お知らせ • Jun 23

Inmune Bio Receives Mhra Written Alignment Supporting Planned 2026 Uk Conditional Marketing Authorization Application for Cordstrom in Rdeb

INmune Bio Inc. has received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application (pre-MAA) Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for CORDStrom (Ebstrocel) in Recessive Dystrophic Epidermolysis Bullosa (RDEB). The May 12, 2026, meeting resulted in written alignment across all questions submitted by the Company and provides a clear regulatory path for INmune Bio’s planned 2026 UK Marketing Authorization Application (MAA) seeking Conditional Marketing Authorization for Ebstrocel in RDEB. Ebstrocel is the name of the RDEB-specific investigational formulation derived from INmune Bio’s proprietary CORDStrom off-the-shelf, pooled, human umbilical cord-derived mesenchymal stromal cell platform. The Company received written comments on its pediatric investigation plan (PIP). In those comments, MHRA recognized MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularly in pain and pruritus. While MissionEB demonstrated improvements in wound quality, inflammation, and granulation during treatment periods, it did not show durable wound closure or sustained reduction in total wound burden after treatment cessation, which is a significant limitation of the study. Nevertheless, these data could support the positioning as chronic or intermittent supportive therapy for RDEB. INmune Bio is incorporating the Agency’s endpoint recommendations into its confirmatory Phase 3 program to better capture patient-relevant benefits in this ultra-rare disease. The MHRA provided constructive guidance on the statistical and clinical evidence challenges inherent in ultra-rare diseases such as RDEB. Regulators noted that traditional frequentist statistical analyses may be less informative in small orphan populations and invited INmune Bio to incorporate alternative approaches, including Bayesian statistical models and qualitative patient and parent interview data describing improvements in systemic symptoms such as chronic pain, intractable itch and sleep quality, to support the Ebstrocel MAA. The Agency also gave clear advice about strengthening our analysis of the qualitative data from the MISSION EB phase II trial for submission, emphasizing the importance of this data. We have taken on board their advice regarding data analyses for the phase III trial required for substantive approval, which is expected to open in 2026. INmune Bio is advancing final commercial manufacturing validation activities and dossier compilation to support the planned UK submission. The Company also intends to use the MHRA feedback to inform future interactions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) with additional filings planned in late 2026 or early 2027, subject to regulatory alignment and completion of required submissions. CORDStrom is a patent-pending cell medicine platform comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells in suspension for injection or infusion. The CORDStrom platform leverages proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP-manufactured and potent cellular medicines that can be produced affordably and with repeatable specifications. Ebstrocel is the indication-specific formulation derived from the CORDStrom platform, optimized with anti-inflammatory, immunomodulatory and wound-healing effector functions to treat the severe systemic effects of RDEB in pediatric patients. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission. XPro1595: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595 is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.

お知らせ • Jun 02

INmune Bio Reports Statistically Significant Treatment Effect On Advanced White Matter MRI Biomarker In Phase 2 MINDFuL Alzheimer's Trial

INmune Bio Inc. announced results from exploratory chi-separation (?-separation) MRI imaging analyses from the MINDFuL Phase 2 clinical trial of XPro™ (XPro1595) in patients with early Alzheimer's disease encompassing both mild cognitive impairment (MCI) and mild Alzheimer’s disease dementia. The new MRI findings add to a growing body of evidence supporting XPro™’s precision-medicine development strategy, including the peer-reviewed publication of the Phase 2 MINDFuL results in NPJ Dementia, FDA End-of-Phase 2 alignment on an integrated Phase 2b/3 registrational pathway, and the recent grant of FDA Fast Track designation for XPro™ in early Alzheimer’s disease. Across multiple independent preclinical models of demyelination and neurological injury, white matter has consistently emerged as the most reliable and reproducible target of XPro™ response, with clear, documented effects on myelin volume and quality. While historical industry efforts in AD have focused heavily on gray matter pathology, white matter (WM) degeneration and myelin loss are increasingly recognized as fundamental, early contributors to cognitive decline. Chi-separation MRI was included in the MINDFuL Phase 2 trial as a target engagement biomarker for white matter. This method was chosen given that the trial enrolled patients with MCI and mild AD, the disease stage at which white matter abnormalities are prominent and highly clinically relevant. Chi-separation is a recently validated imaging technique that resolves key challenges of conventional MRI myelin measurement and can be deployed across standard multi-site clinical infrastructure without requiring specialty scanners, making it a methodologically superior and operationally scalable measure of white matter biology. The blinded analysis, performed by an independent imaging core laboratory, revealed statistically significant treatment effect on myelin: Full mITT Population (N=200): After 24 weeks of treatment, XPro™-treated participants showed a statistically significant difference in myelin compared to placebo (p=0.0028) with a medium effect size (Cohen's d=0.46). This effect across the full treatment population reproduces XPro™'s most reliable preclinical signature, establishing target engagement in AD patients with a high degree of confidence. Biomarker-Enriched AD Population (N=100): In patients with amyloid-positivity and two or more elevated inflammatory biomarkers at baseline, the treatment effect strengthened further to a medium-to-large effect size (Cohen's d=0.59; p=0.0098). This is the patient profile most directly aligned with XPro™'s anti-neuroinflammatory mechanism. INmune Bio will present the complete chi-separation dataset from the MINDFuL study, including longitudinal trajectory analysis, subgroup characterization, dose-response analyses, and mechanistic interpretation at the Alzheimer's Association International Conference (AAIC) 2026 which will take place July 12–15, 2026 in London, UK. The presentation will also include data from complementary advanced MRI endpoints in the MINDFuL imaging package. Additional details will be announced following the presentation. Following a successfully completed End-of-Phase 2 meeting, INmune Bio has secured regulatory alignment with the FDA on the design of its upcoming registrational program, establishing a clear, de-risked pathway toward commercial submission. Supported by FDA Fast Track designation granted on May 14, 2026, the Phase 2b/3 seamless adaptive trial is engineered to support the registration of XPro™ in patients with early Alzheimer's disease who carry biomarkers of inflammation. The registrational strategy is also supported by the favorable safety profile observed in the Phase 2 MINDFuL trial, including no observed ARIA-E or ARIA-H, an important differentiating feature for a disease-modifying Alzheimer’s program focused on neuroinflammation rather than amyloid clearance. Phase 2b Adaptive Advancement: The Phase 2b portion of the study will utilize the Early Alzheimer's Disease Cognitive Composite (EMACC) and plasma pTau217 as rigorous, decision-gating endpoints. These metrics will dictate the adaptive advancement of the program into the Phase 3 cohort. Phase 3 Registrational Evaluation: The Phase 3 portion is expected to evaluate definitive clinical outcomes, including the Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB), which the FDA has raised no objections to using as the sole primary efficacy endpoint for the Phase 3 registrational portion of the program. XPro1595 is a next-generation inflammatory cytokine modulator that neutralizes soluble TNF (sTNF) without affecting transmembrane TNF (tmTNF) or its receptors. This selective targeting is designed to reduce neuroinflammation, a key driver of neurodegeneration in Alzheimer’s disease, while maintaining the protective immune functions of the body. INmune Bio is actively advancing two late-stage product platforms toward registrational milestones: CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell (hucMSC) platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in Recessive Dystrophic Epidermolysis Bullosa (RDEB), the platform is transitioning to regulatory filing phases, with a Marketing Authorization Application (MAA) scheduled for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission. XPro™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer's disease.

総株主利回り	-44.1%
将来の配当利回り	n/a
配当成長	n/a
次回配当支払日	n/a
配当落ち日	n/a
一株当たり配当金	n/a
配当性向	n/a

セグメント	配当利回り
会社 (INMB)	n/a
市場下位25% (US)	1.3%
市場トップ25% (US)	4.1%
業界平均 (Biotechs)	2.1%
アナリスト予想 (INMB) (最長3年)	n/a

データ	最終更新日（UTC時間）
企業分析	2026/07/20 08:48
終値	2026/07/20 00:00
収益	2026/03/31
年間収益	2025/12/31

パッケージ	データ	タイムフレーム	米国ソース例
会社財務	10年	損益計算書キャッシュ・フロー計算書貸借対照表	SECフォーム10-K SECフォーム10-Q
アナリストのコンセンサス予想	+プラス3年	予想財務アナリストの目標株価	アナリストリサーチレポート Blue Matrix
市場価格	30年	株価配当、分割、措置	ICEマーケットデータ SECフォームS-1
所有権	10年	トップ株主インサイダー取引	SECフォーム4 SECフォーム13D
マネジメント	10年	リーダーシップ・チーム取締役会	SECフォーム10-K SECフォームDEF 14A
主な進展	10年	会社からのお知らせ	SECフォーム8-K

アナリスト	機関
James Molloy	Alliance Global Partners
Mayank Mamtani	B. Riley Securities, Inc.
Ilya Zubkov	Freedom Broker

INmune Bio 配当と自社株買い

配当金 基準チェック /06

主要情報

最近の配当と自社株買いの更新

Recent updates

INmune Bio Announces Peer-Reviewed Preclinical Study Results For XPro1595 In Traumatic Brain Injury-Induced Alzheimer’s Pathology

INMB: Extended Cell Therapy Patent Protection Will Drive Future Upside Potential

Inmune Bio Presents Positive Phase 2 Imaging Data for Xpro in Early Alzheimer’S Disease At Aaic

INmune Bio Progresses Next-Generation CORDStrom Platform Patent Toward Potential 2045 Exclusivity

INmune Bio Advances CORDStrom™ Platform Patent Application in the U.S. Following Favorable International Written Opinion

Is INmune Bio (NASDAQ:INMB) In A Good Position To Invest In Growth?

New minor risk - Share price stability

INmune Bio Inc.(NasdaqCM:INMB) dropped from Russell 3000 Growth Benchmark

INMB: Fast Track Alzheimer’s Program Will Drive Future Upside Potential

Inmune Bio Inc. Achieves Mhra Approval of Pediatric Investigation Plan for Ebstrocel for Treatment of Recessive Dystrophic Epidermolysis Bullosa

Inmune Bio Receives Mhra Written Alignment Supporting Planned 2026 Uk Conditional Marketing Authorization Application for Cordstrom in Rdeb

INmune Bio Reports Statistically Significant Treatment Effect On Advanced White Matter MRI Biomarker In Phase 2 MINDFuL Alzheimer's Trial

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

New minor risk - Share price stability

INmune Bio Inc. to Report Q1, 2026 Results on May 07, 2026

INmune Bio Inc., Annual General Meeting, Jun 16, 2026

Inmune Bio Inc. Announces New Preclinical Data At Aacr 2026 Demonstrating Inb03 (Xpro1595) Overcomes Resistance and Reduces Metastases in Her2-Positive Breast Cancer Models

New major risk - Financial position

INmune Bio Inc. to Report Fiscal Year 2025 Results on Mar 30, 2026

Consensus revenue estimates increase by 25%

INmune Bio Inc. Features Mindful Trial of Xpro Pegipanermin At AD/PD 2026 Plenary

Consensus revenue estimates decrease by 20%

Price target increased by 42% to US$7.00

Consensus revenue estimates increase by 25%

New minor risk - Share price stability

INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer's Disease

INmune Bio Advances CORDStrom Towards UK Marketing Authorization in RDEB

Price target increased by 29% to US$6.33

INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $65 million.

INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $75 million.

Can INmune Bio (NASDAQ:INMB) Afford To Invest In Growth?

Peer Reviewed Study Highlights Therapeutic Potential Around Application of Stromal Cell Therapies Such as Inmune Bio's CORDStrom™? Platform

INmune Bio, Inc. Reports New Phase 2 Grey Matter Imaging Data at CTAD Conference Reinforcing XPro1595’s Evidence Base in High-Inflammation Alzheimer's Patients

INmune Bio, Inc. to Report Q3, 2025 Results on Oct 30, 2025

INmune Bio, Inc. Announces Submission of Phase 2 MINDFuL Trial Results in Alzheimer's Disease to Nopj Dementia, a Nature Portfolio Journal

INmune Bio, Inc. Announces Successful Completion of First Commercial Pilot-Scale Manufacturing Run of CORDStrom™? At CGT Catapult

INmune Bio's CaRe PC Trial of INKmune™ in Metastatic Castration-Resistant Prostate Cancer Meets Endpoints and Is Closed to Enrollment

INmune Bio, Inc. to Report Q2, 2025 Results on Aug 07, 2025

INmune Bio Inc. to Present Phase 2 MINDFuL Trial Findings of XPro at the Alzheimer's Association International Conference

New major risk - Shareholder dilution

INmune Bio: What's Left For Investors

New minor risk - Market cap size

INmune Bio, Inc. Reports Key Findings from Phase 2 MINDFuL Trial of XPro in Early Alzheimer's Disease

INmune Bio, Inc. has completed a Follow-on Equity Offering in the amount of $18.9 million.

INmune Bio (NASDAQ:INMB) Will Have To Spend Its Cash Wisely

INmune Bio, Inc. Announces That XPro™ Reduced Amyloid and Enhances Behavior Post Traumatic Brain Injury in an Animal Model of Alzheimer’s Disease: Supported by Department of Defense

First quarter 2025 earnings released: US$0.43 loss per share (vs US$0.61 loss in 1Q 2024)

INmune Bio, Inc. to Report Q1, 2025 Results on May 08, 2025

INmune Bio, Inc., Annual General Meeting, May 28, 2025

INmune Bio, Inc. Auditor Raises 'Going Concern' Doubt

Full year 2024 earnings: EPS and revenues exceed analyst expectations

INmune Bio, Inc. to Report Q4, 2024 Results on Mar 27, 2025

Is INmune Bio (NASDAQ:INMB) A Risky Investment?

Consensus revenue estimates decrease by 25%

Forecast to breakeven in 2027

INmune Bio Opens Phase II in High Dose Cohort of INKmune Trial in Prostate Cancer

INmune Bio, Inc. Announces Plan to Submit FDA Biologics License Application Seeking Approval of Cordstrom for Treatment of Recessive Dystrophic Epidermolysis Bullosa

INmune Bio Inc. Expands INKmune Trial in Prostate Cancer to Veterans

New minor risk - Share price stability

New minor risk - Market cap size

INmune Bio Inc. Announces Final Enrollment of 208 Patients in Phase 2 Trial in Early Alzheimer's Disease

New major risk - Revenue and earnings growth

Is INmune Bio (NASDAQ:INMB) Using Debt In A Risky Way?

Third quarter 2024 earnings released: US$0.60 loss per share (vs US$0.48 loss in 3Q 2023)

INmune Bio, Inc. to Report Q3, 2024 Results on Oct 31, 2024

CFO, Treasurer & Secretary recently bought US$53k worth of stock

INmune Bio Inc. Completes Enrollment for Phase 2 Trial in Early Alzheimer's Disease

INmune Bio: NK Cell Therapy INKmune For mCRPC Is Another Shot On Goal

Co-Founder recently bought US$98k worth of stock

INmune Bio, Inc. Announces Results of Additional Blinded Interim Analysis of Phase 2 Alzheimer's Disease Trial Demonstrating Correlation between EMACC and CDR-SB Endpoints

INmune Bio, Inc. has filed a Follow-on Equity Offering.

INmune Bio, Inc. has filed a Follow-on Equity Offering in the amount of $75 million.

Consensus EPS estimates upgraded to US$2.26 loss

New minor risk - Profitability

Second quarter 2024 earnings released: US$0.51 loss per share (vs US$0.36 loss in 2Q 2023)

配当金基準チェック /06