Aethlon Medical, Inc. 10-Q
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 September 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 November 6, 2024, the registrant had outstanding
13,961,998 shares of common stock, $0.001 par value.
TABLE OF CONTENTS
PART I.
FINANCIAL INFORMATION
4
ITEM 1.
FINANCIAL STATEMENTS
4
CONDENSED CONSOLIDATED BALANCE SHEETS AT SEPTEMBER 30, 2024 (UNAUDITED) AND MARCH 31, 2024
4
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE THREE AND SIX MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 (UNAUDITED)
5
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND SIX MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 (UNAUDITED)
6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 (UNAUDITED)
7
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
8
ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
18
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
25
ITEM 4.
CONTROLS AND PROCEDURES
25
PART II.
OTHER INFORMATION
27
ITEM 1.
LEGAL PROCEEDINGS
27
ITEM 1A.
RISK FACTORS
27
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
28
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
28
ITEM 4.
MINE SAFETY DISCLOSURES
28
ITEM 5.
OTHER INFORMATION
28
ITEM 6.
EXHIBITS
29
SIGNATURES
30
2
CAUTIONARY NOTICE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Quarterly
Report”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (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 our clinical
trials, our 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 (“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 (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 therefore
caution you 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 on favorable terms (or at all) to fund continuing operations, changes in Nasdaq rules, 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.
3
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
2024
March 31,
2024
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 6,859,075
$ 5,441,978
Deferred Offering Cost
–
277,827
Prepaid expenses and other current assets
279,008
505,983
Total current assets
7,138,083
6,225,788
Property and equipment, net
843,617
1,015,229
Operating lease right-of-use asset
743,994
883,054
Patents, net
825
1,100
Restricted cash
87,506
87,506
Deposits
33,305
33,305
Total assets
$ 8,847,330
$ 8,245,982
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 922,888
$ 777,862
Due to related parties
1,011,544
546,434
Operating lease liability, current portion
301,680
290,565
Accrued Professional Fees
95,338
215,038
Total current liabilities
2,331,450
1,829,899
Operating lease liability, less current portion
496,772
649,751
Total liabilities
2,828,222
2,479,650
See Commitments and Contingencies Note 9
–
–
Stockholders’ Equity
Common stock, par value $ 0.001 per share; 60,000,000 shares authorized as of September 30, 2024 and March 31, 2024; 13,961,998 and 2,629,725 shares issued and outstanding as of September 30, 2024 and March 31, 2024, respectively
13,962
2,629
Additional paid-in capital
165,954,256
160,337,371
Accumulated other comprehensive loss
( 3,969 )
( 6,940 )
Accumulated deficit
( 159,945,141 )
( 154,566,728 )
Total stockholders’ equity
6,019,108
5,766,332
Total liabilities and stockholders’ equity
$ 8,847,330
$ 8,245,982
The accompanying notes are an integral part
of these condensed consolidated financial statements .
4
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
For the Three and Six Month Periods Ended September
30, 2024 and 2023
(Unaudited)
Three Months
Ended
September 30,
2024
Three Months
Ended
September 30,
2023
Six Months
Ended
September 30,
2024
Six Months
Ended
September 30,
2023
OPERATING EXPENSES
Professional fees
$ 570,845
$ 1,133,111
$ 1,184,927
$ 2,109,749
Payroll and related expenses
1,372,899
1,191,426
2,627,701
2,314,665
General and administrative
958,375
850,809
1,709,228
2,159,092
Total operating expenses
2,902,119
3,175,346
5,521,856
6,583,506
OPERATING LOSS
( 2,902,119 )
( 3,175,346 )
( 5,521,856 )
( 6,583,506 )
OTHER INCOME
Interest Income
95,146
140,890
143,442
266,871
NET LOSS
( 2,806,973 )
( 3,034,456 )
( 5,378,414 )
( 6,316,635 )
OTHER COMPREHENSIVE INCOME (LOSS)
3,804
( 2,435 )
2,971
( 3,429 )
COMPREHENSIVE LOSS
$ ( 2,803,169 )
$ ( 3,036,891 )
$ ( 5,375,443 )
$ ( 6,320,064 )
Basic and diluted loss per share attributable to common stockholders
$ ( 0.20 )
$ ( 1.22 )
$ ( 0.50 )
$ ( 2.57 )
Weighted average number of common shares outstanding – basic and diluted
13,937,595
2,483,649
10,715,446
2,457,711
The accompanying notes are an integral part
of these condensed consolidated financial statements.
5
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
For the Three and Six Months Ended September 30,
2024 and 2023
(Unaudited)
COMMON STOCK
ADDITIONAL
PAID IN
ACCUMULATED
ACCUMULATED
COMPREHENSIVE
TOTAL
SHARES
AMOUNT
CAPITAL
DEFICIT
INCOME (LOSS)
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 )
$ ( 7,773 )
$ 8,712,616
Issuance of common shares upon vesting of restricted stock units and net stock option exercises
24,671
25
( 3,857 )
–
–
( 3,832 )
Stock-based compensation expense
–
–
113,493
–
–
113,493
Net loss
–
–
–
( 2,806,973 )
–
( 2,806,973 )
Other comprehensive income (loss)
–
–
–
–
3,804
3,804
BALANCE – SEPTEMBER 30, 2024
13,961,998
$ 13,962
$ 165,954,256
$ ( 159,945,141 )
$ ( 3,969 )
$ 6,019,108
COMMON STOCK
ADDITIONAL
PAID IN
ACCUMULATED
ACCUMULATED
COMPREHENSIVE
TOTAL
SHARES
AMOUNT
CAPITAL
DEFICIT
LOSS
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
Issuance of common shares upon vesting of restricted stock units and net stock option exercises
9,329
9
( 9,852 )
–
–
( 9,843 )
Stock-based compensation expense
–
–
257,181
–
–
257,181
Rounding for reverse split
32
–
–
–
–
–
Net Loss
–
–
–
( 3,034,456 )
–
( 3,034,456 )
Other Comprehensive Loss
–
–
–
–
( 2,435 )
( 2,435 )
BALANCE – SEPTEMBER 30, 2023
2,492,908
$ 2,493
$ 159,001,611
$ ( 148,675,190 )
$ ( 9,570 )
$ 10,319,344
The accompanying notes are an integral part
of these condensed consolidated financial statements.
6
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Six Months Ended September 30, 2024 and
2023
(Unaudited)
Six months
Ended
September 30, 2024
Six months
Ended
September 30, 2023
Cash flows used in operating activities:
Net loss
$ ( 5,378,414 )
$ ( 6,316,635 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
171,887
181,752
Stock based compensation
252,821
507,295
Accretion of right-of-use operating lease asset
139,060
1,924
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
292,071
241,411
Accounts payable and other current liabilities
95,370
162,160
Due to related parties
465,110
35,560
Net cash used in operating activities
( 3,962,095 )
( 5,186,533 )
Cash flows used in investing activities:
Purchases of property and equipment
–
( 237,153 )
Net cash used in investing activities
–
( 237,153 )
Cash flows provided by financing activities:
Proceeds from the issuance of common stock, net
5,384,307
1,086,119
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense
( 8,910 )
( 18,215 )
Net cash provided by financing activities
5,375,397
1,067,904
Effect of exchange rate on changes on cash
3,795
( 1,241 )
Net change in cash and restricted cash
1,417,097
( 4,357,023 )
Cash and restricted cash at beginning of period
5,529,484
14,620,449
Cash and restricted cash at end of period
$ 6,946,581
$ 10,263,426
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
$ 53
$ 16
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:
Cash and cash equivalents
$ 6,859,075
$ 10,175,920
Restricted cash
87,506
87,506
Cash and restricted cash
$ 6,946,581
$ 10,263,426
The accompanying notes are an integral part
of these condensed consolidated financial statements .
7
AETHLON MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
September 30, 2024
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION
Aethlon Medical, Inc.
(“Aethlon,” the “Company,” “we” or “us”) is a medical therapeutic company focused on
developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral
infections and for use in organ transplantation. In human studies, 164 sessions with 38 patients, the Hemopurifier was safely
utilized and demonstrated the potential to remove life-threatening viruses. In pre-clinical studies, the Hemopurifier has
demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary
lectin-based technology. This action has potential applications in cancer, where exosomes and exosomal particles may promote immune
suppression and metastasis, and in life-threatening infectious diseases. The U.S. Food and Drug Administration (“FDA”)
has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
·
the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease; and
·
the treatment of life-threatening viruses that are not addressed with approved therapies.
We believe the Hemopurifier may be a substantial
advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes
and exosomal particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned subsidiary in Australia
to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia.
We have recently launched in Australia and in
India safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or
progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary
endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is safety.
The following two hospitals in Australia have
received ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide Hospital
in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia. We have also trained a third hospital in Australia,
but we have not yet received ethics committee approval for that institution and have not yet begun patient enrollment.
We have received ethics committee approval from
Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are
completing the necessary logistical steps before they can open for patient enrollment..
We have entered into an agreement with North American
Science Associates, LLC (“NAMSA”), a world leading medical technology contract research organization (“CRO”) offering
global end-to-end development services, to oversee our clinical trials of the Hemopurifier for patients in Australia with various types
of cancer tumors. We also have engaged Qualtran LLC as the CRO for our clinical trial in India.
We also believe that the Hemopurifier can be part
of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an
already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected with human immunodeficiency virus (“HIV”), hepatitis-C and Ebola.
8
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, 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 (“IDE”) for the Hemopurifier in viral disease to allow for the testing of the
Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. In June 2022, the first patient in this
study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of
our trial sites, we terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial
in India and wish to preserve the option of enrolling patients if the situation with COVID-19 changes.
Under Single Patient Emergency Use regulations,
Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
in our COVID-19 clinical trial discussed above.
We also obtained ethics review board (“ERB”)
approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India,
for a COVID-19 clinical trial at that location. In May 2023, we received ERB approval from the Medanta Medicity Hospital and Maulana Azad
Medical College (“MAMC”), for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established
in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government.
We now have two sites in India for this trial
with the MAMC. One patient has been treated to date; however, we have been informed by our CRO that a new COVID-19 subvariant was detected
in India recently. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the ICUs at our sites in
India.
Additionally, based on preclinical data with acellular
kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines, chemokines and other inflammatory molecules from recovered organs. We initially are focused on recovered kidneys from deceased
donors. We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in
vitro , 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, the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as
well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty
regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines
and future access to capital. The full extent to which inflation, the ongoing military conflicts and other global instability will impact
our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments,
as well as the economic impact on national and international markets that are highly uncertain.
We incorporated in Nevada on March 10, 1999. Our
executive offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360.
Our website address is www.aethlonmedical.com.
Our common stock is listed on the Nasdaq Capital Market under the symbol
“AEMD.”
9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
During the six months ended September 30, 2024,
there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended
March 31, 2024.
REVERSE STOCK SPLIT
On October 4, 2023, we effected a 1-for-10 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 (“GAAP”) for interim
financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission (“SEC”)
Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal
year ended March 31, 2024, included in our Annual Report on Form 10-K filed with the SEC on June 27, 2024. The accompanying unaudited
condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical
Australia Pty Ltd. All significant inter-company transactions and balances have been eliminated in consolidation. The accompanying unaudited
condensed consolidated financial statements, taken as a whole, contain all adjustments that are of a normal recurring nature necessary
to present fairly our operating results, cash flows, and financial position as of and for the period ended September 30, 2024. Estimates
were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial
and research and development expenses. Actual results could differ materially from those estimates. The accompanying condensed consolidated
balance sheet at March 31, 2024 has been derived from the audited consolidated balance sheet at March 31, 2024, contained in the above
referenced 10-K. The results of operations for the three and six months ended September 30, 2024 are not necessarily indicative of the
results to be expected for the full year or any future interim periods.
Reclassifications
Certain prior year balances within the unaudited
condensed consolidated financial statements have been reclassified to conform to the current year presentation, including the impact of
the reverse stock split.
LIQUIDITY AND GOING CONCERN
The accompanying unaudited condensed consolidated
financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the
realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations
and at September 30, 2024 had limited working capital and an accumulated deficit of $ 159,945,141 . These factors, among other matters,
raise substantial doubt about our ability to continue as a going concern within one year of the date these financial statements are issued.
A significant amount of additional capital will be necessary to advance the development of our products to the point at which they may
become commercially viable. We intend to fund operations, working capital and other cash requirements for the twelve-month period subsequent
to September 30, 2024 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic
partnerships.
10
The successful outcome of future activities cannot
be determined at this time and there is no assurance that, if achieved, we will have sufficient funds to execute our intended business
plan or generate positive operating results.
The condensed consolidated financial statements
do not include any adjustments related to this uncertainty and as to the recoverability and classification of asset carrying amounts or
the amount and classification of liabilities that might result should we be unable to continue as a going concern.
Management expects that existing cash as of September
30, 2024 will not be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed
consolidated financial statements.
The accompanying unaudited condensed consolidated
financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the
realization of assets and satisfaction of liabilities in the ordinary course of business.
Restricted Cash
To comply with the terms of our laboratory and
office lease and our lease for our manufacturing space (see Note 9), we caused our bank to issue two standby letters of credit (“L/Cs”)
in the aggregate amount of $ 87,506 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 September 30, 2024 and 2023, an aggregate
of 13,521,135 and 221,839 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- and six-month periods ended September 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
September 30,
September 30,
2024
2023
Three months ended
$ 261,486
$ 628,447
Six months ended
702,115
1,687,010
11
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 anticipates no credit losses from these securities. Additionally, the Company does not have any
revenue or accounts receivables. As a result, the Company did not establish an allowance for expected credit losses.
5. EQUITY TRANSACTIONS IN THE SIX MONTHS ENDED SEPTEMBER 30, 2024
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 approximately $ 3.5
million .
12
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), which was declared effective
by the SEC on May 15, 2024.
Warrant Exercises
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 to the Company of
$ 1,844,400 .
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 (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- and six-months ended September
30, 2024, 24,670 and 52,272 shares were issued upon settlement of 32,894 and 70,673 RSUs, respectively
6. RELATED PARTY TRANSACTIONS
During the three-months ended September 30, 2024,
we accrued $ 68,250 for board fees and paid fees of $ 68,250 owed to our non-employee directors for services in the current and prior quarter
respectively. In the three-months ended September 30, 2023, we accrued $ 68,250 and paid out $ 57,000 in fees owed to our non-employee directors.
In the six-months ended September 30, 2024, we paid out $ 136,500 compared to $ 114,000 in the six-months ended September 30, 2023.
As a result of entering
into a Separation Agreement, effective October 3, 2024, with a former employee we accrued $ 455,397 for salary and related expenses associated
with the Separation Agreement during the three months ended September 30, 2024. Additionally, we accrued $ 27,688 in health insurance
costs in the same period. We paid out $ 199,909 and $ 324,202 in separation expenses
in the three- and six-months ended September 30, 2024, respectively. As of September 30, 2024, the accrued separation expenses totaled
$ 792,627 . There were no accrued separation expenses as of September 30, 2023.
Amounts due to related parties were comprised
of the following items:
Schedule of amounts due to related parties
September 30,
2024
March 31,
2024
Accrued Board fees
$ 68,250
$ 68,250
Accrued vacation to all employees
150,667
167,973
Accrued separation expenses
792,627
310,211
Total due to related parties
$ 1,011,544
$ 546,434
13
7. 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- and six-month
periods ended September 30, 2024 and 2023:
Schedule of share-based compensation
expenses
Three Months
Ended
September 30,
2024
Three Months
Ended
September 30,
2023
Six Months
Ended
September 30,
2024
Six Months
Ended
September 30,
2023
Vesting of stock options and restricted stock units
$ 113,493
$ 257,181
$ 252,821
$ 507,295
Total stock-based compensation expense
$ 113,493
$ 257,181
$ 252,821
$ 507,295
Weighted average number of common shares outstanding – basic and diluted
13,937,595
2,483,649
10,715,446
2,457,711
Basic and diluted loss per common share attributable to stock-based compensation expense
$ ( 0.01 )
$ ( 0.10 )
$ ( 0.02 )
$ ( 0.21 )
All of the stock-based compensation expense recorded
during the six months ended September 30, 2024 and 2023, an aggregate of $ 252,821 and $ 507,295 , 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 six months ended September 30, 2024 and 2023 represented an impact on basic and diluted loss per common share of $ ( 0.02 ) and
$ ( 0.21 ) , respectively.
Stock Option and RSU Activity
We did no t issue any stock options during the
six months ended September 30, 2024 and 2023.
Stock options outstanding that have vested as
of September 30, 2024 and stock options that are expected to vest subsequent to September 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
63,828
$ 17.79
6.10
Expected to vest
14,843
$ 15.61
7.21
Total
78,671
14
A summary of stock option activity during the
six months ended September 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
7,795
$ 6.90-1,425.00
$ 23.79
Outstanding September 30, 2024
78,671
$ 12.80 – 25.20
$ 17.37
Exercisable, September 30, 2024
63,828
$ 12.80 – 25.20
$ 17.79
There were no stock option grants during the three
months ended September 30, 2024 and 2023. There were no RSUs granted during the three months September 30, 2024 and 2023. There were no
stock option exercises during the three months ended September 30, 2024 and 2023. On September 30, 2024, our outstanding stock options
had no intrinsic value, since the closing share price on that date of $ 0.47 per share was below the exercise price of our outstanding
stock options.
The table below summarizes nonvested stock options as of September
30, 2024 and changes during the three months ended September 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
( 8,778 )
$ 1.67
Forfeited
( 5,032 )
$ 0.83
Nonvested stock options at September 30, 2024
14,843
The detail of the options outstanding and exercisable as of September
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
$ 12.80 - 16.80
54,493
6.33 years
$ 13.90
41,665
$ 13.84
$ 25.20
24,178
6.26 years
$ 25.20
22,163
$ 25.20
78,671
63,828
15
The table below summarizes RSUs as of September
30, 2024 and changes during the six months ended September 30, 2024.
Schedule of RSUs
Shares
Nonvested RSUs at April 1, 2024
4,885
Granted
131,576
Vested
( 52,272 )
Tax withholding payments or tax equivalent payments for net share settlement of RSUs
( 18,401 )
Nonvested RSUs at September 30, 2024
65,788
Our total stock-based compensation for the three
months ended September 30, 2024 and 2023 included the following:
Schedule of stock-based compensation
Six Months Ended
September 30, 2024
September 30, 2023
Vesting of restricted stock units
$ 118,750
$ 93,750
Vesting of stock options
134,071
413,545
Total Stock-Based Compensation
$ 252,821
$ 507,295
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 six months ended September 30, 2024 was insignificant.
On September 30, 2024, our outstanding stock options
had no intrinsic value since the closing price on that date of $ 0.47 per share was below the weighted average exercise price of our outstanding
stock options.
At September 30, 2024, there was approximately
$ 305,677 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average
period of 0.96 years.
8. WARRANTS
During the six-months ended September 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 six-months ended
September 2023.
A summary of warrant activity during the six
months ended September 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 September 30, 2024
13,376,676
$ 0.58 – 27.50
$ 0.63
Warrants exercisable at September 30, 2024
13,376,676
$ 0.58 – 27.50
$ 0.63
16
9. 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 $ 12,824 . Cash paid in the three months ended
September 30, 2024 for amounts included in the measurement of operating lease liabilities in operating cash flows was $ 80,202 .
The office, lab and manufacturing leases are coterminous
with a remaining term of 30 months. The weighted average discount rate is 4.25 %.
As of our September 30, 2024 balance sheet, we
have an operating lease right-of-use asset of $ 743,994 and operating lease liability of $ 798,452 .
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 $ 108,000 and $ 105,000 for the three- month periods ended September 30, 2024 and 2023,
respectively. Rent expense for the six-month periods ending September 30, 2024 and September 30, 2023 was approximately $ 210,000 for both
periods.
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.
10. SUBSEQUENT EVENTS
Management has evaluated events subsequent to
September 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.
Management/Board Changes – Effective October
3, 2024, James B. Frakes, MBA, Chief Financial Officer and formerly Interim Chief Executive Officer of Aethlon, was appointed as the permanent
Chief Executive Officer of the Company. Mr. Frakes will additionally remain as Chief Financial Officer of the Company. Effective
as of October 3, 2024, Guy Cipriani, MBA, was terminated as the Company’s Chief Operating Officer.
In November 2024, we received confirmation that
the first two patients enrolled in our Australian 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, such as Keytruda® (pembrolizumab)
or Opdivo® (nivolumab), successfully completed screening and are now advancing to the run-in period of the study. Both of the patients
are enrolled in the trial at the Royal Adelaide Hospital in Australia. The enrollment of the first two eligible patients marks a significant
milestone in advancing our clinical program for the Hemopurifier.
17
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 (this “Quarterly Report”). 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. (“Aethlon”,
the “Company,” “we” or “us”) is a medical therapeutic company focused on developing the Hemopurifier,
a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections and for use in organ transplantation.
In human studies, 164 sessions with 38 patients, the Hemopurifier was safely utilized and demonstrated the potential to remove life-threatening
viruses. In pre-clinical studies, the Hemopurifier has demonstrated the potential to remove harmful exosomes and exosomal particles from
biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes
and exosomal particles may promote immune suppression and metastasis, and in life-threatening infectious diseases. The U.S. Food and Drug
Administration (“FDA”) has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
•
the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy,
and with cancer types in which exosomes or exosomal particles have been shown to participate in the development or severity of the disease;
and
•
the treatment of life-threatening
viruses that are not addressed with approved therapies.
We believe the Hemopurifier may be a substantial
advancement in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes
and exosomal particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned subsidiary in Australia
to initially conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia.
We have recently launched in Australia and in
India safety, feasibility and dose-finding clinical trials of the Hemopurifier in cancer patients with solid tumors who have stable or
progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab). The primary
endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial in each country is the incidence of adverse
events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive
disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy.
Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will
receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine
the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (“EVs”) and whether these
changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses
are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.
The following two hospitals in Australia have
received ethics committee approval, have gone through training on our device and are now open for patient enrollment: Royal Adelaide Hospital
in Adelaide, Australia and Pindara Private Hospital in the Gold Coast section of Australia. We have also trained a third hospital in Australia,
but we have not yet received ethics committee approval for that institution and have not yet begun patient enrollment. In November 2024,
we received confirmation that the first two patients enrolled at the Royal Adelaide Hospital location have successfully completed screening
and are advancing to the run-in period of the trial. The enrollment of the first two eligible patients marks a significant milestone in
advancing our clinical program for the Hemopurifier.
We have received ethics committee approval from
Medanta Medicity Hospital in Gurugram, India for a similar nine to 18-patient, safety, feasibility and dose-finding trial. We are completing
the necessary logistical steps before they can open for patient enrollment.
18
We have entered into an agreement with North American
Science Associates, LLC (“NAMSA”), a world leading medical technology contract research organization (“CRO”) offering
global end-to-end development services, to oversee our clinical trials of the Hemopurifier for patients in Australia with various types
of cancer tumors. We also have engaged Qualtran LLC as the CRO for our clinical trial in India.
We also believe that the Hemopurifier can be part
of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an
already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected with human immunodeficiency virus (“HIV”), hepatitis-C and Ebola.
Additionally, in vitro, 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, 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 (“IDE”), for the Hemopurifier in viral disease to allow for the testing of the
Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. In June 2022, the first patient in this study
was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of our trial
sites, we terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial in India
and wish to preserve the option of enrolling patients if the situation with COVID-19 changes.
Under Single Patient Emergency Use regulations,
Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
in our COVID-19 clinical trial discussed above.
We also obtained ethics review board
(“ERB”) approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty
hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. In May 2023, we received ERB approval from the Medanta
Medicity Hospital and Maulana Azad Medical College (“MAMC”), for a second site for our clinical trial in India to treat
severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi
and is operated by the Delhi government.
We now have two sites in India for this trial
with the MAMC. One patient has been treated to date; however, we have been informed by our CRO that a new COVID-19 subvariant was detected
in India recently. Our COVID-19 trial in India remains open in the event that there are COVID-19 admissions to the ICUs at our sites in
India.
Additionally, based on preclinical data with acellular
kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines, chemokines and other inflammatory molecules from recovered organs. We initially are focused on recovered kidneys from deceased
donors. We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in
vitro, 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, 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, ongoing military conflicts and other global instability will impact
our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments,
as well as the economic impact on national and international markets that are highly uncertain.
19
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 SEPTEMBER 30, 2024 COMPARED TO THE THREE MONTHS
ENDED SEPTEMBER 30, 2023
Operating Expenses
Consolidated operating expenses for the three
months ended September 30, 2024 were $2,902,119, compared to $3,175,346 for the three months ended September 30, 2023. The decrease of
$273,227, or 8.6%, in the 2024 period was due to a decrease of $562,266 in professional fees, partially offset by an increase of $181,473
in payroll and related expenses and a $107,567 increase in general and administrative expenses.
In the three months ended September 30, 2024,
professional fees decreased by $562,266, primarily due to a $270,071 reduction in legal fees following a transition to a new legal firm,
a $211,417 decrease in contract labor expenses due to project completions with contract manufacturing organizations and research and development
consultants, an $80,630 decrease in accounting fees, and a $62,500 reduction in recruiting fees. These decreases were partially offset
by an increase in investor relations expenses to support the dissemination of progress on ongoing clinical trials.
Payroll expenses rose by $181,473, largely
due to an increase of $507,307 in separation expenses related to severance agreements following the termination of an executive and
a reduction in workforce. This increase was partially offset by a $172,419 reduction in ongoing payroll expenses and a $143,688
decrease in stock-based compensation as a result of completion of vesting of some existing stock options and expiration of options
associated with reduced headcount.
The $107,567 increase in general and
administrative expenses was primarily driven by a $162,790 increase in clinical trial expenses associated with our ongoing oncology clinical trial. A decrease of $32,551 in supplies following the completion of certain research and development efforts, a
$10,361 decrease in conference and trade show expenses, and a $9,671 decrease in insurance costs.
Net Loss
As a result of the changes in expenses noted above,
our comprehensive loss decreased to $2,803,169 in the three months ended September 30, 2024 from $3,036,891 in the three months ended
September 30, 2023.
Basic and diluted loss attributable to common
stockholders was ($0.20) for the three months ended September 30, 2024, compared to ($1.22) for the three-month period ended September
30, 2023.
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SIX MONTHS ENDED SEPTEMBER 30, 2024 COMPARED TO THE SIX MONTHS ENDED
SEPTEMBER 30, 2023
Operating Expenses
Consolidated operating expenses for the six months
ended September 30, 2024 were $5,521,856, compared to $6,583,506 for the six months ended September 30, 2023. This decrease of $1,061,651,
or 16.1%, in the 2024 period was due to decreases in our professional fees of $924,822 and general and administrative expenses of $449,864.
These decreases were partially offset by an increase of $313,035 in payroll and related expenses.
The $924,822 decrease in professional fees was
mainly due to a $430,205 reduction in contract labor costs related to completed projects with a contract manufacturing organization, as
well as with outside research and development and regulatory and quality management consultants. Additional decreases included $343,656
in legal fees following a transition to a new legal firm, a $62,500 reduction in recruiting fees, a $48,784 decline in consulting fees
incurred by our Australian subsidiary, and a $32,622 decrease in accounting fees for activities conducted in the prior year with no similar
expenses in the current year.
The $449,864 decrease in general and administrative
expenses was primarily driven by a $479,994 reduction in supplies expenses for raw materials purchased last year for the research, development,
and manufacturing of our Hemopurifier. Other decreases included a $44,137 decrease in cleanroom repair and maintenance expenses, a $27,763 decline in conference, tradeshow,
and travel and entertainment expenses, and a $20,897 decrease in insurance costs. These decreases were partially offset by a $141,928
increase in expenses primarily related to our ongoing oncology clinical trial.
The $313,035 increase in payroll expenses was
primarily due to $827,910 in severance-related salary expenses for two executives and a reduction in workforce. This increase was partially
offset by a $260,401 reduction in ongoing payroll expenses and a $254,474 decrease in stock-based compensation due to reduced headcount.
.
Net Loss
As a result of the changes in expenses noted above, our comprehensive
loss decreased from $6,320,064 in the six months ended September 30, 2023, to $5,375,443 in the six months ended September 30, 2024.
Basic and diluted loss attributable to common
stockholders was ($0.50) for the six months ended September 30, 2024, compared to ($2.57) for the six-month period ended September 30,
2023.
LIQUIDITY AND CAPITAL RESOURCES
As of September 30, 2024, we had a cash balance
of $6,859,075 and working capital of $4,806,633. 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 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.
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We do not expect our existing cash as of September
30, 2024 to be sufficient to fund our operations for at least twelve months from the issuance date of these financial statements. Significant
additional financing must be obtained to provide a sufficient source of operating capital and to allow us to continue to operate as a
going concern. We intend to fund operations, working capital and other cash requirements for the twelve-month period subsequent
to September 30, 2024 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic
partnerships.
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.
Going Concern
The accompanying unaudited
condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing
losses from operations and at September 30, 2024 had limited working capital and an accumulated deficit of $159,945,141. These factors,
among other matters, raise substantial doubt about our ability to continue as a going concern within one year of the date of the financial
statements included in this Quarterly Report. A significant amount of additional capital will be necessary to advance the development
of our products to the point at which they may become commercially viable. We intend to fund operations, working capital and other cash
requirements for the twelve-month period subsequent to September 30, 2024 through a combination of debt and/or equity financing arrangements
and potentially from collaborations or strategic partnerships.
The successful outcome
of future activities cannot be determined at this time and there is no assurance that, if achieved, we will have sufficient funds to execute
our intended business plan or generate positive operating results.
The condensed consolidated
financial statements do not include any adjustments related to this uncertainty and as to the recoverability and classification of asset
carrying amounts or the amount and classification of liabilities that might result should we be unable to continue as a going concern.
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.
22
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 approximately
$3.5 million.
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), which was declared effective
by the SEC on May 15, 2024.
Warrant Exercises
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 to the Company of $1,844,400.
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
September 30,
2024
September 30,
2023
Cash (used in) provided by:
Operating activities
$ (3,962 )
$ (5,187 )
Investing activities
–
(237 )
Financing activities
5,375
1,068
Effect of exchange rate changes on cash
4
(1 )
Net change in cash and restricted cash
$ 1,417
$ (4,357 )
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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 $3,962,000
in the six months ended September 30, 2024, compared to approximately $5,187,000 in the six months ended September 30, 2023. The primary
components in the $1,225,000 decrease in cash used in our operating activities in the 2024 period was a decrease in our net loss of approximately
$938,000 and a positive net change in other working capital components of $555,000, partially offset by the reduction of $268,000 in non-cash
components.
NET CASH USED IN INVESTING ACTIVITIES. We did
not use cash for investing activities in the six months ended September 30, 2024, compared to approximately $237,000 in the six months
ended September 30, 2023. The $237,000 decrease in the 2024 period was primarily a result of equipment purchase for our laboratory incurred
in the six months ended September 2023.
NET CASH PROVIDED BY FINANCING ACTIVITIES. During
the six months ended September 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 2,880,000 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 $9,000 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 $5,375,000.
During the six months ended September 30, 2023,
we raised approximately $1,086,000 from the issuance of our common stock under our at the market facility. That source of cash from our
financing activities was partially offset by the use of approximately $16,000 to pay for the tax withholding on restricted stock units,
for a net aggregate amount of cash provided by financing activities of approximately $1,068,000.
Material Cash Requirements
We expect our clinical trial expenses for
our 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 are obligated under lease agreements
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 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 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.
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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 (“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 have been no changes to our critical accounting
policies and estimates as disclosed in our Annual Report on 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 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 Chief Executive Officer, who also serves as our 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 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 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.
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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 no changes in our internal control over financial reporting during the quarter ending September 30, 2024
that have materially affected, or reasonably likely to materially affect, our internal control over financial reporting.
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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, 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.
·
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.
·
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.
·
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.
·
We face intense competition in the medical device industry.
·
Our Hemopurifier technology may become obsolete.
·
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.
·
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.
27
·
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.
·
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.
·
Our success is dependent in part on our executive
officers.
·
We have not received, and may never receive, approval
from the FDA to market a medical device in the United States. Even though we have received breakthrough device designation for the Hemopurifier
for two independent indications, this designation may not expedite the development or review of the Hemopurifier and does not provide
assurance ultimately of PMA submission or approval by the FDA.
·
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 September 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 September 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.
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ITEM 6. EXHIBITS.
(a) Exhibits. The following documents are filed
as part of this report:
Incorporated
by Reference
Exhibit
Number
Exhibit
Description
Form
SEC
File No.
Exhibit
Number
Date
Filed
Herewith
3.1
Articles
of Incorporation, as amended .
8-K
001-37487
3.1
September 19, 2022
3.2
Amended
and Restated Bylaws of the Company .
8-K
001-37487
3.1
September 12, 2019
4.1
Form
of Common Stock Certificate .
S-1
333-201334
4.1
December 31, 2014
4.2
Form
of Warrant to Purchase Common Stock .
S-1/A
333-234712
4.14
December
11, 2019
4.3
Form
of Underwriter Warrant .
S-1/A
333-234712
4.15
December
11, 2019
4.4
Form
of Common Stock Purchase Warrant .
8-K
001-37487
4.1
January
17, 2020
4.5
Form of Class A Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.1
May 17, 2024
4.6
Form of Class B Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.2
May 17, 2024
4.7
Form of Pre-Funded Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.3
May 17, 2024
10.1
Form of Securities Purchase Agreement.
S-1/A
333-278188
10.20
May 13, 2024
10.2
Aethlon Medical, Inc. 2020 Equity Incentive Plan, as amended to date, Form of Restricted Stock Grant, Form of Option Grant and Agreement.
8-K
001-37487
10.1
October 2, 2024
31.1
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 .
X
32.1^
Certification of the Principal
Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section
1350 .
X
101.INS*
Inline XBRL Instance Document with Embeded Linkbase
Documents
X
101.SCH *
Inline XBRL Taxonomy Extension Schema Document
X
104 *
Cover Page Interactive Data File (formatted in XBRL,
and included in exhibit 101)
^
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.
*
The XBRL related information in Exhibit 101 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability of that section and shall not be incorporated by reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing or document.
29
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.
Date: November 13, 2024
By:
/s/ JAMES B. FRAKES
JAMES B. FRAKES
CHIEF EXECUTIVE OFFICER
CHIEF FINANCIAL OFFICER
(PRINCIPAL EXECUTIVE AND FINANCIAL OFFICER)
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.