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 Interim
Chief Executive Officer and Chief Financial Officer (who is our principal executive officer and principal financial officer), to allow
timely decisions regarding required disclosures.
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 Interim Chief Executive
Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
57
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 Interim Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness
of our internal control over financial reporting as of March 31, 2024. 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 not effective as of March 31, 2024 due to the material weaknesses described below.
Description of Material Weaknesses
Based on such evaluation,
management identified a material weakness in the segregation of duties within our financial systems. Specifically, user access controls
were not sufficiently maintained to properly restrict both user and privileged access to financial applications within our accounting
software system to initiate, record and approve entries. Also noted that check stock was secured in an authorized signatory’s office.
It is difficult to design
and maintain appropriate segregation of duties in the initiation, recording, and approval of transactions within financial systems with
a limited number of personnel. This, coupled with management having not designed and maintained user access controls that adequately
restrict user and privileged access to financial applications, and the absence of sufficient other mitigating controls, created a segregation
of duties weakness which could potentially have resulted in a material misstatement. Management has identified remediation actions that
may require the addition of personnel to the finance and accounting function or a change in accounting software, which will allow the
Company to design the control environment in a manner that provides effective segregation of duties. Management has identified certain
actions beyond staff changes or accounting software changes. As of May 2024, the accounting software was updated, and distinct user roles
were created. Transactions are recorded by personnel who are independent of those who initiate them and are approved by separate personnel
who are independent of those who record them. Additionally, check stock was relocated in November 2023.
During 2017 through 2020,
the Company incorrectly recorded accrued commission liability of approximately $404,000. The Company reversed accrued commission liability
of approximately $404,000 during the year ended March 31, 2024 related to this error in accounting under U.S. GAAP. The Company originally
failed to correctly apply appropriate accounting principles in recording the transaction, and the error was not detected and corrected
in a timely manner, resulting in an adjustment to the financial statements.
Management has discussed with counsel appropriate
measures to record such potential commission liabilities in the future and will implement a quarterly review of all accruals. The reversal
of the accrued commission liability into equity as of March 31, 2024 corrected the impact of the error. The Company is in the process
of implementing quarterly review controls over review and assessment of accruals. This plan, with oversight from our Audit Committee,
is in the process of implementation in response to the identified material weakness.
Limitation on Effectiveness of Controls
In designing and evaluating our
disclosure controls and procedures, management recognized that any disclosure controls and procedures, no matter how well designed and
operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. No evaluation of internal
control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.
In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. There are inherent limitations to the effectiveness of any system of disclosure controls
and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. In addition,
the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be
no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may
become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of
the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
(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, 2024 that has materially affected, or is reasonably likely
to materially affect, our internal control over financial reporting.
58
ITEM 9B. OTHER INFORMATION
On June 27, 2024, we received
a letter, or Notice, from The Nasdaq Stock Market, or Nasdaq, advising us that for 31 consecutive trading days preceding the date of the
Notice, the bid price of our common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital
Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement. The Notice has no effect on the listing of our
common stock at this time, and our common stock continues to trade on The Nasdaq Capital Market under the symbol “AEMD.”
In accordance with Nasdaq
Listing Rule 5810(c)(3)(A), we have 180 calendar days to regain compliance with the Minimum Bid Requirement, or the Grace Period, subject
to a potential 180 calendar day extension, as described below. To regain compliance, the closing bid price of our common stock must be
at least $1.00 per share for a minimum of ten consecutive business days within the Grace Period.
If we do not achieve compliance
with the Minimum Bid Requirement by December 24, 2024, the end of the Grace Period, we may be eligible for an additional 180 calendar
day period to regain compliance. To qualify, we would be required to meet the continued listing requirement for the market value of our
publicly held shares and all other Nasdaq initial listing standards, with the exception of the bid price requirement, and would need to
provide written notice of our intention to cure the deficiency during the second compliance period. However, if it appears to Nasdaq staff
that we will not be able to cure the deficiency, or if we do not meet the other listing standards, Nasdaq could provide notice that our
common stock will be subject to delisting. In the event we receive notice that our common stock is being delisted, we would be entitled
to appeal the determination to a Nasdaq Listing Qualifications Panel and request a hearing.
We intend to monitor the closing
bid price of our common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid
Price Requirement.
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 2024 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.
We maintain a Code of Business
Conduct and Ethics that applies to all our employees, officers and directors. This includes our principal executive officer, principal
financial officer and principal accounting officer or controller, or persons performing similar functions. The full text of our Code of
Business Conduct and Ethics is posted on our website at www.aethlonmedical.com on the “Governance” page of the section titled
“Investors.” If we make any substantive amendments to the Code of Business Conduct and Ethics or grant any waiver from a provision
of the Code of Business Conduct and Ethics to any executive officer or director that are required to be disclosed pursuant to SEC rules,
we will promptly disclose the nature of the amendment or waiver on our website or in a current report on Form 8-K. Information contained
in, or that can be accessed through, our website is not incorporated by reference herein, and you should not consider information on our
website to be part of this Annual Report.
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
Form of Class A Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.1
May 17, 2024
4.6
Form of Class B Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.2
May 17, 2024
4.7
Form of Pre-Funded Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.3
May 17, 2024
4.8
Form of Placement Agent Warrant to Purchase Common Stock, issued on May 17, 2024.
8-K
001-37487
4.4
May 17, 2024
4.9
Description of Aethlon Medical, Inc.’s Securities.
10-K
001-37487
4.16
June 25, 2020
61
Incorporated by Reference
Exhibit
Number
Exhibit
Description
Form
SEC
File No.
Exhibit
No.
Date
Filed Herewith
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++
Amendment No. 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and James B. Frakes.
8-K
001-37487
10.1
December 22, 2023
10.4++
Form of Indemnification Agreement for Officers and Directors.
10-Q
001-37487
10.4
February 11, 2019
10.5++
Form of Option Grant Agreement for Officers and Directors.
10-Q
001-37487
10.5
February 11, 2019
10.6++
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for Directors.
10-Q
001-37487
10.6
February 11, 2019
10.7++
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement for Executives.
10-Q
001-37487
10.7
February 11, 2019
10.8
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
10.9++
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
10.10++
Employment Agreement between the Company and Dr. Fisher, dated October 30, 2020.
8-K
001-37487
10.2
November 3, 2020
10.11++
Separation Agreement between the Company and Dr. Fisher, effective as of November 27, 2023.
8-K
001-37487
10.1
November 27, 2023
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
62
Incorporated by Reference
Exhibit
Number
Exhibit
Description
Form
SEC
File No.
Exhibit
No.
Date
Filed Herewith
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++
Amendment No. 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and Guy F. Cipriani.
8-K
001-3748 7
10.2
December 22, 2023
10.15++
Executive Employment Agreement between the Company and Steven P. LaRosa, MD, dated January 4, 2021.
10-Q
001-37487
10.6
February 10, 2021
10.16++
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
10.17
Lease between Aethlon Medical, Inc. and San Diego Inspire 5, LLC, effective October 27, 2021.
10-Q
001-37487
10.1
November 9, 2021
10.18
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
10.19++
Amendment No. 1 to Executive Employment Agreement, by and between Aethlon Medical, Inc. and Lee D. Arnold, Ph.D., dated May 1, 2023.
10-K
001-37487
10.18
June 28, 2023
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 and Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
X
32.1*
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350.
X
63
Incorporated by Reference
Exhibit
Number
Exhibit
Description
Form
SEC
File No.
Exhibit
No.
Date
Filed Herewith
97.1
Incentive Compensation Recoupment Policy.
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.
*
The information in Exhibit 32.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act (including this Annual Report), unless the Registrant specifically incorporates the foregoing information into those documents by reference.
ITEM 16. FORM 10-K SUMMARY
None.
64
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 27 th d ay of
June, 2024.
By:
/s/ JAMES B. FRAKES
JAMES B. FRAKES
INTERIM CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER.
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person
whose signature appears below constitutes and appoints James B. Frakes 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 attorney-in-fact and agent 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 attorney-in-fact and agent 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/ JAMES B. FRAKES
Interim Chief Executive Officer and Chief Financial Officer, Principal Executive Officer, Principal Financial and Accounting Officer and Director
June 27, 2024
James B. Frakes
/s/ EDWARD G. BROENNIMAN
Chairman and Director
June 27, 2024
Edward G. Broenniman
/s/ CHETAN S. SHAH
Director
June 27, 2024
Chetan S. Shah, M.D.
/s/ ANGELA ROSSETTI
Director
June 27, 2024
Angela Rossetti
/s/ NICOLAS GIKAKIS
Director
June 27, 2024
Nicolas Gikakis
65
Page
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (Baker Tilly US, LLP, San Diego, CA PCAOB ID No. 23 )
F-2
Consolidated Balance Sheets as of March 31, 2024 and 2023
F-3
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended March 31, 2024 and 2023
F-4
Consolidated Statements of Equity for the Years Ended March 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the Years Ended March 31, 2024 and 2023
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, 2024 and 2023, the related consolidated statements of
operations and comprehensive loss, 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, 2024 and 2023, 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.
Going Concern Uncertainty
The accompanying consolidated financial statements
have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 of the consolidated financial statements,
the Company has recurring losses from operations, an accumulated deficit, expects to incur losses for the foreseeable future and requires
additional working capital. These are the reasons that raise substantial doubt about the Company’s ability to continue as a going
concern. Management’s plans in regard to these matters are also described in Note 1. The consolidated financial statements do not
contain any adjustments that might result from the outcome of this uncertainty.
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.
/s/ Baker Tilly US, LLP
We have served as the Company's auditor since 2001.
San Diego, California
June 27, 2024
F- 2
AETHLON MEDICAL, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
March 31,
2024
2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 5,441,978
$ 14,532,943
Deferred offering costs
277,827
–
Prepaid expenses and other current assets
505,983
557,623
TOTAL CURRENT ASSETS
6,225,788
15,090,566
Property and equipment, net
1,015,229
1,144,004
Right-of-use lease asset, net
883,054
1,151,909
Patents, net
1,100
1,650
Restricted cash
87,506
87,506
Deposits
33,305
33,305
TOTAL ASSETS
$ 8,245,982
$ 17,508,940
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable
$ 777,862
$ 432,889
Due to related parties
546,434
214,221
Lease liability, current portion
290,565
269,386
Other current liabilities
215,038
588,592
TOTAL CURRENT LIABILITIES
1,829,899
1,505,088
Lease liability, less current portion
649,751
939,642
TOTAL LIABILITIES
2,479,650
2,444,730
COMMITMENTS AND CONTINGENCIES (Note 8)
–
–
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 60,000,000 shares authorized at March 31, 2024 and 2023; 2,629,725 and 2,299,259 shares issued and outstanding at March 31, 2024 and 2023, respectively
2,629
2,299
Additional paid-in capital
160,337,371
157,426,606
Accumulated other comprehensive loss
( 6,940 )
( 6,141 )
Accumulated deficit
( 154,566,728 )
( 142,358,554 )
TOTAL AETHLON MEDICAL, INC. STOCKHOLDERS’ EQUITY BEFORE NONCONTROLLING INTERESTS
5,766,332
15,064,210
TOTAL STOCKHOLDERS’ EQUITY
5,766,332
15,064,210
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 8,245,982
$ 17,508,940
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,
2024
2023
REVENUES:
Government contract and grant revenue
$ –
$ 574,245
Total revenues
–
574,245
OPERATING COSTS AND EXPENSES
Professional fees
3,526,926
3,548,028
Payroll and related expenses
5,206,451
4,443,552
General and administrative
3,903,191
4,481,303
Total operating expenses
12,636,568
12,472,883
OPERATING LOSS
( 12,636,568 )
( 11,898,638 )
OTHER EXPENSE (INCOME)
Loss on dissolution of subsidiary
–
142,121
Interest income and other
( 428,394 )
( 10,973 )
Other expense (income)
( 428,394 )
131,148
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
( 12,208,174 )
( 12,029,786 )
Basic and diluted net loss per share attributable to common stockholders
$ ( 4.86 )
$ ( 5.86 )
Weighted average number of common shares outstanding - basic and diluted
2,512,774
2,053,744
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
( 12,208,174 )
( 12,029,786 )
OTHER COMPREHENSIVE LOSS
( 799 )
( 6,141 )
COMPREHENSIVE LOSS
$ ( 12,208,973 )
$ ( 12,035,927 )
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, 2024 AND 2023
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, 2022
1,541,926
$ 1,542
$ 147,460,747
$ ( 130,329,181 )
$ –
$ ( 141,708 )
$ 16,991,400
Issuances of common stock for cash
under at the market program
748,084
748
8,926,463
–
–
–
8,927,211
Issuance of common shares upon vesting
of restricted stock units and net stock option exercise
9,249
9
( 12,502 )
–
–
–
( 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
2,299,259
$ 2,299
$ 157,426,606
$ ( 142,358,554 )
$ ( 6,141 )
$ –
$ 15,064,210
Issuances of common stock for cash
under at the market program
296,056
296
1,322,087
–
–
–
1,322,383
Rounding for reverse split
32
–
–
–
–
–
–
Issuance of common shares upon vesting
of restricted stock units
34,378
34
( 34,812 )
–
–
–
( 34,778 )
Reversal of accrued commission liability
(see Note 6)
–
–
404,120
–
–
–
404,120
Stock-based compensation expense
–
–
1,219,370
–
–
–
1,219,370
Net loss
–
–
–
( 12,208,174 )
–
–
( 12,208,174 )
Other comprehensive loss
–
–
–
–
( 799 )
–
( 799 )
BALANCE - MARCH 31, 2024
2,629,725
$ 2,629
$ 160,337,371
$ ( 154,566,728 )
$ ( 6,940 )
$ –
$ 5,766,332
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, 2024 AND 2023
Years Ended March 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 12,208,174 )
$ ( 12,029,786 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
359,057
240,892
Stock-based compensation
1,219,370
1,051,898
Loss on disposal of property, plant and equipment
21,135
–
Loss on dissolution of Subsidiary
–
142,121
Non-cash lease expense
143
24,408
Changes in operating assets and liabilities:
Accounts receivable
–
127,965
Prepaid expenses and other current assets
( 10,232 )
398,169
Accounts payable and other current liabilities
156,678
( 174,727 )
Deferred revenue
–
( 344,547 )
Due to related parties
332,213
58,479
Net cash used in operating activities
( 10,129,810 )
( 10,505,128 )
Cash flows from investing activities:
Purchases of property and equipment
( 250,867 )
( 943,109 )
Net cash used in investing activities
( 250,867 )
( 943,109 )
Cash flows from financing activities:
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units
( 34,778 )
( 12,493 )
Net proceeds from the issuance of common stock
1,322,383
8,927,211
Net cash provided by financing activities
1,287,605
8,914,718
Effect of Exchange Rate on Changes on Cash
2,107
( 5,957 )
Net decrease in cash and restricted cash
( 9,090,965 )
( 2,539,476 )
Cash and restricted cash at beginning of year
14,620,449
17,159,925
Cash and restricted cash at end of year
$ 5,529,484
$ 14,620,449
Supplemental information of non-cash investing and financing activities:
Initial recognition of right-of-use lease asset and lease liability
$ –
$ 625,471
Issuance of shares under vested restricted stock units, net stock option exercises and unvested share issuance for services
$ 35
$ 92
Reversal of accrued commission liability (see Note
6)
$ 404,120
$ –
Deferred offering costs not yet paid
$ 219,117
$ –
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets:
Cash and cash equivalents
$ 5,441,978
$ 14,532,943
Restricted cash
87,506
87,506
Cash and restricted cash
$ 5,529,484
$ 14,620,449
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 the Hemopurifier, a clinical-stage immunotherapeutic device designed to
combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, 164 sessions with 38 patients,
the Hemopurifier was safely utilized and demonstrated the potential to remove life-threatening viruses. In pre-clinical studies, the Hemopurifier
has demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary lectin-based
technology. This action has potential applications in cancer, where exosomes and exosomal particles may promote immune suppression and
metastasis, and in life-threatening infectious diseases. 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.
Oncology
We believe the Hemopurifier may be a substantial advancement
in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes and exosomal
particles that promote the growth and spread of tumors. In October 2022, we formed a wholly-owned subsidiary in Australia to initially
conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia. We are currently
working with our contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid
tumors, including head and neck cancer, and gastrointestinal cancers.
In January 2023, we entered into an agreement with
North American Science Associates, LLC, or NAMSA, a world leading medical technology CRO offering global end-to-end development services,
to oversee our planned clinical trials investigating the Hemopurifier for oncology indications. Pursuant to the agreement, NAMSA agreed
to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer
tumors.
We recently completed an in vitro binding study of relevant oncology
targets, to provide pre-clinical evidence to support our trial design and translational endpoints. Our study indicated positive results
from this study, providing evidence that our Hemopurifier removes extracellular vesicles, or EVs, from plasma. This translational study
provides pre-clinical evidence to support our planned phase 1 safety, feasibility and dose-finding clinical trials of our Hemopurifier
in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or
Opdivo®. In addition to an interested initial trial site in India, we had three interested sites in Australia that were awaiting our
completion of this in vitro binding study. We added the data from this study to our Clinical Investigator Brochure and submitted
that brochure to the Ethics Committee of Royal Adelaide Hospital in Australia and in June 2024, we received approval for our proposed
phase 1 oncology trial from the Ethics Committee from Royal Adelaide Hospital. We are currently in the process of applying to the Ethics
Committees of the two additional interested clinical trial sites in Australia and the site in India.
F- 7
Life-Threatening Viral Infections
We also believe that 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, 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.
We believe the Hemopurifier can be part of the treatment of severe SARS-CoV-2
viremia/COVID-19, or COVID-19, cases. COVID viremia is detected in approximately 34% of patients and is associated with severity, requirement
for intensive care unit, or ICU, stay, development of multi-organ failure and poor outcomes. EVs and exosomal miRNAs may play a role in
the spread of infection as well as ongoing inflammation, development of coagulopathy and lung injury. Our proprietary Galanthus nivalis
agglutinin, or GNA, affinity resin has been shown to bind multiple clinically relevant SARS-CoV-2 variants. Furthermore, studies have
demonstrated in vitro removal of seven SARS-CoV2 variants (104 PFU/mL) in phosphate buffered saline passed over a column of GNA
affinity resin (1g) three times, with capture efficiencies between 53% and 89%.
On June 17, 2020, the FDA approved a supplement to
our open Investigational Device Exemption, or IDE, for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier
in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study. That study was designed to enroll up to 40 subjects at
up to 20 centers in the United States. Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an intensive
care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria. Endpoints for this study,
in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903). In January 2021, the Hemopurifier
was used to treat a viremic patient, under our emergency use approval, with a predicted risk of mortality of 80% and the Hemopurifier
was able to reduce the patient’s SARS-CoV-2 plasma viral load by 58.4%. In June 2022, the first patient in this study was enrolled
and completed the Hemopurifier treatment phase of the protocol. Due to the lack of COVID-19 patients in the ICUs of our trial sites, we
terminated this study in 2022. However, our IDE for this indication remains open, as we have an active COVID-19 trial in India and wish
to preserve the option of enrolling patients if the situation with COVID-19 changes.
Under Single Patient
Emergency Use regulations, Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated
with our Hemopurifier in our COVID-19 clinical trial discussed above .
We previously reported a disruption in our Hemopurifier supply, as our
then existing supply of Hemopurifiers expired on September 30, 2022 and, also as previously disclosed, we are dependent on FDA approval
of qualified suppliers to manufacture our Hemopurifier. We recently completed final testing in order to begin manufacturing Hemopurifiers
at our new manufacturing facility in San Diego, California for use in planned U.S. clinical trials, using GNA from our current supplier.
In April 2024, we received a notice of approval from the FDA for our IDE supplement to add our San Diego manufacturing facility and we
now are able to manufacture Hemopurifiers at this site. We also have sufficient Hemopurifiers on hand for use in our planned Australia
and India oncology trials. Our intended transition to a new supplier for GNA, a component of our Hemopurifier, continues to be delayed
as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing supplier change. We are
working with the FDA to qualify this second supplier of our GNA.
We also obtained ethics review board, or ERB, approval from and entered
into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical
trial at that location.
F- 8
In May 2023, we received ERB approval from the MAMC, for a second site
for our clinical trial in India to treat severe COVID-19. MAMC was established in 1958 and is located in New Delhi, India. MAMC is affiliated
with the University of Delhi and is operated by the Delhi government.
We now have two sites in India for this trial with the Medanta Medicity
Hospital and Maulana Azad Medical College, or MAMC. One patient has been treated to date; however, we have been informed by our CRO that
a new COVID-19 subvariant was detected in India recently. Our COVID-19 trial in India remains open in the event that there are COVID-19
admissions to the ICUs at our sites in India.
Organ Transplantation
Additionally, based on preclinical data with acellular
kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation. We are investigating whether
the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
cytokines, chemokines and other inflammatory molecules from recovered organs. We initially are focused on recovered kidneys from deceased
donors. We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in
vitro , utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation complications by
improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation, and potentially
reducing the number of kidneys rejected for transplant.
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 to us more recently will help protect the proprietary nature of our Hemopurifier treatment technology.
In addition to the foregoing, we are monitoring closely
the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding
areas, as well as related political and economic responses and counter-responses by various global factors on our business. Given the
level of uncertainty regarding the duration and impact of these events on capital markets and the U.S. economy, we are unable to assess
the impact on our timelines and future access to capital. The full extent to which inflation, recent bank failures and the ongoing military
conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on
future developments, as well as the economic impact on national and international markets that are highly uncertain.
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.
The information contained on, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report
on Form 10-K.
.
Our common stock is listed on the Nasdaq Capital Market
under the symbol “AEMD.”
LIQUIDITY AND GOING CONCERN
The Company has incurred losses since inception in devoting substantially
all of its efforts toward research and development and has an accumulated deficit of $ 154,566,728 as of March 31, 2024. During the year
ended March 31, 2024, the Company generated a net loss of approximately $ 12,208,000 and the Company expects that it will continue to generate
operating losses for the foreseeable future. While the Company currently has over $ 9.1 million in cash and cash equivalents and have been
carrying out certain expense reductions since November 2023; our planned additional expense reductions may not materialize and/or our
patient recruitment may occur more rapidly than expected along with the concomitant increases in expenses, therefore there is substantial
doubt that our cash on hand will carry the company for 12 months beyond the filing date of the financial statements included in this Annual
Report.
F- 9
The Company’s ability to execute its current operating plan depends
on its ability to reduce expenses and obtain additional funding via the sale of equity, or other sources of capital. The Company plans
to continue actively pursuing financing alternatives, however, there can be no assurance that it will obtain the necessary funding, raising
substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements
are issued. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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. Operations in our Australian subsidiary is recorded in their functional
currency. The results of operations for our Australian subsidiary are translated from functional currency into U.S. dollars using the
current exchange rate on the date the expense was recognized. Assets and liabilities are translated using the period end exchange rates.
The U.S dollar effects that arise from translating the net assets of are recorded in other comprehensive income (loss). 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, 2024 and 2023, and the consolidated statement of cash flows for the fiscal years ended
March 31, 2024 and 2023.
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.
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.
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.
F- 10
For the fiscal years ended March 31, 2024 and March
31, 2023 our cash and cash equivalents were comprised of the following instruments:
Schedule of cash and cash equivalents
For the year ended
March 31,
2024
March 31,
2023
Cash in US bank checking account
$ 697,908
$ 575,766
Cash equivalents held in US Treasury bills
4,736,469
13,910,973
Cash in Australian bank checking account
7,601
46,204
Total cash and cash equivalents
$ 5,441,978
$ 14,532,943
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, 2024 cash balances were approximately $ 568,000 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,
2024, we maintained cash equivalents of approximately $ 4.7 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, 2024 Australian cash balance was below that threshold.
We did not have any revenue in fiscal year ended March
31, 2024. All of our revenue in the fiscal year ended March 31, 2023 related to our government contracts. We did not have any accounts
receivable at March 31, 2024.
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.
F- 11
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. Management has provided a full valuation allowance against the Company’s net deferred
tax asset. Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine
whether the tax positions are more-likely-than-not to be sustained by the applicable tax authority. Tax positions deemed to not meet a
more-likely-than-not threshold would be recorded as tax expense in the current year. There were no uncertain tax positions that require
accrual to or disclosure in the consolidated financial statements as of March 31, 2024 and 2023.
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, 2024 and 2023.
LOSS PER SHARE
Basic loss per share is computed by dividing net loss
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, 2024 and 2023, a total of 124,028
and 204,501 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 OFFERING COSTS
Specific incremental costs directly attributable to
an actual offering of securities may be deferred and charged against the gross proceeds of the offering. As of March 31, 2024, approximately
$ 278,000 of costs have been deferred.
REVENUE RECOGNITION
We did not recognize revenue in fiscal year ended
March 31, 2024. Our revenues in the fiscal year ended March 31, 2023 consisted entirely of amounts earned under contracts and grants with
the National Institutes of Health, or NIH. During the fiscal year ended March 31, 2023, we recognized revenues totaling $ 574,245 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.
F- 12
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.
We have recognized revenue under the following contract/grant:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the National Cancer Institute,
or NCI, part of the NIH, awarded to us a 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.
F- 13
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
$ 574,245 in fiscal year ended March 31, 2023.
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, 2024 and 2023:
Schedule of share-based compensation expenses
Fiscal Years Ended
March 31, 2024
March 31, 2023
Vesting of Stock Options and Restricted Stock Units
$ 1,219,370
$ 1,051,898
Total Stock-Based Compensation Expense
$ 1,219,370
$ 1,051,898
Weighted average number of common shares outstanding – basic and diluted
2,512,774
2,053,744
Basic and diluted loss per common share
$ ( 0.49 )
$ ( 0.51 )
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.
F- 14
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, 2024 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 $ 2,520,000 and $ 2,745,000 of research and development expenses for the years ended March 31, 2024
and 2023, 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.
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS
In December 2023, the FASB issued Accounting Standards
Update 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced annual disclosures for specific
categories in the rate reconciliation and income taxes paid disaggregated by federal, state and foreign taxes. ASU 2023-09 is effective
for public business entities for annual periods beginning after December 15, 2024. The Company is evaluating if the adoption of this new
standard will have a material effect on our disclosures.
In June 2016, the FASB issued ASU No. 2016-13, Financial
Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The adoption of ASU No. 2016-13 for smaller
reporting companies that did not previously early adopt was January 1, 2023. The Company maintained
US Treasury bills with maturities of less than three months and expects zero credit losses from these securities. As a result,
the Company did not record an allowance for expected credit losses.
F- 15
2. PROPERTY AND EQUIPMENT, NET
Property and equipment, net, consist of the following:
Schedule of property and equipment, net
March 31, 2024
March 31, 2023
Furniture and office equipment, at cost
$ 1,112,648
$ 989,987
Leasehold improvements
893,131
888,224
Accumulated depreciation
( 990,550 )
( 734,207 )
Fixed Assets, net
$ 1,015,229
$ 1,144,004
Depreciation expense for the fiscal years ended March 31, 2024 and 2023
was $ 358,507 and $ 240,342 , respectively.
3. PATENTS, NET
Patents, net consist of the following:
Schedule of patents, net
March 31, 2024
March 31, 2023
Issued patents
$ 157,442
$ 157,442
Accumulated amortization
( 156,342 )
( 155,792 )
Issued patents, net of accumulated amortization
1,100
1,650
Patents, net
$ 1,100
$ 1,650
Amortization expense for our capitalized issued patents
for each of the fiscal years ended March 31, 2024 and 2023 was $ 550 . 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 2.0 years.
4. EQUITY TRANSACTIONS
REVERSE
STOCK SPLIT
On
October 4, 2023, we effected a 1-for-10 reverse stock split of our then outstanding shares of common stock. Accordingly, each
10 shares of outstanding common stock then held by our stockholders were combined into one share of common stock. Any fractional shares
resulting from the reverse split were rounded up to the next whole share. Authorized common stock remained at 60,000,000 shares
following the stock split. The accompanying consolidated financial statements and accompanying notes have been retroactively revised to
reflect such reverse stock split as if it had occurred on April 1, 2022. All shares and per share amounts have been revised accordingly.
ISSUANCES OF COMMON STOCK AND WARRANTS
Equity Transactions in the Fiscal Year Ended March 31, 2024.
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.
F- 16
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, or the 2022 ATM Shares, having
an aggregate offering price of up to $ 15,000,000 , which was subsequently and most recently updated pursuant to our prospectus supplement,
dated September 29, 2022, filed with the SEC that provides for the sale of 2022 ATM Shares having an aggregate offering price of up to
$ 6,625,000 . As of March 31, 2024, $ 5,302,617 of 2022 ATM Shares remained available for sale under the 2022 ATM Agreement.
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 further 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, 2024, we raised
aggregate net proceeds of $ 1,322,383 net of $ 34,118 in commissions to Wainwright and $ 8,202 in other offering expense, through the sale
of 296,056 shares of our common stock at an average price of $ 4.47 per share under the 2022 ATM Agreement.
RSU Grants to Non-Employee Directors
In
April 2023, the Compensation Committee of the Board, or Compensation Committee, approved, 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 under
the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board of Directors of
the Company, or 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 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 non-employee director, with each RSU priced at the average for the closing prices for the five days preceding
and including the date of grant, or $4.30 per share for the April 2023 RSU grants. As a result, in April 2023 the three eligible directors
were each granted an RSU in the amount of 11,628 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.
Unvested RSUs covering 4,885
shares of common stock were outstanding as of March 31, 2024.
Equity Transactions in the Fiscal Year Ended March 31, 2023.
During 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 748,084
shares of our common stock at an average price of $ 11.90 per share under the 2022 ATM Agreement.
F- 17
RSU Grants to Non-Employee Directors
The Compensation
Committee approved, effective as of April 1, 2022, pursuant to the terms of 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, and the grant of an RSU for the then
newly appointed non-employee 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 non-employee director, with each RSU priced at the average for the closing prices for
the five days preceding and including the date of grant, or $14.60 per share as of April 1, 2022. The two then-current eligible
directors each was granted a contingent RSU in the amount of 3,425 shares
under the 2020 Plan and the then newly appointed director received a contingent RSU grant for 5,137 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.
There were no vested RSUs outstanding as of
March 31, 2023.
WARRANTS:
We did not issue any warrants during the fiscal years
ended March 31, 2024 and 2023.
A summary of the aggregate warrant activity for the years ended March 31,
2024 and 2023 is presented below:
Schedule of warrant activity
Fiscal Year Ended March 31,
2024
2023
Warrants
Weighted
Average
Exercise Price
Warrants
Weighted
Average
Exercise Price
Outstanding, beginning of year
32,676
$
20.09
57,678
$
112.11
Granted
–
$
N/A
–
$
N/A
Exercised
–
$
N/A
–
$
N/A
Cancelled/Forfeited
–
$
N/A
( 25,002
)
$
232.38
Outstanding, end of year
32,676
$
20.09
32,676
$
20.09
Exercisable, end of year
32,676
$
20.09
32,676
$
20.09
Weighted average estimated fair value of warrants granted
$
N/A
$
N/A
F- 18
The detail of the warrants outstanding and exercisable as of March 31,
2024 is as follows:
Schedule 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
$18.75 or Below
20,217
.71
$
15.66
20,217
$
15.66
$25.00 - $27.50
12,459
.81
$
27.28
12,459
$
27.28
32,676
32,676
The detail of the warrants outstanding and exercisable as of March 31,
2023 is as follows:
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
$18.75 or Below
20,217
1.71
$
15.66
20,217
$
15.66
$25.00 - $27.50
12,459
1.81
$
27.28
12,459
$
27.28
32,676
32,676
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 168,182 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 180,000 shares. As of March 31, 2024, there were
200,948 shares available under the 2020 Plan.
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
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 non-employee 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.
F- 19
Please see above under the heading "Equity Transactions
in the Fiscal Year Ended March 31, 2024—RSU Grants to Non-Employee Directors" for disclosure regarding equity awards under
the Director Compensation Policy during the fiscal year ended March 31, 2024.
STOCK OPTION ACTIVITY
During the fiscal year ended March 31, 2024, we
did not issue stock option grants. The assumptions used in estimating the fair value of stock options in the fiscal year ended
March 31, 2023 included volatility ranging from 136.1 %
to 140 %,
a 0 %
dividend rate, and risk-free rates between 1.49 %
and 2.14 %.
The weighted average expected volatility was 138.07 %
Options outstanding that were vested as of March 31,
2024 and options that are expected to vest subsequent to March 31, 2024 are as follows:
Schedule of options outstanding that have vested and are expected to
vest
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term in
Years
Vested
57,813
$
19.41
6.96
Expected to vest
28,653
$
15.01
7.78
Total
86,466
The following is a summary of the stock options outstanding
at March 31, 2024 and 2023 and the changes during the years then ended:
Schedule of stock option activity
Fiscal Year Ended March 31,
2024
2023
Options
Weighted
Average
Exercise Price
Options
Weighted
Average
Exercise Price
Outstanding, beginning of year
171,825
$ 22.4
166,595
$ 23.1
Granted
–
$ –
12,222
$ 9.50
Cancelled/Forfeited
( 85,359 )
$ 26.89
( 6,992 )
$ 17.70
Outstanding, end of year
86,466
$ 17.95
171,825
$ 22.4
Exercisable, end of year
57,813
$ 19.41
75,554
$ 24.5
Weighted average estimated fair value of options granted
$ N/A
$ N/A
There were no stock option grants during the fiscal year ended March 31,
2024. There were 12,222 stock options granted during the fiscal year ended March 31, 2023. The weighted average grant date fair value
of stock options granted during the fiscal year ended March 31, 2023 was $ 61,146 . There were 54,428 RSUs granted during the fiscal year ended
March 31, 2024. The weighted average grant date fair value of RSUs granted during the fiscal year ended March 31, 2024 was $ 58,333 . There
were no stock option exercises during the fiscal years ended March 31, 2024 and 2023.
F- 20
The table below summarizes nonvested stock options as of March
31, 2024 and changes during the year ended March 31, 2024.
Schedule of nonvested shares
Shares
Weighted Average Grant Date Fair Value
Nonvested stock options at April 1, 2023
96,273
$ 19.99
Vested
( 21,934 )
$ 1.59
Forfeited
( 45,686 )
$ 2.55
Nonvested stock options at March 31, 2024
28,653
The detail of the options outstanding and exercisable as of March 31, 2024
is as follows:
Schedule of 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
$6.90 - $16.80
62,204
7.48 years
$
13.24
38,589
$
13.48
$25.20
24,178
6.76 years
$
25.20
19,140
$
25.20
$1,425.00
84
.18 years
$
1,425.00
84
$
1,425.00
86,466
57,813
We recorded stock-based compensation expense related
to RSU issuances and to options granted totaling $ 1,219,370 and $ 1,051,898 for the fiscal years ended March 31, 2024 and 2023, 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, 2024 and 2023.
The table below summarizes restricted stock units
as of March 31, 2024 and changes during the year ended March 31, 2024.
Schedule of RSUs
Shares
Nonvested RSUs at April 1, 2023
–
Granted
54,428
Vested
( 34,378 )
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units
( 15,165 )
Nonvested RSUs at March 31, 2024
4,885
Our total stock-based compensation for fiscal years
ended March 31, 2024 and 2023 included the following:
Schedule of stock-based compensation
Fiscal Year Ended
March 31, 2024
March 31, 2023
Vesting of restricted stock units
$ 206,250
$ 175,000
Vesting of stock options
1,013,120
876,898
Total Stock-Based Compensation
$ 1,219,370
$ 1,051,898
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, 2024 was insignificant.
On March 31, 2024, our outstanding stock options had
no intrinsic value since the closing price on that date of $ 1.68 per share was below the weighted average exercise price of our outstanding
stock options.
At March 31, 2024, there was approximately $ 400,002
of unrecognized compensation cost related to share-based payments, which is expected to be recognized over a weighted average period of
1.57 years.
F- 21
5. RELATED PARTY TRANSACTIONS
DUE TO RELATED PARTIES
For the fiscal year ended
March 31, 2024 we accrued unpaid fees of $ 68,250 owed to our non-employee directors.
As a result of entering
into a Separation Agreement effective November 27, 2023 with our former Chief Executive Officer, or CEO, Charles J. Fisher, M.D., or
the Separation Agreement, we paid out accrued vacation of $ 53,076
to Dr. Fisher in the fiscal year ended March 31, 2024. That accrued vacation was previously recorded in the due to related parties
account. In addition, pursuant to the terms of Dr. Fisher’s Executive Employment Agreement, we accrued $ 435,378 for
cash severance payments payable monthly and COBRA payments to be paid monthly over a 12-month period that began on December 1,
2023.
Additionally, $ 393,139
of stock-based compensation was recorded during the fiscal year ended March 31, 2024 for the acceleration of vesting for 50% of then outstanding
options held by Dr. Fisher at the time of his separation from the Company.
Amounts
due to related parties were comprised of the following items:
Schedule of amounts
due to related parties
March 31,
2024
March 31,
2023
Accrued Board fees
$ 68,250
$ 57,000
Accrued vacation to all employees
167,973
157,221
Accrued separation expenses for former executive
310,211
–
Total due to related parties
$ 546,434
$ 214,221
6. OTHER CURRENT LIABILITIES
Other current liabilities were comprised of the following items:
Schedule of other current liabilities
March 31, 2024
March 31, 2023
Accrued professional fees
$ 215,038
$ 184,472
Accrued commission liability
–
404,120
Total other current liabilities
$ 215,038
$ 588,592
During 2017 through 2020, the Company incorrectly
recorded accrued commission liability of approximately $404,000. The Company reversed accrued commission liability of approximately $404,000
during the year ended March 31, 2024.
7. INCOME TAXES
For the years ended March 31, 2024 and 2023, we had
no income tax expense due to our net operating losses and 100% deferred tax asset valuation allowance.
At March 31, 2024 and 2023, 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.
F- 22
Significant components of our net deferred tax assets
at March 31, 2024 and 2023 are shown below:
Schedule of deferred tax assets
YEAR ENDED MARCH 31,
2024
2023
Deferred tax assets:
Research and development credit carryforwards
$
3,442,000
$
3,442,000
Capitalized research and development costs
646,000
519,000
Net operating loss carryforwards (1)
26,927,000
24,158,000
Stock compensation
2,244,000
1,903,000
Total deferred tax assets
33,259,000
30,022,000
Total deferred tax liabilities
–
–
Net deferred tax assets
33,259,000
30,022,000
Valuation allowance for deferred tax assets
( 33,259,000
)
( 30,022,000
)
Net deferred tax assets
$
–
$
–
______________
(1)
Pursuant to Internal Revenue Code Section 382, use of
our tax net operating loss carryforwards may be limited. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately
prior to an ownership change. Subsequent ownership changes may further affect the limitation in future years. If and when the Company
utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation
rules on the NOL carryforward balances.
At March 31, 2024, we had tax net operating loss carryforwards
for federal and state purposes approximating $ 98 million and $ 91 million, respectively, portions of which began to expire in the year
2021. The indefinite position is approximately $ 36 million. Research and Development credits begin to expire in 2025.
The provision for income taxes on earnings subject
to income taxes differs from the statutory federal rate for the years ended March 31, 2024 and 2023 due to the following:
Schedule of provision for income taxes
2024
2023
Income taxes (benefit) at federal statutory rate of 21.00%
$
( 2,564,000
)
$
( 2,526,000
)
Tax effect on non-deductible expenses and credits
2,000
2,000
True up items
( 29,000
)
57,000
Expiration of net operating loss carryforwards (1)
204,000
353,000
Change in valuation allowance
2,387,000
2,114,000
Income Tax Expense (Benefit)
$
–
$
–
______________
(1)
Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited.
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, 2024 and 2023, we did not recognize any interest or penalties relating
to tax matters.
F- 23
At and for the years ended March 31, 2024 and 2023,
management does not believe the Company has any uncertain tax positions. Accordingly, there are no unrecognized tax benefits at March
31, 2024 or March 31, 2023.
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, 2024:
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 $ 14,158 . The current monthly base rent under the manufacturing component of the lease is $ 12,452 .
The office, lab and manufacturing leases are coterminous
with a remaining term of 36 months. The weighted average discount rate is 4.25 %.
As of our March 31, 2024 balance sheet, we have a
right-of-use lease asset of $ 883,054 .
The following table presents a maturity analysis of
expected undiscounted cash flows for operating leases on an annual basis for the next three fiscal years. All of our leases conterminously
expire during the fiscal year ending March 31, 2027.
Schedule of lease maturity
Fiscal Years Ended March 31,
2025
$ 323,812
2026
333,462
2027
343,352
Total minimum lease payments
1,000,626
Less amount representing imputed interest
( 60,310 )
Present value of minimum lease payments
$ 940,316
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. 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 $ 420,353 and $ 519,000 for the fiscal years ended March 31, 2024 and 2023, 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, 2024 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.
Public Offering
On May 17, 2024, we closed a public offering pursuant
to which we sold an aggregate of: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000
shares of common stock and Class B warrants to purchase up to 2,450,000 shares of common stock, at a combined public offering price of
$0.58 per share and accompanying warrants; and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common
stock and accompanying Class A warrants to purchase up to 5,650,000 shares of common stock and Class B warrants to purchase up to 5,650,000
shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal
to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price of each such
pre-funded warrant.
The Class A and Class B warrants each have an exercise
price of $0.58 per share, are immediately exercisable, and, in the case of Class A warrants, will expire on May 17, 2029, and in the case
of Class B warrants, will expire on May 19, 2025. The exercise price of the Class A and Class B warrants is also subject to adjustment
for stock splits, reverse splits, and similar capital transactions as described in such warrants. Maxim Group LLC acted as the exclusive
placement agent for the offering.
The gross proceeds from the offering, before deducting
the placement agent’s fees and other offering expenses, were approximately $4.7 million. The Company intends to use the net proceeds
from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, capital
expenditures and working capital.
In June 2024, holders of Class A and Class B warrants
exercised 295,000 shares and 2,875,000 shares, respectively, for total proceeds of $1,838,600.
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RSU Grants
In April 2024, the Board 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 four 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 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 non-employee director, with each RSU priced at the average for the closing prices
for the five days preceding and including the date of grant, or $1.52 per share for the April 2024 RSU grants. As a result, in April 2024
the four eligible directors were each granted an RSU in the amount of 32,894 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, 2024, September 30, 2024, December 31,
2024, and March 31, 2025, 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.
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