| NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION | 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION Aethlon Medical, Inc.
(“Aethlon,” the “Company,” “we” or “us”) is a medical therapeutic company focused on
developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral
infections and for use in organ transplantation. In human studies, 164 sessions with 38 patients, the Hemopurifier was safely
utilized and demonstrated the potential to remove life-threatening viruses. In pre-clinical studies, the Hemopurifier has
demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary
lectin-based technology. This action has potential applications in cancer, where exosomes and exosomal particles may promote immune
suppression and metastasis, and in life-threatening infectious diseases. The U.S. Food and Drug Administration (“FDA”)
has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
· the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease; and
· the treatment of life-threatening viruses that are not addressed with approved therapies. We believe the Hemopurifier may be a substantial
advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes
and exosomal particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned subsidiary in Australia
to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia. We have recently launched in Australia and in
India safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or
progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary
endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is safety. The following two hospitals in Australia have
received ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide Hospital
in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia. We have also trained a third hospital in Australia,
but we have not yet received ethics committee approval for that institution and have not yet begun patient enrollment. We have received ethics committee approval from
Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are
completing the necessary logistical steps before they can open for patient enrollment.. We have entered into an agreement with North American
Science Associates, LLC (“NAMSA”), a world leading medical technology contract research organization (“CRO”) offering
global end-to-end development services, to oversee our clinical trials of the Hemopurifier for patients in Australia with various types
of cancer tumors. We also have engaged Qualtran LLC as the CRO for our clinical trial in India. We also believe that the Hemopurifier can be part
of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an
already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected with human immunodeficiency virus (“HIV”), hepatitis-C and Ebola. Additionally, in vitro, On June 17, 2020, the FDA approved a supplement
to our open Investigational Device Exemption (“IDE”) for the Hemopurifier in viral disease to allow for the testing of the
Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. In June 2022, the first patient in this
study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of
our trial sites, we terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial
in India and wish to preserve the option of enrolling patients if the situation with COVID-19 changes. Under Single Patient Emergency Use regulations,
Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
in our COVID-19 clinical trial discussed above. We also obtained ethics review board (“ERB”)
approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India,
for a COVID-19 clinical trial at that location. In May 2023, we received ERB approval from the Medanta Medicity Hospital and Maulana Azad
Medical College (“MAMC”), for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established
in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government. We now have two sites in India for this trial
with the MAMC. One patient has been treated to date; however, we have been informed by our CRO that a new COVID-19 subvariant was detected
in India recently. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the ICUs at our sites in
India. Additionally, based on preclinical data with acellular
kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines, chemokines and other inflammatory molecules from recovered organs. We initially are focused on recovered kidneys from deceased
donors. We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in
vitro Successful outcomes of
human trials will also be required by the regulatory agencies of certain foreign countries where we plan to market and sell the Hemopurifier.
Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain
patent applications and/or other patents issued to us more recently will help protect the proprietary nature of our Hemopurifier treatment
technology. In addition to the foregoing, we are monitoring
closely the impact of inflation, the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as
well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty
regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines
and future access to capital. The full extent to which inflation, the ongoing military conflicts and other global instability will impact
our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments,
as well as the economic impact on national and international markets that are highly uncertain. We incorporated in Nevada on March 10, 1999. Our
executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360.
Our website address is www.aethlonmedical.com. Our common stock is listed on the Nasdaq Capital Market under the symbol
“AEMD.” SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES During the six months ended September 30, 2024,
there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended
March 31, 2024. REVERSE STOCK SPLIT On October 4, 2023, we effected a 1-for-10 60,000,000 Basis of Presentation and Use of Estimates Our accompanying unaudited condensed consolidated
financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim
financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission (“SEC”)
Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal
year ended March 31, 2024, included in our Annual Report on Form 10-K filed with the SEC on June 27, 2024. The accompanying unaudited
condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical
Australia Pty Ltd. All significant inter-company transactions and balances have been eliminated in consolidation. The accompanying unaudited
condensed consolidated financial statements, taken as a whole, contain all adjustments that are of a normal recurring nature necessary
to present fairly our operating results, cash flows, and financial position as of and for the period ended September 30, 2024. Estimates
were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial
and research and development expenses. Actual results could differ materially from those estimates. The accompanying condensed consolidated
balance sheet at March 31, 2024 has been derived from the audited consolidated balance sheet at March 31, 2024, contained in the above
referenced 10-K. The results of operations for the three and six months ended September 30, 2024 are not necessarily indicative of the
results to be expected for the full year or any future interim periods. Reclassifications Certain prior year balances within the unaudited
condensed consolidated financial statements have been reclassified to conform to the current year presentation, including the impact of
the reverse stock split. LIQUIDITY AND GOING CONCERN The accompanying unaudited condensed consolidated
financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the
realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations
and at September 30, 2024 had limited working capital and an accumulated deficit of $ 159,945,141 The successful outcome of future activities cannot
be determined at this time and there is no assurance that, if achieved, we will have sufficient funds to execute our intended business
plan or generate positive operating results. The condensed consolidated financial statements
do not include any adjustments related to this uncertainty and as to the recoverability and classification of asset carrying amounts or
the amount and classification of liabilities that might result should we be unable to continue as a going concern. Management expects that existing cash as of September
30, 2024 will not be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed
consolidated financial statements. The accompanying unaudited condensed consolidated
financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the
realization of assets and satisfaction of liabilities in the ordinary course of business. Restricted Cash To comply with the terms of our laboratory and
office lease and our lease for our manufacturing space (see Note 9), we caused our bank to issue two standby letters of credit (“L/Cs”)
in the aggregate amount of $ 87,506 |
