Anavex Life Sciences (AVXL) - 2020 Q1 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents the company's financial statements, management's analysis, market risk disclosures, and internal controls Financial Statements 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 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] Condensed Consolidated Statements of Operations 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] Condensed Consolidated Statements of Cash Flows 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] Notes to the Condensed Consolidated Interim Financial Statements 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] - 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][15] - 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] - 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][59] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical progress, operating expenses, net loss, and strengthened liquidity from equity financing Business Overview 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] - The lead compound, ANAVEX2-73, is being developed for Alzheimer's disease, Parkinson's disease, and the rare neurological disorder Rett syndrome[66] - The company's portfolio consists of five programs: two core programs and three seed programs at various stages of clinical and preclinical development[67] - 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] Clinical Studies Overview 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][76] - 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][80][81][82] - 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] Results of Operations 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][135] - 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] Liquidity and Capital Resources 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][140] - 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] - As of December 31, 2019, approximately $34.4 million remained available for purchase under the 2019 Purchase Agreement with Lincoln Park[144] Quantitative and Qualitative Disclosures About Market Risks This section is not applicable to the company as a smaller reporting company - The company has indicated that this item is not applicable[153] Controls and Procedures 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] - 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] PART II – OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, other information, and exhibits Legal Proceedings 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] Risk Factors 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] [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] Other Information 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] Exhibits This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and PFO, and XBRL data files