UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2020 ☐ 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: 001-37606 ANAVEX LIFE SCIENCES CORP. (Exact name of registrant as specified in its charter) Nevada 98-06084 ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q3 2020 Results Conference Call August 6, 2020 11:00 AM ET Company Participants Clint Tomlinson - IR Dr. Christopher Missling - President and CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Edward Marks - H.C. Wainwright Operator Welcome to the Anavex Life Sciences to announce fiscal 2020 Third Quarter Financial Results Conference Call. My name is Rebecca, and I will be your operator for today's call. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2020 ☐ 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: 001-37606 ANAVEX LIFE SCIENCES CORP. (Exact name of registrant as specified in its charter) Nevada 98-0608404 (State or oth ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q2 2020 Earnings Conference Call May 7, 2020 4:30 PM ET Company Participants Clint Tomlinson – Investor Relations Christopher Missling – President and Chief Executive Officer Sandra Boenisch – Principal Financial Officer Conference Call Participants Raghuram Selvaraju – H.C. Wainwright Tom Bishop – BI Research Operator Good afternoon. My name is Adriane, and I will be your conference call operator today. Welcome to the Anavex Life Sciences Fiscal 2020 Second Quarter ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2020 ☐ 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: 001-37606 ANAVEX LIFE SCIENCES CORP. (Exact name of registrant as specified in its charter) Nevada 98-0608404 (IRSEmployer ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2020 Earnings Conference Call February 6, 2020 4:30 PM ET Company Participants Clint Tomlinson – Investor Relations Christopher Missling – President and Chief Executive Officer Sandra Boenisch – Principal Financial Officer Conference Call Participants Edward Marks – H. C. Wainwright Yun Zhong – Janney Tom Bishop – BI Research Operator Good afternoon. My name is Anna, and I will be your conference operator today. Welcome to the Anavex Life Sciences to announce Fisc ...

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis, market risk disclosures, and internal controls [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Anavex Life Sciences Corp. reported no revenue, a net loss of $6.6 million, and increased cash to $27.5 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets increased to $31.4 million, primarily driven by a $5.3 million rise in cash and cash equivalents Balance Sheet Summary (in USD) | Balance Sheet Items | Dec 31, 2019 (Unaudited) | Sep 30, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $27,458,423 | $22,185,630 | | Total Assets | $31,424,067 | $25,329,373 | | **Liabilities & Equity** | | | | Total Liabilities | $5,463,917 | $5,039,674 | | Total Stockholders' Equity | $25,960,150 | $20,289,699 | | Total Liabilities and Stockholders' Equity | $31,424,067 | $25,329,373 | - The increase in total assets was primarily driven by a rise in cash and cash equivalents, which grew by approximately **$5.3 million** during the quarter[4](index=4&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) Net loss slightly decreased to $6.6 million due to higher other income, despite increased R&D expenses Statement of Operations Summary (in USD, for the three months ended Dec 31) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Research and development | $6,348,668 | $5,712,210 | | General and administrative | $1,352,035 | $1,761,307 | | Total operating expenses | ($7,700,703) | ($7,473,517) | | Total other income, net | $1,117,992 | $562,503 | | Net loss | ($6,591,925) | ($6,919,731) | | Net Loss per share (Basic and diluted) | ($0.12) | ($0.15) | - The net loss decreased slightly year-over-year, primarily due to a significant increase in 'Total other income, net', which was driven by higher research and development incentive income[5](index=5&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Cash increased by $5.3 million, driven by $11.0 million from financing activities offsetting operating cash burn Cash Flow Summary (in USD, for the three months ended Dec 31) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($5,725,159) | ($4,160,169) | | Net cash provided by financing activities | $10,997,952 | $1,944,700 | | Increase (decrease) in cash | $5,272,793 | ($2,215,469) | | Cash and cash equivalents, end of period | $27,458,423 | $20,715,169 | - The company's cash position improved significantly due to **$11.0 million** in net cash provided by financing activities from the issuance of common shares, which more than offset the **$5.7 million** cash used in operations[6](index=6&type=chunk) [Notes to the Condensed Consolidated Interim Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Key notes detail the company's biopharmaceutical focus, funding, and significant stock-based compensation expenses - The company is a clinical-stage biopharmaceutical firm focused on developing therapeutics for Central Nervous System (CNS) diseases, with its lead compound ANAVEX®2-73 being developed for Alzheimer's, Parkinson's, and Rett syndrome[9](index=9&type=chunk) - The company has not generated any revenue and expects to continue experiencing negative cash flows. However, management believes existing cash and financial commitments are sufficient to fund operations for at least the **next two years**[13](index=13&type=chunk)[15](index=15&type=chunk) - During the quarter, the company raised approximately **$11.0 million** by issuing **4,394,160 shares** of common stock under its 2019 Purchase Agreement with Lincoln Park[44](index=44&type=chunk) - Stock-based compensation expense for the quarter was **$1,264,424**, a decrease from **$2,066,987** in the same period of the prior year[57](index=57&type=chunk)[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Management discusses clinical progress, operating expenses, net loss, and strengthened liquidity from equity financing [Business Overview](index=20&type=section&id=Our%20Current%20Business) Anavex is a clinical-stage biopharmaceutical company focused on CNS diseases using a precision medicine approach - Anavex is a clinical-stage biopharmaceutical company focused on developing therapeutics for CNS diseases with high unmet need, utilizing a precision medicine approach by identifying genomic biomarkers[65](index=65&type=chunk) - The lead compound, ANAVEX2-73, is being developed for Alzheimer's disease, Parkinson's disease, and the rare neurological disorder Rett syndrome[66](index=66&type=chunk) - The company's portfolio consists of five programs: two core programs and three seed programs at various stages of clinical and preclinical development[67](index=67&type=chunk) - The company's SIGMACEPTOR™ Discovery Platform has produced small molecule drug candidates that target sigma receptors, which are believed to influence biochemical signals involved in the pathogenesis of neurodegenerative and neurodevelopmental diseases[87](index=87&type=chunk) [Clinical Studies Overview](index=22&type=section&id=Clinical%20Studies%20Overview) Overview of ongoing Phase 2/3 clinical trials for ANAVEX2-73 in Alzheimer's, Rett syndrome, and Parkinson's disease - **Alzheimer's Disease:** A large Phase 2b/3 double-blind, placebo-controlled study of ANAVEX2-73 is ongoing, enrolling approximately **450 patients**. A long-term open-label extension study (ATTENTION-AD) was also initiated for patients completing the main trial[75](index=75&type=chunk)[76](index=76&type=chunk) - **Rett Syndrome:** The company has a comprehensive program with three ongoing Phase 2 studies for ANAVEX2-73: a U.S.-based study, the AVATAR study in Australia, and the EXCELLENCE pediatric study in Australia[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - **Parkinson's Disease:** A double-blind, randomized, placebo-controlled Phase 2 trial of ANAVEX2-73 in Parkinson's Disease Dementia (PDD) is underway, enrolling approximately **120 patients** across Spain and Australia[84](index=84&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating expenses increased to $7.7 million, while net loss slightly improved due to higher other income Operating Results (in millions USD, for the three months ended Dec 31) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Research and development expenses | $6.3 | $5.7 | | General and administrative expenses | $1.4 | $1.8 | | Total operating expenses | $7.7 | $7.5 | | Net loss | $6.6 | $6.9 | | Loss per share | $0.12 | $0.15 | - The increase in total operating expenses was driven by a **$0.6 million** rise in research and development expenses, partially offset by a **$0.4 million** decrease in general and administrative expenses, which was primarily due to lower stock-option compensation charges[134](index=134&type=chunk)[135](index=135&type=chunk) - Other income increased to **$1.1 million** from **$0.6 million**, mainly due to higher Australian research and development incentive income from increased clinical activities in Australia[135](index=135&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Cash increased to $27.5 million due to $11.0 million from financing activities, strengthening working capital Working Capital (in USD) | Metric | Dec 31, 2019 | Sep 30, 2019 | | :--- | :--- | :--- | | Current Assets | $31,424,067 | $25,329,373 | | Current Liabilities | $5,463,917 | $5,039,674 | | Working Capital | $25,960,150 | $20,289,699 | - Cash and cash equivalents increased by **$5.2 million** during the quarter to **$27.5 million**, primarily due to **$11.0 million** in cash received from financing activities under the 2019 Purchase Agreement[137](index=137&type=chunk)[140](index=140&type=chunk) - Net cash used in operating activities increased to **$5.7 million** for the quarter, compared to **$4.2 million** in the prior-year period[139](index=139&type=chunk) - As of December 31, 2019, approximately **$34.4 million** remained available for purchase under the 2019 Purchase Agreement with Lincoln Park[144](index=144&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=33&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) This section is not applicable to the company as a smaller reporting company - The company has indicated that this item is not applicable[153](index=153&type=chunk) [Controls and Procedures](index=33&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES.) Management concluded disclosure controls were effective, implementing new procedures for R&D incentive accounting - Based on an evaluation as of December 31, 2019, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[154](index=154&type=chunk) - In response to a material weakness identified in the previous fiscal year, the company established additional quarterly procedures to ensure proper accounting, estimation, and disclosure for its Australian research and development incentive program[155](index=155&type=chunk) [PART II – OTHER INFORMATION](index=33&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, other information, and exhibits [Legal Proceedings](index=33&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS.) The company reports no material pending legal proceedings outside of ordinary routine litigation - The company is not aware of any material pending legal proceedings to which it or its subsidiaries are a party[157](index=157&type=chunk) [Risk Factors](index=34&type=section&id=ITEM%201A.%20RISK%20FACTORS.) There have been no material changes to the risk factors previously disclosed in the company's Annual Report - The company states there have been no material changes in the significant risk factors affecting its business as described in its Annual Report on Form 10-K for the fiscal year ended September 30, 2019[159](index=159&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECU RITIES%20AND%20USE%20OF%20PROCEEDS.) The company did not have any unregistered sales of equity securities not previously disclosed on a Form 8-K - During the quarter, the company has not sold any equity securities that were not registered under the Securities Act of 1933 and not previously reported on a Form 8-K[160](index=160&type=chunk) [Other Information](index=34&type=section&id=ITEM%205.%20OTHER%20INFORMATION.) On February 4, 2020, the company amended the employment agreement with its Principal Financial Officer (PFO), effective March 1, 2020 - Effective March 1, 2020, the company amended the employment agreement for its Principal Financial Officer, increasing the annual base salary to **$200,000 Canadian dollars**[161](index=161&type=chunk) [Exhibits](index=35&type=section&id=ITEM%206.%20EXHIBITS.) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and PFO, and XBRL data files

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2019 Results Earnings Conference Call December 16, 2019 4:30 PM ET Company Participants Clint Tomlinson - Investor Relations Christopher Missling - President and Chief Executive Officer Sandra Boenisch - Principal Financial Officer Conference Call Participants Edward Marks - H.C. Wainwright Yun Zhong - Janney Operator Good afternoon. My name is Hilda and I will be your conference call operator today. Welcome to the Anavex Life Sciences to announce Fiscal 2019 Four ...

Part I [Business](index=5&type=section&id=ITEM%201.%20BUSINESS) Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing therapeutics for CNS diseases using a precision medicine approach [Overview and Strategy](index=5&type=section&id=Overview%20and%20Strategy) The company develops CNS therapeutics through precision medicine, identifying biomarkers for patient selection, with ANAVEX2-73 targeting sigma-1 receptor to restore cellular homeostasis - Anavex is a clinical-stage biopharmaceutical company using precision medicine for CNS diseases with high unmet needs[12](index=12&type=chunk) - The lead compound, ANAVEX2-73, is being developed for Alzheimer's, Parkinson's, and Rett syndrome[13](index=13&type=chunk) - The company's approach focuses on activating the SIGMAR1 gene to restore cellular homeostasis, which is disrupted in many neurodegenerative diseases[14](index=14&type=chunk)[15](index=15&type=chunk) - Genomic analysis of patients treated with ANAVEX2-73 identified SIGMAR1 and COMT as key biomarkers, suggesting that selecting patients based on these genetic variants could improve clinical outcomes[16](index=16&type=chunk) [Clinical Studies Overview](index=7&type=section&id=Clinical%20Studies%20Overview) Anavex is conducting multiple clinical trials for ANAVEX2-73, including a Phase 2b/3 study for Alzheimer's, three Phase 2 studies for Rett syndrome, and a Phase 2 trial for Parkinson's Disease Dementia - A Phase 2b/3 double-blind, placebo-controlled study of ANAVEX2-73 in approximately **450 Alzheimer's patients** commenced in August 2018[20](index=20&type=chunk) - Three Phase 2 clinical trials for ANAVEX2-73 in Rett syndrome were initiated in 2019: a US-based study, the AVATAR study in Australia, and the EXCELLENCE study for pediatric patients in Australia[23](index=23&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - A Phase 2 double-blind, randomized, placebo-controlled trial with ANAVEX2-73 in **120 Parkinson's Disease Dementia (PDD) patients** was initiated in October 2018[29](index=29&type=chunk) [Our Pipeline](index=9&type=section&id=Our%20Pipeline) The company's SIGMACEPTOR™ Discovery Platform yields a pipeline including lead candidate ANAVEX2-73 for neurodegenerative and neurodevelopmental diseases, and preclinical candidates like ANAVEX3-71 for Alzheimer's and FTD - ANAVEX2-73 has received FDA Orphan Drug Designation for Rett syndrome and infantile spasms, and Rare Pediatric Disease (RPD) designation for Rett syndrome[36](index=36&type=chunk) - ANAVEX3-71, a preclinical candidate, has shown potential in Alzheimer's models by enhancing neuroprotection and cognition and has received FDA Orphan Drug Designation for Frontotemporal dementia (FTD)[53](index=53&type=chunk)[54](index=54&type=chunk) - ANAVEX1-41 is a preclinical sigma-1 agonist showing neuroprotective benefits[56](index=56&type=chunk) - ANAVEX1066 is a preclinical candidate for neuropathic and visceral pain[59](index=59&type=chunk) - ANAVEX1037 is a preclinical candidate for prostate and pancreatic cancer, showing antitumor potential by selectively killing cancer cells[61](index=61&type=chunk) [Patents, Trademarks and Intellectual Property](index=15&type=section&id=Patents%2C%20Trademarks%20and%20Intellectual%20Property) Anavex holds a portfolio of eight U.S. patents and numerous applications covering its drug candidates, with key ANAVEX2-73 patents expiring in the 2030s, forming a core corporate asset - The company holds or has exclusive rights to **eight U.S. patents**, eight U.S. patent applications, and various international patent applications[75](index=75&type=chunk) - Key U.S. patents for ANAVEX2-73 cover its composition with donepezil (exp. **2034**), crystalline forms (exp. **2036-2037**), and methods for treating seizures (exp. **2035**)[76](index=76&type=chunk) - The company holds exclusive rights to **two issued U.S. patents** for ANAVEX3-71, covering the compound and its use in treating diseases like Alzheimer's, expected to expire in **2030**[78](index=78&type=chunk) [Risk Factors](index=18&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks including financial losses, dependence on external financing, internal control weaknesses, drug development uncertainty, intense competition, and intellectual property challenges [Risks Related to our Company](index=18&type=section&id=Risks%20Related%20to%20our%20Company) The company has a history of losses, an accumulated deficit exceeding $133 million, no revenue, and depends on external financing, compounded by a material weakness in internal controls over financial reporting - The company has an accumulated deficit of over **$133 million** since inception through September 30, 2019, has generated no revenue, and expects negative cash flows for the foreseeable future[98](index=98&type=chunk) - The company is an early-stage entity with all potential drug compounds in early clinical development, facing risks of unforeseen capital requirements and failure in clinical trials[99](index=99&type=chunk)[100](index=100&type=chunk) - A material weakness was identified in internal control over financial reporting regarding the accounting for the Australian R&D incentive program, where income was previously recognized upon cash receipt instead of when qualifying expenditures were incurred[103](index=103&type=chunk) [Risks Related to our Business](index=19&type=section&id=Risks%20Related%20to%20our%20Business) The company's business faces substantial risks from extensive R&D and regulatory approval processes, potential clinical trial failures, reliance on third-party manufacturers and CROs, intense competition, and product liability claims - Drug candidates require extensive R&D and regulatory approvals, and there is a high risk of failure in clinical trials due to ineffectiveness or harmful side effects[105](index=105&type=chunk) - Substantial additional funding is required for R&D, and the inability to secure it could halt or cease operations[106](index=106&type=chunk)[107](index=107&type=chunk) - The company relies on third parties like contract research organizations (CROs) and manufacturers, and their failure to perform could cause significant delays[126](index=126&type=chunk)[127](index=127&type=chunk) - The company faces significant competition from large pharmaceutical companies with greater resources and experience[124](index=124&type=chunk) [Risks Related to our Common Stock](index=24&type=section&id=Risks%20Related%20to%20our%20Common%20Stock) The company's common stock is subject to price volatility and potential dilution from future equity issuances, including agreements with Lincoln Park Capital and Cantor Fitzgerald for up to $50 million each - The common stock price is volatile, which could affect the ability to raise capital and may result in dilution for investors if funds are raised at lower prices[135](index=135&type=chunk)[136](index=136&type=chunk) - The sale of up to **$50 million** of common stock to Lincoln Park Capital may cause significant dilution and could cause the stock price to fall[142](index=142&type=chunk)[143](index=143&type=chunk) - The "at-the-market" offering agreement with Cantor Fitzgerald & Co. for up to **$50 million** of common stock may also result in shareholder dilution and a decrease in share price[147](index=147&type=chunk) [Risks Related to our Intellectual Property](index=26&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) The company's success depends on its ability to obtain, maintain, and defend intellectual property, facing risks of patent invalidation, infringement claims, and costly global protection challenges - The company's ability to commercialize products may be impaired if it cannot obtain and maintain sufficient intellectual property protection[148](index=148&type=chunk) - Patents may be challenged, narrowed, or invalidated, and competitors could design around them. Defending patents is expensive and time-consuming[151](index=151&type=chunk)[153](index=153&type=chunk) - The company could face third-party claims of IP infringement, which could lead to substantial damages, litigation expenses, and halt development efforts[162](index=162&type=chunk)[164](index=164&type=chunk) - Failure to comply with obligations in licensing agreements, such as the one with Life Science Research Israel Ltd. for ANAVEX3-71, could lead to termination of the license[157](index=157&type=chunk)[158](index=158&type=chunk) - Protecting intellectual property rights globally is prohibitively expensive, and laws in some foreign countries offer less protection than in the U.S[176](index=176&type=chunk) [Properties](index=31&type=section&id=ITEM%202.%20PROPERTIES) The company leases its main office in New York, NY, for approximately $16,000 per month, deeming the space suitable for current operations - The company leases its main office in New York, NY, with monthly lease costs of approximately **$16,000**[178](index=178&type=chunk) [Legal Proceedings](index=31&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company reports no material pending legal proceedings beyond routine litigation incidental to its business - There are no material pending legal proceedings involving the company, its subsidiaries, directors, or major stockholders[179](index=179&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=31&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on NASDAQ under "AVXL", with 56.1 million shares outstanding as of December 2019, and it retains earnings for development, not paying dividends - Common stock is quoted on NASDAQ under the symbol **"AVXL"**[180](index=180&type=chunk) - As of December 12, 2019, there were **56,123,076 shares** of common stock issued and outstanding[180](index=180&type=chunk) - The company has not paid and does not intend to pay cash dividends, retaining earnings for operations[182](index=182&type=chunk) Equity Compensation Plan Information as of September 30, 2019 | 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 issuances under equity compensation plans (c) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 12,050,553 | $4.02 | 4,934,704 | [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=33&type=section&id=ITEM%207%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATION) In fiscal 2019, operating expenses increased to $29.1 million, driven by a $9.0 million rise in R&D for clinical trials, resulting in a net loss of $26.3 million, with cash maintained by stock issuances [Results of Operations](index=34&type=section&id=Results%20of%20Operations) For fiscal 2019, total operating expenses increased to $29.1 million, primarily due to a $9.0 million rise in R&D costs for ANAVEX2-73 clinical trials, leading to a net loss of $26.3 million Comparison of Operating Expenses (Fiscal Years 2019 vs. 2018) | Expense Category | FY 2019 (in millions) | FY 2018 (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | Research & Development | $22.3 | $13.3 | +$9.0 | | General & Administrative | $6.8 | $6.0 | +$0.8 | | **Total Operating Expenses** | **$29.1** | **$19.3** | **+$9.8** | Net Loss (Fiscal Years 2019 vs. 2018) | Metric | FY 2019 | FY 2018 | | :--- | :--- | :--- | | Net Loss | $26.3 million | $17.3 million | | Net Loss per Share | $0.54 | $0.39 | - The increase in R&D expenses was primarily due to costs associated with the Phase 2b/3 Alzheimer's trial (**$6.2 million**), Phase 2 Parkinson's trial (**$3.3 million**), and Phase 2 Rett syndrome studies (**$3.0 million**)[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2019, the company had $20.3 million in working capital and $22.2 million in cash, with increased operating cash use offset by $17.8 million from stock issuances Working Capital (as of Sept 30) | | 2019 | 2018 | | :--- | :--- | :--- | | Current Assets | $25,329,373 | $26,052,793 | | Current Liabilities | $5,039,674 | $3,884,626 | | **Working Capital** | **$20,289,699** | **$22,168,167** | Cash Flow Summary (Fiscal Years) | Cash Flows | 2019 | 2018 | | :--- | :--- | :--- | | Cash used in operating activities | $(18,527,117) | $(12,582,406) | | Cash provided by financing activities | $17,782,109 | $8,072,787 | - Financing activities in FY2019 included issuing **6.7 million shares** to Lincoln Park for gross proceeds of **$17.8 million**[208](index=208&type=chunk) - As of September 30, 2019, approximately **$45.3 million** remained available for purchase by Lincoln Park under the 2019 Purchase Agreement[212](index=212&type=chunk) [Financial Statements and Supplementary Data](index=39&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section presents audited consolidated financial statements for 2019 and 2018, with the auditor issuing an unqualified opinion on financials but an adverse opinion on internal controls due to a material weakness in R&D incentive accounting Consolidated Balance Sheet Data (as of Sept 30) | | 2019 | 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,185,630 | $22,930,638 | | Total Assets | $25,329,373 | $26,206,322 | | Total Liabilities | $5,039,674 | $3,884,626 | | Total Stockholders' Equity | $20,289,699 | $22,321,696 | Consolidated Statement of Operations Data (for year ended Sept 30) | | 2019 | 2018 | | :--- | :--- | :--- | | Total operating expenses | $(29,106,948) | $(19,333,591) | | Net loss | $(26,294,979) | $(17,252,736) | | Net Loss per share | $(0.54) | $(0.39) | - The independent auditor, BDO USA, LLP, issued an **adverse opinion** on the company's internal control over financial reporting as of September 30, 2019[237](index=237&type=chunk) - A material weakness was identified regarding the accounting for the Australian research and development incentive program[242](index=242&type=chunk) - Prior period financial statements were adjusted to correct the timing of recognition of R&D incentive income, resulting in a decrease to the accumulated deficit at October 1, 2017, by **$1,629,513**[258](index=258&type=chunk)[260](index=260&type=chunk) [Controls and Procedures](index=63&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that disclosure controls were ineffective as of September 30, 2019, due to a material weakness in accounting for the Australian R&D incentive program, with remediation efforts underway - Disclosure controls and procedures were concluded to be **ineffective** as of September 30, 2019[343](index=343&type=chunk) - A material weakness was identified in the internal control over financial reporting for the accounting of the Australian R&D incentive income[344](index=344&type=chunk) - The error involved recognizing the incentive income when cash was received, instead of accruing it in the period the qualifying R&D expenditures were incurred[344](index=344&type=chunk) - Remediation efforts include evaluating policies and procedures to ensure the program's accounting is assessed and reconciled on a quarterly basis[348](index=348&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=65&type=section&id=ITEM%2010%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) This section outlines the company's Board of Directors and executive officers, including Christopher Missling as CEO and Sandra Boenisch as CFO, and details the Audit, Nominating, and Compensation Committees - The company's leadership includes Christopher Missling, PhD (President, CEO, Director) and Sandra Boenisch, CPA, CGA (Principal Financial Officer, Treasurer)[354](index=354&type=chunk) - The company has established an Audit Committee, a Nominating and Corporate Governance Committee, and a Compensation Committee[365](index=365&type=chunk)[368](index=368&type=chunk)[370](index=370&type=chunk) - The Board has determined that Claus van der Velden qualifies as an **"audit committee financial expert"**[365](index=365&type=chunk) [Executive Compensation](index=68&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) The executive compensation program aims to attract and retain talent through competitive pay, with CEO Christopher Missling's total compensation for fiscal 2019 at $3,380,039, largely comprising option awards Summary Compensation for Named Executive Officers (Fiscal Year 2019) | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Christopher Missling, PhD (President, CEO) | 2019 | 512,500 | 50,000 | 2,806,339 | 11,200 | 3,380,039 | | Sandra Boenisch (Principal Financial Officer) | 2019 | 72,327 | 13,561 | 138,672 | - | 224,560 | - CEO Christopher Missling's employment agreement provides for an annual base salary of **$550,000** and eligibility for an annual cash bonus[384](index=384&type=chunk) - Employment agreements for named executive officers contain provisions for vesting of stock options upon a change of control[395](index=395&type=chunk)[396](index=396&type=chunk) [Security Ownership of Certain Beneficial Owners and Management](index=72&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS.) As of December 12, 2019, directors and executive officers collectively owned 11.9% of common stock, with CEO Christopher Missling holding 8.6%, and Park West Asset Management LLC as the only external beneficial owner above 5% Security Ownership as of December 12, 2019 | Name of Beneficial Owner | Amount of Beneficial Ownership | Percent of Class | | :--- | :--- | :--- | | Christopher Missling (CEO/Director) | 5,163,430 | **8.6%** | | Directors & Executive Officers as a group (7 persons) | 7,268,298 | **11.9%** | | Park West Asset Management LLC | 3,495,615 | **6.2%** | [Principal Accounting Fees and Services](index=74&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) This section details the $229,763 in audit fees paid to BDO USA, LLP for fiscal 2019, all pre-approved by the Audit Committee, covering financial statement audits, reviews, and regulatory filings Fees Paid to Independent Registered Public Accounting Firm | Fee Category | 2019 | 2018 | | :--- | :--- | :--- | | Audit Fees | $229,763 | $224,181 | | Audit Related Fees | - | - | | Tax Fees | - | - | | All Other Fees | - | - | | **Total Fees** | **$229,763** | **$224,181** | - All services provided by the independent registered public accounting firm were pre-approved by the Audit Committee[415](index=415&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=75&type=section&id=ITEM%2015.%20EXHIBITS%2C%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists the exhibits filed with the Form 10-K, including corporate governance documents, material contracts, employment agreements, certifications, and XBRL data files - Exhibits filed include corporate governance documents, material contracts, certifications, and XBRL data[419](index=419&type=chunk)[420](index=420&type=chunk)