Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended December 31, 20172023

 

OR

 

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

 

For the transition period from _____to_____

 

COMMISSION FILE NUMBER 001-37487

 

AETHLON MEDICAL, INC.Aethlon Medical, Inc.

(Exact name of registrant as specified in its charter)

 

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

 

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

(Address of principal executive offices)    (Zip Code)

(858) 459-7800

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

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

TITLE OF EACH CLASS

COMMON STOCK, $0.001 PAR VALUE

TRADING SYMBOL

AEMD

NAME OF EACH EXCHANGE ON WHICH REGISTERED

NASDAQ CAPITAL MARKET

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YESYesNONo

 

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

 

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

 

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

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YESYesNONo

 

As of January 31, 2018,February 9, 2024, the registrant had outstanding 16,580,3262,620,399 shares of common stock, $0.001 par value.

 

 

 
 

 

TABLE OF CONTENTS

 

PART I.FINANCIAL INFORMATION34
   
ITEM 1.FINANCIAL STATEMENTS34
   
 CONDENSED CONSOLIDATED BALANCE SHEETS AT DECEMBER 31, 20172023 (UNAUDITED) AND MARCH 31, 2017202334
   
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTH AND NINE MONTH PERIODSMONTHS ENDED DECEMBER 31, 20172023 AND 20162022 (UNAUDITED)45
   
 CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2023 AND 2022 (UNAUDITED)6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED DECEMBER 31, 20172023 AND 20162022 (UNAUDITED)57
   
 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)68
   
ITEM 2.MANAGEMENT'SMANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS1817
   
ITEM 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK2524
   
ITEM 4.CONTROLS AND PROCEDURES2524
   
PART II.OTHER INFORMATION2625
   
ITEM 1.LEGAL PROCEEDINGS2625
   
ITEM 1A.RISK FACTORS2625
   
ITEM 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS26
   
ITEM 3.DEFAULTS UPON SENIOR SECURITIES26
   
ITEM 4.MINE SAFETY DISCLOSURES26
   
ITEM 5.OTHER INFORMATION26
   
ITEM 6.EXHIBITS2627
SIGNATURES28

 

 

 

 2 

 

 

CAUTIONARY NOTICE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the safe harbor created by those sections.

We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements and are based upon our current expectations, beliefs, estimates and projections, and various assumptions, many of which, by their nature, are inherently uncertain and beyond our control. Such statements, include, but are not limited to, statements contained in this Quarterly Report relating to our business, business strategy, products and services we may offer in the future, the timing and results of future clinical trials, and capital outlook, successful completion of our clinical trials, our ability to raise additional capital, our ability to maintain our Nasdaq listing, U.S. Food and Drug Administration, or FDA, approval of our products candidates, our ability to comply with changing government regulations, patent protection of our proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors detailed herein and in other of our filings with the Securities and Exchange Commission, or the SEC. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statement of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward looking statements include, but are not limited to, a decline in general economic conditions nationally and internationally, the ability to protect our intellectual property rights, competition from other providers and products, risks in product development, inability to raise capital to fund continuing operations, changes in government regulation, and other factors (including the risks contained in Item 1A of our most recent Annual Report on Form 10-K under the heading “Risk Factors”) relating to our industry, our operations and results of operations and any businesses that may be acquired by us. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, we undertake no obligation to and do not intend to update any of the forward-looking statements to conform these statements to actual results.

3

PART I. FINANCIAL INFORMATION

 

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

     
 December 31,
2017
  March 31,
2017
  December 31,
2023
 March 31,
2023
 
 (Unaudited)     (Unaudited)     
ASSETS                
Current assets                
Cash $5,610,799  $1,559,701  $7,972,012  $14,532,943 
Prepaid expenses and other current assets  14,537   37,551   277,321   557,623 
Total current assets  5,625,336   1,597,252   8,249,333   15,090,566 
                
Property and equipment, net  32,398   29,223   1,113,880   1,144,004 
Patents and patents pending, net  78,123   84,996 
Right-of-use lease asset, net  951,466   1,151,909 
Patents, net  1,238   1,650 
Restricted cash  87,506   87,506 
Deposits  14,897   14,897   33,305   33,305 
Total assets $5,750,754  $1,726,368  $10,436,728  $17,508,940 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities                
Accounts payable $211,406  $484,423  $693,154  $432,890 
Due to related parties  64,466   57,866   656,045   214,221 
Lease liability, current portion  285,095   269,386 
Other current liabilities  60,534   69,467   466,329   588,592 
Total current liabilities  336,406   611,756   2,100,623   1,505,089 
                
Convertible notes payable, net  810,866   519,200 
        
Lease liability, less current portion  724,848   939,642 
Total liabilities  1,147,272   1,130,956   2,825,471   2,444,731 
                
Commitments and Contingencies (Note 13)        
        
        
Stockholders’ Equity                
Common stock, par value $0.001 per share; 30,000,000 shares authorized as of December 31, 2017 and March 31, 2017; 15,367,658 and 8,797,086 shares issued and outstanding as of December 31, 2017 and March 31, 2017, respectively  15,368   8,796 
Common stock, par value $0.001 per share; 60,000,000 shares authorized as of December 31, 2023 and March 31, 2023; 2,596,538 and 2,299,259 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively  2,596   2,299 
Additional paid-in capital  102,820,906   94,445,739   159,751,591   157,426,606 
Accumulated other comprehensive loss  (1,619)  (6,141)
Accumulated deficit  (98,138,853)  (93,778,156)  (152,141,311)  (142,358,555)
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   7,611,257   15,064,209 
                
Total liabilities and stockholders’ equity $5,750,754  $1,726,368  $10,436,728  $17,508,940 

 

SeeThe accompanying notes.

3

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three and Nine Month Periods Ended December 31, 2017 and 2016

(Unaudited)

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

See accompanying notes.notes are an integral part of these condensed consolidated financial statements.

 

 

 

 4 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSOPERATIONS

For the Three and Nine MonthsMonth Periods Ended December 31, 20172023 and 20162022

(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 
             
  Three Months
Ended
December 31,
2023
  Three Months
Ended
December 31,  
2022
  Nine Months
Ended
December 31,  
2023
  Nine Months
Ended
December 31,  
2022
 
OPERATING EXPENSES                
                 
Professional fees $668,586  $729,665  $2,778,335  $2,575,496 
Payroll and related expenses  1,919,305   1,048,761   4,233,970   3,191,402 
General and administrative  979,197   1,071,327   3,138,289   3,653,832 
Total operating expenses  3,567,088   2,849,753   10,150,594   9,420,730 
OPERATING LOSS  (3,567,088)  (2,849,753)  (10,150,594)  (9,420,730)
                 
OTHER EXPENSE/(INCOME)                
Loss on dissolution of subsidiary           142,121 
Interest and Other Income  (100,967)     (367,838)   
                 
NET LOSS  (3,466,121)  (2,849,753)  (9,782,756)  (9,562,851)
                 
OTHER COMPREHENSIVE INCOME  7,951      4,522    
                 
COMPREHENSIVE LOSS $(3,458,170) $(2,849,753) $(9,778,234) $(9,562,851)
                 
Basic and diluted loss per share attributable to common stockholders $(1.37) $(1.24) $(3.95) $(4.84)
                 
Weighted average number of common shares outstanding – basic and diluted  2,516,511   2,294,649   2,477,282   1,974,146 

 

SeeThe accompanying notes.notes are an integral part of these condensed consolidated financial statements.

 

 

 5 

 

 

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the Three and Nine Months Ended December 31, 2023 and 2022

(Unaudited)

                      
  ATTRIBUTABLE TO AETHLON MEDICAL, INC.          
  COMMON STOCK  ADDITIONAL
PAID IN
  ACCUMULATED  ACCUMULATED
COMPREHENSIVE
  NON-
CONTROLLING
  TOTAL 
  SHARES  AMOUNT  CAPITAL  DEFICIT  LOSS  INTERESTS  EQUITY 
BALANCE – MARCH 31, 2023  2,299,259  $2,299  $157,426,606  $(142,358,555) $(6,141) $  $15,064,209 
Issuances of common stock for cash under at the market program  177,891   178   1,085,941            1,086,119 
Issuance of common shares upon vesting of restricted stock units and net stock option exercises  6,397   7   (8,379)           (8,372)
Stock-based compensation expense        250,114            250,114 
Net loss           (3,282,179)        (3,282,179)
Other comprehensive loss              (994)     (994)
BALANCE – JUNE 30, 2023  2,483,547  $2,484  $158,754,282  $(145,640,734) $(7,135) $  $13,108,897 
Issuance of common shares upon vesting of restricted stock units and net stock option exercises  9,329   9   (9,852)           (9,843)
Stock-based compensation expense        257,181            257,181 
Rounding for reverse split  32                   
Net Loss           (3,034,456)        (3,034,456)
Other Comprehensive Loss              (2,435)     (2,435)
BALANCE – SEPTEMBER 30, 2023  2,492,908  $2,493  $159,001,611  $(148,675,190) $(9,570) $  $10,319,344 
Issuances of common stock for cash under at the market program  94,304   94   186,407           $186,501 
Issuance of common shares upon vesting of restricted stock units and net stock option exercises  9,326   9   (9,382)           (9,373)
Stock-based compensation expense          572,955            572,955 
Net Loss           (3,466,121)        (3,466,121)
Other Comprehensive Income              7,951      7,951 
BALANCE – DECEMBER 31, 2023  2,596,538  $2,596  $159,751,591  $(152,141,311) $(1,619) $  $7,611,257 

  COMMON STOCK  ADDITIONAL
PAID IN
  ACCUMULATED  ACCUMULATED
COMPREHENSIVE
  NON-
CONTROLLING
  TOTAL 
  SHARES  AMOUNT  CAPITAL  DEFICIT  LOSS  INTERESTS  EQUITY 
BALANCE – MARCH 31, 2022  1,541,917  $1,542  $147,460,747  $(130,329,181) $  $(141,708) $16,991,400 
Issuances of common stock for cash under at the market program  57,456   58   619,384            619,442 
Stock-based compensation expense        215,437            215,437 
Net loss           (2,905,668)     (413)  (2,906,081)
BALANCE – JUNE 30, 2022  1,599,373  $1,600  $148,295,568  $(133,234,849) $  $(142,121) $14,920,198 
Issuance of common stock for cash under at the market program  690,628   691   8,307,078            8,307,769 
Issuance of common shares upon vesting of restricted stock units and net stock option exercises  4,624   5   (7,978)           (7,973)
Stock-based compensation expense        313,539            313,539 
Loss on dissolution of subsidiary                      142,121   142,121 
Net Loss           (3,807,430)        (3,807,430)
Other Comprehensive Loss                     
BALANCE – SEPTEMBER 30, 2022  2,294,625  $2,296  $156,908,207  $(137,042,279) $  $  $19,868,224 
Issuance of common shares upon vesting of restricted stock units and net stock option exercises  2,312   2   (1,887)            (1,885)
Stock-based compensation expense          262,613             262,613 
Net Loss           (2,849,753)        (2,849,753)
BALANCE – DECEMBER 31, 2022  2,296,937  $2,298  $157,168,933  $(139,892,032) $  $  $17,279,199 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

AETHLON MEDICAL, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

For the Nine Months Ended December 31, 2023 and 2022

(Unaudited)

       
  Nine Months
Ended
December 31, 2023
  Nine Months
Ended
December 31, 2022
 
       
Cash flows used in operating activities:        
Net loss $(9,782,756) $(9,562,851)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  273,225   161,350 
Stock based compensation  1,080,250   791,588 
Loss on dissolution of subsidiary     142,121 
Loss (gain) on disposal of property and equipment  3,271    
Accretion of right-of-use lease asset  1,358   23,385 
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets  282,192   283,645 
Accounts receivable     127,965 
Accounts payable and other current liabilities  136,268   210,032 
Deferred revenue     229,698 
Due to related parties  441,824   34,655 
Net cash used in operating activities  (7,564,368)  (7,558,412)
         
Cash flows used in investing activities:        
Purchases of property and equipment  (245,960)  (931,820)
Net cash used in investing activities  (245,960)  (931,820)
         
Cash flows provided by financing activities:        
Proceeds from the issuance of common stock, net  1,272,621   8,927,211 
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense  (27,588)  (9,857)
Net cash provided by financing activities  1,245,033   8,917,354 
         
Effect of exchange rate on changes on cash  4,364    
         
Net change in cash and restricted cash  (6,560,931)  427,122 
         
Cash and restricted cash at beginning of period  14,620,449   17,159,925 
         
Cash and restricted cash at end of period $8,059,518  $17,587,047 
         
Supplemental disclosures of cash flow information:        
         
Supplemental disclosures of non-cash investing and financing activities:        
Par value of shares issued for vested restricted stock units and net stock option exercise $25  $69 
Initial recognition of right-of-use lease asset and lease liability $  $625,471 
         
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:        
Cash and cash equivalents $7,972,012  $17,499,541 
Restricted cash  87,506   87,506 
Cash and restricted cash $8,059,518  $17,587,047 

The accompanying notes are an integral part of these condensed consolidated financial statements.

7

AETHLON MEDICAL, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

December 31, 20172023

 

 

1. NATURE OF BUSINESS AND BASIS OF PRESENTATION

ORGANIZATION

 

Aethlon Medical, Inc. and subsidiary (collectively, “Aethlon”, or Aethlon, the “Company”, “we”Company, we or “us”) areus, is a medical technologytherapeutic company focused on addressing unmet needs in global healthdeveloping products to treat cancer and biodefense.life-threatening infectious diseases. The Aethlon Hemopurifier®Hemopurifier is an earlya clinical-stage therapeuticimmunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for the single-use removal of life-threatening viruses from the circulatory system of infected individuals. two independent indications:

·the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and
·the treatment of life-threatening viruses that are not addressed with approved therapies.

We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our contract research organization, or CRO, on preparations to conduct a planned clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers.

In January 2023, we entered into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to oversee our planned clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA agreed to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We anticipate that the initial clinical trials will begin in Australia.

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

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

On June 17, 2020, the FDA approved a supplement to our open Investigational Device Exemption, or IDE, for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States. Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to a lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022.

Under Single Patient Emergency Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above.

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We previously reported a disruption in our Hemopurifier supply, as our then existing supply of Hemopurifiers expired on September 30, 2022, and also as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, continues to be delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change. We are working with the FDA to qualify this second supplier of our GNA. We also are in the process of completing final testing in order to begin manufacturing Hemopurifiers at our new manufacturing facility in San Diego for use in planned U.S. clinical trials, using GNA from our current supplier. The first manufacturing lot that incorporates the GNA from our original supplier was approved and released at the end of December 2023. We also have sufficient Hemopurifiers on hand for use in our planned Australia and India oncology trials.

In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary will initially focus on the planned oncology trials in Australia.

We also obtained ethics review board, or ERB approval, from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. One patient has completed participation in the Indian COVID-19 study. The relevant authorities in India have accepted the use of our Hemopurifiers made with the GNA from our new supplier.

In May 2023, we also received ERB approval from the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government.

In October 2023, we announced that we received clearance from the Drug Controller General of India, the central drug authority in India, to conduct a Phase 1 safety, feasibility and dose-finding trial of the Company's Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following completion of an internal in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

Additionally, we announced that we have begun investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from recovered organs. We initially are focused on recovered kidneys, in a research collaboration with 34 Lives, PBC. We have previously demonstrated the clinical advancementremoval of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier. This process potentially may reduce complications following transplantation of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA.recovered organ, which can include viral infection, delayed graft function and rejection. We recently concluded a feasibility studybelieve this new approach could be additive to demonstrateexisting technologies that currently are in place to increase the safetynumber 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 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.viable kidneys for transplant.

 

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

 

In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the ongoing military conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.

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We incorporated in Nevada on March 10, 1999. Our executive offices are located at 9635 Granite Ridge Drive,11555 Sorrento Valley Road, Suite 100,203, San Diego, California 92123.92121. Our telephone number is (858) 459-7800.(619) 941-0360. Our website address iswww.aethlonmedical.com. www.aethlonmedical.com.

 

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

 

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

During the nine months ended December 31, 2017,2023, there have beenwere no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2017.2023.

 

BASIS OF PRESENTATIONREVERSE STOCK SPLIT

 

On October 4, 2023, we effected a 1-for-10 reverse stock split of our then outstanding shares of common stock. Accordingly, each 10 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares resulting from the reverse split were rounded up to the next whole share. Authorized common stock remained at 60,000,000 shares following the stock split. The accompanying unaudited condensed consolidated financial statements and accompanying notes have been retroactively revised to reflect such reverse stock split as if it had occurred on April 1, 2022. All shares and per share amounts have been revised accordingly.

Basis of the CompanyPresentation and Use of Estimates

Our accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, (GAAP)or GAAP, for interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, (SEC)or SEC, Regulation S-X. Accordingly, they should be read in conjunction with the audited financial statements and notes thereto for the fiscal year ended March 31, 2017,2023, included in the Company'sour Annual Report on Form 10-K filed with the SEC on June 28, 2017.2023. The accompanying unaudited condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd, as well as its previously majority-owned subsidiary.subsidiary, Exosome Sciences, Inc., which dissolved in September 2022. All significant intercompanyinter-company transactions and balances have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements, taken as a whole, contain all adjustments that are of a normal recurring accruals and adjustments that, in the opinion of management, arenature necessary to present fairly the condensed consolidatedour operating results, cash flows, and financial statementsposition as of and for the nine monthsperiod ended December 31, 2017.2023. 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, 20172023 has been derived from the audited consolidated balance sheet at March 31, 2017,2023, contained in the above referenced 10-K. The results of operations for the three and nine months ended December 31, 20172023 are not necessarily indicative of the results to be expected for the full year or any future interim periods.

 

Reclassifications

Certain prior year balances within the unaudited condensed consolidated financial statements have been reclassified to conform to the current year presentation, including the impact of the reverse stock split.

 

 

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LIQUIDITY AND GOING CONCERN

 

Management expects existing cashThe accompanying unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations and at December 31, 20172023 had limited working capital and an accumulated deficit of $152,141,311. These factors, among other matters, raise substantial doubt about our ability to continue as a going concern within one year of the date these financial statements are issued. 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 operations, working capital and other cash requirements for the Company’s operationstwelve month period subsequent to December 31, 2023 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.

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 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 we be unable to continue as a going concern.

Restricted Cash

To comply with the terms of our laboratory and office lease and our lease for at least twelve monthsour manufacturing space, see Note 10, we caused our bank to issue two standby letters of credit, or L/Cs, in the aggregate amount of $87,506 in favor of our landlord. The L/Cs are in lieu of a security deposit. In order to support the L/Cs, we agreed to have our bank withdraw $87,506 from the issuance dateour operating accounts and to place that amount in a restricted certificate of these interim financial statements.deposit. We have classified that amount as restricted cash, a long-term asset, on our balance sheet.

 

2. LOSS PER COMMON SHARE

 

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

 

As of December 31, 20172023 and 2016, a total2022, an aggregate of 9,143,480175,574 and 3,810,642206,825 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants, unvestedand restricted stock units and convertible notes payable were excluded, as their inclusion would be antidilutive.

 

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, 20172023 and 2016,2022, which are included in various operating expense line items in the accompanying condensed consolidated statements of operations. Our research and development expenses in those periods were as follows:

  December 31,  December 31, 
  2017  2016 
Three months ended $129,207  $178,440 
Nine months ended $462,640  $497,075 

4. FUTURE ACCOUNTING PRONOUNCEMENTS

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

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

5. CONVERTIBLE NOTES PAYABLE, NET

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

  Principal  Unamortized
Discount
  Net
Amount
  Accrued
Interest
 
Convertible Notes Payable, Net – Non-Current Portion:                
November 2014 10% Convertible Notes $612,811  $(112,194) $500,617  $19,066 
December 2016 10% Convertible Notes  379,780   (69,531)  310,249   11,820 
Total Convertible Notes Payable, Net $992,591  $(181,725) $810,866  $30,886 
Schedule of research and development expenses      
  December 31,  December 31, 
  2023  2022 
Three months ended $593,401  $558,223 
Nine months ended $1,875,114  $2,129,376 

  

 

 

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During the nine months ended December 31, 2017, we recorded interest expense of $87,641 related to the contractual interest rates of our convertible notes and interest expense of $215,376 related to the amortization of the note discount for a total interest expense of $303,017 related to our convertible notes. All of the unamortized discount at December 31, 2017 related to the note discount established upon the June 2017 amendment to both the November 2014 10% Convertible Notes and the December 2016 10% Convertible Notes (see below).4. RECENT ACCOUNTING PRONOUNCEMENTS

 

During the nine months ended December 31, 2016, we recorded interest expense of $47,730 related to the contractual interest rates of our convertible notes, interest expense of $27,641 related to the amortization of deferred financing costs and interest expense of $37,996 related to the amortization of note discounts for a total interest expense of $113,367 related to our convertible notes.None.

 

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

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

NOVEMBER 2014 10% CONVERTIBLE NOTES

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

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

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

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

Initial Amendment of the November 2014 10% Convertible Note Terms

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

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

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

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

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

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

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

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

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

June 2017 Amendment to the November 2014 10% Convertible Notes

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

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

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

DECEMBER 2016 10% CONVERTIBLE NOTES

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

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

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

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

June 2017 Amendment to the December 2016 10% Convertible Notes

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

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

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

6. 5. EQUITY TRANSACTIONS IN THE NINE MONTHS ENDED DECEMBER 31, 20172023

 

October 2017 Public2022 At The Market Offering

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

Warrant Exercises

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

Common Stock Sales Agreement with H.C. Wainwright

On June 28, 2016, we entered into a Common Stock Sales Agreement (the “Agreement”) with H.C. Wainwright & Co., LLC (“

On March 24, 2022, we entered into an At The Market Offering Agreement, or the 2022 ATM Agreement, with H.C. Wainwright”)Wainwright & Co., LLC, or Wainwright, which establishesestablished an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the 2022 ATM Agreement.

The Agreementoffering was registered under the Securities Act of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-259909), as previously filed with the SEC and declared effective on October 21, 2021. We filed a prospectus supplement, dated March 24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to $12,500,000 (the “Shares”).$15,000,000, or the 2022 ATM Shares.

Under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the 2022 ATM Shares. In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions with our consent and in block transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if the sales cannot be effected at or above the price designated by us from time to time.

We are not obligated to make any sales of the 2022 ATM Shares under the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein.

The 2022 ATM Agreement contains customary representations, warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement.

During the three months ended December 31, 2023, we raised net proceeds of $186,501, net of $4,828 in commissions to Wainwright and $1,784 in other offering expenses, through the sale of 94,304 shares of our common stock at an average price of $1.98 per share under the 2022 ATM Agreement. During the nine months ended December 31, 2023, we raised net proceeds of $1,272,621, net of $32,827 in commissions to Wainwright and $7,630 in other offering expenses, through the sale of 272,195 shares of our common stock at an average price of $4.68 per share under the 2022 ATM Agreement.

Restricted Stock Unit Grants

On April 28, 2023, the Board approved, pursuant to the terms of the Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual restricted stock units, or RSUs, under the Director Compensation Policy to each of our three non-employee directors then serving on the Board. The Director Compensation Policy provides for a grant of $50,000 worth of stock options or of RSUs at the beginning of each fiscal year for current directors then serving on the Board, and for a grant of $75,000 worth of stock options or RSUs for a newly elected director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $4.30 per share for the RSUs granted in April 2023. As a result, in April 2023 the three eligible directors each were granted an RSU in the amount of 11,628 shares under our 2020 Equity Incentive Plan, or the 2020 Plan. The RSUs are subject to vesting in four equal installments, with 25% of the RSUs vesting on each of June 30, 2023, September 30, 2023, December 31, 2023, and March 31, 2024, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date.

 

 

 

 1012 

 

 

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).

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 six months ended September 30, 2017, we raised aggregate net proceeds of $1,650,314 (net of $51,157 in commissions to H.C. Wainwright and $3,750 in other offering expenses) under this agreement through the sale of 601,504 shares at an average price of $2.74 per share of net proceeds.

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

Restricted Shares Issued for Services6. RELATED PARTY TRANSACTIONS

 

During the nine months ended December 31, 2017,2023, we issued 15,000 sharesaccrued unpaid fees 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$68,250 owed to our common stock.non-employee directors.

 

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 cancellationAs a result of 22,993 warrants and we enteredentering into an Exchangea Separation 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, our Board of Directors granted RSUs to certain of our officers and directors and effective November 7, 2017, 127,659 additional RSUs were granted to27, 2023 with our directors pursuant toformer Chief Executive Officer, or CEO, Charles J. Fisher, M.D., or the 2012 Non-Employee Directors Compensation Program. The RSUs represent the right to be issued on a future date shares of our common stock for vested RSUs.

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

During the nine months ended December 31, 2017, 63,829 RSUs held by our outside directors were exchanged into the same number of shares of our common stock. As one of our three outside directors elected to return 40% of his RSUs in exchange for cash in order to pay his withholding taxes on the share issuances, 10,638 of the RSUs were cancelled andSeparation Agreement, we paid $12,127out accrued vacation of $53,076 to Dr. Fisher in cash to that outside director (see Note 9).

7. RELATED PARTY TRANSACTIONS

Due to Related Parties

During the three months ended December 31, 2017,2023 (see Note 10). That accrued vacation was previously recorded in the due to related parties account. In addition, pursuant to the terms of Dr. Fisher’s Executive Employment Agreement, we accrued unpaid Board fees of $35,350 which are owed to our outside directors as of December 31, 2017. On March 31, 2017, we had accrued unpaid board fees of $28,250 owed to our outside directors.$435,378 for salary and related expenses connected with the Separation Agreement.

 

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

Schedule of related party payments      
  December 31,  
2023
  March 31,
2023
 
Accrued Board fees $68,250  $57,000 
Accrued vacation to all employees  152,415   157,221 
Accrued separation expenses for former executive (See Note 10)  435,378    
Total due to related parties $656,043  $214,221 

7. OTHER CURRENT LIABILITIES

 

Other current liabilities were comprised of the following items:

  December 31,  March 31, 
  2017  2017 
Accrued interest $30,886  $5,391 
Other accrued liabilities  29,648   64,076 
Total other current liabilities $60,534  $69,467 
Schedule of other current liabilities      
  December 31,  March 31, 
  2023  2023 
Accrued professional fees $466,329  $588,592 
Total other current liabilities $466,329  $588,592 

 

9. 8. 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, 20172023 and 2016:2022:

Schedule of share-based compensation expense            
  Three Months
Ended
December 31,  
2023
  Three Months
Ended
December 31,  
2022
  Nine Months
Ended
December 31,
2023
  Nine Months
Ended
December 31,
2022
 
Vesting of stock options and restricted stock units $572,955  $262,613  $1,080,250  $791,588 
Total stock-based compensation expense $572,955  $262,613  $1,080,250  $791,588 
                 
Weighted average number of common shares outstanding – basic and diluted  2,516,511   2,294,649   2,477,282   1,974,146 
                 
Basic and diluted loss per common share attributable to stock-based compensation expense $(0.23) $(0.11) $(0.44) $(0.40)

 

  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)

 

13

 

All of the stock-based compensation expense recorded during the nine months ended December 31, 20172023 and 2016, which totaled $887,6072022, an aggregate of $1,080,250 and $1,880,150,$791,588, respectively, is included in payroll and related expense in the accompanying condensed consolidated statements of operations. Stock-based compensation expense recorded during each of the nine months ended December 31, 20172023 and 20162022 represented an impact on basic and diluted loss per common share of $(0.08)$(0.44) and $(0.24)$(0.40), respectively.

12

 

We review share-based compensation on a quarterly basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture adjustments for the nine months ended December 31, 20172023 was insignificant.

Restricted Stock Unit Grants to Directors and Executive Officers

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

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

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

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

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

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

 

Stock Option Activity

 

We did not issue any stock options during the nine months ended December 31, 2023. During the nine months ended December 31, 2017,2022, we issued optionsrecognized a stock option grant made in the fiscal year ended March 31, 2022 to fourpurchase 6,160 shares of our employees to purchase 34,500common stock under our 2020 Plan that previously was contingent on stockholder approval of an increase of 180,000 shares of common stock authorized for issuance under the 2020 Plan, at a pricethe Company’s 2022 annual meeting of $1.68 per share,stockholders. The increase was approved at the closing priceCompany’s 2022 annual meeting of stockholders held in September 2022.

In accordance with the terms of his Executive Employment Agreement, the Separation Agreement also provided for accelerated vesting on the date50% of outstanding and unvested options to purchase shares of our common stock then held by Dr. Fisher as of the approvalSeparation Date of November 7, 2023, such that the accelerated stock options were fully vested and exercisable as of the option grants by our compensation committee. There were no stock option grants during the nine months ended December 31, 2016.Separation Date.

 

OptionsStock options outstanding that have vested as of December 31, 2023 and stock options that are expected to vest as ofsubsequent to December 31, 20172023 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.

Schedule of options outstanding that have vested and are expected to vest         
  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term in
Years
 
Vested  106,862  $24.85   7.30 
Expected to vest  36,036  $14.92   7.99 
Total  142,898         

 

A summary of stock option activity during the nine months ended December 31, 20172023 is presented below:

Schedule of stock option activity         
  Amount  Range of
Exercise Price
  Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2023  171,826  $6.90 – 1,425  $22.39 
Exercised    $  $ 
Granted    $  $ 
Cancelled/Expired  28,934  $12.10 – 750  $21.07 
Stock options outstanding at December 31, 2023  142,898  $6.90 – 1,425  $22.34 
Stock options exercisable at December 31, 2023  106,862  $12.80 – 1,425  $24.85 

 

  Amount  Range of
Exercise Price
  Weighted
Average
Exercise
Price
 
Stock options outstanding at March 31, 2017  432,047   $3.80-$20.50    $10.98 
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 

14

 

On December 31, 2017,2023, our outstanding stock options had no intrinsic value, since the closing share price on that date of $1.13$2.19 per share was below the weighted average exercise price of our outstanding stock options.

 

At December 31, 2017,2023, there was approximately $2.2 million$547,564 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of 1.721.61 years.

 

10. 9. WARRANTS

 

During the nine months ended December 31, 2017,2023 and 2022, we issued 5,618,182 warrants, including 163,636 warrants issued to the placement agent, H.C. Wainwight & Co., in connection with our October 2017 Public Offering (see Note 6). Those warrants have a five year term and have an exercise price of $1.10 per share.did not issue any warrants.

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

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

 

A summary of warrant activity during the nine months ended December 31, 20172023 is presented below:

Schedule of warrant activity         
  Amount  Range of
Exercise
Price
  Weighted
Average
Exercise
Price
 
Warrants outstanding at March 31, 2023  32,676  $15.00 – 27.50  $20.09 
Exercised    $  $ 
Cancelled/Expired    $  $ 
Warrants outstanding at December 31, 2023  32,676  $15.00 – 27.50  $20.09 
Warrants exercisable at December 31, 2023  32,676  $15.00 – 27.50  $20.09 

 

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

10. COMMITMENTS AND CONTINGENCIES

 

14

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

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

The expected volatility was based on the historic volatility. The expected lifeEffective as 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,November 27, 2023, we valued the warrants that were exchanged for common stock (see Note 6) during the nine months ended December 31, 2017 at $130,214.

11. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION

National Institutes of Health (“NIH”)

We entered into a contractthe Separation Agreement 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 contractCharles J. Fisher, M.D., our former Chief Executive Officer. In accordance 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 his Executive Employment Agreement, the contract, we must perform certain incremental work towards the achievement of specific milestones against which we will invoice the governmentSeparation Agreement provides for fixed payment amounts.

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

The details of that milestone were as follows:

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

Defense Advanced Research Projects Agency (“DARPA”)

We entered into a contract with DARPA on September 30, 2011. Under the DARPA award, we have been engaged to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that often results in the death of combat-injured soldiers. The award from DARPA was a fixed-price contract with potential total12 months cash severance payments to us of $6,794,389 over the course of five years. Fixed price contracts require the achievement of multiple, incremental milestones to receive the full award during each year of the contract. Under the terms of the contract, we performed certain incremental work towards the achievement of specific milestones against which we invoiced the government for fixed payment amounts.

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

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

The DARPA contract concluded on September 30, 2016.

In the nine months ended December 31, 2016, we invoiced the U.S. Government for the final two milestones under our DARPA contractDr. Fisher in the aggregate amount of $387,438.$460,000 payable monthly, continued medical coverage under COBRA for a twelve month period that began on December 1, 2023 and the acceleration of 50% of his unvested options at the time of separation, and included a standard release of any and all potential claims against the Company.

The total expense for the quarter ended December 31, 2023 relating to the Separation Agreement, was $891,844, composed of $479,624 payroll and related expense, $19,081 related to health insurance and other benefits and $393,139 of stock based compensation for the acceleration of vesting for 50% of then outstanding options held by Dr. Fisher at the time of his separation from the Company.

Effective as of November 7, 2023, James B. Frakes, MBA was appointed as our Interim Chief Executive Officer. Mr. Frakes will also continue to serve as the Company’s Chief Financial Officer and Senior Vice President – Finance. In connection with Mr. Frakes appointment as our Interim Chief Executive Officer, effective as of November 7, 2023, we amended the Executive Employment Agreement dated December 12, 2018 with Mr. Frakes to provide Mr. Frakes with an annual base salary of $500,000. Also, effective as of November 7, 2023, Guy F. Cipriani, MBA was appointed as our Senior Vice President and Chief Operating Officer and in connection therewith we amended the Executive Employment Agreement dated January 1, 2020 with Mr. Cipriani to provide Mr. Cipriani with an annual base salary of $390,000.

 

 

 

 15 

 

The details of those milestones were as follows:

LEASE COMMITMENTS

 

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 representativeOffice, Lab and the invoice was submitted thereafter.Manufacturing Space Leases

 

Milestone 2.6.1.4 – Prepare and present Final Report for DARPA. The milestone payment was $193,719. Management considers this milestoneIn December 2020, we entered into an agreement to be substantive as it was not dependent on the passage of time nor was it based solely on another party's efforts. We prepared and presented the Final Report for DARPA. The report was accepted by the contracting officer's representative and the invoice was submitted thereafter.

12. SEGMENTS

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

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

The following tables set forth certain information regarding our segments:

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

16

13. COMMITMENTS AND CONTINGENCIES

Lease Commitments

We currently rentlease approximately 2,6002,823 square feet of executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego, CA 92123 at the rate of $6,054 per month on a four-year lease that expires in May 2018. We also rent approximately 1,700and 1,807 square feet of laboratory space located at 1158511555 Sorrento Valley Road, Suite 109,203, San Diego, California 92121 and 11575 Sorrento Valley Road, Suite 200, San Diego, California 92121, respectively. The agreement carries a term of 63 months and we took possession of the office space effective October 1, 2021. We took possession of the laboratory space effective January 1, 2022. In October 2021, we entered into another lease for approximately 2,655 square feet of space to house our manufacturing operations located at 11588 Sorrento Valley Road, San Diego, California 92121. The term is for 55 months and we took possession of the manufacturing space in August 2022. The current monthly base rent under the office and laboratory component of the lease is $13,772. The current monthly base rent under the manufacturing component of the lease is $12,080.

The office, lab and manufacturing leases are coterminous with a remaining term of 42 months. The weighted average discount rate is 4.25%.

As of $4,548our December 31, 2023 balance sheet, we have a right-of-use lease asset of $951,466.

In addition, the lease agreements for the new office, lab and manufacturing space required us to post a standby L/C in favor of the landlord in the aggregate amount of $87,506 in lieu of a security deposit. We arranged for our bank to issue standby L/Cs for the new office and lab in the amounts of $46,726 in the fiscal year ended March 31, 2021 and for the manufacturing space in the amount of $40,780 in the fiscal year ended March 31, 2022. We transferred like amounts to a restricted certificate of deposit which secured the bank’s risk in issuing those L/Cs. We have classified those restricted certificates of deposit on our balance sheet as restricted cash with a balance of $87,506.

Mobile Clean Room

In addition to the leases described above, we rented a mobile clean room on a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed. The mobile clean room was located on leased land near our office and lab and we paid $2,000 per month on a one-year leasefor the right to locate it there. The arrangement was terminated in September 2022 and the mobile clean room was returned to the vendor that was extendedleased it to an expiration date of November 30, 2018.us.

 

RentOverall, our rent expense, which is included in general and administrative expenses, approximated $100,000$315,000 and $114,000$411,000 for the nine month periods ended December 31, 20172023 and 2016,2022, respectively.

 

Legal MattersLEGAL MATTERS

 

FromWe may be involved from time to time in various claims, are made against us inlawsuits, and/or disputes with third parties or breach of contract actions incidental to the ordinarynormal course of our business which could result in litigation. Claims and associated litigationoperations. We 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 outcomecurrently not involved in any specific period could have a material adverse effect on our results of operations for that periodlitigation or future periods. We are not presently a party to any pending or threatened legal proceedings.

 

14. 11. SUBSEQUENT EVENTS

 

Management has evaluated events subsequent to December 31, 20172023 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 –Sales Under 2022 ATM Agreement

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, 2017,2023, 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$49,762, net of $1,291 in commissions to H.C. Wainwright and $1,998$572 in other offering expenses), utilizing the sales agreementexpenses, through the sale of 340,00023,861 shares of our common stock at an average price of $1.34$2.09 per share of net proceeds.

Restricted Stock Unit (“RSU”) Issuances – In January 2018, 46,125 RSUs held by our executives were exchanged intounder the same number of shares of our common stock. As our executives elected to net settle a portion of their RSUs in exchange for the Company paying the related withholding taxes on the share issuance, 26,157 of the RSUs were cancelled, and we issued a net 19,968 shares to our executives.2022 ATM Agreement.

 

 

 

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

 

The following discussion of our financial condition and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. This item containsSome of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those indicated in such forward-looking statements.

FORWARD LOOKING STATEMENTS

All statements, other than statementsFor a complete discussion 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 causesee the 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, 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.section above entitled “Cautionary Notice Regarding Forward Looking Statements.”

 

Overview

 

Aethlon Medical, Inc. and subsidiary (collectively, “Aethlon”, or Aethlon, the “Company”, “we”Company, we or “us”) areus, is a medical technologytherapeutic company focused on addressing unmet needs in global healthdeveloping products to treat cancer and biodefense.life-threatening infectious diseases. The Aethlon Hemopurifier®Hemopurifier is an earlya clinical-stage therapeuticimmunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The FDA has designated the Hemopurifier as a “Breakthrough Device” for the single-use removal of life-threatening viruses from the circulatory system of infected individuals. two independent indications:

·the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and
·the treatment of life-threatening viruses that are not addressed with approved therapies.

We believe the Hemopurifier can be a substantial advance in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes that promote the growth and spread of tumors through multiple mechanisms. We are currently working with our contract research organization, or CRO, on preparations to conduct a planned clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers.

In January 2023, we entered into an agreement with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to oversee our planned clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA agreed to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We anticipate that the initial clinical trials will begin in Australia.

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

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

On June 17, 2020, the FDA approved a supplement to our open Investigational Device Exemption, or IDE, for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19, or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States. Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this study was enrolled and completed the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this study in 2022.

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Under Single Patient Emergency Use regulations, the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier in our COVID-19 clinical trial discussed above.

We previously reported a disruption in our Hemopurifier supply, as our then existing supply of Hemopurifiers expired on September 30, 2022 and, also as previously disclosed, we are dependent on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for galanthus nivalis agglutinin, or GNA, a component of our Hemopurifier, continues to be delayed as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing change. We are working with the FDA to qualify this second supplier of our GNA. We also are in the process of completing final testing in order to begin manufacturing Hemopurifiers at our new manufacturing facility in San Diego for use in planned U.S. clinical trials, using GNA from our current supplier. The first manufacturing lot that incorporates the GNA from our original supplier was approved and released at the end of December 2023. We also have sufficient Hemopurifiers on hand for use in our planned Australia and India oncology trials.

In October 2022, we launched a wholly owned subsidiary in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary will initially focus on the planned oncology trials in Australia.

We also obtained ethics review board, or ERB, approval from and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical trial at that location. One patient has completed participation in the Indian COVID-19 study. The relevant authorities in India have accepted the use of our Hemopurifiers made with the GNA from our new supplier.

In May 2023, we also received ERB approval from the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated with the University of Delhi and is operated by the Delhi government.

In October 2023, we announced that we received clearance from the Drug Controller General of India, the central drug authority in India, to conduct a Phase 1 safety, feasibility and dose-finding trial of the Company’s Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®. The trial is expected to begin following completion of an internal in vitro binding study of relevant targets, and subsequent approval by the respective Ethics Boards of interested sites in India.

Additionally, we announced that we have begun investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our translational studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from recovered organs. We initially are focused on recovered kidneys, in a research collaboration with 34 Lives, PBC. We have previously demonstrated the clinical advancementremoval of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down version of our Hemopurifier. This process potentially may reduce complications following transplantation of the Hemopurifier through investigational device exemptions (IDEs) approved by FDA.recovered organ, which can include viral infection, delayed graft function and rejection. We recently concluded a feasibility studybelieve this new approach could be additive to demonstrateexisting technologies that currently are in place to increase the safetynumber 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 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.viable kidneys for transplant.

 

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

 

In addition to the foregoing, we are monitoring closely the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the ongoing military conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic impact on national and international markets that are highly uncertain.

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We incorporated in Nevada on March 10, 1999. Our executive offices are located at 9635 Granite Ridge Drive,11555 Sorrento Valley Road, Suite 100,203, San Diego, California 92123.92121. Our telephone number is (858) 459-7800.(619) 941-0360. Our website address is www.aethlonmedical.com.

 

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

 

WHERE YOU CAN FIND MORE INFORMATION

 

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

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RESULTS OF OPERATIONS

 

THREE MONTHS ENDED DECEMBER 31, 20172023 COMPARED TO THE THREE MONTHS ENDED DECEMBER 31, 2016

Revenues

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

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

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 three 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.2022

 

Operating Expenses

 

Consolidated operating expenses for the three months ended December 31, 20172023 were $1,238,440 in comparison with $1,235,546$3,567,088 compared to $2,849,753 for the comparable period a year ago.three months ended December 31, 2022. This increase of $2,894,$717,335, or 0.2%25.2%, in the 2023 period was due to an increase in payroll and related expenses of $27,547,$870,544 offset by a $22,251 increasedecrease in professional fees of $61,079 and a $46,904$92,130 decrease in general and administrative expenses.

 

The $27,547$870,544 increase in payroll and related expenses was due to a $17,003 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 in our professional fees at ESI of $15,711. The $37,962 decrease in our professional fees was due to a $62,864 increase in our legal fees, a $22,022 increase in our investor relations fees, a $14,069 increase in our accounting fees, a $7,358 increase in our marketing expenses, and a $6,100 increase in our directors’ fees due to an increase in our Board of Directors, which were partially offset by a $51,548 decrease in our scientific consulting expenses and a $25,000 decrease in business development expenses.

The $46,904 decrease in general and administrative expenses was primarily due to a $34,324 decrease 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.

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Other Expense

Other expense during the three months ended December 31, 20172023 relates primarily to separation expenses for a former executive of $872,763 and 2016 consistedan increase in salary expense of interest expense and$80,577 associated with an increase in average headcount offset by a gain on debt extinguishment. Other expense fordecrease in stock-based compensation of $82,797.

The decrease in professional fees of $61,079 in the three months ended December 31, 20172023 was other expensedue to a $53,641 decrease in scientific consulting, a $22,000 decrease in marketing, a $21,000 decrease in recruiting and a net $33,238 decrease in contract labor related to general research and development. These decreases were offset by an increase of $55,912$44,153 in comparisonlegal expenses relating to the reverse stock split, $11,250 increase in director fees associated with other incomethe addition of $22,126 fora new director and $13,808 increase in investor relations and accounting fees.

General and administrative expenses decreased by $92,130 in the three months ended December 31, 2016.

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

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

Interest Expense

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

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

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

Net Loss

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

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

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

Revenues

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

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

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NIH Contract

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

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

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

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

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

DARPA Contract & Battelle Subcontract

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

Operating Expenses

Consolidated operating expenses for the nine months ended December 31, 2017 were $3,634,862 in comparison with $4,986,148 for the comparable period a year ago. This decrease of $1,351,286, or 27.1%, was2023 primarily due to a decrease in payrollclinical trial expense of $399,255 and related expenses of $882,335, a $33,170 decrease in professional fees of $330,279travel 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 whichconferences. Decreases were partially offset by a $64,949$283,590 increase in marketing expenses, a $17,014supplies for manufacturing and research and development expense, $31,408 increase in website serviceinsurance expense, $13,346 increase in depreciation expense and a $5,732$12,365 increase in investor relations expenses.

The $138,672 decrease in generaloutside services 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.

repairs. 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)

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Loss on Debt Extinguishment

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

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

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

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

Loss on Warrant Repricing

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

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

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

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.

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Interest Expense

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

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

As noted in the above table, the most significant factor in the $191,187 increase in interestinsurance expense was the $177,380 increase in the amortizationincludes $15,811 of note discounts, whichhealth insurance related to the amortization against the discount onSeparation Agreement with 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.former Chief Executive Officer.

  

Net Loss

 

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests decreased from approximately $5,613,000increased to $3,567,088 in the nine month periodthree months ended December 31, 2016 to $4,374,0002023 from $2,849,753 in the nine month periodthree months ended December 31, 2017.2022.

 

Basic and diluted loss attributable to common stockholders was ($1.37) for the three months ended December 31, 2023, compared to ($1.24) for the three month period ended December 31, 2022.

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NINE MONTHS ENDED DECEMBER 31, 2023 COMPARED TO THE NINE MONTHS ENDED DECEMBER 31, 2022

Operating Expenses

Consolidated operating expenses for the nine months ended December 31, 2023 were $10,150,594, compared to $9,420,730 for the nine months ended December 31, 2022. This increase of $729,864, or 7.7%, in the 2023 period was due to increases in payroll and related expenses of $1,042,568 and an increase in professional fees of $202,839, which were partially offset by a decrease of $515,543 in our general and administrative expenses.

The $1,042,568 increase in payroll and related expense was primarily due to separation expenses of $872,763 for our former Chief Executive Officer and an increase of $230,343 in salary expense associated with an increase in headcount for Manufacturing and Research and Development, offset by a $104,477 decrease in stock-based compensation related to employee stock option grants.

The $515,543 decrease in general and administrative expenses was primarily due to the combination of a $716,153 decrease in clinical trial expenses associated with the previous COVID-19 trial, $279,504 decrease in subcontract expenses associated with previous government contracts, $95,475 decrease in rent associated to previously rented mobile cleanroom and $20,251 decrease in office equipment and supplies. The decreases were offset by $335,288 increase in manufacturing supplies related to purchase of raw materials necessary to manufacture the Hemopurifier, $30,992 increase in research and development supplies, $111,874 increase in depreciation expense related to leasehold improvements and new equipment for our manufacturing and lab facilities, $56,608 increase in repairs and maintenance for our manufacturing and lab facilities, and $61,055 increase in insurance expense.

The $202,839 increase in professional fees in the nine months ended December 31, 2023 was due to an increase of $98,572 in investor relations associated with facilitating investor awareness, an increase of $95,055 in accounting fees associated with audit and financial services, an increase of $41,272 in contract labor relating to outside services associated with operations, $87,327 increase of legal expenses associated with general corporate matters and the reverse stock split, $22,500 increase in director fees related to the addition to the board of directors, $20,258 increase for website services relating to compliance to the American Disability Act and $6,101 increase in recruiting expense. The increases were offset by $59,317 decreases in scientific consulting for previously completed studies, and a decrease of $109,362 in regulatory and various outside services.

Net Loss

As a result of the changes in revenues and expenses noted above, our net loss increased to $9,782,756 in the nine months ended December 31, 2023 from $9,562,851 in the nine months ended December 31, 2022.

Basic and diluted loss attributable to common stockholders was ($0.40)3.95) for the nine months ended December 31, 2023, compared to ($4.84) for the nine month period ended December 31, 2017 compared to ($0.72) for the period ended December 31, 2016.2022.

 

LIQUIDITY AND CAPITAL RESOURCES

 

AtAs of December 31, 2017,2023, we had a cash balance of $5,610,799$7,972,012 and working capital of $5,288,930.$6,148,710. This compares to a cash balance of $1,559,701$14,532,943 and working capital of $985,496$13,585,477 at March 31, 2017.2023.

 

On October 4, 2017, we consummated

20

We do not expect our existing cash as of December 31, 2023 to be sufficient to fund our operations for at least twelve months from the issuance date of these financial statements. Significant additional financing must be obtained to provide a public offeringsufficient source of 5,454,546 shares of common stockoperating capital 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 stockallow us to continue to operate as a going concern.  We intend to fund operations, working capital 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 withother cash on hand will finance our operationsrequirements for the twelve month period from the date of this report.

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

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

Also subsequent to December 31, 2017, we sold common stock under our Common Stock Sales Agreement with H.C. Wainwright (see Note 6)2023 through a combination of debt and/or equity financing arrangements and potentially 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.collaborations or strategic partnerships.

 

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, asAs 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 activitiesclinical trials would have a material adverse effect on our ability to conduct planned clinical trials and commercialize our products and to remain as a going concern.products.

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 cashGoing Concern

The accompanying unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the ordinary course of business. We have incurred continuing losses from operations and at December 31, 20172023 had limited working capital and an accumulated deficit of $152,141,311. These factors, among other matters, raise substantial doubt about our ability to be sufficient to fundcontinue as a going concern within one year of the Company’s operations for at least twelve months from the issuance date of these interim financial statements. A significant amount of additional capital will be necessary to advance the development of our products to the point at which they may become commercially viable. We intend to fund operations, working capital and other cash requirements for the twelve month period subsequent to December 31, 2023 through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.

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 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 we be unable to continue as a going concern.

2022 At The Market Offering Agreement with H.C. Wainwright & Co., LLC

On March 24, 2022, we entered into an At The Market Offering Agreement, or the 2022 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, which established an at-the-market equity program pursuant to which we may offer and sell shares of our common stock from time to time as set forth in the 2022 ATM Agreement.

The offering was registered under the Securities Act of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-259909), as previously filed with the SEC and declared effective on October 21, 2021. We filed a prospectus supplement, dated March 24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to $15,000,000, or the 2022 ATM Shares.

21

Under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the 2022 ATM Shares. In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions with our consent and in block transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if the sales cannot be effected at or above the price designated by us from time to time.

We are not obligated to make any sales of the 2022 ATM Shares under the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein.

The 2022 ATM Agreement contains customary representations, warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement.

During the three months ended December 31, 2023, we raised net proceeds of $186,501, net of $4,828 in commissions to Wainwright and $1,784 in other offering expenses, through the sale of 94,304 shares of our common stock at an average price of $1.98 per share under the 2022 ATM Agreement. During the nine months ended December 31, 2023, we raised net proceeds of $1,272,621, net of $32,827 in commissions to Wainwright and $7,630 in other offering expenses, through the sale of 272,195 shares of our common stock at an average price of $4.68 per share under the 2022 ATM Agreement.

 

Cash Flows

 

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

 

 (In thousands)
For the nine months ended
  (In thousands)
For the nine months ended
 
 December 31,
2017
 December 31,
2016
  December 31,
2023
 December 31,
2022
 
Cash provided by (used in):        
Cash (used in) provided by:        
Operating activities $(2,893) $(2,644) $(7,564) $(7,558)
Investing activities  (24)  (3)  (246)  (932)
Financing activities  6,968   1,060   1,245   8,917 
Net increase (decrease) in cash $4,051  $(1,587)
Effect of exchange rate changes on cash  4    
Net decrease in cash and restricted cash $(6,561) $427 

 

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$7,564,000 in the nine months ended December 31, 20172023, compared to $2,644,000approximately $7,558,000 in the nine months ended December 31, 2016, an increase of $249,000.2022.

 

NET CASH USED IN INVESTING ACTIVITIES. We used approximately $24,000$246,000 of cash to purchase laboratory and office equipmentin investing activities in the nine months ended December 31, 20172023, compared to approximately $3,000$932,000 in the nine months ended December 31, 2016.2022. The $686,000 decrease in the 2023 period was primarily a result of the bulk of the equipment purchase and leasehold improvements for our manufacturing facility being incurred in the 2022 period.

 

22

NET CASH PROVIDED BY FINANCING ACTIVITIES. InDuring the nine months ended December 31, 20172023, we generatedraised approximately $6,968,000$1,273,000 from the issuance of our common stock under our at the market facility. That source of cash from our financing activities primarily throughwas partially offset by the use of approximately $28,000 to pay for the tax withholding on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $1,245,000.

During the nine months ended December 31, 2022, we raised approximately $8,927,000 from the issuance of our common stock an increaseunder our at the market facility, which was partially offset by the use of $5,908,000 overapproximately $10,000 to pay for the $1,060,000 raisedtax withholding on restricted stock units, for a net aggregate amount of cash provided by financing activities of approximately $8,917,000.

Material Cash Requirements

As noted above in the results of operations, our clinical trial expense decreased by $716,153 in the nine months ended December 31, 2016.2023, compared to the nine-month period ended December 31, 2022. However, we expect our clinical trial expenses will increase over the foreseeable future as we work to commence and expand our clinical trials both in the United States and internationally.

 

AtFuture capital requirements will depend upon many factors, including progress with pre-clinical testing and clinical trials for our Hemopurifier, the date of this filing, we plan to invest significantly into purchasesnumber and breadth of our raw materialsclinical programs, the time and intocosts involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs involved in obtaining regulatory approvals, competing technological and market developments, as well as our contract manufacturing arrangement subjectability to successfully raisingestablish collaborative arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative cash flows and net losses for the foreseeable future. We will continue to need to raise additional capital.capital for the foreseeable future and intend to through a combination of debt and/or equity financing arrangements and potentially from collaborations or strategic partnerships.

 

CRITICAL ACCOUNTING POLICIESESTIMATES

Use of Estimates

 

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

 

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

24

 

There have been no changes to our critical accounting policiesestimates as disclosed in our Form 10-K for the year ended March 31, 2017.2023.

 

OFF-BALANCE SHEET ARRANGEMENTS

 

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

23

 

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 requestedrequired by this item.

 

ITEM 4. CONTROLS AND PROCEDURES.

 

DISCLOSURE CONTROLS AND PROCEDURES

 

Under the supervision and with the participation of our management, including our Interim 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 Interim Chief Executive Officer and Chief Financial Officer concluded that, as of the end of such period, our disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that we file or submit under the Exchange Act and are effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Interim 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.

 

 

 

 

 

 

 

 

 

 

 2524 

 

 

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.

 

AsRISK FACTOR SUMMARY

Below is a smaller reporting company as defined by Rule 12b-2summary of the Exchange Actprincipal factors that make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2023, filed with the SEC on June 28, 2023, or Annual Report, and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the SEC before making investment decisions regarding our securities.

·We have incurred significant losses and expect to continue to incur losses for the foreseeable future.
·We will require additional financing to sustain our operations, achieve our business objectives and satisfy our cash obligations, which may dilute the ownership of our existing stockholders.
·We have limited experience in identifying and working with large-scale contracts with medical device manufacturers; manufacture of our devices must comply with good manufacturing practices in the United States.
·Delays, interruptions or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, has and may continue to prevent or delay our ability to manufacture our Hemopurifier.
·Our Hemopurifier technology may become obsolete.
·If we fail to comply with extensive regulations of U.S. and foreign regulatory agencies, the commercialization of our products could be delayed or prevented entirely.
·If we are unable to maintain compliance with the listing requirements of the Nasdaq Capital Market, our common stock may be delisted from the Nasdaq Capital Market which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.
·As a public company with limited financial resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors.
·Our success is dependent in part on our executive officers.
·We plan to expand our operations, which may strain our resources; our inability to manage our growth could delay or derail implementation of our business objectives.
·Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.

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Except for the risk factors set forth below, there have been no material changes to the risk factors previously disclosed under the heading “Risk Factors” in our Annual Report. The risks described in this Quarterly Report on Form 10-Q and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and thereforeour Annual Report are not requiredthe only risks facing our company. Additional risks and uncertainties not currently known to provideus or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.

Our success is dependent in part on our executive officers.

Our success depends to a critical extent on the information requested by this item.continued services of our Interim Chief Executive Officer and Chief Financial Officer, James B. Frakes, our Chief Medical Officer, Steven LaRosa, M.D., our Chief Scientific Officer, Lee D. Arnold, Ph.D., and our Chief Business Officer, Guy Cipriani. If any of these key executive officers were to leave us, we would be forced to expend significant time and money in the pursuit of a replacement, which would result in both a delay in the implementation of our business plan and the diversion of limited working capital. The unique knowledge and expertise of these individuals would be difficult to replace within the biotechnology field. We do not currently carry key man life insurance policies on any of our key executive officers which would assist us in recouping our costs in the event of the loss of those officers. If any of our key officers were to leave us, it could make it impossible, if not cause substantial delays and costs, to implement our long-term business objectives and growth.

 

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.2023.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

We have no disclosure applicable to this item.None.

 

ITEM 4. MINE SAFETY DISCLOSURES.

 

We have no disclosure applicable to this item.Not applicable.

 

ITEM 5. OTHER INFORMATION.

 

We have no disclosure applicable to this item.

26

 

ITEM 6. EXHIBITS.

 

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

 

      

Incorporated by Reference

Exhibit
Number
 Exhibit Description Form SEC File No. Exhibit
Number
 Date Filed
Herewith
             
3.1 Articles of Incorporation, as amended. 8-K 001-37487 3.1 September 19, 2022  
             
3.2 Amended and Restated Bylaws of the Company. 8-K 001-37487 3.1 September 12, 2019  
             
4.1 Form of Common Stock Certificate. S-1 333-201334 4.1 December 31, 2014  
             
4.2 Form of Warrant to Purchase Common Stock. S-1/A 333-234712 4.14 December 11, 2019  
             
4.3 Form of Underwriter Warrant. S-1/A 333-234712 4.15 December 11, 2019  
             
4.4 Form of Common Stock Purchase Warrant. 8-K 001-37487 4.1 January 17, 2020  
             
10.1++ Separation Agreement between the Company and Dr. Fisher, effective as of November 27, 2023. 8-K 001-37487 10.1 November 27, 2023  
             
10.2++ Amendment No. 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and James B. Frakes. 8-K 001-37487 10.1 December 22, 2023  
             
10.3++ Amendment No. 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and Guy F. Cipriani. 8-K 001-37487 10.2 December 22, 2023  
             
31.1 Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.         X
             
32.1^ Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.         X
             
101.INS Inline XBRL Instance Document         X
         
101.SCH Inline XBRL Taxonomy Extension Schema Document         X
         
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document         X
         
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document         X
         
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document         X
        
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document         X
        
104 Cover Page Interactive Data File (formatted in XBRL, and included in exhibit 101)          

31.1^CertificationThe information in Exhibit 32.1 shall not be deemed “filed” for purposes of Principal Executive Officer pursuant to SecuritiesSection 18 of the Exchange Act, rules 13a- 14(a) and 15d-14(a) as adopted pursuantor otherwise subject to the liabilities of that section, 302 ofnor shall it be deemed incorporated by reference in any filing under the Sarbanes-OxleySecurities Act of 2002or the Exchange Act (including this Quarterly Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference.
++
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 DocumentIndicates management contract or compensatory plan.

 

 

 

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SIGNATURES

 

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

 

 AETHLON MEDICAL, INC.
 
    
Date: February 1, 201814, 2024By:/s/ JAMES B. FRAKES 
  JAMES B. FRAKES 
  INTERIM CHIEF FINANCIALEXECUTIVE OFFICER 
  CHIEF FINANCIAL OFFICER
CHIEF ACCOUNTING OFFICER 

 

 

 

 

 

 

 


 

 

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