Quarterly Report • Feb 17, 2015
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Download Source File10-Q 1 form10q.htm FORM 10-Q Anavex Life Sciences Corp. - Form 10-Q - Filed by newsfilecorp.com
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: December 31, 2014
[ ] 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 52 nd Street, 7 th Floor, New York, NY USA 10019 (Address of principal executive offices) (Zip Code)
1-844-689-3939 (Registrants telephone number, including area code)
N/A (Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. [X] Yes [ ] No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). [X] Yes [ ] No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
| Large accelerated filer [ ] | Accelerated
filer [
] |
| --- | --- |
| Non-accelerated filer [ ] (Do not check if a smaller reporting company) | Smaller reporting company [ X ] |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [ ] Yes [X] No
APPLICABLE ONLY TO CORPORATE ISSUERS:
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date: 56,441,000 shares of common stock outstanding as of February 13, 2015.
ii
TABLE OF CONTENTS
| PART
I - FINANCIAL INFORMATION | 1 |
| --- | --- |
| ITEM
1. FINANCIAL STATEMENTS. | 1 |
| ITEM
2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS. | 2 |
| ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS. | 9 |
| ITEM
4. CONTROLS AND PROCEDURES. | 10 |
| PART
II OTHER INFORMATION | 10 |
| ITEM
1. LEGAL PROCEEDINGS. | 10 |
| ITEM
1A. RISK FACTORS. | 10 |
| ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. | 11 |
| ITEM
3. DEFAULTS UPON SENIOR SECURITIES. | 11 |
| ITEM
4. MINE SAFETY DISCLOSURES | 11 |
| ITEM
5. OTHER INFORMATION. | 11 |
| ITEM
6. EXHIBITS. | 12 |
| SIGNATURES | 13 |
iii
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
ANAVEX LIFE SCIENCES CORP.
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2014
( Unaudited )
1
ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS December 31, 2014 and September 30, 2014 ( Unaudited )
| 2014 | September 30, — 2014 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current | ||||
| Cash | $ 6,980,924 | $ | 7,262,138 | |
| Prepaid expenses | 67,576 | 89,117 | ||
| 7,048,500 | 7,351,255 | |||
| Equipment | 1,998 | 2,247 | ||
| $ 7,050,498 | $ | 7,353,502 | ||
| LIABILITIES | ||||
| Current | ||||
| Accounts payable | ||||
| and accrued liabilities | $ 1,319,840 | $ | 1,249,084 | |
| Promissory notes payable | 98,312 | 192,065 | ||
| 1,418,152 | 1,441,149 | |||
| Non-interest bearing liabilities | 5,159,220 | 5,719,727 | ||
| 6,577,372 | 7,160,876 | |||
| STOCKHOLDERS' EQUITY | ||||
| Capitalstock | ||||
| Authorized: 150,000,000 common shares, par value $0.001 per | ||||
| share Issued and | ||||
| outstanding: 54,804,905 common shares (September 30, 2014 - 47,200,237) | 54,807 | 47,201 | ||
| Additional paid-in capital | 53,138,362 | 52,078,750 | ||
| Common stock to be issued | 640,000 | 640,000 | ||
| Accumulated deficit | (53,360,043 | ) | (52,573,325 | ) |
| 473,126 | 192,626 | |||
| $ 7,050,498 | $ | 7,353,502 |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS for the three months ended December 31, 2014 and 2013 ( Unaudited )
| Operating expenses | ||||
| General and administrative - | ||||
| Notes 8 and 9 | $ 452,053 | $ 304,428 | ||
| Research and development | 318,625 | 5,180 | ||
| Total operating expenses | (770,678 | ) | (309,608 | ) |
| Other income (expenses) | ||||
| Interest and finance income | ||||
| (expenses), net | (77,009 | ) | (3,287 | ) |
| Financing related charges and adjustments | 37,651 | 683,000 | ||
| Foreign exchange gain (loss) | 23,318 | (11,468 | ) | |
| Total other income | ||||
| (expenses), net | (16,040 | ) | 668,245 | |
| Net loss and comprehensive | ||||
| loss for the period | $ (786,718 | ) | $ 358,637 | |
| Loss per share | ||||
| Basic | $ (0.02 | ) | $ 0.01 | |
| Diluted | $ (0.02 | ) | $ (0.01 | ) |
| Weighted average number of | ||||
| shares outstanding | ||||
| Basic | 51,630,390 | 37,484,793 | ||
| Diluted | 51,630,390 | 43,933,759 |
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS for the three months ended December 31, 2014 and 2013 ( Unaudited )
| Cash Flows used in Operating Activities | ||||
| Net loss for the period | $ (786,718 | ) | $ 358,637 | |
| Adjustments to reconcile net loss to net | ||||
| cash used in operations: | ||||
| Amortization and depreciation | 249 | 192 | ||
| Accretion of debt discount | 7,120 | - | ||
| Stock-based compensation | 15,362 | - | ||
| Non-cash financing related | ||||
| charges | 29,000 | - | ||
| Change in fair value of derivative financial | ||||
| instruments | (2,000 | ) | (683,000 | ) |
| Gain on extinguishment of debt | (42,771 | ) | - | |
| Unrealized foreign exchange | (5,609 | ) | (10,499 | ) |
| Changes in non-cash working capital | ||||
| balances related to operations: | ||||
| Prepaid expenses | (9,373 | ) | (20,449 | ) |
| Accounts payable and accrued | ||||
| liabilities | 101,670 | (79,871 | ) | |
| Net cash used in operating activities | (693,070 | ) | (434,990 | ) |
| Cash Flows used in Investing Activities | ||||
| Acquisition of equipment | - | (2,327 | ) | |
| Net cash used in investing activities | - | (2,327 | ) | |
| Cash Flows provided by Financing Activities | ||||
| Issuance of common shares | 500,000 | 188,170 | ||
| Repayment of promissory note | (88,144 | ) | - | |
| Net cash provided by financing activities | 411,856 | 188,170 | ||
| Increase in cash during the period | (281,214 | ) | (249,147 | ) |
| Cash, beginning of period | 7,262,138 | 345,074 | ||
| Cash, end of period | $ 6,980,924 | $ 95,927 |
Supplemental Cash Flow Information - Note 11
SEE ACCOMPANYING NOTES
ANAVEX LIFE SCIENCES CORP. INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY for the three months ended December 31, 2014 ( Unaudited )
| Common Stock | ||||||||
|---|---|---|---|---|---|---|---|---|
| Additional | Common | |||||||
| Paid-in | Shares to be | Accumulated | ||||||
| Shares | Par | |||||||
| Value | Capital | Issued | Deficit | Total | ||||
| Balance, October 1, 2014 | 47,200,237 | $ 47,201 | $ 52,078,750 | $ 640,000 | $ (52,573,325 | ) | $ 192,626 | |
| Capital stock issued pursuant to debt conversions - at | ||||||||
| $0.25 | 5,604,668 | 5,607 | 1,044,250 | - | - | 1,049,857 | ||
| Capital stock issued for cash - at $0.25 | 2,000,000 | 2,000 | - | - | - | 2,000 | ||
| Stock based compensation | - | - | 15,362 | - | - | 15,362 | ||
| Net loss for the period | - | - | - | - | (786,718 | ) | (786,718 | ) |
| Balance, December 31, 2014 | 54,804,905 | $ 54,807 | $ 53,138,362 | $ 640,000 | $ (53,360,043 | ) | $ 473,126 |
SEE ACCOMPANYING NOTES
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 ( Unaudited )
| Note 1 |
| --- |
| Business |
| Anavex Life Sciences Corp. (the Company) is a clinical
stage biopharmaceutical company engaged in the development of drug
candidates to treat Alzheimers disease, other central nervous system
(CNS) diseases, and various types of cancer. The Companys lead compounds
ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil
(Aricept), are being developed to treat Alzheimers disease and
potentially other central nervous system (CNS) diseases. |
| In December 2014 a Phase 2a clinical trial was initiated
for ANAVEX 2-73, which is being evaluated for the treatment of Alzheimers
disease. The randomized trial is designed to assess the safety and
exploratory efficacy of ANAVEX 2-73 alone as well as in combination with
donepezil (ANAVEX PLUS) in patients with mild to moderate Alzheimers
disease. ANAVEX 2-73 targets sigma-1 and muscarinic receptors, which have
been shown in preclinical studies to reduce stress levels in the brain and
to reverse the pathological hallmarks observed in Alzheimers disease.
ANAVEX 2-73 showed no serious adverse events in a previously performed
Phase 1 study. In pre-clinical studies, ANAVEX 2-73 demonstrated
anti-amnesic and neuroprotective properties in various animal models
including the transgenic mouse model Tg2576. |
| The Company intends to identify and initiate discussions
with potential partners in the next 12 months. Further, the Company may
acquire or develop new intellectual property and assign, license, or
otherwise transfer our intellectual property to further its goals. |
| Basis of Presentation |
| These interim condensed consolidated financial statements
have been prepared, without audit pursuant to the rules and regulations of
the Securities and Exchange Commission. Accordingly, certain information
and footnote disclosures normally included in the annual financial
statements in accordance with generally accepted accounting principles
have been condensed or omitted pursuant to such rules and regulations. In
the opinion of management, the disclosures are adequate to make the
information presented not misleading. |
| These statements reflect all adjustments, consisting of
normal recurring adjustments, which in the opinion of management are
necessary for fair presentation of the information contained herein. These
interim condensed financial statements should be read in conjunction with
the audited financial statements included in its annual report on Form
10-K for the year ended September 30, 2014. The Company follows the same
accounting policies in the preparation of interim reports. |
| Operating results for the three months ended December 31,
2014 are not necessarily indicative of the results that may be expected
for the year ending September 30, 2015. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 2
| | Basic and Diluted Loss per
Share |
| --- | --- |
| | The basic loss per common share is computed by dividing
net loss available to common stockholders by the weighted average number
of common shares outstanding. Diluted loss per common share is computed
similar to basic loss per common share except that the denominator is
increased to include the weighted average of all potentially dilutive
shares of common stock that were outstanding during the period.
Additionally, the numerator is also adjusted for changes in fair value of
the derivative financial instruments where it is presumed they will be
share settled. |
| | As of December 31, 2014, loss per share excludes
107,265,140 (2013 9,023,966) potentially dilutive common shares related
to outstanding options, warrants, and convertible debentures as their
effect was anti-dilutive. |
| Note 2 | Recent Accounting Pronouncements |
| | Recent Accounting Pronouncements Not Yet Adopted |
| | 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 amendments in this ASU are effective for annual periods
and interim periods within those annual periods beginning after December
15, 2015. The Company is currently evaluating the impact this guidance
will have 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 Entitys Ability to Continue as a
Going Concern (ASU 2014-15). ASU 2014-15 will explicitly require
management to assess an entitys ability to continue as a going concern,
and to provide related footnote disclosure in certain circumstances. The
new standard will be effective for all entities in the first annual period
ending after December 15, 2016. The Company is currently evaluating the
impact this guidance will have on its 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, 2016. The Company is currently
evaluating the impact this guidance will have on its financial condition,
results of operations and cash flows. |
| | Other than noted above, the Company does not expect the
adoption of recently issued accounting pronouncements to have a
significant impact on our results of operations, financial position or
cash flow. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 3
Note 3 Equipment
| Accumulated | |||
| Cost | Depreciation | Net | |
| Computer equipment | $ 3,015 | $ 1,017 | $ 1,998 |
| Accumulated | |||
| Cost | Depreciation | Net | |
| Computer equipment | $ 3,015 | $ 768 | $ 2,247 |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 4
Note 4 Promissory Notes Payable
| December 31, — 2014 | September 30, — 2014 | |||
|---|---|---|---|---|
| Promissory note dated | ||||
| December 31, 2012 with a principal balance of CDN$100,000 bearing interest | ||||
| at 12% per annum, due on September 30, 2014 | - | 89,618 | ||
| Promissory note dated January | ||||
| 9, 2013 with a principal balance of CDN$86,677, bearing interest at 12% | ||||
| per annum, secured by all the present and future assets of the Company; | ||||
| due on demand | 74,543 | 77,679 | ||
| Promissory note dated January | ||||
| 9, 2013 with a principal balance of CDN$27,639, bearing interest at 12% | ||||
| per annum, secured by all the present and future assets of the Company; | ||||
| due on demand | 23,769 | 24,768 | ||
| 98,312 | 192,065 | |||
| Less: current portion | (98,312 | ) | (192,065 | ) |
| $ | - | $ | - |
On December 31, 2012, the Company issued a promissory note having a principal balance of CDN$100,000, with terms that included interest at 12% per annum and matured on June 30, 2013, in exchange for an accounts payable owing with respect to unpaid consulting fees. This note was not repaid on June 30, 2013 and the maturity date was extended to September 30, 2014. The Company repaid this note during the three months ended December 31, 2014.
On January 9, 2013, the Company issued two (2) promissory notes (the Secured Notes);
| a) | The Company issued a promissory note in the amount of
CDN$86,677 to the former President, Secretary, Treasurer, CFO and director
of the Company (the President) in exchange for unpaid consulting fees
owing to the President. The note is bearing interest at 12% per annum and
was due June 30, 2013. |
| --- | --- |
| b) | The Company issued a promissory note in the amount of
CDN$27,639 to a former director of the Company (the Director) in
exchange for unpaid consulting fees owing to the Director. The note is
bearing interest at 12% per annum and was due June 30,
2013. |
The Secured Notes are secured by a right to delay the transfer of any or all of the Companys assets until the obligations of the Secured Notes are satisfied, including a restriction on the transfer of cash by the Company and a security interest over the intellectual property of the Company. The security interests of the Secured Notes is ranked senior to any and all security interests granted prior to the issuance of the notes and to all subsequent security interests granted, unless the holders agree in writing to other terms.
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 5
| Note 4 |
| --- |
| In addition, the Secured Notes contain a provision
whereby if they are not repaid within 10 days of their maturity dates,
they shall bear late fees in addition to interest accruing, at a rate of
$100 per day per note. In an event of default by the Company, under the
terms of the Secured Notes, the notes shall bear additional late fees of
$500 per day per note. |
| Subsequent to the issuance of these Secured Notes, the
former President resigned as President, Secretary, Treasurer, CFO and
director of the Company and the former Director resigned as director of
the Company. |
| The Company did not repay the notes on June 30, 2013. The
Company has disputed the issuance and enforceability of the Secured Notes
and should there be an attempt to enforce the Secured Notes or collection
on them, the Company will consider a legal remedy. The Company has not
accrued any late fees in connection with these Secured Notes as of
December 31, 2014 or September 30, 2014, as the Company does not consider
these amounts to be legally enforceable. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 6
| Note 5 |
|---|
| Non-interest bearing liabilities |
| consists of the following: |
| 2014 | 2014 | |
|---|---|---|
| Senior Convertible Debentures | $ 221,220 | $ 263,727 |
| Derivative Financial Instruments | 4,938,000 | 5,456,000 |
| $ 5,159,220 | $ 5,719,727 |
Senior Convertible Debentures
| 2014 | September 30, — 2014 | |||
|---|---|---|---|---|
| Senior Convertible Debentures, non-interest | ||||
| bearing ,unsecured, due March | ||||
| 18, 2044 | 6,044,877 | 7,446,044 | ||
| Less: Debt Discount | (5,823,657 | ) | (7,182,317 | ) |
| Total carrying value | 221,220 | 263,727 | ||
| Less: current portion | - | - | ||
| Long term liability | $ 221,220 | $ | 263,727 |
On March 13, 2014, the Company entered into a Securities Purchase Agreement (the Purchase Agreement) with certain purchasers (the Purchasers) pursuant to which the Company issued senior convertible debentures in the aggregate principal amount of $10,000,000 (the Debentures).
In connection with the issuance of the Debentures, the Company issued an aggregate of 67,666,666 share purchase warrants as follows:
| Purchasers | Non- — purchasers | Total | |
|---|---|---|---|
| Series A Warrants | 33,333,333 | 500,000 | 33,833,333 |
| Series B Warrants | 33,333,333 | 500,000 | 33,833,333 |
| 66,666,666 | 1,000,000 | 67,666,666 |
Each Series A warrant is exercisable into one common share of the Company at $0.30 per share until March 18, 2019.
Each Series B warrant is exercisable into one common share of the Company at $0.42 per share until March 18, 2019
The Debentures are unsecured, non-interest bearing and are due on March 18, 2044. The Debentures were originally convertible, in whole or in part, at the option of the holder into common shares of the Company at $0.30 per share (the Conversion Price). The Conversion Price of the debenture will be adjusted in the event of common stock dividend, split or consolidation. The Conversion Price was later amended to $0.25 per share, as set forth below.
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 7
| Note 5 |
| --- |
| Senior Convertible Debentures (contd) |
| Pursuant to the guidance of ASC 470-20 Debt with
Conversion and Other Options, the Company allocated the proceeds from the
issuance of the Debentures between the Debentures and the detachable
Purchaser warrants using the relative fair value method. The fair value of
the Purchaser warrants of $22,326,200 at issuance resulted in a debt
discount at issuance of $5,989,900. |
| The Company recorded a beneficial conversion feature
discount of $4,010,100 in respect of the Debentures issued, based on the
intrinsic value of the conversion feature limited to a maximum of the
total proceeds of the Debentures allocated to the Debentures. |
| The total debt discount at issuance of $10,000,000 was
being amortized using the effective interest method over the term of the
Debentures. |
| In consideration for the Debentures issued, the Company
issued an aggregate of 1,000,000 share purchase warrants to non-lenders as
described above. The fair value of the Non- Purchaser Warrants of
$334,900, along with finders fees and other financing costs directly
associated with the issuance of the Debentures in the amount of $788,712,
was recorded as a deferred financing charge and was being amortized to
income over the term of the Debentures using the effective interest
method. |
| The fair value of the Purchaser and Non-Purchaser
warrants at issuance was determined using the Black Scholes option pricing
model with the following weighted average assumptions: |
| Risk-free interest rate | 1.56% |
|---|---|
| Expected life (years) | 5.00 |
| Expected volatility | 97.16% |
| Dividend yields | 0.00% |
In connection with the Purchase Agreement, the Company also entered into a registration rights agreement with each Purchaser (the RRA) whereby the Company agreed to file a registration statement with the Securities and Exchange Commission (the SEC) covering the resale of the shares of the Companys common stock issuable upon conversion of the Debentures and upon exercise of the Purchaser warrants.
On July 23, 2014, the registration statement was declared effective by the SEC.
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 8
| Note 5 |
| --- |
| Senior Convertible Debentures (contd) |
| Amendment Agreements |
| On August 25, 2014, the Company entered into amendment
agreements with each Purchaser, pursuant to which all provisions regarding
liquidating damages and the accrual of damages with respect to the
obligations for, and rights enforceable against, the Company, were
eliminated from the RRAs. As consideration for entering into the amendment
agreements and for the Purchasers agreeing to forego an amount of $459,912
in liquidating damages that had accrued and were accruing pursuant to the
terms of the original RRAs, the Company agreed to adjust the fixed
conversion price of the remaining outstanding debentures from $0.30 per
share to $0.25 per share (the Debenture Amendment). |
| The Company assessed the guidance under ASC 470-60 Troubled Debt Restructurings and determined that this guidance did
not apply to the Debenture Amendment. The Debenture Amendment was
considered a substantial change in the terms of the debentures pursuant to
ASC 470-50 Modifications and Extinguishments and accordingly, the
Company was required to apply debt extinguishment accounting.
Consequently, the Company calculated a net non-cash loss on extinguishment
of debt of $8,099,137 as the premium of the aggregate fair value of the
amended debentures over their aggregate carrying values of $906
immediately prior to the Debenture Amendment and the gain from the
forgiveness of accrued liquidating damages of $459,912. This amount is
included in other financing related charges and adjustments on the
consolidated statement of operations during the year ended September 30,
2014. |
| The Company calculated the fair value of the amended
Debentures by discounting future cash flows using rates representative of
current borrowing rates for debt instruments without a conversion feature
and by using the binomial option pricing model to determine the fair value
of the conversion features, using the following assumptions: |
| Risk-free interest rate | 3.13% |
|---|---|
| Expected life (years) | 29.58 |
| Expected volatility | 100.71% |
| Dividend yields | 0.00% |
In addition, in accordance with debt extinguishment accounting, remaining unamortized financing costs of $1,110,568 associated with the original Debentures were immediately amortized through earnings upon entering into the amendments. This amount is also included in other financing related charges and adjustments in the consolidated statement of operations during the year ended September 30, 2014.
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 9
| Note 5 |
| --- |
| Senior Convertible
Debentures (contd) |
| During the three months ended December 31, 2014, the
Company issued an aggregate of 5,604,668 shares of common stock were based
on a conversion price of $0.25 per share pursuant to the conversion of
$1,401,167 in outstanding principal amounts due under the Debentures. |
| As a result of the bifurcation of the embedded conversion
option subsequent to the Debenture Amendments as discussed above, for
accounting purposes, two instruments are considered outstanding and, upon
exercise of the contractual conversion option, extinguishment accounting
is applied. Consequently, the embedded conversion feature is adjusted to
fair value at the conversion date and the shares issued pursuant to
conversion are recorded at their fair value on the date of issuance,
determined with reference to the quoted market price of the Companys
shares on the issuance date. The resulting difference is recorded as a
gain or loss on the consolidated statement of operations. During the three
months ended December 31, 2014, the Company recorded $42,771 (2013: $Nil)
in respect of net gains on these conversion of the Debentures. |
| Embedded conversion options and warrants |
| At December 31, 2014 and September 30, 2014, the Company
had outstanding embedded conversion options associated with the Senior
Convertible Debentures and outstanding warrants being accounted for as
derivative liabilities. |
| These derivative financial instruments arise as a result
of applying ASC 815 Derivatives and Hedging (ASC 815),
which requires the Company to make a determination whether an
equity-linked financial instrument, or embedded feature, is indexed to the
entitys own stock. This guidance applies to any freestanding financial
instrument or embedded features that have the characteristics of a
derivative, and to any freestanding financial instruments that are
potentially settled in an entitys own stock. |
| During the year ended September 30, 2014, the Company
issued debentures with fixed price embedded conversion features and,
subsequent to certain amendments as discussed above, the Company did not
have a sufficient number of authorized and available shares of common
stock to fully settle the conversion feature of such instruments if
exercised. As such, the Company was required to account for these
instruments as derivative financial instruments. On the commitment date of
the related convertible debentures, the Company recorded a debt discount
to the extent of the fair value of the embedded conversion features
required to be accounted for as liabilities under ASC 815. |
| During the three months ended December 31, 2014, the
Company issued units consisting of shares of common stock and share
purchase warrants and, since the Company does not have a sufficient number
of authorized and available shares of common stock to fully settle the
exercise of these warrants if exercised, due to the outstanding embedded
conversion features discussed above. As a result, the Company was required
to account for these instruments as derivative financial instruments. On
the commitment date of the related warrants, the Company allocated the
proceeds from the issuance of units first to the derivative liability at
its fair value, with any remaining proceeds allocated to the common stock. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 10
| Note 5 |
| --- |
| Embedded conversion options
and warrants (contd) |
| During the year ended September 30, 2013, the Company
issued an aggregate of 6,448,966 common stock purchase warrants that were
required to be accounted for as liabilities pursuant to ASC 815 as a
result of certain features embedded in those instruments. During the three
months ended December 31, 2013, the Company amended the terms of these
common stock purchase warrants. As of the modification date, these
warrants were no longer required to be accounted for as liabilities.
Pursuant to the guidance of ASC 815, the Company reclassified the fair
value of these instruments on the date of modification into equity, with
the change in fair value up to the date of modification being recorded on
the consolidated statements of operations as other income. |
| As a result of the application of ASC 815, the Company
has recorded these liabilities at their fair values as follows: |
| 2014 | September 30, — 2014 | |||
|---|---|---|---|---|
| Balance, beginning of the | ||||
| period | $ 5,456,000 | $ | 904,000 | |
| Fair value at issuance | 527,000 | 8,277,000 | ||
| Change in fair value during | ||||
| the period | (2,000 | ) | (2,956,000 | ) |
| Transfer to equity upon modification of | ||||
| warrant terms | - | (221,000 | ) | |
| Transfer to equity upon | ||||
| exercise | (1,043,000 | ) | (548,000 | ) |
| Balance, end of the period | $ 4,938,000 | $ | 5,456,000 |
The embedded conversion features and warrants accounted for as derivative financial instruments have no observable market and the Company estimated their fair values at December 31, 2014 and September 30, 2014 using the binomial option pricing model based on the following weighted average management assumptions:
| December 31, | September 30, 2014 | |
|---|---|---|
| 2014 | ||
| Risk-free interest rate | 2.59% | 3.21% |
| Expected life (years) | 25.77 | 29.48 |
| Expected volatility | 101.94% | 100.07% |
| Stock price | $0.185 | $0.184 |
| Dividend yields | 0.00% | 0.00% |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 11
| Note 6 |
| --- |
| Authorized |
| As at December 31, 2014 and September 30, 2014, the
Companys authorized share capital, consisting of 150,000,000 share of
common stock, was insufficient to fully settle the conversion or exercise
of all outstanding convertible debentures, stock purchase warrants and
stock options at that date. As a result, and in accordance with ASC 815,
the Company has recorded derivative liabilities in connection with certain
embedded conversion options contained in convertible debentures
outstanding at December 31, 2014 and September 30, 2014, as more fully
described in Note 5. |
| Equity Transactions |
| On October 22, 2014, the Company entered into a
Securities Purchase Agreement (the Purchase Agreement) with one investor
for an equity investment of $500,000 at a price of $0.25 per unit.
Pursuant to the terms of the Purchase Agreement, the Company agreed to
sell, and Lincoln Park agreed to purchase, 2,000,000 shares of common
stock. In addition, the Company agreed to issue an aggregate of 4,000,000
stock purchase warrants, of which 2,000,000 are exercisable at $0.30 per
share and 2,000,000 are exercisable at $0.42 per share, each for a period
of five years, subject to normal adjustment for stock splits,
combinations, and reclassification events. |
| As discussed in Note 5, the warrants issued were required
to be accounted for as derivative liabilities pursuant to the guidance of
ASC 815. Consequently, the Company allocated the proceeds from the
issuance of the units first to the warrants, at their fair value of
$527,000 with an amount of $2,000 being allocated to equity at par value.
The $29,000 excess of the sum of fair value and par value over the
proceeds received of $500,000 was recorded as a component of financing
related charges and adjustments on the statement of operations during the
three months ended December 31, 2014. The fair value of the warrants was
determined based on the binomial option pricing model using the following
weighted average assumptions: risk-free interest rate: 1.46%, expected
life: 5 years, expected volatility: 100.21%, dividend yield: 0%. |
| The Company paid a finders fee of $50,000 in connection
with the purchase agreement. This amount was expensed as a component of
financing related charges and adjustments during the three months ended
December 31, 2014. |
| Common stock to be issued |
| On February 28, 2014, the Company received $30,000 in
share subscriptions in respect of the issuance of 100,000 units at $0.30
per unit. Each unit consisted of one common share and one common share
purchase warrant entitling the holder to purchase additional common shares
at $0.75 per share for a period of five years from the date of issuance. |
| Included in common stock to be issued at December 31,
2014 is an amount of $610,000 (September 30, 2014: $610,000) related to
1,000,000 of common stock issuable to a director and officer of the
Company pursuant to the terms of an employment agreement with that
director and officer (Note 8). |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 12
| Note 7 | Lincoln Park Purchase
Agreement |
| --- | --- |
| | On July 5, 2013, the Company entered into a $10,000,000
purchase agreement (the Purchase Agreement) with Lincoln Park Capital
Fund, LLC, (Lincoln Park) an Illinois limited liability company (the
Financing) pursuant to which the Company may sell and issue to Lincoln
Park, and Lincoln Park is obligated to purchase, up to $10,000,000 in
value of its shares of common stock from time to time over a 25 month
period. In connection with the Financing, the Company also entered into a
registration rights agreement with Lincoln Park whereby the Company agreed
to file a registration statement with the Securities and Exchange
Commission (the SEC) covering the shares of the Companys common stock
that may be issued to Lincoln Park under the Purchase Agreement. |
| | The Company will determine, at its own discretion, the
timing and amount of its sales of common stock, subject to certain
conditions and limitations. The purchase price of the shares that may be
sold to Lincoln Park under the Purchase Agreement will be based on the
market price of the Companys shares of common stock immediately preceding
the time of sale without any fixed discount, provided that in no event
will such shares be sold to Lincoln Park when the closing sale price is
less than $0.50 per share. There are no upper limits on the per share
price that Lincoln Park may pay to purchase such common stock. The
purchase price will be equitably adjusted for any reorganization,
recapitalization, non- cash dividend, stock split or similar transaction
occurring during the business days used to compute such price. |
| Note 7 | Lincoln Park Purchase Agreement (contd) |
| | Pursuant to the Purchase Agreement, Lincoln Park
initially purchased 250,000 shares of the Companys common stock for
$100,000. In consideration for entering into the Purchase Agreement, the
Company issued to Lincoln Park 341,858 shares of common stock as a
commitment fee and shall issue up to 133,409 shares pro rata, when and if,
Lincoln Park purchases, at the Companys discretion, the remaining
$10,000,000 aggregate commitment. The Purchase Agreement may be terminated
by the Company at any time at its discretion without any cost to the
Company. |
| | On October 23, 2013, the registration statement was
declared effective by the SEC. |
| | The Company incurred a net $73,787 in direct expenses in
connection with the Purchase Agreement and registration statement. These
were recorded as share issuance costs as a charge against additional paid
in capital in the period incurred. |
| | During the three months ended December 31, 2014, the
Company did not issue any shares under the Purchase Agreement. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 13
| Note 8 |
| --- |
| During the three months ended December 31, 2014, the
Company was charged general and administrative expenses totaling $16,383
in respect of directors fees and stock option based compensation charges
paid or accrued to directors and officers of the Company, inclusive of
amounts noted below (2013: $Nil). |
| As at December 31, 2014, included in accounts payable and
accrued liabilities was $35,732 (September 30, 2014: $28,232) 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. |
| During the year ended September 30, 2013, pursuant to an
employment agreement with the President, Chief Executive Officer, Chief
Financial Officer, Secretary and Treasurer, and Director, of the Company,
the Company: |
| i) | granted 2,000,000 fully vested share purchase options
exercisable at $0.40 per share until July 5, 2023. |
| --- | --- |
| ii) | issued 4,000,000 shares of restricted common stock that
vest as follows: |
| | 25% upon the Company starting a Phase Ib/IIb human study |
|---|---|
| | 25% upon the Company in-licensing additional assets in |
| clinical or pre-clinical stage (vested during the year ended September 30, | |
| 2014 at a value of $610,000) | |
| | 25% upon the Company securing additional non-dilutive |
| equity funding in 2013 of at least $5,000,000 with a share price higher | |
| than the previous funding | |
| | 25% upon the Company obtaining a listing on a major stock |
| exchange |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 14
Note 9 Commitments
| a) |
|---|
| A summary of the Companys share purchase warrants |
| outstanding is presented below: |
| Average | |||
| Exercise | |||
| Number of Shares | Price | ||
| Balance, October 1, 2013 | 9,149,479 | $ 0.75 | |
| Expired | (2,700,513 | ) | $ 0.75 |
| Issued | 68,466,666 | $ 0.36 | |
| Balance, September 30, 2014 | 74,915,632 | $ 0.40 | |
| Issued | 4,300,000 | $ 0.35 | |
| Balance, December 31,2 014 | 79,215,632 | $ 0.39 |
At December 31, 2014, the Company has 78,915,632 currently exercisable share purchase warrants outstanding as follows:
| Number | Expiry Date | |
|---|---|---|
| 6,448,966 | $ 0.75 | July 5, 2018 |
| 500,000 | $ 0.75 | February 14, 2019 |
| 120,000 | $ 1.00 | February 24, 2019 |
| 33,833,333 | $ 0.30 | March 13, 2019 |
| 33,833,333 | $ 0.42 | March 13, 2019 |
| 180,000 | $ 0.31 | May 31, 2019 |
| 2,000,000 | $ 0.30 | October 22, 2019 |
| 2,000,000 | $ 0.42 | October 22, 2019 |
| 250,000 | $ 0.19 | January 31, 2015 |
| 50,000 | $ 0.31 | May 31, 2019 |
| 79,215,632 |
During the three months ended December 31, 2014, the Company issued 250,000 warrants exercisable at $0.19 per share until January 31, 2015 to a consultant of the Company pursuant to a consulting agreement dated October 24, 2014. The warrants were to vest in the event the Company entered into a license agreement or direct sales transaction as a direct result of the consultant. Subsequent to December 31, 2014, these warrants expired unvested and unexercised. No stock-based compensation has been or will be recorded in the financial statements as none of the performance conditions for vesting were met.
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 15
Note 9 Commitments (contd)
| a) | Share Purchase Warrants (contd) |
|---|---|
| During the three months ended December 31, 2014, the | |
| Company issued 50,000 warrants exercisable at $0.31 per share until May | |
| 31, 2019 to a consultant of the Company pursuant to a consulting | |
| agreement. The fair value of these warrants at issuance was calculated to | |
| be $6,000 based on the Black-Scholes option pricing model using the | |
| following assumptions: expected term 4.59 years, expected volatility | |
| 102.33%, expected dividend yield 0.00%, risk free interest rate 1.58%. | |
| Stock based compensation will be recorded in the financial statements over | |
| the vesting term of three years from the date of grant. | |
| All of the 6,448,966 warrants expiring on July 5, 2018 | |
| and the 500,000 warrants expiring February 14, 2019 contain a contingent | |
| call provision whereby the Company may have the option to call for | |
| cancellation of all or any portion of the warrants for consideration equal | |
| to $0.001 per share, provided the quoted market price of the Companys | |
| common stock exceeds $1.50 for a period of twenty consecutive trading | |
| days, subject to certain minimum volume restrictions and other | |
| restrictions as provided in the warrant agreements. | |
| b) | Stockbased Compensation Plan |
| In April, 2007, the Company adopted a stock option plan | |
| which provides for the granting of stock options to selected directors, | |
| officers, employees or consultants in an aggregate amount of up to | |
| 3,000,000 common shares of the Company and, in any case, the number of | |
| shares to be issued to any one individual pursuant to the exercise of | |
| options shall not exceed 10% of the issued and outstanding share capital. | |
| The granting of stock options, exercise prices and terms are determined by | |
| the Company's Board of Directors. If no vesting schedule is specified by | |
| the Board of Directors on the grant of options, then the options shall | |
| vest over a 4-year period with 25% of the granted options vesting each | |
| year commencing 1 year from the grant date. For stockholders who have | |
| greater than 10% of the outstanding common shares of the Company and who | |
| have granted options, the exercise price of their options shall not be | |
| less than 110% of the fair of the stock on grant date. Otherwise, options | |
| granted shall have an exercise price equal to their fair value on grant | |
| date. | |
| On February 2, 2011, the Company amended and restated the | |
| 2007 stock option plan to increase the number of options authorized to | |
| 4,000,000. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 16
Note 9 Commitments (contd)
| b) |
| --- |
| A summary of the status of Companys outstanding stock
purchase options for the three months ended December 31, 2014 and for the
year ended September 30, 2014 is presented
below: |
| Number of | Average | Average Grant | ||
|---|---|---|---|---|
| Shares | Exercise Price | Date | ||
| fairv alue | ||||
| Outstanding at October 1, 2013 | 3,075,000 | $ 1.26 | ||
| Expired | (705,000 | ) | $ 2.70 | |
| Granted | 800,000 | $ 0.32 | $ 0.25 | |
| Outstanding at September 30, 2014 and December 31, 2014 | 3,170,000 | $ 0.70 | ||
| Exercisable at December 31, 2014 | 2,100,000 | $ 0.56 | ||
| Exercisable at September 30, 2014 | 2,100,000 | $ 0.56 |
At December 31, 2014, the following stock options were outstanding:
| Number of
Shares | | Number | Exercise | | Aggregate — Intrinsic | Remaining — Contractual |
| --- | --- | --- | --- | --- | --- | --- |
| Total | | Vested | Price | Expiry Date | Value | Life
(yrs) |
| 100,000 | (1) | 100,000 | $ 3.67 | March 30, 2016 | - | 1.25 |
| 270,000 | (2) | - | $ 3.00 | February 8, 2017 | - | 2.11 |
| 2,000,000 | (3) | 2,000,000 | $ 0.40 | July 5, 2023 | - | 8.52 |
| 300,000 | (4) | - | $ 0.30 | May 7, 2024 | - | 9.36 |
| 500,000 | (5) | - | $ 0.33 | May 8, 2024 | - | 9.36 |
| 3,170,000 | | 2,100,000 | | | - | |
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Companys stock for the options that were in-the-money at December 31, 2014.
| (1) | As of December 31, 2014 and September 30, 2014, these
options had fully vested. These options were granted during the year ended
September 30, 2011 and vested over a period of one year from the date of
grant. The fair value of these options at issuance was calculated to be
$267,000. The Company did not recognize any stock- based compensation
during the three months ended December 31, 2014 (2013: $Nil). |
| --- | --- |
| (2) | As of December 31, 2014 and September 30, 2014, none of
these options had vested. The options vest upon one or more compounds:
entering Phase II trial 90,000 options; entering Phase III trial
90,000 options; and receiving FDA approval 90,000 options. No
stock-based compensation has been recorded in the financial statements as
none of the performance conditions have yet been
met. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 17
Note 9 Commitments (contd)
b) Stockbased Compensation Plan (contd)
| (3) | As of December 31, 2014 and September 30, 2014 these
options had fully vested. These options were granted during the year ended
September 30, 2013 and vested immediately upon granting. The Company
recognized stock based compensation expense of $Nil during the three
months ended December 31, 2014 (2013: $Nil) in connection with these
options. |
| --- | --- |
| (4) | As of December 31, 2014 and September 30, 2014, none of
these options had vested. These options were issued during the year ended
September 30, 2014 and vest annually over a three year period commencing
on the first anniversary of the date of the grant. The Company recognized
stock based compensation expense of $5,830 during the three months ended
December 31, 2014, (2013: $Nil) in connection with these options. These
amounts have been included in general and administrative expenses on the
Companys statement of operations. |
| (5) | As of December 31, 2014 and September 30, 2014, none of
these options had vested. These options were issued during the year ended
September 30, 2014 and vest annually over a four year period commencing on
the first anniversary of the date of the grant. The Company recognized
stock based compensation expense of $8,053 during the three months ended
December 31, 2014 (2013: $Nil) in connection with these
options. |
During the three months ended December 31, 2013, 500,000 options expired for which the Company had recognized stock-based compensation of $Nil (2012: $Nil) during the three months ended December 31, 2013
There has been no stock-based compensation recognized in the financial statements for the three months ended December 31, 2014 (2013: $nil) for options that will vest upon the achievement of performance milestones because the Company has determined that satisfaction of the performance milestones was not probable. Compensation relating to stock options exercisable upon achieving performance milestones will be recognized in the period the milestones are achieved.
| Note 10 |
| --- |
| Subsequent to December 31, 2014 the Company issued an
aggregate of 1,636,096 shares of common stock pursuant to the conversion of
$409,024 face value of convertible debentures at $0.25 per share. |
Anavex Life Sciences Corp. Notes to the Interim Condensed Consolidated Financial Statements December 31, 2014 Stated in US Dollars ( Unaudited ) Page 18
| Note 11 |
| --- |
| Investing and financing activities that do not have a
direct impact on current cash flows are excluded from the statement of
cash flows. |
| During the three months ended December 31, 2014, the
Company issued 5,604,668 shares of common stock of the Company at a fair
value of $1,049,855 pursuant to the conversion of convertible debentures
at a conversion price of $0.25 per share. |
| During the three months ended December 31, 2013, the
Company reclassified an amount of $221,000 into equity upon modification
of the terms of certain derivative instruments. |
| These transactions have been excluded from the statement
of cash flows. |
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward-Looking Statements
This Quarterly Report on Form 10-Q includes forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our anticipated future clinical and regulatory milestone events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words believe, may, estimate, continue, anticipate, intend, expect and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the anticipated start dates, durations and completion dates of our ongoing and future clinical studies, statements regarding the anticipated designs of our future clinical studies, statements regarding our anticipated future regulatory submissions and statements regarding our anticipated future cash position. We have based these forward-looking statements largely on our current expectations and projections about future events, including the responses we expect from the U.S. Food and Drug Administration, or FDA, and other regulatory authorities and financial trends that we believe may affect our financial condition, results of operations, business strategy, preclinical and clinical trials and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions including without limitation the risks described in Risk Factors in Part I, 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
We are a clinical stage biopharmaceutical company engaged in the development of drug candidates to treat Alzheimers disease, other central nervous system (CNS) diseases, and various types of cancer. Our lead compounds ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept), are being developed to treat Alzheimers disease and potentially other central nervous system (CNS) diseases.
In December 2014 a Phase 2a clinical trial was initiated for ANAVEX 2-73, which is being evaluated for the treatment of Alzheimers disease. The randomized trial is designed to assess the safety and exploratory efficacy of ANAVEX 2-73 alone as well as in combination with donepezil (ANAVEX PLUS) in patients with mild to moderate Alzheimers disease. ANAVEX 2-73 targets sigma-1 and muscarinic receptors, which have been shown in preclinical studies to reduce stress levels in the brain and to reverse the pathological hallmarks observed in Alzheimers disease. ANAVEX 2-73 showed no serious adverse events in a previously performed Phase 1 study. In pre-clinical studies, ANAVEX 2-73 demonstrated anti-amnesic and neuroprotective properties in various animal models including the transgenic mouse model Tg2576.
We intend to identify and initiate discussions with potential partners in the next 12 months. Further, we may acquire or develop new intellectual property and assign, license, or otherwise transfer our intellectual property to further our goals.
Our Pipeline
2
Our pipeline includes one 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 Alzheimers disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.
Compounds that have been subjects of our research include the following:
ANAVEX 2-73
ANAVEX 2-73 may offer a disease-modifying approach in Alzheimers disease (AD) by using ligands that activate sigma-1 receptors.
In AD animal models, ANAVEX 2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576 ANAVEX 2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory.
Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73 in 2011. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.
The ANAVEX 2-73 Phase 1 SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimers disease studies, and the Technical University of Dresden.
As well, recent preclinical data validates ANAVEX 2-73 as a prospective platform drug for other neurodegenerative diseases beyond Alzheimers, most specifically epilepsy. The data demonstrates significant improvement in the reduction of seizures relative to three generations of epilepsy drugs currently on the market, as well as significant synergy with each of these drugs.
ANAVEX PLUS
ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept®) is a potential novel combination drug for Alzheimers disease. Aricept® (donepezil) is now generic. ANAVEX 2-73 showed in combination with donepezil an unexpected and clear synergic effect of memory improvement by up to 80% in animal models. A patent application was filed in the US for the combination of donepezil and ANAVEX 2-73 and if granted would give patent protection at least until 2033.
3
In a humanized calibrated cortical network computer model the unexpected pre-clinical synergy between ANAVEX 2-73 and donepezil was confirmed and ANAVEX PLUS showed an anticipated ADAS-Cog response of 7 points at 12 weeks and 5.5 points at 26 weeks, which represents more than 2x the ADAS-Cog of donepezil alone.
ANAVEX 3-71
ANAVEX 3-71, previously named AF710B is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has shown to enhance neuroprotection and cognition in Alzheimer's disease. ANAVEX 3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer's hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer's and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation.
ANAVEX 1-41
ANAVEX 1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and destroys cells and is believed by some scientists to be a primary cause of AD. In addition, in animal models, ANAVEX 1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action.
ANAVEX 1037
ANAVEX 1037 is designed for the treatment of prostate cancer. It is a low molecular weight, synthetic compound exhibiting high affinity for sigma-1 receptors at nanomolar levels and moderate affinity for sigma-2 receptors and sodium channels at micromolar levels. In advanced pre-clinical studies, this compound revealed antitumor potential with no toxic side effects. It has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to significantly suppress tumor growth in immune-deficient mice models. Scientific publications describe sigma receptor ligands positively, highlighting the possibility that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines. Sigma receptors are highly expressed in different tumor cell types. Binding by appropriate sigma-1 and/or sigma-2 ligands can induce selective apoptosis. In addition, through tumor cell membrane reorganization and interactions with ion channels, our drug candidates may play an important role in inhibiting the processes of metastasis (spreading of cancer cells from the original site to other parts of the body), angiogenesis (the formation of new blood vessels) and tumor cell proliferation.
Our compounds are in the pre-clinical and clinical testing stages of development, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human testing.
Our Target Indications
We have developed compounds with potential application to two broad categories and several specific indications. The two categories are diseases of the central nervous system, and cancer. Specific indications include:
4
Recent Corporate Developments
Since October 1, 2014, the commencement of our first quarter ended December 31, 2014, we have experienced the following significant corporate developments:
5
Results of Operations
Revenue
We have not earned any revenues since our inception on January 23, 2004. We do not anticipate earning any revenues until we can establish an alliance with other companies to develop, co-develop, license, acquire or market our products.
Operating Expenses
Three months ended December 31, 2014 compared to three months ended December 31, 2013
Our operating expenses for the three months ended December 31, 2014 were $770,678, which represents an increase of $461,070 compared to $309,608 for the three month period ended December 31, 2013. The increase was mainly attributable to an increase in research and development expenses of $313,445 related to our Phase 2a clinical trial for ANAVEX 2-73, which commenced in December, 2014. We expect our research and development expenses will continue to increase over the remaining quarters in the current fiscal year as a result of this clinical trial and other auxiliary research and development activities. We continue to target potential research partners to further advance our pipeline compounds.
Other income
The aggregate amount in the other income for the three month period ended December 31, 2014, amounted to $(16,040) as compared to $668,245 for the comparable three month period ended December 31, 2013. The decrease in other expenses was mainly as a result of a decrease in financing related income of $683,000 for the three months ended December 31, 2013, related to a change in the calculated fair value over the period of stock purchase warrants being accounted for as derivative liabilities in accordance with US GAAP.
Liquidity and Capital Resources
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Working Capital
| Current Assets | $ 7,048,500 | $ 7,351,255 |
|---|---|---|
| Current Liabilities | 1,418,152 | 1,441,149 |
| Working Capital | $ 5,630,348 | $ 5,910,106 |
As of December 31, 2014, we had $6,980,924 in cash, a decrease of $281,214 from September 30, 2014. The principal reason for this decrease is due to cash used in operations and for the advancement of clinical trial work, offset by funds received during the quarter in respect of a private placement. We intend to use the majority of our capital resources to complete the next clinical trial for ANAVEX 2-73 and ANAVEX PLUS, and to perform work necessary to prepare for further clinical development.
Cash Flows
| 2014 | 2013 | |||
|---|---|---|---|---|
| Cash flows used in operating | ||||
| activities | $ (693,070 | ) | $ (434,990 | ) |
| Cash flows from investing activities | - | (2,327 | ) | |
| Cash flows from financing | ||||
| activities | 411,856 | 188,170 | ||
| Decrease in cash | $ (281,214 | ) | $ (249,147 | ) |
Cash flow used in operating activities
Our cash used in operating activities for the period ended December 31, 2014 was $693,070 compared to $434,990 used in operating activities for the comparative period ended December 31, 2013. The increase in cash used in operating activities was primarily as a result of the increased research and development activities as a result of the commencement of clinical trial work.
Cash used in investing activities
Cash used in investing activities was $Nil in the current period ended December 31, 2014 compared to $2,327 in the comparative period. This is as a result of a small equipment purchase in the comparative period.
Cash flow provided by financing activities
Our cash used in financing activities for the period ended December 31, 2014 was $411,856, mostly attributable to cash received from the issuance of common shares under the Subscription Agreement with Lincoln Park Capital Fund, LLC (described above under Recent Corporate Developments ).
In the comparative period ended December 31, 2013, we had cash inflows of $188,170 from activities related to the issuance of common shares under the Purchase Agreement (described below under Other Financing ).
Other Financing
On July 5, 2013, we entered into a Purchase Agreement (the Purchase Agreement ) with Lincoln Park Capital Fund, LLC ( Lincoln Park ), pursuant to which Lincoln Park committed to purchase up to $10,000,000 of our common stock. Concurrently with the execution of the Purchase Agreement, we issued 341,858 shares of our common stock to Lincoln Park as a fee for its commitment to purchase shares of our common stock under the Purchase Agreement. The purchase shares that may be sold pursuant to the Purchase Agreement may be sold by us to Lincoln Park at our discretion from time to time over a 25-month period commencing after the SEC declared effective the related registration statement.
There are no upper limits on the per share price that Lincoln Park may pay to purchase such common stock. Furthermore, the Company controls the timing and amount of any future sales, if any, of shares of common stock to Lincoln Park except that, pursuant to the terms of the Purchase Agreement, we would be unable to sell shares to Lincoln Park if and when the closing sale price of our common stock is below $0.50 per share, subject to adjustment as set forth in the Purchase Agreement. Lincoln Park has no right to require any sales and is obligated to purchase common stock as directed by the Company.
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Other than our rights related to the Lincoln Park financing, there can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain the additional financing on a timely basis, if and when it is needed, we will be forced to delay or scale down some or all of our research and development activities or perhaps even cease the operation of our business.
We expect that we will be able to continue to fund our operations through existing cash on hand and through equity and debt financing in the future. If we raise additional financing by issuing equity securities, our existing stockholders ownership will be diluted. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to our stockholders.
Application of Critical Accounting Policies
Our financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles in the United States. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. These estimates and assumptions are affected by managements 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.
Stock-based Compensation
We account for all stock-based payments and awards under the fair value based method.
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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.
Derivative Liabilities
From time to time, we may issue warrants and convertible promissory notes with embedded conversion options which, dependent on their specific contractual terms, may be required to be accounted for as separate derivative liabilities. These liabilities are required to be measured at fair value. These instruments are then adjusted to reflect fair value at each period end. Any increase or decrease in the fair value is recorded in results of operations as change in fair value of derivative liabilities. In determining the appropriate fair value, we use the binomial pricing model because these instruments are not quoted on an active market.
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 binomial model does not necessarily provide a reliable single measure of the fair value of these instruments.
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 amendments in this ASU are effective for annual periods and interim periods within those annual periods beginning after December 15, 2015. We are currently evaluating the impact this guidance 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 Entitys Ability to Continue as a Going Concern (ASU 2014-15). ASU 2014-15 will explicitly require management to assess an entitys ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. The new standard will be effective for all entities in the first annual period ending after December 15, 2016. We are currently evaluating the impact this guidance on our financial condition, results of operations and cash flows.
On May 28, 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, 2016. We are currently evaluating the impact this guidance will have on our financial condition, results of operations and cash flows.
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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 a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide information under this item.
ITEM 4. CONTROLS AND PROCEDURES.
Disclosure Controls and Procedures
As required by Rule 13a-15 under the Securities Exchange Act of 1934, our management, with the participation of our principal executive officer and principal financial officer, evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) of the Securities Exchange Act of 1934) as of the end of the period covered by this Quarterly Report on Form 10-Q. Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commissions rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to our principal executive officer and principal financial officer to allow timely decisions regarding required disclosure.
Based on that evaluation, our management, with the participation of our principal executive officer and principal financial officer, concluded that as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were not effective. The ineffectiveness of our disclosure controls and procedures was due to the material weaknesses disclosed in our Annual Report on Form 10-K filed on December 29, 2014.
We intend to take appropriate and reasonable steps to make the necessary improvements to remediate these deficiencies. However, due to the size and nature of our operations, segregation of all duties and job functions has not always been possible and may not be economically feasible.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2014 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
We know of no material, existing or pending legal proceedings to which we or our subsidiary are a party or of which any of our properties is the subject. In addition, we do not know of any such proceedings contemplated by any governmental authorities.
ITEM 1A. RISK FACTORS.
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide information under this item. However, current and prospective investors are encouraged to review the risks set forth in Part I, Item 1A, Risk Factors in our most recent Annual Report on Form 10-K as filed with the Securities and Exchange Commission on December 29, 2014.
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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.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
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ITEM 6. EXHIBITS.
| Exhibit Number | Description |
|---|---|
| (3) | Articles of Incorporation and Bylaws |
| 3.1 | Articles of Incorporation (incorporated by reference to |
| an exhibit to our Registration Statement on Form SB-2 filed on January 13, | |
| 2005) | |
| 3.2 | Bylaws (incorporated by reference to an exhibit to our |
| Current Report on Form 8-K filed on September 28, 2007) | |
| 3.3 | Articles of Merger filed with the Secretary of State of |
| Nevada on January 10, 2007 and which is effective January 25, 2007 | |
| (incorporated by reference to an exhibit to our Current Report on Form 8-K | |
| filed on January 25, 2007) | |
| (4) | Instruments defining rights of security holders, |
| including indentures | |
| 4.1 | Specimen Stock Certificate (incorporated by reference to |
| an exhibit to our Registration Statement on Form SB-2 filed on January 13, | |
| 2005) | |
| 4.2 | Form of Convertible Loan Agreement (incorporated by |
| reference to an exhibit to our Form 8-K filed on April 3, 2009) | |
| 4.3 | 8% Convertible Loan Agreement dated June 3, 2009 |
| (incorporated by reference to an exhibit to our Current Report on Form 8-K | |
| filed on June 23, 2009) | |
| 4.4 | 8% Convertible Loan Agreement dated June 19, 2009 |
| (incorporated by reference to an exhibit to our Current Report on Form 8-K | |
| filed on June 26, 2009) | |
| (10) | Material Contracts |
| 10.1 | Securities Purchase Agreement, dated October 22, 2014, by |
| and between the Company and Lincoln Park Capital Fund, LLC (incorporated | |
| by reference to an exhibit to our Current Report on Form 8- K filed on | |
| October 23, 2014) | |
| 10.2 | Form of Series A Common Stock Purchase Warrant |
| (incorporated by reference to an exhibit to our Current Report on Form 8-K | |
| filed on October 23, 2014) | |
| 10.3 | Form of Series B Common Stock Purchase Warrant |
| (incorporated by reference to an exhibit to our Current Report on Form 8-K | |
| filed on October 23, 2014) | |
| (31) | Section 302 Certifications |
| 31.1* | Section 302 Certification of Christopher Missling, |
| PhD. | |
| (32) | Section 906 Certifications |
| 32.1* | Section 906 Certification of Christopher Missling, |
| PhD. | |
| (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 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ANAVEX LIFE SCIENCES CORP.
| /s/Christopher Missling, PhD |
|---|
| Christopher Missling, PhD |
| Chief Executive Officer and Chief Financial Officer |
| (Principal Executive, Financial and Accounting Officer) |
| Date: February 17, 2015 |
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