Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our
Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December
31, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed
to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the
reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its
principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving
their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and
procedures. Based on the evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures were effective at the reasonable assurance level as of December 31, 2024.
Attestation Report of the Registered Public
Accounting Firm
This annual
report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting.
Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the Securities
and Exchange Commission that permit smaller reporting companies to provide only management’s report in this annual report.
Management’s Report on Internal Control
Over Financial Reporting
Our CEO and our CFO are responsible for establishing
and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Management
conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this
assessment, management used the criteria described in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Our management concluded that our internal controls over financial reporting
were effective based on those criteria, as of December 31, 2024.
Changes in Internal Control over Financial
Reporting
None.
Item 9B. Other Information
(b) Director and Officer
Trading Arrangements
None
of our directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading
arrangement (as such terms are defined in Item 408 of Regulation S-K) during the three months ended December 31, 2024.
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections
Not applicable.
67
PART III
Certain information required by Part III is omitted from this Annual
Report because the Company will file a definitive proxy statement within 120 days after the end of its fiscal year pursuant to Regulation 14A
(the Proxy Statement) for its annual meeting of stockholders, and certain information included in the Proxy Statement is incorporated
herein by reference.
Item 10. Directors, Executive Officers and
Corporate Governance
The information required by this Item 10 will be set forth in the
Proxy Statement and is incorporated in this Annual Report by reference.
Item 11. Executive Compensation
The information required by this item will be set forth in the Proxy Statement
and is incorporated in this Annual Report by reference.
Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
Equity Compensation Plan Information
The following table provides certain information
with respect to all of our compensation plans in effect as of December 31, 2024:
Plan Category
(A)
Number of
Securities to
be Issued
Upon
Exercise of
Outstanding
Options,
Warrants
and Rights
(B)
Weighted
Average
Exercise
Price of
Outstanding
Options,
Warrants
and Rights
(C)
Number of
Securities
Remaining
Available for
Future
Issuance
Under Equity
Compensation
Plans
(excluding
securities
reflected in
column(A))
Equity Compensation Plans approved by stockholders
7,203,307 (1)
$ 8.29
137,218 (2)
Equity Compensation Plans not approved by stockholders
—
—
—
Total
7,203,307
$ 8.29
137,218
(1) Consists
of shares subject to outstanding stock options, under the Amended and Restated INmune Bio Inc. 2021 Stock Incentive Plan (the “2021
Plan”), the 2019 Stock Incentive Plan (the “2019 Plan”) and INmune Bio Inc. 2017 Stock Incentive Plan (the “2017
Plan) some of which are vested and some of which remain subject to the vesting of the respective equity award.
(2) Consists
of shares available for future issuance under the 2021 Plan and the 2019 Plan.
Other
The other information required by this item will be set forth in the Proxy
Statement and is incorporated in this Annual Report by reference.
Item 13. Certain Relationships and Related
Transactions, and Director Independence
The information required by this item will be set forth in the Proxy Statement
and is incorporated in this Annal Report by reference.
Item 14. Principal Accounting Fees and Services
The information required by this item will be set forth in the Proxy Statement
and is incorporated in this Annual Report by reference.
68
PART
IV
Item
15. Exhibits.
Exhibit No.
Description of Exhibit
3.1
Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
3.2
Bylaws (Incorporated by reference to Exhibit 3.2 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
3.3
First Amendment to the Bylaws of INmune Bio Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 23, 2024).
3.4
Certificate of Designations of Series A Junior Participating Preferred Stock of INmune Bio Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K Filed with the SEC on December 30, 2020).
4.1
Description of Securities of INmune Bio Inc. (Incorporated by reference to Exhibit 4.1 to our Annual Report on Form 10-K filed with the SEC on March 3, 2022).
4.2
Form of Registrant’s common stock certificate (Incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1/A filed with the SEC on September 26, 2018).
4.4
Rights Agreement, dated as of December 30, 2020 (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 30, 2020).
4.5
Amendment No. 1 to the Rights Agreement between INmune Bio Inc. and VStock Transfer, LLC (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 21, 2021).
4.6
Amendment No. 2 to the Rights Agreement between INmune Bio Inc. and VStock Transfer, LLC (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 12, 2022).
4.7
Amendment No. 3 to the Rights Agreement between INmune Bio Inc. and VStock Transfer, LLC (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 18, 2023).
4.8
Amendment No. 4 to the Rights Agreement between INmune Bio Inc. and VStock Transfer, LLC (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 9, 2024).
10.1
License Agreement between INmune Bio Inc. and Immune Ventures LLC (Incorporated by reference to Exhibit 10.2 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.2
Assignment and Assumption Agreement with Immune Ventures LLC (Incorporated by reference to Exhibit 10.3 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.3
Exclusive License Agreement by the University of Pittsburgh of the Common Wealth system of Higher Education and Immune Ventures LLC (Incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.4
First Amendment to Exclusive License Agreement by and between the University of Pittsburgh of the Commonwealth system of Higher Education and Immune Ventures, LLC (Incorporated by reference to Exhibit 10.5 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.5
Material Transfer and License Agreement between Anthony Nolan Cord Blood Bank and Immune Bio International LTD. (Incorporated by reference to Exhibit 10.7 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
69
10.6
Consulting Agreement between INmune Bio Inc. and Mark Lowdell (Incorporated by reference to Exhibit 10.10 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.7
INmune Bio Inc. 2017 Stock Incentive Plan (Incorporated by reference to Exhibit 10.11 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.8
Form of Incentive Option Agreement with employees (Incorporated by reference to Exhibit 10.12 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.9
Form of Incentive Option Agreement with non-employee directors (Incorporated by reference to Exhibit 10.13 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.10
License Agreement between INmune Bio Inc. and Xencor, Inc. (Incorporated by reference to Exhibit 10.15 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.11
Amendment to the Consultancy Agreement between INmune Bio Inc. and Mark Lowdell (Incorporated by reference to Exhibit 10.17 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.12
INmune Bio Inc. 2019 Stock Incentive Plan (Incorporated by reference to Exhibit 10.29 to the Form 10-K filed with the SEC on March 11, 2020).
10.13
At-the-Market Sales Agreement, dated April 16, 2020 (Incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the SEC on April 17, 2020).
10.14
Amendment No. 1 to At-the-Market Sales Agreement 2020 (Incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the SEC on August 19, 2020).
10.15
Employment Agreement effective as of January 1, 2021 between INmune Bio Inc. and Raymond J. Tesi (incorporated by reference to Exhibit 10.28 to our Annual Report on Form 10-K filed with the SEC on March 4, 2021).
10.16
Employment Agreement effective as of January 1, 2021 between INmune Bio Inc. and David Moss (incorporated by reference to Exhibit 10.29 to our Annual Report on Form 10-K filed with the SEC on March 4, 2021).
10.17
Lease Agreement dated September 13, 2021 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on September 15, 2021).
10.18
At-the-Market Sales Agreement, dated March 10, 2021 between the Company and BTIG, LLC (incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the SEC on March 11, 2021).
10.19
INmune Bio Inc. 2021 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 3, 2021).
70
10.20
Option Cancellation Agreement between the Company and Xencor, Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.21
First Amendment to License Agreement (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.22
Loan and Security Agreement (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.23
Warrant to purchase common stock issued to SVB Innovation Credit Fund VIII, L.P. (incorporated by reference to Exhibit 10.4 to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.24
Warrant to purchase common stock issued to Silicon Valley Bank (incorporated by reference to Exhibit 10.5 to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.25
Form of nonqualified stock option agreement option agreement between the Company and non-employee directors (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 24, 2021).
10.26
Form of incentive stock option agreement between the Company and employees (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on June 24, 2021).
10.27
Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on July 15, 2021).
10.28
Placement Agency Agreement (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on July 15, 2021).
10.29
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on March 24, 2022).
10.30
Amended and Restated INmune Bio Inc. 2021 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 1, 2023).
10.31
Amendment No. 1 to At-the-Market Sales Agreement, dated August 16, 2023, between INmune Bio Inc., and BTIG, LLC (incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the SEC on August 16, 2023).
10.32
First Amendment to Exclusive License Agreement between INmune Bio Inc. and Immune Ventures LLC dated April 17, 2023 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on April 20, 2023).
10.33
Second Amendment to Exclusive License Agreement by and between the University of Pittsburgh of the Commonwealth system of Higher Education and Immune Ventures, LLC dated April 17, 2023 (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on April 20, 2023).
10.34
Securities purchase agreement to purchase common stock and warrants (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on April 22, 2024).
10.35
Warrant to purchase common stock (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed with the SEC on April 22, 2024).
10.36
Securities purchase agreement to purchase common stock and warrants (incorporated by reference to the Current Report on Form 8-K filed with the SEC on April 26, 2024).
71
10.37
Warrant to purchase common stock (incorporated by reference to the Current Report on Form 8-K filed with the SEC on April 26, 2024).
10.38
Placement
Agency Agreement, dated April 24, 2024, between INmune Bio Inc. and Maxim Group LLC (incorporated by reference to Exhibit 10.2
to Current Report on Form 8-K filed with the SEC on April 26, 2024) .
10.39
Form
of Nonqualified Option Agreement of INmune Bio Inc. (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed
with the SEC on May 16, 2024) .
10.40
Form
of Incentive Stock Option Agreement of INmune Bio Inc. (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed
with the SEC on May 16, 2024) .
10.41
Incentive
Stock Option Agreement between INmune Bio Inc. and Dr. Tesi, dated June 10, 2024 (incorporated by reference to Exhibit 10.1 to Current
Report on Form 8-K filed with the SEC on June 13, 2024) .
10.42
Securities
purchase agreement to purchase common stock and warrants (incorporated by reference to Exhibit 10.1 to the Current Report on Form
8-K filed with the SEC on September 16, 2024).
10.43
Warrant to purchase common stock (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on September 16, 2024).
10.44
At-the-Market Sales Agreement, dated August 9, 2024, by and among INmune Bio Inc., RBC Capital Markets, LLC and BTIG, LLC (incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed on August 9, 2024).
19.1
Insider Trading Policy.*
21.1
Subsidiaries.*
23.1
Consent of Marcum LLP, independent registered public accounting firm.*
31.1
Certification of principal executive officer pursuant to Section 3.02 of the Sarbanes-Oxley Act of 2002.*
31.2
Certification of principal financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
32.1
Certification of principal executive officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
32.2
Certification of principal financial officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
97.1
INmune
Bio Policy for recovery of erroneously awarded compensation (incorporated by reference to Exhibit 97.1 to our Annual Report on Form
10-K filed with the SEC on March 28, 2024).
101.INS
Inline
XBRL Instance Document
101.SCH
Inline XBRL
Taxonomy Extension Schema Document
101.CAL
Inline XBRL
Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL
Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL
Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL
Taxonomy Extension Presentation Linkbase Document
104
Cover Page
Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
* Filed herewith.
** Furnished herewith.
Item 16. Form 10-K Summary
None.
72
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.
INMUNE BIO INC.
/s/ Raymond J. Tesi
Dated: March 27, 2025
Raymond J. Tesi, M.D.
Chief Executive Officer
(Principal Executive Officer)
/s/ David J. Moss
Dated: March 27, 2025
David J. Moss
Chief Financial Officer
(Principal Financial and Accounting 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.
Signature
Title
Date
/s/ Raymond J. Tesi
Raymond J. Tesi, M.D.
President, Chief Executive Officer and Director
(Principal Executive Officer)
March 27, 2025
/s/ David J. Moss
David J. Moss
Chief Financial Officer, Treasurer, Secretary
(Principal Financial and Accounting Officer)
March 27, 2025
/s/ Timothy Schroeder
Timothy Schroeder
Director
March 27, 2025
/s/ J. Kelly Ganjei
J. Kelly Ganjei
Director
March 27, 2025
/s/ Scott Juda, JD
Scott Juda, JD
Director
March 27, 2025
/s/ Marcia Allen
Marcia Allen
Director
March 27, 2025
73