Webcast and Conference Call To be Held Monday, December 23, 2024, 8:30 am ETNEW YORK, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will issue finan ...

Company Update - Anavex Life Sciences Corp announced the acceptance of a peer-reviewed manuscript titled "Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial" in a medical journal focused on Alzheimer's disease, with an expected publication date around Q4 2024/Q1 2025 [1] - The company is on track for regulatory submission of oral blarcamesine in Europe (EMA) in Q4 2024 [2] - Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and Phase 2/3 studies in Rett syndrome [4] - ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies demonstrating potential to halt and/or reverse Alzheimer's disease progression [4] - ANAVEX®3-71, another clinical-stage drug candidate, targets SIGMAR1 and M1 muscarinic receptors and has shown disease-modifying activity against major hallmarks of Alzheimer's disease in preclinical trials [4] Alzheimer's Disease Market - There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030 [3] - The World Health Organization estimated the cost of caring for people with dementia, including Alzheimer's disease, in Europe at $439 billion in 2019, or $31,144 per person [3] Company Overview - Anavex Life Sciences Corp is a publicly traded biopharmaceutical company focused on developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other CNS diseases [4] - The company's drug candidates have shown potential in treating additional CNS disorders, including epilepsy, based on preclinical studies [4] - Anavex received a research grant from The Michael J Fox Foundation for Parkinson's Research to develop ANAVEX®2-73 for Parkinson's disease treatment [4]

On October 31, 2024, Anavex Life Sciences Corp. (NASDAQ: AVXL ) stock rallied on new data from the phase 2b/3 trial in Alzheimer’s patients that was presented at the CTAD conference in Madrid. Though there is something toI am a long-term investor focused on growth markets, AI and biotech opportunities in my more volatile portfolio. I try to look for undervalued and under-the-radar stocks with serious potential and good scientific or other background. My ambition here is to cover stocks with considerable gro ...

Data of Blarcamesine confirm upstream SIGMAR1 activation Presented as Late Breaking Oral Communications at Clinical Trials on Alzheimer's Disease (CTAD) Conference 2024 Oral, once daily blarcamesine meaningfully slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events NEW YORK, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical comp ...

Part A of the placebo-controlled Phase 2 study has been completed ANAVEX®3-71 demonstrates a dose-dependent pharmacodynamic effect on objective EEG biomarkers of schizophrenia Patients are currently being dosed in Part B of the Phase 2 study which will investigate a longer treatment duration NEW YORK, Oct. 17, 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 A ...

Drug Development and Clinical Trials - Anavex Life Sciences Corp. is developing ANAVEX2-73 (blarcamesine) for Alzheimer's disease, Parkinson's disease, and Rett syndrome, with a focus on precision medicine and genomic data analysis[87]. - The Phase 2b/3 trial of ANAVEX2-73 enrolled 509 patients and demonstrated significant efficacy, with a 38.5% and 34.6% reduction in clinical progression at 48 weeks for the 50 mg and 30 mg dosage groups, respectively[96]. - The trial showed significant improvements in cognitive and functional scores, with the primary endpoint ADAS-Cog13 achieving a significance level of P < 0.025[95]. - Anavex has identified actionable genetic variants in Alzheimer's patients, suggesting that excluding patients with specific biomarker variants could lead to 80%-90% of patients showing clinically significant improvements[91]. - The ongoing ATTENTION-AD trial will provide long-term safety and efficacy data for ANAVEX2-73 in Alzheimer's disease, extending up to 96 weeks[97]. - The Phase 2 trial (ANAVEX2-73-RS-001) for Rett syndrome showed that 66.7% of treated subjects had a statistically significant improvement in RSBQ response compared to 10% in the placebo group (p = 0.011) [100]. - The AVATAR trial (ANAVEX2-73-RS-002) met all primary and secondary efficacy endpoints, with RSBQ response showing a p-value of 0.037 and ADAMS response at p = 0.010 [102]. - The EXCELLENCE trial for pediatric patients demonstrated a LS Mean improvement of -12.93 points on RSBQ total score for ANAVEX2-73 compared to -8.32 points for placebo (p=0.063) [106]. - The Phase 2 trial for Parkinson's disease dementia showed clinically meaningful improvements in MDS-UPDRS total score, suggesting ANAVEX2-73's potential to slow and reverse symptoms [111]. - The 48-week OLE trial for Parkinson's disease demonstrated consistent improvement across efficacy endpoints after resuming ANAVEX2-73 treatment [114]. - ANAVEX2-73 has shown significant and dose-related improvements in behavioral paradigms in the MECP2 HET Rett syndrome disease model[127]. - The Phase 2 trial for ANAVEX2-73 in Parkinson's disease dementia enrolled approximately 132 patients for 14 weeks, with doses of 30mg and 50mg[129]. - ANAVEX2-73 demonstrated clinically meaningful, dose-dependent, and statistically significant improvements in the CDR computerized assessment system analysis[130]. - In a Phase 2a clinical trial for Alzheimer's disease, ANAVEX2-73 met both primary and secondary objectives with 32 patients[133]. - The genomic analysis of Phase 2a trial participants identified that approximately 80% of the population worldwide has the common SIGMAR1 wild type gene variant, which showed improved cognitive scores[134]. - ANAVEX3-71 is advancing into a biomarker-driven clinical development program targeting schizophrenia, frontotemporal dementia, and Alzheimer's disease[122]. - ANAVEX3-71 demonstrated significant reduction in cognitive deficits and amyloid beta pathology in aged transgenic animal models[142]. - ANAVEX1-41 has shown significant neuroprotective benefits through modulation of endoplasmic reticulum, mitochondrial, and oxidative stress[146]. - ANAVEX1037 has shown antitumor potential in advanced pre-clinical studies, selectively killing human cancer cells without affecting normal cells[148]. Financial Performance and Expenses - Total operating expenses for Q2 2024 were $14.7 million, an increase from $13.5 million in Q2 2023[174]. - Research and development expenses for Q2 2024 were $11.9 million, up from $10.3 million in Q2 2023, primarily due to increased personnel costs and manufacturing activities[174]. - The increase in personnel costs included $1.3 million for new consultants assisting with the Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA)[174]. - Manufacturing activities for ANAVEX2-73 saw an increase of approximately $2.6 million to support potential commercial use and the MAA[174]. - Expenditures on the ANAVEX3-71-SZ-001 clinical trial increased by $0.9 million compared to the previous period, with the trial commencing in Q2 2024[174]. - Total operating expenses for the nine-month period ended June 30, 2024, were $38.5 million, a decrease from $43.1 million in the same period of 2023[174]. - The company has not earned any revenue since its inception in 2004 and does not anticipate earning revenue until establishing alliances for product development[171]. - Operating costs primarily consist of research and development activities, including clinical trials and personnel-related costs[172]. - General and administrative expenses include costs for outside professional services and compliance as a public company[173]. - Research and development expenses for the nine months ended June 30, 2024, were $30.3 million, a decrease of approximately 10.3% from $33.7 million for the same period in 2023[176]. - General and administrative expenses for the three months ended June 30, 2024, were $2.9 million, down from $3.2 million in the same quarter of 2023, reflecting a reduction in stock-based compensation charges[182]. - Net loss for the three months ended June 30, 2024, was $12.2 million, or $0.14 per share, compared to a net loss of $11.3 million, or $0.14 per share in the same quarter of 2023[182]. - The company had net current assets of $141.5 million as of June 30, 2024, a decrease of approximately $12.9 million from $154.4 million at the end of September 2023[183]. - Cash utilized in operations during the first nine months of fiscal 2024 was $24.2 million, compared to $21.9 million in the same period of fiscal 2023, indicating an increase in operational cash expenses[184]. - The company issued 2,455,646 shares of Common Stock under the 2023 Purchase Agreement during the nine-month period ended June 30, 2024, raising $11.3 million[194]. - The company expects an increase in research and development expenditures as it advances clinical programs, including ANAVEX3-71 for schizophrenia and ANAVEX2-73 for Parkinson's disease[180]. - Other income for the nine months ended June 30, 2024, was $7.3 million, an increase from $5.8 million in the comparable period of 2023, primarily due to higher interest income[181]. - Total research and development costs for the three months ended June 30, 2024, were $11.9 million, compared to $10.3 million in the same period of 2023, reflecting a year-over-year increase[178]. Regulatory and Intellectual Property - The company is focused on obtaining regulatory approvals and successfully commercializing its product candidates, with an emphasis on maintaining intellectual property protection[84]. - The company holds ownership or exclusive rights to twenty-five U.S. patents and various patent applications related to its drug candidates[162]. - The company prepares its financial statements in accordance with generally accepted accounting principles in the United States[199]. - There have been no significant changes in critical accounting policies since the last annual report filed on November 27, 2023[199]. - There have been no material changes in market risk exposure compared to the previous annual report[202]. Market Context - The Alzheimer's Association estimates that by 2024, 6.9 million Americans will suffer from Alzheimer's disease, with new cases projected to double by 2050[152].

Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Aug. 06, 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 Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fiscal ...

NEW YORK, Aug. 01, 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 Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome and other central nervous system (CNS) diseases, today announced that it will issue financial results for its fiscal quarter ended June 30, 2024, on Tuesda ...

ANAVEX®2-73 corrects directly to humans' translatable EEG biomarkers in a model of Fragile X Syndrome (FXS) Therapeutic potential to address behavioral and cognitive deficits in individuals with neurodevelopmental disorders Plans advancing to initiate a clinical trial in individuals with FXS NEW YORK, July 30, 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 Al ...

ANAVEX®2-73 corrects directly to humans’ translatable EEG biomarkers in a model of Fragile X Syndrome (FXS) Therapeutic potential to address behavioral and cognitive deficits in individuals with neurodevelopmental disorders Plans advancing to initiate a clinical trial in individuals with FXS NEW YORK, July 30, 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 A ...