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ATLANTA - Alzamend Neuro, Inc. (NASDAQ: ALZN), a clinical-stage biopharmaceutical company, has announced a partnership with Massachusetts General Hospital to conduct five Phase II clinical trials for its therapeutic drug candidate AL001. The trials, which will involve healthy human subjects and patients with Alzheimer's, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD), aim to evaluate the increased lithium levels in the brain compared to a marketed lithium salt.
The drug AL001 is designed to deliver the benefits of lithium while potentially reducing the toxicities associated with its current use. Alzamend's CEO, Stephan Jackman, stated that the company plans to replace the standard 300 mg TID lithium carbonate dose for BD treatment with a 240 mg TID AL001 lithium equivalent, aiming to reduce the daily lithium intake by 20%.
Alzamend has also secured sufficient capital to finance the initiation and progression of AL001 and ALZN002 clinical trials over the next 18 months. ALZN002, the company's secondary therapeutic candidate, is an active immunotherapy product intended to stimulate the immune system to produce anti-amyloid antibodies, potentially reducing Alzheimer's symptoms.
The company has raised capital through various agreements, including a securities purchase agreement with an entity associated with its founder and largest stockholder and another with an outside investor. These agreements are expected to help Alzamend comply with Nasdaq's Listing Rule 5550(b)(1), which requires stockholder equity of at least $2.5 million.
Alzamend anticipates initiating all five Phase II studies for AL001 in the first half of 2025, with exact dates to be announced before the end of 2024. Meanwhile, the company is seeking a replacement contract research organization (CRO) to resume the Phase I/IIA clinical trial for ALZN002, which is expected to recommence in the fourth quarter of 2024.
The information in this article is based on a press release statement from Alzamend Neuro.
In other recent news, Alzamend Neuro has initiated several Phase II clinical trials in collaboration with Massachusetts General Hospital for its novel lithium-delivery system, AL001. These trials target the treatment of Alzheimer's disease, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD). The studies, led by Dr. Ovidiu Andronesi from Harvard University, aim to establish the minimum effective and safe dose of AL001, potentially improving treatments for millions of Americans affected by these conditions.
In recent developments, Alzamend Neuro has announced a one-for-ten reverse stock split and secured an extension for its Nasdaq listing. The company's shareholders have also approved a significant conversion of preferred stock into common shares and warrants, potentially allowing for a purchase price of up to $25 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.
These recent developments underscore Alzamend Neuro's ongoing efforts in the biopharmaceutical sector, focusing on developing treatments for neurological disorders. The company has not yet provided details regarding the study’s timeline or market opportunity. Alzamend Neuro continues to focus on its mission to develop treatments for neurological disorders, with a particular emphasis on Alzheimer's disease.
InvestingPro Insights
As Alzamend Neuro, Inc. (NASDAQ: ALZN) embarks on a series of Phase II clinical trials for its drug candidate AL001, recent data and analysis from InvestingPro show a mixed financial landscape for the company. With a market capitalization of $2.59 million, Alzamend operates on a small scale in the biopharmaceutical industry. The company's stock has experienced significant price volatility, with a one-week price total return showing a steep decline of 47.35%, and a one-year price total return plummeting by 92.4%.
InvestingPro Tips for Alzamend highlight several challenges the company is facing. The stock has taken a significant hit over the last week and month, reflecting the high price volatility that the stock generally trades with. Moreover, the company is quickly burning through cash, which raises concerns about its financial sustainability. This is further underscored by the fact that Alzamend's short-term obligations exceed its liquid assets, indicating potential liquidity issues.
Despite these financial headwinds, Alzamend's recent capital raise to finance its upcoming clinical trials is a positive development. However, InvestingPro Tips indicate that analysts do not anticipate the company will be profitable this year, and net income is expected to drop. Alzamend also suffers from weak gross profit margins, which could impact its ability to generate profits in the near term.
For investors considering Alzamend Neuro as part of their portfolio, it's essential to weigh these financial metrics and analyst insights. The company does not pay a dividend to shareholders, which may be a consideration for income-focused investors. For those interested in a deeper dive, there are additional InvestingPro Tips available at https://www.investing.com/pro/ALZN, providing a comprehensive analysis of Alzamend's financial health and stock performance.
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