Item 9A. Controls and Procedures
Item
9A. Controls and Procedures
Disclosure
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, 2023. 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, 2023.
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, 2023. 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, 2023.
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, 2023.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not
applicable.
69
PART
III
Certain
information required by Part III is omitted from this 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 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 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, 2023:
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
5,496,000
(1)
$
8.73
1,952,525
(2)
Equity Compensation Plans not approved by stockholders
—
—
—
Total
5,496,000
$
8.73
1,952,525
(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.
Other
The
other information required by this item will be set forth in the Proxy Statement and is incorporated in this 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 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 report by reference.
70
PART
IV
Item
15. Exhibits.
Exhibit No.
Description of Exhibit
1.1
Form of Placement Agent Agreement (Incorporated by reference to Exhibit 1.1 to the Registration Statement on Form S-1/A filed with the SEC on November 20, 2018).
1.2
Underwriting Agreement dated July 16, 2020 (Incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the SEC on July 16, 2020).
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
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).
4.3
Form of Placement Agent Common Stock Warrant (Incorporated by reference to Exhibit 4.2 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).
10.1
Form of Subscription Agreement (Incorporated by reference to Exhibit 10.1 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.2
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).
10.3
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).
10.4
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).
10.5
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).
10.6
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).
71
10.7
Employment Agreement between INmune Bio Inc. and Raymond Tesi (Incorporated by reference to Exhibit 10.8 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.8
Employment Agreement between INmune Bio Inc. and David Moss (Incorporated by reference to Exhibit 10.9 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.9
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).
10.10
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).
10.11
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).
10.12
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).
10.13
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).
10.14
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).
10.15
First Amendment to Stock Issuance Agreement (Incorporated by reference to Exhibit 10.20 to the Registration Statement on Form S-1 filed with the SEC on August 30, 2018).
10.16
Form of Waiver of Registration Rights. (Incorporated by reference to Exhibit 10.21 to the Registration Statement on Form S-1/A filed with the SEC on September 26, 2018).
10.17
Form of Subscription Agreement to be used in connection with the Best Efforts Offering (Incorporated by reference to the Registration Statement on Form S-1/A filed with the SEC on September 26, 2018).
10.18
Purchase Agreement between INmune Bio Inc. and Lincoln Park Capital Fund, LLC, dated May 15, 2019 (Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on May 16, 2019).
10.19
Registration Rights Agreement between INmune Bio Inc. and Lincoln Park Capital Fund, LLC, dated May 15, 2019 (Incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on May 16, 2019).
10.20
Amendment to Securities Purchase Agreement between INmune Bio Inc. and Raymond J. Tesi (Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on May 17, 2019).
72
10.21
Amendment to Securities Purchase Agreement between INmune Bio Inc. and David J. Moss (Incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC on May 17, 2019).
10.22
Sublease between INmune Bio Inc. and CTI-Clinical Trial Services, Inc. (Incorporated by reference to Exhibit 99.1 to the Current Report on Form 8-K filed with the SEC on May 24, 2019).
10.23
Amendment No. 2 to Securities Purchase Agreement between INmune Bio Inc. and Raymond J. Tesi (Incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed with the SEC on May 24, 2019).
10.24
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).
10.25
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).
10.26
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).
10.27
Employment Agreement effective as of January 1, 2021 between INmune Bio Inc. and Raymond J. Tesi (incorporated by reference to our Annual Report on Form 10-K filed with the SEC on March 4, 2021).
10.28
Employment Agreement effective as of January 1, 2021 between INmune Bio Inc. and David Moss (incorporated by reference to our Annual Report on Form 10-K filed with the SEC on March 4, 2021).
10.29
Form of Securities Purchase Agreement (incorporated by reference to the Current Report on 8-K filed with the SEC on July 15, 2021).
10.30
Form of Placement Agency Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on July 15, 2021).
10.31
Lease Agreement dated September 13, 2021 (incorporated by reference to the Current Report on Form 8-K filed with the SEC on September 15, 2021).
10.32
At-the-Market Sales Agreement, dated March 10, 2021 between the Company and BTIG, LLC (incorporated by reference to the Current Report on Form 8-K filed with the SEC on March 11, 2021).
10.33
Financial Advisory Agreement dated March 29, 2021 between the Company and National Securities Corp. (incorporated by reference to the Current Report on Form 8-K filed with the SEC on March 29, 2021).
10.34
INmune Bio Inc. 2021 Stock Incentive Plan (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 3, 2021).
10.35
Option Cancellation Agreement between the Company and Xencor, Inc. (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.36
First
Amendment to License Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.37
Loan
and Security Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.38
Warrant to purchase common stock issued to SVB Innovation Credit Fund VIII, L.P. (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
10.39
Warrant to purchase common stock issued to Silicon Valley Bank (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 15, 2021).
73
10.40
Form of nonqualified stock option agreement option agreement between the Company and non-employee directors (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 24, 2021).
10.41
Form of incentive stock option agreement between the Company and employees (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 24, 2021).
10.42
Securities Purchase Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on July 15, 2021).
10.43
Placement Agency Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on July 15, 2021).
10.44
Lease Agreement dated September 13, 2021 (incorporated by reference to the Current Report on Form 8-K filed with the SEC on September 15, 2021).
10.45
Form of Securities Purchase Agreement (incorporated by reference to the Current Report on Form 8-K filed with the SEC on March 24, 2022).
10.46
Amended and Restated INmune Bio Inc. 2021 Stock Incentive Plan (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 1, 2023).
10.47
Amendment No. 1 to At-the-Market Sales Agreement, dated August 16, 2023, between INmune Bio Inc., and BTIG, LLC (incorporated by reference to the Current Report on Form 8-K filed with the SEC on August 16, 2023).
10.48
First Amendment to Exclusive License Agreement between INmune Bio Inc. and Immune Ventures LLC dated April 17, 2023 (incorporated by reference to the Current Report on Form 8-K filed with the SEC on April 20, 2023).
10.49
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 the Current Report on Form 8-K filed with the SEC on April 20, 2023).
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*
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.
74
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 28, 2024
Raymond J. Tesi, M.D.
Chief Executive Officer
(Principal Executive Officer)
/s/ David J. Moss
Dated: March 28, 2024
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
28, 2024
/s/
David
J. Moss
David
J. Moss
Chief Financial Officer,
Treasurer, Secretary
(Principal Financial and Accounting Officer)
March
28, 2024
/s/
Timothy
Schroeder
Timothy
Schroeder
Director
March
28, 2024
/s/
J.
Kelly Ganjei
J.
Kelly Ganjei
Director
March
28, 2024
/s/
Scott
Juda
Scott
Juda, JD
Director
March
28, 2024
/s/ Edgardo
Baracchini
Edgardo
Baracchini
Director
March
28, 2024
/s/ Marcia
Allen
Marcia
Allen
Director
March
28, 2024
75