[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This part presents the company's interim financial statements and management's discussion and analysis for the quarter ended December 31, 2023 [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) 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](index=9&type=section&id=Note%201%20Business%20Description) 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](index=22&type=chunk) [Note 2: Basis of Presentation and Liquidity](index=9&type=section&id=Note%202%20Basis%20of%20Presentation) 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](index=26&type=chunk) - Management believes the current working capital position is sufficient to fund operations beyond the next 12 months[28](index=28&type=chunk) [Note 3: Other Income](index=11&type=section&id=Note%203%20Other%20Income) 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](index=41&type=chunk) - 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](index=40&type=chunk) [Note 5: Equity Offerings](index=13&type=section&id=Note%205%20Equity%20Of%20erings) 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](index=54&type=chunk)[56](index=56&type=chunk) - As of December 31, 2023, **$122.1 million** remained available for sale under the 2023 Purchase Agreement with Lincoln Park[57](index=57&type=chunk) [Note 6: Commitments and Contingencies](index=14&type=section&id=Note%206%20Commitments%20and%20Contingencies) 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](index=76&type=chunk) - As of December 31, 2023, the company had **160,000** share purchase warrants outstanding with a weighted average exercise price of $3.72[62](index=62&type=chunk) - Approximately **$27.7 million** in unrecognized stock-based compensation is expected to be recorded through fiscal 2026[77](index=77&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=19&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS.) 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](index=85&type=chunk) - The company's lead product candidate, ANAVEX2-73 (blarcamesine), is being developed for multiple CNS indications[85](index=85&type=chunk) - Operating expenses for Q1 FY24 decreased to **$11.3 million** from $15.4 million in Q1 FY23, driven by lower R&D spending[175](index=175&type=chunk) - The company believes its cash position of **$143.8 million** is sufficient to fund operations for more than the next 12 months[28](index=28&type=chunk)[184](index=184&type=chunk) [Our Current Business & Pipeline](index=20&type=section&id=Our%20Current%20Business) 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](index=126&type=chunk)[128](index=128&type=chunk)[143](index=143&type=chunk) - 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](index=130&type=chunk) - ANAVEX3-71 has received Orphan Drug Designation from the FDA for the treatment of Frontotemporal Dementia (FTD)[118](index=118&type=chunk) [Clinical Trials Overview](index=22&type=section&id=Clinical%20Trials%20Overview) 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](index=96&type=chunk)[98](index=98&type=chunk) - 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](index=107&type=chunk)[109](index=109&type=chunk) - Parkinson's Disease (Phase 2): The trial showed clinically meaningful, dose-dependent, and statistically significant improvements in cognitive assessments (CDR system)[115](index=115&type=chunk) - 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](index=121&type=chunk)[124](index=124&type=chunk) [Patents, Trademarks and Intellectual Property](index=34&type=section&id=Patents%2C%20Trademarks%20and%20Intellectual%20Property) 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](index=164&type=chunk) - Key patents for ANAVEX2-73 and its compositions are expected to expire between **2034 and 2039**[165](index=165&type=chunk) - Exclusive rights to patents for ANAVEX3-71 are expected to expire in **2030**[168](index=168&type=chunk) [Financial Overview & Results of Operations](index=35&type=section&id=Financial%20Overview) 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](index=175&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=188&type=chunk) - The company has access to up to **$122.1 million** in additional capital under its 2023 Purchase Agreement with Lincoln Park Capital[195](index=195&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=40&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISKS.) 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](index=203&type=chunk) [Controls and Procedures](index=40&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) 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](index=205&type=chunk) - 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](index=206&type=chunk) [PART II – OTHER INFORMATION](index=41&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, equity sales, and other general information, confirming no material changes or issues [Legal Proceedings](index=41&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not a party to any material pending legal or governmental proceedings - The company knows of no material pending legal proceedings[208](index=208&type=chunk) [Risk Factors](index=41&type=section&id=ITEM%201A.RISK%20FACTORS) 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](index=209&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) 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](index=210&type=chunk) [Other Information (Items 3-6)](index=41&type=section&id=Other%20Information%20%28Items%203-6%29) 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](index=210&type=chunk) - Item 6 lists the exhibits filed with the report, including certifications and XBRL data[212](index=212&type=chunk)

Core Viewpoint - Anavex Life Sciences Corp. is set to release its financial results for the fiscal quarter ending December 31, 2023, on February 7, 2024, and will provide updates on its growth strategy during a conference call [1]. Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing therapeutics for neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and schizophrenia [3]. - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and is also being studied for Parkinson's disease dementia and Rett syndrome [3]. - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, showing potential to halt or reverse Alzheimer's disease progression [3]. - Another candidate, ANAVEX®3-71, targets SIGMAR1 and M1 muscarinic receptors and has demonstrated disease-modifying activity against Alzheimer's disease in preclinical trials [3]. Upcoming Events - A conference call will be held on February 7, 2024, at 8:30 am ET to discuss the financial results and the company's growth strategy, followed by a Q&A session [1][2].

GSK plc (GSK) reported adjusted earnings of 72 cents per American depositary share (“ADS”) in fourth-quarter 2023, missing the Zacks Consensus Estimate of 76 cents. Adjusted earnings rose 12% year over year on a reported basis and 25% at a constant exchange rate (CER).Quarterly revenues increased 9% on a reported basis and 15% on a CER basis to $10.1 billion (£8.1 billion), beating the Zacks Consensus Estimate of $9.8 billion. The upside can be attributed to rising vaccine sales, which was partially offset ...

Anavex Life Sciences (AVXL) closed the last trading session at $6.29, gaining 4.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $39.67 indicates a 530.7% upside potential.The mean estimate comprises three short-term price targets with a standard deviation of $0.58. While the lowest estimate of $39 indicates a 520% increase from the current price level, the most optimistic analys ...

Core Insights - Five stocks have been added to the Zacks Rank 1 (Strong Buy) List, indicating strong potential for investment based on recent earnings estimate increases [1] Company Summaries - **Inhibikase Therapeutics, Inc. (IKT)**: The pharmaceutical company has seen a 16% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **Eldorado Gold Corporation (EGO)**: This mining and mineral exploration company has experienced an 11.5% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **MongoDB, Inc. (MDB)**: The database platform company has reported a 23.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **PagerDuty, Inc. (PD)**: This digital operations platform company has seen a 16.1% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - **Anavex Life Sciences Corp. (AVXL)**: The biopharmaceutical company has experienced a 14.5% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1]

Investors might want to bet on Anavex Life Sciences (AVXL) , as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following ye ...

Placebo-controlled Phase 2 trial cleared by the FDA – Trial to begin in Q2 2024 Trial to include Schizophrenia validated clinical outcomes PANSS and EEG/ERP biomarkers Trial to study positive, negative, and cognitive domains of Schizophrenia based on ANAVEX®3-71's ability to synergistically activate both SIGMAR1 and M1 muscarinic receptors NEW YORK, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing di ...

BOSTON, Jan. 12, 2024 (GLOBE NEWSWIRE) -- Block & Leviton is investigating Anavex Life Sciences Corp. (NASDAQ:AVXL) for potential securities law violations. Investors who have lost money in their Anavex Life Sciences Corp. investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://www.blockleviton.com/cases/avxl. What is this all about? On January 2, Anavex announced results from its Phase 2/3 EXCELLENCE clinical trial for its candidate ANAVEX ...

One stock that might be an intriguing choice for investors right now is Anavex Life Sciences Corp. (AVXL) . This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably ta ...

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2023 Earnings Call Transcript November 27, 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 Tom Bishop - Bishop Research Operator Good morning, and welcome to the Anavex Life Sciences Fiscal 2023 Fourth Quarter Conference Call. My name is Clint Tomlinson and I will be your host for today's call. At this time all pa ...