BOCA RATON, Fla., August 6, 2026
INmune Bio Inc. reported its second quarter 2026 financial results while highlighting significant regulatory, manufacturing, and clinical progress across its late-stage therapeutic platforms, Ebstrocel™ (CORDStrom™) for recessive dystrophic epidermolysis bullosa (RDEB) and XPro™ (XPro1595) for early Alzheimer’s disease. During the quarter, the company achieved several major milestones, including MHRA regulatory alignment, Pediatric Investigation Plan (PIP) approval, and completion of commercial-ready manufacturing for Ebstrocel, positioning the therapy for a planned UK Marketing Authorization Application (MAA) submission by late 2026. Meanwhile, XPro™ received FDA Fast Track Designation and generated statistically significant Phase 2 MRI biomarker data, reinforcing its development as a potential first-in-class neuroimmunology therapy. INmune Bio also reported a cash position of approximately $18.4 million as of June 30, 2026, supporting continued advancement of both late-stage programs.
Ebstrocel Program Reaches Major Regulatory and Manufacturing Milestones
The company’s CORDStrom™ platform made substantial progress toward commercialization during the quarter. INmune Bio successfully processed its first commercial-ready umbilical cord tissues at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in the UK, establishing manufacturing processes designed to meet MHRA, EMA, and FDA standards. The company also received formal MHRA alignment covering clinical, non-clinical, and manufacturing requirements for its planned Conditional Marketing Authorization submission. In addition, regulators approved the Pediatric Investigation Plan within three months, allowing the company to maintain its targeted regulatory timeline. Preparations for the Phase 3 confirmatory trial remain on schedule, with first patient enrollment expected in the fourth quarter of 2026. INmune Bio also strengthened long-term commercialization through expanded supply agreements for umbilical cord tissue and continued intellectual property expansion that could provide platform protection through 2045 if granted.
XPro Strengthens Alzheimer’s Development Program
INmune Bio also reported encouraging progress for XPro™ (pegipanermin), its investigational therapy targeting early Alzheimer’s disease. Results from the Phase 2 MINDFuL trial demonstrated a statistically significant improvement in white matter myelin MRI biomarkers, with treatment effects observed in both the overall study population and a biomarker-enriched subgroup. Additional analyses presented at the Alzheimer’s Association International Conference (AAIC 2026) showed treatment-related improvements across both white matter and cortical gray matter, supporting biological activity and target engagement. During the quarter, the FDA granted Fast Track Designation for XPro in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia, providing opportunities for accelerated regulatory interactions. Supporting evidence also included publication of MINDFuL data in NPJ Dementia and preclinical oncology findings demonstrating that INB03 (XPro1595) enhanced HER2-targeted therapies while reducing metastatic spread in breast cancer models.
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Company Targets Multiple Regulatory Filings Through 2027
Looking ahead, INmune Bio plans to submit the Ebstrocel Marketing Authorization Application to the UK MHRA by late Q3 or early Q4 2026, followed by an EMA submission in Q1 2027 and a planned FDA Biologics License Application (BLA) later in the first quarter of 2027. The company also intends to submit the registrational Phase 2b/3 protocol for XPro™ to the FDA during Q4 2026, while continuing publication of additional imaging analyses from the MINDFuL trial. Financially, the company reported a net loss of approximately $1.3 million for the second quarter, significantly improved from the prior-year period due largely to the absence of impairment charges and recognition of Australian research tax incentives. Together, the regulatory achievements, manufacturing readiness, and advancing clinical programs position INmune Bio to enter a pivotal phase as it seeks regulatory approvals across multiple late-stage assets
Source: INmune Bio press release
