NEW YORK, April 21, 2025 (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 Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman ...

NEW YORK, April 21, 2025 (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 Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman o ...

Core Viewpoint - The ATTENTION-AD trial data indicates that oral blarcamesine has a disease-modifying effect on chronic Alzheimer's disease, emphasizing the importance of early and continuous long-term treatment for patients [1][3][10]. Efficacy Data - Over three years of continuous treatment with blarcamesine showed significant clinical benefits for early Alzheimer's disease patients, as measured by clinical endpoints ADAS-Cog13 and ADCS-ADL [1][3]. - The delayed-start analysis revealed a significant difference in cognitive function between early and late treatment groups, with a LS mean difference of -3.83 for ADAS-Cog13 (P = 0.0165) and +4.30 for ADCS-ADL (P = 0.0206) at Week 192 [6][7]. - Continuous treatment without interruption resulted in improved cognitive and functional outcomes, with LS mean differences of -4.20 for ADAS-Cog13 (P = 0.0083) and +5.75 for ADCS-ADL (P = 0.0015) at Week 192 [9][10]. Safety Data - Blarcamesine exhibited a favorable safety profile, with most adverse events being mild to moderate and manageable through adjusted titration schedules [11][12]. - No severe or life-threatening adverse events were reported, and there were no treatment-related deaths [2][11]. - The frequency of dizziness, the most common treatment-emergent adverse event, decreased significantly from 25.2% in the previous trial to 9.6% in the ATTENTION-AD trial [12]. Compassionate Use - Currently, 74 participants are receiving blarcamesine through a Compassionate Use Program, with some individuals on treatment for over 9 years without severe adverse events [14]. Industry Implications - The results from the ATTENTION-AD trial suggest a potential shift towards more effective and patient-friendly Alzheimer's treatments, addressing disparities in care within global healthcare systems [4][15]. - The findings support the notion that early diagnosis and treatment can lead to greater clinical benefits for Alzheimer's patients, which may enhance the quality of life for patients and their families [15].

Core Insights - The ATTENTION-AD trial data presented at the AD/PDTM 2025 Conference indicates that oral blarcamesine has a disease-modifying effect and emphasizes the importance of early and continuous long-term treatment for chronic Alzheimer's disease [1][3][10] Efficacy Data - Continuous treatment with blarcamesine for up to four years showed a favorable safety profile with no treatment-related deaths and no serious neuroimaging adverse events [2][11] - The delayed-start analysis demonstrated a significant difference in cognitive function between early and late treatment groups, with an LS mean difference of -3.83 for ADAS-Cog13 (P = 0.0165) and +4.30 for ADCS-ADL (P = 0.0206) at Week 192 [6][7] - Patients who started treatment earlier exhibited greater stability in cognitive function compared to those who delayed treatment by approximately one year [6][10] - The analysis confirmed that continuous treatment without interruption led to improved outcomes in both cognition and function, with LS mean differences of -4.20 (P = 0.0083) for ADAS-Cog13 and +5.75 (P = 0.0015) for ADCS-ADL at Week 192 [9][10] Safety Data - Blarcamesine was associated with mostly mild to moderate adverse events, primarily during the initial titration phase, and no severe or life-threatening adverse events were reported [11][12] - The frequency of dizziness, the most common treatment-emergent adverse event, decreased significantly from 25.2% in the previous trial to 9.6% in the ATTENTION-AD trial, indicating better management of side effects [12] Compassionate Use - Currently, 74 participants are receiving blarcamesine through a Compassionate Use Program, with some individuals having been on the treatment for over nine years without severe adverse events [14] Industry Implications - The results suggest a potential shift towards more effective and patient-friendly Alzheimer's treatments, addressing disparities in care within global healthcare systems [4][15] - The findings support the notion that early diagnosis and treatment can lead to greater clinical benefits for patients with Alzheimer's disease [4][15]

NEW YORK, March 31, 2025 (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 present at the 24th Annual Needham Virtual Healthcare Conference, April 7 – 10, 2025. C ...

Core Insights - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for various CNS disorders, including Alzheimer's disease and Parkinson's disease [1][3] - The company will present at the 45th Annual TD Cowen Health Care Conference on March 3, 2025, with CEO Christopher U Missling scheduled to speak [1][2] Company Overview - Anavex Life Sciences Corp. is publicly traded on Nasdaq under the ticker AVXL and is dedicated to developing novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders [3] - The lead drug candidate, ANAVEX2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and has shown potential in treating Parkinson's disease dementia and Rett syndrome [3] - ANAVEX2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, with preclinical studies indicating its potential to halt or reverse Alzheimer's disease [3] - The company is also developing ANAVEX3-71, which targets SIGMAR1 and M1 muscarinic receptors, showing promise in addressing cognitive deficits and other hallmarks of Alzheimer's disease in preclinical trials [3]

I covered Anavex Life Sciences Corp. (NASDAQ: AVXL ) in December, after which, I note with some surprise (given the stock’s generally lackluster performance last year), that the stock jumped over 50% between late December and early January. The basis forAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curate ...

Group 1 - Anavex Life Sciences Corp. (NASDAQ: AVXL) published data from its phase 2b/3 study on blarcamesine for treating early Alzheimer's Disease in The Journal of Prevention of Alzheimer's Disease [2] - The study results are significant for the pharmaceutical industry, particularly in the Alzheimer's treatment sector, as they may influence future research and investment strategies [2] Group 2 - The Biotech Analysis Central service offers extensive resources for investors, including a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The service aims to assist healthcare investors in making informed decisions through deep analysis and live chat features [2]

Financial Data and Key Metrics Changes - The cash position at December 31 was $120.8 million with no debt [17] - Cash utilized in operating activities during the quarter was $12.1 million, indicating a runway of approximately four years at the current cash utilization rate [17][18] - General and administrative expenses increased to $3.1 million from $2.7 million year-over-year [18] - Research and development expenses rose to $10.4 million from $8.7 million year-over-year [18] - The company reported a net loss of $12.1 million for the quarter, equating to $0.14 per share [18] Business Line Data and Key Metrics Changes - The company is advancing a novel precision medicine treatment for early Alzheimer disease, with significant clinical benefits demonstrated in trials [10][12] - The Phase 2b/3 ATTENTION-AD trial showed that blarcamesine significantly reduced clinical decline by 36.3% at 48 weeks [12][78] - A new U.S. patent was issued for a composition of matter related to blarcamesine, expected to remain in force until at least July 2039 [13][79] Market Data and Key Metrics Changes - The company is receiving growing support from stakeholders, including advocacy groups, for its Alzheimer treatment [10][36] - There is ongoing interest from pharmaceutical companies regarding potential partnerships for marketing the drug [39][105] Company Strategy and Development Direction - The company aims to focus on execution and commercial readiness while advancing its therapeutic pipeline [132] - Plans include submitting for approvals in other jurisdictions such as the UK, Canada, and Australia, expanding beyond the EMA [66][130] - The company is prioritizing the Alzheimer program while planning further studies for Rett syndrome [110][108] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of blarcamesine on Alzheimer disease treatment, highlighting its oral administration and safety profile [10][20] - The company is preparing for a review process expected to take 210 days, with feedback anticipated by the end of the year [25][94] - Management noted that the ongoing discussions with stakeholders and advocacy groups are encouraging due to the unmet need in Alzheimer treatment [36][102] Other Important Information - The company has a compassionate use program for 74 participants who continue to take the study drug, with no reported deaths associated with the drug [119] - The recent patent issuance is significant as it protects the composition of matter used in prior clinical studies [112][113] Q&A Session Summary Question: Timeline for feedback from Europe - The review is expected to take 210 days since filing, with feedback anticipated by the end of the year [25][94] Question: Discussion about priority review - The company filed without prime status due to unmet need, which affects the possibility of a priority review [96] Question: Upcoming events - The company expects the ANAVEX3-71 schizophrenia readout in the first half of the year and a scientific presentation at the AD/PD conference in April [30][32] Question: Support from pharmaceutical companies - Ongoing discussions with pharmaceutical companies were initiated last month, and the company has sufficient supply for market entry [105] Question: Status of Rett syndrome - The company plans to conduct another study for Rett syndrome due to the small sample size in the previous trial [108] Question: Significance of the crystalline patent - The patent is significant as it protects the composition used in all prior clinical studies, expiring in July 2039 [112][113] Question: Update on Parkinson's program - Updates on the Parkinson's program will be provided shortly following interactions with regulatory bodies [115] Question: FDA status for blarcamesine - The company plans to have a meeting with the FDA to discuss the recommended procedure for proceeding with Alzheimer disease [117] Question: OLE patients still on the drug - Participants in the open-label extension study continue to take the drug, and the company will follow up for real-world evidence [119]

Drug Development and Clinical Trials - Anavex Life Sciences Corp. is focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, and other CNS disorders, with two core programs and two seed programs currently in various stages of clinical and preclinical development[83][84]. - The Phase 2b/3 trial of ANAVEX2-73 (blarcamesine) in early Alzheimer's disease enrolled 508 patients and demonstrated a significant slowing of clinical progression by 36.3% in the 50 mg group and 34.6% in the 30 mg group compared to placebo at Week 48[96]. - The trial's primary endpoint, ADAS-Cog13, showed significant improvement with blarcamesine (−2.027; P = 0.0079) compared to placebo, while the key secondary endpoint CDR-SB also showed significant improvement (−0.483, P = 0.0104)[96]. - Anavex submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ANAVEX2-73 for Alzheimer's treatment in November 2024, which was accepted for scientific review in December 2024[98]. - A long-term open label extension study (ATTENTION-AD) for ANAVEX2-73 demonstrated continued benefits for up to 4 years, with no new safety findings observed[99]. - The genomic analysis in clinical trials identified that excluding patients with the SIGMAR1 biomarker variant (10%-20% of the population) could help identify 80%-90% of patients likely to show significant improvement[90]. - The Phase 2a clinical trial for ANAVEX2-73 in mild-to-moderate Alzheimer's patients met both primary and secondary endpoints, establishing a concentration-effect relationship[91]. - The Phase 2 trial of ANAVEX2-73 for Rett syndrome showed that 66.7% of treated subjects had a statistically significant improvement in the Rett Syndrome Behaviour Questionnaire (RSBQ) compared to 10% in the placebo group (p = 0.011)[103]. - The AVATAR trial met all primary and secondary efficacy endpoints, with significant improvements in RSBQ response (p = 0.037) and Anxiety, Depression, and Mood Scale (ADAMS) (p = 0.010)[105]. - The EXCELLENCE trial in pediatric patients showed a LS Mean improvement of -12.93 points on the RSBQ total score for ANAVEX2-73-treated patients compared to -8.32 points in placebo (p=0.063)[108]. - The Phase 2 trial for Parkinson's disease dementia enrolled approximately 132 patients and demonstrated clinically meaningful improvements in the MDS-UPDRS total score after 14 weeks of treatment[114]. - The ANAVEX2-73-PDD-EP-001 OLE trial showed consistent improvement in efficacy endpoints during the extension phase, indicating the drug's potential in managing Parkinson's disease symptoms[117]. - Preliminary results from the ANAVEX3-71-SZ-001 trial indicated a dose-dependent effect on EEG biomarkers in schizophrenia, reversing known abnormalities associated with the condition[126]. - The company intends to advance ANAVEX3-71 into a biomarker-driven clinical development program targeting schizophrenia, frontotemporal dementia, and Alzheimer's disease[124]. - ANAVEX2-73 has shown significant and dose-related improvements in behavioral paradigms in the MECP2 HET Rett syndrome disease model[132]. - ANAVEX3-71 is an orally available clinical drug candidate that enhances neuroprotection and cognition in Alzheimer's disease models[149]. - The Phase 1 clinical trial of ANAVEX3-71 met its primary and secondary endpoints of safety, with no serious adverse events or dose-limiting toxicities observed[152]. - ANAVEX1-41 has shown significant neuroprotective benefits through the modulation of endoplasmic reticulum, mitochondrial, and oxidative stress[155]. - ANAVEX1066 demonstrated rapid and significant restoration of nociceptive thresholds in preclinical models of neuropathic and visceral pain[158]. - The FDA granted Orphan Drug Designation to ANAVEX2-73 for the treatment of Rett syndrome and infantile spasms, and Fast Track designation for its clinical development program[133][134]. - ANAVEX2-73 has potential applications in other neurodegenerative diseases beyond Alzheimer's, Parkinson's, and Rett syndrome, including epilepsy and multiple sclerosis[143]. - ANAVEX1037 is in advanced pre-clinical studies, showing antitumor potential and selectively killing human cancer cells without affecting normal cells[159]. Financial Performance and Expenses - The company has not earned any revenue since its inception in 2004 and does not anticipate earning revenue until establishing alliances for product development[182]. - Total operating expenses for the three months ended December 31, 2024, were $13.6 million, an increase of 19.3% compared to $11.4 million for the same period in 2023[185]. - Research and development expenses for the three months ended December 31, 2024, were $10.4 million, up 19.5% from $8.7 million in the same period in 2023[186]. - General and administrative expenses increased to $3.1 million for the three months ended December 31, 2024, compared to $2.7 million in the same quarter of 2023, primarily due to higher legal and professional fees[188]. - Net loss for the three months ended December 31, 2024, was $12.1 million, or $0.14 per share, compared to a net loss of $8.6 million, or $0.11 per share, in the same quarter of 2023[190]. - Net cash used in operating activities for the three months ended December 31, 2024, was $12.1 million, an increase of 65.5% from $7.3 million in the comparable period in 2023[194]. - Current assets as of December 31, 2024, were $124.0 million, down from $135.6 million as of September 30, 2024[191]. - Net current assets decreased by approximately $9.3 million from September 30, 2024, primarily due to cash utilized in operations[192]. - Cash provided by financing activities for the three-month period ended December 31, 2024, was $0.7 million, compared to $0.06 million in the same period in 2023[195]. - As of December 31, 2024, $110.8 million remained available under the 2023 Purchase Agreement with Lincoln Park Capital Fund, LLC[202]. - The increase in research and development expenses was driven by a $1.5 million increase related to manufacturing activities for ANAVEX2-73 and a $1.5 million increase for expenditures on the ANAVEX3-71-SZ-001 clinical trial[187]. Market Projections - The Alzheimer's disease market is projected to double by 2050, with an estimated 6.9 million Americans suffering from the disease in 2024[162]. - The Parkinson's disease market is expected to reach $11.5 billion by 2029[162]. - The malignant melanoma market is projected to grow to $7.5 billion by 2029[163]. - The prostate cancer therapeutics market is expected to increase to nearly $10.1 billion by the end of 2030[169]. - The global pharmaceutical treatment market for pancreatic cancer is predicted to reach $3.7 billion by 2027[169]. - The global antidepressant drug market is projected to reach $21 billion by 2030[163]. Intellectual Property - The company holds ownership or exclusive rights to 26 issued U.S. patents and 19 pending U.S. patent applications[164]. Strategic Partnerships - The company is actively seeking strategic and commercial partners to advance its programs and increase stockholder value[161].