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, 2025. 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, 2025.
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, 2025. 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, 2025.
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, 2025.
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, 2025:
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
9,759,882 (1)
$ 2.63
64,668 (2)
Equity Compensation Plans not approved by stockholders
—
—
—
Total
9,759,882
$ 2.63
64,668
(1)
Consists of shares subject to outstanding stock options, under the Second 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 subject to outstanding stock options, under the Amended and Restated INmune Bio Inc. 2021 Stock Incentive Plan, some of which are vested and some of which remain subject to the vesting of the respective equity award.
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).
4.9
Amendment No. 5 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 8, 2025).
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
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).
10.14
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).
10.15
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).
10.16
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).
10.17
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
10.18
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).
10.19
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).
10.20
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).
10.21
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).
10.22
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).
10.23
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).
10.24
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).
10.25
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).
10.26
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).
10.27
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).
10.28
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).
10.29
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).
10.30
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
10.31
Warrant to purchase common stock (incorporated by reference to the Current Report on Form 8-K filed with the SEC on April 26, 2024).
10.32
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) .
10.33
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) .
10.34
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) .
10.35
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) .
10.36
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).
10.37
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).
10.38
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 with the SEC on August 9, 2024).
10.39
License agreement, dated February 6, 2025 between INmune Bio Inc. and Great Ormond Street Hospital for Children NHS Foundation Trust (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the SEC with the SEC on February 10, 2025).
10.40
Form of Securities Purchase Agreement dated June 27, 2025 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on June 30, 2025).
10.41
Second Amended and Restated INmune Bio In. 2021 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 10, 2025).
10.42
Severance agreement, dated August 4, 2025, between INmune Bio Inc. and Raymond J. Tesi (incorporated by reference to the Current Report on Form 10-Q filed with the SEC on August 7, 2025).
10.43
Employment agreement dated August 4, 0225 between INmune Bio Inc. and Cory Ellspermann (incorporated by reference to the Current Report on From 10-Q filed with the SEC on August 7, 2025).
10.44
Employment agreement dated November 26, 2025, between INmune Bio Inc. and David Moss (incorporated by reference to the Current Report on Form 8-K filed with the SEC on November 28, 2025).
72
10.45
Employment agreement dated November 26, 2025 between INmune Bio Inc. and Cory Ellspermann (incorporated by reference to the Current Report on Form 8-K filed with the SEC on November 28, 2025).
10.46
Employment agreement dated November 26, 2025 between INmune Bio International Limited and Mark Lowdell (incorporated by reference to the Current Report on Form 8-K filed with the SEC on November 28, 2025).
10.47
Amendment to Employment Agreement dated December 2, 2025 between INmune Bio Inc. and David Moss (incorporated by reference to the Current Report on Form 8-K filed with the SEC on December 3, 2025).
10.48
Amendment to Employment Agreement dated December 2, 2025 between INmune Bio Inc. and Cory Ellspermann (incorporated by reference to the Current Report on Form 8-K filed with the SEC on December 3, 2025).
10.49
Sales Agreement dated December 9, 2025 by and between INmune Bio Inc. and A.G.P./Alliance Global Partners (incorporated by reference to the Current Report on Form 8-K filed with the SEC on December 19, 2025).
10.50
Form of Warrant Amendment (incorporated by reference to the Current Report on Form 8-K filed with the SEC on December 23, 2025).
10.51
Form of Placement Agency Agreement, Dated June 27, 2025 (incorporated by reference to the Current Report on Form 8-K filed with the SEC on June 30, 2025).
19.1
Insider Trading Policy.*
21.1
Subsidiaries.*
23.1
Consent of CBIZ CPAs P.C., independent registered public accounting firm.*
23.2
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.
73
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/ David
J. Moss
Dated:
March 30, 2026
David
J. Moss
Chief Executive Officer
(Principal Executive Officer)
/s/ Cory
Ellspermann
Dated:
March 30, 2026
Cory
Ellspermann
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/ David J. Moss
President, Chief Executive Officer, Treasurer, Secretary and Director
March 30, 2026
David J. Moss
(Principal Executive Officer)
/s/ Cory Ellspermann
Chief Financial Officer
March 30, 2026
Cory Ellspermann
(Principal Financial and Accounting Officer)
/s/ Timothy Schroeder
Director
March 30, 2026
Timothy Schroeder
/s/ J. Kelly Ganjei
Director
March 30, 2026
J. Kelly Ganjei
/s/ Scott Juda, JD
Director
March 30, 2026
Scott Juda, JD
/s/ Marcia Allen
Director
March 30, 2026
Marcia Allen
74
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
AUDITED FINANCIAL STATEMENTS:
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID Number 199 ) F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNING FIRM (PCAOB ID Number 688) F-3
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2025 AND 2024 F-4
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED
DECEMBER 31, 2025 AND 2024 F-5
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY FOR THE YEARS ENDED
DECEMBER 31, 2025 AND 2024 F-6
CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024 F-7
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS F-8
F- 1
Report of Independent Registered Public Accounting Firm
To the Stockholders and Board of Directors of
INmune Bio Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of INmune Bio Inc. (the “Company”) as of December 31, 2025, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for the year ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, , the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and the results of its operations and its cash flows for the year ended December 31, 2025, in conformity with accounting principles generally accepted in the United States.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred significant losses and negative cash flows from its operating activities and is projecting insufficient liquidity to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ CBIZ CPAs P.C.
CBIZ CPAs P.C.
We have served as the Company’s auditor since 2017 (such date takes into account the acquisition of the attest business of Marcum LLP by CBIZ CPAs P.C. effective November 1, 2024).
Houston, Texas
March 30, 2026
F- 2
Report of Independent Registered Public Accounting
Firm
To the Stockholders and Board of Directors of
INmune Bio Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of INmune Bio Inc. (the “Company”) as of December 31, 2024, the related consolidated statements of operations
and comprehensive loss, changes in stockholders’ equity and cash flows for the year ended December 31, 2024, and the related notes
(collectively referred to as the “financial statements”) In our opinion, the financial statements present fairly, in all material
respects, the financial position of the Company as of December 31, 2024 and the results of its operations and its cash flows for the year
ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred significant
losses and negative cash flows from its operating activities and is projecting insufficient liquidity to meet its obligations and sustain
its operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans
in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We
are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal
control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ Marcum LLP
Marcum LLP
We served as the Company’s auditor from 2017 through 2025.
Houston, Texas
March 27, 2025
F- 3
INMUNE BIO INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
2025
December 31,
2024
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 24,751 $ 20,922
Research and development tax credit receivable 4,284 1,181
Other tax receivable 257 228
Prepaid expenses and other current assets 595 331
TOTAL CURRENT ASSETS 29,887 22,662
Equipment, net 955 -
Operating lease – right of use asset 914 307
Other assets 595 79
Acquired in-process research and development intangible assets - 16,514
TOTAL ASSETS $ 32,351 $ 39,562
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities $ 7,768 $ 6,539
Accounts payable and accrued liabilities – related parties 25 25
Deferred liabilities - 517
Operating lease, current liability 623 140
TOTAL CURRENT LIABILITIES 8,416 7,221
Long-term operating lease liability 411 244
TOTAL LIABILITIES 8,827 7,465
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Preferred stock, $ 0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding - -
Common stock, $ 0.001 par value, 200,000,000 shares authorized, 26,585,258 and 22,280,451 shares issued and outstanding, respectively 27 22
Additional paid-in capital 233,271 195,754
Accumulated other comprehensive loss ( 737 ) ( 575 )
Accumulated deficit ( 209,037 ) ( 163,104 )
TOTAL STOCKHOLDERS’ EQUITY 23,524 32,097
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 32,351 $ 39,562
See accompanying notes to these consolidated financial
statements.
F- 4
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
( In
thousands, except share and per share amounts)
2025
2024
REVENUE $ 50 $ 14
OPERATING EXPENSES
General and administrative 10,260 9,483
Research and development 20,659 33,166
Impairment of acquired in-process research and development intangible assets 16,514 -
Total operating expenses 47,433 42,649
LOSS FROM OPERATIONS ( 47,383 ) ( 42,635 )
OTHER INCOME, NET 1,450 553
NET LOSS $ ( 45,933 ) $ ( 42,082 )
Net loss per common share – basic and diluted $ ( 1.86 ) $ ( 2.11 )
Weighted average number of common shares outstanding – basic and diluted 24,757,545 19,944,304
COMPREHENSIVE LOSS
Net loss $ ( 45,933 ) $ ( 42,082 )
Other comprehensive income (loss) – foreign currency translation ( 162 ) 224
Total comprehensive loss $ ( 46,095 ) $ ( 41,858 )
See accompanying notes to these consolidated financial
statements.
F- 5
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
(In thousands, except share amounts)
Common Stock
Additional
Paid-In
Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Income (loss)
Deficit
Equity
Balance as of January 1, 2024 17,950,776 $ 18 $ 159,143 $ ( 799 ) $ ( 121,022 ) $ 37,340
Common stock issued for cash 247,126 - 2,361 - - 2,361
Common stock and warrants issued for cash 3,898,852 4 25,424 - - 25,428
Reclassification from redeemable common stock 75,697 - 799 - - 799
Exercise of warrants for cash 108,000 - 422 - - 422
Stock-based compensation - - 7,605 - - 7,605
Gain on foreign currency translation - - - 224 - 224
Net loss - - - - ( 42,082 ) ( 42,082 )
Balance as of December 31, 2024 22,280,451 22 195,754 ( 575 ) ( 163,104 ) 32,097
Common stock issued for cash 4,304,707 5 27,539 - - 27,544
Exercise of warrants for cash 100 - 1 - - 1
Amendment of warrants for cash - - 67 - - 67
Stock-based compensation - - 9,910 - - 9,910
Loss on foreign currency translation - - - ( 162 ) - ( 162 )
Net loss - - - - ( 45,933 ) ( 45,933 )
Balance as of December 31, 2025 26,585,258 $ 27 $ 233,271 $ ( 737 ) $ ( 209,037 ) $ 23,524
See accompanying notes to these consolidated financial
statements.
F- 6
INMUNE BIO INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2025 AND 2024
(In thousands)
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ ( 45,933 ) $ ( 42,082 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 9,910 7,605
Accretion of debt discount - 79
Gain on settlement of accounts payable ( 626 ) -
Depreciation expense 84 -
Impairment of acquired in-process research and development intangible assets 16,514 -
Changes in operating assets and liabilities:
Research and development tax credit receivable ( 3,103 ) 724
Other tax receivable ( 29 ) 309
Prepaid expenses and other current assets ( 264 ) 1,179
Prepaid expenses – related party - 142
Other assets ( 516 ) 52
Accounts payable and accrued liabilities 1,855 ( 1,362 )
Accounts payable and accrued liabilities – related parties - ( 10 )
Deferred liabilities ( 517 ) 28
Operating lease liability 43 ( 25 )
Net cash used in operating activities ( 22,582 ) ( 33,361 )
CASH FROM INVESTING ACTIVITIES
Purchase of fixed assets ( 1,042 ) -
Net cash used in investing activities ( 1,042 ) -
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock and warrants 27,544 27,789
Cash proceeds for amendment of warrants 67 -
Exercise of warrants for cash 1 -
Repayment of debt - ( 10,000 )
Net proceeds from the exercise of stock options - 422
Net cash provided by financing activities 27,612 18,211
Impact on cash from foreign currency translation ( 159 ) 224
NET INCREASE (DECREASE) IN CASH 3,829 ( 14,926 )
CASH AT BEGINNING OF YEAR 20,922 35,848
CASH AT END OF YEAR $ 24,751 $ 20,922
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Cash paid for income taxes $ - $ -
Cash paid for interest expense $ - $ 1,690
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right of use assets obtained in exchange for lease obligations
$ 702 $ -
See accompanying notes to these consolidated financial
statements.
F- 7
INMUNE BIO INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND BASIS OF PRESENTATION
Organization and Business Overview
INmune Bio Inc. (the “Company” or “INmune Bio”) was organized in the State of Nevada on September 25, 2015 and is a clinical stage biotechnology pharmaceutical company focused on developing and commercializing its product candidates to treat diseases where inflammation and immunology cause a dysfunctional immune system contributing to disease. INmune Bio has three product platforms. The CORDStrom product platform is a pooled, human umbilical cord mesenchymal stem cell product currently being developed to treat recessive dystrophic epidermolysis bullosa (“RDEB”). The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases and was used for its Alzheimer’s clinical trial (“XPro”). The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patient’s NK cells to eliminate minimal residual disease in patients with cancer.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements of the Company have been prepared in accordance with Generally Accepted Accounting Principles (“US GAAP”) in the United States of America and the rules of the Securities and Exchange Commission (“SEC”).
The consolidated financial statements herein have been prepared in accordance with US GAAP and include the accounts of INmune Bio, its wholly-owned United Kingdom subsidiary, and its wholly-owned Australia subsidiary (collectively, the “Company”). All significant intercompany accounts and transactions have been eliminated.
NOTE 2 – GOING CONCERN
These consolidated financial statements have been prepared in accordance with generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. The Company had net losses of approximately $ 45.9 million and $ 42.1 million and negative cash flows from operating activities of approximately $ 22.6 million and $ 33.4 million for the years ended December 31, 2025 and 2024, respectively, and an accumulated deficit of approximately $ 209.0 million and $ 163.1 million as of December 31, 2025 and 2024, respectively. Given the Company’s projected operating requirements and its existing cash and cash equivalents, the Company is projecting insufficient liquidity to sustain its operations through one year following the date that the financial statements are issued. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern for the twelve months following the issuance of these financial statements.
In response to these conditions, management is currently evaluating different strategies to obtain the required funding of future operations. Financing strategies may include, but are not limited to, the public or private sale of equity, debt financings or funds from other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. There can be no assurances that the Company will be able to secure additional financing, or if available, that it will be sufficient to meet its needs or on favorable terms. Because management’s plans have not yet been finalized and are not within the Company’s control, the implementation of such plans cannot be considered probable. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.
F- 8
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
Preparing financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. Actual results and outcomes may differ from management’s estimates and assumptions.
Fair Value of Financial Instruments
The Company measures certain assets and liabilities in accordance with authoritative guidance which requires fair value measurements to be classified and disclosed in one of the following three categories:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities.
Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
Level 3: Unobservable inputs are used when little or no market data is available.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented.
The carrying amounts of financial instruments such as cash and cash equivalents, research and development tax credit receivable, other receivable, prepaid expenses, and accounts payable and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical studies, clinical trials and regulatory approval prior to commercialization. These efforts require significant amounts of additional resources, adequate personnel, infrastructure and extensive compliance and reporting.
The Company’s product candidates are still in development and, to date, none of the Company’s product candidates have been approved for sale.
There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained or maintained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate any revenue from any of its products. The Company operates in an environment of rapid change in technology and substantial competition from other pharmaceutical and biotechnology companies.
The Company relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the clinical trial programs. These programs could be adversely affected by a significant interruption in these manufacturing services.
F- 9
Cash and Cash Equivalents
The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company holds cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes risk of loss is minimal as the cash is held by large, highly-rated financial institutions.
Research and Development Tax Incentive Receivable
The Company, through its wholly-owned subsidiary in Australia, participates in the Australian research and development tax incentive program, such that a percentage of our qualifying research and development expenditures are reimbursed by the Australian government, and such incentives are reflected as a reduction of research and development expense. The Australian research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time.
The Company, through its wholly-owned subsidiary in the United Kingdom, participates in the research and development program provided by the United Kingdom tax relief program, such that a percentage of our qualifying research and development expenditures are reimbursed by the United Kingdom government, and such incentives are reflected as a reduction of research and development expense. The United Kingdom research and development tax incentive is recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. At each period end, management estimates the reimbursement available to the Company based on available information at the time.
Equipment
Equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets and consist of scientific equipment with a 5 year life. Repairs and maintenance costs are charged to expense as incurred.
Intangible Assets
The Company capitalizes costs incurred in connection with in-process research and development purchased from others if the asset has alternative uses and such uses are not restricted under applicable license agreements; patent applications (principally legal fees), patent purchases, and trademarks related to its cell line as intangible assets. Acquired in-process research and development costs that do not have alternative uses are expensed as incurred. When the assets are determined to have a finite life (upon completion of the development of the in-process research and development for its DN-TNF platform), the useful life will be determined and the in-process research and development intangible assets will be amortized.
During the fourth quarter and if business factors indicate more frequently, the Company performs an assessment of the qualitative factors affecting the fair value of our in-process research and development. If the qualitative assessment suggests that impairment is more likely than not, a quantitative analysis is performed. The quantitative analysis involves a comparison of the fair value of the in-process research and development with the carrying amount. If the carrying amount of the in-process research and development exceeds its fair value, an impairment loss is recognized in an amount equal to that excess.
During the second quarter of 2025, the Company released the Phase 2 clinical trial results for our Alzheimer’s drug candidate, XPro, which failed to meet the primary endpoint, though a subgroup showed potential benefits. Due to insufficient resources to fund further trials, the Company has halted immediate plans to develop XPro for Alzheimer’s or other indications and are instead seeking a partner to continue these studies. As part of preparing its consolidated financial statements, the Company determined that the intangible asset’s fair value was likely below its carrying value. Following a quantitative impairment assessment, the Company estimated the asset’s fair value at $ 0 , resulting in a recorded impairment of $ 16,514,000 which was recorded during the second quarter of 2025.
Basic and Diluted Loss per Share
Basic loss per share is computed by dividing net loss available to common shareholders by the weighted average number of outstanding common shares during the period. Diluted loss per share gives effect to all dilutive potential common shares outstanding during the period. Dilutive loss per share excludes all potential common shares if their effect is anti-dilutive. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.
F- 10
At December 31, 2025, the Company had 9,759,882 potentially issuable shares of common stock upon the exercise of stock options and 3,944,138 potentially issuable shares of common stock upon the exercise of warrants.
At December 31, 2024, the Company had 7,203,307 potentially issuable shares of common stock upon the exercise of stock options and 3,944,238 potentially issuable shares of common stock upon the exercise of warrants.
Revenue Recognition
The Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed under ASC Topic 606: (1) identify contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenues when (or as) the Company satisfies the performance obligations. The Company records the expenses related to revenue in research and development expense, in the periods such expenses were incurred.
The Company records deferred revenues when cash payments are received or due in advance of performance, including amounts which are refundable.
Stock-Based Compensation
The Company utilizes the Black-Scholes option pricing model to estimate the fair value of stock option awards at the date of grant, which requires the input of highly subjective assumptions, including expected volatility and expected life. Changes in these inputs and assumptions can materially affect the measure of estimated fair value of our share-based compensation. These assumptions are subjective and generally require significant analysis and judgment to develop. When estimating fair value, some of the assumptions will be based on, or determined from, external data and other assumptions may be derived from our historical experience with stock-based payment arrangements. The appropriate weight to place on historical experience is a matter of judgment, based on relevant facts and circumstances. The Company accounts for forfeitures of stock options as they occur.
Research and Development
Research and development (“R&D”) costs are expensed as incurred. Research and development credits are recorded by the Company as a reduction of research and development costs. Major components of research and development costs include cash compensation, stock-based compensation, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, costs of pre-clinical trials, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf.
The Company recognizes grants as contra research and development expense in the consolidated statement of operations on a systematic basis over the periods in which the entity recognizes as expenses the related costs for which the grants are intended to compensate.
F- 11
Income Taxes
The Company follows the liability method of accounting for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the estimated tax consequences attributable to differences between the financial statement carrying values and their respective income tax basis (temporary differences). The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
Foreign Currency Translation
The Company’s financial statements are presented in the U.S. dollar (“$”), which is the Company’s reporting currency, while its functional currencies are the U.S. Dollar for its U.S. based operations, British Pound (“GBP”) for its United Kingdom-based operations and Australian Dollars (“AUD”) for its Australian-based operations. All assets and liabilities are translated at the exchange rate on the balance sheet date, stockholders’ equity is translated at historical rates and statement of operations items are translated at the weighted average exchange rate for the period. The resulting translation adjustments are reported under other comprehensive income. Gains and losses resulting from the translations of foreign currency transactions and balances are reflected in the statement of operations and comprehensive loss.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard was effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company applied the amendments prospectively for the year ended December 31, 2025, and the impact of the adoption of the amendments in this update was not material to the Company’s consolidated balance sheet and results of operations for the year ended December 31, 2025, since the amendments require only enhancement of existing income tax disclosures in the footnotes to the Company’s consolidated financial statements.
New Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). ASU 2024-03 requires additional disclosure of specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. ASU 2024-03 may be applied prospectively with the option for retrospective application for all prior periods presented. The Company is currently evaluating the impact of adopting this guidance on the Company’s current financial position, results of operations or financial statement disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting: Narrow-Scope Improvements . This ASU improves clarity for interim financial reporting requirements under the existing guidance within ASC 270, Interim Reporting, by creating a comprehensive list of interim disclosure requirements, clarifying scope and applicability, along with adding a principle to disclose all material events that have occurred since the most recently filed Form 10-K. This ASU is effective for interim periods within annual periods beginning after December 15, 2027. Early adoption is permitted. The Company plans to adopt this guidance for interim periods within its fiscal year beginning January 1, 2028, and does not expect the adoption of this ASU to have a material impact on its consolidated financial statements and related disclosures.
F- 12
NOTE 4 – RESEARCH AND DEVELOPMENT ACTIVITY
According to AUS tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in AUS for expenses incurred in R&D subject to certain requirements. At December 31, 2025 and 2024, the Company had a research and development tax credit receivable of $ 3,897,000 and $ 1,181,000 , respectively, for R&D expenses incurred in Australia. During the years ended December 31, 2025 and 2024, the Company received $ 0 and $ 2,475,000 of R&D tax credit reimbursements, respectively, from Australia. During January 2026, the Company received approximately $ 3.6 million in tax credit reimbursements from Australia.
According to UK tax law, the Company is allowed an R&D tax credit that reduces a company’s tax bill in the UK for expenses incurred in R&D subject to certain requirements. At December 31, 2025 and 2024, the Company had a research and development tax credit receivable of $ 387,000 and $ 0 , respectively, for R&D expenses incurred in the UK. During the years ended December 31, 2025 and 2024, the Company received no R&D tax credit reimbursements from the UK. During March 2026, the Company received approximately $ 382,000 in tax credit reimbursements from the UK.
CORDStrom Clinical Trial Data License Agreement
On February 6, 2025, the Company and Great Ormond Street Hospital for Children NHS Foundation Trust (“GOSH”) entered into a license agreement for the exclusive commercial use to clinical trial data associated with a GOSH study investigating the potential of CORDStrom to treat RDEB in pediatric patients (the “MissionEB study”). The Company owns the intellectual property covering CORDStrom, the investigational medicinal product used in the Mission EB study. In addition, the Company owns intellectual property and maintains trade secret protections covering the manufacturing of CORDStrom. With this license to the clinical trial data, the Company intends to prepare applications seeking marketing authorization of CORDStrom for treatment of pediatric RDEB in each of the FDA, EMA, and MHRA. Terms of the license agreement include a milestone payment of up to £ 6,000,000 (approximately $ 8.1 million as of December 31, 2025) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA, which had not occurred as of December 31, 2025. The Company was also required to make an upfront payment to GOSH of approximately $ 0.3 million, which the Company paid during July 2025 and recorded in research and development expense.
Under the license agreement, the Company was previously obligated to provide CORDStrom for use in the MissionEB clinical study at no cost. During February 2026, the MissionEB study was formally closed, and the Company’s obligation to supply CORDStrom in connection with that study has terminated in accordance with the terms of the license agreement. As a result, the Company has no remaining contractual product supply obligations related to the MissionEB study under the license agreement. The Company intends to provide CORDStrom at no cost for use in a contemplated follow-on clinical study referred to as “MissionEB II” however, no definitive agreement governing such study has been executed, and the Company has no present contractual obligation to supply product for MissionEB II.
Xencor, Inc. License Agreement
On October 3, 2017, the Company entered into a license agreement (“Xencor License Agreement”) with Xencor, Inc. (“Xencor”), which discovered and developed a proprietary biological molecule that inhibits soluble tumor necrosis factor. On June 10, 2021, the Company and Xencor entered into a First Amendment to License Agreement pursuant to which, among other things, Section 3.2 of the Xencor License Agreement was amended to change the due diligence milestones. Pursuant to the Xencor License Agreement, Xencor granted the Company an exclusive worldwide, royalty-bearing license in licensed patent rights, licensed know-how and licensed materials (as defined in the license agreement) to make, develop, use, sell and import any pharmaceutical product that comprises, contains, or incorporates Xencor’s proprietary protein known as “XPro” that inhibits soluble tumor necrosis factor (or all modifications, formulations and variants of the licensed protein that specifically bind soluble tumor necrosis factor) alone or in combination with one or more active ingredients, in any dosage or formulation (“Licensed Products”). The Company believes the protein has numerous medical applications. Such additional alternative applications of the technology are available under the Xencor License Agreement.
The Company also agreed to pay Xencor a 5 % royalty on Net Sales of all Licensed Products in a given calendar year, which are payable on a country-by- country and licensed product by licensed product basis until the date that is the later of (a) the expiration of the last to expire valid claim covering such Licensed Product in such country or (b) ten years following the first sale to a third party of the licensed product in such country.
During the second quarter of 2025, the Company released the Phase 2 clinical trial results for our Alzheimer’s drug candidate, XPro, which failed to meet the primary endpoint, though a subgroup showed potential benefits. Due to insufficient resources to fund further trials, the Company has halted immediate plans to develop XPro for Alzheimer’s or other indications and are instead seeking a partner to continue these studies. As part of preparing its consolidated financial statements, the Company determined that the intangible asset’s fair value was likely below its carrying value. Following a quantitative impairment assessment, the Company estimated the asset’s fair value at $ 0 , resulting in a recorded impairment of $ 16,514,000 during the second quarter of 2025.
F- 13
INKmune License Agreement
On October 29, 2015, the Company entered into an exclusive license agreement (the “INKmune License Agreement”) with Immune Ventures, LLC (“Immune Ventures”), and subsequently modified the agreement in 2018, 2020 and 2023. Pursuant to the INKmune License Agreement, the Company was granted exclusive worldwide rights to the patents, including rights to incorporate any improvements or additions to the patents that may be developed in the future. In consideration for the patent rights, the Company agreed to the following milestone payments:
(in thousands)
Each Phase I initiation $ 25
Each Phase II initiation $ 250
Each Phase III initiation $ 350
Each NDA/EMA filing $ 1,000
Each NDA/EMA awarded $ 9,000
In addition, the Company agreed to pay the licensor a royalty of 1 % of net sales during the life of each patent granted to the Company. The License is owned by Immune Ventures. David Moss, the Company’s Chief Executive Officer and President, Mark Lowdell, the Company’s Chief Scientific Officer, and RJ Tesi, the Company’s former Chief Executive Officer, are the owners of Immune Ventures. No sales have occurred under this license. During December 2023, the Company initiated a Phase I clinical trial with INKmune in patients with metastatic castration-resistant prostate cancer. The Company recorded a $ 25,000 payable to Immune Ventures related to this trial, which remained outstanding as of December 31, 2025 and 2024.
University of Pittsburg License Agreement
On October 3, 2017, the Company entered into an Assignment and Assumption Agreement with Immune Ventures related to intellectual property licensed from the University of Pittsburgh. Pursuant to the Assignment and Assumption Agreement (“Assignment Agreement”), Immune Ventures assigned all of its rights, obligations and liabilities under an Exclusive License Agreement between the University of Pittsburgh – Of the Commonwealth System of Higher Education (“Licensor”) and Immune Ventures to INmune Bio (“Licensee”), (the “PITT Agreement”).
Consideration under the PITT Agreement includes: (i) annual maintenance fees, (ii) royalty payments based on the sale of products making use of the licensed technology, and (iii) milestone payments.
Annual maintenance fees under the PITT Agreement include $ 25,000 due on June 26, 2025 and thereafter until first commercial sale. At December 31, 2025, the Company owed the University of Pittsburgh $ 25,000 for annual maintenance fees.
Upon first commercial sale of a product making use of the licensed technology under the PITT Agreement, the Licensee is required to pay royalties equal to 2.5 % of Net Sales each calendar quarter. As of December 31, 2025, there have been no commercial sales of product making use of the licensed technology under the PITT Agreement.
F- 14
Moreover, under the PITT Agreement the Licensee is required to make milestone payments as follows:
(in thousands)
Each Phase I initiation $ 50
Each Phase III initiation $ 500
First commercial sale of product making use of licensed technology $ 1,250
The PITT Agreement expires upon the earlier of: (i) expiration of the last claim of the Patent Rights forming the subject matter of the PITT Agreement; or (ii) the date that is 20 years from the effective date of the agreement (June 26, 2037).
The Licensee may terminate the PITT Agreement upon 3 months prior written notice provided all payments under the license are current. The Licensor may terminate the PITT Agreement upon written notice if: (i) Licensee defaults as to performance of material obligations which have not been cured within 60 days after receiving written notice; or (ii) Licensee ceases to carry out its business, becomes bankrupt or insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets or seeks relief under any law for the aid of debtors.
NOTE 5 – FAIR VALUE MEASUREMENTS
The following table presents the hierarchy for assets and liabilities measured at fair value on a recurring basis:
(in thousands) Total Quoted
Price in
Active
Market
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
December 31, 2025:
Cash equivalents
Money market funds $ 24,298 $ 24,298 $ - $ -
Total cash equivalents $ 24,298 $ 24,298 $ - $ -
(in thousands) Total Quoted
Price in
Active
Market
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
December 31, 2024:
Cash equivalents
Treasury bills $ 10,260 $ 10,260 $ - $ -
Money market funds 10,328 10,328 - -
Total cash equivalents $ 20,588 $ 20,588 $ - $ -
NOTE 6 – LEASES
In April 2025, the Company’s wholly-owned subsidiary, INmune Bio International Ltd., entered into an agreement whereby the Company leases manufacturing space from a third party in the United Kingdom for 2 years. The operating lease requires payments of approximately $ 76,000 each quarter during the first year and $ 152,000 each quarter during the second year. The lease commencement date was August 2025.
In September 2021, the Company signed a lease with a third party for office space in Boca Raton, Florida. The lease agreement has a 64 -month term and commenced during the fourth quarter of 2021. During March 2026, the Company exercised its option to renew the term of its office space in Boca Raton, Florida. The option renewal provides for an additional three -year term commencing April 1, 2027. Base rent under the extension will be approximately $ 17,000 per month during the first year, increasing by approximately 3 % annually over the term.
F- 15
As of December 31, 2025, the maturities of our lease liabilities are as follows:
(in thousands, except years)
2026 $ 729
2027 405
Total lease payments 1,134
Less: imputed interest ( 100 )
Present value of future lease payments 1,034
Less: operating lease, current liabilities ( 623 )
Long-term operating lease liabilities $ 411
The weighted average lease term was 1.5 years and 2.3 years as of December 31, 2025 and 2024, respectively. As of December 31, 2025 and December 31, 2024, the weighted-average discount rate for operating leases was 12.0 %. During the years ended December 31, 2025 and 2024, the Company recognized $ 381,000 and $ 161,000 , respectively, of lease expense.
NOTE 7 – RELATED PARTY TRANSACTIONS
University College London
During the years ended December 31, 2025 and 2024, the Company made payments to University College London (“UCL”) of $ 132,000 and $ 321,000 , respectively, for medical research performed on behalf of the Company. UCL is a wholly owned subsidiary of the University of London. The Company’s Chief Scientific and Manufacturing Officer is a professor at the University of London.
AmplifyBio
At December 31, 2025 and December 31, 2024, the Company recorded a payable to AmplifyBio of $ 26,000 and $ 0 , respectively, for medical research performed on behalf of the Company. During the years ended December 31, 2025 and 2024, the Company paid AmplifyBio $ 41,000 and $ 324,000 , respectively. During 2025, AmplifyBio ceased operations. Amplify Bio’s former CEO is on the board of directors of the Company.
NOTE 8 – EQUIPMENT, NET
Equipment, net consisted of the following (in thousands):
December 31,
2025 December 31,
2024
Lab equipment $ 1,042 $ -
Less: Accumulated Depreciation ( 87 ) -
Total $ 955 $ -
F- 16
NOTE 9 – DEBT
During 2021, the Company entered into a Loan and Security Agreement (the “Term Loan”) with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., together (the “Lenders”) in which the Company borrowed $ 15 million. The Term Loan was secured by the Company’s assets. During December 2024, the Company paid off the Term Loan in full. During February 2025, the Company entered into a letter agreement with the Lenders whereby the Term Loan was terminated.
For the years ended December 31, 2025 and 2024, the Company recognized interest expense of $ 0 and $ 789,000 , respectively, related to the Term Loan.
NOTE 10 – STOCKHOLDERS’ EQUITY
Registered Direct Offerings
During June 2025, the Company entered into securities purchase agreements with investors whereby the Company sold 3,000,000 shares of the common stock in a registered direct offering in exchange for gross proceeds of $ 18.9 million (net proceeds of approximately $ 17.4 million).
During September 2024, the Company entered into securities purchase agreements with investors whereby the Company sold 2,341,260 shares of the Company’s common stock and warrants to purchase an additional 2,341,260 shares of the Company’s common stock in a registered direct offering in exchange for gross proceeds of $ 13.0 million (net proceeds of approximately $ 12.0 million). Directors and officers that participated in the offering paid a combined offering price of $ 6.50 per share and warrant, and other investors paid $ 5.50 per share and warrant.
During April 2024, the Company entered into a securities purchase agreement with an investor whereby the Company sold 986,000 shares of the Company’s common stock and warrants to purchase an additional 986,000 shares of the Company’s common stock in a registered direct offering in exchange for gross proceeds of approximately $ 9.7 million (net proceeds of approximately $ 8.9 million).
During April 2024, the Company entered into securities purchase agreements with investors whereby the Company sold 571,592 shares of the Company’s common stock and warrants to purchase an additional 571,592 shares of the Company’s common stock in a registered direct offering in exchange for gross proceeds of approximately $ 4.8 million (net proceeds of approximately $ 4.5 million). Directors and officers that participated in the offering paid a combined offering price of $ 8.445 per share and warrant, and other investors paid $ 8.32 per share and warrant.
Common Stock – At-the-Market Offerings
During March 2021, the Company entered into a sales agreement with BTIG, LLC (“BTIG”), as sales agent, to establish an At-The-Market (“ATM”) offering program of up to $ 45 million of common stock, which the Company amended in August 2023. The Company was required to pay BTIG a commission of 3 % of the gross proceeds from the sale of shares. During the year ended December 31, 2024, the Company issued and sold 198,364 shares of common stock at an average price of $ 10.56 per share under the ATM program. The aggregate net proceeds were approximately $ 2.0 million after BTIG’s commission expenses.
During August 2024, the Company entered into an amended and restated at-the-market sales agreement with RBC Capital Markets LLC and BTIG (together, the “Sales Agents”) relating to the offer and sale of shares of our common stock with an aggregate offering price of up to $ 75.0 million. This amended and restated at-the-market sales agreement replaced the sales agreement entered into with BTIG in March 2021, as amended in August 2023. The Company was required to pay the Sales Agents a commission of 3 % of the gross proceeds from the sale of shares. During the year ended December 31, 2024, the Company issued and sold 48,762 shares of common stock under its at-the-market (“ATM”) program at an average price of $ 6.96 per share, resulting in net proceeds of approximately $ 0.3 million after commissions.. During the year ended December 31, 2025, the Company issued and sold 1,304,707 shares of common stock under the ATM program at an average price of $ 8.01 per share, resulting in net proceeds of approximately $ 10.1 million after commissions. On December 19, 2025, the Company terminated the amended and restated ATM sales agreement with the Sales Agents.
On December 19, 2025, the Company entered into a sales Agreement with A.G.P./Alliance Global Partners (“A.G.P.”), as sales agent, pursuant to which the Company may offer and sell, from time to time, up to $ 65,000,000 of shares of its common stock through A.G.P. in exchange for a 3 % commission on gross proceeds. There were no sales of stock pursuant to this agreement in 2025.
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Stock options
On June 10, 2025, the Company’s shareholders approved an amendment to the 2021 Incentive Stock Plan to increase the shares of the Company’s common stock available for issuance thereunder to 6,500,000 shares.
During August 2025, the Company modified 1,513,882 stock option awards held by its former Chief Executive Officer to extend the post-termination exercise period and provide that unvested stock options shall continue to vest pursuant to the severance agreement, which will result in additional stock-based compensation expense of up to $ 2.4 million to be expensed over the remaining original vesting term, if any, of the stock option awards.
In November 2025, the Company’s stockholders approved the repricing of 5,511,000 outstanding stock options of current employees, which reduced the exercise prices of these options to $ 1.50 per share from their original exercise prices ranging from $ 3.91 to $ 24.82 . All other terms of the options, including vesting schedules, remain unchanged. The repricing resulted in incremental stock-based compensation of approximately $ 1.9 million, which is being recognized over the remaining vesting period, if any, of the stock option awards.
During 2025, the Company granted certain employees and directors options to purchase 2,775,000 shares of its common stock pursuant to the 2021 Incentive Stock Plan. The stock options had a fair value of approximately $ 4.0 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.80 % - 4.60 % based on the applicable US Treasury bill rate (2) expected life of 5.4 – 10.0 years, (3) expected volatility of approximately 96 % - 100 and (4) zero expected dividends.
During 2024, the Company granted certain employees and directors options to purchase 1,964,307 shares of its common stock pursuant to the 2021 Incentive Stock Plan. The stock options had a fair value of approximately $ 11.6 million that was calculated using the Black-Scholes option-pricing model. Variables used in the Black-Scholes option-pricing model include: (1) discount rate of 3.90 % - 4.46 % based on the applicable US Treasury bill rate (2) expected life of 5.5 – 10.0 years, (3) expected volatility of approximately 100 % - 106 % and (4) zero expected dividends.
At December 31, 2025, the Company had 64,668 shares reserved for issuance pursuant to the 2021 Incentive Stock Plan.
The following table summarizes stock option activity:
(in thousands, except share and per share amounts) Number of
Shares Weighted-
average
Exercise
Price Weighted-
average
Remaining
Contractual
Term
(years) Aggregate
Intrinsic
Value
Outstanding at December 31, 2023 5,496,000 $ 8.73 6.18 -
Options granted 1,964,307 $ 7.06 10.0 -
Options exercised ( 149,000 ) $ 9.90 - -
Options cancelled ( 108,000 ) $ 3.91 - -
Outstanding at December 31, 2024 7,203,307 $ 8.29 6.49 1,218
Options granted 2,775,000 $ 1.71 10.0 -
Options cancelled ( 218,425 ) $ 10.79 - -
Options exercised - $ - - -
Outstanding at December 31, 2025 9,759,882 $ 2.63 6.83 $ 545
Exercisable at December 31, 2025 5,467,829 $ 3.16 4.76 $ 256
During the years ended December 31, 2025 and 2024, the Company recognized stock-based compensation expense of $ 9,910 ,000 and $ 7,605 ,000, respectively, related to stock options. As of December 31, 2025, there was $ 9,973,000 of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.37 years.
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Warrants
SVB Warrants
The Company issued warrants to the Company’s lenders upon obtaining a loan in June 2021. The warrants expire in June 2031 and have an exercise price of $ 14.05 . At December 31, 2025 and 2024, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $ 0 .
April 2024 Warrants
In April 2024, the Company issued an aggregate of 1,557,592 warrants to investors in connection with the sale of common stock. The warrants, as originally issued, had exercise prices ranging from $ 9.152 to $ 9.84 per share and were scheduled to expire in April 2026.
In December 2025, warrants to purchase 1,348,315 shares of common stock originally issued in April 2024 were amended in exchange for cash proceeds of approximately $ 67,000 . The exercise price of the amended warrants was reduced to $ 1.95 per share (from $ 9.152 – $ 9.84 ), and the expiration date was extended to June 2026 (from April 2026). The incremental fair value attributable to the modified awards held by employees and consultants, calculated as the difference between the fair value of the modified awards and the fair value of the original awards immediately prior to modification, was approximately $ 95,000 and was recorded as stock-based compensation expense.
As of December 31, 2025 and 2024, all 1,557,592 warrants remain outstanding and exercisable for cash at a weighted-average exercise price of $ 2.92 per share. The intrinsic value of these warrants was $ 0 at December 31, 2025, and they expire between April 2026 and June 2026.
September 2024 Warrants
During September 2024, the Company issued 2,341,260 warrants to investors in connection with the sale of common stock. At December 31, 2025, and 2024, 2,341,260 and 2,341,160 , respectively, of these warrants are outstanding and are exercisable for cash at a weighted average price of $ 6.40 per share and expire in March 2030. The intrinsic value of these warrants was $ 0 as of December 31, 2025.
Stock-based Compensation by Class of Expense
The following summarizes the components of stock-based compensation expense in the consolidated statements of operations for the years ended December 31, 2025 and 2024, respectively:
(in thousands) Year Ended
December 31,
2025 Year Ended
December 31,
2024
Research and development $ 4,048 $ 3,037
General and administrative 5,862 4,568
Total $ 9,910 $ 7,605
Shareholder Rights Agreement
On December 30, 2020, the Board of Directors (the “Board”) of the Company approved and adopted a Rights Agreement, dated as of December 30, 2020, by and between the Company and VStock Transfer, LLC, as rights agent, pursuant to which the Board declared a dividend of one preferred share purchase right (each, a “Right”) for each outstanding share of the Company’s common stock held by stockholders as of the close of business on January 11, 2021. When exercisable, each right initially would represent the right to purchase from the Company one one-thousandth of a share of a newly designated series of preferred stock, Series A Junior Participating Preferred Stock, par value $ 0.001 per share, of the Company, at an exercise price of $ 300.00 per one one-thousandth of a Series A Junior Participating Preferred Share, subject to adjustment. Subject to various exceptions, the Rights become exercisable in the event any person (excluding certain exempted or grandfathered persons) becomes the beneficial owner of twenty percent or more of the Company’s common stock without the approval of the Board. The Rights Agreement was amended in 2021, 2022, 2023, 2024 and 2025. On December 5, 2025, the Rights Agreement was further renewed until December 31, 2026 and shall automatically renew on December 31 of each year thereafter unless the Board determines not the extend the Rights Agreement.
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Preferred Stock
In 2020, the Company designated 45,000 shares of its preferred stock with par value of $ 0.001 per share as Series A Junior Participating Preferred Stock. The remaining 9,955,000 shares of preferred stock with par value of $ 0.001 remain undesignated. None of the preferred shares were issued and outstanding at December 31, 2025 and 2024.
NOTE 11 – INCOME TAXES
Loss before income taxes summarized by region was as follows:
(in thousands) December 31,
2025 December 31,
2024
United States $ 35,763 $ 22,603
Foreign 10,170 19,479
Total loss before income taxes 45,933 42,082
The provision for income taxes consists of the following components:
December 31,
2025 December 31,
2024
Current expense (benefit)
Federal $ - $ -
State - -
Foreign - -
Total current - -
Deferred expense (benefit)
Federal - -
State - -
Foreign - -
Total deferred - -
Income tax expense (benefit) $ - $ -
A reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense for the year ended December 31, 2025 after the adoption of ASU 2023-09 is as follows:
Amount Percent
US Federal Statutory Tax Rate $ ( 9,646 ) 21.0
State and Local Taxes, Net of Federal Income Tax Effect - -
Foreign Tax effects
United Kingdom
Statutory tax rate difference between the United Kingdom and United States 99 ( 0.2 )
Change in valuation allowance 1,046 ( 2.2 )
Other ( 101 ) 0.2
Australia
Statutory tax rate difference between Australia and United States ( 208 ) 0.4
Change in valuation allowance 554 ( 1.2 )
Research and development 745 ( 1.6 )
Changes in Valuation Allowances 6,221 ( 13.6 )
Nontaxable or nondeductible items
Stock-based compensation 1,287 ( 2.8 )
Other 3 ( 0.0 )
Effective Tax Rate $ - -
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A reconciliation of income tax benefit computed using the federal statutory income tax rate to the Company’s tax expense for the year ended December 31, 2024 before the adoption of ASU 2023-09 is as follows:
(in thousands, except percentage) December 31,
2024
Federal tax benefit at statutory rate (21%) $ ( 8,837 )
Stock-based compensation 1,297
State income tax benefit, net of federal tax effect ( 320 )
Foreign tax differential ( 482 )
Research credits 268
Other 2
Return to provision adjustment 2,052
Change in valuation allowance 6,020
Income tax benefit $ -
The principal components of deferred tax assets and liabilities consist of the following at December 31, 2025 and 2024, respectively:
(in thousands) December 31,
2025 December 31,
2024
Deferred tax assets
Stock-based compensation $ 3,100 $ 2,142
Research and development 1,217 4,716
Intangible asset 4,105 -
Federal NOL carryforwards 13,634 8,686
State NOL carryforwards 2,834 1,923
Foreign NOL carryforwards 9,820 8,221
Total deferred tax assets 34,710 25,688
Less valuation allowance ( 34,710 ) ( 25,688 )
Net deferred tax assets $ - $ -
We file income tax returns in the United States, the United Kingdom and Australia. The Company is no longer subject to Internal Revenue Service tax examinations by tax authorities for years prior to 2022. The United Kingdom and Australia are no longer subject to income tax examination for years prior to 2024 and 2023, respectively.
As of December 31, 2025, the Company has a federal net operating loss carryforward of approximately $ 64.9 million, a United Kingdom net operating loss carryforward of $ 22.9 million and an Australia net operating loss carryforward of $ 21.9 million. The federal net operating loss carryforwards for 2017 will begin to expire in the year ending December 31, 2037 . The remaining federal net operating loss carryforwards generated after 2017 have no expiration. The United Kingdom and Australia net operating losses have no expiration. The Company has net operating loss carryforwards in California and Florida of $ 14.9 million and $ 46.5 million, respectively, of which the California net operating losses will begin to expire in the year ending December 31, 2037 , and the Florida net operating losses have no expiration.
The Company’s gross deferred tax assets of $ 34.7 million and $ 25.7 million at December 31, 2025 and 2024, respectively, primarily consist of net operating loss carryforwards for income tax purposes. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets will be realized. Since the Company cannot be assured of generating taxable income and thereby realizing the net deferred tax assets, a full valuation allowance has been recorded. The change in the valuation allowance was $ 9.0 million during the year ended December 31, 2025.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as expensing of U.S. research expenditures and eligible capital expenditures, the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The impacts of the OBBBA are reflected in our results for the year ended December 31, 2025, and there was no impact to our income tax expense or effective income tax rate.
The Company recognizes uncertain tax positions in accordance with ASC 740 on the basis of evaluating whether it is more likely than not that the tax positions will be sustained upon examination by tax authorities. For those tax positions that meet the more-likely-than not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. As of December 31, 2025, and 2024, the Company has no significant uncertain tax positions. There are no unrecognized tax benefits included on the balance sheet that would, if recognized, impact the effective tax rate. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months.
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NOTE 12 – COMMITMENTS AND CONTINGENCIES
Litigation
The Company is subject to claims and suits that arise from time to time in the ordinary course of our business. Although management currently believes that resolving claims against the Company, individually or in aggregate, will not have a material adverse impact in the Company’s consolidated financial statements, these matters are subject to inherent uncertainties and management’s view of these matters may change in the future.
Commitments
During April 2025, the Company’s wholly-owned subsidiary, INmune Bio International Ltd., entered into a 2-year collaboration agreement with a vendor whereby it makes payments to the vendor in exchange for services pursuant to manufacturing CORDStrom in the United Kingdom. which the Company records within research and development expenses. During the year ended December 31, 2025, the Company recorded approximately $869,000 in research and development expense pursuant to the collaboration agreement. A summary of the commitments payable for these services pursuant to the agreement is as follows as of December 31, 2025:
(in thousands, except years)
2026 $ 1,432
2027 1,216
Total $ 2,648
NOTE 13 – SEGMENT INFORMATION
The Company operates as one operating segment. The Company’s chief operating decision maker (“CODM”) is its Chief Executive Officer , who reviews the financial statements on a consolidated basis. The CODM uses the Company’s long-range plan to allocate resources. The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results using consolidated loss from operations .
Significant expenses within loss from operations, as well as within net loss, include research and development and general and administrative expenses, which are each separately presented on the Company’s Consolidated Statements of Operations and Comprehensive Loss. Other segment items within net loss include other income (expense), net.
As of December 31, 2025 and 2024, $ 2.2 million and $ 0 , respectively, of the Company’s long-lived assets were located in the United Kingdom. As of December 31, 2025 and 2024, $ 0.2 million and $ 16.9 million, respectively, of the Company’s long-lived assets were located in the United States.
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