STOCK TITAN

Inmune Bio nets about $4M; going-concern doubt remains

Management identified insufficient projected liquidity for the year after issuance, while an October financing generated approximately $4.0 million in net proceeds.

Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates
(Moderate)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
10-Q

Rhea-AI Filing Summary

Inmune Bio, Inc. (INMB) reported a nine-month net loss of $11.4 million, versus $40.7 million a year earlier, and operating cash use of $10.0 million versus $19.6 million. Lower research and development expense reflected completion of the Alzheimer’s Phase 2 trial and higher rebates, partly offset by increased CORDStrom/INKmune costs; the prior-year period included a $16.5 million impairment. Cash was $16.3 million at September 30, 2026.

Management said projected liquidity is insufficient to sustain operations through one year following issuance of the financial statements, and its plans do not alleviate substantial doubt about the company’s ability to continue as a going concern. On October 29, 2026, it completed a financing, selling 3,000,000 common shares at $1.50 each and agreeing to issue warrants for 3,000,000 shares; net proceeds were approximately $4.0 million.

The company has ceased INKmune development. XPro’s Phase 2 Alzheimer’s trial did not meet its primary endpoint, although a subgroup showed potential benefits; immediate development is halted while it seeks a partner. It intends to file a UK MAA for CORDStrom in February 2027 and plans a U.S. BLA for mid-2027; regulatory timing and outcome remain uncertain.

2 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

1 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointNine-month net loss fell to $11.4 million from $40.7 million.
  • Moderate pointOperating cash use declined to $10.0 million from $19.6 million.

Negative

  • Major point. Forward-looking: it has not happened yet and may not happen.Substantial doubt remains; projected liquidity is insufficient through one year after issuance.

Filing Explained

Warrant shares remain unissued unless exercised, and CORDStrom has a contingent payment of up to six million pounds upon the first listed marketing approval.

The October 29 financing is complete: INmune Bio agreed to issue $3,000,000 of unregistered warrants exercisable beginning April 27, 2027; the separate commitment to register their resale does not itself issue the underlying shares.

If exercised, those additional shares would increase the total share count and reduce existing holders’ percentage ownership, absent offsetting changes.

The CORDStrom license also provides for a payment of up to £6,000,000 when the first marketing authorization is granted by the FDA, EMA, or MHRA; no such authorization had occurred as of September 30, 2026.

The separate at-the-market agreement permits gradual share sales up to $65,000,000, not a committed cash amount; through September 30, INmune Bio had sold 598,947 shares under it for approximately $1.0 million net.

Net loss $11.4 million Nine months ended September 30, 2026
Net cash used in operating activities $10.0 million Nine months ended September 30, 2026
Cash and cash equivalents $16.3 million As of September 30, 2026
Common shares sold 3,000,000 shares October 29, 2026 registered direct offering
Offering price $1.50 per share October 29, 2026 registered direct offering
Net proceeds Approximately $4.0 million October 29, 2026 financing
Warrants to purchase common shares 3,000,000 shares Concurrent private placement on October 29, 2026
Warrant exercise price $1.65 per share Warrants agreed to be issued in the October 29, 2026 financing
going concern financial
"financial statements have been prepared ... applicable to a going concern"
Going concern is the accounting assumption that a company will keep operating and meeting its obligations for the foreseeable future. The phrase matters most when a company or its auditors disclose substantial doubt about it, a formal warning that the business may not have enough resources to continue without raising money, restructuring, or selling assets. That language in a filing or press release signals elevated financial risk.
at-the-market sales agreement financial
"amended and restated at-the-market sales agreement"
An at-the-market sales agreement lets a company raise cash by selling newly issued shares directly into the open market at whatever price buyers are paying that day, using a broker to place the trades over time. Investors should watch these deals because they can dilute existing ownership and put downward pressure on the stock price while giving the company flexible, on-demand funding—like a store gradually listing extra items on an online marketplace at current prices.
Biologics License Application regulatory
"a Biologics License Application (BLA) with the U.S. Food and Drug Administration"
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
warrant inducement agreement financial
"entered into a warrant inducement agreement with certain holders"
A warrant inducement agreement is a contract in which a company offers warrants—rights to buy shares at a set price—to a person or group as a sweetener to secure their support, service, or approval for a transaction or role. Investors care because these warrants can increase the total number of shares if exercised, diluting existing ownership and potentially changing the company’s valuation and control dynamics; think of it as paying someone with future stock-buying tickets to get them on board.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did INMB lose and use in operating cash during the first nine months of 2026?

INMB reported a net loss of $11.4 million and net cash used in operating activities of $10.0 million for the nine months ended September 30, 2026, compared with $40.7 million and $19.6 million, respectively, in the prior-year period.

What were the terms of INMB’s October 2026 financing?

On October 29, 2026, INMB sold 3,000,000 common shares at $1.50 per share and agreed to issue warrants to purchase 3,000,000 shares. The company received approximately $4.5 million in gross proceeds and approximately $4.0 million in net proceeds. The warrants have a $1.65 exercise price, become exercisable on April 27, 2027, and expire on April 27, 2032.

Why did INMB’s research and development expense change in the first nine months of 2026?

Research and development expense was $6.0 million, compared with $18.3 million in the prior-year period. INMB cited $8.9 million less Alzheimer’s clinical-program expense after completing the trial, $4.8 million in higher rebates, and $3.6 million in higher CORDStrom/INKmune expenses related to preparations for marketing authorization.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2026

 

OR

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission File Number: 001-38793

 

INMUNE BIO INC.
(Exact name of registrant as specified in its charter)

 

Nevada   47-5205835
(State of incorporation)   (I.R.S. Employer
Identification No.)

 

225 NE Mizner Blvd., Suite 640

Boca Raton, FL 33432

(Address of principal executive office) (Zip code)

 

(561) 710-0512

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.001 per share   INMB   The NASDAQ Stock Market LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period than the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐    

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

As of November 5, 2026, there were 30,959,079 shares of our common stock, par value $0.001 per share, outstanding.

 

 

 

 

 

 

INMUNE BIO INC.

FORM 10-Q

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2026

 

INDEX

 

PART I – FINANCIAL INFORMATION   1
       
Item 1. Financial Statements   1
       
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations   12
       
Item 3. Quantitative and Qualitative Disclosure About Market Risk   20
       
Item 4. Controls and Procedures   20
       
PART II – OTHER INFORMATION   21
       
Item 1. Legal Proceedings   21
       
Item 1A. Risk Factors   21
       
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds   21
       
Item 3. Defaults Upon Senior Securities   21
       
Item 4. Mine Safety Disclosures   21
       
Item 5. Other Information   21
       
Item 6. Exhibits   21
       
Signatures   22

 

i

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

INMUNE BIO INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

(Unaudited)

 

    September 30,
2026
    December 31,
2025
 
ASSETS            
CURRENT ASSETS            
Cash and cash equivalents   $ 16,329     $ 24,751  
Research and development tax credit receivable     1,211       4,284  
Other tax receivable     519       257  
Prepaid expenses and other current assets     649       595  
TOTAL CURRENT ASSETS     18,708       29,887  
                 
Equipment, net     1,189       955  
Operating lease – right of use asset     1,080       914  
Other assets     531       595  
                 
TOTAL ASSETS   $ 21,508     $ 32,351  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
CURRENT LIABILITIES                
Accounts payable and accrued liabilities   $ 2,200     $ 7,768  
Accounts payable and accrued liabilities – related party     25       25  
Operating lease, current liabilities     692       623  
TOTAL CURRENT LIABILITIES     2,917       8,416  
                 
Long-term operating lease liabilities     518       411  
TOTAL LIABILITIES     3,435       8,827  
                 
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, 27,915,652 and 26,585,258 shares issued and outstanding, respectively     28       27  
Additional paid-in capital     239,324       233,271  
Accumulated other comprehensive loss     (840 )     (737 )
Accumulated deficit     (220,439 )     (209,037 )
TOTAL STOCKHOLDERS’ EQUITY     18,073       23,524  
                 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY   $ 21,508     $ 32,351  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

1

 

 

INMUNE BIO INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

(Unaudited)

 

    For the Three Months Ended
September 30,
    For the Nine Months Ended
September 30,
 
    2026     2025     2026     2025  
REVENUE   $ -     $ -     $ -     $ 50  
                                 
OPERATING EXPENSES                                
General and administrative     1,846       2,546       6,296       7,115  
Research and development     3,163       4,887       6,001       18,330  
Impairment of acquired in-process research and development intangible assets     -       -       -       16,514  
Total operating expenses     5,009       7,433       12,297       41,959  
                                 
LOSS FROM OPERATIONS     (5,009 )     (7,433 )     (12,297 )     (41,909 )
                                 
OTHER INCOME, NET     287       961       895       1,240  
                                 
NET LOSS   $ (4,722 )   $ (6,472 )   $ (11,402 )   $ (40,669 )
                                 
Net loss per common share – basic and diluted   $ (0.17 )   $ (0.24 )   $ (0.42 )   $ (1.68 )
                                 
Weighted average common shares outstanding – basic and diluted     27,807,917       26,585,258       27,041,706       24,141,613  
                                 
COMPREHENSIVE LOSS                                
Net loss   $ (4,722 )   $ (6,472 )   $ (11,402 )   $ (40,669 )
Other comprehensive loss – foreign currency translation     (17 )     (1 )     (103 )     (189 )
Total comprehensive loss   $ (4,739 )   $ (6,473 )   $ (11,505 )   $ (40,858 )

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

2

 

 

INMUNE BIO INC.

 

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2026

(In thousands, except share amounts)

(Unaudited)

 

                            Accumulated              
                Additional           Other           Total  
    Common Stock     Paid-In     Subscription     Comprehensive     Accumulated     Stockholders’  
    Shares     Amount     Capital     Receivable     Gain (Loss)     Deficit     Equity  
Balance as of December 31, 2025     26,585,258     $ 27     $ 233,271     $ -     $ (737 )   $ (209,037 )   $ 23,524  
Stock-based compensation     -       -       1,497       -       -       -       1,497  
Gain on foreign currency translation     -       -       -       -       10       -       10  
Net loss     -       -       -       -       -       (5,407 )     (5,407 )
Balance as of March 31, 2026     26,585,258       27       234,768       -       (727 )     (214,444 )     19,624  
Common stock issued for cash     370,417       -       584       -       -       -       584  
Stock-based compensation     -       -       1,358       -       -       -       1,358  
Exercise of warrants for cash     674,155       1       943       (814 )     -       -       130  
Exercise of stock options for cash     23,959       -       35       -       -       -       35  
Loss on foreign currency translation     -       -       -       -       (96 )     -       (96 )
Net loss     -       -       -       -       -       (1,273 )     (1,273 )
Balance as of June 30, 2026     27,653,789       28       237,688       (814 )     (823 )     (215,717 )     20,362  
Common stock issued for cash     228,530       -       462       -       -       -       462  
Stock-based compensation     -       -       1,124       -       -       -       1,124  
Collection of warrant subscription receivable     -       -       -       814       -       -       814  
Exercise of stock options for cash     33,333       -       50       -       -       -       50  
Loss on foreign currency translation     -       -       -       -       (17 )     -       (17 )
Net loss     -       -       -       -       -       (4,722 )     (4,722 )
Balance as of September 30, 2026     27,915,652     $ 28     $ 239,324     $ -     $ (840 )   $ (220,439 )   $ 18,073  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3

 

 

INMUNE BIO INC.

 

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2025

(In thousands, except share amounts)

(Unaudited)

 

                      Accumulated              
                Additional     Other           Total  
    Common Stock     Paid-In     Comprehensive     Accumulated     Stockholders’  
    Shares     Amount     Capital     Loss     Deficit     Equity  
Balance as of December 31, 2024     22,280,451     $ 22     $ 195,754     $ (575 )   $ (163,104 )   $ 32,097  
Stock-based compensation     -       -       2,076       -       -       2,076  
Sale of common stock for cash     649,860       1       5,272       -       -       5,273  
Exercise of warrants for cash     100       -       1       -       -       1  
Loss on foreign currency translation     -       -       -       (35 )     -       (35 )
Net loss     -       -       -       -       (9,739 )     (9,739 )
Balance as of March 31, 2025     22,930,411       23       203,103       (610 )     (172,843 )     29,673  
Stock-based compensation     -       -       1,534       -       -       1,534  
Sale of common stock for cash     3,654,847       4       22,267       -       -       22,271  
Loss on foreign currency translation     -       -       -       (153 )     -       (153 )
Net loss     -       -                       (24,458 )     (24,458 )
Balance as of June 30, 2025     26,585,258     27     226,904     (763 )   (197,301 )   28,867  
Stock-based compensation     -       -       2,984       -       -       2,984  
Loss on foreign currency translation     -       -       -       (1 )     -       (1 )
Net loss     -       -       -       -       (6,472 )     (6,472 )
Balance as of September 30, 2025     26,585,258     $ 27     $ 229,888     $ (764 )   $ (203,773 )   $ 25,378  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4

 

 

INMUNE BIO INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

    For the Nine Months Ended
September 30,
 
    2026     2025  
CASH FLOWS FROM OPERATING ACTIVITIES:            
Net loss   $ (11,402 )   $ (40,669 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Stock-based compensation     3,979       6,594  
Gain on settlement of accounts payable     (91 )     (626 )
Depreciation expense     191       28  
Impairment of acquired research and development intangible assets     -       16,514  
Changes in operating assets and liabilities:                
Research and development tax credit receivable     3,073       (523 )
Other tax receivable     (262 )     (532 )
Prepaid expenses     (54 )     (141 )
Other assets     64       (667 )
Accounts payable and accrued liabilities     (5,477 )     962  
Deferred liabilities     -       (517 )
Operating lease liabilities     10       (61 )
Net cash used in operating activities     (9,969 )     (19,638 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
Purchase of equipment     (430 )     (899 )
Net cash used in investing activities     (430 )     (899 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Sale of common stock for cash     1,046       27,544  
Exercise of warrants for cash     944       1  
Exercise of stock options for cash     85       -  
Net cash provided by financing activities     2,075       27,545  
                 
Impact on cash from foreign currency translation     (98 )     (196 )
                 
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS     (8,422 )     6,812  
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD     24,751       20,922  
CASH AND CASH EQUIVALENTS AT END OF PERIOD   $ 16,329     $ 27,734  
                 
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:                
Cash paid for income taxes   $ -     $ -  
Cash paid for interest   $ -     $ -  
                 
SUPPLEMENTAL NONCASH INVESTING AND FINANCING ACTIVITIES                
Right of use assets obtained in exchange for lease obligations   $ 587     $ 702  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5

 

 

INMUNE BIO INC.

 

NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 – ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES

 

Description of Business

 

INmune Bio Inc. (the “Company” or “INmune Bio”) 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. The Company has ceased development activities related to INKmune.

 

Basis of Presentation

 

The accompanying financial statements are presented in U.S. dollars and have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”), and pursuant to the accounting and disclosure rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated financial statements include the accounts of INmune Bio Inc. and its subsidiaries. Intercompany transactions and balances have been eliminated.

 

In the opinion of management, the interim financial information includes all normal recurring adjustments necessary for a fair statement of the results for the interim periods. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026.

 

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.

 

Significant Accounting Policies

 

The Company’s significant accounting policies have not changed during the nine months ended September 30, 2026 from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025.

 

Going concern

 

These unaudited condensed 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. During the nine months ended September 30, 2026, the Company incurred a net loss of $11.4 million and had net cash flows used in operating activities of $10.0 million. 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.

 

6

 

 

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 unaudited condensed 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.

 

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. Diluted 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.

 

At September 30, 2026, the Company had 9,743,841 potentially issuable shares of common stock upon the exercise of stock options and 3,060,706 potentially issuable shares of common stock upon the exercise of warrants.

 

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.

 

Segment Information

 

The Company has one primary business activity and operates in one reportable segment.

 

The Company’s chief operating decision maker (“CODM”) is its Chief Executive Officer who evaluates performance and makes operating decisions about allocating resources based on financial data presented on a consolidated basis. The measures of profitability and the significant segment expenses reviewed by the CODM are consistent with these financial statements and footnotes.

 

Recently issued accounting pronouncements not yet adopted

 

In November 2024, the FASB issued ASU 2024-03 related to the disaggregation of certain income statement expenses. The amendments in this update require public entities to disclose incremental information related to purchases of inventory, team member compensation and depreciation, which will provide investors the ability to better understand entity expenses and make their own judgements about entity performance. The amendments in this update are effective for fiscal years beginning after December 15, 2026 and for interim periods beginning after December 15, 2027. The standard permits adoption on either a prospective or retrospective basis. The Company currently plans to adopt this guidance on a prospective basis for the year ending December 31, 2027. Aside from these disclosure changes, we do not expect the amendments to have a material effect on our financial statements.

 

In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies the guidance in Topic 270 to improve the consistency of interim financial reporting. The ASU provides a comprehensive list of required interim disclosures and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. ASU 2025-11 is effective for fiscal years beginning after December 15, 2027, including interim periods within those fiscal years, with early adoption permitted. The standard permits either prospective or retrospective application. The Company currently plans to adopt ASU 2025-11 on a prospective basis for the year ending December 31, 2028. The Company is currently evaluating the impact of adopting ASU 2025-11 on our financial statements.

 

7

 

 

NOTE 2 – RESEARCH AND DEVELOPMENT ACTIVITY

 

Under Australian tax law, the Company may qualify for refundable R&D tax credits for eligible research and development expenditures, subject to certain requirements. The Company’s Australian subsidiary has historically submitted claims for these credits. At September 30, 2026 and December 31, 2025, the Company recorded Australian R&D tax credit receivables of $0 and $3,897,000, respectively. During the three and nine months ended September 30, 2026, the Company received approximately $4.2 million and $7.8 million, respectively, in Australian R&D tax credit reimbursements.

 

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 September 30, 2026 and December 31, 2025, the Company had a research and development tax credit receivable of $1,211,000 and $387,000, respectively, for R&D expenses incurred in the UK. During the three and nine months ended September 30, 2026, the Company received approximately $0.0 million and $0.8 million, respectively, in tax credit reimbursements from the UK.

 

CORDStrom License Agreement

 

During February 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 MissionEB 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 regulatory approval of CORDStrom for treatment of pediatric RDEB from 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 September 30, 2026) due on the first to occur marketing authorization to be granted by the FDA, EMA or MHRA, which had not occurred as of September 30, 2026.

 

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.

 

Xencor, Inc. License Agreement

 

During October 2017, the Company entered into a license agreement with Xencor, Inc., as amended. Under the agreement, the Company obtained an exclusive, worldwide, royalty-bearing license to develop and commercialize products incorporating Xencor’s XPro protein technology targeting soluble tumor necrosis factor.

 

The Company is obligated to pay a 5% royalty on net sales of licensed products on a country-by-country and product-by-product basis for the later of the patent term or ten years following first commercial sale.

 

INKmune License Agreement

 

The Company is party to a license agreement with Immune Ventures, LLC (“Immune Ventures”), a related party, under which it obtained exclusive worldwide rights to certain intellectual property. The agreement provides for milestone payments upon the achievement of specified development and regulatory events and a 1% royalty on future net sales. No sales have occurred under the license.

 

As of September 30, 2026 and December 31, 2025, the Company recorded a $25,000 milestone payable to Immune Ventures, which is included in accounts payable and accrued liabilities – related party.

 

8

 

 

NOTE 3 – 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)
 
September 30, 2026:                        
Cash equivalents                        
Money market funds   $ 15,598     $ 15,598     $            -     $            -  
Total cash equivalents   $ 15,598     $ 15,598     $ -     $ -  

 

(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     $ -     $ -  

 

NOTE 4 – EQUIPMENT, NET

 

Equipment, net consisted of the following (in thousands):

 

    September 30,
2026
    December 31,
2025
 
Lab equipment   $ 1,473     $ 1,042  
Less: accumulated depreciation     (284 )     (87 )
Total   $ 1,189     $ 955  

 

Depreciation expense was approximately $0.1 million and $0.2 million for the three and nine months ended September 30, 2026, respectively.

 

NOTE 5 – LEASE

 

As of September 30, 2026, the maturities of our lease liabilities are as follows:

 

(in thousands, except years)      
2026   $ 236  
2027     632  
2028     235  
2029     221  
2030     56  
Total lease payments     1,380  
Less: imputed interest     (170 )
Present value of future lease payments     1,210  
Less: operating lease, current liabilities     (692 )
Long-term operating lease liabilities   $ 518  

 

The weighted-average lease term as of September 30, 2026 and December 31, 2025 was 2.2 years and 1.5 years, respectively. As of September 30, 2026 and 2025, the weighted-average discount rate for operating leases was 12.0%.

 

During the three and nine months ended September 30, 2026, the Company recognized $208,000 and $561,000, respectively, in operating lease expense. During the three and nine months ended September 30, 2025, the Company recognized $134,000 and $229,000, respectively, in operating lease expense.

 

9

 

 

NOTE 6 – STOCKHOLDERS’ EQUITY

 

Common Stock – At the Market Offering

 

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. The Company was required to pay the Sales Agents a commission of 3% of the gross proceeds from the sale of shares. During the nine months ended September 30, 2025, the Company issued and sold 1,304,707 shares of common stock at an average price of $8.01 per share under the ATM program. The aggregate net proceeds were approximately $10.1 million after commission expenses.  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 (“AGP”), 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 AGP in exchange for a 3% commission on gross proceeds. During the nine months ended September 30, 2026, the Company sold 598,947 shares of common stock at an average price of $1.80 per share under the ATM program. The aggregate net proceeds were approximately $1.0 million after expenses.


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).

 

Stock options

 

On June 16, 2026, stockholders approved the Third Amended and Restated 2021 Stock Incentive Plan, increasing authorized shares from 6,500,000 to 9,158,525 and providing for annual increases from 2027 through 2031 equal to the lesser of 10% of common shares outstanding at the preceding year-end or a smaller amount determined by the Board. At September 30, 2026, 2,681,942 shares remained available for future grants under the plan. 

 

During the nine months ended September 30, 2026, the Company granted a consultant and certain directors options to purchase 225,000 shares of its common stock pursuant to the 2021 Incentive Stock Plan. The stock options had a fair value of approximately $0.4 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 4.83% - 5.00% based on the applicable US Treasury bill rate (2) expected life of 5.75 – 10.0 years, (3) expected volatility of approximately 89% - 95% and (4) zero expected dividends.

 

The following table summarizes stock option activity during the nine months ended September 30, 2026:

 

(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 January 1, 2026     9,759,882     $ 2.63       6.83     $ 545  
Options granted     225,000     $ 2.33       -       -  
Options exercised     (57,292 )   $ 1.49       -       -  
Options cancelled     (183,749 )   $ 4.45       -       -  
Outstanding at September 30, 2026     9,743,841     $ 2.59       6.01     $ 3,639  
Exercisable at September 30, 2026     5,727,099     $ 3.08       4.02     $ 2,020  

 

During the three and nine months ended September 30, 2026, the Company recognized stock-based compensation expense of approximately $1.1 million and $4.0 million, respectively, related to the vesting of stock options. During the three and nine months ended September 30, 2025, the Company recognized stock-based compensation expense of approximately $3.0 million and $6.6 million, respectively, related to the vesting of stock options. As of September 30, 2026, there was approximately $5.9 million of total unrecognized compensation cost related to non-vested stock options which is expected to be recognized over a weighted-average period of 2.1 years.

 

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 September 30, 2026 and December 31, 2025, 45,386 of these warrants are outstanding and the intrinsic value of these warrants is $0.

 

10

 

 

April 2024 Warrants

 

On June 30, 2026, the Company entered into a warrant inducement agreement with certain holders of its April 2024 common stock purchase warrants. Under the agreements, the holders exercised an aggregate of 674,155 warrants, representing 50% of their holdings, at a reduced exercise price of $1.40 per share (original exercise price of $1.95), resulting in gross proceeds to the Company of approximately $0.9 million.

 

In consideration for the exercise, the expiration date of the holders’ remaining 674,160 April 2024 warrants was extended from June 30, 2026 to December 31, 2027. All other terms of the remaining warrants, including the $1.95 exercise price, remained unchanged. The aggregate intrinsic value of these warrants was $0 at September 30, 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 September 30, 2026 and December 31, 2025, 2,341,160 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 September 30, 2026.

 

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 three and nine months ended September 30, 2026 and 2025 respectively:

 

(in thousands)   Three Months
Ended
September 30,
2026
    Three Months
Ended
September 30,
2025
    Nine Months
Ended
September 30,
2026
    Nine Months
Ended
September 30,
2025
 
Research and development   $ 339     $ 1,363     $ 1,006     $ 2,820  
General and administrative     785       1,621       2,973       3,774  
Total   $ 1,124     $ 2,984     $ 3,979     $ 6,594  

 

NOTE 7 – COMMITMENTS

 

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.

 

NOTE 8 – SUBSEQUENT EVENTS

 

Common stock and warrant financing

 

On October 29, 2026, the Company completed a financing in which it issued and sold, in a registered direct offering, 3,000,000 shares of common stock at an offering price of $1.50 per share, and in a concurrent private placement the Company also agreed to issue unregistered warrants to purchase 3,000,000 shares of common stock. The Company received gross proceeds of approximately $4.5 million and net proceeds of approximately $4.0 million, after deducting placement agent fees and other offering expenses.

 

The warrants have an exercise price of $1.65 per share, become exercisable on April 27, 2027, and expire on April 27, 2032.

 

In connection with the financing, the Company agreed to file a registration statement on Form S-1 covering the resale of the shares of common stock issuable upon exercise of the warrants.

 

Stock option exercise

 

During October 2026, the Company issued 43,427 shares of common stock upon the exercise of stock options by a former employee, receiving aggregate cash proceeds of approximately $65,000.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward-Looking Statements

 

This Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control. These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships.

 

Description of Business

 

Overview

 

INmune Bio is a clinical-stage biotechnology company dedicated to developing and commercializing a pipeline of product candidates designed to reprogram the innate immune system. Our mission is to address a broad range of diseases where chronic inflammation and immune dysfunction are primary drivers of pathology.

 

Lead Program: CORDStrom™ for RDEB Our primary focus is the treatment of Recessive Dystrophic Epidermolysis Bullosa (“RDEB”) using CORDStrom, our proprietary, pooled, human umbilical cord-derived mesenchymal stromal cell platform. RDEB is a devastating pediatric orphan disease caused by mutations in the COL7A1 gene. This genetic deficiency leads to systemic complications, including highly debilitating skin blistering, chronic non-healing wounds, dysphagia, and failure to thrive. Over time, the chronic inflammatory environment associated with RDEB often progresses to fatal squamous cell carcinoma. RDEB is a systemic disease with no approved systemic treatments. The only approved products to date are topical and do not address the systemic issues of the disease, which is the focus of CORDStrom.

 

CORDStrom has recently completed a pivotal, blinded, randomized cross-over trial. Based on these data, the Company is transitioning toward regulatory submission and commercialization. We intend to file a Marketing Authorization Application (“MAA”) in the United Kingdom during February 2027, followed by a Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) planned for mid-2027 and then the European Union application.

 

Neuroinflammation and Oncology Pipelines In addition to our lead rare disease program, the Company has two other clinical-stage platforms:

 

  ● XPro1595 (XPro): A next-generation protein therapeutic that targets neuroinflammation by selectively neutralizing soluble TNF. XPro has completed Phase I and Phase II clinical trials for the treatment of Alzheimer’s Disease (“AD”). The Company intends to pursue strategic partnership opportunities to support the further development of XPro in neurodegenerative and/or other indications. The Company does not currently plan to independently advance XPro into later-stage development.

 

  ● INKmune™: A novel natural killer (NK) cell-priming platform designed to harness the patient’s own innate immune system to eliminate cancer cells. The INKmune program is currently nearing the completion of an open-label Phase II trial for the treatment of metastatic castrate-resistant prostate cancer (“mCRPC”). The Company has ceased development activity in the INKmune program.

 

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By targeting the innate immune system across these distinct therapeutic areas, INmune Bio aims to deliver disease-modifying treatments for patients with high unmet medical needs.

 

We continue to incur significant development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a net loss of $11.4 million for the nine months ended September 30, 2026. As of September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $16.3 million and $24.8 million, respectively. We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory approvals for, our product candidates. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues, if any.

 

Our recurring net losses and negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our unaudited condensed consolidated financial statements for the nine months ended September 30, 2026. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financings or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. To date, the Company has relied on equity and debt financing to fund its operations.

 

Amendment to Anthony Nolan License Agreement

 

On April 29, 2026, the Company entered into an amended and restated material transfer and license agreement with Anthony Nolan, a UK-based organization, which amends and restates a prior agreement originally entered into in 2017 by the Company’s wholly owned subsidiary. In connection with the amended agreement, the Company became a direct party and agreed to be jointly and severally liable for certain payment obligations thereunder. The amended agreement expands the Company’s collaboration with Anthony Nolan and is intended to secure a long-term supply of umbilical cord tissue to support the development of CORDStrom, which the Company expects will be the initial application of such materials, with potential use in additional product candidates in the future.

 

Under the amended agreement, the Company has obtained exclusive rights, with the ability to sublicense, to use specified donor materials for research, development and commercialization purposes. The Company is obligated to pay per-sample processing fees and, upon commercialization, royalties on net sales, each subject to certain adjustments and caps, and such fees may be subject to periodic increases tied to inflation indices. The agreement continues until terminated in accordance with its terms or for a period extending beyond the first commercial sale of applicable products.

 

The Company does not expect the amended agreement to have a material impact on its near-term results of operations or liquidity; however, it may result in future payment obligations and become material in the event of successful development and commercialization of product candidates utilizing such materials. The Company believes this agreement is consistent with its strategy to advance its product candidates through collaborations, strategic relationships and licensing arrangements.

 

Research and Development

 

Research and development expense consists of expenses incurred while performing research and development activities to discover and develop our product candidates. This includes conducting preclinical studies and clinical trials, manufacturing development efforts and activities related to regulatory filings for product candidates. We recognize research and development expenses as they are incurred. Our research and development expense primarily consist of:

 

  ● clinical trial and regulatory-related costs;

 

  ● expenses incurred under agreements with investigative sites and consultants that conduct our clinical trials;

 

  ● manufacturing and testing costs and related supplies and materials; and

 

  ● employee-related expenses, including salaries, benefits, travel and stock-based compensation.

 

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The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands):

 

    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2026     2025     2026     2025  
External Costs                        
DN-TNF - Alzheimer’s disease   $ 83     $ 1,188     $ 341     $ 9,289  
CORDStrom (RDEB) & INKmune (Prostate cancer)     2,381       1,084       7,088       3,449  
Preclinical and other programs     239       90       260       152  
Accrued research and development credit reimbursement     (875 )     (150 )     (5,278 )     (486 )
Total external costs     1,828       2,212       2,411       12,404  
Internal costs     1,335       2,675       3,590       5,926  
Total   $ 3,163     $ 4,887     $ 6,001     $ 18,330  

 

We typically use our employee resources across our development programs. We track outsourced development costs by product candidate or development program, but we do not allocate internal personnel costs including salaries and stock-based compensation to specific product candidates or development programs.

 

We participate, through our wholly owned subsidiary in Australia, 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.

 

We participate, through our wholly owned subsidiary in the United Kingdom, 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.

 

Substantially all our research and development expenses to date have been incurred in connection with our current and future product candidates. We expect our research and development expenses to increase significantly for the foreseeable future as we advance an increased number of our product candidates through clinical development, including the conduct of our planned clinical trials and manufacturing drug to be used in those clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. The successful development of product candidates is highly uncertain. At this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates. This is due to the numerous risks and uncertainties associated with the development of product candidates.

 

The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

 

  ● per patient trial costs;

 

  ● the number of sites included in the clinical trials;

 

  ● the countries in which the clinical trials are conducted;

 

  ● the length of time required to enroll eligible patients;

 

  ● the number of patients that participate in the clinical trials;

 

  ● the number of doses that patients receive;

 

  ● the cost of comparative agents used in clinical trials;

 

  ● the drop-out or discontinuation rates of patients;

 

  ● potential additional safety monitoring or other studies requested by regulatory agencies;

 

  ● the duration of patient follow-up;

 

  ● the efficacy and safety profile of the product candidate; and

 

  ● the cost of manufacturing, finishing, labelling and storage of drug used in the clinical trial.

 

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We are targeting regulatory approval for CORDStrom in the United Kingdom in 2027, although the timing and outcome of the regulatory review remain uncertain. If approval is obtained, we intend to commence commercialization following completion of the necessary commercial preparations. We expect to continue to incur significant expenses and operating losses for the foreseeable future, including as we prepare for potential commercialization, and these amounts may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increase substantially as we:

 

  ● continue research and development, including preclinical and clinical development of our existing product candidates;
     
  ● potentially seek regulatory approval for our product candidates;
     
  ● seek to discover and develop additional product candidates;
     
  ● establish a commercialization infrastructure and scale up our manufacturing and distribution capabilities to commercialize any of our product candidates for which we may obtain regulatory approval;

 

  ● seek to comply with regulatory standards and laws;
     
  ● maintain, leverage and expand our intellectual property portfolio;
     
  ● hire clinical, manufacturing, scientific and other personnel to support our product candidates development and future commercialization efforts;
     
  ● add operational, financial and management information systems and personnel; and
     
  ● incur additional legal, accounting and other expenses in operating as a public company.

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2026 and 2025

 

The following table summarizes our results of operations for the periods indicated:

 

    Three Months Ended
September 30,
       
(in thousands)   2026     2025     Change  
Revenues   $ -     $ -     $ -  
Operating expenses:                        
Research and development     3,163       4,887       (1,724 )
General and administrative     1,846       2,546       (700 )
Total operating expenses     5,009       7,433       (2,424 )
Loss from operations     (5,009 )     (7,433 )     2,424  
Other income, net     287       961       (674 )
Net loss   $ (4,722 )   $ (6,472 )   $ 1,750  

 

Research and Development

 

Research and development expense was approximately $3.2 million and $4.9 million during the three months ended September 30, 2026 and 2025, respectively. The Company recorded $0.7 million of additional R&D rebate during the three months ended September 30, 2026 as a result of the Company recording additional amounts which it estimates are recoverable pursuant to the UK R&D rebate program. In addition, the Company incurred $1.1 million less expenses related to our Alzheimer’s clinical program due to the Company completing its Phase 2 trial during 2025, and $1.3 million lower expenses due to the Company incurring lower internal costs, partially offset by the Company incurring $1.3 million of higher CORDStrom/INKmune costs related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.

 

General and Administrative

 

General and administrative expenses were $1.8 million and $2.5 million during the three months ended September 30, 2026 and 2025, respectively. The decrease in costs in 2026 is mainly due to the Company incurring $0.8 million lower stock-based compensation in 2026.

 

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Other Income, net

 

During the three months ended September 30, 2026, the Company’s other income consisted of interest income.

 

During the three months ended September 30, 2025, the Company recorded $1.0 million of other income, of which approximately $0.6 million was gain on forgiveness of payables from two vendors and approximately $0.4 million was due to interest income.

 

Comparison of the Nine Months Ended September 30, 2026 and 2025

 

The following table summarizes our results of operations for the periods indicated:

 

    Nine Months Ended
September 30,
       
(in thousands)   2026     2025     Change  
Revenues   $ -     $ 50     $ (50 )
Operating expenses:                        
Research and development     6,001       18,330       (12,329 )
General and administrative     6,296       7,115       (819 )
Impairment of acquired in-process research and development intangible assets     -       16,514       (16,514 )
Total operating expenses     12,297       41,959       (29,662 )
Loss from operations     (12,297 )     (41,909 )     29,612  
Other income, net     895       1,240       (345 )
Net loss   $ (11,402 )   $ (40,669 )   $ 29,267  

 

Revenues

 

During the nine months ended September 30, 2025, the Company recognized revenue from a license agreement that was terminated during 2025.

 

Research and Development

 

Research and development expenses were approximately $6.0 million and $18.3 million during the nine months ended September 30, 2026 and 2025, respectively. The change in research and development expenses during the nine months ending September 30, 2026 compared to the nine months ending September 30, 2025 is mainly due to the Company incurring $8.9 million less Alzheimer’s clinical program expenses due to the trial being completed in 2025, $4.8 million higher rebate mainly due to additional amounts recorded in connection with the receipt of the 2025 rebate claim by the Australia subsidiary as well as recording additional amounts for the UK subsidiary as a result of additional R&D activity in the UK and $2.3 million lower internal costs, partially offset by the Company recording $3.6 million higher expenses for CORDStrom/INKmune related to preparations to submit CORDStrom for marketing authorization in the United Kingdom, Europe and the United States.

 

General and Administrative

 

General and administrative expenses were approximately $6.3 million and $7.1 million during the nine months ended September 30, 2026 and 2025, respectively. The decrease in general and administrative expenses was mainly due to incurring $0.8 million lower stock-based compensation expense in 2026.

 

Impairment of acquired in-process research and development intangible assets

 

During the nine months ended September 30, 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 is instead seeking a partner to continue these studies. As part of preparing its interim unaudited condensed 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 $16.5 million during the second quarter of 2025.

 

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Other Income, net

 

During the nine months ended September 30, 2026 and 2025, the Company earned $0.9 million and $1.2 million of other income.

 

During the nine months ended September 30, 2026, the Company’s other income mainly consisted of $0.6 million of interest income and $0.1 million of gain on foreign exchange and $0.1 million of gain on settlement of accounts payable.

 

During the nine months ended September 30, 2025, the Company recorded $1.2 million of other income, of which $0.6 million was due to the Company earning interest income on its cash investments and $0.6 million was gain on forgiveness of payables.

 

Liquidity and Capital Resources

 

Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations and otherwise operate on an ongoing basis.

 

We incurred a net loss of $11.4 million and $40.7 million for the nine months ended September 30, 2026 and 2025, respectively. Net cash used in operating activities was $10.0 million and $19.6 million for the nine months ended September 30, 2026 and 2025, respectively. Since inception, we have funded our operations primarily with proceeds from the sales of our common stock. As of September 30, 2026, we had cash and cash equivalents of $16.3 million. We anticipate that operating losses and net cash used in operating activities will increase over the next few years as we advance our products under development.

 

Our primary uses of capital are, and we expect will continue to be, third-party clinical and preclinical research and development services, costs incurred to manufacture our drugs under development, compensation and related expenses, legal, patent and other regulatory expenses and general overhead costs. We believe our use of CROs provides us with flexibility in managing our spending.

 

The Company incurs significant research and development expenses in Australia and the United Kingdom. Fluctuations in the rate of exchange between the United States dollar and the pound sterling as well as the Australian dollar could adversely affect our financial results, including our expenses as well as assets and liabilities. We currently do not hedge foreign currencies but will continue to assess whether that strategy is appropriate. As of September 30, 2026, the cash balance held by our foreign subsidiaries with currencies other than the United States dollar was approximately $0.6 million.

 

Our recurring net losses and negative cash flows from operations, as well as forecast of continued losses and negative cash flows from operations, raised substantial doubt regarding our ability to continue as a going concern within one year after the issuance of our unaudited condensed consolidated financial statements as of and for the nine months ended September 30, 2026. Until we can generate sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private sale of equity, debt financing or other capital sources, such as government funding, collaborations, strategic alliances, divestment of non-core assets, or licensing arrangements with third parties. Our cash and cash equivalents were $16.3 million and total current assets were $18.7 million at September 30, 2026, which the Company is projecting will be insufficient to sustain its operations through one year following the date that the financial statements are issued.

 

Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development of one or more of our product candidates or cease operations. If we raise additional funds through the issuance of additional debt or equity securities it could result in dilution to our existing stockholders, increased fixed payment obligations and these securities may have rights senior to those of our common stock and could contain covenants that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license our intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

 

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ATM Sales Agreement

 

On December 19, 2025, the Company entered into a sales agreement with A.G.P./Alliance Global Partners (“AGP”), 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 AGP in exchange for a 3% commission on gross proceeds. During the nine months ended September 30, 2026, the Company sold 598,947 shares of common stock at an average price of $1.80 per share under the ATM program. The aggregate net proceeds were approximately $1.0 million after expenses.

 

Warrants Inducement

 

On June 30, 2026, the Company entered into a warrant inducement agreement with certain holders of its April 2024 common stock purchase warrants. Under the agreements, the holders exercised an aggregate of 674,155 warrants, representing 50% of their holdings, at a reduced exercise price of $1.40 per share (original exercise price of $1.95), resulting in gross proceeds to the Company of approximately $0.9 million.

 

In consideration for the exercise, the expiration date of the holders’ remaining 674,160 April 2024 warrants was extended from June 30, 2026 to December 31, 2027. All other terms of the remaining warrants, including the $1.95 exercise price, remained unchanged. The aggregate intrinsic value of these warrants was $0 at September 30, 2026.

 

Research and Development Tax Rebates

 

The Company participates in government-sponsored research and development incentive programs in Australia and the United Kingdom, which provide cash rebates for qualifying research and development expenditures. These programs represent a source of non-dilutive funding that supports the Company’s research and development activities, although the timing and amount of future rebates is dependent upon eligible expenditures, applicable program requirements, and governmental review and payment processes.

 

During the nine months ended September 30, 2026, the Company received approximately $8.6 million of cash rebates under these programs, consisting of approximately $7.8 million from Australia and approximately $0.8 million from the United Kingdom. These cash receipts have strengthened the Company’s liquidity and supported the funding of its ongoing operations.

 

Based on our current research and development plans, we do not anticipate receiving material additional research and development tax rebates from Australia in the near term. Accordingly, the Australian rebate receipts during the nine months ended September 30, 2026 are not indicative of expected future receipts.

 

Common stock and warrant financing

 

On October 29, 2026, the Company received approximately $4.0 million in net proceeds from the sale of common stock, in a registered direct offering, and from the issuance in a concurrent private placement of warrants to purchase common stock. These proceeds provided additional liquidity to fund the Company’s ongoing operations.

 

Cash Flows

 

The following table summarizes our cash flows for the periods indicated:

 

    Nine Months Ended
September 30,
 
(in thousands)   2026     2025  
Net cash and cash equivalents (used in) provided by:            
Operating activities   $ (9,969 )   $ (19,638 )
Investing activities     (430 )     (899 )
Financing activities     2,075       27,545  
Change in cash and cash equivalents     (8,324 )     7,008  
Impact on cash from foreign currency translation     (98 )     (196 )
Cash and cash equivalents, beginning of period     24,751       20,922  
Cash and cash equivalents, end of period   $ 16,329     $ 27,734  

 

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Operating Activities

 

Operating activities used approximately $10.0 million of cash during the nine months ended September 30, 2026, primarily reflecting our net loss of $11.4 million and approximately $2.6 million of cash used from changes in operating assets and liabilities, principally a $5.5 million decrease in accounts payable and accrued liabilities and a $0.3 million increase in other taxes receivable. These uses were partially offset by approximately $4.0 million of non-cash stock-based compensation expense.

 

Operating activities used approximately $19.6 million of cash during the nine months ended September 30, 2025, primarily reflecting our net loss of $40.7 million, net cash used from changes in operating assets and liabilities of $1.5 million, and an adjustment to remove a non-cash gain on forgiveness of accounts payable of $0.6 million, partially offset by non-cash impairment expense of $16.5 million and stock-based compensation expense of $6.6 million. The net cash used from changes in operating assets and liabilities primarily reflected increases in other assets of $0.7 million, research and development tax credit receivable of $0.5 million and other tax receivable of $0.5 million, together with a decrease in deferred liabilities of $0.5 million, partially offset by an increase in accounts payable and accrued liabilities of $1.0 million.

 

Investing Activities

 

During the nine months ended September 30, 2026 and 2025, the Company acquired $0.4 million and $0.9 million, respectively, of equipment to be used in its CORDStrom clinical program.

 

Financing Activities

 

During the nine months ended September 30, 2026, the Company sold 598,947 shares of common stock under its ATM program for net proceeds of $1.0 million.

 

During June 2026, holders exercised 674,155 warrants for aggregate gross proceeds of approximately $0.9 million.

 

During the nine months ended September 30, 2026, option holders exercised 57,292 options in exchange for $0.1 million of cash.

 

During the nine months ended September 30, 2025, the Company sold 1,304,707 shares of common stock under its ATM program for net proceeds of $10.1 million.

 

During June 2025, the Company sold 3,000,000 shares of its common stock in a registered direct offering in exchange for gross proceeds of $18.9 million (net proceeds of $17.4 million).

 

Critical Accounting Policies and Estimates

 

Our discussion and analysis of our financial condition and results of operations is based upon our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. Actual results may differ from these estimates. Our critical accounting estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and there have been no material changes during the nine months ended September 30, 2026.

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Pursuant to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1).

 

Item 4. 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 defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) at the end of the period covered by this quarterly report.

 

Based on this evaluation, we concluded that, as of such date, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

We recognize that any controls system, no matter how well designed and operated, can provide only reasonable assurance of achieving its objectives, and our management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during the period covered by this quarterly report that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act).

 

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PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

 

We are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial conditions. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.

 

Item 1A. Risk Factors

 

Not required for smaller reporting companies.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

During the fiscal quarter ended September 30, 2026, none of the Company’s directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement, or a non-Rule 10b5-1 trading arrangement, in each case as defined in Item 408 of Regulation S-K.

 

Item 6. Exhibits

 

No.   Description 
31.1   Rule 13a-14(a)/ 15d-14(a) Certification of Chief Executive Officer*
     
31.2   Rule 13a-14(a)/ 15d-14(a) Certification of Chief Financial Officer*
     
32.1   Section 1350 Certification of Chief Executive Officer**
     
32.2   Section 1350 Certification of Chief Financial Officer**
     
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.

 

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SIGNATURES

 

Pursuant to the requirements 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.
     
Date: November 5, 2026 By:  /s/ David Moss
    David Moss
    Chief Executive Officer
    (Principal Executive Officer)

 

Date: November 5, 2026 By: /s/ Cory Ellspermann
    Cory Ellspermann
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

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