Alzamend Neuro: Brain lithium gap not significant
The presentation says observed differences between AL001 and lithium carbonate were not statistically significant, in line with the small sample size.
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Rhea-AI Filing Summary
Alzamend Neuro, Inc. furnished a presentation by Dr. Ovidiu C. Andronesi, principal investigator on its Phase 1/2A clinical trial, for presentation at the September 29, 2026 International Society for MR Radiographers & Technologists Conference. The presentation describes a 30-participant trial design comparing AL001 with lithium carbonate (Li₂CO₃).
In the healthy cohort, it reports a geometric mean brain lithium concentration of 4,020.64 ng/g with AL001 versus 3,476.94 ng/g with Li₂CO₃, and non-compartmental AUC values of 62,230 h*ng/g versus 59,715 h*ng/g. The presentation says the differences were not statistically significant, in line with the small sample size, and that the observed trends will be tested in subsequent patient cohorts.
8-K Event Classification
Key Figures
Key Terms
Pharmacokinetics medical
co-crystal technical
AUC medical
lower limit of quantitation medical
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 29, 2026, Dr. Ovidiu C. Andronesi, principal investigator on Alzamend Neuro, Inc.’s Phase 1/2A Clinical Trial, Director of Multinuclear MRI, Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School, will presented at the International Society for MR Radiographers & Technologists (ISMRT) Conference. A copy of the presentation, which is furnished herewith as Exhibit 99.1, is incorporated by reference herein.
In accordance with General Instruction B.2 of Form 8-K, the information under this item and Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing. This report will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
The Securities and Exchange Commission encourages registrants to disclose forward-looking information so that investors can better understand the future prospects of a registrant and make informed investment decisions. This Current Report on Form 8-K and exhibits may contain these types of statements, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and which involve risks, uncertainties and reflect the Registrant’s judgment as of the date of this Current Report on Form 8-K. Forward-looking statements may relate to, among other things, operating results and are indicated by words or phrases such as “expects,” “should,” “will,” and similar words or phrases. These statements are subject to inherent uncertainties and risks that could cause actual results to differ materially from those anticipated at the date of this Current Report on Form 8-K. Investors are cautioned not to rely unduly on forward-looking statements when evaluating the information presented within.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits: |
| Exhibit No. | Description | |
| 99.1 | ISMRT Presentation | |
| 101 | Pursuant to Rule 406 of Regulation S-T, the cover page is formatted in Inline XBRL (Inline eXtensible Business Reporting Language). | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101). |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ALZAMEND NEURO, INC. | ||
| Dated: September 29, 2026 |
s/ David J. Katzoff |
|
| David J. Katzoff | ||
| Chief Financial Officer | ||
Exhibit 99.1
DEPARTMENT OF RADIOLOGY Pharmacokinetics imaging of lithium at 7T – results from a phase 1/2A clinical trial with a novel organic lithium salt Massachusetts General Hospital HARVARD Medical School Ovidiu C. Andronesi , Katherine N. Maina, Daniel Park, May Aon, Shuqing Deng, Melanie Brown, Sara Farina, Paul Weiser, Tan - Hanh Pham, Nathaniel Mercaldo, Donald Reitberg, Eve Del Rio, Michael Henry, Kraig Roajphlastien, Stephan Jackman, Kelli S. Devitte - McKee, Alison McManus, Jessica Gerber, Steven Arnold, Hope Taft, Susie Huang, Bruce R. Rosen ISMRM Workshop Advances in X - Nuclei MR, 29 Sept 2026
Speaker Name: Ovidiu C. Andronesi I have the following financial interest or relationship to disclose with regard to the subject matter of this presentation : • Company Name: Alzamend Neuro Inc • Type of Relationship: Sponsored research funding Declaration of Financial Interests or Relationships ISMRM Workshop Series
3 • Lithium is the gold standard treatment for bipolar disorder , and often used in major depressive disorder, schizophrenia or Alzheimer’s disease. • Clinical utility is constrained by a narrow therapeutic window for inorganic lithium salts (Li 2 CO 3 ) which need careful monitoring to manage renal, thyroid, and other systemic toxicity risks. • In this clinical trial we investigated the brain pharmacokinetics of AL001, a novel organic co - crystal containing lithium salicylate/L - proline designed for better brain delivery with less systemic exposure than inorganic salts. LITHIUM TREATMENT
AL001 4 4 AL001 = co - crystal of Lithium salicylate + L - proline (LISPRO crystal) Pre - clinical studies in mice indicated a better PK profile for lithium salicylate Smith A et al, RSC Adv., 2014, 4, 12362 – 12365
5 CLINICAL TRIAL DESIGN Baseline MRI (1x) Baseline Plasma (1x) Period1 MRI (7x) Period1 Plasma (28x) Period2 MRI (7x) Period2 Plasma (28x) 30 Participants: • 6 Healthy • 6 Bipolar • 6 Major Depression • 6 Alzheimer • 6 PTSD Phase 1/2a design: • 2 treatments • 2 periods • randomized • longitudinal • cross - over 14 days 14 days All participants receive both treatments, AL001 and Li 2 CO 3 ClinicalTrials.gov/NCT06921590
6 LITHIUM IMAGING • MR Scanner: 7T Terra.X (Siemens Healthineers) • Dual - tuned coil: 7Li/1H 1Tx/1Tx - 16Rx/16Rx (Tesla Dynamics Coil) • Pulse sequence: 3D radial balanced SSFP (3D bSSFP) • Image reconstruction: Regridding + density compensation (ICE on - line) • Image processing: Super - resolution upsampling + Absolute Quantification + MNI + PK modeling 3D radial bSSFP: • TR/TE = 10ms/5ms, • FA = 22 , • Voxel = 8 cm 3 (20 mm iso) • Spokes = 400, • NA = 375, • TA = 25:02 min:s Image processing: • Freesurfer + FSL + MINC + Python • Pipeline compliant with CFR 2.11 regulations for FDA submission
7 IMAGE PROCESSING PIPELINE
8 IMAGE PROCESSING PIPELINE Xianqi Li et al, Radiology 2020, 294, 589 - 597 ܠ ො ൌ ܽݎ݃ ‹ ሼ ܠ ܡ െ ܪ ሺ ܠ ሻ ଶ ࣅ ܴ ሺ ܠ ሻ ሽ ܴ ܠ ൌ ܠ ܞ െ ܟ ሺ ܞ ǡ ܝ ሻ ܠ ܝ ܝ א π ሺ ܞ ሻ ଶ ܞ Low - res MRSI High - res MRI Super - res MRSI Super - resolution: regularized patch based feature nonlocal means Absolute Quantification: bSSFP relaxation correction with finite RF pulse duration Non - convex optimization Bieri et al, MRM, 2009, 62:1232 Bernstein et al, Handbook of MRI Pulse Sequences
9 PHANTOM VALIDATION Lithium image spatial resolution of 3D radial bSSFP
10 PHANTOM VALIDATION Absolute Quantification of Li concentration from bSSFP images Variability: test - retest triplicates Linearity and lower limit of quantitation
11 Rating of Li Image Quality by Radiologists Gwet’s Agreement Coefficient Agreement Analysis Landis - Koch Benchmark Label Estimate (95%CI) Substantial 0.73 (0.66, 0.80) Primary Analysis - assuming complete independence Moderate - Fair 0.61 (0.28, 0.83) Sensitivity Analysis - not assuming complete independence Very Poor (1) Poor (2) Adequate (3) Good (4) Excellent (5) Li image # 1 - 96 92% of images scored Excellent - Adequate
12 Lithium Brain Concentration Baseline AL001 Li 2 CO 3 1 0 mM 1 0 mM 1 0 mM [Li] in GM and WM [mM]
13 Voxel - wise General Linear Model [Li] Treatment - Baseline 2 1.3 - Log 10 (p) AL001 - Baseline Li 2 CO 3 - Baseline 2 1.3 - Log 10 (p)
14 PK analysis – non - compartmental model [Li] plasma [Li] white matter [Li] gray matter AUC AL001 = 53873 ( hr *ng/mL) AUC Li 2 CO 3 = 51427 ( hr *ng/mL) AUC AL001 = 32370.77 ( hr *ng/mL) AUC Li 2 CO 3 = 29309.12 ( hr *ng/mL) ) AUC AL001 = 37347.73 ( hr *ng/mL) AUC Li 2 CO 3 = 33581.70 ( hr *ng/mL) )
15 PK analysis – two - compartments model K1 (ml/cm 3 /min) 3 0 ml/cm 3 /min
Summary 16 » 7 Tesla provides higher SNR for lithium imaging and allows quantification of lithium concentration in the brain over the PK relevant range ( 0 . 1 - 1 mM ; 694 - 6941 ng/g) with anatomical spatial resolution . » Brain region analysis indicate a trend for slightly higher Li concentration after AL 001 (geometric mean 4020 . 64 ng/g, 64 % CV) compared to Li 2 CO 3 ( geometric mean 3476 . 94 ng/g, 57 % CV), with slightly larger values in white matter than gray matter . » Voxel - wise general linear model indicate a trend for higher Li concentration in the gray matter after AL 001 compared to Li 2 CO 3 . » Non - compartment PK modelling indicate a trend for slightly higher AUC after AL 001 ( geometric mean 62230 h ng /g, 26 % CV) compared to Li 2 CO 3 ( geometric mean 59715 h ng /g, 25 % CV) . » Two compartment PK modelling indicate higher plasma to brain transfer rate (K 1 ) in the white matter than gray matter for AL 001 . » Differences between AL 001 and Li 2 CO 3 are not statistically significant , in line with the small sample size . The observed trends in the healthy cohort generate hypothesis that will be tested in subsequent patient cohorts (bipolar, major depression, Alzheimer and PTSD) .
Acknowledgements MGH, Department of Radiology Martinos Biomedical Imaging Center: Katherine Maina Paul Weiser Tan - Hanh Pham Nathaniel Mercaldo May Aon Shuqing Deng Melanie Brown Sarah Farina Hope Taft Susie Huang Bruce Rosen MGH, Department of Psychiatry: Steven Arnold Michael Henry MGH, Clinical Translation Research Unit Jessica Gerber Kelli S. Devitte - McKee, Alison McManus Alzamend Neuro Inc Stephan Jackman Donald Reitberg, Eve Del Rio, Kraig Roajphlastien, QMENTA Oscar Pena Evie Neylon Kire Trivodaliev Human Predictions William Denney Paul Weiser Shuqing Deng Katy Maina May Aon Melanie Brown Hanh Pham