Alzamend Neuro, Inc.

Alzamend Neuro, Inc. is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Alzheimer’s is the fifth leading cause of death in the United States, currently affecting roughly 7.4 million Americans, a number expected to grow to 13 million individuals by 2050. In 2026, the estimated healthcare costs for treating individuals with Alzheimer’s in the U.S. will be $409 billion, including $263 billion in Medicare and Medicaid payments, and these costs could rise to as high as $1 trillion per year by 2050 if no permanent treatment or cure is found. The company operates in a highly competitive industry subject to rapid and significant technological change, with competition based on product efficacy, safety, reliability, availability, price, and patent position.

The company faces substantial competition from large pharmaceutical and biotechnology companies, including AbbVie, Axsome Therapeutics, Biogen Inc., Eisai Co., Ltd., Takeda Pharmaceuticals, Bristol Myers Squibb, Pfizer Inc., Merck & Co., Inc., Sanofi S.A., Eli Lilly and Company, Bayer AG, Novartis AG, Johnson and Johnson, and Boehringer Ingelheim GmbH, as well as smaller early-stage companies. Alzamend’s competitive advantages are centered on its two novel therapeutic drug candidates: AL001, a patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate, and proline, and ALZN002, a patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine. The company believes AL001 is positioned for a Section 505(b)(2) regulatory pathway and that both candidates are positioned for breakthrough therapy designations, though no such designation has been received.

Alzamend is a clinical-stage biopharmaceutical company with no source of near-term revenue and no products approved for commercial sale. The company generates no revenue from product sales and does not anticipate generating revenue for at least the next several years, if ever. Its business model is to develop AL001 and ALZN002 through successive de-risking milestones towards regulatory approval and then seek marketing approval or enter into partnering transactions with biopharmaceutical companies to provide distribution and marketing capabilities. The company does not anticipate selling products directly into the marketplace, though it may do so depending on market conditions.

The company’s lead product candidate is AL001, an ionic cocrystal of lithium designed to treat Alzheimer’s, BD, MDD, and PTSD. AL001 is licensed through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation. The company completed its Phase I clinical trial in March 2022 and initiated a Phase IIA Multiple Ascending Dose clinical trial in May 2022, completing the clinical portion in March 2023 and announcing full data in October 2024. A maximum tolerated dose was successfully identified, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, designed to be unlikely to require lithium therapeutic drug monitoring. In August 2024, the company announced a partnership with Massachusetts General Hospital and Harvard Medical School to conduct five Phase II imaging clinical trials. In May 2025, the first patient was dosed in the AL001 "Lithium in Brain" Study in healthy human subjects, with the clinical portion completed in November 2025. Pharmacokinetics topline data reported in March 2026 showed that AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonate, showed numerically higher lithium concentrations in all measured brain regions, and reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate. Pharmacodynamic topline data announced in April 2026 indicated that across multiple brain regions, AL001 and lithium carbonate appeared to trend in opposite directions in brain chemistry measures, both showed a trend toward reducing myo-inositol, and lithium carbonate showed large effects across all brain regions whereas AL001 showed minimal glutamate effect in most brain regions. Full pharmacokinetics and pharmacodynamic results are expected in August 2026. In March 2026, the company announced the initiation of the Phase II Clinical Trial of AL001 in Patients with BD, with topline data expected in the fourth quarter of 2026. Clinical trials for MDD and PTSD are expected to commence in the fourth quarter of 2026, followed by Alzheimer’s in the first quarter of 2027.

The company’s second product candidate is ALZN002, a patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine for Alzheimer’s, licensed from the University of South Florida Research Foundation. An IND was submitted to the FDA in September 2022, and a "study may proceed" letter was received in October 2022. In April 2023, the company announced the initiation of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type, with the purpose of assessing safety, tolerability, and efficacy of multiple ascending doses compared with a placebo in 20-30 subjects. In February 2024, the company received notice from Biorasi, LLC, its contract research organization, terminating the contract. The company is currently pursuing engagement of a replacement CRO and does not expect to restart this trial until the first quarter of 2027.

During the fiscal year, the company entered into a Fourth Amendment to the AL001 Licenses on April 25, 2025, which deleted the timing of milestone events. The company also entered into a Securities Purchase Agreement with Orchid Finance on February 28, 2025, issuing shares of Series C Preferred Stock. Additionally, the company utilized an At-The-Market offering program during the fiscal year. As of April 30, 2026, the company had 4 full-time employees and 2 part-time employees.

For the fiscal year ended April 30, 2026, the company reported a net loss of $10,089,000, compared to a net loss of $9,088,000 for the prior fiscal year. Research and development expenses were $4,039,000, down from $5,003,000 in the prior year, while general and administrative expenses were $6,050,000, up from $4,085,000. The company had $711,000 in cash and cash equivalents as of April 30, 2026, and an accumulated deficit of $93,206,000. Net cash used in operating activities was $8,178,000 for the fiscal year.

The primary growth vector is the advancement of AL001 through clinical development for Alzheimer’s, BD, MDD, and PTSD. The company completed the clinical portion of the AL001 "Lithium in Brain" Study in healthy human subjects in November 2025 and reported pharmacokinetics topline data in March 2026. The Phase II Clinical Trial of AL001 in Patients with BD was initiated in March 2026, with topline data expected in the fourth quarter of 2026. Clinical trials for treatment of patients with MDD and PTSD are expected to commence in the fourth quarter of 2026, followed by Alzheimer’s in the first quarter of 2027. Upon completion of these five clinical trials, the company intends to initiate Phase III clinical trials for the respective indications. The company also plans to explore different formulations including liquid, immediate release, and sprinkle capsules to deliver AL001.

The second growth vector is the advancement of ALZN002 for Alzheimer’s treatment. The company submitted an IND to the FDA in September 2022 and received a "study may proceed" letter in October 2022. A Phase I/IIA clinical trial was initiated in April 2023, but the contract with CRO Biorasi was terminated in February 2024. The company is currently pursuing engagement of a replacement CRO and does not expect to restart this trial until the first quarter of 2027. The company intends to seek approval to commercialize ALZN002 through a Biologics License Application if successful Phase III clinical trials are achieved.

The filing does not provide specific margin trajectory, cost structure evolution, or efficiency targets with exact figures.

The company does not have in-house manufacturing capabilities and has outsourced manufacturing to third-party contractors. For AL001 and ALZN002, the company has received Good Manufacturing Practices material manufactured for clinical trial. The company relies on third-party CROs to conduct preclinical and clinical studies. As of April 30, 2026, the company had four full-time employees and two part-time employees, and utilizes independent consultants for medical research and development projects.

The company expects expenses to increase substantially during the next few years as it conducts non-clinical research and clinical development. As of April 30, 2026, the company had $711,000 in cash and cash equivalents, and management believes this funding will not be sufficient to fund operations for the next twelve months. The company will need to raise substantial additional capital to complete the development and commercialization of AL001 and ALZN002. The company does not intend to pay dividends on its common stock in the foreseeable future.

The company faces significant headwinds including the need to obtain substantial additional funding to complete development and any commercialization of AL001 and ALZN002. The company is at an early stage of clinical development with no source of near-term revenue and may never become profitable. The company has both operational and financial milestones that must be met to maintain licensing rights from the University of South Florida Research Foundation, including milestone payments of $1,250,000 upon first patient treated in a Phase III clinical trial and $10,000,000 upon FDA NDA approval for AL001, and $50,000 upon first dosing of patient in first Phase I clinical trial, $500,000 upon completion of first Phase IIB clinical trial, $1,000,000 upon first patient treated in a Phase III clinical trial, and $10,000,000 upon first commercial sale for ALZN002.

The company faces regulatory and clinical development risks including a high rate of failure for drug candidates proceeding through clinical trials, the need to demonstrate safety and efficacy to the FDA, and the uncertainty of the regulatory approval process. The company also faces competition from large pharmaceutical companies with greater financial and human resources. The company is not in compliance with Nasdaq continued listing requirements, having received a notice on March 20, 2026, that stockholders' equity of approximately $2.2 million as of January 31, 2026 did not satisfy the $2.5 million minimum requirement. As of April 30, 2026, stockholders' equity was approximately $0.7 million. Nasdaq granted an extension to regain compliance on or before September 16, 2026.

The company needs substantial additional funding to complete development and commercialization of AL001 and ALZN002, with only $711,000 ¹ in cash and cash equivalents as of April 30, 2026, which management believes will not be sufficient to fund operations for the next twelve months. The independent registered public accounting firm has expressed substantial doubt about the company’s ability to continue as a going concern. The company has both operational and financial milestones that must be met to maintain licensing rights, including milestone payments of $1,250,000 ² upon first patient treated in a Phase III clinical trial and $10,000,000 ³ upon FDA NDA approval for AL001, and $50,000 ⁴ upon first dosing of patient in first Phase I clinical trial, $500,000 ⁵ upon completion of first Phase IIB clinical trial, $1,000,000 ⁶ upon first patient treated in a Phase III clinical trial, and $10,000,000 ⁷ upon first commercial sale for ALZN002. The company is not in compliance with Nasdaq continued listing requirements, with stockholders’ equity of approximately $0.7 million ⁸ as of April 30, 2026, below the $2.5 million ⁹ minimum requirement, and has been granted an extension to regain compliance on or before September 16, 2026. The company is substantially dependent on the success of AL001 and ALZN002, which are in early clinical development and may not receive regulatory approval or be successfully commercialized.

Management’s message emphasizes the company’s focus on advancing clinical development of AL001 for Alzheimer’s, BD, MDD, and PTSD, and ALZN002 for Alzheimer’s treatment. Key strategic priorities include completing the five Phase II imaging clinical trials for AL001, with the Phase II trial in BD patients initiated in March 2026 and topline data expected in the fourth quarter of 2026, and clinical trials for MDD and PTSD expected to commence in the fourth quarter of 2026, followed by Alzheimer’s in the first quarter of 2027. Management also emphasizes the importance of securing a replacement CRO for the ALZN002 Phase I/IIA trial, which is not expected to restart until the first quarter of 2027. The tone is forward-looking but acknowledges significant financial constraints, with management stating that based on the current operating plan, the $711,000 in cash and cash equivalents as of April 30, 2026 will not be sufficient to fund operations for the next twelve months, and that substantial additional funding is needed.