Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended December 31, 2017June 30, 2019

 

OR

 

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

 

For the transition period from _____to_____

 

COMMISSION FILE NUMBER 001-37487

 

AETHLON MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

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

 

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

(Address of principal executive offices)    (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,August 14, 2019, the registrant had outstanding 16,580,32619,697,482 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, 2017JUNE 30, 2019 (UNAUDITED) AND MARCH 31, 201720193
   
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTH AND NINE MONTH PERIODS ENDED DECEMBER 31, 2017JUNE 30, 2019 AND 20162018 (UNAUDITED)4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE MONTHS ENDED JUNE 30, 2019 AND 2018 (UNAUDITED)5
   
 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINETHREE MONTHS ENDED DECEMBER 31, 2017JUNE 30, 2019 AND 20162018 (UNAUDITED)56
   
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)67
   
ITEM 2.MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1817
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2522
   
ITEM 4.CONTROLS AND PROCEDURES2522
   
PART II.OTHER INFORMATION2623
   
ITEM 1.LEGAL PROCEEDINGS2623
   
ITEM 1A.RISK FACTORS2623
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS2623
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES2623
   
ITEM 4.MINE SAFETY DISCLOSURES2623
   
ITEM 5.OTHER INFORMATION2623
   
ITEM 6.EXHIBITS2624

 

 

 

 

 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
 
  (Unaudited)    
ASSETS        
Current assets        
Cash $5,610,799  $1,559,701 
Prepaid expenses and other current assets  14,537   37,551 
Total current assets  5,625,336   1,597,252 
         
Property and equipment, net  32,398   29,223 
Patents and patents pending, net  78,123   84,996 
Deposits  14,897   14,897 
Total assets $5,750,754  $1,726,368 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $211,406  $484,423 
Due to related parties  64,466   57,866 
Other current liabilities  60,534   69,467 
Total current liabilities  336,406   611,756 
         
Convertible notes payable, net  810,866   519,200 
         
Total liabilities  1,147,272   1,130,956 
         
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 
Additional paid-in capital  102,820,906   94,445,739 
Accumulated deficit  (98,138,853)  (93,778,156)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  4,697,421   676,379 
         
Noncontrolling interests  (93,939)  (80,967)
         
Total stockholders’ equity  4,603,482   595,412 
         
Total liabilities and stockholders’ equity $5,750,754  $1,726,368 

  June 30,
2019
  March 31,
2019
 
  (Unaudited)    
ASSETS        
Current assets        
Cash $2,492,354  $3,828,074 
Prepaid expenses and other current assets  151,717   210,042 
Total current assets  2,644,071   4,038,116 
         
Property and equipment, net  6,330   6,021 
Right-of-use lease asset  205,968    
Patents, net  64,377   66,668 
Deposits  12,159   12,159 
Total assets $2,932,905  $4,122,964 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
Current liabilities        
Accounts payable $276,116  $131,931 
Due to related parties  94,442   83,654 
Convertible notes payable, net  892,591   962,301 
Lease liability, current portion  93,077    
Other current liabilities  441,228   646,000 
Total current liabilities  1,797,454   1,823,886 
         
Lease liability, less current portion  117,259    
Total liabilities  1,914,713   1,823,886 
         
Commitments and Contingencies (Note 13)        
         
Stockholders’ Equity        
Common stock, par value $0.001 per share; 30,000,000 shares authorized; 19,103,570 and 19,004,253 shares issued and outstanding as of June 30, 2019 and March 31, 2019, respectively  19,104   19,004 
Additional paid-in capital  108,844,836   108,058,538 
Accumulated deficit  (107,718,857)  (105,652,433)
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests  1,145,083   2,425,109 
         
Noncontrolling interests  (126,891)  (126,031)
         
Total stockholders’ equity  1,018,192   2,299,078 
         
Total liabilities and stockholders’ equity $2,932,905  $4,122,964 

 

See accompanying notes.

 

 3 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Nine Month Periods Ended December 31, 2017June 30, 2019 and 20162018

(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
June 30, 2019
 Three Months
Ended
June 30, 2018
 
              
REVENUES                        
                        
Government contract revenue $74,813  $  $74,813  $392,073  $30,000  $149,625 
                        
OPERATING EXPENSES                        
                
Professional fees  439,117   416,866   1,165,318   1,495,597   607,578   449,435 
Payroll and related expenses  663,245   635,698   1,911,553   2,793,888   605,995   602,565 
General and administrative  136,078   182,982   557,991   696,662   382,615   194,897 
Total operating expenses  1,238,440   1,235,546   3,634,862   4,986,147   1,596,188   1,246,897 
OPERATING LOSS  (1,163,627)  (1,235,546)  (3,560,049)  (4,594,074)  (1,566,188)  (1,097,272)
                        
OTHER EXPENSE (INCOME)                
OTHER EXPENSE        
Interest and other debt expenses  55,912   36,565   306,495   115,308   54,085   55,104 
Loss on share for warrant exchanges        130,214    
(Gain)/loss on debt extinguishment     (58,691)  376,909   558,198 
Warrant repricing expense           345,841 
Total other expense (income)  55,912   (22,126)  813,618   1,019,347 
NET LOSS BEFORE NONCONTROLLING INTERESTS  (1,219,539)  (1,213,420)  (4,373,667)  (5,613,421)
Loss on debt extinguishment  447,011    
Total other expense  501,096   55,104 
NET LOSS  (2,067,284)  (1,152,376)
                        
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS  (4,532)  (7,689)  (12,972)  (23,088)  (860)  (6,148)
                        
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. $(2,066,424) $(1,146,228)
                        
BASIC AND DILUTED LOSS PER COMMON SHARE $(0.08) $(0.15) $(0.40) $(0.72) $(0.11) $(0.06)
                        
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED  14,950,701   7,927,031   10,927,106   7,768,682   19,057,255   17,754,728 

 

 

See accompanying notes.

  

 4 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSSTOCKHOLDERS’ EQUITY

For the NineThree Months Ended December 31, 2017June 30, 2019 and 20162018

(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, 2019  19,004,253  $19,004  $108,058,538  $(105,652,433) $(126,031) $2,299,078 
                         
Issuances of common stock for cash under at the market program  46,300   47   36,575         36,622 
                         
Loss on debt extinguishment        447,011         447,011 
                         
Issuance of common shares upon vesting of restricted stock units  53,017   53   (23,824)        (23,771)
                         
Stock-based compensation expense        326,536         326,536 
                         
Net loss           (2,066,424)  (860)  (2,067,284)
                         
BALANCE - JUNE 30, 2019  19,103,570  $19,104  $108,844,836  $(107,718,857) $(126,891) $1,018,192 
                         
                         
BALANCE - MARCH 31, 2018  17,739,511   17,740   105,574,014   (99,457,714)  (101,246)  6,032,794 
                         
Issuance of common shares upon vesting of restricted stock units  21,695   22   (32,759)        (32,737)
                         
Stock-based compensation expense        263,162         263,162 
                         
Net loss         �� (1,146,228)  (6,148)  (1,152,376)
                         
BALANCE - JUNE 30, 2018  17,761,206  $17,762  $105,804,417  $(100,603,942) $(107,394) $5,110,843 

 

See accompanying notes.

 

 5 


AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Three Months Ended June 30, 2019 and 2018

(Unaudited)

 

  Three Months
Ended
June 30, 2019
  Three Months
Ended
June 30, 2018
 
Cash flows used in operating activities:        
Net loss $(2,067,284) $(1,152,376)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  2,868   8,109 
Stock based compensation  326,536   263,162 
Loss on debt extinguishment  447,011    
Amortization of debt discount  30,287   30,287 
Accretion of right-of-use lease asset  661    
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets  58,325   38,886 
Accounts payable and other current liabilities  (56,877)  (6,499)
Due to related parties  10,788    
Net cash used in operating activities  (1,247,685)  (818,431)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (886)   
Net cash used in investing activities  (886)   
         
Cash flows (used in) provided by financing activities:        
Proceeds from the issuance of common stock, net  36,622    
Principal payments on convertible notes  (100,000)   
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units  (23,771)  (32,737)
Net cash used in financing activities  (87,149)  (32,737)
         
Net decrease in cash  (1,335,720)  (851,168)
         
Cash at beginning of period  3,828,074   6,974,070 
         
Cash at end of period $2,492,354  $6,122,902 
         
Supplemental disclosures of cash flow information:        
         
Cash paid during the period for:        
         
Interest $71,978  $ 
         
Supplemental disclosures of non-cash investing and financing activities:        
Initial recognition of right-of-use lease asset and lease liability $228,694  $ 
Par value of shares issued for vested restricted stock units $53  $22 

See accompanying notes.

6

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

December 31, 2017June 30, 2019

 

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

 

ORGANIZATION

 

Aethlon Medical, Inc. and its subsidiary (collectively, “Aethlon”, the “Company”, “we” or “us”) areis a medical technology company focused on addressing unmet needs in global health and biodefense. The Aethlon Hemopurifier® is an earlya clinical-stage therapeuticimmunotherapeutic device designed forto combat cancer and life-threatening viral infections. In cancer, the single-use removalHemopurifier depletes 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 (FDA) has designated the Hemopurifier as a "Breakthrough Device" related to the following two indications:

the treatment of life-threatening viruses from that are not addressed with approved therapies; and

the circulatory systemtreatment of infected individuals. 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.

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. We are in active communication with FDA in preparation for the initiation of an early clinical trial in one of these areas.

We believe the Hemopurifier can be a part of the broad-spectrum treatment of life-threatening highly glycosylated viruses that are not addressed with an already approved treatment countermeasure objectivesobjective set forth by the U.S. Government to protect citizens from bioterror and pandemic threats. In small-scale or early feasibility human studies, the Hemopurifier has been administered to individuals infected with HIV, Hepatitis-C,hepatitis-C, and Ebola. Additionally, the Hemopurifier has been validated 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 the clinical advancement of the Hemopurifier through investigational device exemptions (IDEs) approved by the FDA. We recently concluded a feasibility study to demonstrate the safety of our device in health-compromised individuals infected with a viral pathogen.

 

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

 

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.

 

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.

 

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

 

7

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

During the ninethree months ended December 31, 2017,June 30, 2019, there have been no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2017.2019 except as described below.

 

BASIS OF PRESENTATIONLeases

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

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

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) for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission (SEC) Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended March 31, 2017,2019, included in the Company's Annual Report on Form 10-K filed with the SEC on June 28, 2017.July 1, 2019. 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 ninethree months ended December 31, 2017.June 30, 2019, and the condensed consolidated statement of cash flows for the three months ended June 30, 2019. 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, 20172019 has been derived from the audited consolidated balance sheet at March 31, 2017,2019, contained in the above referenced 10-K. The results of operations for the ninethree months ended December 31, 2017June 30, 2019 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

  

6

LIQUIDITY AND GOING CONCERN

 

Management expects existing cashThe accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of December 31, 2017assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations and at June 30, 2019 had an accumulated deficit of approximately $107,719,000. These factors, among other matters, raise substantial doubt about our ability to continue as a going concern for the twelve months from the issuance of these financial statements. A significant amount of additional capital will be sufficientnecessary to advance the development of our products to the point at which they may become commercially viable. We intend to fund the Company’s operations, forworking capital and other cash requirements through at least twelve months from the issuance date of these interimcondensed consolidated financial statements.statements through debt and/or equity financing arrangements as well as through revenues and related cash receipts under our government contract (see Note 9).

8

We are currently addressing our liquidity issue by seeking additional investment capital through issuances of common stock under our existing S-3 registration statement, or by issuing shares under S-1 registration statements and by applying for additional grants issued by government agencies in the United States. We believe that our cash on hand and funds expected to be received from additional debt and equity financing arrangements will be sufficient to meet our liquidity needs for the twelve month period from the date of this filing. However, no assurance can be given that we will receive any funds in addition to the funds we have received to date.

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

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

 

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 46,125June 30, 2019 and 2018 included common shares underlying 42,875 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, 2017June 30, 2019 and 2016,2018, a total of 9,143,4807,534,759 and 3,810,6427,145,647 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, unvested restricted stock units and convertible notes payable, were excluded as their inclusion would be antidilutive.

  

3. RESEARCH AND DEVELOPMENT EXPENSES

 

Our research and development costs are expensed as incurred. We incurred research and development expenses during the three and nine month periods ended December 31, 2017June 30, 2019 and 2016,2018, 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, 
  2017  2016 
Three months ended $129,207  $178,440 
Nine months ended $462,640  $497,075 
  June 30,  June 30, 
  2019  2018 
Three months ended $248,871  $194,784 

  

4. FUTURE ACCOUNTING PRONOUNCEMENTSRecent Accounting Pronouncements

 

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

Regarding the new accounting standard on revenue recognition, ASU 2014-09 (Topic 606), which will be effective on April 1, 2018, management believes2019 utilizing the alternative transition method allowed for under ASU 2018-11. As a result, the Company recorded lease liabilities and right-of-use lease assets of $228,694 on its balance sheet as of April 1, 2019. The lease liabilities represent the present value of the remaining lease payments of the Company’s corporate headquarters lease (see Note 13), discounted using the Company’s incremental borrowing rate as of April 1, 2019. The corresponding right-of-use lease assets are recorded based on the lease liabilities and the cumulative difference between rent expense and amounts paid under its corporate headquarters lease. The Company also elected the short-term lease recognition exemption for its laboratory lease. For the laboratory lease that qualified as long as its contracts with government entities consistshort-term, the Company did not recognize ROU assets or lease liabilities at adoption. The adoption of firm, fixed price arrangements with payments that are triggered by achieving contractually stated milestones that new standard willASU 2016-02 did not have a significant effectmaterial impact on our future consolidated financial statements.either the statement of operations or statement of cash flows for the three months ended June 30, 2019.

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

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

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

Hindsight practical expedient. The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets.

9

 

5. CONVERTIBLE NOTES PAYABLE, NET

 

Convertible Notes Payable, Net consisted of the following at December 31, 2017:June 30, 2019:

 

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

7

  Principal  Unamortized
Discount
  Net
Amount
  Accrued
Interest
 
Convertible Notes Payable, Net:                
November 2014 10% Convertible Notes (due July 1, 2019) $512,811  $  $512,811  $6,604 
December 2016 10% Convertible Notes (due July 1, 2019)  379,780      379,780   4,748 
Total Convertible Notes Payable, Net $892,591  $  $892,591  $11,352 

 

During the ninethree months ended December 31, 2017,June 30, 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 ofnotes in the unamortized discount at December 31, 2017 related to the note discount established upon thethree month period ended June 2017 amendment to both the November 2014 10% Convertible Notes and the December 2016 10% Convertible Notes30, 2019. Accrued interest is included in other current liabilities (see below)Note 8).

 

During the ninethree months ended December 31, 2016,June 30, 2019, 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$3.00 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).

8

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

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

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

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

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

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

June 2017 Amendment to the November 2014 10% Convertible Notes

In June 2017, we agreed with the holders of the November 2014 10% Convertible Notes to an extension of the expiration dates of the notes from July 1, 2018 to July 1, 2019 in exchange for the reduction of the conversion price of those notes from $4.00 per share to $3.00$0.68 per share. The modification of the Notes was evaluated under ASC 470-50-40 and the instruments were determined to be substantially different, and the transaction qualified for extinguishment accounting. Under the extinguishment accounting we recorded a loss on debt extinguishment of $178,655 and recalculated a revised debt discount on the notes.

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

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

DECEMBER 2016 10% CONVERTIBLE NOTES

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

9

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

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

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

June 2017 Amendment to the December 2016 10% Convertible Notes

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

 

TheAlso during the three months ended June 30, 2019, we paid down $100,000 of the principal balances of the convertible notes and paid the accrued interest through May 2019. In July 2019, we paid off the remaining principal balance and accrued interest shown in the above table (see Note 14).

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

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

During the changesthree months ended June 30, 2018, we recorded interest expense of $24,817 related to the principal balancecontractual interest rates of our convertible notes and interest expense of $30,287 related to the amortization of the December 2016 10% Convertible Notes:note discount for a total interest expense of $55,104 related to our convertible notes in the three months ended June 30, 2018.

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 NINETHREE 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.JUNE 30, 2019

 

Common Stock Sales Agreement with H.C. Wainwright

 

On June 28, 2016, we entered into a Common Stock Sales Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC (“H.C. 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 provides for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000 (the “Shares”).

10

 

Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon our instructions. We have provided H.C. Wainwright with customary indemnification rights, and H.C. Wainwright will be entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Share sold. In addition, we have agreed to pay certain expenses incurred by H.C. Wainwright in connection 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 (see Note 14).Agreement.

10

 

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

  

In 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, 2017,2019, we raised aggregate net proceeds of $1,650,314$36,622 (net of $51,157$1,141 in commissions to H.C. Wainwright and $3,750$266 in other offering expenses) under this agreementAgreement through the sale of 601,50446,300 shares at an average price of $2.74$0.79 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.

11

Restricted Stock Unit Grants to Directors and Executive Officers

 

On August 9, 2016, ourOur 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, as amended through August 2016, or the Non-Employee Directors Plan, pursuant to which, in addition to cash compensation, directors of the Company who are not also employees may be granted stock-based compensation in the form of restricted stock units, or RSU’s. The RSUs represent the right to be issued on a future date shares of our common stock for vested RSUs.RSUs which have then vested.

 

DuringIn April 2019, pursuant to the nine months endedNon-Employee Directors Plan, we issued RSUs with a value of $35,000 to each of our non-employee directors, as the stock-based compensation element of their overall directors’ compensation, for the fiscal year ending March 31, 2020. Those grants were based on the closing price of our common stock on the one business day prior to the grant date, $0.95 per share. Therefore, 36,842 RSUs were issued to each of our five non-employee directors, for a total of 184,210 RSUs. All of the RSUs are subject to vesting in equal quarterly installments on June 30, 2019, September 30, 2019, December 31, 2017, 138,3752019 and March 31, 2020.

In June 2019, 46,053 vested RSUs held by our non-employee directors were exchanged into the same number of shares of our common stock. Four of our 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 14,737 of the vested RSUs being cancelled in exchange for $5,453 in aggregate cash proceeds to those independent directors.

In April 2019, 46,125 vested RSUs held by our current and former executive officers were exchanged for the same number of shares of our common stock. As these executives elected to net settle a portion of their vested RSUs in exchange for the Company paying the related withholding taxes of $18,318 on the share issuance, 34,174 of the vested RSUs were cancelled and we issued a net 21,701 shares to the executives and former executive.

RSUs outstanding that have vested as of, and are expected to vest subsequent to, June 30, 2019 are as follows:

Number of RSUs
Vested42,875
Expected to vest223,908
Total266,783

During the three months ended June 30, 2019, 101,928 vested RSUs held by our non-employee directors and our executives and a former executive were exchanged into the same number of shares of our common stock. As our non-employee directors and the executives elected to net settle a portion of their RSU’s in exchange for a cash equivalent of the Company paying the related withholdingvalue of their shares equal to their estimated income taxes on the share issuance, 71,08148,911 of the RSUs were cancelled and we issued a net 67,29453,017 shares of common stock to our executives (see Note 9).non-employee directors and the executive.

 

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

 

11

7. RELATED PARTY TRANSACTIONS

Due to Related Parties

 

During the three months ended December 31, 2017,June 30, 2019 we accrued unpaid Board fees of $35,350 which are$69,750 owed to our outsidenon-employee directors as of December 31, 2017. On March 31, 2017, we had accrued unpaid board feesJune 30, 2019.

Due to related parties were comprised of $28,250 owed to our outside directors.the following items:

  June 30, 2019  March 31, 2019 
Accrued Board fees $69,750  $69,750 
Accrued vacation to all employees  24,692   13,904 
Total due to related parties $94,442  $83,654 

 

8. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

 

 December 31, March 31,  June 30, March 31, 
 2017 2017  2019 2019 
Accrued interest $30,886  $5,391  $11,354  $59,573 
Other accrued liabilities  29,648   64,076 
Accrued separation expenses for former executives  218,343   355,189 
Accrued professional fees  211,531   231,238 
Total other current liabilities $60,534  $69,467  $441,228  $646,000 

   

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, 2017June 30, 2019 and 2016:2018:

 

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

  Three Months
Ended
June 30, 2019
  Three Months
Ended
June 30, 2018
 
Vesting of stock options and restricted stock units $326,536  $263,162 
Total stock-based compensation expense $326,536  $263,162 
         
Weighted average number of common shares outstanding – basic and diluted  19,057,255   17,754,728 
         
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.02) $(0.01)

 

All of the stock-based compensation expense recorded during the ninethree months ended December 31, 2017June 30, 2019 and 2016,2018, which totaled $887,607$326,536 and $1,880,150,$263,162, respectively, is included in payroll and related expense in the accompanying condensed consolidated statements of operations.  Stock-based compensation expense recorded during the ninethree months ended December 31, 2017June 30, 2019 and 20162018 represented an impact on basic and diluted loss per common share of $(0.08) and $(0.24), respectively.$(0.02) in both periods.

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 ninethree months ended December 31, 2017June 30, 2019 was insignificant.

   

Restricted Stock Unit Grants to Directors and Executive Officers

 

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

 

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

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

 Number of RSUs
Vested46,125
Expected to vest432,830
Total478,95512 

 

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

 

DuringWe did not issue any stock options during the ninethree 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.June 30, 2019 and June 30, 2018.

 

Options outstanding that have vested and are expected to vest as of December 31, 2017June 30, 2019 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         

13

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

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  325,047  $8.18   3.60 
Expected to vest  561,625  $1.26   9.48 
Total  886,672         

    

A summary of stock option activity during the ninethree months ended December 31, 2017June 30, 2019 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, 2019  886,672   $1.25-$12.50  $3.79 
Exercised        $  $ 
Granted 27,000 $1.68  $1.68     $  $ 
Cancelled/Expired           $  $ 
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 June 30, 2019  886,672   $1.25 – $12.50  $3.79 
Stock options exercisable at June 30, 2019  325,047   $1.68 – $12.50  $8.18 

 

On December 31, 2017,June 30, 2019, our stock options had no intrinsic value since the closing price on that date of $1.13$0.37 per share was below the weighted average exercise price of our outstanding stock options.

 

At December 31, 2017,June 30, 2019, there was approximately $2.2 million$1,847,266 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.721.4 years.

   

10. WARRANTS

 

During the ninethree months ended December 31, 2017,June 30, 2019 and 2018, we issued 5,618,182 warrants, including 163,636 warrants issued to the placement agent, H.C. Wainwight & Co., in connection with our October 2017 Public Offering (see Note 6). Those warrants have a five year term and have an exercise price of $1.10 per share.did not issue any warrants.

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

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

 

A summary of warrant activity during the ninethree months ended December 31, 2017June 30, 2019 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
  Amount  Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2019  5,144,875   $1.10 - $12.05  $2.54 
Cancelled/Expired  (92,901)  $5.35 – $12.05  $6.94 
Warrants outstanding at June 30, 2019  5,051,974   $1.10 – $8.35  $2.46 
Warrants exercisable at June 30, 2019  5,051,974   $1.10 – $8.35  $2.46 

 

 

 

 1413 

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

 

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

Breast Cancer Grant

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

This NCI Phase I grant period runs from September 14, 2018 through August 31, 2019. The total amount of the firm grant is $298,444. The grant calls for two subcontractors to work with us. Those subcontractors are University of Pittsburgh and Massachusetts General Hospital.

During the three months ended June 30, 2019, we recognized $30,000 in government contract revenue under this grant as a result of the work involved in one of the three technical objectives of the contract (Aim 2. “Elution of a population of breast cancer exosomes from Hemopurifier cartridges that bear the signatures of malignancy based on expression of CSPG4 and HER2, for triple-negative or HER2-overexpressing cancers, respectively”).

Melanoma Cancer Contract

 

We entered into a contract with the NIH onNCI in September 15, 2017. This award iswas 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.SBIR program. The title of the award is SBIR“SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.

 

The award from NIH iswas 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 hashad 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 mustwere required to perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts.

 

In October 2017,the three months ended June 30, 2018, 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 completedcovering the remainder of the technical objectives of the contract in September 2016.

In February 2014, DARPA reduced(Aim 1: To validate the scopeHemopurifier as a device for capture and recovery of our contract in years three through fivemelanoma exosomes from plasma and Aim 2: To validate a method of melanoma exosome isolation consisting of the contract. The reduction in scope focused our research onHemopurifier followed by mab-based immunocapture to select out the tumor-derived exosomes virusesfrom non-malignant exosomes and blood processing instrumentation. This scope reduction reducedAim 3: To evaluate the possible payments underfunctional integrity of melanoma exosomes purified by the contract by $858,469 over yearsHemopurifier and immunocapture isolation steps). As a result we invoiced NIH for $149,625 during the 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

June 30, 2018. The details of those milestones were as follows:

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

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

 

12. SEGMENTS

 

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

 

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

     

14

The following tables set forth certain information regarding our segments:

 

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

16

  Three Months Ended June 30, 
  2019  2018 
Revenues:        
Aethlon $30,000  $149,625 
ESI      
Total Revenues $30,000  $149,625 
         
Operating Losses:        
Aethlon $(1,561,885) $(1,066,530)
ESI  (4,303)  (30,742)
Total Operating Loss $(1,566,188) $(1,097,272)
         
Net Losses:        
Aethlon $(2,062,981) $(1,121,634)
ESI  (4,303)  (30,742)
Net Loss Before Non-Controlling Interests $(2,067,284) $(1,152,376)
         
Cash:        
Aethlon $2,492,170  $6,120,796 
ESI  184   2,106 
Total Cash $2,492,354  $6,122,902 
         
Total Assets:        
Aethlon $2,932,721  $6,451,635 
ESI  184   2,106 
Total Assets $2,932,905  $6,453,741 
         
Capital Expenditures:        
Aethlon $886  $ 
ESI      
Capital Expenditures $886  $ 
         
Depreciation and Amortization:        
Aethlon $2,868  $8,109 
ESI      
Total Depreciation and Amortization $2,868  $8,109 
         
Interest Expense:        
Aethlon $(54,085) $(55,104)
ESI      
Total Interest Expense $(54,085) $(55,104)

    

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, 2019 filed by us with the SEC on July 1, 2019.

15

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 “Granite Ridge Lease.” The current rental rate under the lease extension is $8,265 per month. We believe this leased facility will be satisfactory for our office needs over the term of the lease.

We also rent approximately 1,700 square feet of laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego, California 92121 at the rate of $4,548$4,700 per month on a one-year lease that was extended to an expiration date ofexpires on November 30, 2018.2019.

 

Rent expense, which is included in general and administrative expenses, approximated $100,000$40,000 and $114,000$50,000 for the ninethree month periods ended December 31, 2017June 30, 2019 and 2016,2018, respectively.

 

Legal MattersFuture minimum lease payments under the Granite Ridge Lease as of June 30, 2019, are as follows:

July 1, 2019 through March 31, 2020 $74,386 
April 1, 2020 through March 31, 2021  102,074 
April 1, 2021 through August 31, 2021  43,670 
Total future minimum lease payments  220,130 
Less: discount  (9,794)
Total lease liability $210,336 

On April 1, 2019, we recorded a lease liability and ROU lease asset for the Granite Ridge Lease based on the present value of lease payments over the expected remaining lease term of 2.2 years, discounted using our estimated incremental borrowing rate of 4%. For the three months ended June 30, 2019, amortization for the right-of-use lease asset was $22,725 and amortization for the lease liability was $22,064, which resulted in a net accretion of the right-of-use lease asset of $661 during the period (See Note 4).

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, 2017June 30, 2019 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 –Subsequent to December 31, 2017, sixteen investors that participated in the October 2017 public offering exercised 852,700 warrants for aggregate cash proceeds to us of $937,970 before expenses.

ATM Sales-- Subsequent to December 31, 2017, we sold common stock under our Common Stock Sales Agreement with H.C. Wainwright (see Note 6) and from those sales raised net proceeds of $454,654 (after deducting $14,123 in commissions to H.C. Wainwright and $1,998 in other offering expenses), utilizing the sales agreement through the sale of 340,000 shares at an average price of $1.34 per share of net proceeds.

Restricted Stock Unit (“RSU”) Issuances – In January 2018, 46,125July 2019, 42,875 RSUs held by our current and former executives were exchanged into the same number of shares of our common stock. As our executives elected to net settle a portion of their RSUsRSU’s in exchange for the Companyus paying the related withholding taxes on the share issuance, 26,15722,630 of the RSUs were cancelled and we issued a net 19,96820,245 shares of common stock to our executives.

Payoff of Convertible Notes –In July 2019, we paid off the outstanding principal balance on our convertible notes and related accrued interest, in the aggregate amount of $903,944.

ATM Sales– In July 2019, we sold 570,006 shares of our common stock under our Common Stock Sales Agreement with H.C. Wainwright (see Note 6) and from those sales raised net proceeds of $290,976 (after deducting $9,056 in commissions to H.C. Wainwright and $1,843 in other offering expenses), at an average price of $0.51 per share of net proceeds. In August 2019, we executed Amendment No. 1 to our Common Stock Sales Agreement to provide that references in that agreementto the Registration Statement shall refer to the registration statement on Form S-3 (File No. 333-231397), originally filed with the Securities and Exchange Commission on May 10, 2019, declared effective by the Securities and Exchange Commission on August 1, 2019.

 

 

 

 1716 

 

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"), and Section 21E of the Exchange Act. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause theour actual results, performance, or achievements of Aethlon Medical, Inc. ("we" or "us") to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this Form 10-Q. Such potential risks and uncertainties include, without limitation, 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”). The forward-looking statements are made as of the date of this Form 10-Q, and we assume no obligation to update the forward-looking statements, or to update the reasons actual results could differ from those projected in such forward-looking statements.

 

Overview

 

Aethlon Medical, Inc., and its subsidiary, (collectively, “Aethlon”, the “Company”, “we” or “us”) areis a medical technology company focused on addressing unmet needs in global health and biodefense. The Aethlon Hemopurifier® is an earlya clinical-stage therapeuticimmunotherapeutic device designed forto combat cancer and life-threatening viral infections. In cancer, the single-use removalHemopurifier depletes 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 (FDA) has designated the Hemopurifier as a “Breakthrough Device” related to the following two indications:

the treatment of life-threatening viruses from that are not addressed with approved therapies; and
the circulatory systemtreatment of infected individuals. 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.

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. We are in active communication with FDA in preparation for the initiation of an early clinical trial in one of these areas.

In addition, we believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated 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 administered to individuals infected with HIV, Hepatitis-C,hepatitis-C, and Ebola. Additionally, the Hemopurifier has been validated 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 the clinical advancement of the Hemopurifier through an investigational device exemptions (IDEs)exemption (“IDE”) approved by the FDA. We recently concluded a feasibility study to demonstrate the safety of our device in health-compromised individuals infected with a viral pathogen.

 

17

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

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 endeavors is the advancement of a TauSomeTMTauSomeTM 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. At Exosome Sciences we are also investigating diagnostic and prognostic exosomal biomarkers in cancer. 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 intend 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.

 

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.”

  

WHERE YOU CAN FIND MORE INFORMATION

 

We are subject to the informational requirements of the Securities Exchange Act of 1934, as amended, and must file reports, proxy statements and other information with the Commission. The 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 site ishttp://www.aethlonmedical.com.

   

RESULTS OF OPERATIONS

THREE MONTHS ENDED JUNE 30, 2019 COMPARED TO THE THREE MONTHS ENDED JUNE 30, 2018

Government Contract Revenues

We recorded government contract revenue in the three months ended June 30, 2019 and 2018.  This revenue resulted from work performed under our two government contracts with the NIH as follows:

  Three Months
Ended 6/30/19
  Three Months
Ended 6/30/18
  Change in
Dollars
 
Melanoma Cancer Contract $  $149,625  $(149,625)
Breast Cancer Grant  30,000      30,000 
Total Government Contract and Grant Revenue $30,000  $149,625  $(119,625)

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

Breast Cancer Grant

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

 

 

 18 

 

RESULTS OF OPERATIONSThis NCI Phase I grant period runs from September 14, 2018 through August 31, 2019. The total amount of the firm grant is $298,444. The grant calls for two subcontractors to work with us. Those subcontractors are University of Pittsburgh and Massachusetts General Hospital.

 

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

Revenues

We recorded any $74,813 of government contract revenue inDuring the three months ended December 31, 2017 andJune 30, 2019, we did not record anyrecognized $30,000 in government contract revenue under this grant as a result of the work involved in one of the three months ended December 31, 2016. That revenue arosetechnical objectives of the contract: Aim 2. “Elution of a population of breast cancer exosomes from work performed under our government contract withHemopurifier cartridges that bear the National Institutessignatures of Health,malignancy based on expression of CSPG4 and HER2, for triple-negative or NIH, as follows:HER2-overexpressing cancers, respectively”.

 

  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 

Melanoma Cancer Contract

NIH Contract

We entered into a contract with the NIH onNCI in September 15, 2017. This award iswas 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.SBIR program. The title of the award is SBIR“SBIR Topic 359 Phase 1 Device Strategy for Selective Isolation of Oncosomes and Non-Malignant Exosomes.

 

The award from NIH iswas 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 hashad 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 mustwere required to perform certain incremental work towards the achievement of specific milestones against which we will invoice the government for fixed payment amounts.

 

In the three months ended December 31, 2017,June 30, 2018, we completedperformed work under the first milestone on this contract covering the remainder of the technical objectives of the contract: Aim 1: To validate the Hemopurifier as a device for capture and recovery of melanoma exosomes from plasma; Aim 2: To validate a method of melanoma exosome isolation consisting of the Hemopurifier followed by mab-based immunocapture to select out the tumor-derived exosomes from non-malignant exosomes; and Aim 3: To evaluate the functional integrity of melanoma exosomes purified by the Hemopurifier and immunocapture isolation steps. As a result we invoiced NIH for $149,625 during the $74,812.50 payment associated with that milestone.three months ended June 30, 2018. The Melanoma Cancer Contract is now completed.

 

Operating Expenses

 

Consolidated operating expenses for the three months ended December 31, 2017June 30, 2019 were $1,238,440$1,596,188, in comparison with $1,235,546$1,246,897 for the comparable period a year ago.ended June 30, 2018. This increase of $2,894,$349,291, or 0.2%28%, in 2019 was due to an increaseincreases in general and administrative expenses of $187,718, professional fees of $158,143 and payroll and related expenses of $27,547, a $22,251$3,430.

The $187,718 increase in professional fees and a $46,904 decrease in general and administrative expenses.expenses in 2019 was primarily due to the combination of a $119,528 increase in our clinical trial expense, primarily costs associated with the manufacturing of Hemopurifiers for an expected clinical trial in the cancer space, a $38,983 increase in our lab supplies expense, primarily related to our breast cancer grant and a $38,814 increase in travel expense.

 

The $27,547$158,143 increase in our professional fees in 2019 was primarily due to a $152,534 increase in our legal fees.

The $3,430 increase in payroll and related expenses was primarily due to a $17,003$63,374 increase in stock-based compensation, and to a $10,545 increase in our cash-based payroll and related expenses due to bonuses given to our support and scientific staff.

The $22,251 increase in our professional fees was due to an increase in our professional fees of $37,962, which was partially offset by a decrease$59,944 reduction 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.cash-based compensation expense.

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

19

 

Other Expense

 

Other expense during the three months ended December 31, 2017 and 2016June 30, 2019 consisted of interest expense and a gainloss on debt extinguishment.extinguishment and during the three months ended June 30, 2018, consisted of interest expense only. Other expense for the three months ended December 31, 2017June 30, 2019 was other expense of $55,912$501,096, in comparison with other incomeexpense of $22,126$55,104 for the three months ended December 31, 2016.June 30, 2018.

 

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)

 

 

 

 2019 

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.

 

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

 

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

21

  Three Months
Ended
  Three Months
Ended
    
  6/30/19  6/30/18  Change 
Loss on Debt Extinguishment $447,011  $  $447,011 
Interest Expense  54,085   55,104   (1,019)
Total Other Expense $501,096  $55,104  $445,992 

   

Loss on Debt Extinguishment

 

Our loss on debt extinguishment forDuring the ninethree 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 which2019, 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 ofreduced the conversion price of thoseon our outstanding convertible notes from $4.00$3.00 per share to $3.00$0.68 per share. The modification of the convertible notes was evaluated under FASB Accounting Standards Codification (“ASC”) Topic No.ASC 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 Under the extinguishment accounting we recorded a 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.$447,011.

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.

Loss on 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. Additionally, we entered into an agreement with a former placement agent to issue 5,500 restricted shares in exchange for the cancellation of 11,000 warrants held by that placement agent. We measured the fair value of the shares issued and the fair value of the warrants exchanged for those shares and recorded losses for each of those exchanges based on the changes in fair value between the instruments exchanged.

22

   

Interest Expense

 

Interest expense was $306,495$54,085 for the ninethree months ended December 31, 2017 compared to $115,308June 30, 2019, and $55,104 for the three months ended June 30, 2018, a decrease of $1,019 in the corresponding prior period, an increase of $191,187.2019. The various components of our interest expense are shown in the following table:

 

 Nine Months
Ended
 Nine Months
Ended
    Three Months
Ended
 Three Months
Ended
   
 12/31/17 12/31/16 Change  6/30/19 6/30/18 Change 
Interest Expense $91,119  $49,671  $41,448  $23,798  $24,817  $(1,019)
Amortization of Deferred Financing Costs     27,641   (27,641)
Amortization of Note Discounts  215,376   37,996   177,380   30,287   30,287    
Total Interest Expense $306,495  $115,308  $191,187  $54,085  $55,104  $(1,019)

 

As noted in the above table, the most significant factor$1,019 decrease in the $191,187 increase inour interest expense was the $177,380 increase in the amortization of note discounts, which relateddue 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.expense due to a reduced principal balance in the June 2019 period compared to the June 2018 period as result of a partial principal payment in the June 2019 period.

 

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests decreasedincreased from approximately $5,613,000$1,146,000 in the ninethree month period ended December 31, 2016June 30, 2018 to $4,374,000$2,066,000 in the ninethree month period ended December 31, 2017.June 30, 2018.

 

Basic and diluted loss attributable to common stockholders were ($0.40)0.11) for the ninethree month period ended December 31, 2017June 30, 2019, compared to ($0.72)0.06) for the three month period ended December 31, 2016.June 30, 2018.

  

LIQUIDITY AND CAPITAL RESOURCES

 

At December 31, 2017,As of June 30, 2019, we had a cash balance of $5,610,799$2,492,354 and working capital of $5,288,930.$846,614. This compares to a cash balance of $1,559,701$3,828,074 and working capital of $985,496$2,004,188 at March 31, 2017.2019. Significant additional financing must be obtained in order to provide a sufficient source of operating capital and to allow us to continue to operate as a going concern. In addition, we will need to raise capital to complete anticipated future human clinical trials in the U.S. We anticipate the primary sources of this additional financing will be from proceeds of our at-the-market offering program, debt financing and other forms of equity placements.

 

On October 4, 2017, we consummated a public offering of 5,454,546 shares of common stock and warrants to purchase 5,454,546 shares of common stock, for total gross proceeds of $6.0 million. The offering was priced at $1.10 per unit with each unit comprised of one share of common stock and one common stock purchase warrant. The warrants carry a five-year term with an exercise price of $1.10 per share. The net proceeds of the offering were $5,289,735. H.C. Wainwright & Co. acted as exclusive placement agent for the offering. 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.

20

 

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

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

Also subsequent to December 31, 2017, we sold common stock underthree months ended June 30, 2019 was our Common Stock Sales Agreement with H.C. Wainwright (see Note 6)& Co., LLC, or H.C. Wainwright. The cash raised from that activity is noted below:

Common Stock Sales Agreement with H.C. Wainwright

On June 28, 2016, we entered into a Common Stock Sales Agreement, or the Agreement, with H.C. Wainwright, 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 provides for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000, referred to as the “Shares”.

Subject to the terms and conditions set forth in the Agreement, H.C. Wainwright will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Shares from time to time, based upon our instructions. We have provided H.C. Wainwright with customary indemnification rights, and H.C. Wainwright will be entitled to a commission at a fixed rate equal to three percent (3.0%) of the gross proceeds per Share sold. In addition, we have agreed to pay certain expenses incurred by H.C. Wainwright in connection 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 shall 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, including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as otherwise agreed with H.C. Wainwright. We have no obligation to sell any of the Shares, and, at any time, we may suspend offers under the Agreement or terminate the Agreement.

In the three months ended June 30, 2019, we raised aggregate net proceeds of $454,654 (after deducting $14,123$36,622, net of $1,141 in commissions to H.C. Wainwright and $1,998$266 in other offering expenses) utilizing the sales agreementexpenses, under this Agreement through the sale of 340,00046,300 shares at an average price of $1.34$0.79 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 three months ended
 
 December 31,
2017
 December 31,
2016
  June 30,
2019
 June 30,
2018
 
Cash provided by (used in):        
Cash used in:        
Operating activities $(2,893) $(2,644) $(1,248) $(818)
Investing activities  (24)  (3)  (1)   
Financing activities  6,968   1,060   (87)  (33)
Net increase (decrease) in cash $4,051  $(1,587)
Net decrease in cash $(1,336) $(851)

  

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$1,248,000 in the nine monthsthree month period ended December 31, 2017June 30, 2019 compared to $2,644,000approximately $818,000 in the nine monthsthree month period ended December 31, 2016,June 30, 2018. The primary driver in this increase of approximately $430,000 in 2019 in cash used in operating activities was the $915,000 increase in our net loss which was partially offset by the non-cash debt extinguishment expense of approximately $447,000 and an increase in our non-cash stock-based compensation of $249,000.approximately $63,000.

 

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $24,000$1,000 of cash to purchase laboratory and office equipment in the ninethree months ended December 31, 2017 compared to approximately $3,000June 30, 2019. We had no investing activities in the ninethree months ended December 31, 2016.June 30, 2018.

21

 

NET CASH PROVIDED BYUSED IN FINANCING ACTIVITIES. InDuring the ninethree months ended December 31, 2017June 30, 2019, we generatedraised approximately $6,968,000$37,000 from the issuance of common stock. That source of cash from our financing activities primarily throughwas more than offset by the issuanceuse of common$100,000 to partially pay down our convertible notes and the use of approximately $24,000 to pay for the tax withholding on restricted stock units for an increaseaggregate use of $5,908,000 overcash in financing activities of approximately $87,000. During the $1,060,000 raised in the ninethree months ended December 31, 2016.June 30, 2018, we used approximately $33,000 to pay for the 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 into our contract manufacturing arrangement subject to successfully raising additional capital.

  

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, 2017.2019 , except for the leases policy disclosed in Note 4 to the accompanying unaudited condensed consolidated financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

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

   

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

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

   

ITEM 4. CONTROLS AND PROCEDURES.

 

DISCLOSURE CONTROLS AND PROCEDURES

 

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

 

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

 

 

 2522 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS.

 

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

 

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

 

ITEM 1A. RISK FACTORS.

 

As a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information requested by this item. For a discussion of our potential risks and uncertainties, please see the information listed in the item captioned “Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2019. Except as provided below, there have been no material changes to the risk factors as disclosed in the Form 10-K. You should carefully consider the risk factors discussed below and in our Annual Report on Form 10-K for the year ended March 31, 2019, which could materially affect our business, financial position and results of operations.

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

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

 

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.June 30, 2019.  

 

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.  

23

 

ITEM 6. EXHIBITS.

 

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

  

10.1Strategic Joint Cross-Licensing Agreement, dated June 30, 2019, by and between the Registrant and SeaStar Medical, Inc.
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

  

 

 

 2624 

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, 2018August 14, 2019By:/s/ JAMES B. FRAKES 
  JAMES B. FRAKES 
  CHIEF FINANCIAL OFFICER 
  CHIEF ACCOUNTING OFFICER 

 

 

 

 

 

 

 


 

 

 2725