Company Overview Summary of Alzamend Neuro, Inc.

Business Focus

• Type: Clinical-stage biopharmaceutical company
• Main Focus: Developing novel therapeutic products for neurodegenerative and psychiatric disorders
• Indications Targeted:
  • Alzheimer’s disease (AD)
  • Bipolar disorder (BD)
  • Major depressive disorder (MDD)
  • Post-traumatic stress disorder (PTSD)

Product Pipeline

Lead Product Candidate: AL001

• An ionic cocrystal of lithium designed to address neurodegenerative and psychiatric conditions
• Potential benefits:
  • May treat Alzheimer’s, BD, MDD, PTSD
  • Exhibited improved pharmacokinetics over traditional lithium in preclinical studies
  • Indicated to prevent cognitive deficits, depression, irritability in animal models
  • Could be administered at doses designed to minimize monitoring needs

Second Product Candidate: ALZN002

• A cell-based immunotherapeutic vaccine aimed at restoring immune response to combat Alzheimer’s
• Mechanism: Stimulates immune system to clear brain amyloid plaques
• Demonstrated safety in preclinical toxicology studies
• Under clinical evaluation:
  • Phase I/IIA trial initiated
  • Trial to determine dosage for larger efficacy studies
  • Delayed due to CRO termination, expected to resume mid-2026

Clinical Development Status

• AL001:
  • Completed Phase I trial in September 2021
  • Completed Phase IIA multimodal dose studies in March 2023
  • Identified a maximum tolerated dose (MTD) of lithium equivalent to 240 mg TID
  • Conducting five Phase II clinical trials (for Alzheimer’s, BD, MDD, PTSD, healthy subjects)
  • Expect data by end of 2025 for initial trial; subsequent trials for other indications starting Q3 2025
  • Plans for Phase III trials pending successful Phase II outcomes and regulatory submission
• ALZN002:
  • Submitted IND, approved to proceed with clinical trials
  • Phase I/IIA trial initiated in September 2022
  • Delayed in trial due to CRO termination; expected to resume in mid-2026

Licensing and Intellectual Property

• Licenses technology from the University of South Florida Research Foundation
• AL001 licensed under several patents concerning lithium cocrystals
• ALZN002 licensed as a cell-based immunotherapy targeting amyloid-beta
• License agreements contain milestones, royalty payments (4.5% for AL001, 4% for ALZN002), and indefinite terms or patent expiry

Market Opportunity

• Estimated to have over 48.2 million Americans affected by Alzheimer’s, BD, MDD, and PTSD
• Alzheimer’s alone affects roughly 7.2 million in the U.S.
• Significant unmet medical needs with existing treatments only alleviating symptoms temporarily
• Projected costs for Alzheimer’s in the U.S. are $384 billion in 2025, potentially rising to $1 trillion by 2050

Employees and Revenue

• Number of Employees: 4 full-time, 3 part-time employees as of April 30, 2025
• Revenue: No source of near-term revenue; no products commercially available or revenue generated yet
• Income: No reported income; operations are researcher and development focused, with expenses primarily from R&D activities

Financial Condition

• Cash and Equivalents: $3.9 million as of April 30, 2025
• Additional Funding: Raised $4.0 million in February 2025
• Risks: Operating in early clinical development; significant expense expected; no revenue expected for several years; the independent auditors have expressed doubt about the company’s ability to continue as a going concern

Summary:
Alzamend Neuro, Inc. is a pre-commercial, research-focused biopharmaceutical company developing innovative treatments primarily for Alzheimer’s disease and related neuropsychiatric disorders. It has two main product candidates, AL001 and ALZN002, with AL001 in advanced clinical testing (Phase I/IIA) and ALZN002 in early clinical development. The company licenses proprietary technology from the University of South Florida and does not currently have any revenue or products on the market. It has a small workforce (7 employees total), limited cash resources, and significant ongoing risks due to early-stage development and regulatory hurdles.