0001615774-17-002182.txt : 20170510 0001615774-17-002182.hdr.sgml : 20170510 20170510162555 ACCESSION NUMBER: 0001615774-17-002182 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 42 CONFORMED PERIOD OF REPORT: 20170331 FILED AS OF DATE: 20170510 DATE AS OF CHANGE: 20170510 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANAVEX LIFE SCIENCES CORP. CENTRAL INDEX KEY: 0001314052 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 208365999 STATE OF INCORPORATION: NV FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-37606 FILM NUMBER: 17830660 BUSINESS ADDRESS: STREET 1: 51 W 52ND STREET, STREET 2: 7TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10019-6163 BUSINESS PHONE: 800-689-3939 MAIL ADDRESS: STREET 1: 51 W 52ND STREET, STREET 2: 7TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10019-6163 FORMER COMPANY: FORMER CONFORMED NAME: Thrifty Printing Inc. DATE OF NAME CHANGE: 20050111 10-Q 1 s106085_10q.htm QUARTERLY REPORT

  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: March 31, 2017

 

¨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”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ¨   Accelerated filer x
Non-accelerated filer ¨ (Do not check if a smaller reporting company) Smaller reporting company ¨
Emerging growth company ¨      

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act

 

¨ Yes ¨ No

 

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: 41,376,061 shares of common stock outstanding as of May 10, 2017.

 

 

 

 

TABLE OF CONTENTS

 

PART I - FINANCIAL INFORMATION F-1
Item 1. FINANCIAL STATEMENTS F-1
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 3
Item 3. Quantitative and Qualitative Disclosures about Market Risks 13
Item 4. Controls and Procedures 14
PART II – OTHER INFORMATION 14
Item 1. Legal Proceedings 14
Item 1A. Risk Factors 14
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 14
Item 3. Defaults Upon Senior Securities 14
Item 4. Mine Safety Disclosures 15
Item 5. Other Information 15
Item 6. Exhibits 16
SIGNATURES 17

 

 ii

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. FINANCIAL STATEMENTS

 

 

ANAVEX LIFE SCIENCES CORP.

 

INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

March 31, 2017

 

(Unaudited)

 

 F-1 

 

 

ANAVEX LIFE SCIENCES CORP.

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

March 31, 2017 and September 30, 2016

 

   March 31,   September 30, 
   2017   2016 
   (Unaudited)     
ASSETS          
Current          
Cash and cash equivalents  $23,351,567   $9,186,814 
Sales tax recoverable   60,636    79,347 
Prepaid expenses   141,989    180,124 
    23,554,192   9,446,285 
Deposits   52,396    52,396 
   $23,606,588  $9,498,681 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current          
Accounts payable and accrued liabilities  $2,033,692   $3,119,993 
Deferred grant income   86,205    70,532 
    2,119,897   3,190,525 
           
Commitments - Note 6          
           
Capital stock          
Authorized:          
100,000,000 common shares, par value $0.001 per share          
Issued and outstanding:          
41,376,061 common shares (September 30, 2016 - 36,168,299)   41,377    36,169 
Additional paid-in capital   104,159,213    84,290,140 
Accumulated deficit   (82,713,899)   (78,018,153)
    21,486,691   6,308,156 
   $23,606,588   $9,498,681 

 

The Accompanying Notes are an Integral Part of these Condensed Consolidated Interim Financial Statements

 

 F-2 

 

  

ANAVEX LIFE SCIENCES CORP.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

for the three and six months ended March 31, 2017 and 2016

(Unaudited)

 

   Three months ended March 31,   Six months ended March 31, 
   2017   2016   2017   2016 
Operating expenses                    
General and administrative  $1,116,014   $1,089,641   $2,242,198   $3,982,746 
Research and development   2,492,933    1,090,527    4,535,423    2,729,856 
                     
Total operating expenses   (3,608,947)   (2,180,168)   (6,777,621)   (6,712,602)
                     
Other income (expenses)                    
Grant income   16,684    26,879    51,970    65,934 
Research and development incentive income   2,022,902    -    2,022,902    571,093 
Interest income, net   18,147    2,064    21,802    4,206 
Gain on settlement of accounts payable   -    151,402    -    151,402 
Financing related charges and adjustments   -    (72)   -    (1,167)
Foreign exchange gain (loss)   11,722    (30,906)   25,804    (46,561)
                     
Total other income, net   2,069,455    149,367    2,122,478    744,907 
Net loss before provision for income taxes   (1,539,492)   (2,030,801)   (4,655,143)   (5,967,695)
                     
Income tax expense - current   (9,595)   -    (40,603)   (17,615)
                     
Net loss and comprehensive loss  $(1,549,087)  $(2,030,801)  $(4,695,746)  $(5,985,310)
                     
Loss per share                    
Basic  $(0.04)  $(0.06)  $(0.12)  $(0.17)
Diluted  $(0.04)  $(0.06)  $(0.12)  $(0.17)
                     
Weighted average number of shares outstanding                    
Basic   41,159,707    35,214,793    39,761,612    34,589,957 
Diluted   41,159,707    35,214,793    39,761,612    34,589,957 

 

The Accompanying Notes are an Integral Part of these Condensed Consolidated Interim Financial Statements

 

 F-3 

 

 

ANAVEX LIFE SCIENCES CORP.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

for the six months ended March 31, 2017 and 2016

(Unaudited)

 

   2017   2016 
         
Cash Flows used in Operating Activities          
Net loss  $(4,695,746)  $(5,985,310)
Adjustments to reconcile net loss to net cash used in operations:          
Amortization and depreciation   -    497 
Accretion of debt discount   -    1,167 
Stock-based compensation   1,858,160    1,048,710 
Gain on settlement of accounts payable   -    (151,402)
Unrealized foreign exchange   -    2,907 
Changes in non-cash working capital balances related to operations:          
Sales tax recoverable   18,711    (1,830)
Prepaid expenses and deposits   38,135    15,868 
Accounts payable and accrued liabilities   (1,086,301)   (14,187)
Deferred grant income   15,673    (66,169)
Net cash used in operating activities   (3,851,368)   (5,149,749)
           
Cash Flows provided by Financing Activities          
Issuance of common shares, net of share issue costs   18,016,121    1,809,620 
Net cash provided by financing activities   18,016,121    1,809,620 
           
Increase (decrease) in cash during the period   14,164,753    (3,340,129)
Cash and cash equivalents, beginning of period   9,186,814    15,290,976 
Cash and cash equivalents, end of period  $23,351,567   $11,950,847 

 

The Accompanying Notes are an Integral Part of these Condensed Consolidated Interim Financial Statements

 

 F-4 

 

 

ANAVEX LIFE SCIENCES CORP.

INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY

For the six months ended March 31, 2017

(Unaudited)

 

   Common Stock         
   Shares   Par Value   Additional
Paid-in
Capital
   Accumulated
Deficit
   Total 
                     
Balance, October 1, 2016   36,168,299   $36,169   $84,290,140   $(78,018,153)  $6,308,156 
                          
Shares issued under equity line - purchase shares   5,122,841    5,123    18,010,998    -    18,016,121 
Shares issued under equity line - commitment shares   32,359    32    (32)   -    - 
Shares issued upon exercise of warrants - cashless   52,562    53    (53)   -    - 
Share based compensation   -    -    1,858,160    -    1,858,160 
Net loss for the period   -    -    -    (4,695,746)   (4,695,746)
Balance, March 31, 2017   41,376,061   $41,377   $104,159,213   $(82,713,899)  $21,486,691 

 

The Accompanying Notes are an Integral Part of these Condensed Consolidated Interim Financial Statements

 

 F-5 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 1Business Description and Basis of Presentation

 

Business

 

Anavex Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX 2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other CNS diseases, including rare diseases, such as Rett syndrome.

 

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, 2016. The Company follows the same accounting policies in the preparation of interim reports.

 

Operating results for the six months ended March 31, 2017 are not necessarily indicative of the results that may be expected for the year ending September 30, 2017.

 

Cash and cash equivalents

 

The Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months from the date of purchase to be cash equivalents.

 

Research and Development Incentive Income

 

The Company participates, through its subsidiary in Australia, in the Australian government’s research and development incentive program. The research and development incentive program provides a refundable tax offset to eligible companies that engage in research and development activities in Australia. The Company recognizes as other income the amount received for qualified expenses, in the period they are received.

 

 F-6 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 1Business Description and Basis of Presentation – cont’d

 

Basic and Diluted Loss per Share

 

Basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the weighted average number of all potentially dilutive securities convertible into shares of common stock that were outstanding during the period.

 

As of March 31, 2017, loss per share excludes 6,053,309 (September 30, 2016 – 6,008,309) potentially dilutive common shares related to outstanding options and warrants, as their effect was anti-dilutive.

 

Note 2Recent Accounting Pronouncements

 

Recent Accounting Pronouncements Adopted During the Period

 

In June 2014, the FASB issued ASU No. 2014-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period ("ASU 2014-12"). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 explicitly requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In April 2015, the Financial Accounting Standards Board (FASB), issued the Accounting Standards Update 2015-03, Interest - Imputation of Interest (Subtopic 835-30) - Simplifying the Presentation of Debt Issuance Costs, that requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. Upon adoption, an entity must apply the new guidance retrospectively to all prior periods presented in the financial statements. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

 F-7 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 2Recent Accounting Pronouncements – (cont’d)

 

Recent Accounting Pronouncements Not Yet Adopted

 

In May, 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard will supersede nearly all existing revenue recognition guidance. ASU 2014-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact for any period presented.

 

In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-17 “Income Taxes: Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”). ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and non-current on the balance sheet and requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. ASU 2015-17 is effective for public entities in fiscal years beginning after December 15, 2016, and for interim periods within those fiscal years. The amendments for ASU-2015-17 can be applied retrospectively or prospectively and early adoption is permitted. The adoption of this standard is not expected to have a material impact for any period presented.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). The guidance would require lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right –of use assets. The guidance is effective for annual and interim reporting periods beginning on or after December 15, 2018. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

 

In March 2016, the FASB issued ASC 2016-09, “Compensation – Stock Compensation (Topic 718) – Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). These amendments are intended to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2016. Early adoption is permitted. Entities have the option to apply the amendments on either a prospective basis or a modified retrospective basis. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

 

 F-8 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 2Recent Accounting Pronouncements – (cont’d)

 

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments ("ASU 2016-15"). ASU 2016-15 reduces the existing diversity in practice in financial reporting across all industries by clarifying certain existing principles in ASC 230, Statement of Cash Flows, ("ASC 230") including providing additional guidance on how and what an entity should consider in determining the classification of certain cash flows. In addition, in November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ("ASU 2016-18"). ASU 2016-18 clarifies certain existing principles in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2017. Early adoption is permitted. The adoption of ASU 2016-15 and ASU 2016-18 will modify the Company's current disclosures and reclassifications within the consolidated statement of cash flows but they are not expected to have a material effect on the Company’s consolidated financial statements.

 

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

 

Note 3Other Income

 

Deferred Grant Income

 

On June 19, 2015, the Company was awarded grant funding in the amount of $286,455. The grant has been received in exchange for a commitment to provide research and development for preclinical validation of Sigma-1 receptor agonism as potential treatment for Parkinson’s disease.

 

The grant income has been deferred and is being amortized to other income over the related commitment period as the related research and development expenditures are incurred. During the three and six months ended March 31, 2017, the Company recognized $16,684 and $51,970, respectively (2016: $26,879 and $65,934) of this grant on its statement of operations within grant income.

 

Research and development tax incentive

 

During the three and six months ended March 31, 2017, the Company received other income of $2,022,902 and $2,022,902, respectively (2016: $Nil and $571,093, respectively) in respect of a research and development incentive program offered by the Australian government.

 

 F-9 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 4Lincoln Park Purchase Agreement

 

On October 21, 2015, the Company entered into a $50,000,000 purchase agreement (the “2015 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $50,000,000 in value of its shares of common stock from time to time over a 36-month period. In connection with the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park whereby the Company agreed to file registration statements with the Securities and Exchange Commission covering the shares of the Company’s common stock that may be issued to Lincoln Park under the Purchase Agreement.

 

The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 50,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares at the time of sales as described in the 2015 Purchase Agreement.

 

In consideration for entering into the 2015 Purchase Agreement, the Company issued to Lincoln Park 179,598 shares of common stock as a commitment fee and agreed to issue up to 89,799 shares pro rata, when and if, Lincoln Park purchases at the Company’s discretion the $50,000,000 aggregate commitment.

 

During the six months ended March 31, 2017, the Company issued to Lincoln Park an aggregate of 5,155,200 shares of common stock under the Purchase Agreement, including 5,122,841 shares of common stock for an aggregate purchase price of $18,016,121 and 32,359 commitment shares. At March 31, 2017, an amount of $30,626,078 remained available under the 2015 Purchase Agreement.

 

Note 5Related Party Transactions

 

As at March 31, 2017, included in accounts payable and accrued liabilities was $32,042 (September 30, 2016: $59,264) 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.

 

Note 6Commitments

 

a)Lease Commitment

 

The Company is committed to lease payments as follows:

 

Fiscal year ending September 30,    
2017  $56,094 
2018   112,189 
2019   56,094 
   $224,377 

 

 F-10 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 6Commitments – (cont’d)

 

b)Litigation

 

The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company's consolidated financial statements. The Company does not believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements.

 

c)Share Purchase Warrants

 

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

 

   Number of Shares   Weighted
Average
Exercise Price
 
Balance, October 1, 2015   4,272,890   $2.11 
Exercised   (2,463,581)  $1.67 
Balance, September 30, 2016   1,809,309   $2.70 
Exercised   (200,000)  $3.00 
Balance, March 31, 2017   1,609,309   $2.66 

 

At March 31, 2017, the Company had share purchase warrants outstanding of 1,609,309, with a weighted average exercise price of $2.66 as follows:

 

Number   Exercise Price   Expiry Date
 1,262,180   $3.00   July 5, 2018
 30,000   $4.00   February 24, 2019
 277,127   $1.20   March 13, 2019
 1,252   $1.68   March 13, 2019
 31,250   $1.24   May 31, 2019
 7,500   $1.04   May 31, 2019
 1,609,309         

 

All of the warrants expiring on July 5, 2018 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 $6.00 for a period of twenty consecutive trading days, subject to certain minimum volume restrictions and other restrictions as provided in the warrant agreements.

 

 F-11 

 

  

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 6Commitments – (cont’d)

 

c)Share Purchase Warrants – (cont’d)

 

During the six months ended March 31, 2017, 200,000 share purchase warrants were cashless exercised, resulting in the issuance of 52,562 shares of common stock.

 

d)Stock–based Compensation Plan

 

2015 Stock Option Plan

 

On September 18, 2015, the Company’s board of directors approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provides for the grant of stock options and restricted stock awards to directors, officers, employees and consultants of the Company.

 

The maximum number of our common shares reserved for issue under the plan is 6,050,553 shares subject to adjustment in the event of a change of the Company’s capitalization. As a result of the adoption of the 2015 Plan, no further option awards will be granted under any previously existing stock option plan. Stock option awards previously granted under previously existing stock option plans remain outstanding in accordance with their terms.

 

The 2015 Plan is administered by the board of directors, except that it may, in its discretion, delegate such responsibility to a committee of such board. The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock options may be granted under the 2015 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2015 Plan.

 

A summary of the status of Company’s outstanding stock purchase options is presented below:

 

   Number of Shares   Weighted Average
Exercise Price
   Weighted
Average Grant
Date fair value
 
Outstanding at October 1, 2015   1,822,500   $2.00      
Granted   2,401,500   $5.22   $4.38 
Expired   (25,000)  $14.68      
Outstanding at September 30, 2016   4,199,000   $3.76      
Granted   245,000   $4.30   $3.70 
Outstanding at March 31, 2017   4,444,000   $3.80      
Exercisable at March 31, 2017   2,608,133   $2.86      
Exercisable at September 30, 2016   2,290,716   $2.41      

 

 F-12 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 6Commitments – (cont’d)

 

d)Stock-based Compensation Plan – (cont’d)

 

At March 31, 2017, the following stock options were outstanding:

 

Number of Shares          Aggregate   Remaining 
    Number   Exercise      Intrinsic   Contractual 
Total   Vested   Price   Expiry Date  Value   Life (yrs) 
 500,000    500,000   $1.60   July 5, 2023  $2,070,000    6.26 
 75,000    50,000   $1.20   May 7, 2024   340,500    7.10 
 125,000    62,500   $1.32   May 8, 2024   552,500    7.10 
 718,750    479,170   $0.92   April 2, 2025   3,464,375    8.01 
 50,000    29,167   $1.44   June 8, 2025   215,000    8.19 
 50,000    16,667   $1.76   June 15, 2025   199,000    8.21 
 278,750    162,604   $5.04   September 18, 2025   195,125    8.47 
 1,500    1,500   $5.64   September 30, 2025   150    8.50 
 31,250    15,625   $5.68   October 2, 2025   1,875    8.51 
 25,000    12,500   $8.98   October 16, 2025   -    8.54 
 1,500    1,500   $5.57   December 31, 2025   255    8.75 
 1,500    1,500   $4.90   March 31, 2026   1,260    9.00 
 1,500    1,500   $5.66   April 27, 2026   120    9.07 
 50,000    19,697   $4.09   May 18, 2026   82,500    9.13 
 1,500    1,500   $6.11   June 30, 2026   -    9.25 
 379,625    63,271   $6.26   July 5, 2026   -    9.26 
 861,429    143,572   $7.06   July 18, 2026   -    9.30 
 40,000    10,000   $3.06   September 7, 2026   107,200    9.44 
 1,006,696    1,006,696   $3.28   September 22, 2026   2,476,472    9.48 
 140,000    23,331   $3.63   October 3, 2026   295,400    9.51 
 15,000    2,500   $4.35   December 9, 2026   20,850    9.69 
 50,000    -   $5.39   February 7, 2027   17,500    9.86 
 40,000    3,333   $5.26   February 17, 2027   19,200    9.88 
 4,444,000    2,608,133           $10,059,282      

 

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 March 31, 2017.

 

 F-13 

 

 

Anavex Life Sciences Corp.

Notes to the Interim Condensed Consolidated Financial Statements

March 31, 2017

(Unaudited)

 

Note 6Commitments – (cont’d)

 

d)Stock–based Compensation Plan – (cont’d)

 

The Company recognized stock based compensation expense of $968,893 and $1,858,160, respectively, during the three and six months ended March 31, 2017 (2016: $222,690 and $438,710, respectively) in connection with the issuance and vesting of stock options in exchange for services, and $0 and $0 respectively (2016: $0 and $610,000, respectively), in connection with the vesting of restricted stock in exchange for services. These amounts have been included in general and administrative expenses and research and development expenses on the Company’s statement of operations as follows:

 

   Three months ended March 31,   Six months ended March 31, 
   2017   2016   2017   2016 
General and administrative  $450,128   $143,672   $877,711   $574,235 
Research and development   518,765    79,019    980,449    474,476 
Total share based compensation  $968,893   $222,690   $1,858,160   $1,048,710 

 

An amount of approximately $6,898,526 in stock based compensation is expected to be recorded over the remaining term of such options through December 31, 2019.

 

The fair value of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions:

 

   2017   2016 
Risk-free interest rate   1.76%   1.68%
Expected life of options (years)   6.79    6.76 
Annualized volatility   111.81%   101.92%
Dividend rate   0.00%   0.00%

 

The fair value of restricted stock compensation charges during the six months ended March 31, 2016 was determined with reference to the quoted market price of the Company’s shares on the commitment date.

 

Note 7Comparative Figures

 

Certain comparative figures have been reclassified to conform to the current year’s presentation.

 

 F-14 

 

 

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, (“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 “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. 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, we assume no obligation to update or supplement forward-looking statements.

 

As used in this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” and “Anavex” mean Anavex Life Sciences Corp., unless the context clearly requires otherwise.

 

Our Current Business

 

Anavex Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEXTM 2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.

 

In November 2016, a Phase 2a clinical trial going over 52 weeks was completed for ANAVEXTM 2-73 in mild-to-moderate Alzheimer’s patients. This open-label randomized trial met both primary and secondary endpoints, and was designed to assess the safety and exploratory efficacy of ANAVEXTM 2-73 in 32 patients. ANAVEXTM 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological hallmarks observed in Alzheimer’s disease. ANAVEXTM 2-73 showed no serious adverse events in a previously performed Phase 1 study. In preclinical studies, ANAVEXTM 2-73 demonstrated anti-amnesic and neuroprotective properties in various animal models including the transgenic mouse model Tg2576. In March 2016, we received approval from the Ethics Committee in Australia to extend the ongoing Phase 2a clinical trial, which had been requested by patients and their caregivers. The trial extension allows participants who completed 52 weeks in PART B to rollover into a new trial and continue taking ANAVEXTM 2-73 for an additional 104 weeks, providing an opportunity to gather extended safety data. The trial is independent of the Company’s planned larger Phase 2/3 double-blind, placebo-controlled study of ANAVEXTM 2-73 in Alzheimer’s disease.

 

 3 

 

 

In September 2016, the Company presented positive preclinical data for ANAVEXTM 2-73 in Parkinson’s disease, which demonstrated significant improvements on all measures: behavioral, histopathological, and neuroinflammatory endpoints. The study was funded by the Michael J Fox Foundation.

 

In February 2016, the Company presented positive preclinical data for ANAVEXTM 2-73 in Rett syndrome, a rare neurodevelopmental disease indication. The study was funded by the Rettsyndrome.org foundation. In January, 2017, the Company was awarded a financial grant from the Rettsyndrome.org foundation of a minimum of $0.6 million to cover the majority of a planned U.S. multicenter Phase 2 clinical trial of ANAVEXTM 2-73 for the treatment of Rett syndrome. The Phase 2 trial is scheduled to begin in calendar 2017 and will be a randomized, double blind, placebo-controlled study of ANAVEXTM 2-73 in patients with Rett syndrome lasting up to 12 weeks. Primary and secondary endpoints include safety as well as Rett syndrome conditions such as cognitive impairment, motor impairment, behavioral symptoms and seizure activity.

 

We intend to identify and initiate discussions with potential commercial partners within 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

 

Our research and development pipeline includes one clinical 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:

 

ANAVEXTM 2-73

 

ANAVEXTM 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, ANAVEXTM 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, ANAVEXTM 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576, ANAVEXTM 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 significantly 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 ANAVEXTM 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 parameters. ANAVEXTM 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 CNS conditions, including AD.

 

 4 

 

 

The ANAVEXTM 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 and the Technical University of Dresden.

 

In December 2014, a Phase 2a clinical trial was initiated for ANAVEX 2-73TM, which is being evaluated for the treatment of Alzheimer’s disease. The open-label randomized trial is designed to assess the safety and exploratory efficacy of ANAVEXTM 2-73 in 32 patients with mild to moderate Alzheimer’s disease. ANAVEXTM 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain believed to restore cellular homeostasis and to reverse the pathological hallmarks observed in Alzheimer’s disease. ANAVEXTM 2-73 showed no serious adverse events in a previously performed Phase 1 study. In pre-clinical studies ANAVEXTM 2-73 demonstrated anti-amnesic and neuroprotective properties in various animal models including the transgenic mouse model Tg2576.

 

The Phase 2a study met both primary and secondary objectives of the study. The 31-week preliminary exploratory safety and efficacy data from the ongoing Phase 2a study of ANAVEXTM 2-73 in Alzheimer’s patients, with most also receiving donepezil, the current standard of care, demonstrated favorable safety, maximum tolerated dose, positive dose response, sustained efficacy response through 31 weeks for both cognitive and functional measures, as well as positive unexpected therapeutic response events. ANAVEXTM 2-73 continues to demonstrate a favorable adverse event profile through 31 weeks in a patient population of elderly Alzheimer’s patients with varying degrees of physical fragility. The most common side effects across all adverse events categories tended to be of mild severity grade 1, and were resolved with dose reductions that were anticipated within the adaptive design of the study protocol.

 

At 41 weeks, Alzheimer’s patients taking a daily oral dose of ANAVEXTM 2-73 in the exploratory, not yet dose optimized Phase 2a clinical trial, showed a stabilization of cognitive and functional measures. This data of stabilization is promising since Alzheimer’s disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and do not stop the disease from progressing. At 41 weeks, oral daily dosing between 10mg and 50mg, ANAVEXTM 2-73 was well tolerated, and no patients discontinued treatment due to adverse events. There were no clinically significant treatment-related adverse events, and no serious adverse events.

 

Pre-specified exploratory analyses included the cognitive (MMSE) and the functional (ADCS-ADL) changes from baseline. A continued stabilization of both cognitive (MMSE) and functional (ADCS-ADL) measures in patients treated with ANAVEXTM 2-73 was observed. This correlation was positive with all measured scores (MMSE, ADCS-ADL, Cogstate, HAM-D and EEG/ERP).

 

ANAVEXTM 2-73 data presented meets prerequisite information in order to progress into Phase 2/3 placebo controlled studies, which are currently in the planning phase.

 

Recent preclinical data validates ANAVEXTM 2-73 as a prospective platform drug for other neurodegenerative diseases beyond Alzheimer’s as well as neurodevelopmental diseases, more specifically, Parkinson’s disease, epilepsy and Rett syndrome. For Parkinson’s disease, data demonstrates significant improvements and restoration of function in a classic animal model of Parkinson’s disease. Significant improvements were seen on all measures tested: behavioral, histopathological, and neuroinflammatory endpoints. For epilepsy, data demonstrates both significant and dose related improvement in the reduction of seizures, as well as significant synergy with each of three generations of epilepsy drugs currently on the market. In Rett syndrome, a rare neurodevelopmental disease indication, administration of ANAVEXTM 2-73 resulted in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease model.

 

Recent preclinical data presented also indicates that ANAVEXTM 2-73 demonstrates protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases. The FDA has granted Orphan Drug Designation to ANAVEX 2-73 for the treatment of Rett syndrome and infantile spasms, in May 2016 and June 2016, respectively.

 

 5 

 

 

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 been 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.

 

A recent preclinical study examined the response of ANAVEX 3-71 in aged transgenic animal models, and showed a significant reduction in rate of cognitive deficit, amyloid beta pathology and inflammation with the administration of ANAVEX 3-71. In April 2016, the FDA granted Orphan Drug Designation to ANAVEX 3-71 for the treatment of Frontotemporal dementia.

 

In April, 2017, new preclinical data was presented for ANAVEX 3-71 indicating that during pathological conditions, ANAVEX 3-71 demonstrated the formation of new synapses between neurons (synaptogenesis) without causing an abnormal increase in the number of astrocytes. In neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease, synaptogenesis is believed to be impaired. Additional preclinical data presented also indicates that in addition to reducing oxidative stress, ANAVEX 3-71 demonstrates protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.

 

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.

 

Recent preclinical data presented also indicates that ANAVEX 1-41 demonstrates protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions, which, if impaired, are believed to play a role in the pathogenesis of neurodegenerative and neurodevelopmental diseases.

 

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.

 

 6 

 

 

ANAVEX 1066

 

ANAVEX 1066, a mixed sigma-1/sigma-2 ligand is designed for the potential treatment of neuropathic pain and visceral pain. ANAVEX 1066 was tested in two preclinical models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury model of neuropathic pain, a single oral administration of ANAVEX 1066 dose dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and a single oral administration of ANAVEX 1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX 1066 and a favorable safety profile in a battery of behavioral measures.

 

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 2016, an estimated 5.4 million Americans were suffering from Alzheimer’s disease. The Alzheimer’s Association® reports that by 2025, 7.1 million Americans will be afflicted by the disease, a 30 percent increase from currently affected patients. Medications on the market today treat only the symptoms of Alzheimer’s disease 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.

 

·Parkinson’s disease – Parkinson’s disease is a progressive disease of the nervous system marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. Parkinson’s disease afflicts more than 10 million people worldwide, typically middle-aged and elderly people. The Parkinson’s disease market is set to expand from $2.1 billion in 2014 to $3.2 billion by 2021, according to business intelligence provider GBI Research.

 

·Rett syndrome - Rett syndrome is a rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately 1 in every 10,000-15,000 live female births.

 

·Depression - Depression is a major cause of morbidity worldwide according to the World Health Organization. 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.

 

·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 generation anti-epileptic drugs. GBI Research estimates that the epilepsy market will increase to $4.5 billion by 2019.

 

 7 

 

 

·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.

 

·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 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 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. Sales predictions by GBI Research forecast that the market for the pharmaceutical treatment of pancreatic cancer in the United States and five largest European countries will increase to $2.9 billion by 2021.

 

Financial Highlights

 

We had cash of $23.4 million at March 31, 2017, compared to $9.2 million at September 30, 2016. The increase in cash is primarily a result of the sale of shares of common stock for aggregate proceeds of $18.0 million under a Purchase Agreement by and between the Company and Lincoln Park Capital Fund, LLC (“Lincoln Park”) dated October 21, 2015 (the “2015 Purchase Agreement”) pursuant to which Lincoln Park committed to purchase up to $50.0 million of our common stock from time to time through September 6, 2019. During the fiscal quarter ended March 31, 2017, we also received $2.0 million in other income from the Australian Tax Office, as part of a government sponsored research and development incentive program.

 

Operating expenses for the quarter ended March 31, 2017 were $3.6 million, compared to $2.2 million for the comparable quarter in fiscal 2016. The principal reason for the increase in operating costs was due to an increase in research and development costs in the current quarter, as a result of increased preclinical activities, as well as clinical preparatory activities and the ongoing Phase 2a clinical trial extension.

 

We expect our research and development expenses will continue to increase as we proceed into a Phase 2/3 clinical study for Alzheimer’s disease, and continue to advance other auxiliary research and development activities. We continue to target potential research partners to further advance our pipeline compounds.

 

Net loss for the quarter ended March 31, 2017 was $1.5 million, or $0.04 per share, as compared to $2.0 million, or $0.06 per share in the comparable quarter in fiscal 2016.

 

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.

 

 8 

 

 

Three months ended March 31, 2017 compared to three months ended March 31, 2016

 

Operating Expenses

 

Our operating expenses for the three months ended March 31, 2017 were $3.6 million, which represents an increase of $1.4 million from the comparable quarter in fiscal 2016. The increase in operating costs was primarily attributable to an increase in research and development expenses of $1.4 million, primarily as a result of an increase in preclinical programs on ANAVEX 2-73 for additional indications, as well as clinical preparatory activities and an increased research and development team.

 

Other income (expenses)

 

The net amount of other income for the quarter ended March 31, 2017 was $2.1 million as compared to $0.1 million for the comparable quarter ended March 31, 2016. The largest reason for the increase in other income was the receipt of $2.0 million in other income in the quarter ended March 31, 2017 as part of a research and development incentive program offered by the Australian Tax Office, which was granted in connection with eligible expenditures from our clinical trials in Australia.

 

Six months ended March 31, 2017 compared to six months ended March 31, 2016

 

Operating Expenses

 

Our operating expenses for the six months ended March 31, 2017 were $6.8 million, which represents an increase of $0.1 million from the comparable quarter in fiscal 2016. The increase in operating costs was primarily attributable to an increase in research and development expenses of $1.8 million attributable to expanded preclinical programs, clinical preparatory activities and an expanded research and development team. The increase in research and development expenses was substantially offset by a decrease in general and administrative expenses related to one-time charges incurred in the comparable period and increased legal fees in the comparable period as a result of financing and related activities in that period.

 

Other income (expenses)

 

The net amount of other income for the six months ended March 31, 2017 was $2.1 million as compared to $0.7 million for the six months ended March 31, 2016. The largest reason for the increase in other income was the receipt of $2.0 million in other income in the six-month period ended March 31, 2017 as part of a research and development incentive program offered by the Australian Tax Office, which was granted in connection with eligible expenditures from our clinical trials in Australia.

 

Liquidity and Capital Resources

 

Working Capital

 

   March 31, 2017   September 30, 2016 
Current Assets  $23,554,192   $9,446,285 
Current Liabilities   2,119,897    3,190,525 
Working Capital  $21,434,295   $6,255,760 

 

At March 31, 2017, we had $23.4 million in cash, an increase of $14.2 million from September 30, 2016. The principal reason for this increase is the $18.0 million in cash received from the issuance of shares of common stock under the 2015 Purchase Agreement. During the quarter ended March 31, 2017, we also received approximately $2.0 million in other income as part of a research and development incentive program offered by the Australian Tax Office. We intend to use the majority of our capital resources to complete the next clinical trial for ANAVEXTM 2-73, and to perform work necessary to prepare for further clinical development.

 

 9 

 

 

Cash Flows

 

   Six months ended March 31, 
   2017   2016 
Cash flows used in operating activities  $(3,851,368)  $(5,149,749)
Cash flows used in investing activities   -    - 
Cash flows from financing activities   18,016,121    1,809,620 
Increase (decrease) in cash during the period  $14,164,753   $(3,340,129)

 

Cash flow used in operating activities

 

Cash used in operating activities for the period ended March 31, 2017 was $3.9 million, compared to $5.2 million during the quarter ended March 31, 2016. The principal reason for this decrease in cash used from operating activities in the current period is the receipt of $2.0 million in research and development incentive income during the quarter ended March 31, 2017, compared to $0.6 million in the comparable period.

 

Cash flow provided by financing activities

 

Cash provided by financing activities for the period ended March 31, 2017 was $18.0 million, attributable to cash received from the issuance of 5,155,200 common shares at various market prices under the 2015 Purchase Agreement.

 

In the comparable period ended March 31, 2016, cash provided by financing activities amounted to $1.8 million, mostly attributable to cash received pursuant to the exercise of outstanding share purchase warrants and cash received from the issuance of shares of common stock at various market prices under a purchase agreement by and between the Company and Lincoln Park, dated July 5, 2013, pursuant to which the Company sold and issued to Lincoln Park, and Lincoln Park purchased $10.0 million in value of our shares of common stock from time to time over a 25-month period.

 

Other Financing

 

On October 21, 2015, we entered into the Purchase Agreement) with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $50.0 million of our common stock. Concurrently with the execution of the 2015 Purchase Agreement, we issued 179,598 shares of our common stock to Lincoln Park as a fee for its commitment to purchase shares of our common stock under the 2015 Purchase Agreement. The shares that may be sold pursuant to the 2015 Purchase Agreement may be sold by us to Lincoln Park at our discretion from time to time over a 36-month period ending September 6, 2019, the date the Securities and Exchange Commission (the “SEC”) declared effective the related registration statement. As of March 31, 2017, an amount of $30.6 million remained available under the 2015 Purchase Agreement.

 

We may direct Lincoln Park, at our sole discretion, and subject to certain conditions, to purchase up to 50,000 shares of our common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2.0 million. The purchase price of shares of common stock related to the financing are based on the then prevailing market prices of such shares at the time of sales, as described in the 2015 Purchase Agreement.

 

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 the next 12 months using existing cash on hand and through other equity 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.

 

 10 

 

 

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.

 

Contractual Obligations

 

The following table summarizes our contractual obligations as of March 31, 2017, excluding amounts related to uncertain tax positions, funding commitments, contingent development, and regulatory and commercial milestone payments:

 

Contractual Obligations  Payments Due by Period 
   Total   Less
than 1
year
   1-3 years   4 - 5
years
   After 5
years
 
Long-Term Debt   -    -    -    -    - 
Capital Lease Obligations   -    -    -    -    - 
Operating Leases  $224,377   $56,094   $168,283    -    - 
Unconditional Purchase Obligations   -    -    -    -    - 
Other Long-Term Obligations   -    -    -    -    - 
Total Contractual Cash Obligations  $224,377   $56,094   $168,283    -    - 

 

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 and derivative liabilities.

 

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.

 

 11 

 

 

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 ASU No. 2014-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period ("ASU 2014-12"). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on our financial condition, results of operations and cash flows.

 

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 explicitly requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on our financial condition, results of operations and cash flows.

 

In April 2015, the Financial Accounting Standards Board (FASB), issued the Accounting Standards Update 2015-03, Interest - Imputation of Interest (Subtopic 835-30) - Simplifying the Presentation of Debt Issuance Costs, that requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. Upon adoption, an entity must apply the new guidance retrospectively to all prior periods presented in the financial statements. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on our financial condition, results of operations and cash flows.

 

In May, 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard will supersede nearly all existing revenue recognition guidance. ASU 2014-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact for any period presented.

 

 12 

 

 

In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-17 “Income Taxes: Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”). ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and non-current on the balance sheet and requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. ASU 2015-17 is effective for public entities in fiscal years beginning after December 15, 2016, and for interim periods within those fiscal years. The amendments for ASU-2015-17 can be applied retrospectively or prospectively and early adoption is permitted. The adoption of this standard is not expected to have a material impact for any period presented.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). The guidance would require lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right –of use assets. The guidance is effective for annual and interim reporting periods beginning on or after December 15, 2018. We are currently evaluating the impact this guidance will have on our financial condition, results of operations and cash flows.

 

In March 2016, the FASB issued ASC 2016-09, “Compensation – Stock Compensation (Topic 718) – Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). These amendments are intended to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2016. Early adoption is permitted. Entities have the option to apply the amendments on either a prospective basis or a modified retrospective basis. We are currently evaluating the impact this guidance will have on our financial condition, results of operations and cash flows.

 

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments ("ASU 2016-15"). ASU 2016-15 reduces the existing diversity in practice in financial reporting across all industries by clarifying certain existing principles in ASC 230, Statement of Cash Flows, ("ASC 230") including providing additional guidance on how and what an entity should consider in determining the classification of certain cash flows. In addition, in November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ("ASU 2016-18"). ASU 2016-18 clarifies certain existing principles in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2017. Early adoption is permitted. The adoption of ASU 2016-15 and ASU 2016-18 will modify the Company's current disclosures and reclassifications within the consolidated statement of cash flows but is not expected to have a material effect on the our consolidated financial statements.

 

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.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risks.

 

We are exposed to a variety of market risks, including interest rate risk, foreign currency exchange risk and equity price risk.

 

Interest Rate Risk

 

We invest a major portion of our cash surplus in bank deposits in the United States and, to a lesser extent, Australia. Since the bank deposits typically carry fixed interest rates, financial income over the holding period is not sensitive to changes in interest rates, but only the fair value of these instruments. However, our interest gains from future deposits could decline in the future as a result of changes in the financial markets. In any event, given the historic low levels of interest rates, we estimate that a decline in the interest rates we are currently receiving will not result in a material adverse effect to our business.

 

 13 

 

 

Foreign Currency Exchange Risk

 

A significant portion of our expenditures, including clinical research expenses relate to our operations in Australia and a portion of our consultancy expenses are incurred in Euros. The cost of those expenses, as expressed in US dollars, is influenced by the exchange rate of these currencies against the US Dollar. If the US dollar declines in value in relation to these currencies, it will become more expensive for us to fund our operations. To limit this risk, the Company holds minimal cash reserves in Australian Dollars and Euros.

 

Item 4. Controls and Procedures.

 

Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that material information required to be disclosed in our periodic reports filed under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to provide reasonable assurance that such information is accumulated and communicated to our management, our chief executive officer and our principal financial officer, to allow timely decisions regarding required disclosure.

 

We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rule 13(a)15(e) under the Exchange Act. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective, as of March 31, 2017.

 

Changes in Internal Control over Financial Reporting

 

During the quarter ended March 31, 2017, there were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a15(d) or 15d15(d) of the Exchange Act during the period covered by this Form 10-Q that 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 pending legal proceedings, other than ordinary routine litigation incidental to our business, to which our company or our subsidiary is a party or of which any of their property is subject. There are no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial stockholder holding more than 5% of our shares, is an adverse party or has a material interest adverse to our or our subsidiary’s interest.

 

Item 1A. Risk Factors.

 

In addition to the other information set forth in this Form 10-Q, you should carefully consider the factors discussed in “Item 1A – Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended September 30, 2016 filed with the SEC on December 14, 2016. These risks could materially and adversely affect our business, financial condition and results of operations. The risks described in our Form 10-K have not changed materially; however, they are not the only risks we face. Our operations could also be affected by additional factors that are not presently known to us or by factors that we currently consider immaterial to our business.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

During the period covered by this Quarterly Report on Form 10-Q, we have not sold any equity securities that were not registered under the Securities Act of 1933 that were not previously reported in a Current Report on Form 8-K.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

 14 

 

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information.

 

None.

 

 15 

 

 

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)
3.4   Certificate of Amendment to the Articles of Incorporation (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on March 30, 2015)
3.5   Certificate of Change to the Articles of Incorporation (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on October 6, 2015)
(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)
(31)   Rule 13a-14(a)/15(d)-14(a)Certifications
31.1*   Certification of Christopher Missling, PhD.
31.2*   Certification of Sandra Boenisch
(32)   Section 1350 Certifications
32.1*   Certification of Christopher Missling, PhD and Sandra Boenisch.
99.1*   Corporate Investment Policy Adopted May 4, 2017
(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.

 

 16 

 

 

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  
(Principal Executive Officer)  
Date: May 10, 2017  
   
/s/Sandra Boenisch  
   
Sandra Boenisch, CPA, CGA  
Principal Financial Officer  
(Principal Financial and Accounting Officer)  
Date: May 10, 2017  

 

 17 

 

EX-31.1 2 s106085_ex31-1.htm EXHIBIT 31.1

 

Exhibit 31.1

 

CERTIFICATION

 

I, Christopher Missling, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q for the three months ended March 31, 2017 of Anavex Life Sciences Corp. (the “registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:

 

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 10, 2017

 

/s/Christopher Missling, PhD  
Christopher Missling, PhD  
Chief Executive Officer, President and Secretary  
(Principal Executive Officer)  

 

 

 

EX-31.2 3 s106085_ex31-2.htm EXHIBIT 31.2

 

Exhibit 31.2

 

CERTIFICATION

 

I, Sandra Boenisch, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q for the three months ended March 31, 2017 of Anavex Life Sciences Corp. (the “registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have:

 

(a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 10, 2017

 

/s/Sandra Boenisch  
Sandra Boenisch, CPA, CGA  
Principal Financial Officer, Treasurer  
(Principal Financial and Accounting Officer)  

 

 

 

EX-32.1 4 s106085_ex32-1.htm EXHIBIT 32.1

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of Anavex Life Sciences Corp. (the “Company”) on Form 10-Q for the three months ended March 31, 2017 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacities and on the date indicated below, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of our knowledge:

 

(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: May 10, 2017 /s/Christopher Missling, PhD
  Christopher Missling, PhD
   Chief Executive Officer, President, Secretary
  (Principal Executive Officer)
   
  /s/Sandra Boenisch
  Sandra Boenisch, CPA, CGA
  Principal Financial Officer, Treasurer
  (Principal Financial and Accounting Officer)

 

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

 

EX-99.1 5 s106085_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

ANAVEX LIFE SCIENCES CORP.

Investment Policy & Guidelines

 

Purpose:

The purpose of this policy is to set forth the guidelines for managing the available cash of Anavex Life Sciences Corp. by its designated money managers. The funds are to be invested to assure preservation of capital, liquidity, and security of corporate funds while providing a reasonable return of investment.

 

Objectives:

Investments must be selected to achieve the following objectives in priority order:

·Preservation and safety of principal
·Liquidity of operating needs
·Maximization of returns subject to those investment guidelines

 

Responsibilities and Administration:

It is the responsibility of the Audit Committee of the Board of Directors to approve this investment policy. It is the responsibility of the Chief Executive Officer and the Principal Financial Officer to implement the investment policy and designate those who can act on behalf of the Company. The Audit Committee will review the investment policy at least annually and recommend changes as necessary.

 

Investment Guidelines:

Final maturity

No single security will have a final maturity in excess of 24 months. Average life of the portfolio shall not exceed 12 months.

 

U.S. Currency

All investments will be held in U.S. dollars, or another currency which is regularly utilized by the Company in funding its operations, such as the Australian Dollar.

 

Authorized investments

Investments in the portfolio will be limited to:

·Obligations issued by the U.S Treasury
·Obligations issued by U.S. Federal Agencies
·Domestic Money Market Certificates
·Certificates of Deposit
·Bankers Acceptances
·Taxable and tax-exempt municipal notes, bonds and commercial paper
·Commercial/Financial Company Paper
·Asset Backed Letter of Credit
·Money Market Funds
·Corporate Bonds or Notes

 

 

 

 

Credit Quality

All holdings listed in the authorized securities list will have a rating of A1/P1 for short-term investments and AA2/AA for long-term investments. Non-U.S. Government holdings will be subject to the following limitations:

·Commercial paper of corporations which are rated A-1 by Standard & Poor’s Corporation or P-1 by Moody’s Investor Services at the time of investment.
·Repurchase Agreements must have underlying collateral of treasury and agencies of the U.S. Government with a rating quality of AAA@102%.
·Municipal and taxable obligations must have a credit rating of at least AA by at least one recognized credit agency.

 

Diversification

Adequate diversification is required to spread risk amongst various issuers. No more than ten percent (10%) of the portfolio’s asset may be invested in a single issuer, with the exception of money market funds and U.S. government agency securities.

 

Prohibited Securities

The following investments will not be used:

·Direct mortgages or real investment trusts
·Commodities
·Short sales and margin purchases
·Oil, gas, mineral and other types of leases
·Unregistered or other restricted stock
·Common or preferred stock
·Speculative use of futures and options
·Derivative securities
·Auction-rate securities

 

Liquidity

All portfolio investments must be readily marketable under normal trading conditions in each relevant capital market. Assets must be available upon demand. The liquidation value of assets at the time of sales should be reasonable given the period of notice given by the Company and prevailing market conditions. Normal trading conditions are those that prevail in the absence of extraordinary and unanticipated events (e.g. declaration of war, collapse of financial markets, or events of a like nature) which result in the unexpected deterioration of the liquidity of the portfolio holdings.

 

Approved as of May 4, 2017

By the Board of Directors of Anavex Life Sciences Corp.

 

 

 

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Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. Security that gives the holder the right to purchase shares of stock in accordance with the terms of the instrument, usually upon payment of a specified amount. 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Although there are variations, normally, after vesting, when an option is exercised, the employee-holder pays the strike value in cash to the issuing employer-entity and receives equity shares. The equity shares can be sold into the market for cash at the current market price without restriction. Options may be used to attract, retain and incentivize employees, in addition to their regular salary and other benefits. An arrangement whereby an employee is entitled to receive in the future, subject to vesting and other restrictions, a number of shares in the entity at a specified price, as defined in the agreement. Although there are variations, normally, after vesting, when an option is exercised, the employee-holder pays the strike value in cash to the issuing employer-entity and receives equity shares. The equity shares can be sold into the market for cash at the current market price without restriction. Options may be used to attract, retain and incentivize employees, in addition to their regular salary and other benefits. An arrangement whereby an employee is entitled to receive in the future, subject to vesting and other restrictions, a number of shares in the entity at a specified price, as defined in the agreement. Although there are variations, normally, after vesting, when an option is exercised, the employee-holder pays the strike value in cash to the issuing employer-entity and receives equity shares. The equity shares can be sold into the market for cash at the current market price without restriction. Options may be used to attract, retain and incentivize employees, in addition to their regular salary and other benefits. An arrangement whereby an employee is entitled to receive in the future, subject to vesting and other restrictions, a number of shares in the entity at a specified price, as defined in the agreement. Although there are variations, normally, after vesting, when an option is exercised, the employee-holder pays the strike value in cash to the issuing employer-entity and receives equity shares. The equity shares can be sold into the market for cash at the current market price without restriction. Options may be used to attract, retain and incentivize employees, in addition to their regular salary and other benefits. An arrangement whereby an employee is entitled to receive in the future, subject to vesting and other restrictions, a number of shares in the entity at a specified price, as defined in the agreement. Although there are variations, normally, after vesting, when an option is exercised, the employee-holder pays the strike value in cash to the issuing employer-entity and receives equity shares. The equity shares can be sold into the market for cash at the current market price without restriction. Options may be used to attract, retain and incentivize employees, in addition to their regular salary and other benefits. Refers to the weighted average exercise price. Information related to class of warrant or righst expiration date warrants or rights. Description of the entity's cancellation policy. It represents as a remaining stock based compensation. Information related to general sales tax recoverable. Information related to grants payable current. It refers to amount of research and development incentive income during the period. Amount of gain (loss) on settlement of accounts payable. Information pertaining to comparative figures. Tabular disclosure of the changes in other outstanding share-based compensation awards other than stock options or nonvested awards. Value of stock issued pursuant to commitment under terms of purchase agreement during the period. Number of stock issued pursuant to commitment under terms of purchase agreement during the period. It represents amount of shares issued upon exercise of cashless warrants. It represents number of shares issued upon exercise of cashless warrants. Represent information about the share based compensation in connection with the vesting of restricted stock in exchange for services. Assets, Current Assets Liabilities, Current Stockholders' Equity Attributable to Parent Liabilities and Equity Operating Expenses Debt Related Commitment Fees and Debt Issuance Costs Nonoperating Income (Expense) Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest Current Income Tax Expense (Benefit) Foreign Currency Transaction Gain (Loss), Unrealized Increase (Decrease) in Accounts Receivable Increase (Decrease) in Prepaid Expense Increase (Decrease) in Accounts Payable and Accrued Liabilities IncreaseDecreaseInGrantsPayables Net Cash Provided by (Used in) Operating Activities, Continuing Operations Payment of Financing and Stock Issuance Costs Net Cash Provided by (Used in) Financing Activities, Continuing Operations Cash, Period Increase (Decrease) ComparativeFiguresTextBlock New Accounting Pronouncements, Policy [Policy Text Block] Accounts Payable and Accrued Liabilities Operating Leases, Future Minimum Payments Receivable Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number ShareBasedCompensationArrangementByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsOutstandingWeightedAverageExercisePrice ShareBasedCompensationArrangementsByShareBasedPaymentAwardEquityInstrumentsOtherThanOptionsExercisedInPeriodWeightedAverageExercisePrice Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value EX-101.PRE 11 avxl-20170331_pre.xml XBRL PRESENTATION FILE XML 12 R1.htm IDEA: XBRL DOCUMENT v3.7.0.1
Document and Entity Information - shares
6 Months Ended
Mar. 31, 2017
May 10, 2017
Document And Entity Information    
Entity Registrant Name ANAVEX LIFE SCIENCES CORP.  
Entity Central Index Key 0001314052  
Document Type 10-Q  
Trading Symbol AVXL  
Document Period End Date Mar. 31, 2017  
Amendment Flag false  
Current Fiscal Year End Date --09-30  
Entity a Well-known Seasoned Issuer No  
Entity a Voluntary Filer No  
Entity's Reporting Status Current Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   41,376,061
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2017  
XML 13 R2.htm IDEA: XBRL DOCUMENT v3.7.0.1
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
Mar. 31, 2017
Sep. 30, 2016
Current    
Cash and cash equivalents $ 23,351,567 $ 9,186,814
Sales tax recoverable 60,636 79,347
Prepaid expenses 141,989 180,124
Current assets 23,554,192 9,446,285
Deposits 52,396 52,396
Total assets 23,606,588 9,498,681
Current    
Accounts payable and accrued liabilities 2,033,692 3,119,993
Deferred grant income 86,205 70,532
Current liabilities 2,119,897 3,190,525
Commitments - Note 6  
Capital stock Authorized: 100,000,000 common shares, par value $0.001 per share Issued and outstanding: 41,376,061 common shares (September 30, 2016 - 36,168,299) 41,377 36,169
Additional paid-in capital 104,159,213 84,290,140
Accumulated deficit (82,713,899) (78,018,153)
Stockholders' equity 21,486,691 6,308,156
Total liabilities and stockholder's equity $ 23,606,588 $ 9,498,681
XML 14 R3.htm IDEA: XBRL DOCUMENT v3.7.0.1
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2017
Sep. 30, 2016
Statement of Financial Position [Abstract]    
Common shares, authorized 100,000,000 100,000,000
Common shares, par value (in dollars per share) $ 0.001 $ 0.001
Common shares, issued 41,376,061 36,168,299
Common shares, outstanding 41,376,061 36,168,299
XML 15 R4.htm IDEA: XBRL DOCUMENT v3.7.0.1
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Mar. 31, 2017
Mar. 31, 2016
Operating expenses        
General and administrative $ 1,116,014 $ 1,089,641 $ 2,242,198 $ 3,982,746
Research and development 2,492,933 1,090,527 4,535,423 2,729,856
Total operating expenses (3,608,947) (2,180,168) (6,777,621) (6,712,602)
Other income (expenses)        
Grant income 16,684 26,879 51,970 65,934
Research and development incentive income 2,022,902 2,022,902 571,093
Interest income, net 18,147 2,064 21,802 4,206
Gain on settlement of accounts payable 151,402 151,402
Financing related charges and adjustments (72) (1,167)
Foreign exchange gain (loss) 11,722 (30,906) 25,804 (46,561)
Total other income, net 2,069,455 149,367 2,122,478 744,907
Net loss before provision for income taxes (1,539,492) (2,030,801) (4,655,143) (5,967,695)
Income tax expense - current (9,595) (40,603) (17,615)
Net loss and comprehensive loss $ (1,549,087) $ (2,030,801) $ (4,695,746) $ (5,985,310)
Loss per share        
Basic (in dollars per share) $ (0.04) $ (0.06) $ (0.12) $ (0.17)
Diluted (in dollars per share) $ (0.04) $ (0.06) $ (0.12) $ (0.17)
Weighted average number of shares outstanding        
Basic (in shares) 41,159,707 35,214,793 39,761,612 34,589,957
Diluted (in shares) 41,159,707 35,214,793 39,761,612 34,589,957
XML 16 R5.htm IDEA: XBRL DOCUMENT v3.7.0.1
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
6 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Cash Flows used in Operating Activities    
Net loss $ (4,695,746) $ (5,985,310)
Adjustments to reconcile net loss to net cash used in operations:    
Amortization and depreciation 497
Accretion of debt discount 1,167
Stock-based compensation 1,858,160 1,048,710
Gain on settlement of accounts payable (151,402)
Unrealized foreign exchange 2,907
Changes in non-cash working capital balances related to operations:    
Sales tax recoverable 18,711 (1,830)
Prepaid expenses and deposits 38,135 15,868
Accounts payable and accrued liabilities (1,086,301) (14,187)
Deferred grant income 15,673 (66,169)
Net cash used in operating activities (3,851,368) (5,149,749)
Cash Flows provided by Financing Activities    
Issuance of common shares, net of share issue costs 18,016,121 1,809,620
Net cash provided by financing activities 18,016,121 1,809,620
Increase (decrease) in cash during the period 14,164,753 (3,340,129)
Cash and cash equivalents, beginning of period 9,186,814 15,290,976
Cash and cash equivalents, end of period $ 23,351,567 $ 11,950,847
XML 17 R6.htm IDEA: XBRL DOCUMENT v3.7.0.1
INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - 6 months ended Mar. 31, 2017 - USD ($)
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Deficit [Member]
Total
Balance Beginning at Sep. 30, 2016 $ 36,169 $ 84,290,140 $ (78,018,153) $ 6,308,156
Balance Beginning (in shares) at Sep. 30, 2016 36,168,299     36,168,299
Increase (Decrease) in Stockholders' Equity [Roll Forward]        
Shares issued under equity line - purchase shares $ 5,123 18,010,998 $ 18,016,121
Shares issued under equity line - purchase shares (in shares) 5,122,841      
Shares issued under equity line - commitment shares $ 32 (32)
Shares issued under equity line - commitment shares (in shares) 32,359      
Shares issued upon exercise of warrants - cashless $ 53 (53)
Shares issued upon exercise of warrants - cashless (in shares) 52,562      
Share based compensation 1,858,160 1,858,160
Net loss for the period (4,695,746) (4,695,746)
Balance Ending at Mar. 31, 2017 $ 41,377 $ 104,159,213 $ (82,713,899) $ 21,486,691
Balance Ending (in shares) at Mar. 31, 2017 41,376,061     41,376,061
XML 18 R7.htm IDEA: XBRL DOCUMENT v3.7.0.1
Business Description and Basis of Presentation
6 Months Ended
Mar. 31, 2017
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Business Description and Basis of Presentation
  Note 1 Business Description and Basis of Presentation

 

Business

 

Anavex Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX 2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other CNS diseases, including rare diseases, such as Rett syndrome.

 

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, 2016. The Company follows the same accounting policies in the preparation of interim reports.

 

Operating results for the six months ended March 31, 2017 are not necessarily indicative of the results that may be expected for the year ending September 30, 2017.

 

Cash and cash equivalents

 

The Company considers only those investments which are highly liquid, readily convertible to cash and that mature within three months from the date of purchase to be cash equivalents.

 

Research and Development Incentive Income

 

The Company participates, through its subsidiary in Australia, in the Australian government’s research and development incentive program. The research and development incentive program provides a refundable tax offset to eligible companies that engage in research and development activities in Australia. The Company recognizes as other income the amount received for qualified expenses, in the period they are received.

 

Basic and Diluted Loss per Share

 

Basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the weighted average number of all potentially dilutive securities convertible into shares of common stock that were outstanding during the period.

 

As of March 31, 2017, loss per share excludes 6,053,309 (September 30, 2016 – 6,008,309) potentially dilutive common shares related to outstanding options and warrants, as their effect was anti-dilutive.

XML 19 R8.htm IDEA: XBRL DOCUMENT v3.7.0.1
Recent Accounting Pronouncements
6 Months Ended
Mar. 31, 2017
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]  
Recent Accounting Pronouncements
Note 2 Recent Accounting Pronouncements

 

Recent Accounting Pronouncements Adopted During the Period

 

In June 2014, the FASB issued ASU No. 2014-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period ("ASU 2014-12"). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 explicitly requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In April 2015, the Financial Accounting Standards Board (FASB), issued the Accounting Standards Update 2015-03, Interest - Imputation of Interest (Subtopic 835-30) - Simplifying the Presentation of Debt Issuance Costs, that requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. Upon adoption, an entity must apply the new guidance retrospectively to all prior periods presented in the financial statements. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

Recent Accounting Pronouncements Not Yet Adopted

 

In May, 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard will supersede nearly all existing revenue recognition guidance. ASU 2014-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact for any period presented.

 

In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-17 “Income Taxes: Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”). ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and non-current on the balance sheet and requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. ASU 2015-17 is effective for public entities in fiscal years beginning after December 15, 2016, and for interim periods within those fiscal years. The amendments for ASU-2015-17 can be applied retrospectively or prospectively and early adoption is permitted. The adoption of this standard is not expected to have a material impact for any period presented.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). The guidance would require lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right –of use assets. The guidance is effective for annual and interim reporting periods beginning on or after December 15, 2018. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

 

In March 2016, the FASB issued ASC 2016-09, “Compensation – Stock Compensation (Topic 718) – Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). These amendments are intended to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2016. Early adoption is permitted. Entities have the option to apply the amendments on either a prospective basis or a modified retrospective basis. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

 

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments ("ASU 2016-15"). ASU 2016-15 reduces the existing diversity in practice in financial reporting across all industries by clarifying certain existing principles in ASC 230, Statement of Cash Flows, ("ASC 230") including providing additional guidance on how and what an entity should consider in determining the classification of certain cash flows. In addition, in November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ("ASU 2016-18"). ASU 2016-18 clarifies certain existing principles in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2017. Early adoption is permitted. The adoption of ASU 2016-15 and ASU 2016-18 will modify the Company's current disclosures and reclassifications within the consolidated statement of cash flows but they are not expected to have a material effect on the Company’s consolidated financial statements.

 

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

XML 20 R9.htm IDEA: XBRL DOCUMENT v3.7.0.1
Other Income
6 Months Ended
Mar. 31, 2017
Deferred Revenue Disclosure [Abstract]  
Other Income
  Note 3 Other Income

 

Deferred Grant Income

 

On June 19, 2015, the Company was awarded grant funding in the amount of $286,455. The grant has been received in exchange for a commitment to provide research and development for preclinical validation of Sigma-1 receptor agonism as potential treatment for Parkinson’s disease.

 

The grant income has been deferred and is being amortized to other income over the related commitment period as the related research and development expenditures are incurred. During the three and six months ended March 31, 2017, the Company recognized $16,684 and $51,970, respectively (2016: $26,879 and $65,934) of this grant on its statement of operations within grant income.

 

Research and development tax incentive

 

During the three and six months ended March 31, 2017, the Company received other income of $2,022,902 and $2,022,902, respectively (2016: $Nil and $571,093, respectively) in respect of a research and development incentive program offered by the Australian government.

XML 21 R10.htm IDEA: XBRL DOCUMENT v3.7.0.1
Lincoln Park Purchase Agreement
6 Months Ended
Mar. 31, 2017
Business Combinations [Abstract]  
Lincoln Park Purchase Agreement
Note 4 Lincoln Park Purchase Agreement

 

On October 21, 2015, the Company entered into a $50,000,000 purchase agreement (the “2015 Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $50,000,000 in value of its shares of common stock from time to time over a 36-month period. In connection with the Purchase Agreement, the Company also entered into a registration rights agreement with Lincoln Park whereby the Company agreed to file registration statements with the Securities and Exchange Commission covering the shares of the Company’s common stock that may be issued to Lincoln Park under the Purchase Agreement.

 

The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 50,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares at the time of sales as described in the 2015 Purchase Agreement.

 

In consideration for entering into the 2015 Purchase Agreement, the Company issued to Lincoln Park 179,598 shares of common stock as a commitment fee and agreed to issue up to 89,799 shares pro rata, when and if, Lincoln Park purchases at the Company’s discretion the $50,000,000 aggregate commitment.

 

During the six months ended March 31, 2017, the Company issued to Lincoln Park an aggregate of 5,155,200 shares of common stock under the Purchase Agreement, including 5,122,841 shares of common stock for an aggregate purchase price of $18,016,121 and 32,359 commitment shares. At March 31, 2017, an amount of $30,626,078 remained available under the 2015 Purchase Agreement.

XML 22 R11.htm IDEA: XBRL DOCUMENT v3.7.0.1
Related Party Transactions
6 Months Ended
Mar. 31, 2017
Related Party Transactions [Abstract]  
Related Party Transactions
Note 5 Related Party Transactions

 

As at March 31, 2017, included in accounts payable and accrued liabilities was $32,042 (September 30, 2016: $59,264) 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.

XML 23 R12.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments
6 Months Ended
Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]  
Commitments
Note 6 Commitments

  

  a) Lease Commitment

  

The Company is committed to lease payments as follows: 

 

Fiscal year ending September 30,      
2017   $ 56,094  
2018     112,189  
2019     56,094  
    $ 224,377  

   

  b) Litigation

  

The Company is subject to claims and legal proceedings that arise in the ordinary course of business. Such matters are inherently uncertain, and there can be no guarantee that the outcome of any such matter will be decided favorably to the Company or that the resolution of any such matter will not have a material adverse effect upon the Company's consolidated financial statements. The Company does not believe that any of such pending claims and legal proceedings will have a material adverse effect on its consolidated financial statements.

  

  c) Share Purchase Warrants

 

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

 

    Number of Shares     Weighted
Average
Exercise Price
 
Balance, October 1, 2015     4,272,890     $ 2.11  
Exercised     (2,463,581 )   $ 1.67  
Balance, September 30, 2016     1,809,309     $ 2.70  
Exercised     (200,000 )   $ 3.00  
Balance, March 31, 2017     1,609,309     $ 2.66  

 

At March 31, 2017, the Company had share purchase warrants outstanding of 1,609,309, with a weighted average exercise price of $2.66 as follows: 

 

Number     Exercise Price     Expiry Date
  1,262,180     $ 3.00     July 5, 2018
  30,000     $ 4.00     February 24, 2019
  277,127     $ 1.20     March 13, 2019
  1,252     $ 1.68     March 13, 2019
  31,250     $ 1.24     May 31, 2019
  7,500     $ 1.04     May 31, 2019
  1,609,309              

 

All of the warrants expiring on July 5, 2018 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 $6.00 for a period of twenty consecutive trading days, subject to certain minimum volume restrictions and other restrictions as provided in the warrant agreements. 

 

During the six months ended March 31, 2017, 200,000 share purchase warrants were cashless exercised, resulting in the issuance of 52,562 shares of common stock. 

 

  d) Stock–based Compensation Plan

  

2015 Stock Option Plan

 

 

On September 18, 2015, the Company’s board of directors approved a 2015 Omnibus Incentive Plan (the “2015 Plan”), which provides for the grant of stock options and restricted stock awards to directors, officers, employees and consultants of the Company. 

 

The maximum number of our common shares reserved for issue under the plan is 6,050,553 shares subject to adjustment in the event of a change of the Company’s capitalization. As a result of the adoption of the 2015 Plan, no further option awards will be granted under any previously existing stock option plan. Stock option awards previously granted under previously existing stock option plans remain outstanding in accordance with their terms. 

 

The 2015 Plan is administered by the board of directors, except that it may, in its discretion, delegate such responsibility to a committee of such board. The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date. Stock options may be granted under the 2015 Plan for an exercise period of up to ten years from the date of grant of the option or such lesser periods as may be determined by the board, subject to earlier termination in accordance with the terms of the 2015 Plan. 

 

A summary of the status of Company’s outstanding stock purchase options is presented below: 

 

    Number of Shares     Weighted Average
Exercise Price
    Weighted
Average Grant
Date fair value
 
Outstanding at October 1, 2015     1,822,500     $ 2.00          
Granted     2,401,500     $ 5.22     $ 4.38  
Expired     (25,000 )   $ 14.68          
Outstanding at September 30, 2016     4,199,000     $ 3.76          
Granted     245,000     $ 4.30     $ 3.70  
Outstanding at March 31, 2017     4,444,000     $ 3.80          
Exercisable at March 31, 2017     2,608,133     $ 2.86          
Exercisable at September 30, 2016     2,290,716     $ 2.41          

  

At March 31, 2017, the following stock options were outstanding: 

 

Number of Shares               Aggregate     Remaining  
      Number     Exercise         Intrinsic     Contractual  
Total     Vested     Price     Expiry Date   Value     Life (yrs)  
  500,000       500,000     $ 1.60     July 5, 2023   $ 2,070,000       6.26  
  75,000       50,000     $ 1.20     May 7, 2024     340,500       7.10  
  125,000       62,500     $ 1.32     May 8, 2024     552,500       7.10  
  718,750       479,170     $ 0.92     April 2, 2025     3,464,375       8.01  
  50,000       29,167     $ 1.44     June 8, 2025     215,000       8.19  
  50,000       16,667     $ 1.76     June 15, 2025     199,000       8.21  
  278,750       162,604     $ 5.04     September 18, 2025     195,125       8.47  
  1,500       1,500     $ 5.64     September 30, 2025     150       8.50  
  31,250       15,625     $ 5.68     October 2, 2025     1,875       8.51  
  25,000       12,500     $ 8.98     October 16, 2025     -       8.54  
  1,500       1,500     $ 5.57     December 31, 2025     255       8.75  
  1,500       1,500     $ 4.90     March 31, 2026     1,260       9.00  
  1,500       1,500     $ 5.66     April 27, 2026     120       9.07  
  50,000       19,697     $ 4.09     May 18, 2026     82,500       9.13  
  1,500       1,500     $ 6.11     June 30, 2026     -       9.25  
  379,625       63,271     $ 6.26     July 5, 2026     -       9.26  
  861,429       143,572     $ 7.06     July 18, 2026     -       9.30  
  40,000       10,000     $ 3.06     September 7, 2026     107,200       9.44  
  1,006,696       1,006,696     $ 3.28     September 22, 2026     2,476,472       9.48  
  140,000       23,331     $ 3.63     October 3, 2026     295,400       9.51  
  15,000       2,500     $ 4.35     December 9, 2026     20,850       9.69  
  50,000       -     $ 5.39     February 7, 2027     17,500       9.86  
  40,000       3,333     $ 5.26     February 17, 2027     19,200       9.88  
  4,444,000       2,608,133                 $ 10,059,282          

  

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 March 31, 2017.

   

The Company recognized stock based compensation expense of $968,893 and $1,858,160, respectively, during the three and six months ended March 31, 2017 (2016: $222,690 and $438,710, respectively) in connection with the issuance and vesting of stock options in exchange for services, and $0 and $0 respectively (2016: $0 and $610,000, respectively), in connection with the vesting of restricted stock in exchange for services. These amounts have been included in general and administrative expenses and research and development expenses on the Company’s statement of operations as follows: 

 

    Three months ended March 31,     Six months ended March 31,  
    2017     2016     2017     2016  
General and administrative   $ 450,128     $ 143,672     $ 877,711     $ 574,235  
Research and development     518,765       79,019       980,449       474,476  
Total share based compensation   $ 968,893     $ 222,690     $ 1,858,160     $ 1,048,710  

  

An amount of approximately $6,898,526 in stock based compensation is expected to be recorded over the remaining term of such options through December 31, 2019. 

 

The fair value of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions: 

 

    2017     2016  
Risk-free interest rate     1.76 %     1.68 %
Expected life of options (years)     6.79       6.76  
Annualized volatility     111.81 %     101.92 %
Dividend rate     0.00 %     0.00 %

 

The fair value of restricted stock compensation charges during the six months ended March 31, 2016 was determined with reference to the quoted market price of the Company’s shares on the commitment date.

XML 24 R13.htm IDEA: XBRL DOCUMENT v3.7.0.1
Comparative Figures
6 Months Ended
Mar. 31, 2017
Comparative Figures  
Comparative Figures
Note 7 Comparative Figures

 

Certain comparative figures have been reclassified to conform to the current year’s presentation.

XML 25 R14.htm IDEA: XBRL DOCUMENT v3.7.0.1
Recent Accounting Pronouncements (Policies)
6 Months Ended
Mar. 31, 2017
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]  
Recent Accounting Pronouncements

Recent Accounting Pronouncements Adopted During the Period

 

In June 2014, the FASB issued ASU No. 2014-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period ("ASU 2014-12"). ASU 2014-12 requires that a performance target that affects vesting, and that could be achieved after the requisite service period, be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant date fair value of the award. This update further clarifies that compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved and should represent the compensation cost attributable to the period(s) for which the requisite service has already been rendered. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 explicitly requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

In April 2015, the Financial Accounting Standards Board (FASB), issued the Accounting Standards Update 2015-03, Interest - Imputation of Interest (Subtopic 835-30) - Simplifying the Presentation of Debt Issuance Costs, that requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. Upon adoption, an entity must apply the new guidance retrospectively to all prior periods presented in the financial statements. The Company adopted this standard on October 1, 2016. The adoption of this standard did not have any effect on its financial condition, results of operations and cash flows.

 

Recent Accounting Pronouncements Not Yet Adopted

 

In May, 2014, the FASB and the International Accounting Standards Board (IASB) issued a converged standard on revenue recognition from contracts with customers, ASU 2014-09 (Topic 606 and IFRS 15). This standard will supersede nearly all existing revenue recognition guidance. ASU 2014-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017. The adoption of this standard is not expected to have a material impact for any period presented.

 

In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2015-17 “Income Taxes: Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”). ASU 2015-17 eliminates the requirement to bifurcate deferred taxes between current and non-current on the balance sheet and requires that deferred tax liabilities and assets be classified as noncurrent on the balance sheet. ASU 2015-17 is effective for public entities in fiscal years beginning after December 15, 2016, and for interim periods within those fiscal years. The amendments for ASU-2015-17 can be applied retrospectively or prospectively and early adoption is permitted. The adoption of this standard is not expected to have a material impact for any period presented.

 

In February 2016, the FASB issued Accounting Standards Update No. 2016-02, Leases (“ASU 2016-02”). The guidance would require lessees to recognize most leases on their balance sheets as lease liabilities with corresponding right –of use assets. The guidance is effective for annual and interim reporting periods beginning on or after December 15, 2018. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

 

In March 2016, the FASB issued ASC 2016-09, “Compensation – Stock Compensation (Topic 718) – Improvements to Employee Share-Based Payment Accounting” (“ASU 2016-09”). These amendments are intended to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2016. Early adoption is permitted. Entities have the option to apply the amendments on either a prospective basis or a modified retrospective basis. The Company is currently evaluating the impact this guidance will have on its financial condition, results of operations and cash flows.

  

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230), Classification of Certain Cash Receipts and Cash Payments ("ASU 2016-15"). ASU 2016-15 reduces the existing diversity in practice in financial reporting across all industries by clarifying certain existing principles in ASC 230, Statement of Cash Flows, ("ASC 230") including providing additional guidance on how and what an entity should consider in determining the classification of certain cash flows. In addition, in November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230), Restricted Cash ("ASU 2016-18"). ASU 2016-18 clarifies certain existing principles in ASC 230, including providing additional guidance related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. These amendments are effective for annual and interim reporting periods beginning on or after December 15, 2017. Early adoption is permitted. The adoption of ASU 2016-15 and ASU 2016-18 will modify the Company's current disclosures and reclassifications within the consolidated statement of cash flows but they are not expected to have a material effect on the Company’s consolidated financial statements.

 

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

XML 26 R15.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments and Contingencies (Tables)
6 Months Ended
Mar. 31, 2017
Commitments and Contingencies Disclosure [Abstract]  
Schedule of lease payments

The Company is committed to lease payments as follows:

 

Fiscal year ending September 30,      
2017   $ 56,094  
2018     112,189  
2019     56,094  
    $ 224,377  
Schedule of purchase warrants outstanding

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

 

    Number of Shares     Weighted
Average
Exercise Price
 
Balance, October 1, 2015     4,272,890     $ 2.11  
Exercised     (2,463,581 )   $ 1.67  
Balance, September 30, 2016     1,809,309     $ 2.70  
Exercised     (200,000 )   $ 3.00  
Balance, March 31, 2017     1,609,309     $ 2.66
Schedule of exercisable share purchase warrants outstanding

At March 31, 2017, the Company had share purchase warrants outstanding of 1,609,309, with a weighted average exercise price of $2.66 as follows:

 

Number     Exercise Price     Expiry Date
  1,262,180     $ 3.00     July 5, 2018
  30,000     $ 4.00     February 24, 2019
  277,127     $ 1.20     March 13, 2019
  1,252     $ 1.68     March 13, 2019
  31,250     $ 1.24     May 31, 2019
  7,500     $ 1.04     May 31, 2019
  1,609,309              
Schedule of outstanding stock purchase options

A summary of the status of Company’s outstanding stock purchase options is presented below:

 

    Number of Shares     Weighted Average
Exercise Price
    Weighted
Average Grant
Date fair value
 
Outstanding at October 1, 2015     1,822,500     $ 2.00          
Granted     2,401,500     $ 5.22     $ 4.38  
Expired     (25,000 )   $ 14.68          
Outstanding at September 30, 2016     4,199,000     $ 3.76          
Granted     245,000     $ 4.30     $ 3.70  
Outstanding at March 31, 2017     4,444,000     $ 3.80          
Exercisable at March 31, 2017     2,608,133     $ 2.86          
Exercisable at September 30, 2016     2,290,716     $ 2.41    
Schedule of stock options outstanding

At March 31, 2017, the following stock options were outstanding:

 

Number of Shares               Aggregate     Remaining  
      Number     Exercise         Intrinsic     Contractual  
Total     Vested     Price     Expiry Date   Value     Life (yrs)  
  500,000       500,000     $ 1.60     July 5, 2023   $ 2,070,000       6.26  
  75,000       50,000     $ 1.20     May 7, 2024     340,500       7.10  
  125,000       62,500     $ 1.32     May 8, 2024     552,500       7.10  
  718,750       479,170     $ 0.92     April 2, 2025     3,464,375       8.01  
  50,000       29,167     $ 1.44     June 8, 2025     215,000       8.19  
  50,000       16,667     $ 1.76     June 15, 2025     199,000       8.21  
  278,750       162,604     $ 5.04     September 18, 2025     195,125       8.47  
  1,500       1,500     $ 5.64     September 30, 2025     150       8.50  
  31,250       15,625     $ 5.68     October 2, 2025     1,875       8.51  
  25,000       12,500     $ 8.98     October 16, 2025     -       8.54  
  1,500       1,500     $ 5.57     December 31, 2025     255       8.75  
  1,500       1,500     $ 4.90     March 31, 2026     1,260       9.00  
  1,500       1,500     $ 5.66     April 27, 2026     120       9.07  
  50,000       19,697     $ 4.09     May 18, 2026     82,500       9.13  
  1,500       1,500     $ 6.11     June 30, 2026     -       9.25  
  379,625       63,271     $ 6.26     July 5, 2026     -       9.26  
  861,429       143,572     $ 7.06     July 18, 2026     -       9.30  
  40,000       10,000     $ 3.06     September 7, 2026     107,200       9.44  
  1,006,696       1,006,696     $ 3.28     September 22, 2026     2,476,472       9.48  
  140,000       23,331     $ 3.63     October 3, 2026     295,400       9.51  
  15,000       2,500     $ 4.35     December 9, 2026     20,850       9.69  
  50,000       -     $ 5.39     February 7, 2027     17,500       9.86  
  40,000       3,333     $ 5.26     February 17, 2027     19,200       9.88  
  4,444,000       2,608,133                 $ 10,059,282      
Schedule of general and administrative expenses and research and development expenses

These amounts have been included in general and administrative expenses and research and development expenses on the Company’s statement of operations as follows:

 

    Three months ended March 31,     Six months ended March 31,  
    2017     2016     2017     2016  
General and administrative   $ 450,128     $ 143,672     $ 877,711     $ 574,235  
Research and development     518,765       79,019       980,449       474,476  
Total share based compensation   $ 968,893     $ 222,690     $ 1,858,160     $ 1,048,710
Schedule of weighted average assumptions for fair value of each option award

The fair value of each option award is estimated on the date of grant using the Black Scholes option pricing model based on the following weighted average assumptions:

 

    2017     2016  
Risk-free interest rate     1.76 %     1.68 %
Expected life of options (years)     6.79       6.76  
Annualized volatility     111.81 %     101.92 %
Dividend rate     0.00 %     0.00 %
XML 27 R16.htm IDEA: XBRL DOCUMENT v3.7.0.1
Business Description and Basis of Presentation (Details Narrative) - shares
6 Months Ended 12 Months Ended
Mar. 31, 2017
Sep. 30, 2016
Organization, Consolidation and Presentation of Financial Statements [Abstract]    
Loss per share for potentially dilutive common shares 6,053,309 6,008,309
XML 28 R17.htm IDEA: XBRL DOCUMENT v3.7.0.1
Other Income (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Jun. 19, 2015
Mar. 31, 2017
Mar. 31, 2016
Mar. 31, 2017
Mar. 31, 2016
Awarded grant funding amount $ 286,455        
Grant income   $ 16,684 $ 26,879 $ 51,970 $ 65,934
Research & Development Incentive Program (Australian Government) [Member]          
Grant income   $ 2,022,902 $ 2,022,902 $ 571,093
XML 29 R18.htm IDEA: XBRL DOCUMENT v3.7.0.1
Lincoln Park Purchase Agreement (Details Narrative) - 2015 Purchase Agreement [Member] - Lincoln Park Capital Fund, LLC [Member] - USD ($)
6 Months Ended
Oct. 21, 2015
Mar. 31, 2017
Total number of shares obligated to purchase $ 50,000,000  
Agreement term 36 months  
Description of purchases price

The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 50,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase. The amount of a purchase may be increased under certain circumstances provided, however that Lincoln Park’s committed obligation under any single purchase shall not exceed $2,000,000. The purchase price of shares of common stock related to the future funding will be based on the then prevailing market prices of such shares at the time of sales as described in the 2015 Purchase Agreement.

 
Number of shares issued 179,598 5,155,200
Pro rata basic number of shares obligated to purchase 89,799  
Number of shares issued for aggregate purchase price   5,122,841
Number of shares issued for aggregate purchase price, value   $ 18,016,121
Number of shares issued for commitment   32,359
Amount of shares remain available   $ 30,626,078
XML 30 R19.htm IDEA: XBRL DOCUMENT v3.7.0.1
Related Party Transactions (Details Narrative) - USD ($)
Mar. 31, 2017
Sep. 30, 2016
Directors and Officers [Member]    
Related Party Transaction [Line Items]    
Accounts payable and accrued liabilities $ 32,042 $ 59,264
XML 31 R20.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details)
Mar. 31, 2017
USD ($)
Commitments and Contingencies Disclosure [Abstract]  
2017 $ 56,094
2018 112,189
2019 56,094
Operating leases, future minimum payments receivable $ 224,377
XML 32 R21.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details 1) - Purchase Warrants [Member] - $ / shares
6 Months Ended 12 Months Ended
Mar. 31, 2017
Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]    
Balance, at beginning 1,809,309 4,272,890
Exercised (200,000) (2,463,581)
Balance, at end 1,609,309 1,809,309
Share based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Outstanding Weighted Average Exercise Price [Roll Forward]    
Balance, at beginning $ 2.70 $ 2.11
Exercised 3.00 1.67
Balance, at end $ 2.66 $ 2.70
XML 33 R22.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details 2)
6 Months Ended
Mar. 31, 2017
$ / shares
shares
First Purchase Warrants [Member]  
Number 1,262,180
Exercise Price | $ / shares $ 3.00
Expiry Date Jul. 05, 2018
Second Purchase Warrants [Member]  
Number 30,000
Exercise Price | $ / shares $ 4.00
Expiry Date Feb. 24, 2019
Third Purchase Warrants [Member]  
Number 277,127
Exercise Price | $ / shares $ 1.20
Expiry Date Mar. 13, 2019
Four Purchase Warrants [Member]  
Number 1,252
Exercise Price | $ / shares $ 1.68
Expiry Date Mar. 13, 2019
Five Purchase Warrants [Member]  
Number 31,250
Exercise Price | $ / shares $ 1.24
Expiry Date May 31, 2019
Six Purchase Warrants [Member]  
Number 7,500
Exercise Price | $ / shares $ 1.04
Expiry Date May 31, 2019
Purchase Warrants [Member]  
Number 1,609,309
XML 34 R23.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details 3) - 2015 Omnibus Incentive Plan [Member] - $ / shares
6 Months Ended 12 Months Ended
Mar. 31, 2017
Sep. 30, 2016
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]    
Outstanding at beginning 4,199,000 1,822,500
Granted 245,000 2,401,500
Expired   (25,000)
Outstanding at ending 4,444,000 4,199,000
Exercisable at ending 2,608,133 2,290,716
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Roll Forward]    
Outstanding at beginning $ 3.76 $ 2.00
Granted 4.30 5.22
Expired   14.68
Outstanding at ending 3.80 3.76
Exercisable at ending 2.86 2.41
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Roll Forward]    
Granted $ 3.70 $ 4.38
XML 35 R24.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details 4) - USD ($)
6 Months Ended
Mar. 31, 2017
Sep. 30, 2016
Sep. 30, 2015
First Stock Option [Member]      
Total Number of Shares 500,000    
Number of Vested Shares 500,000    
Exercise Price $ 1.6    
Expiry Date Jul. 05, 2023    
Aggregate Intrinsic Value $ 2,070,000    
Remaining Contractual Life (in years) 6 years 3 months 7 days    
Second Stock Option [Member]      
Total Number of Shares 75,000    
Number of Vested Shares 50,000    
Exercise Price $ 1.20    
Expiry Date May 07, 2024    
Aggregate Intrinsic Value $ 340,500    
Remaining Contractual Life (in years) 7 years 1 month 6 days    
Third Stock Option [Member]      
Total Number of Shares 125,000    
Number of Vested Shares 62,250    
Exercise Price $ 1.32    
Expiry Date May 08, 2024    
Aggregate Intrinsic Value $ 552,500    
Remaining Contractual Life (in years) 7 years 1 month 6 days    
Four Stock Option [Member]      
Total Number of Shares 718,750    
Number of Vested Shares 479,170    
Exercise Price $ 0.92    
Expiry Date Apr. 02, 2025    
Aggregate Intrinsic Value $ 3,464,375    
Remaining Contractual Life (in years) 8 years 4 days    
Five Stock Option [Member]      
Total Number of Shares 50,000    
Number of Vested Shares 29,167    
Exercise Price $ 1.44    
Expiry Date Jun. 08, 2025    
Aggregate Intrinsic Value $ 215,000    
Remaining Contractual Life (in years) 8 years 2 months 8 days    
Six Stock Option [Member]      
Total Number of Shares 50,000    
Number of Vested Shares 16,667    
Exercise Price $ 1.76    
Expiry Date Jun. 15, 2025    
Aggregate Intrinsic Value $ 199,000    
Remaining Contractual Life (in years) 8 years 2 months 16 days    
Seven Stock Option [Member]      
Total Number of Shares 278,750    
Number of Vested Shares 162,604    
Exercise Price $ 5.04    
Expiry Date Sep. 18, 2025    
Aggregate Intrinsic Value $ 195,125    
Remaining Contractual Life (in years) 8 years 5 months 19 days    
Eight Stock Option [Member]      
Total Number of Shares 1,500    
Number of Vested Shares 1,500    
Exercise Price $ 5.64    
Expiry Date Sep. 30, 2025    
Aggregate Intrinsic Value $ 150    
Remaining Contractual Life (in years) 8 years 6 months    
Nine Stock Option [Member]      
Total Number of Shares 31,250    
Number of Vested Shares 15,625    
Exercise Price $ 5.68    
Expiry Date Oct. 02, 2025    
Aggregate Intrinsic Value $ 1,875    
Remaining Contractual Life (in years) 8 years 6 months 4 days    
Ten Stock Option [Member]      
Total Number of Shares 25,000    
Number of Vested Shares 12,500    
Exercise Price $ 8.98    
Expiry Date Oct. 16, 2025    
Aggregate Intrinsic Value    
Remaining Contractual Life (in years) 8 years 6 months 14 days    
Eleven Stock Option [Member]      
Total Number of Shares 1,500    
Number of Vested Shares 1,500    
Exercise Price $ 5.57    
Expiry Date Dec. 31, 2025    
Aggregate Intrinsic Value $ 255    
Remaining Contractual Life (in years) 8 years 9 months    
Twelve Stock Option [Member]      
Total Number of Shares 1,500    
Number of Vested Shares 1,500    
Exercise Price $ 4.9    
Expiry Date Mar. 31, 2026    
Aggregate Intrinsic Value $ 1,260    
Remaining Contractual Life (in years) 9 years    
Thirteen Stock Option [Member]      
Total Number of Shares 1,500    
Number of Vested Shares 1,500    
Exercise Price $ 5.66    
Expiry Date Apr. 27, 2026    
Aggregate Intrinsic Value $ 120    
Remaining Contractual Life (in years) 9 years 25 days    
Fourteen Stock Option [Member]      
Total Number of Shares 50,000    
Number of Vested Shares 19,697    
Exercise Price $ 4.09    
Expiry Date May 18, 2026    
Aggregate Intrinsic Value $ 82,500    
Remaining Contractual Life (in years) 9 years 1 month 17 days    
Fifteen Stock Option [Member]      
Total Number of Shares 1,500    
Number of Vested Shares 1,500    
Exercise Price $ 6.11    
Expiry Date Jun. 30, 2026    
Aggregate Intrinsic Value    
Remaining Contractual Life (in years) 9 years 3 months    
Sixteen Stock Option [Member]      
Total Number of Shares 379,625    
Number of Vested Shares 63,271    
Exercise Price $ 6.26    
Expiry Date Jul. 05, 2026    
Aggregate Intrinsic Value    
Remaining Contractual Life (in years) 9 years 3 months 4 days    
Seventeen Stock Option [Member]      
Total Number of Shares 861,429    
Number of Vested Shares 143,572    
Exercise Price $ 7.06    
Expiry Date Jul. 18, 2026    
Aggregate Intrinsic Value    
Remaining Contractual Life (in years) 9 years 3 months 18 days    
Eighteen Stock Option [Member]      
Total Number of Shares 40,000    
Number of Vested Shares 10,000    
Exercise Price $ 3.06    
Expiry Date Sep. 07, 2026    
Aggregate Intrinsic Value $ 107,200    
Remaining Contractual Life (in years) 9 years 5 months 8 days    
Nineteen Stock Option [Member]      
Total Number of Shares 1,006,696    
Number of Vested Shares 1,006,696    
Exercise Price $ 3.28    
Expiry Date Sep. 22, 2026    
Aggregate Intrinsic Value $ 2,476,472    
Remaining Contractual Life (in years) 9 years 5 months 23 days    
Twenty Stock Option [Member]      
Total Number of Shares 140,000    
Number of Vested Shares 23,331    
Exercise Price $ 3.63    
Expiry Date Oct. 03, 2026    
Aggregate Intrinsic Value $ 295,400    
Remaining Contractual Life (in years) 9 years 6 months 4 days    
Twenty One Stock Option [Member]      
Total Number of Shares 15,000    
Number of Vested Shares 2,500    
Exercise Price $ 4.35    
Expiry Date Dec. 09, 2026    
Aggregate Intrinsic Value $ 20,850    
Remaining Contractual Life (in years) 9 years 8 months 8 days    
Twenty Two Stock Option [Member]      
Total Number of Shares 50,000    
Number of Vested Shares    
Exercise Price $ 5.39    
Expiry Date Feb. 07, 2027    
Aggregate Intrinsic Value $ 17,500    
Remaining Contractual Life (in years) 9 years 10 months 10 days    
Twenty Three Stock Option [Member]      
Total Number of Shares 40,000    
Number of Vested Shares 3,333    
Exercise Price $ 5.26    
Expiry Date Feb. 17, 2027    
Aggregate Intrinsic Value $ 19,200    
Remaining Contractual Life (in years) 9 years 10 months 17 days    
2015 Omnibus Incentive Plan [Member]      
Total Number of Shares 4,444,000 4,199,000 1,822,500
Number of Vested Shares 2,608,133    
Exercise Price $ 3.80 $ 3.76 $ 2.00
Aggregate Intrinsic Value $ 10,059,282    
XML 36 R25.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details 5) - USD ($)
3 Months Ended 6 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Mar. 31, 2017
Mar. 31, 2016
Total share based compensation $ 968,893 $ 222,690 $ 1,858,160 $ 1,048,710
General and administrative [Member]        
Total share based compensation 450,128 143,672 877,711 574,235
Research and development [Member]        
Total share based compensation $ 518,765 $ 79,019 $ 980,449 $ 474,476
XML 37 R26.htm IDEA: XBRL DOCUMENT v3.7.0.1
Commitments (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Mar. 31, 2017
Mar. 31, 2016
Mar. 31, 2017
Mar. 31, 2016
Remaining stock based compensation     $ 6,898,526  
Share based compensation $ 968,893 $ 222,690 1,858,160 $ 1,048,710
Share based compensation with the vesting of restricted stock $ 0 $ 0 $ 0 $ 610,000
2015 Omnibus Incentive Plan [Member]        
Maximum number of common shares reserved for future issuance 6,050,553   6,050,553  
Description of grant option    

The exercise price will be determined by the board of directors at the time of grant shall be at least equal to the fair market value on such date. If the grantee is a 10% stockholder on the grant date, then the exercise price shall not be less than 110% of fair market value of the Company’s shares of common stock on the grant date.

 
Expiration period     10 years  
Purchase Warrants [Member]        
Number of warrant exercisable 1,609,309   1,609,309  
Weighted average exercise price $ 2.66   $ 2.66  
Expiration date     Jul. 05, 2018  
Description of cancellation policy    

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 $6.00 for a period of twenty consecutive trading days, subject to certain minimum volume restrictions and other restrictions as provided in the warrant agreements.

 
Number of warrants exercised 200,000   200,000  
Number of common shares called 52,562   52,562  
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