Welcome to our dedicated page for Alzamend Neuro news (Ticker: ALZN), a resource for investors and traders seeking the latest updates and insights on Alzamend Neuro stock.
Alzamend Neuro, Inc. (Nasdaq: ALZN) is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for neurodegenerative diseases and psychiatric disorders. With a primary focus on Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD), the company's mission is to bring safe and effective solutions to the over 43 million Americans suffering from these conditions.
Alzamend Neuro's current pipeline includes two promising therapeutic candidates:
- AL001: A patented ionic cocrystal technology that delivers lithium through a combination of lithium, proline, and salicylate. This advanced delivery system aims to provide the benefits of existing lithium treatments while mitigating toxicity and eliminating the need for therapeutic drug monitoring (TDM). Recent Phase IIA studies have shown a favorable safety profile and identified a maximum tolerated dose that offers improved brain lithium levels with lower systemic exposure.
- ALZN002: A novel cell-based therapeutic vaccine that uses a mutant-peptide sensitized cell to enhance the patient's immune system’s ability to fight Alzheimer’s disease. This approach seeks to restore immune function and provide long-term benefits for patients.
Alzamend has made significant strides in clinical development, with recent achievements including the submission of an investigational new drug (IND) application to the FDA for a Phase IIA study of AL001 in MDD patients. Additionally, the company completed a Phase IIA study of AL001 in Alzheimer's patients, revealing a benign safety profile potentially qualifying for a 505(b)(2) NDA pathway for FDA approval.
Financially, Alzamend is actively working to secure funding and maintain compliance with Nasdaq listing requirements. Recently, the company announced a reverse stock split to meet the Minimum Bid Price Requirement and a major private placement agreement to raise up to $25 million for further clinical trials and operational needs.
Alzamend Neuro has partnered with the University of South Florida Research Foundation, Inc. for exclusive worldwide licenses on all its product candidates. As Alzamend continues to advance its clinical programs, the company remains focused on its mission to bring innovative, safe, and effective treatments to market, addressing the urgent needs of millions of patients.
Alzamend Neuro (ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate for Alzheimer's disease. The study, led by Harvard University Associate Professor Dr. Ovidiu Andronesi, aims to compare AL001 with a marketed lithium carbonate product. The objective is to assess the increase in lithium levels in the brain and its structures among Alzheimer's patients and healthy subjects.
The trial seeks to determine the minimum effective dose of AL001 that is safe and as effective as current products. Alzamend previously completed a Phase IIA trial, identifying a maximum tolerated dose of AL001. The company aims to develop a lithium product with an improved safety profile that doesn't require routine therapeutic drug monitoring, potentially benefiting the 6+ million Americans with Alzheimer's.
Alzamend Neuro (Nasdaq: ALZN) has regained compliance with Nasdaq's Minimum Bid Price Requirement, as announced on July 30, 2024. The company's common stock maintained a closing bid price of at least $1.00 per share for ten consecutive trading days, meeting the requirement on July 29, 2024. However, Alzamend still faces challenges regarding the minimum Market Value of Listed Securities (MVLS) requirement.
Despite initially failing to meet the $35 million MVLS requirement, Alzamend appealed Nasdaq's delisting determination. A Hearings Panel granted the company an extension until September 23, 2024, to demonstrate compliance with the alternative requirement of stockholder equity of at least $2.5 million or meet another listing standard to maintain its Nasdaq listing.
Alzamend Neuro, a clinical-stage biopharmaceutical company, announced a one-for-ten reverse stock split of its common stock, effective July 16, 2024. The split is intended to help the company regain compliance with Nasdaq's Minimum Bid Price Requirement of $1.00 per share. Post-split, the stock will trade under the existing symbol 'ALZN' with a new CUSIP number 02262M506. The reverse split will uniformly affect all issued and outstanding shares, as well as shares available under equity incentive plans, and reduce the number of shares issuable upon the exercise of stock options or warrants. The par value will remain at $0.0001 per share, and no fractional shares will be issued. Instead, stockholders entitled to fractional shares will receive cash payments.
Alzamend Neuro (Nasdaq: ALZN) announced that the Nasdaq Hearings Panel has granted the company an extension to remain listed on the Nasdaq Capital Market.
To comply with Nasdaq’s Listing Rule 5550(b)(1), Alzamend must achieve a stockholder equity of at least $2.5 million by September 23, 2024.
CEO Stephan Jackman expressed gratitude towards the Panel and affirmed the company's commitment to executing their compliance plan.
Alzamend Neuro focuses on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD.
Alzamend Neuro announced the initial closing of a private placement, securing $500,000 from an investor. The total agreement allows for up to $25 million in preferred shares. Proceeds will fund clinical trials for treatments targeting Alzheimer's, bipolar disorder, major depressive disorder, and PTSD. The investor also received warrants for 800,000 shares of common stock, with potential for up to 20 million more if the full $25 million is invested. Additional funding milestones are tied to regulatory filings and partnership agreements. The initial funds include $311,356.16 from a converted term note. This financing supports ongoing clinical trials, including a Phase I/IIA trial of an Alzheimer's vaccine.
Alzamend Neuro, Inc. (ALZN) has entered into a Securities Purchase Agreement to sell $25 million of Preferred Shares in a registered direct offering and concurrent private placement. The Preferred Shares are convertible into Common Stock, have a 15% annual dividend, and come with Warrants to purchase up to 20 million shares of Common Stock. The proceeds will fund clinical trials and general working capital.
Alzamend Neuro, Inc. (ALZN) terminated its 'at-the-market' equity offering program to limit uncertainty and unfavorable dilution for its stockholders. The company had sold over 1 million shares and raised about $1.3 million. The termination will be effective on May 16, 2024, with no further sales planned under the program.
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