Alzamend Neuro(US:ALZN)2025-12-09 21:30Product Development - The company has developed two product candidates, AL001 and ALZN002, targeting Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder[103]. - AL001, an ionic cocrystal of lithium, has shown superior results in preclinical studies, preventing cognitive deficits and improving memory compared to traditional lithium carbonate treatments[109]. - A Phase IIA clinical trial for AL001 was completed in March 2023, with positive topline data announced in June 2023, and full data expected in October 2024[110]. - The maximum tolerated dose for AL001 was identified as 240 mg three times daily, designed to mitigate risks for fragile populations like Alzheimer's patients[111]. - The company plans to initiate five clinical trials to compare lithium levels in the brain between AL001 and marketed lithium salts, with a partnership established with Massachusetts General Hospital for these trials[115]. - ALZN002 is an active immunotherapy vaccine designed to treat mild to moderate Alzheimer's dementia, with a Phase I/IIA clinical trial initiated in April 2023[120][121]. - The company has received a "study may proceed" letter from the FDA for ALZN002, indicating regulatory progress for this product candidate[120]. - AL001's formulation aims to reduce systemic toxicity and improve brain bioavailability, potentially offering a safer long-term treatment option for patients[118]. Financial Performance - For the three months ended October 31, 2025, total operating expenses decreased by 27% to $998,109 from $1,358,068 in 2024[124]. - Research and development expenses for the three months ended October 31, 2025, were $176,283, a decrease of 43% from $311,088 in 2024[126]. - General and administrative expenses for the three months ended October 31, 2025, were $821,826, down 22% from $1,046,980 in 2024[130]. - The net loss for the three months ended October 31, 2025, was $1,000,758, a reduction of 26% compared to a net loss of $1,361,563 in 2024[124]. - For the six months ended October 31, 2025, research and development expenses surged by 270% to $1.9 million from $518,000 in 2024[139]. - Clinical trial fees for the six months ended October 31, 2025, increased significantly to $1.7 million from $124,000 in 2024, reflecting a 1,270% rise[141]. - The company did not generate any revenue during the three months ended October 31, 2025, and does not anticipate generating revenue in the foreseeable future[125]. - Basic and diluted net loss per common share improved to $(0.30) for the three months ended October 31, 2025, from $(3.61) in 2024[124]. - Total general and administrative expenses for the six months ended October 31, 2025, were $1.8 million, consistent with the previous year[143]. - The company incurred no marketing fees for the three months ended October 31, 2025, compared to $304,000 in 2024[136]. - Professional fees increased to $712,000 in the six months ended October 31, 2025, from $371,000 in the same period of 2024, primarily due to higher legal fees related to the termination of the ALZN002 clinical trial[146][147]. - Insurance expenses decreased to $118,000 in the six months ended October 31, 2025, compared to $139,000 in the same period of 2024[148]. - Stock-based compensation expense decreased to $74,000 in the six months ended October 31, 2025, from $163,000 in the same period of 2024, due to fewer stock options vesting[149]. - Marketing fees decreased to $150,000 in the six months ended October 31, 2025, from $344,000 in the same period of 2024[150]. - As of October 31, 2025, the company had cash of $4.4 million, working capital of $4.0 million, and an accumulated deficit of $62.2 million[152]. - The company reported net losses of $1.0 million and $3.7 million for the three and six months ended October 31, 2025, respectively[152]. - Net cash used in operating activities was $3.5 million for the six months ended October 31, 2025, primarily due to a net loss of $3.7 million[157]. - Net cash provided by financing activities was $4.0 million from the sale of Series C Convertible Preferred Stock during the six months ended October 31, 2025[159]. - The company will need to obtain substantial additional funding for clinical development activities and continuing operations[153]. Licensing and Royalties - Royalty payments for the AL001 License Agreements are set at 4.5% on net sales, with minimum royalties starting at $40,000 on the first anniversary of the first commercial sale[161].