4 unchanged sentences
required to be disclosed, in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified
−Removed: in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive
−Removed: Officer and Chief Financial Officer (who are our principal executive officer and principal financial officer, respectively), to allow
+Added: in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Interim
+Added: Chief Executive Officer and Chief Financial Officer (who is our principal executive officer and principal financial officer), to allow
timely decisions regarding required disclosures.
−Removed: In designing and evaluating
−Removed: the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
+Added: In designing and evaluating the
+Added: 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
1 unchanged sentence
We have carried out an evaluation as of the end of the period
−Removed: covered by this Annual Report under the supervision and with the participation of our management, including our Chief Executive Officer
−Removed: and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
−Removed: Based on such evaluation,
−Removed: our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this Annual Report,
−Removed: our disclosure controls and procedures were effective.
+Added: covered by this Annual Report under the supervision and with the participation of our management, including our Interim Chief Executive
+Added: Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.
Internal Control over Financial Reporting
5 unchanged sentences
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting
−Removed: Under the supervision and
−Removed: with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we conducted an evaluation
−Removed: of the effectiveness of our internal control over financial reporting as of March 31, 2023.
−Removed: According to the guidelines established by
−Removed: Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, one or more
−Removed: material weaknesses renders a company’s internal control over financial reporting ineffective.
−Removed: Based on this evaluation, we have
−Removed: concluded that our internal control over financial reporting was effective as of March 31, 2023.
+Added: Under the supervision and with the participation of
+Added: our management, including our Interim Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness
+Added: of our internal control over financial reporting as of March 31, 2024.
+Added: According to the guidelines established by Internal Control—Integrated
+Added: Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, one or more material weaknesses renders a company’s
+Added: internal control over financial reporting ineffective.
+Added: Based on this evaluation, we have concluded that our internal control over financial
+Added: reporting was not effective as of March 31, 2024 due to the material weaknesses described below.
+Added: Description of Material Weaknesses
+Added: Based on such evaluation,
+Added: management identified a material weakness in the segregation of duties within our financial systems.
+Added: Specifically, user access controls
+Added: were not sufficiently maintained to properly restrict both user and privileged access to financial applications within our accounting
+Added: software system to initiate, record and approve entries.
+Added: Also noted that check stock was secured in an authorized signatory’s office.
+Added: It is difficult to design
+Added: and maintain appropriate segregation of duties in the initiation, recording, and approval of transactions within financial systems with
+Added: a limited number of personnel.
+Added: This, coupled with management having not designed and maintained user access controls that adequately
+Added: restrict user and privileged access to financial applications, and the absence of sufficient other mitigating controls, created a segregation
+Added: of duties weakness which could potentially have resulted in a material misstatement.
+Added: Management has identified remediation actions that
+Added: may require the addition of personnel to the finance and accounting function or a change in accounting software, which will allow the
+Added: Company to design the control environment in a manner that provides effective segregation of duties.
+Added: Management has identified certain
+Added: actions beyond staff changes or accounting software changes.
+Added: As of May 2024, the accounting software was updated, and distinct user roles
+Added: were created.
+Added: Transactions are recorded by personnel who are independent of those who initiate them and are approved by separate personnel
+Added: who are independent of those who record them.
+Added: Additionally, check stock was relocated in November 2023.
+Added: During 2017 through 2020,
+Added: the Company incorrectly recorded accrued commission liability of approximately $404,000.
+Added: The Company reversed accrued commission liability
+Added: of approximately $404,000 during the year ended March 31, 2024 related to this error in accounting under U.S.
+Added: The Company originally
+Added: failed to correctly apply appropriate accounting principles in recording the transaction, and the error was not detected and corrected
+Added: in a timely manner, resulting in an adjustment to the financial statements.
+Added: Management has discussed with counsel appropriate
+Added: measures to record such potential commission liabilities in the future and will implement a quarterly review of all accruals.
+Added: of the accrued commission liability into equity as of March 31, 2024 corrected the impact of the error.
+Added: The Company is in the process
+Added: of implementing quarterly review controls over review and assessment of accruals.
+Added: This plan, with oversight from our Audit Committee,
+Added: is in the process of implementation in response to the identified material weakness.
+Added: Limitation on Effectiveness of Controls
+Added: In designing and evaluating our
+Added: disclosure controls and procedures, management recognized that any disclosure controls and procedures, no matter how well designed and
+Added: operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives.
+Added: No evaluation of internal
+Added: control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.
+Added: In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit
+Added: relationship of possible controls and procedures.
+Added: There are inherent limitations to the effectiveness of any system of disclosure controls
+Added: and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures.
+Added: the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be
+Added: no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
+Added: Over time, controls may
+Added: become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.
+Added: the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Changes in Internal Control Over Financial Reporting
−Removed: There was no change in our
−Removed: internal control over financial reporting during the last fiscal quarter ended March 31, 2023 that has materially affected, or is reasonably
−Removed: likely to materially affect, our internal control over financial reporting.
+Added: There was no change in our internal
+Added: control over financial reporting during the last fiscal quarter ended March 31, 2024 that has materially affected, or is reasonably likely
+Added: to materially affect, our internal control over financial reporting.
OTHER INFORMATION
−Removed: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT
+Added: On June 27, 2024, we received
+Added: a letter, or Notice, from The Nasdaq Stock Market, or Nasdaq, advising us that for 31 consecutive trading days preceding the date of the
+Added: 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
+Added: Market pursuant to Nasdaq Listing Rule 5550(a)(2), or the Minimum Bid Price Requirement.
+Added: The Notice has no effect on the listing of our
+Added: common stock at this time, and our common stock continues to trade on The Nasdaq Capital Market under the symbol “AEMD.”
+Added: In accordance with Nasdaq
+Added: Listing Rule 5810(c)(3)(A), we have 180 calendar days to regain compliance with the Minimum Bid Requirement, or the Grace Period, subject
+Added: to a potential 180 calendar day extension, as described below.
+Added: To regain compliance, the closing bid price of our common stock must be
+Added: at least $1.00 per share for a minimum of ten consecutive business days within the Grace Period.
+Added: If we do not achieve compliance
+Added: with the Minimum Bid Requirement by December 24, 2024, the end of the Grace Period, we may be eligible for an additional 180 calendar
+Added: day period to regain compliance.
+Added: To qualify, we would be required to meet the continued listing requirement for the market value of our
+Added: publicly held shares and all other Nasdaq initial listing standards, with the exception of the bid price requirement, and would need to
+Added: provide written notice of our intention to cure the deficiency during the second compliance period.
+Added: However, if it appears to Nasdaq staff
+Added: 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
+Added: common stock will be subject to delisting.
+Added: In the event we receive notice that our common stock is being delisted, we would be entitled
+Added: to appeal the determination to a Nasdaq Listing Qualifications Panel and request a hearing.
+Added: We intend to monitor the closing
+Added: bid price of our common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid
+Added: Price Requirement.
+Added: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
−Removed: Certain information required
−Removed: by Part III is omitted from this Annual Report and incorporated by reference to our definitive proxy statement for our 2023 Annual Meeting
+Added: Certain information required by
+Added: 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.
3 unchanged sentences
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: Except as set forth below,
−Removed: the information required by this item will be contained in the sections titled “Information About our Board of Directors and Executive
+Added: Except as set forth below, the
+Added: 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
4 unchanged sentences
Committee” and “Executive and Director Compensation” in our Proxy Statement and is incorporated herein by reference.
+Added: We maintain a Code of Business
+Added: Conduct and Ethics that applies to all our employees, officers and directors.
+Added: This includes our principal executive officer, principal
+Added: financial officer and principal accounting officer or controller, or persons performing similar functions.
+Added: The full text of our Code of
+Added: Business Conduct and Ethics is posted on our website at www.aethlonmedical.com on the “Governance” page of the section titled
+Added: “Investors.” If we make any substantive amendments to the Code of Business Conduct and Ethics or grant any waiver from a provision
+Added: of the Code of Business Conduct and Ethics to any executive officer or director that are required to be disclosed pursuant to SEC rules,
+Added: we will promptly disclose the nature of the amendment or waiver on our website or in a current report on Form 8-K.
+Added: Information contained
+Added: in, or that can be accessed through, our website is not incorporated by reference herein, and you should not consider information on our
+Added: website to be part of this Annual Report.
EXECUTIVE COMPENSATION
−Removed: The information required by
−Removed: this item will be contained in the sections titled “Executive and Director Compensation” and “Information About our
−Removed: Board of Directors and Executive Officers – Information Regarding Committees of the Board of Directors – Compensation Committee”
+Added: The information required by this
+Added: item will be contained in the sections titled “Executive and Director Compensation” and “Information About our Board
+Added: 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.
1 unchanged sentence
AND RELATED STOCKHOLDER MATTERS
−Removed: The information required by
−Removed: this item will be contained in the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Executive
+Added: The information required by this
+Added: 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
1 unchanged sentence
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR
−Removed: The information required by
−Removed: this item will be contained in the sections titled “Information About our Board of Directors and Executive Officers – Board
−Removed: of Directors” and “Certain Relationships and Related Transactions” in our Proxy Statement and is incorporated herein
−Removed: by reference.
+Added: The information required by this
+Added: item will be contained in the sections titled “Information About our Board of Directors and Executive Officers – Board of
+Added: Directors” and “Certain Relationships and Related Transactions” in our Proxy Statement and is incorporated herein by
PRINCIPAL ACCOUNTANT FEES AND SERVICES
−Removed: The information required by
−Removed: this item will be contained in the section titled “Ratification of Appointment of Independent Registered Public Accounting Firm”
+Added: The information required by this
+Added: 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.
2 unchanged sentences
(a)(1) Financial Statements.
−Removed: The response to this portion of Item 15 is set
−Removed: forth under Part II, Item 8 above.
+Added: The response to this portion of Item 15 is set forth
+Added: under Part II, Item 8 above.
(a)(2) Financial Statement Schedules.
−Removed: All schedules have been omitted because they are
−Removed: not required or because the required information is given in the Financial Statements or Notes thereto set forth under Item 8 above.
+Added: All schedules have been omitted
+Added: because they are not required or because the required information is given in the Financial Statements or Notes thereto set forth under
+Added: Item 8 above.
(a)(3) Exhibits required by Item 601 of Regulation
Incorporated by Reference
−Removed: Exhibit Description
Filed Herewith
11 unchanged sentences
January 17, 2020
+Added: Form of Class A Warrant to Purchase Common Stock, issued on May 17, 2024.
+Added: Form of Class B Warrant to Purchase Common Stock, issued on May 17, 2024.
+Added: Form of Pre-Funded Warrant to Purchase Common Stock, issued on May 17, 2024.
+Added: Form of Placement Agent Warrant to Purchase Common Stock, issued on May 17, 2024.
Description of Aethlon Medical, Inc.’s Securities.
June 25, 2020
+Added: Incorporated by Reference
+Added: Filed Herewith
Aethlon Medical, Inc.
4 unchanged sentences
February 11, 2019
+Added: Amendment No.
+Added: 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and James B.
+Added: December 22, 2023
Form of Indemnification Agreement for Officers and Directors.
February 11, 2019
−Removed: Incorporated by Reference
−Removed: Exhibit Description
−Removed: Filed Herewith
Form of Option Grant Agreement for Officers and Directors.
4 unchanged sentences
February 11, 2019
−Removed: SBIR Phase II Award Contract, by and among Aethlon Medical, Inc., the National Institutes of Health and the National Cancer Institute, dated September 12, 2019.
−Removed: November 1, 2019
−Removed: Amendment to SBIR Phase II Award Contract, by and among Aethlon Medical, Inc., the National Institutes of Health and the National Cancer Institute, dated October 28, 2020.
−Removed: June 28, 2022
Assignment Agreement, by and between Aethlon Medical, Inc.
7 unchanged sentences
November 3, 2020
+Added: Separation Agreement between the Company and Dr.
+Added: Fisher, effective as of November 27, 2023.
+Added: November 27, 2023
Lease, by and between the Company and San Diego Inspire 1, LLC.
1 unchanged sentence
February 10, 2021
+Added: Incorporated by Reference
+Added: Filed Herewith
Executive Employment Agreement between the Company and Guy Cipriani, dated January 1, 2021.
February 10, 2021
+Added: Amendment No.
+Added: 1 to Executive Employment Agreement, effective as of November 7, 2023, by and between the Company and Guy F.
+Added: December 22, 2023
Executive Employment Agreement between the Company and Steven P.
10 unchanged sentences
March 24, 2022
−Removed: Incorporated by Reference
−Removed: Exhibit Description
−Removed: Filed Herewith
Amendment No.
1 unchanged sentence
Arnold, Ph.D., dated May 1, 2023.
+Added: June 28, 2023
List of Subsidiaries.
1 unchanged sentence
Power of Attorney (see signature page)
−Removed: Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.
−Removed: Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
−Removed: Certification of the Principal Executive Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C.
−Removed: Section 1350.
−Removed: Certification of the Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C.
+Added: 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.
+Added: 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.
−Removed: 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)
+Added: Incorporated by Reference
+Added: Filed Herewith
+Added: Incentive Compensation Recoupment Policy.
+Added: Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File
+Added: because its XBRL tags are embedded within the Inline XBRL document)
Inline XBRL Taxonomy Extension Schema Document
6 unchanged sentences
Indicates management contract or compensatory plan.
+Added: 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.
FORM 10-K SUMMARY
1 unchanged sentence
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
−Removed: its behalf by the undersigned, thereunto duly authorized, o n the 28 th d ay
−Removed: of June, 2023.
−Removed: /s/ CHARLES J.
−Removed: Fisher, Jr., M.D.
−Removed: Chief Executive Officer
+Added: its behalf by the undersigned, thereunto duly authorized, o n the 27 th d ay of
+Added: INTERIM CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER.
POWER OF ATTORNEY
−Removed: KNOW ALL PERSONS BY THESE PRESENTS, that each
−Removed: person whose signature appears below constitutes and appoints James B.
−Removed: Frakes and Charles J.
−Removed: Fisher, Jr., M.D., his or her true and lawful
−Removed: 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,
−Removed: 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
−Removed: in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them,
−Removed: full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as
−Removed: fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
−Removed: and agents, or any of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
−Removed: Pursuant to the requirements
−Removed: of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person
+Added: whose signature appears below constitutes and appoints James B.
+Added: Frakes his or her true and lawful attorney-in-fact and agent, with full
+Added: 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
+Added: to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with
+Added: the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each
+Added: 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
+Added: might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or his substitutes or substitute,
+Added: may lawfully do or cause to be done by virtue hereof.
+Added: Pursuant to the requirements of
+Added: 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.
−Removed: /s/ CHARLES J.
−Removed: Chief Executive Officer, Principal Executive Officer and Director
−Removed: June 28, 2023
−Removed: Fisher, Jr., M.D.
−Removed: Chief Financial Officer and Principal Financial and Accounting Officer
+Added: Interim Chief Executive Officer and Chief Financial Officer, Principal Executive Officer, Principal Financial and Accounting Officer and Director
June 27, 2024
7 unchanged sentences
Angela Rossetti
−Removed: /s/ GUY CIPRIANI
−Removed: Senior Vice President, Chief Business Officer and Director
+Added: /s/ NICOLAS GIKAKIS
June 27, 2024
+Added: Nicolas Gikakis
Consolidated Financial Statements
−Removed: Report of Independent Registered Public Accounting Firm (PCAOB ID 23 )
+Added: Report of Independent Registered Public Accounting Firm (Baker Tilly US, LLP, San Diego, CA PCAOB ID No.
Consolidated Balance Sheets as of March 31, 2024 and 2023
−Removed: Consolidated Statements of Operations for the Years Ended March 31, 2023 and 2022
+Added: Consolidated Statements of Operations and Comprehensive Loss for the Years Ended March 31, 2024 and 2023
Consolidated Statements of Equity for the Years Ended March 31, 2024 and 2023
1 unchanged sentence
Notes to Consolidated Financial Statements
−Removed: REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
−Removed: To the Stockholders and the Board of Directors
−Removed: of Aethlon Medical, Inc.
+Added: REPORT OF INDEPENDENT REGISTERED
+Added: PUBLIC ACCOUNTING FIRM
+Added: To the Stockholders and the Board of Directors of
+Added: Aethlon Medical, Inc.
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated
−Removed: balance sheets of Aethlon Medical, Inc.
−Removed: and its subsidiary (the Company) as of March 31, 2023 and 2022, the related consolidated statements
−Removed: of operations, equity and cash flows for the years then ended, and the related notes to the consolidated financial statements (collectively,
−Removed: the financial statements).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of
−Removed: the Company as of March 31, 2023 and 2022, and the results of its operations and its cash flows for the years then ended, in conformity
−Removed: with accounting principles generally accepted in the United States of America.
+Added: We have audited the accompanying consolidated balance
+Added: sheets of Aethlon Medical, Inc.
+Added: and its subsidiary (the Company) as of March 31, 2024 and 2023, the related consolidated statements of
+Added: operations and comprehensive loss, equity and cash flows for the years then ended, and the related notes to the consolidated financial
+Added: statements (collectively, the financial statements).
+Added: In our opinion, the financial statements present fairly, in all material respects,
+Added: 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
+Added: then ended, in conformity with accounting principles generally accepted in the United States of America.
+Added: Going Concern Uncertainty
+Added: The accompanying consolidated financial statements
+Added: have been prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 1 of the consolidated financial statements,
+Added: the Company has recurring losses from operations, an accumulated deficit, expects to incur losses for the foreseeable future and requires
+Added: additional working capital.
+Added: These are the reasons that raise substantial doubt about the Company’s ability to continue as a going
+Added: Management’s plans in regard to these matters are also described in Note 1.
+Added: The consolidated financial statements do not
+Added: contain any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
6 unchanged sentences
of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the
−Removed: standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
−Removed: statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged
−Removed: to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits we are required to obtain an understanding
−Removed: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
−Removed: control over financial reporting.
+Added: We conducted our audits in accordance with the standards
+Added: of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
+Added: are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform,
+Added: an audit of its internal control over financial reporting.
+Added: As part of our audits we are required to obtain an understanding of internal
+Added: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control
+Added: over financial reporting.
Accordingly, we express no such opinion.
7 unchanged sentences
Critical Audit Matters
−Removed: Critical audit matters are matters arising from
−Removed: the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
−Removed: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
−Removed: subjective, or complex judgments.
+Added: Critical audit matters are matters arising from the
+Added: current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective,
+Added: or complex judgments.
We determined that there are no critical audit matters.
−Removed: Baker Tilly US, LLP
+Added: /s/ Baker Tilly US, LLP
We have served as the Company's auditor since 2001.
6 unchanged sentences
Cash and cash equivalents
−Removed: Accounts receivable
+Added: Deferred offering costs
Prepaid expenses and other current assets
1 unchanged sentence
Property and equipment, net
−Removed: Right-of-use lease asset
+Added: Right-of-use lease asset, net
Restricted cash
3 unchanged sentences
Due to related parties
−Removed: Deferred revenue
Lease liability, current portion
5 unchanged sentences
STOCKHOLDERS’ EQUITY
−Removed: Common stock, $ 0.001 par value, 60,000,000 and 30,000,000 shares authorized at March 31, 2023 and 2022, respectively;
+Added: 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
6 unchanged sentences
STOCKHOLDERS’ EQUITY BEFORE NONCONTROLLING INTERESTS
−Removed: NONCONTROLLING INTERESTS
TOTAL STOCKHOLDERS’ EQUITY
17 unchanged sentences
Loss on dissolution of subsidiary
−Removed: Interest income
+Added: Interest income and other
Other expense (income)
−Removed: NET LOSS BEFORE NONCONTROLLING INTERESTS
+Added: NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
( 12,208,174 )
( 12,029,786 )
−Removed: LOSS ATTRIBUTABLE TO NONCONTROLLING INTERESTS
+Added: Basic and diluted net loss per share attributable to common stockholders
+Added: Weighted average number of common shares outstanding - basic and diluted
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
5 unchanged sentences
$ ( 12,035,927 )
−Removed: Basic and diluted net loss per share attributable to common stockholders
−Removed: Weighted average number of common shares outstanding - basic and diluted
See accompanying notes to the consolidated financial
10 unchanged sentences
$ ( 141,708 )
−Removed: Issuances of common stock for cash under at the market program
−Removed: Issuances of common stock for cash in registered direct financing
−Removed: Issuances of common stock for cash under warrant exercises
−Removed: Issuances of common stock for cash under stock option exercises
−Removed: Issuances of common stock under cashless warrant exercises
−Removed: Issuance of common shares upon vesting of restricted stock units and net
−Removed: stock option exercise
+Added: Issuances of common stock for cash
+Added: under at the market program
+Added: Issuance of common shares upon vesting
+Added: of restricted stock units and net stock option exercise
+Added: Loss on dissolution of subsidiary
Stock-based compensation expense
1 unchanged sentence
( 12,029,786 )
+Added: Other comprehensive loss
BALANCE - MARCH 31, 2023
1 unchanged sentence
$ ( 142,358,554 )
−Removed: $ ( 141,708 )
−Removed: Issuances of common stock for cash under at the market program
−Removed: Issuance of common shares upon vesting of restricted stock units
−Removed: Loss on dissolution of subsidiary
+Added: Issuances of common stock for cash
+Added: under at the market program
+Added: Rounding for reverse split
+Added: Issuance of common shares upon vesting
+Added: of restricted stock units
+Added: Reversal of accrued commission liability
Stock-based compensation expense
17 unchanged sentences
Stock-based compensation
−Removed: Loss of dissolution of subsidiary
−Removed: Accretion of right-of-use lease asset
+Added: Loss on disposal of property, plant and equipment
+Added: Loss on dissolution of Subsidiary
+Added: Non-cash lease expense
Changes in operating assets and liabilities:
12 unchanged sentences
Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units
−Removed: Net proceeds from the issuance of common stock and exercise of warrants
+Added: Net proceeds from the issuance of common stock
Net cash provided by financing activities
Effect of Exchange Rate on Changes on Cash
−Removed: Net (decrease) increase in cash and restricted cash
+Added: Net decrease in cash and restricted cash
( 9,090,965 )
+Added: ( 2,539,476 )
Cash and restricted cash at beginning of year
1 unchanged sentence
Supplemental information of non-cash investing and financing activities:
−Removed: Issuances of common stock under cashless warrant exercises
Initial recognition of right-of-use lease asset and lease liability
Issuance of shares under vested restricted stock units, net stock option exercises and unvested share issuance for services
+Added: Reversal of accrued commission liability (see Note
+Added: Deferred offering costs not yet paid
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets:
2 unchanged sentences
Cash and restricted cash
−Removed: See accompanying notes to the
−Removed: consolidated financial statements.
+Added: See accompanying notes to the consolidated financial
Aethlon Medical, Inc.
2 unchanged sentences
ORGANIZATION, LIQUIDITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: Aethlon Medical, Inc., or Aethlon, the Company,
−Removed: we or us, is a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.
−Removed: Aethlon Hemopurifier is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections.
−Removed: cancer, the Hemopurifier is designed to deplete the presence of circulating tumor-derived exosomes that promote immune suppression, seed
−Removed: the spread of metastasis and inhibit the benefit of leading cancer therapies.
−Removed: Food and Drug Administration, or FDA, has designated
−Removed: the Hemopurifier as a “Breakthrough Device” for two independent indications:
−Removed: treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy,
−Removed: and with cancer types in which exosomes have been shown to participate in the development or severity of the disease;
−Removed: treatment of life-threatening viruses that are not addressed with approved therapies.
−Removed: We believe the Hemopurifier can be a substantial
−Removed: advance in the treatment of patients with advanced and metastatic cancer through the clearance of exosomes that promote the growth and
−Removed: spread of tumors through multiple mechanisms.
−Removed: We are currently working with our new contract research organization, or CRO, on preparations
−Removed: to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other
−Removed: On October 4, 2019, the FDA approved our Investigational
−Removed: Device Exemption, or IDE, application to initiate an Early Feasibility Study, or EFS, of the Hemopurifier in patients with head and neck
−Removed: cancer in combination with standard of care pembrolizumab (Keytruda).
−Removed: The primary endpoint for the EFS, designed to enroll 10 to 12 subjects
−Removed: at a single center, is safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response
−Removed: and survival rates.
−Removed: This clinical trial, initially conducted at the UPMC Hillman Cancer Center in Pittsburgh, PA, or UPMC, treated two
−Removed: Due to lack of further patient enrollment, we and UPMC terminated this trial.
−Removed: In January 2023, we entered into an agreement
−Removed: with North American Science Associates, LLC, or NAMSA, a world leading MedTech CRO offering global end-to-end development services, to
−Removed: oversee our clinical trials investigating the Hemopurifier for oncology indications.
−Removed: Pursuant to the agreement, NAMSA will manage our
−Removed: clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer tumors.
−Removed: We anticipate
−Removed: that the initial clinical trials will begin in Australia.
−Removed: We also believe the Hemopurifier can be part of
−Removed: the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already
−Removed: approved treatment.
+Added: Aethlon Medical, Inc., or Aethlon, the Company, we
+Added: or us, is a medical therapeutic company focused on developing the Hemopurifier, a clinical-stage immunotherapeutic device designed to
+Added: combat cancer and life-threatening viral infections and for use in organ transplantation.
+Added: In human studies, 164 sessions with 38 patients,
+Added: the Hemopurifier was safely utilized and demonstrated the potential to remove life-threatening viruses.
+Added: In pre-clinical studies, the Hemopurifier
+Added: has demonstrated the potential to remove harmful exosomes and exosomal particles from biological fluids, utilizing its proprietary lectin-based
+Added: This action has potential applications in cancer, where exosomes and exosomal particles may promote immune suppression and
+Added: metastasis, and in life-threatening infectious diseases.
+Added: Food and Drug Administration, or FDA, has designated the Hemopurifier
+Added: as a “Breakthrough Device” for two independent indications:
+Added: · the treatment of individuals with advanced or metastatic cancer
+Added: who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to
+Added: participate in the development or severity of the disease;
+Added: · the treatment of life-threatening viruses that are not addressed
+Added: with approved therapies.
+Added: We believe the Hemopurifier may be a substantial advancement
+Added: in the treatment of patients with advanced and metastatic cancer through its design to bind to and remove harmful exosomes and exosomal
+Added: particles that promote the growth and spread of tumors.
+Added: In October 2022, we formed a wholly-owned subsidiary in Australia to initially
+Added: conduct oncology-related clinical research, then seek regulatory approval and commercialize our Hemopurifier in Australia.
+Added: We are currently
+Added: working with our contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid
+Added: tumors, including head and neck cancer, and gastrointestinal cancers.
+Added: In January 2023, we entered into an agreement with
+Added: North American Science Associates, LLC, or NAMSA, a world leading medical technology CRO offering global end-to-end development services,
+Added: to oversee our planned clinical trials investigating the Hemopurifier for oncology indications.
+Added: Pursuant to the agreement, NAMSA agreed
+Added: to manage our planned clinical trials of the Hemopurifier for patients in the United States and Australia with various types of cancer
+Added: We recently completed an in vitro binding study of relevant oncology
+Added: targets, to provide pre-clinical evidence to support our trial design and translational endpoints.
+Added: Our study indicated positive results
+Added: from this study, providing evidence that our Hemopurifier removes extracellular vesicles, or EVs, from plasma.
+Added: This translational study
+Added: provides pre-clinical evidence to support our planned phase 1 safety, feasibility and dose-finding clinical trials of our Hemopurifier
+Added: in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or
+Added: In addition to an interested initial trial site in India, we had three interested sites in Australia that were awaiting our
+Added: completion of this in vitro binding study.
+Added: We added the data from this study to our Clinical Investigator Brochure and submitted
+Added: that brochure to the Ethics Committee of Royal Adelaide Hospital in Australia and in June 2024, we received approval for our proposed
+Added: phase 1 oncology trial from the Ethics Committee from Royal Adelaide Hospital.
+Added: We are currently in the process of applying to the Ethics
+Added: Committees of the two additional interested clinical trial sites in Australia and the site in India.
+Added: Life-Threatening Viral Infections
+Added: We also believe that the Hemopurifier can be part
+Added: of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an
+Added: already approved treatment.
In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals
5 unchanged sentences
In several cases, these studies were conducted in collaboration with leading government or non-government research
−Removed: On June 17, 2020, the FDA approved a supplement
−Removed: to our open IDE for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier in patients with SARS-CoV-2/COVID-19,
−Removed: or COVID-19, in a New Feasibility Study.
−Removed: That study was designed to enroll up to 40 subjects at up to 20 centers in the United States.
−Removed: Subjects had to have an established laboratory diagnosis of COVID-19, be admitted to an intensive care unit, or ICU, and have acute lung
−Removed: injury and/or severe or life-threatening disease, among other criteria.
−Removed: Endpoints for this study, in addition to safety, included reduction
−Removed: in circulating virus as well as clinical outcomes (NCT # 04595903).
−Removed: In June 2022, the first patient in this study was enrolled and completed
−Removed: the Hemopurifier treatment phase of the protocol.
−Removed: Due to lack of COVID-19 patients in the ICUs of our trial sites, we terminated this
−Removed: study in 2022.
−Removed: Under Single Patient Emergency Use regulations,
−Removed: the Company has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated with our Hemopurifier
−Removed: in our COVID-19 clinical trial discussed above.
−Removed: We currently are experiencing a disruption in
−Removed: our Hemopurifier supply, as our existing supply of Hemopurifiers expired on September 30, 2022 and, as previously disclosed, we are dependent
−Removed: on FDA approval of qualified suppliers to manufacture our Hemopurifier.
−Removed: Our intended transition to a new supplier for galanthus nivalis
−Removed: agglutinin, or GNA, a component of our Hemopurifier, is delayed as we work with the FDA for approval of our supplement to our IDE, which
−Removed: is required to make this manufacturing change.
−Removed: In October 2022, we launched a wholly owned subsidiary
−Removed: in Australia, formed to conduct clinical research, seek regulatory approval and commercialize our Hemopurifier in that country.
−Removed: The subsidiary
−Removed: will initially focus on oncology trials in Australia.
−Removed: There were only insignificant expenses in that subsidiary in the three months ended
−Removed: December 31, 2022.
−Removed: We also obtained Ethics Review Board, or ERB,
−Removed: approval and entered into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for
−Removed: a COVID-19 clinical trial at that location.
−Removed: One patient has completed participation in the Indian COVID-19 study.
−Removed: The relevant authorities
−Removed: in India have accepted the use of the Hemopurifiers made with the GNA from our new supplier.
−Removed: In May 2023, we also received ERB approval from
−Removed: the Maulana Azad Medical College, or MAMC, for a second site for our clinical trial in India to treat severe COVID-19.
−Removed: MAMC was established
−Removed: in 1958 and is located in New Delhi, India.
−Removed: MMAC is affiliated with the University of Delhi and is operated by the Delhi government.
−Removed: We also recently announced that we also have begun
−Removed: investigating the use of our Hemopurifier in the organ transplant setting.
−Removed: Our objective is to confirm that the Hemopurifier, in our translational
−Removed: studies, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses and exosomes from harvested
−Removed: We have previously demonstrated the removal of multiple viruses and exosomes from buffer solutions, in vitro, utilizing a scaled-down
−Removed: version of our Hemopurifier.
−Removed: This process potentially may reduce complications following transplantation of the harvested organ, which
−Removed: can include viral infection, delayed graft function and rejection.
−Removed: We believe this new approach could be additive to existing technologies
−Removed: that currently are in place to increase the number of viable organs for transplant.
−Removed: Previously, we were the majority owner of Exosome
−Removed: Sciences, Inc., or ESI, a company formed to focus on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases,
−Removed: and thus consolidated ESI in our consolidated financial statements.
−Removed: For more than four years, the primary activities of ESI were limited
−Removed: to the payment of patent maintenance fees and applications.
−Removed: In September 2022, the Board of Directors of ESI and we, as the majority stockholder
−Removed: of ESI, approved the dissolution of ESI.
+Added: We believe the Hemopurifier can be part of the treatment of severe SARS-CoV-2
+Added: viremia/COVID-19, or COVID-19, cases.
+Added: COVID viremia is detected in approximately 34% of patients and is associated with severity, requirement
+Added: for intensive care unit, or ICU, stay, development of multi-organ failure and poor outcomes.
+Added: EVs and exosomal miRNAs may play a role in
+Added: the spread of infection as well as ongoing inflammation, development of coagulopathy and lung injury.
+Added: Our proprietary Galanthus nivalis
+Added: agglutinin, or GNA, affinity resin has been shown to bind multiple clinically relevant SARS-CoV-2 variants.
+Added: Furthermore, studies have
+Added: demonstrated in vitro removal of seven SARS-CoV2 variants (104 PFU/mL) in phosphate buffered saline passed over a column of GNA
+Added: affinity resin (1g) three times, with capture efficiencies between 53% and 89%.
+Added: On June 17, 2020, the FDA approved a supplement to
+Added: our open Investigational Device Exemption, or IDE, for the Hemopurifier in viral disease to allow for the testing of the Hemopurifier
+Added: in patients with SARS-CoV-2/COVID-19, or COVID-19, in a new feasibility study.
+Added: That study was designed to enroll up to 40 subjects at
+Added: up to 20 centers in the United States.
+Added: Subjects were to have established laboratory diagnosis of COVID-19, be admitted to an intensive
+Added: care unit, or ICU, and have acute lung injury and/or severe or life-threatening disease, among other criteria.
+Added: Endpoints for this study,
+Added: in addition to safety, included reduction in circulating virus as well as clinical outcomes (NCT # 04595903).
+Added: In January 2021, the Hemopurifier
+Added: was used to treat a viremic patient, under our emergency use approval, with a predicted risk of mortality of 80% and the Hemopurifier
+Added: was able to reduce the patient’s SARS-CoV-2 plasma viral load by 58.4%.
+Added: In June 2022, the first patient in this study was enrolled
+Added: and completed the Hemopurifier treatment phase of the protocol.
+Added: Due to the lack of COVID-19 patients in the ICUs of our trial sites, we
+Added: terminated this study in 2022.
+Added: However, our IDE for this indication remains open, as we have an active COVID-19 trial in India and wish
+Added: to preserve the option of enrolling patients if the situation with COVID-19 changes.
+Added: Under Single Patient
+Added: Emergency Use regulations, Aethlon has treated two patients with COVID-19 with the Hemopurifier, in addition to the COVID-19 patient treated
+Added: with our Hemopurifier in our COVID-19 clinical trial discussed above .
+Added: We previously reported a disruption in our Hemopurifier supply, as our
+Added: then existing supply of Hemopurifiers expired on September 30, 2022 and, also as previously disclosed, we are dependent on FDA approval
+Added: of qualified suppliers to manufacture our Hemopurifier.
+Added: We recently completed final testing in order to begin manufacturing Hemopurifiers
+Added: at our new manufacturing facility in San Diego, California for use in planned U.S.
+Added: clinical trials, using GNA from our current supplier.
+Added: 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
+Added: now are able to manufacture Hemopurifiers at this site.
+Added: We also have sufficient Hemopurifiers on hand for use in our planned Australia
+Added: and India oncology trials.
+Added: Our intended transition to a new supplier for GNA, a component of our Hemopurifier, continues to be delayed
+Added: as we work with the FDA for approval of our supplement to our IDE, which is required to make this manufacturing supplier change.
+Added: working with the FDA to qualify this second supplier of our GNA.
+Added: We also obtained ethics review board, or ERB, approval from and entered
+Added: into a clinical trial agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, for a COVID-19 clinical
+Added: trial at that location.
+Added: In May 2023, we received ERB approval from the MAMC, for a second site
+Added: for our clinical trial in India to treat severe COVID-19.
+Added: MAMC was established in 1958 and is located in New Delhi, India.
+Added: MAMC is affiliated
+Added: with the University of Delhi and is operated by the Delhi government.
+Added: We now have two sites in India for this trial with the Medanta Medicity
+Added: Hospital and Maulana Azad Medical College, or MAMC.
+Added: One patient has been treated to date;
+Added: however, we have been informed by our CRO that
+Added: a new COVID-19 subvariant was detected in India recently.
+Added: Our COVID-19 trial in India remains open in the event that there are COVID-19
+Added: admissions to the ICUs at our sites in India.
+Added: Organ Transplantation
+Added: Additionally, based on preclinical data with acellular
+Added: kidney perfusates, we believe that the Hemopurifier has potential applications in organ transplantation.
+Added: We are investigating whether
+Added: the Hemopurifier, when incorporated into a machine perfusion organ preservation circuit, can remove harmful viruses, exosomes, RNA molecules,
+Added: cytokines, chemokines and other inflammatory molecules from recovered organs.
+Added: We initially are focused on recovered kidneys from deceased
+Added: We have previously demonstrated the removal of multiple viruses and exosomes and exosomal particles from buffer solutions, in
+Added: vitro , utilizing a scaled-down version of our Hemopurifier and believe this process could reduce transplantation complications by
+Added: improving graft function, reducing graft rejection, maintaining or improving organ viability prior to transplantation, and potentially
+Added: reducing the number of kidneys rejected for transplant.
Successful outcomes of human trials will also
3 unchanged sentences
However, we believe that certain patent applications
−Removed: and/or other patents issued more recently will help protect the proprietary nature of the Hemopurifier treatment technology.
−Removed: In addition to the foregoing, we are monitoring
−Removed: closely the impact of inflation, recent bank failures and the war in Ukraine on our business.
−Removed: Given the level of uncertainty regarding
−Removed: the duration and impact of these events on capital markets and the U.S.
−Removed: economy, we are unable to assess the impact on our timelines and
−Removed: future access to capital.
−Removed: The full extent to which inflation, recent bank failures and the war in Ukraine will impact our business, results
−Removed: of operations, financial condition, clinical trials and preclinical research will depend on future developments, as well as the economic
−Removed: impact on national and international markets that are highly uncertain.
+Added: and/or other patents issued to us more recently will help protect the proprietary nature of our Hemopurifier treatment technology.
+Added: In addition to the foregoing, we are monitoring closely
+Added: the impact of inflation, recent bank failures and the war between Russia and Ukraine and the military conflicts in Israel and the surrounding
+Added: areas, as well as related political and economic responses and counter-responses by various global factors on our business.
+Added: level of uncertainty regarding the duration and impact of these events on capital markets and the U.S.
+Added: economy, we are unable to assess
+Added: the impact on our timelines and future access to capital.
+Added: The full extent to which inflation, recent bank failures and the ongoing military
+Added: conflicts will impact our business, results of operations, financial condition, clinical trials and preclinical research will depend on
+Added: 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
2 unchanged sentences
Our website address is www.aethlonmedical.com.
−Removed: Our common stock is listed on the Nasdaq Capital
−Removed: Market under the symbol “AEMD.”
+Added: The information contained on, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report
+Added: on Form 10-K.
+Added: Our common stock is listed on the Nasdaq Capital Market
+Added: under the symbol “AEMD.”
LIQUIDITY AND GOING CONCERN
−Removed: Management expects existing cash as of March 31,
−Removed: 2023 and funds raised subsequent to that date to be sufficient to fund the Company’s operations for at least twelve months from
−Removed: the issuance date of these consolidated financial statements.
+Added: The Company has incurred losses since inception in devoting substantially
+Added: all of its efforts toward research and development and has an accumulated deficit of $ 154,566,728 as of March 31, 2024.
+Added: During the year
+Added: 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
+Added: operating losses for the foreseeable future.
+Added: While the Company currently has over $ 9.1 million in cash and cash equivalents and have been
+Added: carrying out certain expense reductions since November 2023;
+Added: our planned additional expense reductions may not materialize and/or our
+Added: patient recruitment may occur more rapidly than expected along with the concomitant increases in expenses, therefore there is substantial
+Added: 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
+Added: The Company’s ability to execute its current operating plan depends
+Added: on its ability to reduce expenses and obtain additional funding via the sale of equity, or other sources of capital.
+Added: The Company plans
+Added: to continue actively pursuing financing alternatives, however, there can be no assurance that it will obtain the necessary funding, raising
+Added: substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements
+Added: The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
PRINCIPLES OF CONSOLIDATION
3 unchanged sentences
majority-owned subsidiary, ESI, which dissolved in September 2022.
−Removed: All significant inter-company transactions and balances have been eliminated
−Removed: in consolidation.
−Removed: The consolidated financial statements contain all normal recurring accruals and adjustments that, in the opinion of
−Removed: management, are necessary to present fairly the consolidated financial statements as of and for the fiscal years ended March 31, 2023
−Removed: and 2022, and the consolidated statement of cash flows for the fiscal years ended March 31, 2023 and 2022.
−Removed: Estimates were made relating
−Removed: to useful lives of fixed assets, impairment of assets, share-based compensation expense and accruals for clinical trial and research and
−Removed: development expenses.
+Added: Operations in our Australian subsidiary is recorded in their functional
+Added: The results of operations for our Australian subsidiary are translated from functional currency into U.S.
+Added: dollars using the
+Added: current exchange rate on the date the expense was recognized.
+Added: Assets and liabilities are translated using the period end exchange rates.
+Added: The U.S dollar effects that arise from translating the net assets of are recorded in other comprehensive income (loss).
+Added: All significant
+Added: inter-company transactions and balances have been eliminated in consolidation.
+Added: The consolidated financial statements contain all normal
+Added: recurring accruals and adjustments that, in the opinion of management, are necessary to present fairly the consolidated financial statements
+Added: 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
+Added: March 31, 2024 and 2023.
RISKS AND UNCERTAINTIES
4 unchanged sentences
USE OF ESTIMATES
−Removed: We prepare our consolidated financial statements
−Removed: in conformity with accounting principles generally accepted in the United States of America, or GAAP, which requires us to make a number
+Added: We prepare our consolidated financial statements in
+Added: 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
5 unchanged sentences
under different future conditions.
−Removed: We believe that the estimates and assumptions that are most important to the portrayal of our financial
−Removed: condition and results of operations, in that they require the most difficult, subjective or complex judgments, form the basis for the
−Removed: accounting policies deemed to be most critical to us.
−Removed: These critical accounting estimates relate to revenue recognition, stock purchase
−Removed: warrants issued with notes payable, beneficial conversion feature of convertible notes payable, impairment of intangible assets and long
−Removed: lived assets, stock compensation, deferred tax asset valuation allowance, and contingencies.
+Added: We believe that the estimates and assumptions that
+Added: are most important to the portrayal of our financial condition and results of operations, in that they require the most difficult, subjective
+Added: or complex judgments, form the basis for the accounting policies deemed to be most critical to us.
CASH AND CASH EQUIVALENTS
−Removed: Accounting standards define “cash and cash
−Removed: equivalents” as any short-term, highly liquid investment that is both readily convertible to known amounts of cash and so near their
−Removed: maturity that they present insignificant risk of changes in value because of changes in interest rates.
−Removed: For the purpose of financial statement
−Removed: presentation, we consider all highly liquid investment instruments with original maturities of three months or less when purchased, or
−Removed: any investment redeemable without penalty or loss of interest to be cash equivalents.
−Removed: Cash is carried at cost, which approximates fair
−Removed: value, and cash equivalents are carried at fair value.
−Removed: As of March 31, 2023, our cash and cash equivalents
−Removed: were comprised of the following instruments:
+Added: Accounting standards define “cash and cash equivalents”
+Added: as any short-term, highly liquid investment that is both readily convertible to known amounts of cash and so near their maturity that
+Added: they present insignificant risk of changes in value because of changes in interest rates.
+Added: For the purpose of financial statement presentation,
+Added: we consider all highly liquid investment instruments with original maturities of three months or less when purchased, or any investment
+Added: redeemable without penalty or loss of interest to be cash equivalents.
+Added: Cash is carried at cost, which approximates fair value, and cash
+Added: equivalents are carried at fair value.
+Added: For the fiscal years ended March 31, 2024 and March
+Added: 31, 2023 our cash and cash equivalents were comprised of the following instruments:
Schedule of cash and cash equivalents
+Added: For the year ended
Cash in US bank checking account
2 unchanged sentences
Total cash and cash equivalents
−Removed: As of March 31, 2022, we had no assets that were
−Removed: classified as cash equivalents.
CONCENTRATIONS OF CREDIT RISKS
6 unchanged sentences
2024, we maintained cash equivalents of approximately $ 4.7 million in US Treasury bills with maturities of less than three months.
−Removed: We do not believe that the Company is exposed to any significant risk with respect to its cash equivalents since they represent US government
−Removed: Cash is maintained at one Australian financial
−Removed: institution in checking accounts.
+Added: do not believe that the Company is exposed to any significant risk with respect to its cash equivalents since they represent US government
+Added: Cash is maintained at one Australian financial institution
+Added: in checking accounts.
Accounts at this institution are secured by the Financial Claims Scheme for up to Australian $250,000.
−Removed: Our March 31, 2023 Australian cash balance was below that threshold.
−Removed: All of our revenue in the fiscal years ended March
−Removed: 31, 2023 and 2022 related to our government contracts.
−Removed: We did not have any accounts receivable at March 31, 2023.
+Added: 31, 2024 Australian cash balance was below that threshold.
+Added: We did not have any revenue in fiscal year ended March
+Added: All of our revenue in the fiscal year ended March 31, 2023 related to our government contracts.
+Added: We did not have any accounts
+Added: receivable at March 31, 2024.
RESTRICTED CASH
14 unchanged sentences
statements of operations.
−Removed: Deferred tax assets and liabilities are recognized
−Removed: for the future tax consequences attributable to the difference between the consolidated financial statements and their respective tax
−Removed: Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities
−Removed: for financial reporting purposes and the amounts reported for income tax purposes, and (b) tax credit carryforwards.
−Removed: We record a valuation
−Removed: allowance for deferred tax assets when, based on our best estimate of taxable income (if any) in the foreseeable future, it is more likely
−Removed: than not that some portion of the deferred tax assets may not be realized.
+Added: Deferred tax assets and liabilities are recognized for the future tax consequences
+Added: attributable to the difference between the consolidated financial statements and their respective tax basis.
+Added: Deferred income taxes reflect
+Added: the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes
+Added: and the amounts reported for income tax purposes, and (b) tax credit carryforwards.
+Added: We record a valuation allowance for deferred tax assets
+Added: 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
+Added: the deferred tax assets may not be realized.
+Added: Management has provided a full valuation allowance against the Company’s net deferred
+Added: Tax positions taken or expected to be taken in the course of preparing tax returns are required to be evaluated to determine
+Added: whether the tax positions are more-likely-than-not to be sustained by the applicable tax authority.
+Added: Tax positions deemed to not meet a
+Added: more-likely-than-not threshold would be recorded as tax expense in the current year.
+Added: There were no uncertain tax positions that require
+Added: accrual to or disclosure in the consolidated financial statements as of March 31, 2024 and 2023.
LONG-LIVED ASSETS
−Removed: Long-lived assets are reviewed for impairment
−Removed: whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable.
−Removed: If the cost basis of a long-lived
−Removed: asset is greater than the projected future undiscounted net cash flows from such asset, an impairment loss is recognized.
−Removed: We believe no
−Removed: impairment charges were necessary during the fiscal years ended March 31, 2023 and 2022.
+Added: Long-lived assets are reviewed for impairment whenever
+Added: events or changes in circumstances indicate that their carrying amounts may not be recoverable.
+Added: If the cost basis of a long-lived asset
+Added: is greater than the projected future undiscounted net cash flows from such asset, an impairment loss is recognized.
+Added: We believe no impairment
+Added: charges were necessary during the fiscal years ended March 31, 2024 and 2023.
LOSS PER SHARE
−Removed: Basic loss per share is computed by dividing net
−Removed: income available to common stockholders by the weighted average number of common shares outstanding during the period of computation.
−Removed: Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional
+Added: Basic loss per share is computed by dividing net loss
+Added: available to common stockholders by the weighted average number of common shares outstanding during the period of computation.
+Added: 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.
2 unchanged sentences
As of March 31, 2024 and 2023, a total of 124,028
−Removed: and 2,243,838 potential common shares, consisting of shares underlying outstanding stock options, restricted stock units, or RSUs, and
−Removed: warrants were excluded as their inclusion would be antidilutive.
−Removed: DEFERRED FINANCING COSTS
−Removed: Costs related to the issuance of debt are capitalized
−Removed: as a deduction to our convertible notes based on the accounting standard on imputation of interest, and amortized to interest expense
−Removed: over the life of the related debt using the effective interest method.
−Removed: There was no amortization related to our deferred financing costs
−Removed: in the fiscal years ended March 31, 2023 and 2022.
+Added: and 204,501 potential common shares, consisting of shares underlying outstanding stock options, restricted stock units, or RSUs, and warrants
+Added: were excluded as their inclusion would be antidilutive.
+Added: DEFERRED OFFERING COSTS
+Added: Specific incremental costs directly attributable to
+Added: an actual offering of securities may be deferred and charged against the gross proceeds of the offering.
+Added: As of March 31, 2024, approximately
+Added: $ 278,000 of costs have been deferred.
REVENUE RECOGNITION
−Removed: Our revenues consist entirely of amounts earned
−Removed: under contracts and grants with the National Institutes of Health, or NIH.
−Removed: During the fiscal years ended March 31, 2023 and 2022, we recognized
−Removed: revenues totaling $ 574,245 and $ 294,165 , respectively, under such contracts.
−Removed: We have concluded that these agreements are not within the
−Removed: scope of ASC Topic, 606, Revenue from Contracts with Customers, or Topic 606, as the NIH grants and contracts do not meet the definition
−Removed: of a “customer” as defined by Topic 606.
−Removed: Prior to the effective date of ASC Topic 606, which for the Company was April 1,
−Removed: 2018, we accounted for our grant/contract revenues under the Milestone Method as prescribed by the legacy guidance of ASC 605-28, Revenue
−Removed: Recognition – Milestone Method, or Milestone Method.
−Removed: In the absence of other applicable guidance under US GAAP, effective April
−Removed: 1, 2018, we elected to continue to use the Milestone Method by analogy to recognize revenue under these grants/contracts.
+Added: We did not recognize revenue in fiscal year ended
+Added: March 31, 2024.
+Added: Our revenues in the fiscal year ended March 31, 2023 consisted entirely of amounts earned under contracts and grants with
+Added: the National Institutes of Health, or NIH.
+Added: During the fiscal year ended March 31, 2023, we recognized revenues totaling $ 574,245 under
+Added: such contracts.
+Added: We have concluded that these agreements are not within the scope of ASC Topic, 606, Revenue from Contracts with Customers,
+Added: or Topic 606, as the NIH grants and contracts do not meet the definition of a “customer” as defined by Topic 606.
+Added: 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
+Added: Method as prescribed by the legacy guidance of ASC 605-28, Revenue Recognition – Milestone Method, or Milestone Method.
+Added: In the absence
+Added: of other applicable guidance under US GAAP, effective April 1, 2018, we elected to continue to use the Milestone Method by analogy to
+Added: recognize revenue under these grants/contracts.
We identify the deliverables included within these
5 unchanged sentences
characteristics:
−Removed: (1) There is substantive uncertainty at the date
−Removed: the arrangement is entered into that the event will be achieved.
−Removed: A vendor’s assessment that it expects to achieve a milestone does
−Removed: not necessarily mean that there is not substantive uncertainty associated with achieving the milestone.
+Added: (1) There is substantive uncertainty at the date the
+Added: arrangement is entered into that the event will be achieved.
+Added: A vendor’s assessment that it expects to achieve a milestone does not
+Added: necessarily mean that there is not substantive uncertainty associated with achieving the milestone.
(2) The event can only be achieved based in whole
4 unchanged sentences
payments being due to the vendor.
−Removed: A milestone does not include events for which
−Removed: the occurrence is either:
+Added: A milestone does not include events for which the
+Added: occurrence is either:
(a) contingent solely upon the passage of time;
11 unchanged sentences
(2) The consideration relates solely to past performance;
−Removed: (3) The consideration is reasonable relative to
−Removed: all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement.
−Removed: A milestone is not considered substantive if any
−Removed: portion of the associated milestone consideration relates to the remaining deliverables in the unit of accounting (i.e., it does not relate
−Removed: solely to past performance).
−Removed: To recognize the milestone consideration in its entirety as revenue in the period in which the milestone
−Removed: is achieved, the milestone must be substantive in its entirety.
−Removed: Milestone consideration cannot be bifurcated into substantive and nonsubstantive
−Removed: In addition, if a portion of the consideration earned from achieving a milestone may be refunded or adjusted based on future
−Removed: performance, the related milestone is not considered substantive.
−Removed: We have recognized revenue under the following
−Removed: contracts/grants:
+Added: (3) The consideration is reasonable relative to all
+Added: of the deliverables and payment terms (including other potential milestone consideration) within the arrangement.
+Added: A milestone is not considered substantive if any portion
+Added: of the associated milestone consideration relates to the remaining deliverables in the unit of accounting (i.e., it does not relate solely
+Added: to past performance).
+Added: To recognize the milestone consideration in its entirety as revenue in the period in which the milestone is achieved,
+Added: the milestone must be substantive in its entirety.
+Added: Milestone consideration cannot be bifurcated into substantive and nonsubstantive components.
+Added: In addition, if a portion of the consideration earned from achieving a milestone may be refunded or adjusted based on future performance,
+Added: the related milestone is not considered substantive.
+Added: We have recognized revenue under the following contract/grant:
Phase 2 Melanoma Cancer Contract
On September 12, 2019, the National Cancer Institute,
−Removed: or NCI, part of the NIH, awarded to us an SBIR Phase II Award Contract, for NIH/NCI Topic 359, entitled “A Device Prototype for
−Removed: Isolation of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract.
+Added: 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
+Added: of Melanoma Exosomes for Diagnostics and Treatment Monitoring”, or the Award Contract.
The Award Contract amount was $1,860,561
6 unchanged sentences
the design and testing of a pre-commercial prototype of a more advanced version of the exosome isolation platform.
−Removed: The Award Contract ended on September 15, 2022
−Removed: and we presented the required final report to the NCI.
+Added: The Award Contract ended on September 15, 2022 and
+Added: we presented the required final report to the NCI.
As the NCI completed its close out review of the contract, we recognized as revenue
−Removed: the $ 574,245 previously recorded as deferred revenue on our December 31, 2022 balance sheet.
−Removed: Subaward with University of Pittsburgh
−Removed: In December 2020, we entered into a cost reimbursable
−Removed: subaward arrangement with the University of Pittsburgh in connection with an NIH contract entitled “Depleting Exosomes to Improve
−Removed: Responses to Immune Therapy in HNNCC.” Our share of the award was $ 256,750 .
−Removed: We did no t record revenue related to this subaward in
−Removed: the fiscal year ended March 31, 2023.
−Removed: We recorded $ 64,467 of revenue related to this subaward in the fiscal year ended March 31, 2022.
−Removed: In October 2022, we agreed with the University
−Removed: of Pittsburgh to terminate the subaward arrangement, effective as of November 10, 2022, since it related to our clinical trial in head
−Removed: and neck cancer in which the University of Pittsburgh was unable to recruit patients.
−Removed: There are no provisions in the subaward arrangement
−Removed: requiring repayment of cash received for work completed through November 10, 2022.
+Added: $ 574,245 in fiscal year ended March 31, 2023.
STOCK-BASED COMPENSATION
−Removed: Employee stock options and rights to purchase
−Removed: shares under stock participation plans are accounted for under the fair value method.
−Removed: Accordingly, share-based compensation is measured
−Removed: when all granting activities have been completed, generally the grant date, based on the fair value of the award.
−Removed: The exercise price of
−Removed: options is generally equal to the market price of the Company’s common stock (defined as the closing price as quoted on the Nasdaq
−Removed: Capital Market or OTCBB on the date of grant).
−Removed: Compensation cost recognized by the Company includes (a) compensation cost for all equity
−Removed: incentive awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair value estimated in accordance with the
−Removed: original provisions of the then current accounting standards, and (b) compensation cost for all equity incentive awards granted subsequent
−Removed: to March 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of subsequent accounting standards.
−Removed: We use a Binomial Lattice option pricing model for estimating fair value of options granted (see Note 4).
+Added: Employee stock options and rights to purchase shares
+Added: under stock participation plans are accounted for under the fair value method.
+Added: Accordingly, share-based compensation is measured when
+Added: all granting activities have been completed, generally the grant date, based on the fair value of the award.
+Added: The exercise price of options
+Added: is generally equal to the market price of the Company’s common stock (defined as the closing price as quoted on the Nasdaq Capital
+Added: Market or OTCBB on the date of grant).
+Added: Compensation cost recognized by the Company includes (a) compensation cost for all equity incentive
+Added: awards granted prior to April 1, 2006, but not yet vested, based on the grant-date fair value estimated in accordance with the original
+Added: provisions of the then current accounting standards, and (b) compensation cost for all equity incentive awards granted subsequent to March
+Added: 31, 2006, based on the grant-date fair value estimated in accordance with the provisions of subsequent accounting standards.
+Added: Binomial Lattice option pricing model for estimating fair value of options granted (see Note 4).
The following table summarizes share-based compensation
8 unchanged sentences
Basic and diluted loss per common share
−Removed: We record share-based compensation expenses for
−Removed: awards of stock options and RSUs under ASC 718, Share-based compensation, or ASC 718.
−Removed: For awards to non-employees for periods prior to
−Removed: the adoption of ASU 2018-07, Compensation-Stock Compensation:
−Removed: Improvements to Non-employee Share-Based Payment Accounting, on April 1,
−Removed: 2019, the Company had applied ASC 505-50, Equity – Equity-based payments to non-employees, or ASC 505-50.
−Removed: ASC 718 establishes guidance
−Removed: for the recognition of expenses arising from the issuance of share-based compensation awards at their fair value at the grant date.
−Removed: We recognize share-based compensation expense
−Removed: related to stock options and stock appreciation rights granted to employees, directors and consultants based on the estimated fair value
−Removed: of the awards on the date of grant.
−Removed: We estimate the grant date fair value, and the resulting share-based compensation expense, for stock
−Removed: options that only have service vesting requirements or performance-based vesting requirements without market conditions using the binomial
−Removed: lattice option-pricing model.
−Removed: The grant date fair value of the share-based awards with service vesting requirements is generally recognized
−Removed: on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards.
−Removed: the appropriate amount to expense for performance-based awards based on the achievement of stated goals requires judgment.
−Removed: of expense is revised periodically based on the probability of achieving the required performance targets and adjustments are made as
+Added: We record share-based compensation expenses for awards
+Added: of stock options and RSUs under ASC 718, Share-based compensation, or ASC 718.
+Added: For awards to non-employees for periods prior to the adoption
+Added: of ASU 2018-07, Compensation-Stock Compensation:
+Added: Improvements to Non-employee Share-Based Payment Accounting, on April 1, 2019, the Company
+Added: had applied ASC 505-50, Equity – Equity-based payments to non-employees, or ASC 505-50.
+Added: ASC 718 establishes guidance for the recognition
+Added: of expenses arising from the issuance of share-based compensation awards at their fair value at the grant date.
+Added: We recognize share-based compensation expense related
+Added: to stock options and stock appreciation rights granted to employees, directors and consultants based on the estimated fair value of the
+Added: awards on the date of grant.
+Added: We estimate the grant date fair value, and the resulting share-based compensation expense, for stock options
+Added: that only have service vesting requirements or performance-based vesting requirements without market conditions using the binomial lattice
+Added: option-pricing model.
+Added: The grant date fair value of the share-based awards with service vesting requirements is generally recognized on
+Added: a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards.
+Added: Determining the
+Added: appropriate amount to expense for performance-based awards based on the achievement of stated goals requires judgment.
+Added: The estimate of
+Added: 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.
−Removed: If any applicable financial performance goals
−Removed: are not met, no compensation cost is recognized and any previously recognized compensation cost is reversed.
−Removed: For performance-based awards
−Removed: with market conditions, we determine the fair value of awards as of the grant date using a Monte Carlo simulation model.
+Added: If any applicable financial performance goals are not met,
+Added: no compensation cost is recognized and any previously recognized compensation cost is reversed.
+Added: For performance-based awards with market
+Added: conditions, we determine the fair value of awards as of the grant date using a Monte Carlo simulation model.
We review share-based compensation on a quarterly
10 unchanged sentences
STOCK PURCHASE WARRANTS
−Removed: In the past we issued warrants for the purchase
−Removed: of shares of our common stock in connection with the issuance of common stock for cash.
−Removed: Warrants issued in connection with common stock
−Removed: for cash, if classified as equity, are considered issued in connection with equity transactions and the warrant fair value is recorded
−Removed: to additional paid-in-capital.
+Added: In the past we issued warrants for the purchase of
+Added: shares of our common stock in connection with the issuance of common stock for cash.
+Added: Warrants issued in connection with common stock for
+Added: cash, if classified as equity, are considered issued in connection with equity transactions and the warrant fair value is recorded to
+Added: additional paid-in-capital.
RESEARCH AND DEVELOPMENT EXPENSES
−Removed: Our research and development costs are expensed
+Added: Our research and development costs are expensed as
We incurred approximately $ 2,520,000 and $ 2,745,000 of research and development expenses for the years ended March 31, 2024
1 unchanged sentence
OFF-BALANCE SHEET ARRANGEMENTS
−Removed: We have not entered into any off-balance sheet
−Removed: arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial statements.
+Added: We have not entered into any off-balance sheet arrangements
+Added: that have or are reasonably likely to have a current or future material effect on our consolidated financial statements.
SIGNIFICANT RECENT ACCOUNTING PRONOUNCEMENTS
+Added: In December 2023, the FASB issued Accounting Standards
+Added: Update 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced annual disclosures for specific
+Added: categories in the rate reconciliation and income taxes paid disaggregated by federal, state and foreign taxes.
+Added: ASU 2023-09 is effective
+Added: for public business entities for annual periods beginning after December 15, 2024.
+Added: The Company is evaluating if the adoption of this new
+Added: standard will have a material effect on our disclosures.
In June 2016, the FASB issued ASU No.
−Removed: Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting, or ASU No.
−Removed: expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees.
−Removed: 2018-07 is effective for interim and annual reporting periods beginning after December 15, 2018.
−Removed: Entities must apply the guidance retrospectively
−Removed: with a cumulative effect adjustment to retained earnings as of the beginning of the period of adoption.
+Added: 2016-13, Financial
+Added: Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments.
The adoption of ASU No.
−Removed: on April 1, 2019 did not have a material impact on the Company's consolidated financial position, results of operations and related disclosures.
−Removed: On April 1, 2019, the Company adopted ASC Topic
−Removed: 842, “Leases,” utilizing the alternative transition method allowed for under this guidance.
−Removed: As a result, the Company recorded
−Removed: lease liabilities and right-of-use lease assets on its balance sheet.
−Removed: Topic 842 also allows lessees and lessors to elect
−Removed: certain practical expedients.
−Removed: The Company elected the following practical expedients:
−Removed: Transitional practical expedients, which must be elected as a package and applied consistently to all of the Company’s leases:
−Removed: The Company need not reassess whether any expired or existing contracts are or contain leases.
−Removed: The Company need not reassess the lease classification for any expired or existing leases (that is, all existing leases that were classified as operating leases in accordance with the previous guidance will be classified as operating leases, and all existing leases that were classified as capital leases in accordance with the previous guidance will be classified as finance leases).
−Removed: The Company need not reassess initial direct costs for any existing leases.
−Removed: Hindsight practical expedient.
−Removed: The Company elected the hindsight practical expedient in determining the lease term (that is, when considering lessee options to extend or terminate the lease and to purchase the underlying asset) and in assessing impairment of the Company’s right-of-use assets.
+Added: 2016-13 for smaller
+Added: reporting companies that did not previously early adopt was January 1, 2023.
+Added: The Company maintained
+Added: US Treasury bills with maturities of less than three months and expects zero credit losses from these securities.
+Added: the Company did not record an allowance for expected credit losses.
PROPERTY AND EQUIPMENT, NET
Property and equipment, net, consist of the following:
−Removed: Schedule of property and equipment
+Added: Schedule of property and equipment, net
March 31, 2024
3 unchanged sentences
Accumulated depreciation
−Removed: Furniture and office equipment, net
+Added: Fixed Assets, net
Depreciation expense for the fiscal years ended March 31, 2024 and 2023
1 unchanged sentence
Patents, net consist of the following:
−Removed: Schedule of patents
+Added: Schedule of patents, net
March 31, 2024
3 unchanged sentences
Issued patents, net of accumulated amortization
−Removed: Patents pending
−Removed: Amortization expense for our capitalized issued
−Removed: patents for each of the fiscal years ended March 31, 2023 and 2022 was $ 550 and $ 54,754 , respectively.
−Removed: As only one capitalized patent
−Removed: remains to be amortized, future amortization expense on patents is estimated to be approximately $550 per year based on the estimated
−Removed: life of the patent.
−Removed: The weighted average remaining life of our remaining capitalized patent is approximately 3 years.
+Added: Amortization expense for our capitalized issued patents
+Added: for each of the fiscal years ended March 31, 2024 and 2023 was $ 550 .
+Added: As only one capitalized patent remains to be amortized, future amortization
+Added: expense on patents is estimated to be approximately $550 per year based on the estimated life of the patent.
+Added: The weighted average remaining
+Added: life of our remaining capitalized patent is approximately 2.0 years.
EQUITY TRANSACTIONS
+Added: October 4, 2023, we effected a 1-for-10 reverse stock split of our then outstanding shares of common stock.
+Added: Accordingly, each
+Added: 10 shares of outstanding common stock then held by our stockholders were combined into one share of common stock.
+Added: Any fractional shares
+Added: resulting from the reverse split were rounded up to the next whole share.
+Added: Authorized common stock remained at 60,000,000 shares
+Added: following the stock split.
+Added: The accompanying consolidated financial statements and accompanying notes have been retroactively revised to
+Added: reflect such reverse stock split as if it had occurred on April 1, 2022.
+Added: All shares and per share amounts have been revised accordingly.
ISSUANCES OF COMMON STOCK AND WARRANTS
1 unchanged sentence
2022 At The Market Offering Agreement with H.C.
−Removed: On March 24, 2022, we entered into an At The Market Offering Agreement,
−Removed: or the 2022 ATM Agreement, with H.C.
−Removed: Wainwright & Co., LLC, or Wainwright, which established an at-the-market equity program pursuant
−Removed: to which we may offer and sell shares of our common stock from time to time as set forth in the 2022 ATM Agreement.
−Removed: The offering was registered under the Securities Act of 1933, as amended,
−Removed: or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No.
−Removed: 333-259909), as previously
−Removed: filed with the Securities and Exchange Commission, or SEC, and declared effective on October 21, 2021.
−Removed: We filed a prospectus supplement,
−Removed: dated March 24, 2022, with the SEC that provides for the sale of shares of our common stock having an aggregate offering price of up to
−Removed: $15,000,000, or the 2022 ATM Shares.
−Removed: Under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares
−Removed: by any method permitted by law and deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities
−Removed: Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the 2022 ATM Shares.
−Removed: under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions with our consent and in block
−Removed: transactions.
−Removed: Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if the sales cannot be effected
−Removed: at or above the price designated by us from time to time.
−Removed: We are not obligated to make any sales of the 2022 ATM Shares under
−Removed: the 2022 ATM Agreement.
−Removed: The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate upon the termination of
−Removed: the 2022 ATM Agreement by Wainwright or us, as permitted therein.
−Removed: The 2022 ATM Agreement contains customary representations, warranties
−Removed: and agreements by us, and customary indemnification and contribution rights and obligations of the parties.
−Removed: We agreed to pay Wainwright
−Removed: a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares.
−Removed: We also agreed to reimburse Wainwright
−Removed: for certain specified expenses in connection with entering into the 2022 ATM Agreement.
−Removed: In the fiscal year ended March 31, 2023, we raised net proceeds of
−Removed: $ 8,927,211 , net of $ 229,610 in commissions to Wainwright and $ 27,153 in other offering expense, through the sale of, 7,480,836 shares
−Removed: of our common stock at an average price of $1.19 per share under the 2022 ATM Agreement.
−Removed: RSU Grants to Non-Employee Directors
−Removed: The Compensation Committee of the Board of Directors
−Removed: of the Company, or Compensation Committee, approved, effective as of April 1, 2022, pursuant to the terms of the Company’s Amended
−Removed: and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual RSUs to each of the
−Removed: two non-employee directors of the Company then serving on the Board of Directors of the Company, or Board, and the grant of an RSU for
−Removed: the then newly appointed director.
−Removed: The RSU grants were made subject to stockholder approval of an increase of 1,800,000 shares of common
−Removed: stock authorized for issuance under the Company’s 2020 Equity Incentive Plan, or the 2020 Plan, at the Company’s 2022 annual
−Removed: meeting of stockholders.
−Removed: The increase was approved at the Company’s 2022 annual meeting of stockholders held in September 2022.
−Removed: 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
−Removed: 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
−Removed: director, with each RSU priced at the average for the closing prices for the five days preceding and including the date of grant, or $1.46
−Removed: per share as of April 1, 2022.
−Removed: The two then-current eligible directors each was granted a contingent RSU in the amount of 34,247 shares
−Removed: under the 2020 Plan and the then newly appointed director received a contingent RSU grant for 51,370 shares under the 2020 Plan.
−Removed: 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
−Removed: to the recipient's continued service with the Company on each such vesting date.
−Removed: Equity Transactions in the Fiscal Year Ended March 31, 2022.
−Removed: 2021 At The Market Offering Agreement with H.C.
+Added: Wainwright & Co.,
On March 24, 2022, we entered into an At The Market
−Removed: Offering Agreement, or the 2021 ATM Agreement, with Wainwright, as sales agent, pursuant to which we could offer and sell shares of our
−Removed: common stock, from time to time as set forth in the 2021 ATM Agreement.
−Removed: The offering was registered under the Securities
−Removed: Act pursuant to our shelf registration statement on Form S-3 (Registration Statement No.
−Removed: 333-237269), as previously filed with the SEC
−Removed: and declared effective on March 30, 2020.
−Removed: We filed a prospectus supplement with the SEC, dated March 22, 2021, in connection
−Removed: with the offer and sale of the shares of common stock, pursuant to which we could offer and sell shares of common stock having an aggregate
−Removed: offering price of up to $5,080,000 from time to time.
−Removed: Subject to the terms and conditions set forth
−Removed: in the 2021 ATM Agreement, Wainwright agreed to use its commercially reasonable efforts consistent with its normal trading and sales practices
−Removed: to sell the shares under the 2021 ATM Agreement from time to time, based upon our instructions.
−Removed: We provided Wainwright with customary
−Removed: indemnification rights under the 2021 ATM Agreement, and Wainwright was entitled to a commission at a fixed rate equal to up to three
−Removed: percent of the gross proceeds per share sold.
−Removed: In addition, we agreed to reimburse Wainwright for certain specified expenses in connection
−Removed: with entering into the 2021 ATM Agreement.
−Removed: The 2021 ATM Agreement provided that it would terminate upon the written termination by either
−Removed: party as permitted thereunder.
−Removed: Sales of the shares, under the 2021 ATM Agreement
−Removed: are made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act,
−Removed: including sales made by means of ordinary brokers’ transactions, including on the Nasdaq Capital Market, at market prices or as
−Removed: otherwise agreed with Wainwright.
−Removed: The 2021 ATM Agreement provided that we have no obligation under the 2021 ATM Agreement to sell any
−Removed: of the shares, and, at any time, we could suspend offers under the 2021 ATM Agreement or terminate the agreement.
+Added: Offering Agreement, or the 2022 ATM Agreement, with H.C.
+Added: Wainwright & Co., LLC, or Wainwright, which established an at-the-market
+Added: 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.
+Added: The offering was registered under the Securities Act
+Added: of 1933, as amended, or the Securities Act, pursuant to our shelf registration statement on Form S-3 (Registration Statement No.
+Added: as previously filed with the Securities and Exchange Commission, or SEC, and declared effective on October 21, 2021.
+Added: We filed a prospectus
+Added: 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
+Added: an aggregate offering price of up to $ 15,000,000 , which was subsequently and most recently updated pursuant to our prospectus supplement,
+Added: 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
+Added: $ 6,625,000 .
+Added: As of March 31, 2024, $ 5,302,617 of 2022 ATM Shares remained available for sale under the 2022 ATM Agreement.
+Added: Under the 2022 ATM Agreement, Wainwright may sell
+Added: 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
+Added: under the Securities Act, including sales made directly on the Nasdaq Capital Market, or on any other existing trading market for the
+Added: 2022 ATM Shares.
+Added: In addition, under the 2022 ATM Agreement, Wainwright may sell the 2022 ATM Shares in privately negotiated transactions
+Added: with our consent and in block transactions.
+Added: Under certain circumstances, we may instruct Wainwright not to sell the 2022 ATM Shares if
+Added: the sales cannot be effected at or above the price designated by us from time to time.
+Added: We are not obligated to make any further sales of
+Added: the 2022 ATM Shares under the 2022 ATM Agreement.
+Added: The offering of the 2022 ATM Shares pursuant to the 2022 ATM Agreement will terminate
+Added: upon the termination of the 2022 ATM Agreement by Wainwright or us, as permitted therein.
+Added: The 2022 ATM Agreement contains customary representations,
+Added: warranties and agreements by us, and customary indemnification and contribution rights and obligations of the parties.
+Added: We agreed to pay
+Added: Wainwright a placement fee of up to 3.0% of the aggregate gross proceeds from each sale of the 2022 ATM Shares.
+Added: We also agreed to reimburse
+Added: Wainwright for certain specified expenses in connection with entering into the 2022 ATM Agreement.
In the fiscal year ended March 31, 2024, we raised
−Removed: aggregate net proceeds under the 2021 ATM Agreement described above of $ 4,947,785 , net of $ 126,922 in commissions to Wainwright and $ 2,154
−Removed: in other offering expense, through the sale of 626,000 shares of our common stock at an average price of $ 7.90 per share of net proceeds.
−Removed: No further sales can be made under the 2021 ATM Agreement.
−Removed: Registered Direct Financing
−Removed: In the fiscal year ended March 31, 2022, we sold
−Removed: an aggregate of 1,380,555 shares of our common stock at a purchase price per share of $9.00, for aggregate net proceeds to us of $ 11,659,044 ,
−Removed: after deducting fees payable to Maxim Group LLC, the placement agent, and other offering expenses.
−Removed: These shares were sold through a securities
−Removed: purchase agreement with certain institutional investors.
−Removed: The shares were issued pursuant to an effective shelf registration statement
−Removed: on Form S-3, which was originally filed with the SEC on March 19, 2020, and was declared effective on March 30, 2020 (File No.
−Removed: and a prospectus supplement thereunder.
−Removed: Warrant Exercises
−Removed: In the fiscal year ended March 31, 2022, pursuant
−Removed: to the exercise of outstanding warrants to purchase 531,167 shares of our common stock, we received proceeds in the amount of $ 820,938
−Removed: from institutional investors.
−Removed: Also in the fiscal year ended March 31, 2022,
−Removed: pursuant to the exercise of 874,664 outstanding warrants on a cashless basis, we issued 675,554 shares of our common stock.
−Removed: The difference
−Removed: of 199,110 shares of common stock issuable pursuant to the warrants were cancelled.
−Removed: Stock Option Exercises
−Removed: In the fiscal year ended March 31, 2022, former
−Removed: employees paid us an aggregate of $ 28,325 for the exercise of outstanding options to purchase 11,562 shares of our common stock.
+Added: 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
+Added: 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
−Removed: The Company maintains the Director Compensation
−Removed: Policy which provides for cash and equity compensation for persons serving as non-employee directors of the Company.
−Removed: Under this policy,
−Removed: each new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock
−Removed: options or of RSUs at the beginning of each fiscal year.
−Removed: The (i) stock options are subject to vesting and (ii) RSUs are subject to vesting
−Removed: and represent the right to be issued on a future date shares of our common stock upon vesting.
−Removed: On April 1, 2021, pursuant to the Director Compensation
−Removed: Policy, the Compensation Committee granted RSUs under the 2020 Plan to each non-employee director of the Company.
−Removed: The Director Compensation
−Removed: Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning of each fiscal year, with the RSUs priced at the
−Removed: average for the closing prices for the five days preceding and including the date of grant, or $2.06 per share as of April 1, 2021.
−Removed: eligible director was granted an RSU in the amount of 24,295 shares under the 2020 Plan.
−Removed: The RSUs were subject to vesting in four equal
−Removed: quarterly installments on June 30, September 30, December 31, 2021, and March 31, 2022, subject to the recipient’s continued service
−Removed: with the Company on each such vesting date.
−Removed: In June 2021, 18,221 vested RSUs held by our non-employee
−Removed: directors were exchanged into the same number of shares of our common stock.
−Removed: All three non-employee directors elected to return 40% of
−Removed: their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 7,289 of the vested
−Removed: RSUs being cancelled in exchange for $ 35,786 in aggregate cash proceeds to those independent directors.
−Removed: In September 2021, 18,221 vested RSUs held by
−Removed: our non-employee directors were exchanged into the same number of shares of our common stock.
−Removed: All three non-employee directors elected
−Removed: to return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in
−Removed: 7,289 of the vested RSUs being cancelled in exchange for $ 28,134 in aggregate cash proceeds to those independent directors.
−Removed: In December 2021, 18,221 vested RSUs held by our
−Removed: non-employee directors were exchanged into the same number of shares of our common stock.
−Removed: All three non-employee directors elected to
−Removed: return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 7,289
−Removed: of the vested RSUs being cancelled in exchange for $ 13,557 in aggregate cash proceeds to those independent directors.
−Removed: In March 2022, 18,221 vested RSUs held by our
−Removed: non-employee directors were exchanged into the same number of shares of our common stock.
−Removed: All three non-employee directors elected to
−Removed: return 40% of their vested RSUs in exchange for cash, in order to pay their withholding taxes on the share issuances, resulting in 7,289
−Removed: of the vested RSUs being cancelled in exchange for $ 10,641 in aggregate cash proceeds to those independent directors.
−Removed: There were no vested RSUs outstanding as of March
−Removed: We did not issue any warrants during the fiscal
−Removed: years ended March 31, 2023 and 2022.
+Added: April 2023, the Compensation Committee of the Board, or Compensation Committee, approved, pursuant to the terms of the Company’s
+Added: Amended and Restated Non-Employee Director Compensation Policy, or the Director Compensation Policy, the grant of the annual RSUs under
+Added: the Director Compensation Policy to each of the three non-employee directors of the Company then serving on the Board of Directors of
+Added: the Company, or Board.
+Added: The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs at the beginning
+Added: 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
+Added: RSUs for a newly elected non-employee director, with each RSU priced at the average for the closing prices for the five days preceding
+Added: and including the date of grant, or $4.30 per share for the April 2023 RSU grants.
+Added: As a result, in April 2023 the three eligible directors
+Added: were each granted an RSU in the amount of 11,628 shares under the 2020 Plan.
+Added: The RSUs are subject to vesting in four equal installments,
+Added: 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
+Added: in each case to the director’s Continuous Service (as defined in the 2020 Plan), through such dates.
+Added: Vesting will terminate upon
+Added: the director’s termination of Continuous Service prior to any vesting date.
+Added: Unvested RSUs covering 4,885
+Added: shares of common stock were outstanding as of March 31, 2024.
+Added: Equity Transactions in the Fiscal Year Ended March 31, 2023.
+Added: During the fiscal year ended March 31, 2023, we raised
+Added: 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
+Added: shares of our common stock at an average price of $ 11.90 per share under the 2022 ATM Agreement.
+Added: RSU Grants to Non-Employee Directors
+Added: The Compensation
+Added: Committee approved, effective as of April 1, 2022, pursuant to the terms of the Director Compensation Policy, the grant of the
+Added: 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
+Added: newly appointed non-employee director.
+Added: The RSU grants were made subject to stockholder approval of an increase of 1,800,000
+Added: shares of common stock authorized for issuance under the Company’s 2020 Equity Incentive Plan, or the 2020 Plan, at the
+Added: Company’s 2022 Annual Meeting of Stockholders.
+Added: The increase was approved at the Company’s 2022 Annual Meeting of
+Added: Stockholders held in September 2022.
+Added: The Director Compensation Policy provides for a grant of stock options or $50,000 worth of RSUs
+Added: at the beginning of each fiscal year for current non-employee directors then serving on the Board and for a grant of stock options
+Added: 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
+Added: the five days preceding and including the date of grant, or $14.60 per share as of April 1, 2022.
+Added: The two then-current eligible
+Added: directors each was granted a contingent RSU in the amount of 3,425 shares
+Added: under the 2020 Plan and the then newly appointed director received a contingent RSU grant for 5,137 shares
+Added: under the 2020 Plan.
+Added: RSUs were subject to vesting in three installments, 50% on September 30, 2022, and 25% on each of December 31, 2022, and March 31,
+Added: 2023, subject to the recipient's continued service with the Company on each such vesting date.
+Added: There were no vested RSUs outstanding as of
+Added: March 31, 2023.
+Added: We did not issue any warrants during the fiscal years
+Added: 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:
−Removed: Summary of warrant activity
+Added: Schedule of warrant activity
Fiscal Year Ended March 31,
8 unchanged sentences
2024 is as follows:
−Removed: Summary of warrant activity exercisable and outstanding
+Added: Schedule of warrant activity exercisable and outstanding
Warrants Outstanding
5 unchanged sentences
$25.00 - $27.50
+Added: The detail of the warrants outstanding and exercisable as of March 31,
+Added: 2023 is as follows:
+Added: Warrants Outstanding
+Added: Warrants Exercisable
+Added: Exercise Prices
+Added: Exercise Price
+Added: Exercise Price
+Added: $18.75 or Below
+Added: $25.00 - $27.50
STOCK-BASED COMPENSATION:
2020 EQUITY INCENTIVE PLAN
−Removed: In September 2020, our stockholders approved the
−Removed: adoption of the 2020 Plan, to provide incentives to attract, retain and motivate employees, directors and consultants, whose present and
−Removed: potential contributions are important to our success, by offering them an opportunity to participate in our future performance through
−Removed: awards of options, the right to purchase common stock, stock bonuses and stock appreciation rights and other awards.
−Removed: We initially authorized
−Removed: a total of 1,842,556 common shares for issuance under the 2020 Plan pursuant to stock option grants, RSUs or other forms of stock-based
−Removed: compensation.
−Removed: In September 2022, our stockholders approved an
−Removed: increase in the number of shares of common stock authorized for issuance under the 2020 Plan by 1,800,000 shares.
−Removed: As of March 31, 2023,
−Removed: there were 1,667,479 shares available under the 2020 Plan.
+Added: In September 2020, our stockholders approved the adoption
+Added: of the 2020 Plan, to provide incentives to attract, retain and motivate employees, directors and consultants, whose present and potential
+Added: contributions are important to our success, by offering them an opportunity to participate in our future performance through awards of
+Added: options, the right to purchase common stock, stock bonuses and stock appreciation rights and other awards.
+Added: We initially authorized a total
+Added: of 168,182 common shares for issuance under the 2020 Plan pursuant to stock option grants, RSUs or other forms of stock-based compensation.
+Added: In September 2022, our stockholders approved an increase
+Added: in the number of shares of common stock authorized for issuance under the 2020 Plan by 180,000 shares.
+Added: As of March 31, 2024, there were
+Added: 200,948 shares available under the 2020 Plan.
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
−Removed: The Company maintains the Director Compensation
−Removed: Policy which provides cash and equity compensation for persons serving as non-employee directors of the Company.
+Added: The Company maintains the Director Compensation Policy
+Added: which provides for cash and equity compensation for persons serving as non-employee directors of the Company.
Under this policy, each
−Removed: new director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant of stock options
−Removed: or RSUs at the beginning of each fiscal year.
−Removed: The (i) stock options are subject to vesting and (ii) RSUs are subject to vesting and represent
−Removed: the right to be issued on a future date shares of our common stock upon vesting.
−Removed: Please see above under the heading "Equity
−Removed: Transactions in the Fiscal Year Ended March 31, 2023—RSU Grants to Non-Employee Directors" for disclosure regarding equity
−Removed: awards under the Director Compensation Policy during the fiscal year ended March 31, 2023.
+Added: new non-employee director receives either stock options or a grant of RSUs upon appointment/election, as well as either an annual grant
+Added: of stock options or of RSUs at the beginning of each fiscal year.
+Added: The (i) stock options are subject to vesting and (ii) RSUs are subject
+Added: to vesting and represent the right to be issued on a future date shares of our common stock upon vesting.
+Added: Please see above under the heading "Equity Transactions
+Added: in the Fiscal Year Ended March 31, 2024—RSU Grants to Non-Employee Directors" for disclosure regarding equity awards under
+Added: the Director Compensation Policy during the fiscal year ended March 31, 2024.
STOCK OPTION ACTIVITY
During the fiscal year ended March 31, 2024, we
−Removed: issued stock option grants to two executives for the purchase of an aggregate of 266,888 shares of our common stock under our 2020 Plan.
−Removed: The weighted-average exercise prices for the shares subject to the options is $ 0.95 per share, which exercise prices were based on the
−Removed: fair market value of the common stock on the applicable grant dates.
−Removed: The shares subject to the options are subject to vesting over four
−Removed: years, commencing on the grant dates, or Vesting Commencement Dates, with twenty-five percent (25%) of the shares subject to the option
−Removed: vesting on the first anniversary of the Vesting Commencement Date and the remaining shares vesting in equal monthly installments over
−Removed: the following thirty-six (36) months.
+Added: did not issue stock option grants.
+Added: The assumptions used in estimating the fair value of stock options in the fiscal year ended
+Added: March 31, 2023 included volatility ranging from 136.1 %
+Added: dividend rate, and risk-free rates between 1.49 %
+Added: 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:
−Removed: Options outstanding that have vested and are expected to vest
+Added: Schedule of options outstanding that have vested and are expected to
Expected to vest
−Removed: The following is a summary of the stock options
−Removed: outstanding at March 31, 2023 and 2022 and the changes during the years then ended:
+Added: The following is a summary of the stock options outstanding
+Added: at March 31, 2024 and 2023 and the changes during the years then ended:
Schedule of stock option activity
7 unchanged sentences
Weighted average estimated fair value of options granted
+Added: There were no stock option grants during the fiscal year ended March 31,
+Added: There were 12,222 stock options granted during the fiscal year ended March 31, 2023.
+Added: The weighted average grant date fair value
+Added: of stock options granted during the fiscal year ended March 31, 2023 was $ 61,146 .
+Added: There were 54,428 RSUs granted during the fiscal year ended
+Added: March 31, 2024.
+Added: The weighted average grant date fair value of RSUs granted during the fiscal year ended March 31, 2024 was $ 58,333 .
+Added: were no stock option exercises during the fiscal years ended March 31, 2024 and 2023.
+Added: The table below summarizes nonvested stock options as of March
+Added: 31, 2024 and changes during the year ended March 31, 2024.
+Added: Schedule of nonvested shares
+Added: Weighted Average Grant Date Fair Value
+Added: Nonvested stock options at April 1, 2023
+Added: Nonvested stock options at March 31, 2024
The detail of the options outstanding and exercisable as of March 31, 2024
is as follows:
−Removed: Detail of options outstanding and exercisable by exercise price
+Added: Schedule of detail of options outstanding and exercisable by exercise
Options Outstanding
2 unchanged sentences
$6.90 - $16.80
−Removed: $2.45 - $5.17
−Removed: $57.00 - $142.50
We recorded stock-based compensation expense related
2 unchanged sentences
of operations for the years ended March 31, 2024 and 2023.
−Removed: Our total stock-based compensation for fiscal
−Removed: years ended March 31, 2023 and 2022 included the following:
+Added: The table below summarizes restricted stock units
+Added: as of March 31, 2024 and changes during the year ended March 31, 2024.
+Added: Schedule of RSUs
+Added: Nonvested RSUs at April 1, 2023
+Added: Tax withholding payments or tax equivalent payments for net share settlement of restricted stock units
+Added: Nonvested RSUs at March 31, 2024
+Added: Our total stock-based compensation for fiscal years
+Added: ended March 31, 2024 and 2023 included the following:
Schedule of stock-based compensation
3 unchanged sentences
Vesting of restricted stock units
−Removed: Vesting of restricted shares issued for services
Vesting of stock options
6 unchanged sentences
adjustments for the fiscal year ended March 31, 2024 was insignificant.
−Removed: On March 31, 2023, our outstanding stock options
−Removed: had no intrinsic value since the closing price on that date of $ 0.38 per share was below the weighted average exercise price of our outstanding
+Added: On March 31, 2024, our outstanding stock options had
+Added: 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.
3 unchanged sentences
DUE TO RELATED PARTIES
−Removed: Historically, certain of our officers and other
−Removed: related parties have advanced us funds, agreed to defer compensation and/or paid expenses on our behalf to cover working capital deficiencies.
−Removed: There were no such related party transactions during the fiscal year ended March 31, 2023, except that we had accrued unpaid Board fees
−Removed: of $ 57,000 owed to our outside directors as of March 31, 2023.
+Added: For the fiscal year ended
+Added: March 31, 2024 we accrued unpaid fees of $ 68,250 owed to our non-employee directors.
+Added: As a result of entering
+Added: into a Separation Agreement effective November 27, 2023 with our former Chief Executive Officer, or CEO, Charles J.
+Added: Fisher, M.D., or
+Added: the Separation Agreement, we paid out accrued vacation of $ 53,076
+Added: Fisher in the fiscal year ended March 31, 2024.
+Added: That accrued vacation was previously recorded in the due to related parties
+Added: In addition, pursuant to the terms of Dr.
+Added: Fisher’s Executive Employment Agreement, we accrued $ 435,378 for
+Added: cash severance payments payable monthly and COBRA payments to be paid monthly over a 12-month period that began on December 1,
+Added: Additionally, $ 393,139
+Added: of stock-based compensation was recorded during the fiscal year ended March 31, 2024 for the acceleration of vesting for 50% of then outstanding
+Added: options held by Dr.
+Added: Fisher at the time of his separation from the Company.
due to related parties were comprised of the following items:
+Added: Schedule of amounts
due to related parties
−Removed: March 31, 2023
−Removed: March 31, 2022
Accrued Board fees
−Removed: Accrued vacation
+Added: Accrued vacation to all employees
+Added: Accrued separation expenses for former executive
Total due to related parties
1 unchanged sentence
Other current liabilities were comprised of the following items:
−Removed: Other Current Liabilities
+Added: Schedule of other current liabilities
March 31, 2024
1 unchanged sentence
Accrued professional fees
+Added: Accrued commission liability
Total other current liabilities
−Removed: For the years ended March 31, 2023 and 2022, we
−Removed: had no income tax expense due to our net operating losses and 100% deferred tax asset valuation allowance.
−Removed: At March 31, 2023 and 2022, we had net deferred
−Removed: tax assets as detailed below.
−Removed: These deferred tax assets are primarily composed of capitalized research and development costs and tax net
−Removed: operating loss carryforwards.
−Removed: Due to uncertainties surrounding our ability to generate future taxable income to realize these assets,
−Removed: a 100% valuation allowance has been established to offset the net deferred tax assets.
−Removed: Significant components of our net deferred tax
−Removed: assets at March 31, 2023 and 2022 are shown below:
+Added: During 2017 through 2020, the Company incorrectly
+Added: recorded accrued commission liability of approximately $404,000.
+Added: The Company reversed accrued commission liability of approximately $404,000
+Added: during the year ended March 31, 2024.
+Added: For the years ended March 31, 2024 and 2023, we had
+Added: no income tax expense due to our net operating losses and 100% deferred tax asset valuation allowance.
+Added: At March 31, 2024 and 2023, we had net deferred tax
+Added: assets as detailed below.
+Added: These deferred tax assets are primarily composed of capitalized research and development costs and tax net operating
+Added: loss carryforwards.
+Added: Due to uncertainties surrounding our ability to generate future taxable income to realize these assets, a 100% valuation
+Added: allowance has been established to offset the net deferred tax assets.
+Added: Significant components of our net deferred tax assets
+Added: at March 31, 2024 and 2023 are shown below:
Schedule of deferred tax assets
9 unchanged sentences
Valuation allowance for deferred tax assets
−Removed: ( 30,022,000 )
−Removed: ( 27,090,000 )
Net deferred tax assets
______________
−Removed: Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss
−Removed: carryforwards may be limited.
−Removed: At March 31, 2023, we had tax net operating loss
−Removed: carryforwards for federal and state purposes approximating $ 88 million and $ 80 million, portions of which began to expire in the year
+Added: Pursuant to Internal Revenue Code Section 382, use of
+Added: our tax net operating loss carryforwards may be limited.
+Added: The amount of the annual limitation, if any, will be determined based on the value of the Company immediately
+Added: prior to an ownership change.
+Added: Subsequent ownership changes may further affect the limitation in future years.
+Added: If and when the Company
+Added: utilizes the NOL carryforwards in a future period, it will perform an analysis to determine the effect, if any, of these loss limitation
+Added: rules on the NOL carryforward balances.
+Added: At March 31, 2024, we had tax net operating loss carryforwards
+Added: for federal and state purposes approximating $ 98 million and $ 91 million, respectively, portions of which began to expire in the year
+Added: The indefinite position is approximately $ 36 million.
+Added: 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:
−Removed: Provision for income taxes
+Added: Schedule of provision for income taxes
Income taxes (benefit) at federal statutory rate of 21.00%
−Removed: $ ( 2,526,000 )
−Removed: $ ( 2,188,000 )
Tax effect on non-deductible expenses and credits
5 unchanged sentences
Pursuant to Internal Revenue Code Section 382, use of our tax net operating loss carryforwards may be limited.
−Removed: ASC 740, “Income Taxes”, clarifies
−Removed: the accounting for uncertainty in income taxes recognized in an entity's financial statements, and prescribes recognition thresholds and
−Removed: measurement attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return.
−Removed: Under ASC 740,
−Removed: 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
−Removed: to be sustained upon audit by the relevant taxing authority.
+Added: ASC 740, “Income Taxes”, clarifies the
+Added: accounting for uncertainty in income taxes recognized in an entity's financial statements, and prescribes recognition thresholds and measurement
+Added: attributes for financial statement disclosure of tax positions taken or expected to be taken on a tax return.
+Added: Under ASC 740, the impact
+Added: 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
+Added: be sustained upon audit by the relevant taxing authority.
An uncertain income tax position will not be recognized if it has less than
10 unchanged sentences
31, 2024 or March 31, 2023.
−Removed: Our tax returns remain open for examination by
−Removed: the applicable authorities, generally 3 years for federal and 4 years for state.
−Removed: We are currently not under examination by any taxing
+Added: Our tax returns remain open for examination by the
+Added: applicable authorities, generally 3 years for federal and 4 years for state.
+Added: We are currently not under examination by any taxing authorities.
COMMITMENTS AND CONTINGENCIES
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
−Removed: We have had the following material changes to
−Removed: our contractual obligations and commitments outside the ordinary course of business during the fiscal year ended March 31, 2023:
+Added: We have had the following material changes to our
+Added: 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
−Removed: In December 2020, we entered into an agreement
−Removed: to lease approximately 2,823 square feet of office space and 1,807 square feet of laboratory space located at 11555 Sorrento Valley Road,
+Added: In December 2020, we entered into an agreement to
+Added: 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.
10 unchanged sentences
The current monthly base rent under the manufacturing component of the lease is $ 12,452 .
−Removed: During the fiscal year ended March 31, 2023, we
−Removed: recorded a $ 625,471 right-of-use lease asset and associated lease liability related to the manufacturing space component of the lease
−Removed: based on the present value of lease payments over the expected lease term of 55 months, discounted using our estimated incremental borrowing
−Removed: rate of 4.25 %.
The office, lab and manufacturing leases are coterminous
1 unchanged sentence
The weighted average discount rate is 4.25 %.
−Removed: As of our March 31, 2023 balance sheet, we have
−Removed: a right-of-use lease asset of $ 1,151,909 .
−Removed: The following table presents a maturity analysis
−Removed: of expected undiscounted cash flows for operating leases on an annual basis for the next four fiscal years.
+Added: As of our March 31, 2024 balance sheet, we have a
+Added: right-of-use lease asset of $ 883,054 .
+Added: The following table presents a maturity analysis of
+Added: 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.
−Removed: Schedule of lease maturities
+Added: Schedule of lease maturity
Fiscal Years Ended March 31,
3 unchanged sentences
Mobile Clean Room
−Removed: In addition, we rented a mobile clean room on
−Removed: a short term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed.
−Removed: 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.
−Removed: We paid approximately $ 168,171 in total rent expense to lease the mobile clean room located on this space during the fiscal year ended
−Removed: March 31, 2023.
−Removed: The arrangement was terminated in September 2022 and the mobile clean room was returned to the vendor that leased it to
−Removed: Overall, our rent expense, which is included
−Removed: in general and administrative expenses, approximated $ 519,000
−Removed: and $ 401,000 for the fiscal years
−Removed: ended March 31, 2023 and 2022, respectively.
+Added: In addition, we rented a mobile clean room on a short
+Added: term, month-to-month basis, where we housed our manufacturing operations until our permanent manufacturing space was completed.
+Added: 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.
+Added: The arrangement
+Added: was terminated in September 2022 and the mobile clean room was returned to the vendor that leased it to us.
+Added: Overall, our rent expense, which is included in general
+Added: and administrative expenses, approximated $ 420,353 and $ 519,000 for the fiscal years ended March 31, 2024 and 2023, respectively.
LEGAL MATTERS
−Removed: From time to time, claims are made against us
−Removed: in the ordinary course of business, which could result in litigation.
+Added: From time to time, claims are made against us in the
+Added: ordinary course of business, which could result in litigation.
Claims and associated litigation are subject to inherent uncertainties
1 unchanged sentence
products or engaging in other activities.
−Removed: The occurrence of an unfavorable outcome in any
−Removed: specific period could have a material adverse effect on our results of operations for that period or future periods.
−Removed: We are not presently
−Removed: a party to any pending or threatened legal proceedings.
+Added: The occurrence of an unfavorable outcome in any specific
+Added: period could have a material adverse effect on our results of operations for that period or future periods.
+Added: We are not presently a party
+Added: to any pending or threatened legal proceedings.
SUBSEQUENT EVENTS
−Removed: Management has evaluated events subsequent to
−Removed: March 31, 2023 through the date that the accompanying consolidated financial statements were filed with the Securities and Exchange Commission
+Added: Management has evaluated events subsequent to March
+Added: 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.
−Removed: Sales Under 2022 ATM Agreement
−Removed: Subsequent to March 31, 2023, we raised net proceeds
−Removed: of $1,086,119, net of $27,999 in commissions to Wainwright and $5,846 in other offering expense, through the sale of 1,778,901 shares
−Removed: of our common stock at an average price of $0.61 per share under the 2022 ATM Agreement.
−Removed: In April 2023, the Compensation Committee approved,
−Removed: pursuant to the terms of the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation Policy to each
−Removed: of the three non-employee directors of the Company then serving on the Board.
−Removed: The Director Compensation Policy provides for a grant of
−Removed: stock options or $50,000 worth of RSUs at the beginning of each fiscal year for current directors then serving on the Board, and for a
−Removed: grant of stock options or $75,000 worth of RSUs for a newly elected director, with each RSU priced at the average for the closing prices
+Added: Public Offering
+Added: On May 17, 2024, we closed a public offering pursuant
+Added: to which we sold an aggregate of:
+Added: (i) 2,450,000 shares of our common stock and accompanying Class A warrants to purchase up to 2,450,000
+Added: 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
+Added: $0.58 per share and accompanying warrants;
+Added: and (ii) in lieu of common stock, pre-funded warrants to purchase 5,650,000 shares of common
+Added: 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
+Added: shares of common stock, at a combined public offering price of $0.579 per pre-funded warrant and accompanying warrants, which is equal
+Added: to the public offering price per share of common stock, and accompanying warrants less the $0.001 per share exercise price of each such
+Added: pre-funded warrant.
+Added: The Class A and Class B warrants each have an exercise
+Added: 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
+Added: of Class B warrants, will expire on May 19, 2025.
+Added: The exercise price of the Class A and Class B warrants is also subject to adjustment
+Added: for stock splits, reverse splits, and similar capital transactions as described in such warrants.
+Added: Maxim Group LLC acted as the exclusive
+Added: placement agent for the offering.
+Added: The gross proceeds from the offering, before deducting
+Added: the placement agent’s fees and other offering expenses, were approximately $4.7 million.
+Added: The Company intends to use the net proceeds
+Added: from this offering for general corporate purposes, which may include clinical trial expenses, research and development expenses, capital
+Added: expenditures and working capital.
+Added: In June 2024, holders of Class A and Class B warrants
+Added: exercised 295,000 shares and 2,875,000 shares, respectively, for total proceeds of $1,838,600.
+Added: In April 2024, the Board approved, pursuant to the
+Added: terms of the Director Compensation Policy, the grant of the annual RSUs under the Director Compensation Policy to each of the four non-employee
+Added: directors of the Company then serving on the Board.
+Added: The Director Compensation Policy provides for a grant of stock options or $50,000
+Added: 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
+Added: 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
−Removed: the three eligible directors each was granted an RSU in the amount of 116,279 shares under the 2020 Plan.
+Added: 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
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.