Alzamend Neuro, Inc.

Alzamend Neuro, Inc.

Overview

Alzamend Neuro is a clinical-stage biopharmaceutical company developing therapies for Alzheimer’s disease and related neuropsychiatric disorders, including bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). Its two lead programs are AL001 (an ionic lithium cocrystal) and ALZN002 (an autologous dendritic cell vaccine), both licensed from the University of South Florida Research Foundation.

Lead product candidates

AL001

• Type: Ionic lithium cocrystal designed to treat Alzheimer’s disease, BD, MDD, and PTSD.
• Status: Licensed and in human clinical development.
• Key milestones:
  • Phase I completed in 2022; Phase IIA multiple-ascending-dose (MAD) study conducted May 2022–March 2023; full data reported October 2024.
  • Independent safety review committee identified a maximum tolerated dose (MTD) of 240 mg lithium carbonate equivalent, administered three times daily (TID).
  • August 2024: partnership with Massachusetts General Hospital and Harvard Medical School to conduct five Phase II imaging trials.
  • May 2025: first healthy subject dosed in the “Lithium in Brain” study.
  • November 2025: topline PK data showed AL001 is bioequivalent to lithium carbonate in total exposure (101%) and peak levels (97%), with superior brain penetration and faster brain uptake (peak at 6.7 hours vs. 8.4 hours for lithium carbonate).
  • April 2026: pharmacodynamic topline data suggested a distinct brain profile and indications of preserved glutamate balance with a potentially better long‑term tolerability profile.
  • March 2026: Phase II bipolar disorder trial initiated; MDD/PTSD trials expected to start in Q4 2026; Alzheimer’s trial planned for Q1 2027.
• Regulatory plan: pursuing a 505(b)(2) pathway for AL001 with potential for Breakthrough Therapy designation and an NDA after successful pivotal studies.

ALZN002

• Type: Autologous dendritic cell vaccine intended to stimulate the patient’s immune system to reduce brain beta-amyloid burden.
• Mechanism: Patient-specific dendritic cells pulsed with a modified amyloid‑beta peptide (E22W) to elicit an anti‑amyloid immune response.
• Status: Phase I/IIA program; IND filed and trial initiated April 2023 to treat mild–moderate Alzheimer’s-type dementia.
• Development challenges and timeline: CRO Biorasi terminated its engagement in February 2024; a replacement CRO has been engaged but the trial has not yet restarted. The company expects a restart no earlier than Q1 2027.
• Regulatory path: potential BLA submission contingent on successful late‑stage development.

Licensing and intellectual property

• Alzamend Neuro licenses AL001 and ALZN002 technologies from the University of South Florida Research Foundation.
• AL001 license (USF)
  • Patents: US 9,840,521 and US 9,603,869 (lithium ionic co‑crystal technology).
  • Royalties: 4.5% of net sales.
  • Initial license fee: $200,000; licensor received 14,853 shares of common stock.
  • Minimum annual royalties: $40,000 after first commercial sale, increasing to $80,000 and $100,000 in later years.
  • Milestones: multiple payments, including amounts up to $10,000,000 tied to NDA approval and other specified development events.
  • Additional AL001 licenses for expanded indications carry a 3% royalty on net sales in those fields and include minimum royalties and milestone payments (examples include $2,000,000 upon first patient treated in Phase III and $16,000,000 upon first commercial sale).
• ALZN002 license (USF)
  • Patent: US 8,188,046 (amyloid‑beta peptides and methods of use).
  • Royalties: 4% of net sales.
  • Milestones: up to $10,000,000 upon first commercial sale, plus payments tied to IND and phase progression.
  • Initial license fee: $200,000; licensor received 24,012 shares of common stock.
• November AL001 license (additional indications)
  • Fields: neurodegenerative diseases excluding Alzheimer’s and psychiatric diseases/disorders.
  • Royalty: 3% of net sales in those fields with milestone and minimum royalty structures similar to other AL001 licenses.
• Other terms: license durations are tied to patent status and applicable market exclusivity. Failure to meet milestones or retain licensors can jeopardize rights; license agreements include termination provisions.

Development pipeline and stage

• AL001 is the lead candidate in human trials with completed Phase I and Phase IIA MAD work, multiple Phase II imaging studies underway with MGH/HMS, and ongoing Phase II trials in BD and planned trials in MDD, PTSD, and Alzheimer’s. The company is pursuing a 505(b)(2) regulatory route.
• ALZN002 is in Phase I/IIA with recruitment paused due to CRO transition; a restart is anticipated in 2027. A BLA pathway is contemplated if late‑stage studies succeed.

Market and regulatory context

• Addressable populations include patients with Alzheimer’s, BD, MDD, and PTSD; public health data indicate large affected populations and substantial caregiver and healthcare costs in the U.S.
• Regulatory considerations include pursuing FDA NDA or BLA filings, potential Breakthrough Therapy designation for AL001, REMS and post‑approval monitoring requirements, and standard European regulatory pathways (CTAs, marketing authorization, centralized or decentralized procedures as applicable).

Financial and operational snapshot

• Employees: four full‑time and two part‑time employees as of April 30, 2026; additional independent consultants support operations.
• Cash: $711,000 in cash and cash equivalents as of April 30, 2026.
• Revenue: no product revenue reported to date; the company expects revenue may not arise for several years and is dependent on additional capital and strategic collaborations.
• Going concern: the company’s independent auditor reported substantial doubt about its ability to continue as a going concern due to insufficient capital; management plans to raise capital and pursue partnerships.
• Stock and capitalization: 4,791,525 outstanding shares as of July 22, 2026.
• Corporate status and facilities: listed on the Nasdaq Capital Market; maintains a small Atlanta office (~150 sq ft) and California and New York offices hosted within HDI facilities (no rent for CA and NY locations). The company discloses risks related to meeting Nasdaq listing requirements.

People and governance

• Key executives include CEO Stephan Jackman, CFO David J. Katzoff, and EVP/GC Henry Nisser.
• Governance features include exclusive forum provisions in governing documents and standard corporate disclosure and compliance processes. The company plans to expand its scientific advisory board as programs advance.

Summary of activities

Alzamend Neuro develops AL001, an ionic lithium cocrystal in clinical development, and ALZN002, an autologous dendritic cell vaccine in early clinical stages. Both programs are licensed from the University of South Florida and carry milestone and royalty obligations. Operations are lean, development relies on third‑party manufacturing and CRO support, and near‑term progress depends on additional funding, trial execution, and regulatory interactions.