Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain “disclosure
controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information
required to be disclosed, in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer (who are our principal executive officer and principal financial officer, respectively), to allow
timely decisions regarding required disclosures.
58
In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in
evaluating the cost-benefit relationship of possible controls and procedures. We have carried out an evaluation as of the end of the period
covered by this Annual Report under the supervision and with the participation of our management, including our Chief Executive Officer
and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
Based on such evaluation,
our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report,
our disclosure controls and procedures were effective.
Internal Control over Financial Reporting
(a)
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under
the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles.
Under the supervision and
with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we conducted an evaluation
of the effectiveness of our internal control over financial reporting as of March 31, 2023. According to the guidelines established by
Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, one or more
material weaknesses renders a company’s internal control over financial reporting ineffective. Based on this evaluation, we have
concluded that our internal control over financial reporting was effective as of March 31, 2023.
(b)
Changes in Internal Control Over Financial Reporting
There was no change in our
internal control over financial reporting during the last fiscal quarter ended March 31, 2023 that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
INSPECTIONS
Not applicable.
59
PART III
Certain information required
by Part III is omitted from this Annual Report and incorporated by reference to our definitive proxy statement for our 2023 Annual Meeting
of Stockholders, or the Proxy Statement, to be filed pursuant to Regulation 14A of the Exchange Act. If our Proxy Statement is not filed
within 120 days after the end of the fiscal year covered by this Annual Report, the omitted information will be included in an amendment
to this Annual Report filed not later than the end of such 120-day period.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Except as set forth below,
the information required by this item will be contained in the sections titled “Information About our Board of Directors and Executive
Officers,” “Information About our Board of Directors and Executive Officers – Code of Ethics,” “Information
About our Board of Directors and Executive Officers – Information Regarding Committees of the Board of Directors – Nominating
and Corporate Governance Committee,” “Information About our Board of Directors and Executive Officers – Information
Regarding Committees of the Board of Directors – Audit Committee and Audit Committee Financial Expert,” “Information
About our Board of Directors and Executive Officers – Information Regarding Committees of the Board of Directors – Compensation
Committee” and “Executive and Director Compensation” in our Proxy Statement and is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by
this item will be contained in the sections titled “Executive and Director Compensation” and “Information About our
Board of Directors and Executive Officers – Information Regarding Committees of the Board of Directors – Compensation Committee”
in our Proxy Statement and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS
The information required by
this item will be contained in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive
and Director Compensation – Narrative Disclosure to Executive Summary – Equity-Based Incentive Awards” in our Proxy
Statement and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR
INDEPENDENCE
The information required by
this item will be contained in the sections titled “Information About our Board of Directors and Executive Officers – Board
of Directors” and “Certain Relationships and Related Transactions” in our Proxy Statement and is incorporated herein
by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by
this item will be contained in the section titled “Ratification of Appointment of Independent Registered Public Accounting Firm”
in our Proxy Statement and is incorporated herein by reference.
60
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The following documents are filed as part of this Annual Report:
(a)(1) Financial Statements.
The response to this portion of Item 15 is set
forth under Part II, Item 8 above.
(a)(2) Financial Statement Schedules.
All schedules have been omitted because they are
not required or because the required information is given in the Financial Statements or Notes thereto set forth under Item 8 above.
(a)(3) Exhibits required by Item 601 of Regulation
S-K.
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
SEC File No.
Exhibit
No.
Date
Filed Herewith
3.1
Articles of Incorporation, as amended.
8-K
001-37487
3.1
September 19, 2022
3.2
Amended and Restated Bylaws of the Company.
8-K
001-37487
3.1
September 12, 2019
4.1
Form of Common Stock Certificate.
S-1
333-201334
4.1
December 31, 2014
4.2
Form of Warrant to Purchase Common Stock.
S-1/A
333-234712
4.14
December 11, 2019
4.3
Form of Underwriter Warrant.
S-1/A
333-234712
4.15
December 11, 2019
4.4
Form of Common Stock Purchase Warrant.
8-K
001-37487
4.1
January 17, 2020
4.5
Description of Aethlon Medical, Inc.’s Securities.
10-K
001-37487
4.16
June 25, 2020
10.1++
Aethlon Medical, Inc. Amended and Restated Non-Employee Director Compensation Policy, as Modified on February 10, 2022.
10-Q
001-37487
10.2
February 14, 2022
10.2++
Employment Agreement, by and between Aethlon Medical, Inc. and James Frakes, dated December 12, 2018.
10-Q
001-37487
10.3
February 11, 2019
10.3++
Form of Indemnification Agreement for Officers and Directors.
10-Q
001-37487
10.4
February 11, 2019
61
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
SEC File No.
Exhibit
No.
Date
Filed Herewith
10.4++
Form of Option Grant Agreement for Officers and Directors.
10-Q
001-37487
10.5
February 11, 2019
10.5++
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for Directors.
10-Q
001-37487
10.6
February 11, 2019
10.6++
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for Executives.
10-Q
001-37487
10.7
February 11, 2019
10.7
SBIR Phase II Award Contract, by and among Aethlon Medical, Inc., the National Institutes of Health and the National Cancer Institute, dated September 12, 2019.
10-Q
001-37487
10.2
November 1, 2019
10.8
Amendment to SBIR Phase II Award Contract, by and among Aethlon Medical, Inc., the National Institutes of Health and the National Cancer Institute, dated October 28, 2020.
10-K
001-37487
10.8
June 28, 2022
10.9
Assignment Agreement, by and between Aethlon Medical, Inc. and London Health Sciences Center Research Inc., dated November 7, 2006.
S-1
001-37487
10.27
November 15, 2019
10.10++
Aethlon Medical, Inc. 2020 Equity Incentive Plan, Form of Restricted Stock Grant, Form of Option Grant and Agreement.
8-K
001-37487
99.1
September 19, 2022
10.11++
Employment Agreement between the Company and Dr. Fisher, dated October 30, 2020.
8-K
001-37487
10.2
November 3, 2020
10.12
Lease, by and between the Company and San Diego Inspire 1, LLC. and San Diego Inspire 2, LLC, effective December 7, 2020.
10-Q
001-37487
10.3
February 10, 2021
10.13++
Executive Employment Agreement between the Company and Guy Cipriani, dated January 1, 2021.
10-Q
001-37487
10.5
February 10, 2021
10.14++
Executive Employment Agreement between the Company and Steven P. LaRosa, MD, dated January 4, 2021.
10-Q
001-37487
10.6
February 10, 2021
10.15++
Executive Employment Agreement, by and between Aethlon Medical, Inc. and Lee D. Arnold, Ph.D., dated February 1, 2023.
10-Q
001-37487
10.1
February 13, 2023
10.16
Lease between Aethlon Medical, Inc. and San Diego Inspire 5, LLC, effective October 27, 2021.
10-Q
001-37487
10.1
November 9, 2021
10.17
At the Market Offering Agreement, dated March 24, 2022, by and between Aethlon Medical, Inc. and H.C. Wainwright & Co., LLC.
8-K
001-37487
1.1
March 24, 2022
62
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
SEC File No.
Exhibit
No.
Date
Filed Herewith
10.18++
Amendment No. 1 to Executive Employment Agreement, by and between Aethlon Medical, Inc. and Lee D. Arnold, Ph.D., dated May 1, 2023.
X
21.1
List of Subsidiaries.
X
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (see signature page)
X
31.1
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
X
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1
Certification of the Principal Executive Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.
X
32.2
Certification of the Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.
X
101.INS
Inline XBRL Instance Document (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
__________________
++
Indicates management contract or compensatory plan.
ITEM 16. FORM 10-K SUMMARY
None.
63
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized, o n the 28 th d ay
of June, 2023.
By:
/s/ CHARLES J. FISHER
Charles J. Fisher, Jr., M.D.
Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each
person whose signature appears below constitutes and appoints James B. Frakes and Charles J. Fisher, Jr., M.D., his or her true and lawful
attorney-in-fact and agent, with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities,
to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents
in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as
fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents, or any of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant
and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ CHARLES J. FISHER
Chief Executive Officer, Principal Executive Officer and Director
June 28, 2023
Charles J. Fisher, Jr., M.D.
/s/ JAMES B. FRAKES
Chief Financial Officer and Principal Financial and Accounting Officer
June 28, 2023
James B. Frakes
/s/ EDWARD G. BROENNIMAN
Chairman and Director
June 28 , 2023
Edward G. Broenniman
/s/ CHETAN S. SHAH
Director
June 28, 2023
Chetan S. Shah, M.D.
/s/ ANGELA ROSSETTI
Director
June 28, 2023
Angela Rossetti
/s/ GUY CIPRIANI
Senior Vice President, Chief Business Officer and Director
June 28, 2023
Guy Cipriani
64
Page
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID 23 )
F-2
Consolidated Balance Sheets as of March 31, 2023 and 2022
F-3
Consolidated Statements of Operations for the Years Ended March 31, 2023 and 2022
F-4
Consolidated Statements of Equity for the Years Ended March 31, 2023 and 2022
F-5
Consolidated Statements of Cash Flows for the Years Ended March 31, 2023 and 2022
F-6
Notes to Consolidated Financial Statements
F-7
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and the Board of Directors
of Aethlon Medical, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheets of Aethlon Medical, Inc. and its subsidiary (the Company) as of March 31, 2023 and 2022, the related consolidated statements
of operations, equity and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively,
the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of
the Company as of March 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, in conformity
with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from
the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
Baker Tilly US, LLP
We have served as the Company's auditor since
2001.
San Diego, California
June 28, 2023
F- 2
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
March 31,
2023
2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 14,532,943
$ 17,072,419
Accounts receivable
–
127,965
Prepaid expenses and other current assets
557,623
956,623
TOTAL CURRENT ASSETS
15,090,566
18,157,007
Property and equipment, net
1,144,004
441,238
Right-of-use lease asset
1,151,909
696,698
Patents, net
1,650
2,200
Restricted cash
87,506
87,506
Deposits
33,305
33,305
TOTAL ASSETS
$ 17,508,940
$ 19,417,954
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$ 432,890
$ 499,962
Due to related parties
214,221
155,742
Deferred revenue
–
344,547
Lease liability, current portion
269,386
126,905
Other current liabilities
588,592
696,893
TOTAL CURRENT LIABILITIES
1,505,089
1,824,049
Lease liability, less current portion
939,642
602,505
TOTAL LIABILITIES
2,444,731
2,426,554
COMMITMENTS AND CONTINGENCIES (Note 9)
–
–
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 60,000,000 and 30,000,000 shares authorized at March 31, 2023 and 2022, respectively; 22,992,466 and 15,419,163 shares issued and outstanding at March 31, 2023 and 2022, respectively
22,994
15,421
Additional paid-in capital
157,405,911
147,446,868
Accumulated other comprehensive loss
( 6,141 )
–
Accumulated deficit
( 142,358,555 )
( 130,329,181 )
TOTAL AETHLON MEDICAL, INC. STOCKHOLDERS’ EQUITY BEFORE NONCONTROLLING INTERESTS
15,064,209
17,133,108
NONCONTROLLING INTERESTS
–
( 141,708 )
TOTAL STOCKHOLDERS’ EQUITY
15,064,209
16,991,400
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 17,508,940
$ 19,417,954
See accompanying notes to the consolidated financial
statements.
F- 3
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
Years Ended March 31,
2023
2022
REVENUES:
Government contract and grant revenue
$ 574,245
$ 294,165
Total revenues
574,245
294,165
OPERATING COSTS AND EXPENSES
Professional fees
3,548,028
2,634,026
Payroll and related expenses
4,443,552
4,625,802
General and administrative
4,481,303
3,455,222
Total operating expenses
12,472,883
10,715,050
OPERATING LOSS
( 11,898,638 )
( 10,420,885 )
OTHER EXPENSE (INCOME)
Loss on dissolution of subsidiary
142,121
–
Interest income
( 10,973 )
–
Other expense (income)
131,148
–
NET LOSS BEFORE NONCONTROLLING INTERESTS
( 12,029,786 )
( 10,420,885 )
LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS
–
( 4,794 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
( 12,029,786 )
( 10,416,091 )
OTHER COMPREHENSIVE LOSS
( 6,141 )
–
COMPREHENSIVE LOSS
$ ( 12,035,927 )
$ ( 10,416,091 )
Basic and diluted net loss per share attributable to common stockholders
$ ( 0.59 )
$ ( 0.71 )
Weighted average number of common shares outstanding - basic and diluted
20,537,434
14,756,967
See accompanying notes to the consolidated financial
statements.
F- 4
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF EQUITY
FOR THE YEARS ENDED MARCH 31, 2023 AND 2022
`
ATTRIBUTABLE TO AETHLON
MEDICAL, INC.
COMMON STOCK
ADDITIONAL
PAID IN
ACCUMULATED
ACCUMULATED
COMPREHENSIVE
NON-
CONTROLLING
TOTAL
SHARES
AMOUNT
CAPITAL
DEFICIT
LOSS
INTERESTS
EQUITY
BALANCE - MARCH 31, 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 and net
stock option exercise
43,728
44
( 88,162 )
–
–
–
( 88,118 )
Stock-based compensation expense
–
–
750,621
–
–
–
750,621
Net loss
–
–
–
( 10,416,091 )
–
( 4,794 )
( 10,420,885 )
BALANCE - MARCH 31, 2022
15,419,163
$ 15,421
$ 147,446,868
$ ( 130,329,181 )
$ –
$ ( 141,708 )
$ 16,991,400
Issuances of common stock for cash under at the market program
7,480,836
7,481
8,919,730
–
–
–
8,927,211
Issuance of common shares upon vesting of restricted stock units
92,467
92
( 12,585 )
–
–
–
( 12,493 )
Loss on dissolution of subsidiary
–
–
–
–
–
142,121
142,121
Stock-based compensation expense
–
–
1,051,898
–
–
–
1,051,898
Net loss
–
–
–
( 12,029,373 )
–
( 413 )
( 12,029,786 )
Other comprehensive loss
–
–
–
–
( 6,141 )
–
( 6,141 )
BALANCE - MARCH 31, 2023
22,992,466
$ 22,994
$ 157,405,911
$ ( 142,358,554 )
$ ( 6,141 )
$ –
$ 15,064,209
See accompanying notes to the consolidated financial
statements.
F- 5
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED MARCH 31, 2023 AND 2022
Years Ended March 31,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 12,029,786 )
$ ( 10,420,885 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
240,892
123,685
Stock based compensation
1,051,898
750,621
Loss of dissolution of subsidiary
142,121
–
Accretion of right-of-use lease asset
24,408
30,532
Changes in operating assets and liabilities:
Accounts receivable
127,965
21,117
Prepaid expenses and other current assets
398,169
( 636,688 )
Accounts payable and other current liabilities
( 174,727 )
97,541
Deferred revenue
( 344,547 )
229,698
Due to related parties
58,479
37,222
Net cash used in operating activities
( 10,505,128 )
( 9,767,157 )
Cash flows from investing activities:
Purchases of property and equipment
( 943,109 )
( 349,193 )
Net cash used in investing activities
( 943,109 )
( 349,193 )
Cash flows from financing activities:
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units
( 12,493 )
( 88,118 )
Net proceeds from the issuance of common stock and exercise of warrants
8,927,211
17,456,092
Net cash provided by financing activities
8,914,718
17,367,974
Effect of Exchange Rate on Changes on Cash
( 5,957 )
–
Net (decrease) increase in cash and restricted cash
( 2,533,519 )
7,251,624
Cash and restricted cash at beginning of year
17,159,925
9,908,301
Cash and restricted cash at end of year
$ 14,620,449
$ 17,159,925
Supplemental information of non-cash investing and financing activities:
Issuances of common stock under cashless warrant exercises
$ –
$ 676
Initial recognition of right-of-use lease asset and lease liability
$ 625,471
$ 744,430
Issuance of shares under vested restricted stock units, net stock option exercises and unvested share issuance for services
$ 92
$ 44
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets:
Cash and cash equivalents
$ 14,532,943
$ 17,072,419
Restricted cash
87,506
87,506
Cash and restricted cash
$ 14,620,449
$ 17,159,925
See accompanying notes to the
consolidated financial statements.
F- 6
Aethlon Medical, Inc. and Subsidiary
Notes to Consolidated Financial Statements
1. ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION
Aethlon Medical, Inc., or Aethlon, the Company,
we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious 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 working with our new contract research organization, or CRO, on preparations
to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other
cancers.
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, 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 clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two
patients. Due to lack of further patient enrollment, we and UPMC terminated this trial.
In January 2023, we entered into an agreement
with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to
oversee our clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA will manage our
clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors. We anticipate
that the initial clinical trials will begin in Australia.
We also believe the Hemopurifier can be part of
the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already
approved treatment. 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.
F- 7
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, Monkeypox 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,
or COVID-19, in a New Feasibility Study. That study was designed to enroll up to 40 subjects at up to 20 centers in the United States.
Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung
injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study, in addition to safety, included reduction
in circulating virus as well as clinical outcomes (NCT # 04595903). In June 2022, the first patient in this study was enrolled and completed
the Hemopurifier treatment phase of the protocol. Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this
study in 2022.
Under Single Patient Emergency Use regulations,
the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
in our COVID-19 clinical trial discussed above.
We currently are experiencing a disruption in
our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, as previously disclosed, we are dependent
on FDA approval of qualified suppliers to manufacture our Hemopurifier. Our intended transition to a new supplier for galanthus nivalis
agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement to our IDE, which
is required to make this manufacturing change.
In October 2022, we launched a wholly owned subsidiary
in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country. The subsidiary
will initially focus on oncology trials in Australia. There were only insignificant expenses in that subsidiary in the three months ended
December 31, 2022.
We also obtained Ethics Review Board, or ERB,
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. One patient has completed participation in the Indian COVID-19 study. The relevant authorities
in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier.
In May 2023, we also received ERB approval from
the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19. MAMC was established
in 1958 and is located in New Delhi, India. MMAC is affiliated with the University of Delhi and is operated by the Delhi government.
We also recently announced that we also have begun
investigating the use of our Hemopurifier in the organ transplant setting. Our objective is to confirm that the Hemopurifier, in our translational
studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from harvested
organs. We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down
version of our Hemopurifier. This process potentially may reduce complications following transplantation of the harvested organ, which
can include viral infection, delayed graft function and rejection. We believe this new approach could be additive to existing technologies
that currently are in place to increase the number of viable organs for transplant.
F- 8
Previously, we were 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,
and thus consolidated ESI in our consolidated financial statements. For more than four years, the primary activities of ESI were limited
to the payment of patent maintenance fees and applications. In September 2022, the Board of Directors of ESI and we, as the majority stockholder
of ESI, approved the dissolution of ESI.
Successful outcomes of human trials will also
be required by the regulatory agencies of certain foreign countries where we plan to market and 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 inflation, recent bank failures and the war in Ukraine on our business. Given the level of uncertainty regarding
the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess the impact on our timelines and
future access to capital. The full extent to which inflation, recent bank failures and the war in Ukraine will impact our business, results
of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic
impact on national and international markets that are highly uncertain.
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.”
LIQUIDITY AND GOING CONCERN
Management expects existing cash as of March 31,
2023 and funds raised subsequent to that date to be sufficient to fund the Company’s operations for at least twelve months from
the issuance date of these consolidated financial statements.
PRINCIPLES OF CONSOLIDATION
The accompanying consolidated financial statements
include the accounts of Aethlon Medical, Inc. and its wholly owned subsidiary, Aethlon Medical Australia Pty Ltd, as well as its previously
majority-owned subsidiary, ESI, which dissolved in September 2022. All significant inter-company transactions and balances have been eliminated
in consolidation. The consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of
management, are necessary to present fairly the consolidated financial statements as of and for the fiscal years ended March 31, 2023
and 2022, and the consolidated statement of cash flows for the fiscal years ended March 31, 2023 and 2022. 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.
RISKS AND UNCERTAINTIES
We operate in an industry that is subject to intense
competition, government regulation and rapid technological change. Our operations are subject to significant risk and uncertainties including
financial, operational, technological, regulatory, and including the potential risk of business failure.
F- 9
USE OF ESTIMATES
We prepare our consolidated financial statements
in conformity with accounting principles generally accepted in the United States of America, or GAAP, which 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. Such 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.
CASH AND CASH EQUIVALENTS
Accounting standards define “cash and cash
equivalents” as any short-term, highly liquid investment that is both readily convertible to known amounts of cash and so near their
maturity that they present insignificant risk of changes in value because of changes in interest rates. For the purpose of financial statement
presentation, we consider all highly liquid investment instruments with original maturities of three months or less when purchased, or
any investment redeemable without penalty or loss of interest to be cash equivalents. Cash is carried at cost, which approximates fair
value, and cash equivalents are carried at fair value.
As of March 31, 2023, our cash and cash equivalents
were comprised of the following instruments:
Schedule of cash and cash equivalents
Cash in US bank checking account
$ 575,766
Cash equivalents held in US Treasury bills
13,910,973
Cash in Australian bank checking account
46,204
Total cash and cash equivalents
$ 14,532,943
As of March 31, 2022, we had no assets that were
classified as cash equivalents.
CONCENTRATIONS OF CREDIT RISKS
Cash is maintained at one US financial institution
in a checking account. Accounts at this institution are secured by the Federal Deposit Insurance Corporation up to $250,000. Our March
31, 2023 cash balances were approximately $ 574,572 over such insured amount. We do not believe that
the Company is exposed to any significant risk with respect to its cash in that checking account.
At March
31, 2023, we maintained cash equivalents of approximately $ 13.9 million in US Treasury bills with maturities of less than three months.
We do not believe that the Company is exposed to any significant risk with respect to its cash equivalents since they represent US government
risk.
Cash is maintained at one Australian financial
institution in checking accounts. Accounts at this institution are secured by the Financial Claims Scheme for up to Australian $ 250,000 .
Our March 31, 2023 Australian cash balance was below that threshold.
All of our revenue in the fiscal years ended March
31, 2023 and 2022 related to our government contracts. We did not have any accounts receivable at March 31, 2023.
F- 10
RESTRICTED CASH
To comply with the terms of our laboratory, office,
and manufacturing space leases, we caused our bank to issue two standby letters of credit, or the L/Cs, in the 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 restricted certificates of deposit. We have classified that amount as restricted
cash, a long-term asset, on our balance sheet.
PROPERTY AND EQUIPMENT
Property and equipment are stated at cost. Depreciation
is computed using the straight-line method over the estimated useful lives of the related assets, which range from two to five years.
Repairs and maintenance are charged to expense as incurred while improvements are capitalized. Upon the sale or retirement of property
and equipment, the accounts are relieved of the cost and the related accumulated depreciation with any gain or loss included in the consolidated
statements of operations.
INCOME TAXES
Deferred tax assets and liabilities are recognized
for the future tax consequences attributable to the difference between the consolidated financial statements and their respective tax
basis. Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities
for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax credit carryforwards. We record a valuation
allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in the foreseeable future, it is more likely
than not that some portion of the deferred tax assets may not be realized.
LONG-LIVED ASSETS
Long-lived assets are reviewed for impairment
whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. If the cost basis of a long-lived
asset is greater than the projected future undiscounted net cash flows from such asset, an impairment loss is recognized. We believe no
impairment charges were necessary during the fiscal years ended March 31, 2023 and 2022.
LOSS PER SHARE
Basic loss per share is computed by dividing net
income available to common stockholders 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
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 March 31, 2023 and 2022, a total of 2,045,006
and 2,243,838 potential common shares, consisting of shares underlying outstanding stock options, restricted stock units, or RSUs, and
warrants were excluded as their inclusion would be antidilutive.
DEFERRED FINANCING COSTS
Costs related to the issuance of debt are capitalized
as a deduction to our convertible notes based on the accounting standard on imputation of interest, and amortized to interest expense
over the life of the related debt using the effective interest method. There was no amortization related to our deferred financing costs
in the fiscal years ended March 31, 2023 and 2022.
F- 11
REVENUE RECOGNITION
Our revenues consist entirely of amounts earned
under contracts and grants with the National Institutes of Health, or NIH. During the fiscal years ended March 31, 2023 and 2022, we recognized
revenues totaling $ 574,245 and $ 294,165 , respectively, under such contracts. We have concluded that these agreements are not within the
scope of ASC Topic, 606, Revenue from Contracts with Customers, or Topic 606, as the NIH grants and contracts do not meet the definition
of a “customer” as defined by Topic 606. Prior to the effective date of ASC Topic 606, which for the Company was April 1,
2018, we accounted for our grant/contract revenues under the Milestone Method as prescribed by the legacy guidance of ASC 605-28, Revenue
Recognition – Milestone Method, or Milestone Method. In the absence of other applicable guidance under US GAAP, effective April
1, 2018, we elected to continue to use the Milestone Method by analogy to recognize revenue under these grants/contracts.
We identify the deliverables included within these
agreements and evaluate which deliverables represent separate units of accounting based on if certain criteria are met, including whether
the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting,
and the applicable revenue recognition criteria are applied to each of the separate units.
A milestone is an event having all of the following
characteristics:
(1) There is substantive uncertainty at the date
the arrangement is entered into that the event will be achieved. A vendor’s assessment that it expects to achieve a milestone does
not necessarily mean that there is not substantive uncertainty associated with achieving the milestone.
(2) The event can only be achieved based in whole
or in part on either: (a) the vendor’s performance; or (b) a specific outcome resulting from the vendor’s performance.
(3) If achieved, the event would result in additional
payments being due to the vendor.
A milestone does not include events for which
the occurrence is either: (a) contingent solely upon the passage of time; or (b) the result of a counterparty’s performance.
The policy for recognizing deliverable consideration
contingent upon achievement of a milestone must be applied consistently to similar deliverables.
The assessment of whether a milestone is substantive
is performed at the inception of the arrangement. The consideration earned from the achievement of a milestone must meet all of the following
for the milestone to be considered substantive:
(1) The consideration is commensurate with either:
(a) the vendor’s performance to achieve the milestone; or (b) the enhancement of the value of the delivered item or items as a result
of a specific outcome resulting from the vendor’s performance to achieve the milestone;
(2) The consideration relates solely to past performance;
and
(3) The consideration is reasonable relative to
all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement.
A milestone is not considered substantive if any
portion of the associated milestone consideration relates to the remaining deliverables in the unit of accounting (i.e., it does not relate
solely to past performance). To recognize the milestone consideration in its entirety as revenue in the period in which the milestone
is achieved, the milestone must be substantive in its entirety. Milestone consideration cannot be bifurcated into substantive and nonsubstantive
components. In addition, if a portion of the consideration earned from achieving a milestone may be refunded or adjusted based on future
performance, the related milestone is not considered substantive.
F- 12
We have recognized revenue under the following
contracts/grants:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the National Cancer Institute,
or NCI, part of the NIH, 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 was $ 1,860,561
and, as amended, ran for the period from September 16, 2019 through September 15, 2022.
The work performed pursuant to this Award Contract
was focused on melanoma exosomes. This work followed 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 involved
the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
The Award Contract ended on September 15, 2022
and we presented the required final report to the NCI. As the NCI completed its close out review of the contract, we recognized as revenue
the $ 574,245 previously recorded as deferred revenue on our December 31, 2022 balance sheet.
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 was $ 256,750 . We did no t record revenue related to this subaward in
the fiscal year ended March 31, 2023. We recorded $ 64,467 of revenue related to this subaward in the fiscal year ended March 31, 2022.
In October 2022, we agreed with the University
of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head
and neck cancer in which the University of Pittsburgh was unable to recruit patients. There are no provisions in the subaward arrangement
requiring repayment of cash received for work completed through November 10, 2022.
STOCK-BASED COMPENSATION
Employee stock options and rights to purchase
shares under stock participation plans are accounted for under the fair value method. Accordingly, share-based compensation is measured
when all granting activities have been completed, generally the grant date, based on the fair value of the award. The exercise price of
options is generally equal to the market price of the Company’s common stock (defined as the closing price as quoted on the Nasdaq
Capital Market or OTCBB on the date of grant). Compensation cost recognized by the Company includes (a) compensation cost for all equity
incentive awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair value estimated in accordance with the
original provisions of the then current accounting standards, and (b) compensation cost for all equity incentive awards granted subsequent
to March 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of subsequent accounting standards.
We use a Binomial Lattice option pricing model for estimating fair value of options granted (see Note 4).
The following table summarizes share-based compensation
expenses relating to shares and options granted and the effect on loss per common share during the years ended March 31, 2023 and 2022:
Schedule of share-based compensation expenses
Fiscal Years Ended
March 31, 2023
March 31, 2022
Vesting of Stock Options and Restricted Stock Units
$ 1,051,898
$ 750,621
Total Stock-Based Compensation Expense
$ 1,051,898
$ 750,621
Weighted average number of common shares outstanding – basic and diluted
20,537,434
14,756,967
Basic and diluted loss per common share
$ ( 0.59 )
$ ( 0.71 )
F- 13
We record share-based compensation expenses for
awards of stock options and RSUs under ASC 718, Share-based compensation, or ASC 718. For awards to non-employees for periods prior to
the adoption of ASU 2018-07, Compensation-Stock Compensation: Improvements to Non-employee Share-Based Payment Accounting, on April 1,
2019, the Company had applied ASC 505-50, Equity – Equity-based payments to non-employees, or ASC 505-50. ASC 718 establishes guidance
for the recognition of expenses arising from the issuance of share-based compensation awards at their fair value at the grant date.
We recognize share-based compensation expense
related to stock options and stock appreciation rights granted to employees, directors and consultants based on the estimated fair value
of the awards on the date of grant. We estimate the grant date fair value, and the resulting share-based compensation expense, for stock
options that only have service vesting requirements or performance-based vesting requirements without market conditions using the binomial
lattice option-pricing model. The grant date fair value of the share-based awards with service vesting requirements is generally recognized
on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Determining
the appropriate amount to expense for performance-based awards based on the achievement of stated goals requires judgment. The estimate
of expense is revised periodically based on the probability of achieving the required performance targets and adjustments are made as
appropriate. The cumulative impact of any revisions is reflected in the period of change. If any applicable financial performance goals
are not met, no compensation cost is recognized and any previously recognized compensation cost is reversed. For performance-based awards
with market conditions, we determine the fair value of awards as of the grant date using a Monte Carlo simulation model.
We review share-based compensation on a quarterly
basis for changes to the estimate of expected award forfeitures based on actual forfeiture experience. The effect of adjusting the forfeiture
rate for all expense amortization after March 31, 2007 is recognized in the period the forfeiture estimate is changed. The effect of forfeiture
adjustments for the fiscal year ended March 31, 2023 was insignificant.
PATENTS
Patents include both foreign and domestic patents.
We capitalize the cost of patents, some of which were acquired, and amortize such costs over the shorter of the remaining legal life or
their estimated economic life, upon issuance of the patent. The unamortized costs of patents are subject to our review for impairment
under our long-lived asset policy above.
STOCK PURCHASE WARRANTS
In the past we issued warrants for the purchase
of shares of our common stock in connection with the issuance of common stock for cash. Warrants issued in connection with common stock
for cash, if classified as equity, are considered issued in connection with equity transactions and the warrant fair value is recorded
to additional paid-in-capital.
RESEARCH AND DEVELOPMENT EXPENSES
Our research and development costs are expensed
as incurred. We incurred approximately $ 2,745,000 and $ 2,341,000 of research and development expenses for the years ended March 31, 2023
and 2022, respectively, which are included in various operating expenses in the accompanying consolidated statements of operations.
OFF-BALANCE SHEET ARRANGEMENTS
We have not entered into any off-balance sheet
arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial statements.
F- 14
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS
In June 2018, the FASB issued ASU No. 2018-07,
Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, or ASU No. 2018-07. ASU No. 2018-07
expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ASU No.
2018-07 is effective for interim and annual reporting periods beginning after December 15, 2018. Entities must apply the guidance retrospectively
with a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption. The adoption of ASU No. 2018-07
on April 1, 2019 did not have a material impact on the Company's consolidated financial position, results of operations and related disclosures.
On April 1, 2019, the Company adopted ASC Topic
842, “Leases,” utilizing the alternative transition method allowed for under this guidance. As a result, the Company recorded
lease liabilities and right-of-use lease assets on its balance sheet.
Topic 842 also allows lessees and lessors to elect
certain practical expedients. The Company elected the following practical expedients:
·
Transitional practical expedients, which must be elected as a package and applied consistently to all of the Company’s leases:
°
The Company need not reassess whether any expired or existing contracts are or contain leases.
°
The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases).
°
The Company need not reassess initial direct costs for any existing leases.
·
Hindsight practical expedient. The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets.
2. PROPERTY AND EQUIPMENT, NET
Property and equipment, net, consist of the following:
Schedule of property and equipment
March 31, 2023
March 31, 2022
Furniture and office equipment, at cost
$ 989,987
$ 813,412
Leasehold improvements
888,224
121,690
Accumulated depreciation
( 734,207 )
( 493,864 )
Furniture and office equipment, net
$ 1,144,004
$ 441,238
Depreciation expense for the fiscal years ended March 31, 2023 and
2022 was $ 240,342 and $ 68,931 , respectively.
F- 15
3. PATENTS, NET
Patents, net consist of the following:
Schedule of patents
March 31, 2023
March 31, 2022
Issued patents
$ 157,442
$ 157,442
Accumulated amortization
( 155,792 )
( 155,242 )
Issued patents, net of accumulated amortization
1,650
2,200
Patents pending
–
–
Patents, net
$ 1,650
$ 2,200
Amortization expense for our capitalized issued
patents for each of the fiscal years ended March 31, 2023 and 2022 was $ 550 and $ 54,754 , respectively. As only one capitalized patent
remains to be amortized, future amortization expense on patents is estimated to be approximately $550 per year based on the estimated
life of the patent. The weighted average remaining life of our remaining capitalized patent is approximately 3 years.
4. EQUITY TRANSACTIONS
ISSUANCES OF COMMON STOCK AND WARRANTS
Equity Transactions in the Fiscal Year Ended March 31, 2023.
2022 At The Market Offering Agreement with H.C. Wainwright &
Co., LLC
On March 24, 2022, we entered into an At The Market Offering Agreement,
or the 2022 ATM Agreement, with H.C. Wainwright & Co., LLC, or Wainwright, which established an at-the-market equity program pursuant
to which we may offer and sell shares of our common stock from time to time as set forth in the 2022 ATM Agreement.
The offering was registered under the Securities Act of 1933, as amended,
or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No. 333-259909), as previously
filed with the Securities and Exchange Commission, or SEC, and declared effective on October 21, 2021. We filed a prospectus supplement,
dated March 24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to
$15,000,000, or the 2022 ATM Shares.
Under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares
by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities
Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the 2022 ATM Shares. In addition,
under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions with our consent and in block
transactions. Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if the sales cannot be effected
at or above the price designated by us from time to time.
We are not obligated to make any sales of the 2022 ATM Shares under
the 2022 ATM Agreement. The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon the termination of
the 2022 ATM Agreement by Wainwright or us, as permitted therein.
The 2022 ATM Agreement contains customary representations, warranties
and agreements by us, and customary indemnification and contribution rights and obligations of the parties. We agreed to pay Wainwright
a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares. We also agreed to reimburse Wainwright
for certain specified expenses in connection with entering into the 2022 ATM Agreement.
In the fiscal year ended March 31, 2023, we raised net proceeds of
$ 8,927,211 , net of $ 229,610 in commissions to Wainwright and $ 27,153 in other offering expense, through the sale of, 7,480,836 shares
of our common stock at an average price of $1.19 per share under the 2022 ATM Agreement.
F- 16
RSU Grants to Non-Employee Directors
The Compensation Committee of the Board of Directors
of the Company, or Compensation Committee, approved, effective as of April 1, 2022, pursuant to the terms of the Company’s Amended
and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual RSUs to each of the
two non-employee directors of the Company then serving on the Board of Directors of the Company, or Board, and the grant of an RSU for
the then newly appointed director. The RSU grants were made subject to stockholder approval of an increase of 1,800,000 shares of common
stock authorized for issuance under the Company’s 2020 Equity Incentive Plan, or the 2020 Plan, at the Company’s 2022 annual
meeting of stockholders. The increase was approved at the Company’s 2022 annual meeting of stockholders held in September 2022.
The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year for
current non-employee directors then serving on the Board and for a grant of stock options or $75,000 worth of RSUs for a newly elected
director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $1.46
per share as of April 1, 2022. The two then-current eligible directors each was granted a contingent RSU in the amount of 34,247 shares
under the 2020 Plan and the then newly appointed director received a contingent RSU grant for 51,370 shares under the 2020 Plan. The RSUs
were subject to vesting in three installments, 50% on September 30, 2022, and 25% on each of December 31, 2022, and March 31, 2023, subject
to the recipient's continued service with the Company on each such vesting date.
Equity Transactions in the Fiscal Year Ended March 31, 2022.
2021 At The Market Offering Agreement with H.C. Wainwright &
Co., LLC
On March 22, 2021, we entered into an At the Market
Offering Agreement, or the 2021 ATM 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 2021 ATM Agreement.
The offering was 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 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 2021 ATM Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices
to sell the shares under the 2021 ATM Agreement from time to time, based upon our instructions. We provided Wainwright with customary
indemnification rights under the 2021 ATM Agreement, and Wainwright was entitled to a commission at a fixed rate equal to up 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 2021 ATM Agreement. The 2021 ATM Agreement provided that it would terminate upon the written termination by either
party as permitted thereunder.
Sales of the shares, under the 2021 ATM 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 2021 ATM Agreement provided that we have no obligation under the 2021 ATM Agreement to sell any
of the shares, and, at any time, we could suspend offers under the 2021 ATM Agreement or terminate the agreement.
In the fiscal year ended March 31, 2022, we raised
aggregate net proceeds under the 2021 ATM 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 2021 ATM Agreement.
F- 17
Registered Direct Financing
In the fiscal year ended March 31, 2022, 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.
Warrant Exercises
In the fiscal year ended March 31, 2022, 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 fiscal year ended March 31, 2022,
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 fiscal year ended March 31, 2022, former
employees paid us an aggregate of $ 28,325 for the exercise of outstanding options to purchase 11,562 shares of our common stock.
RSU Grants to Non-Employee Directors
The Company maintains the Director Compensation
Policy which provides for cash and equity compensation for persons serving as non-employee directors of the Company. Under this policy,
each new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock
options or of RSUs at the beginning of each fiscal year. The (i) stock options are subject to vesting and (ii) 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 Director Compensation
Policy, the Compensation Committee granted RSUs under the 2020 Plan to each non-employee director of the Company. The Director Compensation
Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year, with the RSUs 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 RSUs were 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.
F- 18
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.
In March 2022, 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 $ 10,641 in aggregate cash proceeds to those independent directors.
There were no vested RSUs outstanding as of March
31, 2022.
WARRANTS:
We did not issue any warrants during the fiscal
years ended March 31, 2023 and 2022.
A summary of the aggregate warrant activity for the years ended March
31, 2023 and 2022 is presented below:
Summary of warrant activity
Fiscal Year Ended March 31,
2023
2022
Warrants
Weighted
Average
Exercise Price
Warrants
Weighted
Average
Exercise Price
Outstanding, beginning of year
576,738
$
11.21
1,991,973
$
5.23
Granted
–
$
N/A
–
$
N/A
Exercised
–
$
N/A
( 1,206,721
)
$
2.21
Cancelled/Forfeited
( 249,985
)
$
23.24
( 208,514
)
$
6.11
Outstanding, end of year
326,753
$
2.01
576,738
$
11.21
Exercisable, end of year
326,753
$
2.01
576,738
$
11.21
Weighted average estimated fair value of warrants granted
$
N/A
$
N/A
The detail of the warrants outstanding and exercisable as of March
31, 2023 is as follows:
Summary of warrant activity exercisable and outstanding
Warrants Outstanding
Warrants Exercisable
Range of
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Life (Years)
Weighted
Average
Exercise Price
Number
Outstanding
Weighted
Average
Exercise Price
$1.88 or Below
202,167
1.75
$
1.57
202,167
$
1.57
$2.50 - $2.75
124,586
1.83
$
2.73
124,586
$
2.73
326,753
326,753
F- 19
STOCK-BASED COMPENSATION:
2020 EQUITY INCENTIVE PLAN
In September 2020, our stockholders approved the
adoption of the 2020 Plan, to provide incentives to attract, retain and motivate employees, directors and consultants, whose present and
potential contributions are important to our success, by offering them an opportunity to participate in our future performance through
awards of options, the right to purchase common stock, stock bonuses and stock appreciation rights and other awards. We initially authorized
a total of 1,842,556 common shares for issuance under the 2020 Plan pursuant to stock option grants, RSUs or other forms of stock-based
compensation.
In September 2022, our stockholders approved an
increase in the number of shares of common stock authorized for issuance under the 2020 Plan by 1,800,000 shares. As of March 31, 2023,
there were 1,667,479 shares available under the 2020 Plan.
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
The Company maintains the Director Compensation
Policy which provides cash and equity compensation for persons serving as non-employee directors of the Company. Under this policy, each
new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock options
or RSUs at the beginning of each fiscal year. The (i) stock options are subject to vesting and (ii) RSUs are subject to vesting and represent
the right to be issued on a future date shares of our common stock upon vesting.
Please see above under the heading "Equity
Transactions in the Fiscal Year Ended March 31, 2023—RSU Grants to Non-Employee Directors" for disclosure regarding equity
awards under the Director Compensation Policy during the fiscal year ended March 31, 2023.
STOCK OPTION ACTIVITY
During the fiscal year ended March 31, 2023, we
issued stock option grants to two executives for the purchase of an aggregate of 266,888 shares of our common stock under our 2020 Plan.
The weighted-average exercise prices for the shares subject to the options is $ 0.95 per share, which exercise prices were based on the
fair market value of the common stock on the applicable grant dates. The shares subject to the options are subject to vesting over four
years, commencing on the grant dates, or Vesting Commencement Dates, 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.
Options outstanding that were vested as of March
31, 2023 and options that are expected to vest subsequent to March 31, 2023 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
755,531
$
2.45
7.74
Expected to vest
962,722
$
2.07
8.45
Total
1,718,253
F- 20
The following is a summary of the stock options
outstanding at March 31, 2023 and 2022 and the changes during the years then ended:
Schedule of stock option activity
Fiscal Year Ended March 31,
2023
2022
Options
Weighted
Average
Exercise Price
Options
Weighted
Average
Exercise Price
Outstanding, beginning of year
1,665,948
$
2.31
844,089
$
3.07
Granted
122,220
$
.95
941,188
$
2.48
Exercised
–
$
–
( 11,562
)
$
2.45
Cancelled/Forfeited
( 69,915
)
$
1.77
( 107,767
)
$
9.66
Outstanding, end of year
1,718,253
$
2.24
1,665,948
$
2.31
Exercisable, end of year
755,531
$
2.45
267,221
$
2.51
Weighted average estimated fair value of options granted
$
.92
$
2.41
The detail of the options outstanding and exercisable as of March 31,
2023 is as follows:
Detail of options outstanding and exercisable by exercise price
Options Outstanding
Options Exercisable
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Life (Years)
Weighted
Average
Exercise
Price
Number
Outstanding
Weighted
Average
Exercise
Price
$0.69 - $1.68
1,207,034
8.28 years
$
1.35
505,246
$
1.36
$2.45 - $5.17
508,654
8.05 years
$
3.91
247,720
$
3.77
$57.00 - $142.50
2,565
.85 years
$
91.09
2,565
$
91.09
1,718,253
755,531
We recorded stock-based compensation expense related
to RSU issuances and to options granted totaling $ 1,051,898 and $ 750,621 for the fiscal years ended March 31, 2023 and 2022, respectively.
These expenses were recorded as stock compensation included in payroll and related expenses in the accompanying consolidated statement
of operations for the years ended March 31, 2023 and 2022.
F- 21
Our total stock-based compensation for fiscal
years ended March 31, 2023 and 2022 included the following:
Schedule of stock-based compensation
Fiscal Year Ended
March 31, 2023
March 31, 2022
Vesting of restricted stock units
$ 175,000
$ 150,000
Vesting of restricted shares issued for services
–
16,500
Vesting of stock options
876,898
584,121
Total Stock-Based Compensation
$ 1,051,898
$ 750,621
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 fiscal year ended March 31, 2023 was insignificant.
On March 31, 2023, our outstanding stock options
had no intrinsic value since the closing price on that date of $ 0.38 per share was below the weighted average exercise price of our outstanding
stock options.
At March 31, 2023, there was approximately $ 1,877,000
of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of
2.3 years.
5. RELATED PARTY TRANSACTIONS
DUE TO RELATED PARTIES
Historically, certain of our officers and other
related parties have advanced us funds, agreed to defer compensation and/or paid expenses on our behalf to cover working capital deficiencies.
There were no such related party transactions during the fiscal year ended March 31, 2023, except that we had accrued unpaid Board fees
of $ 57,000 owed to our outside directors as of March 31, 2023.
Due to related parties were comprised of the following items:
Due to related parties
March 31, 2023
March 31, 2022
Accrued Board fees
$ 57,000
$ 55,750
Accrued vacation
157,221
99,992
Total due to related parties
$ 214,221
$ 155,742
6. OTHER CURRENT LIABILITIES
Other current liabilities were comprised of the following items:
Other Current Liabilities
March 31, 2023
March 31, 2022
Accrued professional fees
$ 588,592
$ 696,893
Total other current liabilities
$ 588,592
$ 696,893
F- 22
7. INCOME TAXES
For the years ended March 31, 2023 and 2022, we
had no income tax expense due to our net operating losses and 100% deferred tax asset valuation allowance.
At March 31, 2023 and 2022, we had net deferred
tax assets as detailed below. These deferred tax assets are primarily composed of capitalized research and development costs and tax net
operating loss carryforwards. Due to uncertainties surrounding our ability to generate future taxable income to realize these assets,
a 100% valuation allowance has been established to offset the net deferred tax assets.
Significant components of our net deferred tax
assets at March 31, 2023 and 2022 are shown below:
Schedule of deferred tax assets
YEAR ENDED MARCH 31,
2023
2022
Deferred tax assets:
Research and development credit carryforwards
$ 3,442,000
$ 3,442,000
Capitalized research and development costs
519,000
–
Net operating loss carryforwards (1)
24,158,000
22,039,000
Stock compensation
1,903,000
1,609,000
Total deferred tax assets
30,022,000
27,090,000
Total deferred tax liabilities
–
–
Net deferred tax assets
30,022,000
27,090,000
Valuation allowance for deferred tax assets
( 30,022,000 )
( 27,090,000 )
Net deferred tax assets
$ –
$ –
______________
(1)
Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss
carryforwards may be limited.
At March 31, 2023, we had tax net operating loss
carryforwards for federal and state purposes approximating $ 88 million and $ 80 million, portions of which began to expire in the year
2021.
The provision for income taxes on earnings subject
to income taxes differs from the statutory federal rate for the years ended March 31, 2023 and 2022 due to the following:
Provision for income taxes
2023
2022
Income taxes (benefit) at federal statutory rate of 21.00%
$ ( 2,526,000 )
$ ( 2,188,000 )
Tax effect on non-deductible expenses and credits
2,000
1,000
True up items
57,000
( 5,000 )
Expiration of net operating loss carryforwards (1)
353,000
593,000
Change in valuation allowance
2,114,000
1,599,000
Income Tax Expense (Benefit)
$ –
$ –
______________
(1)
Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited.
F- 23
ASC 740, “Income Taxes”, clarifies
the accounting for uncertainty in income taxes recognized in an entity's financial statements, and prescribes recognition thresholds and
measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return. Under ASC 740,
the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not
to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than
a 50% likelihood of being sustained. Additionally, ASC 740 provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. Our practice is to recognize interest and/or penalties related to income tax
matters in income tax expense. During the years ended March 31, 2023 and 2022, we did not recognize any interest or penalties relating
to tax matters.
At and for the years ended March 31, 2023 and
2022, management does not believe the Company has any uncertain tax positions. Accordingly, there are no unrecognized tax benefits at March
31, 2023 or March 31, 2022.
Our tax returns remain open for examination by
the applicable authorities, generally 3 years for federal and 4 years for state. We are currently not under examination by any taxing
authorities.
8. COMMITMENTS AND CONTINGENCIES
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
We have had the following material changes to
our contractual obligations and commitments outside the ordinary course of business during the fiscal year ended March 31, 2023:
LEASE COMMITMENTS
Office, Lab and Manufacturing Space 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 located at 11555 Sorrento Valley Road,
Suite 203, San Diego, California 92121 and 11575 Sorrento Valley Road, Suite 200, San Diego, California 92121, respectively. The agreement
carries a term of 63 months and we took possession of the office space effective October 1, 2021. We took possession of the laboratory
space effective January 1, 2022. In October 2021, we entered into another lease for approximately 2,655 square feet of space to house
our manufacturing operations located at 11588 Sorrento Valley Road, San Diego, California 92121. The term is for 55 months and we took
possession of the manufacturing space in August 2022. The current monthly base rent under the office and laboratory component of the lease
is $ 13,772 . The current monthly base rent under the manufacturing component of the lease is $ 12,080 .
During the fiscal year ended March 31, 2023, we
recorded a $ 625,471 right-of-use lease asset and associated lease liability related to the manufacturing space component of the lease
based on the present value of lease payments over the expected lease term of 55 months, discounted using our estimated incremental borrowing
rate of 4.25 %.
The office, lab and manufacturing leases are coterminous
with a remaining term of 48 months. The weighted average discount rate is 4.25 %.
As of our March 31, 2023 balance sheet, we have
a right-of-use lease asset of $ 1,151,909 .
The following table presents a maturity analysis
of expected undiscounted cash flows for operating leases on an annual basis for the next four fiscal years. All of our leases conterminously
expire during the fiscal year ending March 31, 2027.
Schedule of lease maturities
Fiscal Years Ended March 31,
2024
$ 314,493
2025
323,812
2026
333,462
2027
343,351
Total minimum lease payments
1,315,118
Less amount representing imputed interest
( 106,090 )
Present value of minimum lease payments
$ 1,209,028
F- 24
Mobile Clean Room
In addition, we rented a mobile clean room on
a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed.
The mobile clean room was located on leased land near our office and lab and we paid $ 2,000 per month for the right to locate it there.
We paid approximately $ 168,171 in total rent expense to lease the mobile clean room located on this space during the fiscal year ended
March 31, 2023. The arrangement was terminated in September 2022 and the mobile clean room was returned to the vendor that leased it to
us.
Overall, our rent expense, which is included
in general and administrative expenses, approximated $ 519,000
and $ 401,000 for the fiscal years
ended March 31, 2023 and 2022, 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.
9. SUBSEQUENT EVENTS
Management has evaluated events subsequent to
March 31, 2023 through the date that the accompanying consolidated financial statements were filed with the Securities and Exchange Commission
for transactions and other events which may require adjustment of and/or disclosure in such financial statements.
Sales Under 2022 ATM Agreement
Subsequent to March 31, 2023, we raised net proceeds
of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of 1,778,901 shares
of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement.
RSU GRANTS
In April 2023, the Compensation Committee approved,
pursuant to the terms of the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation Policy to each
of the three non-employee directors of the Company then serving on the Board. The Director Compensation Policy provides for a grant of
stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current directors then serving on the Board, and for a
grant of stock options or $75,000 worth of RSUs for a newly elected director, with each RSU priced at the average for the closing prices
for the five days preceding and including the date of grant, or $0.43 per share for the April 2023 RSU grants. As a result, in April 2023
the three eligible directors each was granted an RSU in the amount of 116,279 shares under the 2020 Plan. The RSUs are subject to vesting
in four equal installments, with 25% of the restricted stock units vesting on each of June 30, 2023, September 30, 2023, December 31,
2023, and March 31, 2024, subject in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such
dates. Vesting will terminate upon the director’s termination of Continuous Service prior to any vesting date.
F- 25