INmune Bio Inc. Announces Third Quarter 2026 Results and Provides Business Update

Lower development and administrative spending accompanied a narrower quarterly loss, while October financing added $4.5 million gross.

Rhea-AI Summary

INmune Bio (NASDAQ: INMB) narrowed its third-quarter 2026 net loss while advancing Ebstrocel toward a planned UK marketing application.

Net loss was $4.722 million, versus $6.472 million a year earlier; loss per share narrowed to $0.17 from $0.24. Cash totaled $16.329 million at September 30. An October financing raised $4.5 million gross through shares and warrants. The company expects cash resources to fund operations through the third quarter of 2027.

Following its October 20 pre-application submission, INmune Bio targets a complete UK application for Ebstrocel, its treatment candidate for recessive dystrophic epidermolysis bullosa, in early February 2027. It anticipates potential UK approval in mid-2027, subject to validation, review and information requests. A U.S. application is targeted for mid-2027, subject to FDA feedback. A Uniphar agreement establishes a framework for potential international named-patient access.

20 points · 0 major

PositiveiHow this balance works

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

How the balance worksHow Sentiment works

0 major · 9 points

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

Positive

• Moderate pointThird-quarter net loss narrowed to $4.722 million from $6.472 million; loss per share improved to $0.17 from $0.24.
• Moderate pointNine-month operating cash use decreased to $9.969 million from $19.638 million a year earlier.
• Moderate pointOctober financing raised $4.5 million gross before fees and expenses. 11% of market cap
• Moderate pointR&D rebates provided approximately $4.2 million from Australia in July and approximately $0.4 million from Britain in June.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash resources are expected by INmune Bio to fund operations through the third quarter of 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Complete UK marketing application is targeted for early February 2027, replacing the previously planned rolling review.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Potential UK approval is anticipated in mid-2027, with an agency response expected approximately three to six months after submission.
• Moderate point. Forward-looking: it has not happened yet and may not happen.U.S. marketing application is targeted for mid-2027, with regulatory advisors engaged for a planned FDA meeting request.
• Moderate pointUniphar agreement creates a potential named-patient access framework in selected European, Middle Eastern and North African markets.

11 minor points

• Minor pointThird-quarter research and development expenses fell to $3.163 million from $4.887 million a year earlier.
• Minor pointThird-quarter administrative expenses fell to $1.846 million from $2.546 million a year earlier.
• Minor pointNine-month net loss narrowed to $11.402 million from $40.669 million; per-share loss improved to $0.42 from $1.68.
• Minor pointNine-month research and development expenses declined to $6.001 million from $18.330 million a year earlier.
• Minor pointNine-month administrative expenses declined to $6.296 million from $7.115 million a year earlier.
• Minor pointAcquired research and development impairment charges were zero over nine months, versus $16.514 million a year earlier.
• Minor pointEbstrocel's final UK pre-application package was submitted on October 20, 2026.
• Minor pointEbstrocel's Pediatric Investigation Plan has been approved, alongside prior written UK agency alignment on application elements.
• Minor pointCommercial-scale manufacturing preparations advanced, supported by an Anthony Nolan Cord Blood Bank agreement for umbilical cord tissue.
• Minor point. Forward-looking: it has not happened yet and may not happen.CORDStrom patent application entered the U.S. national phase; protection is expected into at least 2045 if granted.
• Minor pointXPro rare-disease evaluation continues with Quantum Computing to prioritize indications, patient populations and biomarkers.

Negative

• Moderate pointCash declined to $16.329 million at September 30, 2026, from $24.751 million at December 31, 2025.
• Moderate pointOctober financing issued three million common shares and warrants for up to three million shares, diluting holders.
• Minor pointUK approval remains subject to validation, agency review and requests for additional information.
• Minor point. Forward-looking: it has not happened yet and may not happen.U.S. application timing remains subject to FDA feedback following the planned regulatory interaction.
• Minor point. Forward-looking: it has not happened yet and may not happen.Uniphar implementation depends on country-specific arrangements and regulatory and reimbursement requirements.

4 minor points

• Minor pointNew XPro clinical spending awaits Ebstrocel approval or dedicated XPro resources.
• Minor pointNine-month revenue fell to zero from $50,000 a year earlier; quarterly revenue remained zero.
• Minor pointThird-quarter other income declined to $287,000 from $961,000 a year earlier.
• Minor pointNine-month other income declined to $895,000 from $1.240 million a year earlier.

News Explained

The company reports that its October offering raised $4.5 million gross through a sale of 3 million common shares and warrants to buy up to 3 million more. The sale includes 3 million common shares, while the warrants are for up to 3 million additional shares; if exercised, those additional shares would reduce existing holders’ percentage ownership.

Key Figures

Net loss: $4.722M vs. $6.472M Cash and cash equivalents: $16.329M Gross offering proceeds: $4.5M +5 more

Net loss

$4.722M vs. $6.472M

Three months ended September 30, 2026 vs. 2025

Cash and cash equivalents

$16.329M

As of September 30, 2026

Gross offering proceeds

$4.5M

October 2026 sale of common stock and warrants, before fees and expenses

Common shares offered

3 million shares

Registered direct offering announced October 28, 2026

Warrants

Up to 3 million shares

Concurrent private placement announced October 28, 2026

Cash runway

Through the third quarter of 2027

Company estimate based on its current operating plan

UK MAA submission target

Early February 2027

Complete Ebstrocel application targeted for submission to the MHRA

U.S. BLA submission target

Mid-2027

Targeted submission, subject to FDA feedback

Previous Earnings Reports

2 past events · Latest: Aug 06

Same Type 2 events

1. Aug 06

   2Q26 earnings

   24h Move

   +9.2%

   Reported lower net loss year over year and highlighted Ebstrocel and XPro development progress

2. Oct 30

   3Q25 earnings

   24h Move

   +5.8%

   Reported lower net loss year over year alongside CORDStrom and XPro program updates

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

marketing authorization application, biologics license application, priority review voucher, soluble TNF, +1 more

5 terms

marketing authorization application regulatory

"complete MAA in early February 2027"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

biologics license application regulatory

"preparations for a U.S. Biologics License Application (BLA)"

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.

priority review voucher regulatory

"the FDA’s Priority Review Voucher program"

A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.

soluble TNF medical

"selective inhibition of soluble TNF"

Soluble TNF is the circulating form of tumor necrosis factor, a small signaling protein the immune system uses to call cells to action during inflammation. It matters to investors because levels of soluble TNF can serve as a measurable marker of disease activity and because many drugs aim to block it; changes in test results, trial outcomes or regulatory status for TNF-targeting therapies can directly affect a company’s value.

recessive dystrophic epidermolysis bullosa medical

"treatment of recessive dystrophic epidermolysis bullosa (RDEB)"

A rare inherited disorder in which the skin and mucous membranes are extremely fragile, causing painful blisters and wounds from minor friction; “recessive” means a person develops the condition only if they inherit two faulty copies of the responsible gene. It matters to investors because the severe, chronic nature and lack of widely effective treatments create a clear medical need and potential market for therapies, while also carrying high clinical and regulatory risk similar to developing any novel drug.

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

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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

FAQ

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

When does INmune Bio expect to submit Ebstrocel for UK approval?

INmune Bio targets a complete UK marketing application in early February 2027. It anticipates an agency response approximately three to six months after submission, supporting potential approval in mid-2027. That timing remains subject to validation, agency review and requests for additional information.

What were INmune Bio's third-quarter 2026 earnings results?

INmune Bio reported a $4.722 million net loss, or $0.17 per share, compared with a $6.472 million loss, or $0.24 per share, a year earlier. Research and development expenses decreased to $3.163 million, while general and administrative expenses decreased to $1.846 million.

What must happen before INmune Bio funds a new XPro clinical program?

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 analysis and partnership discussions continue in the meantime. Qualifying rare pediatric indications could offer a Priority Review Voucher opportunity, subject to qualifying approval and applicable program requirements.

How could patients access INmune Bio's Ebstrocel through Uniphar?

The Uniphar framework provides a pathway for physicians to request Ebstrocel for eligible named patients where local regulations permit. It covers selected European, Middle Eastern and North African markets. Implementation remains subject to country-specific arrangements and applicable regulatory and reimbursement requirements.