INmune Bio (INMB) investor relations material

Pipeline and regulatory progress

• Two late-stage assets, CORDStrom (RDEB) and XPro1595 (Alzheimer's), are entering pivotal regulatory phases with filings planned in the US, UK, and EU between late 2026 and 2027.

• CORDStrom has received Rare Pediatric Disease and Orphan Drug Designations, with regulatory alignment on trial design and a clear path to Priority Review Voucher monetization.

• XPro1595's Phase 2b/3 adaptive trial design is FDA-aligned, targeting early Alzheimer's patients with inflammation, using biomarker-driven enrichment.

• Commercial readiness for CORDStrom includes validated CMC, scalable manufacturing, and clinician-friendly packaging.

CORDStrom for RDEB: Clinical and market insights

• CORDStrom is the first systemic therapy for RDEB, showing significant improvements in itch, pain, skin healing, and quality of life in a randomized, placebo-controlled trial.

• The therapy addresses multi-organ pathology, with benefits observed across all age and severity groups, and an excellent safety profile.

• Mechanistically, CORDStrom modulates immune responses, reduces IL-31 and TNF, and promotes wound healing via M1 to M2 macrophage differentiation.

• Annual treatment cost is estimated at $120–180K, with potential reimbursement around $700K and a total addressable market exceeding $1.4 billion.

• Regulatory submissions are planned for 2026, with conditional approvals targeted in the US, UK, and EU.

XPro1595 for Alzheimer's: Clinical and scientific validation

• XPro1595 targets TNF-driven inflammation in early Alzheimer's, with over 90 peer-reviewed publications supporting its neuroprotective and disease-modifying effects.

• Phase 2 MINDFUL trial showed consistent efficacy across cognitive, neuropsychiatric, and biomarker endpoints, with a superior safety profile and no ARIA events.

• Biomarker enrichment strategy (≥2 of 4: hsCRP, ESR, HbA1c, APOE4) identifies patients most likely to benefit, reducing misclassification and accommodating biological heterogeneity.

• The adaptive Phase 2b/3 trial includes a go/no-go decision after Phase 2b, with FDA endorsement of the enrichment and endpoint strategy.

• Strategic roadmap includes partnership for registration, staged investment, and leveraging CORDStrom revenue and PRV for further development.