Alzamend Neuro(US:ALZN)2021-12-12 16:00Financial Performance - Research and development expenses for the three months ended October 31, 2021, were $1,750,050, a 268% increase from $474,913 in the same period of 2020[127] - General and administrative expenses for the three months ended October 31, 2021, were $1,833,884, a 123% increase from $823,033 in the same period of 2020[127] - Total operating expenses for the three months ended October 31, 2021, were $3,583,934, compared to $1,297,946 for the same period in 2020, reflecting a significant increase[127] - The net loss for the three months ended October 31, 2021, was $3,599,929, compared to a net loss of $1,354,097 for the same period in 2020, representing a 166% increase[127] - The basic and diluted net loss per common share for the three months ended October 31, 2021, was $(0.04), compared to $(0.02) for the same period in 2020[127] - Total operating expenses for the six months ended October 31, 2021, were $5.9 million, a significant increase from $2.6 million in the same period of 2020[146] - General and administrative expenses for the six months ended October 31, 2021, were $3.2 million, a 76% increase from $1.8 million in the prior year[148] - The company recorded a net loss of $5.9 million for the six months ended October 31, 2021, compared to a net loss of $2.7 million in the same period of 2020, representing a 122% increase in losses[146] - The company reported a net loss of $5.9 million for the six months ended October 31, 2021, compared to a net loss of $2.7 million for the same period in 2020[161] - The company expects to continue incurring losses for the foreseeable future and needs to raise additional capital until it can generate sufficient revenues[164] Revenue Generation - The company did not generate any revenues during the three months ended October 31, 2021, and does not anticipate generating revenue for the foreseeable future[129] - The company did not generate any revenue during the six months ended October 31, 2021, and does not anticipate generating revenue in the foreseeable future[147] Research and Development - The company submitted an Investigational New Drug (IND) application for AL001 to the FDA on June 30, 2021, and received a "Study May Proceed" letter on July 28, 2021[119] - The Phase I relative bioavailability study for AL001 began in September 2021, with topline data expected in mid to late December 2021[121] - The company has an additional preclinical candidate, AL002, which has transitioned to an extensive program of preclinical study and evaluation[122] - The FDA has agreed to a combined Phase 1/2 study for AL002, with the IND filing now expected in the second quarter of 2022[124] - Research and development expenses for the six months ended October 31, 2021, totaled $2.7 million, a 240% increase from $784,000 in the same period of 2020[155] - The company incurred interest expense of $30,000 for the six months ended October 31, 2021, related to a convertible promissory note[160] - The company experienced delays in drug development and manufacturing activities due to COVID-19, impacting clinical protocol development[173] - The Phase I relative bioavailability study for AL001 commenced on September 10, 2021, to determine safe dosing for future studies[163] Expenses - Stock compensation expense for the three months ended October 31, 2021, was $1.2 million, a 114% increase from $547,000 in the same period of 2020[132] - Professional fees for the three months ended October 31, 2021, were $232,000, up 40% from $166,000 in the prior year[133] - Research and development stock compensation expense for the three months ended October 31, 2021, was $111,000, a 410% increase from $22,000 in the same period of 2020[142] - Total general and administrative expenses for the six months ended October 31, 2021, included $1.8 million in stock compensation expense, a 58% increase from $1.1 million in the same period of 2020[149] - Professional fees increased by 197% to $2.1 million in the six months ended October 31, 2021, compared to $710,000 in 2020, primarily due to costs associated with the Phase I relative bioavailability study for AL001[157] Cash and Financing - As of October 31, 2021, the company had cash of $13.6 million and an accumulated deficit of $22.8 million[161] - Net cash provided by financing activities was $14.9 million for the six months ended October 31, 2021, primarily from the IPO proceeds of approximately $12.9 million[171] Licensing and Royalties - The company has accrued $65,000 in license fees related to the IND application submitted on June 30, 2021, and $190,000 for the first dosing of patients in the Phase I study for AL001[158] - The company has milestone payments totaling $9,600,000 related to the AL001 license agreements, with specific due dates tied to clinical trial events[181] - A royalty payment of 3% is required for License 18110, while License 1811 requires a 1.5% royalty on net sales of products developed from the licensed technology[181] Accounting and Reporting - The company does not have any off-balance sheet arrangements that materially affect its financial condition or operations[182] - Recent accounting standards may impact the company's financial statements, as detailed in Note 3 of the Notes to Unaudited Condensed Financial Statements[183] - The company is classified as a smaller reporting company, which exempts it from certain market risk disclosures[185]