• Topline data expected by year end
• Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects

Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the dosing of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.

In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.

By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current U.S. Food and Drug Administration-approved lithium salts are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. By reducing the systemic burden, Alzamend’s novel AL001 formulation could signify a major shift in managing conditions like Alzheimer’s, by minimizing risks associated with kidney and thyroid side effects traditionally linked to lithium therapies.

“The dosing of the first patient in our first Phase II trial of AL001 is another significant step forward in our goal to introduce a next-generation lithium treatment that offers enhanced safety, better central nervous system targeting, and eliminates the requirement for TDM,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “This advancement stands to potentially enhance the lives of over 43 million Americans suffering from Alzheimer’s, BD, MDD and PTSD. We expect to announce topline data from this study before the end of 2025.”