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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2024
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)
nevada |
13-3632859 |
(State or other jurisdiction
of incorporation or organization) |
(I.R.S. Employer Identification
No.) |
|
|
11555 SORRENTO VALLEY ROAD, SUITE 203, SAN DIEGO, CA |
92121 |
(Address of principal executive
offices) |
(Zip Code) |
(619) 941-0360
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
TITLE OF EACH CLASS
COMMON STOCK, $0.001 PAR VALUE |
TRADING SYMBOL
AEMD |
NAME OF EACH EXCHANGE ON WHICH REGISTERED
NASDAQ CAPITAL MARKET |
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.
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
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of August 14, 2024, the registrant had outstanding
13,937,327 shares of common stock, $0.001 par value.
TABLE OF CONTENTS
CAUTIONARY NOTICE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly
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 Quarterly
Report relating to our business, business strategy, products and services we may offer in the future, the timing and results of future
clinical trials, and capital outlook, successful completion of our clinical trials, our ability to raise additional capital, our ability
to maintain our Nasdaq listing, U.S. Food and Drug Administration, or FDA, approval of our products candidates, our ability to comply
with changing government regulations, patent protection of our proprietary technology, product liability exposure, uncertainty of market
acceptance, competition, technological change, and other risk factors detailed herein and in other of our filings with the Securities
and Exchange Commission, or the SEC. 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 statement 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, and other factors (including
the risks contained in Item 1A of our most recent Annual Report on Form 10-K 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.
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
| |
| | |
| |
| |
June 30, 2024 | | |
March 31, 2024 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 9,072,379 | | |
$ | 5,441,978 | |
Deferred Offering Cost | |
| – | | |
| 277,827 | |
Prepaid expenses and other current assets | |
| 478,058 | | |
| 505,983 | |
Total current assets | |
| 9,550,437 | | |
| 6,225,788 | |
| |
| | | |
| | |
Property and equipment, net | |
| 929,306 | | |
| 1,015,229 | |
Operating lease right-of-use asset | |
| 813,900 | | |
| 883,054 | |
Patents, net | |
| 963 | | |
| 1,100 | |
Restricted cash | |
| 87,506 | | |
| 87,506 | |
Deposits | |
| 33,305 | | |
| 33,305 | |
Total assets | |
$ | 11,415,417 | | |
$ | 8,245,982 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,068,134 | | |
$ | 777,862 | |
Due to related parties | |
| 732,518 | | |
| 546,434 | |
Operating lease liability, current portion | |
| 296,093 | | |
| 290,565 | |
Other current liabilities | |
| 32,203 | | |
| 215,038 | |
Total current liabilities | |
| 2,128,948 | | |
| 1,829,899 | |
| |
| | | |
| | |
Operating lease liability, less current portion | |
| 573,852 | | |
| 649,751 | |
Total liabilities | |
| 2,702,801 | | |
| 2,479,650 | |
| |
| | | |
| | |
Stockholders’ Equity | |
| | | |
| | |
Common stock, par value $0.001 per share; 60,000,000 shares authorized as of June
30, 2024 and March 31, 2024; 13,937,327 and 2,629,725 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively | |
| 13,937 | | |
| 2,629 | |
Additional paid-in capital | |
| 165,844,620 | | |
| 160,337,371 | |
Accumulated other comprehensive loss | |
| (7,773 | ) | |
| (6,940 | ) |
Accumulated deficit | |
| (157,138,168 | ) | |
| (154,566,728 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 8,712,616 | | |
| 5,766,332 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 11,415,417 | | |
$ | 8,245,982 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Month Periods Ended June 30, 2024
and 2023
(Unaudited)
| |
| | |
| |
| |
Three Months Ended June 30, 2024 | | |
Three Months Ended June 30, 2023 | |
| |
| | |
| |
OPERATING EXPENSES | |
| | | |
| | |
| |
| | | |
| | |
Professional fees | |
$ | 614,082 | | |
$ | 976,638 | |
Payroll and related expenses | |
| 1,254,802 | | |
| 1,123,239 | |
General and administrative | |
| 751,974 | | |
| 1,308,283 | |
Total operating expenses | |
| 2,620,858 | | |
| 3,408,160 | |
OPERATING LOSS | |
| (2,620,858 | ) | |
| (3,408,160 | ) |
| |
| | | |
| | |
OTHER INCOME | |
| | | |
| | |
Interest income | |
| 49,418 | | |
| 125,981 | |
| |
| | | |
| | |
NET LOSS | |
| (2,571,440 | ) | |
| (3,282,179 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. | |
| (2,571,440 | ) | |
| (3,282,179 | ) |
| |
| | | |
| | |
OTHER COMPREHENSIVE LOSS | |
| (833 | ) | |
| (994 | ) |
| |
| | | |
| | |
COMPREHENSIVE LOSS | |
$ | (2,572,273 | ) | |
$ | (3,283,173 | ) |
| |
| | | |
| | |
Basic and diluted net loss per share attributable to common stockholders | |
$ | (0.34 | ) | |
$ | (1.35 | ) |
| |
| | | |
| | |
Weighted average number of common shares outstanding – basic and diluted | |
| 7,457,888 | | |
| 2,431,476 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
For the Three Months Ended June 30, 2024 and 2023
(Unaudited)
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| |
ATTRIBUTABLE TO AETHLON
MEDICAL, INC. | | |
| | |
| | |
| |
| |
COMMON STOCK | | |
ADDITIONAL PAID IN | | |
ACCUMULATED | | |
ACCUMULATED COMPREHENSIVE | | |
NON- CONTROLLING | | |
TOTAL | |
| |
SHARES | | |
AMOUNT | | |
CAPITAL | | |
DEFICIT | | |
LOSS | | |
INTERESTS | | |
EQUITY | |
BALANCE – MARCH
31, 2024 | |
| 2,629,725 | | |
$ | 2,629 | | |
$ | 160,337,371 | | |
$ | (154,566,728 | ) | |
$ | (6,940 | ) | |
$ | – | | |
$ | 5,766,332 | |
Issuances of common stock for public
offering | |
| 8,100,000 | | |
| 8,100 | | |
| 3,531,807 | | |
| – | | |
| – | | |
| – | | |
| 3,539,907 | |
Issuances of common stock for Class A and Class B warrant exercises | |
| 3,180,000 | | |
| 3,180 | | |
| 1,841,220 | | |
| – | | |
| – | | |
| – | | |
| 1,844,400 | |
Issuance of common shares upon vesting
of restricted stock units and net stock option exercises | |
| 27,602 | | |
| 28 | | |
| (5,106 | ) | |
| – | | |
| – | | |
| – | | |
| (5,078 | ) |
Stock-based compensation expense | |
| – | | |
| – | | |
| 139,328 | | |
| – | | |
| – | | |
| – | | |
| 139,328 | |
Net loss | |
| – | | |
| – | | |
| – | | |
| (2,571,440 | ) | |
| – | | |
| – | | |
| (2,571,440 | ) |
Other comprehensive
loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| (833 | ) | |
| – | | |
| (833 | ) |
BALANCE –
JUNE 30, 2024 | |
| 13,937,327 | | |
$ | 13,937 | | |
$ | 165,844,620 | | |
$ | (157,138,168 | ) | |
$ | (7,733 | ) | |
$ | – | | |
$ | 8,712,616 | |
|
|
COMMON
STOCK |
|
|
ADDITIONAL
PAID IN |
|
|
ACCUMULATED |
|
|
ACCUMULATED
COMPREHENSIVE |
|
|
NON-
CONTROLLING |
|
|
TOTAL |
|
|
|
SHARES |
|
|
AMOUNT |
|
|
CAPITAL |
|
|
DEFICIT |
|
|
LOSS |
|
|
INTERESTS |
|
|
EQUITY |
|
BALANCE
– MARCH 31, 2023 |
|
|
2,299,259 |
|
|
$ |
2,299 |
|
|
$ |
157,426,606 |
|
|
$ |
(142,358,555 |
) |
|
$ |
(6,141 |
) |
|
$ |
– |
|
|
$ |
15,064,209 |
|
Issuances
of common stock for cash under at the market program |
|
|
177,891 |
|
|
|
178 |
|
|
|
1,085,941 |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
1,086,119 |
|
Issuance
of common shares upon vesting of restricted stock units and net stock option exercises |
|
|
6,397 |
|
|
|
7 |
|
|
|
(8,379 |
) |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(8,372 |
) |
Stock-based
compensation expense |
|
|
– |
|
|
|
– |
|
|
|
250,114 |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
250,114 |
|
Net
loss |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(3,282,179 |
) |
|
|
– |
|
|
|
– |
|
|
|
(3,282,179 |
) |
Other
comprehensive loss |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(994 |
) |
|
|
– |
|
|
|
(994 |
) |
BALANCE
– JUNE 30, 2023 |
|
|
2,483,547 |
|
|
$ |
2,484 |
|
|
$ |
158,754,282 |
|
|
$ |
(145,640,734 |
) |
|
$ |
(7,135 |
) |
|
$ |
– |
|
|
$ |
13,108,897 |
|
The accompanying notes are an integral part
of these condensed consolidated financial statements.
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended June 30, 2024 and 2023
(Unaudited)
| |
| | |
| |
| |
Three months Ended June 30, 2024 | | |
Three months Ended June 30, 2023 | |
| |
| | |
| |
Cash flows used in operating activities: | |
| | | |
| | |
Net loss | |
$ | (2,571,440 | ) | |
$ | (3,282,179 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 86,060 | | |
| 90,325 | |
Stock based compensation | |
| 139,328 | | |
| 250,114 | |
Accretion of right-of-use operating lease asset | |
| (1,217 | ) | |
| 1,238 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 89,872 | | |
| 146,409 | |
Accounts payable and other current liabilities | |
| 323,776 | | |
| 334,613 | |
Deferred revenue | |
| – | | |
| – | |
Due to related parties | |
| 186,084 | | |
| (22,907 | ) |
Net cash used in operating activities | |
| (1,747,537 | ) | |
| (2,482,387 | ) |
| |
| | | |
| | |
Cash flows used in investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| – | | |
| (230,383 | ) |
Net cash used in investing activities | |
| – | | |
| (230,383 | ) |
| |
| | | |
| | |
Cash flows provided by financing activities: | |
| | | |
| | |
Proceeds from the issuance of common stock, net | |
| 3,539,907 | | |
| 1,086,119 | |
Proceeds from the issuance of common stock
upon Class A and Class B warrant exercises | |
| 1,844,400 | | |
| – | |
Tax withholding payments or tax equivalent
payments for net share settlement of restricted stock units and net stock option expense | |
| (5,078 | ) | |
| (8,372 | ) |
Net cash provided by financing activities | |
| 5,379,229 | | |
| 1,077,747 | |
| |
| | | |
| | |
Effect of exchange rate on changes on cash | |
| (1,290 | ) | |
| (186 | ) |
| |
| | | |
| | |
Net increase (decrease) in cash, cash equivalents and restricted cash | |
| 3,630,402 | | |
| (1,635,209 | ) |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash at beginning of period | |
| 5,529,483 | | |
| 14,620,449 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 9,159,885 | | |
$ | 12,985,240 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
| |
| | | |
| | |
Supplemental disclosures of non-cash investing and financing activities: | |
| | | |
| | |
Par value of shares issued for vested restricted
stock units and net stock option exercise | |
$ | 28 | | |
$ | 64 | |
| |
| | | |
| | |
Reconciliation of cash, cash equivalents and restricted cash
to the condensed consolidated balance sheets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 9,072,379 | | |
$ | 12,897,734 | |
Restricted cash | |
| 87,506 | | |
| 87,506 | |
Cash, cash equivalents and restricted cash | |
$ | 9,159,885 | | |
$ | 12,985,240 | |
The accompanying notes are an integral part
of these condensed consolidated financial statements.
AETHLON MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
June 30, 2024
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 binding
study of relevant oncology targets, to provide pre-clinical evidence to support our trial design and translational endpoints. Our study
indicated positive results, providing evidence that our Hemopurifier removes extracellular vesicles, or EVs, from plasma.
This translational study provides pre-clinical evidence to support our planned 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®. In addition to an interested initial trial site in India, we had three interested sites in Australia
that were awaiting our completion of this in vitro binding study. We added the data from this study to our Clinical Investigator
Brochure and submitted that brochure to the Ethics Committee of Royal Adelaide Hospital in Australia and in June 2024, we received approval
for our proposed phase 1 oncology trial from the Ethics Committee from Royal Adelaide Hospital. We are currently in the process of applying
to the Ethics Committees of the two additional interested clinical trial sites in Australia and the site 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, or HIV, hepatitis-C and Ebola.
Additionally, in vitro, the
Hemopurifier has been demonstrated to capture H5N1 bird flu virus, H1N1 swine flu virus, Zika virus, Lassa virus, MERS-CoV,
cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related
viruses, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in
collaboration with leading government or non-government research institutes.
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, utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation
complications by improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation,
and potentially reducing the number of kidneys rejected for transplant.
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 reverse
stock split of our then outstanding shares of common stock. Accordingly, each 10 shares of outstanding common stock then held by our
stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to
the next whole share. Authorized common stock remained at 60,000,000 shares following the stock split. The accompanying unaudited condensed
consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it
had occurred on April 1, 2023. All shares and per share amounts have been revised accordingly.
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,
net, through the combination of an equity offering and warrant exercises, combined with our recent financial performance which has
shown a significant decrease in expenses and use of cash. For the three-month period ended June 30, 2024, expenses decreased by
approximately $787,000
compared to June 30, 2023, accompanied by an approximate $964,000
decrease in cash used in operating and investing activities. As a result of these actions, management believes that the substantial
doubt regarding our ability to continue as a going concern has been alleviated.
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 in favor of our landlord. The L/Cs are in lieu of a security deposit. In order to support the L/Cs,
we agreed to have our bank withdraw $87,506 from our operating accounts and to place that amount in a restricted certificate of deposit.
We have classified that amount as restricted cash, a long-term asset, on our balance sheet.
2. LOSS PER COMMON SHARE
Basic loss per share is computed by dividing
net loss by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed
similar to basic loss per share, except that the denominator is increased to include the number of additional dilutive common shares
that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we
had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have
been excluded, as their effect would be antidilutive.
As of June 30, 2024 and 2023, an aggregate of
13,523,429 and 2,291,234 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants,
and restricted stock units were excluded, as their inclusion would be antidilutive.
3. RESEARCH AND DEVELOPMENT EXPENSES
Our research and development costs are expensed
as incurred. We incurred research and development expenses during the three-month periods ended June 30, 2024 and 2023, which are included
in various operating expense line items in the accompanying condensed consolidated statements of operations. Our research and development
expenses in those periods were as follows:
Schedule of research and development
expenses | |
| | |
| |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | |
Three months ended | |
$ | 414,658 | | |
$ | 678,922 | |
4. RECENT ACCOUNTING PRONOUNCEMENTS
In November 2023, the Financial Accounting Standards
Board (“FASB”) issued ASU 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures”
(“ASU 2023-07”). ASU 2023-07 intends to improve reportable segment disclosure requirements, enhance interim disclosure requirements
and provide new segment disclosure requirements for entities with a single reportable segment. ASU 2023-07 is effective for fiscal years
beginning after December 15, 2023, and for interim periods with fiscal years beginning after December 15, 2024. ASU 2023-07 is to be
adopted retrospectively to all prior periods presented. We are currently assessing the impact this guidance will have on our consolidated
financial statements; however, we do not expect a material impact.
In December 2023, the FASB issued Accounting
Standards Update 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced annual disclosures
for specific categories in the rate reconciliation and income taxes paid disaggregated by federal, state and foreign taxes. ASU 2023-09
is effective for public business entities for annual periods beginning after December 15, 2024. The Company is evaluating if the adoption
of this new standard will have a material effect on our disclosures.
In June 2016, the FASB issued ASU No. 2016-13,
Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The adoption of ASU No. 2016-13
for smaller reporting companies that did not previously early adopt was January 1, 2023. The Company maintained US Treasury bills with
maturities of less than three months and expects zero credit losses from these securities. As a result, the Company did not record an
allowance for expected credit losses.
5. EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2024
2022 At The Market Offering Agreement with H.C. Wainwright &
Co., LLC
On March 24, 2022, we entered into an At The
Market Offering Agreement, or the 2022 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, which established an at-the-market
equity program pursuant to which we may offer and sell shares of our common stock from time to time, as set forth in the 2022 ATM Agreement.
The offering was registered under the Securities
Act of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No.
333-259909), as previously filed with the SEC and declared effective on October 21, 2021. We filed a prospectus supplement, dated March
24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to $15,000,000,
or the 2022 ATM Shares.
Under the 2022 ATM Agreement, Wainwright may
sell the 2022 ATM Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415
promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market
for the 2022 ATM Shares. In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions
with our consent and in block transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if
the sales cannot be effected at or above the price designated by us from time to time.
We are not obligated to make any sales of the
2022 ATM Shares under the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon
the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein.
The 2022 ATM Agreement contains customary representations,
warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay
Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse
Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement.
During the three months ended June 30, 2024,
we did not raise proceeds under the 2022 ATM Agreement. During the three months ended June 30, 2023, we raised net proceeds of $1,086,119,
net of $27,999 in commissions to Wainwright and $5,846 in other offering expenses, through the sale of 177,890 shares of our common
stock at an average price of $6.11 per share under the 2022 ATM Agreement.
May 2024 Public Offering
On May 17, 2024, we closed a public offering pursuant
to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000
shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering price of
$0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common
stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase up to 5,650,000
shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal
to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price of each such
pre-funded warrant.
All pre-funded warrants issued in the offering were
exercised in the quarter ended June 30, 2024. The Class A and Class B warrants each have an exercise
price of $0.58 per share, are immediately exercisable, and, in the case of Class A warrants, will expire on May 17, 2029, and in the case
of Class B warrants, will expire on May 19, 2025. The exercise price of the Class A and Class B warrants is also subject to adjustment
for stock splits, reverse splits, and similar capital transactions as described in such warrants.
Maxim Group LLC (“Maxim”),
served as the exclusive placement agent in connection with the offering. We paid Maxim a cash fee of 6.5% of the aggregate gross proceeds
raised at the closing of the offering, and reimbursement of certain expenses and legal fees in the amount of $100,000. We also issued
to designees of Maxim warrants to purchase up to an aggregate of 324,000 shares of common stock (the “Placement Agent Warrants”).
The Placement Agent Warrants have an exercise price of $0.58 per share and have substantially the same terms as the Class A warrants,
except the Placement Agent Warrants are not subject to an exercise price reset, are non-exercisable until November 15, 2024, and will
expire on May 15, 2029.
The gross proceeds from
the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4.7 million. Net
proceeds, of the offering, after deducting the placement agent fees and expenses and other offering expenses payable by us, were are
approximately $3.5 million. In June 2024, and holders of Class A and Class B warrants exercised 300,000 shares and 2,880,000 shares,
respectively, for additional proceeds of $1,844,400.
The shares of Common Stock,
the Class A and Class B warrants, the pre-funded warrants and the Placement Agent Warrants described above and the underlying shares of
Common Stock were offered pursuant to a Registration Statement on Form S-1, as amended (File No. 333-278188) (the “Registration
Statement”), which was declared effective by the Securities and Exchange Commission (the “SEC”) on May 15, 2024.
Restricted Stock Unit Grants
On April 16, 2024, our Board of Directors
approved, pursuant to the terms of the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation
Policy to each of the four non-employee directors of the Company then serving on the Board of Directors. The Director Compensation
Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current non-employee
directors then serving on the Board of Directors, and for a grant of stock options or $75,000 worth of RSUs for a newly elected
non-employee director, with each RSU priced at the average of the closing prices for the five trading days preceding and including
the date of grant, or $1.52 per share for the RSUs granted in April 2024. As a result, in April 2024, the four eligible directors
were each granted 32,894
RSUs under the Company’s 2020 Equity Incentive Plan, as amended, or the 2020 Plan. The
RSUs are subject to vesting in four equal installments, with 25% of the restricted stock units vesting on each of June 30, 2024,
September 30, 2024, December 31, 2024, and March 31, 2025, subject in each case to the director’s Continuous Service (as
defined in the 2020 Plan), through such dates. Vesting will automatically terminate upon the director’s termination of
Continuous Service prior to any vesting date.
During the three-months ended June 30, 2024,
27,602
shares were issued upon settlement of 37,779
RSUs.
6. RELATED PARTY TRANSACTIONS
During the three months ended June 30, 2024,
we accrued unpaid fees of $68,250 owed to our non-employee directors.
As a result of entering
into a Separation Agreement effective July 1, 2024 with a former employee, we paid out accrued vacation of $9,688 in the three months
ended June 30, 2024. That accrued vacation was previously recorded in the due to related parties account. In addition, pursuant to the
terms of the Separation Agreement, we accrued $323,534 for salary and related expenses connected with the Separation Agreement. Accrued
separation expenses includes a balance of approximately $186,000 owed to our former Chief Executive Officer, as stipulated in his Separation
Agreement.
Amounts due to related parties were comprised
of the following items:
Schedule of amounts due to related parties | |
| | |
| |
| |
June 30, 2024 | | |
March 31, 2024 | |
Accrued Board fees | |
$ | 68,250 | | |
$ | 68,250 | |
Accrued vacation to all employees | |
| 154,816 | | |
| 167,973 | |
Accrued separation expenses | |
| 509,452 | | |
| 310,211 | |
Total due to related parties | |
$ | 732,518 | | |
$ | 546,434 | |
7. OTHER CURRENT LIABILITIES
Other current liabilities were comprised of the following items:
Schedule of other current liabilities | |
| | |
| |
| |
June 30, | | |
March 31, | |
| |
2024 | | |
2024 | |
Accrued professional fees | |
$ | 32,203 | | |
$ | 215,038 | |
Total other current liabilities | |
$ | 32,203 | | |
$ | 215,038 | |
8. STOCK COMPENSATION
The following tables summarize share-based compensation
expenses relating to RSUs and stock options and the effect on basic and diluted loss per common share during the three month periods
ended June 30, 2024 and 2023:
Schedule of share-based compensation
expenses | |
| | |
| |
| |
June 30, 2024 | | |
June 30, 2023 | |
Vesting of stock options and restricted stock units | |
$ | 139,328 | | |
$ | 250,114 | |
Total stock-based compensation expense | |
$ | 139,328 | | |
$ | 250,114 | |
| |
| | | |
| | |
Weighted average number of common shares
outstanding – basic and diluted | |
| 7,457,888 | | |
| 2,431,476 | |
| |
| | | |
| | |
Basic and diluted loss per common share
attributable to stock-based compensation expense | |
$ | (0.10 | ) | |
$ | (0.16 | ) |
All of the stock-based compensation expense recorded
during the three months ended June 30, 2024 and 2023, an aggregate of $139,328 and $250,114, respectively, is included in payroll and
related expense in the accompanying condensed consolidated statements of operations. Stock-based compensation expense recorded during
each of the three months ended June 30, 2024 and 2023 represented an impact on basic and diluted loss per common share of $(0.02) and
$(0.16), respectively.
Stock Option Activity
We did not issue any stock options during the
three months ended June 30, 2024 and 2023.
Stock options outstanding that have vested as
of June 30, 2024 and stock options that are expected to vest subsequent to June 30, 2024 are as follows:
Schedule of stock options outstanding | |
| | |
| | |
| |
| |
Number of Shares | | |
Weighted Average Exercise
Price | | |
Weighted Average Remaining
Contractual Term in Years | |
Vested | |
| 61,977 | | |
$ | 17.37 | | |
| 6.81 | |
Expected to vest | |
| 23,873 | | |
$ | 14.60 | | |
| 7.60 | |
Total | |
| 85,850 | | |
| | | |
| | |
A summary of stock option activity during the
three months ended June 30, 2024 is presented below:
Schedule of stock option activity | |
| | |
| | |
| |
| |
Amount | | |
Range of Exercise Price | | |
Weighted Average Exercise
Price | |
Outstanding at beginning of year | |
| 86,466 | | |
$ | 6.90
– 25.20 | | |
$ | 22.40 | |
Granted | |
| – | | |
$ | – | | |
$ | – | |
Cancelled/Expired | |
| 616 | | |
$ | 14.10-1,425.00 | | |
$ | 206.34 | |
Outstanding June 30, 2024 | |
| 85,850 | | |
$ | 6.90
– 25.20 | | |
$ | 16.60 | |
Exercisable, June 30, 2024 | |
| 61,977 | | |
$ | | | |
$ | 17.37 | |
There were no stock option grants during the three months ended June 30, 2024 and 2023. There were 131,576
RSUs granted during the three months June 30, 2024. The weighted average grant date fair value of RSUs granted during the three
months ended June 30, 2024 was $1.52.
There were no
stock option exercises during the three months ended June 30, 2024 and 2023. On June 30, 2024, our outstanding stock options had no intrinsic value, since the closing share price on that date of $0.50
per share was below the exercise price of our outstanding stock options.
The table below summarizes nonvested stock options as of June 30,
2024 and changes during the three months ended June 30, 2024.
Schedule of non vested stock options | |
| | |
| |
| |
Shares | | |
Weighted Average Grant Date Fair Value | |
Nonvested stock options at April 1, 2024 | |
| 28,653 | | |
$ | 1.44 | |
Vested | |
| (4,780 | ) | |
$ | 1.62 | |
Forfeited | |
| – | | |
| | |
Nonvested stock options at June 30, 2024 | |
| 23,873 | | |
| | |
The detail of the options outstanding and exercisable as of June 30,
2024 is as follows:
Schedule of options outstanding and exercisable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
Outstanding |
|
|
|
Options
Exercisable |
|
|
Exercise
Prices |
|
|
|
Number
Outstanding |
|
|
|
Weighted
Average
Remaining
Life (Years) |
|
|
|
Weighted
Average
Exercise
Price |
|
|
|
Number
Outstanding |
|
|
|
Weighted
Average
Exercise
Price |
|
$ |
6.90 - 16.80 |
|
|
|
61,672 |
|
|
|
7.23 years |
|
|
$ |
13.23 |
|
|
|
41,326 |
|
|
$ |
13.46 |
|
$ |
25.20 |
|
|
|
24,178 |
|
|
|
6.52 years |
|
|
$ |
25.20 |
|
|
|
20,651 |
|
|
$ |
25.20 |
|
|
|
|
|
|
85,850 |
|
|
|
|
|
|
|
|
|
|
|
61,977 |
|
|
|
|
|
We recorded stock-based compensation expense
related to RSU issuances and to options granted totaling $139,328 and $250,114 for the three months ended June 30, 2024 and 2023, respectively.
These expenses were recorded as stock compensation included in payroll and related expenses in the accompanying consolidated statement
of operations for the three months ended June 30, 2024 and 2023.
The table below summarizes restricted stock units
as of June 30, 2024 and changes during the three months ended June 30, 2024.
Schedule of restricted stock units restricted stock units | |
| |
| |
Shares | |
Nonvested RSUs at April 1, 2024 | |
| 4,885 | |
Granted | |
| 131,576 | |
Vested | |
| (27,602 | ) |
Tax withholding payments or tax equivalent payments for net share settlement of
restricted stock units | |
| (10,177 | ) |
Nonvested RSUs at June 31, 2024 | |
| 98,682 | |
Our total stock-based compensation for the three
months ended June 30, 2024 and 2023 included the following:
Schedule of stock-based compensation | |
| | |
| |
| |
Three Months Ended | |
| |
June 30, 2024 | | |
June 30, 2023 | |
Vesting of restricted stock units | |
$ | 68,750 | | |
$ | 37,500 | |
Vesting of stock options | |
| 70,578 | | |
| 212,614 | |
Total Stock-Based Compensation | |
$ | 139,328 | | |
$ | 250,114 | |
We review share-based compensation on a quarterly
basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting
the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture
adjustments for the three months ended June 30, 2024 was insignificant.
On June 30, 2024, our outstanding stock options
had no intrinsic value since the closing price on that date of $0.50 per share was below the weighted average exercise price of our outstanding
stock options.
At June 30, 2024, there was approximately $310,674
of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period
of 1.45 years.
9. WARRANTS
During the three-months ended June 30, 2024,
we issued 16,524,000 warrants in connection with the May 17, 2024 public offering. We did not issue any warrants in the three-months
ended June 2023.
A summary of warrant activity during the three
months ended June 30, 2024 is presented below:
Schedule of warrant activity | |
| | |
| | |
| |
| |
Amount | | |
Range of Exercise Price | | |
Weighted Average Exercise
Price | |
Warrants outstanding at March 31, 2024 | |
| 32,676 | | |
$ | 15.00
– 27.50 | | |
$ | 20.09 | |
| |
| | | |
| | | |
| | |
Granted | |
| 16,524,000 | | |
| 0.58 | | |
| 0.58 | |
Exercised | |
| (3,180,000 | ) | |
$ | 0.58 | | |
$ | 0.58 | |
Cancelled/Expired | |
| – | | |
$ | – | | |
$ | – | |
Warrants outstanding at June 30, 2024 | |
| 13,376,676 | | |
$ | 0.58
– 27.50 | | |
$ | 0.63 | |
Warrants exercisable at June 30, 2024 | |
| 13,376,676 | | |
$ | 0.58
– 27.50 | | |
$ | 0.63 | |
10. COMMITMENTS AND CONTINGENCIES
LEASE COMMITMENTS
Office, Lab and Manufacturing Space Leases
In December 2020, we entered into an agreement
to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space located at 11555 Sorrento Valley Road,
Suite 203, San Diego, California 92121 and 11575 Sorrento Valley Road, Suite 200, San Diego, California 92121, respectively. The agreement
carries a term of 63 months and we took possession of the office space effective October 1, 2021. We took possession of the laboratory
space effective January 1, 2022. In October 2021, we entered into another lease for approximately 2,655 square feet of space to house
our manufacturing operations located at 11588 Sorrento Valley Road, San Diego, California 92121. The term is for 55 months and we took
possession of the manufacturing space in August 2022. The current monthly base rent under the office and laboratory component of the
lease is $14,158. The current monthly base rent under the manufacturing component of the lease is $12,452. Cash paid in the three months
ended June 30, 2024 for amounts included in the measurement of operating lease liabilities in operating cash flows was $79,830.
The office, lab and manufacturing leases are
coterminous with a remaining term of 33 months. The weighted average discount rate is 4.25%.
As of our June 30, 2024 balance sheet, we have
an operating lease right-of-use asset of $813,900 and operating lease liability of $869,945.
In addition, the lease agreements for the new
office, lab and manufacturing space required us to post a standby L/C in favor of the landlord in the aggregate amount of $87,506 in
lieu of a security deposit. We arranged for our bank to issue standby L/Cs for the new office and lab in the amounts of $46,726 in the
fiscal year ended March 31, 2021 and for the manufacturing space in the amount of $40,780 in the fiscal year ended March 31, 2022. We
transferred like amounts to a restricted certificate of deposit which secured the bank’s risk in issuing those L/Cs. We have classified
those restricted certificates of deposit on our balance sheet as restricted cash with a balance of $87,506.
Overall, our rent expense, which is included
in general and administrative expenses, approximated $102,000 and $105,000 for the three month periods ended June 30, 2024 and 2023,
respectively.
LEGAL MATTERS
We may be involved from time to time in various
claims, lawsuits, and/or disputes with third parties or breach of contract actions incidental to the normal course of our business operations.
We are currently not involved in any litigation or any pending legal proceedings.
11. SUBSEQUENT EVENTS
Management has evaluated events subsequent to
June 30, 2024 through the date that the accompanying consolidated financial statements were filed with the SEC for transactions and other
events which may require adjustment of and/or disclosure in such financial statements.
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.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion of our financial condition
and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial
statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion
and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business,
includes forward-looking statements that involve risks and uncertainties. For a complete discussion of forward-looking statements, see
the section above entitled “Cautionary Notice Regarding Forward Looking Statements.”
Overview
Aethlon Medical, Inc., or Aethlon, the Company,
we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. The
Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In
cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed
the spread of metastasis and inhibit the benefit of leading cancer therapies. The 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 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 can be a substantial
advance in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes that
promote the growth and spread of tumors through multiple mechanisms. We are currently working with our contract research organization,
or CRO, on preparations to conduct a planned clinical trial in Australia in patients with solid tumors, including head and neck cancer,
gastrointestinal cancers and other cancers.
In January 2023, we entered into an agreement
with North American Science Associates, LLC, or NAMSA, a world leading MedTech 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 anticipate that the initial clinical trials will begin 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 believe 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 Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya
virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed
Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government
research institutes.
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 intensive
care unit, or 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 June 2022, the first
patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in
the ICUs of our trial sites, we terminated this study in 2022.
Under Single Patient Emergency Use regulations,
the Company 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 previously reported a disruption in our
Hemopurifier supply, as our then existing supply of Hemopurifiers expired on September 30, 2022 and, also as previously disclosed,
we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier
for galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, continues to be delayed as we work with the FDA for
approval of our supplement to our IDE, which is required to make this manufacturing change. We are working with the FDA to qualify
this second supplier of our GNA. We also are in the process of completing final testing in order to begin manufacturing
Hemopurifiers at our new manufacturing facility in San Diego, California for use in planned U.S. clinical trials, using GNA from our
current supplier. The first manufacturing lot that incorporates the GNA from our original supplier was approved and released at the
end of December 2023. We also have sufficient Hemopurifiers on hand for use in our planned Australia and India oncology trials.
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.
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. One patient has completed participation in the Indian COVID-19 study. The relevant authorities
in India have accepted the use of our Hemopurifiers made with the GNA from our new supplier.
In May 2023, we also received ERB approval from
the Maulana Azad Medical College, or 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.
In October 2023, we announced that we received
clearance from the Drug Controller General of India, the central drug authority in India, to conduct a Phase 1 safety, feasibility and
dose-finding trial of the Company’s Hemopurifier in patients with solid tumors who have stable or progressive disease during
anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following
completion of an internal in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested
sites in India.
Additionally, we announced that we have begun
investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our
translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes
from recovered organs. We initially are focused on recovered kidneys, in a research collaboration with 34 Lives, PBC. We have previously
demonstrated the removal of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier.
This process potentially may reduce complications following transplantation of the recovered organ, which can include viral infection,
delayed graft function and rejection. We believe this new approach could be additive to existing technologies that currently are in place
to increase the number of viable kidneys for transplant.
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.”
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements
of the Exchange Act, and must file reports, proxy statements and other information with the SEC. The SEC maintains a website (http://www.sec.gov)
that contains reports, proxy and information statements and other information regarding registrants, like us, which file electronically
with the SEC.
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2024 COMPARED TO THE THREE MONTHS ENDED
JUNE 30, 2023
Operating Expenses
Consolidated operating expenses for the three
months ended June 30, 2024 were $2,620,858 compared to $3,408,7160 for the three months ended June 30, 2023. This decrease of $787,302,
or 23.1%, in the 2024 period was due to a decrease of $556,309 in general and administrative expenses and a decrease of $362,556 in professional
fees, partially offset by an increase in payroll and related expenses of $131,563.
The $556,309 decrease in general and
administrative expenses in the three months ended June 30, 2024 was due to a $447,393 decrease in supplies related to the purchase
of raw materials for manufacturing of the Hemopurifier and for lab supplies, a $39,017 decrease in repairs and maintenance
associated with the certification of the cleanroom, a $29,092 decrease in travel related to former employee and consultant, $11,226
in insurance expense, a $7,572 decrease in clinical trial expense and $22,000 in various other general operating expenses.
The decrease in professional fees of $362,556
was related to a $136,481 decrease in consulting expenses primarily related to termination of services with a contract manufacturing
organization, a $110,418 decrease in scientific consulting, an $83,865 decrease in investor relations expenses associated with more widespread
awareness and dissemination of Company news, a $77,920 decrease in legal fees relating to general corporate matters and a decrease of
$16,063 associated with a reduction in website services. These decreases were partially offset by a $50,940 increase in audit and accounting
expense, and $11,250 increase in board of director fees associated with the addition of a new board member.
Payroll expenses increased by $131,563 due to
an increase in separation expenses of $320,604 related to the termination of an employee and a $16,172 increase in payroll expense associated
with an increase in manufacturing headcount. These increases were offset by a decrease of $110,786 in stock based compensation and an
$89,152 decrease in general and administration headcount.
Net Loss
As a result of the changes in expenses noted
above, our net loss decreased to $2,571,440 in the three months ended June 30, 2024 from $3,282,179 in the three months ended June 30,
2023.
Basic and diluted loss attributable to common
stockholders was ($0.34) for the three months ended June 30, 2024, compared to ($1.35) for the three-month period ended June 30, 2023.
LIQUIDITY AND CAPITAL RESOURCES
As of June 30, 2024, we had a cash balance of
$9,072,379 and working capital of $7,421,489. This compares to a cash balance of $5,441,978 and working capital of $4,395,889 at March
31, 2024.
On May 17, 2024, we closed a public offering of our
equity, pursuant to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase
up to 2,450,000 shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering
price of $0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares
of common stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase
up to 5,650,000 shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants,
which is equal to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price
of each such pre-funded warrant. The gross proceeds from the offering, before deducting the placement agent’s fees and other offering
expenses, were approximately $4.7 million. Net proceeds, of the offering, after deducting the placement agent fees and expenses and other
offering expenses payable by us, were are approximately $3.5 million. In June 2024, holders of Class A and Class B warrants exercised
300,000 shares and 2,880,000 shares, respectively, for additional total proceeds of $1,844,400. See the section entitled “May 2024
Public Offering,” below, for additional information regarding this offering.
We expect our existing cash as of June 30, 2024 to
be sufficient to fund our operations for at least twelve months from the issuance date of these 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, net, through a combination of a equity offering and warrant exercises, combined with our
recent financial performance which has shown a significant decrease in expenses and use of cash. For the three-month period ended June
30,2024, expenses decreased by approximately $787,000 compared to June 30, 2023 accompanied by an approximate $964,000 decrease in cash
used in operating and investing activities. As a result of these actions, management believes that the substantial doubt regarding our
ability to continue as a going concern has been alleviated.
As we expand our activities, our overhead costs to
support personnel, laboratory materials and infrastructure will increase and significant additional financing must be obtained to provide
a sufficient source of operating capital. Should the financing we require to sustain our working capital needs be unavailable to us on
reasonable terms, if at all, when we require it, we may be unable to support our research and our planned clinical trials. The failure
to implement our research and clinical trials would have a material adverse effect on our ability to conduct planned clinical trials and
commercialize our products.
Future capital requirements will depend upon
many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the
time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the
time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our ability to
establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue
to incur increasing negative cash flows and net losses for the foreseeable future.
2022 At The Market Offering Agreement with H.C. Wainwright &
Co., LLC
On March 24, 2022, we entered into the 2022 ATM
Agreement with Wainwright, which established an at-the-market equity program pursuant to which we may offer and sell shares of our common
stock from time to time as set forth in the 2022 ATM Agreement.
The offering was registered under the Securities
Act pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-259909), as previously filed with the SEC
and declared effective on October 21, 2021. We filed a prospectus supplement, dated March 24, 2022, with the SEC that provides for the
sale of shares of our common stock, or the 2022 ATM Shares, having an aggregate offering price of up to $15,000,000, which was subsequently
and most recently updated pursuant to our prospectus supplement, dated September 29, 2022, filed with the SEC that provides for the sale
of 2022 ATM Shares having an aggregate offering price of up to $6,625,000. As of June 30, 2024, $5,302,617 of 2022 ATM Shares remained
available for sale under the 2022 ATM Agreement.
Under the 2022 ATM Agreement, Wainwright may
sell the 2022 ATM Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415
promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market
for the 2022 ATM Shares. In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions
with our consent and in block transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if
the sales cannot be effected at or above the price designated by us from time to time.
We are not obligated to make any further sales
of the 2022 ATM Shares under the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate
upon the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein.
The 2022 ATM Agreement contains customary representations,
warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay
Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse
Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement
During the three months ended June 30, 2024,
we did not sell shares of our common stock under the 2022 ATM Agreement.
May 2024 Public Offering
On May 17, 2024, we closed a public offering pursuant
to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000
shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering price of
$0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common
stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase up to 5,650,000
shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal
to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price of each such
pre-funded warrant.
All pre-funded warrants issued in the offering were
exercised in the quarter ended June 30, 2024. The Class A and Class B warrants each have an exercise
price of $0.58 per share, are immediately exercisable, and, in the case of Class A warrants, will expire on May 17, 2029, and in the case
of Class B warrants, will expire on May 19, 2025. The exercise price of the Class A and Class B warrants is also subject to adjustment
for stock splits, reverse splits, and similar capital transactions as described in such warrants.
Maxim Group LLC (“Maxim”),
served as the exclusive placement agent in connection with the offering. We paid Maxim a cash fee of 6.5% of the aggregate gross proceeds
raised at the closing of the offering, and reimbursement of certain expenses and legal fees in the amount of $100,000. We also issued
to designees of Maxim warrants to purchase up to an aggregate of 324,000 shares of common stock (the “Placement Agent Warrants”).
The Placement Agent Warrants have an exercise price of $0.58 per share and have substantially the same terms as the Class A warrants,
except the Placement Agent Warrants are not subject to an exercise price reset, are non-exercisable until November 15, 2024, and will
expire on May 15, 2029.
The gross proceeds from the
offering, before deducting the placement agent’s fees and other offering expenses, were approximately $4.7 million. Net proceeds,
of the offering, after deducting the placement agent fees and expenses and other offering expenses payable by us, were are approximately
$3.5 million. In June 2024, and holders of Class A and Class B warrants exercised 300,000 shares and 2,880,000 shares, respectively, for
additional proceeds of $1,844,400.
The shares of Common Stock,
the Class A and Class B warrants, the pre-funded warrants and the Placement Agent Warrants described above and the underlying shares of
Common Stock were offered pursuant to a Registration Statement on Form S-1, as amended (File No. 333-278188) (the “Registration
Statement”), which was declared effective by the Securities and Exchange Commission (the “SEC”) on May 15, 2024.
Cash Flows
Cash flows from operating, investing and financing
activities, as reflected in the accompanying Condensed Consolidated Statements of Cash Flows, are summarized as follows:
| |
(In thousands) For the three months ended | |
| |
June 30, 2024 | | |
June 30, 2023 | |
Cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (1,748 | ) | |
$ | (2,482 | ) |
Investing activities | |
| – | | |
| (230 | ) |
Financing activities | |
| 5,379 | | |
| 1,077 | |
Effect of exchange rate changes on cash | |
| (1 | ) | |
| – | |
Net decrease in cash and restricted cash | |
$ | 3,630 | | |
$ | (1,635 | ) |
NET CASH USED IN OPERATING ACTIVITIES. We used
cash in our operating activities due to our losses from operations. Net cash used in operating activities was approximately $1,748,000
in the three months ended June 30, 2024, compared to approximately $2,482,000 in the three months ended June 30, 2023. The primary components
in the $734,000 decrease in cash used in our operating activities in the 2024 period was a decrease in our net loss of approximately
$711,000 offset by a decrease in non-cash components of approximately $118,000 and a positive net change in other working capital components
of $141,000.
NET CASH USED IN INVESTING ACTIVITIES. We did not
use cash for investing activities in the three months ended June 30, 2024, compared to approximately $230,000 in the three months ended
June 30, 2023. The $230,000 decrease in the 2024 period was primarily a result of equipment purchase for our laboratory incurred in the
three months ended June 2023.
NET CASH PROVIDED BY FINANCING ACTIVITIES. During
the three months ended June 30, 2024, we raised approximately $5,384,000, net of placement agent fees and offering costs, from the sale
and issuance of our common stock and warrants in connection with a public offering and the exercise of 300,000 and 1,880,000 Class A and
Class B warrants, respectively, by holders thereof. The source of cash from our financing activities was partially offset by the use of
approximately $5,000 to pay for the tax withholding upon settlement of on restricted stock units, for a net aggregate amount of cash provided
by financing activities of approximately $5,379,000.
Material Cash Requirements
We expect our clinical trial expenses for the
planned oncology trials in Australia and India to increase for the foreseeable future. Those increases in clinical trial expenses include
the cost of manufacturing additional Hemopurifiers.
In addition, we have entered into leases for
our headquarters, laboratory and manufacturing facilities. We expect our rent payments to continue to increase for the foreseeable future.
Future capital requirements will depend upon
many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the
time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the
time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our ability to
establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue
to incur increasing negative cash flows and net losses for the foreseeable future. We will continue to need to raise additional capital
either through equity and/or debt financing for the foreseeable future.
We do plan to access the equity markets for additional
capital, however, there can be no assurance that we will be able to access such additional capital on favorable terms, or at all.
Our ability to raise additional funds may be
adversely impacted by potential worsening global economic conditions and disruptions to and volatility in the credit and financial markets
in the United States, including due to bank failures, actual or perceived changes in interest rates and economic inflation, and worldwide
resulting from macroeconomic factors. Because of the numerous risks and uncertainties associated with product development, we cannot
predict the timing or amount of increased expenses and we may never be profitable or generate positive cash flow from operating activities.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Management’s discussion and analysis of
financial condition and results of operations is based on our interim condensed consolidated financial statements, that we prepared in
accordance with accounting principles generally accepted in the United States, or GAAP. Preparing these financial statements requires
management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures.
We base our estimates on historical experience and on various assumptions we believe to be reasonable under the circumstances. We believe
our judgment is applied consistently and produces financial information that fairly depicts our results of operations for all periods.
Actual results may differ materially from these estimates.
We believe that the estimates and assumptions
that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult,
subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting
estimates relate to long lived assets, stock compensation, deferred tax asset valuation allowance, contingencies and clinical trial accruals.
There were no accounting estimates in the three
months ended June 30, 2024 with a high degree of uncertainty or amounts that are with a high likelihood to change from period to period
that would materially impact the presentation of our financial statements for the three months ended June 30, 2024.
There have been no changes to our critical accounting
policies and estimates as disclosed in our Form 10-K for the year ended March 31, 2024.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.
As a smaller reporting company, as defined by
Item 10(f)(1) of Regulation S-K, we are not required to provide the information required by this item.
ITEM 4. CONTROLS AND PROCEDURES.
DISCLOSURE CONTROLS AND PROCEDURES
We maintain “disclosure controls and procedures”
(as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed,
in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules
and forms, and that such information is accumulated and communicated to our management, including our Interim Chief Executive Officer
and Chief Financial Officer (who is our principal executive officer and principal financial officer), to allow timely decisions regarding
required disclosures.
Under the supervision
and with the participation of our management, including our Interim Chief Executive Officer and Chief Financial Officer, we evaluated
the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)
of the Exchange Act) as of the end of the period covered by this Quarterly Report.
Based on such evaluation,
our Interim Chief Executive Officer and Chief Financial Officer concluded that, as of the end of such period, our disclosure controls
and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed
by us in the reports that we file or submit under the Exchange Act and are effective in ensuring that information required to be disclosed
by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Interim
Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
As previously reported in our Annual Report on
Form 10-K for the year ended March 31, 2024, we identified a material weakness in our internal control over financial reporting related
to segregation of duties within our financial systems. Specifically, user access controls were not sufficiently maintained to properly
restrict both user and privileged access to financial applications within our accounting software system to initiate, record and approve
entries. Also noted that check stock was secured in an authorized signatory’s office.
Since identifying the material weakness, we have
been actively engaged in implementing measures to remediate the weakness and enhance our internal control over financial reporting. These
measures include but are not limited to updating the accounting software and creating distinct user roles. Transactions are recorded
by personnel who are independent of those who initiate them and are approved by separate personnel who are independent of those who record
them. Additionally, check stock had been relocated in November 2023.
We believe that these
measures, once fully implemented and operational for a sufficient period of time, will effectively remediate the material weakness. We
are committed to maintaining a strong internal control environment and will continue to monitor the effectiveness of these controls and
procedures.
CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
Other than the changes to remediate the material
weakness noted above, there were not changes in our internal control over financial reporting during the quarter ending June 30, 2024
that have materially affected, or reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
From time to time, claims are made against us
in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties
and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more
products or engaging in other activities.
The occurrence of an unfavorable outcome in any
specific period could have a material adverse effect on our results of operations for that period or future periods. We are not presently
a party to any pending or threatened legal proceedings.
ITEM 1A. RISK FACTORS.
RISK FACTOR SUMMARY
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 under the heading “Risk Factors”
in our Annual Report on Form 10-K for the fiscal year ended March 31, 2024, filed with the SEC on June 27, 2024, or Annual Report, and
should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the
SEC before making investment decisions regarding our securities.
|
· |
We have incurred significant
losses and expect to continue to incur losses for the foreseeable future. |
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· |
We will require additional
financing to sustain our operations, achieve our business objectives and satisfy our cash obligations, which may dilute the ownership
of our existing stockholders. |
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· |
We have limited experience
in identifying and working with large-scale contracts with medical device manufacturers; manufacture of our devices must comply with
good manufacturing practices in the United States. |
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· |
Delays, interruptions or
the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, has and may
continue to prevent or delay our ability to manufacture our Hemopurifier. |
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· |
Our Hemopurifier technology
may become obsolete. |
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· |
If we fail to comply with
extensive regulations of U.S. and foreign regulatory agencies, the commercialization of our products could be delayed or prevented
entirely. |
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· |
If we are unable to regain
compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market,
which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares. |
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· |
As a public company with limited financial
resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management
and directors.
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· |
We plan to expand our operations, which may
strain our resources; our inability to manage our growth could delay or derail implementation of our business objectives.
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· |
Our success is dependent in part on our executive
officers.
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· |
Delays in successfully
commencing or completing our planned clinical trials could jeopardize our ability to obtain regulatory approval and sustain our operations. |
There have been no material changes to the risk
factors previously disclosed under the heading “Risk Factors” in our Annual Report. The risks described in our Annual Report
are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be
immaterial also may materially adversely affect our business, financial condition or future results.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS.
We did not issue or sell any unregistered securities during the three
months ended June 30, 2024.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
Rule 10b5-1 Trading Plans
During the three months ended June 30, 2024,
none of our directors or officers entered into, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule
10b5-1 trading arrangement,” that were intended to satisfy the affirmative defense conditions of Rule 10b5-1, in each case as defined
in Item 408 of Regulation S-K.
ITEM 6. EXHIBITS.
(a) Exhibits. The following documents are filed
as part of this report:
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Incorporated
by Reference |
Exhibit
Number |
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Exhibit
Description |
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Form |
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SEC
File No. |
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Exhibit
Number |
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Date |
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Filed
Herewith |
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3.1 |
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Articles
of Incorporation, as amended. |
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8-K |
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001-37487 |
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3.1 |
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September 19, 2022 |
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3.2 |
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Amended
and Restated Bylaws of the Company. |
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8-K |
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001-37487 |
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3.1 |
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September 12, 2019 |
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4.1 |
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Form
of Common Stock Certificate. |
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S-1 |
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333-201334 |
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4.1 |
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December 31, 2014 |
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4.2 |
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Form
of Warrant to Purchase Common Stock. |
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S-1/A |
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333-234712 |
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4.14 |
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December
11, 2019 |
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4.3 |
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Form
of Underwriter Warrant. |
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S-1/A |
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333-234712 |
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4.15 |
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December
11, 2019 |
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4.4 |
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Form
of Common Stock Purchase Warrant. |
|
8-K |
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001-37487 |
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4.1 |
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January
17, 2020 |
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4.5 |
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Form of Class A Warrant to Purchase Common Stock, issued on May 17, 2024. |
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8-K |
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001-37487 |
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4.1 |
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May 17, 2024 |
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4.6 |
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Form of Class B Warrant to Purchase Common Stock, issued on May 17, 2024. |
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8-K |
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001-37487 |
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4.2 |
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May 17, 2024 |
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4.7 |
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Form of Pre-Funded Warrant to Purchase Common Stock, issued on May 17, 2024. |
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8-K |
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001-37487 |
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4.3 |
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May 17, 2024 |
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10.1 |
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Form of Securities Purchase Agreement. |
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S-1/A |
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333-278188 |
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10.20 |
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May 13, 2024 |
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31.1 |
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Certification of the Principal
Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934. |
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X |
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32.1^ |
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Certification of the Principal
Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section
1350. |
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X |
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101.INS |
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Inline XBRL Instance Document with Embeded Linkbase
Documents |
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X |
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101.SCH |
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Inline XBRL Taxonomy Extension Schema Document |
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X |
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104 |
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Cover Page Interactive Data File (formatted in XBRL,
and included in exhibit 101) |
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^ |
The information
in Exhibit 32.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange
Act (including this Quarterly Report), unless the Registrant specifically incorporates the foregoing information into those documents
by reference. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
AETHLON MEDICAL, INC. |
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Date: August 14, 2024 |
By: |
/s/ JAMES B.
FRAKES |
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JAMES B. FRAKES |
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INTERIM CHIEF EXECUTIVE
OFFICER |
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CHIEF FINANCIAL OFFICER |
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(PRINCIPAL EXECUTIVE AND FINANCIAL OFFICER) |
|
EXHIBIT 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a),
AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT
OF 2002
I, James B. Frakes, certify that:
1. I have reviewed this Quarterly
Report on Form 10-Q of Aethlon Medical, Inc.;
2. Based on my knowledge, this report
does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light
of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial
statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying
officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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(c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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(d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. The registrant’s other certifying
officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s
auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
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(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 14, 2024
|
/s/ JAMES B. FRAKES |
|
|
JAMES B. FRAKES |
|
|
INTERIM CHIEF EXECUTIVE OFFICER AND
CHIEF FINANCIAL OFFICER |
|
|
(PRINCIPAL EXECUTIVE AND FINANCIAL OFFICER) |
|
EXHIBIT 32.1
CERTIFICATION PURSUANT TO RULE 13a-14(b) OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
AND SECTION 1350 OF CHAPTER 63 OF TITLE 18 OF THE
UNITED STATES CODE (18 U.S.C. SECTION 1350),
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY
ACT OF 2002
In connection with the Quarterly
Report of Aethlon Medical, Inc., or the Registrant, on Form 10-Q for the period ended June 30, 2024 as filed with the Securities and Exchange
Commission on the date hereof, I, James B. Frakes, Interim Chief Executive Officer and Chief Financial Officer of the Registrant, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. The Quarterly Report on Form
10-Q, to which this Certification is attached as Exhibit 32.2, fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934, as amended, and
2. The information contained in
such Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the
Registrant.
Dated: August 14, 2024 |
/s/ JAMES B. FRAKES |
|
James B. Frakes |
|
Interim Chief Executive Officer and Chief Financial Officer |
|
(Principal Executive and Financial Officer) |
|
Aethlon Medical, Inc. |
This certification accompanies the Form 10-Q to which
it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing
of Aethlon Medical, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made
before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
v3.24.2.u1
Cover - shares
|
3 Months Ended |
|
Jun. 30, 2024 |
Aug. 14, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
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Document Transition Report |
false
|
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Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q1
|
|
Document Fiscal Year Focus |
2025
|
|
Current Fiscal Year End Date |
--03-31
|
|
Entity File Number |
001-37487
|
|
Entity Registrant Name |
Aethlon Medical, Inc.
|
|
Entity Central Index Key |
0000882291
|
|
Entity Tax Identification Number |
13-3632859
|
|
Entity Incorporation, State or Country Code |
NV
|
|
Entity Address, Address Line One |
11555 SORRENTO VALLEY ROAD
|
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Entity Address, Address Line Two |
SUITE 203
|
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Entity Address, City or Town |
SAN DIEGO
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Entity Address, State or Province |
CA
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|
Entity Address, Postal Zip Code |
92121
|
|
City Area Code |
619
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Local Phone Number |
941-0360
|
|
Title of 12(b) Security |
COMMON STOCK, $0.001 PAR VALUE
|
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Trading Symbol |
AEMD
|
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Security Exchange Name |
NASDAQ
|
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Entity Current Reporting Status |
Yes
|
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Entity Interactive Data Current |
Yes
|
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Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)
|
Jun. 30, 2024 |
Mar. 31, 2024 |
Current assets |
|
|
Cash and cash equivalents |
$ 9,072,379
|
$ 5,441,978
|
Deferred Offering Cost |
0
|
277,827
|
Prepaid expenses and other current assets |
478,058
|
505,983
|
Total current assets |
9,550,437
|
6,225,788
|
Property and equipment, net |
929,306
|
1,015,229
|
Operating lease right-of-use asset |
813,900
|
883,054
|
Patents, net |
963
|
1,100
|
Restricted cash |
87,506
|
87,506
|
Deposits |
33,305
|
33,305
|
Total assets |
11,415,417
|
8,245,982
|
Current liabilities |
|
|
Accounts payable |
1,068,134
|
777,862
|
Due to related parties |
732,518
|
546,434
|
Operating lease liability, current portion |
296,093
|
290,565
|
Other current liabilities |
32,203
|
215,038
|
Total current liabilities |
2,128,948
|
1,829,899
|
Operating lease liability, less current portion |
573,852
|
649,751
|
Total liabilities |
2,702,801
|
2,479,650
|
Stockholders’ Equity |
|
|
Common stock, par value $0.001 per share; 60,000,000 shares authorized as of June 30, 2024 and March 31, 2024; 13,937,327 and 2,629,725 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively |
13,937
|
2,629
|
Additional paid-in capital |
165,844,620
|
160,337,371
|
Accumulated other comprehensive loss |
(7,773)
|
(6,940)
|
Accumulated deficit |
(157,138,168)
|
(154,566,728)
|
Total stockholders’ equity |
8,712,616
|
5,766,332
|
Total liabilities and stockholders’ equity |
$ 11,415,417
|
$ 8,245,982
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v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Mar. 31, 2024 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
60,000,000
|
60,000,000
|
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13,937,327
|
2,629,725
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
|
3 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
OPERATING EXPENSES |
|
|
Professional fees |
$ 614,082
|
$ 976,638
|
Payroll and related expenses |
1,254,802
|
1,123,239
|
General and administrative |
751,974
|
1,308,283
|
Total operating expenses |
2,620,858
|
3,408,160
|
OPERATING LOSS |
(2,620,858)
|
(3,408,160)
|
OTHER INCOME |
|
|
Interest income |
49,418
|
125,981
|
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. |
(2,571,440)
|
(3,282,179)
|
OTHER COMPREHENSIVE LOSS |
(833)
|
(994)
|
COMPREHENSIVE LOSS |
$ (2,572,273)
|
$ (3,283,173)
|
Basic net loss per share attributable to common stockholders |
$ (0.34)
|
$ (1.35)
|
Diluted net loss per share attributable to common stockholders |
$ (0.34)
|
$ (1.35)
|
Weighted average number of common shares outstanding, basic |
7,457,888
|
2,431,476
|
Weighted average number of common shares outstanding, diluted |
7,457,888
|
2,431,476
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Noncontrolling Interest [Member] |
Total |
BALANCE – MARCH 31, 2023 at Mar. 31, 2023 |
$ 2,299
|
$ 157,426,606
|
$ (142,358,555)
|
$ (6,141)
|
|
$ 15,064,209
|
Beginning balance, shares at Mar. 31, 2023 |
2,299,259
|
|
|
|
|
|
Issuances of common stock for cash under at the market program |
$ 178
|
1,085,941
|
|
|
|
1,086,119
|
BALANCE – JUNE 30, 2023 at Jun. 30, 2023 |
$ 2,484
|
158,754,282
|
(145,640,734)
|
(7,135)
|
|
13,108,897
|
Issuances of common stock for cash under at the market program, shares |
177,891
|
|
|
|
|
|
Issuance of common shares upon vesting of restricted stock units and net stock option exercises |
$ 7
|
(8,379)
|
|
|
|
(8,372)
|
Issuance of common shares upon vesting of restricted stock units and net stock option exercises, shares |
6,397
|
|
|
|
|
|
Stock-based compensation expense |
|
250,114
|
|
|
|
250,114
|
Net loss |
|
|
(3,282,179)
|
|
|
(3,282,179)
|
Other comprehensive loss |
|
|
|
(994)
|
|
(994)
|
Ending balance, shares at Jun. 30, 2023 |
2,483,547
|
|
|
|
|
|
BALANCE – MARCH 31, 2023 at Mar. 31, 2024 |
$ 2,629
|
160,337,371
|
(154,566,728)
|
(6,940)
|
|
5,766,332
|
Beginning balance, shares at Mar. 31, 2024 |
2,629,725
|
|
|
|
|
|
BALANCE – JUNE 30, 2023 at Jun. 30, 2024 |
$ 13,937
|
165,844,620
|
(157,138,168)
|
(7,733)
|
|
8,712,616
|
Issuances of common stock for public offering |
$ 8,100
|
3,531,807
|
|
|
|
3,539,907
|
Issuances of common stock for cash under at the market program, shares |
8,100,000
|
|
|
|
|
|
Issuances of common stock for Class A and Class B warrant exercises |
$ 3,180
|
1,841,220
|
|
|
|
1,844,400
|
Issuances of common stock for Class A and Class B warrant exercises, shares |
3,180,000
|
|
|
|
|
|
Issuance of common shares upon vesting of restricted stock units and net stock option exercises |
$ 28
|
(5,106)
|
|
|
|
(5,078)
|
Issuance of common shares upon vesting of restricted stock units and net stock option exercises, shares |
27,602
|
|
|
|
|
|
Stock-based compensation expense |
|
139,328
|
|
|
|
139,328
|
Net loss |
|
|
(2,571,440)
|
|
|
(2,571,440)
|
Other comprehensive loss |
|
|
|
$ (833)
|
|
$ (833)
|
Ending balance, shares at Jun. 30, 2024 |
13,937,327
|
|
|
|
|
|
X |
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v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
3 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows used in operating activities: |
|
|
Net loss |
$ (2,571,440)
|
$ (3,282,179)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
86,060
|
90,325
|
Stock based compensation |
139,328
|
250,114
|
Accretion of right-of-use operating lease asset |
(1,217)
|
1,238
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
89,872
|
146,409
|
Accounts payable and other current liabilities |
323,776
|
334,613
|
Deferred revenue |
0
|
0
|
Due to related parties |
186,084
|
(22,907)
|
Net cash used in operating activities |
(1,747,537)
|
(2,482,387)
|
Cash flows used in investing activities: |
|
|
Purchases of property and equipment |
0
|
(230,383)
|
Net cash used in investing activities |
0
|
(230,383)
|
Cash flows provided by financing activities: |
|
|
Proceeds from the issuance of common stock, net |
3,539,907
|
1,086,119
|
Proceeds from the issuance of common stock upon Class A and Class B warrant exercises |
1,844,400
|
0
|
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense |
(5,078)
|
(8,372)
|
Net cash provided by financing activities |
5,379,229
|
1,077,747
|
Effect of exchange rate on changes on cash |
(1,290)
|
(186)
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
3,630,402
|
(1,635,209)
|
Cash, cash equivalents and restricted cash at beginning of period |
5,529,483
|
14,620,449
|
Cash, cash equivalents and restricted cash |
9,159,885
|
12,985,240
|
Supplemental disclosures of non-cash investing and financing activities: |
|
|
Par value of shares issued for vested restricted stock units and net stock option exercise |
28
|
64
|
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets: |
|
|
Cash and cash equivalents |
9,072,379
|
12,897,734
|
Restricted cash |
$ 87,506
|
$ 87,506
|
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v3.24.2.u1
NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION
|
3 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
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 binding
study of relevant oncology targets, to provide pre-clinical evidence to support our trial design and translational endpoints. Our study
indicated positive results, providing evidence that our Hemopurifier removes extracellular vesicles, or EVs, from plasma.
This translational study provides pre-clinical evidence to support our planned 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®. In addition to an interested initial trial site in India, we had three interested sites in Australia
that were awaiting our completion of this in vitro binding study. We added the data from this study to our Clinical Investigator
Brochure and submitted that brochure to the Ethics Committee of Royal Adelaide Hospital in Australia and in June 2024, we received approval
for our proposed phase 1 oncology trial from the Ethics Committee from Royal Adelaide Hospital. We are currently in the process of applying
to the Ethics Committees of the two additional interested clinical trial sites in Australia and the site 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, or HIV, hepatitis-C and Ebola.
Additionally, in vitro, the
Hemopurifier has been demonstrated to capture H5N1 bird flu virus, H1N1 swine flu virus, Zika virus, Lassa virus, MERS-CoV,
cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related
viruses, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in
collaboration with leading government or non-government research institutes.
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, utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation
complications by improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation,
and potentially reducing the number of kidneys rejected for transplant.
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 reverse
stock split of our then outstanding shares of common stock. Accordingly, each 10 shares of outstanding common stock then held by our
stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to
the next whole share. Authorized common stock remained at 60,000,000 shares following the stock split. The accompanying unaudited condensed
consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it
had occurred on April 1, 2023. All shares and per share amounts have been revised accordingly.
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,
net, through the combination of an equity offering and warrant exercises, combined with our recent financial performance which has
shown a significant decrease in expenses and use of cash. For the three-month period ended June 30, 2024, expenses decreased by
approximately $787,000
compared to June 30, 2023, accompanied by an approximate $964,000
decrease in cash used in operating and investing activities. As a result of these actions, management believes that the substantial
doubt regarding our ability to continue as a going concern has been alleviated.
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 in favor of our landlord. The L/Cs are in lieu of a security deposit. In order to support the L/Cs,
we agreed to have our bank withdraw $87,506 from our operating accounts and to place that amount in a restricted certificate of deposit.
We have classified that amount as restricted cash, a long-term asset, on our balance sheet.
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- DefinitionThe entire disclosure for the basis of presentation and significant accounting policies concepts. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). Accounting policies describe all significant accounting policies of the reporting entity.
+ ReferencesReference 1: http://fasb.org/us-gaap/role/ref/legacyRef -Topic 235 -Name Accounting Standards Codification -Publisher FASB -URI https://asc.fasb.org/235/tableOfContent
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v3.24.2.u1
LOSS PER COMMON SHARE
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3 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
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LOSS PER COMMON SHARE |
2. LOSS PER COMMON SHARE
Basic loss per share is computed by dividing
net loss by the weighted average number of common shares outstanding during the period of computation. Diluted loss per share is computed
similar to basic loss per share, except that the denominator is increased to include the number of additional dilutive common shares
that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we
had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have
been excluded, as their effect would be antidilutive.
As of June 30, 2024 and 2023, an aggregate of
13,523,429 and 2,291,234 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants,
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