Anavex Life Sciences (AVXL) - 2024 Q4 - Annual Report

Stock and Shareholders - The company has 48 stockholders of record and 84,815,517 shares of common stock issued and outstanding as of December 23, 2024[304] - The company issued 2,455,646 shares of common stock to Lincoln Park under the 2023 Purchase Agreement during the year ended September 30, 2024[312] - The company issued 2,450,000 purchase shares and 273,360 shares pursuant to stock option exercises in 2024[42] Dividends and Retained Earnings - The company has not paid any cash dividends and intends to retain earnings for business development[304] Research and Development - Research and development expenses for 2024 totaled $41.8 million, with$21.97 million allocated to external service providers[309] - Research and development costs are expensed as incurred, including preclinical studies, clinical trials, manufacturing costs, employee salaries, and share-based compensation[49] - Nonrefundable advance payments for future R&D activities are deferred and amortized over the period goods are delivered or services are performed[49] - The company estimates costs related to external CROs and clinical site costs, accruing expenses based on work performed and stage of completion[49] - Accrued CRO costs are subject to revisions as trials progress, with revisions charged to expense in the period they become known[49] - Clinical site cost payments depend on factors like patient recruitment, trial completion, or achievement of specific events[49] - The company expenses the acquisition of patents and trademarks due to uncertainties in commercialization[49] Cash Flow and Financial Position - The company's cash and cash equivalents decreased to $132.2 million as of September 30, 2024, from$151.0 million in 2023[311] - Cash flow used in operating activities increased by $3.0 million in fiscal 2024, primarily due to higher net cash expenses[311] - The company entered into a$150 million purchase agreement with Lincoln Park Capital Fund, LLC, with $110.8 million remaining available as of September 30, 2024[311][312] Agreements and Terminations - The company terminated the 2020 Sales Agreement on July 24, 2024[316] - The company is party to an exclusive license agreement with Life Science Research Israel Ltd. for the ANAVEX3-71 product candidate[317] Intellectual Property Risks - The company may face disputes over intellectual property rights, which could impact its ability to develop and commercialize products[317] Tax and Valuation Allowance - The company reduced federal NOLs by$12.1 million and R&D tax credit carryforwards by $0.8 million due to a Section 382 study[33] - A change in ownership in 2015 resulted in$25.8 million of federal NOLs being subject to an annual limitation[33] - The company recorded a reduction of $2.5 million in NOLs and$0.8 million in R&D credits, with a corresponding $3.3 million reduction in valuation allowance[33] - As of September 30, 2024, the company did not provide foreign withholding taxes on undistributed earnings of foreign subsidiaries[33] Share-Based Compensation and Financial Results - Share-based compensation for 2024 amounted to$9,438[42] - The company reported a net loss of $43,002 for the year ended September 30, 2024[42] - Total additional paid-in capital as of September 30, 2024, was$456,249[42] - Accumulated deficit as of September 30, 2024, was $336,071[42] Internal Controls and Financial Reporting - The company’s internal controls over financial reporting were effective as of September 30, 2024[45] Board of Directors and Governance - The Board of Directors is composed of a majority of independent directors, with Dr. Jiong Ma serving as the independent Board Chair[47] - The Board oversees risk management, including economic, operational, financial, competitive, legal, regulatory, cybersecurity, compliance, and reputational risks[47] - The Audit, Compensation, and Nominating and Corporate Governance Committees oversee specific areas of responsibility[47] - Christopher Missling, PhD, serves as Director, President, CEO, and Secretary, appointed on July 5, 2013[48]