Financial Performance - The net loss for the three months ended July 31, 2021, was $2,319,867, compared to a net loss of $1,316,752 for the same period in 2020, reflecting an increase of $1,003,115[128]. - Basic and diluted net loss per common share was $(0.03) for the three months ended July 31, 2021, compared to $(0.02) in the prior year[128]. - The company reported a net loss of $2.3 million for the three months ended July 31, 2021, compared to a net loss of $1.3 million for the same period in 2020[151]. - During the three months ended July 31, 2021, net cash used in operating activities was $1.2 million, compared to $205,000 for the same period in 2020[156]. - The company expects to continue incurring losses and needs to raise additional capital until it can generate sufficient revenues[155]. Expenses - Research and development expenses increased by 197% to $916,408 for the three months ended July 31, 2021, compared to $308,846 for the same period in 2020[128]. - General and administrative expenses rose by 38% to $1,389,831 for the three months ended July 31, 2021, up from $1,009,461 in the prior year[128]. - The total operating expenses for the three months ended July 31, 2021, were $2,306,239, an increase of $987,932 compared to $1,318,307 in 2020[128]. - Stock compensation expense for the three months ended July 31, 2021, was $597,705, a slight increase of 5% from $569,620 in the same period of 2020[132]. - Professional fees increased by 69% to $300,122 for the three months ended July 31, 2021, compared to $177,793 in the prior year[132]. - Professional fees for the three months ended July 31, 2021, were $705,000, representing a 174% increase from $257,000 in the same period of 2020[144]. - The company incurred $114,000 in regulatory filing services, $79,000 in audit fees, and $29,000 in legal fees during the three months ended July 31, 2021[138]. - The company accrued $65,000 in license fees during the three months ended July 31, 2021, related to its IND application submitted on June 30, 2021[146]. Revenue Generation - The company did not generate any revenue during the three months ended July 31, 2021, and does not anticipate generating revenue for the foreseeable future[130]. Capital and Funding - The company raised approximately $14.4 million from its IPO, which closed on June 17, 2021[154]. - As of July 31, 2021, the company had cash of $15.6 million and an accumulated deficit of $19.2 million[151]. Drug Development and Regulatory Milestones - The company submitted an 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[122]. - AL002 has transitioned from early-stage development to an extensive preclinical study program, with a comprehensive report received on July 23, 2021[123]. - The company has met the Pre-IND meeting and IND application filing milestones for AL001, with potential termination of the license agreement if future milestones are not met[171]. - Milestone payments for AL001 include $50,000 upon IND application filing and $10,000,000 upon FDA approval, with various other payments totaling $1,250,000 for Phase II and III clinical trials[167][168]. - The company experienced delays in drug development and manufacturing activities due to COVID-19, impacting clinical protocol development[164]. Licensing Agreements - The company has entered into a Standard Exclusive License Agreement for AL002 with a royalty-bearing exclusive worldwide license, requiring a 4% royalty on net sales and an initial license fee of $100,000[166]. - The company is required to pay a 3% royalty on net sales for License 18110 and a 1.5% royalty for License 1811, with initial license fees totaling $200,000 due in 2018[170]. Operational Status - The company expects to return to normal operations for the remainder of the calendar year following temporary office closures due to health recommendations[165]. - There are no off-balance sheet arrangements that materially affect the company's financial condition or operations[172].
Alzamend Neuro(ALZN) - 2022 Q1 - Quarterly Report