0000882291 false --03-31 2023 Q1 0000882291 2023-04-01 2023-06-30 0000882291 2023-08-09 0000882291 2023-06-30 0000882291 2023-03-31 0000882291 2022-04-01 2022-06-30 0000882291 us-gaap:CommonStockMember 2023-03-31 0000882291 us-gaap:AdditionalPaidInCapitalMember 2023-03-31 0000882291 us-gaap:RetainedEarningsMember 2023-03-31 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-03-31 0000882291 us-gaap:NoncontrollingInterestMember 2023-03-31 0000882291 us-gaap:CommonStockMember 2022-03-31 0000882291 us-gaap:AdditionalPaidInCapitalMember 2022-03-31 0000882291 us-gaap:RetainedEarningsMember 2022-03-31 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-03-31 0000882291 us-gaap:NoncontrollingInterestMember 2022-03-31 0000882291 2022-03-31 0000882291 us-gaap:CommonStockMember 2023-04-01 2023-06-30 0000882291 us-gaap:AdditionalPaidInCapitalMember 2023-04-01 2023-06-30 0000882291 us-gaap:RetainedEarningsMember 2023-04-01 2023-06-30 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-04-01 2023-06-30 0000882291 us-gaap:NoncontrollingInterestMember 2023-04-01 2023-06-30 0000882291 us-gaap:CommonStockMember 2022-04-01 2022-06-30 0000882291 us-gaap:AdditionalPaidInCapitalMember 2022-04-01 2022-06-30 0000882291 us-gaap:RetainedEarningsMember 2022-04-01 2022-06-30 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-04-01 2022-06-30 0000882291 us-gaap:NoncontrollingInterestMember 2022-04-01 2022-06-30 0000882291 us-gaap:CommonStockMember 2023-06-30 0000882291 us-gaap:AdditionalPaidInCapitalMember 2023-06-30 0000882291 us-gaap:RetainedEarningsMember 2023-06-30 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2023-06-30 0000882291 us-gaap:NoncontrollingInterestMember 2023-06-30 0000882291 us-gaap:CommonStockMember 2022-06-30 0000882291 us-gaap:AdditionalPaidInCapitalMember 2022-06-30 0000882291 us-gaap:RetainedEarningsMember 2022-06-30 0000882291 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2022-06-30 0000882291 us-gaap:NoncontrollingInterestMember 2022-06-30 0000882291 2022-06-30 0000882291 aemd:RestrictedCashMember 2022-06-30 0000882291 aemd:OfferingAgreementMember 2023-04-01 2023-06-30 0000882291 aemd:HcWainwrightMember aemd:OfferingAgreementMember 2023-04-01 2023-06-30 0000882291 aemd:OfferingAgreementMember aemd:OtherOfferingExpenseMember 2023-04-01 2023-06-30 0000882291 aemd:EligibleDirectorsEachMember us-gaap:RestrictedStockUnitsRSUMember 2023-04-01 2023-06-30 0000882291 aemd:AccruedBoardFeesMember 2023-06-30 0000882291 aemd:AccruedBoardFeesMember 2023-03-31 0000882291 aemd:AccruedVacationMember 2023-06-30 0000882291 aemd:AccruedVacationMember 2023-03-31 0000882291 aemd:StockBasedCompensationMember 2023-04-01 2023-06-30 0000882291 aemd:StockBasedCompensationMember 2022-04-01 2022-06-30 0000882291 us-gaap:OptionMember 2023-06-30 0000882291 us-gaap:StockOptionMember 2023-04-01 2023-06-30 0000882291 us-gaap:StockOptionMember 2023-06-30 0000882291 us-gaap:OptionMember 2023-03-31 0000882291 us-gaap:OptionMember 2023-04-01 2023-06-30 0000882291 us-gaap:WarrantMember 2023-03-31 0000882291 us-gaap:WarrantMember 2023-04-01 2023-06-30 0000882291 us-gaap:WarrantMember 2023-06-30 0000882291 2022-08-31 0000882291 aemd:OfficeAndLaboratoryMember 2023-04-01 2023-06-30 0000882291 aemd:ManufacturingMember 2023-04-01 2023-06-30 0000882291 aemd:OfficeLabAndManufacturingLeasesMember 2023-06-30 0000882291 aemd:NewOfficeAndLabSpaceMember 2023-06-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure

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, 2023

 

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 9, 2023, the registrant had outstanding 24,835,321 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 JUNE 30, 2023 (UNAUDITED) AND MARCH 31, 2023 4
     
  CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED) 5
     
  CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED) 6
     
  CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED JUNE 30, 2023 AND 2022 (UNAUDITED) 7
     
  NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) 8
     
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 17
     
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 22
     
ITEM 4. CONTROLS AND PROCEDURES 22
     
PART II. OTHER INFORMATION 23
     
ITEM 1. LEGAL PROCEEDINGS 23
     
ITEM 1A. RISK FACTORS 23
     
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 24
     
ITEM 3. DEFAULTS UPON SENIOR SECURITIES 24
     
ITEM 4. MINE SAFETY DISCLOSURES 24
     
ITEM 5. OTHER INFORMATION 24
     
ITEM 6. EXHIBITS 25
     
  SIGNATURES 26

 

 

 

 2 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 3 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

         
   June 30,
2023
   March 31,
2023
 
    (Unaudited)      
ASSETS          
Current assets          
Cash  $12,897,734   $14,532,943 
Prepaid expenses and other current assets   410,223    557,623 
Total current assets   13,307,957    15,090,566 
           
Property and equipment, net   1,284,200    1,144,004 
Right-of-use lease asset   1,086,108    1,151,909 
Patents, net   1,513    1,650 
Restricted cash   87,506    87,506 
Deposits   33,305    33,305 
Total assets  $15,800,589   $17,508,940 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities          
Accounts payable  $844,536   $432,890 
Due to related parties   191,314    214,221 
Lease liability, current portion   274,520    269,386 
Other current liabilities   511,377    588,592 
Total current liabilities   1,821,747    1,505,089 
           
Lease liability, less current portion   869,945    939,642 
Total liabilities   2,691,692    2,444,731 
           
Stockholders’ Equity          
Common stock, par value $0.001 per share; 60,000,000 shares authorized as of June 30, 2023 and March 31, 2023; 24,835,321 and 22,992,466 shares issued and outstanding as of June 30, 2023 and March 31, 2023, respectively   24,837    22,994 
Additional paid-in capital   158,731,929    157,405,911 
Accumulated other comprehensive loss   (7,135)   (6,141)
Accumulated deficit   (145,640,734)   (142,358,555)
           
Total stockholders’ equity   13,108,897    15,064,209 
           
Total liabilities and stockholders’ equity  $15,800,589   $17,508,940 

 

See accompanying notes.

 

 

 

 4 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three Month Periods Ended June 30, 2023 and 2022

(Unaudited)

 

         
   Three Months
Ended
June 30,
2023
   Three Months
Ended
June 30,
2022
 
         
         
OPERATING EXPENSES          
           
Professional fees  $976,638   $844,028 
Payroll and related expenses   1,123,239    1,029,686 
General and administrative   1,308,283    1,032,367 
Total operating expenses   3,408,160    2,906,081 
OPERATING LOSS   (3,408,160)   (2,906,081)
           
OTHER INCOME          
Interest income   125,981     
           
NET LOSS   (3,282,179)   (2,906,081)
           
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS       (413)
           
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC.   (3,282,179)   (2,905,668)
           
OTHER COMPREHENSIVE LOSS   (994)    
           
COMPREHENSIVE LOSS  $(3,283,173)  $(2,905,668)
           
Basic and diluted net loss per share attributable to common stockholders  $(0.14)  $(0.19)
           
Weighted average number of common shares outstanding – basic and diluted   24,314,759    15,486,621 

 

See accompanying notes.

 

 

 

 5 

 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the Three Months Ended June 30, 2023 and 2022

(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, 2023   22,992,466   $22,994   $157,405,911   $(142,358,555)  $(6,141)  $   $15,064,209 
                                    
Issuances of common stock for cash under at the market program   1,778,901    1,779    1,084,340                1,086,119 
                                    
Issuance of common shares upon vesting of restricted stock units and net stock option exercises   63,954    64    (8,436)               (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   24,835,321   $24,837   $158,731,929   $(145,640,734)  $(7,135)  $   $13,108,897 
                                    
                                    
                                    
                                    
BALANCE - MARCH 31, 2022   15,419,163   $15,421   $147,446,868   $(130,329,181)  $   $(141,708)  $16,991,400 
                                    
Issuances of common stock for cash under at the market program   574,560    575    618,867                619,442 
                                    
Stock-based compensation expense           215,437                215,437 
                                    
Net loss               (2,905,668)       (413)   (2,906,081)
                                    
BALANCE – JUNE 30, 2022   15,993,723   $15,996   $148,281,172   $(133,234,849)  $   $(142,121)  $14,920,198 

 

See accompanying notes.

 

 

 

 6 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Three Months Ended June 30, 2023 and 2022

(Unaudited)

         
   Three months
Ended
June 30, 2023
   Three months
Ended
June 30, 2022
 
         
Cash flows used in operating activities:          
Net loss  $(3,282,179)  $(2,906,081)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   90,325    30,650 
Stock based compensation   250,114    215,437 
Accretion of right-of-use lease asset   1,238    7,800 
Changes in operating assets and liabilities:          
Prepaid expenses and other current assets   146,409    99,336 
Accounts receivable       13,116 
Accounts payable and other current liabilities   334,613    (310,327)
Deferred revenue       114,849 
Due to related parties   (22,907)   6,303 
Net cash used in operating activities   (2,482,387)   (2,728,917)
           
Cash flows used in investing activities:          
Purchases of property and equipment   (230,383)   (41,169)
Net cash used in investing activities   (230,383)   (41,169)
           
Cash flows provided by financing activities:          
Proceeds from the issuance of common stock, net   1,086,119    619,442 
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense   (8,372)    
Net cash provided by financing activities   1,077,747    619,442 
           
Effect of exchange rate on changes on cash   (186)    
           
Net decrease in cash and restricted cash   (1,635,209)   (2,150,644)
           
Cash and restricted cash at beginning of period   14,620,449    17,159,925 
           
Cash and restricted cash at end of period  $12,985,240   $15,009,281 
           
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  $64   $ 
           
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:          
Cash and cash equivalents  $12,897,734   $14,921,775 
Restricted cash   87,506    87,506 
Cash and restricted cash  $12,985,240   $15,009,281 

 

See accompanying notes.

 

 

 

 7 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

June 30, 2023

 

 

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 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 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 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 the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or CRO, on preparations to conduct a 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 clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our 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.

 

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.

 

 

 

 8 

 

 

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 currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, 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, is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change.

 

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 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. MMAC is affiliated with the University of Delhi and is operated by the Delhi government.

 

We also recently announced that we also 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 in Ukraine 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 war in Ukraine 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 three months ended June 30, 2023, 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, 2023.

 

Basis of Presentation and Use of Estimates

 

The accompanying unaudited condensed consolidated financial statements of the Company 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, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on June 28, 2023. 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 unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated financial statements as of and for the three months ended June 30, 2023, and the condensed consolidated statement of cash flows for the three months ended June 30, 2023. 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, 2023 has been derived from the audited consolidated balance sheet at March 31, 2023, contained in the above referenced 10-K. The results of operations for the three months ended June 30, 2023 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.

 

LIQUIDITY AND GOING CONCERN

 

Management expects existing cash as of June 30, 2023 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed consolidated financial statements.

 

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 the 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, 2023 and 2022, an aggregate of 2,291,234 and 2,227,286 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, and restricted stock units were excluded, as their inclusion would be antidilutive.

 

 

 

 10 

 

 

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, 2023 and 2022, 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:

         
   June 30,   June 30, 
    2023    2022 
Three months ended  $678,922   $858,347 

  

4. RECENT ACCOUNTING PRONOUNCEMENTS

 

None.

 

5. EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2023

 

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, 2023, we raised net proceeds of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of, 1,778,901 shares of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement.

 

 

 

 11 

 

 

Restricted Stock Unit Grants

 

On April 28, 2023, the Board approved, pursuant to the terms of the Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual restricted stock units, or RSUs, under the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board. 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 directors then serving on the Board, and for a grant of stock options or $75,000 worth of RSUs for a newly elected director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $0.43 per share for the RSUs granted in April 2023. As a result, in April 2023 the three eligible directors each were granted an RSU in the amount of 116,279 shares under the Company’s 2020 Equity Incentive Plan, 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, 2023, September 30, 2023, December 31, 2023, and March 31, 2024, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date.

 

6. RELATED PARTY TRANSACTIONS

 

During the three months ended June 30, 2023, we accrued unpaid fees of $57,000 owed to our non-employee directors. Amounts due to related parties were comprised of the following items:

         
   June 30,
2023
   March 31,
2023
 
Accrued Board fees  $57,000   $57,000 
Accrued vacation to all employees   134,314    157,221 
Total due to related parties  $191,314   $214,221 

 

7. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

 Schedule of other current liabilities        
   June 30,   March 31, 
   2023   2023 
Accrued professional fees  $511,377   $588,592 
Total other current liabilities  $511,377   $588,592 

 

 

 

 12 

 

 

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, 2023 and 2022:

        
   June 30,
2023
   June 30,
2022
 
Vesting of stock options and restricted stock units  $250,114   $215,437 
Total stock-based compensation expense  $250,114   $215,437 
           
Weighted average number of common shares outstanding – basic and diluted   24,314,759    15,486,621 
           
Basic and diluted loss per common share attributable to stock-based compensation expense  $(0.01)  $(0.01)

  

All of the stock-based compensation expense recorded during the three months ended June 30, 2023 and 2022, an aggregate of $250,114 and $215,437, 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, 2023 and 2022 represented an impact on basic and diluted loss per common share of $(0.01) in each period.

 

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, 2023 was insignificant.

 

Stock Option Activity

 

We did not issue any stock options during the three months ended June 30, 2023 and 2022.

 

Stock options outstanding that have vested as of June 30, 2023 and stock options that are expected to vest subsequent to June 30, 2023 are as follows:

            
   Number of
Shares
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested   842,610   $2.44    7.68 
Expected to vest   860,243   $2.06    8.24 
Total   1,702,853           

  

 

 

 13 

 

 

A summary of stock option activity during the three months ended June 30, 2023 is presented below:

             
   Amount   Range of
Exercise Price
   Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2023   1,718,253   $.69 - 142.50   $2.31 
Exercised      $   $ 
Granted      $   $ 
Cancelled/Expired   15,400   $1.21   $1.21 
Stock options outstanding at June 30, 2023   1,702,853   $.69 - 142.50   $2.25 
Stock options exercisable at June 30, 2023   842,610   $1.28 - 142.50   $2.44 

 

On June 30, 2023, our outstanding stock options had no intrinsic value since the closing share price on that date of $0.36 per share was below the weighted average exercise price of our outstanding stock options.

 

At June 30, 2023, there was approximately $1,719,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.84 years.

 

9. WARRANTS

 

During the three months ended June 30, 2023 and 2022, we did not issue any warrants.

 

A summary of warrant activity during the three months ended June 30, 2023 is presented below:

            
   Amount   Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2023   326,753   $1.50 – 2.75   $2.01 
Exercised      $   $ 
Cancelled/Expired      $   $ 
Warrants outstanding at June 30, 2023   326,753   $1.50 – 2.75   $2.01 
Warrants exercisable at June 30, 2023   326,753   $1.50 – 2.75   $2.01 

  

 

 

 14 

 

 

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 $13,772. The current monthly base rent under the manufacturing component of the lease is $12,080.

 

The office, lab and manufacturing leases are coterminous with a remaining term of 45 months. The weighted average discount rate is 4.25%.

 

As of our June 30, 2023 balance sheet, we have a right-of-use lease asset of $1,086,108.

 

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.

  

Mobile Clean Room

 

In addition, we rented a mobile clean room on a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed. The mobile clean room was located on leased land near our office and lab and we paid $2,000 per month for the right to locate it there. The arrangement was terminated in September 2022 and the mobile clean room was returned to the vendor that leased it to us.

 

Overall, our rent expense, which is included in general and administrative expenses, approximated $105,000 and $140,000 for the three month periods ended June 30, 2023 and 2022, 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.

 

 

 

 15 

 

 

11. SUBSEQUENT EVENTS

 

Management has evaluated events subsequent to June 30, 2023 through the date that the accompanying consolidated financial statements were filed with the Securities and Exchange Commission for transactions and other events which may require adjustment of and/or disclosure in such financial statements.

 

In July 2023, Mr. Nikolas Gikakis was appointed as a member our Board of Directors and as a member of the Nominating and Corporate Governance Committee of the Board, or the N&CG Committee. Pursuant to the Director Compensation Policy, upon his appointment to the Board, Mr. Gikakis (i) will receive an (a) annual cash retainer of $40,000 for his service on the Board, and (b) an additional annual cash retainer of $5,000 for his service as a member of the N&CG Committee, and (ii) was granted, on the date of his appointment to the Board, restricted stock units for 195,414 shares of our common stock under the 2020 Plan, which will vest in equal quarterly installments over one year from the date of grant, in each case subject to Mr. Gikakis’s Continuous Service (as defined in the 2020 Plan) as of each such vesting date. The Director Compensation Policy also provides for further annual grants to its independent directors, at the beginning of each fiscal year, of restricted stock units with a grant date fair value of $50,000 or, at the option of our Board, options to purchase shares of our common stock, subject to vesting as determined by our Board. Mr. Gikakis has also entered into our standard form of indemnification agreement for directors.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 16 

 

 

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 the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or CRO, on preparations to conduct a 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 clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our 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.

 

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.

 

 

 

 17 

 

 

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 currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, 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, is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change.

 

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 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. MMAC is affiliated with the University of Delhi and is operated by the Delhi government.

 

We also recently announced that we also 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 in Ukraine 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 war in Ukraine 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.”

 

 

 

 18 

 

 

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 web site (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, 2023 COMPARED TO THE THREE MONTHS ENDED JUNE 30, 2022

 

Operating Expenses

 

Consolidated operating expenses for the three months ended June 30, 2023 were $3,408,160, compared to $2,906,081 for the three months ended June 30, 2022. This increase of $502,079, or 17.3%, in the 2023 period was due to increases in our general and administrative expenses of $275,916, professional fees of $132,610 and in our payroll and related expenses of $93,553.

 

The $275,916 increase in general and administrative expenses was primarily due to the combination of a $343,853 increase in purchase of raw materials for production of our Hemopurifier, $132,546 increase related to our Australian subsidiary’s activities, $104,908 increase in depreciation and equipment maintenance associated with leasehold improvements and new equipment for our manufacturing and lab facilities and an increase of $14,224 in insurance expense. The increases were offset by a $160,290 decrease in clinical trial expenses, $139,752 decrease in subcontract expense associated with government contracts and a net decrease of $28,564 in expenses related to the previously rented mobile cleanroom.

 

The $132,610 increase in our professional fees was due to an increase of $123,077 in investor relations associated with facilitating investor awareness and assistance with more widespread dissemination of Company news, an increase of $36,623 associated with accounting and legal services for our Australian subsidiary and $86,410 of legal expenses associated with year-end filings and general corporate matters. Increases were offset by decreases in regulatory services of $85,037, recruiting expense of $27,525 and $5,994 in consulting services.

 

The $93,553 increase in payroll expense was due to $58,876 in salary expense related to increase in headcount and $34,677 increase in stock based compensation related to employee stock option grants.

 

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss increased to $3,282,179 in the three months ended June 30, 2023, from approximately $2,906,081 in the three months ended June 30, 2022.

 

Basic and diluted loss attributable to common stockholders was ($0.14) for the three months ended June 30, 2023, compared to ($0.19) for the three month period ended June 30, 2022.

 

LIQUIDITY AND CAPITAL RESOURCES

 

As of June 30, 2023, we had a cash balance of $12,897,734 and working capital of $11,486,210. This compares to a cash balance of $14,532,943 and working capital of $13,585,477 at March 31, 2023. We expect our existing cash as of June 30, 2023 to be sufficient to fund our operations for at least twelve months from the issuance date of these financial statements.

 

 

 

 19 

 

 

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, 2023, we raised net proceeds of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of, 1,778,901 shares of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement.

  

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,
2023
   June 30,
2022
 
Cash (used in) provided by:          
Operating activities  $(2,482)  $(2,729)
Investing activities   (230)   (41)
Financing activities   1,077    619 
Net decrease in cash and restricted cash  $(1,635)  $(2,151)

 

 

 

 20 

 

 

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 $2,482,000 in the three months ended June 30, 2023, compared to approximately $2,729,000 in the three months ended June 30, 2022. The primary components in the $247,000 decrease in cash used in our operating activities in the 2023 period was an increase in accounts payable and other current liabilities of $645,000, offset by an increase in our net loss of $376,000.

 

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $230,000 of cash in investing activities in the three months ended June 30, 2023, compared to approximately $41,000 in the three months ended June 30, 2022. The $189,000 increase in the 2023 period was primarily a result of equipment purchase for our laboratory to facilitate and enhance our research and development activities.

 

NET CASH PROVIDED BY FINANCING ACTIVITIES. During the three months ended June 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 $8,000 to pay for the tax withholding on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $1,077,000.

 

During the three months ended June 30, 2022, we raised approximately $619,000 from the issuance of our common stock under our at the market facility.

 

Material Cash Requirements

 

As noted above in the results of operations, our clinical trial expense decreased by $160,290 in the three months ended June 30, 2023, compared to the three-month period ended June 30, 2022. However, we expect our clinical trial expenses will increase over the foreseeable future as we continue to expand our clinical trials both in the United States and internationally.

 

Future capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials for our Hemopurifier, 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.

 

CRITICAL ACCOUNTING ESTIMATES

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements. These estimates and assumptions affect the reported amounts of expenses during the reporting period. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future conditions.

 

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 revenue recognition, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance and contingencies.

 

There have been no changes to our critical accounting estimates as disclosed in our Form 10-K for the year ended March 31, 2023.

 

 

 

 21 

 

 

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

 

Under the supervision and with the participation of our management, including our Chief Executive Officer and 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.

 

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

 

There have been no changes in our internal control over financial reporting during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 22 

 

 

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, 2023, filed with the SEC on June 28, 2023, 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.
     
  · 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.
     
  · 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.
     
  · 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.
     
  · Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.

 

 

 

 23 

 

 

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, 2023.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

We have no disclosure applicable to this item.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 24 

 

 

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    
                         
10.1++   Amendment No. 1 to Executive Employment Agreement, by and between Aethlon Medical, Inc. and Lee D. Arnold, Ph.D., dated May 1, 2023.   10-K   001-37487   10.18   June 28, 2023    
                         
31.1   Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.                   X
                         
31.2   Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.                   X
                         
32.1   Certification of the Principal Executive Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.                   X
                         
32.2   Certification of the Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.                   X
                         
101.INS   Inline XBRL Instance Document                   X
                 
101.SCH   Inline XBRL Taxonomy Extension Schema Document                   X
                 
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document                   X
                 
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document                   X
                 
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document                   X
               
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document                   X
               
104   Cover Page Interactive Data File (formatted in XBRL, and included in exhibit 101)                    

 

 

++ Indicates management contract or compensatory plan.

 

 25 

 

 

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: August 10, 2023 By: /s/ JAMES B. FRAKES  
    JAMES B. FRAKES  
    CHIEF FINANCIAL OFFICER  
    CHIEF ACCOUNTING OFFICER  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 26 

 

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, Charles J. Fisher, Jr., M.D. 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;

 

  (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;

 

  (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

 

  (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

 

  (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 10, 2023

 

  /s/ CHARLES J. FISHER  
  CHARLES J. FISHER, JR., M.D.  
  CHIEF EXECUTIVE OFFICER  
  (PRINCIPAL EXECUTIVE OFFICER)  

 

 

 

 

EXHIBIT 31.2

 

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;

 

  (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;

 

  (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

 

  (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

 

  (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 10, 2023

 

  /s/ JAMES B. FRAKES  
  JAMES B. FRAKES  
  CHIEF FINANCIAL OFFICER  
  (PRINCIPAL 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, 2023 as filed with the Securities and Exchange Commission on the date hereof, I, Charles J. Fisher, Jr., MD, Chief Executive 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 32.1, 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 10, 2023 /s/ CHARLES J. FISHER
  Charles J. Fisher, Jr., M.D.
  Chief Executive 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.

 

 

 

 

EXHIBIT 32.2

 

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, 2023 as filed with the Securities and Exchange Commission on the date hereof, I, James B. Frakes, 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 10, 2023 /s/ JAMES B. FRAKES
  James B. Frakes
  Chief 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.

 

v3.23.2
Cover - shares
3 Months Ended
Jun. 30, 2023
Aug. 09, 2023
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Jun. 30, 2023  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2023  
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  
Entity Address, Address Line Two SUITE 203  
Entity Address, City or Town SAN DIEGO  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 92121  
City Area Code (619)  
Local Phone Number 941-0360  
Title of 12(b) Security COMMON STOCK, $0.001 PAR VALUE  
Trading Symbol AEMD  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   24,835,321
v3.23.2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
Jun. 30, 2023
Mar. 31, 2023
Current assets    
Cash $ 12,897,734 $ 14,532,943
Prepaid expenses and other current assets 410,223 557,623
Total current assets 13,307,957 15,090,566
Property and equipment, net 1,284,200 1,144,004
Right-of-use lease asset 1,086,108 1,151,909
Patents, net 1,513 1,650
Restricted cash 87,506 87,506
Deposits 33,305 33,305
Total assets 15,800,589 17,508,940
Current liabilities    
Accounts payable 844,536 432,890
Due to related parties 191,314 214,221
Lease liability, current portion 274,520 269,386
Other current liabilities 511,377 588,592
Total current liabilities 1,821,747 1,505,089
Lease liability, less current portion 869,945 939,642
Total liabilities 2,691,692 2,444,731
Stockholders’ Equity    
Common stock, par value $0.001 per share; 60,000,000 shares authorized as of June 30, 2023 and March 31, 2023; 24,835,321 and 22,992,466 shares issued and outstanding as of June 30, 2023 and March 31, 2023, respectively 24,837 22,994
Additional paid-in capital 158,731,929 157,405,911
Accumulated other comprehensive loss (7,135) (6,141)
Accumulated deficit (145,640,734) (142,358,555)
Total stockholders’ equity 13,108,897 15,064,209
Total liabilities and stockholders’ equity $ 15,800,589 $ 17,508,940
v3.23.2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Jun. 30, 2023
Mar. 31, 2023
Statement of Financial Position [Abstract]    
Common stock par value (in dollars per share) $ 0.001 $ 0.001
Common stock shares authorized 60,000,000 60,000,000
Common stock issued 24,835,321 22,992,466
Common stock outstanding 24,835,321 22,992,466
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
OPERATING EXPENSES    
Professional fees $ 976,638 $ 844,028
Payroll and related expenses 1,123,239 1,029,686
General and administrative 1,308,283 1,032,367
Total operating expenses 3,408,160 2,906,081
OPERATING LOSS (3,408,160) (2,906,081)
OTHER INCOME    
Interest income 125,981 0
NET LOSS (3,282,179) (2,906,081)
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS 0 (413)
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. (3,282,179) (2,905,668)
OTHER COMPREHENSIVE LOSS (994) 0
COMPREHENSIVE LOSS $ (3,283,173) $ (2,905,668)
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (Parenthetical) - $ / shares
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Income Statement [Abstract]    
Basic loss per share $ (0.14) $ (0.19)
Diluted loss per share $ (0.14) $ (0.19)
Weighted average number of common shares outstanding basic 24,314,759 15,486,621
Weighted average number of common shares outstanding diluted 24,314,759 15,486,621
v3.23.2
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, 2022 at Mar. 31, 2022 $ 15,421 $ 147,446,868 $ (130,329,181) $ (141,708) $ 16,991,400
Beginning balance, shares at Mar. 31, 2022 15,419,163          
Issuances of common stock for cash under at the market program $ 575 618,867 619,442
Issuances of common stock for cash under at the market program, shares 574,560          
Stock-based compensation expense 215,437 215,437
Net loss (2,905,668) (413) (2,906,081)
BALANCE – JUNE 30, 2022 at Jun. 30, 2022 $ 15,996 148,281,172 (133,234,849) (142,121) 14,920,198
Ending balance, shares at Jun. 30, 2022 15,993,723          
BALANCE - MARCH 31, 2022 at Mar. 31, 2023 $ 22,994 157,405,911 (142,358,555) (6,141) 15,064,209
Beginning balance, shares at Mar. 31, 2023 22,992,466          
Issuances of common stock for cash under at the market program $ 1,779 1,084,340 1,086,119
Issuances of common stock for cash under at the market program, shares 1,778,901          
Issuance of common shares upon vesting of restricted stock units and net stock option exercises $ 64 (8,436) (8,372)
Issuance of common shares upon vesting of restricted stock units and net stock option exercise, shares 63,954          
Stock-based compensation expense 250,114 250,114
Net loss (3,282,179) (3,282,179)
Other comprehensive loss (994) (994)
BALANCE – JUNE 30, 2022 at Jun. 30, 2023 $ 24,837 $ 158,731,929 $ (145,640,734) $ (7,135) $ 13,108,897
Ending balance, shares at Jun. 30, 2023 24,835,321          
v3.23.2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Cash flows used in operating activities:    
Net loss $ (3,282,179) $ (2,906,081)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 90,325 30,650
Stock based compensation 250,114 215,437
Accretion of right-of-use lease asset 1,238 7,800
Changes in operating assets and liabilities:    
Prepaid expenses and other current assets 146,409 99,336
Accounts receivable 0 13,116
Accounts payable and other current liabilities 334,613 (310,327)
Deferred revenue 0 114,849
Due to related parties (22,907) 6,303
Net cash used in operating activities (2,482,387) (2,728,917)
Cash flows used in investing activities:    
Purchases of property and equipment (230,383) (41,169)
Net cash used in investing activities (230,383) (41,169)
Cash flows provided by financing activities:    
Proceeds from the issuance of common stock, net 1,086,119 619,442
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense (8,372) 0
Net cash provided by financing activities 1,077,747 619,442
Effect of exchange rate on changes on cash (186) 0
Net decrease in cash and restricted cash (1,635,209) (2,150,644)
Cash and restricted cash at beginning of period 14,620,449 17,159,925
Cash and restricted cash 12,985,240 15,009,281
Supplemental disclosures of non-cash investing and financing activities:    
Par value of shares issued for vested restricted stock units and net stock option exercise 64 0
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:    
Cash and cash equivalents 12,897,734 14,921,775
Restricted cash $ 87,506 $ 87,506
v3.23.2
NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION
3 Months Ended
Jun. 30, 2023
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 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 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 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 the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our new contract research organization, or CRO, on preparations to conduct a 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 clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our 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.

 

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 currently are experiencing a disruption in our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, 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, is delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change.

 

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 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. MMAC is affiliated with the University of Delhi and is operated by the Delhi government.

 

We also recently announced that we also 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 in Ukraine 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 war in Ukraine 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, 2023, 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, 2023.

 

Basis of Presentation and Use of Estimates

 

The accompanying unaudited condensed consolidated financial statements of the Company 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, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on June 28, 2023. 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 unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated financial statements as of and for the three months ended June 30, 2023, and the condensed consolidated statement of cash flows for the three months ended June 30, 2023. 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, 2023 has been derived from the audited consolidated balance sheet at March 31, 2023, contained in the above referenced 10-K. The results of operations for the three months ended June 30, 2023 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.

 

LIQUIDITY AND GOING CONCERN

 

Management expects existing cash as of June 30, 2023 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed consolidated financial statements.

 

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 the 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.

 

v3.23.2
LOSS PER COMMON SHARE
3 Months Ended
Jun. 30, 2023
Earnings Per Share [Abstract]  
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, 2023 and 2022, an aggregate of 2,291,234 and 2,227,286 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, and restricted stock units were excluded, as their inclusion would be antidilutive.

 

v3.23.2
RESEARCH AND DEVELOPMENT EXPENSES
3 Months Ended
Jun. 30, 2023
Research and Development [Abstract]  
RESEARCH AND DEVELOPMENT EXPENSES

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, 2023 and 2022, 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:

         
   June 30,   June 30, 
    2023    2022 
Three months ended  $678,922   $858,347 

  

v3.23.2
RECENT ACCOUNTING PRONOUNCEMENTS
3 Months Ended
Jun. 30, 2023
Accounting Changes and Error Corrections [Abstract]  
RECENT ACCOUNTING PRONOUNCEMENTS

4. RECENT ACCOUNTING PRONOUNCEMENTS

 

None.

 

v3.23.2
EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2023
3 Months Ended
Jun. 30, 2023
Equity [Abstract]  
EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2023

5. EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2023

 

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, 2023, we raised net proceeds of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of, 1,778,901 shares of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement.

 

Restricted Stock Unit Grants

 

On April 28, 2023, the Board approved, pursuant to the terms of the Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual restricted stock units, or RSUs, under the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board. 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 directors then serving on the Board, and for a grant of stock options or $75,000 worth of RSUs for a newly elected director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $0.43 per share for the RSUs granted in April 2023. As a result, in April 2023 the three eligible directors each were granted an RSU in the amount of 116,279 shares under the Company’s 2020 Equity Incentive Plan, 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, 2023, September 30, 2023, December 31, 2023, and March 31, 2024, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date.

 

v3.23.2
RELATED PARTY TRANSACTIONS
3 Months Ended
Jun. 30, 2023
Related Party Transactions [Abstract]  
RELATED PARTY TRANSACTIONS

6. RELATED PARTY TRANSACTIONS

 

During the three months ended June 30, 2023, we accrued unpaid fees of $57,000 owed to our non-employee directors. Amounts due to related parties were comprised of the following items:

         
   June 30,
2023
   March 31,
2023
 
Accrued Board fees  $57,000   $57,000 
Accrued vacation to all employees   134,314    157,221 
Total due to related parties  $191,314   $214,221 

 

v3.23.2
OTHER CURRENT LIABILITIES
3 Months Ended
Jun. 30, 2023
Other Liabilities Disclosure [Abstract]  
OTHER CURRENT LIABILITIES

7. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

 Schedule of other current liabilities        
   June 30,   March 31, 
   2023   2023 
Accrued professional fees  $511,377   $588,592 
Total other current liabilities  $511,377   $588,592 

 

v3.23.2
STOCK COMPENSATION
3 Months Ended
Jun. 30, 2023
Equity [Abstract]  
STOCK COMPENSATION

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, 2023 and 2022:

        
   June 30,
2023
   June 30,
2022
 
Vesting of stock options and restricted stock units  $250,114   $215,437 
Total stock-based compensation expense  $250,114   $215,437 
           
Weighted average number of common shares outstanding – basic and diluted   24,314,759    15,486,621 
           
Basic and diluted loss per common share attributable to stock-based compensation expense  $(0.01)  $(0.01)

  

All of the stock-based compensation expense recorded during the three months ended June 30, 2023 and 2022, an aggregate of $250,114 and $215,437, 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, 2023 and 2022 represented an impact on basic and diluted loss per common share of $(0.01) in each period.

 

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, 2023 was insignificant.

 

Stock Option Activity

 

We did not issue any stock options during the three months ended June 30, 2023 and 2022.

 

Stock options outstanding that have vested as of June 30, 2023 and stock options that are expected to vest subsequent to June 30, 2023 are as follows:

            
   Number of
Shares
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested   842,610   $2.44    7.68 
Expected to vest   860,243   $2.06    8.24 
Total   1,702,853           

  

A summary of stock option activity during the three months ended June 30, 2023 is presented below:

             
   Amount   Range of
Exercise Price
   Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2023   1,718,253   $.69 - 142.50   $2.31 
Exercised      $   $ 
Granted      $   $ 
Cancelled/Expired   15,400   $1.21   $1.21 
Stock options outstanding at June 30, 2023   1,702,853   $.69 - 142.50   $2.25 
Stock options exercisable at June 30, 2023   842,610   $1.28 - 142.50   $2.44 

 

On June 30, 2023, our outstanding stock options had no intrinsic value since the closing share price on that date of $0.36 per share was below the weighted average exercise price of our outstanding stock options.

 

At June 30, 2023, there was approximately $1,719,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.84 years.

 

v3.23.2
WARRANTS
3 Months Ended
Jun. 30, 2023
Warrants  
WARRANTS

9. WARRANTS

 

During the three months ended June 30, 2023 and 2022, we did not issue any warrants.

 

A summary of warrant activity during the three months ended June 30, 2023 is presented below:

            
   Amount   Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2023   326,753   $1.50 – 2.75   $2.01 
Exercised      $   $ 
Cancelled/Expired      $   $ 
Warrants outstanding at June 30, 2023   326,753   $1.50 – 2.75   $2.01 
Warrants exercisable at June 30, 2023   326,753   $1.50 – 2.75   $2.01 

  

v3.23.2
COMMITMENTS AND CONTINGENCIES
3 Months Ended
Jun. 30, 2023
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS AND CONTINGENCIES

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 $13,772. The current monthly base rent under the manufacturing component of the lease is $12,080.

 

The office, lab and manufacturing leases are coterminous with a remaining term of 45 months. The weighted average discount rate is 4.25%.

 

As of our June 30, 2023 balance sheet, we have a right-of-use lease asset of $1,086,108.

 

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.

  

Mobile Clean Room

 

In addition, we rented a mobile clean room on a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed. The mobile clean room was located on leased land near our office and lab and we paid $2,000 per month for the right to locate it there. The arrangement was terminated in September 2022 and the mobile clean room was returned to the vendor that leased it to us.

 

Overall, our rent expense, which is included in general and administrative expenses, approximated $105,000 and $140,000 for the three month periods ended June 30, 2023 and 2022, 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.

 

v3.23.2
SUBSEQUENT EVENTS
3 Months Ended
Jun. 30, 2023
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

11. SUBSEQUENT EVENTS

 

Management has evaluated events subsequent to June 30, 2023 through the date that the accompanying consolidated financial statements were filed with the Securities and Exchange Commission for transactions and other events which may require adjustment of and/or disclosure in such financial statements.

 

In July 2023, Mr. Nikolas Gikakis was appointed as a member our Board of Directors and as a member of the Nominating and Corporate Governance Committee of the Board, or the N&CG Committee. Pursuant to the Director Compensation Policy, upon his appointment to the Board, Mr. Gikakis (i) will receive an (a) annual cash retainer of $40,000 for his service on the Board, and (b) an additional annual cash retainer of $5,000 for his service as a member of the N&CG Committee, and (ii) was granted, on the date of his appointment to the Board, restricted stock units for 195,414 shares of our common stock under the 2020 Plan, which will vest in equal quarterly installments over one year from the date of grant, in each case subject to Mr. Gikakis’s Continuous Service (as defined in the 2020 Plan) as of each such vesting date. The Director Compensation Policy also provides for further annual grants to its independent directors, at the beginning of each fiscal year, of restricted stock units with a grant date fair value of $50,000 or, at the option of our Board, options to purchase shares of our common stock, subject to vesting as determined by our Board. Mr. Gikakis has also entered into our standard form of indemnification agreement for directors.

 

v3.23.2
NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION (Policies)
3 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Basis of Presentation and Use of Estimates

Basis of Presentation and Use of Estimates

 

The accompanying unaudited condensed consolidated financial statements of the Company 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, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on June 28, 2023. 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 unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated financial statements as of and for the three months ended June 30, 2023, and the condensed consolidated statement of cash flows for the three months ended June 30, 2023. 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, 2023 has been derived from the audited consolidated balance sheet at March 31, 2023, contained in the above referenced 10-K. The results of operations for the three months ended June 30, 2023 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

  

Reclassifications

Reclassifications

 

Certain prior year balances within the unaudited condensed consolidated financial statements have been reclassified to conform to the current year presentation.

 

LIQUIDITY AND GOING CONCERN

LIQUIDITY AND GOING CONCERN

 

Management expects existing cash as of June 30, 2023 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed consolidated financial statements.

 

Restricted Cash

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 the 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.

 

v3.23.2
RESEARCH AND DEVELOPMENT EXPENSES (Tables)
3 Months Ended
Jun. 30, 2023
Research and Development [Abstract]  
Research and development expenses
         
   June 30,   June 30, 
    2023    2022 
Three months ended  $678,922   $858,347 
v3.23.2
RELATED PARTY TRANSACTIONS (Tables)
3 Months Ended
Jun. 30, 2023
Related Party Transactions [Abstract]  
Due to related parties
         
   June 30,
2023
   March 31,
2023
 
Accrued Board fees  $57,000   $57,000 
Accrued vacation to all employees   134,314    157,221 
Total due to related parties  $191,314   $214,221 
v3.23.2
OTHER CURRENT LIABILITIES (Tables)
3 Months Ended
Jun. 30, 2023
Other Liabilities Disclosure [Abstract]  
Schedule of other current liabilities
 Schedule of other current liabilities        
   June 30,   March 31, 
   2023   2023 
Accrued professional fees  $511,377   $588,592 
Total other current liabilities  $511,377   $588,592 
v3.23.2
STOCK COMPENSATION (Tables)
3 Months Ended
Jun. 30, 2023
Equity [Abstract]  
Schedule of share-based compensation expense
        
   June 30,
2023
   June 30,
2022
 
Vesting of stock options and restricted stock units  $250,114   $215,437 
Total stock-based compensation expense  $250,114   $215,437 
           
Weighted average number of common shares outstanding – basic and diluted   24,314,759    15,486,621 
           
Basic and diluted loss per common share attributable to stock-based compensation expense  $(0.01)  $(0.01)
Schedule of options outstanding that have vested and are expected to vest
            
   Number of
Shares
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested   842,610   $2.44    7.68 
Expected to vest   860,243   $2.06    8.24 
Total   1,702,853           
Schedule of stock option activity
             
   Amount   Range of
Exercise Price
   Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2023   1,718,253   $.69 - 142.50   $2.31 
Exercised      $   $ 
Granted      $   $ 
Cancelled/Expired   15,400   $1.21   $1.21 
Stock options outstanding at June 30, 2023   1,702,853   $.69 - 142.50   $2.25 
Stock options exercisable at June 30, 2023   842,610   $1.28 - 142.50   $2.44 
v3.23.2
WARRANTS (Tables)
3 Months Ended
Jun. 30, 2023
Warrants  
Schedule of warrant activity
            
   Amount   Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2023   326,753   $1.50 – 2.75   $2.01 
Exercised      $   $ 
Cancelled/Expired      $   $ 
Warrants outstanding at June 30, 2023   326,753   $1.50 – 2.75   $2.01 
Warrants exercisable at June 30, 2023   326,753   $1.50 – 2.75   $2.01 
v3.23.2
NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION (Details Narrative)
Jun. 30, 2022
USD ($)
Restricted Cash [Member]  
Security deposit $ 87,506
v3.23.2
LOSS PER COMMON SHARE (Details Narrative) - shares
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Earnings Per Share [Abstract]    
Antidilutive shares 2,291,234 2,227,286
v3.23.2
RESEARCH AND DEVELOPMENT EXPENSES (Details) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Research and Development [Abstract]    
Research and development expense $ 678,922 $ 858,347
v3.23.2
EQUITY TRANSACTIONS IN THE THREE MONTHS ENDED JUNE 30, 2023 (Details Narrative)
3 Months Ended
Jun. 30, 2023
USD ($)
shares
Eligible Directors Each [Member] | Restricted Stock Units (RSUs) [Member]  
Securities Financing Transaction [Line Items]  
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period | shares 116,279
Offering Agreement [Member]  
Securities Financing Transaction [Line Items]  
Proceeds from issuance of equity $ 1,086,119
Stock issued new, shares issued | shares 1,778,901
Offering Agreement [Member] | Other Offering Expense [Member]  
Securities Financing Transaction [Line Items]  
Payment of stock issuance costs $ 5,846
Offering Agreement [Member] | Hc Wainwright [Member]  
Securities Financing Transaction [Line Items]  
Payment of commissions $ 27,999
v3.23.2
RELATED PARTY TRANSACTIONS (Details) - USD ($)
Jun. 30, 2023
Mar. 31, 2023
Related Party Transaction [Line Items]    
Due to related parties $ 191,314 $ 214,221
Accrued Board Fees [Member]    
Related Party Transaction [Line Items]    
Due to related parties 57,000 57,000
Accrued Vacation [Member]    
Related Party Transaction [Line Items]    
Due to related parties $ 134,314 $ 157,221
v3.23.2
RELATED PARTY TRANSACTIONS (Details Narrative)
Jun. 30, 2023
USD ($)
Related Party Transactions [Abstract]  
Accrued director fees $ 57,000
v3.23.2
OTHER CURRENT LIABILITIES (Details) - USD ($)
Jun. 30, 2023
Mar. 31, 2023
Other Liabilities Disclosure [Abstract]    
Accrued professional fees $ 511,377 $ 588,592
Total other current liabilities $ 511,377 $ 588,592
v3.23.2
STOCK COMPENSATION (Details - Stock compensation) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Offsetting Assets [Line Items]    
Vesting of stock options and restricted stock units $ 250,114 $ 215,437
Total stock-based compensation expense $ 250,114 $ 215,437
Weighted Average Number of Shares Outstanding, Basic 24,314,759 15,486,621
Weighted Average Number of Shares Outstanding, Diluted 24,314,759 15,486,621
Earnings Per Share, Basic $ (0.14) $ (0.19)
Earnings Per Share, Diluted (0.14) (0.19)
Stock Based Compensation [Member]    
Offsetting Assets [Line Items]    
Earnings Per Share, Basic (0.01) (0.01)
Earnings Per Share, Diluted $ (0.01) $ (0.01)
v3.23.2
STOCK COMPENSATION (Details - Options vested and expected to vest) - Equity Option [Member]
3 Months Ended
Jun. 30, 2023
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Options vested 842,610
Weighted average exercise price options vested | $ / shares $ 2.44
Weighted average remaining contractual term options vested 7 years 8 months 4 days
Options expected to vest 860,243
Weighted average exercise price options expected to vest | $ / shares $ 2.06
Weighted average remaining contractual term options expected to vest 8 years 2 months 26 days
Total options outstanding 1,702,853
v3.23.2
STOCK COMPENSATION (Details - Option activity) - Options Held [Member]
3 Months Ended
Jun. 30, 2023
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Stock options Outstanding, beginning balance | shares 1,718,253
Range of exercise prices, Option beginning 69 - 142.50
Outstanding, Weighted Average Exercise Price, beginning price | $ / shares $ 2.31
Stock options exercised | shares 0
Exercised, Weighted Average Exercise Price | $ / shares $ 0
Stock options granted | shares 0
Range of exercise prices, Option Granted
Granted, Weighted Average Exercise Price | $ / shares $ 0
Stock options cancelled/forfeited | shares 15,400
Range of exercise prices, Option cancelled/expired 1.21
Cancelled/Forfeited, Weighted Average Exercise Price | $ / shares $ 1.21
Stock options outstanding, ending balance | shares 1,702,853
Range of exercise prices, Option ending 69 - 142.50
Outstanding Weighted Average Exercise Price, ending price | $ / shares $ 2.25
Stock options exercisable | shares 842,610
Range of exercise prices, Option exercisable 1.28 - 142.50
Exercisable, Weighted Average Exercise Price | $ / shares $ 2.44
v3.23.2
STOCK COMPENSATION (Details Narrative) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock based compensation $ 250,114 $ 215,437
Unrecognized compensation costs $ 1,719,000  
Unrecognized compensation cost amortization period 1 year 10 months 2 days  
Options Held [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Share price $ 0.36  
v3.23.2
Warrant (Details) - Warrant [Member]
3 Months Ended
Jun. 30, 2023
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Number of Warrants Outstanding, Beginning | shares 326,753
Range of Exercise Price Outstanding, Beginning 1.50 – 2.75
Weighted Average Exercise Price Outstanding, Beginning | $ / shares $ 2.01
Number of Warrants Exercised | shares 0
Weighted Average Exercise Price, Exercised | $ / shares $ 0
Number of Warrants Cancelled/Expired | shares 0
Range of Exercise Price Cancelled Expired
Weighted Average Exercise Price Cancelled/Expired | $ / shares $ 0
Number of Warrants Outstanding, Ending | shares 326,753
Range of Exercise Price Outstanding, Ending 1.50 – 2.75
Weighted Average Exercise Price Outstanding, Ending | $ / shares $ 2.01
Number of Warrants Exercisable, Ending | shares 326,753
Range of Exercise Price Exercisable 1.50 – 2.75
Weighted Average Exercise Price Exercisable | $ / shares $ 2.01
v3.23.2
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Mar. 31, 2023
Aug. 31, 2022
Lease term       55 months
Right of use lease asset $ 1,086,108   $ 1,151,909  
Restricted Cash 87,506 $ 87,506 $ 87,506  
Payment for rent per month 2,000      
Operating Lease, Expense 105,000 $ 140,000    
Office And Laboratory [Member]        
Monthly base rent 13,772      
Manufacturing [Member]        
Monthly base rent $ 12,080      
Office Lab And Manufacturing Leases [Member]        
Lease term 45 months      
Weighted average discount rate 4.25%      
New Office And Lab Space [Member]        
Line of credit $ 87,506      

Aethlon Medical (NASDAQ:AEMD)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Aethlon Medical Charts.
Aethlon Medical (NASDAQ:AEMD)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Aethlon Medical Charts.