notes and managements discussion and analysis of financial condition and results of operations.
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Recent accounting pronouncements
Recently Adopted Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”. This Statement defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosure related to the use of fair value measures in financial statements. We adopted SFAS 157 effective October 1, 2008. The adoption of SFAS 157 did not have a material effect on our financial position, results of operations or cash flows.
In February, 2007, the FASB issued SFAS No. 159 The Fair Value Option for Financial Assets and Financial Liabilities. This Statement establishes presentation and disclosure requirements designed to facilitate comparisons between companies that choose different measurement attributes for similar types of assets and liabilities. We adopted SFAS 159 effective October 1, 2008. The adoption of SFAS 159 did not have a material effect on our financial position, results of operations or cash flows.
Recent Accounting Pronouncements Not Yet Adopted
In December 2007, the EITF reached a consensus on EITF No. 07-01, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property (“EITF 07-01”). EITF 07-01 discusses the appropriate income statement presentation and classification for the activities and payments between the participants in arrangements related to the development and commercialization of intellectual property. The sufficiency of disclosure related to these arrangements is also specified. EITF 07-01 is effective for fiscal years beginning after December 15, 2008. As a result, EITF 07-01 is effective for our company as of October 1, 2009. We expect that the adoption of EITF 07-01 will have minimal, if any, impact on its financial position and results of operations. However, based upon the nature of the our business, EITF 07-01 could have a material impact on our financial position and results of operations in future years.
In December 2007, the Emerging Issues Task Force (“EITF”) reached a consensus on EITF No. 07-01, Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property (“EITF 07-01”). EITF 07-01 discusses the appropriate income statement presentation and classification for the activities and payments between the participants in arrangements related to the development and commercialization of intellectual property. The sufficiency of disclosure related to these arrangements is also specified. EITF 07-01 was effective for fiscal years beginning after December 15, 2008. As a result, EITF 07-01 is effective for our company for the fiscal year beginning October 1, 2009. The adoption of EITF 07-01 is expected to have minimal, if any, impact on our financial position and results of operations. However, based upon the nature of the Company’s business, EITF 07-01 could have a material impact on our financial position and results of operations in future years.
In December 2007, FASB issued Statement No. 141 (Revised 2007), Business Combinations (SFAS 141(R)) and SFAS No. 160, Accounting and Reporting of Non- controlling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (SFAS 160). SFAS 141(R) requires companies to: (i) recognize, with certain exceptions, 100% of the fair values of assets acquired, liabilities assumed, and non-controlling interests in acquisitions of less than a 100% controlling interest when the acquisition constitutes a change in control of the acquired entity; (ii) measure acquirer shares issued in consideration for a business combination at fair value on the acquisition date; (iii) recognize contingent consideration arrangements at their acquisition-date fair values, with subsequent changes in fair value generally reflected in earnings; (iv) with certain exceptions, recognize pre-acquisition loss and gain contingencies at their acquisition-date fair values; (v) capitalize in-process research and development (IPR&D) assets acquired; (vi) expense, as incurred, acquisition-related transaction costs; (vii) capitalize acquisition- related restructuring costs only if the criteria in SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities , are met as of the acquisition date; and (viii) recognize changes that result from a business combination transaction in an acquirers existing income tax valuation allowances and tax uncertainty accruals as adjustments to income tax expense. SFAS 141(R) is required to be adopted concurrently with SFAS 160 and is effective for business combination transactions for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. The adoption of these statements is not expected to have a material impact on significant acquisitions completed after October 1, 2009.
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In April 2008, the FASB issued FSP 142-3, “Determination of the Useful Life of Intangible Assets.” This FSP amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FASB Statement No. 142, “Goodwill and Other Intangible Assets.” The intent of this FSP is to improve the consistency between the useful life of a recognized intangible asset under Statement 142 and the period of expected cash flows used to measure the fair value of the asset under FASB Statement No. 141 (Revised 2007), “Business Combinations,” and other U.S. generally accepted accounting principles (GAAP). This FSP is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited.We are in the process of evaluating the impact, if any, of FSP 142-3 on our financial statements.
In May 2008, the FASB issued FSP No. APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (“FSP APB 14-1”). FSP APB 14-1 applies to convertible debt instruments that, by their stated terms, may be settled in cash (or other assets) upon conversion, including partial cash settlement, unless the embedded conversion option is required to be separately accounted for as a derivative under SFAS 133. Convertible debt instruments within the scope of FSP APB 14-1 are not addressed by the existing APB 14. FSP APB 14-1 requires that the liability and equity components of convertible debt instruments within the scope of FSP APB 14-1 be separately accounted for in a manner that reflects the entity’s nonconvertible debt borrowing rate. This requires an allocation of the convertible debt proceeds between the liability component and the embedded conversion option (i.e., the equity component). The difference between the principal amount of the debt and the amount of the proceeds allocated to the liability component will be reported as a debt discount and subsequently amortized to earnings over the instrument’s expected life using the effective interest method. FSP APB 14-1 is effective for our fiscal year beginning October 1, 2009 and will be applied retrospectively to all periods presented. We are currently evaluating the effects of adopting FSP APB 14-1.
In June 2008, the FASB ratified EITF Issue No. 07-05, “Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock”, or EITF 07-05. Equity-linked instruments (or embedded features) that otherwise meet the definition of a derivative as outlined in SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities”, or SFAS 133, are not accounted for as derivatives if certain criteria are met, one of which is that the instrument (or embedded feature) must be indexed to the entity’s own stock. EITF 07-05 provides guidance on how to determine if equity-linked instruments (or embedded features) such as warrants and convertible notes are considered indexed to our stock. Wewill adopt EITF 07-05, beginning October 1, 2009. Under EITF 07-05, equity-linked instruments that are not indexed tour own stock and thus classified as liabilities are carried at fair value and adjusted quarterly.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events. This statement establishes guidance related to accounting for and disclosure of events that happen after the date of the balance sheet but before the release of the financial statements. SFAS No. 165 is effective for reporting periods ending after June 15, 2009. We do not expect the adoption of this statement to have a material effect on our results of operations or financial position.
In June 2009, the FASB issued SFAS No.168, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles (SFAS 168). SFAS 168 establishes the FASB Accounting Standards Codification (Codification), which officially launched July 1, 2009, to become the source of authoritative U.S. generally accepted accounting principles (GAAP) recognized by the FASB to be applied by nongovernmental entities. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. The subsequent issuances of new standards will be in the form of Accounting Standards Updates that will be included in the Codification. Generally, the Codification is not expected to change U.S. GAAP. All other accounting literature excluded from the Codification will be considered non-authoritative. SFAS 168 is effective for financial statements issued for interim and annual periods ending after September 15, 2009. We will adopt SFAS 168 for our quarter ending September 30, 2009. We are currently evaluating the effect on our financial statement disclosures as all future references to authoritative accounting literature will be references in accordance with the Codification.
Item 3. Quantitative and Qualitative Disclosures about Market Risks.
Not Applicable.
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Item 4T. Controls and Procedures.
Disclosure Controls and Procedures
As required by Rule 13a-15 under the Securities Exchange Act of 1934, our management, with the participation of our principal executive officer and our principal financial officer, evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) of the Securities Exchange Act of 1934) as of the end of the period covered by this quarterly report on Form 10-Q. Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commissions rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to our principal executive officer and our principal financial officer to allow timely decisions regarding required disclosure.
Based on that evaluation, our management, with the participation of our principal executive officer and our principal financial officer, concluded that as of the end of the period covered by this quarterly report on Form 10-Q, our disclosure controls and procedures were not effective.
Changes in Internal Control over Financial Reporting
We continue to have weaknesses as disclosed in our annual report on Form 10-K filed on January 13, 2009. We intend to take appropriate and reasonable steps to make the necessary improvements to remediate these deficiencies at some time in the future. This will depend on our financial position and the managements determination of which changes should be made and when. We intend to consider the results of our remediation efforts and related testing as part of our year-end 2009 assessment of the effectiveness of our internal control over financial reporting.
We have not made any changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2009 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
We know of no material, existing or pending legal proceedings to which we are a party or of which any of our properties is the subject. In addition, we do not know of any such proceedings contemplated by any governmental authorities. We know of no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial stockholder is a party adverse to our company or has a material interest adverse to our company.
Item 1A. Risk Factors.
In addition to other information in this quarterly report, the following risk factors should be carefully considered in evaluating our business because such factors may have a significant impact on our business, operating results, liquidity and financial condition. As a result of the risk factors set forth below, actual results could differ materially from those projected in any forward-looking statements. Additional risks and uncertainties not presently known to us, or that we currently consider to be immaterial, may also impact our business, operating results, liquidity and financial condition. If any such risks occur, our business, operating results, liquidity and financial condition could be materially affected in an adverse manner. Under such circumstances, the trading price of our securities could decline, and you may lose all or part of your investment.
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Risks Related to our Company
We have had a history of losses and no revenue, which raise substantial doubt about our ability to continue as a going concern.
Since inception on January 23, 2004, we have incurred aggregate net losses of $10,571,866 from operations. We can offer no assurance that we will ever operate profitably or that we will generate positive cash flow in the future. To date, we have not generated any revenues from our operations. Our history of losses and no revenues raise substantial doubt about our ability to continue as a going concern. We will not be able to generate significant revenues in the future and our management expects acquisitions and exploration expenditures and operating expenses to increase substantially over the next 12 months. As a result, our management expects the business to continue to experience negative cash flow for the foreseeable future and cannot predict when, if ever, our business might become profitable. We will need to raise additional funds, and such funds may not be available on commercially acceptable terms, if at all. If we are unable to raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements. This may seriously harm our business, financial condition and results of operations.
We are an early development stage biotechnology research and development company and may never be able to successfully develop marketable products or generate any revenue. We have a very limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.
We are an early development stage company and have not generated any revenues to date and have no operating history. All of our potential drug compounds are in the concept stage and have not undergone significant testing in non-clinical studies or in clinical trials. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial revenues. We have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of potential drug compounds either in non-clinical testing or in clinical trials, failure to establish business relationships and competitive disadvantages as against larger and more established companies. If we fail to become profitable, we may suspend or cease operations.
We will need additional funding and may be unable to raise additional capital when needed, which would force us to delay, reduce or eliminate our research and development activities.
We will need to raise additional funding, but the current economic crisis and its impact on the stock markets will most likely have a negative impact on our ability to raise additional needed capital on terms that are favorable to our company or at all. We do not anticipate that we will generate significant revenues for several years, if at all. Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research and development activities.
We may be unable to continue as a going concern in which case our securities will have little or no value.
Our independent auditors have noted in their report concerning our annual financial statements as of September 30, 2008 that we have incurred substantial losses since inception, which raises substantial doubt abut our ability to continue as a going concern. In the event we are not able to continue operations you will likely suffer a complete loss of your investment in our securities.
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Risks Related to our Business
Even if we are able to develop our potential drug compounds, we may not be able to receive regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results and financial condition and we will have to delay or terminate some or all of our research and development plans and we may be forced to cease operations.
All of our potential drug compounds will require extensive additional research and development, including non-clinical testing and clinical trials, as well as regulatory approvals, before we can market them. We cannot predict if or when any of the potential drug compounds we intend to develop will be approved for marketing. There are many reasons that we may fail in our efforts to develop our potential drug compounds. These include:
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the possibility that non-clinical testing or clinical trials may show that our potential drug compounds are ineffective and/or cause harmful side effects;
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our potential drug compounds may prove to be too expensive to manufacture or administer to patients;
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our potential drug compounds may fail to receive necessary regulatory approvals from the United States Food and Drug Administration or foreign regulatory authorities in a timely manner, or at all;
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even if our potential drug compounds are approved, we may not be able to produce them in commercial quantities or at reasonable costs;
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even if our potential drug compounds are approved, they may not achieve commercial acceptance;
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regulatory or governmental authorities may apply restrictions to any of our potential drug compounds, which could adversely affect their commercial success; and
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the proprietary rights of other parties may prevent us or our potential collaborative partners from marketing our potential drug compounds.
If we fail to develop our potential drug compounds, our financial results and financial condition will be adversely affected, we will have to delay or terminate some or all of our research and development plans and may be forced to cease operations.
Our research and development plans will require substantial additional future funding which could impact our operational and financial condition. Without the required additional funds, we will likely cease operations.
It will take several years before we are able to develop marketable potential drug compounds, if at all. Our research and development plans will require substantial additional capital, arising from costs to:
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conduct research, non-clinical testing and human studies;
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establish pilot scale and commercial scale manufacturing processes and facilities; and
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establish and develop quality control, regulatory, marketing, sales, finance and administrative capabilities to support these programs.
Our future operating and capital needs will depend on many factors, including:
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the pace of scientific progress in our research and development programs and the magnitude of these programs;
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the scope and results of preclinical testing and human studies;
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the time and costs involved in obtaining regulatory approvals;
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the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;
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competing technological and market developments;
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our ability to establish additional collaborations;
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changes in our existing collaborations;
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the cost of manufacturing scale-up; and
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the effectiveness of our commercialization activities.
We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include the success of our research initiatives, regulatory approvals, the timing of events outside our direct control such as negotiations with potential strategic partners and other factors. Any of these uncertain events can significantly change our cash requirements as they determine such one-time events as the receipt or payment of major milestones and other payments.
Additional funds will be required to support our operations and if we are unable to obtain them on favorable terms, we may be required to cease or reduce further research and development of our drug product programs, sell some or all of our intellectual property, merge with another entity or cease operations.
If we fail to demonstrate efficacy in our non-clinical studies and clinical trials our future business prospects, financial condition and operating results will be materially adversely affected.
The success of our research and development efforts will be greatly dependent upon our ability to demonstrate potential drug compound efficacy in non-clinical studies, as well as in clinical trials. Non-clinical studies involve testing potential drug compounds in appropriate non-human disease models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in humans. If certain non-clinical data reveals potential safety issues or the results are inconsistent with an expectation of the potential drug compounds efficacy in humans, the regulatory agencies may require additional more rigorous testing, before allowing human clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our potential drug compounds if, in the judgment of our management and advisors, the non-clinical test results do not support further development.
Moreover, success in non-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and non-clinical testing. The clinical trial process may fail to demonstrate that our potential drug compounds are safe for humans and effective for indicated uses. This failure would cause us to abandon a drug candidate and may delay development of other potential drug compounds. Any delay in, or termination of, our non-clinical testing or clinical trials will delay the filing of an investigational new drug application and new drug application with the Food and Drug Administration and, ultimately, our ability to commercialize our potential drug compounds and generate product revenues. In addition, we expect that our clinical trials will involve small patient populations. Because of the small sample size, the results of these early clinical trials may not be indicative of future results.
Following successful non-clinical testing, potential drug compounds will need to be tested in a clinical development program to provide data on safety and efficacy prior to becoming eligible for product approval and licensure by regulatory agencies. From the first human trial through product approval can take many years and 10-12 years is not unusual.
If any of our future clinical development potential drug compounds become the subject of problems, our ability to sustain our development programs will become critically compromised. For example, efficacy or safety concerns may arise, whether or not justified, that could lead to the suspension or termination of our clinical programs. Examples of problems that could arise include, among others:
- efficacy or safety concerns with the potential drug compounds, even if not justified;
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unexpected side-effects;
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regulatory proceedings subjecting the potential drug compounds to potential recall;
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publicity affecting doctor prescription or patient use of the potential drug compounds;
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pressure from competitive products; or
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introduction of more effective treatments.
Each clinical phase is designed to test attributes of the drug and problems that might result in the termination of the entire clinical plan can be revealed at any time throughout the overall clinical program. The failure to demonstrate efficacy in our clinical trials would have a material adverse effect on our future business prospects, financial condition and operating results.
If we do not obtain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be limited, which would have a material adverse effect on our business.
We will need to establish relationships with leading scientists and research institutions. We believe that such relationships are pivotal to establishing products using our technologies as a standard of care for various indications. Additionally, although in discussion, there is no assurance that our current research partners will continue to work with us or that we will be able to attract additional research partners. If we are not able to establish scientific relationships to assist in our research and development, we may not be able to successfully develop our potential drug compounds. If this happens, our business will be adversely affected.
We may not be able to develop market or generate sales of our products to the extent anticipated. Our business may fail and investors could lose all of their investment in our company.
Assuming that we are successful in developing our potential drug compounds and receiving regulatory clearances to market our products, our ability to successfully penetrate the market and generate sales of those products may be limited by a number of factors, including the following:
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If our competitors receive regulatory approvals for and begin marketing similar products in the United States, the European Union, Japan and other territories before we do, greater awareness of their products as compared to ours will cause our competitive position to suffer;
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Information from our competitors or the academic community indicating that current products or new products are more effective than our future products could be, if and when they are generated, impede our market penetration or decrease our future market share; and,
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The price for our future products, as well as pricing decisions by our competitors, may have an effect on our revenues.
If this happens, our business will be adversely affected.
None of our potential drug compounds may reach the commercial market for a number of reasons and our business may fail.
Successful research and development of pharmaceutical products is high risk. Most products and development candidates fail to reach the market. Our success depends on the discovery of new drug compounds that we can commercialize. It is possible that our potential drug compounds may never reach the market for a number of reasons. They may be found ineffective or may cause harmful side-effects during non-clinical testing or clinical trials or fail to receive necessary regulatory approvals. We may find that certain potential drug compounds cannot be manufactured at a commercial scale and, therefore, they may not be economical to produce. Our potential drug compounds could also fail to achieve market acceptance or be precluded from commercialization by proprietary rights of third parties. Furthermore, we do not expect our potential drug compounds to be commercially available for
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a number of years, if at all. If none of our potential drug compounds reach the commercial market, our business will likely fail and investors will lose all of their investment in our company. If this happens, our business will be adversely affected.
If our competitors succeed in developing products and technologies that are more effective than our own, or if scientific developments change our understanding of the potential scope and utility of our potential drug compounds, then our technologies and future potential drug compounds may be rendered undesirable or obsolete.
We face significant competition from industry participants that are pursuing technologies similar to those that we are pursuing and are developing pharmaceutical products that are competitive with our potential drug compounds. Nearly all of our industry competitors have greater capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development, obtaining regulatory approval and pharmaceutical product manufacturing and marketing than we do. With these additional resources, our competitors may be able to respond to the rapid and significant technological changes in the biotechnology and pharmaceutical industries faster than we can. Our future success will depend in large part on our ability to maintain a competitive position with respect to these technologies. Rapid technological development, as well as new scientific developments, may result in our potential drug compounds becoming obsolete before we can recover any of the expenses incurred to develop them. For example, changes in our understanding of the appropriate population of patients who should be treated with a targeted therapy like we are developing may limit the drugs market potential if it is subsequently demonstrated that only certain subsets of patients should be treated with the targeted therapy.
Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them.
In the course of product development, we may engage university laboratories, other biotechnology companies or contract or clinical manufacturing organizations to manufacture drug material for us to be used in non-clinical and clinical testing and contract research organizations to conduct and manage non-clinical and clinical studies. If we engage these organizations to help us with our non-clinical and clinical programs, many important aspects of this process have been and will be out of our direct control. If any of these organizations we may engage in the future fail to perform their obligations under our agreements with them or fail to perform non-clinical testing and/or clinical trials in a satisfactory manner, we may face delays in completing our clinical trials, as well as commercialization of any of our potential drug compounds. Furthermore, any loss or delay in obtaining contracts with such entities may also delay the completion of our clinical trials, regulatory filings and the potential market approval of our potential drug compounds.
If we fail to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to research and develop our potential drug compounds.
Our competitors compete with us to attract established biotechnology and pharmaceutical companies or organizations for acquisitions, joint ventures, licensing arrangements or other collaborations. Collaborations include contracting with academic research institutions for the performance of specific scientific testing. If our competitors successfully enter into partnering arrangements or license agreements with academic research institutions, we will then be precluded from pursuing those specific opportunities. Since each of these opportunities is unique, we may not be able to find a substitute. Other companies have already begun many drug development programs, which may target diseases that we are also targeting, and have already entered into partnering and licensing arrangements with academic research institutions, reducing the pool of available opportunities.
Universities and public and private research institutions also compete with us. While these organizations primarily have educational or basic research objectives, they may develop proprietary technology and acquire patents that we may need for the development of our potential drug compounds. We will attempt to license this proprietary technology, if available. These licenses may not be available to us on acceptable terms, if at all. If we are unable to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to develop new products.
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The use of any of our potential drug compounds in clinical trials may expose us to liability claims, which may cost us a significant amounts of money to defend against or pay out, causing our business to suffer.
The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of our potential drug compounds. We currently do not have any potential drug compounds in clinical trials, however, when any of our potential drug compounds enter into clinical trials or become marketed products they could potentially harm people or allegedly harm people and we may be subject to costly and damaging product liability claims. Some of the patients who participate in clinical trials are already critically ill when they enter a trial. The waivers we obtain may not be enforceable and may not protect us from liability or the costs of product liability litigation. Although we intend to obtain product liability insurance that we believe is adequate, we are subject to the risk that our insurance will not be sufficient to cover claims. The insurance costs along with the defense or payment of liabilities above the amount of coverage could cost us significant amounts of money, causing our business to suffer.
The patent positions of biopharmaceutical products are complex and uncertain and we may not be able to protect our patented or other intellectual property. If we cannot protect this property, we may be prevented from using it or our competitors may use it and our business could suffer significant harm. Also, the time and money we spend on acquiring and enforcing patents and other intellectual property will reduce the time and money we have available for our research and development, possibly resulting in a slow down or cessation of our research and development.
We own four patents related to certain of our potential drug compounds. However, these patents do not ensure the protection of our intellectual property for a number of reasons, including the following:
1. |
Competitors may interfere with our patent process in a variety of ways. Competitors may claim that they invented the claimed invention prior to us. Competitors may also claim that we are infringing on their patents and therefore cannot practice our technology as claimed under our patents and patent applications. Competitors may also contest our patents and patent application, if issued, by showing the patent examiner that the invention was not original, was not novel or was obvious. In litigation, a competitor could claim that our patents and patent application are not valid for a number of reasons. If a court agrees, we would lose that patents or patent application. As a company, we have no meaningful experience with competitors interfering with our patents or patent applications. | ||
2. |
Because of the time, money and effort involved in obtaining and enforcing patents, our management may spend less time and resources on developing potential drug compounds than they otherwise would, which could increase our operating expenses and delay product programs. | ||
3. |
Receipt of a patent may not provide much practical protection. If we receive a patent with a narrow scope, then it will be easier for competitors to design products that do not infringe on our patent. | ||
4. |
In addition, competitors also seek patent protection for their inventions. Due to the number of patents in our field, we cannot be certain that we do not infringe on existing patents or that we will not infringe on patents granted in the future. If a patent holder believes our potential drug compound infringes on their patent, the patent holder may sue us even if we have received patent protection for our technology. If someone else claims we infringe on their patent, we would face a number of issues which could cause a slow down or cessation of our research and development, including the following: | ||
(a) |
Defending a lawsuit takes significant time and can be very expensive. | ||
(b) |
If the court decides that our potential drug compound infringes on the competitors patent, we may have to pay substantial damages for past infringement. | ||
(c) |
The court may prohibit us from selling or licensing the potential drug compound unless the patent holder licenses the patent to us. The patent holder is not required to grant us a |
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license. If a license is available, we may have to pay substantial royalties or grant cross licenses to our patents. | ||
(d) |
Redesigning our potential drug compounds so that they do not infringe on other patents may not be possible or could require substantial funds and time. |
It is also unclear whether our trade secrets are adequately protected. While we use reasonable efforts to protect our trade secrets, our employees or consultants may unintentionally or willfully disclose our information to competitors. Enforcing a claim that someone else illegally obtained and is using our trade secrets, like patent litigation, is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Our competitors may independently develop equivalent knowledge, methods and know-how.
We may also support and collaborate in research conducted by government organizations, hospitals, universities or other educational institutions. These research partners may be unwilling to grant us any exclusive rights to technology or products derived from these collaborations prior to entering into the relationship.
If we do not obtain required licenses or rights, we could encounter delays in our product development efforts while we attempt to design around other patents or even be prohibited from developing, manufacturing or selling potential drug compounds requiring these licenses. There is also a risk that disputes may arise as to the rights to technology or potential drug compounds developed in collaboration with other parties.
We will incur increased costs as a result of recently enacted and proposed changes in laws and regulations and we cannot predict the impact of any future changes in law.
We face burdens relating to the recent trend toward stricter corporate governance and financial reporting standards. New legislation or regulations such as Section 404 of the Sarbanes-Oxley Act of 2002 follow the trend of imposing stricter corporate governance and financial reporting standards have led to an increase in our costs of compliance including increases in consulting, auditing and legal fees. The new rules could make it more difficult or more costly for us to obtain certain types of insurance, including directors and officers liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers. A failure to comply with these new laws and regulations may impact market perception of our financial condition and could materially harm our business. Additionally, it is unclear what additional laws or regulations may develop, and we cannot predict the ultimate impact of any future changes in law.
Risks Related to our Common Stock
A decline in the price of our common stock could affect our ability to raise further working capital and adversely impact our operations and would severely dilute existing or future investors if we were to raise funds at lower prices.
A prolonged decline in the price of our common stock could result in a reduction in the liquidity of our common stock and a reduction in our ability to raise capital. Because our operations have been financed through the sale of equity securities, a decline in the price of our common stock could be especially detrimental to our liquidity and our continued operations. Any reduction in our ability to raise equity capital in the future would force us to reallocate funds from other planned uses and would have a significant negative effect on our business plans and operations, including our ability to develop new products and continue our current operations. If the stock price declines, there can be no assurance that we can raise additional capital or generate funds from operations sufficient to meet our obligations. We believe the following factors could cause the market price of our common stock to continue to fluctuate widely and could cause our common stock to trade at a price below the price at which you purchase your shares of common stock:
- actual or anticipated variations in our quarterly operating results;
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announcements of new services, products, acquisitions or strategic relationships by us or our competitors;
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changes in accounting treatments or principles;
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changes in earnings estimates by securities analysts and in analyst recommendations; and
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general political, economic, regulatory and market conditions.
The market price for our common stock may also be affected by our ability to meet or exceed expectations of analysts or investors. Any failure to meet these expectations, even if minor, could materially adversely affect the market price of our common stock.
If we issue additional shares of common stock in the future, it will result in the dilution of our existing stockholders.
Our articles of incorporation authorize the issuance of 150,000,000 shares of common stock. Our board of directors has the authority to issue additional shares of common stock up to the authorized capital stated in the articles of incorporation. Our board of directors may choose to issue some or all of such shares of common stock to acquire one or more businesses or to provide additional financing in the future. The issuance of any such shares of common stock will result in a reduction of the book value or market price of the outstanding shares of our common stock. If we do issue any such additional shares of common stock, such issuance also will cause a reduction in the proportionate ownership and voting power of all other stockholders. Further, any such issuance may result in a change of control of our corporation.
Trading on the OTC Bulletin Board may be volatile and sporadic, which could depress the market price of our common stock and make it difficult for our stockholders to resell their shares.
There is currently a limited market for our common stock. Our common stock is quoted on the OTC Bulletin Board service of the Financial Industry Regulatory Authority. Trading in stock quoted on the OTC Bulletin Board is often thin and characterized by wide fluctuations in trading prices, due to many factors that may have little to do with our operations or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operating performance. Moreover, the OTC Bulletin Board is not a stock exchange, and trading of securities on the OTC Bulletin Board is often more sporadic than the trading of securities listed on a quotation system like Nasdaq or a stock exchange like Amex. There is no assurance that a sufficient market will develop in the stock, in which case it could be difficult for our stockholders to resell their stock.
Our stock is a penny stock. Trading of our stock may be restricted by the Securities and Exchange Commissions penny stock regulations which may limit a stockholders ability to buy and sell our stock.
Our stock is a penny stock. The Securities and Exchange Commission has adopted Rule 15g-9 which generally defines penny stock to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and accredited investors. The term accredited investor refers generally to institutions with assets in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouse. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the Securities and Exchange Commission which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customers account. The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customers confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchasers written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the
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secondary market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules discourage investor interest in and limit the marketability of our common stock.
The Financial Industry Regulatory Authority sales practice requirements may also limit a stockholders ability to buy and sell our stock.
In addition to the penny stock rules described above, the Financial Industry Regulatory Authority or FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customers financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for shares of our common stock.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On June 26, 2009 we issued 22,222 common shares for finders’ fees related to the issuance of $500,000 promissory note on June 3, 2009. We issued these common shares to one non-U.S. persons (as that term is defined in Regulation S of the Securities Act of 1933, as amended) in an offshore transaction in which we relied on the registration exemption provided for in Regulation S of the Securities Act of 1933, as amended.
Item 3. Defaults upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders.
None.
Item 5. Other Information.
On May 5, 2009, we issued a promissory note in the amount of $150,000 bearing interest at 8% and maturing on December 31, 2009. We issued the security to one non-U.S. person (as that term is defined in Regulation S of the Securities Act of 1933, as amended) in an offshore transaction in which we relied on the registration exemption provided for in Regulation S and/or Section 4(2) of the Securities Act of 1933, as amended.
Item 6. Exhibits.
Exhibit Number |
|
(3) |
Articles of Incorporation and Bylaws |
3.1 |
Articles of Incorporation (incorporated by reference to an exhibit to our Registration Statement on Form SB-2 filed on January 13, 2005) |
3.2 |
Bylaws (incorporated by reference to an exhibit to our Registration Statement on Form SB-2 filed on January 13, 2005) |
3.3 |
Articles of Merger filed with the Secretary of State of Nevada on January 10, 2007 and which is effective January 25, 2007 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on January 25, 2007) |
(4) |
Instruments defining rights of security holders, including indentures |
4.1 |
Specimen Stock Certificate (incorporated by reference to an exhibit to our Registration Statement on Form SB-2 filed on January 13, 2005) |
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Exhibit Number |
Description |
4.2 |
Form of Convertible Loan Agreement (incorporated by reference to an exhibit to our Form 8-K filed on April 3, 2009) |
4.3 |
8% Convertible Loan Agreement dated June 3, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
4.4 |
8% Convertible Loan Agreement dated June 19, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 26, 2009) |
(10) |
Material Contracts |
10.1 |
Agreement between Anavex Life Sciences Corp. and Dr. Alexandre Vamvakides dated January 31, 2007 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007) |
10.2 |
Abstract of Disclosure of Greek Patent Number 1002616 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007) |
10.3 |
Abstract of Disclosure of Greek Patent Number 1004208 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007) |
10.4 |
Abstract of Disclosure of Greek Patent Number 1004868 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007) |
10.5 |
Written description of Greek Patent Application Number 20070100020 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007) |
10.6 |
Form of Stock Option Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 22, 2007) |
10.7 |
Shares for Services and Subscription Agreement dated September 11, 2007 between our company and Eurogenet Labs S.A. (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2007) |
10.8 |
2007 Stock Option Plan (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 28, 2007) |
10.9 |
Consulting Agreement with Cameron Durrant dated May 20, 2008 (incorporated by reference to an exhibit to our Quarterly Report on Form 10-QSB filed on August 18, 2008 |
10.10 |
Form of Convertible Loan Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009) |
10.11 |
Consulting Agreement with Tariq Arshad dated March 2, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009) |
10.13 |
Consulting Agreement with Dr. Mark Smith dated January 13, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009) |
10.14 |
Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009) |
10.15 |
Form of Warrant Certificate (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009) |
10.16 |
Amended Consulting Agreement with Cameron Durrant dated May 14, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.17 |
CEO Consulting Agreement with Dr. Herve de Kergrohen dated June 12, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.18 |
Form of Private Placement subscription agreement dated June 15, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.19 |
Shares for Services Agreement with Andreas Eleuthariadis dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.20 |
Shares for Services Agreement with Vasileios Kourafalos dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.21 |
Shares for Services Agreement with George Kalkanis dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.22 |
Stock Option Agreement with Alexandre Vamvakides dated June 11, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009) |
10.23 |
Form of Private Placement Subscription Agreement Convertible Loan (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 26, 2009) |
20
Exhibit Number |
Description |
10.24 | Form of Private Placement Subscription Agreement for Units (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 26, 2009) |
(14) | Code of Ethics |
14.1 | Code of Conduct (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 28, 2007) |
(31) | Section 302 Certification |
31.1* | |
31.2* | |
(32) | Section 906 Certification |
32.1* | |
32.2* |
* Filed herewith.
21
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ANAVEX LIFE SCIENCES CORP.
By:
/s/ Herve de
Kergrohen
Dr. Herve de Kergrohen
Chief Executive Officer
(Principal
Executive Officer)
Date: August 19, 2009
By:
/s/ Harvey
Lalach
Harvey
Lalach
President, Chief Financial Officer, Secretary and Director
(Principal Financial Officer and Principal Accounting Officer)
Date:
August 19, 2009