Alzamend Neuro, Inc. filed a Current Report on Form 8-K dated September 29, 2026, announcing that Dr. Ovidiu C. Andronesi, the principal investigator on the company’s Phase 1/2A Clinical Trial, presented findings at the International Society for MR Radiographers & Technologists (ISMRT) Conference. The presentation, included as Exhibit 99.1, details the results of a study investigating the brain pharmacokinetics of AL001, a novel organic co-crystal containing lithium salicylate and L-proline.

The study compares AL001 to inorganic lithium carbonate (Li2CO3), the current standard treatment for bipolar disorder, which is often used for major depressive disorder, schizophrenia, and Alzheimer’s disease. The presentation notes that the clinical utility of inorganic lithium salts is constrained by a narrow therapeutic window, requiring careful monitoring to manage renal, thyroid, and systemic toxicity risks.

The clinical trial design involved 30 participants across five groups: 6 healthy individuals, 6 with bipolar disorder, 6 with major depression, 6 with Alzheimer’s disease, and 6 with PTSD. The study utilized a randomized, longitudinal, cross-over design where all participants received both treatments, AL001 and Li2CO3, for 14 days each.

Imaging was conducted using a 7 Tesla Terra.X MRI scanner (Siemens Healthineers) equipped with a dual-tuned 7Li/1H coil. The researchers utilized a 3D radial balanced SSFP pulse sequence to image lithium concentration in the brain. Image processing involved super-resolution upsampling and absolute quantification.

The analysis indicates that 7 Tesla provides sufficient signal-to-noise ratio to quantify lithium concentration in the brain over a pharmacokinetic relevant range of 0.1 to 1 mM. Brain region analysis showed a trend for slightly higher lithium concentration after AL001 administration compared to Li2CO3. Specifically, the geometric mean lithium concentration in the brain was 4,020.64 ng/g for AL001 and 3,476.94 ng/g for Li2CO3.

Non-compartment pharmacokinetic modeling also showed a trend for a slightly higher Area Under the Curve (AUC) for AL001 (geometric mean 62,230 hr·ng/g) compared to Li2CO3 (geometric mean 59,715 hr·ng/g). However, the presentation notes that differences between the two treatments were not statistically significant, attributed to the small sample size. The authors state that the observed trends in the healthy cohort will generate hypotheses to be tested in subsequent patient cohorts.