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EX-31.1 - EXHIBIT 31.1 - ANAVEX LIFE SCIENCES CORP.exhibit31-1.htm
EX-32.1 - EXHIBIT 32.1 - ANAVEX LIFE SCIENCES CORP.exhibit32-1.htm
EXCEL - IDEA: XBRL DOCUMENT - ANAVEX LIFE SCIENCES CORP.Financial_Report.xls

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, 2014

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 98-0608404
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)

51 West 52nd Street, 7th Floor, New York, NY USA 10019
(Address of principal executive offices) (Zip Code)

1-844-689-3939
(Registrant’s telephone number, including area code)

N/A
(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.
[X] Yes      [   ] 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).
[X] 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]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
[   ] Yes      [X] No


APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:
38,260,098 shares of common stock outstanding as of August 12, 2014.

ii


TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION 1
   
ITEM 1. FINANCIAL STATEMENTS. 1
   
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. 2
   
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS. 9
   
ITEM 4. CONTROLS AND PROCEDURES. 9
   
PART II – OTHER INFORMATION 10
   
ITEM 1. LEGAL PROCEEDINGS. 10
   
ITEM 1A. RISK FACTORS. 10
   
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. 10
   
ITEM 3. DEFAULTS UPON SENIOR SECURITIES. 10
   
ITEM 4. MINE SAFETY DISCLOSURES 10
   
ITEM 5. OTHER INFORMATION. 10
   
ITEM 6. EXHIBITS. 11
   
SIGNATURES 12

iii


PART I - FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

 


 

 

ANAVEX LIFE SCIENCES CORP.

INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2014

(Unaudited)

 

 


ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED BALANCESHEETS
June 30, 2014 and September 30, 2013
(Unaudited)

    June 30,     September 30,  
    2014     2013  
             
ASSETS    
             
Current            
   Cash $ 8,179,681   $ 345,074  
   Prepaid expenses   18,919     48,375  
    8,198,600     - 393,449  
Deferred financing charges   1,113,565     -  
Equipment   1,751     -  
  $ 9,313,916   $ 393,449  
             
LIABILITIES  
             
Current            
   Accounts payable and accrued liabilities $ 1,703,307   $ 1,741,797  
   Promissory notes payable   200,835     210,863  
    1,904,142     1,952,660  
Derivative financial instruments - warrants   -     904,000  
Convertible debentures, net of debt discounts   1,091     -  
    1,905,233     2,856,660  
             
STOCKHOLDERS' EQUITY (CAPITAL DEFICIT)  
             
Capital stock            
   Authorized: 
         150,000,000 common shares, par value $0.001 per share 
   Issued and outstanding:
          38,260,098 common shares (September 30, 2013 - 37,237,588)
  38,261     37,238  
Additional paid-inc apital   49,604,707     38,644,523  
Common stock to be issued   640,000     60,000  
Accumulated deficit   (42,874,285 )   (41,204,972 )
    7,408,683     (2,463,211 )
  $ 9,313,916   $ 393,449  

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
for the three and nine months ended June 30, 2014 and 2013
(Unaudited)

    Three months ended June 30,     Nine months ended June 30,  
    2014     2013     2014     2013  
Operating expenses                        
General and administrative - Notes 9 and 10 $ 733,818   $ 86,961   $ 1,941,261   $ 502,376  
Research and development   265,015     39,021     388,347     166,584  
                         
Total operating expenses   (998,833 )   (125,982 )   (2,329,608 )   (668,960 )
                         
Other income (expenses)                        
Interest and finance expenses, net   (8,492 )   (14,855 )   (16,858 )   (41,638 )
Accretion of debt discounts   (80 )   -     (1,091 )   -  
Change in fair value of derivative financial instruments   -     -     683,000     -  
Gain on settlement of accounts payable   5,500     -     5,500     -  
Foreign exchange loss   (7,185 )   (11,087 )   (10,256 )   (943 )
                         
Total other income (expenses), net   (10,257 )   (25,942 )   660,295     (42,581 )
                         
Net loss and comprehensive loss for the period $ (1,009,090 ) $ (151,924 ) $ (1,669,313 ) $ (711,541 )
                         
Loss per share                        
   Basic $ (0.03 ) $ (0.01 ) $ (0.04 ) $ (0.02 )
   Diluted $ (0.03 ) $ (0.01 ) $ (0.06 ) $ (0.02 )
                         
Weighted average number of shares outstanding                        
   Basic   39,260,098     30,240,687     38,218,237     30,240,687  
   Diluted   39,260,098     30,240,687     38,218,237     30,240,687  

SEE ACCOMPANYING  NOTES


ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
for the nine months ended June 30, 2014 and 2013
(Unaudited)

    Nine months ended June 30,  
    2014     2013  
             
Cash Flows used in Operating Activities            
Net loss for the period $ (1,669,313 ) $ (711,541 )
Adjustments to reconcile net loss to net cash used in operations:            
Amortization and depreciation   576     576  
Accretion of debt discount   1,091     -  
Stock-based compensation   9,589     -  
Common shares to be issued for services   610,000     -  
Amortization of deferred financing charge   10,047     1,215  
Change in fair value of derivative financial instruments   (683,000 )   -  
Loss on settlement of accounts payable   (5,500 )   -  
Unrealized foreign exchange   (10,028 )   (7,282 )
Changes in non-cash working capital balances related to operations:            
Prepaid expenses   (19,000 )   -  
Accounts payable and accrued liabilities   13,014     423,967  
Net cash used in operating activities   (1,742,524 )   (293,065 )
             
Cash Flows used in Investing Activities            
Acquisition of equipment   (2,327 )   -  
Net cash used in investing activities   (2,327 )   -  
             
Cash Flows provided by Financing Activities            
Issuance of common shares, net of share issue costs   368,170     -  
Share subscriptions received   -     33,348  
Proceeds from the issuance of promissory notes   -     250,000  
Financing fees paid   (788,712 )   -  
Proceeds from the issuance of convertible debentures   10,000,000        
Net cash provided by financing activities   9,579,458     283,348  
             
Increase (decrease) in cash during the period   7,834,607     (9,717 )
Cash, beginning of period   345,074     11,362  
Cash, end of period $ 8,179,681   $ 1,645  
             
Supplemental Cash Flow Information - Note 11            

SEE ACCOMPANYING NOTES


Anavex LifeSciences Corp.
Consolidated Statement of Changes in Capital (Deficit)
For the nine months ended June 30, 2014

    Common Stock              
                Additional     Common              
                Paid-in     Shares to be     Accumulated        
    Shares     ParValue     Capital     Issued     Deficit     Total  
                                     
Balance, October 1, 2013   37,237,588   $  37,238   $ 38,644,523   $  60,000   $ (41,204,972 )   (2,463,211 )
Equity units issued under Purchase Agreement   400,000     400     187,770     -     -     188,170  
Commitment shares issued under terms of Purchase Agreement   2,510     3     (3 )   -     -     -  
Capital stock issued for cash - at $0.50   120,000     120     59,880     (60,000 )         -  
Capital stock issued for cash - at $0.30   500,000     500     149,500     30,000           180,000  
Share issue costs, net of recovery   -     -     (2,452 )   -     -     (2,452 )
Issuance of detachable warrants   -     -     5,989,900     -     -     5,989,900  
Agent's warrants issued in connection with convertible debentures   -     -     334,900     -     -     334,900  
Beneficial conversion feature on convertible debentures issued   -     -     4,010,100     -     -     4,010,100  
Reclassification of derivative financia linstruments upon                                    
modification of warrant terms   -     -     221,000     -     -     221,000  
Capital stock to be issued pursuant to employment agreement   -     -     -     610,000     -     610,000  
Stock based compensation   -     -     9,589     -           9,589  
Net loss for the period   -     -     -     -     (1,669,313 )   (1,669,313 )
                                     
Balance, June 30, 2014   38,260,098   $ 38,261   $ 49,604,707   $ 640,000   $ (42,874,285 ) $ 7,408,683  

SEE ACCOMPANYING  NOTES


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
(Unaudited)

Note 1 Business Description, Basis of Presentation
   
  Business
   

Anavex Life Sciences Corp. (the “Company”) is a pharmaceutical company engaged in the development of drug candidates.

   

The Company’s lead compound, ANAVEX 2-73 is being developed to treat Alzheimer’s disease through disease modification.

   

In pre-clinical studies conducted in France and in Greece, ANAVEX 2-73 demonstrated anti-amnesic and neuroprotective properties. Based on these pre-clinical studies, the Company sponsored a Phase 1 single ascending dose study of ANAVEX 2-73, which was initiated and completed in 2011. This study was conducted in Germany in collaboration with ABX-CRO Advanced Pharmaceutical Services. The study indicated that ANAVEX 2-73 was well tolerated by study subjects in doses up to 55mg. Clinical trials had been delayed due to lack of funding. During the nine months ended June 30, 2014, the Company completed the closing of a securities purchase agreement in the aggregate principal amount of $10,000,000 (Note 6), the proceeds from which the Company intends to use to further its business plan and clinical trials of ANAVEX 2-73 and ANAVEX PLUS.

   

The Company plans to continue human clinical trials, among them a prospective Phase 2a study of ANAVEX 2-73 and ANAVEX PLUS, and a Phase 2 trial thereafter and to identify and initiate discussions with potential partners in the next 12 months. Further, the Company may acquire or develop new intellectual property and assign, license, or otherwise transfer its intellectual property to further its goals.

   
 

Basis of Presentation

   

These interim condensed consolidated financial statements have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Accordingly, certain information and footnote disclosures normally included in the annual financial statements in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the disclosures are adequate to make the information presented not misleading.

   

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 herein. These interim condensed financial statements should be read in conjunction with the audited financial statements included in its annual report on Form 10-K for the year ended September 30, 2013. The Company follows the same accounting policies in the preparation of interim reports.

   

Certain amounts for the prior periods have been reclassified to conform to the current period’s presentation. These reclassifications did not impact reported results or earnings per share.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 2

Note 1

Business Description and Basis of Presentation – (cont’d)

 

 

Operating results for the nine months ended June 30, 2014 are not necessarily indicative of the results that may be expected for the year ending September 30, 2014.

 

 

 

Basic and Diluted Loss per Share

 

 

The basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Additionally, the numerator is also adjusted for changes in fair value of the warrant liability which is presumed to be share settled.

 

 

As of June 30, 2014, loss per share excludes 77,905,632 (2013 – 4,175,513) potentially dilutive common shares (related to outstanding options and warrants) as their effect was anti-dilutive.

 

 

Note 2

Recent Accounting Pronouncements

 

 

In June 2014, the FASB issued Accounting Standards Updated No. 2014-10, "Development Stage Entities” (“ASU 2014-10”) which removes the definition of a development stage entity from the Master Glossary of the Accounting Standards Codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. In addition, the update eliminates the requirements for development stage entities to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage.

 

 

During the nine months ended June 30, 2014, the Company has elected to early adopt ASU 2014-10. The adoption of this ASU allowed the Company to remove the inception to date information and all references to development stage.

 

 

Other than noted above, we do not expect the adoption of recently issued accounting pronouncements to have a significant impact on our results of operations, financial position or cash flow.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 3

Note 3 Equipment

      June 30, 2014  
            Accumulated        
      Cost     Depreciation     Net  
                     
  Computer equipment $ 2,327   $ 576   $ 1,751  

      September 30, 2013  
            Accumulated        
      Cost     Depreciation     Net  
                     
  Computer equipment $ 5,631   $ 5,631   $ -  

Note 4 Derivative Financial Instruments
   

During the year ended September 30, 2013, the Company issued an aggregate of 6,448,966 common stock purchase warrants that were required to be accounted for as liabilities pursuant to ASC 815.

   

At September 30, 2013, these common stock purchase warrants were still outstanding and were being accounted for pursuant to the guidance of ASC 815, whereby these derivative instruments are required to be recorded as liabilities on the balance sheet measured at fair value and were marked-to-market at each balance sheet date with the change in fair value being recorded in the consolidated statements of operations as other income or expense.

   

Effective in the nine months ended June 30, 2014, the common stock purchase warrants were amended. As of the modification date, these warrants are no longer required to be accounted for as liabilities.

   

Pursuant to the guidance of ASC 815, the Company reclassified the fair value of these instruments on the date of modification into equity, with the change in fair value up to the date of modification being recorded on the consolidated statements of operations as other income.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 4

Note 4 Derivative Financial Instruments – (cont’d)
   

A summary of the Company’s derivative liabilities for the nine months ended June 30, 2014 and for the year ended September 30, 2013 is as follows:


      June 30     September 30,  
      2014     2013  
               
  Balance, beginning of the period $ 904,000   $ -  
  Fair value at issuance of derivative liability   -     919,000  
  Change in fair value of derivative liability   (683,000 )   (15,000 )
  Transfer to equity upon modification of warrant terms   (221,000 )   -  
  Balance, end of the period $ -   $ 904,000  

Note 5 Promissory Notes Payable

      June 30,     September 30,  
      2014     2013  
  Promissory note dated December 31, 2012 with a principal balance of $93,710 (CDN$100,000) bearing interest at 12% per annum, due on September 30, 2014   93,710     100,000  
               
  Promissory note dated January 9, 2013 with a principal balance of $81,225 (CDN$86,677), bearing interest at 12% per annum, secured by all the present and future assets of the Company; due on demand   81,225     84,060  
               
  Promissory note dated January 9, 2013 with a principal balance of $25,900 (CDN$27,639), bearing interest at 12% per annum, secured by all the present and future assets of the Company; due on demand   25,900     26,803  
    $ 200,835   $ 210,863  

On December 31, 2012, the Company issued a promissory note having a principal balance of $93,710 (CDN$100,000) with terms that included interest at 12% per annum and matured on June 30, 2013, in exchange for an accounts payable owing with respect to unpaid consulting fees. This note was not repaid on June 30, 2013 and the maturity date has been extended to September 30, 2014.


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 5

Note 5 Promissory Notes Payable – (cont’d)
   
On January 9, 2013, the Company issued two (2) promissory notes (the “Secured Notes”);

  a)

The Company issued a promissory note in the amount of $81,225 (CDN$86,677) to the former President, Secretary, Treasurer, CFO and director of the Company (the “President”) in exchange for unpaid consulting fees owing to the President. The note is bearing interest at 12% per annum and was due June 30, 2013.

     
  b)

The Company issued a promissory note in the amount of $25,900 (CDN$27,639) to a former director of the Company (the “Director”) in exchange for unpaid consulting fees owing to the Director. The note is bearing interest at 12% per annum and was due June 30, 2013.

The Secured Notes are secured by a right to delay the transfer of any or all of the Company’s assets until the obligations of the Secured Notes are satisfied, including a restriction on the transfer of cash by the Company and a security interest over the intellectual property of the Company. The security interests of the Secured Notes is ranked senior to any and all security interests granted prior to the issuance of the notes and to all subsequent security interests granted, unless the holders agree in writing to other terms.

In addition, the Secured Notes contain a provision whereby if they are not repaid within 10 days of their maturity dates, they shall bear late fees in addition to interest accruing, at a rate of $100 per day per note. In an event of default by the Company, under the terms of the Secured Notes, the notes shall bear additional late fees of $500 per day per note.

Subsequent to the issuance of these Secured Notes, the former President resigned as President, Secretary, Treasurer, CFO and director of the Company and the former Director resigned as director of the Company.

The Company did not repay the notes on June 30, 2013. The Company has disputed the issuance and enforceability of the Secured Notes and should there be an attempt to enforce the Secured Notes or collection on them, the Company will consider a legal remedy. The Company has not accrued any late fees in connection with these Secured Notes as of June 30, 2014 or September 30, 2013, as the Company does not consider these amounts to be legally enforceable.


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 6

Note 6 Senior Convertible Debentures

      June 30,     September 30,  
      2014     2013  
  Senior Convertible Debentures, non-interest bearing,unsecured, due March 18, 2044   10,000,000     -  
               
  Less: Debt Discount   (9,998,909 )   -  
    $ 1,091   $ -  

On March 13, 2014, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasers (the “Purchasers”) pursuant to which the Company issued senior convertible debentures in the aggregate principal amount of $10,000,000 (the “Debentures”).

In connection with the issuance of the Debentures, the Company issued an aggregate of 67,666,666 share purchase warrants as follows:

          Non-        
    Purchasers     purchasers     Total  
Series A Warrants   33,333,333     500,000     33,833,333  
Series B Warrants   33,333,333     500,000     33,833,333  
    66,666,666     1,000,000     67,666,666  

Each Series A warrant is exercisable into one common share of the Company at $0.30 per share until March 18, 2019.

Each Series B warrant is exercisable into one common share of the Company at $0.42 per share until March 18, 2019

The Debentures are unsecured, non-interest bearing and are due on March 18, 2044. At any time, the Purchasers are entitled to convert the Debentures, in whole or in part, into common shares of the Company at $0.30 per share (“the Conversion Price”). The Conversion Price of the debenture will be adjusted in the event of common stock dividend, split or consolidation.


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 7

Note 6 Senior Convertible Debentures
   

Pursuant to the guidance of ASC 470-20 Debt with Conversion and Other Options, the Company allocated the proceeds from the issuance of the Debentures between the Debentures and the detachable Purchaser warrants using the relative fair value method. The fair value of the Purchaser warrants of $22,326,200 at issuance resulted in a debt discount at issuance of $5,989,900.

 

 

The Company recorded a beneficial conversion feature discount of $4,010,100 in respect of the Debentures issued, based on the intrinsic value of the conversion feature limited to a maximum of the total proceeds of the Debentures allocated to the Debentures.

 

 

The total debt discount at issuance of $10,000,000 is being amortized using the effective interest method over the term of the Debentures. During the nine months ended June 30, 2014, the Company recorded accretion expense of $1,091 (2013: $Nil) in respect of the accretion of this discount.

 

 

In consideration for the Debentures issued, the Company issued an aggregate of 1,000,000 share purchase warrants to non-lenders as described above. The fair value of the Non-Purchaser Warrants of $334,900, along with finder’s fees and other financing costs directly associated with the issuance of the Debentures in the amount of $788,712, was recorded as a deferred financing charge and is being amortized to income over the term of the Debentures using the effective interest method. During the nine months ended June 30, 2014, the Company had recorded financing expense of $10,047 (2013: $Nil) in respect of the amortization of these charges. Accumulated amortization as at June 30, 2014 was $10,047 (2013: $Nil).

 

 

The fair value of the Purchaser and Non-Purchaser warrants at issuance was determined using the Black Scholes option pricing model with the following weighted average assumptions:


Risk-free interest rate 1.56%
Expected life (years) 5.00
Expected volatility 97.16%
Dividend yields 0.00%

In connection with the Purchase Agreement, the Company also entered into a registration rights agreement with each Purchaser whereby the Company agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) covering the resale of the shares of the Company’s common stock issuable upon conversion of the Debentures and upon exercise of the Purchaser warrants.

On July 23, 2014, the registration statement was declared effective by the SEC.


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 8

Note 7 Capital Stock
   

On February 24, 2014, the Company issued 120,000 units at $0.50 per unit for gross proceeds of $60,000, which was received during the year ended September 30, 2013. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase additional common shares at $1.00 per share for a period of five years from the date of issuance.

   

On February 24, 2014, the Company issued 500,000 units at $0.30 per unit for gross proceeds of $150,000. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase additional common shares at $0.75 per share for a period of five years from the date of issuance.

   
 

Common stock to be issued

   

On February 28, 2014, the Company received $30,000 in share subscriptions in respect of the issuance of 100,000 units at $0.30 per unit. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase additional common shares at $0.75 per share for a period of five years from the date of issuance.

   
Note 8

Lincoln Park Purchase Agreement

   

On July 5, 2013, the Company entered into a $10,000,000 purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC, (“Lincoln Park”) an Illinois limited liability company (the “Financing”) pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $10,000,000 in value of its shares of common stock from time to time over a 25 month period. In connection with the Financing, the Company also entered into a registration rights agreement with Lincoln Park whereby the Company agreed to file a registration statement with the Securities and Exchange Commission (the “SEC”) covering the shares of the Company’s common stock that may be issued to Lincoln Park under the Purchase Agreement.

   

The Company will determine, at its own discretion, the timing and amount of its sales of common stock, subject to certain conditions and limitations. The purchase price of the shares that may be sold to Lincoln Park under the Purchase Agreement will be based on the market price of the Company’s shares of common stock immediately preceding the time of sale without any fixed discount, provided that in no event will such shares be sold to Lincoln Park when the closing sale price is less than $0.50 per share. There are no upper limits on the per share price that Lincoln Park may pay to purchase such common stock. The purchase price will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split or similar transaction occurring during the business days used to compute such price.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 9

Note 8 Lincoln Park Purchase Agreement – (Cont’d)
   

Pursuant to the Purchase Agreement, Lincoln Park initially purchased 250,000 shares of the Company’s common stock for $100,000. In consideration for entering into the Purchase Agreement, the Company issued to Lincoln Park 341,858 shares of common stock as a commitment fee and shall issue up to 133,409 shares pro rata, when and if, Lincoln Park purchases, at the Company’s discretion, the remaining $10,000,000 aggregate commitment. The Purchase Agreement may be terminated by the Company at any time at its discretion without any cost to the Company.

   
 

On October 23, 2013, the registration statement was declared effective by the SEC.

   

The Company incurred $98,939 in direct expenses in connection with the Purchase Agreement and registration statement. These were recorded as share issuance costs as a charge against additional paid in capital during the year ended September 30, 2013 and during the nine months ended June 30, 2014.

   

During the nine months ended June 30, 2014, the Company issued to Lincoln Park an aggregate of 402,510 shares of common stock under the Purchase Agreement, including 400,000 shares of common stock for an aggregate purchase price of $188,170 and 2,510 commitment shares.

   
Note 9

Related Party Transactions

 

 

During the three and nine months ended June 30, 2014, the Company was charged general and administrative expenses totaling $412,089 and $1,022,089, respectively, in respect of directors fees, management bonuses and share and stock option based compensation charges paid or accrued to directors and officers of the Company, inclusive of amounts noted below (2013: $Nil and $81,072, respectively in respect of consulting fees paid to directors, officers, and a company controlled by a director and officer of the Company).

 

 

As of June 30, 2014, included in accounts payable and accrued liabilities was $32,004 (September 30, 2013: $30,447) owing to directors and officers of the Company for director fees and reimbursable expenses, and a former director and officer of the Company for unpaid fees.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 10

Note 9 Related Party Transactions – (Cont’d)
   

During the year ended September 30, 2013, pursuant to an employment agreement with the President, Chief Executive Officer, Chief Financial Officer, Secretary and Treasurer, and Director, of the Company, the Company:


  i)

granted 2,000,000 fully vested share purchase options exercisable at $0.40 per share until July 5, 2023. No stock based compensation expense has been recognized during the three months ended June 30, 2014 and 2012 in connection with these options. The Company recognized stock based compensation expense of $1,002,500 during the year ended September 30, 2013 in connection with these options.

     
  ii)

issued 4,000,000 shares of restricted common stock that vest as follows:


 

25% upon the Company starting a Phase Ib/IIb human study

25% upon the Company in-licensing additional assets in clinical or pre- clinical stage (vested during the nine months ended June 30, 2014)

25% upon the Company securing additional non-dilutive equity funding in 2013 of at least $5,000,000 with a share price higher than the previous funding

 

25% upon the Company obtaining a listing on a major stock exchange


Included in operating results for the three and nine months ended June 30, 2014 is an amount of $610,000 relating to the vesting of 1,000,000 shares of restricted common stock upon the achievement of certain performance conditions. The fair value of $0.61 per share was determined with reference to the quoted market price of the Company’s shares on the commitment date. This amount has been included in common stock to be issued at June 30, 2014.
   
Note 10 Commitments

  a)

Share Purchase Warrants

     
 

A summary of the Company’s share purchase warrants outstanding is presented below:


          Weighted  
          Average  
          Exercise  
    Number of Shares     Price  
             
Balance, September 30, 2012   4,250,141   $ 1.16  
Expired   (1,549,628 ) $ 2.56  
Issued   6,448,966   $ 0.75  
Balance, September 30, 2013   9,149,479   $ 0.75  
Expired   (2,700,513 ) $ 0.75  
Issued   68,286,666   $ 0.36  
Balance, June 30, 2014   74,735,632   $ 0.40  


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 11

Note 10 Commitments – (Cont’d)

  a)

Share Purchase Warrants

     
 

At June 30, 2014, the Company had 74,735,632 share purchase warrants outstanding as follows:


Number       Exercise Price     Expiry Date  
6,448,966     $ 0.75     July 5, 2018  
500,000     $ 0.75     February 14, 2019  
120,000     $ 1.00     February 24, 2019  
33,833,333     $ 0.30     March 13, 2019  
33,833,333     $ 0.42     March 13, 2019  
74,735,632                

 

All of the 6,448,966 warrants expiring on July 5, 2018 and the 500,000 warrants expiring February 14, 2019 contain a contingent call provision whereby the Company may have the option to call for cancellation of all or any portion of the warrants for consideration equal to $0.001 per share, provided the quoted market price of the Company’s common stock exceeds $1.50 for a period of twenty consecutive trading days, subject to certain minimum volume restrictions and other restrictions as provided in the warrant agreements.

     
  b)

Stock–based Compensation Plan

     
 

In April, 2007, the Company adopted a stock option plan which provides for the granting of stock options to selected directors, officers, employees or consultants in an aggregate amount of up to 3,000,000 common shares of the Company and, in any case, the number of shares to be issued to any one individual pursuant to the exercise of options shall not exceed 10% of the issued and outstanding share capital. The granting of stock options, exercise prices and terms are determined by the Company's Board of Directors. If no vesting schedule is specified by the Board of Directors on the grant of options, then the options shall vest over a 4-year period with 25% of the options granted vesting each year commencing 1 year from the grant date. For stockholders who have greater than 10% of the outstanding common shares of the Company and who have granted options, the exercise price of their options shall not be less than 110% of the fair of the stock on grant date. Otherwise, options granted shall have an exercise price equal to their fair value on grant date.

     
 

On February 2, 2011, the Company amended and restated the 2007 stock option plan to increase the number of options authorized to 4,000,000.



Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 12

Note 10 Commitments – (Cont’d)

A summary of the status of Company’s outstanding stock purchase options for the year ended June 30, 2014 is presented below:

            Weighted        
            Average     Weighted  
      Number of     Exercise     Average Grant  
      Shares     Price     Date fair value  
  Outstanding at September 30, 2012   1,775,000   $ 2.94        
  Expired   (550,000 ) $ 3.86        
  Forfeited   (150,000 ) $ 3.72        
  Granted   2,000,000   $ 0.40   $ 0.50  
  Outstanding at September 30, 2013   3,075,000   $ 1.26        
  Expired   (705,000 ) $ 2.70        
  Granted   800,000   $ 0.32   $ 0.25  
  Outstanding at June 30, 2014   3,170,000   $ 0.70        
  Exercisable at June 30, 2014   2,100,000   $ 0.56        
  Exercisable at September 30, 2013   2,305,000   $ 0.79        

At June 30, 2014, the following stock options were outstanding:

  Number of Shares           Aggregate     Remaining  
        Number     Exercise           Intrinsic     Contractual  
  Total     Vested     Price     Expiry Date     Value     Life (yrs)  
  100,000 (1)   100,000   $ 3.67     March 30, 2016     -     1.75  
  270,000 (2)   -   $ 3.00     February 8, 2017     -     2.61  
  2,000,000 (3)   2,000,000   $ 0.40     July 5, 2023     -     9.02  
  300,000 (4)   -   $ 0.30     May 7, 2024     15,000     9.86  
  500,000 (5)   -   $ 0.33     May 8, 2024     10,000     9.86  
  3,170,000     2,100,000                 25,000        


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 13

Note 10 Commitments – (Cont’d)

  c)

Stock–based Compensation Plan – (cont’d)

       
 

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Company’s stock for the options that were in-the-money at June 30, 2014.

       
  (1)

As of June 30, 2014 and September 30, 2013, these options had fully vested. The fair value of these options at issuance was calculated to be $267,000. The Company did not recognize any stock-based compensation during the three and nine months ended June 30, 2014 (2013: $Nil and $Nil, respectively).

       
  (2)

As of June 30, 2014 and September 30, 2013, none of these options had vested. The options vest upon one or more compounds: entering Phase II trial – 90,000 options; entering Phase III 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.

       
  (3)

As of June 30, 2014 and September 30, 2013 these options had fully vested. These options were granted during the year ended September 30, 2013 and vested immediately upon granting. The Company recognized stock based compensation expense of $Nil and $Nil, respectively, during the three and nine months ended June 30, 2014 (2013: $Nil and $Nil, respectively) in connection with these options. These amounts have been included in general and administrative expenses on the Company’s statement of operations.

       
  (4)

As of June 30, 2014 none of these options had vested. These options were issued during the nine months ended June 30, 2014 and vest annually over a three year period commencing on the first anniversary of the date of the grant. The Company recognized stock based compensation expense of $3,422 and $3,422 during the three and nine months ended June 30, 2014, respectively (2013: $Nil and $Nil, respectively) in connection with these options. These amounts have been included in general and administrative expenses on the Company’s statement of operations.

       
  (5)

As of June 30, 2014 none of these options had vested. These options were issued during the nine months ended June 30, 2014 and vest annually over a four year period commencing on the first anniversary of the date of the grant. The Company recognized stock based compensation expense of $6,167 and $6,167 during the three and nine months ended June 30, 2014, respectively (2013: $Nil and $Nil, respectively) in connection with these options.

During the nine months ended June 30, 2014, 705,000 options expired for which the Company had recognized stock-based compensation of $Nil and $Nil, respectively (2013: $Nil and $Nil, respectively) during the three and nine months ended June 30, 2014.


Anavex Life Sciences Corp.
Notes to the Interim Condensed Consolidated Financial Statements
June 30, 2014 and 2013
Unaudited – Page 14

Note 10 Commitments – (Cont’d)

  a)

Stock–based Compensation Plan – (cont’d)

     
 

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 during the periods:


  2014 2013
Risk-free interest rate 2.17% -
Expected life of options (years) 6.50 -
Annualized volatility 91.21% -
Dividend rate 0.00% -

There has been no stock-based compensation recognized in the financial statements for the three and nine months ended June 30, 2014 (2013: $nil and $nil, respectively) for options that will 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.

Note 11 Supplemental Cash Flow Information
   

Investing and financing activities that do not have a direct impact on current cash flows are excluded from the statement of cash flows.

   

During the nine months ended June 30, 2014, the Company reclassified an amount of $221,000 into equity upon modification of the terms of certain derivative instruments.

   

During the nine months ended June 30, 2013, the Company issued three promissory notes in the aggregate principal amount of $212,292 in exchange for accounts payable owing to three vendors in respect of unpaid consulting fees.

   
  These transactions have been excluded from the statements of cash flows.


ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Forward-Looking Statements

This Quarterly Report on Form 10-Q includes forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the anticipated start dates, durations and completion dates of our ongoing and future clinical studies, statements regarding the anticipated designs of our future clinical studies, statements regarding our anticipated future regulatory submissions and statements regarding our anticipated future cash position. We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the U.S. Food and Drug Administration, or FDA, and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, preclinical and clinical trials and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions including, without limitation, the risks described in the section entitled “Risk Factors.” These risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws of the United States and Canada, we assume no obligation to update or supplement forward-looking statements.

As used in this report, the terms “we,” “us,” “our,” “Company,” and “Anavex” mean Anavex Life Sciences Corp., unless the context clearly requires otherwise.

Our Current Business

We are a pharmaceutical company engaged in the development of drug candidates. Our lead compounds ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept®), are being developed to treat Alzheimer’s disease and potentially other central nervous system (CNS) diseases.

In pre-clinical studies conducted in France and in Greece, ANAVEX 2-73 demonstrated anti-amnesic and neuroprotective properties in various animal models including the transgenic mouse model Tg2576. Based on pre-clinical studies, we sponsored a Phase 1 single ascending dose study of ANAVEX 2-73, which was initiated and completed in 2011. This study was conducted in Germany in collaboration with ABX-CRO Advanced Pharmaceutical Services (ABX-CRO). The study indicated that ANAVEX 2-73 was well tolerated by study subjects in doses up to 55mg. We intend to use the funds raised from our recently issued convertible debentures to implement our plan of operation of researching and developing our compounds, the related patents and completing the next clinical trials for ANAVEX PLUS and to perform work necessary to prepare for further clinical development.

The Company plans to continue human clinical trials, among them a prospective Phase 2a study of ANAVEX 2-73 and ANAVEX PLUS, and a Phase 2 trial thereafter in 2014. Additionally, we intend to identify and initiate discussions with potential partners in the next 12 months. Further, we may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.

Our Pipeline

2


Our pipeline includes one drug candidate and several compounds in different stages of pre-clinical study.

Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer’s disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.

Compounds that have been subjects of our research include the following:

ANAVEX 2-73

ANAVEX 2-73 may offer a disease-modifying approach in Alzheimer’s disease (AD) by using ligands that activate sigma-1 receptors.

In AD animal models, ANAVEX 2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576 ANAVEX 2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.

Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73 in 2011. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.

The ANAVEX 2-73 Phase 1 SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical University of Dresden.

ANAVEX PLUS

ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept®) is a potential novel combination drug for Alzheimer’s disease. Aricept® (donepezil) is now generic. ANAVEX 2-73 showed in combination with donepezil an unexpected and clear synergic effect of memory improvement by up to 80% in animal models. A patent application was filed in the US for the combination of donepezil and ANAVEX 2-73 and if granted would give patent protection at least until 2033.

In a humanized calibrated cortical network computer model the unexpected pre-clinical synergy between ANAVEX 2-73 and donepezil was confirmed and ANAVEX PLUS showed an anticipated ADAS-Cog response of 7 points at 12 weeks and 5.5 points at 26 weeks, which represents more than 2x the ADAS-Cog of donepezil alone.

3


ANAVEX 3-71

ANAVEX 3-71, previously named AF710B is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has shown to enhance neuroprotection and cognition in Alzheimer's disease. ANAVEX 3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.

ANAVEX 1-41

ANAVEX 1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and destroys cells and is believed by some scientists to be a primary cause of AD. In addition, in animal models, ANAVEX 1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.

ANAVEX 1037

ANAVEX 1037 is designed for the treatment of prostate cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies, this compound revealed antitumor potential with no toxic side effects. It has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications describe sigma receptor ligands positively, highlighting the possibility that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of new blood vessels) and tumor cell proliferation.

Our compounds are in the pre-clinical and clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human testing.

Our Target Indications

We have developed compounds with potential application to two broad categories and several specific indications. The two categories are diseases of the central nervous system, and cancer. Specific indications include:

  • Alzheimer’s disease – In 2014, an estimated 5.2 million Americans are suffering from Alzheimer’s disease. The Alzheimer’s Association® reports that by 2025, 7.1 million Americans will be afflicted by the disease, a 40 percent increase from currently affected patients. Medications on the market today treat only the symptoms of AD and do not have the ability to stop its onset or its progression. There is an urgent and unmet need for both a disease modifying cure for Alzheimer’s disease as well as for better symptomatic treatments.

  • Depression - Depression is a major cause of morbidity worldwide according to the World Health Organization (WHO). Pharmaceutical treatment for depression is dominated by blockbuster brands, with the leading nine brands accounting for approximately 75% of total sales. However, the dominance of the

  • leading brands is waning, largely due to the effects of patent expiration and generic competition. Our market research leads us to believe that the worldwide market for pharmaceutical treatment of depression exceeds $11 billion annually.

4


  • Epilepsy - Epilepsy is a common chronic neurological disorder characterized by recurrent unprovoked seizures. These seizures are transient signs and/or symptoms of abnormal, excessive or synchronous neuronal activity in the brain. According to the Centers for Disease Control and Prevention, epilepsy affects 2.2 million Americans. Today, epilepsy is often controlled, but not cured, with medication that is categorized as older traditional anti-epileptic drugs and second generation anti epileptic drugs. Because epilepsy afflicts sufferers in different ways, there is a need for drugs used in combination with both traditional anti-epileptic drugs and second generations anti-epileptic drugs. Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the epilepsy market will increase from $2.9 billion in 2011 to nearly $3.7 billion in 2016.

  • Neuropathic Pain – We define neuralgia, or neuropathic pain, as pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is more difficult to treat than some other types of pain because it does not respond well to normal pain medications. Special medications have become more specific to neuralgia and typically fall under the category of membrane stabilizing drugs or antidepressants. Our market research leads us to believe the worldwide market for pharmaceutical treatment of neuropathic pain exceeds $5 billion annually.

  • Malignant Melanoma - Predominantly a skin cancer, malignant melanoma can also occur in melanocytes found in the bowel and the eye. Malignant melanoma accounts for 75% of all deaths associated with skin cancer. The treatment includes surgical removal of the tumor, adjuvant treatment, chemo and immunotherapy, or radiation therapy. According to IMS Health the worldwide Malignant Melanoma market is expected to grow from about $900 million in 2012 to $4.4 billion by 2022.

  • Prostate Cancer – Specific to men, prostate cancer is a form of cancer that develops in the prostate, a gland in the male reproductive system. The cancer cells may metastasize from the prostate to other parts of the body, particularly the bones and lymph nodes. Drug therapeutics for Prostate Cancer are expected to increase from $8.1 billion in 2012 to nearly $18.6 billion in 2017 according to BCC Research.

  • Pancreatic Cancer - Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States approximately 45,000 new cases of pancreatic cancer will be diagnosed this year and approximately 38,000 patients will die as a result of their cancer. Our market research leads us to believe that the market for the pharmaceutical treatment of pancreatic cancer will exceed $1.2 billion by 2015.

Recent Corporate Developments

Since the commencement of our third quarter ended June 30, 2014, we have experienced the following significant corporate developments:

  • On May 6, 2014, the Board of Directors appointed two of new directors Bernd Metzner, PhD and Elliot Favus, MD, to our board of directors.

  • On July 21, 2014, we announced that our Company has secured cGMP manufacturing of ANAVEX 2-73 for our Phase 2a clinical trials, which will allow us to initiate clinical trials with ANAVEX PLUS for the treatment of Alzheimer’s disease.

5


Results of Operations

Revenue

We have not earned any revenues since our inception on January 23, 2004. We do not anticipate earning any revenues until we can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.

Operating Expenses

Three months ended June 30, 2014 compared to three months ended June 30, 2013

Our operating expenses for the three months ended June 30, 2014 were $998,833, which represents an increase of $872,851 compared to $125,982 for the three month period ended June 30, 2013. The increase was mainly attributable to (i) an increase in professional fees and bonus payment as a result of our capital raising efforts and related activities relating to our Company’s success in securing $10,000,000 in financing under the March 13, 2014 Securities Purchase Agreement (the “March Financing”) and (ii) an increase in research and development activities in the current period.. We expect our research and development expenses will continue to increase over the remaining quarters in the current fiscal year as a result of continued research and development expenses. We continue to target potential research partners to further advance our pipeline compounds.

Other income (expenses)

The aggregate amount in the other income (expense) for the three month period ended June 30, 2014, amounted to $(10,257) as compared to $(25,942) for the comparable three month period ended June 30, 2013. The decrease in other expenses was mainly as a result of a decrease in interest expense in the current period as a result of the settlement of various promissory notes during the fourth quarter of fiscal 2013 and an increase in interest income as a result of interest earned on a larger cash balance existing in the current period.

Nine months ended June 30, 2014 compared to nine months ended June 30, 2013

Our operating expenses for the nine months ended June 30, 2014 were $2,329,608, which represents an increase of $1,660,648 compared to $668,960 for the nine month period ended June 30, 2013. The increase was mainly attributable to (i) an increase in investor relations expenses and other professional fees and bonus payment as a result of our capital raising efforts related to the March Financing, which resulted in one-time compensation charges in the aggregate amount of $1,010,000, consisting of a non-cash charge of $610,000 for the vesting of common stock under our President’s employment agreement and (ii) an increase in research and development activities in the current period.

Other income (expenses)

The aggregate amount in the other income (expense) for the nine month period ended June 30, 2014, amounted to $660,295 as compared to $(42,581) for the comparable nine month period ended June 30, 2013. The largest single increase was as a result of a non-cash benefit related to a change in the calculated fair value during the period of stock purchase warrants being accounted for as derivative liabilities in accordance with US GAAP. These gains arose as a result of the requirement of generally accepted accounting principles in the United States to re-measure derivatives to their respective fair values each reporting period with the changes in fair value being reported as a non-operating item on the consolidated statement of operations.

On December 21, 2013, we entered into amendment agreements with all of the holders of these warrants such that these warrants are no longer required to be accounted for in this manner. As a result of the modification, we expect this type of non-operating income will not be incurred in future periods.

6


Liquidity and Capital Resources

Working Capital

    June 30, 2014     September 30, 2013  
Current Assets $  8,198,600   $  393,449  
Current Liabilities   1,904,142     1,952,660  
Working Capital (Deficiency) $  6,294,458   $  (1,559,211 )

As of June 30, 2014, we had $8,179,681 in cash, an increase of $7,834,607 from September 30, 2013. The principal reason for this increase is due to cash received in respect of the issuance of senior convertible debentures in the aggregate principal amount of $10,000,000 that were issued in the current nine month period. We intend to use the funds from these debentures to implement our plan of operation of researching and developing our compounds, the related patents and any further intellectual property we may acquire. We intend to use the majority of our capital resources to complete the next clinical trial for ANAVEX 2-73 and ANAVEX PLUS, and to perform work necessary to prepare for further clinical development.

Cash Flows

    Nine months ended June 30,  
    2014     2013  
Cash flows used in operating activities $  (1,742,524 ) $  (293,065 )
Cash flows from investing activities   (2,327 )   -  
Cash flows from financing activities   9,579,458     283,348  
Increase (decrease) in cash $  7,834,607   $  (9,717 )

Cash flow used in operating activities

Our cash used in operating activities for the nine month period ended June 30, 2014 was $1,742,524 compared to $293,065 used in operating activities for the comparative nine month period ended June 30, 2013. The increase in cash used in operating activities was primarily as a result of the increased net loss for the current period as a result of an increase in corporate activities and research and development following the March Financing.

Cash used in investing activities

Cash used in investing activities was $2,327 in the current nine month period ended June 30, 2014. This is as a result of a small equipment purchase in the current period.

Cash flow provided by financing activities

Our cash provided by financing activities for the nine month period ended June 30, 2014 was $9,579,458, mostly attributable to cash received from the issuance of convertible debentures in the aggregate principal amount of $10,000,000, less related fees and expenses of $788,712 incurred in connection with the closing of these debentures. We also received cash from the issuance of common shares under the Purchase Agreement with Lincoln Park Capital Fund, LLC (described under Future Financing below).

In the comparative nine month period ended June 30, 2013, we had cash inflows of $283,348 from activities related to the issuance of short term debt and a small private placement equity financing.

Other Financing

On July 5, 2013, the Company entered into a Purchase Agreement (“Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the Purchase Agreement, Lincoln Park initially purchased 250,000 shares of the Company’s common stock for $100,000. During the nine months ended June 30, 2014, we issued an aggregate of 402,510 shares of common stock under the Purchase Agreement, including 400,000 shares of common stock for an aggregate purchase price of $188,170 and 2,510 commitment shares.

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The Company has the right, in its sole discretion over a 25-month period, to sell to Lincoln Park up to the additional aggregate commitment of $9.9 Million of shares of common stock. There are no upper limits on the per share price that Lincoln Park may pay to purchase such common stock. Furthermore, the Company controls the timing and amount of any future sales, if any, of shares of common stock to Lincoln Park except that, pursuant to the terms of the Purchase Agreement, we would be unable to sell shares to Lincoln Park if and when the closing sale price of our common stock is below $0.50 per share, subject to adjustment as set forth in the Purchase Agreement. Lincoln Park has no right to require any sales and is obligated to purchase common stock as directed by the Company.

Other than our rights related to the Lincoln Park financing, 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.

We expect that we will be able to continue to fund our operations through existing cash on hand and through equity and debt financing in the future. 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.

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 are 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 management’s application of accounting policies. We believe that understanding the basis and nature of the estimates and assumptions involved with the following aspects of our financial statements is critical to an understanding of our financial statements.

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 made by us 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.

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Stock-based Compensation

We account for all 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.

Recent Accounting Pronouncements

In June 2014, the FASB issued Accounting Standards Updated No. 2014-10, "Development Stage Entities” (“ASU 2014-10”) which removes the definition of a development stage entity from the Master Glossary of the Accounting Standards Codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. In addition, the update eliminates the requirements for development stage entities to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage.

The adoption of this ASU in the current period allowed our company to remove the inception to date information and all references to development stage.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide information under this item.

ITEM 4. 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 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 Commission’s 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 principal financial officer to allow timely decisions regarding required disclosure.

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Based on that evaluation, our management, with the participation of our principal executive officer and 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. The ineffectiveness of our disclosure controls and procedures was due to the material weaknesses disclosed in our Annual Report on Form 10-K filed on December 30, 2013.

We intend to take appropriate and reasonable steps to make the necessary improvements to remediate these deficiencies. However, due to our size and nature, segregation of all conflicting duties has not always been possible and may not be economically feasible.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2014 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 or our subsidiary 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.

ITEM 1A. RISK FACTORS.

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide information under this item. However, current and prospective investors are encouraged to review the risks set forth in Part I, Item 1A, “Risk Factors” in our most recent Annual Report on Form 10-K as filed with the Securities and Exchange Commission on December 30, 2013.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None.

ITEM 4. MINE SAFETY DISCLOSURES

Not applicable.

ITEM 5. OTHER INFORMATION.

None.

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ITEM 6. EXHIBITS.

Exhibit
Number

Description
(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 Current Report on Form 8-K filed on September 28, 2007)

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)

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

Form of Amendment No. 1 to Common StockSecurities Purchase Warrant, entered into December 21, 2013Agreement, dated March 13, 2014, by and among the Company and the Purchasers named therein (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 10March 19, 20132014)

10.2

Form of Registration Rights Agreement, dated March 13, 2014, by and among the Company and the parties identified therein (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on March 19, 2014)

10.3

Form of Senior Convertible Debenture (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on March 19, 2014)

10.4

Form of Series A/B Warrant (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on March 19, 2014)

(31)

Section 302 Certifications

31.1*

Section 302 Certification of Christopher Missling, PhD.

(32)

Section 906 Certifications

32.1*

Section 906 Certification of Christopher Missling, PhD.

(99)

Additional Exhibits

99.1

Insider Trading Policy Adopted August 27, 2010 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2010)

(101)

XBRL

101.INS*

XBRL INSTANCE DOCUMENT

101.SCH*

 XBRL TAXONOMY EXTENSION SCHEMA

101.CAL*

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE

101.DEF*

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

101.LAB*

XBRL TAXONOMY EXTENSION LABEL LINKBASE

101.PRE*

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

* Filed herewith.

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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.

 

/s/Christopher Missling, PhD  
   
Christopher Missling, PhD  
Chief Executive Officer and Chief Financial Officer  
(Principal Executive, Financial and Accounting Officer)  
Date: August 12, 2014  

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