INmune Bio Inc. Announces Third Quarter 2025 Results and Provides Business Update

Rhea-AI Summary

INmune Bio (NASDAQ: INMB) reported Q3 2025 results and operational milestones on October 30, 2025. The company posted a net loss of $6.5M vs $12.1M in Q3 2024 and held $27.7M cash as of September 30, 2025, with ~26.6M shares outstanding as of October 30, 2025.

Clinical progress: completed two pilot-scale CORDStrom manufacturing runs with an MAA planned mid-2026 and anticipated subsequent BLA; XPro1595 (DN-TNF) Phase 2 MINDFuL data show clinical benefits in an amyloid-positive, high-inflammation subgroup and an excellent safety profile; INKmune CARE-PC met its primary endpoint and two secondary endpoints with final data pending.

Positive

• Net loss improved ~46% year-over-year to $6.5M
• R&D expense reduced ~51% YoY to $4.9M
• Cash and cash equivalents of $27.7M as of Sept 30, 2025
• Completed two pilot-scale CORDStrom manufacturing runs
• XPro1595 showed clinical benefit in amyloid-positive, high-inflammation ADi cohort
• INKmune CARE-PC met primary endpoint and two secondary endpoints

Negative

• General and administrative expenses rose ~13% YoY to $2.5M
• CARE-PC trial closed to recruitment due to high patient disease burden
• Final INKmune CARE-PC data release delayed until Q4 2026

Insights

Clinical development expert

Clinical updates show measurable progress across three platforms with several near-term regulatory and data milestones.

The CORDStrom program completed two pilot commercial manufacturing runs and targets an MAA mid-2026, followed by an anticipated BLA filing; this creates a clear regulatory path tied to manufacturing scale-up and regulatory dossiers. The DN-TNF/XPro1595 Phase 2 MINDFuL manuscript reports consistent signals in an amyloid-positive, high-inflammation subgroup (n=100) across cognitive and biomarker endpoints and an excellent safety profile with no reported ARIA despite ~70% of participants at high ARIA risk, which materially differentiates the agent in safety terms.

Dependencies and risks include regulatory review timing for the MAA/BLA and the FDA End-of-Phase-2 interaction anticipated in Q1, 2026. Final INKmune CARE-PC results will shape next trial design; current messaging notes the trial met its primary endpoint and two secondary endpoints but also highlights high baseline tumor burden among early subjects. Watch near-term items: imaging data from MINDFuL and additional CORDStrom data in Q4 2025, the FDA EOP2 meeting in Q1, 2026, and full INKmune final data in Q4 2025.

Corporate finance analyst

Results show lower quarterly losses and a modest cash runway that focuses near-term importance on upcoming milestones.

The company reported a net loss of approximately $6.5 million for the quarter versus $12.1 million year‑ago, driven by lower R&D spending ($4.9 million vs $10.1 million) while G&A remained near prior levels ($2.5 million vs $2.2 million). Cash and cash equivalents totaled approximately $27.7 million as of September 30, 2025, and share count stood at about 26.6 million on October 30, 2025.

Key near‑term financial dependencies include milestone timing and potential regulatory actions tied to the MAA mid-2026/BLA timelines and the planned FDA EOP2 meeting in Q1, 2026. Monitor cash burn versus milestone cadence; upcoming data releases in Q4 2025 could materially affect strategic options and funding needs within a roughly 12‑ to 18‑month horizon given current cash levels.

Company to Host Conference Call Today, October 30, at 4:30pm ET

BOCA RATON, Fla., Oct. 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2025 and provides a business update.

Q3 2025 and Recent Corporate Highlights  

CORDStrom™ Platform:

• Announced successful completion of first two commercial pilot-scale manufacturing runs of CORDStrom™ at CGT Catapult in preparation of regulatory filings to seek approval of CORDStrom™ for recessive dystrophic epidemolysis bullosa (RDEB).
• CORDStrom™ is on target to file an MAA submission mid-2026, followed shortly thereafter by an anticipated BLA filing with the FDA.
• A recent BBC news article shared a patient insight from the recently completed trial of CORDStrom in RDEB.
• Participated in a Dermatologic Rare Disease Panel at the Maxim Growth Summit presented by Maxim Group LLC.
  
  

DN-TNF Platform Highlights (XPro™):

• Submitted a manuscript, entitled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” for peer review to npj Dementia, a Nature Portfolio journal.
• Additional data in the manuscript demonstrates that participants with higher drug exposure (“dose-compliant”) show larger effect sizes across clinical endpoints, implying that adherence to XPro1595 treatment enhances its therapeutic benefits in cognition and neuropsychiatric outcomes. In the predefined ADi population, of amyloid-positive early Alzheimer's patients with high inflammatory burden (n=100), XPro™ demonstrated consistent clinical benefits, including slowed cognitive decline on EMACC (effect size 0.27), reduced neuropsychiatric symptoms on the NPI (effect size -0.23, with particular improvement in agitation/hyperactivity with an effect size of -0.37), and attenuated AD pathology biomarkers such as pTau217 (effect size -0.18), underscoring the potential of selective TNF inhibition to improve outcomes in biologically-aligned individuals.
• XPro1595 demonstrated an excellent safety profile, with no reported cases of amyloid-related imaging abnormalities (ARIA). This finding is especially significant given that approximately 70% of trial participants were considered at high risk for ARIA. These results differentiate XPro1595 from anti-amyloid therapies and suggest its potential suitability for use in populations susceptible to ARIA and unable to take anti-amyloid therapies and or as an adjunct to anti-amyloid therapies.
• The company is on track to request an End of Phase 2 meeting with the FDA which is anticipated to occur in Q1, 2026.
  
  

INKmune® Platform:

• Concluded that the CARE-PC trial met its primary endpoint and 2 of the 3 secondary endpoints. Analysis of the first 9 patients treated showed evidence of NK cell proliferation in vivo and generation of functional, memory-like NK cells in 4 of 6 patients at the lowest and intermediate dose levels (data from patients in the highest dose cohort are awaiting analysis). Thus, two of the secondary endpoints were met. The final secondary endpoint was “reduction in tumor load” and our primary measure was PSMA-PET scans. It was obvious from the analyses of the first 6 subjects that the patients being enrolled had very high disease burden; beyond that which would respond to immunotherapy. As a result, the trial has provided all the data needed to design a future randomized trial and we have closed the trial to further recruitment to ensure completion of follow-up by end of Q4 2025.
• Final data analysis is underway, and release is expected in Q4 2026.
  
  

Corporate:

• Announced the retirement of Dr. RJ Tesi and the appointment of David Moss to the role of President & Chief Executive Officer, and to the board of directors.
• Cory Ellspermann has been appointed as CFO.
• Kelly Ganjei named as Chairman of the board of directors.
  
  

Upcoming Events and Milestones:

• Additional CORDStrom™ data will be presented in Q4 2025.
• Imaging data from the phase 2 MINDFuL trial in Alzheimer’s Disease should be released in Q4 2025.
• Final data on the INKmune CARE-PC trial is expected in Q4 2025.
  
  

Financial Results for the Third Quarter Ended September 30, 2025:

• Net loss attributable to common stockholders for the quarter ended September 30, 2025 was approximately $6.5 million, compared to approximately $12.1 million during the quarter ended September 30, 2024.
• Research and development expenses totaled approximately $4.9 million for the quarter ended September 30, 2025, compared to approximately $10.1 million during the quarter ended September 30, 2024.
• General and administrative expenses were approximately $2.5 million for the quarter ended September 30, 2025, compared to approximately $2.2 million during the quarter ended September 30, 2024.
• As of September 30, 2025, the Company had cash and cash equivalents of approximately $27.7 million.
• As of October 30, 2025, the Company had approximately 26.6 million common shares 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 Second Quarter Conference Call when reaching an operator.

Date: October 30, 2025
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-225-9448
Participant Dial-in (international): 1-203-518-9708
Conference ID: INMUNE

A live audio webcast of the call can be accessed using this link:
https://viavid.webcasts.com/starthere.jsp?ei=1733354&tp_key=a3c75da53b

A replay will be available approximately 3 hours after the call through November 13, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11159914.

About CORDStrom™

CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at low cost and with repeatable specification independent of donor characteristics.

Initially developed at the INKmune® manufacturing facilities utilizing UK academic grant funding, CORDStrom™ is an MSC product platform that shows promise as a first systemic therapy for potentially treating RDEB and many other debilitating conditions. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro™

XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio’s website.

About INKmune™

INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells). INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.

INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer. INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. The second program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. The third program, INKmune®, is designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer and is currently in a trial in metastatic castration-resistance prostate cancer. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages 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 the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, 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) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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.

Company Contact:

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, 2025				December 31, 2024
ASSETS
CURRENT ASSETS
Cash and cash equivalents	$	27,734			$	20,922
Research and development tax credit receivable		1,704				1,181
Other tax receivable		760				228
Prepaid expenses and other current assets		472				331
TOTAL CURRENT ASSETS		30,670				22,662
Equipment, net		878				-
Operating lease – right of use asset		1,064				307
Other assets		746				79
Acquired in-process research and development intangible assets		-				16,514
TOTAL ASSETS	$	33,358			$	39,562
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities	$	6,875			$	6,539
Accounts payable and accrued liabilities – related parties		25				25
Deferred liabilities		-				517
Operating lease, current liabilities		457				140
TOTAL CURRENT LIABILITIES		7,357				7,221
Long-term operating lease liabilities		623				244
TOTAL LIABILITIES		7,980				7,465
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Preferred stock, $0.001 par value, 10,000,000 shares authorized, 0 shares issued and outstanding		-				-
Common stock, $0.001 par value, 200,000,000 shares authorized, 26,585,258 and 22,280,451 shares issued and outstanding, respectively		27				22
Additional paid-in capital		229,888				195,754
Accumulated other comprehensive loss		(764	)			(575	)
Accumulated deficit		(203,773	)			(163,104	)
TOTAL STOCKHOLDERS’ EQUITY		25,378				32,097
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	33,358			$	39,562

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,
	2025				2024				2025				2024
REVENUE	$	-			$	-			$	50			$	14
OPERATING EXPENSES
General and administrative		2,546				2,219				7,115				7,369
Research and development		4,887				10,067				18,330				25,813
Impairment of acquired in-process research and development intangible assets		-				-				16,514				-
Total operating expenses		7,433				12,286				41,959				33,182
LOSS FROM OPERATIONS		(7,433	)			(12,286	)			(41,909	)			(33,168	)
OTHER INCOME, NET		961				193				1,240				304
NET LOSS	$	(6,472	)		$	(12,093	)		$	(40,669	)		$	(32,864	)
Net loss per common share – basic and diluted	$	(0.24	)		$	(0.60	)		$	(1.68	)		$	(1.71	)
Weighted average common shares outstanding – basic and diluted		26,585,258				20,185,676				24,141,613				19,176,853
COMPREHENSIVE LOSS
Net loss	$	(6,472	)		$	(12,093	)		$	(40,669	)		$	(32,864	)
Other comprehensive loss – foreign currency translation		(1	)			(323	)			(189	)			(237	)
Total comprehensive loss	$	(6,473	)		$	(12,416	)		$	(40,858	)		$	(33,101	)

INMUNE BIO INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited)
	For the Nine Months Ended September 30,
	2025				2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(40,669	)		$	(32,864	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		6,594				5,848
Accretion of debt discount		-				73
Gain on settlement of accounts payable		(626	)			-
Depreciation expense		28				-
Impairment of acquired in-process research and development intangible assets		16,514				-
Changes in operating assets and liabilities:
Research and development tax credit receivable		(523	)			796
Other tax receivable		(532	)			226
Prepaid expenses		(141	)			646
Prepaid expenses – related party		-				127
Other assets		(667	)			49
Accounts payable and accrued liabilities		962				2,689
Accounts payable and accrued liabilities – related parties		-				20
Deferred liabilities		(517	)			60
Operating lease liabilities		(61	)			(18	)
Net cash used in operating activities		(19,638	)			(22,348	)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of equipment		(899	)			-
Net cash used in investing activities		(899	)			-
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock and warrants		27,544				27,789
Exercise of warrants for cash		1				-
Repayments of debt		-				(7,500	)
Net cash provided by financing activities		27,545				20,289
Impact on cash from foreign currency translation		(196	)			(237	)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS		6,812				(2,296	)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD		20,922				35,848
CASH AND CASH EQUIVALENTS AT END OF PERIOD	$	27,734			$	33,552
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION:
Cash paid for income taxes	$	-			$	-
Cash paid for interest expense	$	-			$	661
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right of use assets obtained in exchange for lease obligations	$	702			$	-

FAQ

What were INmune Bio (INMB) Q3 2025 financial results?

INmune reported a net loss of $6.5M for Q3 2025, with $27.7M cash on hand as of Sept 30, 2025.

When does INmune plan to file regulatory submissions for CORDStrom (INMB)?

CORDStrom is on target for a MAA submission mid-2026, followed shortly by an anticipated BLA filing with FDA.

What did Phase 2 MINDFuL results for XPro1595 show for INMB?

In an amyloid-positive, high-inflammation ADi subgroup (n=100), XPro1595 showed slowed cognitive decline and reduced neuropsychiatric symptoms with an excellent safety profile.

Did INKmune (INKmune) trial meet its endpoints for INMB?

The CARE-PC trial met its primary endpoint and two of three secondary endpoints; final data analysis is underway.

How many INMB shares were outstanding as of Oct 30, 2025?

INmune had approximately 26.6 million common shares outstanding as of Oct 30, 2025.

When will INmune release additional imaging and trial data for INMB?

Additional CORDStrom data and MINDFuL imaging data are expected in Q4 2025; final INKmune CARE-PC data is expected by Q4 2026.

Who are the new INmune executives named in October 2025 for INMB?

David Moss was appointed President & CEO, Cory Ellspermann named CFO, and Kelly Ganjei named Chairman of the board.