• 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

ATLANTA, May 07, 2025 (GLOBE NEWSWIRE) -- 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 its partnership with Mint Labs Inc. d/b/a QMENTA (“QMENTA”), a leading medical imaging artificial intelligence (“AI”) company, to support its five upcoming Phase II clinical trials of AL001 at Massachusetts General Hospital.

QMENTA’s cloud-based platform will manage and analyze medical imaging data throughout the trials, ensuring regulatory compliance, enhancing operational efficiency and supporting data management. Their advanced AI solutions will play a critical role in optimizing the imaging workflow across all five clinical studies.

In collaboration with QMENTA and 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.

“QMENTA has developed an all-in-one management platform for medical imaging clinical trials incorporating advancing AI solutions,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are thrilled to add QMENTA to the team and have full confidence in their ability encompassing our five phase II clinical studies of AL001. Moreover, this collaboration lays a foundation for future phase III programs and broader clinical deployment of advanced AI-based imaging biomarkers.”

“It’s a privilege to collaborate with Alzamend on such groundbreaking work. I truly believe that the right imaging strategy combined with innovative compounds like AL001 will transform how we treat complex neurodegenerative diseases and psychiatric disorders,” said Vesna Prchkovska, Chief Executive Officer of QMENTA. “By applying AI-driven imaging technologies, we believe we can advance safer, more effective treatments that could significantly impact patients with Alzheimer’s, BD, MDD, PTSD, among other diseases.”

About Alzamend Neuro

Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, 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 by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

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