Company Advances Ebstrocel™ Toward Potential UK Approval

Company to Host Conference Call on November 5, 2026, at 4:30pm ET

BOCA RATON, Fla., Nov. 05, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announces its financial results for the quarter ended September 30, 2026, and provides a business update.

“INmune Bio is approaching regulatory milestones for Ebstrocel that can establish our first commercial product,” said David Moss, Chief Executive Officer of INmune Bio. “We have made substantial progress in manufacturing, regulatory preparation and international patient access, giving us increased confidence in our ability to bring Ebstrocel to patients suffering from recessive dystrophic epidermolysis bullosa (RDEB). We believe the strength of our clinical data, our alignment with the MHRA and our progress in manufacturing provide a compelling foundation for approval. Importantly, our agreement with Uniphar builds a framework that could provide access to patients in additional international markets ahead of broader commercial launches. We are focused on executing our regulatory strategy, building commercial readiness and allocating capital to the milestones that we believe will create the greatest value for patients and shareholders.”

2026 and Recent Corporate Highlights

CORDStrom™ Platform (Ebstrocel™):

  • Submitted its final pre-Marketing Authorization Application (pre-MAA) package for Ebstrocel™ to the UK Medicines and Healthcare products Regulatory Agency (MHRA) on October 20, 2026, marking an important milestone toward the Company's planned UK regulatory submission for the treatment of RDEB. Following agency feedback, INmune Bio plans to submit a complete MAA in early February 2027. Manufacturing progress supports the complete submission in place of the previously planned rolling review.
  • The Company anticipates an MHRA response within three to six months after submission, supporting potential UK approval in mid-2027, subject to validation, agency review and requests for additional information. The application builds on prior MHRA written alignment across clinical, non-clinical and manufacturing elements and approval of the Pediatric Investigation Plan.
  • Established an international access and commercialization framework with Uniphar to support potential named-patient access to Ebstrocel™ in selected European, Middle Eastern and North African markets. The agreement provides a pathway for physicians to request treatment for eligible patients where permitted by local regulations and could create opportunities for revenue before full commercial approval in individual markets. Implementation remains subject to country-specific arrangements and applicable regulatory and reimbursement requirements.
  • Advanced preparations for a U.S. Biologics License Application (BLA), including engagement of rare-disease regulatory advisors to support a planned Type B meeting request with the U.S. Food and Drug Administration (FDA). The Company currently targets a BLA submission mid-2027, subject to FDA feedback, and is prioritizing its U.S. submission ahead of a European Medicines Agency filing.
  • Continued progress in commercial-scale manufacturing and supply chain readiness, supported by the Company's agreement with Anthony Nolan Cord Blood Bank for access to high-quality umbilical cord tissue. The Company's proprietary pooled-cell manufacturing approach is designed to improve product consistency, reduce donor variability and support scalable commercial supply.
  • Advanced its CORDStrom™ platform patent application into the U.S. national phase following a favorable international written opinion. If granted, the patent family is expected to provide intellectual property protection extending into at least 2045.

DN-TNF Platform Development Strategy (XPro™):

The Company is evaluating rare diseases where XPro™’s selective inhibition of soluble TNF, existing preclinical and clinical evidence, and clinical development requirements could support a small, fast and capital-efficient program. The evaluation is being conducted in collaboration with Quantum Computing Inc., applying quantum optimization, artificial intelligence and conventional analytics to clinical, preclinical and public biomedical datasets to prioritize indications, patient populations and biomarkers. Qualifying rare pediatric indications could offer additional upside through the FDA’s Priority Review Voucher program, subject to a qualifying approval and applicable program requirements.

INmune Bio does not intend to commit Company capital to a new XPro™ clinical program until Ebstrocel™ is approved or dedicated XPro™ resources are in place. Indication selection, analysis and partnership discussions continue in the meantime.

Corporate:

  • Received approximately $4.2 million through Australia's research and development rebate program in July 2026, following approximately $0.4 million received through the United Kingdom's R&D rebate program in June, providing non-dilutive funding to support ongoing development activities.
  • In September, R. Duane Clark II and James Sapirstein joined the Board of Directors, adding rare-disease commercialization, business development and financing experience.
  • Announced a registered direct offering of three million shares of common stock and a concurrent private placement of warrants to purchase up to three million common stock on October 28, 2026, with gross proceeds of $4.5 million before fees and expenses.
  • Continued prioritizing financial resources toward Ebstrocel™ regulatory submissions, manufacturing readiness and the development of international patient access and distribution capabilities.

Upcoming Events and Milestones

  • UK Regulatory Submission: Submission of a complete Ebstrocel Marketing Authorization Application to the MHRA targeted for early February 2027.
  • Potential UK Approval: Anticipated MHRA review and response within approximately three to six months following submission, supporting the Company's expectation of potential UK approval in mid-2027, subject to validation, agency review and requests for additional information.
  • U.S. Regulatory Submission: Planned FDA Type B meeting interaction to clarify the regulatory pathway, followed by a targeted BLA submission mid-2027, subject to agency feedback.
  • International Patient Access: Continued implementation of the Uniphar framework to establish country-specific named-patient access and potential commercial distribution arrangements.
  • XPro Development Strategy: Continued evaluation of rare-disease opportunities through the Quantum Computing collaboration and other analytical work, with the objective of selecting an indication for future development.

Financial Results for the Third Quarter Ended September 30, 2026

  • Net loss attributable to common stockholders for the quarter ended September 30, 2026, was approximately $4.7 million, compared with approximately $6.5 million during the quarter ended September 30, 2025.
  • Research and development expenses totaled approximately $3.2 million for the quarter ended September 30, 2026, compared with approximately $4.9 million during the quarter ended September 30, 2025.
  • General and administrative expenses were approximately $1.8 million for the quarter ended September 30, 2026, compared with approximately $2.5 million during the quarter ended September 30, 2025.
  • As of September 30, 2026, the Company had cash and cash equivalents of approximately $16.3 million. During October, the Company raised $4.5 million in gross proceeds from the sale of common stock and warrants. Based on its current operating plan, the Company believes its cash resources are sufficient to fund operations through the third quarter of 2027.
  • As of November 5, 2026, the Company had approximately 31 million shares of common stock outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Third Quarter Conference Call when reaching the operator.

Date: November 5, 2026

Time: 4:30pm Eastern Time

Participant Dial-in: 1-800-717-1738

International Dial-in: 1-646-307-1865

Conference ID: INMUNE

A live audio webcast of the call can be accessed using the following link:

https://viavid.webcasts.com/starthere.jsp?ei=1779628&tp_key=6eb5414d70

A transcript will follow approximately 24 hours after the scheduled call. Replay information will be made available following the event.

About INmune Bio Inc.

INmune Bio Inc. (NASDAQ: INMB) develops medicines targeting inflammation and innate immune dysfunction. Its CORDStrom™ platform uses selected, pooled, allogeneic human umbilical cord-derived mesenchymal stromal cells to develop disease-specific cellular medicines. Ebstrocel™ (pobistrocel), the platform’s lead product, is being developed as a systemic treatment for RDEB. XPro™ (XPro1595, pegipanermin) is designed to neutralize soluble TNF while preserving transmembrane TNF signaling. The Company’s product candidates remain investigational and have not received marketing approval. Visit www.inmunebio.com for more information.

Forward Looking Statements

The Company’s product candidates remain in clinical development stage and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including  Ebstrocel™, XPro™ and INKmune™ trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contacts

David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

The following tables summarize our results of operations for the periods indicated:

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 
         


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)
                 


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