Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures” as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and such information is accumulated and communicated to our management, including the individual that serves as both our Chief Executive Officer and Principal Financial Officer, to allow timely decisions regarding required disclosure.
As of the end of the period covered by this Annual Report, we carried out an evaluation, under the supervision and with the participation of senior management, including our Chief Executive Officer (our Principal Executive and Financial Officer), of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15(b) and 15d-15(b). Based upon this evaluation, our Chief Executive Officer concluded that disclosure controls and procedures were effective as of the end of the period covered by this Annual Report.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting has been designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.
Our internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of our assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with authorization of our management and directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of June 30, 2025. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control—Integrated Framework (2013) . Based on that assessment under those criteria, our management has determined that, as of June 30, 2025, our internal control over financial reporting was effective.
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Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Attestation Report of Independent Registered Public Accounting Firm
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Item 9B. Other Information.
During the fiscal year ended June 30, 2025, no director or officer of the Company adopted or terminated a "Rule 10b5-1 trading agreement" or "non-Rule 10b5-1 trading agreement" as each term is defined in Item 408 of Regulation S-K.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this Item is set forth in our 2025 Proxy Statement to be filed with the SEC within 120 days of June 30, 2025, and is incorporated by reference into this Annual Report on Form 10-K.
Item 11. Executive Compensation.
The information required by this Item is set forth in our 2025 Proxy Statement to be filed with the SEC within 120 days of June 30, 2025, and is incorporated by reference into this Annual Report on Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item is set forth in our 2025 Proxy Statement to be filed with the SEC within 120 days of June 30, 2025, and is incorporated by reference into this Annual Report on Form 10-K.
Item 13. Certain Relationships and Related Transactions and Director Independence.
The information required by this Item is set forth in our 2025 Proxy Statement to be filed with the SEC within 120 days of June 30, 2025, and is incorporated by reference into this Annual Report on Form 10-K.
Item 14. Principal Accounting Fees and Services.
The information required by this Item is set forth in our 2025 Proxy Statement to be filed with the SEC within 120 days of June 30, 2025, and is incorporated by reference into this Annual Report on Form 10-K.
PART IV
Item 15. Exhibit and Financial Statement Schedules.
(a)(1) Financial Statements
Reference is made to Item 8 of Part II for the Company’s consolidated financial statements filed as part of this Report.
(a)(2) Financial Statement Schedules
All financial statement schedules are omitted because they are not applicable, or the amounts are immaterial, not required, or the required information is presented in the financial statements and notes thereto included in Item 8 of Part II of this Report.
(a)(3) Exhibits
Certain of the agreements filed as exhibits to this Report contain representations and warranties by the parties to the agreements that have been made solely for the benefit of the parties to the agreement. These representations and warranties:
● may have been qualified by disclosures that were made to the other parties in connection with the negotiation of the agreements, which disclosures are not necessarily reflected in the agreements;
● may apply standards of materiality that differ from those of a reasonable investor; and
● were made only as of specified dates contained in the agreements and are subject to subsequent developments and changed circumstances.
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Accordingly, these representations and warranties may not describe the actual state of affairs as of the date that these representations and warranties were made or at any other time. Investors should not rely on them as statements of fact.
The following exhibits of Rezolute, Inc. are filed or incorporated by reference as part of this Report. For exhibits that are incorporated by reference, we have indicated the document previously filed with the SEC in which the exhibit was included.
Exhibit
No.
Description
1.1
Underwriting Agreement, dated as of April 23, 2025, by and between the Company and Guggenheim Securities LLC (incorporated by reference to Exhibit 1.1 of the Company’s Form 8-K filed on April 23, 2025)
1.2
Underwriting Agreement, dated as of October 12, 2021, by and between the Company and Oppenheimer & Co., Inc. (incorporated by reference to Exhibit 1.1 of the Company's Form 8-K filed on October 13, 2021)
1.3
Underwriting Agreement, dated as of May 1, 2022, by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 of the Company’s Form 8-K filed on May 4, 2022)
1.4
Underwriting Agreement, dated as of June 13, 2024, by and between the Company and Jefferies LLC (incorporated by reference to Exhibit 1.1 of the Company’s Form 8-K filed on June 14, 2024)
2.1
Agreement and Plan of Merger dated as of June 18, 2021, by and between Rezolute, Inc. and Rezolute Nevada Merger Corporation (incorporated by reference to Exhibit 2.1 of the Company’s Form 8-K filed on June 21, 2021)
3.1
Delaware Certificate of Merger, effective as of June 18, 2021 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed on June 21, 2021)
3.2
Nevada Articles of Merger, effective as of June 18, 2021 (incorporated by reference to Exhibit 3.3 of the Company’s Form 8-K filed on June 21, 2021 )
3.3
Amended and Restated Articles of Incorporation of Rezolute Nevada Merger Corporation (incorporated by reference to Exhibit 3.3 of the Company’s Form 8-K filed on June 21, 2021)
3.4
Certificate of Amendment, as filed with the Secretary of State of the State of Nevada on June 16, 2022 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed on June 17, 2022)
3.5
Certificate of Amendment, as filed with the Secretary of State of the State of Nevada on December 6, 2024 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed on December 10, 2024 )
3.6
Amended and Restated Bylaws of Rezolute Nevada Merger Corporation ( incorporated by reference to Exhibit 3.4 of the Company’s Form 10-K filed on September 15, 2021 )
4.1
Description of Securities *
10.1
Amended and Restated Employment Agreement of Nevan Elam, dated January 8, 2023 ( incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filed on May 11, 2023 )
10.2
Amended and Restated Employment Agreement of Brian Roberts, dated January 8, 2023 ( incorporated by reference to Exhibit 10.2 of the Company’s Form 10-Q filed on May 11, 2023 )
10.3
Amended and Restated Employment Agreement of Daron Evans, dated September 15, 2024 ( incorporated by reference to Exhibit 10.4 of the Company’s Form 10-K filed on September 19, 2024)
10.4
AntriaBio, Inc. 2015 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.5 of the Company’s Form 8-K filed on February 24, 2015)
10.5
AntriaBio, Inc. 2016 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.2 of the Company’s Form 8-K filed on November 4, 2016)
10.6
AntriaBio, Inc. 2016 Non Qualified Stock Option Plan, as Amended (incorporated by reference to Exhibit 10.25 of the Company’s Form 10-K filed on September 21, 2017 )
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10.7
Rezolute, Inc. First Amendment to the 2016 Non-Qualified Stock Option Plan (incorporated by reference to Exhibit C to the Company’s Schedule 14A definitive proxy statement filed on April 5, 2019 )
10.8
2019 Non Qualified Stock Option Plan (incorporated by reference to Exhibit 10.3 of the Company’s Form 8-K filed on August 6, 2019)
10.9
Rezolute, Inc. Amended and Restated 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.23 of the Company’s Form 10-K filed on September 15, 2022)
10.10
Rezolute, Inc. 2022 Employee Stock Purchase Plan (Incorporated by reference to Exhibit 4.2 of the Registration Statement on Form S-8 filed on November 7, 2022)
10.11
2021 Incentive Compensation Plan Amendment ( incorporated by reference to Appendix A of the Company’s Schedule 14A definitive proxy statement filed on April 15, 2024 )
10.12
2021 Incentive Compensation Plan Amendment ( incorporated by reference to Appendix A of the Company’s Schedule 14A definitive proxy statement filed on October 21, 2024 )
10.13
Development and License Agreement with ActiveSite Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K filed on August 7, 2017)
10.14
License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filed on February 14, 2018)
10.15
Amendment No. 2 to the Stock Purchase Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company's Form 10-Q filed on February 14, 2019)
10.16
Amendment No. 2 to the License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.2 of the Company's Form 10-Q filed on February 14, 2019)
10.17
Amendment No. 3 to the License Agreement with XOMA (US) LLC (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q filed on May 14, 2020)
10.18
License Agreement with Handok, Inc. entered into on September 15, 2020 (incorporated by reference to Exhibit 10.21 of the Company’s Form 10-K filed on October 13, 2020)
10.19
Exit Fee Agreement, dated as of April 14, 2021 by and among Rezolute, Inc., SLR Investment Corp, as collateral agent and lender, and the other lenders named therein (incorporated by reference to Exhibit 10.2 of the Company’s Form 10-Q filed on May 17, 2021)
10.20
Open Market Sale Agreement by and between Rezolute, Inc. and Jefferies, LLC ( incorporated by reference to Exhibit 1.2 of the Registration Statement on Form S-3 filed on November 14, 2023 )
10.21
Form of Financing Warrant (incorporated by reference to Exhibit 4.1 of the Company's Form 8-K filed on April 3, 2018 )
10.22
Form of Common Stock Purchase Warrant by and between the Company and the Investor identified therein ( incorporated by reference to Exhibit 4.1 the Company’s Form 8-K filed on October 13, 2020 )
10.23
Form of Pre-Funded Warrant to Purchase Common Stock ( Incorporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed on October 13, 2021 )
10.24
Form of Class A Pre-Funded Warrant ( incorporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed on May 4, 2022 )
10.25
Form of Class B Pre-Funded Warrant ( incorporated by reference to Exhibit 4.2 of the Company’s Form 8-K filed on May 4, 2022 )
10.26
Form of Exchange Warrant ( incorporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed on March 14, 2024 )
10.27
Form of Securities Exchange Agreement ( incorporated by reference to Exhibit 10.1 of the Company’s Form 8-k filed on March 14, 2024 )
10.28
Form of Pre-funded Warrant to Purchase Common Stock (in corporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed on June 14, 2024 )
10.29
Form of Pre-funded Warrant to Purchase Common Stock (in corporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed on A pril 23 , 2025 )
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10.30
Form of Securities Purchase Agreement, dated June 25, 2024, by and between Rezolute, Inc., and the purchasers identified therein (incorporated by reference to Exhibit 10.36 of the Company’s Form 10-K filed on September 19, 2024 )
10.31
Registration Rights Agreement, dated June 25, 2024, by and between Rezolute, Inc., and the purchasers identified therein (incorporated by reference to Exhibit 10.37 of the Company’s Form 10-K filed on September 19, 2024)
10.32
Form of Securities Purchase Agreement, dated May 23, 2025 by and between Rezolute, Inc., and the purchasers identified therein ( incorporated by reference to Exhibit 10.1 of the Registration Statement on Form S-3 filed on July 17, 2025 )
10.33
Registration Rights Agreement, dated May 23, 2025 by and between Rezolute, Inc., and the purchasers identified therein ( incorporated by reference to Exhibit 10.1 of the Registration Statement on Form S-3 filed on July 17, 2025 )
10.34
Form of Award Agreement for Inducement Award Outside of 2021 Equity Incentive Plan ( incorporated by reference to Exhibit 99.1 of the Registration Statement on Form S-8 filed on December 30, 2024 )
10.35
Employment Agreement of Sunil Karnawat, dated August 18, 2025 *
14.1
Rezolute, Inc. Code of Ethics, as amended and restated as of May 30, 2023 (incorporated by reference to Exhibit 14.1 of the Company’s Form 8-K filed on June 2, 2023)
19.1
Rezolute, Inc. Insider Trading Policy, as amended and restated as of June 10, 2025 *
21.1
Listing of Subsidiaries *
23.1
Consent of Grant Thornton, LLP*
31.1
Certifications of Chief Executive Officer and Principal Financial Officer as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
32.1
Certifications of Chief Executive Officer and Principal Financial Officer as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
97
Clawback Policy (incorporated by reference to Exhibit 97 of the Company’s Form 10-K filed on September 19, 2024)
101.INS
Inline XBRL Instance Document*
101.SCH
Inline XBRL Taxonomy Extension Schema*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase*
104
Cover Page Interactive Data File, formatted in Inline XBRL (included as Exhibit 101)
* Filed herewith.
In accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed.
Item 16. Form 10-K Summary.
Not applicable
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
REZOLUTE, INC.
Date: September 17, 2025
By:
/s/ Nevan Charles Elam
Nevan Charles Elam
Acting Chair of the Board of Directors and Chief Executive Officer
(Principal Executive and Financial Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Date: September 17, 2025
By:
/s/ Nevan Charles Elam
Nevan Charles Elam
Acting Chair of the Board of Directors and Chief Executive Officer
(Principal Executive and Financial Officer)
Date: September 17, 2025
By:
/s/ Erik Harris
Erik Harris
Director
Date: September 17, 2025
By:
/s/ Gil Labrucherie
Gil Labrucherie
Director
Date: September 17, 2025
By:
/s/ Nerissa Kreher
Nerissa Kreher
Director
Date: September 17, 2025
By:
/s/ Philippe Fauchet
Philippe Fauchet
Director
Date: September 17, 2025
By:
/s/ Wladimir Hogenhuis
Wladimir Hogenhuis
Director
Date: September 17, 2025
By:
/s/ Young-Jin Kim
Young-Jin Kim
Director
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