Aethlon Medical, Inc. 10-K
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(MARK ONE)
☒ ANNUAL REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended March 31, 2025
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to __________
COMMISSION FILE NUMBER 001-37487
Aethlon Medical, Inc.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
San Diego, California 92121
(Address of principal executive office) (Zip Code)
REGISTRANT’S TELEPHONE NUMBER, INCLUDING
AREA CODE: (619) 941-0360
SECURITIES REGISTERED PURSUANT TO SECTION 12(b)
OF THE EXCHANGE ACT:
SECURITIES REGISTERED UNDER SECTION 12(g) OF THE
EXCHANGE ACT:
NONE
(TITLE OF CLASS)
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes
☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”,
and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to § 240.10D-1(b). ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value of the common stock
held by non-affiliates of the registrant as of September 30, 2024 (the last trading day of the registrant’s most recently completed
second quarter) was approximately $6.65 million, computed by reference to the closing sale price of the common stock of $3.73 per share
on the Nasdaq Capital Market on September 30, 2024. Shares of common stock held by each executive officer and director and by each person
who owns 10% or more of the outstanding common stock have been excluded in that such persons may be deemed to be affiliates. The determination
of affiliate status is not necessarily a conclusive determination for other purposes.
The number of shares of the common stock of the registrant
outstanding as of June 24, 2025 was 2,585,316,
as adjusted for the Company’s 1-for-8 reverse stock split, which was effective as of the close of business on June 6, 2025
with an effective trading date of June 9, 2025.
TABLE OF CONTENTS
PAGE
PART I.
Item 1. Business 1
Item 1A. Risk Factors 16
Item 1B. Unresolved Staff Comments 47
Item 1C. Cybersecurity 47
Item 2. Properties 49
Item 3. Legal Proceedings 49
Item 4. Mine Safety Disclosures 49
PART II.
Item 6. [Reserved] 50
Item 7A. Quantitative and Qualitative Disclosures about Market Risk 59
Item 8. Financial Statements and Supplementary Data 59
Item 9A. Controls and Procedures 60
Item 9B. Other Information 61
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 61
PART III.
Item 10. Directors, Executive Officers and Corporate Governance 62
Item 11. Executive Compensation 66
Item 14. Principal Accountant Fees and Services 78
PART IV.
Item 15. Exhibits and Financial Statement Schedules 79
Signatures 83
i
CAUTIONARY
NOTICE REGARDING FORWARD LOOKING STATEMENTS
This Annual Report on Form
10-K, or Annual Report, contains “forward-looking statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act,
which are subject to the safe harbor created by those sections.
We may, in some cases, use
words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” or the negative of these terms, and similar expressions that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking
statements and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by
their nature, are inherently uncertain and beyond our control. Such statements, include, but are not limited to, statements contained
in this Annual Report relating to our business, business strategy, products and services we may offer in the future, the timing and results
of future regulatory filings, the timing and results of future clinical trials, and capital outlook. Forward-looking statements are based
on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward looking statements
relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our
actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical
fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements.
Important factors that could cause actual results to differ materially from those in the forward looking statements include, but are not
limited to, a decline in general economic conditions nationally and internationally; the ability to protect our intellectual property
rights; competition from other providers and products; risks in product development; inability to raise capital to fund continuing operations;
changes in government regulation; the ability to complete capital raising transactions, and other factors (including the risks contained
in Item 1A of this Annual Report under the heading “Risk Factors”) relating to our industry, our operations and results of
operations and any businesses that may be acquired by us. Should one or more of these risks or uncertainties materialize, or should the
underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected,
intended or planned.
Factors or events that could
cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them, nor can we assess
the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance
on these forward-looking statements. We cannot guarantee future results, levels of activity, performance or achievements. Except as required
by applicable law, we undertake no obligation to and do not intend to update any of the forward-looking statements to conform these statements
to actual results.
SUMMARY RISK FACTORS
Below is a summary of the principal factors that
make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion
of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors”
in Part I of this Annual Report and should be carefully considered, together with other information in this Annual Report and our other
filings with the SEC before making investment decisions regarding our securities.
ii
· Our Hemopurifier technology may become obsolete.
· Our success is dependent in part on our executive officers.
iii
PART I
ITEM 1. BUSINESS
Unless otherwise indicated
or the context otherwise requires, references to the “Company”, “Aethlon”, “we”, “us”
and “our” refer to Aethlon Medical, Inc.
Overview and Corporate History
Overview
We are a medical therapeutic
company focused on developing the Hemopurifier® (HP), a clinical-stage immunotherapeutic device intended for applications in cancer,
life-threatening viral infections, and organ transplantation and other areas of significant unmet needs. In human studies (164 sessions
with 38 patients), the Hemopurifier was used safely and demonstrated the potential to remove enveloped viruses. In pre-clinical studies,
the Hemopurifier has exhibited the capacity to remove harmful extracellular vesicles (EVs) and enveloped viruses from biological fluids,
utilizing its proprietary lectin-based mechanism. These extracellular vesicles have been implicated in disease processes such as immune
suppression and metastasis in cancer as well as in the progression of severe life-threatening infectious diseases. The U.S. Food and Drug
Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
We
are also evaluating the Hemopurifier’s potential in additional clinical contexts based on its mechanism of action and preclinical
findings.
Oncology
We believe that 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 remove harmful extracellular vesicles 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 completed an in vitro
binding study of extracellular vesicles from cancer patient samples, to provide pre-clinical evidence to support our trial design and
translational endpoints. Our study indicated positive results from this study, providing evidence that our Hemopurifier removes extracellular
vesicles, or EVs, from plasma. This translational study provides pre-clinical evidence to support our phase 1 safety, feasibility and
dose-finding clinical trials of our Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1
monotherapy treatment, such as Keytruda® or Opdivo®.
We have launched in an Australia
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-patients, is safety. Exploratory analyses will be conducted to explore the number of HP treatments required
to produce sustained reductions of EVs as well as improve anti-tumor T cell activity. We plan to open a similarly designed trial in India.
The following three hospitals
in Australia have received ethics committee approval, have gone through training on our device and are open for patient enrollment: Royal
Adelaide Hospital in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia and GenesisCare North Shore
Hospital in Sydney, Australia. As of June 26, 2025, we have treated three participants in the first of the three treatment cohorts. Once
these patients have completed the pre-specified 7-day safety follow-up period, the data will be presented to an independent Data Safety
Monitoring Board (DSMB). The DSMB will provide a recommendation to Aethlon senior leadership on advancing to the next cohort where participants
will receive 2 HP treatments during the one week treatment period.
The Company continues to pursue
approval of a similar clinical trial in India. HREC approval has previously been obtained at Medanta Medicity Hospital. Following this
a meeting with Subject Expert Committee (SEC) of the India Regulatory Agency CDSCO was held 5JUN2025. We are awaiting the formal approval
letter of the CDSCO. The clinical trial at Medanta can commence following a Site Initiation Visit (SIV) by the company’s India CRO,
Qualtran.
Life-Threatening Viral Infections
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, the
Hemopurifier has been demonstrated to capture Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex,
Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. In several cases, these studies
were conducted in collaboration with leading government or non-government research institutes.
The
Hemopurifier has previously been studied under FDA and international regulatory frameworks for the treatment of severe SARS-CoV-2 infection.
While we terminated our U.S. and India-based COVID-19 studies due to low ICU patient volume and shifting priorities, these programs demonstrated
real-world use of the Hemopurifier in critically ill patients. We maintain an open IDE for viral indications to preserve optionality for
future outbreaks or emergent pathogens.
We have sufficient inventory
of Hemopurifiers to support our ongoing oncology trial in Australia as well as any near-term expansion of that study or potential trial
activity in India. While we have received FDA approval to begin manufacturing at our San Diego facility under our IDE supplement, we are
still awaiting FDA approval of a separate supplement to qualify an additional supplier of a key Hemopurifier component. We continue to
work with the FDA on this process.
Pre-Clinical Exploration of Additional Clinical
Uses for the Hemopurifier
The
Aethlon R&D laboratory continues to explore potential new indications for the Hemopurifier. We have published in the peer-reviewed
journal Transplant Immunology the ability of the device to remove extracellular vesicles and their microRNA cargo from acellular
perfusates of discarded kidneys that had undergone normothermic machine perfusion.
On
May 12, 2025, the results of our pre-clinical ex vivo study entitled “Ex Vivo Removal of CD41 positive platelet microparticles from
Plasma by a Medical Device containing a Galanthus nivalis agglutinin (GNA) affinity resin” were published in the pre-print vehicle
bioRxiv. This manuscript has been submitted to a peer-reviewed publication for review.
Platelet-derived
extracellular vesicles (PD-EVs) are the most numerous EV population in the body and are released by platelets in response to a variety
of stimuli. The cargo contained within these EVs have been noted to take part in damage to blood vessels, activation of immune cells and
spread of tumor cells. Excessive levels of PD-EVs have been implicated in a myriad of diseases including cancer, lupus, systemic sclerosis,
multiple sclerosis, Alzheimer’s disease, sepsis, acute and Long COVID.
We
hypothesized that the Aethlon Hemopurifier which contains a propriety GNA affinity resin would remove platelet derived EVs from plasma.
In this experiment two hundred milliliters on donated healthy human plasma were circulated over the Aethlon Hemoupurifier (HP) to simulate
a clinical HP session. The study results showed a 98.5% removal of platelet -derived EVs at a timepoint equivalent to a 4-hour HP treatment.
The results of this study support the current Australian Clinical Trial in Oncology as well as open the investigation of the Hemopurifier
in many indications.
Extracellular
vesicles have been implicated in the pathogenesis of Long COVID. As we had previously demonstrated removal of extracellular vesicles
by the Hemopurifier in a patient with severe acute COVID-19 infection, we hypothesized that patients with Long COVID would have
extracellular vesicles with the mannose sugar on their surface that would bind to the affinity resin in our device. We partnered
with investigators at the Univ of California San Francisco Medical Center Long COVID clinic to obtain samples from participants with
Long COVID as well as controls that had had COVID -10 infection but had recovered. The data to be presented will review the binding
of larger and smaller extracellular vesicles to the GNA lectin and the lectin affinity resin, respectively. We believe the data from
this pre-clinical study calls for additional study of the Hemopurifier and look forward to receiving feedback from the Long COVID
scientific community at the Keystone Symposium.
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.
On March 10, 1999, Aethlon,
Inc., a California corporation, Hemex, Inc., a Delaware corporation and the accounting predecessor to Aethlon, Inc., and Bishop Equities,
Inc., a publicly traded Nevada corporation, completed an Agreement and Plan of Reorganization structured to result in Bishop Equities,
Inc.’s acquisition of all of the outstanding common stock of Aethlon, Inc. and Hemex, Inc. Under the plan’s terms, Bishop Equities, Inc.
issued shares of its common stock to the stockholders of Aethlon, Inc. and Hemex, Inc. such that Bishop Equities, Inc. then owned 100%
of each company. Upon completion of the transaction, Bishop Equities, Inc. was renamed Aethlon Medical, Inc. 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. The information contained on, or that can be accessed through, our website is not part of, and is not incorporated
into, this Annual Report.
The Mechanism of Action (MOA) of the Hemopurifier
The Hemopurifier is a lectin-affinity
plasmapheresis extracorporeal device designed for the removal of harmful extracellular vesicles and life-threatening enveloped viruses
from the plasma component of the bloodstream. In the United States, the Hemopurifier is classified as a combination product whose regulatory
jurisdiction is the Center for Devices and Radiological Health, or CDRH, the branch of FDA responsible for the premarket approval of all
medical devices.
In our current applications,
our Hemopurifier can be used with approved dialysis machines serving as a blood pump. It could also potentially be developed as part of
a proprietary closed system with its own pump and tubing set, negating the requirement for dialysis infrastructure.
The Hemopurifier - Clinical Experience
Hepatitis C and HIV
The initial clinical development
of the Hemopurifier focused on the viral infections Hepatitis C and HIV. Clinical trials conducted in India and a safety trial demonstrated
the removal of both viruses from the bloodstream with a benign safety profile. Prior to FDA approval of the IDE feasibility study, we
conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute in India.
In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier treatments during
the first three days of a 48-week peginterferon+ribavirin treatment regimen. The study was conducted under the leadership of Dr. Vijay
Kher. Dr. Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events in the 12
patients treated.
Of these 12 patients, ten
completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.
Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as
undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen. Both genotype-3 patients
achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines
a cure of the infection. Our IDE safety study in end stage renal disease patients on dialysis who were infected with HCV was conducted
at DaVita MedCenter Dialysis in Houston, Texas. We reported that there were no device-related adverse events in enrolled subjects who
met the study inclusion-exclusion criteria. We also reported that an average capture of 154 million copies of HCV (in International Units,
I.U.) within the Hemopurifier during four-hour treatments.
The initial clinical development
of the Hemopurifier was focused on the viral infections Hepatitis C and HIV. Clinical trials conducted in India and a safety trial demonstrated
the removal of both viruses from the bloodstream with a benign safety profile. Prior to FDA approval of the IDE feasibility study, we
conducted investigational HCV treatment studies at the Apollo Hospital, Fortis Hospital, and the Medanta Medicity Institute in India.
In the Medanta Medicity Institute study, 12 HCV-infected individuals were enrolled to receive three six-hour Hemopurifier treatments during
the first three days of a 48-week peginterferon+ribavirin treatment regimen. The study was conducted under the leadership of Dr. Vijay
Kher. Dr. Kher’s staff reported that Hemopurifier therapy was well tolerated and without device-related adverse events in the 12
treated.
Of these 12 patients, ten
completed the Hemopurifier-peginterferon+ribavirin treatment protocol, including eight genotype-1 patients and two genotype-3 patients.
Eight of the ten patients achieved a sustained virologic response, which is the clinical definition of treatment cure and is defined as
undetectable HCV in the blood 24 weeks after the completion of the 48-week peginterferon+ribavirin drug regimen. Both genotype-3 patients
achieved a sustained virologic response, while six of the eight genotype-1 patients achieved a sustained virologic response, which defines
a cure of the infection. Our IDE safety study in end stage renal disease patients on dialysis who were infected with HCV was conducted
at DaVita MedCenter Dialysis in Houston, Texas. We reported that there were no device-related adverse events in enrolled subjects who
met the study inclusion-exclusion criteria. We also reported that an average capture of 154 million copies of HCV (in International Units,
I.U.) within the Hemopurifier during four-hour treatments.
In addition to treating Ebola
and HCV-infected individuals, we also conducted a single proof-of-principle treatment study at the Sigma New Life Hospital in an AIDS
patient who was not being administered HIV antiviral drugs. In the study, viral load was reduced by 93% as the result of 12 Hemopurifier
treatments (each four hours in duration) that were administered over the course of one month.
With the advent of highly
effective anti-retroviral drugs for HIV (HAART), and curative direct acting antivirals (DACs) for Hepatitis C, clinical development for
these indications was abandoned.
Ebola Virus-Single Patient Emergency Use
Under Emergency use conditions a single patient
with Ebola infection with multiple organ dysfunction was treated with the Hemopurifier at Frankfurt University Hospital in Germany. The
patient tolerated a single 6.5-hour Hemopurifier treatment. Prior to treatment, the Ebola viral load was measured at 400,000 copies/ml.
The post-treatment viral load was 1,000 copies/ml. Calculations by the treating physician indicated that 242 million copies of Ebola virus
were captured within the Hemopurifier during treatment. The patient made a full recovery. Based on this experience, the Company filed
an Expanded Access protocol with the FDA to treat Ebola virus infected patients in up to ten centers in the United States and a corresponding
protocol was approved by HealthCanada. These protocols remain open, allowing Hemopurifier treatment to be offered to patients presenting
for care in both countries. In 2018, the FDA designated the Hemopurifier as a Breakthrough Device “... for the treatment of
life-threatening viruses that are not addressed with approved therapies.”
Severe Acute SARS-CoV-2/COVID-19Infection –
Emergency Use and Clinical Trials
SARS-COV-2, the
causative agent of COVID-19 is a member of the coronavirus family, which includes the original SARS virus, SARS-CoV, and the MERS
virus. SARS-CoV-2, found to contain mannose on the envelope surface. This suggests that the Hemopurifier could potentially clear it
from biological fluids, including blood.
Under Single Patient Emergency
Use regulations, we have treated two patients with COVID-19 with the Hemopurifier. We published a manuscript reviewing case studies covering
those two Single Patient Emergency Use treatments entitled “Removal of COVID-19 Spike Protein, Whole Virus, Exosomes and Exosomal
microRNAs by the Hemopurifier® Lectin-Affinity Cartridge in Critically Ill Patients with COVID-19 Infection” in the peer-reviewed
journal Frontiers in Medicine
The manuscript described the
use of the Hemopurifier for a total of nine sessions in two critically ill COVID-19 patients. The first case study demonstrated the improvement
in the patient who was a SARS-COV-2 positive COVID-19 present at entry to the hospital, with associated coagulopathy, or CAC, lung injury,
inflammation, and tissue injury despite the absence of demonstrable COVID-19 viremia at the start of treatment at Day 22.This patient
received eight Hemopurifier treatments without complications and eventually was weaned from a ventilator and was discharged from the hospital.
Plasma samples from this patient revealed a decrease in extracellular vesicle counts over the course of the eight treatments and decreases
in exosomal microRNAs associated with the development of coagulopathy and acute lung injury.
The second patient case study
demonstrated in vivo removal of SARS-CoV-2 virus from the blood stream of an infected patient. This patient completed a six-hour Hemopurifier
treatment without complications and subsequently was placed on continuous renal replacement therapy, or CRRT. The patient ultimately expired
three hours after being placed on CRRT because of the advanced stage of the patient’s disease.
On June 17, 2020, the FDA
approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with
SARS-CoV-2/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 had to have an 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,
include reduction in circulating virus, as well as clinical outcomes (NCT # 04595903). In June 2022, the Company completed the treatment
protocol for its first patient in this study.
In
June 2022, the Company completed the treatment protocol of the only participant enrolled in the study. study. The patient received one
HP treatment daily for 4 days. This patient died following cardiac arrest (not related to the HP treatment) as a consequence of severe
COVID-19 pneumonia. Blood samples taken from the patient did not reveal any evidence of viremia. Plasma sent for cytokine analysis revealed
a numeric decrease in the levels of IP-10, MCP-1, and IL-10.
A similarly designed trial
was also conducted in India. One patient was enrolled on February 16, 2022, at Medanta Medicity Hospital, Gurugram, Haryana 12200, India.
The patient tolerated one HP treatment daily for three days. On 19 February 2022, in the first 15 min during the 3rd treatment, one nonserious
Grade 2 AE was reported (hemolysis and leaking of the filter). The filter was replaced, and therapy resumed without sequalae. On Day #4
the patient suffered asystole and died due to clinical deterioration unrelated to the device. During the first Hemopurifier treatment
(T1) there was a gradual decrease in viral load from the baseline at 4923 copies/mL decreasing steadily to 1307 copies/mL over five hours,
indicating a 73% reduction from baseline. At the beginning of the second Hemopurifier treatment (T2), the viral load was 850 copies/mL,
dropped below the lower limit of quantification within an hour, and remained undetectable, suggesting rapid clearance. The viral load
before the third treatment (T3) was below the quantification limit but unexpectedly rose at 3 hours (636 copies/mL), peaking at 4 hours
(1583 copies/mL), and slightly decreasing at 5 hours (1104 copies/mL). This irregular pattern suggests possible delayed RNA release, sample
variability, or another biological factor affecting detection. The cumulative data shows a reduced SARs-CoV-2 viral load during the first
two Hemopurifier treatments but not during the third treatment.
Due to lack of eligible patients
in the ICU the clinical trial was closed as November 22, 2022.
Oncology- U.S. Clinical Trial in Head and Neck
Cancer
A single center clinical trial
entitled “Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer: An Early Feasibility Phase
I Clinical Trial” was conducted under a US IDE at the University of Pittsburgh. This was a single arm Phase 1 clinical trial designed
to evaluate the safety and efficacy of the Hemopurifier plus pembrolizumab for the treatment of patients with recurrent or metastatic
head and neck squamous cell cancer. All patients were treated with pembrolizumab every 21 days as standard of care. The patients were
to receive a 4-hour Hemopurifier treatment before Pembrolizumab infusions 2 occasions 21 days apart. A total of 2 patients were enrolled
in the study with the first occurring on Dec 14, 2020. The first patients received 2 HP treatments, and the second patient received one
HP treatment. The second treatment in the second patient was terminated due to operator error. Eighteen no serious adverse events occurred
in the two patients with none thought related to the device.
The only exploratory efficacy
laboratory analysis that was performed in this study was a determination of the total nanoparticle concentrations in the 1st patient prior
to and for 14 days after the second HP treatment. Total nanoparticle concentrations decreased following each Hemopurifier treatment. Following
Hemopurifier treatment, the total nanoparticle concentrations rose by about Day 7 but did not reach the baseline levels. Exosomes levels
are a component of the total nanoparticle concentration but exosome levels over time were not specifically determined.
Research and Development Costs
A substantial portion of our
operating budget is used for research and development activities. The cost of research and development, all of which has been charged
to operations, amounted to approximately $2,212,000 and $2,520,000 in the fiscal years ended March 31, 2025 and 2024, respectively.
Recent Developments
On June 25,
2025, the Company received notice from Nasdaq stating the Company has regained compliance with Listing Rule 5550(a)(2), and that
the matter is now closed.
Reverse
Split – Following the approval of a reverse stock split at a Special Meeting of Stockholders on May 13, 2025, our Board of Directors
approved a 1-for-8 reverse stock split of our outstanding shares of Common Stock, effective as of the close of business on June 6, 2025
with an effective trading date of June 9, 2025. Accordingly, each eight shares of outstanding common stock held by stockholders were combined
into one share of common stock. Our authorized common stock remained at 60,000,000 shares following the stock split. We issued an additional
77 shares as a result of rounding up fractional shares related to the reverse stock split.
On
June 2, 2025 a second patient was treated with the Hemopurifier at GenesisCare North Shore Hospital in Sydney, Australia. The patient
was treated with the Aethlon Hemopurifier for 4 hours in a single day and tolerated the procedure without complications. The patient will
have follow-up safety visits, EV and T cell measurements as well as imaging for clinical response.
Intellectual Property
We currently own or have license
rights to a number of U.S. and foreign patents and patent applications and endeavor to continually improve our intellectual property position.
We consider the protection of our technology, whether owned or licensed, to the exclusion of use by others, to be vital to our business.
While we intend to focus primarily on patented or patentable technology, we also rely on trade secrets, unpatented property, know-how,
regulatory exclusivity, patent extensions and continuing technological innovation to develop our competitive position. We also own certain
trademarks.
Our success depends in large
part on our ability to protect our proprietary technology, including the Hemopurifier product platform, and to operate without infringing
the proprietary rights of third parties. We rely on a combination of patent, trade secret, copyright and trademark laws, as well as confidentiality
agreements, licensing agreements and other agreements, to establish and protect our proprietary rights. Our success also depends, in part,
on our ability to avoid infringing patents issued to others. If we were judicially determined to be infringing on any third-party patent,
we could be required to pay damages, alter our products or processes, obtain licenses or cease sales of products or certain activities.
To protect our proprietary
medical technologies, including the Hemopurifier product platform and other scientific discoveries, we have a portfolio of over 32 issued
patents and pending applications worldwide. We currently have three issued U.S. patents and 14 issued patents in countries outside of
the United States. In addition, we have 15 patent applications pending worldwide related to our Hemopurifier product platform and other
technologies. We are seeking additional patents on our scientific discoveries.
It is possible that our pending
patent applications may not result in issued patents, that we will not develop additional proprietary products that are patentable, that
any patents issued to us may not provide us with competitive advantages or will be challenged by third parties and that the patents of
others may prevent the commercialization of products incorporating our technology. Furthermore, others may independently develop similar
products, duplicate our products or design around our patents. U.S. patent applications are not immediately made public, so it is possible
that a third party may obtain a patent on a technology we are actively using.
There is a risk that any patent
applications that we file and any patents that we hold or later obtain could be challenged by third parties and declared invalid or unenforceable.
For many of our pending applications, patent interference proceedings may be instituted with the U.S. Patent and Trademark Office, or
the USPTO, when more than one person files a patent application covering the same technology, or if someone wishes to challenge the validity
of an issued patent. At the completion of the interference proceeding, the USPTO will determine which competing applicant is entitled
to the patent, or whether an issued patent is valid. Patent interference proceedings are complex, highly contested legal proceedings,
and the USPTO’s decision is subject to appeal. This means that if an interference proceeding arises with respect to any of our patent
applications, we may experience significant expenses and delays in obtaining a patent, and if the outcome of the proceeding is unfavorable
to us, the patent could be issued to a competitor rather than to us. Third parties can file post-grant proceedings in the USPTO,
seeking to have issued patent invalidated, within nine months of issuance. This means that patents undergoing post-grant proceedings may
be lost, or some or all claims may require amendment or cancellation, if the outcome of the proceedings is unfavorable to us. Post-grant
proceedings are complex and could result in a reduction or loss of patent rights. The institution of post-grant proceedings against our
patents could also result in significant expenses.
Patent law outside the United
States is uncertain and in many countries, is currently undergoing review and revisions. The laws of some countries may not protect our
proprietary rights to the same extent as the laws of the United States. Third parties may attempt to oppose the issuance of patents to
us in foreign countries by initiating opposition proceedings. Opposition proceedings against any of our patent filings in a foreign country
could have an adverse effect on our corresponding patents that are issued or pending in the United States. It may be necessary or useful
for us to participate in proceedings to determine the validity of our patents or our competitors’ patents that have been issued
in countries other than the United States. This could result in substantial costs, divert our efforts and attention from other aspects
of our business, and could have a material adverse effect on our results of operations and financial condition. Outside of the United
States, we currently have pending patent applications or issued patents in Europe, India, Russia, Canada, Japan, Singapore and Hong Kong.
In addition to patent protection,
we rely on unpatented trade secrets and proprietary technological expertise. It is possible that others could independently develop or
otherwise acquire substantially equivalent technology, somehow gain access to our trade secrets and proprietary technological expertise
or disclose such trade secrets, or that we may not successfully ultimately protect our rights to such unpatented trade secrets and proprietary
technological expertise. We rely, in part, on confidentiality agreements with our marketing partners, employees, advisors, vendors and
consultants to protect our trade secrets and proprietary technological expertise. We cannot assure you that these agreements will not
be breached, that we will have adequate remedies for any breach or that our unpatented trade secrets and proprietary technological expertise
will not otherwise become known or be independently discovered by competitors.
Patents
The following table lists
our issued patents and patent applications, including their ownership status, including relevant patent term adjustments (PTA), which
is a process of extending the term of a U.S. patent:
Patents Issued in the United States
PATENT # PATENT NAME ISSUANCE DATE OWNED OR LICENSED EXPIRATION DATE
Patent Applications Pending in the United States
APPLICATION # APPLICATION NAME FILING DATE OWNED OR LICENSED
Foreign Patents
PATENT # PATENT NAME ISSUANCE DATE OWNED OR LICENSED EXPIRATION DATE
Pending Foreign Patent Applications
APPLICATION # APPLICATION NAME FILING DATE OWNED OR LICENSED
Pending International Patent Applications
APPLICATION # APPLICATION NAME FILING DATE OWNED OR LICENSED
Trademarks
APPLICATION NAME Countries Priority Date OWNED OR LICENSED
*SANSAGITTA Madrid, Australia, Canada, the EU, UK, and India 7/8/2021 Owned
* The US Application for SANSAGITTA abandoned
on 12/2/24. It was used as the basis application for a Madrid registration, and the corresponding above-listed designated country registrations
can be converted to national applications to avoid abandonment.
Trademarks
In addition to the Sansagitta
trademarks noted in the above table, we also have trademark registrations in the United States for Hemopurifier and Aethlon Medical, Inc.,
and obtained a trademark registration in India for Hemopurifier. We also have common law trademark rights in Aethlon ADAPTTM and
ELLSATM.
Industry & Competition
The industry for treating
infectious disease and cancer is extremely competitive, and companies developing new treatment procedures face significant capital and
regulatory challenges. As our Hemopurifier is a clinical-stage device, we have the additional challenge of establishing medical industry
support, which will be driven by treatment data resulting from human clinical studies. Should our device become market cleared by the
FDA or the regulatory body of another country, we may face significant competition from well-funded pharmaceutical organizations. Additionally,
we would likely need to establish large-scale production of our device in order to be competitive. Our competitors include blood filters
produced by ExThera Medical Corporation.
Government Regulation
The Hemopurifier is subject
to regulation by numerous regulatory bodies, primarily the FDA, and comparable international regulatory agencies. These agencies require
manufacturers of medical devices to comply with applicable laws and regulations governing the development, testing, manufacturing, labeling,
marketing, storage, distribution, advertising and promotion, and post-marketing surveillance reporting of medical devices. As the primary
mode of action of the Hemopurifier is attributable to the device component of this combination product, the CDRH has primary jurisdiction
over its premarket development, review and approval. Failure to comply with applicable requirements may subject a device and/or its manufacturer
to a variety of administrative sanctions, such as issuance of warning letters, import detentions, civil monetary penalties and/or judicial
sanctions, such as product seizures, injunctions and criminal prosecution.
FDA’s Pre-market Clearance and Approval
Requirements
Each medical device we seek
to commercially distribute in the United States will require either a prior 510(k) clearance, unless it is exempt, or a pre-market approval
from the FDA. Generally, if a new device has a predicate that is already on the market under a 510(k) clearance, the FDA will allow that
new device to be marketed under a 510(k) clearance; otherwise, a premarket approval, or PMA, is required. Medical devices are classified
into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each
medical device and the extent of control needed to provide reasonable assurance of safety and effectiveness. Class I devices are
deemed to be low risk and are subject to the general controls of the Federal Food, Drug and Cosmetic Act, such as provisions that relate
to: adulteration; misbranding; registration and listing; notification, including repair, replacement, or refund; records and reports;
and good manufacturing practices. Most Class I devices are classified as exempt from pre-market notification under section 510(k)
of the FD&C Act, and therefore may be commercially distributed without obtaining 510(k) clearance from the FDA. Class II devices
are subject to both general controls and special controls to provide reasonable assurance of safety and effectiveness. Special controls
include performance standards, post market surveillance, patient registries and guidance documents. A manufacturer may be required to
submit to the FDA a pre-market notification requesting permission to commercially distribute some Class II devices. Devices deemed
by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially
equivalent to a previously cleared 510(k) device, are placed in Class III. A Class III device cannot be marketed in the United
States unless the FDA approves the device after submission of a PMA. However, there are some Class III devices for which FDA has
not yet called for a PMA. For these devices, the manufacturer must submit a pre-market notification and obtain 510(k) clearance in orders
to commercially distribute these devices. The FDA can also impose sales, marketing or other restrictions on devices in order to assure
that they are used in a safe and effective manner. We believe that the Hemopurifier will be classified as a Class III device and as such
will be subject to PMA submission and approval.
Pre-market Approval Pathway
A pre-market approval application
must be submitted to the FDA for Class III devices for which the FDA has required a PMA. The pre-market approval application process
is much more demanding than the 510(k) pre-market notification process. A pre-market approval application must be supported by extensive
data, including but not limited to technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s
satisfaction reasonable evidence of safety and effectiveness of the device.
After a pre-market approval
application is submitted, the FDA has 45 days to determine whether the application is sufficiently complete to permit a substantive review
and thus whether the FDA will file the application for review. The FDA has 180 days to review a filed pre-market approval application,
although the review of an application generally occurs over a significantly longer period of time and can take up to several years. During
this review period, the FDA may request additional information or clarification of the information already provided. Also, an advisory
panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as
to the approvability of the device.
Although the FDA is not bound
by the advisory panel decision, the panel’s recommendations are important to the FDA’s overall decision making process. In
addition, the FDA may conduct a preapproval inspection of the manufacturing facility to ensure compliance with the Quality System Regulation,
or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.
Upon completion of the PMA
review, the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more
indications, which can be more limited than those originally sought; (ii) issue an approvable letter which indicates the FDA’s
belief that the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must
be agreed to prior to approval; (iii) issue a not approvable letter which outlines steps required for approval, but which are typically
more onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming
and can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvable
letter, the applicant has 180 days to respond, after which the FDA’s review clock is reset.
Emergency Use Authorizations,
or EUAs, are granted by FDA in public health emergencies but allow use of the authorized device only during the period of the respective
public health emergency, and do not change the requirement to ultimately seek PMA approval after the authorization period has ended.
Clinical Trials
Clinical trials are almost
always required to support pre-market approval and are sometimes required for 510(k) clearance. In the United States, for significant
risk devices, these trials require submission of an application for an IDE to the FDA. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is
scientifically sound. The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites. During
the trial, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial monitoring, reporting and recordkeeping.
The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition
of investigational devices and comply with all reporting and recordkeeping requirements. Clinical trials for significant risk devices
may not begin until the IDE application is approved by the FDA and the appropriate institutional review boards, or IRBs, at the clinical
trial sites. An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving
subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety and welfare
of human research subjects. The FDA or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical
trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply
with FDA or IRB requirements. Even if a trial is completed, the results of clinical testing may not demonstrate the safety and effectiveness
of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.
Ongoing Regulation by the FDA
Even after a device receives clearance or approval
and is placed on the market, numerous regulatory requirements apply. These include:
· establishment registration and device listing;
Some changes to an approved
PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of
a new PMA or PMA supplement, as appropriate, before the change can be implemented. Supplements to a PMA often require the submission of
the same type of information required for an original PMA, except that the supplement is generally limited to that information needed
to support the proposed change from the device covered by the original PMA. The FDA uses the same procedures and actions in reviewing
PMA supplements as it does in reviewing original PMAs.
Failure by us or by our suppliers
to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include
any of the following sanctions:
· operating restrictions, partial suspension or total shutdown of production;
· withdrawing approvals that have already been granted; and
· criminal prosecution.
The Medical Device Reporting
laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably
suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause
or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being
marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label
uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial
monetary penalties and criminal prosecution.
Newly discovered or developed
safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications,
and also may require the implementation of other risk management measures. Also, new government requirements, including those resulting
from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or
approval of our products under development.
Healthcare Regulation
In addition to the FDA’s
restrictions on marketing of pharmaceutical products, the U.S. healthcare laws and regulations that may affect our ability to operate
include: the federal fraud and abuse laws, including the federal anti-kickback and false claims laws; federal data privacy and security
laws; and federal transparency laws related to payments and/or other transfers of value made to physicians (defined to include doctors,
dentists, optometrists, podiatrists and chiropractors) and other healthcare professionals (such as physicians assistants and nurse practitioners)
and teaching hospitals. Many states have similar laws and regulations that may differ from each other and federal law in significant ways,