Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended December 31, 20172020

 

OR

 

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

 

For the transition period from _____to_____

 

COMMISSION FILE NUMBER 001-37487

 

AETHLON MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

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

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (ss.232.405(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). 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. (Check one)

 

Large accelerated filer ☐Accelerated filer ☐
Non-accelerated filer ☐ (Do not check if a smaller reporting company)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 January 31, 2018,February 4, 2021, the registrant had outstanding 16,580,32612,123,524 shares of common stock, $0.001 par value.

 

 

 
 

 

TABLE OF CONTENTS

 

PART I.FINANCIAL INFORMATION3
   
ITEM 1.FINANCIAL STATEMENTS3
   
 CONDENSED CONSOLIDATED BALANCE SHEETS AT DECEMBER 31, 20172020 (UNAUDITED) AND MARCH 31, 201720203
   
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTH AND NINE MONTH PERIODSMONTHS ENDED DECEMBER 31, 20172020 AND 20162019 (UNAUDITED)4
   
 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2020 AND 2019 (UNAUDITED)5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED DECEMBER 31, 20172020 AND 20162019 (UNAUDITED)57
   
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)68
   
ITEM 2.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1821
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2531
   
ITEM 4.CONTROLS AND PROCEDURES2531
   
PART II.OTHER INFORMATION2632
   
ITEM 1.LEGAL PROCEEDINGS2632
   
ITEM 1A.RISK FACTORS2632
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2634
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2634
   
ITEM 4.MINE SAFETY DISCLOSURES2634
   
ITEM 5.OTHER INFORMATION2634
   
ITEM 6.EXHIBITS2635

 

 

 

 

 2 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 December 31,
2017
  March 31,
2017
  December 31,
2020
 March 31,
2020
 
 (Unaudited)     (Unaudited)     
ASSETS                
Current assets                
Cash $5,610,799  $1,559,701  $12,131,593  $9,604,780 
Accounts receivable  114,849   206,729 
Prepaid expenses and other current assets  14,537   37,551   75,829   229,604 
Total current assets  5,625,336   1,597,252   12,322,271   10,041,113 
                
Property and equipment, net  32,398   29,223   166,751   140,484 
Patents and patents pending, net  78,123   84,996 
Right-of-use lease asset  64,750   136,426 
Patents, net  57,092   57,504 
Restricted cash  46,726    
Deposits  14,897   14,897   12,159   12,159 
Total assets $5,750,754  $1,726,368  $12,669,749  $10,387,686 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities                
Accounts payable $211,406  $484,423  $175,422  $285,036 
Due to related parties  64,466   57,866   131,746   111,707 
Deferred revenue     100,000 
Lease liability, current portion  67,698   98,557 
Other current liabilities  60,534   69,467   860,697   472,420 
Total current liabilities  336,406   611,756   1,235,563   1,067,720 
                
Convertible notes payable, net  810,866   519,200 
        
Lease liability, less current portion     42,540 
Total liabilities  1,147,272   1,130,956   1,235,563   1,110,260 
                
Commitments and Contingencies (Note 13)                
                
        
Stockholders’ Equity                
Common stock, par value $0.001 per share; 30,000,000 shares authorized as of December 31, 2017 and March 31, 2017; 15,367,658 and 8,797,086 shares issued and outstanding as of December 31, 2017 and March 31, 2017, respectively  15,368   8,796 
Common stock, par value $0.001 per share; 30,000,000 shares authorized; 12,123,524 and 9,366,873 shares issued and outstanding as of December 31, 2020 and March 31, 2020, respectively  12,125   9,368 
Additional paid-in capital  102,820,906   94,445,739   129,207,491   121,426,563 
Accumulated deficit  (98,138,853)  (93,778,156)  (117,650,120)  (112,026,381)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  4,697,421   676,379   11,569,496   9,409,550 
                
Noncontrolling interests  (93,939)  (80,967)  (135,310)  (132,124)
                
Total stockholders’ equity  4,603,482   595,412   11,434,186   9,277,426 
                
Total liabilities and stockholders’ equity $5,750,754  $1,726,368  $12,669,749  $10,387,686 

 

See accompanying notes.

 

 

 

 3 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Nine Month Periods Ended December 31, 20172020 and 20162019

(Unaudited)

 

 Three Months
Ended
December 31,
2017
  Three Months
Ended
December 31,
2016
  Nine Months
Ended
December 31,
2017
  Nine Months
Ended
December 31,
2016
  Three Months
Ended
December 31,
2020
 Three Months
Ended
December 31,
2019
 Nine Months
Ended
December 31,
2020
 Nine Months
Ended
December 31,
2019
 
                  
REVENUES                                
                                
Government contract revenue $74,813  $  $74,813  $392,073  $624,871  $413,458  $624,871  $443,458 
                                
OPERATING EXPENSES                                
                                
Professional fees  439,117   416,866   1,165,318   1,495,597   624,979   609,933   1,845,659   1,979,848 
Payroll and related expenses  663,245   635,698   1,911,553   2,793,888   1,523,650   406,421   2,520,805   1,609,942 
General and administrative  136,078   182,982   557,991   696,662   919,830   273,510   1,883,802   998,465 
Total operating expenses  1,238,440   1,235,546   3,634,862   4,986,147   3,068,459   1,289,864   6,250,266   4,588,255 
OPERATING LOSS  (1,163,627)  (1,235,546)  (3,560,049)  (4,594,074)  (2,443,588)  (876,406)  (5,625,395)  (4,144,797)
                                
OTHER EXPENSE (INCOME)                
OTHER EXPENSE                
Interest and other debt expenses  55,912   36,565   306,495   115,308   802   126   1,530   54,232 
Loss on share for warrant exchanges        130,214    
(Gain)/loss on debt extinguishment     (58,691)  376,909   558,198 
Warrant repricing expense           345,841 
Total other expense (income)  55,912   (22,126)  813,618   1,019,347 
NET LOSS BEFORE NONCONTROLLING INTERESTS  (1,219,539)  (1,213,420)  (4,373,667)  (5,613,421)
(Gain) on share for warrant exchanges     (55,593)     (51,190)
Loss on debt extinguishment           447,011 
Total other expense  802   (55,467)  1,530   450,053 
                
NET LOSS  (2,444,390)  (820,939)  (5,626,925)  (4,594,850)
                                
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS  (4,532)  (7,689)  (12,972)  (23,088)  (1,498)  (1,358)  (3,186)  (3,808)
                                
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $(1,215,007) $(1,205,731) $(4,360,695) $(5,590,333)
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC. $(2,442,892) $(819,581) $(5,623,739) $(4,591,042)
                                
BASIC AND DILUTED LOSS PER COMMON SHARE $(0.08) $(0.15) $(0.40) $(0.72) $(0.20) $(0.28) $(0.50) $(2.52)
                                
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED  14,950,701   7,927,031   10,927,106   7,768,682   12,093,361   2,887,883   11,265,725   1,821,557 

 

 

See accompanying notes.

 

 

 

 4 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSSTOCKHOLDERS’ EQUITY

For the Three and Nine Months Ended December 31, 20172020 and 20162019

(Unaudited)

 

  Nine Months
Ended
December 31, 2017
  Nine Months
Ended
December 31, 2016
 
Cash flows from operating activities:        
Net loss $(4,373,667) $(5,613,421)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  27,402   26,365 
Stock based compensation  887,607   1,880,150 
Warrant repricing expense     345,841 
Common stock issued for services  33,600    
Loss on share for warrant exchanges  130,214    
Loss on debt extinguishment  376,909   558,198 
Amortization of debt discount and deferred financing costs  215,376   65,637 
Changes in operating assets and liabilities:        
Accounts receivable     199,471 
Prepaid expenses and other current assets  23,014   21,522 
Accounts payable and other current liabilities  (219,806)  51,053 
Due to related parties  6,600   (86,750)
Net cash used in operating activities  (2,892,751)  (2,551,934)
         
Cash flows from investing activities:        
Purchases of property and equipment  (23,705)  (2,961)
Net cash used in investing activities  (23,705)  (2,961)
         
Cash flows from financing activities:        
Proceeds from the issuance of common stock, net  7,166,081   554,306 
Proceeds from the issuance of convertible notes payable, net     577,460 
Cash paid for repurchase of restricted stock units  (198,527)  (71,993)
Net cash provided by financing activities  6,967,554   1,059,773 
         
Net increase (decrease) in cash  4,051,098   (1,495,122)
         
Cash at beginning of period  1,559,701   2,123,737 
         
Cash at end of period $5,610,799  $628,615 
         
Supplemental disclosures of non-cash investing and financing activities:        
         
Issuance of shares under conversions of convertible notes payable and related accrued interest $362,765  $61,766 
         
Issuance of shares under vested restricted stock units $120  $33 
         
Recorded debt discount on convertible notes $  $863,868 
         
Issuance of shares under cashless warrant exchanges $  $3 
         
Reclassification of accrued interest to convertible notes payable $  $85,031 
  ATTRIBUTABLE TO AETHLON MEDICAL, INC.       
  COMMON STOCK  ADDITIONAL PAID IN  ACCUMULATED  NON-
CONTROLLING
  TOTAL 
  SHARES  AMOUNT  CAPITAL  DEFICIT  INTERESTS  EQUITY 
                   
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  2,685,600   2,686   7,258,183         7,260,869 
                         
Issuance of common shares upon vesting of restricted stock units  17,920   18   (24,269)        (24,251)
                         
Stock-based compensation expense        84,207         84,207 
                         
Net loss           (1,410,283)  (863)  (1,411,146)
                         
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  17,920  $17  $(16,145) $  $  $(16,128)
                         
Stock-based compensation expense        167,042          167,042 
                         
Net loss           (1,770,564)  (825)  (1,771,389)
                         
BALANCE - SEPTEMBER 30, 2020  12,088,313  $12,089  $128,895,581  $(115,207,228) $(133,812) $13,566,630 
                         
Issuance of common shares upon vesting of restricted stock units and net stock option exercise  35,211  $36  $(66,048) $  $   (66,012)
                         
Stock-based compensation expense        377,958          377,958 
                         
Net loss           (2,442,892)  (1,498)  (2,444,390)
                         
BALANCE - DECEMBER 31, 2020  12,123,524  $12,125  $129,207,491  $(117,650,120) $(135,310) $11,434,186 

 

See accompanying notes.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   4   (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  $1,339  $109,571,708  $(109,423,894) $(128,480) $20,672 
                         
Proceeds from the issuance of common stock, net  3,432,056  $3,432  $4,560,802  $  $  $4,564,234 
                         
Issuance of common shares upon vesting of restricted stock units  3,439   3   (6,772)        (6,769)
                         
Issuances of common stock upon warrant exchanges  2,914   3   (55,596)        (55,593)
                         
Par value of DTC roundup of shares following reverse split  3,946   4   (4)         
                         
Stock-based compensation expense        102,576         102,576 
                         
Net loss           (819,581)  (1,358)  (820,939)
                         
BALANCE – DECEMBER 31, 2019  4,779,614  $4,781  $114,172,714  $(110,243,475) $(129,838) $3,804,182 

See accompanying notes.

6

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Nine Months Ended December 31, 2020 and 2019

(Unaudited)

  Nine Months
Ended
December 31, 2020
  Nine Months
Ended
December 31, 2019
 
       
Cash flows used in operating activities:        
Net loss $(5,626,925) $(4,594,850)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  28,775   15,992 
Stock based compensation  629,207   755,648 
Loss on debt extinguishment     447,011 
Gain on share for warrant exchanges     (51,190)
Accretion of right-of-use lease asset  (1,723)  862 
Amortization of debt discount     30,287 
Changes in operating assets and liabilities:        
Accounts receivable  91,880   (206,729)
Prepaid expenses and other current assets  153,775   169,691 
Accounts payable and other current liabilities  278,663   (271,533)
Deferred revenue  (100,000)  100,000 
Due to related parties  20,039   27,558 
Net cash used in operating activities  (4,526,309)  (3,577,253)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (54,630)  (148,064)
Net cash used in investing activities  (54,630)  (148,064)
         
Cash flows provided by (used in) financing activities:        
Proceeds from the issuance of common stock, net  7,260,869   4,987,468 
Principal payments on convertible notes     (992,591)
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option exercise  (106,391)  (38,981)
Net cash provided by financing activities  7,154,478   3,955,896 
         
Net increase in cash and restricted cash  2,573,539   230,579 
         
Cash and restricted cash at beginning of period  9,604,780   3,828,074 
         
Cash and restricted cash at end of period $12,178,319  $4,058,653 
         
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 round up following reverse stock split $  $4 
Par value of shares issued for vested restricted stock units and net stock option exercise $71  $10 
         
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:        
Cash and cash equivalents $12,131,593  $4,058,653 
Restricted cash  46,726    
Cash and restricted cash $12,178,319  $4,058,653 

See accompanying notes.

7

AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

December 31, 2017

2020

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

ORGANIZATION

 

Aethlon Medical, Inc. and its subsidiary (collectively, “Aethlon”, the “Company”, “we” or “us”) are, is a medical technology company focused on addressing unmet needs in global healthdeveloping products to diagnose and biodefense.treat life and organ threatening diseases. The Aethlon Hemopurifier®, or Hemopurifier, is an earlya clinical-stage therapeuticimmunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for 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 single-use removalinitiation of life-threatening viruses fromclinical trials in patients with advanced and metastatic cancers. We are initially focused on the circulatory systemtreatment of infected individuals. 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 is 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. This 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 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 countermeasure objectives set forth by the U.S. Government to protect citizens from bioterror and pandemic threats.treatment. In small-scale or early feasibility human studies, the Hemopurifier has been administeredused to treat individuals infected with human immunodeficiency virus, or HIV, Hepatitis-C,Hepatitis C, and Ebola.

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

On June 17, 2020, the clinical advancementFDA approved a supplement to the Company’s open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA. Wein 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 concludedtreated a feasibility study to demonstratepatient with COVID-19 who successfully completed eight daily treatments with the safety of our device in health-compromised individuals infected with a viral pathogen.Hemopurifier.

8

 

We are also the majority owner of Exosome Sciences, Inc. (ESI), or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s endeavorsactivities is the advancement of a TauSomeTMTauSome™ biomarker candidate to diagnose Chronic Traumatic Encephalopathy (CTE)chronic traumatic encephalopathy, or CTE, in the living. ESI previously documented that TauSome levels in former NFL players to be nine times higher than same age-group control subjects. 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.

 

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

 

In addition to the foregoing, we are monitoring closely the impact of the COVID-19 global pandemic 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 iswww.aethlonmedical.com. www.aethlonmedical.com.

 

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

REVERSE STOCK SPLIT

Following the approval of a reverse stock split at our 2019 Annual Meeting of Stockholders’ held on October 14, 2019, our 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. 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, 2019. All shares and per share amounts have been revised accordingly.

 

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

During the nine months ended December 31, 2017,2020, 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, 2017.2020.

 

BASIS OF PRESENTATION

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Basis of Presentation and Use of Estimates

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles, (GAAP)or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, (SEC)or SEC Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended March 31, 2017,2020, included in the Company's Annual Report on Form 10-K filed with the SEC on June 28, 2017.25, 2020. The accompanying unaudited condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its majority-owned subsidiary. All significant intercompanyinter-company transactions and balances have been eliminated in consolidation. The unaudited condensed consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed consolidated financial statements as of and for the three and nine months ended December 31, 2017.2020, and the condensed consolidated statement of cash flows for the nine months ended December 31, 2020. Estimates were made relating to useful lives of fixed assets, valuation allowances, the fair value of warrants, impairment of assets, share-based compensation expense and accruals for clinical trial and research and development expenses. Actual results could differ materially from those estimates. Certain amounts previously reported in the financial statements have been reclassified to conform to the current presentation. Such reclassifications did not affect net loss, equity or cash flows. The accompanying condensed consolidated balance sheet at March 31, 20172020 has been derived from the audited consolidated balance sheet at March 31, 2017,2020, contained in the above referenced 10-K. The results of operations for the three and nine months ended December 31, 20172020 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

  

Reclassifications

 

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

6

 

Restricted Cash

To comply with the terms of our new laboratory and office lease (see Note 13), we caused our bank to issue a standby letter of credit, or the L/C, in the amount of $46,726 in favor of the landlord. The L/C is in lieu of a security deposit. In order to support the L/C, we agreed to have our bank withdraw $46,726 from our operating accounts and to place that amount in a restricted certificate of deposit. We have classified that amount as restricted cash, a long-term asset, on our balance sheet.

 

LIQUIDITY AND GOING CONCERN

 

Management expects existing cash as of December 31, 20172020 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these interimcondensed consolidated financial statements.

  

2. LOSS PER COMMON SHARE

 

Basic loss per share is computed by dividing net income available to common stockholdersloss by the weighted average number of common shares outstanding during the period of computation. The weighted average number of common shares outstanding for the three and nine months ended December 31, 2017 includes 46,125 vested restricted stock units. Diluted loss per share is computed similar to basic loss per share, except that the denominator is increased to include the number of additional dilutive common shares that would have been outstanding if potential common shares had been issued, if such additional common shares were dilutive. Since we had net losses for all periods presented, basic and diluted loss per share are the same, and additional potential common shares have been excluded, as their effect would be antidilutive.

 

As of December 31, 20172020, and 2016, a total2019, an aggregate of 9,143,4802,626,485 and 3,810,6423,779,301 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.

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3. RESEARCH AND DEVELOPMENT EXPENSES

 

Our research and development costs are expensed as incurred. We incurred research and development expenses during the three and nine month periods ended December 31, 20172020 and 2016,2019, 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:

 

 December 31, December 31,  December 31, December 31, 
 2017 2016  2020 2019 
Three months ended $129,207  $178,440   $461,176  $218,571 
Nine months ended $462,640  $497,075   $1,367,333  $692,022 

  

4. FUTURE ACCOUNTING PRONOUNCEMENTSRecent Accounting Pronouncements

 

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

Regarding the new accounting standard on revenue recognition, ASU 2014-09 (Topic 606), which will be effective on April 1, 2018, management believes that as long as its contracts with government entities consist of firm, fixed price arrangements with payments that are triggered by achieving contractually stated milestones that new standard will not have a significant effect on our future consolidated financial statements.

 

5. CONVERTIBLE NOTES PAYABLE, NET

 

Convertible Notes Payable, Net consistedIn July 2019, all of our previously outstanding convertible notes, in the following at December 31, 2017:

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

aggregate amount of $992,591, were paid in full.

 

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DuringFor the nine months ended December 31, 2017,2019, we recorded interest expense of $87,641$23,759 related to the contractual interest rates of our convertible notes and interest expense of $215,376$30,287 related to the amortization of the note discount for a total interest expense of $303,017$54,046 related to our convertible notes. All of the unamortized discount at December 31, 2017 related to the note discount established upon the June 2017 amendment to both the November 2014 10% Convertible Notes and the December 2016 10% Convertible Notes (see below).

 

During the nine months ended December 31, 2016,2019, prior to paying off the notes, we recorded interest expense of $47,730 related to the contractual interest rates of our convertible notes, interest expense of $27,641 related to the amortization of deferred financing costs and interest expense of $37,996 related to the amortization of note discounts for a total interest expense of $113,367 related to our convertible notes.

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

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

NOVEMBER 2014 10% CONVERTIBLE NOTES

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

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

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

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

Initial Amendment of the November 2014 10% Convertible Note Terms

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

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

On June 27, 2016, we and certain investors entered into further Amendments (the “Amendments”) to the Notes and the Warrants. The Amendments provide that the Maturity Date (as defined in the Notes) was extended from June 1, 2016 to July 1, 2017 and that the conversion price per share ofon the Notes was reducedconvertible notes from $5.60 per share of common stock to $5.00 per share of common stock. In addition, we reduced the purchase price (as defined in the Warrants) from $8.40$45.00 per share to $5.00 per share of common stock. In connection with these modifications, each of the investors signed a Consent and Waiver providing its consent under certain restrictive provisions, and waiving certain rights, including a right to participate in certain offerings made by us, under a Securities Purchase Agreement dated June 23, 2015, (the “2015 SPA”) to which we, the investors and certain other investors are parties, in order to facilitate an at-the-market equity program (see Note 6).

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

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

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

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

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

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

June 2017 Amendment to the November 2014 10% Convertible Notes

In June 2017, we agreed with the holders of the November 2014 10% Convertible Notes to an extension of the expiration dates of the notes from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00$10.20 per share. The modification of the Notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. Under the extinguishment accounting we recorded a loss on debt extinguishment of $178,655 and recalculated a revised debt discount on the notes.

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

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

DECEMBER 2016 10% CONVERTIBLE NOTES

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

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

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

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

June 2017 Amendment to the December 2016 10% Convertible Notes

In June 2017, we agreed with the holders of the December 2016 10% Convertible Notes to an extension of the expiration dates of the notes from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00 per share. The modification of the notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. Under the extinguishment accounting we recorded a loss on debt extinguishment of $198,254 and recalculated a revised debt discount on the notes.$447,011.

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

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

 

6. EQUITY TRANSACTIONS IN THE NINE MONTHS ENDED DECEMBER 31, 2017

October 2017 Public Offering

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

Warrant Exercises

In December 2017, four investors that participated in the October 2017 Public Offering exercised 218,600 warrants for aggregate cash proceeds to us of $240,460 before expenses.2020

 

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

 

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

On March 30, 2020, we executed Amendment No. 2 to the Agreement with Wainwright, effective as of 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. 333-237269), originally filed with the SEC on March 19, 2020, declared effective by the SEC on March 30, 2020.

 

 

 

 1011 

 

 

Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright willagreed 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 will beis entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Shareshare sold. In addition, we have 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 (see Note 14).Agreement.

  

Sales of the Shares,shares, if any, under the Agreement shallwill 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 July 2016, we commenced sales of common stock under our Common Stock Sales Agreement with H.C. Wainwright. In the sixthree months ended SeptemberJune 30, 2017,2020, we raised aggregate net proceeds of $1,650,314 (net$7,260,869, net of $51,157$224,825 in commissions to H.C. Wainwright and $3,750$8,472 in other offering expenses)expenses, under this agreementthe Agreement, through the sale of 601,5042,685,600 shares at an average price of $2.74$2.70 per share of net proceeds.

  

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

Restricted Shares Issued for Services

During the nine months ended December 31, 2017, we issued 15,000 shares of restricted common stock at a price of $2.24 per share, the market price at time of issuance, in payment for investor relations consulting services valued at $33,600 based on the grant date closing market price of our common stock.

Share for Warrant Exchanges

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

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

Stock Option Issuances

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

Termination of Restricted Share Grant

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

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Restricted Stock Unit Grants to Directors and Executive Officers

 

On August 9, 2016,In 2012, as amended through July 16, 2020, our Board of Directors granted RSUs to certain of our officers and directors and effective November 7, 2017, 127,659 additional RSUs were granted to our directors pursuant toestablished the 2012 Non-Employee Directors Compensation Program.Program, to provide for cash and equity compensation for persons serving as non-employee directors of the Company. Under this program, each new director receives either stock options or a grant of restricted stock units, or 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 vested RSUs.upon vesting.

 

DuringOn April 3, 2020, pursuant to the nine months endedterms of the Company’s Non-Employee Directors Compensation 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 non-employee director for fiscal year 2020 would be 24,822 shares of our common stock.  On 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 each eligible director a contingent grant under our 2020 Equity Incentive Plan, or the 2020 Plan, for the remaining portion of the annual RSU grants, or 929 RSU’s to each eligible director, contingent upon stockholder approval of the 2020 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 subject to the grants will vest on December 31, 2017, 138,3752020 and 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 2020, 29,866 vested RSUs held by our executives were exchanged into the same number of shares of our common stock. As our executives elected to net settle a portion of their RSU’s in exchange for the Company paying the related withholding taxes on the share issuance, 71,081 of the RSUs were cancelled and we issued a net 67,294 shares to our executives (see Note 9).

During the nine months ended December 31, 2017, 63,829 RSUs held by our outsidenon-employee directors were exchanged into the same number of shares of our common stock. As one of our three outsideAll five non-employee directors elected to return 40% of histheir vested RSUs in exchange for cash, in order to pay histheir withholding taxes on the share issuances, 10,638resulting in 11,947 of the vested RSUs being cancelled in exchange for $24,251 in aggregate cash proceeds to those independent directors.

In September 2020, 29,866 vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock. All 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 11,947 of the vested RSUs being cancelled in exchange for $16,128 in aggregate cash proceeds to those independent directors.

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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 cancelledconsidered effective and we paid $12,127 in cash tono longer contingent as of that outside director (seedate (See Note 9).

In December 2020, 32,189 vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock. All 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 12,876 of the vested RSUs being cancelled in exchange for $31,802 in aggregate cash proceeds to those independent directors.

RSUs outstanding that have vested as of, and are expected to vest subsequent to, December 31, 2020 are as follows:

Number of RSUs
Vested
Expected to vest32,189
Total32,189

  

7. RELATED PARTY TRANSACTIONS

Due to Related Parties

 

During the three months ended December 31, 2017,2020, we accrued unpaid Board fees of $35,350 which are$69,292 owed to our outsidenon-employee directors as of December 31, 2017. On March 31, 2017,2020.

As a result of entering into a Separation Agreement on October 30, 2020 with our former Chief Executive Officer, or CEO, Timothy Rodell, M.D., or the Separation Agreement, we hadpaid out accrued unpaid board feesvacation of $28,250 owed$20,260 to our outside directors.Dr. Rodell in the three months ended December 2020 (see Note 8 and Note 13). That accrued vacation was previously recorded in the due to related parties account.

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

  December 31,
2020
  March 31,
2020
 
Accrued Board fees $69,292  $69,750 
Accrued vacation to all employees  62,454   41,957 
Total due to related parties $131,746  $111,707 

 

8. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

 

  December 31,  March 31, 
  2017  2017 
Accrued interest $30,886  $5,391 
Other accrued liabilities  29,648   64,076 
Total other current liabilities $60,534  $69,467 
  December 31,  March 31, 
  2020  2020 
Accrued separation expenses for former executive $400,578  $ 
Accrued professional fees  460,119   472,420 
Total other current liabilities $860,697  $472,420 

13

 

9. STOCK COMPENSATION

 

The following tables summarize share-based compensation expenses relating to Restricted Stock Units (“RSU”s)RSUs and stock options granted and the effect on basic and diluted loss per common share during the three and nine month periods ended December 31, 20172020 and 2016:2019:

 

 Three Months
Ended
December 31,
2017
 Three Months
Ended
December 31,
2016
 Nine Months
Ended
December 31,
2017
 Nine Months
Ended
December 31,
2016
  Three Months
Ended
December 31,
2020
 Three Months
Ended
December 31,
2019
 Nine Months
Ended
December 31,
2020
 Nine Months
Ended
December 31,
2019
 
Vesting of stock options and restricted stock units $323,162  $306,159  $887,607  $1,880,150  $377,958  $102,576  $629,207  $755,648 
Total stock-based compensation expense $323,162  $306,159  $887,607  $1,880,150  $377,958  $102,576  $629,207  $755,648 
                
Weighted average number of common shares outstanding – basic and diluted  14,950,701   7,927,031   10,927,106   7,768,682   12,093,361   2,887,883   11,265,725   1,821,557 
                                
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.02) $(0.04) $(0.08) $(0.24) $(0.03) $(0.04) $(0.06) $(0.41)

  

 

All of the stock-based compensation expense recorded during the nine months ended December 31, 20172020 and 2016,2019, which totaled $887,607$629,207 and $1,880,150,$755,648, respectively, is included in payroll and related expense in the accompanying condensed consolidated statements of operations.  Stock-based compensation expense recorded during the nine months ended December 31, 20172020 and 20162019 represented an impact on basic and diluted loss per common share of $(0.08)$(0.06) and $(0.24)$(0.41), respectively.

12

 

We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the nine months ended December 31, 20172020 was insignificant.

 

Restricted Stock Unit Grants to DirectorsOption Activity and Executive OfficersApproval of 2020 Plan

 

On August 9, 2016,From February 2020 through May 2020, our Board of Directorscompensation committee granted RSUsoptions to certain of our officers and directors and effective November 7, 2017, 127,659 additional RSUs were granted to our directors pursuant to the 2012 Non-Employee Directors Compensation Program. The RSUs represent the right to be issued on a future datepurchase 521,476 shares of our common stock for vested RSUs. Our Compensation Committee recommendedthat were contingent upon stockholder approval of the 2020 Plan. Upon approval of the 2020 Plan at the Annual Meeting, these option grants based on a compensation assessment provided by a third-party compensation consulting firm engaged by uswere considered effective and no longer contingent as of that developed a peer group of companies for market assessment and analyzed compensation at such companies.date.

 

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

We issued an option to purchase shares 239,122 shares of our Amended 2010 Stock Incentivecommon stock pursuant to the 2020 Plan and we recorded expense of $842,095 into our Chief Executive Officer during the ninethree months ended December 31, 2017 related to2020, in connection with the RSU grants.

RSUs outstanding that have vested and are expected to vestappointment of Dr. Fisher as our Chief Executive Officer, effective as of December 31, 2017 are as follows:October 30, 2020.

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

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

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

Stock Option Activity

During the nine months ended December 31, 2017, we issued options to four of our employees to purchase 34,500 shares of common stock at a price of $1.68 per share, the closing price on the date of the approval of the option grants by our compensation committee. There were no stock option grants during the nine months ended December 31, 2016.

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

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

 

 

 

 1314 

 

 

The following outlinesIn connection with the significant weighted average assumptions usedSeparation Agreement and pursuant to estimateDr. Rodell’s employment agreement with the fair value information presented, with respectCompany, the vesting was accelerated on 50% of outstanding and unvested options to purchase shares of our common stock option grants utilizingheld by Dr. Rodell as of the Binomial Lattice option pricing models at,Separation Date of October 30, 2020, such that the accelerated stock options were fully vested and duringexercisable as of the nine months endedSeparation Date.

In December 2020, Dr. Rodell elected to net exercise a portion of his stock options. As a result, we issued Dr. Rodell an aggregate of 15,896 shares of our common stock and we paid the estimated withholding taxes of $34,209 related to the net exercise.

Options outstanding that were vested as of December 31, 2017:2020 and options that are expected to vest subsequent to December 31, 2020 are as follows:

 

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

The expected volatility was based on the historic volatility. The expected life of options granted was based on the "simplified method" as described in the SEC's guidance due to changes in the vesting terms and contractual life of current option grants compared to our historical grants.

  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested  34,509  $32.53   5.84 
Expected to vest  567,814  $1.51   9.67 
Total  602,323         

 

A summary of stock option activity during the nine months ended December 31, 20172020 is presented below:

 

 Amount Range of
Exercise Price
 Weighted
Average
Exercise
Price
  Amount  Range of
Exercise Price
  Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2017 432,047 $3.80-$20.50   $10.98 
Stock options outstanding at March 31, 2020  51,124   $18.75 - $187.50  $44.12 
Exercised      (15,896)  $1.28  $1.28 
Granted 27,000 $1.68  $1.68   770,094   $1.28 – $2.45  $1.45 
Cancelled/Expired         (202,999)  $1.28 - $187.50  $6.76 
Stock options outstanding at December 31, 2017  459,047  $1.68-$20.50  $10.44 
Stock options exercisable at December 31, 2017  432,047  $3.80-$20.50  $10.98 
Stock options outstanding at December 31, 2020  602,323   $1.28 - $187.50  $3.29 
Stock options exercisable at December 31, 2020  34,509   $1.28 - $187.50  $32.53 

 

On December 31, 2017,2020, our outstanding stock options had no intrinsic value since the closing price on that date of $1.13$2.47 per share was below the weighted average exercise price of our outstanding stock options.

 

At December 31, 2017,2020, there was approximately $2.2 million$2,240,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.721.48 years.

10. WARRANTS

During the nine months ended December 31, 2017, we issued 5,618,182 warrants, including 163,636 warrants issued to the placement agent, H.C. Wainwight & Co., in connection with our October 2017 Public Offering (see Note 6). Those warrants have a five year term and have an exercise price of $1.10 per share.

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

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

A summary of warrant activity during the nine months ended December 31, 2017 is presented below:

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

14

The following outlines the significant weighted average assumptions used to estimate the fair value information presented, with respect to warrants utilizing the Binomial Lattice option pricing models issued during the nine months ended December 31, 2016:

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

The expected volatility was based on the historic volatility. The expected life of options granted was based on the "simplified method" as described in the SEC's guidance due to changes in the vesting terms and contractual life of current option grants compared to our historical grants.

Based on the above assumptions, we valued the warrants that were exchanged for common stock (see Note 6) during the nine months ended December 31, 2017 at $130,214.

11. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

National Institutes of Health (“NIH”)

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

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

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

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

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

The details of that milestone were as follows:

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

Defense Advanced Research Projects Agency (“DARPA”)

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

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

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

The DARPA contract concluded on September 30, 2016.

In the nine months ended December 31, 2016, we invoiced the U.S. Government for the final two milestones under our DARPA contract in the aggregate amount of $387,438.

 

 

 

 15 

 

The details of those milestones were as follows:

10. WARRANTS

 

Milestone 2.6.1.3 - QuantifyDuring the degreenine months ended December 31, 2020 and 2019, we did not issue any warrants.

A summary of warrant activity during the nine months ended December 31, 2020 is presented below:

  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  (29,395)  $90.75 – $135.00  $97.17 
Warrants outstanding at December 31, 2020  1,991,973   $1.50 – $99.00  $5.23 
Warrants exercisable at December 31, 2020  1,991,973   $1.50 – $99.00  $5.23 

11. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

We have recognized revenue under the following two 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 whichus 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 MERS virus can be extractedAward Contract. The Award Contract amount is $1,860,561 and runs for the period from circulation in vitro using miniature Hemopurifiers. September 16, 2019 through September 15, 2021.

The milestone payment was $193,719. Management considers this milestonework to be substantiveperformed pursuant to this Award Contract focuses on melanoma exosomes. This work follows from our completion of a phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as it was not dependentdescribed below. Following on the passagephase I work, the deliverables in the phase II program involve the design and testing of time nor was it based solely on another party's efforts. We quantifieda pre-commercial prototype of a more advanced version of the degree to which the MERS virus can be extracted from circulation in vitro using miniature Hemopurifiers. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.exosome isolation platform.

 

Milestone 2.6.1.4 – Prepare and present Final Report for DARPA. The milestone payment was $193,719. Management considers this milestoneDuring the period ended December 31, 2020, we completed all of the milestones relevant to be substantive as it was not dependentthat time period. As a result, we recorded $436,427 of government contract revenue on the passagePhase 2 Melanoma Cancer Contract in the nine months ended December 31, 2020.   Of the total revenue recognized during the current period relating to this grant, a total of time nor$117,849 was it based solelyinvoiced to the NCI during the three months ended December 31, 2020 and we recorded $318,578 which had previously been recognized as deferred revenue.

Breast Cancer Grant

In the nine months ended December 31, 2020, we completed and submitted the final reports applicable to this NCI 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,” or the Breast Cancer Grant.

16

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 another party's efforts.this grant; through August 31, 2020. The total amount of the firm grant was $298,444. The grant called for two subcontractors to work with us. Those subcontractors were University of Pittsburgh and Massachusetts General Hospital. As of December 31, 2020, we have received all of the funds allocated to the Breast Cancer Grant.

During the nine months ended December 31, 2020, we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant, as we achieved two of the three milestones related to the Breast Cancer Grant. We preparedconcluded in our final report to the SBIR that our pre-clinical results demonstrated that our work under the grant provided support that the Hemopurifier has the capacity to clear exosomes from breast cancer patients. That amount previously was recorded as deferred revenue.

As of December 31, 2020, we received all of the funds allocated to the Breast Cancer Grant and presentedhave submitted the Final Report for DARPA. The report was accepted byfinal reports applicable to this grant.

Subaward with University of Pittsburgh

In addition, we are completing the contracting officer's representativelogistical elements of documentation and billing the invoice was submitted thereafter.University of Pittsburgh in connection with a cost reimbursable subaward arrangement under an NIH project entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award is $256,750. We have not recorded any revenues as of December 31, 2020 related to the subaward. We anticipate billing and recognizing revenue under this subaward in future periods.

 

12. SEGMENTS

 

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

 

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

 

17

The following tables set forth certain information regarding our segments:

 

 Nine Months Ended December 31,  Nine Months Ended December 31, 
 2017 2016  2020 2019 
Revenues:          
Aethlon $74,813  $392,073  $624,871  $443,458 
ESI            
Total Revenues $74,813  $392,073  $624,871  $443,458 
                
Operating Losses:                
Aethlon $(3,495,189) $(4,478,631) $(5,609,464) $(4,125,758)
ESI  (64,860)  (115,443)  (15,931)  (19,039)
Total Operating Loss $(3,560,049) $(4,594,074) $(5,625,395) $(4,144,797)
                
Net Losses:                
Aethlon $(4,308,807) $(5,497,978) $(5,610,994) $(4,575,811)
ESI  (64,860)  (115,443)  (15,931)  (19,039)
Net Loss Before Non-Controlling Interests $(4,373,667) $(5,613,421) $(5,626,925) $(4,594,850)
                
Cash:                
Aethlon $5,610,061  $625,531  $12,131,396  $4,058,456 
ESI  738   3,084   197   197 
Total Cash $5,610,799  $628,615  $12,131,593  $4,058,653 
                
Total Assets:                
Aethlon $5,745,031  $752,578  $12,669,552  $4,682,294 
ESI  5,723   37,019   197   197 
Total Assets $5,750,754  $789,597  $12,669,749  $4,682,491 
                
Capital Expenditures:                
Aethlon $23,705  $2,961  $54,630  $148,064 
ESI            
Capital Expenditures $23,705  $2,961  $54,630  $148,064 
                
Depreciation and Amortization:                
Aethlon $27,402  $16,322  $28,775  $15,992 
ESI     10,043       
Total Depreciation and Amortization $27,402  $26,365  $28,775  $15,992 
                
Interest Expense:                
Aethlon $(306,495) $(115,308) $(1,530) $(54,232)
ESI            
Total Interest Expense $(306,495) $(115,308) $(1,530) $(54,232)

 

 

 1618 

 

 

13. COMMITMENTS AND CONTINGENCIES

 

Lease CommitmentsCONTRACTUAL 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, 2020, filed by us with the SEC on June 25, 2020.

On October 30, 2020, we entered into a Separation Agreement with Timothy Rodell, M.D., our former Chief Executive Officer, or the Separation Agreement. Under this agreement, we agreed to pay Dr. Rodell a total of $444,729 and to cover his medical insurance costs over a twelve-month period that began on November 1, 2020, all in accordance with the terms of his employment agreement with the Company. We also paid Dr. Rodell accrued vacation in the amount of $20,260 in November 2020.

The total expense accrued at December 31, 2020 relating to the Separation Agreement, was $400,578 (see Note 7 and Note 8).

On October 30, 2020, we entered into an Executive Employment Agreement, or Agreement, with Charles J. Fisher Jr., M.D. The Agreement provides Dr. Fisher with (i) an initial annualized base salary of $430,000 per year; (ii) eligibility for a discretionary annual cash bonus, (iii) eligibility for a one-time cash bonus and additional equity grant upon attaining a specified performance goal, (iv) eligibility to participate in and receive additional stock options or equity award grants under the Company’s equity incentive plans from time to time, in the discretion of the Board or the Compensation Committee, and in accordance with the terms and conditions of such plans; and (iv) severance payments in the event that Dr. Fisher’s employment is terminated by the Company for any reason other than Cause (as defined in the Agreement) or if it is terminated by Dr. Fisher for Good Reason (as defined in the Agreement).

LEASE COMMITMENTS

 

We currently rentlease approximately 2,600 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego CA, California 92123 at the rate of $6,054 per month onunder a four-year39-month gross plus utilities lease that commenced on December 1, 2014 and expires in May 2018. on August 31, 2021. The current rental rate under the lease extension is $8,265 per month.

We also rent approximately 1,700 square feet of laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego, California 92121 at the rate of $4,548$6,148 per month on a one-year lease that originally was extended to an expirationexpire on November 30, 2020. In December 2020, we entered into a short-term lease extension running from December 1, 2020 through the completion date of November 30, 2018.our construction of our planned new laboratory space which is adjacent to our current laboratory.

 

Rent expense, which is included in general and administrative expenses, approximated $100,000$50,000 and $114,000$44,000 for the three month periods ended December 31, 2020 and 2019, respectively. For the nine month periods ended December 31, 20172020 and 2016,2019, rent expense approximated $144,000 and $130,000, respectively.

 

Legal MattersFuture minimum lease payments under the Granite Ridge Lease as of December 31, 2020, are as follows:

January 1, 2021 through March 31, 2021 $25,663 
April 1, 2021 through August 31, 2021  43,670 
Total future minimum lease payments  69,333 
Less: discount  (1,635)
Total lease liability $67,698 

19

During 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 lease liabilities and right-of-use lease assets of $228,694 on our balance sheet as of April 1, 2019. The lease liabilities represent the present value of the remaining lease payments of our corporate headquarters lease, discounted using our 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. We also elected the short-term lease recognition exemption for its laboratory lease. For the laboratory lease that qualified as short-term, we did not recognize right-of-use assets or lease liabilities at adoption.

In December 2020, we entered into an agreement to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space. The agreement carries a term of 63 months and we will commence paying rent when we take occupancy of those spaces, which is expected to occur in the second quarter of 2021. Upon taking occupancy of the space, we will record lease liabilities and right-of-use lease assets related to this agreement on our balance sheet. We estimate that the present value of the contractual payments under the lease agreement to be approximately $806,000.

In addition, the new lease agreement required us to post a standby letter of credit in favor of the landlord in the amount of $46,726 in lieu of a security deposit. We arranged for our bank to issue the standby letter of credit in the three months ended December 31, 2020 and transferred a like amount to a restricted certificate of deposit which secured the bank’s risk in issuing that letter of credit. We have classified that restricted certificate of deposit on our balance sheet as restricted cash .

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 December 31, 20172020 through the date that the accompanying condensed consolidated financial statements were filed with the Securities and Exchange CommissionSEC for transactions and other events which may require adjustment of and/or disclosure in such financial statements.

 

Warrant Exercises –SubsequentIn January 2021, we hired two senior executives, Guy Cipriani as Senior Vice President, Chief Business Officer, and Steven LaRosa, M.D., as Chief Medical Officer and entered into employment agreements with each executive. Mr. Cipriani will oversee business development and partnerships, while also contributing to December 31, 2017, sixteen investors that participatedfundraising and corporate development. Mr. Cipriani’s initial annual base salary is $340,000 and Mr. Cipriani also is eligible for a discretionary annual cash bonus.  Mr. Cipriani also is eligible for reimbursement of relocation expenses in the October 2017 public offering exercised 852,700 warrantsaggregate amount of up to $75,000.  Dr. LaRosa will be responsible for aggregatethe clinical development of Aethlon's Hemopurifier®, including leading clinical operations and regulatory strategy. In addition to a one-time signing bonus of $100,000, subject to repayment if Dr. LaRosa leaves Aethlon prior to two years with the Company, Dr. LaRosa’s initial annual base salary is $400,000. Dr. LaRosa also is eligible for a discretionary annual cash proceedsbonus and relocation expense reimbursement of up to us$50,000.  Upon commencement of $937,970 before expenses.

ATM Sales-- Subsequentemployment each of Mr. Cipriani and Dr. LaRosa was granted an option to December 31, 2017, we sold common stock under ourpurchase 120,883 shares of the Company’s Common Stock, Sales Agreement with H.C. Wainwright (see Note 6) and from those sales raised net proceeds of $454,654 (after deducting $14,123 in commissionsan exercise price equal to H.C. Wainwright and $1,998 in other offering expenses), utilizing the sales agreement through the sale of 340,000 shares at an average price of $1.34 per share of net proceeds.

Restricted Stock Unit (“RSU”) Issuances – In January 2018, 46,125 RSUs held by our executives were exchanged into the same number of shares of our common stock. As our executives elected to net settle a portion of their RSUs in exchange for the Company paying the related withholding taxesfair market value on the share issuance, 26,157date of grant, subject to a four-year vesting schedule and other terms and conditions of the RSUs were cancelled, and we issued a net 19,968 shares to our executives.Company’s 2020 Equity Incentive Plan.

 

 

 

 1720 

 

 

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, (the “Securities Act"),or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause theour actual results, performance, or achievements of Aethlon Medical, Inc. ("we" or "us") to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this Form 10-Q. Such 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, or FDA, 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, (the “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 subsidiary (collectively, “Aethlon”, the “Company”, “we” or “us”)We are a medical technology company focused on addressing unmet needs in global healthdeveloping products to diagnose and biodefense.treat life and organ threatening diseases. The Aethlon Hemopurifier®, or Hemopurifier, is an earlya clinical-stage therapeuticimmunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for the single-use removal of life-threatening viruses from the circulatory system of infected individuals. two independent indications:

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

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

We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently 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.

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 is 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. This 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 now open for patient enrollment.

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We also believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment countermeasure objectives set forth by the U.S. Government to protect citizens from bioterror and pandemic threats.treatment. In small-scale or early feasibility human studies, the Hemopurifier has been administeredused to treat individuals infected with human immunodeficiency virus, or HIV, Hepatitis-C, and Ebola.

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

On June 17, 2020, the clinical advancementFDA approved a supplement to the Company’s open IDE for the Company’s Hemopurifier in viral disease to allow for the testing of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA. Wein 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 concludedtreated a feasibility study to demonstratepatient with COVID-19, who successfully completed eight daily treatments with the safety of our device in health-compromised individuals infected with a viral pathogen.Hemopurifier.

 

We are also the majority owner of Exosome Sciences, Inc. (ESI), or ESI, a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. Included among ESI’s endeavorsactivities is the advancement of a TauSomeTMTauSome™ biomarker candidate to diagnose Chronic Traumatic Encephalopathy (CTE)chronic traumatic encephalopathy, or CTE, in the living. ESI previously documented that TauSome levels in former NFL players to be nine times higher than same age-group control subjects. 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.

 

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

 

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

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RESULTS OF OPERATIONS

  

THREE MONTHS ENDED DECEMBER 31, 20172020 COMPARED TO THE THREE MONTHS ENDED DECEMBER 31, 20162019

 

Government Contract Revenues

 

We recorded any $74,813 of$624,871 in government contract revenue in the three months ended December 31, 2020. This revenue resulted from work performed under our government contracts with NIH as follows:

  Three Months
Ended 12/31/20
  Three Months
Ended 12/31/19
  Change in
Dollars
 
Phase 2 Melanoma Cancer Contract $436,427  $413,458  $22,969 
Breast Cancer Grant  188,444   30,000   158,444 
Total Government Contract and Grant Revenue $624,871  $443,458  $181,413 

We have recognized revenue under the following two 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 focuses on melanoma exosomes. This work follows from our completion of a phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the phase I work, the deliverables in the phase II program involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

23

During the period ended December 31, 2020, we did not record anycompleted all of the milestones relevant to that time period. As a result, we recorded $436,427 of government contract revenue on the Phase 2 Melanoma Cancer Contract in the three months ended December 31, 2016. That2020.   Of the total revenue arose from work performed under our government contract withrecognized during the National Institutescurrent period relating to this grant, a total of Health, or NIH,$117,849 was invoiced to the NCI during the three months ended December 31, 2020 and we recorded $318,578 which had previously been recognized as follows:

  Three Months
Ended
12/31/17
  Three Months
Ended
12/31/16
  Change in
Dollars
 
NIH Contract $74,813  $  $74,813 
Total Government Contract Revenue $74,813  $  $74,813 

NIH Contract

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

  

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

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

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

 

In the three months ended December 31, 2017,2020, we completed and submitted the first milestonefinal reports applicable to this NCI 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,” or the Breast 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 contractgrant; through August 31, 2020. The total amount of the firm grant was $298,444. The grant called for two subcontractors to work with us. Those subcontractors were University of Pittsburgh and invoicedMassachusetts General Hospital. As of December 31, 2020, we have received all of the funds allocated to the Breast Cancer Grant.

During the three months ended December 31, 2020, we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant as we achieved two of the three milestones related to the Breast Cancer Grant and concluded in our final report that our work under the grant provided nonclinical support that the Hemopurifier has the capacity to clear exosomes from breast cancer patients. That amount previously was recorded as deferred revenue.

Subaward with University of Pittsburgh

In addition, we are completing the logistical elements of documentation and billing the University of Pittsburgh in connection with a cost reimbursable subaward arrangement under an NIH forproject entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the $74,812.50 payment associated with that milestone.award is $256,750. We have not recorded any revenues as of December 31, 2020 related to the subaward. We anticipate billing and recognizing revenue under this subaward in future periods.

 

Operating Expenses

 

Consolidated operating expenses for the three months ended December 31, 20172020 were $1,238,440 in comparison with $1,235,546$3,068,459, compared to $1,289,864 for the comparable period a year ago.three months ended December 31, 2019. This increase of $2,894,$1,778,595, or 0.2%137.9%, in the 2020 period was due to an increaseincreases in payroll and related expenses of $27,547, a $22,251 increase in professional fees and a $46,904 decrease$1,117,229, in general and administrative expenses.expenses of $646,320, and in professional fees of $15,046.

 

The $27,547$1,117,229 increase in payroll and related expenses was due to the combination of an $841,847 increase in our cash-based compensation expense and a $17,003$275,382 increase in stock-based compensation andexpense. The largest factor in the cash-based compensation increase was a result of recording an aggregate of $593,272 related to severance costs associated with the Separation Agreement. Additional factors were a $10,545$125,000 increase in our cash-based payrollyear-end bonus payments, increased headcount and related expenses due to bonuses given to our support and scientific staff.salary increases.

 

The $22,251$646,320 increase in our professional fees was due to an increase in our professional fees of $37,962, which was partially offset by a decrease in our professional fees at ESI of $15,711. The $37,962 decrease in our professional fees was due to a $62,864 increase in our legal fees, a $22,022 increase in our investor relations fees, a $14,069 increase in our accounting fees, a $7,358 increase in our marketing expenses, and a $6,100 increase in our directors’ fees due to an increase in our Board of Directors, which were partially offset by a $51,548 decrease in our scientific consulting expenses and a $25,000 decrease in business development expenses.

The $46,904 decrease in general and administrative expenses was primarily due to a $34,324 decrease$360,703 increase in our clinical trial expenses, a $6,519$132,542 increase in subcontractor expenses associated with our government contracts and grants, a $130,019 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 $39,667 increase in our insurance expenses.

The $15,046 increase in our professional fees was primarily due to a $28,421 increase in contract labor, predominantly research scientists hired on a consulting basis, and a $23,151 increase in our legal fees, which were partially offset by a $35,189 decrease in the cost of our lab supplies and a $4,743 refund on previous state franchise tax payments.accounting fees.

 

 

 

 1924 

 

 

Other ExpenseIncome (Expense)

 

OtherWe had $802 of other expense during the three months ended December 31, 2017 and 20162020. In the three months ended December 31, 2019, other expense consisted of interest expense and a gain on debt extinguishment. Other expense for the three months ended December 31, 2017 was other expense of $55,912 in comparison with other income of $22,126 for the three months ended December 31, 2016.

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

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

Interest Expense

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

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

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

Net Loss

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests increased from approximately $1,213,000 in the three month period ended December 31, 2016 to $1,220,000 in the three month period ended December 31, 2017.

Basic and diluted loss attributable to common stockholders were ($0.08) for the three month period ended December 31, 2017 compared to ($0.15) for the period ended December 31, 2016.

NINE MONTHS ENDED DECEMBER 31, 2017 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 2016

Revenues

We recorded government contract revenue of $74,813 in the nine months ended December 31, 2017 and we recorded government contract revenue of $392,073 in the nine months ended December 31, 2016. This revenue arose from work performed under our government contracts with the National Institutes of Health, or NIH, with the Defense Advanced Research Projects Agency, or DARPA, and our government subcontract with Battelle Memorial Institute as follows:

  Nine Months
Ended 12/31/17
  Nine Months
Ended 12/31/16
  Change in
Dollars
 
NIH Contract $74,813  $  $74,813 
DARPA Contract     387,438   (387,438)
Battelle Subcontract     4,635   (4,635)
Total Government Contract Revenue $74,813  $392,073  $(317,260)

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NIH Contract

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

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

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

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

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

DARPA Contract & Battelle Subcontract

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

Operating Expenses

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

The $882,335 decrease in payroll and related expenses was primarily due to a $992,543 decrease in stock-based compensation. The decrease in stock-based compensation was due to the upfront vesting percentage of the RSU grants to our officers and directors in August 2016. Our cash-based payroll and related expenses increased by $110,208 due to headcount additions in our scientific staff.

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

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

Other Expense

Other expense during the nine months ended December 31, 2017 and 2016 consisted of losses on debt extinguishment, warrant repricing expense, losses on share for warrant exchanges and interest expense. Other expense for the nine months ended December 31, 2017 was other expense of $813,618 in comparison with other expense of $1,019,347 for the nine months ended December 31, 2016.exchanges.

  

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

  

  Nine Months
Ended
  Nine Months
Ended
    
  12/31/17  12/31/16  Change 
Loss on Debt Extinguishment $376,909  $558,198  $(181,289)
Loss on Warrant Repricing     345,841   (345,841)
Loss on Share for Warrant Exchanges  130,214      130,214 
Interest Expense  306,495   115,308   191,187 
Total Other Expense $813,618  $1,019,347  $(205,729)
  Three Months
Ended
  Three Months
Ended
    
  12/31/20  12/31/19  Change 
(Gain) on Share for Warrant Exchanges $  $(55,593) $55,593 
Interest Expense  802   126   676 
Total Other Expense $802  $(55,467) $56,269 

 

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Loss on Debt Extinguishment

Our loss on debt extinguishment for the nine months ended December 31, 2017 arose from a $376,909 loss associated with the June 2017 amendments to our convertible notes. This compared to a loss of debt extinguishment of $558,198 for the nine months ended December 31, 2016 - see below for additional information.

June 2017 Amendments – The $376,909 loss on debt extinguishment in the six months ended September 30, 2017 arose from an Exchange Agreement with two institutional investors under which we issued 57,844 restricted shares in exchange for the cancellation of 77,125 warrants held by those investors (see Loss on Share for Warrant Exchanges below). Additionally, we agreed with those investors that they would extend the expiration dates of the convertible notes held by those investors from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00 per share. The modification of the notes was evaluated under FASB Accounting Standards Codification (“ASC”) Topic No. 470-50-40, “Debt Modification and Extinguishments”. Therefore, according to the guidance, the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting.

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

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

Loss on Warrant Repricing

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

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

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

LossGain on Share for Warrant Exchanges

 

DuringThere was no warrant exchange activity during the ninethree months ended December 31, 2017,2020. During the three months ended December 31, 2019, we agreed with two individualaccredited investors to exchange 11,497 restrictedissue 2,914 shares for the cancellation of 22,993 warrants and we entered into an Exchange Agreement with two institutionalour common stock to these investors under which we issued 57,844 restricted shares in exchange for the cancellation of 77,125outstanding warrants then held by those investors. Additionally, we entered into an agreement with a former placement agentthe investors to issue 5,500 restrictedpurchase 29,141 shares in exchange for the cancellation of 11,000 warrants held by that placement agent.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 losses for eacha gain of $55,593 on those exchanges based on the changes in fair value between the instruments exchanged.

  

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Interest Expense

 

InterestWe had $802 in interest expense was $306,495 forin the ninethree months ended December 31, 2017 compared to $115,308 in2020. Interest expense was $126 for the corresponding prior period, an increase of $191,187.three months ended December 31, 2019. The various components of our interest expense are shown in the following table:

 

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

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

  Three Months
Ended
  Three Months
Ended
    
  12/31/20  12/31/19  Change 
Interest Expense $802  $126  $676 

 

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests decreased fromincreased to approximately $5,613,000$2,447,000 in the ninethree month period ended December 31, 2016 to $4,374,0002020, from approximately $821,000 in the ninethree month period ended December 31, 2017.2019.

  

Basic and diluted loss attributable to common stockholders were ($0.40)0.20) for the three month period ended December 31, 2020, compared to ($0.28) for the three month period ended December 31, 2019.

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NINE MONTHS ENDED DECEMBER 31, 2020 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 2019

Government Contract Revenues

We recorded $624,871 in government contract revenue in the nine months ended December 31, 2020. This revenue resulted from work performed under our government contracts with NIH as follows:

  Nine Months
Ended 12/31/20
  Nine Months
Ended 12/31/19
  Change in
Dollars
 
Phase 2 Melanoma Cancer Contract $436,427  $413,458  $22969 
Breast Cancer Grant  188,444   30,000   158,444 
Total Government Contract and Grant Revenue $624,871  $443,458  $181,413 

We have recognized revenue under the following two 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 focuses on melanoma exosomes. This work follows from our completion of a phase I contract for the Topic 359 solicitation that ran from September 2017 through June 2018, as described below. Following on the phase I work, the deliverables in the phase II program involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.

During the period ended December 31, 2020, we completed all of the milestones relevant to that time period. As a result, we recorded $436,427 of government contract revenue on the Phase 2 Melanoma Cancer Contract in the nine months ended December 31, 2020.   Of the total revenue recognized during the current period relating to this grant, a total of $117,849 was invoiced to the NCI during the three months ended December 31, 2020 and we recorded $318,578 which had previously been recognized as deferred revenue.

Breast Cancer Grant

In the nine months ended December 31, 2020, we completed and submitted the final reports applicable to this NCI 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,” or the Breast 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; through August 31, 2020. The total amount of the firm grant was $298,444. The grant called for two subcontractors to work with us. Those subcontractors were University of Pittsburgh and Massachusetts General Hospital. As of December 31, 2020, we have received all of the funds allocated to the Breast Cancer Grant.

26

During the nine months ended December 31, 2020, we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant as we achieved two of the three milestones related to the Breast Cancer Grant and concluded in our final report that our work under the grant provided nonclinical support that the Hemopurifier has the capacity to clear exosomes from breast cancer patients. That amount previously was recorded as deferred revenue.

Subaward with University of Pittsburgh

In addition, we are completing the logistical elements of documentation and billing the University of Pittsburgh in connection with a cost reimbursable subaward arrangement under an NIH project entitled “Depleting Exosomes to Improve Responses to Immune Therapy in HNNCC.” Our share of the award is $256,750. We have not recorded any revenues as of December 31, 2020 related to the subaward. We anticipate billing and recognizing revenue under this subaward in future periods.

Operating Expenses

Consolidated operating expenses for the nine months ended December 31, 2020 were $6,250,266, compared to $4,588,255 for the nine months ended December 31, 2019. This increase of $1,662,011, or 36.2%, in the 2020 period was due to increases in payroll and related expenses of $910,863 and in general and administrative expenses of $885,337, which were partially offset by a decrease in professional fees of $134,189.

The $910,863 increase in payroll and related expenses in the nine months ended December 31, 2020 was due to a $934,726 increase in our cash-based compensation expense, which was partially offset by a $23,865 reduction in stock-based compensation expense. The largest factor in the cash-based compensation increase was a result of recording an aggregate of $593,272 related to severance costs associated with the Separation Agreement. Additional factors were a $125,000 increase in year-end bonus payments and our headcount and salary increases.

The $885,337 increase in general and administrative expenses in the nine months ended December 31, 2020 was primarily due to a $441,246 increase in our clinical trial expenses, a $67,542 increase in subcontractor expenses associated with our government contracts and grants, a $318,100 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 $60,958 increase in our insurance expenses.

The $134,189 decrease in our professional fees was due to a $116,432 decrease in our accounting fees, a $92,820 decrease in our legal fees, and a $23,610 decrease in other consulting fees, which were partially offset by a $102,243 increase in contact labor, predominantly research scientists hired on a consulting basis.

Other Expense

Other expense during the nine months ended December 31, 2020 consisted of interest expense and during the nine months ended December 31, 2019, consisted of interest expense, a gain on share for warrant exchanges and a loss on debt extinguishment. Other expense for the nine months ended December 31, 2020 was $1,530, compared to other expense of $450,053 for the nine months ended December 31, 2019.

27

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

  Nine Months
Ended
  Nine Months
Ended
    
  12/31/20  12/31/19  Change 
Loss on Debt Extinguishment $  $447,011  $(447,011)
Gain on Share for Warrant Exchanges $  $(51,190) $51,190 
Interest Expense $1,530  $54,232  $(52,702)
Total Other Expense $1,530  $450,053  $(448,523)

Loss on Debt Extinguishment

There were no losses on debt extinguishment during the nine months ended December 31, 2020. During the nine months ended December 31, 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.

Gain on Share for Warrant Exchanges

There was no warrant exchange activity during the nine months ended December 31, 2020. During the nine months ended December 31, 2019, we agreed with seven accredited investors to issue 3,992 shares of our common stock to these investors in exchange for the cancellation of outstanding warrants then held by the investors to purchase 39,900 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 gain of $51,190 on those exchanges based on the changes in fair value between the instruments exchanged.

Interest Expense

Total interest expense was $1,530 for the nine months ended December 31, 2020, and $54,232 for the nine months ended December 31, 2019, a decrease of $52,702. The various components of our interest expense are shown in the following table:

  Nine Months
Ended
  Nine Months
Ended
    
  12/31/20  12/31/19  Change 
Interest Expense $1,530  $23,945  $(22,415)
Amortization of Note Discounts $  $30,287  $(30,287)
Total Interest Expense $1,530  $54,232  $(52,702)

The $52,702 decrease in our total interest expense in the nine months ended December 2020 was due to the payment in full of our convertible notes in July 2019.

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Net Loss

As a result of the changes in revenues and expenses noted above, our net loss increased to approximately $5,630,000 in the nine month period ended December 31, 2020, from approximately $4,595,000 in the nine month period ended December 31, 2019.

Basic and diluted loss attributable to common stockholders were ($0.50) for the nine month period ended December 31, 20172020, compared to ($0.72)2.52) for the nine month period ended December 31, 2016.2019.

 

LIQUIDITY AND CAPITAL RESOURCES

 

AtAs of December 31, 2017,2020, we had a cash balance of $5,610,799$12,131,593 and current working capital of $5,288,930.$11,086,708. This compares to a cash balance of $1,559,701$9,604,780 and working capital of $985,496$8,973,393 at March 31, 2017.2020. We expect our existing cash as of December 31, 2020 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these financial statements.

 

On October 4, 2017, we consummated a public offeringThe primary source of 5,454,546 shares of common stock and warrants to purchase 5,454,546 shares of common stock, for total gross proceeds of $6.0 million. The offering was priced at $1.10 per unit with each unit comprised of one share of common stock and one common stock purchase warrant. The warrants carry a five-year term with an exercise price of $1.10 per share. The net proceeds ofour increase in cash during the offering were $5,289,735. H.C. Wainwright & Co. acted as exclusive placement agent for the offering. We expect the net proceeds from that offering coupled with cash on hand will finance our operations for the twelve month period from the date of this report.

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

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

Also subsequent to December 31, 2017, we sold common stock under2020 resulted from our Common Stock Sales Agreement with H.C. Wainwright (see Note 6)& Co., LLC, or Wainwright. The cash raised from that activity is described below:

Common Stock Sales Agreement with Wainwright

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

On March 30, 2020, we executed Amendment No. 2 to the Agreement with Wainwright, effective as of 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. 333-237269), originally filed with the SEC on March 19, 2020, declared effective by the SEC on March 30, 2020.

Subject to the terms and conditions set forth in the Agreement Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the shares under the Agreement from time to time, based upon our instructions. We provided Wainwright with customary indemnification rights under the Agreement, and Wainwright is entitled to a commission at a fixed rate equal to three percent of the gross proceeds per share sold. In addition, we agreed to pay certain expenses incurred by 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 shares 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 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.

29

In the nine months ended December 31, 2020, we raised aggregate net proceeds of $454,654 (after deducting $14,123$7,260,869, net of $224,825 in commissions to H.C. Wainwright and $1,998$8,472 in other offering expenses) utilizingexpenses, under the sales agreementAgreement through the sale of 340,0002,685,600 shares at an average price of $1.34$2.70 per share of net proceeds.

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

23

 

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, any continued delays in completing our clinical trials, competing technological and market developments, as well as our ability to establish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future.

 

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

Cash Flows

 

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

 

 (In thousands)
For the nine months ended
  (In thousands)
For the nine months ended
 
 December 31,
2017
 December 31,
2016
  December 31,
2020
 December 31,
2019
 
Cash provided by (used in):                
Operating activities $(2,893) $(2,644) $(4,526) $(3,577)
Investing activities  (24)  (3) $(55) $(148)
Financing activities  6,968   1,060  $7,154  $3,956 
Net increase (decrease) in cash $4,051  $(1,587)
Net increase (decrease) in cash and cash equivalents $2,573  $231 

   

NET CASH USED IN OPERATING ACTIVITIES. We used cash in our operating activities due to our losses from operations. Net cash used in operating activities was approximately $2,893,000$4,526,000 in the nine monthsmonth period ended December 31, 20172020, compared to $2,644,000approximately $3,577,000 in the nine monthsmonth period ended December 31, 2016, an increase of $249,000.2019.

  

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $24,000$55,000 of cash to purchase laboratory and office equipment in the nine months ended December 31, 20172020, compared to approximately $3,000$148,000 in the nine month period ended December 31, 2019.

NET CASH PROVIDED BY/(USED IN) FINANCING ACTIVITIES. During the nine months ended December 31, 2016.

NET CASH PROVIDED BY FINANCING ACTIVITIES. In2020, 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 $106,000 to pay for the tax withholding on restricted stock units and on a net stock option exercise by our former Chief Executive Officer, for an aggregate increase of cash provided by financing activities of approximately $7,154,000. During the nine months ended December 31, 20172019, we generatedraised approximately $6,968,000$4,987,000 from our financing activities primarily through the issuance of common stock, an increasewhich was offset by the use of $5,908,000 overapproximately $993,000 to pay off our then outstanding convertible notes and approximately $39,000 to pay for the $1,060,000 raised in the nine months ended December 31, 2016.tax withholding on restricted stock units.

 

AtAs 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.

 

30

CRITICAL ACCOUNTING POLICIES

 

Use of Estimates

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

 

We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting policiesestimates relate to revenue recognition, measurement of stock purchase warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance, and the classification of warrant obligations, and evaluation of contingencies. We believe estimates and assumptions related to these critical accounting policies are appropriate under the circumstances; however, should future events or occurrences result in unanticipated consequences, there could be a material impact on our future financial condition or results of operations.

24

 

There have been no changes to our critical accounting policies as disclosed in our Form 10-K for the year ended March 31, 2017.2020.

  

OFF-BALANCE SHEET ARRANGEMENTS

 

WeAs of December 31, 2020, we did not have no obligations required to be disclosed herein asany off-balance sheet arrangements.

  

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

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

     

ITEM 4. CONTROLS AND PROCEDURES.

 

DISCLOSURE CONTROLS AND PROCEDURES

 

Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Quarterly Report.

 

Based on such evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of the end of such period, our disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the 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.

 

 

 

 

 2531 

 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

From time to time, claims are made against us in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more products or engaging in other activities.

 

The occurrence of an unfavorable outcome in any specific period could have a material adverse effect on our results of operations for that period or future periods. We are not presently a party to any pending or threatened legal proceedings.

 

ITEM 1A. RISK FACTORS.

RISK FACTOR SUMMARY

Below is a summary of the principal factors that make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making investment decisions regarding our securities.

·We have incurred significant operating losses since our inception and have not generated any revenue. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.
·We will require substantial additional funding to sustain our operations. If we are unable to raise capital on favorable terms when needed, we could be forced to delay, reduce or eliminate our research or device development programs or any future commercialization efforts.
·To achieve the levels of production necessary to commercialize our Hemopurifier and any other future products, we will need to secure large-scale manufacturing agreements with contract manufacturers which comply with good manufacturing practice standards and other standards prescribed by various federal, state and local regulatory agencies in the U.S. and any other country of use. We have limited experience coordinating and overseeing the manufacture of medical device products on a large-scale.
·Our Hemopurifier product may be made unmarketable prior to commercialization by us by new scientific or technological developments by others with new treatment modalities that are more efficacious and/or more economical than our products. Any one of our competitors could develop a more effective product which would render our technology obsolete.
·Our Hemopurifier product is subject to extensive government regulations related to development, testing, manufacturing and commercialization in the U.S. and other countries. If we fail to comply with these extensive regulations of the U.S. and foreign agencies, the commercialization of our products could be delayed or prevented entirely.
·As a public company with limited financial resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors.
·We will need to significantly expand our operations to implement our longer-term business plan and growth strategies. We will also be required to manage multiple relationships with various strategic partners, technology licensors, customers, manufacturers and suppliers, consultants and other third parties. The time and costs to effectuate these steps may place a significant strain on our management personnel, systems and resources, particularly given the limited amount of financial resources and skilled employees that may be available at the time.
·Our business prospects will depend on our ability to complete studies, clinical trials, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our Hemopurifier product candidate. Delays in successfully completing the clinical trials could jeopardize our ability to obtain regulatory approval.
·If we are unable to adequately address these and other risks we face, our business, financial condition, operating results and prospects may be adversely affected.
·Our business could be adversely affected by the effects of health pandemics or epidemics, including the COVID-19 pandemic.

32

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, 2020.

*Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.

Our business prospects will depend on our ability to complete studies, clinical trials, including our EFS trial in 10 to 12 patients, obtain satisfactory results, obtain required regulatory approvals and successfully commercialize our Hemopurifier product candidate. Completion of our clinical trials, announcement of results of the trials and our ability to obtain regulatory approvals could be delayed for a variety of reasons, including:

·slow patient enrollment;
·serious adverse events related to our medical device candidates;
·unsatisfactory results of any clinical trial;
·the failure of our principal third-party investigators to perform our clinical trials on our anticipated schedules;
·different interpretations of our pre-clinical and clinical data, which could initially lead to inconclusive results; and
·delays resulting from the coronavirus pandemic.

Our development costs will increase if we have material delays in any clinical trial or if we need to perform more or larger clinical trials than planned. If the delays are significant, or if any of our product candidates do not prove to be safe or effective or do not receive required regulatory approvals, our financial results and the commercial prospects for our product candidates will be harmed. Furthermore, our inability to complete our clinical trials in a timely manner could jeopardize our ability to obtain regulatory approval.

*The approval requirements for medical products used to fight bioterrorism are still evolving, and any products we develop for such uses may not meet these requirements.

We are advancing product candidates under governmental policies that regulate the development and commercialization of medical treatment countermeasures against bioterror and pandemic threats. While we intend to pursue FDA market clearance to treat infectious bioterror and pandemic threats, it is often not feasible to conduct human studies against these deadly high threat pathogens. For example, the Hemopurifier is an investigational device that has not yet received FDA approval for any indication. We continue to investigate the potential for the use of the Hemopurifier in viral diseases under an open IDE and our FDA Breakthrough Designation for “…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy.” We currently have an open FDA approved Expanded Access Protocol for the treatment of Ebola infected patients in the U.S. and a corresponding HealthCanada approval in Canada. Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV and Ebola. We do have preclinical data suggesting that it could clear a closely related coronavirus (MERS). Additionally, we have a very limited supply of Hemopurifiers and therefore any use in this pandemic will be only investigational in a very small number of patients, even if it appears that the device can help those patients.

Thus, we may not be able to demonstrate the effectiveness of our treatment countermeasures through controlled human efficacy studies. Additionally, a change in government policies could impair our ability to obtain regulatory approval and the FDA may not approve any of our product candidates.

33

*Should any of our potential products, including the Hemopurifier, be approved for commercialization, adverse changes in reimbursement policies and procedures by payors may impact our ability to market and sell our products.

Healthcare costs have risen significantly over the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors to decrease costs. Third-party payors are increasingly challenging the prices charged for medical products and services and instituting cost containment measures to control or significantly influence the purchase of medical products and services.

For example, in the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, PPACA, among other things, reduced and/or limited Medicare reimbursement to certain providers. However, on December 14, 2018, a Texas U.S. District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act of 2017. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the PPACA are invalid as well. The United States Supreme Court is currently reviewing this case, but it is unclear when a decision will be made. The Budget Control Act of 2011, as amended by subsequent legislation, further reduces Medicare’s payments to providers by two percent through fiscal year 2030. The Coronavirus Aid, Relief and Economic Security Act, or CARES Act, and other COVID-19 relief legislation have, among other things, temporarily suspended the two percent Medicare sequester from May 1, 2020 through March 31,2021. These reductions may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies. Furthermore, the healthcare industry in the U.S. has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs by imposing lower payment rates and negotiating reduced contract rates with service providers. Legislation could be adopted in the future that limits payments for our products from governmental payors. It is possible that additional governmental action is taken to address the COVID-19 pandemic. It is also possible that additional health reform measures will be implemented as a result of the new Presidential administration. In addition, commercial payors such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore, it is possible that our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective level. We face similar risks relating to adverse changes in reimbursement procedures and policies in other countries where we may market our products. Reimbursement and healthcare payment systems vary significantly among international markets. Our inability to obtain international reimbursement approval, or any adverse changes in the reimbursement policies of foreign payors, could negatively affect our ability to sell our products and have a material adverse effect on our business and financial condition.

 

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

 

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

34

 

ITEM 6. EXHIBITS.

 

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

 

31.1Certification of Principal Executive Officer pursuant to Securities Exchange Act rules 13a- 14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002
31.2Certification of Principal Financial Officer pursuant to Securities Exchange Act rules 13a- 14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002
32.1Certification of Principal Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002
32.2Certification of Principal Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002
101Interactive Data Files
101.INSXBRL Instance Document
101.SCHXBRL Schema Document
101.CALXBRL Calculation Linkbase Document
101.DEFXBRL Definition Linkbase Document
101.LABXBRL Label Linkbase Document
101.PREXBRL Presentation Linkbase Document
      Incorporated by Reference
Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
             
 3.1 Articles of Incorporation. 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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      Incorporated by Reference
Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
              
 10.1 Separation Agreement between the Company and Dr. Rodell, dated October 30, 2020. 8-K 001-37487 10.1 November 3, 2020  
              
 10.2* Employment Agreement between the Company and Dr. Fisher, dated October 30, 2020. 8-K 001-37487 10.2 November 3, 2020  
              
 10.3 Lease, by and between the Company and San Diego Inspire 1, LLC. and San Diego Inspire 2, LLC, effective December 7, 2020.         X
              
 10.4 Eighth Amendment to Standard Industrial Net Lease, by and between the Company and San Diego Inspire 1, LLC., effective December 7, 2020.         X
              
 10.5 Executive Employment Agreement between the Company and Guy Cipriani, dated January 1, 2021.         X
              
 10.6 Executive Employment Agreement between the Company and Steven P. LaRosa, MD, dated January 4, 2021.         X
              
 31.1 Certification of our Chief Executive Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.         X
              
 31.2 Certification of our Chief Financial Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.         X
              
 32.1 Statement of our Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350).         X
              
 32.2 Statement of our Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350).         X
              
 101.INS 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

 ___________________

++Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedules will be furnished to the SEC upon request.

36

SIGNATURES

 

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

 

 AETHLON MEDICAL, INC.
 
    
Date: February 1, 201810, 2021By:/s/ JAMES B. FRAKES 
  JAMES B. FRAKES 
  CHIEF FINANCIAL OFFICER 
  CHIEF ACCOUNTING OFFICER 

 

 

 

 

 

 

 


 

 

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