ALZN News & Events

Alzamend Neuro announced positive topline data from its first Phase II "Lithium in Brain" clinical trial in healthy human subjects, demonstrating that AL001 meets bioequivalence standards while also showing numerically superior lithium delivery to the brain compared to standard lithium carbonate across all 26 measured brain regions including whole brain. These results suggest a promising differentiated pharmacological profile with significant implications for patients with Alzheimer's, BD, MDD and PTSD. The trial was conducted at Massachusetts General Hospital and represents a meaningful clinical and regulatory advance for AL001. Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonate. Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brain. Faster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate.

Alzamend Neuro announced the initiation of its Phase II clinical trial evaluating AL001 in patients diagnosed with BD type 1. The trial is being conducted at Massachusetts General Hospital and represents a significant step toward advancement of AL001 as a potentially safer and more effective lithium-based therapy. This Phase II study builds upon Alzamend's prior "Lithium in Brain" clinical trial in healthy subjects, for which the clinical portion was completed in November 2025. Topline data from that study are expected by the end of March 2026. Following completion in healthy volunteers, Alzamend and MGH are now expanding the program to subjects with BD type I, with plans to also initiate further trials in the near future in MDD, Alzheimer's and PTSD.

Alzamend Neuro will have a poster presentation at the Military Health System Research Symposium, being held from August 4-7, 2025, in Orlando, Florida. Title: Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate: Summary: The current study is designed to quantitate differences in lithium brain-to-plasma exposure in PTSD subjects between AL001 and lithium carbonate for the purpose of contributing to a composite database of analogously studied brain-plasma assessments that include data from healthy subjects and multiple additional neurodegenerative, neurological and neuropsychiatric disorders. Currently, AL001 is targeted for treatment of Alzheimer's, BD type 1, MDD and PTSD. It's anticipated that this study design may help target appropriate AL001 lithium systemic dosing for these indications in future studies. Using this study design, comparable target organ lithium concentrations may be quantitated between AL001 and lithium carbonate and, by equivalence inference, lithium citrate solution and syrup.

Alzamend Neuro reported its financial results for the year ended April 30, 2025, which were disclosed on an annual report on Form 10-K filed on July 22, 2025, with the Securities and Exchange Commission. Alzamend has strengthened its financial position, reflecting a strategic focus on fiscal prudence and effective capital management. Key financial highlights include: Net cash provided by financing activities of $10.4 million for the year ended April 30, 2025; Stockholder equity of $3.9 million at April 30, 2025, compared to a stockholder deficit of $2.6 million at April 30, 2024; Cash of $3.9 million at April 30, 2025, compared to $0.4 million at April 30, 2024; and Total liabilities of $0.6 million at April 30, 2025, compared to $3.2 million at April 30, 2024. "The successful completion of this Financing, months ahead of schedule, reflects confidence in our mission and strong belief in our vision," said Stephan Jackman, Chief Executive Officer of Alzamend. "The capital raised will be used to support the five Phase II clinical trials of AL001 "Lithium in Brain" Studies in partnership with Massachusetts General Hospital and Harvard Medical School."