Alzamend Neuro begins phase II trial for novel lithium delivery system

Published 29/05/2025, 13:14
Alzamend Neuro begins phase II trial for novel lithium delivery system

ATLANTA - Alzamend Neuro, Inc. (NASDAQ:ALZN), a biopharmaceutical company engaged in developing treatments for neurological disorders, announced the commencement of a Phase II clinical trial for its investigational drug AL001. The first dose has been administered to a participant in a study seeking to compare the pharmacokinetics of AL001 with conventional lithium carbonate in healthy subjects. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt and a current ratio of 5.44x, though it’s currently burning through cash at a notable rate as it advances its clinical programs.

The trial, conducted in collaboration with Massachusetts General Hospital, aims to establish the potential of AL001 to deliver lithium more effectively to the brain, potentially offering a safer alternative with fewer systemic side effects. This could be particularly beneficial for patients with Alzheimer’s, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. InvestingPro subscribers can access 15 additional key insights about Alzamend’s financial health and market position, helping investors make more informed decisions about this clinical-stage biotech company.

Previous research in mice suggests AL001 achieves better brain absorption of lithium while maintaining lower blood levels, which may reduce the need for therapeutic drug monitoring (TDM) currently required for lithium treatments. Lithium is a well-established treatment for bipolar disorder but is often underused due to the complexities involved in monitoring its levels in the blood.

Alzamend’s novel approach with AL001 could mark a significant shift in the management of neurological conditions by minimizing risks associated with kidney and thyroid side effects, which are common with existing lithium therapies. The company anticipates releasing topline data from the Phase II study before the end of 2025. With a market capitalization of just $2.43 million and an InvestingPro Financial Health Score labeled as ’WEAK’, the company faces significant challenges in its development journey.

AL001, which has completed a Phase IIA multiple-ascending dose study, was identified to have a maximum tolerated dose that likely does not require TDM. The formulation is designed to distribute lithium favorably in the brain, resulting in lower exposure to other body organs and potentially an improved safety profile compared to current lithium salts.

Alzamend Neuro’s CEO, Stephan Jackman, expressed optimism about the trial, stating, "The dosing of the first patient in our first Phase II trial of AL001 is another significant step forward in our goal to introduce a next-generation lithium treatment."

This press release statement is based on information provided by Alzamend Neuro, Inc. and contains forward-looking statements subject to risks and uncertainties. Actual results could differ materially from those projected. The company maintains no obligation to update any forward-looking statements publicly in response to new information or future events. Based on InvestingPro Fair Value analysis, the stock appears to be undervalued at current levels, though investors should note the company is not yet profitable and faces significant cash flow challenges.

In other recent news, Alzamend Neuro, Inc. has initiated a Phase II clinical study for its investigational drug AL001, designed to improve lithium delivery to the brain while minimizing blood levels. This trial aims to compare AL001 with existing lithium carbonate products and is being conducted at Massachusetts General Hospital. In another development, Alzamend announced a one-for-nine reverse stock split to comply with Nasdaq’s minimum bid price requirement. This split will consolidate approximately 7,208,591 shares to about 800,954 shares and ensure continued Nasdaq listing.

Additionally, Alzamend has amended its corporate bylaws to reduce the quorum requirement for stockholder meetings from a majority to 35% of outstanding shares. The company also introduced a new Series C Convertible Preferred Stock, which offers enhanced financial flexibility. This strategic move was part of an agreement with a sophisticated investor to exchange Series A for Series C Preferred Stock and sell up to 500 shares of Series C stock, potentially raising up to $5 million. The Series C stock carries a 15% annual dividend and preferential liquidation rights, with conversion and warrant exercise conditions. These recent developments are part of Alzamend’s ongoing efforts to advance its treatment pipeline and secure necessary funding.

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