Aethlon Medical(AEMD) - 2023 Q2 - Quarterly Report

Financial Performance - Total assets increased to $23.05 million as of September 30, 2022, compared to $19.42 million as of March 31, 2022, representing a growth of approximately 18.5%[6] - Total current assets rose to $20.50 million, up from $18.16 million, marking an increase of about 12.9%[6] - Total liabilities increased to $3.18 million from $2.43 million, reflecting a rise of approximately 31%[7] - Net loss for the three months ended September 30, 2022, was $3.81 million, compared to a net loss of $2.01 million for the same period in 2021, indicating an increase in losses of about 89.1%[10] - Operating expenses for the three months ended September 30, 2022, totaled $3.67 million, up from $2.14 million in the prior year, representing an increase of approximately 71%[10] - Basic loss per share for the three months ended September 30, 2022, was $0.18, compared to $0.13 for the same period in 2021, reflecting a deterioration in per-share performance[10] - Weighted average number of common shares outstanding increased to 20,744,999 for the three months ended September 30, 2022, compared to 15,386,486 in the same period last year, an increase of approximately 35%[10] - For the six months ended September 30, 2022, the net loss was $6,715,166 compared to a net loss of $4,107,242 for the same period in 2021, representing an increase of approximately 63.5%[16] - Cash flows used in operating activities for the six months ended September 30, 2022, totaled $5,607,298, an increase from $3,949,961 in the prior year[16] - The company reported stock-based compensation of $528,975 for the six months ended September 30, 2022, compared to $321,216 in the same period of 2021, reflecting a 64.7% increase[16] Cash and Equity - Cash balance as of September 30, 2022, was $19.60 million, up from $17.07 million as of March 31, 2022, indicating a growth of about 14.8%[6] - Total stockholders' equity increased to $19.87 million as of September 30, 2022, from $16.99 million, representing an increase of approximately 16.5%[8] - The cash and restricted cash at the end of the period was $19,691,531, down from $23,271,651 at the end of the same period in 2021[18] - The company raised net proceeds of $8,927,211 from the sale of 7,480,836 shares at an average price of $1.19 per share under the 2022 ATM Agreement[42] Research and Development - The company is focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device for treating cancer and life-threatening viral infections[20] - The Hemopurifier has received FDA designation as a "Breakthrough Device" for treating advanced or metastatic cancer and life-threatening viruses[20] - The company is conducting a clinical trial for the Hemopurifier in patients with advanced and metastatic head and neck cancer, with initial focus on solid tumors[21] - The FDA approved the Investigational Device Exemption for an Early Feasibility Study of the Hemopurifier in combination with pembrolizumab, with a primary endpoint of safety[22] - The study at UPMC Hillman Cancer Center has treated two patients to date, but has been terminated due to lack of further patient enrollment[22] - The Hemopurifier has been used in small-scale human studies to treat infections from HIV, hepatitis-C, and Ebola, and has shown efficacy in capturing various viruses in vitro[23] - The FDA approved a supplement for the Hemopurifier to test its efficacy in COVID-19 patients, with a study designed to enroll up to 40 subjects across 20 centers in the U.S.[24] - A short-term disruption in Hemopurifier supply occurred as the existing supply expired on September 30, 2022, pending FDA approval for a new supplier[26] Operational Costs - Research and development expenses for the three months ended September 30, 2022, were $852,464, compared to $478,201 for the same period in 2021, reflecting a year-over-year increase of 78.2%[37] - Accrued professional fees as of September 30, 2022, were $741,529, indicating ongoing operational costs[48] - The company incurred total rent expense of approximately $309,000 and $167,000 for the six-month periods ended September 30, 2022, and 2021, respectively, reflecting an increase of 84.4%[75] Corporate Developments - The company dissolved its majority-owned subsidiary, Exosome Sciences, Inc., as of September 30, 2022, which had limited activities for over four years[27] - Aethlon Medical launched a wholly-owned subsidiary in Australia in October 2022, focusing initially on the oncology market[79] - The company provided a 30-day termination notice to the CRO in November 2022 due to lack of patient enrollment and delays in FDA approval[78] - Aethlon entered into a CRO Agreement on September 29, 2021, to manage clinical studies for the Hemopurifier, specifically targeting critically ill COVID-19 patients[78] - The CRO Agreement has a five-year term but can be terminated by Aethlon with a 30-day notice due to lack of patient enrollment and FDA approval delays[78] Market and Economic Conditions - The company is monitoring the impact of the COVID-19 pandemic, inflation, and the war in Ukraine on its business and capital access[29]