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, 2021
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____to_____
COMMISSION FILE NUMBER 001-37487
AETHLON
MEDICAL, INC.
(Exact name of registrant as specified in its charter)
nevada
13-3632859
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
11555 SORRENTO VALLEY ROAD , SUITE 203 , SAN DIEGO , CA
92121
(Address of principal executive offices)
(Zip Code)
( 619 ) 941-0360
(Registrant’s telephone number, including
area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class
Trading Symbol
Name of each exchange on which registered
Common Stock
AEMD
The Nasdaq Capital Market
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ NO ☐
Indicate by check mark whether the registrant has submitted electronically
every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ NO ☐
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions
of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging
growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated Filer ☐
Accelerated Filer ☐
Non-accelerated Filer ☒
Smaller reporting company ☒
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
As of February 11, 2022, the registrant had outstanding 15,408,231
shares of common stock, $0.001 par value.
TABLE OF CONTENTS
PART I.
FINANCIAL INFORMATION
3
ITEM 1.
FINANCIAL STATEMENTS
3
CONDENSED CONSOLIDATED BALANCE SHEETS AT DECEMBER 31, 2021 (UNAUDITED) AND MARCH 31, 2021
3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2021 AND 2020 (UNAUDITED)
4
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2021 AND 2020 (UNAUDITED)
5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED DECEMBER 31, 2021 AND 2020 (UNAUDITED)
7
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
8
ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
22
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
31
ITEM 4.
CONTROLS AND PROCEDURES
31
PART II.
OTHER INFORMATION
32
ITEM 1.
LEGAL PROCEEDINGS
32
ITEM 1A.
RISK FACTORS
32
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
34
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
34
ITEM 4.
MINE SAFETY DISCLOSURES
34
ITEM 5.
OTHER INFORMATION
34
ITEM 6.
EXHIBITS
34
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31,
2021
March 31,
2021
(Unaudited)
ASSETS
Current assets
Cash
$ 20,394,536
$ 9,861,575
Accounts receivable
131,966
149,082
Prepaid expenses and other current assets
683,722
341,081
Total current assets
21,210,224
10,351,738
Property and equipment, net
254,024
160,976
Right-of-use lease asset
328,869
40,363
Patents, net
2,338
56,954
Restricted cash
87,506
46,726
Deposits
33,305
12,159
Total assets
$ 21,916,266
$ 10,668,916
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
$ 234,118
$ 337,678
Due to related parties
130,375
118,520
Deferred revenue
229,698
114,849
Lease liability, current portion
53,545
42,543
Other current liabilities
421,956
761,636
Total current liabilities
1,069,692
1,375,226
Lease liability, less current portion
287,221
–
Total liabilities
1,356,913
1,375,226
Stockholders’ Equity
Common stock, par value $ 0.001 per share; 30,000,000 shares authorized; 15,408,231 and 12,150,597 shares issued and outstanding as of December 31, 2021 and March 31, 2021, respectively
15,410
12,152
Additional paid-in capital
147,229,134
129,331,542
Accumulated deficit
( 126,544,103 )
( 119,913,090 )
Total Aethlon Medical, Inc. stockholders’ equity before noncontrolling interests
20,700,441
9,430,604
Noncontrolling interests
( 141,088 )
( 136,914 )
Total stockholders’ equity
20,559,353
9,293,690
Total liabilities and stockholders’ equity
$ 21,916,266
$ 10,668,916
See accompanying notes.
3
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three and Nine Month Periods Ended December
31, 2021 and 2020
(Unaudited)
Three Months
Ended
December 31,
2021
Three Months
Ended
December 31,
2020
Nine Months
Ended
December 31,
2021
Nine Months
Ended
December 31,
2020
REVENUES
Government contract revenue
$ 17,117
$ 624,871
$ 281,049
$ 624,871
OPERATING EXPENSES
Professional fees
433,404
624,979
1,666,333
1,845,659
Payroll and related expenses
999,500
1,523,650
2,821,850
2,520,805
General and administrative
1,112,159
920,632
2,428,053
1,885,332
Total operating expenses
2,545,063
3,069,261
6,916,236
6,251,796
OPERATING LOSS
( 2,527,946 )
( 2,444,390 )
( 6,635,187 )
( 5,626,925 )
NET LOSS
( 2,527,946 )
( 2,444,390 )
( 6,635,187 )
( 5,626,925 )
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS
( 2,214 )
( 1,498 )
( 4,174 )
( 3,186 )
NET LOSS ATTRIBUTABLE TO AETHLON MEDICAL, INC.
$ ( 2,525,732 )
$ ( 2,442,892 )
$ ( 6,631,013 )
$ ( 5,623,739 )
BASIC AND DILUTED LOSS PER COMMON SHARE
$ ( 0.16 )
$ ( 0.20 )
$ ( 0.46 )
$ ( 0.50 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING – BASIC AND DILUTED
15,397,418
12,093,361
14,543,787
11,265,725
See accompanying notes.
4
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
For the Nine Months Ended December 31, 2021 and
2020
(Unaudited)
COMMON STOCK
ADDITIONAL
PAID IN
ACCUMULATED
NON-
CONTROLLING
TOTAL STOCKHOLDERS’
SHARES
AMOUNT
CAPITAL
DEFICIT
INTERESTS
EQUITY
BALANCE AT MARCH 31, 2021
12,150,597
$ 12,152
$ 129,331,542
$ ( 119,913,090 )
$ ( 136,914 )
$ 9,293,690
Issuances of common stock for cash under at the market program
626,000
626
4,947,159
–
–
4,947,785
Issuances of common stock for cash in registered direct financing
1,380,555
1,381
11,657,663
–
–
11,659,044
Issuances of common stock for cash under warrant exercises
531,167
531
820,407
–
–
820,938
Issuances of common stock for cash under stock option exercises
11,562
11
28,314
–
–
28,325
Issuances of common stock under cashless warrant exercises
675,554
676
( 676 )
–
–
–
Issuance of common shares upon vesting of restricted stock units
10,932
11
( 35,797 )
–
–
( 35,786 )
Stock-based compensation expense
–
–
120,154
–
–
120,154
Net loss
–
–
–
( 2,097,303 )
( 1,135 )
( 2,098,438 )
BALANCE AT June 30, 2021
15,386,367
15,388
146,868,766
( 122,010,393 )
( 138,049 )
24,735,712
Issuance of common shares upon vesting of restricted stock units
10,932
11
( 28,145 )
–
–
( 28,134 )
Stock-based compensation expense
–
–
201,062
–
–
201,062
Net loss
–
–
–
( 2,007,978 )
( 825 )
( 2,008,803 )
BALANCE AT September 30, 2021
15,397,299
15,399
147,041,683
( 124,018,371 )
( 138,874 )
22,899,837
Issuance of common shares upon vesting of restricted stock units
10,932
11
( 13,568 )
–
–
( 13,557 )
Stock-based compensation expense
–
–
201,019
–
–
201,019
Net loss
–
–
–
( 2,525,732 )
( 2,214 )
( 2,527,946 )
BALANCE AT December 31, 2021
15,408,231
$ 15,410
$ 147,229,134
$ ( 126,544,103 )
$ ( 141,088 )
$ 20,559,353
Continued on following page
5
COMMON STOCK
ADDITIONAL
PAID IN
ACCUMULATED
NON-
CONTROLLING
TOTAL
SHARES
AMOUNT
CAPITAL
DEFICIT
INTERESTS
EQUITY
BALANCE AT MARCH 31,
2020
9,366,873
$ 9,368
$ 121,426,563
$ ( 112,026,381 )
$ ( 132,124 )
$ 9,277,426
Issuances of common stock for cash under at the market program
2,685,600
2,686
7,258,183
–
–
7,260,869
Issuance of common shares upon vesting of restricted stock units
17,920
18
( 24,269 )
–
–
( 24,251 )
Stock-based compensation expense
–
–
84,207
–
–
84,207
Net loss
–
–
–
( 1,410,283 )
( 863 )
( 1,411,146 )
BALANCE AT JUNE 30, 2020
12,070,393
12,072
128,744,684
( 113,436,664 )
( 132,987 )
15,187,105
Issuance of common shares upon vesting of restricted stock units
17,920
17
( 16,145 )
–
–
( 16,128 )
Stock-based compensation expense
–
–
167,042
–
–
167,042
Net loss
–
–
–
( 1,770,564 )
( 825 )
( 1,771,389 )
BALANCE AT SEPTEMBER 30,
2020
12,088,313
12,089
128,895,581
( 115,207,228 )
( 133,812 )
13,566,630
Issuance of common shares upon vesting of restricted stock units and net
stock option exercise
35,211
36
( 66,048 )
–
–
( 66,012 )
Stock-based compensation expense
–
–
377,958
–
–
377,958
Net loss
–
–
–
( 2,442,892 )
( 1,498 )
( 2,444,390 )
BALANCE AT DECEMBER 31,
2020
12,123,524
$ 12,125
$ 129,207,491
$ ( 117,650,120 )
$ ( 135,310 )
$ 11,434,186
See accompanying notes.
6
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Nine Months Ended December 31, 2021 and
2020
(Unaudited)
Nine Months
Ended
December 31, 2021
Nine Months
Ended
December 31, 2020
Cash flows used in operating activities:
Net loss
$ ( 6,635,187 )
$ ( 5,626,925 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
98,363
28,775
Stock based compensation
522,234
629,207
Accretion of right-of-use lease asset
9,717
( 1,723 )
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 342,641 )
153,775
Accounts receivable
17,116
91,880
Deposits
( 21,146 )
–
Accounts payable and other current liabilities
( 443,239 )
278,663
Deferred revenue
114,849
( 100,000 )
Due to related parties
11,855
20,039
Net cash used in operating activities
( 6,668,079 )
( 4,526,309 )
Cash flows used in investing activities:
Purchases of property and equipment
( 136,795 )
( 54,630 )
Net cash used in investing activities
( 136,795 )
( 54,630 )
Cash flows provided by financing activities:
Proceeds from the issuance of common stock, net
17,456,092
7,260,869
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units and net stock option expense
( 77,477 )
( 106,391 )
Net cash provided by financing activities
17,378,615
7,154,478
Net increase in cash and restricted cash
10,573,741
2,573,539
Cash and restricted cash at beginning of period
9,908,301
9,604,780
Cash and restricted cash at end of period
$ 20,482,042
$ 12,178,319
Supplemental disclosures of cash flow information:
Supplemental disclosures of non-cash investing and financing activities:
Issuance of common stock under cashless warrant exercises
$ 676
$ –
Par value of shares issued for vested restricted stock units and net stock option exercise
$ 33
$ 71
Reconciliation of cash, cash equivalents and restricted cash to the condensed consolidated balance sheets:
Cash and cash equivalents
$ 20,394,536
$ 12,131,593
Restricted cash
87,506
46,726
Cash and restricted cash
$ 20,482,042
$ 12,178,319
See accompanying notes.
7
AETHLON MEDICAL, INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
December 31, 2021
1. NATURE OF BUSINESS AND BASIS OF PRESENTATION ORGANIZATION
Aethlon Medical, Inc. and its subsidiary (collectively,
“Aethlon”, the “Company”, “we” or “us”), is a medical technology company focused on developing
products to diagnose and treat life and organ threatening diseases. The Aethlon Hemopurifier is a clinical-stage immunotherapeutic device
designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete the presence of circulating
tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies.
The U.S. Food and Drug Administration, or FDA, has designated the Hemopurifier as a “Breakthrough Device” for two independent
indications:
·
the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and
·
the treatment of life-threatening viruses that are not addressed with approved therapies.
We believe the Hemopurifier can be a substantial
advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and
spread of tumors through multiple mechanisms. We are currently conducting a clinical trial in patients with advanced and metastatic head
and neck cancer. We are initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and
other cancers. As we advance our clinical trials, we are in close contact with our clinical sites to navigate and assess the impact of
the COVID-19 global pandemic on our clinical trials and current timelines.
On October 4, 2019, the FDA approved our Investigational
Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck
cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, which is designed to enroll 10
to 12 subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as
well as response and survival rates. This study, which is being conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, has treated
two patients and is in the process of recruiting additional patients. We are considering adding one or more additional sites to this trial
to accelerate patient recruitment and we are also considering starting additional trials in other forms of cancer.
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. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected with human immunodeficiency virus, or HIV, hepatitis-C, and Ebola.
Additionally, in vitro, the Hemopurifier
has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya
virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, and the reconstructed Spanish
flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research
institutes.
On June 17, 2020, the FDA approved a supplement
to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19
in a New Feasibility Study. That study is designed to enroll up to 40 subjects at up to 20 centers
in the U.S. Subjects will have established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and will have
acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, will
include reduction in circulating virus as well as clinical outcomes (NCT # 04595903). Under Single Patient Emergency Use regulations,
the Company has also treated two patients with COVID-19 with the Hemopurifier.
8
In September
2021, we entered into an agreement with PPD, Inc., or PPD, a leading global contract research organization, or CRO, to oversee our U.S.
clinical studies investigating the Hemopurifier for critically ill COVID-19 patients. We now have three hospitals, Hoag Newport Beach,
Hoag Irvine, and Loma Linda Medical Center, fully activated for patient enrollment and they are actively screening patients for the trial.
Together with PPD, we are currently advancing site readiness for LSU Shreveport, Valley Baptist Medical Center in Texas, University of
California Davis, University of Miami Medical Center, and Thomas Jefferson Medical Center. We are in discussions to bring on board other
key U.S. medical centers.
We also obtained ethics review board approval
and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19
clinical trial at that location. We have completed all site initiation activities at Medanta Medicity Hospital and this site is now open
for enrollment and is actively screening patients.
We are also the majority owner of Exosome Sciences,
Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. We
consolidate ESI’s activities in our consolidated financial statements.
Successful outcomes of human trials will also
be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier. Some of our patents may expire
before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or
other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.
In addition to the foregoing, we are monitoring
closely the impact of the COVID-19 global pandemic on our business and have taken steps designed to protect the health and safety of our
employees while continuing our operations. Given the level of uncertainty regarding the duration and impact of the COVID-19 pandemic on
capital markets and the U.S. economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and the resulting COVID-19
pandemic on our timelines and future access to capital. We are continuing to monitor the spread of COVID-19 and its potential impact on
our operations. The full extent to which the COVID-19 pandemic will impact our business, results of operations, financial condition, clinical
trials, and preclinical research will depend on future developments that are highly uncertain, including actions taken to contain or treat
COVID-19 and their effectiveness, as well as the economic impact on national and international markets.
Our executive offices are located at 11555 Sorrento
Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360. Our website address is www.aethlonmedical.com.
Our common stock is listed on the Nasdaq Capital Market under the symbol
“AEMD.”
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
During the three months ended December 31, 2021,
there were no changes to our significant accounting policies as described in our Annual Report on Form 10-K for the fiscal year ended
March 31, 2021.
Basis of Presentation and Use of Estimates
The accompanying unaudited condensed consolidated
financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for
interim financial information and with the instructions to Form 10-Q and Article 8 of the Securities and Exchange Commission, 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, 2021, included in the Company’s Annual Report on Form 10-K filed with the SEC on June 24, 2021. The accompanying unaudited
condensed consolidated financial statements include the accounts of Aethlon Medical, Inc. and its majority-owned subsidiary. All significant
inter-company transactions and balances have been eliminated in consolidation. The unaudited condensed consolidated financial statements
contain all normal recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the condensed
consolidated financial statements as of and for the nine months ended December 31, 2021, and the condensed consolidated statement of cash
flows for the nine months ended December 31, 2021. Estimates were made relating to useful lives of fixed assets, impairment of assets,
share-based compensation expense and accruals for clinical trial and research and development expenses. Actual results could differ materially
from those estimates. The accompanying condensed consolidated balance sheet at March 31, 2021 has been derived from the audited consolidated
balance sheet at March 31, 2021, contained in the above referenced 10-K. The results of operations for the nine months ended December
31, 2021 are not necessarily indicative of the results to be expected for the full year or any future interim periods.
9
Reclassifications
Certain prior year balances within the unaudited condensed consolidated
financial statements have been reclassified to conform to the current year presentation.
LIQUIDITY AND GOING CONCERN
Management expects existing cash as of December
31, 2021 to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed
consolidated financial statements.
Restricted Cash
To comply with the terms of our laboratory and
office lease and our new lease for our manufacturing space, see Note 12, we caused our bank to issue two standby letters of credit, or
the L/Cs, in the aggregate amount of $ 87,506 in favor of the landlord. The L/Cs are in lieu of a security deposit. In order to support
the L/Cs, we agreed to have our bank withdraw $87,506 from our operating accounts and to place that amount in a restricted certificate
of deposit. We have classified that amount as restricted cash, a long-term asset, on our balance sheet.
2. LOSS PER COMMON SHARE
Basic loss per share is computed by dividing net
loss by the weighted average number of common shares outstanding during the period of computation. 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, 2021 and 2020, an aggregate
of 1,587,759 and 2,626,485 potential common shares, respectively, consisting of shares underlying outstanding stock options, warrants
and unvested restricted stock units, 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, 2021 and 2020,
which are included in various operating expense line items in the accompanying condensed consolidated statements of operations. Our research
and development expenses in those periods were as follows:
Research and Development expenses
December 31,
December 31,
2021
2020
Three months ended
$ 354,571
$ 461,176
Nine months ended
$ 1,403,891
$ 1,367,333
10
4. RECENT ACCOUNTING PRONOUNCEMENTS
None.
5. EQUITY TRANSACTIONS IN THE NINE MONTHS ENDED DECEMBER 31, 2021
Common Stock Sales Agreement with H.C. Wainwright & Co., LLC
On March 22, 2021, we entered into an At the Market
Offering Agreement, or the Offering Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, as sales agent, pursuant to which we
could offer and sell shares of our common stock, from time to time as set forth in the Offering Agreement.
The offering
was registered under the Securities Act of 1933, as amended, or Securities Act , pursuant
to our shelf registration statement on Form S-3 (Registration Statement No. 333-237269), as previously filed with the SEC
and declared effective on March 30, 2020. We filed a prospectus supplement with the SEC, dated March 22, 2021, in connection with the
offer and sale of the shares of common stock, pursuant to which we could offer and sell shares of
common stock having an aggregate offering price of up to $5,080,000 from time to time.
Subject to the terms and conditions set forth
in the Offering Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices
to sell the shares under the Offering Agreement from time to time, based upon our instructions. We provided Wainwright with customary
indemnification rights under the Offering Agreement, and Wainwright was entitled to a commission at a fixed rate equal to three percent
of the gross proceeds per share sold. In addition, we agreed to reimburse Wainwright for certain specified expenses in connection with
entering into the Offering Agreement. The Offering Agreement provided that it would terminate upon the written termination by either party
as permitted thereunder.
Sales of the shares, under the Offering Agreement
are made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act,
including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as
otherwise agreed with Wainwright. The Offering Agreement provided that we have no obligation under the Offering Agreement to sell any
of the shares, and, at any time, we could suspend offers under the Offering Agreement or terminate the agreement.
In the nine months ended December 31, 2021, we
raised aggregate net proceeds under the Offering Agreement described above of $ 4,947,785 , net of $ 126,922 in commissions to Wainwright
and $ 2,154 in other offering expense, through the sale of 626,000 shares of our common stock at an average price of $ 7.90 per share of
net proceeds. No further sales can be made under the Offering Agreement.
Registered Direct Financing
In the nine months ended December 31, 2021, we
sold an aggregate of 1,380,555 shares of our common stock at a purchase price per share of $ 9.00 , for aggregate net proceeds to us of
$ 11,659,044 , after deducting fees payable to Maxim Group LLC, the placement agent, and other offering expenses. These shares were sold
through a securities purchase agreement with certain institutional investors. The shares were issued pursuant to an effective shelf registration
statement on Form S-3, which was originally filed with the SEC on March 19, 2020, and was declared effective on March 30, 2020 (File No.
333-237269) and a prospectus supplement thereunder.
11
Warrant Exercises
In the nine months ended December 31, 2021, pursuant
to the exercise of outstanding warrants to purchase 531,167 shares of our common stock, we received proceeds in the amount of $ 820,938
from institutional investors.
Also in the nine months ended December 31, 2021,
pursuant to the exercise of 874,664 outstanding warrants on a cashless basis, we issued 675,554 shares of our common stock. The difference
of 199,110 shares of common stock issuable pursuant to the warrants were cancelled.
Stock Option Exercises
In the nine months ended December 31, 2021, former
employees paid us an aggregate of $ 28,325 for the exercise of outstanding options to purchase 11,562 shares of our common stock.
Restricted Stock Unit Grants
In 2012, as amended through October 30, 2020,
our Board of Directors established the Non-Employee Directors Compensation Program, to provide for cash and equity compensation for persons
serving as non-employee directors of the Company. Under this program, each new director receives either stock options or a grant of restricted
stock units, or RSUs, as well as an annual grant of RSUs at the beginning of each fiscal year. The RSUs are subject to vesting and represent
the right to be issued on a future date shares of our common stock upon vesting.
On April 1, 2021, pursuant to the terms of the
Company’s 2012 Non-Employee Directors Compensation Program, as amended, or the Directors Plan, the Compensation Committee of the
Board granted RSUs under the Company’s 2020 Equity Incentive Plan, or the 2020 Plan, to each non-employee director of the Company.
The Director’s Plan provides for a grant of $50,000 worth of RSUs at the beginning of each fiscal year, priced at the average for
the closing prices for the five days preceding and including the date of grant, or $2.06 per share as of April 1, 2021. Each eligible
director was granted an RSU in the amount of 24,295 shares under the 2020 Plan. The RSU’s are subject to vesting in four equal quarterly
installments on June 30, September 30, December 31, 2021, and March 31, 2022, subject to the recipient’s continued service with
the Company on each such vesting date.
In June 2021, 18,221 vested RSUs held by our non-employee
directors were exchanged into the same number of shares of our common stock. All three non-employee directors elected to return 40% of
their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 7,289 of the vested
RSUs being cancelled in exchange for $ 35,786 in aggregate cash proceeds to those independent directors.
In September 2021, 18,221 vested RSUs held by
our non-employee directors were exchanged into the same number of shares of our common stock. All three non-employee directors elected
to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in
7,289 of the vested RSUs being cancelled in exchange for $ 28,134 in aggregate cash proceeds to those independent directors.
In December 2021, 18,221 vested RSUs held by our
non-employee directors were exchanged into the same number of shares of our common stock. All three non-employee directors elected to
return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 7,289
of the vested RSUs being cancelled in exchange for $ 13,557 in aggregate cash proceeds to those independent directors.
12
RSUs outstanding that have vested as of, and
are expected to vest subsequent to, December 31, 2021 are as follows:
Schedule of RSU activity
Number of RSUs
Vested
–
Expected to vest
18,221
Total
18,221
6. RELATED PARTY TRANSACTIONS
During the three months ended December 31, 2021,
we accrued unpaid fees of $ 52,000 owed to our non-employee directors as of December 31, 2021. We also paid the relocation expenses, including
a gross up for the expected income tax impact, of $ 200,041 in December 2021 for two senior executives that relocated to our headquarters
as part of their employment arrangement. Amounts due to related parties were comprised of the following items:
Due to related parties
December 31,
2021
March 31,
2021
Accrued Board fees
$ 52,000
$ 52,000
Accrued vacation to all employees
78,375
66,520
Total due to related parties
$ 130,375
$ 118,520
7. OTHER CURRENT LIABILITIES
Other current liabilities were comprised of the following items:
Other Current Liabilities
December 31,
March 31,
2021
2021
Accrued separation expenses for former executive (see Note 12)
$ –
$ 284,270
Accrued professional fees
421,956
477,366
Total other current liabilities
$ 421,956
$ 761,636
13
8. STOCK COMPENSATION
The following tables summarize share-based compensation expenses relating
to RSUs and stock options and the effect on basic and diluted loss per common share during the three and nine month periods ended December
31, 2021 and 2020:
Share-based compensation expense relating to RSUs
Three Months
Ended
December 31,
2021
Three Months
Ended
December 31,
2020
Nine Months
Ended
December 31,
2021
Nine Months
Ended
December 31,
2020
Vesting of stock options and restricted stock units
$ 201,019
$ 377,958
$ 522,234
$ 629,207
Total stock-based compensation expense
$ 201,019
$ 377,958
$ 522,234
$ 629,207
Weighted average number of common shares outstanding – basic and diluted
15,397,418
12,093,361
14,543,787
11,265,725
Basic and diluted loss per common share attributable to stock-based compensation expense
$ ( 0.01 )
$ ( 0.03 )
$ ( 0.04 )
$ ( 0.06 )
All of the stock-based compensation expense recorded
during the nine months ended December 31, 2021 and 2020, an aggregate of $ 522,234 and $ 629,207 , respectively, is included in payroll and
related expense in the accompanying condensed consolidated statements of operations. Stock-based compensation expense recorded during
the nine months ended December 31, 2021 and 2020 represented an impact on basic and diluted loss per common share of $(0.04) and $(0.06),
respectively.
We review share-based compensation on a quarterly
basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The cumulative effect of adjusting
the forfeiture rate for all expense amortization is recognized in the period the forfeiture estimate is changed. The effect of forfeiture
adjustments for the nine months ended December 31, 2021 was insignificant.
Stock Option Activity
During the nine months ended December 31, 2021,
we issued a stock option grant to our Chief Executive Officer, or CEO, for the purchase of 266,888 shares of our common stock under our
2020 Plan. The purchase price for the shares subject to the option is $ 5.17 per share, the fair market value of the common stock on the
date of the grant. The shares subject to the option are subject to vesting over four years, commencing on the date of grant, or Vesting
Commencement Date, with twenty-five percent (25%) of the shares subject to the option vesting on the first anniversary of the Vesting
Commencement Date and the remaining shares vesting in equal monthly installments over the following thirty-six (36) months, in each case
subject to Dr. Fisher’s Continuous Service (as defined in the 2020 Plan) through each vesting date.
From February 2020 through May 2020, our compensation
committee granted 521,476 stock options that were contingent upon stockholder approval of the 2020 Plan at the Aethlon 2020 Annual Meeting
of Stockholders. Upon approval of the 2020 Plan at that meeting, these option grants were considered effective and no longer contingent
as of that date.
Under the 2020 Plan, up to 1,842,556 shares of
common stock are authorized for issuance, pursuant to the grant of stock options, RSUs or other forms of stock-based compensation.
14
Stock options outstanding that have vested as of December 31, 2021
and stock options that are expected to vest subsequent to December 31, 2021 are as follows:
Options outstanding that have vested and are expected to vest
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term in
Years
Vested
166,717
$ 2.92
8.43
Expected to vest
824,931
$ 2.93
8.97
Total
991,648
A summary of stock option activity during the nine months ended December
31, 2021 is presented below:
Schedule of stock option activity
Amount
Range of
Exercise Price
Weighted
Average
Exercise
Price
Stock options outstanding at March 31, 2021
844,089
$ 1.28 - 142.50
$ 3.07
Exercised
( 11,562 )
$ 2.45
$ 2.45
Granted
266,888
$ 5.17
$ 5.17
Cancelled/Expired
( 107,767 )
$ 2.45 – 142.50
$ 9.66
Stock options outstanding at December 31, 2021
991,648
$ 1.28 - 142.50
$ 2.93
Stock options exercisable at December 31, 2021
166,717
$ 1.28 - 142.50
$ 2.92
On December 31, 2021, our outstanding stock options had no intrinsic
value since the closing share price on that date of $ 1.86 per share was below the weighted average exercise price of our outstanding stock
options.
At December 31, 2021, there was approximately
$ 3,320,000 of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average
period of 4.1 years.
15
9. WARRANTS
During the nine months ended December 31, 2021 and 2020, we did not
issue any warrants.
A summary of warrant activity during the nine months ended December
31, 2021 is presented below:
Schedule of Warrant Activity
Amount
Range of
Exercise
Price
Weighted
Average
Exercise
Price
Warrants outstanding at March 31, 2021
1,991,973
$ 1.50 – 99.00
$ 5.23
Exercised
( 1,206,721 )
$ 1.50 – 2.50
$ 2.21
Cancelled/Expired
( 207,362 )
$ 2.50 – 99.00
$ 5.78
Warrants outstanding at December 31, 2021
577,890
$ 1.50 – 65.63
$ 11.32
Warrants exercisable at December 31, 2021
577,890
$ 1.50 – 65.63
$ 11.32
10. GOVERNMENT CONTRACTS AND RELATED REVENUE RECOGNITION
We entered into the following contract with the National Cancer Institute,
or NCI, part of the National Institutes of Health, or NIH, over the past two years:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the NCI awarded to us an
SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics
and Treatment Monitoring”, or the Award Contract. The Award Contract amount is $ 1,860,561 and, as amended, runs for the period from
September 16, 2019 through September 15, 2022.
The work to be performed pursuant to this Award
Contract is focused on melanoma exosomes. This work follows from our completion of a Phase I contract for the Topic 359 solicitation that
ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program
involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
We recorded $ 229,698 of government contract revenue
on the Phase 2 Melanoma Cancer Contract in the nine months ended December 31, 2021. That revenue related to work performed in the three
months ended March 31, 2021 and June 30, 2021 that had previously been recorded as deferred revenue as a result of falling short on certain
milestones. We then achieved those March period milestones in the June quarter and the June period milestones in the September quarter
and therefore recorded the previously deferred revenue as government contract revenue in the quarter ended September 30, 2021. We recorded
the invoices related to the September 30, 2021 and December 31, 2021 periods as deferred revenue, since we fell short of certain milestones
related to those periods.
16
During the period ended December 31, 2020, we
completed all of the milestones relevant to that time period. As a result, we recorded $ 436,427 of government contract revenue on the
Phase 2 Melanoma Cancer Contract in the nine months ended December 31, 2020. Of the total revenue recognized during the nine
months ended December 31, 2020 relating to this grant, a total of $ 117,849 was invoiced to the NCI during the three months ended December
31, 2020 and we recorded $ 318,578 which had previously been recognized as deferred revenue.
Subaward with University of Pittsburgh
In December 2020, we entered into a cost reimbursable
subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve
Responses to Immune Therapy in HNNCC.” Our share of the award is $ 256,750 . We recorded $ 51,351 of revenue related to this subaward
in the nine months ended December 31, 2021.
11. SEGMENTS
We operate our businesses principally through
two reportable segments: Aethlon, which represents our therapeutic business activities, and ESI, which represents our diagnostic subsidiary.
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 have any revenues. We have not included any allocation of corporate overhead to the
ESI segment.
17
The following tables set forth certain information regarding our segments:
Schedule of segment activity
Nine Months Ended December 31,
2021
2020
Revenues:
Aethlon
$ 281,049
$ 624,871
ESI
–
–
Total Revenues
$ 281,049
$ 624,871
Operating Losses:
Aethlon
$ ( 6,614,318 )
$ ( 5,610,994 )
ESI
( 20,869 )
( 15,931 )
Total Operating Loss
$ ( 6,635,187 )
$ ( 5,626,925 )
Net Losses:
Aethlon
$ ( 6,614,318 )
$ ( 5,610,994 )
ESI
( 20,869 )
( 15,931 )
Net Loss Before Non-Controlling Interests
$ ( 6,635,187 )
$ ( 5,626,925 )
Depreciation and Amortization:
Aethlon
$ 98,363
$ 28,775
ESI
–
–
Total Depreciation and Amortization
$ 98,363
$ 28,775
Capital Expenditures:
Aethlon
$ 136,795
$ 54,630
ESI
–
–
Capital Expenditures
$ 136,795
$ 54,630
December 31, 2021
December 31, 2020
Cash:
Aethlon
$ 20,394,339
$ 12,131,396
ESI
197
197
Total Cash
$ 20,394,536
$ 12,131,593
Total Assets:
Aethlon
$ 21,916,069
$ 12,669,552
ESI
197
197
Total Assets
$ 21,916,266
$ 12,669,749
18
12. COMMITMENTS AND CONTINGENCIES
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
On September 29, 2021, we entered into an agreement
with PPD, Inc., a leading global contract research organization, for PPD to oversee our clinical studies investigating the Hemopurifier
(the PPD Agreement). Pursuant to the PPD Agreement, PPD agreed to manage our ongoing study of the Hemopurifier for patients who are critically
ill with COVID-19 (NCT04595903), with the option for the parties to agree to include additional studies under the PPD Agreement. The agreement
has a five year term, but may be extended by mutual agreement. The PPD Agreement also may be terminated by Aethlon without cause upon
30 days’ prior written notice and may be terminated by either party following notice for breach or insolvency of the other party.
SEPARATION AGREEMENT
On October 30, 2020, we entered into a Separation
Agreement with Timothy Rodell, M.D., our former Chief Executive Officer, or the Separation Agreement. Under the Separation Agreement,
we agreed to pay Dr. Rodell a total cash amount of $ 444,729 and agreed to cover his medical insurance costs over a twelve-month period
that began on November 1, 2020, all in accordance with the terms of his employment agreement with the Company. All of those contractually
agreed payments have been completed as of December 31, 2021 (see Note 7).
LEASE COMMITMENTS
Previous Office and Lab Leases
In September 2021, our lease of approximately
2,600 square feet of our previous executive office space at 9635 Granite Ridge Drive, Suite 100, San Diego , California 92123 expired.
Through December 31, 2021, we rented approximately
1,700 square feet of laboratory space at 11585 Sorrento Valley Road, Suite 109, San Diego, California 92121, at the rate of $6,148 per
month on a one-year lease that originally was to expire on November 30, 2020. In December 2020, we entered into a short-term lease extension
running from December 1, 2020 through the completion date of our construction of our new laboratory space which is adjacent to our current
laboratory.
New Office and Lab Leases
In December 2020, we entered into an
agreement to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space. 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 lab space
effective January 1, 2022 (see Note 13).
On October 1, 2021, we recorded a $ 343,633 right-of-use
lease asset and associated lease liability related to the office space component of the lease based on the present value of lease payments
over the expected lease term of 63 months, discounted using our estimated incremental borrowing rate of 4.25 %. The current monthly base
rent under the office component of the lease is $ 6,121 . As of our December 31, 2021 consolidated balance sheet, we have a right-of-use
lease asset of $ 328,869 .
During the three months ended March 31, 2022,
we will record a $ 400,797 right-of-use lease asset and associated lease liability related to the lab space component of the lease based
on the present value of lease payments over the expected lease term of 60 months, discounted using our estimated incremental borrowing
rate of 4.25 %. The initial monthly base rent under the lab component of the lease is $ 7,456 .
19
In addition, the new lease agreement of the new
office and lab required us to post a standby letter of credit in favor of the landlord in the amount of $ 46,726 in lieu of a security
deposit. We arranged for our bank to issue the standby letter of credit in the fiscal year ended March 31, 2021 and transferred a like
amount to a restricted certificate of deposit which secured the bank’s risk in issuing that letter of credit. We have classified
that restricted certificate of deposit on our balance sheet as restricted cash.
Manufacturing Space Lease
In October 2021, we entered into another lease
for an initial period of 58 months for (i) approximately 22,260 square feet of space located at 11588 Sorrento Valley Road, San Diego,
California 92121 (the “Building”), and (ii) 2,655 square feet of space located in the Building and commonly known as Suite
18 to house our manufacturing operations. That manufacturing space is located at 11588 Sorrento Valley Road, San Diego, California 92121
and it is near our new lab and office locations. We anticipate that the landlord will complete construction on this new space in the second
or third quarter of 2022 and we will take occupancy at that time. The initial base rent for the manufacturing space will be $12,080 per
month.
Based on the assumptions that we used to
calculate the right-of-use lease asset for the new office and lab spaces, we estimate that we will record a right- of- use lease
asset of $614,240 and associated lease liability for the manufacturing space lease when we take possession of that space.
The lease for the manufacturing space also required
us to post a standby letter of credit in favor of the landlord in the amount of $ 40,780 in lieu of a security deposit. We arranged for
our bank to issue the standby letter of credit in October 2021 and transferred a like amount to a restricted certificate of deposit which
secured the bank’s risk in issuing that letter of credit. We have classified that restricted certificate of deposit on our balance
sheet as restricted cash.
Mobile Clean Room
In addition, we rent a mobile clean room on a
short term, month-to-month basis, where we will house our manufacturing operations until our permanent manufacturing space is completed.
The mobile clean room is located on leased land near our office and lab and we pay $ 2,000 per month for the right to locate it there.
We paid approximately $ 119,000 in rent expense to lease the mobile clean room located on this space during the nine months ended December
31, 2021.
Overall, our rent expense, which is included in
general and administrative expenses, approximated $ 288,000 and $ 144,000 for the nine month periods ended December 31, 2021 and 2020, respectively.
LEGAL MATTERS
From time to time, claims are made against us
in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties
and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more
products or engaging in other activities.
The occurrence of an unfavorable outcome in any
specific period could have a material adverse effect on our results of operations for that period or future periods. We are not presently
a party to any pending or threatened legal proceedings.
20
13. SUBSEQUENT EVENTS
Management has evaluated events subsequent to
December 31, 2021 through the date that the accompanying condensed consolidated financial statements were filed with the SEC for transactions
and other events which may require adjustment of and/or disclosure in such financial statements.
Lab Lease
In December 2020, we entered into an agreement
to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space. The agreement carries a term of 63
months and we took possession of the office space effective October 1, 2021. We took possession of the lab space effective January 1,
2022 (see Note 12).
During the three months ending March 31, 2022,
we will record a $400,797 right-of-use lease asset and associated lease liability related to the lab space component of the lease based
on the present value of lease payments over the expected lease term of 60 months, discounted using our estimated incremental borrowing
rate of 4.25%. The initial monthly base rent under the lab component of the lease is $7,456.
2021 Target Bonus Awards
On February 10, 2022, the Compensation Committee of the Board (the
“Committee”) approved cash bonus awards to the Company’s executive officers in accordance with the terms of their respective
employment agreements with the Company after review of Company and individual performance for 2021 and review of data from the Company’s
independent compensation consultant. The Committee approved cash bonuses for the Company’s Chief Executive Officer, Chief Medical
Officer, Chief Operating Officer and Chief Financial Officer in the amount of $215,000, $160,000, $136,000 and $110,000, respectively.
The awards were based on a percentage of their respective 2021 annual base salaries.
2022 Annual Base Salaries and Target Bonus Levels
On February 10, 2022, after review of data provided by the Company’s
independent compensation consultant, the Committee approved annual base salaries for its executive officers for 2022, as follows, Chief
Executive Officer $460,000, Chief Medical Officer, $400,000, Chief Operating Officer $340,000, and Chief Financial Officer $325,000, effective
January 1, 2022. The Committee also approved target bonus levels for its executive officers for 2022 as follows, Chief Executive Officer,
50% bonus target, Chief Medical Officer, Chief Operating Officer and Chief Financial Officer each at 40% bonus target for 2022. The Committee
targeted the 50 th percentile for companies in its peer group when approving 2022 base salaries and target bonus levels.
Stock Option Grants
On February 10, 2022, after review of data provided by the Company’s
independent compensation consultant, the Committee awarded stock option grants to each of its executive officers. Each executive officer
was granted an option to purchase shares of the Company’s common stock under the Company’s 2020 Equity Incentive Plan (the
“Plan”), at an exercise price equal to the fair market value on the date of grant, or $[1.41] per share. The Committee awarded
the grants as follows: the Chief Executive Officer was granted an option to purchase 192,600 shares of common stock, and the Chief Medical
Officer, Chief Operating Officer and Chief Financial Officer each were granted an option to purchase 100,200 shares of common stock. The
options are subject to vesting over four years at the rate of 25% at the end of the first year following the grant date, then monthly
vesting over the following 36 months, subject to Continuous Service with the Company, as defined in the Plan.
Non-Employee Director Compensation Policy
On February 10, 2022, at the recommendation of the Company’s
independent compensation consultant, the Committee approved an amendment to the Company’s Non-Employee Director Compensation Policy
to increase the annual Board service retainer from $35,000 to $40,000, effective as of January 1, 2022.
21
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS.
The following discussion of our financial condition
and results of operations should be read in conjunction with, and is qualified in its entirety by, the condensed consolidated financial
statements and notes thereto included in Item 1 in this Quarterly Report on Form 10-Q. This item contains forward-looking statements that
involve risks and uncertainties. Actual results may differ materially from those indicated in such forward-looking statements.
FORWARD LOOKING STATEMENTS
All statements, other than statements of historical
fact, included in this Form 10-Q are, or may be deemed to be, “forward-looking statements” within the meaning of Section 27A
of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such forward-looking statements
involve assumptions, known and unknown risks, uncertainties and other factors which may cause our actual results, performance, or achievements
to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements
contained in this Form 10-Q. Such potential risks and uncertainties include, without limitation, successful completion of our clinical
trials, our ability to raise additional capital, our ability to maintain our Nasdaq listing, 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 Commission. The forward-looking statements are made as of the date of this Form 10-Q,
and we assume no obligation to update the forward-looking statements, or to update the reasons actual results could differ from those
projected in such forward-looking statements.
Overview
We are a medical technology company focused on
developing products to diagnose and treat life and organ threatening diseases. The Aethlon Hemopurifier®, or Hemopurifier, is a clinical-stage
immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier is designed to deplete
the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit
of leading cancer therapies. The FDA has designated the Hemopurifier as a “Breakthrough Device” for two independent indications:
·
the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and
·
the treatment of life-threatening viruses that are not addressed with approved therapies.
We believe the Hemopurifier can be a substantial
advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and
spread of tumors through multiple mechanisms. We are currently conducting a clinical trial in patients with advanced and metastatic head
and neck cancer. We are initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and
other cancers. As we advance our clinical trials, we are in close contact with our clinical sites to navigate and assess the impact of
the global COVID-19 pandemic on our clinical trials and current timelines.
On October 4, 2019, the FDA approved our Investigational
Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck
cancer in combination with standard of care pembrolizumab (Keytruda). The primary endpoint for the EFS, which is designed to enroll 10-12
subjects at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well
as response and survival rates. This study, which will be conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, has treated two
patients and is in the process of recruiting additional patients. We are considering adding one or more additional sites to this trial
to accelerate patient recruitment and we are also considering starting additional trials in other forms of cancer.
22
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. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
infected with HIV, hepatitis-C, and Ebola.
Additionally, in-vitro , the Hemopurifier
has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya
virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, and the reconstructed Spanish
flu virus of 1918. In several cases, these validations were conducted in collaboration with leading government or non-government research
institutes.
On June 17, 2020, the FDA approved a supplement
to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19
in a New Feasibility Study. That study is designed to enroll up to 40 subjects at up to 20 centers in the U.S. Subjects will have established
laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and will have acute lung injury and/or severe or life-threatening
disease, among other criteria. Endpoints for this study, in addition to safety, will include reduction in circulating virus as well as
clinical outcomes (NCT # 04595903). Under Single Patient Emergency Use regulations, the Company has also treated two patients with COVID-19
with the Hemopurifier.
In September 2021, we entered into an agreement
with PPD, Inc., or PPD, a leading global contract research organization, or CRO, to oversee our U.S. clinical studies investigating the
Hemopurifier for critically ill COVID-19 patients. We now have three hospitals, Hoag Newport Beach, Hoag Irvine, and Loma Linda Medical
Center, fully activated for patient enrollment and they are actively screening patients for the trial. Together with PPD, we are currently
advancing site readiness for LSU Shreveport, Valley Baptist Medical Center in Texas, Loma Linda Medical Center, Hoag Hospitals in Southern
California, University of California Davis, University of Miami Medical Center, and Thomas Jefferson Medical Center.. We are in discussions
to bring on board other key U.S. medical centers.
We also obtained ethics review board approval
and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19
clinical trial at that location. We have completed all site initiation activities at Medanta Medicity Hospital and this site is now open
for enrollment and is actively screening patients.
We are also the majority owner of ESI, a company
formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. We consolidate ESI’s
activities in our consolidated financial statements.
We are also the majority owner of ESI, a company
formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases. We consolidate ESI’s
activities in our consolidated financial statements.
Successful outcomes of human trials will also
be required by the regulatory agencies of certain foreign countries where we plan to sell the Hemopurifier. Some of our patents may expire
before FDA approval or approval in a foreign country, if any, is obtained. However, we believe that certain patent applications and/or
other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.
We were formed on March 10, 1999. Our executive
offices are located at 11555 Sorrento Valley Road, Suite 203, San Diego, California 92121. Our telephone number is (619) 941-0360. Our
website address is www.aethlonmedical.com.
Our common stock is listed on the Nasdaq Capital Market under the symbol
“AEMD.”
23
COVID-19 Update
In March 2020, the World Health Organization declared
COVID-19 a pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant
volatility and disruption of financial markets.
We are monitoring closely the impact of the COVID-19
global pandemic on our business and have taken steps designed to protect the health and safety of our employees while continuing our operations,
including clinical trials. Given the level of uncertainty regarding the duration and impact of the COVID-19 pandemic on capital markets
and the U.S. economy, we are unable to assess the impact of the worldwide spread of SARS-CoV-2 and the resulting COVID-19 pandemic on
our future access to capital. Further, while we have not experienced significant disruptions to our manufacturing supply chain, business,
results of operations, financial condition, clinical trials, or preclinical research to date, we are unable to assess the potential impact
this pandemic could have on our manufacturing supply chain, business, results of operations, financial condition, clinical trials, or
preclinical research in the future.
As we continue to actively advance our clinical
trials, we remain in close contact with our clinical sites and are assessing the impact of COVID-19 on our trials, expected timelines
and costs on an ongoing basis. We will assess any potential delays in our ability to timely ship clinical trial materials, including internationally,
due to transportation interruptions. The extent of the impact of COVID-19 on our operational and financial performance will depend on
certain developments, including the duration and spread of the outbreak, impact on our clinical trials, employees and vendors, all of
which are uncertain and cannot be predicted. Given these uncertainties, we cannot reasonably estimate the related impact to our business,
operating results and financial condition, if any.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the informational requirements
of the Exchange Act, and must file reports, proxy statements and other information with the Commission. The Commission maintains a web
site (http://www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, like us,
which file electronically with the Commission. Our headquarters are located at 11555 Sorrento Valley Road, Suite 203, San Diego, CA 92121.
Our phone number at that address is (619) 941-0360. Our website is http://www.aethlonmedical.com.
RESULTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2021 COMPARED TO THE THREE MONTHS ENDED
DECEMBER 31, 2020
Government Contract Revenues:
We recorded $17,117 in government contract revenue
in the three months ended December 31, 2021 and we recorded $624,871 in government contract revenue in the three months ended December
31, 2020. This revenue resulted from work performed under our government contracts with NIH as follows:
Three Months
Ended 12/31/21
Three Months
Ended 12/31/20
Change in
Dollars
Phase 2 Melanoma Cancer Contract
$ –
$ 436,427
$ (436,427 )
Breast Cancer Grant
–
188,444
(188,444 )
Subaward with University of Pittsburgh
17,117
–
17,117
Total Government Contract and Grant Revenue
$ 17,117
$ 624,871
$ (607,754 )
24
We have recognized revenue under the following contracts/grants:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the NCI awarded to us an
SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics
and Treatment Monitoring”, or the Award Contract. The Award Contract amount is $1,860,561 and, as amended, runs for the period from
September 16, 2019 through September 15, 2022.
The work to be performed pursuant to this Award
Contract is focused on melanoma exosomes. This work follows from our completion of a Phase I contract for the Topic 359 solicitation that
ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program
involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
During the three months ended December 31, 2021,
we did not complete the milestones relevant to that time period. As a result, we did not record any government contract revenue on the
Phase 2 Melanoma Cancer Contract in the three months ended December 31, 2021. We recorded the invoice related to the December
31, 2021 period as deferred revenue.
During the three months ended December 31, 2020,
we completed all of the milestones relevant to that time period. As a result, we recorded $436,427 of government contract revenue on the
Phase 2 Melanoma Cancer Contract in the three months ended December 31, 2020. Of the total revenue recognized during the three
months ended December 31, 2020 relating to this grant, a total of $117,849 was invoiced to the NCI during the three months ended December
31, 2020 and we recorded $318,578 which had previously been recognized as deferred revenue.
Breast Cancer Grant
This NCI Small Business Innovation Research, or
SBIR Phase I grant, titled “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation,”
or the Breast Cancer Grant, was originally for a period that ran from September 14, 2018 through August 31, 2019. In August 2019, we applied
for and received a no cost, twelve-month extension on this grant through August 31, 2020. The total amount of the firm grant was $298,444.
The grant called for two subcontractors to work with us. Those subcontractors were University of Pittsburgh and Massachusetts General
Hospital. In the three months ended December 31, 2020, we completed and submitted the final reports applicable to this NCI grant (number
1R43CA232977-01). As of December 31, 2020, we have received all of the funds allocated to the Breast Cancer Grant.
During the three months ended December 31, 2020,
we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant as we achieved two of the three milestones related to
the Breast Cancer Grant and concluded in our final report that our work under the grant provided nonclinical support that the Hemopurifier
has the capacity to clear exosomes from breast cancer patients. That amount previously was recorded as deferred revenue.
Subaward with University of Pittsburgh
In December 2020, we entered into a cost reimbursable
subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve
Responses to Immune Therapy in HNNCC.” Our share of the award is $256,750. We recorded $17,117 of revenue related to this subaward
in the three months ended December 31, 2021.
25
Operating Expenses
Consolidated operating expenses for the three
months ended December 31, 2021 were $2,545,063, compared to $3,069,261 for the three months ended December 31, 2020. This decrease of
$524,198, or 17.1%, in the 2021 period was due to decreases in payroll and related expenses of $524,150 and in professional fees of $191,575,
which were partially offset by an increase in general and administrative expenses of $191,527.
The $524,150 decrease in payroll and related expenses
was primarily due to the combination of a $444,729 accrual in the December 2020 period related to the separation agreement with our former
CEO and $249,950 in bonuses paid in the December 2020 period, with no comparable expenses in the December 2021 period. Additionally, stock-based
compensation expense decreased by $176,939 in the December 2021 period, largely due to the separation agreement with our former CEO. Partially
offsetting those decreases were $179,853 in relocation-related compensation to two senior executives that relocated to San Diego, California
as a condition of their employment, and increases in cash-based compensation of $89,280 and $89,236 in our general and administrative
payroll and in our research and development payroll, respectively, due to headcount increases.
The $191,575 decrease in our professional fees
was primarily due to a $79,706 decrease in our scientific consulting expenses, a $51,092 decrease in our legal fees, a $37,212 decrease
in recruiting fees, a $19,069 decrease in website services, and a $17,292 decrease in our directors’ compensation, which were partially
offset by a $17,111 increase in our accounting fees.
The $191,527 increase in general and administrative
expenses was primarily due to a $182,844 increase in our clinical trial expenses.
Net Loss
As a result of the changes in revenues and expenses
noted above, our net loss increased to approximately $2,528,000 in the three months ended December 31, 2021, from approximately $2,444,000
in the three months ended December 31, 2020.
Basic and diluted loss attributable to common
stockholders were ($0.16) for the three months ended December 31, 2021, compared to ($0.20) for the three month period ended December
31, 2020.
NINE MONTHS ENDED DECEMBER 31, 2021 COMPARED TO THE NINE MONTHS ENDED
DECEMBER 31, 2020
Government Contract Revenues:
We recorded $281,049 in government contract revenue
in the nine months ended December 31, 2021 and we recorded $624,871 in government contract revenue in the nine months ended December 31,
2020. This revenue resulted from work performed under our government contracts with NIH as follows:
Nine Months
Ended 12/31/21
Nine Months
Ended 12/31/20
Change in
Dollars
Phase 2 Melanoma Cancer Contract
$ 229,698
$ 436,427
$ (206,729 )
Breast Cancer Grant
–
188,444
(188,444 )
Subaward with University of Pittsburgh
51,351
–
51,351
Total Government Contract and Grant Revenue
$ 281,049
$ 624,871
$ (343,822 )
26
We have recognized revenue under the following contracts/grants:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the NCI awarded to us an
SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for Isolation of Melanoma Exosomes for Diagnostics
and Treatment Monitoring”, or the Award Contract. The Award Contract amount is $1,860,561 and, as amended, runs for the period from
September 16, 2019 through September 15, 2022.
The work to be performed pursuant to this Award
Contract is focused on melanoma exosomes. This work follows from our completion of a Phase I contract for the Topic 359 solicitation that
ran from September 2017 through June 2018, as described below. Following on the Phase I work, the deliverables in the Phase II program
involve the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
We recorded $229,698 of government contract revenue
on the Phase 2 Melanoma Cancer Contract in the nine months ended December 31, 2021. That revenue related to work performed in the three
months ended March 31, 2021 and June 30, 2021 that had previously been recorded as deferred revenue as a result of falling short on certain
milestones. We then achieved those March period milestones in the June quarter and the June period milestones in the September quarter
and therefore recorded the previously deferred revenue as government contract revenue in the quarter ended September 30, 2021. We recorded
the invoices related to the September 30, 2021 and December 31, 2021 periods as deferred revenue, since we fell short of certain milestones
related to those periods.
During the period ended December 31, 2020, we
completed all of the milestones relevant to that time period. As a result, we recorded $436,427 of government contract revenue on the
Phase 2 Melanoma Cancer Contract in the nine months ended December 31, 2020. Of the total revenue recognized during the nine
months ended December 31, 2020 relating to this grant, a total of $117,849 was invoiced to the NCI during the three months ended December
31, 2020 and we recorded $318,578 which had previously been recognized as deferred revenue.
Breast Cancer Grant
This NCI Small Business Innovation Research,
or SBIR Phase I grant, titled “The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from the Blood Circulation,”
or the Breast Cancer Grant, was originally for a period that ran from September 14, 2018 through August 31, 2019. In August 2019, we
applied for and received a no cost, twelve-month extension on this grant through August 31, 2020. The total amount of the firm grant
was $298,444. The grant called for two subcontractors to work with us. Those subcontractors were University of Pittsburgh and Massachusetts
General Hospital. In the three months ended December 31, 2020, we completed and submitted the final reports applicable to this NCI grant
(number 1R43CA232977-01). As of December 31, 2020, we have received all of the funds allocated to the Breast Cancer Grant.
During the nine months ended December 31, 2020,
we recorded the remaining $188,444 of revenue related to the Breast Cancer Grant as we achieved two of the three milestones related to
the Breast Cancer Grant and concluded in our final report that our work under the grant provided nonclinical support that the Hemopurifier
has the capacity to clear exosomes from breast cancer patients. That amount previously was recorded as deferred revenue.
Subaward with University of Pittsburgh
In December 2020, we entered into a cost reimbursable
subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve
Responses to Immune Therapy in HNNCC.” Our share of the award is $256,750. We recorded $51,351 of revenue related to this subaward
in the nine months ended December 31, 2021.
27
Operating Expenses
Consolidated operating expenses for the nine months
ended December 31, 2021 were $6,916,236, compared to $6,251,796 for the nine months ended December 31, 2020. This increase of $664,440,
or 10.6%, in the 2021 period was due to increases in payroll and related expenses of $301,045, and in general and administrative expenses
of $542,721, which were partially offset by a decrease in professional fees of $179,326.
The $301,045 increase in payroll and related expenses
in the 2021 period was primarily due to increases in cash-based compensation of $245,702 and $424,183 in our general and administrative
payroll and in our research and development payroll, respectively, due to headcount increases, and $198,347 in relocation-related compensation
to two senior executives that relocated to San Diego, California as a condition of their employment. Those increases were partially offset
by the combination of a $444,729 accrual in the December 2020 period related to the separation agreement with our former CEO, with no
comparable expense in the December 2021 period, and net decrease of $34,950 in bonuses paid in the December 2021 period compared to the
December 2020 period. Additionally, stock-based compensation expense decreased by $106,973 in the December 2021 period, largely due to
the separation agreement with our former CEO.
The $542,721 increase in general and administrative
expenses in the 2021 period was primarily due to a $161,466 increase in our insurance expenses, a $143,932 increase in our rent expense,
a $82,483 increase in our lab fees and small lab equipment expenses, a $74,666 increase in our clinical trial expenses, a $69,587 increase
in our depreciation and amortization expenses and a $15,976 increase in our utility costs.
The $179,326 decrease in our professional fees
in the 2021 period was primarily due to a $163,988 decrease in our scientific consulting expenses and a $69,417 decrease in directors’
fees, which were partially offset by a $51,088 increase in our legal fees and a $10,497 increase in our accounting expenses.
Net Loss
As a result of the changes in revenues and expenses
noted above, our net loss increased to approximately $6,635,000 in the nine months ended December 31, 2021, from approximately $5,627,000
in the nine months ended December 31, 2020.
Basic and diluted loss attributable to common
stockholders were ($0.46) for the nine month period ended December 31, 2021 and ($0.50) for the nine month period ended December 31, 2020.
LIQUIDITY AND CAPITAL RESOURCES
As of December 31, 2021, we had a cash balance
of $20,394,536 and working capital of $20,140,532. This compares to a cash balance of $9,861,575 and working capital of $8,976,512 at
March 31, 2021. We expect our existing cash as of December 31, 2021 to be sufficient to fund the Company’s operations for at least
twelve months from the issuance date of these financial statements.
The primary sources of our increase in cash during
the nine months ended December 31, 2021 resulted from our Common Stock Sales Agreement with Wainwright and our registered direct financing
through Maxim Group LLC. The cash raised from those activities is noted below:
28
Common Stock Sales Agreement with H.C. Wainwright & Co., LLC
On March 22, 2021, we entered into the Offering
Agreement, with Wainwright as sales agent, pursuant to which we could offer and sell shares of our common stock, from time to time as
set forth in the Offering Agreement.
The offering
has been registered under the Securities Act pursuant to our shelf registration statement
on Form S-3 (Registration Statement No. 333-237269), as previously filed with the SEC and declared effective on March 30,
2020. We filed a prospectus supplement, dated March 22, 2021, with the SEC in connection with the offer and sale of the shares of common
stock, pursuant to which we could offer and sell shares of common stock having an aggregate
offering price of up to $5,080,000 from time to time.
Subject to the terms and conditions set forth
in the Offering Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices
to sell the shares under the Offering Agreement from time to time, based upon our instructions. We provided Wainwright with customary
indemnification rights under the Offering Agreement, and Wainwright was entitled to a commission at a fixed rate equal to three percent
of the gross proceeds per share sold. In addition, we agreed to reimburse Wainwright for certain specified expenses in connection with
entering into the Offering Agreement. The Offering Agreement provided that it would terminate upon the written termination by either party
as permitted thereunder.
Sales of the shares, under the Offering Agreement
are made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act,
including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as
otherwise agreed with Wainwright. We have no obligation to sell any of the shares, and, at any time, we could suspend offers under the
Offering Agreement or terminate the agreement.
In the nine months ended December 31, 2021, we
raised aggregate net proceeds under the Offering Agreement described above of $4,947,785, net of $126,922 in commissions to Wainwright
and $2,154 in other offering expense, through the sale of 626,000 shares of our common stock at an average price of $7.90 per share of
net proceeds. No further sales may be made under the agreement.
Registered Direct Financing
In the nine months ended December 31, 2021, we
sold an aggregate of 1,380,555 shares of our common stock at a purchase price per share of $9.00, for aggregate net proceeds to us of
$11,659,044, after deducting fees payable to Maxim Group LLC, the placement agent, and other offering expenses. These shares were sold
through a securities purchase agreement with certain institutional investors, The shares were issued pursuant to an effective shelf registration
statement on Form S-3, which was originally filed with the SEC on March 19, 2020, and was declared effective on March 30, 2020 (File No.
333-237269) and a prospectus supplement thereunder.
Future capital requirements will depend upon many
factors, including progress with pre-clinical testing and clinical trials, the number and breadth of our clinical programs, the time and
costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights, the time and costs
involved in obtaining regulatory approvals, competing technological and market developments, as well as our ability to establish collaborative
arrangements, effective commercialization, marketing activities and other arrangements. We expect to continue to incur increasing negative
cash flows and net losses for the foreseeable future.
29
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
December 31,
2021
December 31,
2020
Cash provided by (used in):
Operating activities
$ (6,668 )
$ (4,526 )
Investing activities
(137 )
(55 )
Financing activities
17,379
7,154
Net increase (decrease) in cash and restricted cash
$ 10,574
$ 2,573
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 $6,668,000
in the nine months ended December 31, 2021, compared to approximately $4,526,000 in the nine months ended December 31, 2020. The primary
components in the $2,142,000 increase in cash used in our operating activities were a $1,008,000 increase in our net losses, a $343,000
increase in prepaid expenses related to our clinical trials and a $443,000 increase in payments on our accounts payable.
NET CASH USED IN INVESTING ACTIVITIES. We used
approximately $137,000 of cash to purchase laboratory and office equipment in the nine months ended December 31, 2021, compared to approximately
$55,000 in the nine months ended December 31, 2020.
NET CASH PROVIDED BY FINANCING ACTIVITIES. During
the nine months ended December 31, 2021, we raised approximately $17,456,000 from the issuance of common stock. That source of cash from
our financing activities was partially offset by the use of approximately $77,000 to pay for the tax withholding on restricted stock units,
for an aggregate increase of cash provided by financing activities of approximately $17,379,000.
During the nine months ended December 31, 2020,
we raised approximately $7,260,000 from the issuance of common stock. That source of cash from our financing activities was partially
offset by the use of approximately $106,000 to pay for the net share settlement of restricted stock units and net stock option exercises,
for an aggregate increase of cash provided by financing activities of approximately $7,154,000.
As of the date of this filing, we plan to invest
significantly into purchases of our raw materials and in our internal manufacturing facility for our clinical trials.
30
CRITICAL ACCOUNTING ESTIMATES
Use of Estimates
The preparation of consolidated financial statements
in conformity with accounting principles generally accepted in the United States of America, or GAAP, requires us to make a number of
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements. These estimates and assumptions affect the reported amounts of expenses during the reporting
period. On an ongoing basis, we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances.
We believe our estimates and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates
under different future conditions.
We believe that the estimates and assumptions
that are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult,
subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These critical accounting
estimates relate to revenue recognition, stock purchase warrants issued with notes payable, beneficial conversion feature of convertible
notes payable, impairment of intangible assets and long lived assets, stock compensation, deferred tax asset valuation allowance, and
contingencies.
There have been no changes to our critical accounting estimates as
disclosed in our Form 10-K for the year ended March 31, 2021.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
As a smaller reporting company as defined by Rule 12b-2 of the Exchange
Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore are not required to
provide the information requested by this item.
ITEM 4. CONTROLS AND PROCEDURES.
DISCLOSURE CONTROLS AND PROCEDURES
Under the supervision and with the participation
of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end
of the period covered by this Quarterly Report.
Based on such evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that, as of the end of such period, our disclosure controls and procedures are effective
in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by us in the reports that
we file or submit under the Exchange Act and are effective in ensuring that information required to be disclosed by us in the reports
that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING
There have been no changes in our internal control
over financial reporting during the last fiscal quarter that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
31
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
From time to time, claims are made against us
in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties
and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting us from selling one or more
products or engaging in other activities.
The occurrence of an unfavorable outcome in any
specific period could have a material adverse effect on our results of operations for that period or future periods. We are not presently
a party to any pending or threatened legal proceedings.
ITEM 1A. RISK FACTORS.
RISK FACTOR SUMMARY
Below is a summary of the principal factors that
make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additional discussion
of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors”
and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the
SEC before making investment decisions regarding our securities.
·
We have incurred significant operating losses since our inception and have not generated any revenue. We expect to incur continued losses for the foreseeable future and may never achieve or maintain profitability.
·
We will require substantial additional funding to sustain our operations. If we are unable to raise capital on favorable terms when needed, we could be forced to delay, reduce or eliminate our research or device development programs or any future commercialization efforts.
·
To achieve the levels of production necessary to commercialize our Hemopurifier product candidate and any other
future products, if any, we will need to secure large-scale manufacturing agreements with contract manufacturers which comply with good
manufacturing practice standards and other standards prescribed by various federal, state and local regulatory agencies in the U.S. and
any other country of use. We have limited experience coordinating and overseeing the manufacture of medical device products on a large-scale.
·
Our Hemopurifier product candidate may be made unmarketable prior to commercialization by us by new scientific or technological developments by others with new treatment modalities that are more efficacious and/or more economical than our products. Any one of our competitors could develop a more effective product which would render our technology obsolete.
·
Our Hemopurifier product candidate is subject to extensive government regulations related to development, testing, manufacturing and commercialization in the U.S. and other countries. If we fail to comply with these extensive regulations of the U.S. and foreign agencies, the commercialization of our products could be delayed or prevented entirely.
·
As a public company with limited financial resources undertaking the launch of new medical technologies, we may have difficulty attracting and retaining executive management and directors.
32
·
We will need to significantly expand our operations to implement our longer-term business plan and growth strategies. We will also be required to manage multiple relationships with various strategic partners, technology licensors, customers, manufacturers and suppliers, consultants and other third parties. The time and costs to effectuate these steps may place a significant strain on our management personnel, systems and resources, particularly given the limited amount of financial resources and skilled employees that may be available at the time.
·
Our business prospects and the successful commercial development of our Hemopurifier product candidate depends on our ability to complete studies, clinical trials, obtain satisfactory results, obtain required regulatory approvals. Delays in successfully completing the clinical trials could jeopardize our ability to obtain regulatory approval.
·
If we are unable to adequately address these and other risks we face, our business, financial condition, operating results and prospects may be adversely affected.
·
Our business could be adversely affected by the effects of health pandemics or epidemics, including the COVID-19 pandemic.
As a smaller reporting company as defined by Rule
12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations and therefore
are not required to provide the information requested by this item. For a discussion of our potential risks and uncertainties, please
see the information listed in the item captioned “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended
March 31, 2021.
*Should any of our potential products, including
the Hemopurifier, be approved for commercialization, certain health reform measures and adverse changes in reimbursement policies and
procedures may impact our ability to market and sell our products.
Healthcare costs have risen significantly over
the past decade, and there have been and continue to be proposals by legislators, regulators and third-party payors to decrease costs.
Third-party payors are increasingly challenging the prices charged for medical products and services and instituting cost containment
measures to control or significantly influence the purchase of medical products and services.
For example, in the U.S., the Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, PPACA, among other things,
reduced and/or limited Medicare reimbursement to certain providers. However, on December 14, 2018, a Texas U.S. District Court Judge ruled
that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress
as part of legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act of 2017. Additionally, on June 17, 2021, the U.S.
Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual
mandate” was repealed by Congress. Thus, the ACA will remain in effect in its current form. Further, prior to the U.S. Supreme Court
ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining
health insurance coverage through the ACA marketplace, which began on February 15, 2021 and remained open through August 15, 2021. The
executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access
to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements,
and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible
that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and litigation,
and the healthcare reform measures of the Biden administration will impact the ACA and our business. The Budget Control Act of 2011, as
amended by subsequent legislation, further reduces Medicare’s payments to providers by two percent through fiscal year 2031. However,
COVID-19 relief legislation suspended the two percent Medicare sequester from May 1, 2020 through March 31, 2022. Under current legislation,
the actual reduction in Medicare payments will vary from 1% in 2022 to up to 3% in the final fiscal year of this sequester. These reductions
may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies. Furthermore, the healthcare
industry in the U.S. has experienced a trend toward cost containment as government and private insurers seek to control healthcare costs
by imposing lower payment rates and negotiating reduced contract rates with service providers. Legislation could be adopted in the future
that limits payments for our products from governmental payors. In addition, Congress is considering additional health reform measures.
It is also possible that additional governmental action is taken in response to the COVID-19 pandemic. In addition, commercial payors
such as insurance companies, could adopt similar policies that limit reimbursement for medical device manufacturers’ products. Therefore,
it is possible that our product or the procedures or patient care performed using our product will not be reimbursed at a cost-effective
level. We face similar risks relating to adverse changes in reimbursement procedures and policies in other countries where we may market
our products. Reimbursement and healthcare payment systems vary significantly among international markets. Our inability to obtain international
reimbursement approval, or any adverse changes in the reimbursement policies of foreign payors, could negatively affect our ability to
sell our products and have a material adverse effect on our business and financial condition.
33
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
We did not issue or sell any unregistered securities during the three
months ended December 31, 2021.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
We have no disclosure applicable to this item.
ITEM 4. MINE SAFETY DISCLOSURES.
We have no disclosure applicable to this item.
ITEM 5. OTHER INFORMATION.
Please see the information under the headings “2021 Target Bonus
Awards,” “2022 Annual Base Salaries and Target Bonus Levels,” “Stock Option Grants” and “Non-Employee
Director Compensation Policy” in Note 13, Subsequent Events, of the Notes to Condensed Consolidated Financial Statements included
in Part I, Item 1 of this Quarterly Report on Form 10-Q, which is incorporated herein by reference.
ITEM 6. EXHIBITS.
(a) Exhibits. The following documents are filed as part of this report:
Incorporated by Reference
Exhibit Number
Exhibit Description
Form
SEC File No.
Exhibit Number
Date
Filed Herewith
3.1
Articles of Incorporation.
S-3
333-211151
3.1
May 5, 2016
3.2
Amended and Restated Bylaws of the Company.
8-K
001-37487
3.1
September 12, 2019
4.1
Form of Common Stock Certificate.
S-1
333-201334
4.1
December 31, 2014
4.2
Form of Warrant Agreement dated March 27, 2017.
8-K
001-37487
4.1
March 22, 2017
4.3
Form of Warrant dated 2017.
S-1/A
333-219589
4.29
September 18, 2017
4.4
Form of Placement Agent Warrant dated 2017.
S-1/A
333-219589
4.30
September 22, 2017
4.5
Form of Warrant to Purchase Common Stock.
S-1/A
333-234712
4.14
December 11, 2019
4.6
Form of Underwriter Warrant.
S-1/A
333-234712
4.15
December 11, 2019
4.7
Form of Common Stock Purchase Warrant.
8-K
001-37487
4.1
January 17, 2020
10.1¥
Lease between Aethlon Medical, Inc. and San Diego Inspire 5, LLC, effective as of October 27, 2021.
10-Q
001-37487
10.1
November 9, 2021
34
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
SEC File No.
Exhibit
Number
Date
Filed
Herewith
10.2++
Aethlon Medical, Inc. Amended and Restated Non-Employee Directors Compensation Policy, as modified on February 10, 2022.
X
31.1
Certification of our Chief Executive Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
X
31.2
Certification of our Chief Financial Officer, pursuant to Securities Exchange Act rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
X
32.1
Statement of our Chief Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350).
X
32.2
Statement of our Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350).
X
101.INS
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover Page Interactive Data File (formatted in IXBRL, and included in exhibit 101).
X
________________
¥ Schedules have been omitted pursuant to Item 601(a)(5) of Regulation
S-K. The registrant undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC.
++ Indicates management contract or
compensatory plan.
35
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 14, 2022
By:
/s/ JAMES B. FRAKES
JAMES B. FRAKES
CHIEF FINANCIAL OFFICER
CHIEF ACCOUNTING OFFICER
36
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.