Alzamend Neuro(US:ALZN)2022-09-12 16:00Drug Development and Clinical Trials - Alzamend Neuro submitted an Investigational New Drug (IND) application for AL001 to the FDA on June 30, 2021, and received a "Study May Proceed" letter for a Phase I study on July 28, 2021[99]. - The Phase I study for AL001 aims to determine safe dosing for Alzheimer's patients, with a proposed dose of 150 mg lithium carbonate equivalent, which is 50% of the currently approved dosage[105]. - Alzamend has an additional preclinical candidate, AL002, which has transitioned to extensive preclinical studies, with positive toxicology results supporting its development[102]. - The company plans to conduct a combined Phase I/II study for AL002, with the IND filing now expected in Q3 2022 due to extended timelines[104]. - The Phase IIA study for AL001 commenced enrollment in May 2022, evaluating safety and tolerability under multiple doses in patients with mild to moderate Alzheimer's[108]. - The maximum tolerated dose from the Phase IIA trial will inform further studies, with a target dose of 450 mg daily for Alzheimer's treatment[110]. - The company has contracted with Altasciences and iResearch to manage and conduct its clinical studies for AL001[108]. Financial Performance - Research and development expenses increased by 50% to $1,375,953 in Q3 2022 from $916,408 in Q3 2021[124]. - General and administrative expenses rose by 19% to $1,659,589 in Q3 2022 compared to $1,389,831 in Q3 2021[116]. - Net loss for Q3 2022 was $3,037,074, a 31% increase from the net loss of $2,319,867 in Q3 2021[130]. - Basic and diluted net loss per common share remained at $(0.03) for both Q3 2022 and Q3 2021[130]. - Cash balance as of July 31, 2022, was $11.5 million, with an accumulated deficit of $32.2 million[130]. - Net cash used in operating activities for Q3 2022 was $2,536,690, compared to $1,222,664 in Q3 2021[137]. - Professional fees in research and development increased by 73% to $1,216,672 in Q3 2022 from $704,692 in Q3 2021[126]. - Interest expense decreased significantly by 89% to $(1,532) in Q3 2022 from $(13,628) in Q3 2021[130]. - The company does not anticipate generating revenue for the foreseeable future as its product candidates are still in early clinical stages[115]. - The company expects to continue incurring losses and will need to raise additional capital to fund operations and development activities[133]. Licensing and Royalties - The company has entered into a Standard Exclusive License Agreement for AL002, granting a royalty-bearing exclusive worldwide license for Alzheimer's Immunotherapy and Diagnostics[138]. - The company is required to pay a royalty of 4% on net sales for AL002 and 4.5% for AL001, with initial license fees of $200,000 each for AL001 and AL002[139]. - Minimum royalties for AL001 are set at $25,000 in 2023, $45,000 in 2024, and $70,000 in 2025, while AL002 minimum royalties are $20,000 in 2022, $40,000 in 2023, and $50,000 in 2024[139]. - Milestone payments for AL001 include $1,250,000 due 12 months from the completion of the first Phase II clinical trial and $10,000,000 upon FDA approval[140]. - For AL002, milestone payments include $1,000,000 due 12 months from the completion of the first Phase II clinical trial and $10,000,000 upon FDA BLA approval[142]. - The company has obtained two additional licenses for AL001, requiring a 3% royalty on net sales and initial license fees of $20,000[144]. - Milestone payments for the additional AL001 licenses include $1,000,000 due 36 months from the completion of the first Phase II clinical trial and $8,000,000 upon the first commercial sale[145]. Financial Condition and Market Classification - The company has no off-balance sheet arrangements that materially affect its financial condition or operations[146]. - Recent accounting standards may impact the company's financial statements, as noted in the financial disclosures[147]. - The company is classified as a smaller reporting company, making certain market risk disclosures not applicable[147]. Treatment Approach - Alzamend's approach to Alzheimer's treatment focuses on immunotherapy, aiming to provide a potential cure rather than just symptom relief[90].