Core Viewpoint - Alzamend Neuro, Inc. is set to present its innovative research on AL001, a novel lithium-delivery system, at the Military Health System Research Symposium, highlighting its potential benefits for treating PTSD and other mental health disorders in military personnel and veterans [1][2]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [9]. - The company’s pipeline includes two main drug candidates: AL001, a patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine aimed at combating Alzheimer's [9]. Research Presentation Details - The poster presentation titled "Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate" will take place on August 6, 2025, at the Gaylord Palms Resort & Convention Center [4][5]. - The session will focus on innovations in military suicide prevention and related research [5]. Study Objectives - The study aims to quantify differences in lithium exposure in the brain versus plasma in PTSD subjects, comparing AL001 with traditional lithium carbonate [6]. - This research is part of a broader effort to create a composite database that includes data from various neurodegenerative and neuropsychiatric disorders [6]. AL001 Characteristics - AL001 is designed to provide the benefits of lithium while minimizing toxicities associated with conventional lithium salts, potentially improving safety and efficacy [7]. - Results from a completed Phase IIA study indicated a maximum tolerated dose that does not require therapeutic drug monitoring, suggesting a favorable safety profile [7]. Clinical Trials - Alzamend initiated the first of five Phase II clinical studies of AL001 in May 2025, focusing on healthy human subjects to establish baseline data for future studies in patients with Alzheimer's, BD, MDD, and PTSD [8]. - Previous animal studies indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, which could lead to safer treatments [8].

Core Insights - Alzamend Neuro, Inc. has initiated its first Phase II clinical study of AL001, targeting conditions such as Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [1][4] - The study aims to evaluate AL001's ability to deliver lithium more effectively in the brain compared to existing lithium salts, with a focus on safety and reduced side effects [2][5] Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6] - The company's pipeline includes two main candidates: AL001, a lithium-delivery system, and ALZN002, a cell-based therapeutic vaccine targeting Alzheimer's [6] Product Details - AL001 is designed to provide the benefits of lithium while minimizing toxicities associated with traditional lithium therapies, potentially eliminating the need for therapeutic drug monitoring [3][5] - Previous studies indicate that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, which could lead to safer treatment options [2][5] Clinical Study Insights - The Phase II study will involve healthy human subjects to establish a baseline for AL001's effectiveness and safety profile [2][4] - Topline data from the study is expected by the end of the year, with plans for head-to-head comparisons against marketed lithium carbonate products [4][9]

Core Viewpoint - Alzamend Neuro is set to initiate a phase II clinical study of AL001 for PTSD treatment in Q4 2025, following the successful completion of a key component for the trial [1][2]. Group 1: Clinical Development - The phase II study will be conducted in collaboration with Massachusetts General Hospital, focusing on AL001's unique properties and its effects on lithium delivery in the brain compared to existing lithium salts [2]. - Previous studies in mice indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, potentially leading to safer treatments [2][5]. Group 2: Treatment Implications - AL001 could eliminate the need for lithium therapeutic drug monitoring (TDM), which has historically complicated the use of lithium in treating bipolar disorder and PTSD [3]. - Current lithium salts have a narrow therapeutic window requiring regular monitoring, which limits their use; however, low doses of lithium carbonate have shown effectiveness in alleviating symptoms in PTSD patients [3][4]. Group 3: Market Potential - The introduction of AL001 could significantly enhance treatment options for over 9 million Americans suffering from PTSD, potentially reshaping treatment paradigms and improving patient quality of life [4]. - AL001 is designed to provide the benefits of marketed lithium salts while reducing associated toxicities, thus addressing the limitations of current lithium therapies [5]. Group 4: Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer's, bipolar disorder, major depressive disorder, and PTSD [6]. - The company's pipeline includes AL001, a novel lithium-delivery system, and ALZN002, a cell-based therapeutic vaccine aimed at combating Alzheimer's disease [6].