Alzamend begins phase II trial for novel lithium therapy

ATLANTA - Alzamend Neuro, Inc. (NASDAQ:ALZN), a clinical-stage biopharmaceutical company with a market capitalization of $2.49 million, has initiated the first Phase II clinical study of its investigational drug AL001, enrolling the first participant earlier this week. While the company maintains a healthy current ratio of 5.44 and holds more cash than debt, InvestingPro analysis indicates rapid cash burn that could impact future operations. The study, conducted at Massachusetts General Hospital, aims to compare the pharmacokinetics of AL001—a novel lithium-delivery system—with those of marketed lithium carbonate products in healthy subjects.

AL001 is designed to enhance the delivery of lithium to the brain while reducing lithium levels in the blood, potentially offering safer and more efficient treatment options for patients with Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Prior animal studies have indicated that AL001 may improve brain absorption of lithium and minimize the need for therapeutic drug monitoring (TDM), which is often required due to the narrow therapeutic window of current lithium treatments.

The drug’s development has been supported by the creation of a novel head coil by Tesla Dynamic Coils BV, which is a crucial component of the clinical trial. This study in healthy volunteers is expected to provide baseline data that will guide further research in patients with the aforementioned conditions.

Stephan Jackman, CEO of Alzamend, highlighted the potential of AL001 to transform patient care by improving treatment safety and efficacy. He anticipates topline data from the trial by the end of the year. The company’s stock, currently trading at $3.40, has experienced significant pressure with a year-to-date decline of 67.43%. InvestingPro subscribers have access to 14 additional key insights about ALZN’s financial health and market performance.

AL001, which has completed a Phase IIA multiple-ascending dose study, has identified a maximum tolerated dose that is unlikely to require TDM while still providing an effective amount of lithium. This could represent a significant shift in the management of conditions traditionally treated with lithium, reducing the risks of kidney and thyroid side effects.

Alzamend Neuro’s mission is to rapidly develop and bring to market treatments that are safe and effective. Their pipeline includes another therapeutic candidate, ALZN002, which is a cell-based therapeutic vaccine for Alzheimer’s disease.

This press release statement is based on information provided by Alzamend Neuro, Inc. and contains forward-looking statements that involve risks and uncertainties. According to InvestingPro analysis, the company currently shows weak overall financial health with a score of 1.63, and analysts do not anticipate profitability this year. The company has provided no update on these statements in light of new information or future events. Investors are advised that actual results could differ from those projected.

In other recent news, Alzamend Neuro has announced a one-for-nine reverse stock split to comply with Nasdaq’s minimum bid price requirements. This move will reduce the number of shares outstanding from approximately 7.2 million to about 800,954, with no fractional shares issued. Additionally, Alzamend Neuro has amended its corporate bylaws, lowering the quorum requirement for stockholder meetings from a majority to 35% of outstanding capital stock. The company also introduced a new Series C Convertible Preferred Stock, exchanging Series A shares and selling up to 500 Series C shares to a sophisticated investor. This agreement, valued at up to $5 million, includes warrants for common stock and aims to enhance financial flexibility. Furthermore, Alzamend Neuro completed a specialized head coil for its upcoming Phase II clinical trials of AL001, a novel lithium-delivery system. These trials will compare AL001 with traditional lithium carbonate in treating neurological and psychiatric conditions. The company plans to collaborate with Massachusetts General Hospital for these studies.

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