| NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION | 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION Aethlon Medical, Inc., or 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, or 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 are currently working with our contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in
patients with solid tumors, including head and neck cancer, and gastrointestinal cancers. In January 2023, we entered into an agreement
with North American Science Associates, LLC, or NAMSA, a world leading medical technology CRO offering global end-to-end development
services, to oversee our planned clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement,
NAMSA agreed to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types
of cancer tumors. We recently completed an in vitro in vitro 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, or HIV, hepatitis-C and Ebola. Additionally, in vitro, On June 17, 2020, the FDA approved a supplement
to our open Investigational Device Exemption, or 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. That study was designed to enroll up to 40 subjects
at up to 20 centers in the United States. Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an ICU and
have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety,
included reduction in circulating virus, as well as clinical outcomes (NCT # 04595903). In January 2021, the Hemopurifier was used to
treat a viremic patient, under our emergency use approval, with a predicted risk of mortality of 80% and the Hemopurifier was able to
reduce the patient’s SARS-CoV-2 plasma viral load by 58.4%. 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. In October 2022, we launched a wholly owned subsidiary
in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary
will initially focus on the planned oncology trials in Australia. In August 2024, the Bellberry Human Research
Ethics Committee granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial
of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment
(AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco
Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia. In June 2024, the Human Research Ethics Committee
(HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for the same safety, feasibility and dose-finding
clinical trial 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) (AEMD-2022-06 Hemopurifier Study). The approval is valid
for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials
Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia. We also obtained ethics review board, or 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
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 Medanta Medicity Hospital and Maulana Azad Medical College, or 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, recent bank failures and 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, recent bank failures and the
ongoing military conflicts 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 three months ended June 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, or GAAP, for interim financial
information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, or 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, as well
as its previously majority-owned subsidiary, Exosome Sciences, Inc., which dissolved in September 2022. 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 June 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 months ended June 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 Management expects existing cash as of June
30, 2024 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these
condensed consolidated financial statements. In previous filings, we disclosed substantial doubt about our ability to continue as a
going concern due to recurring losses and negative cash flows. We have addressed these concerns by raising $ 5,379,229 787,000 964,000 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 10), we caused our bank to issue two standby letters of credit, or L/Cs,
in the aggregate amount of $ 87,506 |
