Oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events Clinical benefit of blarcamesine consistently observed for both 30 mg and 50 mg treatment groups Benefits of blarcamesine on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer's disease EMA submission expected in Q4 NEW YORK, July 28, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ...

Oral, once daily blarcamesine significantly slowed clinical decline for early Alzheimer's disease patients with good comparative safety profile and no associated neuroimaging adverse events Clinical benefit of blarcamesine consistently observed for both 30 mg and 50 mg treatment groups Benefits of blarcamesine on both amyloid-beta and brain volume, two underlying pathological hallmarks of Alzheimer’s disease EMA submission expected in Q4 NEW YORK, July 28, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ...

NEW YORK, June 20, 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, neurodevelopmental and neuropsychiatric disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Ana ...

NEW YORK, June 20, 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, neurodevelopmental and neuropsychiatric disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of An ...

NEW YORK, May 22, 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, neurodevelopmental, and neuropsychiatric disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced the addition and appointment of new senior team members with a track record of ...

Anavex Life Sciences (AVXL) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changin ...

Clinical Development and 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[85]. - The Phase 2b/3 trial of ANAVEX2-73 enrolled 509 patients and demonstrated a 45% reduction in cognitive decline compared to placebo, with a mean score difference of -1.85 points (p=0.033) on the ADAS-Cog scale[95]. - Patients treated with ANAVEX2-73 had 1.84 times higher odds of cognitive improvement compared to placebo, with an ADAS-Cog score threshold change of -0.5 points or better (Odds Ratio = 1.84, p = 0.015)[95]. - The treatment also showed a 27% reduction in clinical decline of cognition and function compared to placebo, with a mean score difference of -0.42 points (p=0.040) on the CDR-SB scale[95]. - In September 2023, additional data indicated significant reductions in pathological amyloid beta levels and brain atrophy rates in patients treated with ANAVEX2-73, with a P-value of 0.0005 for whole brain volume loss[97]. - The ongoing ATTENTION-AD trial is an open-label extension study for patients who completed the Phase 2b/3 trial, evaluating the long-term safety and efficacy of ANAVEX2-73 over an additional 96 weeks[99]. - 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) [102]. - 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 [105]. - The EXCELLENCE trial for pediatric patients demonstrated an LS Mean improvement of -12.93 points on RSBQ for ANAVEX2-73-treated patients compared to -8.32 points for placebo (p = 0.063) [108]. - In the EXCELLENCE trial, ANAVEX2-73-treated patients showed a statistically significant improvement at 4 weeks with an LS Mean difference of -4.65 points (p = 0.041) [108]. - The Phase 2 trial for Parkinson's disease dementia enrolled approximately 132 patients and demonstrated clinically meaningful improvements in MDS-UPDRS total score after 14 weeks [114]. - The 48-week Open Label Extension trial for Parkinson's disease showed consistent improvement across efficacy endpoints after resuming ANAVEX2-73 treatment [116]. - ANAVEX2-73 has shown significant and dose-related improvements in behavioral paradigms in the MECP2 HET Rett syndrome disease model[130]. - The Phase 2 trial for ANAVEX2-73 in Parkinson's disease dementia enrolled approximately 132 patients for 14 weeks, randomized 1:1:1 to two different doses of 30mg and 50mg, or placebo[132]. - ANAVEX2-73 demonstrated clinically meaningful, dose-dependent, and statistically significant improvements in the CDR computerized assessment system analysis[133]. - In a transgenic Alzheimer's disease animal model, ANAVEX2-73 induced a statistically significant neuroprotective effect against oxidative stress and improved functional and synaptic plasticity markers[134]. - The Phase 2a clinical trial for ANAVEX2-73 in Alzheimer's disease met both primary and secondary objectives with 32 patients[137]. - Genetic analysis in the Phase 2a trial identified that participants with the common SIGMAR1 wild type gene variant (approximately 80% of the population) showed improved cognitive and functional scores[138]. Financial Performance - Total operating expenses for Q1 2024 were $12.5 million, down from $14.2 million in Q1 2023, representing a decrease of approximately 12%[176]. - Research and development expenses for Q1 2024 were $9.7 million, compared to $11.3 million in Q1 2023, indicating a reduction of about 14%[176]. - Total operating expenses for the six-month period ended March 31, 2024, were $23.8 million, down from $29.6 million in the same period of 2023, a decrease of approximately 20%[176]. - Research and development expenses for the six-month period ended March 31, 2024, were $18.4 million, compared to $23.4 million in the same period of 2023, reflecting a decline of about 21%[176]. - The decrease in research and development expenses was primarily due to a reduction in stock-based compensation expense of $1.0 million in Q1 and $3.3 million in the six-month period[176]. - The company has not earned any revenue since its inception in 2004 and does not anticipate earning revenue until establishing alliances for product development or marketing[172]. - The net loss for the three months ended March 31, 2024, was $10.5 million, or $0.13 per share, compared to a net loss of $13.1 million, or $0.17 per share in the same quarter of 2023, reflecting a 20% reduction in loss[184]. - Cash utilized in operations during the first six months of fiscal 2024 was $19.0 million, compared to $14.3 million in the same period of fiscal 2023, representing a 33% increase[186]. - The net amount of other income for the three months ended March 31, 2024, was $2.1 million, up from $1.1 million in the same period of 2023, marking a 91% increase[183]. - Total research and development costs for the six months ended March 31, 2024, were $18.4 million, down from $23.4 million in the same period of 2023, a decrease of 21%[178]. - Cash provided by financing activities for the six-month period ended March 31, 2024, was $7.3 million, compared to $18.6 million in the same period of 2023, a decline of 61%[191]. - The company had net current assets of $144.5 million as of March 31, 2024, a decrease of $10.0 million from September 30, 2023[185]. - The company expects an increase in research and development expenditures as it advances clinical programs, including trials for Alzheimer's and Rett syndrome[182]. - As of March 31, 2024, the company had $114.7 million remaining available under the 2023 Purchase Agreement with Lincoln Park Capital[198]. Market Potential - The global malignant melanoma market is expected to grow to $7.5 billion by 2029, while the prostate cancer drug therapeutics market is projected to reach nearly $10.1 billion by the end of 2030[162]. - The global antidepressant drug market is projected to reach $21 billion by 2030, indicating significant growth potential in the sector[159]. - The market for the global pharmaceutical treatment of pancreatic cancer is expected to increase to $3.7 billion by 2027[163]. Research and Development Initiatives - The company holds ownership or exclusive rights to 25 U.S. patents and various patent applications related to its drug candidates and research programs[165]. - The proprietary SIGMACEPTOR™ Discovery Platform aims to develop therapeutics targeting sigma receptors for neurodegenerative and neurodevelopmental diseases[127]. - ANAVEX3-71 is advancing into a biomarker-driven clinical development program targeting schizophrenia, frontotemporal dementia, and Alzheimer's disease [124]. - ANAVEX3-71 demonstrated significant reduction in cognitive deficits and amyloid beta pathology in aged transgenic animal models[146]. - ANAVEX1-41 showed significant neuroprotective benefits through modulation of endoplasmic reticulum, mitochondrial, and oxidative stress[149].

Anavex Life Sciences Corp. (NASDAQ:AVXL) Q2 2024 Earnings Conference Call May 9, 2024 8:30 AM ET Company Participants Dr. Christopher Missling - President and CEO Sandra Boenisch - Principal Financial Officer Conference Call Participants Soumit Roy - Jones Research Ram Selvaraju - H.C. Wainwright Tom Bishop - BI Research Operator Good morning. And welcome to the Anavex Life Sciences Fiscal 2024 Second Quarter Conference Call. My name is Clint Tomlinson, and I will be your host for today’s call. At this time ...

EXHIBIT 99.1 Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK – May 9, 2024 – Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental and neuropsychiatric disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome, sch ...

Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 09, 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, neurodevelopmental and neuropsychiatric disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today reported financial results for i ...