Alzamend Neuro® , Inc., (“Alzamend® ”), a Delaware corporation with its headquarters in Atlanta, Georgia, is a clinical-stage, biopharmaceutical company. At Alzamend, we are committed to “Making Alzheimer’s Just a Memory™ ” as well as developing effective treatments for psychiatric disorders which affect over 600 million people globally. Our mission is to rapidly develop and market safe and effective treatments. We are driven by the belief that strong support of research is the foundation for true innovation and uniquely position us to understand and effectively address the unmet needs of the patients we serve. Alzamend strives to provide hope through the commercialization of existing patented intellectual properties and know-how while simultaneously funding future treatments for other neurodegenerative diseases and psychiatric disorders, through advanced research and development.

Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and ALZN002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Our lead product candidate (AL001) that we have licensed and have begun clinical development in humans for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our preclinical data for AL001 treatment showed prevention of cognitive deficits, depression and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning, memory, and irritability, compared with lithium carbonate treatments. On September 11, 2021, a first-in-human Phase I six-month clinical trial for AL001 commenced with the first patients dosed. Topline data for AL001 was reported on December 17, 2021, and the full data set was released in March 2022. The data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were observed to be well-tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign. In May 2022 we initiated our Phase II multiple-ascending dose study in Alzheimer’s patients and completed the clinical portion of the trial in March 2023. Topline data announced in June 2023. In July 2022 we received written response from the U.S. Food and Drug Administration (the “FDA”) regarding our meeting request relating to its Type B Pre-Investigational New Drug (“IND”) application. The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for the treatment of Bipolar Disorder, MDD and PTSD. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data.

ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“DCs”), which are activated white blood cells taken from each individual patient that are then engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s; the goal of this treatment approach is to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. In October 2022 we received a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for a phase I/IIA clinical trial under its Investigational New Drug (“IND”) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. We initiated the Phase I/IIA clinical trial in March 2023.