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EX-31.1 - SECTION 302 CERTIFICATION OF HARVEY LALACH - ANAVEX LIFE SCIENCES CORP.exhibit31-1.htm
EX-32.1 - SECTION 906 CERTIFICATION OF HARVEY LALACH - ANAVEX LIFE SCIENCES CORP.exhibit32-1.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K

(Mark One)

[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended: September 30, 2011
or

[   ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________________ to __________________

Commission file number: 000-51652

ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)

Nevada 20-8365999
State or other jurisdiction of (I.R.S. Employer
incorporation or organization Identification No.)

45 Tintern Lane, Portola Valley, California 84028
(Address of principal executive offices)( Zip Code)

Registrant’s telephone number, including area code 1-800-689-3939

Securities registered pursuant to Section 12(b) of the Act

Title of each class Name of each exchange on which registered
Nil Nil

Securities registered pursuant to Section 12(g) of the Act
Common Stock
(Title of Class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes [   ]     No [X]

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes [   ]     No [X]


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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes [X]     No [   ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes [X]     No [   ]

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [   ]

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 Act).
Yes [   ]     No [X]

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter. $64,321,329

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date: 27,187,174 shares of common stock are issued and outstanding as of December 19, 2011.

DOCUMENTS INCORPORATED BY REFERENCE

List hereunder the following documents if incorporated by reference and the Part of the Form 10-K (e.g., Part I, Part II, etc.) into which the document is incorporated: (1) Any annual report to security holders; (2) Any proxy or information statement; and (3) Any prospectus filed pursuant to Rule 424(b) or (c) under the Securities Act of 1933. The listed documents should be clearly described for identification purposes (e.g., annual report to security holders for fiscal year ended December 24, 1980).
Not applicable.


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TABLE OF CONTENTS

PART I 1
ITEM 1. BUSINESS 1
ITEM 1 A. RISK FACTORS 13
ITEM 1B. UNRESOLVED STAFF COMMENTS 26
ITEM 2. PROPERTIES 26
ITEM 3. LEGAL PROCEEDINGS 26
ITEM 4. (REMOVED AND RESERVED) 27
PART II 27
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 27
ITEM 6 SELECTED FINANCIAL DATA 29
ITEM 7 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION 29
ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 35
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 36
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL MATTERS 37
ITEM 9A. CONTROLS AND PROCEDURES 37
ITEM 9B OTHER INFORMATION 39
PART III 39
ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 39
ITEM 11. EXECUTIVE COMPENSATION 44
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 48
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 50
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 51
PART IV 51
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 51
SIGNATURES 57


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Forward-Looking Statements

This Annual Report on Form 10-K includes forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, 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 Annual Report on Form 10-K. These risks are not exhaustive. Other sections of this Annual Report on Form 10-K include additional factors which could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable laws including the securities laws of the United States and Canada, we assume no obligation to update or supplement forward-looking statements.

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


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PART I

ITEM 1. BUSINESS

Our Current Business

We are a biopharmaceutical company engaged in the discovery and development of novel drug targets to treat serious diseases for which there are urgent unmet medical needs. The ANAVEX portfolio involves novel compounds (ligands) directed to sigma receptor in preclinical and clinical stages of development that target neurodegenerative diseases and cancer. Our lead drug candidate, ANAVEX 2-73, targeting Alzheimer’s disease (AD), entered first Human Clinical Trials (HCT) in the first quarter of 2011. This study was conducted in Germany in collaboration with ABX-CRO Advanced Pharmaceutical Services. On November 14, 2011, we announced the successful completion of a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73. We plan to continue preclinical work on other CNS compounds targeting epilepsy, depression and neuropathic pain provided sufficient capital is available. Additionally, we intend to further develop compounds in earlier preclinical phases, which target various types of cancer and continue to develop and expand our SIGMACEPTOR™ Discovery platform.

Our Pipeline

Our proprietary SIGMACEPTOR™ Discovery Platform has resulted in and continues to generate small molecule drug candidates with unique modes of action, by making use of our leading understanding of sigma receptors. Sigma receptors represent potential targets for therapeutics to potentially combat many human diseases, including AD. When bound by the appropriate ligands, these receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease.

With our SIGMACEPTOR™-N program, we are focused on developing disease-modifying treatments for CNS conditions using ligands that activate sigma-1 receptors. Among our lead CNS drug candidates, we have made significant progress with ANAVEX 2-73, our lead drug candidate for the treatment of AD, and ANAVEX 19-144, the only and active metabolite of ANAVEX 2-73.

Our molecules may offer a disease-modifying approach in AD. Preclinical data reveals that ANAVEX 2-73 and ANAVEX 19-144 exhibit significant anti-amnesic, neuroprotective and anticonvulsant properties in a variety of in vitro systems and specialized animal models. These activities involve sigma-1, muscarinic and NMDA receptors as well as ion channels, indicating a unique mode of action. 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. ANAVEX 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. ANAVEX 19-144 controls seizures and the epileptogenesis process in animal models. Moreover, its neuroprotective properties may prevent the process that causes long-term damage to tissue and cells as well as biochemical and physiological alterations to the brain from epileptic seizures.


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On November 14, 2011 we announced the successful completion of a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73. 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 volunteers. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.

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

We have also reported promising developments with ANAVEX 1-41, which is a sigma-1 agonist. Preclinical 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.

Our SIGMACEPTOR™-C program leverages the unique properties of sigma-1 and/or sigma-2 receptor ligands, which may allow for the development of a new class of promising drug candidates designed to combat various types of solid tumors. 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 are believed to 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. The compounds in our oncology program are in pre-clinical testing, and there is no guarantee that the activity demonstrated in pre-clinical models will be shown in human testing.

ANAVEX 7-1037, our lead drug candidate for the treatment of prostate cancer, 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 preclinical 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 emphasize the promise of sigma receptor ligands, highlighting the fact that these ligands may stop tumor growth and induce selective cell death in various tumor cell lines, including leukemia, melanoma and cancers of the colon, breast, prostate, lung, brain, ovary and kidney.


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Numerous additional compounds are currently in the early discovery and lead optimization stages of our SIGMACEPTOR™-N and SIGMACEPTOR™-C programs.

Diseases of the Central Nervous System

We believe that our compounds may be useful for the treatment of diseases of the central nervous system and cancer. We expect that the market for treatments for diseases of the central nervous system will grow over the next several decades. We believe that this expansion will be driven by the introduction of new technologies and products which will be developed as a result of a clearer understanding of the underlying biochemical mechanisms that cause neurological disorders. We believe that this enhanced understanding has led, and will continue to lead to the development of rationally designed drugs specifically targeted to the neuropharmacological mechanisms responsible for central nervous system disorders.

The market for treatments for diseases of the central nervous system is expected to be the fastest growing disease area over the next two decades for several reasons:

  • Improved patient and physician awareness of central nervous system disorders

  • Aging of the general population and greater risk of, for example, Alzheimer’s disease and other neurological conditions associated with aging

  • A better understanding of the neuropharmacological mechanisms underlying those disorders.

Central nervous system disorders include many of the classic diseases of old age, e.g., Parkinson’s and Alzheimer’s. Central nervous system disorders also include psychiatric disorders such as depression and schizophrenia.

Alzheimer’s disease

According to the World Health Organization, dementia currently affects an estimated 37 million people worldwide and approximately 50% of these cases are caused by Alzheimer’s disease (AD). The worldwide prevalence of AD was over 26 million in 2006, as reported by Johns Hopkins University. By 2050, it is anticipated to quadruple and 1 in 85 people worldwide are anticipated to be living with the disease. AD is considered to be a healthcare system ‘time-bomb’. Medications on the market today only treat the symptoms of AD -- they do not have the ability to stop its onset or its progression. Meanwhile, the majority of AD treatments currently in development are focused on reducing or dissolving amyloid-beta plaques. To date there have been several well-publicized failures of therapies that were highly effective at clearing amyloid-beta plaques but which had no impact on the disease.


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Depression

Depression is a major cause of morbidity worldwide according to the World Health Organization (“WHO”). According to statistics published by the WHO, lifetime prevalence varies widely, from 3% in Japan to 17% in the US. In most countries the number of people who would suffer from depression during their lives falls within an 8–12% range. In North America the probability of having a major depressive episode within a year-long period is 3–5% for males and 8–10% for females. Population studies have consistently shown major depression to be about twice as common in women as in men, although it is unclear why this happens. The relative increase in occurrence is related to pubertal development rather than chronological age which reaches adult ratios between the ages of 15 and 18, and appears associated with psychosocial more than hormonal factors.

The depression market is dominated by a large number of 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. It has been estimated that about 50 million people worldwide suffer from epilepsy, according to the International Bureau for Epilepsy, with almost 90% of these people located in developing countries. Epilepsy is more likely to occur in young children or people over the age of 65 years; however it can occur at any time. Epilepsy may be controlled, but not cured, with medication, although surgery may be considered in difficult cases. Nevertheless, over 30% of people with epilepsy do not have seizure control even with the best available medications.

The epilepsy market features two classes of drugs: older traditional Anti Epileptic Drugs and second generation Anti Epileptic Drugs, with the former marketed before 1980, and the latter marketed in the early 1990s and developed through intelligent synthetic design techniques. They are currently the driving force of the market. However, second generation anti-convulsants offer limited benefits in terms of efficacy over traditional anticonvulsants but often confer improvements in side effects and dosing. Because epilepsy afflicts sufferers in several different ways, there is considerable need for an array of drugs that can be used in combination with both traditional Anti Epileptic Drugs and second generations Anti Epileptic Drugs. Furthermore, with additional benefits in supplementary indications such as migraine prophylaxis, bipolar disorder and neuropathic pain, second-generation Anti Epileptic Drugs have greatly expanded the potential of the market for epilepsy treatments and are the driving force behind sales.

According to the International Bureau for Epilepsy, the world market for epilepsy therapies was estimated at US $ 10.4 billion in 2004 while this number is projected to increase to US $ 13.2 billion by 2010 and to US $ 15.3 billion by 2015.


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Neuropathic Pain

Neuralgia or neuropathic pain can be defined as a pain that is not related to activation of pain receptor cells in any part of the body. Neuralgia is a pain produced by a change in neurological structure or function. Unlike nociceptive pain, neuralgia exists with no continuous nociceptive input. Neuralgia falls into two categories: central neuralgia and peripheral neuralgia. This unusual pain is thought to be linked to four possible mechanisms: ion gate malfunctions; the nerve becomes mechanically sensitive and creates an ectopic signal; cross signals between large and small fibers; and malfunction due to damage in the central processor.

Neuralgia is often difficult to diagnose, and most treatments show little or no effectiveness. Diagnosis typically involves locating the damaged nerve by identifying missing sensory or motor function. Neuralgia is more difficult to be treated than 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.

Cancer

Cancer is the second leading cause of mortality worldwide, with seven million deaths per year globally. In the US, one in two men and one in three women are anticipated to develop cancer during their lifetime. From diagnosis, five year survival is estimated at 64% in the US and even lower in other countries. Currently available treatments are not effective for all patients, and have limited impact on survival for patients with metastatic disease. New treatments with novel mechanisms of action that can overcome resistance mechanisms, inhibit tumor cell proliferation, and trigger tumor cell death could offer greater therapeutic benefit and improved survival.

IMS estimates that the market for cancer drugs will reach $ 80 billion annually by 2012, almost double the 2007 value (IMS Global Oncology Forecast, 2008).

Malignant Melanoma

Malignant melanoma is due to uncontrolled growth of pigment cells, called melanocytes. It is predominantly a skin cancer, but can also occur in melanocytes found in the bowel and the eye. It is one of the less common types of skin cancer but causes the majority of skin cancer related deaths, accounting 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. Despite many years of intensive laboratory and clinical research, the sole effective cure is surgical resection of the primary tumor before it achieves a Breslow thickness greater than 1 mm. Around 160,000 new cases of melanoma are diagnosed each year, and it is more frequent in males. According to a World Health Organization (WHO) report about 48,000 melanoma related deaths occur worldwide per year.

Prostate Cancer

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.


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Rates of detection of prostate cancers vary widely across the world, with South and East Asia detecting less frequently than in Europe, and especially the United States.

Over 65% of men over the age of 70 estimated to carry microscopic evidence of the disease in their bodies. The growth in the number of cases of prostate cancer is expected to continue to be high in relation to other cancer types, with the market for treatments projected to reach $7 billion by 2015 as determined by IMS.

Pancreatic Cancer

Pancreatic cancer is a malignant neoplasm of the pancreas. In the United States approximately 42,000 new cases of pancreatic cancer were diagnosed and approximately 35,000 patients died in 2009 as a result. The prognosis is in general poor, as less than 5% of those diagnosed live for more than five years after diagnosis. Complete remission is extremely rare. About 95% of exocrine pancreatic cancers are adenocarcinomas. The remaining 5% include adenosquamous carcinomas, squamous cell carcinomas, and giant cell carcinomas. Exocrine pancreatic cancers are far more common than endocrine pancreatic cancers (islet cell carcinomas), which make up about 1% of total cases.

The Market in General

In 2010, IMS Health forecasts American annual spending on all pharmaceuticals to reach $880 billion in 2011.

In 2011, Medical Expenditure Panel Survey described a market for outpatient pharmaceutical prescriptions in America in excess of $230 billion, with CNS prescriptions as the second largest therapeutic expenditure at more than $35 billion.

The leading AD pharmaceutical treatment is Aricept® (donepezil). In 2010, Aricept® went ‘off patent’ with annual sales in excess of $3.5 billion.

Competition

The biopharmaceutical industry is intensely competitive in general. Furthermore, our business strategy is to target large unmet medical needs, and those markets are even more highly competitive

At this time, we view our competition as other biomedical development companies that are also trying to discover compounds to be used in the treatment of Alzheimer’s disease, and those companies already doing so. Those companies include Prana Biotechnology Limited (NASDAQ:PRAN), Elan Corporation, plc. (NYSE:ELN), Pfizer Inc. (NYSE:PFE), Forest Pharmaceuticals, Inc. (NYSE:FRX), Novartis AG (NYSE:NVS), GlaxoSmithKline Inc. (NYSE:GSK), Merck & Co., Inc. (NYSD:MRK), and F. Hoffman-La Roche Ltd. (SIX:ROG).


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Each of our competitors have greater capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development, obtaining regulatory approval, and pharmaceutical product manufacturing and marketing than we do. With these additional resources, our competitors will be able to respond to the rapid and significant technological changes in the biotechnology and pharmaceutical industries faster than we can. Our future success will depend in large part on our ability to acquire funding for our research and development. To continue to acquire funding for our research and development, we will likely have to show progress toward our goals and will eventually be expected to develop a compound that may result in a transaction with a major pharmaceutical company.

Our research and development is highly speculative and we may never discover or develop any compounds that we are capable of selling to pharmaceutical companies.

Rapid technological development, as well as new scientific developments, may result in our compounds becoming obsolete before we can recover any of the expenses incurred to develop them.

Patents, Trademarks and Intellectual Property

We currently own the following patents:

 ANAVEX INTELLECTUAL PROPERTY ASSETS
Title of Application/
Patent No./Jurisdiction
Filing/
Expiration

Claims
Patent No.
1002616/Greece
February 21, 1996
February 22, 2016
Synthesis and method of synthesis of molecule Tetrahydro - N, N - dimethyl - 2,2 - diphenyl - 3 - furanemethanamine (AE 37), with anticonvulsant, antidepressant and nootropic activity
Patent No.
1004208/Greece
October 15, 2001
October 14, 2021
Aminotetrahydrofuran derivatives, muscarinic/sigma/sodium channel ligands, with synergic sigma/muscarinic (neuroactivating) and sigma/sodium channel (neuroprotective) components, as prototypical activating – neuroprotectors and neuroregenerative drugs
Patent No.
1004868/Greece
April 22, 2003
April 21, 2023
Aminotetrahydrofuran derivatives, muscarinic/sigma/sodium channel ligands, ortho-and allo-sterically operating, as prototypical neuromodulating and neuroregenerative drugs
Patent No.
1005865/ Greece
January 17, 2007
January 16, 2027
New sigma (σ) receptor ligands with anti-apoptotic and/or pro- apoptotic properties over cellular biochemical mechanisms, with neuroprotective, anti-cancer, anti- metastatic and anti-(chronic) inflammatory action
Patent No.
1006794/Greece
February 26, 2009
February 27, 2029
Sigma (σ) receptor ligands with anti-apoptotic and/or pro-apoptotic properties, over cellular mechanisms, exhibiting prototypical cytoprotective and also anticancer activity
Patent Application
201100100140
Greece
March 9, 2010
March 10, 2030
Synthesis and method of synthesis of molecules 1- methylo-4-[4,4-difainylo-4(Adantylo1-boutylo)] piperzine and its structural analogues with anticancer properties


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Patent Application
20110100397
Greece
July 8, 2011
July 7, 2031
Synthesis of (+) and (-) 1-(5,5-difainylotetraydrofourane-
3-yl)-Ν,Ν-dimethylomethylamine, (+) and (-) 1-(2,2-
difainylotetraydrofourane-3-yl)-Ν,Ν-
dimethylomethylamine, and (+) and (-) 1-(2,2-
difainylotetraydrofourane-3-yl)-Ν- methylomethylamine
PATENTS AND PATENTS APPLICATIONS REGISTERED WITH THE WORLD INTELLECTUAL
ORGANISATION (WIPO) UNDER THE PATENT COOPERATION TREATY (PCT)
PCT/ National Phase
- GR 2008/000002

Europe – 08702158.0
USA – 12/522.761
Russia – 2009125211
India – 2392/KOLNP/2009
China – 200880002334.5
Hong Kong 004800011111
January 17, 2007


May 28, 2009
July 10, 2009
June 26, 2009
June 29, 2009
July 16, 2009
July 2, 2010
On basis of Greek Patent 1005865
(Application 20070100020/17-01-2007)
PCT Request
International Filing
GR2010/000009

India – 3266/KOLNP/2011
Russia – 2011131708
USA – 13/201.271
China – 201080009029.6
Europe – 10706348.9
February 17, 2010



July 19, 2011
July 28, 2011
August 12, 2011
August 23, 2011
August 30, 2011
On basis of Greek Patent 1006794
(Application 20090100115/26-02-2009)

We regard patents and other proprietary technology rights a key element in our goal of building a successful biomedical company. Accordingly, we plan to protect all of our key technology, inventions and improvements to our inventions by filing patent applications in a timely fashion. We are currently seeking patent protection in the United States, China, Russia, India and Europe and intend to seek protection for additional countries on a selective basis for our compounds or other inventions and improvements. However, we note that filing and prosecuting patent applications are expensive processes and we have very limited financial resources.

We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. It is now our policy to require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, and other advisors to execute confidentiality agreements upon the commencement of employment, advisory, or consulting relationships with us. We expect that these agreements will provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances.

We also intend to require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements will generally provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as our exclusive property. There can be no assurance, however, that all persons who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.


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Our patent position, like that of many biomedical companies, is uncertain and involves complex legal and technical questions for which important legal principles are unresolved. Much of our intellectual property is still only filed with the Greek National Office of Industrial Property and we plan to file additional patent applications in Canada and the U.S. for further inventions. We may not be successful in obtaining critical claims or in protecting our potential drug compounds or processes. Even if we do obtain patents, they may not adequately protect the technology we own or have licensed. In addition, others may challenge, seek to invalidate, infringe or circumvent any patents we own or license, and rights we receive under those patents may not provide competitive advantages to us. Further, the manufacture, use or sale of our potential drug compounds may infringe the patent rights of others.

Our success will also depend in part on our ability to commercialize our compounds without infringing the proprietary rights of others. We have not conducted extensive freedom of use patent searches and no assurance can be given that patents do not exist or could not be filed which would have an adverse affect on our ability to market our technology or maintain our competitive position with respect to our technology. If our compounds or other subject matter are claimed under other existing United States or other patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions. In such event, we may challenge the validity of such patents or other proprietary rights or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology. There can be no assurances that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms. Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing all of our potential drug compounds based on our drug technology or the inability to proceed with the development, manufacture or sale of potential drug compounds requiring such licenses, which could have a material adverse affect on our business, financial condition and results of operations. If we are required to defend ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether we are successful. Such proceedings are typically protracted with no certainty of success. An adverse outcome could subject us to significant liabilities to third parties and force us to curtail or cease our research and development of our technology.

Government Approval

Regulation by governmental authorities in the United States and foreign countries is a significant factor in the development, manufacture, and expected marketing of our potential drug compounds and in our ongoing research and development activities. The nature and extent to which such regulation will apply to us will vary depending on the nature of any potential drug compounds developed. We anticipate that all of our potential drug compounds will require regulatory approval by governmental agencies prior to commercialization.


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In particular, human therapeutic products are subject to rigorous non-clinical and clinical testing and other approval procedures of the FDA and similar regulatory authorities in other countries. Various federal statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage, and record-keeping related to such products and their marketing. The process of obtaining these approvals and the subsequent compliance with the appropriate federal statutes and regulations requires substantial time and financial resources. Any failure by us or our collaborators to obtain, or any delay in obtaining, regulatory approval could adversely affect the marketing of any potential drug compounds developed by us, our ability to receive product revenues, and our liquidity and capital resources.

The steps ordinarily required before a new drug may be marketed in the United States, which are similar to steps required in most other countries, include:

  • non-clinical laboratory tests, non-clinical studies in animals, formulation studies and the submission to the FDA of an investigational new drug application;

  • adequate and well-controlled clinical trials to establish the safety and efficacy of the drug;

  • the submission of a new drug application or biologic license application to the FDA; and

  • FDA review and approval of the new drug application or biologics license application.

Non-clinical tests include laboratory evaluation of potential drug compound chemistry, formulation and toxicity, as well as animal studies. The results of non-clinical testing are submitted to the FDA as part of an investigational new drug application. A 30-day waiting period after the filing of each investigational new drug application is required prior to commencement of clinical testing in humans. At any time during the 30-day period or at any time thereafter, the FDA may halt proposed or ongoing clinical trials until the FDA authorizes trials under specified terms. The investigational new drug application process may be extremely costly and substantially delay the development of our potential drug compounds. Moreover, positive results of non-clinical tests will not necessarily indicate positive results in subsequent clinical trials. The FDA may require additional animal testing after an initial investigational new drug application is approved and prior to Phase III trials.

Clinical trials to support new drug applications are typically conducted in three sequential phases, although the phases may overlap. During Phase I, clinical trials are conducted with a small number of subjects to assess metabolism, pharmacokinetics, and pharmacological actions and safety, including side effects associated with increasing doses. Phase II usually involves studies in a limited patient population to assess the efficacy of the drug in specific, targeted indications; assess dosage tolerance and optimal dosage; and identify possible adverse effects and safety risks.

If a compound is found to be potentially effective and to have an acceptable safety profile in Phase I and II evaluations, Phase III trials are undertaken to further demonstrate clinical efficacy and to further test for safety within an expanded patient population at geographically dispersed clinical trial sites.


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After successful completion of the required clinical trials, a new drug application is generally submitted. The FDA may request additional information before accepting the new drug application for filing, in which case the new drug application must be resubmitted with the additional information. Once the submission has been accepted for filing, the FDA reviews the new drug application and responds to the applicant. The FDA’s requests for additional information or clarification often significantly extend the review process. The FDA may refer the new drug application to an appropriate advisory committee for review, evaluation, and recommendation as to whether the new drug application should be approved, although the FDA is not bound by the recommendation of an advisory committee.

The Food and Drug Administration’s Modernization Act codified the FDA’s policy of granting “fast track” review of certain therapies targeting “orphan” indications and other therapies intended to treat severe or life threatening diseases and having potential to address unmet medical needs. Orphan indications are defined by the FDA as having a prevalence of less than 200,000 patients in the United States. We anticipate that certain neurodegenerative diseases which could potentially be treated using our technology could qualify for fast track review under these revised guidelines.

Previously, the FDA approved cancer therapies primarily based on patient survival rates or data on improved quality of life. The FDA considered evidence of partial tumor shrinkage, while often part of the data relied on for approval was insufficient by itself to warrant approval of a cancer therapy, except in limited situations. Under the FDA’s revised policy, which became effective in 1998, the FDA has broadened authority to consider evidence of partial tumor shrinkage or other clinical outcomes for approval. This revised policy is intended to facilitate the study of solid tumor therapies and shorten the total time for marketing approvals. We intend to take advantage of this policy; however, it is too early to tell what effect, if any, these provisions may have on the approval of our potential drug compounds.

Sales outside the United States of potential drug compounds we develop will also be subject to foreign regulatory requirements governing human clinical trials and marketing for drugs. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources. In most cases, if the FDA has not approved a potential drug compound for sale in the United States, the potential drug compound may be exported for sale outside of the United States, only if it has been approved in any one of the following: the European Union, Canada, Australia, New Zealand, Japan, Israel, Switzerland and South Africa. There are specific FDA regulations that govern this process.

We are also subject to various federal, state, local, and foreign laws, regulations and recommendations relating to safe working conditions, laboratory and manufacturing practices, and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research work. We cannot accurately predict the extent of government regulation that might result from future legislation or administrative action.


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Research and Development Expenses

A significant portion of our operating expenses is related to research and development, and we intend to maintain a strong commitment to research and development activities. See Item 8 “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K for costs and expenses related to research and development, and other financial information for fiscal years 2011 and 2010.

Scientific Advisory Board

We maintain a Scientific Advisory Board comprised of scientists with experience relevant to our company and our product candidates. Members of our Scientific Advisory Board have agreed to consult and advise us in their respective areas of expertise. We have placed special emphasis on identifying members of our Scientific Advisory Board with expertise in the treatment of the clinical indications targeted by our programs. Our Scientific Advisory Board consists of the following members:

Alexandre Vamvakides, Ph.D. Dr. Vamvakides has spent 30 years in research, focusing on the therapeutic/pharmacological areas of anti-neurodegenerative, antiepileptic and anti-depressive molecules. The author of more than 80 scientific papers, he has worked at the Institut national de la santé et de la recherche médicale (INSERM), the University of Athens, Ciba-Geigy (now Novartis), Sanofi (now sanofi-aventis) and many other research laboratories throughout Europe, for the discovery and development of new concepts in the therapeutic areas of CNS, oncology and anti-inflammatory diseases. Dr. Vamvakides entered into an agreement by which he transferred intellectual property to Anavex in exchange for certain consideration. His consideration includes a royalty on commercial sales based on the intellectual property transferred. To date, the Company’s product development has been based exclusively on intellectual property received in the transfer.

Tangui Nicolas Maurice, Ph.D. Dr. Maurice has spent 15 years in the field of neurosciences, including behavioral and molecular neuropharmacology, sigma receptors, neuropeptides, neurosteroids, neurotrophic factors, normal/pathological aging models for Alzheimer’s and related disorders, and behavioural phenotyping of rodent models. Previously, Dr. Maurice held research positions with INSERM U710 at Montpellier, CNRS, INSERM U336, the department of neuropsychopharmacology and hospital pharmacy at Meijo University (Nagoya, Japan), and Jouveinal Research Institute (Fresnes, France). A past recipient of the CNRS bronze medal, Dr. Maurice holds a Ph.D. in cellular and molecular biology with a specialty in neuropharmacology from Université Montpellier.

Dr. Paul Aisen. Dr. Aisen is a leading clinician and researcher in Alzheimer’s disease clinical trials and is on the faculty of the University of California, San Diego (UCSD) School of Medicine’s Department of Neurosciences. His primary research interests focus on the development of new strategies for the treatment of Alzheimer’s disease. Since 2007, Dr. Aisen has been Director of the Alzheimer’s Disease Cooperative Study, a consortium funded by the National Institute on Aging (NIA) to develop assessment instruments and conduct clinical trials. Dr. Aisen is Associate Editor of Alzheimer’s Research and Therapy, a major international peer-reviewed journal, and sits on the editorial board of BMC Medicine. He has published more than 180 peer-reviewed papers.


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Dr. Rachelle Doody. Dr. Doody is the Effie Marie Cain Chair in Alzheimer’s Disease Research and Professor of Neurology at Baylor College of Medicine, where she received an M.D. She completed internship and residency training at the Royal Victoria Hospital and Montreal Neurologic Institute in Montreal, and at Baylor College of Medicine. Dr. Doody has a Ph.D. in Cognitive Anthropology from Rice University and has published over 135 original articles. She participates in national and international collaborative efforts, review boards, and advisory boards including Steering Committees for the NIH AD Cooperative Study and the AD Neuroimaging Initiative.

Dr. Jeffrey Cummings. Dr. Cummings is Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic and Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada and Cleveland, Ohio. Dr. Cummings was formerly the Augustus S. Rose Professor of Neurology and Professor of Psychiatry and Biobehavioral Sciences at the David Geffen School of Medicine at UCLA, Los Angeles, California. He was Director of the Mary S. Easton Center for Alzheimer’s Disease Research and Director of the Deane F. Johnson Center for Neurotherapeutics at UCLA. Dr. Cummings has expertise in neuropsychiatric assessment, outcomes in clinical trials, clinical trial design and analysis, and global clinical trials and is an experienced consultant to industry.

Officers

We currently engage the services of two consultants who act for our company in the capacity of president, secretary, chief operating officer and interim chief financial officer, and executive director respectively. We also have 14 consultants assisting us in our research and development activities.

ITEM 1 A. RISK FACTORS

In addition to other information in this annual report, the following risk factors should be carefully considered in evaluating our business because such factors may have a significant impact on our business, operating results, liquidity and financial condition. As a result of the risk factors set forth below, actual results could differ materially from those projected in any forward-looking statements. Additional risks and uncertainties not presently known to us, or that we currently consider to be immaterial, may also impact our business, operating results, liquidity and financial condition. If any such risks occur, our business, operating results, liquidity and financial condition could be materially affected in an adverse manner. Under such circumstances, the trading price of our securities could decline, and you may lose all or part of your investment.


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Risks Related to our Company

We have had a history of losses and no revenue, which raise substantial doubt about our ability to continue as a going concern.

Since inception on January 23, 2004, we have incurred aggregate net losses of $ 28,652,417 from operations. We can offer no assurance that we will ever operate profitably or that we will generate positive cash flow in the future. To date, we have not generated any revenues from our operations. Our history of losses and no revenues raise substantial doubt about our ability to continue as a going concern. As a result, our management expects the business to continue to experience negative cash flow for the foreseeable future and cannot predict when, if ever, our business might become profitable. We will need to raise additional funds, and such funds may not be available on commercially acceptable terms, if at all. If we are unable to raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements. This may seriously harm our business, financial condition and results of operations.

We are an early development stage pharmaceutical research and development company and may never be able to successfully develop marketable products or generate any revenue. We have a very limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.

We are an early development stage company and have not generated any revenues to date and have no operating history. All of our potential drug compounds are in the concept stage or early clinical development stage. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our potential drug compounds will ever be approved for sales to pharmaceutical companies or generate commercial revenues. We have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of potential drug compounds either in non-clinical testing or in clinical trials, failure to establish business relationships and competitive disadvantages as against larger and more established companies. If we fail to become profitable, we may suspend or cease operations.

We will need additional funding and may be unable to raise additional capital when needed, which would force us to delay, reduce or eliminate our research and development activities.

We will need to raise additional funding, but the current economic condition will most likely have a negative impact on our ability to raise additional needed capital on terms that are favorable to our company or at all. We do not anticipate that we will generate significant revenues for several years, if at all. Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing. We cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research and development activities.


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We may be unable to continue as a going concern in which case our securities will have little or no value.

Our independent auditors have noted in their report concerning our annual financial statements for the fiscal year ended September 30, 2011 that we have incurred substantial losses since inception, which raises substantial doubt about our ability to continue as a going concern. In the event we are not able to continue operations you will likely suffer a complete loss of your investment in our securities.

Risks Related to our Business

Even if we are able to develop our potential drug compounds, we may not be able to receive regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results and financial condition and we will have to delay or terminate some or all of our research and development plans and we may be forced to cease operations.

All of our potential drug compounds will require extensive additional research and development, including non-clinical testing and clinical trials, as well as regulatory approvals, before we can market them. We cannot predict if or when any of the potential drug compounds we intend to develop will be approved for marketing. There are many reasons that we may fail in our efforts to develop our potential drug compounds. These include:

  • the possibility that non-clinical testing or clinical trials may show that our potential drug compounds are ineffective and/or cause harmful side effects;

  • our potential drug compounds may prove to be too expensive to manufacture or administer to patients;

  • our potential drug compounds may fail to receive necessary regulatory approvals from the United States Food and Drug Administration or foreign regulatory authorities in a timely manner, or at all;

  • even if our potential drug compounds are approved, we may not be able to produce them in commercial quantities or at reasonable costs;

  • even if our potential drug compounds are approved, they may not achieve commercial acceptance;

  • regulatory or governmental authorities may apply restrictions to any of our potential drug compounds, which could adversely affect their commercial success; and

  • the proprietary rights of other parties may prevent us or our potential collaborative partners from marketing our potential drug compounds.


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If we fail to develop our potential drug compounds, our financial results and financial condition will be adversely affected, we will have to delay or terminate some or all of our research and development plans and may be forced to cease operations.

Our research and development plans will require substantial additional future funding which could impact our operational and financial condition. Without the required additional funds, we will likely cease operations.

It will take several years before we are able to develop potentially marketable products, if at all. Our research and development plans will require substantial additional capital, arising from costs to:

  • conduct research, non-clinical testing and human studies;

  • establish pilot scale and commercial scale manufacturing processes and facilities; and

  • establish and develop quality control, regulatory, marketing, sales, finance and administrative capabilities to support these programs.

Our future operating and capital needs will depend on many factors, including:

  • the pace of scientific progress in our research and development programs and the magnitude of these programs;

  • the scope and results of preclinical testing and human studies;

  • the time and costs involved in obtaining regulatory approvals;

  • the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;

  • competing technological and market developments;

  • our ability to establish additional collaborations;

  • changes in our existing collaborations;

  • the cost of manufacturing scale-up; and

  • the effectiveness of our commercialization activities.

We base our outlook regarding the need for funds on many uncertain variables. Such uncertainties include the success of our research initiatives, regulatory approvals, the timing of events outside our direct control such as negotiations with potential strategic partners and other factors. Any of these uncertain events can significantly change our cash requirements as they determine such one-time events as the receipt or payment of major milestones and other payments.


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Additional funds will be required to support our operations and if we are unable to obtain them on favorable terms, we may be required to cease or reduce further research and development of our drug product programs, sell some or all of our intellectual property, merge with another entity or cease operations.

If we fail to demonstrate efficacy in our non-clinical studies and clinical trials our future business prospects, financial condition and operating results will be materially adversely affected.

The success of our research and development efforts will be greatly dependent upon our ability to demonstrate potential drug compound efficacy in non-clinical studies, as well as in clinical trials. Non-clinical studies involve testing potential drug compounds in appropriate non-human disease models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in humans. If certain non-clinical data reveals potential safety issues or the results are inconsistent with an expectation of the potential drug compound’s efficacy in humans, the regulatory agencies may require additional more rigorous testing, before allowing human clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our potential drug compounds if, in the judgment of our management and advisors, the non-clinical test results do not support further development.

Moreover, success in non-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and non-clinical testing. The clinical trial process may fail to demonstrate that our potential drug compounds are safe for humans and effective for indicated uses. This failure would cause us to abandon a drug candidate and may delay development of other potential drug compounds. Any delay in, or termination of, our non-clinical testing or clinical trials will delay the filing of an investigational new drug application and new drug application with the Food and Drug Administration or the equivalent applications with pharmaceutical regulatory authorities outside the United States and, ultimately, our ability to commercialize our potential drug compounds and generate product revenues. In addition, we expect that our early clinical trials will involve small patient populations. Because of the small sample size, the results of these early clinical trials may not be indicative of future results.

Following successful non-clinical testing, potential drug compounds will need to be tested in a clinical development program to provide data on safety and efficacy prior to becoming eligible for product approval and licensure by regulatory agencies. From the first human trial through to regulatory approval can take many years and 10-12 years is not unusual for certain compounds.

If any of our future clinical development potential drug compounds become the subject of problems, our ability to sustain our development programs will become critically compromised. For example, efficacy or safety concerns may arise, whether or not justified, that could lead to the suspension or termination of our clinical programs. Examples of problems that could arise include, among others:

  • efficacy or safety concerns with the potential drug compounds, even if not justified;

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  • manufacturing difficulties or concerns;

  • regulatory proceedings subjecting the potential drug compounds to potential recall;

  • publicity affecting doctor prescription or patient use of the potential drug compounds;

  • pressure from competitive products; or

  • introduction of more effective treatments.

Each clinical phase is designed to test attributes of the drug and problems that might result in the termination of the entire clinical plan can be revealed at any time throughout the overall clinical program. The failure to demonstrate efficacy in our clinical trials would have a material adverse effect on our future business prospects, financial condition and operating results.

If we do not obtain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be limited, which would have a material adverse effect on our business.

We will need to establish relationships with leading scientists and research institutions. We believe that such relationships are pivotal to establishing products using our technologies as a standard of care for various indications. Additionally, although in discussion, there is no assurance that our current research partners will continue to work with us or that we will be able to attract additional research partners. If we are not able to establish scientific relationships to assist in our research and development, we may not be able to successfully develop our potential drug compounds. If this happens, our business will be adversely affected.

We may not be able to develop market or generate sales of our products to the extent anticipated. Our business may fail and investors could lose all of their investment in our company.

Assuming that we are successful in developing our potential drug compounds and receiving regulatory clearances to market our products, our ability to successfully penetrate the market and generate sales of those products may be limited by a number of factors, including the following:

  • If our competitors receive regulatory approvals for and begin marketing similar products in the United States, the European Union, Japan and other territories before we do, greater awareness of their products as compared to ours will cause our competitive position to suffer;

  • Information from our competitors or the academic community indicating that current products or new products are more effective or offer compelling other benefits than our future products could impede our market penetration or decrease our future market share; and,

  • The pricing and reimbursement environment for our future products, as well as pricing and reimbursement decisions by our competitors and by payers, may have an effect on our revenues.


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If this happens, our business will be adversely affected.

None of our potential drug compounds may reach the commercial market for a number of reasons and our business may fail.

Successful research and development of pharmaceutical products is high risk. Most products and development candidates fail to reach the market. Our success depends on the discovery of new drug compounds that we can commercialize. It is possible that our products may never reach the market for a number of reasons. They may be found ineffective or may cause harmful side-effects during non-clinical testing or clinical trials or fail to receive necessary regulatory approvals. We may find that certain products cannot be manufactured at a commercial scale and, therefore, they may not be economical to produce. Our potential products could also fail to achieve market acceptance or be precluded from commercialization by proprietary rights of third parties. Our patents, trademarks and other intellectual property may be challenged and this may delay or prohibit us from effectively commercializing our products. Furthermore, we do not expect our potential drug compounds to be commercially available for a number of years, if at all. If none of our potential drug compounds reach the commercial market, our business will likely fail and investors will lose all of their investment in our company. If this happens, our business will be adversely affected.

If our competitors succeed in developing products and technologies that are more effective or with a better profile than our own, or if scientific developments change our understanding of the potential scope and utility of our potential products, then our technologies and future products may be rendered undesirable or obsolete.

We face significant competition from industry participants that are pursuing technologies in similar disease states to those that we are pursuing and are developing pharmaceutical products that are competitive with our products. Nearly all of our industry competitors have greater capital resources, larger overall research and development staffs and facilities, and a longer history in drug discovery and development, obtaining regulatory approval and pharmaceutical product manufacturing and marketing than we do. With these additional resources, our competitors may be able to respond to the rapid and significant technological changes in the biotechnology and pharmaceutical industries faster than we can. Our future success will depend in large part on our ability to maintain a competitive position with respect to these technologies. Rapid technological development, as well as new scientific developments, may result in our products becoming obsolete before we can recover any of the expenses incurred to develop them. For example, changes in our understanding of the appropriate population of patients who should be treated with a targeted therapy like we are developing may limit the drug’s market potential if it is subsequently demonstrated that only certain subsets of patients should be treated with the targeted therapy.


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Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them.

In the course of product development, we may engage university laboratories, other biotechnology companies or contract or clinical manufacturing organizations to manufacture drug material for us to be used in non-clinical and clinical testing and contract research organizations to conduct and manage non-clinical and clinical studies. If we engage these organizations to help us with our non-clinical and clinical programs, many important aspects of this process have been and will be out of our direct control. If any of these organizations we may engage in the future fail to perform their obligations under our agreements with them or fail to perform non-clinical testing and/or clinical trials in a satisfactory manner, we may face delays in completing our clinical trials, as well as commercialization of any of our potential drug compounds. Furthermore, any loss or delay in obtaining contracts with such entities may also delay the completion of our clinical trials, regulatory filings and the potential market approval of our potential drug compounds.

If we fail to compete successfully with respect to partnering, licensing, mergers, acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to research and develop our potential drug compounds.

Our competitors compete with us to attract established biotechnology and pharmaceutical companies or organizations for partnering, licensing, mergers, acquisitions, joint ventures or other collaborations. Collaborations include contracting with academic research institutions for the performance of specific scientific testing. If our competitors successfully enter into partnering arrangements or license agreements with academic research institutions, we will then be precluded from pursuing those specific opportunities. Since each of these opportunities is unique, we may not be able to find a substitute. Other companies have already begun many drug development programs, which may target diseases that we are also targeting, and have already entered into partnering and licensing arrangements with academic research institutions, reducing the pool of available opportunities.

Universities and public and private research institutions also compete with us. While these organizations primarily have educational or basic research objectives, they may develop proprietary technology and acquire patents that we may need for the development of our potential drug compounds. We will attempt to license this proprietary technology, if available. These licenses may not be available to us on acceptable terms, if at all. If we are unable to compete successfully with respect to acquisitions, joint venture and other collaboration opportunities, we may be limited in our ability to develop new products.


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The use of any of our products in clinical trials may expose us to liability claims, which may cost us a significant amounts of money to defend against or pay out, causing our business to suffer.

The nature of our business exposes us to potential liability risks inherent in the testing, manufacturing and marketing of our products. We currently have one drug compound in clinical trials, however, when any of our products enter into clinical trials or become marketed products they could potentially harm people or allegedly harm people and we may be subject to costly and damaging product liability claims. Some of the patients who participate in clinical trials are already ill when they enter a trial or may intentionally or unintentionally fail to meet the exclusion criteria. The waivers we obtain may not be enforceable and may not protect us from liability or the costs of product liability litigation. Although we intend to obtain product liability insurance that we believe is adequate, we are subject to the risk that our insurance will not be sufficient to cover claims. The insurance costs along with the defence or payment of liabilities above the amount of coverage could cost us significant amounts of money and management distraction from other elements of the business, causing our business to suffer.

The patent positions of biopharmaceutical products are complex and uncertain and we may not be able to protect our patented or other intellectual property. If we cannot protect this property, we may be prevented from using it or our competitors may use it and our business could suffer significant harm. Also, the time and money we spend on acquiring and enforcing patents and other intellectual property will reduce the time and money we have available for our research and development, possibly resulting in a slow down or cessation of our research and development.

We own patents related to our potential drug compounds. However, these patents do not ensure the protection of our intellectual property for a number of reasons, including the following:

1.           Competitors may interfere with our patent process in a variety of ways. Competitors may claim that they invented the claimed invention prior to us. Competitors may also claim that we are infringing their patents and restrict our freedom to operate as claimed under our patents and patent applications. Competitors may also contest our patents and patent application, if issued, by showing the patent examiner that the invention was not original, was not novel or was obvious. In litigation, a competitor could claim that our patents and patent application are not valid for a number of reasons. If a court agrees, we would lose that patents or patent application. As a company, we have no meaningful experience with competitors interfering with our patents or patent applications.

2.           Because of the time, money and effort involved in obtaining and enforcing patents, our management may spend less time and resources on developing potential drug compounds than they otherwise would, which could increase our operating expenses and delay product programs.

3.           Receipt of a patent may not provide much practical protection. If we receive a patent with a narrow scope, then it will be easier for competitors to design products that do not infringe our patent(s).

4.           Our patents are not issued in all possible geographies where our products may be marketed. Currently, we have submitted for patent protection and have been issued patents for certain claims in Greece. We have submitted for patent protection on all of the major markets in the world. We may not necessarily be successful in securing patents for further claims and products in Greece, nor may we necessarily be successful in securing the existing claims and product patents in countries and jurisdictions where we have applied but have not yet had those patents issued. If we do not receive issued patents in these other key markets, our ability to advance our compounds will be severely hampered and we will be much less attractive to potential partners.


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5.           In addition, competitors also seek patent protection for their inventions. Due to the number of patents in our field, we cannot be certain that we do not infringe on existing patents or that we will not infringe on patents granted in the future. If a patent holder believes our potential drug compound infringes on their patent, the patent holder may sue us even if we have received patent protection for our technology. If someone else claims we infringe on their patent, we would face a number of issues which could cause a slow down or cessation of our research and development, including the following:

(a)          Defending a lawsuit takes significant time and can be very expensive.

(b)          If the court decides that our potential drug compound infringes on the competitor’s patent, we may have to pay substantial damages for past infringement.

(c)          The court may prohibit us from selling or licensing the potential drug compound unless the patent holder licenses the patent to us. The patent holder is not required to grant us a license. If a license is available, we may have to pay substantial royalties or grant cross licenses to our patents.

(d)          Redesigning our potential drug compounds so that they do not infringe on other patents may not be possible or could require substantial funds and time.

It is also unclear whether our trade secrets are adequately protected. While we use reasonable efforts to protect our trade secrets, our employees or consultants may unintentionally or willfully disclose our information to competitors. Enforcing a claim that someone else illegally obtained and is using our trade secrets, like patent litigation, is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Our competitors may independently develop equivalent knowledge, methods and know-how.

We may also support and collaborate in research conducted by government organizations, hospitals, universities or other educational institutions. These research partners may be unwilling to grant us any exclusive rights to technology or products derived from these collaborations prior to entering into the relationship.

If we do not obtain required licenses or rights, we could encounter delays in our product development efforts while we attempt to design around other patents or even be prohibited from developing, manufacturing or selling potential drug compounds requiring these licenses. There is also a risk that disputes may arise as to the rights to technology or potential drug compounds developed in collaboration with other parties.


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We incur substantial costs as a result of laws and regulations and proposed changes in laws and regulations and we cannot predict the impact of any future changes in law.

We face burdens relating to corporate governance and financial reporting standards. Legislations or regulations such as Section 404 of the Sarbanes-Oxley Act of 2002 impose strict corporate governance and financial reporting standards and have led to substantial costs of compliance including consulting, auditing and legal fees. Any new rules could make it more difficult or more costly for us to obtain certain types of insurance, including directors’ and officers’ liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these events could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers. A failure to comply with these new laws and regulations may impact market perception of our financial condition and could materially harm our business. Additionally, it is unclear what additional laws or regulations may develop, and we cannot predict the ultimate impact of any future changes in law.

Our substantial debt and other financial obligations could impair our financial condition and our ability to fulfill our debt obligations. Any refinancing of this substantial debt could be at significantly higher interest rates.

As of September 30, 2011, we had total liabilities of $1,345,443 and accumulated deficit of $29,203,221. Our substantial indebtedness and other current financial obligations and any that we may become a party to in the future could:

  • impair our ability to obtain financing in the future for working capital, capital expenditures, or general corporate purposes;

  • have a material adverse effect on us if we fail to comply with financial and affirmative and restrictive covenants in debt agreements and an event of default occurs as a result of a failure that is not cured or waived;

  • require us to dedicate a substantial portion of our cash flow for interest payments on our indebtedness and other financial obligations, thereby reducing the availability of our cash flow to fund working capital and capital expenditures;

  • limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; and

  • place us at a competitive disadvantage compared to our competitors that have proportionally less debt.

If we are unable to meet our debt service obligations and other financial obligations, we could be forced to restructure or refinance our indebtedness and other financial transactions, seek additional equity capital or sell our assets. We might then be unable to obtain such financing or capital or sell our assets on satisfactory terms, if at all. Any refinancing of our indebtedness could be at significantly higher interest rates, and/or incur significant transaction fees.


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Risks Related to our Common Stock

A decline in the price of our common stock could affect our ability to raise further working capital and adversely impact our operations and would severely dilute existing or future investors if we were to raise funds at lower prices.

A prolonged decline in the price of our common stock could result in a reduction in our ability to raise capital. Because our operations have been financed through the sale of equity securities, a decline in the price of our common stock could be especially detrimental to our continued operations. Any reduction in our ability to raise equity capital in the future would force us to reallocate funds from other planned uses and would have a significant negative effect on our business plans and operations, including our ability to develop new products and continue our current operations. If the stock price declines, there can be no assurance that we can raise additional capital or generate funds from operations sufficient to meet our obligations. We believe the following factors could cause the market price of our common stock to continue to fluctuate widely and could cause our common stock to trade at a price below the price at which you purchase your shares of common stock:

  • actual or anticipated variations in our quarterly operating results;

  • announcements of new services, products, acquisitions or strategic relationships by us or our competitors;

  • changes in accounting treatments or principles;

  • changes in earnings estimates by securities analysts and in analyst recommendations; and

  • general political, economic, regulatory and market conditions.

The market price for our common stock may also be affected by our ability to meet or exceed expectations of analysts or investors. Any failure to meet these expectations, even if minor, could materially adversely affect the market price of our common stock.

If we issue additional shares of common stock in the future, it will result in the dilution of our existing stockholders.

Our articles of incorporation authorize the issuance of 150,000,000 shares of common stock. Our board of directors has the authority to issue additional shares of common stock up to the authorized capital stated in the articles of incorporation. Our board of directors may choose to issue some or all of such shares of common stock to acquire one or more businesses or to provide additional financing in the future. The issuance of any such shares of common stock will result in a reduction of the book value or market price of the outstanding shares of our common stock. If we do issue any such additional shares of common stock, such issuance also will cause a reduction in the proportionate ownership and voting power of all other stockholders. Further, any such issuance may result in a change of control of our corporation.


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Trading of our common stock may be volatile and sporadic, which could depress the market price of our common stock and make it difficult for our stockholders to resell their shares.

There is currently a limited market for our common stock and the volume of our common stock traded on any day may vary significantly from one period to another. Our common stock is quoted on the OTC Bulletin Board. Trading in stock quoted on the OTC Bulletin Board is often thin and characterized by wide fluctuations in trading prices, due to many factors that may have little to do with our operations or business prospects. The availability of buyers and sellers represented by this volatility could lead to a market price for our common stock that is unrelated to operating performance. Moreover, the OTC Bulletin Board is not a stock exchange, and trading of securities quoted on the OTC Bulletin Board is often more sporadic than the trading of securities listed on a stock exchange like NASDAQ. There is no assurance that a sufficient market will develop in the stock, in which case it could be difficult for our stockholders to resell their stock.

Our stock is classed as a “penny stock”. Trading of our stock may be restricted by the Securities and Exchange Commission’s penny stock regulations which may limit a stockholder’s ability to buy and sell our stock.

Our stock is a penny stock. The Securities and Exchange Commission has adopted Rule 15g-9 which generally defines “penny stock” to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors”. The term “accredited investor” refers generally to institutions with assets in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 (excluding the value of the primary residence of such individuals) or annual income exceeding $200,000 or $300,000 jointly with their spouse. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the Securities and Exchange Commission which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer’s confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules discourage investor interest in and limit the marketability of our common stock.


26

The Financial Industry Regulatory Authority sales practice requirements may also limit a stockholder’s ability to buy and sell our stock.

In addition to the “penny stock” rules described above, the Financial Industry Regulatory Authority or FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. The FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for shares of our common stock.

ITEM 1B. UNRESOLVED STAFF COMMENTS

Not Applicable.

ITEM 2. PROPERTIES

We currently contract with Eurogenet Labs SA, a private Greek company with a research laboratory located at 27 Marathonos Ave., 15351 Athens, Greece for our research activities. This facility comprises approximately 10,000 square feet. This facility is leased on a month to month basis for $125,000 per month and which amount is included in research and development expenses in our financial statements.

ITEM 3. LEGAL PROCEEDINGS

We know of no material, existing or pending legal proceedings to which we are a party or of which any of our properties is the subject. In addition, we do not know of any such proceedings contemplated by any governmental authorities. We know of no proceedings in which any of our directors, officers or affiliates, or any registered or beneficial stockholder is a party adverse to our company or has a material interest adverse to our company.


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ITEM 4. (REMOVED AND RESERVED)

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market information

Our common stock is quoted on the OTC Bulletin Board under the symbol “AVXL.OB”.

The following table shows the quarterly range of high and low bid information for our common stock over the fiscal quarters for the last two fiscal years as quoted on the OTC Bulletin Board. We obtained the following high and low bid information from the OTC Bulletin Board. These over-the-counter market quotations reflect inter-dealer prices without retail mark-up, mark-down or commission, and may not represent actual transactions. Investors should not rely on historical prices of our common stock as an indication of its future price performance. On December 16, 2011, the closing price of our common stock as reported by the OTC Bulletin Board was $1.21 per share.

Quarter Ended High Low
September 30, 2011 $2.50 $0.00
June 30, 2011 $3.65 $1.01
March 31, 2011 $4.45 $0.00
December 31, 2010 $4.25 $3.05
September 30, 2010 $4.15 $3.00
June 30, 2010 $3.61 $2.30
March 31, 2010 $3.30 $1.94
December 31, 2009 $2.83 $1.80

Transfer Agent

Shares of our common stock are issued in registered form. The Nevada Agency and Trust Company, 50 West Liberty Street, Reno, Nevada (Telephone: (775) 322-0626; Facsimile: (775) 322-5623) is the registrar and transfer agent for shares of our common stock.

Holders of Common Stock

As of December 19, 2011, there were 84 holders of record of our common stock. As of such date, 27,187,174 shares of our common stock were issued and outstanding.

Dividends

We have not paid any cash dividends on our common stock and have no present intention of paying any dividends on the shares of our common stock. Our current policy is to retain earnings, if any, for use in our operations and in the development of our business. Our future dividend policy will be determined from time to time by our board of directors.


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Securities Authorized for Issuance under Equity Compensation Plans or Individual Compensation Arrangements

The following table summarizes certain information regarding our equity compensation plan or individual compensation arrangements as at September 30, 2011:

 Equity Compensation Plan Information 






Plan Category

Number of securities
to be issued upon
exercise of outstanding
options, warrants and
rights
(a)


Weighted-average
exercise price of
outstanding options,
warrants and rights
(b)
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in column (a)
Equity compensation plans approved by security holders 2,375,000 3.18 1,625,000
Equity compensation plans not approved by security holders nil - nil
Total 2,375,000 3.18 1,625,000

Stock Option Plan

On April 17, 2007, our directors adopted the 2007 Stock Option Plan. On May 25, 2007, our stockholders ratified and approved the 2007 Stock Option Plan at the annual meeting of stockholders. As of September 30, 2011, 2,375,000 options have been granted to employees, directors, officers and consultants of our company.

The purpose of the 2007 Stock Option Plan is to retain the services of valued key employees and consultants of our company and such other persons as will be select in accordance with the 2007 Stock Option Plan, and to encourage such persons to acquire a greater proprietary interest in our company, thereby strengthening their incentive to achieve the objectives of the shareholders of our company, and to serve as an aid and inducement in the hiring of new employees and to provide an equity incentive to consultants.

The exercise price of shares subject to any option must be at least 100% of the fair market value of the shares on the date of grant. The maximum term of any stock option is 10 years from the date the option is granted.

On February 2, 2011 we amended and restated our 2007 stock option plan to increase the number of shares authorized to be issued under the plan to 4,000,000

Recent Sales of Unregistered Securities

Since the beginning of our fiscal year ended September 30, 2011, we have not sold any equity securities that were not registered under the Securities Act of 1933 that were not previously reported in a quarterly report on Form 10-Q or in a current report on Form 8-K.


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Purchases of Equity Securities by Our Company and Affiliated Purchasers

None.

ITEM 6 SELECTED FINANCIAL DATA

Not applicable.

ITEM 7 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion should be read in conjunction with our audited consolidated financial statements and notes thereto for the fiscal year ended September 30, 2011, included elsewhere in this annual report. The following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains “forward-looking statements”. Forward-looking statements are generally written in the future tense and/or are preceded by words such as “may,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “anticipate,” “intend,” “plan,” or other similar words. The forward-looking statements contained in this annual report involve a number of risks and uncertainties, many of which are outside of our control. Factors that could cause actual results to differ materially from projected results include, but are not limited to, those discussed in “Risk Factors” elsewhere in this annual report. Readers are expressly advised to review and consider those Risk Factors, which include risks associated with (1) our ability to successfully conduct clinical and preclinical trials for our product candidates, (2) our ability to obtain required regulatory approvals to develop and market our product candidates, (3) our ability to raise additional capital on favorable terms, (4) our ability to execute our development plan on time and on budget, (5) our ability to obtain commercial partners, (6) our ability, whether alone or with commercial partners, to successfully commercialize any of our product candidates that may be approved for sale, and (7) our ability to identify and obtain additional product candidates. Although we believe that the assumptions underlying the forward-looking statements contained in this annual report are reasonable, any of the assumptions could be inaccurate, and therefore there can be no assurance that such statements will be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that the results or conditions described in such statements or our objectives and plans will be achieved. Furthermore, past performance in operations and share price is not necessarily indicative of future performance. Except as required by applicable laws including the securities laws of the United States and Canada, we disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Our Business

We are a biopharmaceutical company engaged in the discovery and development of novel drug targets to treat serious diseases for which there are urgent unmet medical needs. The ANAVEX portfolio involves novel compounds (ligands) directed to sigma receptors in preclinical and clinical stages that target neurodegenerative diseases and cancer. Our lead drug candidate, ANAVEX 2-73, targeting Alzheimer’s disease (AD), entered first Human Clinical Trials (HCT) in the first quarter of 2011. This study was conducted in Germany in collaboration with ABX-CRO Advanced Pharmaceutical Services. On November 14, 2011, we announced the successful completion of a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73. We plan to continue clinical work for ANAVEX 2-73 and on other CNS compounds, including those targeting epilepsy, depression and neuropathic pain, provided sufficient capital is available. Additionally, we intend to further develop compounds in earlier preclinical phases, which target various types of cancer and continue to develop and expand our SIGMACEPTORTM Discovery platform.


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Results of Operations

Revenue

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

Expenses

Our expenses for the fiscal year ended September 30, 2011 and 2010 were as follows:

    Year Ended September 30,  
    2011     2010  
Accounting and audit fees $  158,225   $  151,010  
Amortization and depreciation   1,657     910  
Bank charges and interest   8,701     6,867  
Consulting fees   2,757,835     2,082,888  
Insurance   48,152     -  
Investor relations   133,805     186,221  
Legal fees   140,613     173,369  
Management fees   -     -  
Office and miscellaneous   30,068     39,722  
Registration and filing fees   58,878     27,675  
Rent and administration   63,110     12,810  
Research and development   2,597,279     2,728,836  
Travel   182,259     236,268  
Website design and maintenance   -     1,692  
Total expenses $  6,180,582   $  5,648,268  

Year ended September 30, 2011 and 2010

Expenses for the fiscal year ended September 30, 2011 increased by $532,314 over the same period in 2010. Accounting and audit fees have increased by $7,215 from $151,010 for the fiscal year ended September 30, 2010 to $158,225 for the fiscal year ended September 30, 2011 primarily as a result of our company having to address complex accounting matters resulting from our various agreements, thereby requiring increased attention by our external auditors. Consulting fees have increased by $674,947 from $2,082,888 for the fiscal year ended September 30, 2010 to $2,757,835 for the fiscal year ended September 30, 2011 as a result of higher stock-based compensation charges related to the re-pricing of stock options during the year. Investor relations expenses have decreased by $52,416 from $186,221 for the fiscal year ended September 30, 2010 to $133,805 for the fiscal year ended September 30, 2011 as a result of decreased fundraising and corporate awareness activities. Legal fees have decreased by $32,756 from $173,369 for the fiscal year ended September 30, 2010 to $140,613 for the fiscal year ended September 30, 2011 primarily related to decreased private placement activities and drafting and review of agreements related to clinical trials and other activities during the fiscal year ended September 30, 2011. Registration and filing fees have increased by $31,203 from $27,675 for the fiscal year ended September 30, 2010 to $58,878 for the fiscal year ended September 30, 2011 as a result of increased corporate activities and enhanced filing requirements. Rent and administration fees have increased by $50,300 from $12,810 for the fiscal year ended September 30, 2010 to $63,110 for the fiscal year ended September 30, 2011 as a result of office lease expenses in North America. Research and development expenses have decreased by $131,557 from $2,728,836 for the fiscal year ended September 30, 2010 to $2,597,279 for the fiscal year ended September 30, 2011 as a result of decreased preclinical activities relating to preparation for clinical trials for Anavex 2-73. Travel expenses have decreased by $54,009 from $236,268 for the fiscal year ended September 30, 2010 to $182,259 for the fiscal year ended September 30, 2011 as a result of decreased travel related to clinical trial and fundraising and corporate awareness activities.


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Interest and financing fees decreased by $194,713 from $284,959 to $90,246 largely as a result of converting promissory notes to shares during the year and thus avoiding further long-term debt interest charges. Similarly, accretion of debt discount decreased by $1,767,578 from $1,836,997 to $69,419 as a result of modifying the terms of the convertible notes in the year ended September 30, 2010 such that embedded conversion features were no longer required to be bifurcated as a derivative liability. Debt conversion expense increased to $504,160 from $Nil as a result of inducing conversion of promissory notes during the year by reducing a contracted conversion price.

Liquidity and Capital Resources

Working Capital

    September 30, 2011     September 30, 2010  
Cash $ 134,702   $ 264,669  
Current Assets   200,605     325,758  
Current Liabilities   1,345,443     3,290,071  
Working Capital (Deficit)$ $ (1,144, 838 ) $ (2,964,313 )

As of September 30, 2011, we had $134,702 in cash, a decrease of $129,967 from September 30, 2010. The principal components of this decrease in cash relate to the cash used in operating activities of $3,801,479, offset by the cash provided by financing activities of $3,671,512, including proceeds from the issuance of common shares of $3,021,512 and proceeds from the issuance of promissory notes of $750,000. As of September 30, 2011, we had a working capital deficit of $1,144,838, a decrease in deficit of $1,819,475 from September 30, 2010. The principal component of this decrease in working capital deficit was the decrease in promissory notes payable of $1,624,389 that were converted to common equity during the year ended September 30, 2011.


32

We anticipate that we will require up to $10,000,000 for the 12 month period ending September 30, 2012to implement our plan of operation of researching and developing our patents, the related compounds and any further intellectual property we may acquire. The majority of our capital resources requirement is needed to continue clinical trials of Anavex 2-73 and continued research and development of our Sigmaceptor™ platform. If we are not able to secure additional financing, we will not be able to implement and fund this work.

Going Concern

At September 30, 2011, we had an accumulated deficit of $29,203,221 since our inception and incurred a net loss of $7,307,147 for the fiscal year ended September 30, 2011. We expect to incur further losses in the development of our business, all of which casts substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate future profitable operations and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business operations when they come due. Our independent auditors included an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern in their report on our annual financial statements for the fiscal year ended September 30, 2011.

Future Financing

We will require additional financing to fund our planned operations, including further strengthening our patents, securing patents for other compounds and any further intellectual property that we may acquire and commencing clinical development. We currently do not have committed sources of additional financing and may not be able to obtain additional financing, particularly, if the volatile conditions in the stock and financial markets, and especially the market for early development stage pharmaceutical and biotechnology research and development company stocks persist.

There can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain the additional financing on a timely basis, if and when it is needed, we will be forced to delay or scale down some or all of our research and development activities or perhaps even cease the operation of our business.

Since inception we have funded our operations primarily through equity and debt financings and we expect that we will continue to fund our operations through the equity and debt financing. If we raise additional financing by issuing equity securities, our existing stockholders’ ownership will be diluted. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.

There is no assurance that we will be able to maintain operations at a level sufficient for investors to obtain a return on their investment in our common stock. Further, we may continue to be unprofitable.


33

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to our stockholders.

Application of Critical Accounting Policies

Our financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles in the United States. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. These estimates and assumptions are affected by 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 financials.

We base our assumptions and estimates on historical experience and other sources that we believe to be reasonable at the time. Actual results may vary from our estimates due to changes in circumstances, weather, politics, global economics, mechanical problems, general business conditions and other factors. Our significant estimates are related to the valuation of warrants and options.

There are accounting policies that we believe are significant to the presentation of our financial statements. The most significant of these accounting policies relates to the accounting for our research and development expenses and stock-based compensation expense.

Research and Development Expenses

Research and developments costs are expensed as incurred. These expenses are comprised of the costs of our proprietary research and development efforts, including salaries, facilities costs, overhead costs and other related expenses as well as costs incurred in connection with third-party collaboration efforts. Milestone payments 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.


34

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

Our convertible promissory notes include embedded conversion options which, prior to their amendments, were required to be accounted for as separate derivative liabilities. These liabilities were required to be measured at fair value. These instruments were adjusted to reflect fair value at each period end. Any increase or decrease in the fair value was recorded in results of operations as change in fair value of derivative liabilities. In determining the appropriate fair value, we used the binomial pricing model.

The debt discount arising from bifurcating the derivative liability from the host debt instrument was accreted to income during the period.

Recent Accounting Pronouncements

In October 2009, the FASB issued ASU No. 2009-13, “Multiple-Deliverable Revenue Arrangements,” or ASU 2009-13, which amends existing revenue recognition accounting pronouncements that are currently within the scope of ASC 605. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management’s estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. ASU 2009-13 is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. The adoption of this guidance did not have a material impact on our consolidated financial statements.


35

In January 2010, the FASB issued Accounting Standards Update 2010-06, Fair Value Measurements and Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements. The ASU amends Subtopic 820-10 with new disclosure requirements and clarification of existing disclosure requirements. New disclosures required include the amount of significant transfers in and out of levels 1 and 2 fair value measurements and the reasons for the transfers. In addition, the reconciliation for level 3 activity will be required on a gross rather than net basis. The ASU provides additional guidance related to the level of disaggregation in determining classes of assets and liabilities and disclosures about inputs and valuation techniques. The amendments are effective for annual or interim reporting periods beginning after December 15, 2009, except for the requirement to provide the reconciliation for level 3 activities on a gross basis, which is effective for fiscal years beginning after December 15, 2010. We are currently assessing the impact of ASU 2010-6 and do not expect the adoption of this guidance to have a material impact on our consolidated financial statements.

ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not Applicable


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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA


 

ANAVEX LIFE SCIENCES CORP.

(A Development Stage Company)

CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2011 and 2010

(Stated in US Dollars)

 


 
Tel: 604 688 5421
Fax: 604 688 5132
www.bdo.ca
BDO Canada LLP
600 Cathedral Place
925 West Georgia Street
Vancouver BC V6C 3L2 Canada

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Directors and Stockholders,
Anavex Life Sciences Corp.
(a Development Stage Company)

We have audited the accompanying consolidated balance sheets of Anavex Life Sciences Corp. (the “Company”) as of September 30, 2011 and 2010, and the related consolidated statements of operations, cash flows and changes in capital deficit for the years then ended and for the period from January 23, 2004 (date of inception) to September 30, 2011. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Anavex Life Sciences Corp. at September 30, 2011 and 2010, and the results of its operations and its cash flows for the years then ended and for the period from January 23, 2004 (date of inception) to September 30, 2011, in conformity with accounting principles generally accepted in the United States.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company had an accumulated deficit of $29,203,221 at September 30, 2011 and incurred a net loss of $7,307,147 for the year then ended. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ BDO Canada LLP

Chartered Accountants

Vancouver, Canada

December 16, 2011

 

BDO Canada LLP, a Canadian limited liability partnership, is a member of BDO International Limited, a UK company limited by guarantee, and forms part of the international BDO network of independent member firms.


ANAVEX LIFESCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
September 30, 2011 and September 30, 2010
(Stated in US Dollars)

ASSETS   September 30,     September 30,  
    2011     2010  
             
Current            
Cash $  134,702   $  264,669  
VAT recoverable   809     37,820  
Deferred financing charge - Note 5   55,464     -  
Prepaid expenses   9,630     23,269  
    200,605     325,758  
Equipment   2,434     4,091  
  $  203,039   $  329,849  
             
LIABILITIES            
             
Current            
Accounts payable and accrued liabilities - Note 7 $  410,024   $  797,763  
Derivative liability - Note 4   67,500     -  
Promissory notes payable - Note 5   867,919     2,492,308  
    1,345,443     3,290,071  
             
             
CAPITAL DEFICIT            
             
Capital stock - Note 6            
Authorized:
150,000,000 common shares, par value $0.001 per share
Issued and outstanding:
26,571,574 common shares (September 30, 2010 - 23,516,952)
  26,572     23,517  
Additional paid-in capital   28,034,245     18,912,335  
Deficit accumulated during the development stage   (29,203,221 )   (21,896,074 )
    (1,142,404 )   (2,960,222 )
  $  203,039   $  329,849  

SEE ACCOMPANYING NOTES


ANAVEX LIFESCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
for the years ended September 30, 2011 and 2010 and
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

    Years Ended     January 23, 2004  
    September 30,     (Date of Inception) to  
    2011     2010     September 30, 2011  
Expenses                  
Accounting and audit fees $  158,225   $  151,010   $  522,353  
Amortization and depreciation   1,657     910     3,197  
Bank charges and interest   8,701     6,867     36,344  
Consulting fees - Note 7   2,757,835     2,082,888     10,588,725  
Insurance   48,152     -     48,152  
Investor relations   133,805     186,221     723,569  
Legal fees   140,613     173,369     527,102  
Management fees   -     -     14,625  
Office and miscellaneous   30,068     39,722     138,537  
Registration and filing fees   58,878     27,675     127,604  
Rent and administration   63,110     12,810     224,670  
Research and development   2,597,279     2,728,836     9,905,089  
Travel   182,259     236,268     674,318  
Website design and maintenance   -     1,692     28,417  
                   
Loss before other income (expenses)   (6,180,582 )   (5,648,268 )   (23,562,702 )
                   
Other income (expenses)                  
Interest and financing fees   (90,246 )   (284,959 )   (487,680 )
Accretion of debt discount - Note 5   (69,419 )   (1,836,997 )   (2,076,580 )
Change in fair value of derivative liability - Note 4   100,000     (630,774 )   (530,774 )
Debt conversion expense - Note 5   (504,160 )   -     (504,160 )
Loss on settlement of accounts payable - Note 6   (334,053 )   (444,000 )   (778,053 )
Loss on extinguishment of debt - Note 5   (198,738 )   -     (686,207 )
Foreign exchange gain (loss)   (29,949 )   61,961     (26,261 )
                   
Net loss for the period $  (7,307,147 ) $  (8,783,037 ) $  (28,652,417 )
                   
Basic and diluted loss per share $  (0.29 ) $  (0.41 )      
                   
Weighted average number of shares outstanding   25,169,065     21,440,558        

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
for the years ended September 30, 2011 and 2010 and
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                January 23, 2004  
    Years ended September 30,     (Date of Inception) to  
    2011     2010     September 30, 2011  
                   
Cash Flows used in Operating Activities                  
Net loss for the period $  (7,307,147 ) $  (8,783,037 ) $  (28,652,417 )
Adjustments to reconcile net loss to net cash used in operations:                  
Amortization and depreciation   1,657     910     3,197  
Accretion of debt discount   69,419     1,836,997     2,076,580  
Stock-based compensation   1,273,162     770,055     4,540,339  
Amortization of deferred financing charge   44,536     55,777     100,313  
Change in fair value of derivative liability   (100,000 )   630,774     530,774  
Consulting expense recorded in exchange for shares to be issued   -     -     236,337  
Common shares issued for consulting expenses   -     -     390,510  
Promissory note issued for severance   -     -     71,500  
Common shares issued for severance   -     -     340,600  
Common shares issued for research and development expenses   -     -     800,000  
Management fees contributed   -     -     14,625  
Debt conversion expense   504,160     -     504,160  
Loss on settlement of accounts payable   334,053     444,000     778,053  
Loss on extinguishment of debt   198,738     -     686,207  
Rent contributed   -     -     3,750  
Changes in non-cash working capital balances related to operations:               -  
VAT recoverable   37,011     (37,820 )   (809 )
Prepaid expenses   13,639     (23,088 )   (9,630 )
Accounts payable and accrued liabilities   1,129,293     511,844     3,491,496  
Net cash used in operating activities   (3,801,479 )   (4,593,588 )   (14,094,415 )
                   
Cash Flows provided by Financing Activities                  
Issuance of common shares, net of share issue costs   3,021,512     3,095,573     9,250,583  
Financing fee   (100,000 )         (100,000 )
Proceeds from promissory notes   750,000     1,415,000     4,817,500  
Repayment of promissory note   -     -     (100,000 )
Due to related parties   -     -     33,665  
Shareholder advances   -     -     333,000  
Net cash provided by financing activities   3,671,512     4,510,573     14,234,748  
                   
Cash Flows used in Investing Activities                  
Acquisition of equipment   -     (3,310 )   (5,631 )
Net cash used in investing activities   -     (3,310 )   (5,631 )
                   
Increase (decrease) in cash during the period   (129,967 )   (86,325 )   134,702  
Cash, beginning of period   264,669     350,994     -  
Cash, end of period $  134,702   $  264,669   $  134,702  

Supplemental Cash Flow Information - Note 10

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIT
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                            Deficit        
    Common Stock     Accumulated        
    Shares     Par Value     Additional     Common     During the        
                Paid-in     Shares to be     Development        
                Capital     Issued     Stage     Total  
                                     
Capital stock issued for cash on January 23, 2004 - at $0.0033   12,000,000   $  12,000   $  28,000   $  -   $  -   $  40,000  
Net loss from January 23, 2004 to September 30, 2004   -     -     -     -     (14,395 )   (14,395 )
                                     
Balance, September 30, 2004   12,000,000     12,000     28,000     -     (14,395 )   25,605  
Capital stock issued for cash on December 31, 2004 - at $0.0033   7,200,000     7,200     16,800     -     -     24,000  
Management fees contributed   -     -     13,000     -     -     13,000  
Rent contributed   -     -     3,000     -     -     3,000  
Net loss for the year   -     -     -     -     (91,625 )   (91,625 )
                                     
Balance, September 30, 2005   19,200,000     19,200     60,800     -     (106,020 )   (26,020 )
Management fees contributed   -     -     1,625     -     -     1,625  
Rent contributed   -     -     750     -     -     750  
Debt forgiven by directors   -     -     33,666     -     -     33,666  
Net loss for the year   -     -     -     -     (25,532 )   (25,532 )
                                     
Balance, September 30, 2006   19,200,000     19,200     96,841     -     (131,552 )   (15,511 )
Capital stock issued for research and development services on September 24, 2007 - at $3.60   222,222     222     799,778     -     -     800,000  
Capital stock issued for settlement of loan payable on September 25, 2007 - at $3.60   92,500     93     332,907     -     -     333,000  
Net loss for the year   -     -     -     -     (1,579,993 )   (1,579,993 )
                                     
Balance, September 30, 2007   19,514,722     19,515     1,229,526     -     (1,711,545 )   (462,504 )

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIT
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                            Deficit        
    Common Stock     Accumulated        
    Shares     Par Value     Additional     Common     During the        
                Paid-in     Shares to be     Development        
                Capital     Issued     Stage     Total  
                                     
Balance, September 30, 2007 - brought forward   19,514,722     19,515     1,229,526     -     (1,711,545 )   (462,504 )
Capital stock issued for cash on December 10, 2007 - at $3.50   150,000     150     524,850     -     -     525,000  
Capital stock issued for consulting services on December 18, 2007 - at $3.86   50,000     50     192,950     -     -     193,000  
Capital stock issued in settlement of debt on December 18, 2007 - at $4.50   10,000     10     44,990     -     -     45,000  
Stock-based compensation for shares issued at a discount   -     -     65,000     -     -     65,000  
Capital stock issued for severance on May 15, 2008 - at $5.24   65,000     65     340,535     -     -     340,600  
Common shares to be issued for consulting services   -     -     -     252,599     -     252,599  
Common stock issued for consulting services on August 19, 2008 - at $5.07   25,000     25     126,725     (126,750 )   -     -  
Capital stock issued for cash on August 19, 2008 - at $4.25   142,698     142     606,325     -     -     606,467  
Stock-based compensation   -     -     1,493,937     -     -     1,493,937  
Net loss for the year   -     -     -     -     (5,351,269 )   (5,351,269 )
                                     
Balance, September 30, 2008   19,957,420     19,957     4,624,838     125,849     (7,062,814 )   (2,292,170 )

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIT
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                            Deficit        
    Common Stock     Accumulated        
    Shares     Par Value     Additional     Common     During the        
                Paid-in     Shares to be     Development        
                Capital     Issued     Stage     Total  
                                     
Balance, September 30, 2008 - brought forward   19,957,420     19,957     4,624,838     125,849     (7,062,814 )   (2,292,170 )
Stock-based compensation - Note 10   -     -     812,336     -     -     812,336  
Capital stock issued for consulting services on November 20, 2008 - $2.63   25,000     25     65,725     (65,750 )   -     -  
Capital stock issued for consulting services on February 20, 2009 - $2.50   25,000     25     62,475     (62,500 )   -     -  
Capital stock issued for cash on March 6, 2009 - at $2.25   89,148     89     200,494     -     -     200,583  
Capital stock issued for consulting services on March 20, 2009 - at $2.00   2,500     3     4,997     -     -     5,000  
Capital stock issued for cash on March 20, 2009 - at $2.25   10,800     11     24,289     -     -     24,300  
Capital stock issued for cash on June 11, 2009 - at $2.25   36,000     36     80,964     -     -     81,000  
Capital stock issued for services on June 11, 2009 - at $2.25   29,227     29     65,731     -     -     65,760  
Capital stock issued for cash on June 19, 2009 - at $2.25   495,556     496     1,114,504     -     -     1,115,000  
Capital stock issued for finders' fees on June 26, 2009 - at $2.51   22,222     22     55,755     -     -     55,777  
Shares to be issued for consulting services - Note 8   -     -     -     236,337     -     236,337  
Capital stock issued for cash on August 19, 2009 - at $2.25   128,888     129     289,869     -     -     289,998  
Less: Finders fees               (72,850 )   -     -     (72,850 )
Beneficial conversion features on convertible debt issuances   -     -     333,056     -     -     333,056  
Extinguishment of debt - Note 4   -     -     487,469     -     -     487,469  
Cancellation of common shares - Note 6   (75,000 )   (75 )   234,011     (233,936 )   -     -  
Share subscriptions received   -     -     -     300,000     -     300,000  
Net loss for the year   -     -     -     -     (5,499,419 )   (5,499,419 )
                                     
Balance, September 30, 2009   20,746,761     20,747     8,383,663     300,000     (12,562,233 )   (3,857,823 )

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIT
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                            Deficit        
    Common Stock     Accumulated        
    Shares     Par Value     Additional     Common     During the        
                Paid-in     Shares to be     Development        
                Capital     Issued     Stage     Total  
                                     
Balance, September 30, 2009 - brought forward   20,746,761     20,747     8,383,663     300,000     (12,562,233 )   (3,857,823 )
Cumulative effect of accounting changes   -     -     (333,056 )   -     (550,804 )   (883,860 )
Capital stock issued for cash on October 2, 2009 - at $2.25   266,666     267     599,733     (300,000 )   -     300,000  
Capital stock issued in settlement of promissory note on February 2, 2010 - at $2.02   49,505     49     99,951     -     -     100,000  
Capital stock issued for cash on April 9, 2010 - at $2.60   92,499     93     240,405     -     -     240,498  
Capital stock issued in settlement of debt on April 30, 2010 - at $2.85   9,825     9     27,991     -     -     28,000  
Finders' fees paid in cash   -     -     (24,050 )   -     -     (24,050 )
Capital stock issued for cash on June 29, 2010 - at $2.50   941,000     941     2,351,559     -     -     2,352,500  
Finders' fees paid in cash   -     -     (206,500 )   -     -     (206,500 )
Capital stock issued in settlement of debt on July 5, 2010 - at $2.50   400,000     400     999,600     -     -     1,000,000  
Capital stock issued for cash on September 3, 2010 - at $2.75   163,000     163     448,087     -     -     448,250  
Capital stock issued for finders' fees on September 3, 2010 - at $2.75   9,000     9     (9 )   -     -     -  
Finders' fees paid in cash   -     -     (15,125 )   -     -     (15,125 )
Shares issud on conversion of promissory note on September 30, 2010 - at $2.25   328,058     328     737,802     -     -     738,130  
Shares issud on conversion of promissory note on September 30, 2010 - at $2.35   510,638     511     1,199,489     -     -     1,200,000  
Reclassification of dervative liability on modification of note terms   -     -     3,144,520     -     -     3,144,520  
Settlement of accounts payable - Note 6   -     -     444,000     -     -     444,000  
Stock-based compensation   -     -     770,055     -     -     770,055  
Equity component of convertible promissory note   -     -     44,220     -     -     44,220  
Net loss for the year   -     -     -     -     (8,783,037 )   (8,783,037 )
                                     
Balance, September 30, 2010   23,516,952     23,517     18,912,335     -     (21,896,074 )   (2,960,222 )

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIT
for the period from January 23, 2004 (Date of Inception) to September 30, 2011
(Stated in US Dollars)

                            Deficit        
    Common Stock     Accumulated        
    Shares     Par Value     Additional     Common     During the        
                Paid-in     Shares to be     Development        
                Capital     Issued     Stage     Total  
                                     
Balance, September 30, 2010 - brought forward   23,516,952     23,517     18,912,335     -     (21,896,074 )   (2,960,222 )
Capital stock issued for cash on November 18, 2010 - at $2.75   393,846     393     1,082,682     -     -     1,083,075  
Less: Share issue costs   -     -     (65,363 )   -     -     (65,363 )
Capital stock issued for finders' fees on November 18, 2010 - at $2.75   3,636     4     (4 )   -     -     -  
Shares issued on the conversion of promissory note on November 18, 2010 - at $2.25 - Note 5   853,075     853     1,918,565     -     -     1,919,418  
Debt conversion expense - Note 5   -     -     504,160     -     -     504,160  
Shares issued on the conversion of a promissory note on November 18, 2010 - at $4.12 - Note 5   145,063     145     597,515     -     -     597,660  
Capital stock issued in settlement of debt on November 18, 2010 - at $4.12   181,818     182     748,908     -     -     749,090  
Capital stock issued for cash on November 25, 2010 - at $3.35   29,851     30     99,970     -     -     100,000  
Capital stock issued for finders' fees on on November 25, 2010 - at $3.35   2,985     3     (3 )   -     -     -  
Capital stock issued for cash on February 1, 2011 - at $3.75   61,014     61     228,739     -     -     228,800  
Capital stock issued for cash on May 3, 2011 - at $3.00   33,334     34     99,966     -     -     100,000  
Capital stock issued on exercise of warrants for cash on June 19, 2011 - at $2.25   700,000     700     1,574,300     -     -     1,575,000  
Equity units issued in settlement of an account payable on September 28, 2011 - Note 6   650,000     650     1,059,313             1,059,963  
Stock-based compensation - Note 9   -     -     1,273,162     -     -     1,273,162  
Net loss for the period   -     -     -     -     (7,307,147 )   (7,307,147 )
                                     
Balance, September 30, 2011   26,571,574   $  26,572   $  28,034,245     -   $  (29,203,221 ) $  (1,142,404 )

SEE ACCOMPANYING NOTES


ANAVEX LIFE SCIENCES CORP.
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2011 and 2010
(Stated in US Dollars)

Note 1 Business Description, Basis of Presentation and Liquidity
   
  Business
   

Anavex Life Sciences Corp. (“the Company”) is a biopharmaceutical company engaged in the discovery and development of novel drug targets to treat serious diseases for which there are urgent unmet medical needs. The Company’s portfolio involves novel compounds (ligands) directed to sigma receptors in preclinical and clinical stages of development that target neurodegenerative diseases and cancer. The Company’s lead drug candidate, ANAVEX 2-73, targeting Alzheimer’s disease (AD), entered first Human Clinical Trials (HCT) in the first quarter of fiscal 2011. The Company plans to continue preclinical work on other compounds, including backup compounds to ANAVEX 2-73, provided sufficient capital is available. Additionally, the Company intends to further develop compounds in earlier preclinical phases, and continue to develop and expand its SIGMACEPTORTM Discovery platform.

 

 

Basis of Presentation and Liquidity

 

These financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America and the instructions to Form 10-K.

 

The financial statements have been prepared on a going concern basis, which assumes that the Company will continue to realize its assets and discharge its obligations and commitments in the normal course of operations. Realization values may be substantially different from carrying values as shown and these financial statements do not give effect to adjustments that would be necessary to the carrying values and classification of assets and liabilities should the Company be unable to continue as a going concern. At September 30, 2011, the Company had not yet generated any recurring revenue or achieved profitable operations; the Company had an accumulated deficit of $29,203,221 since its inception and incurred a net loss of $7,307,147 for the year then ended and expects to incur further losses in the development of its business, all of which casts substantial doubt about the Company’s ability to continue as a going concern. The Company’s ability to continue as a going concern is dependent upon its ability to generate future profitable operations and/or to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. Management has no formal plan in place to address this concern but considers obtaining additional funds by equity financing and/or from issuing promissory notes. Management expects the Company’s cash requirement over the twelve-month period ended September 30, 2012 to be approximately $10,000,000. While the Company is expending its best efforts to achieve the above plans, there is no assurance that any such activity will generate funds for operations.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 2

Note 2 Summary of Significant Accounting Policies

  a)

Use of Estimates

     
 

The preparation of financial statements in accordance with United States generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting period. The Company regularly evaluates estimates and assumptions related to deferred income tax asset valuations, asset impairment, conversion features embedded in convertible notes payable, derivative valuations, stock based compensation and loss contingencies. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected.

     
  b)

Principles of Consolidation

     
 

These consolidated financial statements include the accounts of Anavex Life Sciences Corp. and its wholly-owned subsidiary, Anavex Life Sciences (France) SA, a company incorporated under the laws of France. All inter-company transactions and balances have been eliminated.

     
  c)

Development Stage Company

     
 

The Company is devoting substantially all of its present efforts to establish a new business and none of its planned principal operations have commenced. All losses accumulated since inception has been considered as part of the Company’s development stage activities.

     
  d)

Equipment

     
 

Equipment is recorded at cost and is depreciated at 33% per annum on the straight-line basis.

     
  e)

Impairment of Long-Lived Assets

     
 

The Company reviews the recoverability of its long-lived assets whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The estimated future cash flows are based upon, among other things, assumptions about future operating performance, and may differ from actual cash flows. Long-lived assets evaluated for impairment are grouped with other assets to the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities. If the sum of the projected undiscounted cash flows (excluding interest) is less than the carrying value of the assets, the assets will be written down to the estimated fair value in the period in which the determination is made.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 3

Note 2 Summary of Significant Accounting Policies – (cont’d)

  f)

Financial Instruments

     
 

The carrying value of the Company’s financial instruments, consisting of cash and accounts payable and accrued liabilities approximate their fair value due to the short-term maturity of such instruments. Based on borrowing rates currently available to the Company for similar terms and based on the short term duration of the debt instruments, the carrying value of the promissory notes payable approximate their fair value. Unless otherwise noted, it is management’s opinion that the Company is not exposed to significant interest, currency or credit risks arising from these financial instruments.

     
  g)

Foreign Currency Translation

     
 

The functional currency of the Company is the US dollar. Monetary items denominated in a foreign currency are translated into US dollars at exchange rates prevailing at the balance sheet date and non-monetary items are translated at exchange rates prevailing when the assets were acquired or obligations incurred. Foreign currency denominated expense items are translated at exchange rates prevailing at the transaction date. Unrealized gains or losses arising from the translations are credited or charged to income in the period in which they occur.

     
  h)

Research and Development Expenses

     
 

Research and developments costs are expensed as incurred. These expenses are comprised of the costs of the Company’s 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 the Company to third parties are expensed when the specific milestone has been achieved.

     
 

In addition, the Company incurs 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, the acquisition of patents and trademarks does not meet the definition of an asset and thus are expensed as incurred.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 4

Note 2 Summary of Significant Accounting Policies – (cont’d)

  i)

Income Taxes

     
 

The Company has adopted the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

     
 

The Company has adopted the provisions of FASB ASC 740 "Income Taxes" regarding accounting for uncertainty in income taxes. The Company initially recognizes tax positions in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions are initially and subsequently measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. Application requires numerous estimates based on available information. The Company considers many factors when evaluating and estimating our tax positions and tax benefits, and our recognized tax positions and tax benefits may not accurately anticipate actual outcomes. As additional information is obtained, there may be a need to periodically adjust the recognized tax positions and tax benefits. These periodic adjustments may have a material impact on the consolidated statements of operations.

     
  j)

Basic and Diluted Loss per Share

     
 

The basic loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding. Diluted loss per common share is computed similar to basic loss per common share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. For the year ended September 30, 2011, loss per share excludes 5,080,479(September 30, 2010 – 5,594,362) potentially dilutive common shares (related to convertible notes payable and outstanding options and warrants) as their effect was anti-dilutive.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 5

Note 2 Significant Accounting Policies – (cont’d)

  k)

Stock-based Compensation

     
 

The Company accounts 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 the Company had paid cash instead of paying with or using equity based instruments. Compensation costs for stock-based payments with graded vesting are recognized on a straight-line basis. 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.

     
 

The Company accounts 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 paid-in capital.

     
 

The Company uses 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 these assumptions can materially affect the fair value estimates.

     
  l)

Website Costs

     
 

Direct costs incurred during the application stage of development of the Company’s website are capitalized and amortized over the estimated useful life. Fees incurred for web site hosting are expensed over the period of the benefit. Costs of operating a web site are expensed as incurred.

     
  m)

Comprehensive Income (Loss)

     
 

Comprehensive income (loss) represents the net change in stockholders’ equity during a period from sources other than transactions with stockholders. The Company has not recorded any components of comprehensive income (loss) for the years ended September 30, 2011 and 2010 and, as at September 30, 2011, the Company does not have a balance recorded in respect of accumulated comprehensive income (loss).



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 6

Note 2 Significant Accounting Policies – (cont’d)

  n)

Recent Accounting Pronouncements

     
 

In October 2009, the FASB issued Accounting Standards Update (“ASU”) No. 2009-13, Multiple- Deliverable Revenue Arrangements. The new standard changes the requirements for establishing separate units of accounting in a multiple element arrangement and requires the allocation of arrangement consideration to each deliverable based on the relative selling price. The selling price for each deliverable is based on vendor-specific objective evidence (“VSOE”) if available, third-party evidence if VSOE is not available, or estimated selling price if neither VSOE or third-party evidence is available. ASU 2009-13 is effective for revenue arrangements entered into in fiscal years beginning on or after June 15, 2010. The adoption of this standard did not have a material effect on the Company’s consolidated financial statements.

     
 

In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures about Fair Value Measurements, which requires additional disclosures about the amounts of and reasons for significant transfers in and out of Level 1 and Level 2 fair value measurements. This standard also clarifies existing disclosure requirements related to the level of disaggregation of fair value measurements for each class of assets and liabilities and disclosures about inputs and valuation techniques used to measure fair value for both recurring and non-recurring Level 2 and Level 3 measurements. Since this new accounting standard only required additional disclosure, the adoption of the standard in the first quarter of 2010 did not impact the Company’s consolidated financial statements. Additionally, effective for annual periods beginning after December 15, 2010 and interim periods within those fiscal years, this standard will require additional disclosure and require an entity to present disaggregated information about activity in Level 3 fair value measurements on a gross basis, rather than one net amount.


Note 3 Equipment

            September 30, 2011        
            Accumulated        
      Cost     Depreciation     Net  
                     
  Computer equipment $  5,631   $  3,197   $  2,434  

            September 30, 2010        
            Accumulated        
      Cost     Depreciation     Net  
                     
  Computer equipment $  5,631   $  1,540   $  4,091  


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 7

Note 4 Derivative Liabilities
   

Derivative liabilities, consisting of the embedded conversion features in the Company’s convertible promissory notes, are accounted for as separate liabilities measured at their respective fair values, as follows:


      September 30, 2011     September 30, 2010  
               
  Balance, beginning of the year $  -   $  2,513,746  
               
  Fair value of embedded conversion feature of convertible promissory notes   167,500     -  
  Change in fair value of derivative liability   (100,000 )   630,774  
  Reclassification of derivative liability to additional paid- in capital on amendment to terms of promissory note payable - Note 5   -     (3,144,520 )
               
  Balance, end of the year $  67,500   $  -  

The fair values of the convertible promissory notes embedded call options have been determined using the binomial pricing model using the following weighted average assumptions:

      September 30, 2011     September 30, 2010  
               
  Risk-free interest rate   0.13%     0.42%  
  Expected life of derivative liability   0.56 years     2 years  
  Annualized volatility   93.45%     68.51%  
  Dividend rate   0.00%     0.00%  

Note 5 Promissory Notes Payable

      September 30,     September 30,  
      2011     2010  
               
  Convertible non-interest bearing promissory notes payable $  -   $  1,919,418  
  Convertible interest bearing promissory notes payable   750,000     -  
  Interest bearing promissory notes payable   216,000     572,890  
  Less: fair value of derivative liabilities on date of issuance   (167,500 )   (2,489,422 )
  Less: equity component of convertible note   -     (44,220 )
  Add: accumulated accretion   69,419     2,533,642  
      867,919     2,492,308  
  Less: current portion   (867,919 )   (2,492,308 )
    $  -   $  -  


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 8

Note 5

Promissory Notes Payable – (cont’d)

 

 

Convertible non-interest bearing promissory notes

 

The convertible non-interest bearing promissory notes were due on demand and were convertible into units at $2.25 per unit with respect to $100,000 and at $2.50 per unit with respect to $1,819,418. Each unit was comprised of one common share and one common share purchase warrant exercisable at $3.00 per share for a period of two years from the conversion date.

 

The embedded conversion features included in these promissory notes were recorded as separate derivative liability along with a corresponding debt discount and were determined to have a cumulative fair value of $1,698,631 at their respective issuance dates. During the year ended September 30, 2010, the Company recorded an accretion expense of $1,202,816 in respect of the debt discount on these notes.

 

During the year ended September 30, 2010, the Company and the respective note-holders agreed to amend the notes by removing certain dilutive issuance clauses with the result that, as at September 30, 2010, the embedded conversion features were no longer required to be recorded as a separate derivative liability. In accordance with the guidance of ASC 815-15-50-3, “Embedded Conversion Option that Is No Longer Bifurcated”, the Company re-measured the fair value of the derivative liability associated with the embedded conversion features in these notes on the date the notes were amended and determined it to be $3,144,520 which was then reclassified from liabilities to additional paid-in capital.

 

During the year ended September 30, 2011, a convertible non-interest bearing promissory note in the amount of $100,000 was converted to 44,444 units. Each unit consisted of one share of the Company’s common stock and one share purchase warrant exercisable at $3.00 until November 18, 2012. As well, during the year ended September 30, 2011, the remaining two convertible non-interest bearing promissory notes in the amount of $1,819,418 were converted to 808,631 units. Each unit consisted of one share of the Company’s common stock and one share purchase warrant exercisable at $3.00 until November 18, 2012. The Company agreed to convert these notes at $2.25 as an inducement to the note holders to convert at that time. As a result of the reduction in the conversion price, the Company issued 80,864 more units than it would have had it converted the notes at the original conversion price. The Company recorded the fair value of the additional units as a debt conversion expense of $504,160 using a fair value of $4.12 for the shares based on their quoted market price on the date of the conversion and $2.09 for each warrant based on their fair value using the Black-Scholes model with the following assumptions: stock price - $4.12; strike price - $3.00; expected life – 2 years; expected volatility – 78.33%; risk-free discount rate – 0.52%.

 

 

Convertible interest bearing promissory notes

 

The Company issued unsecured convertible interest bearing promissory notes totaling $750,000 during the year ended September 30, 2011. Included in these notes is a promissory note in the amount of $250,000 that matures on April 20, 2012 and a note in the amount of $500,000 that matures on May 4, 2012. Each of these notes incurs interest at 8% per annum. These notes are convertible at any time at the option of the holder into units of the Company at $3.00 per unit with each unit consisting of one common share and one common share purchase warrant entitling the holder thereof to purchase an additional common share for $4.00 for a period of 2 years from the date of issuance. Otherwise, the notes will automatically be either converted or redeemed should the Company undertake equity financing of an amount of or greater than $2,000,000 within any consecutive 30 calendar days during the period the notes are outstanding. Additionally, by way of an anti-dilution clause, the conversion price on the notes will be adjusted if the Company issues common shares in excess of 10% of common shares outstanding on the dates the notes were issued.

 

In connection with the issuance of these notes, the Company paid a finder’s fee totaling $100,000 which was deferred and is being amortized to income using the effective interest method over the terms of the notes. As at September 30, 2011, there remains $55,464 unamortized in respect of this deferred financing charge.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 9

Note 5 Promissory Notes Payable – (cont’d)

Convertible interest bearing promissory notes – (cont’d)

Pursuant to the guidance of ASC 815-40, the Company determined that the embedded conversion feature of the notes failed to meet the “fixed for fixed” criteria contained within the guidance. Accordingly, the Company bifurcated the embedded conversion features as a separate derivative liability having a fair value of $167,500 at inception. The corresponding debt discount is being accreted over the term of the note. During the year ended September 30, 2011, the Company recorded accretion expense of $69,419 in respect of this debt discount. During the twelve months ended September 30, 2010, the Company recorded accretion expense of $634,181 in respect of convertible interest bearing notes that were converted to equity units during the year then ended.

Interest bearing promissory notes

During the year ended September 30, 2010, the Company issued a promissory note having a principal balance of $200,000 with terms that included interest at 8% per annum and maturing on May 4, 2011. On May 4, 2011, this note, including accrued interest of $16,000 thereon, was exchanged for a new 8% interest bearing promissory note having a principal balance of $216,000 maturing May 4, 2012.

During the year ended September 30, 2011, the Company exchanged interest bearing promissory notes totaling $398,922 including accrued interest thereon of $26,032 for 145,063 common shares. Each common share had a fair value of $4.12 based on its quoted market price on the day of conversion for a total fair value of $597,660. Therefore, as a result of this conversion, the Company recorded a loss on debt extinguishment of $198,738.

Note 6 Capital Stock

On May 24, 2006, the board of directors approved a six (6) for one (1) forward split of the authorized issued and outstanding common stock. The Company’s authorized capital increased from 25,000,000 shares of common stock to 150,000,000 shares of common stock.

On September 24, 2007, the Company issued 222,222 common shares common shares at $3.60 per share for a total of $800,000 for research and development expenses. The common shares were recorded based upon the quoted market price of the Company’s common stock on the agreement date.

On September 25, 2007, the Company settled a loan payable in the amount of $333,000 by issuing 92,500 common shares at $3.60 per share, being the quoted market price of the Company’s common stock on the settlement date.

On December 10, 2007, the Company issued 150,000 units at $3.50 per unit for proceeds of $525,000. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $5.00 per share until December 10, 2009.

On December 18, 2007, the Company issued 10,000 shares at $4.50 per share for a total of $45,000 pursuant to an agreement to settle a debt and issued 50,000 shares at $3.86 per share for a total of $193,000 pursuant to a consulting agreement. The Company recorded compensation expense of $65,000 in respect of these issuances based on the excess of the fair value of these shares over the balances at which they were recorded by the Company.

On May 15, 2008, the Company issued 65,000 common shares at $5.24 per share for a total of $340,600 to its former CEO in accordance with the terms of a severance agreement upon the termination of his services. The common shares were recorded based upon the quoted market price of the Company’s common stock on the agreement date.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 10

Note 6 Capital Stock – (cont’d)

On August 19, 2008, the Company issued 25,000 common shares at $5.07 per share for a total of $ 126,750 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Company’s common stock on the agreement date.

On August 19, 2008, the Company issued 142,698 units at $4.25 per unit for proceeds of $606,467 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $5.00 per share until August 19, 2009.

On November 20, 2008, the Company issued 25,000 common shares at $2.63 per share for a total of $65,750 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Company’s common stock on the issuance date.

On February 20, 2009, the Company issued 25,000 common shares at $2.50 per share for a total of $62,500 to a director of the Company pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Company’s common stock on the issuance date.

On March 6, 2009, the Company issued 89,148 units at $2.25 per unit for proceeds of $200,583 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until March 6, 2010.

On March 20, 2009, the Company issued 10,800 units at $2.25 per unit for proceeds of $24,300 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until March 20, 2010.

On March 20, 2009, the Company issued 2,500 common shares at $2.00 per share for a total of $5,000 to a public relations consultant pursuant to an agreement to provide consulting services. The common shares were recorded based upon the quoted market price of the Company’s common stock on the issuance date. On May 14, 2009, the Company entered into a revised consulting agreement with a director whereby the consultant returned 75,000 common shares to the Company for cancellation. The return of shares was recorded in the same amount at which they were originally issued.

On June 11, 2009 the Company issued 36,000 units at $2.25 per unit for proceeds of $81,000 pursuant to private placement agreements. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until June 11, 2010. The Company paid finders’ fees in the amount of $8,100 in relation to this private placement.

On June 11, 2009 the Company issued 29,227 common shares at $2.25 per share for service rendered by consultants. The common shares were recorded based upon the fair value of the Company’s common stock on the issuance date of the shares.

On June 19, 2009, the Company issued 495,556 units at $2.25 per Unit for total proceeds of $1,115,000 pursuant to private placement agreements. Each unit consisted on one common share and one and one-half of a common share purchase warrant entitling the holder to purchase additional common shares at $2.25 per share until June 19, 2011.

On June 26, 2009, the Company issued 22,222 common shares at $2.51 per share for finder’s fees related to the issuance of a $500,000 note payable. The common shares were recorded based upon the quoted market price of the Company’s common stock on the issue date.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 11

Note 6 Capital Stock – (cont’d)

On August 19, 2009, the Company issued 128,888 units at $2.25 per Unit for total proceeds of $289,998. Of these placements, 40,000 Units consisted of one common share and one share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until July 9, 2010 and 88,888 Units consisted on one common share and one and one-eighth share purchase warrant entitling the holder to purchase an additional common shares at $2.25 per share until August 4, 2011. The Company paid finders’ fees totalling $19,000 in respect of these private placements.

On October 2, 2009 the Company issued 266,666 units at $2.25 per unit for proceeds of $600,000 pursuant to private placement agreement. Each unit consisted of one common share and one and one-eighth common share purchase warrant entitling the holder to purchase an additional common share at $2.25 per share until October 2, 2011. The Company had received $300,000 of this amount in the year ended September 30, 2010.

On February 2, 2010 the Company issued 49,505 common shares of the Company, at their fair value of $2.02 per share pursuant to an agreement with a former officer to settle an outstanding amount owed.

On April 9, 2010, the Company issued 92,499 units at $2.60 per unit for proceeds of $240,498 pursuant to private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $3.50 per share until April 9, 2011.

On April 30, 2010, the Company issued 9,825 common shares of the Company, at $2.85 per share as consideration for terminating a consulting agreement and for services rendered under the agreement. The common shares were recorded based upon the quoted market price of the Company’s common stock on the date of the termination of the agreement.

On June 29, 2010, the Company issued 941,000 units at $2.50 per unit for total proceeds of $2,352,500 pursuant to private placement agreements. Each unit consisted on one common share and one-half of a common share purchase warrant entitling the holder to purchase additional common shares at $3.50 per share until December 29, 2011.

On July 5, 2010, the Company issued 400,000 units in settlement of $1,000,000 owing to a creditor. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at 3.50 per share until January 5, 2012. The fair value of the units issued was determined to be $1,444,000 on the date they were issued and thus the Company recorded a loss on settlement of accounts payable of $444,000 with a corresponding credit to additional paid-in capital of the same amount on date of issuance. The fair value of the shares included in the units was determined with reference to their quoted market price and the value of the warrants was determined using the Black-Scholes model with the following assumptions: exercise price - $3.50, stock price - $3.15, expected volatility – 68.45%, expected life – 1.5 years, dividend yield – 0.00%.

On September 3, 2010, the Company issued 163,000 units at $2.75 per unit for proceeds of $448,250 pursuant to private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $3.75 per share until March 3, 2012.

On September 3, 2010, the Company issued 9,000 units at $2.75 per unit for finder’s fees related to the private placement of the same date. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $3.75 per share until March 3, 2012.

On September 30, 2010, the Company issued 510,638 common shares at $2.35 per share pursuant to the terms of a convertible note payable.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 12

Note 6 Capital Stock – (cont’d)

On September 30, 2010, the Company issued 82,310 units at $2.25 per unit pursuant to the terms of convertible notes payable. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $3.50 per share until September 30, 2011.

On September 30, 2010, the Company issued 245,748 units at $2.25 per unit pursuant to the terms of convertible notes payable. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $3.00 per share until September 30, 2012.

On November 18, 2010, the Company issued 393,846 units at $2.75 per unit for proceeds of $1,083,075 pursuant to a private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until May 18, 2012. The Company paid a finder’s fee totalling $65,363 in respect of this private placement.

On November 18, 2010, the Company issued 3,636 units at $2.75 per unit for finder’s fees related to the private placement of the same date. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until May 18, 2012.

On November 18, 2010, the Company issued 853,075 units in the conversion of two notes payable originally convertible at $2.50. The Company recorded debt conversion expense of $504,160, related to the fair value of the additional units issued as a result of converting at the lower conversion price. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $3.00 per share until November 18, 2012. The fair value of the shares included in the units was determined with reference to their quoted market price and the value of the warrants was determined using the Black-Scholes model with the following assumptions: exercise price - $3.00, stock price - $4.12, expected volatility – 78.33%, expected life – 2.0 years, dividend yield – 0.00%, risk-free rate – 0.52%.

On November 18, 2010, the Company issued 145,063 shares of common stock at their fair value of $4.12 per share based on their quoted market price pursuant to settling non-convertible interest bearing notes payable outstanding in the amount of $398,922, including accrued interest of $26,032. The Company recorded a loss on settlement of debt of $198,738 based on the difference between the carrying value of the debt settled and the fair value of the shares issued.

On November 18, 2010, the Company issued 181,818 shares of common stock at their fair value of $4.12 per share based on the quoted value of units issued in a private placement on the same date to one creditor in settlement of $500,000 of debt owing. The Company recorded a loss on settlement of accounts payable of $249,090 based on the difference of the carrying value of the account payable and the fair value of the shares issued.

On November 25, 2010, the Company issued 29,851 units at $3.35 per unit for proceeds of $100,000 pursuant to a private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until November 25, 2012.

On November 25, 2010, the Company issued 2,985 units at $3.35 per unit for finder’s fees related to the private placement of the same date. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until November 25, 2012.

On February 1, 2011, the Company issued 61,014 units at $3.75 per unit for proceeds of $228,800 pursuant to a private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $5.25 per share until August 1, 2012.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 13

Note 6 Capital Stock – (cont’d)
   

On May 3, 2011, the Company issued 33,334 units at $3.00 per unit for proceeds of $100,000 pursuant to a private placement agreement. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.00 per share until April 20, 2013.

 

On June 19, 2011, the Company issued 700,000 common shares at $2.25 per share for proceeds of $1,575,000 pursuant to the exercise of warrants.

 

On September 26, 2011, the Company issued 650,000 units in settlement of $975,000 of debt owing. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $2.00 per share until September 26, 2012. The Company recorded a loss on settlement of account payable in the amount of $84,963 based on the fair value of shares being $975,000 at their issuance and the fair value of the warrants determined to be $84,963. The fair value of the shares included in the units was determined with reference to their quoted market price and the value of the warrants was determined using the Black-Scholes model with the following assumptions: exercise price - $2.00, stock price - $1.50, expected volatility – 69%, expected life – 1.0 years, dividend yield – 0.00%, risk-free interest rate – 0.10%.

 

Note 7

Related Party Transactions

 

 

The following amounts have been donated to the Company by the directors:


                  January 23,  
                  2004 (Date of
      Years ended     Inception) to  
      September 30,     September 30,  
      2010     2009     2010  
                     
  Management fees $  -   $  -   $ 14,625  
  Rent   -     -     3,750  
  Debt forgiven by directors   -     -     33,666  
                     
    $  -   $  -   $ 52,041  

During the year ended September 30, 2011, the Company was charged consulting fees totaling $674,917(2010: $725,310) by directors, officers and a significant shareholder of the Company.

As at September 30, 2011, included in accounts payable and accrued liabilities is $20,833 (2010: $9,521) owing to directors and officers of the Company.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 14

Note 8 Income Taxes
   

The tax effects of the temporary differences that give rise to the Company's estimated deferred tax assets and liabilities are as follows:


      2011     2010  
      34%     34%  
               
  Net operating loss carryforwards $  5,548,000   $  3,848,000  
  Research and development tax credits   500,000     331,000  
  Foreign exchange   15,000     17,000  
  Intangible asset costs   32,000     35,000  
  Valuation allowance for deferred tax assets   (6,095,000 )   (4,231,000 )
               
  Net deferred tax assets $  -   $  -  

The provision for income taxes differ from the amount established using the statutory income tax rate as follows:

      2011     2010  
  Income tax benefit at statutory rate $  (2,532,000 ) $  (2,986,000 )
  Stock-based compensation   433,000     263,000  
  Foreign income taxed at foreign statutory rate   1,000     4,000  
  Debt extinguishment   181,000     150,000  
  Debt accretion   24,000     625,000  
  Other permanent differences   29,000     125,000  
  Change in valuation allowance   1,864,000     1,819,000  
               
  Deferred income tax recovery $  -   $  -  

As of September 30, 2011, the Company had net operating loss carry-forwards of approximately $16,300,000 available to offset future taxable income. The carry-forwards will begin expiring in 2027 unless utilized in earlier years. The Company is in arrears in filing its income tax returns in the United States for years prior to 2008 and the Company has not filed any income tax returns in France as they are not yet due.

The Company evaluates its valuation allowance requirements based on projected future operations. When circumstances change and this causes a change in management’s judgment about the recoverability of deferred tax assets, the impact of the change on the valuation allowance is reflected in current income. As management of the Company does not currently believe that it is more likely than not that the Company will receive the benefit of this asset, a valuation allowance equal to the deferred tax asset has been established at both September 30, 2011 and September 30, 2010.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 15

Note 8 Income Taxes – (cont’d)
   
  Uncertain Tax Positions
   

The Company files income tax returns in the U.S. federal jurisdiction, various state and foreign jurisdictions. The Company’s tax returns are subject to tax examinations by U.S. federal and state tax authorities, or examinations by foreign tax authorities until respective statute of limitation. It is subject to tax examinations by tax authorities for all taxation years commencing on or after 2004.

 

Provision has not been made for U.S. or additional foreign taxes on undistributed earnings of foreign subsidiaries. Such earnings have been and will continue to be reinvested but could become subject to additional tax if they were remitted as dividends, or were loaned to the Company affiliate. It is not practicable to determine the amount of additional tax, if any, that might be payable on the undistributed foreign earnings.

   
Note 9 Commitments

  a)

Share Purchase Warrants

     
 

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


            Weighted Average  
      Number of Shares     Exercise Price  
               
  Balance, September 30, 2009   983,448   $  2.93  
  Expired   (325,948 ) $  4.46  
  Issued   1,389,651   $  3.16  
  Balance, September 30, 2010   2,047,151   $  2.87  
  Expired   (148,749 ) $  2.64  
  Exercised   (700,000 ) $  2.25  
  Issued   1,457,077   $  3.07  
  Balance, September 30, 2011   2,655,479   $  3.16  


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 16

Note 9 Commitments – (cont’d)

  a)

Share Purchase Warrants – (cont’d)

     
 

At September 30, 2011, the Company has 2,655,479 currently exercisable share purchase warrants outstanding as follows:


Number     Exercise Price     Expiry Date  
154,999   $  2.25     October 2, 2011  
470,500   $  3.50     December 29, 2011  
200,000   $  3.50     January 5, 2012  
86,000   $  3.75     March 3, 2012  
198,741   $  4.50     May 18, 2012  
30,508   $  5.25     August 1, 2012  
325,000   $  2.00     September 26, 2012  
41,155   $  3.50     September 30, 2012  
245,748   $  3.00     September 30, 2012  
853,075   $  3.00     November 18, 2012  
16,419   $  4.50     November 25, 2012  
33,334   $  4.00     April 20, 2013  
2,655,479              

 

Subsequent to September 30, 2011, the 154,999 warrants exercisable at $2.25 until October 2, 2011 expired unexercised.

     
  b)

Stock–based Compensation Plan

     
 

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

     
 

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



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 17

Note 9 Commitments – (cont’d)

  b)

Stock–based Compensation Plan – (cont’d)

     
 

A summary of the status of Company’s outstanding stock purchase options for the years ended September 30, 2011 and September 30, 2010 is presented below:


          Weighted  
          Average  
    Number of Shares     Exercise Price  
Outstanding at September 30, 2009   3,195,000   $  3.37  
Cancelled   (820,000 ) $  2.50  
Granted   400,000   $  3.48  
Outstanding at September 30, 2010   2,775,000   $  3.29  
Forfeited   (1,000,000 ) $  3.93  
Cancelled   (50,000 ) $  2.75  
Granted   650,000   $  4.06  
Outstanding at September 30, 2011   2,375,000   $  3.18  
Exercisable at September 30, 2011   930,000   $  2.90  
Exercisable at September 30, 2010   1,613,333   $  3.52  

At September 30, 2011, the following stock options were outstanding:

Number of Shares                            
                                     
Total   Number     Exercise     Expiry Date     Aggregate     Remaining  
          Vested     Price           Intrinsic     Contractual  
                            Value     Life (yrs)  
                                   
100,000   (1   100,000   $  3.75     November 1, 2012     -     1.09  
                                   
100,000   (2   -   $  3.86     December 1, 2012     -     1.17  
                                   
300,000   (3   300,000   $  3.10     June 3, 2013     -     1.68  
                                   
400,000   (4   400,000   $  2.50     September 15, 2013     -     1.96  
                                   
500,000   (5   -   $  2.50     October 19, 2013     -     2.05  
                                   
5,000   (6   5,000   $  2.50     March 2, 2014     -     2.42  
                                   
50,000   (7   50,000   $  3.50     June 29, 2015     -     3.75  
                                   
400,000   (8   -   $  4.28     February 1, 2016     -     4.34  
                                   
150,000   (9   -   $  3.72     February 24, 2016     -     4.41  
                                   
100,000   (10   75,000   $  3.67     March 30, 2016     -     4.50  
                                   
270,000   (11   -   $  3.00     February 8, 2017     -     5.36  
2,375,000         930,000                 -        


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 18

Note 9 Commitments – (cont’d)

  b)

Stock–based Compensation Plan – (cont’d)

       
 

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted market price of the Company’s stock for the options that were in- the-money at September 30, 2011.

       
  (1)

As at September 30, 2011 and September 30, 2010, these options had fully vested. The Company did not recognize any stock-based compensation for these options in the year ended September 30, 2011 (2010: $nil).

       
  (2)

As at September 30, 2011 and September 30, 2010, these options have not vested. The options vest upon the Company listing its shares on the American Stock Exchange or any other nationally recognized stock exchange by December 1, 2012 or in the event of a change of control a listing on a nationally recognized stock exchange is not required. No stock-based compensation has been recorded in the financial statements as the performance condition has not yet been met.

       
  (3)

As at September 30, 2011 and September 30, 2010, these options had fully vested. The Company did not recognize any stock-based compensation during the year ended September 30, 2011. As a result of re-pricing these options on March 26, 2010, the Company recognized stock-based compensation of $130,950 during the year ended September 30, 2010.

       
  (4)

As at September 30, 2011 and September 30, 2010, these options had fully vested. The Company did not recognize any stock-based compensation for these options during the year ended September 30, 2011 (2010: $64,268). As a result of extending these options on September 16, 2011, the Company recognized stock-based compensation of $138,411.

       
  (5)

As at September 30, 2011 and September 30, 2010 none of these options have vested. The options vest as to 100,000 per compound entered into a phase II trial. The fair value of these options was calculated to be $740,000, which the Company has not yet recognized in the financial statements as the performance conditions have not yet been met.

       
  (6)

As at September 30, 2011 and September 30, 2010, these options had fully vested. The Company did not recognize any stock-based compensation for these options in the year ended September 30, 2011 (2010: $nil).

       
  (7)

As at September 30, 2011 these options had fully vested (2010: 25,000). The Company recognized $62,500 as stock-based compensation for the year ended September 30, 2011 (2010: $187,500).

       
  (8)

These options were granted during the year ended September 30, 2011, none of these options have vested. The options vest as to 100,000 upon completion of the phase I trial, 100,000 upon approval of a phase II a trial, 100,000 upon completion of a phase II a trial and 100,000 upon approval of a phase II trial for ANAVEX 2-73. The fair value of these options was calculated to be $860,000, which the Company has not yet recognized in the financial statements as the performance conditions have not yet been met.

       
  (9)

These options were granted during the year ended September 30, 2011, none of these options have vested. The options vest on February 24, 2012. The fair value of these options was calculated to be $281,000, of which the Company recognized stock-based compensation in the amount of $243,084 for the year ended September 30, 2011.

       
  (10)

These options were granted during the year ended September 30, 2011 , 75,000 of these options have vested. The remaining 25,000 options vest on December 31, 2011. The fair value of these options was calculated to be $183,000, of which the Company has recognized $120,250 as stock based compensation in the year ended September 30, 2011.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 19

Note 9 Commitments – (cont’d)

  b)

Stock–based Compensation Plan – (cont’d)

       
  (11)

As at September 30, 2011 and September 30, 2010, these options have not 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.

       
 

During the year ended September 30, 2011, a total of 1,000,000 options were forfeited for which the Company had recognized stock-based compensation of $708,917 (2010: $304,927) in respect of these options.

       
 

During the year ended September 30, 2011, a total of 50,000 options were cancelled for which the Company had recognized stock-based compensation of $9,910 for the year ended September 30, 2010.

       
 

During the year ended September 30, 2010, a total of 700,000 options were cancelled for which the Company had recognized stock-based compensation totalling $72,500.

The fair value of stock options granted has been determined using the Black-Scholes option pricing model using the following weighted average assumptions applied to stock options granted during the years:

    2011     2010  
Risk-free interest rate   0.96% - 2.21%     0.79% - 2.20%  
Expected life of options   4.5 - 5.0 years     5.0 years  
Annualized volatility   56.27% - 62.52%     88.54% - 95.45%  
Dividend rate   0%     0%  

At September 30, 2011, the following summarizes the unvested stock options:

                  Weighted  
                  Average  
      Number of     Weighted Average     Grant-Date  
      Shares     Exercise Price     Fair Value  
                     
  Unvested options at September 30, 2009   1,865,000   $  4.31   $  1.55  
  Cancelled   (820,000 ) $  2.50   $  1.57  
  Granted   400,000   $  3.48   $  2.51  
  Vested   (283,333 ) $  2.90   $  1.82  
                     
  Unvested options at September 30, 2010   1,161,667   $  2.98   $  1.80  
  Granted   650,000   $  4.11   $  2.06  
  Forfeited   (748,334 ) $  3.45   $  2.51  
  Vested   (133,333 ) $  3.63   $  2.00  
  Unvested options at September 30, 2011   930,000   $  3.33   $  1.38  


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 20

Note 9 Commitments – (cont’d)

  b)

Stock–based Compensation Plan – (cont’d)

     
 

As at September 30, 2011, there was a total of $50,250 of unrecognized compensation cost associated with unvested share-based compensation awards that will become vested exclusive of achieving any performance milestones that is expected to be recognized in the year ended September 30, 2012. There has been no stock-based compensation recognized in the financial statements for the year ended September 30, 2011 (2010: $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.

     
 

Stock-based compensation amounts, including those relating to shares issued for services during the year ended September 30, 2011 are classified in the Company’s Statement of Operations as follows:


      2011     2010  
               
  Consulting fees $  1,273,162   $  770,055  

  c)

Patent and Collaboration Agreement

       
 

On February 1, 2007, the Company signed a contract with an officer of the Company to acquire property for the development of a new drug compound including three patents and one patent application. Pursuant to the agreement, the Company agreed to the following:

       
  i)

Invest a minimum of $200,000 every fiscal year into scientific research and;

       
  ii)

Hire the officer as a consultant to carry out the Company’s Research and Development program at $US6, 000 per month and;

       
  iii)

Pay the officer 6% of the net income earned from the exploitation of the patent and patent application; and

       
  iv)

Disburse a one-time payment to the officer an amount of $72,000 before December 31, 2007 as consideration for the transfer of the patents and the patent application. (paid)

Effective January 1, 2008, the monthly salary paid to the director was increased to 7,000 Euros.


Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 21

Note 10

Supplemental Cash Flow Information

 

 

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

 

 

 

During the year ended September 30, 2011:


  a)

The Company issued 3,636 units at $2.75 per unit for finder’s fees related to the private placement. Each unit consists of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until May 18, 2012.

     
  b)

The Company issued 853,075 units in the conversion of two notes payable. The Company recorded debt conversion expense of $504,160, related to the fair value of the additional units issued based on the difference between the fair value of the units issued and the carrying value of the debt. Each unit consisted of one common share and one common share purchase warrant entitling the holder to purchase an additional common share at $3.00 per share until November 18, 2012.

     
  c)

The Company issued 145,063 shares of common stock at their fair value of $4.12 per share to settle non-convertible interest bearing notes payable outstanding in the amount of $398,922, including accrued interest of $26,032. The Company recorded a loss on debt settlement of $198,738 as a result of this transaction.

     
  d)

The Company issued 181,818 shares of common stock at their fair value of $4.12 per share based on their quoted market price to one creditor in settlement of $500,000 of accounts payable. The Company recorded a loss on settlement of accounts payable of $249,090 as a result of the difference between the carrying value of the account payable and the fair value of the shares issued.

     
  e)

The Company issued 2,985 units at $3.35 per unit for finder’s fees related to the private placement of the same date. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at $4.50 per share until November 25, 2012.

     
  f) On September 26, 2011, the Company issued 650,000 units having a fair value of $1,059,963 to settle an account payable totalling $975,000 and thus recorded a loss of $84,963 on the settlement of account payable.
     
  g)

The Company issued an 8% interest bearing promissory note having a principal balance of $216,000 in exchange for a promissory note that had a principal balance of $200,000 with accrued interest of $16,000 thereon.



Anavex Life Sciences Corp.
(A Development Stage Company)
Notes to the Consolidated Financial Statements
September 30, 2011 and 2010
(Stated in US Dollars) – Page 22

Note 10 Supplemental Cash Flow Information – (cont’d)
   
  During the year ended September 30, 2010, the Company:

  a)

issued 49,505 common shares at $2.20 per share in settlement of a promissory note to a former officer of the Company for a total of $100,000.

     
  b)

issued 9,825 common shares at $2.85 per share for a total of $28,000 as consideration for amounts owing in respect of consulting services which was included in accounts payable as at September 30, 2009.

     
  c)

issued 400,000 units at $2.50 per unit for a total of $1,000,000 as consideration for amounts owing for services rendered in prior years. Each unit consisted of one common share and one-half common share purchase warrant entitling the holder to purchase an additional common share at 3.50 per share until January 5, 2012. The fair value of the units issued was determined to be $1,444,000 on the date they were issued and thus the Company recorded a loss on settlement of accounts payable of $444,000 with a corresponding credit to additional paid-in capital of the same amount on date of issuance.

     
  d)

issued 9,000 common shares at $2.75 per share for a total of $24,750 as consideration for finders’ fees associated with a private placement.

     
  e)

issued 328,058 common shares at $2.25 per share upon conversion of promissory notes in the amount of $738,130, including accrued interest of $70,130.

     
  f)

issued 510,638 common shares at $2.35 per share upon settlement of a promissory note in the amount of $1, 200,000 including accrued interest of $200,000.


Note 11 Subsequent Events
   
  Subsequent to September 30, 2011, the Company:

  a)

issued an interest bearing promissory note totaling $250,000. The note bears interest at 8% and matures January 30, 2012.

     
  b)

issued 615,600 units at $1.25 for a total of $769,500. Each unit consisted of one common share and one-half common share purchase warrant. Each whole warrant entitles the holder to purchase an additional share at $2.00 for a period of one year from the date of closing. The Company paid a cash finders’ fee in the amount of $57,000.



37

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL MATTERS

None

ITEM 9A. 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 Rule 13a-15(e) of the Securities Exchange Act of 1934) as of the end of the period covered by this annual report.

Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to our principal executive officer and principal financial officer to allow timely decisions regarding required disclosure.

Based on its 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 annual report, our disclosure controls and procedures were not effective. The ineffectiveness of our disclosure controls and procedures was due to material weaknesses described below.

Management’s Annual Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934. Our management evaluated, under the supervision and with the participation of our principal executive officer and principal financial officer, the effectiveness of our internal control over financial reporting as of September 30, 2011.

Based on its evaluation under the framework in Internal Control—Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission, our management, with the participation of our principal executive officer and principal financial officer concluded that our internal control over financial reporting was not effective as of September 30, 2011. The ineffectiveness of our internal control over financial reporting was due to the existence of significant deficiencies constituting material weaknesses, as described in greater detail below. A material weakness is a control deficiency, or combination of control deficiencies, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.


38

Material Weaknesses Identified

Based on our management’s evaluation required by Rule 13a-15 of the Securities Exchange Act of 1934, certain significant deficiencies in internal control became evident to management that our management believes represent material weaknesses, including:

  (i)

Insufficient segregation of duties in our finance and accounting functions due to limited personnel. During the fiscal year ended September 30, 2011, we had limited staff that performed nearly all aspects of our financial reporting process, including, but not limited to, access to the underlying accounting records and systems, the ability to post and record journal entries and responsibility for the preparation of the financial statements. This creates certain incompatible duties and a lack of review over the financial reporting process that would likely result in a failure to detect errors in spreadsheets, calculations, or assumptions used to compile the financial statements and related disclosures as filed with the Securities and Exchange Commission. These control deficiencies could result in a material misstatement to our interim or annual financial statements that would not be prevented or detected;

     
  (ii)

There has been a lack of sufficient supervision and review by our management;

     
  (iii)

Insufficient corporate governance policies. Although we have a code of ethics which provides broad guidelines for corporate governance, our corporate governance activities and processes have not always been formally documented; and

     
  (iv)

Our company’s accounting staff has not had sufficient technical accounting knowledge relating to accounting for income taxes and complex US GAAP matters. Management was advised of certain material errors related to the calculation of stock-based compensation, certain of our financial instruments and incorrect postings of debt and equity issuance costs by our external auditors and corrected these items prior to the release of our company’s September 30, 2011 financial statements.

Plan for Remediation of Material Weaknesses

We intend to take appropriate and reasonable steps to make the necessary improvements to remediate these deficiencies. We intend to consider the results of our remediation efforts and related testing as part of our year-end 2012 assessment of the effectiveness of our internal control over financial reporting.

In our fiscal year ended September 30, 2012, we intend to hire accounting staff that possess the requisite knowledge of accounting for complex US GAAP matters.

Due to our size and nature, segregation of all conflicting duties has not always been possible and may not be economically feasible. However, we are in the process of implementing new processes and procedures that will mitigate any material weaknesses identified,


39

We believe that the foregoing steps will remediate the deficiencies identified above, and we intend to continue to monitor the effectiveness of these steps and make any changes that our management deems appropriate.

Limitations on Effectiveness of Controls

Our principal executive officer and principal financial officer do not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additional controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the fourth quarter ended September 30, 2011 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.

ITEM 9B OTHER INFORMATION

None.

PART III

ITEM 10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Directors and Executive Officers

Our directors are to be elected at our annual meeting and each director elected is to hold office until his or her successor is elected and qualified. Our board of directors may remove our officers at any time.

Our directors and executive officers, their age, positions held, and duration of such, are as follows:


40


Name

Position Held with Our Company

Age
Date First Elected
or Appointed
Harvey Lalach President, Chief Operating Officer, Secretary, Interim Chief Financial Officer and Director 46 April 25, 2006
Sean Lowry Director 39 February 24, 2011
Robert Chisholm Director 49 May 13, 2011
George Tidmarsh Executive Director 51 October 10, 2011

Business Experience

The following is a brief account of the education and business experience of directors and executive officers during at least the past five years, indicating their principal occupation during the period, and the name and principal business of the organization by which they were employed.

Harvey Lalach

For the past 25 years Mr. Lalach has been involved in various aspects of the securities industry. From 1986 through to 1997 he was involved in various roles in financial institutions starting at the Vancouver Stock Exchange and later working in securities related roles for BMO Nesbitt Burns and TD Bank and for the past 10 years Mr. Lalach has focused on the operation and administration of numerous start-up US and Canadian public companies serving as both director and officer in various capacities. Most recently Mr. Lalach served as President and CEO for Assure Energy, Inc. (OTCBB: ASUR) and Quarry Oil & Gas Corp. (TSXV: QUC). Throughout his career, Mr. Lalach has gained extensive experience in the management and governance of listed public companies.

We believe Mr. Lalach is qualified to serve on our board of directors because of his knowledge of our company’s history and current operations, which he gained from serving as our officer and director since April 25, 2006, in addition to his business experiences described above.

Sean Lowry

Since 2001, Mr. Lowry has been president of Wm. Lowry Consulting, a management consulting company. He has been a partner and portfolio manager in Gulfstream Ventures, a venture capital firm, since 2006. Mr. Lowry has served as an officer and director of several private companies as well as director of investor relations for Workbrain Inc. (TSX:WB) between 2004 and 2006.

We believe Mr. Lowry is qualified to serve on our board of directors because of his knowledge of our company’s history and current operations, which he gained from serving as our director since February 24, 2011, in addition to his business experiences described above.

Robert Chisholm

Mr. Chisholm is currently an officer and partner of Emprise Capital Corp, a private company focused on advising portfolio companies on managing finances, including development and implementation of comprehensive budgeting processes, public market listings and oversight of contract negotiations. Mr. Chisholm has been the Chief Financial Officer and a director of Savary Capital Corp. since March 2011 and Windamere Ventures Ltd. (formerly Advanced Vision Systems Corp.) since May 2010. Mr. Chisholm is also a member of the Board of Directors for Rare Earth Industries Limited (formerly Seymour Ventures Corp.) and Chief Financial Officer of TMT Resources Inc. Mr. Chisholm served as CFO for PNI Digital Media (formerly PhotoChannel Networks Inc.) between September 2001 and March 2009 and joined PNI's Board of Directors in April 2009. Prior to 2001, Mr. Chisholm was CFO for SCS Solars Computing Systems Inc. In addition, Mr. Chisholm’s background includes previous appointments as CFO and a director of Brookwater Ventures Inc. and Ocean Park Ventures Corp. and CFO of Chantrell Ventures Corp. (formerly Tiger Pacific Mining Corp.). Mr. Chisholm holds a professional accounting designation from the Certified Management Accountants of Canada and received his BBA with a major in accounting from Saint Francis Xavier University in Nova Scotia.


41

We believe Mr. Chisholm is qualified to serve on our board of directors because of his knowledge of our company’s history and current operations, which he gained from serving as our director since May 13, 2011, in addition to his business experiences described above.

George Tidmarsh

Dr. Tidmarsh is also a consultant for biopharmaceutical companies and is currently working with Citizen’s Oncology Foundation and Solana Therapeutics among others. He has also founded several successful companies including Horizon Therapeutics (now Horizon Pharma) (NASDAQ: HZNP). From 2005 through 2008 Dr. Tidmarsh served as Horizon’s Chief Executive Officer, successfully completing four Phase I and two large Phase III trials, including the registration trials for Duexa. Prior to Horizon, Dr. Tidmarsh founded Threshold Pharmaceuticals (NASDAQ: THLD) where he served as the company’s President and as a Director from 2001 to 2006. Most recently, Dr. Tidmarsh served as Chief Scientific Officer at Spectrum Pharmaceuticals as a part of their acquisition of Metronome Therapeutics, a novel cancer drug development company that Dr. Tidmarsh founded in 2007. In addition, Dr. Tidmarsh’s background includes various positions at Coulter Pharmaceuticals, including Chief Medical Officer, and SEQQUS where he played a key role in the approval of Doxil. He has also held scientific and clinical positions at Gilead Sciences and SyStemix.

Dr. Tidmarsh has published 25 peer-reviewed articles in leading journals and authored 15 U.S. patents. He received his Bachelor of Science, M.D., and Ph.D. from Stanford University, where he also completed Residency and Fellowship training. In addition, Dr. Tidmarsh is currently an Associate Professor of Pediatrics and Neonatology at Stanford University School of Medicine.

We believe Mr. Tidmarsh is qualified to serve on our board of directors because of his knowledge of our company’s history and current operations, which he gained from serving as our director since October 10, 2011, in addition to his business experiences described above.

Family Relationships

There are no family relationships between any director or executive officer.


42

Involvement in Certain Legal Proceedings

There are no material proceedings to which any director or executive officer or any associate of any such director or officer is a party adverse to our company or has a material interest adverse to our company.

No director or executive officer has been involved in any of the following events during the past ten years:

  1.

any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;

     
  2.

any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offences);

     
  3.

being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities;

     
  4.

being found by a court of competent jurisdiction (in a civil action), the Securities and Exchange Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

     
  5.

being the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged violation of: (i) any federal or state securities or commodities law or regulation; or (ii) any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease- and- desist order, or removal or prohibition order; or (iii) any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

     
  6.

being the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Securities Exchange Act of 1934), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.



43

Compliance with Section 16(a) of the Securities Exchange Act of 1934

Section 16(a) of the Securities Exchange Act of 1934 requires our executive officers and directors and persons who own more than 10% of our common stock to file with the Securities and Exchange Commission initial statements of beneficial ownership, reports of changes in ownership and annual reports concerning their ownership of our common stock and other equity securities, on Forms 3, 4 and 5 respectively. Executive officers, directors and greater than 10% shareholders are required by the Securities and Exchange Commission regulations to furnish us with copies of all Section 16(a) reports that they file.

Based solely on our review of the copies of such forms received by us, or written representations from certain reporting persons, we believe that during fiscal year ended September 30, 2011, all filing requirements applicable to our officers, directors and greater than 10% percent beneficial owners were complied with the exception of the following:



Name

Number of
Late Reports
Number of Transactions
Not Reported on a Timely
Basis

Failure to File
Required Forms
Harvey Lalach 2 6 Nil
Robert Chisholm 1 1 Nil

Code of Ethics

We have adopted a code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. We undertake herewith to provide by mail to any person without charge, upon request, a copy of such code of ethics if we receive the request in writing by mail to Anavex Life Sciences Corp., 45 Tintern Lane, Portola Valley, California 84028, Attention: President.

Audit Committee and Audit Committee Financial Experts

We have an audit committee, comprised of three directors, Harvey Lalach, Robert Chisholm, and Sean Lowry. During the fiscal year ended September 30, 2011, our audit committee held one meeting. The audit committee represents our board of directors in discharging its responsibility relating to the accounting, reporting and financial practices of our company, and has general responsibility for oversight of internal controls, accounting and audit activities and legal compliance of our company. However, the audit committee’s function is one of oversight only and does not relieve our management of its responsibilities for preparing financial statements which accurately and fairly present our financial results and conditions or the responsibilities of the independent registered public accounting firm relating to the audit or review of financial statements.

Sean Lowry, and Robert Chisholm are each considered an “audit committee financial expert” as defined in Item 407(d)(5)(ii) of Regulation S-K. Sean Lowry is Chairman of the audit committee.


44

Nominating and Compensation Committees

We do not have standing nominating or compensation committees, or committees performing similar functions. Our board of directors believes that it is not necessary to have a standing compensation committee at this time because the functions of such committee are adequately performed by our board of directors. Our board of directors has not adopted a charter for the compensation committee.

Our board of directors also is of the view that it is appropriate for us not to have a standing nominating committee because our board of directors has performed and is expected to perform adequately the functions of a nominating committee. Our board of directors has not adopted a charter for the nominating committee. There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. Our board of directors does not believe that a defined policy with regard to the consideration of candidates recommended by stockholders is necessary at this time because we believe that, at this stage of our development, a specific nominating policy would be premature and of little assistance until our business operations are at a more advanced level. There are no specific, minimum qualifications that our board of directors believes must be met by a candidate recommended by our board of directors. The process of identifying and evaluating nominees for director typically begins with our board of directors soliciting professional firms with whom we have an existing business relationship, such as law firms, accounting firms or financial advisory firms, for suitable candidates to serve as directors. It is followed by our board of directors’ review of the candidates’ resumes and interview of candidates. Based on the information gathered, our board of directors then makes a decision on whether to recommend the candidates as nominees for director. We do not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.

ITEM 11. EXECUTIVE COMPENSATION

Summary Compensation

The particulars of compensation paid to the following persons:

  (a)

our principal executive officers;

     
  (b)

each of our two most highly compensated executive officers who were serving as executive officers at the end of the fiscal year ended September 30, 2011 who had total compensation exceeding $100,000; and

     
  (c)

up to two additional individuals for whom disclosure would have been provided under (b) but for the fact that the individual was not serving as our executive officer at the end of the most recently completed financial year, who we will collectively refer to as the named executive officers, for our fiscal years ended September 30, 2011 and 2010, are set out in the following summary compensation table:



45

  SUMMARY COMPENSATION TABLE   



Name
and Principal
Position






Year





Salary
($)





Bonus
($)




Stock
Awards
($)




Option
Awards
($)(4)

Non-
Equity
Incentive
Plan
Compensa-
tion
($)

Nonqualified
Deferred
Compensation
Earnings
($)


All
Other
Compensa-
tion
($)





Total
($)

Dr. Cameron Durrant(1)
Former Executive Chairman and Director
2011
2010
300,000
$200,000
Nil
Nil
Nil
Nil
Nil
$Nil
Nil
Nil
Nil
Nil
Nil
Nil
$300,000
$200,000
Harvey Lalach(2)
President, Chief Operating Officer, Secretary and Director and Former Chief Financial Officer
2011
2010
$150,000
$150,000
Nil
Nil
Nil
Nil
Nil
$Nil
Nil
Nil
Nil
Nil
Nil
Nil
150,000
$150,000

(1)

Dr. Cameron Durrant was appointed as our Executive Chairman on January 2, 2010. Prior to that date, Dr. Durrant served as an advisor to the company and as a director and received certain stock option awards for his services in that capacity. Dr. Durrant resigned as a director and officer of the Company on September 16, 2011.

   
(2)

Mr. Lalach was appointed President and Secretary on April 25, 2006. On August 27, 2011, Mr. Lalach was appointed Chief Operating Officer and on May 13, 2011 he was appointed Interim Chief Financial Officer.

   
(3)

Details of our stock-based compensation arrangements, including the assumptions used in calculating the fair value of our share based awards, are disclosed in footnote 9 to our financial statements.

Consulting Agreements

Cameron Durrant

On May 20, 2008, we entered into a consulting agreement with Cameron Durrant to provide certain management and consulting services to our company. Consideration for his services included:

  (a)

the issuance of 200,000 shares of common stock to be paid installments of 25,000 shares every quarter;

     
  (b)

the issuance of 400,000 stock options exercisable at $5.25 per share for a period of three years, subject to vesting provisions; and

     
  (c)

a payment of a finder’s fee for any financing our company receives in the amount of 4% on the first $100,000,000 and 2% on the balance.

On May 14, 2009, we signed an amended consulting agreement with Cameron Durrant, whereby the consideration of 200,000 common shares to be paid in installments of 25,000 common shares every quarter was replaced with a grant of 400,000 options at an exercise price of $2.50 per share until May 12, 2014 and vest as follows:

  (a)

200,000 options upon the execution of the amended consulting agreement;

     
  (b)

50,000 options on August 14, 2009

     
  (c)

50,000 options on November 14, 2009



46

  (d)

50,000 on February 14, 2010

     
  (e)

50,000 options on May 14, 2010

Dr. Durrant received 75,000 shares of common stock pursuant to the consulting agreement dated May 20, 2008 and subsequently returned these 75,000 shares to our company for cancellation as a result of the award modification.

On January 2, 2010 we signed a second amended consulting agreement with Dr. Durrant, whereby we retained his services as our Executive Chairman commencing as of January 2, 2010. In consideration of Dr. Durrant’s services, we agreed to pay him a monthly fee of $25,000, which equates to $300,000 over the course of one year. The term of this agreement was for a period of two years commencing on January 2, 2010 and expiring on January 1, 2012. Effective September 16, 2011, Dr. Durrant resigned from our board of directors and as an officer of our company.

Harvey Lalach

We have a consulting agreement dated February 1, 2007 with Harvey Lalach to provide management services to our company for consideration of $7,000 per month. The contract had a two year term, and was extended for an additional two year term expiring January 31, 2011. During the fiscal year ended September 30, 2008, we agreed to increase the compensation of Mr. Lalach to $12,500 per month. Effective February 1, 2011 we entered into a consulting agreement with Mr. Lalach whereby Mr. Lalach agreed to continue to provide management services to our company in return for compensation of $12,500 per month for an additional two years.

Dr. George Tidmarsh

Effective October 10, 2011 we entered into a consulting agreement with Dr. Tidmarsh to act as our executive director for the following consideration:

  (a)

a monthly consulting fee of $10,000;

     
  (b)

500,000 Share purchase options exercisable at $1.50 per option share until October 10, 2016 (subject to certain vesting provisions);

     
  (c)

reimbursement of all reasonable expenditures.

The consulting agreement is for a period of one year and may be reviewed by either our company or Dr. Tidmarsh.

Outstanding Equity Awards at Fiscal Year-End

The following table sets forth for each named executive officer and director certain information concerning the outstanding equity awards as of September 30, 2011.


47















Name
Option Awards Stock Awards








Number of
Securities
Underlying
Unexercised
Options
Exercisable








Number of
Securities
Underlying
Unexercised
Options
Unexercisable






Equity Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options











Option
Exercise
Price











Option
Expiration
Date





Number
of
Shares
or Units
of Stock
that
Have
Not
Vested


Market
Value
of
Shares
or
Units
of
Stock
that
Have
Not
Vested
Equity
Incentive
Plan
Awards :
Number
of
Unearned
Shares,
Units or
Other
Rights
that
Have Not
Vested






Equity Incentive Plan
Awards :
Market or Payout Value of
Unearned
Shares, Units or Other
Rights that
Have Not
Vested
Harvey
Lalach

150,000
50,000

Nil
Nil

Nil
Nil

$3.10
$3.50

June 3, 2013
June 29,2015
Nil


Nil


Nil


Nil


Alison
Ayers


Cameron
Durrant
150,000
50,000


400,000
400,000
150,000
25,000
Nil
Nil


Nil
Nil
Nil
25,000
Nil
Nil


Nil
Nil
Nil
Nil
$3.10
$3.50


$5.25
$2.50
$3.10
$3.50
June 3, 2013
June 29, 2015


May 20, 2011
May 12, 2012
Dec 12, 2012
June 29, 2015
Nil



Nil


Nil



Nil

Nil



Nil

Nil



Nil

Sean Lowry


Robert
Chisholm
150,000

Nil
Nil

Nil
Nil

Nil
$3,72

-
Feb 24, 2016

-
Nil

Nil
Nil

Nil
Nil

Nil
Nil

Nil

We have not adopted any other equity compensation plan other than our 2007 Stock Option Plan.

Compensation of Directors

The table below shows the compensation of our directors who were not our named executive officers for the fiscal year ended September 30, 2011:





Name


Fees Earned or
Paid in Cash
($)


Stock
Awards
($)


Option
Awards(1)
($)

Non-Equity
Incentive Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)


All other
Compensation
($)



Total
($)
Alison (2)
Ayers
Nil
Nil
Nil
Nil
Nil
Nil
Nil
Sean Lowry
40,000
NIL
406,500
Nil
Nil
Nil
446,500
Robert
Chisholm
Nil
Nil
Nil
Nil
Nil
Nil
Nil


48

(1)

Details of our stock-based compensation arrangements, including the assumptions used in calculating the fair value of our share based awards, are disclosed in footnote 2 to our financial statements. The amount indicated for the value of the option award reflects the fair value of the award on its grant date.

(2)

Alison Ayers resigned as a director of our company on October 21, 2011.

We reimburse our directors for expenses incurred in connection with attending board meetings. We have not paid any director’s fees or other cash compensation for services rendered as a director since our inception to September 30, 2011.

During the fiscal year ended September 30, 2011, there were no standard or other arrangements pursuant to which any of our directors were compensated for services provided in their capacity as directors.

We currently have no formal plan for compensating our directors for their services in their capacity as directors, although we may elect to issue stock options to such persons in the future. Directors are entitled to reimbursement for reasonable travel and other out-of-pocket expenses incurred in connection with attendance at meetings of our board of directors. Our board of directors may award special remuneration to any director undertaking any special services on our behalf other than services ordinarily required of a director.

Retirement or Similar Benefit Plans

There are no arrangements or plans in which we provide retirement or similar benefits for our directors or executive officers.

Resignation, Retirement, Other Termination, or Change in Control Arrangements

We have no contract, agreement, plan or arrangement, whether written or unwritten, that provides for payments to our directors or executive officers at, following, or in connection with the resignation, retirement or other termination of our directors or executive officers, or a change in control of our company or a change in our directors’ or executive officers’ responsibilities following a change in control.

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth, as of December 19, 2011, certain information with respect to the beneficial ownership of our common stock by each stockholder known by us to be the beneficial owner of more than 5% of our common stock, by each of our current directors and executive officers. Each person has sole voting and investment power with respect to the shares of common stock, except as otherwise indicated. Beneficial ownership consists of a direct interest in the shares of common stock, except as otherwise indicated.


49

Security ownership of certain beneficial owners

In the following tables, we have determined the number and percentage of shares beneficially owned in accordance with Rule 13d-3 of the Securities Exchange Act of 1934 based on information provided to us by our controlling stockholder, named executive officers, current executive officers and directors, and this information does not necessarily indicate beneficial ownership for any other purpose. In determining the number of shares of our common stock beneficially owned by a person and the percentage ownership of that person, we include any shares as to which the person has sole or shared voting power or investment power, as well as any shares subject to warrants or options held by that person that are currently exercisable or exercisable within 60 days.

Title of class Name and address of
beneficial owner
Amount and nature of
beneficial ownership
Percent of
class 1
Common Stock Athanasios Skarpelos
2, Place du Port
Geneva, Switzerland
CH 1204
6,725,832 24.73%

Security Ownership of Management


Title of class
Name and address of
beneficial owner
Amount and nature of
beneficial ownership
Percent of
class 1
Common Stock Harvey Lalach
4837 Canyon Ridge Crescent
Kelowna, British Columbia
Canada
768,572    Direct 2 2.8%
Common Stock Sean Lowry
300-1172 Bay Street
Toronto, Ontario M5S 1L9
150,000    Direct3 0.5%
Common Stock Robert Chisholm
c/o 1600 – 609 Granville
Street Vancouver, BC V7Y
1C3
0      Direct 0%
Common Stock George Tidmarsh
951 Gateway Blvd., Suite 3A
South, San Francisco, CA,
USA 94060
0      Direct 0%
Common Stock Cameron Durrant
#90 Fairmount Road West
Califon, NJ 07830-3330
400,000    Direct4 1.4%
Directors & Executive
Officers as a group (4
persons)
918,572      Direct 3.3%

1 Percentage of ownership is based on 27,187,174shares of our common stock issued and outstanding as of December19, 2011. Except as otherwise indicated, we believe that the beneficial owners of the common stock listed above, based on information furnished by such owners, have sole investment and voting power with respect to such shares, subject to community property laws where applicable. Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities. Shares of common stock subject to options or warrants currently exercisable, or exercisable within 60 days, are deemed outstanding for purposes of computing the percentage ownership of the person holding such option or warrants, but are not deemed outstanding for purposes of computing the percentage ownership of any other person.
2 Includes 568,572 shares of common stock and 200,000 stock options exercisable within 60 days.
3Includes 150,000 stock options exercisable within 60 days.
4 Dr. Durrant resigned as executive chairman on September 16, 2011


50

Changes in Control

We are unaware of any contract or other arrangement the operation of which may at a subsequent date result in a change of control of our company.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Transactions with related persons

There has been no transaction, since October 1, 2009, or currently proposed transaction, in which we were or are to be a participant and the amount involved exceeds the lesser of $120,000 or one percent of the average of our total assets at year end for the last two completed fiscal years, and in which any of the following persons had or will have a direct or indirect material interest.

  (i)

any director or executive officer of our company;

     
  (ii)

any beneficial owner of shares carrying more than 5% of the voting rights attached to our outstanding shares of common stock; and

     
  (iii)

any member of the immediate family (including spouse, parents, children, siblings and in-laws) of any of the foregoing persons.

Compensation of Executive Officers and Directors

For information regarding compensation of our executive officers and directors, please see “Item 11. Executive Compensation.”

Director Independence

Under NASDAQ Rule 5605(a)(2), a director is not considered to be independent if he or she is also an executive officer or employee of the company or accepted any compensation from the company in excess of $120,000 during any period of twelve consecutive months within the three years preceding the determination of independence.

We determined that Harvey Lalach and Dr. George Tidmarsh are not independent as that term is defined by NASDAQ 5605(a)(2) because Mr. Lalach is our President, Chief Operating Officer and interim Chief Financial Officer and Dr. Tidmarsh is an executive director. We determined that Robert Chisholm and Sean Lowry are independent as that term is defined by NASDAQ Rule 5605(a)(2).


51

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

Fees Paid to Our Independent Registered Public Accounting Firm

The following table sets forth the aggregate fees billed or expected to be billed to our company for professional services rendered by our independent registered public accounting firms, for the fiscal years ended September 30, 2011 and 2010:

Fees   2011     2010  
             
   Audit fees $ 87,570   $ 86,656  
   Audit related fees $ Nil     Nil  
   Tax fees $ 7,349   $ 6,537  
   All other fees $ NIL     Nil  
Total Fees $ 94,919   $ 93,193  

Audit Fees. Consist of fees billed for professional services rendered for the audits of our financial statements, reviews of our interim financial statements included in quarterly reports, services performed in connection with filings with the Securities and Exchange Commission and other services that are normally provided by BDO Dunwoody LLP for the fiscal years ended September 30, 2011 and 2010, in connection with statutory and regulatory filings or engagements.

Policy on Pre-Approval by Audit Committee of Services Performed by Independent Registered Public Accounting Firm

Our audit committee pre-approves all services provided by our independent registered public accounting firm. All of the above services and fees were reviewed and approved by our audit committee before the respective services were rendered.

Our audit committee has considered the nature and amount of fees billed by BDO Dunwoody LLP and believes that the provision of services for activities unrelated to the audit was compatible with maintaining BDO Dunwoody LLP’s independence.

PART IV

ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES

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 Registration Statement on Form SB-2 filed on January 13, 2005)

3.3

Articles of Merger filed with the Secretary of State of Nevada on January 10, 2007 and which is effective January 25, 2007 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on January 25, 2007)



52

Exhibit
Number


Description

(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

Agreement between Anavex Life Sciences Corp. and Dr. Alexandre Vamvakides dated January 31, 2007 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007)

10.2

Abstract of Disclosure of Greek Patent Number 1002616 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007)

10.3

Abstract of Disclosure of Greek Patent Number 1004208 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007)

10.4

Abstract of Disclosure of Greek Patent Number 1004868 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007)

10.5

Written description of Greek Patent Application Number 20070100020 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2007)

10.6

Form of Stock Option Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 22, 2007)

10.7

Shares for Services and Subscription Agreement dated September 11, 2007 between our company and Eurogenet Labs S.A. (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2007)

10.8

2007 Stock Option Plan (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 28, 2007)

10.9

Consulting Agreement with Cameron Durrant dated May 20, 2008 (incorporated by reference to an exhibit to our Quarterly Report on Form 10-QSB filed on August 18, 2008

10.10

Form of Convertible Loan Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009)

10.11

Consulting Agreement with Tariq Arshad dated March 2, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009)

10.13

Consulting Agreement with Dr. Mark Smith dated January 13, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009)

10.14

Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009)

10.15

Form of Warrant Certificate (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 3, 2009)



53

Exhibit
Number

Description
10.16

Amended Consulting Agreement with Cameron Durrant dated May 14, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.17

CEO Consulting Agreement with Dr. Herve de Kergrohen dated June 12, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.18

Form of Private Placement subscription agreement dated June 15, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.19

Shares for Services Agreement with Andreas Eleuthariadis dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.20

Shares for Services Agreement with Vasileios Kourafalos dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.21

Shares for Services Agreement with George Kalkanis dated June 10, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.22

Stock Option Agreement with Alexandre Vamvakides dated June 11, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 23, 2009)

10.23

Form of Private Placement Subscription Agreement Convertible Loan (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 26, 2009)

10.24

Form of Private Placement Subscription Agreement for Units (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on June 26, 2009)

10.25

Consultant Services Agreement with NAD Ltd. dated July 1, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 24, 2009)

10.26

Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 24, 2009)

10.27

Form of Warrant Certificate (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on August 12, 2009)

10.28

Stock Option Agreement with Alexander Vamvakides dated October 19, 2009 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 24, 2009)

10.29

Promissory note issued to Stonehedge Limited on January 1, 2010 (incorporated by reference to an exhibit to our Quarterly Report on Form 10-Q filed on March 31, 2010)

10.30

Second Amended Consulting Agreement with Dr. Cameron Durrant dated January 2, 2010 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 9, 2010)

10.31

Contract Lease Agreement with Euro Genet Labs SA dated February 1, 2010 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 9, 2010)



54

Exhibit
Number


Description

10.32

Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 9, 2010)

10.33

Form of Warrant Certificate (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 9, 2010)

10.34

Form of Convertible Loan Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 9, 2010)

10.35

Form of Subscription Agreement for US subscribers (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 6, 2010)

10.36

Form of Subscription Agreement for non-US subscribers (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 6, 2010)

10.37

Form of Warrant Certificate for US warrant holders (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 6, 2010)

10.38

Form of Warrant Certificate for non-US warrant holders (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 6, 2010)

10.39

Shares for Services Agreement dated July 5, 2010 with Eurogenet Labs SA (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 9, 2010)

10.40

Form of Warrant Certificate for non-US warrant holders (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on July 9, 2010)

10.41

Agreement for Services with Genesis Biopharma Group LLC dated August 10, 2010 (incorporated by reference to an exhibit of our Current Report on Form 8-K filed on August 18, 2010) (portions of the exhibit have been omitted pursuant to a request for confidential treatment)

10.42

Agreement for Services with ABX-CRO Advanced Pharmaceutical Services dated August 10, 2010 (incorporated by reference to an exhibit of our Current Report on Form 8-K filed on August 18, 2010) (portions of the exhibit have been omitted pursuant to a request for confidential treatment)

10.43

Form of Subscription Agreement (US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 9, 2010)

10.44

Form of Subscription Agreement (Canadian and Offshore Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 9, 2010)

10.45

Form of Warrant Certificate (US warrant holders)(incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 9, 2010)

10.46

Form of Warrant Certificate (Canadian and Offshore warrant holders) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 9, 2010)

10.47

Consulting Agreement dated August 2, 2010 with Tom Skarpelos (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2010)

10.48

Independent Contractor Agreement dated September 1, 2010 with David Tousley (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2010)



55

Exhibit
Number


Description

10.49

Sublease Contract with Genesis Research LLC dated September 15, 2010 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 27, 2010)

10.50

Form of Subscription Agreement (US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.51

Form of Subscription Agreement (non-US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.52

Form of Warrant Certificate (US Warrant Holders) (US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.53

Form of Warrant Certificate (non-US Warrant Holders) (US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.54

Shares for Service and Subscription Agreement dated November 1, 2010 with Eurogenet Labs SA (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.55

Subscription Agreement with Stonehedge Limited dated November 17, 2010 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 22, 2010)

10.56

Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 30, 2010)

10.57

Form of Warrant Certificate Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 30, 2010)

10.58

Shares for Services Agreement Form of Subscription Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on November 30, 2010)

10.59

Form of Subscription Agreement (non-US Purchasers) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2011)

10.60

Form of Warrant Certificate (non-US Warrant Holders) (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2011)

10.61

Termination Agreement dated February 2, 2011 with Genesis BioPharma Group, LLC (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2011)

10.62

Independent Contractor Agreement with Harvey Lalach dated February 1, 2011 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2011)

10.63

Independent Contractor Agreement with Dr. Angelos Stergiou dated February 1, 2011 (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 7, 2011)

10.64

Amended and Restated 2007 Stock Option Plan (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 8, 2011)



56

Exhibit
Number

Description

10.65

Form of Advisory Board Consulting Agreement (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on February 28, 2011)

10.66

Consulting Agreement dated March 30, 2011 with Shackleton Consulting Corp. (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 13, 2011)

10.67

Form of subscription agreement for convertible debenture (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on April 26, 2011)

10.68

Form of subscription agreement for convertible debenture (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on May 9, 2011)

10.69

Form of warrant certificate (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on May 9, 2011)

10.70

Amended Stock Option Agreement dated September 16, 2011 with Cameron Durrant (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 21, 2011)

10.71

Consulting Agreement dated effective October 10, 2011, with George Tidmarsh (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on October 14, 2011)

(14)

Code of Ethics

14.1

Code of Conduct (incorporated by reference to an exhibit to our Current Report on Form 8-K filed on September 28, 2007)

(21)

Subsidiaries

21.1

Anavex Life Sciences (France) SA, incorporated under the laws of France

(31)

Section 302 Certifications

31.1*

Section 302 Certification of Harvey Lalach

(32)

Section 906 Certifications

32.1*

Section 906 Certification of Harvey Lalach

(99)

Additional Exhibits

99.1

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

(101)

XBRL

101.INS*

XBRL INSTANCE DOCUMENT

101.SCH*

XBRL TAXONOMY EXTENSION SCHEMA

101.CAL*

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE

101.DEF*

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE

101.LAB*

XBRL TAXONOMY EXTENSION LABEL LINKBASE

101.PRE*

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

* Filed herewith.


57

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ANAVEX LIFE SCIENCES CORP.  
   
By:  
/s/ Harvey Lalach  
Harvey Lalach  
President, Chief Operating Officer, Secretary, Interim Chief Financial Officer and Director (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
Date: December 21, 2011  

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

By:  
/s/ Harvey Lalach  
Harvey Lalach  
President, Chief Operating Officer, Secretary, Interim Chief Financial Officer and Director (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer)
Date: December 21, 2011  
   
By:  
/s/ Sean Lowry  
Sean Lowry  
Director  
Date: December 21, 2011  
   
By:  
/s/ Robert Chisholm  
Robert Chisholm  
Director  
Date: December 21, 2011  
   
By:  
/s/ George Tidmarsh  
George Tidmarsh  
Executive Director  
Date: December 21, 2011