ATLANTA - Alzamend Neuro, Inc. (NASDAQ:ALZN), a biopharmaceutical company engaged in the development of treatments for neurological disorders, has announced the completion of a nonclinical study that suggests its investigational lithium therapy, AL001, may offer therapeutic benefits for Alzheimer's disease and other neurological conditions with a potentially improved safety profile.
The study, conducted at the University of South Florida and analyzed by Sannova Analytical LLC, compared the brain and plasma lithium levels achieved by AL001 to those of lithium carbonate, a current FDA-approved treatment. In the study, 5XFAD mice, a model for Alzheimer's research, received varying doses of both substances over a two-week period. The findings indicated that AL001 led to consistently higher lithium concentrations in critical brain regions at lower doses than lithium carbonate, while also showing lower plasma lithium levels, suggesting a reduced risk of adverse systemic effects.
These results could have significant implications for patients with Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, as they suggest that AL001 may deliver brain-specific lithium treatment more effectively and with fewer side effects. The reduced systemic exposure observed with AL001 implies a potentially safer therapeutic index for lithium, which may alleviate the need for routine blood lithium monitoring and reduce the risk of thyroid and kidney complications.
Alzamend's CEO, Stephan Jackman, expressed optimism about the study's outcomes, stating that the data will guide the upcoming "Lithium in Brain" Phase II clinical trials in partnership with Massachusetts General Hospital. These trials will assess AL001 in healthy subjects and patients diagnosed with mild to moderate Alzheimer's and other conditions, based on the dosing level deemed appropriate from the nonclinical study.
Alzamend's pipeline also includes AL002, a cell-based therapeutic vaccine for Alzheimer's. Both AL001 and AL002 are licensed from the University of South Florida Research Foundation, Inc.
While these findings are encouraging, they are based on animal models, and the efficacy and safety of AL001 in humans will be further evaluated in the forthcoming clinical trials. The information in this article is based on a press release statement from Alzamend Neuro, Inc.
In other recent news, Alzamend Neuro has made significant strides in Alzheimer's treatment with the successful determination of a maximum tolerated dose for its AL001 dementia treatment. The company has also regained compliance with Nasdaq's stockholders' equity requirement through the sale of $25 million of its Series A Convertible Preferred Stock. Additionally, Alzamend Neuro has entered into an At-the-Market issuance sales agreement with Ascendiant Capital Markets, facilitating the sale of common stock up to $6.5 million. Ascendiant Capital has adjusted its outlook on Alzamend Neuro, reducing the 12-month price target to $21 from the previous $25, while maintaining a Buy rating on the stock.
The company has launched multiple Phase II clinical trials in collaboration with Massachusetts General Hospital for its therapeutic drug candidates AL001 and ALZN002. These trials aim to evaluate increased lithium levels in the brain, potentially improving treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Alzamend Neuro has also announced a one-for-ten reverse stock split and initiated a significant conversion of preferred stock into common shares and warrants, potentially allowing for a purchase price of up to $25 million. These are recent developments in Alzamend Neuro's ongoing efforts in the biopharmaceutical sector.
InvestingPro Insights
While Alzamend Neuro's recent study results for AL001 are promising, investors should consider the company's financial position and market performance. According to InvestingPro data, Alzamend's market capitalization stands at a modest $6.04 million, reflecting its early-stage status in drug development.
InvestingPro Tips highlight some challenges facing the company. Alzamend is "quickly burning through cash" and "suffers from weak gross profit margins," which is not uncommon for biotech firms in the research and development phase. The company's financial health is further underscored by the fact that its "short term obligations exceed liquid assets," although it "holds more cash than debt on its balance sheet."
The stock's recent performance has been concerning, with InvestingPro data showing a 19.4% decline in the past month and a substantial 92.01% drop over the last year. This aligns with the InvestingPro Tip that the "stock has taken a big hit over the last week" and is "trading near 52-week low."
Investors should note that analysts "do not anticipate the company will be profitable this year," which is consistent with the nature of early-stage biopharmaceutical companies investing heavily in research and development.
For a more comprehensive analysis, InvestingPro offers 16 additional tips on Alzamend Neuro, providing deeper insights into the company's financial health and market position.
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