INmune Bio Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro™ Platform

Rhea-AI Summary

INmune Bio (NASDAQ: INMB) reported that Phase 2 MINDFuL trial results of XPro™ in mild Alzheimer’s disease were published in peer-reviewed journal NPJ Dementia. The study assessed safety, biomarker engagement and clinical efficacy in inflammation-defined patients.

In a pre-specified ADi subgroup, XPro™ showed directionally consistent benefits across multiple clinical and biomarker endpoints over 24 weeks, with no ARIA observed, supporting a biomarker-enriched strategy and future Phase 3 development of the XPro platform.

Positive

• Phase 2 MINDFuL results for XPro in Alzheimer’s published in NPJ Dementia
• Pre-specified ADi subgroup (n=100) showed directionally consistent multi-domain benefits
• Effect sizes (Cohen’s d) reported up to 0.27 across key endpoints
• No amyloid-related imaging abnormalities (ARIA) observed over 24 weeks
• Supports biomarker-enriched design focusing on inflammation-positive patients
• FDA Fast Track designation and publication together bolster perceived XPro platform value

Negative

• None.

News Market Reaction – INMB

-7.74%

5 alerts

-7.74% Session close to close

+2.5% Peak Tracked

-3.7% Trough Tracked

$44.66M Market Cap

0.1x Rel. Volume

In the May 15 session, INMB declined 7.74%, reflecting a notable negative market reaction. Argus tracked a peak move of +2.5% during that session. Argus tracked a trough of -3.7% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -7.7% in the session following this news. A negative reaction despite publication of...

Analysis

The stock moved -7.7% in the session following this news. A negative reaction despite publication of peer-reviewed Phase 2 MINDFuL data would have fit a pattern where clinical updates sometimes met with selling, as seen after prior MINDFuL disclosures. Average historical clinical-trial moves of -9.78% underscore that investors often discounted subgroup-driven signals. Elevated short interest at 14.29% and 10.07 days-to-cover could also have contributed to volatility on disappointing interpretations.

Key Figures

Enriched subgroup size: n=100 Treatment duration: 24 weeks Effect size (Cohen’s d): 0.27

3 metrics

Enriched subgroup size n=100 Amyloid-positive AD patients with ≥2 inflammation biomarkers in MINDFuL

Treatment duration 24 weeks Assessment period for cognitive, behavioral, and biomarker endpoints

Effect size (Cohen’s d) 0.27 Maximum reported effect size across evaluated endpoints

Previous Clinical trial Reports

5 past events · Latest: May 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 14	Fast Track designation	Positive	+15.1%	FDA Fast Track status for XPro1595 in early Alzheimer’s disease.
Feb 19	CORDStrom data webinar	Positive	-2.2%	Announcement of webinar to present new Phase III CORDStrom data in RDEB.
Dec 01	MINDFuL imaging data	Positive	-10.1%	New grey-matter MRI analyses from MINDFuL suggesting slowed cortical disarray.
Sep 29	MINDFuL results submitted	Neutral	+5.0%	Journal submission noting overall endpoint miss but promising ADi subgroup results.
Jun 30	MINDFuL top-line data	Negative	-56.7%	Phase 2 MINDFuL miss on primary endpoint with positive findings limited to a subgroup.

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

Pattern Detected

Clinical-trial headlines have produced mixed reactions, with some positive updates selling off sharply while a recent Fast Track designation was rewarded.

Recent Company History

Over the past year, INMB’s news flow has centered on XPro and CORDStrom clinical progress. Phase 2 MINDFuL Alzheimer’s data on Jun 30, 2025 and subsequent imaging analyses showed subgroup benefits but triggered a steep -56.66% move, highlighting sensitivity to trial nuances. Later MINDFuL submissions and CTAD imaging data produced smaller, mixed reactions. The May 14, 2026 Fast Track designation for XPro delivered a +15.07% gain. Today’s NPJ Dementia publication continues this clinical-trial narrative, emphasizing the ADi subgroup and consistency across endpoints.

Key Terms

amyloid-related imaging abnormalities (ARIA), HbA1c, APOE ε4 allele, Cohen’s d, +2 more

6 terms

amyloid-related imaging abnormalities (ARIA) medical

"with no amyloid-related imaging abnormalities (ARIA) observed."

Amyloid-related imaging abnormalities (ARIA) are changes seen on brain MRI—typically swelling or small bleeding—that can appear in patients receiving therapies targeting amyloid proteins. Think of ARIA as a dashboard warning light that signals a treatment-related side effect; it matters to investors because frequency and severity of ARIA affect a drug’s safety label, regulatory approvals, required monitoring, market uptake, and potential liability, all of which influence commercial prospects.

HbA1c medical

"two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele)."

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

APOE ε4 allele medical

"two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele)."

ApoE ε4 allele is a specific genetic variant of the APOE gene that changes how the body handles fats and clears certain brain proteins; think of it as a different version of a blueprint that raises the chance of Alzheimer’s disease and some cardiovascular issues. Investors care because its presence can alter clinical trial results, affect demand and pricing for therapies, change regulatory and insurance decisions, and influence the commercial outlook for drugs targeting related conditions.

Cohen’s d medical

"highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive..."

Cohen’s d is a simple numerical measure of how large the difference is between two groups, calculated by taking the gap between their average results and scaling it by the typical spread of individual results. Investors use it to judge whether an observed change or treatment is meaningfully big or just a small blip — like saying two players differ by a full game versus a few minutes — which helps assess the real-world importance of trial results, strategy tests, or performance comparisons.

Neuropsychiatric Inventory medical

"behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP)"

A neuropsychiatric inventory is a standardized questionnaire used by clinicians and researchers to measure behavioral and emotional symptoms such as agitation, depression, delusions, sleep changes and appetite in people with brain disorders. For investors, it matters because changes on this scale are often used as clinical trial endpoints or safety signals that can affect a therapy’s perceived benefit, regulatory prospects and market value—think of it as a scorecard for a drug’s real-world impact on patients’ behavior.

pTau217 medical

"biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro..."

ptau217 is a specific form of the brain protein tau that carries a small chemical tag at a particular spot (position 217) and can be measured in blood or spinal fluid as a signal of Alzheimer’s disease. It matters to investors because a reliable early signal — like a smoke alarm for brain changes — can speed drug trials, enable earlier diagnosis and create markets for tests and treatments, affecting the value of biotech and diagnostic companies.

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

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Boca Raton, FL, May 15, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing therapies that target innate immune dysfunction, today announced that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro™ (XPro1595, pegipanermin) in patients with mild Alzheimer’s disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed.

The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro™ demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele). The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro™ treatment effect. These findings support prioritization of the enriched population in future studies to optimize detection of treatment effects.

CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio, said, “MINDFuL is the first peer-reviewed trial to prospectively identify Alzheimer’s patients by both amyloid pathology and a biomarker-defined inflammatory signature. In this pre-specified subgroup, we observed directional improvements across cognitive, global, functional, behavioral, and biomarker endpoints, with no ARIA. The cross-domain consistency tracks with the underlying biology and represents the type of signal a Phase 2 trial is designed to identify, forming the foundation of a Phase 3 program.”

David Moss, CEO of INmune Bio, said, “The publication of the Phase 2 results from MINDFuL in NPJ Dementia, together with the FDA Fast Track designation, strengthens the value of the XPro platform. The trial also supports a biomarker-enriched (inflammation-enriched) strategy designed to improve future trial design and enhance the potential for clinical success, while reinforcing the broader potential of selective sTNF neutralization across inflammation-driven diseases.”

The full paper is available on the NPJ Dementia website or by clicking here.

For more information about the MINDFuL trial or for additional details about INmune Bio’s ongoing programs, please visit www.inmunebio.com.

About XPro™

XPro™ is a next-generation, dominant-negative protein biologic that acts as a selective inhibitor of soluble tumor necrosis factor (sTNF). Unlike non-selective TNF inhibitors, XPro™ neutralizes the pathological driver — sTNF signaling through TNFR1 — while preserving transmembrane TNF (tmTNF) and its homeostatic signaling through TNFR2, which is essential for normal immune function, cellular repair, and host defense. By targeting innate immune dysfunction rather than broadly suppressing immune function, XPro™ is designed to selectively restore immune balance in the central nervous system.

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company building therapeutics around the innate immune system. The company’s lead platform, Dominant-Negative Tumor Necrosis Factor (DN-TNF), is designed to selectively neutralize soluble TNF — a driver of innate immune dysfunction implicated across a range of inflammation-driven diseases. XPro™ (pegipanermin), the lead DN-TNF candidate, is in clinical development in Alzheimer’s disease with inflammation (ADi), with FDA Fast Track designation, and in treatment-resistant depression. INmune Bio’s two additional platforms — INKmune®, a natural killer cell priming platform in clinical development for metastatic castration-resistant prostate cancer, and CORDStrom™, an allogeneic human umbilical cord-derived mesenchymal stromal/stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa — extend the company’s precision immunology focus. To learn more, please visit www.inmunebio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include any statements related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates. 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™, XPro™ (XPro1595, 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 manufacture sufficient drug supply 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
Co-founder and Chief Executive Officer
(858) 964-3720
info@inmunebio.com

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

FAQ

What did INmune Bio (NASDAQ: INMB) publish about the Phase 2 MINDFuL Alzheimer’s trial?

INmune Bio published Phase 2 MINDFuL trial results of XPro in mild Alzheimer’s disease in NPJ Dementia. According to INmune Bio, the study reported safety, biomarker engagement and directionally consistent benefits across cognitive, functional, behavioral and biomarker endpoints in an inflammation-defined patient subgroup.

How did XPro perform in the Alzheimer’s Disease with inflammation (ADi) subgroup in INMB’s MINDFuL trial?

In the protocol-defined ADi subgroup, XPro showed directionally consistent benefit across cognitive, global, functional, behavioral and biomarker endpoints over 24 weeks. According to INmune Bio, this enriched population was characterized by amyloid-beta positivity and at least two inflammation biomarkers, supporting its prioritization in future studies.

Were any ARIA safety signals seen with XPro in INmune Bio’s Phase 2 MINDFuL Alzheimer’s trial?

No amyloid-related imaging abnormalities (ARIA) were observed with XPro over 24 weeks in MINDFuL. According to INmune Bio, this safety finding in the pre-specified inflammation-enriched subgroup complements the directionally consistent improvements seen across multiple clinical and biomarker endpoints.

What effect sizes were reported for XPro in INMB’s Phase 2 MINDFuL Alzheimer’s study?

Effect sizes (Cohen’s d) for XPro were reported up to 0.27 across evaluated endpoints. According to INmune Bio, these included cognitive tests, patient-reported outcomes, behavioral measures and biomarkers such as pTau217 and GFAP, suggesting a cross-domain signal consistent with a Phase 2 exploratory trial.

How does the MINDFuL trial guide future Phase 3 plans for INmune Bio’s XPro platform (INMB)?

MINDFuL’s results form the foundation of a potential Phase 3 program for XPro. According to INmune Bio, the cross-domain directional improvements and biomarker-defined inflammatory signature support a biomarker-enriched strategy aimed at optimizing treatment-effect detection in future Alzheimer’s trials.

What does the MINDFuL Phase 2 publication and FDA Fast Track mean for INmune Bio shareholders?

The peer-reviewed publication and existing FDA Fast Track designation together strengthen perceived value of the XPro platform. According to INmune Bio, results support an inflammation-enriched trial design and reinforce broader potential for selective sTNF neutralization across inflammation-driven diseases, which may interest long-term INMB investors.