Alzamend Neuro Inc Stock Price, News & Analysis

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.

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.