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 (NASDAQ: ALZN) announced its upcoming poster presentation at the Society of Toxicology Annual Meeting in March 2025, featuring non-clinical data on AL001, a lithium-based treatment. The presentation will showcase comparative data between AL001 and lithium carbonate in Alzheimer's transgenic mice. Key findings demonstrate AL001's enhanced brain-specific lithium delivery with minimized systemic exposure, showing no adverse effects while maintaining higher brain lithium concentrations at lower doses compared to lithium carbonate.
Following successful Phase I and IIA trials, Alzamend plans five Phase II trials in partnership with Massachusetts General Hospital in 2025, targeting treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The company aims to pursue FDA 505(b)(2) approval pathway for AL001.
Alzamend Neuro (ALZN) reported Q2 2025 financial results, showing significant balance sheet improvements. Net cash from financing activities reached $8.3 million for the six months ended October 31, 2024. Stockholder equity improved to $3.8 million from a deficit of $2.6 million, while cash position strengthened to $4.1 million from $0.4 million.
The company secured financing agreements including a $25 million preferred stock and warrants purchase agreement and a $6.5 million at-the-market sales agreement. These improvements helped regain Nasdaq compliance and prepare for five clinical trials in 2025. The company's lead drug candidate AL001, a novel lithium therapy, is advancing to Phase II trials at Massachusetts General Hospital, while ALZN002, an immunotherapy for Alzheimer's, plans trial resumption in 2025.
Alzamend Neuro (NASDAQ: ALZN) has completed analyzing data from a nonclinical study comparing AL001, their novel lithium formulation, with lithium carbonate in Alzheimer's transgenic mice. The study, conducted at the University of South Florida, revealed that AL001 achieved higher brain lithium concentrations while maintaining lower plasma levels compared to lithium carbonate, particularly at lower doses. The results showed no adverse effects, suggesting enhanced safety and efficacy potential for treating Alzheimer's, bipolar disorder, major depressive disorder, and PTSD. The company plans to proceed with five Phase II 'Lithium in Brain' clinical trials in partnership with Massachusetts General Hospital.
Alzamend Neuro (ALZN) has received the full data set from its multiple ascending dose clinical trial for AL001, a treatment for dementia related to Alzheimer's. The data confirms the positive topline results announced in June 2023, identifying a maximum tolerated dose (MTD) that is unlikely to require lithium therapeutic drug monitoring. The MTD delivers lithium at a lithium carbonate equivalent dose of 240 mg, taken three times daily.
AL001 is a novel lithium-salicylate/L-proline engineered ionic cocrystal designed to overcome toxicities associated with conventional lithium salts. It promises a next-generation lithium treatment with an enhanced safety profile and improved brain bioavailability. This innovation could potentially benefit the 43+ million Americans afflicted with Alzheimer's, bipolar disorder, major depressive disorder, and PTSD.
Alzamend plans to further evaluate AL001 in five 'Lithium in Brain' Phase II clinical trials in partnership with Massachusetts General Hospital.
Alzamend Neuro (Nasdaq: ALZN) has regained compliance with Nasdaq's minimum stockholders' equity requirement of $2,500,000. This follows a period of non-compliance and a subsequent appeal to a Hearings Panel. The company had been at risk of delisting but was granted an extension until September 23, 2024, to demonstrate compliance.
Alzamend has secured a $25 million securities purchase agreement for Series A Convertible Preferred Stock, with $8 million already purchased and additional funds expected. This financial arrangement has helped the company meet the equity requirement.
CEO Stephan Jackman expressed satisfaction with regaining compliance and reaffirmed the company's focus on initiating five phase II clinical trials of AL001 in partnership with Massachusetts General Hospital in 2025.
Alzamend Neuro (Nasdaq: ALZN) announced that CEO Stephan Jackman will participate in a fireside chat at the Maxim Group Virtual Healthcare Conference on October 17, 2024, at 1:30 PM ET. The conversation will be with a senior member of Maxim Group's biotech research team.
Mr. Jackman will provide an overview of Alzamend's therapeutic pipeline, followed by an interactive discussion and Q&A session. The conference, held from October 15-17, 2024, will feature presentations and discussions with CEOs and key management from various healthcare companies.
Alzamend Neuro is a clinical-stage biopharmaceutical company developing novel products for the treatment of Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Interested parties can register to watch the fireside chat through the provided link.
Alzamend Neuro (ALZN) has announced partnerships for five Phase II clinical trials of AL001, involving healthy subjects and patients with Alzheimer's, bipolar disorder, major depressive disorder, and PTSD. The company has secured funding for the next 18 months to finance these trials and those for ALZN002. AL001, their lead candidate, is a novel lithium-delivery system showing promising results in preclinical and Phase I studies. ALZN002, their secondary candidate, is an immunotherapy product for Alzheimer's, currently in Phase I/IIA trials. Alzamend has also addressed its Nasdaq compliance issues, with a panel granting a request to continue listing subject to meeting stockholder equity requirements by September 23, 2024.
Alzamend Neuro (NASDAQ: ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate, for patients with Post-Traumatic Stress Disorder (PTSD). The study, led by Harvard University Associate Professor Dr. Ovidiu Andronesi, aims to compare AL001 with a marketed lithium carbonate product to identify an ideal dose that is safe and effective. AL001 is designed to provide lithium treatment without requiring therapeutic drug monitoring, potentially offering an improved safety profile and enhanced brain biodistribution compared to current lithium-based treatments. This study could significantly impact the treatment of the 9+ million Americans affected by PTSD.
Alzamend Neuro (Nasdaq: ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic drug candidate for Major Depressive Disorder (MDD). The study, led by Harvard University Associate Professor Dr. Ovidiu Andronesi, aims to compare AL001 with a marketed lithium carbonate product to identify an ideal dose that is safe and effective.
AL001 is designed to provide lithium at a carbonate equivalent dose of 240 mg 3-times daily, potentially eliminating the need for therapeutic drug monitoring. This could be a significant improvement over current lithium-based treatments, which require regular monitoring due to a narrow therapeutic window. The study's objective is to assess the comparative increase in lithium levels within the brain and its structures, potentially impacting the 21+ million Americans afflicted with MDD.
Alzamend Neuro (ALZN) has partnered with Massachusetts General Hospital for a Phase II clinical trial of AL001, a next-generation lithium therapeutic for bipolar disorder. 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 lithium levels in the brain and its structures to identify an optimal dose of AL001 that is safe and effective.
AL001 is designed to provide lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, potentially eliminating the need for therapeutic drug monitoring. This could be a significant improvement over current lithium-based treatments, which require regular monitoring due to a narrow therapeutic window. The study could help Alzamend meet FDA regulatory safety standards through the Section 505(b)(2) pathway.
FAQ
What is the current stock price of Alzamend Neuro (ALZN)?
What is the market cap of Alzamend Neuro (ALZN)?
What is Alzamend Neuro's primary focus?
What are Alzamend's key therapeutic candidates?
What recent achievements has Alzamend Neuro made?
What is AL001?
What is ALZN002?
What financial steps has Alzamend taken recently?
Why is the recent Phase IIA study of AL001 significant?
What partnerships does Alzamend Neuro have?
How does AL001 improve on existing lithium treatments?
What is the mission of Alzamend Neuro?
