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 ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q3 2022 Results Conference Call August 9, 2022 4:30 PM ET Company Participants Clint Tomlinson - IR Dr. Christopher Missling - President and CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Soumit Roy - Jones Research Yun Zhong - BTIG Raghuram Selvaraju - H.C. Wainwright Clint Tomlinson Good afternoon. Welcome to the Anavex Life Sciences’ Fiscal 2022 Third Quarter Conference Call. My name is Clint Tomlinson, and I’ll be your host for tod ...

[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Presents unaudited interim consolidated financial statements, reporting a net loss of **$12.4 million** for the quarter and **$33.7 million** for nine months, with a cash position of **$153.2 million** Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2022 | September 30, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $153,199,352 | $152,107,745 | | Total Assets | $160,221,144 | $161,616,490 | | Total Liabilities | $9,484,544 | $10,798,386 | | Total Stockholders' Equity | $150,736,600 | $150,818,104 | Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Nine Months Ended June 30, 2022 | Nine Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total operating expenses | $(12,458,720) | $(11,398,655) | $(35,701,857) | $(29,749,416) | | Net loss | $(12,367,341) | $(10,180,141) | $(33,687,519) | $(26,190,428) | | Net Loss per share (Basic and diluted) | $(0.16) | $(0.14) | $(0.44) | $(0.39) | Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity (Nine months ended June 30) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,193,929) | $(22,709,166) | | Net cash provided by financing activities | $21,285,536 | $151,020,193 | | Increase in cash and cash equivalents | $1,091,607 | $128,311,027 | - The company is a clinical-stage biopharmaceutical firm developing therapeutics for Central Nervous System (CNS) diseases, with its lead compound **ANAVEX2-73** being developed for Alzheimer's, Parkinson's, and Rett syndrome[22](index=22&type=chunk) - Management believes the current working capital position is sufficient to meet requirements for **more than 12 months**, despite expecting continued negative cash flows from operations as the company has not yet generated any revenue[26](index=26&type=chunk)[29](index=29&type=chunk) - During the nine months ended June 30, 2022, the company sold **1,623,566 shares** under its Sales Agreement, generating gross proceeds of **$20,982,148**[49](index=49&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=20&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) Discusses the company's business, clinical programs, and financial results, noting increased operating expenses and net loss, alongside a strong liquidity position of **$153.2 million** in cash [Business Overview and Pipeline](index=22&type=section&id=Business%20Overview%20and%20Pipeline) Outlines Anavex's clinical-stage focus on CNS diseases, featuring lead compound **ANAVEX2-73** in late-stage trials for Alzheimer's, Rett syndrome, and Parkinson's, and **ANAVEX3-71** for Frontotemporal Dementia - The company's lead compound, **ANAVEX2-73**, is being developed to treat Alzheimer's disease, Parkinson's disease, and Rett syndrome[84](index=84&type=chunk) - The Phase 2b/3 study of **ANAVEX2-73** in Alzheimer's disease enrolled **509 patients** and completed enrollment in June 2021[93](index=93&type=chunk) - The AVATAR Phase 3 study for Rett syndrome met all primary and secondary endpoints, and a pediatric Phase 2/3 study (EXCELLENCE) is ongoing[99](index=99&type=chunk)[100](index=100&type=chunk) - A Phase 1 clinical trial of **ANAVEX3-71** for Frontotemporal Dementia (FTD) met its primary and secondary safety endpoints, with plans for further clinical development[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - The company holds **fifteen U.S. patents** and various international patent applications related to its drug candidates and research programs[146](index=146&type=chunk) [Financial Overview and Results of Operations](index=33&type=section&id=Financial%20Overview%20and%20Results%20of%20Operations) Reports increased operating expenses for Q3 2022 to **$12.5 million** and for nine months to **$35.7 million**, driven by higher non-cash stock-based compensation and R&D, resulting in a wider net loss Operating Expenses Comparison (in millions) | Expense Category | Q3 2022 | Q3 2021 | 9M 2022 | 9M 2021 | | :--- | :--- | :--- | :--- | :--- | | General & Administrative | $3.2 | $2.4 | $9.2 | $6.1 | | Research & Development | $9.3 | $9.0 | $26.5 | $23.6 | | **Total Operating Expenses** | **$12.5** | **$11.4** | **$35.7** | **$29.7** | Net Loss Comparison | Period | Net Loss 2022 | EPS 2022 | Net Loss 2021 | EPS 2021 | | :--- | :--- | :--- | :--- | :--- | | Q3 (3 months) | $12.4M | $(0.16) | $10.2M | $(0.14) | | 9 Months | $33.7M | $(0.44) | $26.2M | $(0.39) | - The increase in G&A and R&D expenses was primarily driven by higher non-cash stock option compensation charges, increased corporate insurance costs, and intellectual property professional fees[158](index=158&type=chunk)[159](index=159&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) Details Anavex's strong liquidity with **$153.2 million** in cash and equivalents, noting **$20.2 million** net cash used in operations and **$21.3 million** raised from ATM equity offering - The company held **$153.2 million** in cash and cash equivalents as of June 30, 2022[163](index=163&type=chunk) Cash Flow Summary (Nine months ended June 30, 2022) | Metric | Amount | | :--- | :--- | | Net cash used in operating activities | $(20.2) million | | Net cash provided by financing activities | $21.3 million | | Net increase in cash | $1.1 million | - During the nine months ended June 30, 2022, the company raised gross proceeds of **$21.0 million** (**$20.3 million** net) through its At-the-Market (ATM) Offering[171](index=171&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=36&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) States this section is **not applicable**, indicating no material exposure to market risks requiring quantitative and qualitative disclosure - The company states this item is "**Not applicable**"[175](index=175&type=chunk) [Controls and Procedures](index=36&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and Principal Financial Officer, deemed disclosure controls and procedures **effective** as of June 30, 2022, with no material changes to internal control over financial reporting - Management, including the principal executive officer and principal financial officer, concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2022[177](index=177&type=chunk) - There were no changes to the company's internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[178](index=178&type=chunk) [PART II – OTHER INFORMATION](index=36&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) Reports no material pending legal proceedings, other than ordinary litigation incidental to business operations - The company is not aware of any material pending legal proceedings, other than ordinary routine litigation incidental to its business[179](index=179&type=chunk) [Risk Factors](index=36&type=section&id=ITEM%201A.%20RISK%20FACTORS) Indicates no material changes to risk factors previously disclosed in the Annual Report on Form 10-K for fiscal year ended September 30, 2021 - There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended September 30, 2021[180](index=180&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECU%20RITIES%20AND%20USE%20OF%20PROCEEDS) Confirms no unregistered equity securities sales during the period that were not previously reported on a Form 8-K - The company has not sold any equity securities that were not registered under the Securities Act of 1933 that were not previously reported in a Current Report on Form 8-K[181](index=181&type=chunk) [Defaults Upon Senior Securities](index=36&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) Reports no defaults upon its senior securities - The company reports "**None**" regarding defaults upon senior securities[181](index=181&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) States this item is not applicable to the company's business operations - This item is noted as "**Not applicable**"[181](index=181&type=chunk) [Other Information](index=37&type=section&id=ITEM%205.%20OTHER%20INFORMATION) Reports no other information to disclose for this item - The company reports "**None**" for this item[182](index=182&type=chunk) [Exhibits](index=37&type=section&id=ITEM%206.%20EXHIBIT) Lists exhibits filed with Form 10-Q, including Articles of Incorporation, Bylaws, CEO and PFO certifications, and XBRL data files - The report includes a list of filed exhibits, such as CEO and PFO certifications (Exhibits 31.1, 31.2, 32.1) and XBRL data files[182](index=182&type=chunk)

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2022 Earnings Conference Call February 9, 2022 4:30 PM ET Company Participants Clint Tomlinson - Investor Relations Christopher Missling - President & Chief Executive Officer Sandra Boenisch - Principal Financial Officer. Conference Call Participants Charles Duncan - Cantor Fitzgerald Soumit Roy - Jones Research Tom Bishop - BI Research Clint Tomlinson Good afternoon. Welcome to the Anavex Life Sciences Fiscal 2022 First Quarter Conference Call. My name is Clint T ...

Financial Data and Key Metrics Changes - The cash position as of September 30, 2021, was $152.1 million, sufficient to fund operations and clinical programs beyond 2025 [10] - The net loss for fiscal year 2021 was $37.9 million, or $0.54 per share, compared to a net loss of $26.3 million, or $0.45 per share in fiscal year 2020 [10] - Research and development expenses increased to $33 million from $25.2 million in the previous fiscal year, primarily due to ongoing clinical trials [11] Business Line Data and Key Metrics Changes - The company is advancing three clinical trials: the Phase 2b/3 ANAVEX®2-73 trial for Alzheimer's disease, the AVATAR trial for Rett Syndrome, and ANAVEX 3-71 for Frontotemporal dementia [5][6] - The Phase 2b/3 Alzheimer's trial exceeded its enrollment target with 509 patients across North America, Europe, and Australia [7] - The EXCELLENCE study for Rett Syndrome was expanded from 69 to 84 patients to allow for additional sub-analysis [16] Market Data and Key Metrics Changes - The company is focusing on expanding its pipeline for ANAVEX®2-73 to include Parkinson's disease and Fragile X Syndrome, with strong preclinical data supporting its efficacy [9][12] - The market for neurological disorders is expected to grow, with unmet medical needs in conditions like Alzheimer's and Rett Syndrome [12] Company Strategy and Development Direction - The company aims to drive growth through its SIGMAR1 platform, focusing on treatments for degenerative and developmental neurological disorders [12] - Plans include the initiation of pivotal studies for new rare disease indications and expanding the use of precision medicine [9][12] - The company is considering partnerships for larger indications like Alzheimer's and Parkinson's diseases to enhance market penetration [48] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's potential and the progress of its clinical trials, emphasizing the importance of data from ongoing studies [12] - The company is committed to early intervention strategies for Alzheimer's disease, based on promising preclinical data [33] Other Important Information - The Independent Data Safety Monitoring Board recommended continuing the Phase 2b/3 Alzheimer's study without modification after reviewing interim safety data [8] - The company is exploring the use of ANAVEX®2-73 in a prophylactic manner, indicating a proactive approach to treatment [33] Q&A Session Summary Question: Efficacy measures in Rett Syndrome studies - Management noted that the efficacy effect size in the U.S. study was significant, and they expect similar or higher results in the AVATAR study due to higher dosing [15][16] Question: Changes to primary and secondary endpoints in the EXCELLENCE study - The changes were driven by regulatory requests for additional sub-analysis to ensure sufficient power for the study [17][18] Question: Updates on the Parkinson's disease dementia program - Management confirmed plans to discuss data with foundations and prepare for pivotal studies [22] Question: Timeline for NDA filing in Rett Syndrome - Management indicated that the timeline would depend on the data from the ongoing trials [26] Question: Cross-analysis of data between Rett Syndrome and Fragile X Syndrome - Management confirmed that overlapping symptoms and endpoints would be considered in the analysis [28] Question: Updates on the 3-71 program for Frontotemporal dementia - Management stated that they would proceed with Frontotemporal dementia but would wait for solid Phase 1 data before committing [46] Question: Prioritization of indications for partnerships - Management highlighted the potential for partnerships in larger indications like Alzheimer's and Parkinson's diseases while focusing on rare diseases for direct commercialization [48]