Anavex Life Sciences (AVXL) - 2024 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION This part presents the company's interim financial statements and management's discussion and analysis for the quarter ended December 31, 2023 Financial Statements This section presents the unaudited interim financial statements, reporting a net loss of $8.6 million and $143.8 million in cash Condensed Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2023 (Unaudited) | Sep 30, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $143,765 | $151,024 | | Total Assets | $148,070 | $154,386 | | Total Liabilities | $12,495 | $12,534 | | Total Stockholders' Equity | $135,575 | $141,852 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three months ended Dec 31, 2023 | Three months ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $8,684 | $12,067 | | General and administrative | $2,609 | $3,317 | | Total operating expenses | $11,293 | $15,384 | | Net loss | $(8,622) | $(12,972) | | Net Loss per share (Basic and diluted) | $(0.11) | $(0.17) | Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three months ended Dec 31, 2023 | Three months ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,318) | $(5,794) | | Net cash provided by financing activities | $59 | $258 | | Decrease in cash and cash equivalents | $(7,259) | $(5,536) | Note 1: Business Description Anavex Life Sciences is a clinical-stage biopharmaceutical company developing CNS therapeutics using a precision medicine approach - The company's lead compound, ANAVEX2-73, is in development for the treatment of Alzheimer's disease, Parkinson's disease, and rare neurological disorders like Rett syndrome[22] Note 2: Basis of Presentation and Liquidity The financial statements are prepared under U.S. GAAP, with management affirming sufficient working capital for over 12 months despite no revenue - The company has not yet generated any revenues and expects to experience negative cash flows from operations for the foreseeable future[26] - Management believes the current working capital position is sufficient to fund operations beyond the next 12 months[28] Note 3: Other Income Other income primarily includes $0.6 million in R&D incentive income from Australia, with no grant income recognized this quarter - The company recorded research and development incentive income of $0.6 million from the Australia R&D credit program for the three months ended December 31, 2023, compared to $0.7 million in the prior-year period[41] - No grant income was recognized in the quarter ended December 31, 2023, compared to $25,000 in the same period in 2022, with $0.9 million in deferred grant income remaining to be recognized[40] Note 5: Equity Offerings No shares were sold under the ATM facility or Lincoln Park Purchase Agreement this quarter, with $122.1 million remaining available - No shares were sold under the Sales Agreement (ATM facility) or the 2023 Purchase Agreement with Lincoln Park during the three months ended December 31, 2023[54][56] - As of December 31, 2023, $122.1 million remained available for sale under the 2023 Purchase Agreement with Lincoln Park[57] Note 6: Commitments and Contingencies This note details commitments, contingencies, and stock-based compensation, which was $2.3 million for the quarter - The company recognized stock-based compensation expense of $2.3 million for the three months ended December 31, 2023, a decrease from $5.3 million in the prior-year period[76] - As of December 31, 2023, the company had 160,000 share purchase warrants outstanding with a weighted average exercise price of $3.72[62] - Approximately $27.7 million in unrecognized stock-based compensation is expected to be recorded through fiscal 2026[77] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) The MD&A details the company's business strategy, clinical trial progress, and financial performance, highlighting decreased expenses and sufficient liquidity - Anavex is a clinical-stage biopharmaceutical company developing differentiated therapeutics for CNS diseases with high unmet need, including Alzheimer's, Parkinson's, and Rett syndrome[85] - The company's lead product candidate, ANAVEX2-73 (blarcamesine), is being developed for multiple CNS indications[85] - Operating expenses for Q1 FY24 decreased to $11.3 million from $15.4 million in Q1 FY23, driven by lower R&D spending[175] - The company believes its cash position of $143.8 million is sufficient to fund operations for more than the next 12 months[28][184] Our Current Business & Pipeline This section describes the company's portfolio focused on SIGMAR1 activation, led by ANAVEX2-73 for CNS diseases - The company's pipeline includes ANAVEX2-73 (clinical stage for Alzheimer's, Parkinson's, Rett), ANAVEX3-71 (clinical stage for Schizophrenia, FTD), and several other compounds in preclinical development[126][128][143] - ANAVEX2-73 has received Orphan Drug Designation for Rett syndrome and infantile spasms, Rare Pediatric Disease designation for Rett syndrome, and Fast Track designation for Rett syndrome from the FDA[130] - ANAVEX3-71 has received Orphan Drug Designation from the FDA for the treatment of Frontotemporal Dementia (FTD)[118] Clinical Trials Overview This section provides updates on key clinical trials, including ANAVEX2-73 in Alzheimer's, Rett Syndrome, and Parkinson's, and ANAVEX3-71 - Alzheimer's Disease (Phase 2b/3): ANAVEX2-73 met co-primary endpoints (ADAS-Cog and ADCS-ADL) and the key secondary endpoint (CDR-SB), demonstrating a slowdown in cognitive and functional decline[96][98] - Rett Syndrome (EXCELLENCE, Phase 2/3): The trial did not meet statistical significance on the co-primary endpoint RSBQ (p=0.063) at 12 weeks, though it showed a statistically significant improvement at 4 weeks (p=0.041), and the other co-primary endpoint, CGI-I, was not met[107][109] - Parkinson's Disease (Phase 2): The trial showed clinically meaningful, dose-dependent, and statistically significant improvements in cognitive assessments (CDR system)[115] - ANAVEX3-71 (Phase 1): The trial met its primary safety endpoints, was well-tolerated, and is set to advance into a Phase 2 study for schizophrenia[121][124] Patents, Trademarks and Intellectual Property Anavex holds a robust intellectual property portfolio with 24 U.S. patents, covering drug candidates with expirations extending to 2039 - The company holds or has exclusive rights to 24 U.S. patents and 23 U.S. patent applications[164] - Key patents for ANAVEX2-73 and its compositions are expected to expire between 2034 and 2039[165] - Exclusive rights to patents for ANAVEX3-71 are expected to expire in 2030[168] Financial Overview & Results of Operations Total operating expenses decreased to $11.3 million, resulting in an improved net loss of $8.6 million for the quarter Comparison of Operating Results (in thousands, except per share data) | Metric | Q1 FY2024 (ended Dec 31, 2023) | Q1 FY2023 (ended Dec 31, 2022) | | :--- | :--- | :--- | | Research & Development Expenses | $8,684 | $12,067 | | General & Administrative Expenses | $2,609 | $3,317 | | Total Operating Expenses | $11,293 | $15,384 | | Net Loss | $(8,622) | $(12,972) | | Net Loss Per Share | $(0.11) | $(0.17) | - The decrease in R&D expenses was mainly due to reduced costs related to the Rett syndrome program ($0.8 million decrease) and the Alzheimer's program ($1.2 million decrease) following the completion of major clinical trials[175] Liquidity and Capital Resources The company maintains $143.8 million in cash and working capital of $135.6 million, sufficient to fund operations for over 12 months Working Capital Summary (in thousands) | Metric | Dec 31, 2023 | Sep 30, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $143,765 | $151,024 | | Working Capital | $135,575 | $141,852 | - Net cash used in operating activities was $7.3 million for the three months ended December 31, 2023[188] - The company has access to up to $122.1 million in additional capital under its 2023 Purchase Agreement with Lincoln Park Capital[195] Quantitative and Qualitative Disclosures About Market Risks No material changes to market risk exposure have occurred since the prior fiscal year's annual report - There have been no material changes in the company's market risk exposure since the last annual report[203] Controls and Procedures Disclosure controls and procedures were effective as of December 31, 2023, with no material changes to internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[205] - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[206] PART II – OTHER INFORMATION This part covers legal proceedings, risk factors, equity sales, and other general information, confirming no material changes or issues Legal Proceedings The company is not a party to any material pending legal or governmental proceedings - The company knows of no material pending legal proceedings[208] Risk Factors No material changes to the risk factors previously disclosed in the most recent annual report on Form 10-K have occurred - There have been no material changes to the risk factors discussed in the company's most recent Form 10-K[209] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities were made during the reporting period that were not previously disclosed - No unregistered sales of equity securities were made during the reporting period that were not previously disclosed[210] Other Information (Items 3-6) This section confirms no defaults on senior securities, no applicable mine safety disclosures, and lists exhibits filed with the report - The company reports 'None' for Item 3 (Defaults Upon Senior Securities) and Item 5 (Other Information), and 'Not applicable' for Item 4 (Mine Safety Disclosures)[210] - Item 6 lists the exhibits filed with the report, including certifications and XBRL data[212]