Investment Considerations
- AL001 is bioequivalent to marketed lithium carbonate but with improved brain targeting and reduced systemic exposure.
- Five Phase II trials for AL001 are underway or planned, targeting a broad range of neuropsychiatric indications.
- Partnership with Massachusetts General Hospital and QMENTA enhances scientific rigor and operational scale.
- ALZN002 offers a first-in-class, adjuvant-free vaccine approach to Alzheimer’s immunotherapy.
- Alzamend holds global exclusive rights to key patents through at least 2036 for both AL001 and ALZN002.
Alzamend Neuro Inc. (NASDAQ: ALZN) is a clinical-stage biopharmaceutical company developing transformative therapies for Alzheimer’s disease, Bipolar Disorder (BD), Major Depressive Disorder (MDD), and Post-Traumatic Stress Disorder (PTSD). The company is committed to rapidly advancing safe, effective treatments that address critical unmet needs across these debilitating conditions. Its flagship Alzheimer’s program reflects its broader mission to deliver hope to patients and families — a vision captured in its rallying call to “Make Alzheimer’s Just a Memory™.”
With hundreds of millions of people worldwide affected by the neurological and psychiatric conditions Alzamend targets, the company aims to fundamentally reshape how these disorders are treated. Rather than incremental improvements, it focuses on breakthroughs in safety, tolerability, and long-term efficacy — including eliminating burdens like therapeutic drug monitoring. Its programs are supported by exclusive worldwide licenses from the University of South Florida and developed in collaboration with leading clinical and technology partners.
In 2025, Alzamend began executing a multi-trial Phase II clinical program for its lead candidate AL001, working alongside Massachusetts General Hospital and imaging AI partner QMENTA. These efforts represent a critical inflection point in the company’s path to delivering next-generation therapies.
The company is headquartered in Atlanta, Georgia.
Pipeline
AL001 (LISPRO®) is a patented ionic cocrystal formulation of lithium, proline, and salicylate, targeting Alzheimer’s, BD, MDD, and PTSD. It has shown superior brain penetration and safety in preclinical studies, with Phase I and Phase IIA trials confirming bioequivalence to marketed lithium carbonate with fewer systemic effects. The first of five planned Phase II trials began in Q2 2025, with topline data expected by year-end. These trials — supported by Tesla Dynamic Coils BV’s novel head coil technology — are evaluating lithium distribution in the brain versus blood in healthy subjects.
ALZN002 (E22W) is a patient-specific immunotherapy that uses autologous dendritic cells pulsed with a mutant amyloid-beta peptide to elicit an immune response against Alzheimer’s-related plaque. The Phase I/IIA trial, initiated in March 2023, is designed to measure safety, tolerability, and immunogenicity. Though paused in February 2024, the study is expected to resume in 2025. Non-clinical data show strong and sustained antibody production without inflammatory cytokine activation.
Market Opportunity
Alzamend is addressing a combined U.S. patient population of more than 43 million individuals living with Alzheimer’s, BD, MDD, or PTSD, and a global population exceeding 660 million. The economic burden is staggering. In 2023, the U.S. cost of Alzheimer’s and other dementias alone was estimated at $345 billion, with projections rising to $1.1 trillion by 2050 without effective treatment breakthroughs. BD and MDD are leading causes of disability worldwide, while PTSD continues to affect millions annually, particularly among veterans. These disorders are associated with high levels of functional impairment, suicide risk, and treatment resistance.
Despite decades of use, lithium-based therapies remain underutilized due to the narrow therapeutic window, toxicity concerns, and the requirement for intensive drug monitoring. Alzamend’s AL001 is specifically designed to overcome these barriers, offering a better-tolerated, brain-targeted lithium alternative. The company’s ability to tap into this large, underserved market with safer and more effective formulations gives it strong positioning across both psychiatry and neurology domains. ALZN002, meanwhile, addresses the urgent need for disease-modifying treatments in Alzheimer’s, where few therapeutic options exist beyond symptom management.
Leadership Team
Stephan Jackman, Chief Executive Officer and Director, brings over two decades of experience in biotechnology, operations, and product development, with a background spanning Novartis Pharmaceuticals, L’Oréal, and multiple emerging biotech firms. He joined Alzamend in 2018 and was appointed a director in 2020.
David J. Katzoff, Chief Financial Officer, has held financial leadership roles at Ault Alliance, Lumina Media, and Local Corporation. He joined Alzamend in 2019 and became CFO in 2022, bringing more than 30 years of experience in finance and operations.
Henry C.W. Nisser, Executive Vice President, General Counsel and Director, is a seasoned corporate attorney specializing in U.S. securities law, M&A, and corporate governance. He also holds executive roles at Ault Alliance and Avalanche, and previously practiced at Sichenzia Ross Ference LLP.
Kenneth S. Cragun, Senior Vice President of Finance, has served as CFO of multiple Nasdaq-listed companies and held senior roles at Deloitte and several technology firms. He joined Alzamend in 2018 and is currently CFO of Ault Alliance and audit chair of Verb Technology.