Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

x     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 20192020

 

OR

 

o     TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _____to_____

 

COMMISSION FILE NUMBER 001-37487

 

AETHLON MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

NEVADA 13-3632859
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)

 

9635 GRANITE RIDGE DRIVE, SUITE 100, SAN DIEGO, CA 92123

(Address of principal executive offices)    (Zipoffices, including Zip Code)

 

(858) 459-7800

(Registrant'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. YES ☒ NO ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES   ☒ NO  ☐

 

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

 

Large accelerated filer ☐Accelerated filer ☐
Non-accelerated filer ☐Smaller reporting company ☒
 Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒

 

As of October 31, 2019,27, 2020, the registrant had outstanding 1,441,27512,088,313 shares of common stock, $0.001 par value.

  

 

 

   

 

 

TABLE OF CONTENTS

 

PART I.FINANCIAL INFORMATION3
   
ITEM 1.FINANCIAL STATEMENTS3
   
 CONDENSED CONSOLIDATED BALANCE SHEETS AT SEPTEMBER 30, 20192020 (UNAUDITED) AND MARCH 31, 201920203
   
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE AND SIX MONTH PERIODSMONTHS ENDED SEPTEMBER 30, 2020 AND 2019 AND 2018 (UNAUDITED)4
   
 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND SIX MONTHS ENDED SEPTEMBER 30, 2020 AND 2019 AND 2018 (UNAUDITED)5
   
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED SEPTEMBER 30, 2020 AND 2019 AND 2018 (UNAUDITED)67
   
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)78
   
ITEM 2.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS2120
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK3230
   
ITEM 4.CONTROLS AND PROCEDURES3230
   
PART II.OTHER INFORMATION3331
   
ITEM 1.LEGAL PROCEEDINGS3331
   
ITEM 1A.RISK FACTORS3331
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS3431
  ��
ITEM 3.DEFAULTS UPON SENIOR SECURITIES3431
   
ITEM 4.MINE SAFETY DISCLOSURES3431
   
ITEM 5.OTHER INFORMATION3431
   
ITEM 6.EXHIBITS3532

 

 

 

 

 2 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

  September 30,
2019
  March 31,
2019
 
   (Unaudited)     
ASSETS        
Current assets        
Cash $785,658  $3,828,074 
Prepaid expenses and other current assets  114,036   210,042 
Total current assets  899,694   4,038,116 
         
Property and equipment, net  124,833   6,021 
Right-of-use lease asset  183,018    
Patents, net  62,086   66,668 
Deposits  12,159   12,159 
Total assets $1,281,790  $4,122,964 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $586,960  $131,931 
Due to related parties  101,462   83,654 
Convertible notes payable, net     962,301 
Deferred revenue  100,000    
Lease liability, current portion  94,885    
Other current liabilities  285,211   646,000 
Total current liabilities  1,168,518   1,823,886 
         
Lease liability, less current portion  92,600    
Total liabilities  1,261,118   1,823,886 
         
Commitments and Contingencies (Note 13)        
         
Stockholders’ Equity        
Common stock, par value $0.001 per share; 30,000,000 shares authorized; 1,337,259 and 1,266,979 shares issued and outstanding as of September 30, 2019 and March 31, 2019, respectively  1,338   1,267 
Additional paid-in capital  109,571,708   108,076,275 
Accumulated deficit  (109,423,894)  (105,652,433)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  149,152   2,425,109 
         
Noncontrolling interests  (128,480)  (126,031)
         
Total stockholders’ equity  20,672   2,299,078 
         
Total liabilities and stockholders’ equity $1,281,790  $4,122,964 

  September 30,
2020
  March 31,
2020
 
   (Unaudited)     
ASSETS        
Current assets        
Cash $14,473,232  $9,604,780 
Accounts receivable  111,849   206,729 
Prepaid expenses and other current assets  167,178   229,604 
Total current assets  14,752,259   10,041,113 
         
Property and equipment, net  145,855   140,484 
Right-of-use lease asset  88,888   136,426 
Patents, net  57,229   57,504 
Deposits  12,159   12,159 
Total assets $15,056,390  $10,387,686 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $311,724  $285,036 
Due to related parties  156,909   111,707 
Deferred revenue  507,022   100,000 
Lease liability, current portion  92,603   98,557 
Other current liabilities  421,502   472,420 
Total current liabilities  1,489,760   1,067,720 
         
Lease liability, less current portion     42,540 
Total liabilities  1,489,760   1,110,260 
         
Commitments and Contingencies (Note 13)        
         
Stockholders’ Equity        
Common stock, par value $0.001 per share; 30,000,000 shares authorized; 12,088,313 and 9,366,873 shares issued and outstanding as of September 30, 2020 and March 31, 2020, respectively  12,089   9,368 
Additional paid-in capital  128,895,581   121,426,563 
Accumulated deficit  (115,207,228)  (112,026,381)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  13,700,442   9,409,550 
         
Noncontrolling interests  (133,812)  (132,124)
         
Total stockholders’ equity  13,566,630   9,277,426 
         
Total liabilities and stockholders’ equity $15,056,390  $10,387,686 

 

See accompanying notes.

 

 

 

 3 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Six Month Periods Ended September 30, 20192020 and 20182019

(Unaudited)

 

 

  Three Months
Ended
September 30,
2019
  Three Months
Ended
September 30,
2018
  Six Months
Ended
September 30,
2019
  Six Months
Ended
September 30,
2018
 
             
REVENUES                
                 
Government contract revenue $  $  $30,000  $149,625 
                 
OPERATING EXPENSES                
                 
Professional fees  762,337   403,044   1,369,915   852,479 
Payroll and related expenses  597,526   672,279   1,203,521   1,274,844 
General and administrative  342,339   271,631   724,955   466,528 
Total operating expenses  1,702,202   1,346,954   3,298,391   2,593,851 
OPERATING LOSS  (1,702,202)  (1,346,954)  (3,268,391)  (2,444,226)
                 
OTHER EXPENSE                
Interest and other debt expenses  21   55,106   54,106   110,210 
Loss on share for warrant exchanges  4,403      4,403    
Loss on debt extinguishment        447,011    
Total other expense  4,424   55,106   505,520   110,210 
NET LOSS  (1,706,626)  (1,402,060)  (3,773,911)  (2,554,436)
                 
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS  (1,589)  (8,715)  (2,450)  (14,864)
                 
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. $(1,705,037) $(1,393,345) $(3,771,461) $(2,539,572)
                 
BASIC AND DILUTED LOSS PER COMMON SHARE $(1.29) $(1.17) $(2.91) $(2.14)
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED  1,317,418   1,185,949   1,294,206   1,184,795 

  Three Months
Ended
September 30,
2020
  Three Months
Ended
September 30,
2019
  Six Months
Ended
September 30,
2020
  Six Months
Ended
September 30,
2019
 
             
REVENUES                
                 
Government contract revenue $  $  $  $30,000 
                 
OPERATING EXPENSES                
                 
Professional fees  656,396   762,337   1,220,680   1,369,915 
Payroll and related expenses  560,244   597,526   997,155   1,203,521 
General and administrative  554,749   342,339   963,972   724,955 
Total operating expenses  1,771,389   1,702,202   3,181,807   3,298,391 
OPERATING LOSS  (1,771,389)  (1,702,202)  (3,181,807)  (3,268,391)
                 
OTHER EXPENSE                
Interest and other debt expenses     21   728   54,106 
Loss on share for warrant exchanges     4,403      4,403 
Loss on debt extinguishment           447,011 
Total other expense     4,424   728   505,520 
NET LOSS  (1,771,389)  (1,706,626)  (3,182,535)  (3,773,911)
                 
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS  (825)  (1,589)  (1,688)  (2,450)
                 
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. $(1,770,564) $(1,705,037) $(3,180,847) $(3,771,461)
                 
BASIC AND DILUTED LOSS PER COMMON SHARE $(0.15) $(1.29) $(0.29) $(2.91)
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED  12,070,592   1,317,418   10,845,049   1,294,206 

 

See accompanying notes.

 

 

 

 4 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the Three and Six Months Ended September 30, 20192020 and 20182019

(Unaudited)

 

 ATTRIBUTABLE TO AETHLON MEDICAL, INC.      ATTRIBUTABLE TO AETHLON MEDICAL, INC.     
 COMMON STOCK ADDITIONAL PAID IN ACCUMULATED NON-
CONTROLLING
 TOTAL  COMMON STOCK ADDITIONAL PAID IN ACCUMULATED NON-
CONTROLLING
 TOTAL 
 SHARES AMOUNT CAPITAL DEFICIT INTERESTS EQUITY  SHARES AMOUNT CAPITAL DEFICIT INTERESTS EQUITY 
                                     
BALANCE - MARCH 31, 2019  1,266,979  $1,267  $108,076,275  $(105,652,433) $(126,031) $2,299,078 
BALANCE - MARCH 31, 2020  9,366,873  $9,368  $121,426,563  $(112,026,381) $(132,124) $9,277,426 
                                                
Issuances of common stock for cash under at the market program  3,087   3   36,619         36,622   2,685,600   2,686   7,258,183         7,260,869 
                        
Loss on debt extinguishment        447,011         447,011 
                                                
Issuance of common shares upon vesting of restricted stock units  3,539   4   (23,775)        (23,771)  17,920   18   (24,269)        (24,251)
                                                
Stock-based compensation expense        326,536         326,536         84,207         84,207 
                                                
Net loss           (2,066,424)  (860)  (2,067,284)           (1,410,283)  (863)  (1,411,146)
                                                
BALANCE - JUNE 30, 2019  1,273,605  $1,274  $108,862,666  $(107,718,857) (126,891) $1,018,192 
                        
Issuances of common stock for cash under the market program  59,340   60   386,552         386,612 
                        
Issuance of common shares upon vesting of restricted stock units  3,236   3   (8,448)        (8,445)
                        
Issuances of common stock upon warrant exchanges  1,078   1   4,402         4,403 
                        
Stock-based compensation expense        326,536         326,536 
                        
Net loss           (1,705,037)  (1,589)  (1,706,626)
                        
BALANCE - SEPTEMBER 30, 2019  1,337,259  $1,338  $109,571,708  $(109,423,894) $(128,480) $20,672 
                        
                        
BALANCE - MARCH 31, 2018  1,182,634  $1,183  $105,590,571  $(99,457,714) $(101,246) $6,032,794 
BALANCE - JUNE 30, 2020  12,070,393  $12,072  $128,744,684  $(113,436,664) $(132,987) $15,187,105 
                                                
Issuance of common shares upon vesting of restricted stock units  1,446   1   (32,738)        (32,737) 17,920 17 (16,145)   (16,128)
                                     
Stock-based compensation expense        263,162         263,162        167,042       167,042 
                                            
Net loss           (1,146,228)  (6,148)  (1,152,376)           (1,770,564)  (825)  (1,771,389)
                                     
BALANCE - JUNE 30, 2018  1,184,080  $1,184  $105,820,995  $(100,603,942) $(107,394) $5,110,843 
                        
Issuance of common shares upon vesting of restricted stock units  3,897   4   (53,036)        (53,032)
                        
Common stock issued for services  1,000   1   19,349         19,350 
                        
Stock-based compensation expense        336,496         336,496 
                        
Net loss           (1,393,345)  (8,715)  (1,402,060)
                        
BALANCE - SEPTEMBER 30, 2018  1,188,977  $1,189  $106,123,804  $(101,997,287) $(116,109) $4,011,597 
BALANCE - SEPTEMBER 30, 2020 12,088,313 $12,089 $128,895,581 $(115,207,228) $(133,812) $13,566,630 

Continued on following page

 

 


5

  ATTRIBUTABLE TO AETHLON MEDICAL, INC.       
  COMMON STOCK  ADDITIONAL PAID IN  ACCUMULATED  NON-
CONTROLLING
  TOTAL 
  SHARES  AMOUNT  CAPITAL  DEFICIT  INTERESTS  EQUITY 
BALANCE - MARCH 31, 2019  1,266,979  $1,267  $108,076,275  $(105,652,433) $(126,031) $2,299,078 
                         
Issuances of common stock for cash under at the market program  3,087   3   36,619         36,622 
                         
Loss on debt extinguishment        447,011         447,011 
                         
Issuance of common shares upon vesting of restricted stock units  3,539   4   (23,775)        (23,771)
                         
Stock-based compensation expense        326,536         326,536 
                         
Net loss           (2,066,424)  (860)  (2,067,284)
                         
BALANCE - JUNE 30, 2019  1,273,605  $1,274  $108,862,666  $(107,718,857) $(126,891) $1,018,192 
                         
Issuances of common stock for cash under at the market program  59,340   60   386,552         386,612 
                         
Issuance of common shares upon vesting of restricted stock units  3,236   3   (8,448)        (8,445)
                         
Issuance of common shares upon warrant exchanges  1,078   1   4,402   --   --   4,403 
                         
Stock-based compensation expense        326,536         326,536 
                         
Net loss           (1,705,037)  (1,589)  (1,706,626)
                         
BALANCE - SEPTEMBER 30, 2019  1,337,259  $1,338  $109,571,708  $(109,423,894) $(128,480) $20,672 

See accompanying notes.

 

 

 

 56 

 


AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Six Months Ended September 30, 20192020 and 20182019

(Unaudited)

 

  Six Months
Ended
September 30, 2019
  Six Months
Ended
September 30, 2018
 
         
Cash flows used in operating activities:        
Net loss $(3,773,911) $(2,554,436)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  5,751   16,040 
Stock based compensation  653,072   599,658 
Loss on debt extinguishment  447,011    
Loss on share for warrant exchanges  4,403    
Amortization of debt discount  30,287   60,574 
Common stock issued for services     19,350 
Noncash lease expense  45,676    
Changes in operating assets and liabilities:        
Accounts receivable     74,813 
Prepaid expenses and other current assets  96,006   93,163 
Accounts payable and other current liabilities  97,947   (127,358)
Change in lease liability  (44,916)   
Deferred revenue  100,000    
Due to related parties  17,808   8,500 
Net cash used in operating activities  (2,320,866)  (1,809,696)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (119,981)   
Net cash used in investing activities  (119,981)   
         
Cash flows (used in) provided by financing activities:        
Proceeds from the issuance of common stock, net  423,234    
Principal payments on convertible notes  (992,591)   
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units  (32,212)  (85,769)
Net cash used in financing activities  (601,569)  (85,769)
         
Net decrease in cash  (3,042,416)  (1,895,465)
         
Cash at beginning of period  3,828,074   6,974,070 
         
Cash at end of period $785,658  $5,078,605 
         
Supplemental disclosures of cash flow information:        
         
Cash paid during the period for:        
         
Interest $83,332  $95,388 
         
Supplemental disclosures of non-cash investing and financing activities:        
Initial recognition of right-of-use lease asset and lease liability $228,694  $ 
Par value of shares issued for vested restricted stock units $7  $4 

  Six Months
Ended
September 30, 2020
  Six Months
Ended
September 30, 2019
 
       
Cash flows used in operating activities:        
Net loss $(3,182,535) $(3,773,911)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  18,041   5,751 
Stock based compensation  251,249   653,072 
Loss on debt extinguishment     447,011 
Loss on share for warrant exchanges     4,403 
Accretion of right-of-use lease asset  (956)  760 
Amortization of debt discount     30,287 
Changes in operating assets and liabilities:        
Accounts receivable  94,880    
Prepaid expenses and other current assets  62,426   96,006 
Accounts payable and other current liabilities  (24,230)  97,947 
Deferred revenue  407,022   100,000 
Due to related parties  45,202   17,808 
Net cash used in operating activities  (2,328,901)  (2,320,866)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (23,137)  (119,981)
Net cash used in investing activities  (23,137)  (119,981)
         
Cash flows provided by (used in) financing activities:        
Proceeds from the issuance of common stock, net  7,260,869   423,234 
Principal payments on convertible notes     (992,591)
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units  (40,379)  (32,212)
Net cash provided by (used in) financing activities  7,220,490   (601,569)
         
Net increase (decrease) in cash  4,868,452   (3,042,416)
         
Cash at beginning of period  9,604,780   3,828,074 
         
Cash at end of period $14,473,232  $785,658 
         
Supplemental disclosures of cash flow information:        
         
Cash paid during the period for:        
         
Interest $  $83,332 
         
Supplemental disclosures of non-cash investing and financing activities:        
Initial recognition of right-of-use lease asset and lease liability $  $228,694 
Par value of shares issued for vested restricted stock units $35  $7 

 

See accompanying notes.

 

 

 

 67 

 


AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

September 30, 2019

2020

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

ORGANIZATION

 

Aethlon Medical, Inc. and its subsidiary (collectively, “Aethlon”, the “Company”, “we” or “us”), is a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases. The Aethlon Hemopurifier®, or Hemopurifier, is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier depletesis designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:

 

·the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and

·the treatment of life-threatening viruses that are not addressed with approved therapies.

 

We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. We are initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. As we advance our clinical trials, we are in close contact with our clinical sites to navigate and assess the impact of the COVID-19 global pandemic on our clinical trials and current timelines.

 

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) (NCT # 04453046).  The primary endpoint for the EFS, which willis designed to enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approvalThis study, which will be conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, has been approved by the Institutional Review Board, or IRB, and is subject to FDA approval of Informed Consent documents from the trial site.now open for patient enrollment.

 

We also believe the Hemopurifier can be a part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C,Hepatitis C, and Ebola.

Additionally,in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes.

On June 17, 2020, the FDA approved a supplement to the Company’s open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a New Feasibility Study. That study’s plan is to enroll up to 40 subjects at up to 20 centers in the U.S. 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, will include reduction in circulating virus as well as clinical outcomes (NCT # 04595903). The first sites for this trial, Hoag Memorial Hospital Presbyterian in Newport Beach, CA and Hoag Hospital – Irvine in Irvine, CA now have IRB approval and are preparing to open for patient enrollment. Under Single Patient Emergency Use regulations, the Company has also recently treated a patient with COVID-19 who successfully completed eight daily treatments with the Hemopurifier.

8

 

We are also the majority owner of Exosome Sciences, Inc., or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s activities is the advancement of a TauSome™ biomarker candidate to diagnose chronic traumatic encephalopathy, or CTE, in the living. ESI previously documented TauSome levels in former NFL players to be nine times higher than same age-group control subjects. Through ESI, we are also developing exosome based biomarkers in patients with, or at risk for, a number of cancers. We consolidate ESI’s activities in our consolidated financial statements.

 

7

We also recently announced the execution of a cross-licensing and development agreement with SeaStar Medical, Inc., which will be focused on co-development of our Hemopurifier cartridge with SeaStar’s proprietary cartridges and the development of a closed system for the Hemopurifier using the SeaStar pump and cassettes. This collaboration may allow the deployment of the Hemopurifier into settings that lack dialysis infrastructure, such as chemotherapy infusion centers and field operations for life threatening viral epidemics.

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued 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 on our business and have taken steps designed to protect the health and safety of our employees while continuing our operations. Given the level of uncertainty regarding the duration and impact of the COVID-19 pandemic on capital markets and the U.S. economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and the resulting COVID-19 pandemic on our timelines and future access to capital. We are continuing to monitor the spread of COVID-19 and its potential impact on our operations. The full extent to which the COVID-19 pandemic will impact our business, results of operations, financial condition, clinical trials, and preclinical research will depend on future developments that are highly uncertain, including actions taken to contain or treat COVID-19 and their effectiveness, as well as the economic impact on national and international markets.  

Our executive offices are located at 9635 Granite Ridge Drive, Suite 100, San Diego, California 92123. Our telephone number is (858) 459-7800. Our website address is www.aethlonmedical.com.

 

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

 

REVERSE STOCK SPLIT

 

OnFollowing the approval of a reverse stock split at our 2019 Annual Meeting of Stockholders’ held on October 14, 2019, the Company completedour Board of Directors approved a 1-for-15 reverse stock split. Accordingly, 15 shares of outstanding common stock then held by stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock remained at 30,000,000 shares (see Note 14). The accompanying unaudited condensed consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2018.2019. All shares and per share amounts have been revised accordingly.

 

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

During the six months ended September 30, 2019,2020, 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, 2019 except as described below.

Leases

At lease commencement, the Company records a lease liability based on the present value of lease payments over the expected lease term. The Company calculates the present value of lease payments using the discount rate implicit in the lease, unless that rate cannot be readily determined. In that case, the Company uses its incremental borrowing rate, which is the rate of interest that the Company would have to pay to borrow on a collateralized basis an amount equal to the lease payments over the expected lease term. The Company records a corresponding right-of-use lease asset based on the lease liability, adjusted for any lease incentives received and any initial direct costs paid to the lessor prior to the lease commencement date.

After lease commencement, the Company measures its leases as follows: (i) the lease liability based on the present value of the remaining lease payments using the discount rate determined at lease commencement; and (ii) the right-of-use lease asset based on the remeasured lease liability, adjusted for any unamortized lease incentives received, any unamortized initial direct costs and the cumulative difference between rent expense and amounts paid under the lease agreement. Rent expense is recorded on a straight-line basis over the expected lease term (See Note 4).2020.

 

 

 

 89 

 

 

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, 2019,2020, included in the Company's Annual Report on Form 10-K filed with the SEC on July 1, 2019.June 25, 2020. The accompanying unaudited condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its majority-owned subsidiary. All significant inter-company transactions and balances have been eliminated in consolidation. The unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated financial statements as of and for the three and six months ended September 30, 2019,2020, and the condensed consolidated statement of cash flows for the six months ended September 30, 2019.2020. Estimates were made relating to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial and research and development expenses. Actual results could differ materially from those estimates. The accompanying condensed consolidated balance sheet at March 31, 20192020 has been derived from the audited consolidated balance sheet at March 31, 2019,2020, contained in the above referenced 10-K. The results of operations for the three and six months ended September 30, 20192020 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

  

Reclassifications

 

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

 

LIQUIDITY AND GOING CONCERN

 

The accompanying condensed consolidated financial statements have been prepared assuming that we will continueManagement expects existing cash as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations and at September 30, 2019 had an accumulated deficit of approximately $109,424,000. These factors, among other matters, raise substantial doubt about our ability2020 to continue as a going concern for the twelve months from the issuance of these financial statements. A significant amount of additional capital will be necessary to advance the development of our products to the point at which they may become commercially viable. We intendsufficient to fund the Company’s operations working capital and other cash requirements throughfor at least twelve months from the issuance date of these condensed consolidated financial statements through equity and/or debt financing arrangements as well as through revenues and related cash receipts under our government contracts (see Note 11).statements.

Significant additional financing must be obtained in order to provide a sufficient source of operating capital and to allow us to continue to operate as a going concern and to meet our liquidity needs for a twelve month period from the date of this filing. In addition, we will need to raise capital to complete anticipated future human clinical trials in the U.S. We anticipate the primary sources of this additional financing will be from proceeds of our at-the-market offering program, pursuant to our Form S-3 Registration Statement, debt financing and other forms of equity placements. However, no assurance can be given that we will receive any funds in addition to the funds we have received to date.

The successful outcome of future activities cannot be determined at this time and there is no assurance that, if achieved, we will have sufficient funds to execute our intended business plan or generate positive operating results.

The unaudited condensed consolidated financial statements do not include any adjustments related to this uncertainty and as to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.

9

  

2. LOSS PER COMMON SHARE

 

Basic loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period of computation. The weighted average number of common shares outstanding for the three and six months ended September 30, 2019 and 2018 included common shares underlying 2,857 and 3,075 vested restricted stock units, respectively. Diluted loss per share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional dilutive common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded, as their effect would be antidilutive.

 

As of September 30, 20192020 and 2018,2019, an aggregate of 386,2202,620,567 and 437,113386,220 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants and unvested restricted stock units, and convertible notes payable, were excluded, as their inclusion would be antidilutive.

  

3. RESEARCH AND DEVELOPMENT EXPENSES

 

Our research and development costs are expensed as incurred. We incurred research and development expenses during the three and six month periods ended September 30, 20192020 and 2018,2019, 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:

 

  September 30,  September 30, 
  2019  2018 
Three months ended $222,857  $178,800 
Six months ended $470,882  $402,566 

4.Recent Accounting Pronouncements

The Company adopted ASU Topic 842 on April 1, 2019 utilizing the alternative transition method allowed for under this guidance. As a result, the Company recorded lease liabilities and right-of-use lease assets of $228,694 on its balance sheet as of April 1, 2019. The lease liabilities represent the present value of the remaining lease payments of the Company’s corporate headquarters lease (see Note 13), discounted using the Company’s incremental borrowing rate as of April 1, 2019. The corresponding right-of-use lease assets are recorded based on the lease liabilities and the cumulative difference between rent expense and amounts paid under its corporate headquarters lease. The Company also elected the short-term lease recognition exemption for its laboratory lease. For the laboratory lease that qualified as short-term, the Company did not recognize ROU assets or lease liabilities at adoption. The adoption of ASU 2016-02 did not have a material impact on either the statement of operations or statement of cash flows for the six months ended September 30, 2019.

Topic 842 also allows lessees and lessors to elect certain practical expedients. The Company elected the following practical expedients:

·Transitional practical expedients, which must be elected as a package and applied consistently to all of the Company’s leases:

°The Company need not reassess whether any expired or existing contracts are or contain leases.
°The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases).
°The Company need not reassess initial direct costs for any existing leases.

·Hindsight practical expedient. The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets.
   September 30,  September 30, 
   2020  2019 
Three months ended  $508,897  $222,857 
Six months ended  $884,985  $470,882 

 

 

 

 10 

 

4. Recent Accounting Pronouncements

We do not expect the adoption of any recent accounting pronouncement to have a material impact on our financial statements.

 

5. CONVERTIBLE NOTES PAYABLE, NET

 

In July 2019, we paid offall of our Convertible Notes Payable. We paid the remaining principal balance of $892,591 and accrued interest of $11,352. As a result, we did not incur any interest expense related to the Convertible Notespreviously outstanding convertible notes, in the three months ended September 30, 2019.aggregate amount of $992,591, were paid in full.

 

For the six months ended September 30, 2019, we recorded interest expense of $23,759 related to the contractual interest rates of our convertible notes and interest expense of $30,287 related to the amortization of the note discount for a total interest expense of $54,046 related to our convertible notes.

 

Convertible Notes Payable, Net consisted of the following at March 31, 2019:

  Principal  Unamortized
Discount
  Net
Amount
  Accrued
Interest
 
Convertible Notes Payable, Net:                
November 2014 10% Convertible Notes (due July 1, 2019) $612,811  $(18,701) $594,110  $37,309 
December 2016 10% Convertible Notes (due July 1, 2019)  379,780   (11,589)  368,191   22,264 
Total Convertible Notes Payable, Net $992,591  $(30,290) $962,301  $59,573 

During the six months ended September 30, 2018,2019, prior to paying off the notes, we reduced the conversion price on the convertible notes from $45.00 per share to $10.20 per share. The modification of the convertible 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 interest expensea loss on debt extinguishment of $49,630 related to the contractual interest rates of our convertible notes and interest expense of $60,574 related to the amortization of the note discount for a total interest expense of $110,204 related to our convertible notes in the six months ended September 30, 2018. All of the unamortized discount at September 30, 2018 related to the note discount established upon the June 2017 amendment to the November 2014 10% Convertible Notes and to the December 2016 10% Convertible Notes.$447,011.

 

6. EQUITY TRANSACTIONS IN THE SIX MONTHS ENDED SEPTEMBER 30, 20192020

 

Common Stock Sales Agreement with H.C. Wainwright & Co., LLC

 

On June 28, 2016, we entered into a Common Stock Sales Agreement, or the Agreement, with H.C. Wainwright & Co., LLC, or H.C. Wainwright, which established an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the Agreement. The Agreement providesprovided for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000, or the Shares.$12,500,000.

 

On August 6, 2019,March 30, 2020, we executed Amendment No. 12 to the Agreement with H.C. Wainwright, effective as of August 5, 2019.the same date. The amendment provides that references in the Agreement to the registration statement shall refer to the registration statement on Form S-3 (File No. 333-231397)333-237269), originally filed with the Securities and Exchange CommissionSEC on May 10, 2019,March 19, 2020, declared effective by the Securities and Exchange CommissionSEC on August 1, 2019.March 30, 2020.

 

Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Sharesshares under the Agreement from time to time, based upon our instructions. We have provided H.C. Wainwright with customary indemnification rights under the Agreement, and H.C. Wainwright is entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Shareshare sold. In addition, we agreed to pay certain expenses incurred by H.C. Wainwright in connection with the Agreement, including up to $50,000 of the fees and disbursements of their counsel. The Agreement will terminate upon the sale of all of the Sharesshares under the Agreement, unless terminated earlier by either party as permitted under the Agreement.

 

 

 

 11 

 

 

Sales of the Shares,shares, if any, under the Agreement will be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell any of the Shares,shares, and, at any time, we may suspend offers under the Agreement or terminate the Agreement.

  

In the sixthree months ended SeptemberJune 30, 2019,2020, we raised aggregate net proceeds of $423,234 (net$7,260,869, net of $13,213$224,825 in commissions to H.C. Wainwright and $3,997$8,472 in other offering expenses)expenses, under thisthe Agreement, through the sale of 62,4272,685,600 shares at an average price of $6.78$2.70 per share of net proceeds.

  

Restricted Stock Unit Grants

 

OurIn 2012, as amended through July 16, 2020, our Board of Directors established the 2012 Non-Employee Directors Compensation Program, to provide for cash and equity compensation for persons serving as amended through August 2016, or the Non-Employee Directors Plan, pursuant to which, in addition to cash compensation,non-employee directors of the Company who are not also employees may be granted stock-based compensation in the formCompany. Under this program, each new director receives either stock options or a grant of restricted stock units, or RSU’s.RSUs, as well as an annual grant of RSUs at the beginning of each fiscal year. The RSUs are subject to vesting and represent the right to be issued on a future date shares of our common stock for RSUs which have then vested.upon vesting.

 

InOn April 2019,3, 2020, pursuant to the terms of the Company’s Non-Employee Directors Plan, we issuedCompensation Program, the Compensation Committee of the Board of Directors granted RSUs to each non-employee director of the Company. The Non-Employee Directors Compensation Program provided for a grant of RSUs with a grant date fair value of $35,000, priced at the average of the closing prices for the five trading days ending on the date of grant, which was $1.41 per share, so that the total number of RSUs to be granted to each of our non-employee directors, as the stock-based compensation element of their overall directors’ compensation,director for the fiscal year ending March 31, 2020. Those grants were based on the closing price of our common stock on the one business day prior to the grant date, $14.25 per share. Therefore, 2,456 RSUs were issued to each of our five non-employee directors, for a total of 12,280 RSUs. All of the RSUs are subject to vesting in equal quarterly installments on June 30, 2019, September 30, 2019, December 31, 2019 and March 31, 2020.

In April 2019, 2,859 vested RSUs held by our current and former executive officers were exchanged for the same number of2020 would be 24,822 shares of our common stock.  As these executives electedOn April 3, 2020, each eligible director was granted an RSU for 23,893 shares under the Company’s 2010 Stock Plan, or the 2010 Plan, as the number of shares that remained available for grant under the 2010 Plan was not sufficient for each director’s full RSU grant. The Compensation Committee also granted to net settleeach eligible director a contingent grant under our 2020 Equity Incentive Plan, or the 2020 Plan, for the remaining portion of their vested RSUs in exchange for the Company paying the related withholding taxes of $18,318 on the share issuance, 1,512annual RSU grants, or 929 RSU’s to each eligible director, contingent upon stockholder approval of the vested2020 Plan at the Company’s 2020 Annual Meeting of Stockholders, or the Annual Meeting. These grants are subject to vesting as follows: 50% of the RSUs were cancelled and we issued a net 1,347 sharessubject to the executivesgrants will vest on December 31, 2020 and former executive.50% of the RSUs will vest on March 31, 2021, subject in each case to the continuous service of each director, through such vesting dates, as well as approval of the 2020 Plan by the stockholders at the Annual Meeting, which was obtained at the Annual Meeting.

 

In June 2019, 3,0752020, 29,866 vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock. Four of ourAll five non-employee directors elected to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 98411,947 of the vested RSUs being cancelled in exchange for $5,453$24,251 in aggregate cash proceeds to those independent directors.

 

In July 2019, 2,861 vested RSUs held by our current and former executive officers were exchanged for the same number of shares of our common stock. As these executives elected to net settle a portion of their vested RSUs in exchange for the Company paying the related withholding taxes of $4,979 on the share issuance, 1,510 of the vested RSUs were cancelled and we issued a net 1,351 shares to the executives and former executive.

In September 2019, 3,0752020, 29,866 vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock. Four of ourAll five non-employee directors elected to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 98411,947 of the vested RSUs being cancelled in exchange for $3,463$16,128 in aggregate cash proceeds to those independent directors.

 

Also in September 2020, our stockholders approved the 2020 Plan at the Annual Meeting, at which point the grants of 929 RSUs to each of our eligible independent directors for a total of 4,645 RSUs were considered effective and no longer contingent as of that date (See Note 9).

12

 

RSUs outstanding that have vested as of, and are expected to vest subsequent to, September 30, 20192020 are as follows:

 

  Number of RSUs 
Vested  2,857 
Expected to vest  8,99764,378 
Total  11,85464,378 

 

Common Stock for Warrant Cancellation

 

During the six months ended September 30, 2019, we agreed with five accredited investors to issue 1,078 shares of our common stock to these investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase 10,759 shares of our common stock. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded a loss of $4,403 on those exchanges based on the changes in fair value between the instruments exchanged.

12

 

7. RELATED PARTY TRANSACTIONS

 

During the three months ended September 30, 2019,2020, we accrued unpaid fees of $69,750$86,375 owed to our non-employee directors as of September 30, 2019. For the six months ended September 30, 2019, we recorded $139,500 in fees to our non-employee directors.

2020. Amounts due to related parties were comprised of the following items:

 

 September 30, 2019 March 31, 2019  

September 30,

2020

 

March 31,

2020

 
Accrued Board fees $69,750  $69,750  $86,375  $69,750 
Accrued vacation to all employees  31,712   13,904   70,534   41,957 
Total due to related parties $101,462  $83,654  $156,909  $111,707 

 

8. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

 

  September 30,  March 31, 
  2019  2019 
Accrued interest $  $59,573 
Accrued separation expenses for former executives  109,930   355,189 
Accrued professional fees  175,281   231,238 
Total other current liabilities $285,211  $646,000 

13

  September 30,  March 31, 
  2020  2020 
Accrued professional fees $421,502  $472,420 
Total other current liabilities $421,502  $472,420 

 

9. STOCK COMPENSATION

 

The following tables summarize share-based compensation expenses relating to RSUs and stock options and the effect on basic and diluted loss per common share during the three and six month periods ended September 30, 20192020 and 2018:2019:

 

 Three Months
Ended
September 30,
2019
 Three Months
Ended
September 30,
2018
 Six Months
Ended
September 30,
2019
 Six Months
Ended
September 30,
2018
  Three Months
Ended
September 30,
2020
 Three Months
Ended
September 30,
2019
 Six Months
Ended
September 30,
2020
 Six Months
Ended
September 30,
2019
 
Vesting of stock options and restricted stock units $326,536  $336,496  $653,072  $599,658  $167,042  $326,536  $251,249  $653,072 
Total stock-based compensation expense $326,536  $336,496  $653,072  $599,658  $167,042  $326,536  $251,249  $653,072 
                                
Weighted average number of common shares outstanding – basic and diluted  1,317,418   1,185,949   1,294,206   1,184,795   12,070,592   1,317,418   10,845,049   1,294,206 
                                
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.25) $(0.28) $(0.50) $(0.51) $(0.01) $(0.25) $(0.02) $(0.50)

13

 

All of the stock-based compensation expense recorded during the six months ended September 30, 20192020 and 2018,2019, which totaled $653,072$251,249 and $599,658,$653,072, respectively, is included in payroll and related expense in the accompanying condensed consolidated statements of operations.  Stock-based compensation expense recorded during the six months ended September 30, 20192020 and 20182019 represented an impact on basic and diluted loss per common share of $(0.50)$(0.02) and $(0.51)$(0.50), respectively.

 

We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the six months ended September 30, 20192020 was insignificant.

 

Stock Option Activity and Approval of 2020 Plan

From February 2020 through May 2020, our compensation committee granted 521,476 stock options that were contingent upon stockholder approval of the 2020 Plan. Upon approval of the 2020 Plan at the Annual Meeting, these option grants were considered effective and no longer contingent as of that date.

The 2020 Plan approved by our stockholders at the Annual Meeting, authorizes up to 1,842,556 shares for issuance under stock option grants, RSUs or other forms of stock-based compensation. No future grants will be made under the 2010 Plan.

 

We did not issue any stock options during the sixthree months ended September 30, 2019 and September 30, 2018.2019.

 

Options outstanding that have vested as of September 30, 2020 and options that are expected to vest as ofsubsequent to September 30, 20192020 are as follows:

 

  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested  13,684  $113.27   3.21 
Expected to vest  37,440  $18.85   8.24 
Total  51,124         

14

  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested  26,865  $44.83   5.62 
Expected to vest  521,476  $2.18   9.42 
Total  548,341         

   

A summary of stock option activity during the six months ended September 30, 20192020 is presented below:

 

  Amount  Range of
Exercise Price
  Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2019  59,111  $18.75 - 187.50  $56.85 
Adjustment for reverse split  14   n/a   n/a 
Exercised    $  $ 
Granted    $  $ 
Cancelled/Expired  (8,001) $75.00 - 142.50  $138.75 
Stock options outstanding at September 30, 2019  51,124  $18.75 - 187.50  $44.12 
Stock options exercisable at September 30, 2019  13,684  $25.20 - 187.50  $113.27 
  Amount  Range of
Exercise Price
  Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2020  51,124   $18.75 - $187.50  $44.12 
Exercised       $ 
Granted  500,752   $1.28 – $2.45  $1.49 
Cancelled/Expired  3,535   $187.50  $187.50 
Stock options outstanding at September 30, 2020  548,341   $1.28 - $187.50  $4.27 
Stock options exercisable at September 30, 2020  26,865   $1.28 - $187.50  $44.83 

14

 

On September 30, 2019,2020, our stock options had no intrinsic value since the closing price on that date of $3.45$1.35 per share was below the weighted average exercise price of our outstanding stock options.

 

At September 30, 2019,2020, there was approximately $1,520,729$1,989,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.23.0 years.

   

10. WARRANTS

 

During the six months ended September 30, 20192020 and 2018,2019, we did not issue any warrants. During the six months ended September 30, 2019, we agreed with five accredited investors to issue 1,078 shares of our common stock to these investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase 10,759 shares of our common stock. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded a loss of $4,403 on those exchanges based on the changes in fair value between the instruments exchanged.

 

A summary of warrant activity during the six months ended September 30, 20192020 is presented below:

 

  Amount  Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2019  342,992  $16.50 - 180.75  $38.10 
Adjustment for reverse split  73   n/a   n/a 
Cancelled/Expired  (19,823) $64.50 - 180.75  $99.85 
Warrants outstanding at September 30, 2019  323,242  $16.50 - 135.00  $38.26 
Warrants exercisable at September 30, 2019  323,242  $16.50 - 135.00  $38.26 

15

  Amount  Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2020  2,021,368   $1.50 - $125.25  $5.21 
Cancelled/Expired  (13,520)  $90.75 – $125.25  $100.31 
Warrants outstanding at September 30, 2020  2,007,848   $1.50 – $125.25  $5.93 
Warrants exercisable at September 30, 2020  2,007,848   $1.50 – $125.25  $5.93 

    

11. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

 

We have entered into the following threetwo contracts/grants with the National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH, over the past two years:

  

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 runs for the period from September 16, 2019 through September 15, 2021.

 

The work to be performed pursuant to this Award Contract will focusfocuses on melanoma exosomes. This work follows from our completion of a Phasephase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, (see Phase 1 Melanoma Cancer Contract below).as described below. Following on the Phasephase I work, the deliverables in the Phasephase II program will involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

 

NoWe did not record any government contract revenue was recognized under this contract inon the three and six month periods ended September 30, 2019.

Phase 12 Melanoma Cancer Contract

We entered into a contract with the NIH on September 15, 2017. This award was under the NIH’s 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. The award from NIH was 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 had 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 were required to perform certain incremental work toward the achievement of specific milestones against which we invoiced the government for fixed payment amounts.

In in the six months ended September 30, 2018, we performed work under2020. We did invoice the contract covering the remainder of the technical objectives of the contract Aim 1: To validate the Hemopurifier as a deviceNCI for capture and recovery of melanoma exosomes from plasma, and Aim 2: To validate a method of melanoma exosome isolation consisting of the Hemopurifier followed by mab-based immunocapture to select out the tumor-derived exosomes from non-malignant exosomes and Aim 3: To evaluate the functional integrity of melanoma exosomes purified by the Hemopurifier and immunocapture isolation steps. As a result, we invoiced NIH for $149,625$114,849 during the sixthree months ended September 30, 2018. The Phase 1 Melanoma Cancer Contract is now completed.2020, however we have recorded that amount as deferred revenue since we did not achieve the milestones associated with that quarterly billing cycle.

 

 

 

 1615 

 

 

Breast Cancer Grant

 

In September 2018, the NCI awarded us a government grant (number 1R43CA232977-01). The title of this Small Business Innovation Research, or SBIR, Phase I grant is “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation.Circulation, or the Breast Cancer Grant.

 

This NCI Phasephase I grant period originally ran from September 14, 2018 through August 31, 2019. In August 2019, we applied for and received aat no cost, a twelve month extension on this grant, so thegrant. The expiration date was extended to August 31, 2020. The total amount of the firm grant is $298,444. The grant calls for two subcontractors to work with us. Those subcontractors are University of Pittsburgh and Massachusetts General Hospital. During

We did not record any government contract revenue on the Breast Cancer Grant in the six months ended September 30, 2019, we recognized $30,000 in government contract revenue under this grant as a result of2020. We did invoice the work involved in one ofNCI for $88,444 during the three technical objectives of the contract (Aim 2. “Elution of a population of breast cancer exosomes from Hemopurifier cartridges that bear the signatures of malignancy based on expression of CSPG4 and HER2, for triple-negative or HER2-overexpressing cancers, respectively”). We also invoiced the NCI an additional $100,000 in the six month periodmonths ended September 30, 2019 in order to pay our subcontractors under the contract. As2020, and have recorded that amount as deferred revenue since we did not complete any ofachieve the technical objectives beyond Aim 2 noted above during the September period, we recorded this $100,000 as deferred revenue asmilestones associated with that quarterly billing cycle.

As of September 30, 2019.2020, we received all of the funds allocated to the Breast Cancer Grant and are now composing the final reports applicable to this grant.

 

12. SEGMENTS

 

We operate our businesses principally through two reportable segments: Aethlon, which represents our therapeutic business activities, and Exosome Sciences, Inc., or 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.

 

 

 

 1716 

 

 

The following tables set forth certain information regarding our segments:

 

 Six Months Ended September 30,  Six Months Ended September 30, 
 2019 2018  2020 2019 
Revenues:          
Aethlon $30,000  $149,625  $  $30,000 
ESI            
Total Revenues $30,000  $149,625  $  $30,000 
                
Operating Losses:                
Aethlon $(3,256,142) $(2,369,907) $(3,173,367) $(3,256,142)
ESI  (12,249)  (74,319)  (8,440)  (12,249)
Total Operating Loss $(3,268,391) $(2,444,226) $(3,181,807) $(3,268,391)
                
Net Losses:                
Aethlon $(3,761,662) $(2,480,117) $(3,174,095) $(3,761,662)
ESI  (12,249)  (74,319)  (8,440)  (12,249)
Net Loss Before Non-Controlling Interests $(3,773,911) $(2,554,436) $(3,182,535) $(3,773,911)
                
Cash:                
Aethlon $785,461  $5,076,872  $14,473,035  $785,461 
ESI  197   1,733   197   197 
Total Cash $785,658  $5,078,605  $14,473,232  $785,658 
                
Total Assets:                
Aethlon $1,281,593  $5,270,690  $15,056,193  $1,281,593 
ESI  197   1,733   197   197 
Total Assets $1,281,790  $5,272,423  $15,056,390  $1,281,790 
                
Capital Expenditures:                
Aethlon $119,981  $  $23,137  $119,981 
ESI            
Capital Expenditures $119,981  $  $23,137  $119,981 
                
Depreciation and Amortization:                
Aethlon $5,751  $16,040  $18,041  $5,751 
ESI            
Total Depreciation and Amortization $5,751  $16,040  $18,041  $5,751 
                
Interest Expense:                
Aethlon $(54,106) $(110,210) $(728) $(54,106)
ESI            
Total Interest Expense $(54,106) $(110,210) $(728) $(54,106)

 

 

 

 1817 

 

 

13. COMMITMENTS AND CONTINGENCIES

 

CONTRACTUAL OBLIGATIONS AND COMMITMENTS

 

There have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those disclosed under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Contractual Obligations and Commitments” as contained in our Annual Report on Form 10-K for the year ended March 31, 20192020, filed by us with the SEC on July 1, 2019.June 25, 2020.

 

LEASE COMMITMENTS

 

We currently lease approximately 2,600 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego,California 92123 under a 39-month gross plus utilities lease that commenced on December 1, 2014 and expires on August 31, 2021 the “Granite Ridge Lease.”2021. The current rental rate under the lease extension is $8,265 per month. We believe this leased facility will be satisfactory for our office needs over the term of the lease.

 

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 $4,700 per month on a one-year lease that expiresoriginally was to expire on November 30, 2019. In October 2019, we entered into a lease extension for an additional twelve months running from December 1, 2019 through November 30, 2020, at the rate of $5,961 per month (see Note 14).month. We are currently evaluating other laboratory space in the San Diego area.

 

Rent expense, which is included in general and administrative expenses, approximated $47,000 and $34,000$45,000 for the three month periods ended September 30, 20192020 and 2018,2019, respectively. For the six month periods ended September 30, 20192020 and 2018,2019, rent expense approximated $87,000$94,000 and $84,000,$87,000, respectively.

 

Future minimum lease payments under the Granite Ridge Lease as of September 30, 2019,2020, are as follows:

 

October 1, 2019 through March 31, 2020 $49,591 
April 1, 2020 through March 31, 2021  102,074 
July 1, 2020 through March 31, 2021 $51,326 
April 1, 2021 through August 31, 2021  43,670  $43,670 
Total future minimum lease payments  195,335  $94,996 
Less: discount  (7,850) $(2,393)
Total lease liability $187,485  $92,603 

 

OnDuring the fiscal year ended March 31, 2020, we adopted ASU Topic 842 on April 1, 2019 utilizing the alternative transition method allowed for under this guidance. As a result, we recorded a lease liabilityliabilities and ROUright-of-use lease asset for the Granite Ridge Lease basedassets of $228,694 on our balance sheet as of April 1, 2019. The lease liabilities represent the present value of the remaining lease payments over the expected remainingof our corporate headquarters lease, term of 2.2 years, discounted using our estimated incremental borrowing rate as of 4%.April 1, 2019. The corresponding right-of-use lease assets are recorded based on the lease liabilities and the cumulative difference between rent expense and amounts paid under its corporate headquarters lease. We also elected the short-term lease recognition exemption for its laboratory lease. For the six months ended September 30, 2019, reduction of thelaboratory lease that qualified as short-term, we did not recognize right-of-use assets or lease asset was $45,676 and reduction of the lease liability was $44,916, which resulted in a net increase in the right-of-use lease asset of $760 during the period (See Note 4).liabilities at adoption.

 

 

 

 1918 

 

 

LEGAL 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. SUBSEQUENT EVENTS

 

Management has evaluated events subsequent to September 30, 20192020 through the date that the accompanying condensed consolidated financial statements were filed with the SEC for transactions and other events which may require adjustment of and/or disclosure in such financial statements.

 

Reverse Split –Following the approval of a reverse stock split at our Annual Stockholders’ Meeting held on October 14, 2019, our Board of Directors approved a 1-for-15 reverse stock split. Accordingly, each 15 shares of outstanding common stock held by stockholders were combined into one share of common stock. Our authorized common stock remained at 30,000,000 shares. As the result of the rounding up of fractional shares related to the reverse split, we have issued an additional 3,946 shares to our shareholders in October 2019.

 

FDA Approval of IDE for Oncology Indications –On October 4, 2019, the FDA approved our Investigational Device Exemption (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, which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approval is subject to FDA approval of Informed Consent documents from the trial site.

 

Restricted Stock Unit (“RSU”) Issuances – In October 2019, 2,859 RSUs held by our current and former 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 us paying the related withholding taxes on the share issuance, 1,511 of the RSUs were cancelled and we issued a net 1,348 shares of common stock to our executives.

 

ATM Sales– In October 2019, we sold 98,722 shares of our common stock under our Common Stock Sales Agreement with H.C. Wainwright (see Note 6) and from those sales raised net proceeds of $472,798 (after deducting $14,682 in commissions to H.C. Wainwright and $1,932 in other offering expenses), at an average price of $4.79 per share of net proceeds.

 

Government Contract Funding – In October 2019, we billed the NCI for $206,729 after achieving the first milestone in our Phase 2 Melanoma Cancer Contract.

 

 

 

 2019 

 

 

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

 

The following discussion of our financial condition and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. This 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" within the meaning of Section 27A of the Securities Act of 1933, as amended, 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 our actual results, performance, or achievements 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 potentialPotential risks and uncertainties include, without limitation, completion of our capital-raising activities, our ability to maintain our Nasdaq listing, U.S. Food and Drug Administration, approval of our products, other regulations, patent protection of our proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors detailed herein and in other of our filings with the Securities and Exchange Commission, or the Commission. 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 its subsidiary (collectively, “Aethlon”, the “Company”, “we” or “us”) isWe are a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases. The Aethlon Hemopurifier®, or Hemopurifier, is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier depletesis 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 the FDA, has designated the Hemopurifier as a "Breakthrough Device"“Breakthrough Device” for two independent indications:

 

·the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and

·the treatment of life-threatening viruses that are not addressed with approved therapies.

 

We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. We are initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. As we advance our clinical trials, we are in close contact with our clinical sites to navigate and assess the impact of the global COVID-19 pandemic on our clinical trials and current timelines.

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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) (NCT # 04453046). The primary endpoint for the EFS, which willis designed to enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approvalThis study, which will be conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, has been approved by the Institutional Review Board, or IRB, and is subject to FDA approval of Informed Consent documents from the trial site.now open for patient enrollment.

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We also believe the Hemopurifier can be a part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C,Hepatitis-C, and Ebola.

Additionally,in vitro,in-vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, and the reconstructed Spanish flu virus of 1918. In several cases, these studiesvalidations were conducted in collaboration with leading government or non-government research institutes.

On June 17, 2020, the FDA approved a supplement to the Company’s open IDE for the Company’s Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19 in a New Feasibility Study. That study’s plan is to enroll up to 40 subjects at up to 20 centers in the U.S.  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, will include reduction in circulating virus as well as clinical outcomes (NCT # 04595903). The first sites for this trial, Hoag Memorial Hospital Presbyterian in Newport Beach, CA and Hoag Hospital – Irvine in Irvine, CA now have IRB approval and are preparing to open for patient enrollment. Under Single Patient Emergency Use regulations, the Company has also recently treated a patient with COVID-19, who successfully completed eight daily treatments with the Hemopurifier.

 

We are also the majority owner of Exosome Sciences, Inc., or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s activities is the advancement of a TauSome™ biomarker candidate to diagnose chronic traumatic encephalopathy, or CTE, in the living. ESI previously documented TauSome levels in former NFL players to be nine times higher than same age-group control subjects. Through ESI, we are also developing exosome based biomarkers in patients with, or at risk for, a number of cancers. We consolidate ESI’s activities in our consolidated financial statements.

 

We also recently announced the execution of a cross-licensing and development agreement with SeaStar Medical, Inc., which will be focused on co-development of our Hemopurifier cartridge with SeaStar’s proprietary cartridges and the development of a closed system for the Hemopurifier using the SeaStar pump and cassettes. This collaboration may allow the deployment of the Hemopurifier into settings that lack dialysis infrastructure, such as chemotherapy infusion centers and field operations for life threatening viral epidemics.

Successful outcomes of human trials will also be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier. Some of our patents may expire before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.

 

We were formed on March 10, 1999. Our executive offices are located at 9635 Granite Ridge Drive, Suite 100, San Diego, California 92123. Our telephone number is (858) 459-7800. Our website address is www.aethlonmedical.com.

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

COVID-19 Update

In March 2020, the World Health Organization declared COVID-19 a global pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption of financial markets.

We are monitoring closely the impact of the COVID-19 global pandemic on our business and have taken steps designed to protect the health and safety of our employees while continuing our operations, including clinical trials. Given the level of uncertainty regarding the duration and impact of the COVID-19 pandemic on capital markets and the U.S. economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and the resulting COVID-19 pandemic 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 this pandemic could have on our manufacturing supply chain, business, results of operations, financial condition, clinical trials, or preclinical research in the future.

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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 on our operational and financial performance will depend on certain developments, including the duration and spread of the outbreak, 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, of 1934, as amended, and must file reports, proxy statements and other information with the Commission. The Commission maintains a web site (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, like us, which file electronically with the 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 sitewebsite ishttp://www.aethlonmedical.com.www.aethlonmedical.com.

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RESULTS OF OPERATIONS

  

THREE MONTHS ENDED SEPTEMBER 30, 20192020 COMPARED TO THE THREE MONTHS ENDED SEPTEMBER 30, 20182019

 

Government Contract Revenues

 

We did not record any government contract revenue in the three months ended September 30, 2019 and 2018.2020.  We did invoice the NCI for an aggregate of $203,293 during the three months ended September 30, 2020, however we recorded that amount as deferred revenue since we did not achieve the milestones associated with that quarterly billing cycle.

 

We have entered into the following threetwo contracts/grants with the National Cancer Institute, or NCI, part of the National Institutes of Health, or NIH over the past two years:

 

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 runs for the period from September 16, 2019 through September 15, 2021.

 

The work to be performed pursuant to this Award Contract will focusfocuses on melanoma exosomes. This work follows from our completion of a Phasephase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, (see Phase 1 Melanoma Cancer Contract below).as described below. Following on the Phasephase I work, the deliverables in the Phasephase II program will involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

 

NoWe did not record any government contract revenue was recognized under this contracton the Phase 2 Melanoma Cancer Contract in the three months and sixended September 30, 2020.  We did invoice the NCI for $114,849 during the three months ended September 30, 2019.

Phase 1 Melanoma Cancer Contract

We entered into a contract2020, however we have recorded that amount as deferred revenue since we did not achieve the milestones associated with the NCI in September 2017. This award was under the NIH’s SBIR program. The title of the award is “SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.” The award from NIH was 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 had 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 were required to perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts. The Phase 1 Melanoma Cancer Contract was completed in June 2018. that quarterly billing cycle.

 

 

 

 2322 

 

 

Breast Cancer Grant

 

In September 2018, the NCI awarded us a government grant (number 1R43CA232977-01). The title of this Small Business Innovation Research, or SBIR, Phase I grant is “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation.Circulation, or the Best Cancer Grant.

 

This NCI Phase I grant period originally ran from September 14, 2018 through August 31, 2019. In August 2019, we applied for and received a no cost, twelve month extension on this grant, so the expiration date was extended togrant; through August 31, 2020. The total amount of the firm grant is $298,444. The grant calls for two subcontractors to work with us. Those subcontractors are University of Pittsburgh and Massachusetts General Hospital.

 

While weWe did not record any government contract revenue from this granton the Breast Cancer Grant in the three months ended September 30, 2020.  We did invoice the NCI for $88,444 during the three months ended September 30, 2019, we did invoice the NCI for $100,000 during the period in order to pay our subcontractors under the contract. As2020, and have recorded that amount as deferred revenue since we did not complete anyachieve the milestones associated with that quarterly billing cycle.

As of September 30, 2020, we have received all of the technical objectives duringfunds allocated to this Best Cancer Grant and are now composing the September period, we recordedfinal reports applicable to this $100,000 as deferred revenue.grant.

 

Operating Expenses

 

Consolidated operating expenses for the three months ended September 30, 20192020 were $1,771,389, compared to $1,702,202 in comparison with $1,346,954 for the comparable periodthree months ended September 30, 2018.2019. This increase of $355,248,$69,187, or 26%4.1%, in 2019the 2020 period was due to increases in professional fees of $359,293 andan increase in general and administrative expenses of $70,708,$212,410, which was partially offset by decreases in professional fees of $105,941 and in payroll and related expenses of $37,282.

The $212,410 increase in general and administrative expenses was primarily due to a $142,696 increase in lab supplies, in connection with our ongoing effort to continue to build an inventory of Hemopurifiers for our clinical trials, and to a $54,361 increase in our clinical trial expenses.

The $105,941 decrease in our professional fees was primarily due to a $93,640 decrease in our legal fees and a $59,614 decrease in our accounting fees, which were partially offset by a decrease$37,986 increase in payroll and related expenses of $74,753.scientific consulting expenses.

  

The $359,293 increase in our professional fees in 2019 was primarily due to a $278,892 increase in our legal fees, a $68,715 increase in our accounting fees and a $65,000 payment to the University of Pittsburgh, a subcontractor on our Breast Cancer grant related to their work on that grant. The increase in legal and accounting fees related to increased activity in our registration statement filings and in intellectual property actions, among other matters.

The $70,708 increase in general and administrative expenses in 2019 was primarily due to the combination of a $21,264 increase in our clinical trial expense, primarily costs associated with the manufacturing of Hemopurifiers for an expected clinical trial in the cancer space and a $44,999 increase in our lab supplies expense, primarily related to our breast cancer grant and lab work related to our IDE application.

The $74,753$37,282 decrease in payroll and related expenses was due to the combination of a $64,793$159,494 reduction in stock-based compensation expense and a $122,212 increase in our cash-based compensation expenseexpense. The cash-based compensation increase was in turn due to additions to our headcount and a $9,960 decrease in stock-based compensation.to salary increases.

 

Other Expense

 

OtherThere was no other expense during the three months ended September 30, 2020. In the three months ended September 30, 2019, other expense consisted of interest expense and a loss on share for warrant exchanges and during the three months ended September 30, 2018, consisted of interest expense only. Other expense for the three months ended September 30, 2019 was $4,424, in comparison with other expense of $55,106 for the three months ended September 30, 2018.exchanges.

 

 

 

 2423 

 

 

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

  

 Three Months
Ended
 Three Months
Ended
    Three Months
Ended
 Three Months
Ended
   
 9/30/19 9/30/18 Change  9/30/20 9/30/19 Change 
Loss on Share for Warrant Exchanges $4,403  $  $4,403  $  $4,403  $(4,403)
Interest Expense  21   55,106   (55,085) $  $21  $(21)
Total Other Expense $4,424  $55,106  $(50,682) $  $4,424  $(4,424)

 

Loss on Common StockShare for Warrant CancellationExchanges

 

We did not record a loss on share for warrant exchanges in the three months ended September 30, 2020. During the three months ended September 30, 2019, we agreed with five accredited investors to issue 1,078 shares of our common stock to these investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase 10,759 shares of our common stock. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded a loss of $4,403 on those exchanges based on the changes in fair value between the instruments exchanged.

  

Interest Expense

 

We did not have any interest expense in the three months ended September 30, 2020. Interest expense was $21 for the three months ended September 30, 2019, and $55,106 for the three months ended September 30, 2018, a decrease of $55,085 in 2019. The various components of our interest expense are shown in the following table:

 

  Three Months
Ended
  Three Months
Ended
    
  9/30/19  9/30/18  Change 
Interest Expense $21  $24,819  $(24,798)
Amortization of Note Discounts     30,287   (30,287)
Total Interest Expense $21  $55,106  $(55,085)

The $55,085 decrease in our interest expense was due to the payoff of our convertible notes in July 2019.

  Three Months
Ended
  Three Months
Ended
    
  9/30/20  9/30/19  Change 
Interest Expense $  $21  $(21)

 

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss increased fromto approximately $1,402,000$1,771,000 in the three month period ended September 30, 2018 to2020, from approximately $1,707,000 in the three month period ended September 30, 2019.

  

Basic and diluted loss attributable to common stockholders were ($0.15) for the three month period ended September 30, 2020, compared to ($1.29) for the three month period ended September 30, 2019, compared to ($1.17) for the three month period ended September 30, 2018.2019.

 

 

 

 2524 

 

RESULTS OF OPERATIONS

 

SIX MONTHS ENDED SEPTEMBER 30, 20192020 COMPARED TO THE SIX MONTHS ENDED SEPTEMBER 30, 20182019

 

Government Contract Revenues

 

We recordeddid not record any government contract revenue in the six months ended September 30, 2019 and 2018.  This2020. We did invoice the NCI for an aggregate of $407,022 during the six months ended September 30, 2020, however we recorded that amount as deferred revenue resulted from work performed under our government contractssince we did not achieve the milestones associated with the NIH as follows:those quarterly billing cycles.

 

  Six Months
Ended 9/30/19
  Six Months
Ended 9/30/18
  Change in
Dollars
 
Melanoma Cancer Contract $  $149,625  $(149,625)
Breast Cancer Grant  30,000      30,000 
Total Government Contract and Grant Revenue $30,000  $149,625  $(119,625)

We have entered into the following threetwo contracts/grants with the NCI, part of the NIH over the past two years:

 

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 runs for the period from September 16, 2019 through September 15, 2021.

 

The work to be performed pursuant to this Award Contract will focusfocuses on melanoma exosomes. This work follows from our completion of a Phasephase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, (see Phase 1 Melanoma Cancer Contract below).as described below. Following on the Phasephase I work, the deliverables in the Phasephase II program will involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

 

NoWe did not record any government contract revenue was recognized under this contracton the Phase 2 Melanoma Cancer Contract in the six months ended September 30, 2019.

Phase 1 Melanoma Cancer Contract

2020. We entered into a contract withdid invoice the NIH on September 15, 2017. This award was under the NIH’s 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. The award from NIH was a firm, fixed-price contract with potential total payments to us of $299,250 over the course of nine months.

26

Fixed price contracts require the achievement of multiple, incremental milestones to receive the full award during each period of the contract. The NIH also had the unilateral right to require us to perform additional work under an option periodNCI for an additional fixed amountaggregate of $49,800. Under the terms of the contract, we were required to perform certain incremental work toward the achievement of specific milestones against which we invoiced the government for fixed payment amounts.

In the six months ended September 30, 2018, we performed work under the contract covering the remainder of the technical objectives of the contract (Aim 1: To validate the Hemopurifier as a device for capture and recovery of melanoma exosomes from plasma and Aim 2: To validate a method of melanoma exosome isolation consisting of the Hemopurifier followed by mab-based immunocapture to select out the tumor-derived exosomes from non-malignant exosomes and Aim 3: To evaluate the functional integrity of melanoma exosomes purified by the Hemopurifier and immunocapture isolation steps). As a result, we invoiced NIH for $149,625$321,578 during the six months ended September 30, 2018. The Phase 1 Melanoma Cancer Contract is now completed. 2020, however we have recorded that amount as deferred revenue since we did not achieve the milestones associated with those quarterly billing cycles.

 

Breast Cancer Grant

 

In September 2018, the NCI awarded us a government grant (number 1R43CA232977-01). The title of this Small Business Innovation Research, (SBIR)or SBIR, Phase I grant is “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation.Circulation, or Breast Cancer Grant.

 

This NCI Phasephase I grant period originally ran from September 14, 2018 through August 31, 2019. In August 2019, we applied for and received a no cost, twelve month extension on this grant,grant; so the expiration date was extended to August 31, 2020. The total amount of the firm grant is $298,444. The grant calls for two subcontractors to work with us. Those subcontractors are University of Pittsburgh and Massachusetts General Hospital.

 

We did not record any government contract revenue on the Breast Cancer Grant in the six months ended September 30, 2020. We did invoice the NCI for $88,444 during the six months ended September 30, 2020, however we have recorded that amount as deferred revenue since we did not achieve the milestones associated with that quarterly billing cycle.

As of September 30, 2020, we have received all of the funds allocated to this grant and are now composing the final reports applicable to this Breast Cancer Grant.

During the six months ended September 30, 2019, we recognized $30,000 in government contract revenue under this grant as a result of the work involved in one of the three technical objectives of the contract (Aimcontract: Aim 2. “Elution of a population of breast cancer exosomes from Hemopurifier cartridges that bear the signatures of malignancy based on expression of CSPG4 and HER2, for triple-negative or HER2-overexpressing cancers, respectively”). We also invoiced the NCI for an additional $100,000 during the six month period ended September 30, 2019 in order to pay our subcontractors under the contract. As we did not complete any additional technical objectives beyond Aim 2 noted above during the period, we recorded this $100,000 as deferred revenue as of September 30, 2019.

25

 

Operating Expenses

 

Consolidated operating expenses for the six months ended September 30, 20192020 were $3,181,807, compared to $3,298,391 in comparison with $2,593,851 for the comparable periodsix months ended September 30, 2018.2019. This increasedecrease of $704,540,$116,584, or 27%3.5%, in 2019the 2020 period was due to increasesa decrease in payroll and related expenses of $206,366 and in professional fees of $517,436 and$149,235, which was partially offset by an increase in general and administrative expenses of $258,427, which were partially offset by a reduction in and payroll and related expenses of $71,323.$239,017.

 

The $517,436 increase in our professional fees in 2019 was primarily due to a $421,145 increase in our legal fees, a $125,804 increase in our accounting fees and a $65,000 payment to the University of Pittsburgh, a subcontractor on our Breast Cancer grant related to their work on that grant. The increase in legal and accounting fees related to increased activity in our registration statement filings and in intellectual property actions among other matters.

27

The $258,427 increase in general and administrative expenses in 2019 was primarily due to the combination of a $140,792 increase in our clinical trial expense, primarily costs associated with the manufacturing of Hemopurifiers for an expected clinical trial in the cancer space, a $83,520 increase in our lab supplies expense, primarily related to our breast cancer grant and lab work related to our IDE application and a $58,520 increase in travel expense.

The $71,323$206,366 decrease in payroll and related expenses was due to the combination of a $124,737$401,823 reduction in stock-based compensation expense and a $195,457 increase in our cash-based compensation expenseexpense. The cash-based compensation increase was in turn due to additions to our headcount and to salary increases.

The $149,235 decrease in our professional fees was primarily due to a $112,285 decrease in our legal fees, a $81,242 decrease in our accounting fees, and a $53,414$65,000 decrease in subcontractor fees on our government contracts, which were partially offset by a $62,236 increase in stock-based compensation.scientific consulting expenses and a $28,976 increase in investor relations expenses.

The $239,017 increase in general and administrative expenses was primarily due to a $188,081 increase in lab supplies, in connection with our ongoing effort to continue to build an inventory of Hemopurifiers for our clinical trials, and to a $80,544 increase in our clinical trial expenses.

 

Other Expense

 

Other expense during the six months ended September 30, 2020 consisted of interest expense and during the three months ended September 30, 2019, consisted of interest expense, a loss on share for warrant exchanges and a loss on debt extinguishment and during the six months ended September 30, 2018, consisted of interest expense only.extinguishment. Other expense for the six months ended September 30, 20192020 was $505,520, in comparison with$728, compared to other expense of $110,210$505,520 for the six months ended September 30, 2018.2019.

 

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

 

 Six Months
Ended
 Six Months
Ended
    Six Months
Ended
 Six Months
Ended
   
 9/30/19 9/30/18 Change  9/30/20 9/30/19 Change 
Loss on Debt Extinguishment $447,011  $  $447,011  $  $447,011  $(447,011)
Loss on Share for Warrant Exchanges  4,403      4,403  $  $4,403  $(4,403)
Interest Expense  54,106   110,210   (56,104) $728  $54,106  $(53,378)
Total Other Expense $505,520  $110,210  $395,310  $728  $505,520  $(504,792)

 

Loss on Debt Extinguishment

 

We did not record a loss on debt extinguishment in the six months ended September 30, 2020. During the six months ended September 30, 2019, we reduced the conversion price on our then outstanding convertible notes from $45.00 per share to $10.20 per share. The modification of the convertible 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 $447,011.

 

Loss on Common Stock for Warrant Cancellation

 

26

Loss on Share for Warrant Exchanges

We did not record a loss on share for warrant exchanges in the six months ended September 30, 2020. During the threesix months ended September 30, 2019, we agreed with five accredited investors to issue 1,078 shares of our common stock to these investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase 10,759 shares of our common stock. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded a loss of $4,403 on those exchanges based on the changes in fair value between the instruments exchanged.

  

28

Interest Expense

 

InterestTotal interest expense was $728 for the six months ended September 30, 2020, and $54,106 for the six months ended September 30, 2019, and $110,210 for the six months ended September 30, 2018, a decrease of $56,104 in 2019.$53,378. The various components of our interest expense are shown in the following table:

 

 Six Months
Ended
 Six Months
Ended
    Six Months
Ended
 Six Months
Ended
   
 9/30/19 9/30/18 Change  9/30/20 9/30/19 Change 
Interest Expense $23,819  $49,636  $(25,817) $728  $23,819  $(23,091)
Amortization of Note Discounts  30,287   60,574   (30,287) $  $30,287  $(30,287)
Total Interest Expense $54,106  $110,210  $(56,104) $728  $54,106  $(53,378)

 

The $56,104$53,378 decrease in our total interest expense in the six months ended September 2020 was due to the payoffpayment in full of our convertible notes in July 2019.

 

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss increased fromdecreased to approximately $2,554,000$3,183,000 in the six month period ended September 30, 2018 to2020, from approximately $3,774,000 in the six month period ended September 30, 2019.

  

Basic and diluted loss attributable to common stockholders were ($0.29) for the six month period ended September 30, 2020, compared to ($2.91) for the six month period ended September 30, 2019, compared to ($2.14) for the six month period ended September 30, 2018.2019.

 

LIQUIDITY AND CAPITAL RESOURCES

 

As of September 30, 2019,2020, we had a cash balance of $785,658$14,473,232 and negativecurrent working capital of $268,824.$13,262,499. This compares to a cash balance of $3,828,074$9,604,780 and working capital of $2,214,230$8,973,393 at March 31, 2019. Significant additional financing must2020. We expect our existing cash as of September 30, 2020 to be obtained in ordersufficient to provide a sufficient sourcefund the Company’s operations for at least twelve months from the issuance date of operating capital and to allow us to continue to operate as a going concern. In addition, we will need to raise capital to complete anticipated future human clinical trials in the U.S. We anticipate the primary sources of this additional financing will be from proceeds of our at-the-market offering program, debt financing and other forms of equity placements.these financial statements.

 

OurThe primary source of capitalour increase in cash during the six months ended September 30, 2019 was the2020 resulted from our Common Stock Sales Agreement with H.C. Wainwright & Co., LLC, or H.C. Wainwright. The cash raised from that activity is noteddescribed below:

 

 

 

 2927 

 

 

Common Stock Sales Agreement with H.C. Wainwright

 

On June 28, 2016, we entered into a Common Stock Sales Agreement, or the Agreement, with H.C. Wainwright & Co., LLC, or H.C. Wainwright, which established an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the Agreement. The Agreement providesprovided for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000, or the Shares.$12,500,000.

  

On August 6, 2019,March 30, 2020, we executed Amendment No. 12 to the Agreement with H.C. Wainwright, effective as of August 5, 2019.the same date. The amendment provides that references in the Agreement to the registration statement shall refer to the registration statement on Form S-3 (File No. 333-231397)333-237269), originally filed with the Securities and Exchange CommissionSEC on May 10, 2019,March 19, 2020, declared effective by the Securities and Exchange CommissionSEC on August 1, 2019.March 30, 2020.

 

Subject to the terms and conditions set forth in the Agreement H.C. Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Sharesshares under the Agreement from time to time, based upon our instructions. We have provided H.C. Wainwright with customary indemnification rights under the Agreement, and H.C. Wainwright is entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Shareshare sold. In addition, we agreed to pay certain expenses incurred by H.C. Wainwright in connection with the Agreement, including up to $50,000 of the fees and disbursements of their counsel. The Agreement will terminate upon the sale of all of the Sharesshares under the Agreement, unless terminated earlier by either party as permitted under the Agreement.

  

Sales of the Shares, if any, under the Agreement will 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, including on the Nasdaq Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell any of the Shares, and, at any time, we may suspend offers under the Agreement or terminate the Agreement.

  

In the six months ended September 30, 2019,2020, we raised aggregate net proceeds of $423,234 (net$7,260,869, net of $13,213$224,825 in commissions to H.C. Wainwright and $3,997$8,472 in other offering expenses)expenses, under thisthe Agreement through the sale of 62,4272,685,600 shares at an average price of $6.78$2.70 per share of net proceeds.

 

Future capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future.

 

Cash Flows

 

Cash flows from operating, investing and financing activities, as reflected in the accompanying Condensed Consolidated Statements of Cash Flows, are summarized as follows:

 

 (In thousands)
For the six months ended
  (In thousands)
For the six months ended
 
 September 30,
2019
 September 30,
2018
  September 30,
2020
 September 30,
2019
 
Cash used in:        
Cash provided by (used in):        
Operating activities $(2,321) $(1,809) $(2,329) $(2,321)
Investing activities  (120)    $(23) $(120)
Financing activities  (601)  (86) $7,220  $(601)
Net decrease in cash $(3,042) $(1,895)
Net increase (decrease) in cash $4,868  $(3,042)

  

 

 

 3028 

 

 

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 $2,329,000 in the six month period ended September 30, 2020, compared to approximately $2,321,000 in the six month period ended September 30, 2019 compared to approximately $1,895,000 in the six month period ended September 30, 2018. The primary driver in this increase of approximately $512,000 in 2019 in cash used in operating activities was the $1,220,000 increase in our net loss which was partially offset by the non-cash debt extinguishment expense of approximately $447,000, an increase in our non-cash stock-based compensation of approximately $53,000, and the receipt of $100,000 under our Breast Cancer Grant that we recorded as deferred revenue.2019.

  

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $120,000$23,000 of cash to purchase laboratory and office equipment in the six months ended September 30, 2019. We had no investing activities2020, compared to approximately $120,000 in the threesix month period ended September 30, 2019.

NET CASH PROVIDED BY/(USED IN) FINANCING ACTIVITIES. During the six months ended September 30, 2018.

NET CASH USED IN FINANCING ACTIVITIES.2020, we raised approximately $7,261,000 from the issuance of common stock. That source of cash from our financing activities was partially offset by the use of approximately $40,000 to pay for the tax withholding on restricted stock units, for an aggregate increase of cash provided by financing activities of approximately $7,220,000. During the six months ended September 30, 2019, we raised approximately $423,000 from the issuance of common stock. That source of cash from our financing activitiesstock, which was more than offset by the use of approximately $993,000 to partially pay downpayoff our then outstanding convertible notes and the use of approximately $32,000 to pay for the tax withholding on restricted stock units for an aggregate use of cash in financing activities of approximately $602,000. During the six months ended September 30, 2018, we used approximately $86,000 to pay for the tax withholding on restricted stock units.

 

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

  

CRITICAL ACCOUNTING POLICIES

 

Use of Estimates

 

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

 

We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting estimates relate to revenue recognition, 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 contingencies.

 

There have been no changes to our critical accounting policies as disclosed in our Form 10-K for the year ended March 31, 2019 , except for the leases policy disclosed in Note 4 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.2020.

31

  

OFF-BALANCE SHEET ARRANGEMENTS

 

WeAs of September 30, 2020, we did not have no obligations required to be disclosed herein asany off-balance sheet arrangements.

29

 

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 Securities Exchange Act of 1934, as amended, and are effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, 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.

 

 

 

 

 

 3230 

 

 

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.

 

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. For a discussion of our potential risks and uncertainties, please see the information listed in the item captioned “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2019. Except as provided below, there have been no material changes to the risk factors as disclosed in the Form 10-K. You should carefully consider the risk factors discussed below and in our Annual Report on Form 10-K for the year ended March 31, 2019, which could materially affect our business, financial position and results of operations.2020.

*Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

If we fail to satisfy the continued listing requirements of The Nasdaq Capital Market, or Nasdaq, such as the minimum stockholders’ equity requirement or the minimum closing bid price requirement, Nasdaq may take steps to de-list our common stock. In May 2019, we received a letter from Nasdaq indicating that Nasdaq has determined that we failed to comply with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2). Nasdaq Listing Rule 5550(a)(2) requires that companies listed on the Nasdaq Capital Market maintain a minimum closing bid price of at least $1.00 per share. Although we currently are in compliance with the minimum bid price requirement, it is possible that we may not be in the future. In July 2019, we received another letter from Nasdaq indicating that Nasdaq has determined that we failed to comply with the minimum stockholder’s equity requirement of Nasdaq Listing Rule 5550(b)(1). Nasdaq Listing Rule 5550(b)(1) requires that companies listed on the Nasdaq Capital Market maintain a minimum of $2,500,000 in stockholder’s equity. If we fail to regain and maintain compliance with these, or any other of the continued listing requirements of The Nasdaq Capital Market, Nasdaq may take steps to de-list our common stock. A de-listing of our common stock would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a de-listing, we would take actions to restore our compliance with Nasdaq’s listing requirements, but any such action taken by us may not be successful.

33

 

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

 

In July, August and September 2019, an aggregate of 844 shares of our common stock were issued to five accredited investors in exchange for the cancellation of outstanding warrants previously held by these investors to purchase an aggregate of 8,442 shares of our common stock.

The offers, sales and issuances of the securities described in paragraphs (1) and (2) were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) in that the issuance of securities to the accredited investorsWe did not involve a public offering. The recipients ofissue or sell any unregistered securities in each of these transactions acquiredduring the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. No underwriters were involved in these transactions.three months ended September 30, 2020.

 

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.

 

 

 

 3431 

 

 

ITEM 6. EXHIBITS.

 

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

      Incorporated by Reference
Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
             
 3.1 Articles of Incorporation. S-3 333-211151 3.1 May 5, 2016  
              
 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 Common Stock Purchase Warrant dated August 29, 2012. 8-K 000-21846 4.1 September 6, 2012  
              
 4.3 Form of Common Stock Purchase Warrant dated October, November and December 2012. 10-Q 000-21846 4.1 February 13, 2013  
              
 4.4 Form of Common Stock Purchase Warrant dated June 14, 2013. 10-Q 000-21846 4.1 August 13, 2013  
              
 4.5 Form of Common Stock Purchase Warrant dated June 24, 2014. 8-K 000-21846 4.1 June 30, 2014  
              
 4.6 Form of Common Stock Purchase Warrant dated July 24, 2014. 8-K 000-21846 4.1 July 28, 2014  
              
 4.7 Form of Common Stock Purchase Warrant dated August and September 2014. 10-Q 000-21846 4.3 November 10, 2014  
              
 4.8 Form of Warrant to Purchase Common Stock dated June 25, 2015. 8-K 000-21846 4.1 June 24, 2015  

      Incorporated by Reference
Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
             
 3.1 Articles of Incorporation. S-3 333-211151 3.1 May 5, 2016  
              
 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 Common Stock Purchase Warrant dated August 29, 2012. 8-K 000-21846 4.1 September 6, 2012  
              
 4.3 Form of Common Stock Purchase Warrant dated October, November and December 2012. 10-Q 000-21846 4.1 February 12, 2013  
              
 4.4 Form of Common Stock Purchase Warrant dated June 14, 2013. 10-Q 000-21846 4.1 August 13, 2013  
              
 4.5 Form of Common Stock Purchase Warrant dated June 24, 2014. 8-K 000-21846 4.1 June 30, 2014  
              
 4.6 Form of Common Stock Purchase Warrant dated July 24, 2014. 8-K 000-21846 4.1 July 28, 2014  
              
 4.7 Form of Common Stock Purchase Warrant dated August and September 2014. 10-Q 000-21846 4.3 November 10, 2014  
              
 4.8 Form of Warrant to Purchase Common Stock dated June 25, 2015. 8-K 000-21846 4.1 June 24, 2015  
              
 4.9 Form of Purchase Agent Warrant dated June 25, 2015. 8-K 000-21846 4.1 June 26, 2015  
              
 4.10 Form of Warrant Agreement dated March 27, 2017. 8-K 001-37487 4.1 March 22, 2017  
              
 4.11 Form of Warrant dated _______, 2017. S-1/A 333-219589 4.29 September 18, 2017  
              
 4.12 Form of Placement Agent Warrant dated _______, 2017. S-1/A 333-219589 4.30 September 22, 2017  
              
 4.13 Form of Warrant to Purchase Common Stock. S-1/A 333-234712 4.14 December 11, 2019  
              
 4.14 Form of Underwriter Warrant. S-1/A 333-234712 4.15 December 11, 2019  
              
 4.15 Form of Common Stock Purchase Warrant. 8-K 001-37487 4.1 January 17, 2020  

 

 

 

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 4.9 Form of Purchase Agent Warrant dated June 25, 2015. 8-K 000-21846 4.1 June 26, 2015  
              
 4.10 Form of Warrant Agreement dated March 27, 2017. 8-K 001-37487 4.1 March 22, 2017  
              
 4.11 Form of Warrant dated _______, 2017. S-1/A 333-219589 4.29 September 18, 2017  
              
 4.12 Form of Placement Agent Warrant dated _______, 2017. S-1/A 333-219589 4.30 September 22, 2017  
              
 10.1 Seventh Amendment to Standard Industrial Net Lease, dated September 9, 2019, between Aethlon Medical Inc. and San Diego Inspire 1, LLC.         X
              
 10.2 SBIR Phase II Award Contract, effective as of September 12, 2019, by and among Aethlon Medical, Inc., the National Institutes of Health and the National Cancer Institute.         X
              
 31.1 Certification 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.         X
              
 31.2 Certification 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.         X
              
 32.1 Certification 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.         X
              
 32.2 Certification 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.         X
              
 101 Interactive Data Files          
 101.INS XBRL Instance Document          
 101.SCH XBRL Schema Document          
 101.CAL XBRL Calculation Linkbase Document          
 101.DEF XBRL Definition Linkbase Document          
 101.LAB XBRL Label Linkbase Document          
 101.PRE XBRL Presentation Linkbase Document          
      Incorporated by Reference
Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
              
 10.1 Aethlon Medical, Inc. 2020 Equity Incentive Plan, Form of Restricted Stock Grant, Form of Option Grant and Agreement. 8-K 001-37487 10.1 September 15, 2020  
              
 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 XBRL Instance Document         X
 101.SCH XBRL Schema Document         X
 101.CAL XBRL Calculation Linkbase Document         X
 101.DEF XBRL Definition Linkbase Document         X
 101.LAB XBRL Label Linkbase Document         X
 101.PRE XBRL Presentation Linkbase Document         X

 ___________________

++Indicates management contract or compensatory plan.

 

 

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 AETHLON MEDICAL, INC. 
    
Date: November 1, 2019October 28, 2020By:/s/ JAMES B. FRAKES 
  JAMES B. FRAKES 
  CHIEF FINANCIAL OFFICER 
  CHIEF ACCOUNTING OFFICER 

 

 

 

 

 

 

 

 

 

 

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