Williams Syndrome

Grant of Its Newest U.S. Patent Expands Anavex’s Intellectual Property Portfolio in Neurologic IndicationsNEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor Relations Tel: 516-662-9461Email: andrew@barwicki.com 1 https://www.empowerbh.com/blog/what-are-neurodevelopmental-disorders/2 https://ourworldindata.org/neurodevelopmental-disorders

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at . You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com 1 2

Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal year ended September 30, 2022. “This is an exciting time in neuroscience and rare disease drug development and we remain on track for the readout of the placebo-controlled ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical trial, a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our recent progress highlights the potential of our clinical Precision Medicine SIGMAR1 platform and portfolio, and we look forward to sharing additional program and data updates.” ANAVEX®2-73 Program and other Near-Term Pipeline Data Updates: Late breaking oral communication presentation of top line data of randomized, double-blind, multicenter, placebo-controlled Phase 2b/3 study ANAVEX®2-73-AD-004 for the treatment of early Alzheimer’s disease at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022, December 1, 2022, at 4:30pm PT in San Francisco, CA. Nearing the enrollment completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of pediatric patients with Rett syndrome. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX®2-73 for the treatment of Fragile X syndrome in a double-blind, randomized, placebo-controlled Phase 2/3 development program. Upcoming Pipeline expansion of the ANAVEX platform using gene biomarkers of response and applying precision medicine for treatment of neurological disorders with high unmet medical need are expected: Meeting with FDA to discuss ANAVEX®2-73 Parkinson’s disease program including pivotal Phase 3 study. Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study. Planned initiation of a Phase 2/3 clinical trial for the treatment of a new rare-disease indication. Planned initiation of ANAVEX®3-71 Phase 2 clinical trial for schizophrenia. Recent Business Highlights: Anavex announced a peer-reviewed publication in the journal of Science Translational Medicine, titled “Widespread cell stress and mitochondrial dysfunction occur in patients with early Alzheimer’s disease”, which provided further scientific evidence of the relevance of sigma-1 receptor (SIGMAR1) activation as a compensatory mechanism to chronic CNS diseases. Anavex announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,446,275 to Anavex, with claims to treatment methods using its leading drug candidate, ANAVEX®2-73 (blarcamesine) and its analogs, for ameliorating biochemical and functional abnormalities associated with methyl-CpG binding protein 2 defects (MeCP2 defects). Such defects encompass a range of neurodevelopmental and neurological disorders, including but not limited to, Rett syndrome, Angelman syndrome, Williams syndrome, cerebral palsy, autism spectrum disorder, and multiple sclerosis. Anavex announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 Financial Highlights: Cash and cash equivalents of $149.2 million at September 30, 2022, compared to $152.1 million at September 30, 2021. Net loss for the fourth quarter of $14.3 million, or $0.18 per share, compared to a net loss of $11.7 million, or $0.15 per share for the same period in fiscal 2021. Net loss for the full fiscal year ended September 30, 2022 of $48.0 million, or $0.62 per compared to net loss of $37.9 million, or $0.54 per share for the full fiscal 2021 year. Research and development expenses for the fourth quarter of $11.4 million compared to $9.4 million for the same period in fiscal 2021. General and administrative expenses of $3.9 million for fiscal 2022 compared to $2.9 million for the comparable quarter of fiscal 2021. The financial information for the fiscal year ended September 30, 2022, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, and will be available on the Anavex website at . Webcast / Conference Call Information: Management will host a conference call today at 8:30 am ET. The live webcast of the conference call will be available on Anavex’s website at . The conference call can be also accessed by dialing +1 929 205 6099 for participants in the U.S. using the reference passcode 511901. A replay of the conference call will also be available on Anavex’s website for up to 30 days. Economic Burden of Alzheimer’s Disease2 Alzheimer’s disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer disease in 2020 is estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer’s disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated and are associated with significant negative societal and personal burden. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at . You can also connect with the company on Twitter,Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. Anavex Life Sciences Corp. Consolidated Statements of Operations and Comprehensive Loss (Unaudited - Expressed in US Dollars) Three months ended September 30, Years ended September 30, 2022 2021 2022 2021 Operating Expenses General and administrative $ 3,902,508 $ 2,878,983 $ 13,070,068 $ 9,017,511 Research and development 11,381,450 9,372,786 37,915,747 32,983,674 Total operating expenses 15,283,958 12,251,769 50,985,815 42,001,185 Operating loss (15,283,958 ) (12,251,769 ) (50,985,815 ) (42,001,185 ) Other income (expenses) Grant income - - - 54,100 Research and development incentive income 994,336 953,243 3,323,011 4,547,099 Interest income, net 704,583 7,151 946,988 26,261 Foreign exchange (loss) gain, net (495,070 ) (284,535 ) (903,611 ) (267,344 ) Total other income, net 1,203,849 675,859 3,366,388 4,360,116 Net loss before provision for income taxes (14,080,109 ) (11,575,910 ) (47,619,427 ) (37,641,069 ) Income tax expense, current (210,291 ) (142,296 ) (358,492 ) (267,565 ) Net loss and comprehensive loss $ (14,290,400 ) $ (11,718,206 ) $ (47,977,919 ) $ (37,908,634 ) Net loss per share Basic and diluted $ (0.18 ) $ (0.15 ) $ (0.62 ) $ (0.54 ) Weighted average number of shares outstanding Basic and diluted 77,442,470 75,714,558 76,909,993 69,802,960 Anavex Life Sciences Corp. Consolidated Balance Sheets At September 30, 2022 and 2021 Expressed in US Dollars 2022 2021 Assets Current Cash and cash equivalents $ 149,157,861 $ 152,107,745 Incentive and tax receivables 3,192,580 9,136,831 Prepaid expenses and other current assets 354,162 371,914 Total Assets $ 152,704,603 $ 161,616,490 Liabilities and stockholders' equity Current Liabilities Accounts payable $ 3,824,777 $ 4,739,781 Accrued liabilities 5,944,953 5,614,774 Deferred grant income 443,831 443,831 Total Liabilities 10,213,561 10,798,386 Capital Stock 77,944 75,920 Additional paid-in capital 387,976,881 348,328,048 Accumulated deficit (245,563,783 ) (197,585,864 ) Total Stockholders' Equity 142,491,042 150,818,104 Total Liabilities and Stockholders' Equity $ 152,704,603 $ 161,616,490 For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com ____________________________ 1 2 W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183