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 ...

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, 2019 ¨ 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 ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited interim condensed consolidated financial statements for the period ended June 30, 2019, including balance sheets, statements of operations, cash flows, and changes in stockholders' equity, along with accompanying notes, for a clinical-stage biopharmaceutical firm with no revenue to date [Interim Condensed Consolidated Balance Sheets](index=3&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2019, total assets decreased to **$22.0 million** from **$24.4 million** at September 30, 2018, primarily due to reduced cash and cash equivalents, while total liabilities slightly increased to **$4.3 million** and total stockholders' equity decreased from **$20.5 million** to **$17.6 million** Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Items | June 30, 2019 | September 30, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $21,249,206 | $22,930,638 | | Total Assets | $21,968,271 | $24,376,136 | | Total Liabilities | $4,336,607 | $3,884,626 | | Total Stockholders' Equity | $17,631,664 | $20,491,510 | [Interim Condensed Consolidated Statements of Operations](index=5&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the nine months ended June 30, 2019, the company reported a net loss of **$22.4 million**, nearly double the **$11.7 million** loss from the same period in 2018, driven by a significant rise in research and development expenses, widening the loss per share to **$0.47** from **$0.26** year-over-year Statement of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Nine Months Ended June 30, 2019 | Nine Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,758,446 | $2,997,634 | $17,549,442 | $8,936,969 | | Total operating expenses | ($7,147,175) | ($4,618,013) | ($22,760,729) | ($13,444,601) | | Net loss | ($7,074,261) | ($2,849,164) | ($22,415,568) | ($11,660,353) | | Loss per share (Basic and diluted) | ($0.14) | ($0.06) | ($0.47) | ($0.26) | [Interim Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=INTERIM%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the nine months ended June 30, 2019, net cash used in operating activities increased to **$16.0 million** from **$8.5 million** in the prior-year period due to higher clinical development costs, largely offset by **$14.3 million** in net cash provided by financing activities, resulting in a **$1.7 million** decrease in cash and cash equivalents Cash Flow Summary (Unaudited) | Cash Flow Item | Nine months ended June 30, 2019 | Nine months ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($15,992,811) | ($8,529,234) | | Net cash provided by financing activities | $14,311,379 | $6,916,569 | | Decrease in cash and cash equivalents | ($1,681,432) | ($1,612,665) | | Cash and cash equivalents, end of period | $21,249,206 | $25,827,592 | [Notes to the Condensed Consolidated Interim Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) The notes provide detailed explanations of accounting policies and specific financial statement items, including the company's business focus on CNS diseases, its liquidity position, significant equity offering agreements for financing, and commitments related to stock-based compensation and litigation - The company is a clinical-stage biopharmaceutical company 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[18](index=18&type=chunk) - The company has not generated any revenue and anticipates continued negative cash flows, however, management believes existing cash and financial commitments are sufficient to fund operations for more than two years[22](index=22&type=chunk)[23](index=23&type=chunk) - The company entered into a new **$50 million** purchase agreement with Lincoln Park in June 2019 and has a separate **$50 million** "at-the-market" offering agreement with Cantor Fitzgerald to secure future funding[39](index=39&type=chunk)[45](index=45&type=chunk) - In January 2019, the Board approved the 2019 Omnibus Incentive Plan, making **6.0 million** additional shares available for issuance as stock-based compensation[58](index=58&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 the company's business, financial performance, and outlook, highlighting the progress of its clinical programs, particularly for its lead compound ANAVEX2-73, with a significant increase in R&D expenses noted as the primary driver for the increased net loss, and its liquidity strategy relying on equity financing agreements [Our Current Business and Pipeline](index=19&type=section&id=Our%20Current%20Business%20and%20Pipeline) Anavex is a clinical-stage biopharmaceutical company focused on CNS diseases, using its proprietary SIGMACEPTOR™ Discovery Platform, with its lead compound, ANAVEX2-73, in clinical development for Alzheimer's, Parkinson's, and Rett syndrome, and a pipeline including four other preclinical candidates - The company's core focus is on developing therapeutics for CNS diseases by applying precision medicine and analyzing genomic data to identify biomarkers[69](index=69&type=chunk) - The lead compound, ANAVEX2-73, is being developed for Alzheimer's disease, Parkinson's disease, and the rare disease Rett syndrome[70](index=70&type=chunk) - The company's pipeline includes ANAVEX2-73 and several preclinical compounds such as ANAVEX3-71, ANAVEX1-41, ANAVEX1066, and ANAVEX1037, targeting various neurodegenerative diseases, pain, and cancer[84](index=84&type=chunk)[109](index=109&type=chunk)[113](index=113&type=chunk) [Clinical Studies Overview](index=21&type=section&id=Clinical%20Studies%20Overview) The company is actively advancing its lead compound, ANAVEX2-73, through multiple clinical trials, including a Phase 2b/3 study for Alzheimer's disease initiated in October 2018, and Phase 2 trials for Rett syndrome (March and June 2019) and Parkinson's Disease Dementia (October 2018) - A Phase 2b/3 double-blind, placebo-controlled study of ANAVEX2-73 in approximately 450 Alzheimer's disease patients commenced in October 2018[78](index=78&type=chunk) - A Phase 2 clinical trial of ANAVEX2-73 for Rett syndrome commenced in the United States in March 2019, followed by a second Phase 2 study (AVATAR) in Australia in June 2019[80](index=80&type=chunk)[81](index=81&type=chunk) - A double-blind, randomized, placebo-controlled Phase 2 trial with ANAVEX2-73 in approximately 120 Parkinson's Disease Dementia (PDD) patients was initiated in October 2018[83](index=83&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Operating expenses for the nine months ended June 30, 2019, increased to **$22.8 million** from **$13.4 million** in the prior-year period, driven by an **$8.6 million** rise in R&D expenses to **$17.5 million** due to three new clinical studies, while other income declined to **$0.4 million** from **$1.8 million** due to a delay in Australian R&D incentive income Operating Expense Comparison | Expense Category | Nine Months Ended June 30, 2019 | Nine Months Ended June 30, 2018 | | :--- | :--- | :--- | | Research and development | $17.5 million | $8.9 million | | Total operating expenses | $22.8 million | $13.4 million | - The increase in R&D expenses was primarily due to the commencement of a Phase 2b/3 study for Alzheimer's, a Phase 2 study for Parkinson's Disease Dementia, and a Phase 2 program for Rett syndrome[140](index=140&type=chunk) - Other income for the nine-month period decreased to **$0.4 million** from **$1.8 million** year-over-year, mainly because the Australian research and development incentive income was received in the fourth quarter of fiscal 2019, compared to the third quarter in fiscal 2018[141](index=141&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2019, the company had **$21.2 million** in cash and cash equivalents and **$17.5 million** in working capital, with **$16.0 million** in cash used for operations primarily funded by **$14.3 million** from equity issuances, and future liquidity supported by a **$50 million** "at-the-market" offering facility and a new **$50 million** purchase agreement Working Capital | | June 30, 2019 | September 30, 2018 | | :--- | :--- | :--- | | Current Assets | $21,817,138 | $24,222,607 | | Current Liabilities | $4,336,607 | $3,884,626 | | Working Capital | $17,480,531 | $20,337,981 | - Cash used in operations increased to **$16.0 million** for the nine months ended June 30, 2019, compared to **$8.5 million** in the prior year period, due to increased clinical development activities[146](index=146&type=chunk)[147](index=147&type=chunk) - The company secured a new **$50 million** purchase agreement with Lincoln Park on June 7, 2019, to provide capital over a 36-month period, succeeding the fully utilized 2015 agreement[153](index=153&type=chunk)[156](index=156&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=32&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) This section is not applicable to the company for this reporting period - Not applicable[163](index=163&type=chunk) [Controls and Procedures](index=32&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES.) Based on an evaluation as of June 30, 2019, the company's management, including the principal executive and financial officers, concluded that its disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2019[164](index=164&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2019, that materially affected, or are reasonably likely to materially affect, internal controls[165](index=165&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS.) The company reports that it is not a party to any material pending legal proceedings, other than ordinary routine litigation incidental to its business - The company knows of no material pending legal proceedings to which it or its subsidiaries are a party[165](index=165&type=chunk) [Risk Factors](index=33&type=section&id=ITEM%201A.%20RISK%20FACTORS.) The company states that there have been no material changes to the significant risk factors affecting its business as described in its Annual Report on Form 10-K for the fiscal year ended September 30, 2018 - There have been no material changes in the significant risk factors from those disclosed in the Annual Report on Form 10-K for the fiscal year ended September 30, 2018[166](index=166&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECU RITIES%20AND%20USE%20OF%20PROCEEDS.) During the quarter, the company did not sell any equity securities that were not registered under the Securities Act of 1933 and not previously reported in a Form 8-K - No unregistered sales of equity securities occurred during the reporting period that were not previously reported[167](index=167&type=chunk) [Defaults Upon Senior Securities](index=33&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES.) The company reports no defaults upon senior securities - None[167](index=167&type=chunk) [Mine Safety Disclosures](index=33&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section is not applicable to the company - Not applicable[167](index=167&type=chunk) [Other Information](index=33&type=section&id=ITEM%205.%20OTHER%20INFORMATION.) The company reports no other information for this period - None[167](index=167&type=chunk) [Exhibits](index=34&type=section&id=ITEM%206.%20EXHIBITS.) This section lists the exhibits filed with the Form 10-Q, which include material contracts such as the Purchase Agreement with Lincoln Park Capital Fund, LLC, and certifications by the company's officers - Filed exhibits include the Purchase Agreement with Lincoln Park Capital Fund, LLC dated June 7, 2019, and certifications from the CEO and Principal Financial Officer[169](index=169&type=chunk) [Signatures](index=35&type=section&id=SIGNATURES)

Financial Data and Key Metrics - Cash used to fund operations in Q2 2019 was $4.3 million, with operating expenses at $8.1 million, up from $4.7 million in Q2 2018 [9] - R&D expenses for Q2 2019 were $6.1 million, compared to $3.2 million in Q2 2018, driven by clinical study advancements for ANAVEX2-73 [9] - Net loss for Q2 2019 was $8 million or $0.17 per share, compared to $4.8 million or $0.11 per share in Q2 2018 [10] - Cash resources as of March 31, 2019, were $19.5 million, sufficient to fund objectives for the next 18 months [10] Business Line Data and Key Metrics - Phase 2 ANAVEX2-73 Parkinson's disease dementia study achieved 70% of the total patient enrollment target [6] - Phase 2b/3 ANAVEX2-73 Alzheimer's disease study has enrolled over 20% of patients [6] - Phase 2 ANAVEX2-73 Rett Syndrome study in the U.S. has enrolled 40% of patients, with a Phase 2 AVATAR study in Australia approved and actively enrolling [7][8] Market Data and Key Metrics - The AVATAR study in Australia is supported by the Rett Syndrome Association of Australia, with the government providing a cashback payment of over 40% for every dollar spent [18] - The Australian dollar's favorable exchange rate provides cost advantages for conducting studies in Australia compared to the U.S. [18] Company Strategy and Industry Competition - The company is focused on executing current clinical studies for ANAVEX2-73, with a strategy to expand studies internationally if needed [16][18] - The sigma-1 receptor activation approach is highlighted as a unique strategy, differentiating from traditional amyloid beta-focused treatments in Alzheimer's disease [25][26] Management Commentary on Operating Environment and Future Outlook - Management is pleased with the pace of clinical study advancements and expects to provide further updates as progress continues [11] - The company believes its cash resources and government support will sustain operations and clinical trials for the next 18 months [10] Other Important Information - Non-cash charges for Q2 2019 totaled $1.9 million, compared to $1.2 million in Q2 2018 [10] - The AVATAR study in Australia is double-blind, randomized, and placebo-controlled, with safety and efficacy endpoints [8] Q&A Session Summary Question: Differences between U.S. and Australian Rett Syndrome studies - The U.S. study focuses on safety and PK with 15 patients, while the AVATAR study in Australia focuses on safety and efficacy with 30 patients [14] - The AVATAR study may not need to be repeated in the U.S. if results are positive, but international expansion is possible [16] Question: Cost and enrollment for the AVATAR study - The AVATAR study is expected to fully enroll in Australia, with potential for additional international sites to accelerate enrollment [18] - The Australian government provides a 40% cashback on study expenses, and the favorable exchange rate reduces costs [18] Question: Enrollment updates for ongoing trials - The company will publicly announce once complete enrollment is achieved for any ongoing trial [20] Question: Enrollment of sigma-1 receptor variant carriers - Both U.S. and AVATAR studies will enroll patients with genetic variances, with no need for balancing between arms [22][23] Question: Sigma-1 receptor approach in Alzheimer's disease - The sigma-1 receptor activation strategy addresses multiple pathological factors in Alzheimer's, beyond amyloid beta [25][26] Question: Cash usage discrepancy - The difference between net loss and cash used is attributed to accruals of accounts payable [29] Question: Age limits in Rett Syndrome trials - Both U.S. and AVATAR studies initially enroll patients aged 18 and older, with plans for separate studies in younger populations [30][32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 APPLICABLE ONLY TO CORPORATE ISSUERS: 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, 2019 ☐ 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 c ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2019 Earnings Conference Call February 7, 2019 4:30 PM ET Company Participants Scott Gordon - IR Christopher Missling - President & CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Jotin Marango - Roth Capital Ram Selvaraju - H.C. Wainwright Operator Good afternoon my name is Michelle, and I will be your conference call operator for today's call. Welcome to the Anavex Life Sciences Fiscal 2019 First Quarter Financial Results Conferenc ...

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: December 31, 2018 ☐ 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 ...