INmune Bio (INMB) investor relations material

Late-stage pipeline and regulatory progress

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

• CORDStrom has received Orphan Drug and Rare Pediatric Disease Designations, and XPro has FDA alignment on Phase 2b/3 trial design.

• Priority Review Voucher monetization is planned to fund operations, leveraging regulatory incentives.

• Both assets target multi-billion-dollar markets in rare disease and neurodegeneration.

CORDStrom: Innovation, clinical data, and market opportunity

• CORDStrom is a pooled allogeneic umbilical cord MSC therapy for RDEB, administered systemically via IV infusion, addressing systemic pathology beyond topical care.

• Phase III data show clinically meaningful reductions in itch and pain, improved skin scores, and enhanced quality of life for RDEB patients.

• Proprietary manufacturing yields over 300,000 doses from four cords, solving cost and consistency issues.

• Anticipated annual reimbursement is ~$700,000 per patient, with a total addressable market estimated at $1.4bn.

• Regulatory submissions are planned for mid-to-late 2026, with commercial readiness and validated potency assays in place.

Mechanism of action and differentiation

• CORDStrom modulates immune response by shifting macrophages from M1 to M2 phenotype, reducing IL-31 and TNF, and enhancing wound healing.

• Demonstrates systemic improvements in pain, itch, sleep, gastrointestinal symptoms, and skin quality.

• Engineered homogeneity through donor selection and pooling ensures high potency and reproducibility.