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 December 31, 20172022

 

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)

 

NEVADAnevada13-3632859
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
11555 SORRENTO VALLEY ROAD, SUITE 203, SAN DIEGO, CA92121
(Address of principal executive offices)(Zip Code)

 

9635 GRANITE RIDGE DRIVE, SUITE 100, SAN DIEGO, CA 92123(619)941-0360

(Address of principal executive offices)    (Zip Code)

(858) 459-7800

(Registrant'sRegistrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading SymbolName of each exchange on which registered
Common StockAEMDThe 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. YESYesNONo

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (ss.232.405(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YESYes   ☒ NONo  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one)

 

Large accelerated filerFilerAccelerated filerFiler
Non-accelerated filer  ☐ (Do not check if a smaller reporting company)FilerSmaller 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). YESYesNONo

 

As of January 31, 2018,February 9, 2023, the registrant had outstanding 16,580,32622,969,349 shares of common stock, $0.001 par value.

 

 

 
 

 

TABLE OF CONTENTS

 

PART I.FINANCIAL INFORMATION3
   
ITEM 1.FINANCIAL STATEMENTS3
   
 CONDENSED CONSOLIDATED BALANCE SHEETS AT DECEMBER 31, 20172022 (UNAUDITED) AND MARCH 31, 201720223
   
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTH AND NINE MONTH PERIODSMONTHS ENDED DECEMBER 31, 20172022 AND 20162021 (UNAUDITED)4
   
 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE NINE MONTHS ENDED DECEMBER 31, 2022 AND 2021 (UNAUDITED)5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED DECEMBER 31, 20172022 AND 20162021 (UNAUDITED)56
   
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)67
   
ITEM 2.MANAGEMENT'SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1817
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK25
   
ITEM 4.CONTROLS AND PROCEDURES25
   
PART II.OTHER INFORMATION26
   
ITEM 1.LEGAL PROCEEDINGS26
   
ITEM 1A.RISK FACTORS26
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2629
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2629
   
ITEM 4.MINE SAFETY DISCLOSURES2629
   
ITEM 5.OTHER INFORMATION2629
   
ITEM 6.EXHIBITS2630
SIGNATURES31

 

 

 

 2 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

     
 December 31,
2017
  March 31,
2017
  December 31,
2022
 March 31,
2022
 
 (Unaudited)    (Unaudited)     
ASSETS                
Current assets                
Cash $5,610,799  $1,559,701  $17,499,541  $17,072,419 
Accounts receivable     127,965 
Prepaid expenses and other current assets  14,537   37,551   672,781   956,623 
Total current assets  5,625,336   1,597,252   18,172,322   18,157,007 
                
Property and equipment, net  32,398   29,223   1,212,120   441,238 
Patents and patents pending, net  78,123   84,996 
Right-of-use lease asset  1,217,458   696,698 
Patents, net  1,788   2,200 
Restricted cash  87,506   87,506 
Deposits  14,897   14,897   33,305   33,305 
Total assets $5,750,754  $1,726,368  $20,724,499  $19,417,954 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities                
Accounts payable $211,406  $484,423  $226,791  $499,962 
Due to related parties  64,466   57,866   190,397   155,742 
Deferred revenue  574,245   344,547 
Lease liability, current portion  264,278   126,905 
Other current liabilities  60,534   69,467   1,180,312   696,893 
Total current liabilities  336,406   611,756   2,436,023   1,824,049 
                
Convertible notes payable, net  810,866   519,200 
        
Lease liability, less current portion  1,009,277   602,505 
Total liabilities  1,147,272   1,130,956   3,445,300   2,426,554 
                
Commitments and Contingencies (Note 13)        
        
        
Stockholders’ Equity                
Common stock, par value $0.001 per share; 30,000,000 shares authorized as of December 31, 2017 and March 31, 2017; 15,367,658 and 8,797,086 shares issued and outstanding as of December 31, 2017 and March 31, 2017, respectively  15,368   8,796 
Common stock, par value $0.001 per share; 60,000,000 and 30,000,000 shares authorized as of December 31, 2022 and March 31, 2022, respectively; 22,969,349 and 15,419,163 shares issued and outstanding as of December 31, 2022 and March 31, 2022, respectively  22,971   15,421 
Additional paid-in capital  102,820,906   94,445,739   157,148,260   147,446,868 
Accumulated deficit  (98,138,853)  (93,778,156)  (139,892,032)  (130,329,181)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  4,697,421   676,379   17,279,199   17,133,108 
                
Noncontrolling interests  (93,939)  (80,967)     (141,708)
                
Total stockholders’ equity  4,603,482   595,412   17,279,199   16,991,400 
                
Total liabilities and stockholders’ equity $5,750,754  $1,726,368  $20,724,499  $19,417,954 

 

See accompanying notes.

 

 

 

 3 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Nine Month Periods Ended December 31, 20172022 and 20162021

(Unaudited)

 

  Three Months
Ended
December 31,
2017
  Three Months
Ended
December 31,
2016
  Nine Months
Ended
December 31,
2017
  Nine Months
Ended
December 31,
2016
 
             
REVENUES                
                 
Government contract revenue $74,813  $  $74,813  $392,073 
                 
OPERATING EXPENSES                
                 
Professional fees  439,117   416,866   1,165,318   1,495,597 
Payroll and related expenses  663,245   635,698   1,911,553   2,793,888 
General and administrative  136,078   182,982   557,991   696,662 
Total operating expenses  1,238,440   1,235,546   3,634,862   4,986,147 
OPERATING LOSS  (1,163,627)  (1,235,546)  (3,560,049)  (4,594,074)
                 
OTHER EXPENSE (INCOME)                
Interest and other debt expenses  55,912   36,565   306,495   115,308 
Loss on share for warrant exchanges        130,214    
(Gain)/loss on debt extinguishment     (58,691)  376,909   558,198 
Warrant repricing expense           345,841 
Total other expense (income)  55,912   (22,126)  813,618   1,019,347 
NET LOSS BEFORE NONCONTROLLING INTERESTS  (1,219,539)  (1,213,420)  (4,373,667)  (5,613,421)
                 
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS  (4,532)  (7,689)  (12,972)  (23,088)
                 
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $(1,215,007) $(1,205,731) $(4,360,695) $(5,590,333)
                 
BASIC AND DILUTED LOSS PER COMMON SHARE $(0.08) $(0.15) $(0.40) $(0.72)
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED  14,950,701   7,927,031   10,927,106   7,768,682 

             
  Three Months
Ended
December 31,
2022
  Three Months
Ended
December 31,
2021
  Nine Months
Ended
December 31,
2022
  Nine Months
Ended
December 31,
2021
 
             
REVENUES                
                 
Government contract revenue $  $17,117  $  $281,049 
                 
OPERATING EXPENSES                
                 
Professional fees  729,665   433,404   2,575,496   1,666,333 
Payroll and related expenses  1,048,761   999,500   3,191,402   2,821,850 
General and administrative  1,071,327   1,112,159   3,653,832   2,428,053 
Total operating expenses  2,849,753   2,545,063   9,420,730   6,916,236 
OPERATING LOSS  (2,849,753)  (2,527,946)  (9,420,730)  (6,635,187)
                 
OTHER EXPENSE                
Loss on dissolution of subsidiary        142,121    
                 
NET LOSS  (2,849,753)  (2,527,946)  (9,562,851)  (6,635,187)
                 
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS     (2,214)     (4,174)
                 
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. $(2,849,753) $(2,525,732) $(9,562,851) $(6,631,013)
                 
BASIC LOSS PER SHARE $(0.12) $(0.16) $(0.48) $(0.46)
DILUTED LOSS PER SHARE $(0.12) $(0.16) $(0.48) $(0.46)
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC  22,946,483   15,397,418   19,741,451   14,543,787 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – DILUTED  22,946,483   15,397,418   19,741,451   14,543,787 

 

See accompanying notes.

 

 

 

 4 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSSTOCKHOLDERS’ EQUITY

For the Nine Months Ended December 31, 20172022 and 20162021

(Unaudited)

                   
  Common Stock  Additional
Paid In
  Accumulated  Non-
Controlling
  Total 
  Shares  Amount  Capital  Deficit  Interests  Equity 
                   
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 
Issuances of common stock for cash under at the market program  6,906,276   6,906   8,300,863         8,307,769 
Issuance of common stock upon vesting of restricted stock units  46,233   46   (8,019)        (7,973)
Stock-based compensation expense        313,539         313,539 
Loss on dissolution of subsidiary              142,121   142,121 
Net loss           (3,807,430)     (3,807,430)
BALANCE – SEPTEMBER 30, 2022  22,946,232   22,948   156,887,555   (137,042,279)     19,868,224 
Issuances of common stock upon vesting of
restricted stock units
  23,117   23   (1,908)        (1,885)
Stock-based compensation expense   –       262,613         262,613 
Net loss           (2,849,753)     (2,849,753)
BALANCE – DECEMBER 31, 2022  22,969,349  $22,971  $157,148,260  $(139,892,032) $  $17,279,199 

 

  Nine Months
Ended
December 31, 2017
  Nine Months
Ended
December 31, 2016
 
Cash flows from operating activities:        
Net loss $(4,373,667) $(5,613,421)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  27,402   26,365 
Stock based compensation  887,607   1,880,150 
Warrant repricing expense     345,841 
Common stock issued for services  33,600    
Loss on share for warrant exchanges  130,214    
Loss on debt extinguishment  376,909   558,198 
Amortization of debt discount and deferred financing costs  215,376   65,637 
Changes in operating assets and liabilities:        
Accounts receivable     199,471 
Prepaid expenses and other current assets  23,014   21,522 
Accounts payable and other current liabilities  (219,806)  51,053 
Due to related parties  6,600   (86,750)
Net cash used in operating activities  (2,892,751)  (2,551,934)
         
Cash flows from investing activities:        
Purchases of property and equipment  (23,705)  (2,961)
Net cash used in investing activities  (23,705)  (2,961)
         
Cash flows from financing activities:        
Proceeds from the issuance of common stock, net  7,166,081   554,306 
Proceeds from the issuance of convertible notes payable, net     577,460 
Cash paid for repurchase of restricted stock units  (198,527)  (71,993)
Net cash provided by financing activities  6,967,554   1,059,773 
         
Net increase (decrease) in cash  4,051,098   (1,495,122)
         
Cash at beginning of period  1,559,701   2,123,737 
         
Cash at end of period $5,610,799  $628,615 
         
Supplemental disclosures of non-cash investing and financing activities:        
         
Issuance of shares under conversions of convertible notes payable and related accrued interest $362,765  $61,766 
         
Issuance of shares under vested restricted stock units $120  $33 
         
Recorded debt discount on convertible notes $  $863,868 
         
Issuance of shares under cashless warrant exchanges $  $3 
         
Reclassification of accrued interest to convertible notes payable $  $85,031 
  Common Stock  Additional
Paid In
  Accumulated  Non-
Controlling
  Total 
  Shares  Amount  Capital  Deficit  Interests  Equity 
                   
BALANCE - MARCH 31, 2021  12,150,597  $12,152  $129,331,542  $(119,913,090) $(136,914) $9,293,690 
Issuances of common stock for cash under at the market program  626,000   626   4,947,159         4,947,785 
Issuances of common stock for cash in registered direct financing  1,380,555   1,381   11,657,663         11,659,044 
Issuances of common stock for cash under warrant exercises  531,167   531   820,407         820,938 
Issuances of common stock for cash under stock option exercises  11,562   11   28,314         28,325 
Issuances of common stock under cashless warrant exercises  675,554   676   (676)         
Issuance of common stock upon vesting of restricted stock units  10,932   11   (35,797)        (35,786)
Stock-based compensation expense        120,154         120,154 
Net loss           (2,097,303)  (1,135)  (2,098,438)
BALANCE - JUNE 30, 2021  15,386,367   15,388   146,868,766   (122,010,393)  (138,049)  24,735,712 
Issuances of common stock upon vesting of restricted stock units  10,932   11   (28,145)        (28,134)
Stock-based compensation expense        201,062         201,062 
Net loss           (2,007,978)  (825)  (2,008,803)
BALANCE – SEPTEMBER 30, 2021  15,397,299   15,399   147,041,683   (124,018,371)  (138,874)  22,899,837 
Issuance of common stock upon vesting of restricted stock units  10,932   11   (13,568)        (13,557)
Stock-based compensation expense        201,019         201,019 
Net Loss           (2,525,732)  (2,214)  (2,527,946)
BALANCE – DECEMBER 31, 2021  15,408,231  $15,410  $147,229,134  $(126,544,103) $(141,088) $20,559,353 

 

See accompanying notes.

 

 

 5 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Nine Months Ended December 31, 2022 and 2021

(Unaudited)

       
  Nine Months
Ended
December 31, 2022
  Nine Months
Ended
December 31, 2021
 
       
Cash flows used in operating activities:        
Net loss $(9,562,851) $(6,635,187)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  161,350   98,363 
Stock based compensation  791,588   522,234 
Accretion of right-of-use lease asset  23,385   9,717 
Loss of dissolution of subsidiary  142,121    
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets  283,645   (342,641)
Accounts receivable  127,965   17,116 
Deposits      (21,146)
Accounts payable and other current liabilities  210,032   (443,239)
Deferred revenue  229,698   114,849 
Due to related parties  34,655   11,855 
Net cash used in operating activities  (7,558,412)  (6,668,079)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (931,820)  (136,795)
Net cash used in investing activities  (931,820)  (136,795)
         
Cash flows provided by financing activities:        
Proceeds from the issuance of common stock, net  8,927,211   17,456,092 
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense  (9,857)  (77,477)
Net cash provided by financing activities  8,917,354   17,378,615 
         
Net increase in cash and restricted cash  427,122   10,573,741 
         
Cash and restricted cash at beginning of period  17,159,925   9,908,301 
         
Cash and restricted cash at end of period $17,587,047  $20,482,042 
         
Supplemental disclosures of cash flow information:        
         
Supplemental disclosures of non-cash investing and financing activities:        
Issuance of common stock under cashless warrant exercises $  $676 
Par value of shares issued for vested restricted stock units and net stock option exercise $69  $33 
Initial recognition of right-of-use lease asset and lease liability $625,471  $228,694 
         
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:        
Cash and cash equivalents $17,499,541  $20,394,536 
Restricted cash  87,506   87,506 
Cash and restricted cash $17,587,047  $20,482,042 

See accompanying notes.

6


AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

December 31, 2017

2022

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

ORGANIZATION

 

Aethlon Medical, Inc. and subsidiary (collectively, “Aethlon”, or Aethlon, the “Company”, “we”Company, we or “us”) areus, is a medical technologytherapeutic company focused on addressing unmet needs in global healthdeveloping products to diagnose and biodefense.treat cancer and life-threatening infectious diseases. The Aethlon Hemopurifier®Hemopurifier is an earlya clinical-stage therapeuticimmunotherapeutic 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 the single-use removal of life-threatening viruses from the circulatory system of infected individuals. 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.

On October 4, 2019, the FDA approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. This clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two patients. Due to lack of further patient enrollment, we and UPMC terminated this trial. We are in the process of designing other clinical trials in oncology, to include additional solid tumors. These trials initially are planned to be conducted 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 countermeasure objectives set forth by the U.S. Government to protect citizens from bioterror and pandemic threats.treatment. In small-scale or early feasibility human studies, the Hemopurifier has been administeredused in the past to treat individuals infected with human immunodeficiency virus, or HIV, Hepatitis-C,hepatitis-C and Ebola.

Additionally,in vitro, the Hemopurifier has been validateddemonstrated to capture Zika virus, Lassa virus, MERS-CoV, Cytomegalovirus,cytomegalovirus, Epstein-Barr virus, Herpes Simplexsimplex virus, Chikungunya virus, Dengue virus, West Nile virus, Smallpox-relatedsmallpox-related viruses, H1N1 Swine Fluswine flu virus, H5N1 Bird Flubird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these validationsstudies were conducted in collaboration with leading government or non-government research institutes. Domestically, we are focused on

On June 17, 2020, the clinical advancementFDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA. 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 will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and will 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. Under Single Patient Emergency Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier.

7

We recently concludedcurrently are experiencing a feasibility studydisruption 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 demonstratemanufacture our Hemopurifier. Our intended transition to a new supplier for Galanthus nivalis agglutinin, or GNA, is delayed as we work with the safetyFDA for approval of our devicesupplement to our IDE, which is required to make this manufacturing change.

In October 2022, we launched a wholly owned subsidiary in health-compromised individuals infected with a viral pathogen.Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary will initially focus on the oncology market in Australia. There were only insignificant expenses in that subsidiary in the three months ended December 31, 2022.

 

We are also obtained ethics review board approval 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 the Hemopurifiers made with the GNA from our new supplier.

Previously, we were the majority owner of Exosome Sciences, Inc. (ESI), or ESI, a company focusedformed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s endeavorsdiseases, and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI were limited to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and the Company, as the majority stockholder of ESI, approved the dissolution of ESI. Accordingly, ESI is the advancement of a TauSomeTM biomarker candidate to diagnose Chronic Traumatic Encephalopathy (CTE) in the living. ESI previously documented that TauSome levels in former NFL players to be nine times higher than same age-group control subjects.eliminated from our December 31, 2022 balance sheet.

 

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we intendplan to sell this device.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 more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

 

In addition to the foregoing, we are monitoring closely the impact of the COVID-19 global pandemic, inflation 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 the COVID-19 pandemic, inflation 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.

Our executive offices are located at 9635 Granite Ridge Drive,11555 Sorrento Valley Road, Suite 100,203, San Diego, California 92123.92121. Our telephone number is (858) 459-7800.(619) 941-0360. Our website address iswww.aethlonmedical.com. www.aethlonmedical.com.

 

Our common stock is quotedlisted on the Nasdaq Capital Market under the symbol “AEMD.”

 

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

During the ninethree months ended December 31, 2017,2022, there have beenwere no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2017.2022.

 

BASIS OF PRESENTATION

8

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, (GAAP)or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, (SEC)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, 2017,2022, included in the Company'sCompany’s Annual Report on Form 10-K filed with the SEC on June 28, 2017.2022. 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.subsidiary, ESI, which dissolved in September 2022. All significant intercompanyinter-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 nine months ended December 31, 2017.2022, and the condensed consolidated statement of cash flows for the nine months ended December 31, 2022. Estimates were made relating to useful lives of fixed assets, valuation allowances, the fair value of warrants, 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. Certain amounts previously reported in the financial statements have been reclassified to conform to the current presentation. Such reclassifications did not affect net loss, equity or cash flows. The accompanying condensed consolidated balance sheet at March 31, 20172022 has been derived from the audited consolidated balance sheet at March 31, 2017,2022, contained in the above referenced 10-K. The results of operations for the nine months ended December 31, 20172022 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.

6

 

LIQUIDITY AND GOING CONCERN

 

Management expects existing cash as of December 31, 20172022 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these interimcondensed 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 11, 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 income available to common stockholdersloss by the weighted average number of common shares outstanding during the period of computation. The weighted average number of common shares outstanding for the three and nine months ended December 31, 2017 includes 46,125 vested restricted stock units. 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 December 31, 20172022 and 2016, a total2021, an aggregate of 9,143,480 2,068,252 and 3,810,6421,587,759 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, unvestedand restricted stock units and convertible notes payable were excluded, as their inclusion would be antidilutive.

 

9

3. RESEARCH AND DEVELOPMENT EXPENSES

 

Our research and development costs are expensed as incurred. We incurred research and development expenses during the three and nine month periods ended December 31, 20172022 and 2016,2021, 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:

Research and Development expenses      
 December 31, December 31,  December 31, December 31, 
 2017 2016  2022 2021 
Three months ended $129,207  $178,440  $558,223  $354,571 
Nine months ended $462,640  $497,075  $2,129,376  $1,403,891 

  

4. FUTURERECENT ACCOUNTING PRONOUNCEMENTS

 

Management is evaluating significant recent accounting pronouncements that are not yet effective for us, including the new accounting standard on improvements to employee share based payment accounting, ASU 2016-09 (Topic 718), the new accounting standard related to leases, ASU 2016-02 (Topic 842), the new accounting standard for recognition and measurement of financial assets and financial liabilities, and have not yet concluded whether any such pronouncements will have a significant effect on our future consolidated financial statements.

Regarding the new accounting standard on revenue recognition, ASU 2014-09 (Topic 606), which will be effective on April 1, 2018, management believes that as long as its contracts with government entities consist of firm, fixed price arrangements with payments that are triggered by achieving contractually stated milestones that new standard will not have a significant effect on our future consolidated financial statements.None.

 

5. CONVERTIBLE NOTES PAYABLE, NET

Convertible Notes Payable, Net consisted of the following at December 31, 2017:

  Principal  Unamortized
Discount
  Net
Amount
  Accrued
Interest
 
Convertible Notes Payable, Net – Non-Current Portion:                
November 2014 10% Convertible Notes $612,811  $(112,194) $500,617  $19,066 
December 2016 10% Convertible Notes  379,780   (69,531)  310,249   11,820 
Total Convertible Notes Payable, Net $992,591  $(181,725) $810,866  $30,886 

7

During the nine months ended December 31, 2017, we recorded interest expense of $87,641 related to the contractual interest rates of our convertible notes and interest expense of $215,376 related to the amortization of the note discount for a total interest expense of $303,017 related to our convertible notes. All of the unamortized discount at December 31, 2017 related to the note discount established upon the June 2017 amendment to both the November 2014 10% Convertible Notes and the December 2016 10% Convertible Notes (see below).

During the nine months ended December 31, 2016, we recorded interest expense of $47,730 related to the contractual interest rates of our convertible notes, interest expense of $27,641 related to the amortization of deferred financing costs and interest expense of $37,996 related to the amortization of note discounts for a total interest expense of $113,367 related to our convertible notes.

Convertible Notes Payable, Net consisted of the following at March 31, 2017 (our most recent fiscal year end):

  Principal  Unamortized
Discount
  Net
Amount
  Accrued
Interest
 
Convertible Notes Payable, Net – Non-Current Portion:                
November 2014 10% Convertible Notes $612,811  $(275,363) $337,448  $2,555 
December 2016 10% Convertible Notes  680,400   (498,648)  181,752   2,836 
Total Convertible Notes Payable, Net $1,293,211  $(774,011) $519,200  $5,391 

NOVEMBER 2014 10% CONVERTIBLE NOTES

In November 2014, we entered into a subscription agreement with two accredited investors providing for the issuance and sale of (i) convertible promissory notes in the aggregate principal amount of $527,780 (the “Notes”) and (ii) five year warrants to purchase up to 47,125 shares of common stock at a fixed exercise price of $8.40 per share (the “Warrants”). These Notes bear interest at the annual rate of 10% and originally matured on April 1, 2016.

The aggregate gross cash proceeds to us were $415,000 after subtracting legal fees of $35,000, a $27,780 due diligence fee and an original issuance discount of $50,000. We recorded deferred financing costs of $112,780 to reflect the legal fees, due diligence fee and original issuance discount and will amortize those costs over the life of the Notes using the effective interest method.

These Notes are convertible at the option of the holders into shares of our common stock at a fixed price of $5.60 per share, for up to an aggregate of 94,246 shares of common stock. There are no registration requirements with respect to the shares of common stock underlying the Notes or the Warrants.

The estimated relative fair value of Warrants issued in connection with the Notes was recorded as a debt discount and is amortized as additional interest expense over the term of the underlying debt. We recorded debt discount of $240,133 based on the relative fair value of these Warrants. In addition, as the effective conversion price of the Notes was less than market price of the underlying common stock on the date of issuance, we recorded an additional debt discount of $287,647 related to the beneficial conversion feature.

Initial Amendment of the November 2014 10% Convertible Note Terms

On November 12, 2015, we entered into an amendment of terms (“Amendment of Terms”) with the two investors that participated in the November 2014 10% Convertible Notes. The Amendment of Terms modified the terms of the subscription agreement, Notes and Warrants held by those investors to, among other things, extended the maturity date of the Notes from April 1, 2016 to June 1, 2016, temporarily reduced the number of shares that we must reserve with respect to conversion of the Notes, and temporarily suspended the time period during which one of the investors may exercise its Warrants. In exchange for the investors’ agreements in the Amendment of Terms, we paid one of the investors a cash fee of $90,000, which we recorded as deferred financing costs and amortized over the remaining term of the notes.

Second Amendment and Extension of the November 2014 10% Convertible Notes

On June 27, 2016, we and certain investors entered into further Amendments (the “Amendments”) to the Notes and the Warrants. The Amendments provide that the Maturity Date (as defined in the Notes) was extended from June 1, 2016 to July 1, 2017 and that the conversion price per share of the Notes was reduced from $5.60 per share of common stock to $5.00 per share of common stock. In addition, we reduced the purchase price (as defined in the Warrants) from $8.40 per share to $5.00 per share of common stock. In connection with these modifications, each of the investors signed a Consent and Waiver providing its consent under certain restrictive provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under a Securities Purchase Agreement dated June 23, 2015, (the “2015 SPA”) to which we, the investors and certain other investors are parties, in order to facilitate an at-the-market equity program (see Note 6).

8

The Amendments also increase the principal amount of the Notes to $692,811 (in the aggregate) to (i) include accrued and unpaid interest through June 15, 2016, and (ii) increase the principal amount by $80,000 (in the aggregate) as an extension fee for the extended maturity date of the Notes. With respect to each Note, we entered into an Allonge to Convertible Promissory Note (each, an “Allonge”) reflecting the changes in the principal amount, Maturity Date and conversion price of the Note.

We also issued to the investors new warrants (the “New Warrants”) to purchase an aggregate of 30,000 shares of common stock with a Purchase Price (as defined in the New Warrants) of $5.00 per share of common stock. We issued the New Warrants in substantially the same form as the prior Warrants, and the New Warrants will expire on November 6, 2019, the same date on which the prior Warrants will expire.

The modification of the Notes was evaluated under FASB Accounting Standards Codification (“ASC”) Topic No. 470-50-40, “Debt Modification and Extinguishments” (“ASC 470-50-40”). Therefore, according to the guidance, the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. As a result, we recorded a loss on debt extinguishment of $536,889 and recognized an extension fee expense of $80,000, which are included in other (income) expenses in the accompanying condensed consolidated statements of operations. The debt extinguishment is comprised from the fair value of prior warrants issued in connection with the Notes of $287,676, as well as $325,206 related to beneficial conversion feature and offset by debt discount of $75,993. The beneficial conversion feature is a result of the effective conversion price of the new Notes being less than the market price of the underlying common stock on the date of modification.

Third Amendment and Extension of the November 2014 10% Convertible Notes

In connection with the issuance of the December 2016 10% Convertible Notes, the conversion price of the November 2014 10% Convertible Notes was reduced from $5.00 to $4.00 per share and the expiration date of the November 2014 10% Convertible Notes was extended from July 1, 2017 to July 1, 2018.

The modification of the Notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. As a result, we recorded a gain on debt extinguishment of $58,691, which is included in other (income) expenses in the accompanying condensed consolidated statements of operations. The recording of the modified Notes resulted in a beneficial conversion of $233,748 which is the result of the effective conversion price of the new Notes being less than the market price of the underlying common stock on the date of modification.

June 2017 Amendment to the November 2014 10% Convertible Notes

In June 2017, we agreed with the holders of the November 2014 10% Convertible Notes to an extension of the expiration dates of the notes from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00 per share. The modification of the Notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. Under the extinguishment accounting we recorded a loss on debt extinguishment of $178,655 and recalculated a revised debt discount on the notes.

The following table shows the changes to the principal balance of the November 2014 10% Convertible Notes:

Activity in the November 2014 10% Convertible Notes
Initial principal balance $527,780 
Increase in principal balance under the second amendment (see above)  165,031 
Conversions during the fiscal year ended March 31, 2017  (80,000)
Balance as of December 31, 2017 $612,811 

DECEMBER 2016 10% CONVERTIBLE NOTES

In December 2016, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with two accredited investors (collectively, the “Holders”), pursuant to which the Holders purchased an aggregate of $680,400 principal amount of Notes (inclusive of due diligence fee of $30,000 deemed paid as a subscription amount in the form of a Note in the principal amount of $32,400) for an aggregate cash subscription amount of $600,000 and (b) warrants to purchase 127,575 shares of Common Stock (collectively, the “Warrants”).

9

The Notes bear interest at the rate of 10% per annum, and the principal amount and all accrued and unpaid interest thereon is convertible into shares of our common stock at a $4.00 per share conversion price, which is subject to customary adjustment provisions for stock splits, dividends, recapitalizations and the like. The Notes mature on July 1, 2018 and are subject to customary and usual terms for events of default and the like. Each Holder has contractually agreed to restrict its ability to convert its Note such that the number of shares of the Common Stock held by the Holder and its affiliates after such exercise does not exceed 4.99% of our then issued and outstanding shares of Common Stock.

The Warrants issued to the Holders are exercisable for a period of five years from the date of issuance at an exercise price of $4.50, subject to adjustment. A Holder may exercise a Warrant by paying the exercise price in cash or by exercising the Warrant on a cashless basis. In the event a Holder exercises a Warrant on a cashless basis, we will not receive any proceeds. The exercise price of the Warrants is subject to customary adjustments provision for stock splits, stock dividends, recapitalizations and the like. Each Holder has contractually agreed to restrict its ability to exercise its Warrant such that the number of shares of the Common Stock held by the Holder and its affiliates after such exercise does not exceed 4.99% of our then issued and outstanding shares of Common Stock.

The estimated relative fair value of Warrants issued in connection with the Notes was recorded as a debt discount and is being amortized as additional interest expense over the term of the underlying debt. We recorded debt discount of $232,718 based on the relative fair value of these Warrants. In addition, as the effective conversion price of the Notes was less than market price of the underlying common stock on the date of issuance, we recorded an additional debt discount of $262,718 related to the beneficial conversion feature. We also recorded deferred financing costs of $102,940, which was composed of an 8% original issue discount of $50,400, a $30,000 due diligence fee (which was paid in the form of a note), $22,500 in legal fees, and a $40 bank charge. The combination of the above items led to a combined discount against the convertible notes of $598,376.

June 2017 Amendment to the December 2016 10% Convertible Notes

In June 2017, we agreed with the holders of the December 2016 10% Convertible Notes to an extension of the expiration dates of the notes from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00 per share. The modification of the notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. Under the extinguishment accounting we recorded a loss on debt extinguishment of $198,254 and recalculated a revised debt discount on the notes.

The following table shows the changes to the principal balance of the December 2016 10% Convertible Notes:

Activity in the December 2016 10% Convertible Notes
Initial principal balance $680,400 
Conversions during the nine months ended December 31, 2017  (300,620)
Balance as of December 31, 2017 $379,780 

6. EQUITY TRANSACTIONS IN THE NINE MONTHS ENDED DECEMBER 31, 20172022

 

October 2017 Public2022 At The Market Offering

On October 4, 2017, we consummated a public offering of 5,454,546 shares of common stock and warrants to purchase 5,454,546 shares of common stock, for total gross proceeds of $6.0 million. The offering was priced at $1.10 per unit with each unit comprised of one share of common stock and one common stock purchase warrant. Neither the warrants nor the units are listed on an exchange and therefore do not trade. The warrants carry a five-year term with an exercise price of $1.10 per share. The net proceeds of the offering were $5,289,735. H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

Warrant Exercises

In December 2017, four investors that participated in the October 2017 Public Offering exercised 218,600 warrants for aggregate cash proceeds to us of $240,460 before expenses.

Common Stock Sales Agreement with H.C. Wainwright

On June 28, 2016, we entered into a Common Stock Sales Agreement (the “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”)Wainwright & Co., LLC, or Wainwright, which establishesestablished 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 Agreementoffering was registered under the Securities Act of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on 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 $12,500,000 (the “Shares”).$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.

In the nine months ended December 31, 2022, we raised net proceeds of $8,927,211, net of $229,610 in commissions to Wainwright and $27,153 in other offering expense, through the sale of, 7,480,836 shares of our common stock at an average price of $1.19 per share under the 2022 ATM Agreement.

 

 

 

 10 

 

 

SubjectRestricted Stock Unit Grants

The Compensation Committee of the Board of Directors of the Company approved, effective as of April 1, 2022, pursuant to the terms and conditions set forth in the Agreement, H.C. Wainwright will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon our instructions. We have provided H.C. Wainwright with customary indemnification rights, and H.C. Wainwright will be entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Share sold. In addition, we have agreed to pay certain expenses incurred by H.C. Wainwright in connection withCompany’s Amended and Restated Non-Employee Directors Compensation Policy, or the Agreement, including up to $50,000Directors Compensation Policy, the grant of the fees and disbursements of their counsel. The Agreement will terminate upon the sale of allannual Restricted Stock Unit awards, or RSUs, to each of the Shares under the Agreement unless terminated earlier by either party as permitted under the Agreement (see Note 14).

Salestwo non-employee directors of the Shares, if any, under the Agreement shall be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act, including sales made by means of ordinary brokers’ transactions, includingCompany then serving on the Nasdaq Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell anyBoard of Directors of the Shares,Company, or Board, and at any time, we may suspend offers under the Agreement or terminategrant of an RSU for the Agreement.

In July 2016, we commenced salesthen newly appointed director. The RSU grants were made subject to stockholder approval of an increase of 1,800,000 shares of common stock authorized for issuance under our Common Stock Sales Agreementthe Company’s 2020 Equity Incentive Plan, or the 2020 Plan, at the Company’s 2022 annual meeting of stockholders. The increase was approved at the Company’s 2022 annual meeting of stockholders held in September 2022. The Directors Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current non-employee directors then serving on the Board and for a grant of stock options or $75,000 worth of RSUs for a newly elected director, with H.C. Wainwright. Ineach RSU priced at the six months endedaverage for the closing prices for the five days preceding and including the date of grant, or $1.46 per share as of April 1, 2022. The two then-current eligible directors each was granted a contingent RSU in the amount of 34,247 shares under the 2020 Plan and the then newly appointed director received a contingent RSU grant for 51,370 shares under the 2020 Plan. The RSUs are subject to vesting in three installments, 50% on September 30, 2017, we raised aggregate net proceeds2022, and 25% on each of $1,650,314 (net of $51,157 in commissionsDecember 31, 2022, and March 31, 2023, subject to H.C. Wainwright and $3,750 in other offering expenses) under this agreement through the sale of 601,504 shares at an average price of $2.74 per share of net proceeds.recipient's continued service with the Company on each such vesting date.

  

In connection with our October 2017 Public Offering (see above), we agreed to restrict our ability to use the ATM facility for a 90 day period immediately post-closing.

Restricted Shares Issued for Services6. RELATED PARTY TRANSACTIONS

 

During the ninethree months ended December 31, 2017,2022, we issued 15,000 sharesaccrued unpaid fees of restricted common stock at a price$57,000 owed to our non-employee directors as of $2.24 per share,December 31, 2022. Amounts due to related parties were comprised of the market price at time of issuance, in payment for investor relations consulting services valued at $33,600 based on the grant date closing market price of our common stock.following items:

Due to related parties       
  December 31,
2022
  March 31,
2022
 
Accrued Board fees $57,000  $55,750 
Accrued vacation to all employees  133,397   99,992 
Total due to related parties $190,397  $155,742 

7. OTHER CURRENT LIABILITIES

 

Share for Warrant Exchanges

During the nine months ended December 31, 2017, we agreed with two individual investors to exchange 11,497 restricted shares for the cancellation of 22,993 warrants and we entered into an Exchange Agreement with two institutional investors under which we issued 57,844 restricted shares in exchange for the cancellation of 77,125 warrants held by those investors. We also agreed with those institutional investors that they would extend the expiration dates of convertible notes held by those investors from July 1, 2018 to July 1, 2019 in exchange for the reductionOther current liabilities were comprised of the conversion price of those notes from $4.00 per share to $3.00 per share (see Note 5).following items:

Additionally, we entered into an agreement with a former placement agent to issue 5,500 restricted shares in exchange for the cancellation of 11,000 warrants held by that placement agent. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded losses for each of those exchanges based on the changes in fair value between the instruments exchanged. Based upon the fair value of the shares issued and warrants exchanged, we recorded a loss of $130,214 during the nine months ended December 31, 2017 for all of the above share for warrant exchanges.

Stock Option Issuances

During the nine months ended December 31, 2017, we issued options to four of our employees to purchase 34,500 shares of common stock at an exercise price of $1.68 per share, the closing price on the date of the approval of the option grants by our compensation committee (see Note 9).

Termination of Restricted Share Grant

During the nine months ended December 31, 2017, we terminated a previously recorded but unissued share issuance of 68,000 shares under a fully vested restricted stock grant to our CEO and issued to him 32,674 shares as a net settlement of shares and the Company paid the withholding taxes associated with that share issuance in return for the cancellation of 35,326 shares. The compensation cost of that restricted stock grant had been fully recorded over prior fiscal years, therefore no expense was recorded regarding this net issuance.

Other Current Liabilities       
  December 31,  March 31, 
  2022  2022 
Accrued professional fees $1,180,312  $696,893 
Total other current liabilities $1,180,312  $696,893 

 

 

 

 11 

 

 

Restricted Stock Unit Grants to Directors and Executive Officers

On August 9, 2016, our Board of Directors granted RSUs to certain of our officers and directors and effective November 7, 2017, 127,659 additional RSUs were granted to our directors pursuant to the 2012 Non-Employee Directors Compensation Program. The RSUs represent the right to be issued on a future date shares of our common stock for vested RSUs.

During the nine months ended December 31, 2017, 138,375 vested RSUs held by our executives were exchanged into the same number of shares of our common stock. As our executives elected to net settle a portion of their RSU’s in exchange for the Company paying the related withholding taxes on the share issuance, 71,081 of the RSUs were cancelled and we issued a net 67,294 shares to our executives (see Note 9).

During the nine months ended December 31, 2017, 63,829 RSUs held by our outside directors were exchanged into the same number of shares of our common stock. As one of our three outside directors elected to return 40% of his RSUs in exchange for cash in order to pay his withholding taxes on the share issuances, 10,638 of the RSUs were cancelled and we paid $12,127 in cash to that outside director (see Note 9).

7. RELATED PARTY TRANSACTIONS

Due to Related Parties

During the three months ended December 31, 2017, we accrued unpaid Board fees of $35,350 which are owed to our outside directors as of December 31, 2017. On March 31, 2017, we had accrued unpaid board fees of $28,250 owed to our outside directors.

8. OTHER CURRENT LIABILITIES

Other current liabilities were comprised of the following items:

  December 31,  March 31, 
  2017  2017 
Accrued interest $30,886  $5,391 
Other accrued liabilities  29,648   64,076 
Total other current liabilities $60,534  $69,467 

9. STOCK COMPENSATION

 

The following tables summarize share-based compensation expenses relating to Restricted Stock Units (“RSU”s)RSUs and stock options granted and the effect on basic and diluted loss per common share during the three and nine month periods ended December 31, 20172022 and 2016:2021:

  Three Months
Ended
December 31,
2017
  Three Months
Ended
December 31,
2016
  Nine Months
Ended
December 31,
2017
  Nine Months
Ended
December 31,
2016
 
Vesting of stock options and restricted stock units $323,162  $306,159  $887,607  $1,880,150 
Total stock-based compensation expense $323,162  $306,159  $887,607  $1,880,150 
                 
Weighted average number of common shares outstanding – basic and diluted  14,950,701   7,927,031   10,927,106   7,768,682 
                 
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.02) $(0.04) $(0.08) $(0.24)

Schedule of share-based compensation expense             
  Three Months
Ended
December 31,
2022
  Three Months
Ended
December 31,
2021
  Nine Months
Ended
December 31,
2022
  Nine Months
Ended
December 31,
2021
 
Vesting of stock options and restricted stock units $262,613  $201,019  $791,588  $522,234 
Total stock-based compensation expense $262,613  $201,019  $791,588  $522,234 
                 
Weighted average number of common shares outstanding – basic and diluted  22,946,483   15,397,418   19,741,451   14,543,787 
                 
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.01) $(0.01) $(0.04) $(0.04)

  

All of the stock-based compensation expense recorded during the nine months ended December 31, 20172022 and 2016, which totaled $887,6072021, an aggregate of $791,588 and $1,880,150,$522,234, 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 nine months ended December 31, 20172022 and 20162021 represented an impact on basic and diluted loss per common share of $(0.08) and $(0.24), respectively.$(0.04) in each period.

12

 

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 nine months ended December 31, 20172022 was insignificant.

Restricted Stock Unit Grants to Directors and Executive Officers

On August 9, 2016, our Board of Directors granted RSUs to certain of our officers and directors and effective November 7, 2017, 127,659 additional RSUs were granted to our directors pursuant to the 2012 Non-Employee Directors Compensation Program. The RSUs represent the right to be issued on a future date shares of our common stock for vested RSUs. Our Compensation Committee recommended the grants based on a compensation assessment provided by a third-party compensation consulting firm engaged by us that developed a peer group of companies for market assessment and analyzed compensation at such companies.

The RSUs were granted under our Amended 2010 Stock Incentive Plan and we recorded expense of $842,095 in the nine months ended December 31, 2017 related to the RSU grants.

RSUs outstanding that have vested and are expected to vest as of December 31, 2017 are as follows:

Number of RSUs
Vested46,125
Expected to vest432,830
Total478,955

During the nine months ended December 31, 2017, 138,375 vested RSUs held by our executives were exchanged into the same number of shares of our common stock. As our executives elected to net settle a portion of their RSU’s in exchange for the Company paying the related withholding taxes on the share issuance, 71,081 of the RSUs were cancelled and we issued a net 67,294 shares to our executives.

During the nine months ended December 31, 2017, 63,829 RSUs held by our outside directors were exchanged into the same number of shares of our common stock. As one of our three outside directors elected to return 40% of his RSUs in exchange for cash in order to pay his withholding taxes on the share issuances, 10,638 of the RSUs were cancelled and we paid $12,127 in cash to that outside director.

 

Stock Option Activity

 

During the nine months ended December 31, 2017,2022, we issued optionsrecognized a stock option grant made in the fiscal year ended March 31, 2022 to fourpurchase 61,600 shares of our employees to purchase 34,500common stock under our 2020 Plan that previously was contingent on stockholder approval of an increase of 1,800,000 shares of common stock authorized for issuance under the 2020 Plan, at a pricethe Company’s 2022 annual meeting of $1.68 per share,stockholders. The increase was approved at the closing price on the dateCompany’s 2022 annual meeting of the approval of the option grants by our compensation committee. There were no stock option grants duringstockholders held in September 2022.

During the nine months ended December 31, 2016.

Options outstanding that have vested2021, we issued a stock option grant to Charles J. Fisher, Jr., MD, our Chief Executive Officer, or CEO, for the purchase of 266,888 shares of our common stock under our 2020 Plan. The purchase price for the shares subject to the option is $5.17 per share, the fair market value of the common stock on the date of the grant. The shares subject to the option are subject to vesting over four years, commencing on the date of grant, or Vesting Commencement Date, with twenty-five percent (25%) of the shares subject to the option vesting on the first anniversary of the Vesting Commencement Date and are expectedthe remaining shares vesting in equal monthly installments over the following thirty-six (36) months, in each case subject to vest as of December 31, 2017 are as follows:Dr. Fisher’s Continuous Service (as defined in the 2020 Plan) through each vesting date.

  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term in
Years
 
          
Vested  432,047  $10.98   3.64 
Expected to vest  27,000  $1.68   9.46 
Total  459,047         

 

 

 

 1312 

 

 

The following outlines the significant weighted average assumptions used to estimate the fair value information presented, with respect to stock option grants utilizing the Binomial Lattice option pricing models at, and during the nine months endedStock options outstanding that have vested as of December 31, 2017:

Risk free interest rate2.21%
Average expected life10 years
Expected volatility92.14%
Expected dividendsNone

The2022 and stock options that are expected volatility was based on the historic volatility. The expected life of options granted was based on the "simplified method"to vest subsequent to December 31, 2022 are as described in the SEC's guidance due to changes in the vesting terms and contractual life of current option grants compared to our historical grants.follows:

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  501,985  $2.83   7.83 
Expected to vest  1,201,848  $2.03   8.21 
Total  1,703,833         

  

A summary of stock option activity during the nine months ended December 31, 20172022 is presented below:

Schedule of stock option activity        
 Amount Range of
Exercise Price
 Weighted
Average
Exercise
Price
  Amount  Range of
Exercise Price
 Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2017 432,047 $3.80-$20.50   $10.98 
Stock options outstanding at March 31, 2022  1,665,948  $1.28 - 142.50  $2.31 
Exercised        $  $ 
Granted 27,000 $1.68  $1.68   61,600  $1.21  $1.21 
Cancelled/Expired         (23,715) $1.41 - 57  $2.85 
Stock options outstanding at December 31, 2017  459,047  $1.68-$20.50  $10.44 
Stock options exercisable at December 31, 2017  432,047  $3.80-$20.50  $10.98 
Stock options outstanding at December 31, 2022  1,703,833  $1.21 - 142.50  $2.26 
Stock options exercisable at December 31, 2022  501,985  $1.28 - 142.50  $2.83 

 

On December 31, 2017,2022, our outstanding stock options had no intrinsic value since the closing share price on that date of $1.13$0.28 per share was below the weighted average exercise price of our outstanding stock options.

 

At December 31, 2017,2022, there was approximately $2.2 million$2,151,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.722.51 years.

 

10.

13

9. WARRANTS

 

During the nine months ended December 31, 2017,2022 and 2021, we issued 5,618,182 warrants, including 163,636 warrants issued to the placement agent, H.C. Wainwight & Co., in connection with our October 2017 Public Offering (see Note 6). Those warrants have a five year term and have an exercise price of $1.10 per share.did not issue any warrants.

The following outlines the significant weighted average assumptions used to estimate the fair value information presented, with respect to warrants utilizing the Binomial Lattice option pricing models, issued during the nine months ended December 31, 2017:

Risk free interest rate1.38% - 1.92%
Average expected life5 years
Expected volatility100.2% - 111.1%
Expected dividendsNone

 

A summary of warrant activity during the nine months ended December 31, 20172022 is presented below:

Schedule of Warrant Activity          
  Amount  Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2022  576,738  $1.50 – 59.25  $11.21 
Exercised    $  $ 
Cancelled/Expired  (249,985) $20.63 – 59.25  $23.24 
Warrants outstanding at December 31, 2022  326,753  $1.50 – 2.75  $2.01 
Warrants exercisable at December 31, 2022  326,753  $1.50 – 2.75  $2.01 

  

  Amount  Range of
Exercise
Price
 Weighted
Average
Exercise
Price
Warrants outstanding at March 31, 2017  2,604,096  $2.10 - $12.05 $3.64
Exercised  (218,600) $1.10 $1.10
Issued  5,618,182  $1.10 $1.10
Cancelled/Expired  (139,357) $5.00 –$15.00 $6.52
Warrants outstanding at December 31, 2017  7,864,321  $1.10 - $12.05 $1.38
Warrants exercisable at December 31, 2017  7,864,321  $1.10 - $12.05 $1.38

10. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

We entered into the following contract with the National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, in September 2019:

Phase 2 Melanoma Cancer Contract

On September 12, 2019, the NCI awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract. The Award Contract amount is $1,860,561 and, as amended, ran for the period from September 16, 2019 through September 15, 2022.

The work performed pursuant to this Award Contract was focused on melanoma exosomes. This work followed from our completion of a Phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program involved the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

We did not record government contract revenue on the Phase 2 Melanoma Cancer Contract in the three and nine month periods ended December 31, 2022. We recorded $114,849 and $229,698 of government contract revenue on the Phase 2 Melanoma Cancer Contract in the three and nine month periods ended December 31, 2021, respectively.

The contract ended on September 15, 2022 and we presented the required final report to the NCI. Once the NCI completes the close out review of the contract, we expect to recognize as revenue the $574,245 currently recorded as deferred revenue on our December 31, 2022 balance sheet.

 

 

 

 14 

 

 

Subaward with University of Pittsburgh

In December 2020, we entered into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $256,750. We did not record revenue related to this subaward in the three- and nine- month periods ended December 31, 2022. We recorded $17,117 and $51,351 of revenue related to this subaward in the three- and nine-month periods ended December 31, 2021, respectively.

In October 2022, we agreed with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement requiring repayment of cash received for work completed through November 10, 2022.

11. 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 following outlinesagreement carries a term of 63 months and we took possession of the significantoffice space effective October 1, 2021. We took possession of the lab space effective January 1, 2022. In October 2021, we entered into another lease for (i) approximately 22,260 square feet of space located at 11588 Sorrento Valley Road, San Diego, California 92121, or the Building, and (ii) 2,655 square feet of space located in the Building and commonly known as Suite 18 to house our manufacturing operations. The term is for 55 months and we took possession of the manufacturing space in August 2022.

During the nine months ended December 31, 2022, we recorded a $625,471 right-of-use lease asset and associated lease liability related to the manufacturing space component of the lease based on the present value of lease payments over the expected lease term of 55 months, discounted using our estimated incremental borrowing rate of 4.25%. The current monthly base rent under the manufacturing component of the lease is $12,540.

The office, lab and manufacturing leases are coterminous with a remaining term of 54 months. The weighted average assumptions useddiscount rate is 4.25%.

As of our December 31, 2022 balance sheet, we have a right-of-use lease asset of $1,217,458.

In addition, the lease agreements for the new office, lab and manufacturing space required us to estimatepost a standby L/C in favor of the fair value information presented,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 respecta 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 warrants utilizinglocate it there. We paid approximately $167,615 in total rent expense to lease the Binomial Lattice option pricing models issuedmobile clean room located on this space during the nine months ended December 31, 2016:

Risk free interest rate0.79% – 1.38%
Average expected life3 months – 2.33 years
Expected volatility65.9% – 111.1%
Expected dividendsNone

2022. The expected volatilityarrangement was based onterminated in September 2022 and the historic volatility. The expected life of options grantedmobile clean room was based onreturned to the "simplified method" as described in the SEC's guidance duevendor that leased it to changes in the vesting terms and contractual life of current option grants compared to our historical grants.us.

 

Based on the above assumptions, we valued the warrants that were exchangedOverall, our rent expense, which is included in general and administrative expenses, approximated $411,000 and $288,000 for common stock (see Note 6) during the nine monthsmonth periods ended December 31, 2017 at $130,214.

11. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

National Institutes of Health (“NIH”)

We entered into a contract with the NIH on September 15, 2017. This award is under the NIH’s Small Business Innovation Research (SBIR) program which is designed to fund early stage small businesses that are seeking to commercialize innovative biomedical technologies. The title of the award is SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes2022 and Non-Malignant Exosomes.

The award from NIH is a firm, fixed-price contract with potential total payments to us of $299,250 over the course of nine months.

Fixed price contracts require the achievement of multiple, incremental milestones to receive the full award during each period of the contract. The NIH also has the unilateral right to require us to perform additional work under an option period for an additional fixed amount of $49,800.

Under the terms of the contract, we must perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts.

In October 2017, we completed the first milestone on this contract and invoiced NIH for the $74,812.50 payment associated with that milestone.

The details of that milestone were as follows:

Milestone HHSN261201700022C-01 – Prepare and present the kick-off presentation to NIH. The milestone payment was $74,812.50. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We prepared and presented the kick-off presentation to NIH. The report was accepted by NIH and the invoice was submitted thereafter.

Defense Advanced Research Projects Agency (“DARPA”)

We entered into a contract with DARPA on September 30, 2011. Under the DARPA award, we have been engaged to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that often results in the death of combat-injured soldiers. The award from DARPA was a fixed-price contract with potential total payments to us of $6,794,389 over the course of five years. Fixed price contracts require the achievement of multiple, incremental milestones to receive the full award during each year of the contract. Under the terms of the contract, we performed certain incremental work towards the achievement of specific milestones against which we invoiced the government for fixed payment amounts.

Originally, only the base year (year one of the contract) was effective for the parties; however, DARPA subsequently exercised its option on the remaining years of the contract. The milestones were comprised of planning, engineering and clinical targets, the achievement of which in some cases required the participation and contribution of third-party participants under the contract. We commenced work under the contract in October 2011 and completed the contract in September 2016.

In February 2014, DARPA reduced the scope of our contract in years three through five of the contract. The reduction in scope focused our research on exosomes, viruses and blood processing instrumentation. This scope reduction reduced the possible payments under the contract by $858,469 over years three through five.

The DARPA contract concluded on September 30, 2016.

In the nine months ended December 31, 2016, we invoiced the U.S. Government for the final two milestones under our DARPA contract in the aggregate amount of $387,438.2021, respectively.

 

 

 

 15 

 

The details of those milestones were as follows:

Milestone 2.6.1.3 - Quantify the degree to which the MERS virus can be extracted from circulation in vitro using miniature Hemopurifiers. The milestone payment was $193,719. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We quantified the degree to which the MERS virus can be extracted from circulation in vitro using miniature Hemopurifiers. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.

Milestone 2.6.1.4 – Prepare and present Final Report for DARPA. The milestone payment was $193,719. Management considers this milestone to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We prepared and presented the Final Report for DARPA. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.

12. SEGMENTS

We operate our businesses principally through two reportable segments: Aethlon, which represents our therapeutic business activities, and ESI, which represents our diagnostic business activities. Our reportable segments have been determined based on the nature of the potential products being developed. We record discrete financial information for ESI and our chief operating decision maker reviews ESI’s operating results in order to make decisions about resources to be allocated to the ESI segment and to assess its performance.

Aethlon’s revenue is generated primarily from government contracts to date and ESI does not yet have any revenues. We have not included any allocation of corporate overhead to the ESI segment.

The following tables set forth certain information regarding our segments:

  Nine Months Ended December 31, 
  2017  2016 
Revenues:      
Aethlon $74,813  $392,073 
ESI      
Total Revenues $74,813  $392,073 
         
Operating Losses:        
Aethlon $(3,495,189) $(4,478,631)
ESI  (64,860)  (115,443)
Total Operating Loss $(3,560,049) $(4,594,074)
         
Net Losses:        
Aethlon $(4,308,807) $(5,497,978)
ESI  (64,860)  (115,443)
Net Loss Before Non-Controlling Interests $(4,373,667) $(5,613,421)
         
Cash:        
Aethlon $5,610,061  $625,531 
ESI  738   3,084 
Total Cash $5,610,799  $628,615 
         
Total Assets:        
Aethlon $5,745,031  $752,578 
ESI  5,723   37,019 
Total Assets $5,750,754  $789,597 
         
Capital Expenditures:        
Aethlon $23,705  $2,961 
ESI      
Capital Expenditures $23,705  $2,961 
         
Depreciation and Amortization:        
Aethlon $27,402  $16,322 
ESI     10,043 
Total Depreciation and Amortization $27,402  $26,365 
         
Interest Expense:        
Aethlon $(306,495) $(115,308)
ESI      
Total Interest Expense $(306,495) $(115,308)

16

13. COMMITMENTS AND CONTINGENCIES

Lease Commitments

We currently rent approximately 2,600 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123 at the rate of $6,054 per month on a four-year lease that expires in May 2018. We also rent approximately 1,700 square feet of laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego, California 92121 at the rate of $4,548 per month on a one-year lease that was extended to an expiration date of November 30, 2018.

Rent expense, which is included in general and administrative expenses, approximated $100,000 and $114,000 for the nine month periods ended December 31, 2017 and 2016, respectively.

Legal MattersLEGAL MATTERS

 

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.

 

14. 12. SUBSEQUENT EVENTS

 

Management has evaluated events subsequent to December 31, 20172022 through the date that the accompanying condensed consolidated financial statements were filed with the Securities and Exchange CommissionSEC for transactions and other events which may require adjustment of and/or disclosure in such financial statements.

 

Warrant Exercises –SubsequentIn 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 December 31, 2017, sixteen investors that participatedoversee the Company’s 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 October 2017 public offering exercised 852,700 warrants for aggregate cash proceeds to usUnited States and Australia with various types of $937,970 before expenses.cancer tumors. We anticipate that the initial clinical trials will begin in Australia.

 

ATM Sales-- Subsequent to December 31, 2017,In February 2023, we sold common stock underentered into an executive employment agreement with a new Chief Scientific Officer, Dr. Lee Arnold, effective February 1, 2023. Dr. Arnold initially will serve as our Common Stock Sales Agreement with H.C. Wainwright (see Note 6) and from those sales raised net proceeds of $454,654 (after deducting $14,123 in commissions to H.C. Wainwright and $1,998 in other offering expenses), utilizing the sales agreement through the sale of 340,000 shares at an average price of $1.34Chief Scientific Offer on a part-time, three days per share of net proceeds.

Restricted Stock Unit (“RSU”) Issuances – In January 2018, 46,125 RSUs held byweek basis. Previously, Dr. LaRosa served as interim Chief Scientific Officer, as well as our executives were exchanged into the same number of shares ofChief Medical Officer. Dr. LaRosa will continue as our common stock. As our executives elected to net settle a portion of their RSUs in exchange for the Company paying the related withholding taxes on the share issuance, 26,157 of the RSUs were cancelled, and we issued a net 19,968 shares to our executives.Chief Medical Officer.

 

 

 

 1716 

 

 

ITEM 2. MANAGEMENT'SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

 

The following discussion of our financial condition and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. This item contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those indicated in such forward-looking statements.

 

FORWARD LOOKING STATEMENTS

 

All statements, other than statements of historical fact, included in this Form 10-Q are, or may be deemed to be, "forward-looking statements"“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, (the “Securities Act"),or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause theour actual results, performance, or achievements of Aethlon Medical, Inc. ("we" or "us") to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this Form 10-Q. Such potential risks and uncertainties include, without limitation, successful completion of our capital-raising activities,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 othercandidates, our ability to comply with changing government regulations, patent protection of our proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors detailed herein and in other of our filings with the Securities and Exchange Commission, (the “Commission”).or the SEC. The forward-looking statements are made as of the date of this Form 10-Q, and we assume no obligation to update the forward-looking statements, or to update the reasons actual results could differ from those projected in such forward-looking statements.

 

Overview

 

Aethlon Medical, Inc. and subsidiary (collectively, “Aethlon”, or Aethlon, the “Company”, “we”Company, we or “us”) areus, is a medical technologytherapeutic company focused on addressing unmet needs in global healthdeveloping products to diagnose and biodefense.treat cancer and life-threatening infectious diseases. The Aethlon Hemopurifier®Hemopurifier is an earlya clinical-stage therapeuticimmunotherapeutic 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 single-use removaltreatment 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 from the circulatory system of infected individuals. 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.

On October 4, 2019, the FDA approved our Investigational Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, designed to enroll 10 to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. This clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two patients. Due to lack of further patient enrollment, we and UPMC terminated this trial. We are in the process of designing other clinical trials in oncology, to include additional solid tumors. These trials initially are planned to be conducted in Australia.

17

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 countermeasure objectives set forth by the U.S. Government to protect citizens from bioterror and pandemic threats.treatment. In small-scale or early feasibility human studies, the Hemopurifier has been administeredused in the past to treat individuals infected with human immunodeficiency virus, or HIV, Hepatitis-C,hepatitis-C and Ebola.

Additionally, in vitro, the Hemopurifier has been validateddemonstrated to capture Zika virus, Lassa virus, MERS-CoV, Cytomegalovirus,cytomegalovirus, Epstein-Barr virus, Herpes Simplexsimplex virus, Chikungunya virus, Dengue virus, West Nile virus, Smallpox-relatedsmallpox-related viruses, H1N1 Swine Fluswine flu virus, H5N1 Bird Flubird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these validationsstudies were conducted in collaboration with leading government or non-government research institutes. Domestically, we are focused on

On June 17, 2020, the clinical advancementFDA approved a supplement to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA. We recently concludedin patients with SARS-CoV-2/COVID-19, or COVID-19, in a feasibilityNew Feasibility Study. That study was designed to demonstrateenroll up to 40 subjects at up to 20 centers in the United States. Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and will 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 trial was enrolled and completed the Hemopurifier treatment phase of our device in health-compromised individuals infectedthe protocol. Under Single Patient Emergency Use regulations, the Company has treated two patients with a viral pathogen.COVID-19 with the Hemopurifier.

 

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, is delayed as we work with the FDA for approval of our supplement to our Investigational Device Exemption, 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 market in Australia. There were only insignificant expenses in that subsidiary in the three months ended December 31, 2022.

We also obtained ethics review board approval 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 the Hemopurifiers made with the GNA from our new supplier.

Previously we were the majority owner of Exosome Sciences, Inc. (ESI), or ESI, a company focusedformed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s endeavorsdiseases, and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI were limited to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and the Company, as the majority stockholder of ESI, approved the dissolution of ESI. Accordingly, ESI is the advancement of a TauSomeTM biomarker candidate to diagnose Chronic Traumatic Encephalopathy (CTE) in the living. ESI previously documented that TauSome levels in former NFL players to be nine times higher than same age-group control subjects.eliminated from our December 31, 2022 balance sheet.

 

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we intendplan to sell this device.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 more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

 

In addition to the foregoing, we are monitoring closely the impact of the COVID-19 global pandemic, inflation 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 the COVID-19 pandemic, inflation 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.

18

Our executive offices are located at 9635 Granite Ridge Drive,11555 Sorrento Valley Road, Suite 100,203, San Diego, California 92123.92121. Our telephone number is (858) 459-7800.(619) 941-0360. Our website address is www.aethlonmedical.com.

 

Our common stock is quotedlisted on the Nasdaq Capital Market under the symbol “AEMD.”

COVID-19, Inflation and International Conflicts

The COVID-19 pandemic, the conflict in Ukraine and inflation has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption of financial markets.  Given the level of uncertainty regarding the COVID-19 pandemic, Ukraine conflict and inflationary environment on capital markets and the U.S. economy, we are unable to assess the impact of these events on our future access to capital. Further, while we have not experienced significant disruptions to our manufacturing supply chain, business, results of operations, financial condition, clinical trials or preclinical research to date, we are unable to assess the potential impact these events could have on our manufacturing supply chain, business, results of operations, financial condition, clinical trials or preclinical research in the future.

As we continue to actively advance our clinical trials, we remain in close contact with our clinical sites and are assessing the impact of COVID-19 on our trials, expected timelines and costs on an ongoing basis. We will assess any potential delays in our ability to timely ship clinical trial materials, including internationally, due to transportation interruptions. The extent of the impact of COVID-19, the Ukraine conflict and inflation on our operational and financial performance will depend on certain developments, including the impact on our clinical trials, employees and vendors, all of which are uncertain and cannot be predicted. Given these uncertainties, we cannot reasonably estimate the related impact to our business, operating results and financial condition, if any.

 

WHERE YOU CAN FIND MORE INFORMATION

 

We are subject to the informational requirements of the Securities Exchange Act, and must file reports, proxy statements and other information with the Commission.SEC. The reports, information statements and other information we file with the Commission can be inspected and copied at the Commission Public Reference Room, 100 F Street, N.E., Washington, D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling the Commission at (800) SEC-0330. The Commission alsoSEC maintains a Webweb site (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, like us, which file electronically with the Commission. Our headquarters are located at 9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123. Our phone number at that address is (858) 459-7800. Our Web site ishttp://www.aethlonmedical.com.SEC.

18

 

RESULTS OF OPERATIONS

 

THREE MONTHS ENDED DECEMBER 31, 20172022 COMPARED TO THE THREE MONTHS ENDED DECEMBER 31, 20162021

 

Government Contract Revenues

 

We recorded any $74,813 ofdid not record government contract revenue in the three months ended December 31, 2017 and we did not record any2022. We recorded $17,117 in government contract revenue in the three months ended December 31, 2016. That2021. This revenue aroseresulted from work performed under our government contractcontracts with the National Institutes of Health, or NIH, as follows:

 

  Three Months
Ended
12/31/17
  Three Months
Ended
12/31/16
  Change in
Dollars
 
NIH Contract $74,813  $  $74,813 
Total Government Contract Revenue $74,813  $  $74,813 
  Three Months
Ended
12/31/22
  Three Months
Ended
12/31/21
  Change in
Dollars
 
Phase 2 Melanoma Cancer Contract $  $  $ 
Subaward with University of Pittsburgh     17,117   (17,117)
Total Government Contract and Grant Revenue $  $17,117  $(17,117)

NIH Contract

19

We entered into a contract withhave recognized revenue under the NIH onfollowing contracts/grants:

Phase 2 Melanoma Cancer Contract

On September 12, 2019, the National Cancer Institute, or NCI, awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract. The Award Contract amount was $1,860,561 and, as amended, ran for the period from September 16, 2019 through September 15, 2017. This award is under the NIH’s Small Business Innovation Research (SBIR) program which is designed to fund early stage small businesses that are seeking to commercialize innovative biomedical technologies. The title of the award is SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.2022.

 

The awardwork performed pursuant to this Award Contract was focused on melanoma exosomes. This work followed from NIH isour completion of a firm, fixed-pricePhase I contract with potential total payments to usfor the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program involved the design and testing of $299,250 overa pre-commercial prototype of a more advanced version of the course of nine months.exosome isolation platform.

 

Fixed price contracts requireWe did not record government contract revenue on the achievement of multiple, incremental milestones to receive the full award during each period of the contract. The NIH also has the unilateral right to require us to perform additional work under an option period for an additional fixed amount of $49,800.

Under the terms of the contract, we must perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts.

InAward Contract in the three months ended December 31, 2017,2022 or in the three months ended December 31, 2021.

The Award Contract ended on September 15, 2022 and we presented the required final report to the NCI. Once the NCI completes the close out review of the contract, we expect to recognize as revenue the $574,245 currently recorded as deferred revenue on our December 31, 2022 balance sheet.

Subaward with University of Pittsburgh

In December 2020, we entered into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award was $256,750. We did not record revenue related to this subaward in the three months ended December 31, 2022. We recorded $17,117 of revenue related to this subaward in the three months ended December 31, 2021.

In October 2022, we agreed with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement requiring repayment of cash received for work completed the first milestone on this contract and invoiced NIH for the $74,812.50 payment associated with that milestone.through November 10, 2022.

 

Operating Expenses

 

Consolidated operating expenses for the three months ended December 31, 20172022 were $1,238,440 in comparison with $1,235,546$2,849,753, compared to $2,545,063 for the comparable period a year ago.three months ended December 31, 2021. This increase of $2,894,$304,690, or 0.2%12%, in the 2022 period was due to an increaseincreases in our professional fees of $296,261 and in our payroll and related expenses of $27,547,$49,261, offset by a $22,251decrease in our general and administrative expenses of $40,832.

The $296,261 increase in our professional fees was primarily due to the combination of a $144,684 increase in our contract labor expense associated with product development and scientific analytical services, a $73,115 increase in our scientific consulting expense, a $71,029 increase in our legal fees, a $25,622 increase related to outside regulatory services, and a $46,904$21,712 increase associated with recruiting. These expenses were partially offset by a $13,687 decrease in general and administrativeour accounting expenses.

 

The $27,547$49,261 increase in our payroll and related expenses was due to an increase of $167,520 in salary expense and an increase of $61,594 of stock based compensation expense related to increased headcount, offset by a $17,003 increasedecrease of $179,853 in stock-based compensation and to a $10,545 increase in our cash-based payroll and related expenses due to bonuses given to our support and scientific staff.relocation expense.

 

The $22,251 increase$40,832 decrease in our professional feesadministrative expenses was due to an increasea $74,894 decrease in our professional fees of $37,962,clinical trial expenses, a $18,914 decrease in rent expense and a $19,774 decrease in licenses and permits, which was partially offset by a decrease in our professional fees at ESI of $15,711. The $37,962 decrease in our professional fees was due to a $62,864$60,455 increase in our legal fees, a $22,022 increase in our investor relations fees, a $14,069 increase in our accounting fees, a $7,358 increase in our marketing expenses, and a $6,100 increase in our directors’ fees due to an increase in our Board of Directors, which were partially offset by a $51,548 decrease in our scientific consulting expenses and a $25,000 decrease in business development expenses.

The $46,904 decrease in general and administrative expenses was primarily due to a $34,324 decrease in our clinical trial expenses, a $6,519 decrease in the cost of our lab supplies and a $4,743 refund on previous state franchise tax payments.depreciation expense.

  

 

 

 1920 

 

 

Other Expense

Other expense during the three months ended December 31, 2017 and 2016 consisted of interest expense and a gain on debt extinguishment. Other expense for the three months ended December 31, 2017 was other expense of $55,912 in comparison with other income of $22,126 for the three months ended December 31, 2016.

The following table breaks out the various components of our other expense (income) for both periods:

  Three Months
Ended
  Three Months
Ended
    
  12/31/17  12/31/16  Change 
Gain on Debt Extinguishment $  $(58,691) $58,691 
Interest Expense  55,912   36,565   19,347 
Total Other Expense (Income) $55,912  $(22,126) $78,038 

Interest Expense

Interest expense was $55,912 for the three months ended December 31, 2017 compared to $36,565 in the corresponding prior period, an increase of $19,347. The various components of our interest expense are shown in the following table:

  Three Months
Ended
  Three Months
Ended
    
  12/31/17  12/31/16  Change 
Interest Expense $25,625  $17,567  $8,058 
Amortization of Note Discounts  30,287   18,998   11,289 
Total Interest Expense $55,912  $36,565  $19,347 

As noted in the above table, the factors in the $19,347 increase in interest expense were the $8,058 increase in our contractual interest expense and the $11,289 increase in the amortization of note discounts, which related to the amortization against the discount on our convertible notes.

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests increased fromto approximately $1,213,000$2,850,000 in the three month periodmonths ended December 31, 2016 to $1,220,0002022, from approximately $2,528,000 in the three month periodmonths ended December 31, 2017.2021.

 

Basic and diluted loss attributable to common stockholders were ($0.08)0.12) for the three months ended December 31, 2022, compared to ($0.16) for the three month period ended December 31, 2017 compared to ($0.15) for the period ended December 31, 2016.2021.

 

NINE MONTHS ENDED DECEMBER 31, 20172022 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 20162021

 

Government Contract Revenues

 

We recordeddid not record government contract revenue of $74,813 in the nine months ended December 31, 2017 and we2022. We recorded $281,049 in government contract revenue of $392,073 in the nine months ended December 31, 2016.2021. This revenue aroseresulted from work performed under our government contracts with the National Institutes of Health, or NIH with the Defense Advanced Research Projects Agency, or DARPA, and our government subcontract with Battelle Memorial Institute as follows:

 

  Nine Months
Ended 12/31/17
  Nine Months
Ended 12/31/16
  Change in
Dollars
 
NIH Contract $74,813  $  $74,813 
DARPA Contract     387,438   (387,438)
Battelle Subcontract     4,635   (4,635)
Total Government Contract Revenue $74,813  $392,073  $(317,260)
  Nine Months
Ended
12/31/22
  Nine Months
Ended
12/31/21
  Change in
Dollars
 
Phase 2 Melanoma Cancer Contract $  $229,698  $(229,698)
Subaward with University of Pittsburgh     51,351   (51,351)
Total Government Contract and Grant Revenue $  $281,049  $(281,049)

 

We have recognized revenue under the following contracts/grants:

 

20

NIHPhase 2 Melanoma Cancer Contract

 

We entered into a contract withOn September 12, 2019, the NIH onNCI awarded to us the Award Contract. The Award Contract amount was $1,860,561 and, as amended, ran for the period from September 16, 2019 through September 15, 2017. This award is under the NIH’s Small Business Innovation Research (SBIR) program which is designed to fund early stage small businesses that are seeking to commercialize innovative biomedical technologies. The title of the award is SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.2022.

 

The awardwork performed pursuant to this Award Contract was focused on melanoma exosomes. This work followed from NIH isour completion of a firm, fixed-pricePhase I contract with potential total payments to usfor the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program involved the design and testing of $299,250 overa pre-commercial prototype of a more advanced version of the course of nine months.exosome isolation platform.

  

Fixed price contracts requireWe did not record government contract revenue on the achievement of multiple, incremental milestones to receive the full award during each period of the contract. The NIH also has the unilateral right to require us to perform additional work under an option period for an additional fixed amount of $49,800.

Under the terms of the contract, we must perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts.

InAward Contract in the nine months ended December 31, 2017, we completed the first milestone on this contract and invoiced NIH for the $74,812.50 payment associated with that milestone.

DARPA Contract & Battelle Subcontract

Previously, we generated2022. We recorded $229,698 of government contract revenue under a contract with DARPA that we entered into on September 30, 2011. Under the DARPA award, we were engaged to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that often resultsAward Contract in the death of combat-injured soldiers. That contract was completed on September 30, 2016 and the related subcontract with Battelle was completed in March 2017. In the nine months ended December 31, 2016, we invoiced the U.S. Government for the final two milestones under our DARPA contract in the aggregate amount of $387,438.

Operating Expenses

Consolidated operating expenses for the nine months ended December 31, 2017 were $3,634,862 in comparison with $4,986,148 for the comparable period a year ago. This decrease of $1,351,286, or 27.1%, was due to a decrease in payroll and related expenses of $882,335, a decrease in professional fees of $330,279 and a $138,672 decrease in general and administrative expenses.2021.

 

The $882,335 decrease in payrollAward Contract ended on September 15, 2022 and related expenses was primarily due to a $992,543 decrease in stock-based compensation. The decrease in stock-based compensation was duewe presented the required final report to the upfront vesting percentageNCI. Once the NCI completes the close out review of the RSU grantscontract, we expect to our officers and directors in August 2016. Our cash-based payroll and related expenses increased by $110,208 due to headcount additions in our scientific staff.

The $330,279 decrease in our professional fees was due to decreases in our non-DARPA-related professional fees of $263,328, in our DARPA-related professional fees of $38,928 and in our professional fees at ESI of $28,023. The $263,328 decrease in our non-DARPA-related professional fees was due to a $124,941 decrease in our legal fees, a $123,859 decrease in scientific consulting expenses, and a $110,000 decrease in business development expenses which were partially offset by a $64,949 increase in marketing expenses, a $17,014 increase in website service expense and a $5,732 increase in investor relations expenses.

The $138,672 decrease in general and administrative expenses was primarily due to decreases of $101,757 in our DARPA-related general and administrative expenses and $22,224 inrecognize as revenue the general and administrative expenses at ESI.

Other Expense

Other expense during the nine months ended$574,245 currently recorded as deferred revenue on our December 31, 2017 and 2016 consisted of losses on debt extinguishment, warrant repricing expense, losses on share for warrant exchanges and interest expense. Other expense for the nine months ended December 31, 2017 was other expense of $813,618 in comparison with other expense of $1,019,347 for the nine months ended December 31, 2016.2022 balance sheet.

The following table breaks out the various components of our other expense for both periods:

  Nine Months
Ended
  Nine Months
Ended
    
  12/31/17  12/31/16  Change 
Loss on Debt Extinguishment $376,909  $558,198  $(181,289)
Loss on Warrant Repricing     345,841   (345,841)
Loss on Share for Warrant Exchanges  130,214      130,214 
Interest Expense  306,495   115,308   191,187 
Total Other Expense $813,618  $1,019,347  $(205,729)

 

 

 

 21 

 

 

Loss on Debt ExtinguishmentSubaward with University of Pittsburgh

 

In December 2020, we entered into a cost reimbursable subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our loss on debt extinguishmentshare of the award was $256,750. We did not record revenue related to this subaward in the nine months ended December 31, 2022. We recorded $51,351 of revenue related to this subaward in the nine months ended December 31, 2021.

In October 2022, we agreed with the University of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement requiring repayment of cash received for work completed through November 10, 2022.

Operating Expenses

Consolidated operating expenses for the nine months ended December 31, 2017 arose from a $376,909 loss associated with the June 2017 amendments to our convertible notes. This2022 were $9,420,730, compared to a loss of debt extinguishment of $558,198$6,916,236 for the nine months ended December 31, 2016 - see below for additional information.2021. This increase of $2,504,494, or 36.2%, in the 2022 period was due to increases in our general and administrative expenses of $1,225,779, in our professional fees of $909,163 and in our payroll and related expenses of $369,552. 

 

June 2017 Amendments – The $376,909 loss on debt extinguishment$1,225,779 increase in our general and administrative expenses was primarily due to the six months ended September 30, 2017 arose fromcombination of a $470,022 increase in our clinical trial expenses, a $406,410 increase in supplies and materials, primarily for manufacturing Hemopurifiers, a $146,962 increase in subcontract expenses related to our government contracts, a $122,912 increase in our rent expense, and a $72,199 increase in our insurance expense.

The $909,163 increase in our professional fees was primarily due to the combination of a $450,767 increase in our contract labor expense associated with product development and analytical services, a $204,943 increase in our legal fees, a $145,924 increase in professional fees associated with regulatory strategy services, a $64,602 increase in our investor relations expenses, primarily related to solicitation expenses associated with our 2022 annual meeting of stockholders and an Exchange Agreement with two institutional investors under which we issued 57,844 restricted sharesincrease of $36,485 in exchange for the cancellationscientific consulting related to product development and scientific analytical services.

The $369,552 increase in our payroll and related expenses was due to an increase in our cash-based compensation expense of 77,125 warrants held$508,620 and stock-based compensation expense of $269,354 due to our increased headcount. This increase was partially offset by those investors (see Loss on Share for Warrant Exchanges below). Additionally, we agreed with those investors that they would extend the expiration dates of the convertible notes held by those investors from July 1, 2018 to July 1, 2019 in exchange for thea reduction of the conversion price of those notes from $4.00 per share to $3.00 per share. The modification of the notes was evaluated under FASB Accounting Standards Codification (“ASC”) Topic No. 470-50-40, “Debt Modification$215,000 in bonus expense and Extinguishments”. Therefore, according to the guidance, the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting.$198,347 in relocation expense.

 

June 2016 Amendments - This loss on debt extinguishment arose fromOther Expense

In September 2022, the Amendments (the “Amendments”) to our November 2014 convertible notes The Amendments provided thatBoard of Directors of ESI and Aethlon, as the maturity datemajority stockholder of ESI, approved the notes was extended from June 1, 2016 to July 1, 2017 and that the conversion price was reduced from $5.60 per sharedissolution of common stock to $5.00 per share of common stock. In addition, we reduced the purchase price of warrants issued in connection with the notes from $8.40 per share to $5.00 per share. In connection with these modifications, each of the Investors signedESI. As a consent and waiver providing its consent under certain restrictive provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under a securities purchase agreement dated June 23, 2015, (the “2015 SPA”) to which we, the Investors and certain other investors are parties, in order to facilitate an at-the-market equity program described in the liquidity and capital resources sectionresult of this report below. This loss also included an $80,000 fee to extend the November 2014 convertible notes from June 1, 2016 to July 1, 2017. The $80,000 amount was not a cash payment but rather was added to the principal of the notes.

This modification of the notes was also evaluated under ASC Topic No. 470-50-40, “Debt Modification and Extinguishments”. Therefore, according to the guidance, the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting.

Loss on Warrant Repricing

On June 27, 2016,dissolution, we and certain investors (the “Unit Investors”) entered into Consent and Waiver and Amendment agreements (the “CWAs”), relating to an aggregate of 264,000 Warrants to Purchase Common Stock (the “Unit Warrants”) we had issued to the Unit Investors on December 2, 2014 pursuant to a Securities Purchase Agreement dated November 26, 2014 (the “2014 SPA”). In the CWAs, each of the Unit Investors provided its consent under certain restrictive provisions, and waived certain rights, including a right to participate in certain offerings made by us, under the 2014 SPA in order to facilitate the at-the-market equity program described in the notes to the Financial Statements. Pursuant to the CWAs, we reduced the Exercise Price (as defined in the Unit Warrants) from $15.00 per share of common stock to $5.00 per share of common stock.

On June 27, 2016, each of the Unit Investors also entered into a Consent and Waiver providing its consent under certain provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under the 2015 SPA in order to facilitate the at-the market equity program described in the notes to the Financial Statements.

We measured the change in fair value that arose from the reduction in exercise price from $15.00 to $5.00 and recorded a non-cash charge of $345,841 to our$142,121 as other expense to reflect this change.

Loss on Share for Warrant Exchanges

Duringin the nine months ended December 31, 2017, we agreed with two individual investors to exchange 11,497 restricted shares for the cancellation of 22,993 warrants and we entered into an Exchange Agreement with two institutional investors under which we issued 57,844 restricted shares in exchange for the cancellation of 77,125 warrants held by those investors. Additionally, we entered into an agreement with a former placement agent to issue 5,500 restricted shares in exchange for the cancellation of 11,000 warrants held by that placement agent. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded losses for each of those exchanges based on the changes in fair value between the instruments exchanged.

22

Interest Expense

Interest expense was $306,495 for the nine months ended December 31, 2017 compared to $115,308 in the corresponding prior period, an increase of $191,187. The various components of our interest expense are shown in the following table:

  Nine Months
Ended
  Nine Months
Ended
    
  12/31/17  12/31/16  Change 
Interest Expense $91,119  $49,671  $41,448 
Amortization of Deferred Financing Costs     27,641   (27,641)
Amortization of Note Discounts  215,376   37,996   177,380 
Total Interest Expense $306,495  $115,308  $191,187 

As noted in the above table, the most significant factor in the $191,187 increase in interest expense was the $177,380 increase in the amortization of note discounts, which related to the amortization against the discount on our convertible notes. Other smaller factors in the change in our total interest were a $27,641 decrease in the amortization of deferred financing costs and a $41,448 increase in our contractual interest expense.2022.

  

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests decreased fromincreased to approximately $5,613,000$9,563,000 in the nine month periodmonths ended December 31, 2016 to $4,374,0002022, from approximately $6,635,000 in the nine month periodmonths ended December 31, 2017.2021.

 

Basic and diluted loss attributable to common stockholders were ($0.40)0.48) for the nine month periodmonths ended December 31, 20172022, compared to ($0.72)0.46) for the periodnine months ended December 31, 2016.2021.

22

 

LIQUIDITY AND CAPITAL RESOURCES

 

AtAs of December 31, 2017,2022, we had a cash balance of $5,610,799$17,499,541 and working capital of $5,288,930.$15,736,299. This compares to a cash balance of $1,559,701$17,072,419 and working capital of $985,496$16,332,958 at March 31, 2017.

On October 4, 2017, we consummated a public offering of 5,454,546 shares of common stock and warrants to purchase 5,454,546 shares of common stock, for total gross proceeds of $6.0 million. The offering was priced at $1.10 per unit with each unit comprised of one share of common stock and one common stock purchase warrant. The warrants carry a five-year term with an exercise price of $1.10 per share. The net proceeds of the offering were $5,289,735. H.C. Wainwright & Co. acted as exclusive placement agent for the offering.2022. We expect the net proceeds from that offering coupled withour existing cash on hand will financeas of December 31, 2022 to be sufficient to fund our operations for theat least twelve month periodmonths from the issuance date of this report.these financial statements.

 

In December 2017, four investors in the October 2017 Public2022 At The Market Offering exercised 218,600 warrants through the payment of an aggregate of $240,460 before expenses to us.

Subsequent to December 31, 2017, sixteen investors that participated in the October 2017 Public Offering exercised 852,700 warrants for aggregate cash proceeds to us of $937,970 before expenses.

Also subsequent to December 31, 2017, we sold common stock under our Common Stock Sales Agreement with H.C. Wainwright (see Note 6)& 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 thosetime to time as set forth in the 2022 ATM Agreement.

The offering was registered under the Securities Act pursuant to our shelf registration statement on 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.

In the nine months ended December 31, 2022, we raised net proceeds of $454,654 (after deducting $14,123$8,927,211, net of $229,610 in commissions to H.C. Wainwright and $1,998$27,153 in other offering expenses) utilizing the sales agreementexpense, through the sale of 340,0007,480,836 shares of our common stock at an average price of $1.34$1.19 per share of net proceeds.under the 2022 ATM Agreement.

  

We will require significant additionalCash Flows

Cash flows from operating, investing and financing beyond the 12 month period subsequent to the filing date of this Form 10-Q to fund the expected additional future clinical trials of our productactivities, as reflected in the U.S.,accompanying Condensed Consolidated Statements of Cash Flows, are summarized as well as fund all of our continued research and development activities for the Hemopurifier. In addition, as we expand our activities, our overhead costs to support personnel, laboratory materials and infrastructure will increase. Should the financing we require to sustain our working capital needs be unavailable to us on reasonable terms, if at all, when we require it, we may be unable to support our research and FDA clearance activities including our planned clinical trials. The failure to implement our research and clearance activities would have a material adverse effect on our ability to commercialize our products and to remain as a going concern.follows:

  (In thousands)
For the nine months ended
 
  December 31,
2022
  December 31,
2021
 
Cash provided by (used in):        
Operating activities $(7,558) $(6,668)
Investing activities  (932)  (137)
Financing activities  8,917   17,379 
Net increase (decrease) in cash and restricted cash $427  $10,574 

 

 

 23 

 

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 $7,558,000 in the nine months ended December 31, 2022, compared to approximately $6,668,000 in the nine months ended December 31, 2021. The primary components in the $890,000 increase in cash used in our operating activities in the 2022 period were a $2,928,000 increase in our net losses, offset by an increase in accounts payable and other current liabilities of $653,271, a decrease of prepaid expenses of $626,483 primarily related to our clinical trials, an increase in non-cash charge of $269,354 from stock-based compensation related to increased headcount, a $142,121 non-cash charge for the loss on dissolution of subsidiary, an increase in deferred revenue of $114,849, a decrease of $110,000 in accounts receivable, and an increase of $63,000 in depreciation and amortization associated with leasehold improvements.

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $932,000 of cash for leasehold improvements and to purchase laboratory and office equipment in the nine months ended December 31, 2022, compared to approximately $137,000 in the nine months ended December 31, 2022. The increase in the 2022 period was primarily a result of leasehold improvements and furnishings for our manufacturing space and purchasing additional laboratory equipment.

NET CASH PROVIDED BY FINANCING ACTIVITIES. During the nine months ended December 31, 2022, we raised approximately $8,927,000 from the issuance of common stock. That source of cash from our financing activities was partially offset by the use of approximately $10,000 to pay for the tax withholding on restricted stock units, for an aggregate amount of cash provided by financing activities of approximately $8,917,000.

During the nine months ended December 31, 2021, we raised approximately $17,456,000 from the issuance of common stock. That source of cash from our financing activities was partially offset by the use of approximately $77,000 to pay for the tax withholding on restricted stock units, for an aggregate amount of cash provided by financing activities of approximately $17,379,000.

Material Cash Requirements

As noted above in the results of operations, our clinical trial expense decreased by $74,894 in the three months ended December 31, 2022, compared to the three-month period ended December 31, 2021. 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.

In addition, we have entered into leases for our corporate headquarters, laboratory and manufacturing facilities. As noted above in the results of operations, our rent expense increased by $122,912 in the nine months ended December 31, 2022, compared to the nine months ended December 31, 2021.

 

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, any continued delays in completing our clinical trials, 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.

  

Management expects existing cash as of December 31, 2017 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these interim financial statements.

 

Cash Flows

24

 

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 nine months ended
 
  December 31,
2017
  December 31,
2016
 
Cash provided by (used in):        
Operating activities $(2,893) $(2,644)
Investing activities  (24)  (3)
Financing activities  6,968   1,060 
Net increase (decrease) in cash $4,051  $(1,587)

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 $2,893,000 in the nine months ended December 31, 2017 compared to $2,644,000 in the nine months ended December 31, 2016, an increase of $249,000.

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $24,000 of cash to purchase laboratory and office equipment in the nine months ended December 31, 2017 compared to approximately $3,000 in the nine months ended December 31, 2016.

NET CASH PROVIDED BY FINANCING ACTIVITIES. In the nine months ended December 31, 2017 we generated approximately $6,968,000 from our financing activities primarily through the issuance of common stock, an increase of $5,908,000 over the $1,060,000 raised in the nine months ended December 31, 2016.

At the date of this filing, we plan to invest significantly into purchases of our raw materials and into our contract manufacturing arrangement subject to successfully raising additional capital.

 

CRITICAL ACCOUNTING POLICIESESTIMATES

Use of Estimates

 

The preparation of condensed 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. SuchThese 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 policiesestimates relate to revenue recognition, measurement of stock purchase warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance and the classification of warrant obligations, and evaluation of contingencies. We believe estimates and assumptions related to these critical accounting policies are appropriate under the circumstances; however, should future events or occurrences result in unanticipated consequences, there could be a material impact on our future financial condition or results of operations.

24

 

There have been no changes to our critical accounting policiesestimates as disclosed in our Form 10-K for the year ended March 31, 2017.2022.

OFF-BALANCE SHEET ARRANGEMENTS

We have no obligations required to be disclosed herein as off-balance sheet arrangements.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

As a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information requested 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.

 

 

 

 

 

 

 

 25 

 

 

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 below under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2022, filed with the SEC on June 28, 2022, or Annual Report, and in this Item 1A below 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, may prevent or delay our ability to manufacture or process 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.

26

Except for the risk factors set forth below, 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 this Quarterly Report on Form 10-Q and 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.

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.

Most of the raw materials used in the process for manufacturing our Hemopurifier are available from more than one supplier. However, there are materials within the manufacturing and production process that come from single suppliers. We do not have written contracts with all of our single source suppliers, and at any time they could stop supplying our orders. FDA review of a new supplier is required if these materials become unavailable from our current suppliers. Currently, we are experiencing an interruption in the manufacturing of our Hemopurifier as we transition to a new supplier of Galanthus nivalis agglutinin, or GNA, used in the manufacture of our Hemopurifier. We have not received the required FDA approval of our proposal to approve a new qualified supplier of the GNA and are working with the FDA to gain approval of this supplier. Although we have recently completed the manufacture of 112 Hemopurifiers, which have passed our quality control measures, we cannot ship the cartridges until we have FDA approval of our new GNA supplier. FDA review of the new supplier could take several additional months to obtain.

In addition, an uncorrected impurity, a supplier’s variation in a raw material or testing, either unknown to us or incompatible with its manufacturing process, or any other problem with our materials, testing or components, would prevent or delay the release of our Hemopurifiers for use in our clinical trials. For example, in late 2020, we identified during our device quality review procedures prior to product release that one of our critical suppliers had produced a Hemopurifier component that was not produced to our specifications, although no affected Hemopurifiers were released into our inventory or to any clinical trial sites. Our current inventory of Hemopurifiers expired on September 30, 2022. Any further delay in achieving the required FDA approvals for our new supplier will limit our ability to meet any demand for the Hemopurifier in the United States. and delay our clinical trials in the United States., which could have a material adverse impact on our business, results of operations and financial condition.

Difficulties in manufacturing our Hemopurifier could have an adverse effect upon our expenses, our product revenues and our ability to complete our clinical trials.

We currently outsource most of the manufacturing of our Hemopurifier. The manufacturing of our Hemopurifier is difficult and complex. To support our current clinical trial needs, we comply with and intend to continue to comply with cGMP in the manufacture of our product. Our ability to adequately manufacture and supply our Hemopurifier in a timely matter is dependent on the uninterrupted and efficient operation of our facilities and those of third parties producing raw materials and supplies upon which we rely in our manufacturing. We currently are experiencing an interruption in our Hemopurifier manufacturing due to delays in obtaining necessary regulatory approval of a new manufacturer of GNA. The manufacture of our products may also be impacted by:

·availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;
·our ability to comply with new regulatory requirements, including our ability to comply with cGMP;
·natural disasters;
·changes in forecasts of future demand for product components;
·potential facility contamination by microorganisms or viruses;
·updating of manufacturing specifications;
·product quality success rates and yields; and
·global viruses and pandemics, including the current COVID-19 pandemic.

The current interruption in the manufacture and supply of our Hemopurifier has and may continue to delay shipments of our Hemopurifier for use in clinical trials in the United States.

27

Our products are manufactured with raw materials that are sourced from specialty suppliers with limited competitors and we may therefore be unable to access the materials we need to manufacture our products.

 

Specifically, the Hemopurifier contains three critical components with limited supplier numbers. The base cartridge on which the Hemopurifier is constructed is sourced from Medica S.p.A and we are dependent on the continued availability of these cartridges. We currently purchase the diatomaceous earth from Janus Scientific Inc., our distributor; however, the product is manufactured by Imerys Minerals Ltd., which is the only supplier of this product. The GNA is sourced from Vector Laboratories, Inc. and also is available from other suppliers; however, Sigma Aldrich is our only back up supplier at this time and we are in the process of working with the FDA to obtain regulatory approval for this supplier. A business interruption at any of these sources, including the interruption resulting from the delay in obtaining FDA approval of our new GNA supplier, has and may continue to have a material impact on our ability to manufacture the Hemopurifier.

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.

Our common stock is listed on the Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly held shares, market value of listed shares, minimum bid price per share (subject to a 180-day grace period, as discussed below), and minimum stockholders' equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements, we may be delisted from the Nasdaq Capital Market.

On October 25, 2022, we received a notice, or Notice, from The Nasdaq Stock Market, or Nasdaq, that we were not in compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(a)(1), or the Minimum Bid Price Requirement. The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), we had 180 days, or until April 24, 2023, to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of our common stock meet or exceed $1.00 per share for at least ten consecutive business days.

If we do not achieve compliance with the Minimum Bid Price Requirement by April 24, 2023, we may be eligible for an additional 180 calendar day period to regain compliance. To qualify, we would be required to meet the continued listing requirement for the market value of its publicly held shares and all other Nasdaq initial listing standards, with the exception of the bid price requirement, and would need to provide written notice of our intention to cure the deficiency during the second compliance period. However, if it appears to Nasdaq staff that we will not be able to cure the deficiency, or if we do not meet the other listing standards, Nasdaq could provide notice that our common stock will be subject to delisting. In the event we receive notice that our common stock is being delisted, we would be entitled to appeal the determination to a Nasdaq Listing Qualifications Panel and request a hearing.

There can be no assurance, however, that we will be able to regain compliance with the Minimum Bid Price Requirement. Even if we do regain compliance, we may not be able to maintain compliance with the continued listing requirements for the Nasdaq Capital Market or our common stock could be delisted in the future. In addition, we may be unable to meet other applicable listing requirements of the Nasdaq Capital Market, including maintaining minimum levels of stockholders’ equity or market values of our common stock in which case, our common stock could be delisted notwithstanding our ability to demonstrate compliance with the Minimum Bid Price Requirement.

Delisting from the Nasdaq Capital Market may adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest in business development opportunities.

28

If we are delisted from Nasdaq and we are not able to list our common stock on another exchange, our common stock could be quoted on the OTC Bulletin Board or in the “pink sheets.” As a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K,result, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information requested by this item.could face significant adverse consequences including, among others:

·a limited availability of market quotations for our securities;
·a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
·a limited amount of news and little or no analyst coverage for us;
·an inability to qualify for exemptions from state securities registration requirements, which may require us to comply with applicable state securities laws; and
·a decreased ability to issue additional securities (including pursuant to registration statements on Form S-3) or obtain additional financing in the future.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

DuringWe did not issue or sell any unregistered securities during the three months ended December 31, 2017, 63,829 RSUs held by our outside directors were exchanged into the same number of shares of our common stock. As one of our three outside directors elected to return 40% of his RSUs in exchange for cash in order to pay his withholding taxes on the share issuances, 10,638 of the RSUs were cancelled and we paid $12,127 in cash to that outside director.2022.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

We have no disclosure applicable to this item.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

We have no disclosure applicable to this item.

 

ITEM 5. OTHER INFORMATION.

 

We have no disclosure applicable to this item.

29

 

ITEM 6. EXHIBITS.

 

(a) Exhibits. The following documents are filed as part of this report:

 

31.1Certification of Principal Executive Officer pursuant to Securities Exchange Act rules 13a- 14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002
31.2Certification of Principal Financial Officer pursuant to Securities Exchange Act rules 13a- 14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002
32.1Certification of Principal Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002
32.2Certification of Principal Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002
101Interactive Data Files
101.INSXBRL Instance Document
101.SCHXBRL Schema Document
101.CALXBRL Calculation Linkbase Document
101.DEFXBRL Definition Linkbase Document
101.LABXBRL Label Linkbase Document
101.PREXBRL Presentation Linkbase Document
      

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 

Executive Employment Agreement, by and between Aethlon Medical, Inc. and Lee Arnold, Ph.D., dated February 1, 2023

         X
             
31.1 Certification of our Chief Executive Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002         X
             
31.2 Certification of our Chief Financial Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002         X
             
32.1 Statement of our Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)         X
             
32.2 Statement of our Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)         X
             
101.INS Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL 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 IXBRL, and included in exhibit 101)          

 

 

 

 2630 

 

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: February 1, 201813, 2023By:/s/ JAMES B. FRAKES 
  JAMES B. FRAKES 
  CHIEF FINANCIAL OFFICER 
  CHIEF ACCOUNTING OFFICER 

 

 

 

 

 

 

 


 

 

 2731