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, 2023 ☐ 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 2023 Earnings Conference Call August 8, 2023 8:30 AM ET Company Participants Clint Tomlinson - IR Christopher Missling - President and CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Soumit Roy - Jones Trading Operator Good morning and welcome to the Anavex Life Sciences’ Fiscal 2023 Third Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today’s call. At this time, all participants are in a listen-only ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Anavex Life Sciences Corp. reported a **$37.4 million net loss** for the nine months ended June 30, 2023, with cash increasing to **$154.8 million** from financing activities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2023 ($) | September 30, 2022 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $154,817,164 | $149,157,861 | | Total Assets | $157,809,863 | $152,704,603 | | **Liabilities & Equity** | | | | Total Liabilities | $11,055,267 | $10,213,561 | | Total Stockholders' Equity | $146,754,596 | $142,491,042 | | Total Liabilities and Stockholders' Equity | $157,809,863 | $152,704,603 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Nine Months Ended June 30, 2023 ($) | Nine Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | Research and development | $33,656,364 | $26,534,297 | | General and administrative | $9,447,447 | $9,167,560 | | Total operating expenses | $43,103,811 | $35,701,857 | | Operating loss | $(43,103,811) | $(35,701,857) | | Net loss | $(37,358,973) | $(33,687,519) | | Net Loss per share (Basic and diluted) | $(0.47) | $(0.44) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Nine Months Ended June 30, 2023 ($) | Nine Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,935,371) | $(20,193,929) | | Net cash provided by financing activities | $27,594,674 | $21,285,536 | | Increase in cash and cash equivalents | $5,659,303 | $1,091,607 | - The company is a clinical-stage biopharmaceutical firm focused on developing therapeutics for central nervous system (CNS) diseases, with its lead compound, ANAVEX2-73, in development for Alzheimer's, Parkinson's, and Rett syndrome[23](index=23&type=chunk) - During the nine months ended June 30, 2023, the company issued **3,138,348 shares** of common stock, raising aggregate proceeds of **$26,687,017** under the 2023 Purchase Agreement with Lincoln Park[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=18&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) The MD&A highlights the company's clinical-stage status, increased operating expenses to **$43.1 million**, a widened net loss of **$37.4 million**, and a strong liquidity position with **$154.8 million** in cash [Business Overview and Clinical Pipeline](index=19&type=section&id=Business%20Overview%20and%20Clinical%20Pipeline) Anavex is a clinical-stage biopharmaceutical company developing therapeutics for CNS diseases, with lead compound ANAVEX2-73 showing promise in multiple trials - Anavex is a clinical-stage biopharmaceutical company developing therapeutics for CNS diseases like Alzheimer's, Parkinson's, and Rett syndrome, using a precision medicine approach with genomic biomarkers[83](index=83&type=chunk) - The lead product, ANAVEX2-73, has completed a Phase 2b/3 trial for Alzheimer's disease, meeting co-primary and key secondary endpoints by slowing cognitive and functional decline[89](index=89&type=chunk)[90](index=90&type=chunk) - In Rett Syndrome, the ANAVEX2-73 program includes the completed AVATAR Phase 3 trial, which met all primary and secondary endpoints, and the ongoing EXCELLENCE Phase 2/3 pediatric trial, with topline results expected in the second half of 2023[98](index=98&type=chunk)[99](index=99&type=chunk) - The ANAVEX2-73 Phase 2 trial in Parkinson's disease dementia showed statistically significant improvements in cognitive measures, and a 48-week open-label extension demonstrated longitudinal beneficial effects[101](index=101&type=chunk)[102](index=102&type=chunk)[105](index=105&type=chunk) - ANAVEX3-71, another pipeline candidate, has completed a Phase 1 trial for Frontotemporal Dementia (FTD) and is being advanced into a biomarker-driven program for dementia, schizophrenia, and Alzheimer's[107](index=107&type=chunk)[110](index=110&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Operating expenses increased to **$43.1 million** for the nine months ended June 30, 2023, primarily due to higher R&D costs, leading to a net loss of **$37.4 million** Comparison of Operating Expenses (in millions) | Expense Category | Three Months Ended June 30, 2023 ($M) | Three Months Ended June 30, 2022 ($M) | Nine Months Ended June 30, 2023 ($M) | Nine Months Ended June 30, 2022 ($M) | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $10.3 | $9.3 | $33.7 | $26.5 | | General & Administrative | $3.2 | $3.2 | $9.4 | $9.2 | | **Total Operating Expenses** | **$13.5** | **$12.5** | **$43.1** | **$35.7** | - The increase in R&D expenses for the nine-month period was primarily due to higher personnel costs (**$1.8M**), stock-based compensation (**$1.1M**), manufacturing activities (**$2.9M**), new trial start-up costs (**$0.4M**), and expanded enrollment in the EXCELLENCE trial (**$1.6M**)[163](index=163&type=chunk) Net Loss Summary | Metric | Three Months Ended June 30, 2023 ($M) | Three Months Ended June 30, 2022 ($M) | Nine Months Ended June 30, 2023 ($M) | Nine Months Ended June 30, 2022 ($M) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $(11.3M) | $(12.4M) | $(37.4M) | $(33.7M) | | Loss Per Share | $(0.14) | $(0.16) | $(0.47) | $(0.44) | [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents increased to **$154.8 million**, supported by a **$150 million** purchase agreement with Lincoln Park Capital, ensuring sufficient funding Working Capital Summary | Account | June 30, 2023 ($) | September 30, 2022 ($) | | :--- | :--- | :--- | | Current Assets | $157,809,863 | $152,704,603 | | Current Liabilities | $11,055,267 | $10,213,561 | | **Working Capital** | **$146,754,596** | **$142,491,042** | - Cash and cash equivalents increased to **$154.8 million** at June 30, 2023, from **$149.2 million** at September 30, 2022, driven by **$27.6 million** in financing activities, partially offset by **$21.9 million** used in operations[167](index=167&type=chunk)[178](index=178&type=chunk) - On February 3, 2023, the company entered into a **$150 million** purchase agreement with Lincoln Park Capital Fund, LLC, with **$123.3 million** remaining available as of June 30, 2023[179](index=179&type=chunk)[184](index=184&type=chunk) - No shares were sold under the Controlled Equity Offering Sales Agreement during the nine months ended June 30, 2023, unlike the prior year period which raised **$21.0 million** in gross proceeds[187](index=187&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=37&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) The company reports no material changes in its market risk exposure since the Annual Report on Form 10-K for the fiscal year ended September 30, 2022 - There have been no material changes in the company's market risk exposure since its last annual report[192](index=192&type=chunk) [Controls and Procedures](index=37&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) As of June 30, 2023, disclosure controls and procedures were deemed effective, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and principal financial officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[194](index=194&type=chunk) - No changes to internal control over financial reporting occurred during the quarter ended June 30, 2023, that have materially affected or are likely to materially affect internal controls[195](index=195&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=38&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company reports no material pending legal proceedings beyond routine litigation incidental to its business - The company is not aware of any material pending legal proceedings[197](index=197&type=chunk) [Risk Factors](index=38&type=section&id=ITEM%201A.%20RISK%20FACTORS) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2022 - No material changes have occurred to the risk factors disclosed in the company's 2022 Form 10-K[198](index=198&type=chunk) [Other Part II Items](index=38&type=section&id=Other%20Part%20II%20Items) The company reported no unregistered equity sales, defaults on senior securities, or mine safety disclosures for the period - The company reports no unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, or other information for the period[199](index=199&type=chunk) [Exhibits](index=39&type=section&id=ITEM%206.%20EXHIBIT) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - The report includes a list of filed exhibits, such as officer certifications (**31.1, 31.2, 32.1**) and XBRL interactive data files (**101 series**)[201](index=201&type=chunk) [Signatures](index=40&type=section&id=SIGNATURES) - The report was duly signed and authorized on **August 8, 2023**, by Christopher Missling, PhD, Chief Executive Officer, and Sandra Boenisch, CPA, CGA, Principal Financial Officer[203](index=203&type=chunk)[204](index=204&type=chunk)

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q2 2023 Earnings Conference Call May 9, 2023 8:30 AM ET Company Participants Clint Tomlinson - Investor Relations Christopher Missling - President and Chief Executive Officer Sandra Boenisch - Principal Financial Officer Conference Call Participants Soumit Roy - Jones Research Clint Tomlinson Good morning. Welcome to the Anavex Life Sciences Fiscal 2023 Second Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, ...

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [ITEM 1. FINANCIAL STATEMENTS](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents unaudited interim consolidated financial statements, including balance sheets, statements of operations, equity changes, and cash flows, with notes on business and accounting policies [Condensed Interim Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Interim%20Consolidated%20Balance%20Sheets) Total assets increased to **$159.2 million** at March 31, 2023, from **$152.7 million** at September 30, 2022, driven by cash and cash equivalents, with liabilities and equity also rising Condensed Interim Consolidated Balance Sheets | Metric | March 31, 2023 | September 30, 2022 | | :-------------------------------- | :------------- | :----------------- | | Cash and cash equivalents | $153,466,962 | $149,157,861 | | Total Assets | $159,186,397 | $152,704,603 | | Total Liabilities | $14,021,343 | $10,213,561 | | Total Stockholders' Equity | $145,165,054 | $142,491,042 | [Condensed Interim Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Operations) Net loss increased for both three and six months ended March 31, 2023, primarily due to higher operating expenses, especially research and development, despite increased other income Condensed Interim Consolidated Statements of Operations | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total operating expenses | $14,189,159 | $11,519,747 | $29,573,114 | $23,243,137 | | Operating loss | $(14,189,159) | $(11,519,747) | $(29,573,114) | $(23,243,137) | | Total other income, net | $1,131,880 | $1,111,736 | $3,524,071 | $1,982,739 | | Net loss | $(13,107,279) | $(10,437,811) | $(26,078,997) | $(21,320,178) | | Net Loss per share (Basic and diluted) | $(0.17) | $(0.14) | $(0.33) | $(0.28) | [Condensed Interim Consolidated Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased from **$142.5 million** to **$145.2 million** due to additional paid-in capital from common stock issuances and stock-based compensation, partially offset by net loss Condensed Interim Consolidated Statements of Changes in Stockholders' Equity | Metric | Balance, Oct 1, 2022 | Balance, Mar 31, 2023 | | :-------------------------------- | :------------------- | :-------------------- | | Common Stock Par Value | $77,944 | $80,236 | | Additional Paid-in Capital | $387,976,881 | $416,727,598 | | Accumulated Deficit | $(245,563,783) | $(271,642,780) | | Total Stockholders' Equity | $142,491,042 | $145,165,054 | - Shares issued under 2023 purchase agreement: **2.15 million** shares for **$18.15 million**[19](index=19&type=chunk) - Share based compensation: **$9.32 million** for the six months ended March 31, 2023[19](index=19&type=chunk) - Net loss for the six months ended March 31, 2023: **$(26.08) million**[19](index=19&type=chunk) [Condensed Interim Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$14.3 million** for the six months ended March 31, 2023, while cash provided by financing activities rose to **$18.6 million** from common share issuances, leading to a **$4.3 million** increase in cash and cash equivalents Condensed Interim Consolidated Statements of Cash Flows | Metric | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(14,282,836) | $(13,140,439) | | Net cash provided by financing activities | $18,591,937 | $14,375,250 | | Increase in cash and cash equivalents | $4,309,101 | $1,234,811 | | Cash and cash equivalents, end of period | $153,466,962 | $153,342,556 | - Issuance of common shares: **$18.15 million** in 2023 vs **$14.40 million** in 2022[21](index=21&type=chunk) [Notes to the Condensed Interim Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the interim consolidated financial statements, covering business, accounting policies, liquidity, estimates, and specific financial items [Note 1 Business Description](index=10&type=section&id=Note%201%20Business%20Description) Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company developing precision medicine for CNS diseases, with lead compound ANAVEX2-73 targeting Alzheimer's, Parkinson's, Rett, and Fragile X syndromes - Clinical stage biopharmaceutical company developing precision medicine for CNS diseases[23](index=23&type=chunk) - Lead compound: ANAVEX2-73, targeting Alzheimer's, Parkinson's, Rett syndrome, and Fragile X syndrome[23](index=23&type=chunk) [Note 2 Basis of Presentation](index=10&type=section&id=Note%202%20Basis%20of%20Presentation) Unaudited interim consolidated financial statements are prepared under SEC rules and U.S. GAAP, with management believing current working capital is sufficient for 12 months, while consolidating subsidiaries and using estimates - Financial statements are unaudited and prepared under SEC rules and U.S. GAAP for interim reporting[24](index=24&type=chunk) - Management believes current working capital is sufficient to meet requirements beyond the next 12 months[29](index=29&type=chunk) - The company has not generated any revenues from operations and expects negative cash flows for the foreseeable future[27](index=27&type=chunk) - Consolidates Anavex Australia, Anavex Germany GmbH, and Anavex Canada Ltd[32](index=32&type=chunk) [Note 3 Other Income](index=12&type=section&id=Note%203%20Other%20Income) Grant income of **$25,000** and R&D incentive income of **$1.48 million** were recognized for the six months ended March 31, 2023, with the latter decreasing from the prior year Other Income | Income Type | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Grant income | $0 | $0 | $25,000 | $0 | | Research and development incentive income | $749,681 | $835,513 | $1,483,271 | $1,646,243 | - Received **$0.50 million** of a **$1.00 million** Michael J. Fox Foundation grant during the six months ended March 31, 2023[40](index=40&type=chunk) - Deferred grant income at March 31, 2023: **$0.92 million** (September 30, 2022: **$0.44 million**)[42](index=42&type=chunk) [Note 4 Accrued Liabilities](index=13&type=section&id=Note%204%20Accrued%20Liabilities) Total accrued liabilities increased to **$6.8 million** at March 31, 2023, from **$5.9 million**, driven by clinical site costs, compensation, and milestone-based contract accruals Accrued Liabilities | Accrued Liability Component | March 31, 2023 | September 30, 2022 | | :-------------------------------- | :------------- | :----------------- | | Accrued clinical site and patient visits costs | $2,168,950 | $2,031,105 | | Accrued compensation and benefits | $1,572,500 | $1,297,337 | | Milestone based contract accruals | $1,041,930 | $137,337 | | Total accrued liabilities | $6,822,838 | $5,944,953 | [Note 5 Equity Offerings](index=13&type=section&id=Note%205%20Equity%20Offerings) The company entered a new **$150 million** Purchase Agreement in February 2023, issuing **2.16 million** common shares for **$18.2 million** during the period, with **$131.8 million** remaining available, while no shares were sold under the previous Sales Agreement - Entered into a **$150 million** Purchase Agreement with Lincoln Park Capital Fund, LLC on February 3, 2023, valid for three years[53](index=53&type=chunk) - Issued **75,000** common shares as an initial commitment fee for the Purchase Agreement, valued at **$0.84 million**[54](index=54&type=chunk) - Issued **2.16 million** common shares under the 2023 Purchase Agreement for an aggregate purchase price of **$18.15 million** during the six months ended March 31, 2023[55](index=55&type=chunk) - **$131.85 million** remained available under the 2023 Purchase Agreement as of March 31, 2023[55](index=55&type=chunk) - No shares sold under the Sales Agreement during the six months ended March 31, 2023[52](index=52&type=chunk) [Note 6 Commitments and Contingencies](index=15&type=section&id=Note%206%20Commitments%20and%20Contingencies) Office lease expenses and 401(k) contributions increased, with **160,000** share purchase warrants outstanding. Stock-based compensation expense rose to **$9.3 million**, with **$21.8 million** expected through fiscal 2026, and **14.8 million** options outstanding - Office lease expense for six months ended March 31, 2023: **$60,140** (2022: **$21,333**)[58](index=58&type=chunk) - 401(k) matching contributions for six months ended March 31, 2023: **$99,876** (2022: **$93,622**)[59](index=59&type=chunk) - **160,000** share purchase warrants outstanding at March 31, 2023, with a weighted average exercise price of **$3.72**[61](index=61&type=chunk)[62](index=62&type=chunk) - Stock-based compensation expense for six months ended March 31, 2023: **$9.32 million** (2022: **$8.35 million**)[73](index=73&type=chunk)[74](index=74&type=chunk) - Approximately **$21.78 million** in stock-based compensation expected to be recorded through fiscal 2026[74](index=74&type=chunk) - Outstanding stock options at March 31, 2023: **14.84 million** shares with a weighted average exercise price of **$6.97**[69](index=69&type=chunk) - Exercisable stock options at March 31, 2023: **9.94 million** shares with a weighted average exercise price of **$4.78**[69](index=69&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.](index=17&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Management discusses financial condition, operations, forward-looking statements, business, clinical trials, pipeline, target indications, IP, and financial performance for Q1 and H1 2023 vs 2022 [Forward-Looking Statements](index=19&type=section&id=Forward-Looking%20Statements) The report contains forward-looking statements on clinical milestones, financial position, strategy, and operations, subject to risks and uncertainties detailed in the 'Risk Factors' section of the annual report - Report contains forward-looking statements about future clinical/regulatory milestones, financial position, business strategy, and operations[79](index=79&type=chunk) - Statements are subject to risks and uncertainties, including those in the "Risk Factors" section of the Annual Report on Form 10-K[80](index=80&type=chunk) [Our Current Business](index=20&type=section&id=Our%20Current%20Business) Anavex is a clinical-stage biopharmaceutical company developing precision medicine for CNS diseases, with ANAVEX2-73 as its lead candidate, and a portfolio of SIGMAR1-activating compounds - Clinical-stage biopharmaceutical company developing precision medicine for CNS diseases[83](index=83&type=chunk) - Utilizes genomic data to identify biomarkers for clinical trials[83](index=83&type=chunk) - Lead product candidate: ANAVEX2-73, for Alzheimer's, Parkinson's, Rett syndrome, and other CNS diseases[83](index=83&type=chunk) - Portfolio of compounds varying in sigma-1 receptor (SIGMAR1) binding activities, aiming to restore cellular homeostasis[84](index=84&type=chunk)[87](index=87&type=chunk) [Clinical Trials Overview](index=22&type=section&id=Clinical%20Trials%20Overview) Anavex provides an overview of clinical trials for ANAVEX2-73 in Alzheimer's, Rett, and Parkinson's, and ANAVEX3-71 in FTD, emphasizing a precision medicine approach with genomic biomarkers - ANAVEX2-73-specific Biomarkers: Genomic analysis in Alzheimer's trials identified actionable genetic variants (SIGMAR1, COMT) impacting drug response, supporting a precision medicine approach[89](index=89&type=chunk) - Alzheimer's Disease: Completed Phase 2a trial met primary and secondary endpoints[90](index=90&type=chunk) Completed Phase 2b/3 trial met co-primary endpoints (ADAS-Cog, ADCS-ADL) and key secondary endpoint (CDR-SB), showing ANAVEX2-73 slowed cognitive and functional decline[92](index=92&type=chunk)[94](index=94&type=chunk) Patients treated with ANAVEX2-73 had **1.84 times higher odds** to improve cognitively (p=0.015) and **2.67 times higher odds** to improve function (p=0.0255) compared to placebo[95](index=95&type=chunk) An open-label extension study (ATTENTION-AD) is ongoing[95](index=95&type=chunk) - Rett Syndrome: Positive preclinical data[96](index=96&type=chunk) Completed Phase 2 trial (ANAVEX2-73-RS-001) showed statistically significant improvements in RSBQ (p=0.011) and CGI-I (p=0.014)[98](index=98&type=chunk) Completed Phase 3 AVATAR trial (ANAVEX2-73-RS-002) met all primary and secondary efficacy and safety endpoints[101](index=101&type=chunk) EXCELLENCE trial (Phase 2/3 in pediatric patients) completed enrollment in February 2023, with topline results expected in H2 2023[102](index=102&type=chunk) - Parkinson's Disease: Positive preclinical data[103](index=103&type=chunk) Completed Phase 2 proof-of-concept trial showed ANAVEX2-73 was safe, well-tolerated, and resulted in clinically meaningful, dose-dependent, and statistically significant improvements in CDR computerized assessment and MDS-UPDRS total score[104](index=104&type=chunk)[105](index=105&type=chunk) Preliminary data from the 48-week Open Label Extension (OLE) trial demonstrated longitudinal beneficial effects[108](index=108&type=chunk) Awarded a **$1.0 million** research grant from The Michael J. Fox Foundation in January 2021[109](index=109&type=chunk) - Frontotemporal Dementia (FTD): ANAVEX3-71 granted orphan drug designation by the FDA[110](index=110&type=chunk) Completed First-in-Human Phase 1 trial met primary and secondary endpoints for safety, tolerability, and PK[111](index=111&type=chunk)[112](index=112&type=chunk) Intends to advance ANAVEX3-71 into a biomarker-driven clinical development dementia program for schizophrenia, FTD, and Alzheimer's disease[113](index=113&type=chunk) [Our Pipeline](index=26&type=section&id=Our%20Pipeline) Anavex's SIGMACEPTOR™ Discovery Platform generates small molecule drug candidates, primarily through sigma-1 receptor activation, for neurodegenerative and neurodevelopmental diseases, including ANAVEX2-73, ANAVEX3-71, ANAVEX1-41, ANAVEX1066, and ANAVEX1037 - Proprietary SIGMACEPTOR™ Discovery Platform produces small molecule drug candidates targeting sigma receptors[116](index=116&type=chunk) - ANAVEX2-73 (blarcamesine): Disease-modifying approach by activating SIGMAR1 for neurodegenerative and neurodevelopmental diseases[117](index=117&type=chunk) Granted Orphan Drug Designation by FDA for Rett syndrome (May 2016) and infantile spasms (June 2016)[119](index=119&type=chunk) Granted Rare Pediatric Disease (RPD) designation for Rett syndrome (November 2019) and Fast Track designation for Rett syndrome clinical development (February 2020)[128](index=128&type=chunk)[130](index=130&type=chunk) Preclinical data supports use in epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex (TSC)[131](index=131&type=chunk)[132](index=132&type=chunk) - ANAVEX3-71: Clinical drug candidate with novel mechanism via SIGMAR1 activation and M1 muscarinic allosteric modulation[133](index=133&type=chunk) Demonstrated disease-modifying activity against Alzheimer's hallmarks in preclinical studies[134](index=134&type=chunk) Granted Orphan Drug Designation for FTD by FDA (April 2016)[134](index=134&type=chunk) - ANAVEX1-41: Sigma-1 agonist showing significant neuroprotective benefits by modulating endoplasmic reticulum, mitochondrial, and oxidative stress[138](index=138&type=chunk) - ANAVEX1066: Mixed sigma-1/sigma-2 ligand designed for neuropathic and visceral pain, showing rapid and significant efficacy in preclinical models[139](index=139&type=chunk) - ANAVEX1037: Designed for prostate and pancreatic cancer, exhibiting high affinity for SIGMAR1 and moderate for sigma-2 receptors, showing antitumor potential in preclinical studies[140](index=140&type=chunk) [Our Target Indications](index=30&type=section&id=Our%20Target%20Indications) Anavex is developing compounds for CNS diseases like Alzheimer's, Parkinson's, Rett syndrome, Fragile X, Depression, and Epilepsy, as well as for Cancer indications including Neuropathic Pain, Malignant Melanoma, Prostate Cancer, and Pancreatic Cancer - Central Nervous System Diseases: Alzheimer's disease (**6.7 million** Americans age 65+ in 2023, urgent unmet need)[144](index=144&type=chunk) Parkinson's disease (**10 million+** worldwide, market expected to reach **$11.5 billion** by 2029)[145](index=145&type=chunk) Rett syndrome (**1 in 10,000-15,000** females, severe impairments)[146](index=146&type=chunk) Fragile X syndrome (**1:4,000** males, **1:6,000-8,000** females, intellectual disability/autism)[147](index=147&type=chunk) Depression (global antidepressant market projected to **$21 billion** by 2030)[148](index=148&type=chunk) Epilepsy (**3.4 million** Americans in 2015, need for combination drugs)[149](index=149&type=chunk) - Cancer: Neuropathic Pain (difficult to treat)[151](index=151&type=chunk) Malignant Melanoma (worldwide market expected to grow to **$7.5 billion** by 2029)[152](index=152&type=chunk) Prostate Cancer (drug therapeutics market expected to increase to **$10.1 billion** by 2030)[152](index=152&type=chunk) Pancreatic Cancer (global pharmaceutical treatment market predicted to reach **$3.73 billion** by 2027)[152](index=152&type=chunk) [Patents, Trademarks and Intellectual Property](index=31&type=section&id=Patents%2C%20Trademarks%20and%20Intellectual%20Property) Anavex holds **18** U.S. patents, **21** U.S. patent applications, and international applications covering its drug candidates and research programs for various CNS disorders and cancer, actively protecting its intellectual property - Holds **18** U.S. patents, **21** U.S. patent applications, and various international applications[153](index=153&type=chunk) - Patents cover ANAVEX2-73 compositions, crystalline forms, and methods for neuroprotection, Alzheimer's, seizure treatment, neurodevelopmental disorders, cardiac dysfunction, insomnia/anxiety, and melanoma[154](index=154&type=chunk)[156](index=156&type=chunk) - Patents for ANAVEX2-73 and related compounds are expected to expire between 2030 and 2039[154](index=154&type=chunk)[156](index=156&type=chunk) - Owns two U.S. patents for ANAVEX1066 related to pain treatment, expiring in November 2036[157](index=157&type=chunk) - Owns exclusive rights to two U.S. patents for ANAVEX3-71 compound and methods of treating diseases, expiring in April 2030 and January 2030[158](index=158&type=chunk) - Protects intellectual property through filings and confidentiality agreements[159](index=159&type=chunk) [Financial Overview](index=33&type=section&id=Financial%20Overview) Anavex is a development-stage company with no revenue since 2004, anticipating revenue only upon establishing alliances, with operating costs primarily driven by research and development and general and administrative expenses - Development-stage company with no revenue since 2004[162](index=162&type=chunk) - Anticipates revenue only after establishing alliances for product development or marketing[162](index=162&type=chunk) - Operating costs primarily consist of research and development (clinical trials, manufacturing, personnel) and general and administrative expenses (personnel, professional services, public company operations)[163](index=163&type=chunk)[164](index=164&type=chunk) [Comparison of the three and six months ended March 31, 2023 and 2022](index=33&type=section&id=Comparison%20of%20the%20three%20and%20six%20months%20ended%20March%2031%2C%202023%20and%202022) This section compares financial performance for the three and six months ended March 31, 2023, versus 2022, focusing on operating expenses, other income, and net loss, driven by increased R&D [Operating Expenses](index=33&type=section&id=Operating%20Expenses) Total operating expenses increased for both three and six months ended March 31, 2023, primarily due to higher R&D expenses from personnel, manufacturing, and trial enrollment, while G&A expenses remained consistent or slightly increased Operating Expenses | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total operating expenses | $14.2 million | $11.5 million | $29.6 million | $23.2 million | | Research and development expenses | $11.3 million | $8.6 million | $23.4 million | $17.3 million | | General and administrative expenses | $2.9 million | $2.9 million | $6.2 million | $6.0 million | - R&D increase (3 months): **+$0.5 million** personnel, **+$1.0 million** ANAVEX2-73 manufacturing, **+$0.4 million** ANAVEX3-71 manufacturing/Phase 1, increased EXCELLENCE trial enrollment costs[166](index=166&type=chunk) - R&D increase (6 months): **+$1.2 million** personnel, **+$1.2 million** stock-based compensation, **+$2.1 million** manufacturing (ANAVEX2-73 & ANAVEX3-71), increased EXCELLENCE trial enrollment costs[167](index=167&type=chunk) - G&A increase (6 months): **+$0.2 million** primarily due to professional and IP related costs[172](index=172&type=chunk) [Other income (net)](index=34&type=section&id=Other%20income%20%28net%29) Net other income remained consistent at **$1.1 million** for the three months ended March 31, 2023, but significantly increased to **$3.5 million** for the six-month period, primarily due to higher returns on excess cash equivalents Other Income (Net) | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Total other income, net | $1.1 million | $1.1 million | $3.5 million | $2.0 million | - 3-month period: Increase in interest income offset by **$0.96 million** one-time financing expense from 2023 Purchase Agreement[174](index=174&type=chunk) - 6-month period: Increase primarily due to higher return on excess cash invested in cash equivalents[174](index=174&type=chunk) [Net loss](index=35&type=section&id=Net%20loss) Net loss increased to **$13.1 million** ($0.17 per share) for the three months and **$26.1 million** ($0.33 per share) for the six months ended March 31, 2023, primarily due to higher research and development expenditures Net Loss | Metric | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Net loss | $(13.1) million | $(10.4) million | $(26.1) million | $(21.3) million | | Net Loss per share | $(0.17) | $(0.14) | $(0.33) | $(0.28) | - Increase in net loss primarily due to increased research and development fees[176](index=176&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Working capital increased due to higher cash and cash equivalents from common share issuances, despite increased cash used in operations, and the company secured future funding through a new **$150 million** purchase agreement [Working Capital](index=35&type=section&id=Working%20Capital) Working capital increased to **$145.2 million** at March 31, 2023, from **$142.5 million**, driven by a **$6.5 million** rise in current assets from common share issuance, offset by cash used in operations, with current liabilities also increasing Working Capital | Metric | March 31, 2023 | September 30, 2022 | | :---------------- | :------------- | :----------------- | | Current Assets | $159,186,397 | $152,704,603 | | Current Liabilities | $14,021,343 | $10,213,561 | | Working Capital | $145,165,054 | $142,491,042 | - Increase in cash and cash equivalents of **$4.3 million**, mainly from **$18.0 million** net proceeds from common shares issuance, offset by **$14.3 million** cash used in operations[177](index=177&type=chunk) - Increase in current liabilities partly due to **$0.5 million** deferred grant income and manufacturing/laboratory costs[178](index=178&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) Net cash used in operating activities increased to **$14.3 million**, while net cash provided by financing activities significantly increased to **$18.6 million** from common share issuances, resulting in a **$4.3 million** overall increase in cash and cash equivalents Cash Flows | Metric | 6 Months Ended Mar 31, 2023 | 6 Months Ended Mar 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash flows used in operating activities | $(14,282,836) | $(13,140,439) | | Net cash flows from financing activities | $18,591,937 | $14,375,250 | | Increase in cash and cash equivalents | $4,309,101 | $1,234,811 | - Increase in cash used in operating activities due to increased net loss[181](index=181&type=chunk) - Cash provided by financing activities mainly from common shares issuance under 2023 Purchase Agreement[182](index=182&type=chunk) [Other Financings](index=36&type=section&id=Other%20Financings) The company entered a **$150 million** Purchase Agreement in February 2023, issuing **2.16 million** common shares for **$18.2 million** during the period, with **$131.8 million** remaining available, and no sales under the previous agreement - Entered **$150 million** Purchase Agreement with Lincoln Park Capital Fund, LLC on February 3, 2023, for a three-year period[183](index=183&type=chunk) - Issued **2.16 million** common shares for **$18.2 million** under the 2023 Purchase Agreement during the six months ended March 31, 2023[187](index=187&type=chunk) - **$131.8 million** in common stock remains available for purchase under the Purchase Agreement as of March 31, 2023[187](index=187&type=chunk) - No shares sold under the Controlled Equity Offering Sales Agreement during the six months ended March 31, 2023[190](index=190&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no material off-balance sheet arrangements that are reasonably likely to affect its financial condition, results of operations, or capital resources - No material off-balance sheet arrangements[191](index=191&type=chunk) [CRITICAL ACCOUNTING POLICIES](index=37&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) Financial statements are prepared using U.S. GAAP, requiring estimates and assumptions, with no significant changes to critical accounting policies since the September 30, 2022, Annual Report on Form 10-K - Financial statements prepared in accordance with U.S. GAAP, requiring estimates and assumptions[192](index=192&type=chunk) - No significant changes to critical accounting policies since the September 30, 2022, 10-K[192](index=192&type=chunk) [RECENT ACCOUNTING PRONOUNCEMENTS](index=37&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) Readers should refer to Note 2 'Recent Accounting Pronouncements' within the Condensed Interim Consolidated Financial Statements for details on recently adopted accounting standards - Refer to Note 2 for recent accounting pronouncements[193](index=193&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS.](index=35&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) This item is marked 'Not applicable,' indicating no material market risks requiring disclosure in this interim report - Not applicable[193](index=193&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=35&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section confirms the effectiveness of disclosure controls and procedures as of March 31, 2023, with no material changes in internal control over financial reporting [Disclosure Controls and Procedures](index=37&type=section&id=Disclosure%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated and concluded that the company's disclosure controls and procedures were effective as of March 31, 2023, ensuring timely and accurate reporting of material information - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2023[196](index=196&type=chunk) - Controls designed to ensure timely and accurate reporting of material information[195](index=195&type=chunk) [Changes in Internal Control over Financial Reporting](index=38&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2023 - No material changes to internal control over financial reporting during the quarter ended March 31, 2023[197](index=197&type=chunk) [PART II OTHER INFORMATION](index=36&type=section&id=PART%20II%20OTHER%20INFORMATION) [ITEM 1. LEGAL PROCEEDINGS](index=36&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not aware of any material pending legal proceedings, and no directors, officers, affiliates, or major stockholders have adverse interests in any proceedings - No material pending legal proceedings[198](index=198&type=chunk) - No adverse interests from directors, officers, affiliates, or major stockholders in any proceedings[198](index=198&type=chunk) [ITEM 1A. RISK FACTORS](index=38&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously discussed in the 'Risk Factors' section of the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2022 - No material changes to risk factors since the Annual Report on Form 10-K filed November 28, 2022[199](index=199&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=38&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) During the reporting period, the company did not sell any unregistered equity securities that were not previously reported in a Current Report on Form 8-K - No unregistered sales of equity securities not previously reported[199](index=199&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=38&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This item is marked 'None,' indicating no defaults upon senior securities during the reporting period - None[199](index=199&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=38&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is marked 'Not applicable,' indicating that mine safety disclosures are not relevant to the company's operations - Not applicable[199](index=199&type=chunk) [ITEM 5. OTHER INFORMATION](index=38&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This item is marked 'None,' indicating no other information to disclose that is not covered elsewhere in the report - None[199](index=199&type=chunk) [ITEM 6. EXHIBIT](index=37&type=section&id=ITEM%206.%20EXHIBIT) This section lists the exhibits filed with the Form 10-Q, including corporate documents, agreements, and various certifications, as well as XBRL documents - Lists exhibits including corporate documents, agreements, and certifications[201](index=201&type=chunk) - Includes Registration Rights Agreement and Purchase Agreement dated February 3, 2023[201](index=201&type=chunk) [SIGNATURES](index=38&type=section&id=SIGNATURES) The report is signed by Christopher Missling, PhD (CEO) and Sandra Boenisch (CFO), dated May 9, 2023 - Signed by Christopher Missling, PhD (CEO) and Sandra Boenisch (CFO)[203](index=203&type=chunk)[204](index=204&type=chunk) - Signatures dated May 9, 2023[204](index=204&type=chunk)

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2023 Earnings Conference Call February 7, 2023 8:30 AM ET Company Participants Clint Tomlinson - IR Christopher Missling - President and CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Soumit Roy - Jones Trading Yun Zhong - BTIG Clint Tomlinson Good morning, everyone. And welcome to the Anavex Life Sciences’ Fiscal 2023 First Quarter Conference Call. My name is Clint Tomlinson, and I’ll be your host for today’s call. At this time, al ...

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, 2022 ☐ 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 ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2022 Earnings Conference Call November 28, 2022 8:30 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 Soumit Roy - Jones Trading Yun Zhong - BTIG Clint Tomlinson Welcome to the Anavex Life Sciences’ Fiscal 2022 Fourth Quarter Conference Call. My name is Clint Tomlinson, and I’ll be your host for today’s call. At ...