ANAVEX-11-141

On track to release top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the second half of 2023 Newly available preliminary efficacy results of surrogate biomarkers from the ANAVEX®2-73-AD-004 study in Alzheimer’s disease with convenient oral treatment to be released in the second half of 2023 Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Aug. 08, 2023 (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 quarter ended June 30, 2023. “We are very excited to be entering an important phase of the Company, with several key data readouts based on innovative science at Anavex with ANAVEX®2-73 (blarcamesine), an orally available, small-molecule activator of the upstream sigma-1 receptor (SIGMAR1), involved in restoring neural cell homeostasis and promoting neuroplasticity,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We remain focused on execution as we prepare for a pivotal year ahead of us potentially involving a digital ‘Healthcare Sales Marketing’ pharma platform and also making meaningful advances in our other neurodevelopmental and neurodegenerative precision medicine portfolio, including schizophrenia and Parkinson’s disease.” Key Near Term Pipeline Updates: Rett syndrome: Top-line data of potentially pivotal ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial. Company expects to announce topline results from this study in the second half of 2023. Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial. The Company intends to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing a much-needed treatment to the millions of patients living with Alzheimer’s disease with a convenient once-daily oral treatment. Company expects to announce data in the second half of 2023. Parkinson’s disease: Initiation of ANAVEX®2-73 pivotal clinical trial. Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused clinical trial. Fragile X: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial. Schizophrenia: Initiation of ANAVEX®3-71 Phase 2 clinical trial. New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial. Publications: Several clinical publications involving ANAVEX®2-73, ANAVEX®3-71 and Rett syndrome Burden of Illness study. Recent Business Highlights: On August 7, 2023, the Company announced a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved its cardiovascular safety objectives. The publication is entitled, ‘Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease’. On June 28, 2023, the Company announced that long-term clinical study results from the U.S. ANAVEX®2-73-RS-001 clinical trial demonstrate disease-modifying effect of ANAVEX®2-73 (blarcamesine) for adult patients with Rett syndrome. On June 27, 2023, the Company announced a strategic partnership with Partex N.V. Group, the first Data-to-Drugs digital pharma platform in which Partex will implement AI-based ‘Healthcare Sales Marketing’ in preparation for Anavex’s late-stage drug pipeline. On June 12, 2023, the Company announced the publication of a relevant new peer-reviewed study in the American Journal on Intellectual and Developmental Disabilities, entitled ‘Rett Syndrome Behaviour Questionnaire in Children and Adults With Rett Syndrome: Psychometric Characterization and Revised Factor Structure.’ In the EXCELLENCE Phase 2/3 ANAVEX®2-73-RS-003 Rett syndrome pediatric clinical trial, the characterized Rett Syndrome Behaviour Questionnaire (RBSQ), together with the Clinical Global Impression Improvement Scale (CGI-I), represent the co-primary efficacy endpoints of the study. On June 6, 2023, the Company announced completion of dosing of all participants of the placebo-controlled EXCELLENCE Phase 2/3 clinical trial ANAVEX®2-73-RS-003 in pediatric patients with Rett syndrome. On June 1, 2023, the Company announced that it was awarded a new U.S. Patent No. 11,661,405 entitled “CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof. Financial Highlights: Cash and cash equivalents of $154.8 million at June 30, 2023 compared to $149.2 million at fiscal year end September 30, 2022. General and administrative expenses for the quarter of $3.2 million compared to $3.2 million for the comparable quarter of fiscal 2022. Research and development expenses for the quarter of $10.3 million compared to $9.3 million for the comparable quarter of fiscal 2022. Net loss for the quarter of $11.3 million, inclusive of $3.9 million in non-cash items, or $0.14 per share, compared to a net loss of $12.4 million, inclusive of $4.0 million in non-cash items, or $0.16 per share for the comparable quarter of fiscal 2022. The financial information for the quarter ended June 30, 2023, should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, and will be available on the Anavex website at . Webcast / Conference Call Information: 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 Meeting ID# 891 9995 1143 and reference passcode 511901. A replay of the conference call will also be available on Anavex’s website for up to 30 days. 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 recently 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. Anavex Life Sciences Corp. Interim Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited - Expressed in US Dollars) Three months ended June 30, 2023 2022 Operating Expenses General and administrative $ 3,247,843 $ 3,185,451 Research and development 10,282,854 9,273,269 Total operating expenses 13,530,697 12,458,720 Operating loss (13,530,697 ) (12,458,720 ) Other income Research and development incentive income 564,842 682,432 Interest income, net 1,827,945 229,917 Foreign exchange loss, net (101,066 ) (732,549 ) Total other income, net 2,291,721 179,800 Net loss before provision for income taxes (11,238,976 ) (12,278,920 ) Income tax expense, current (41,000 ) (88,421 ) Net loss and comprehensive loss $ (11,279,976 ) $ (12,367,341 ) Net loss per share Basic and diluted $ (0.14 ) $ (0.16 ) Weighted average number of shares outstanding Basic and diluted 80,875,235 77,442,236 Anavex Life Sciences Corp. Interim Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited - Expressed in US Dollars) Nine months ended June 30, 2023 2022 Operating Expenses General and administrative $ 9,447,447 $ 9,167,560 Research and development 33,656,364 26,534,297 Total operating expenses 43,103,811 35,701,857 Operating loss (43,103,811 ) (35,701,857 ) Other income Grant income 25,000 - Research and development incentive income 2,048,113 2,328,675 Interest income, net 4,560,784 242,405 Other financing expense (964,344 ) - Foreign exchange gain (loss), net 146,239 (408,541 ) Total other income, net 5,815,792 2,162,539 Net loss before provision for income taxes (37,288,019 ) (33,539,318 ) Income tax expense, current (70,954 ) (148,201 ) Net loss and comprehensive loss $ (37,358,973 ) $ (33,687,519 ) Net loss per share Basic and diluted $ (0.47 ) $ (0.44 ) Weighted average number of shares outstanding Basic and diluted 79,051,038 76,561,940 Anavex Life Sciences Corp. Interim Condensed Consolidated Balance Sheets At June 30, 2023 and September 30, 2022 (Unaudited – Expressed in US Dollars) June 30, 2023 September 30, 2022 Assets Current Cash and cash equivalents $ 154,817,164 $ 149,157,861 Incentive and tax receivables 2,165,127 3,192,580 Prepaid expenses and other current assets 827,572 354,162 Total Assets $ 157,809,863 $ 152,704,603 Liabilities and stockholders' equity Current Liabilities Accounts payable $ 4,152,846 $ 3,824,777 Accrued liabilities 5,985,658 5,944,953 Deferred grant income 916,763 443,831 Total Liabilities 11,055,267 10,213,561 Capital Stock 81,391 77,944 Additional paid-in capital 429,595,961 387,976,881 Accumulated deficit (282,922,756 ) (245,563,783 ) Total Stockholders' Equity 146,754,596 142,491,042 Total Liabilities and Stockholders' Equity $ 157,809,863 $ 152,704,603 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