INmune Bio (INMB) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic focus and pipeline updates

• Two late-stage platforms target inflammation and immunology without immunosuppression.

• XPro, aimed at neuroinflammation in Alzheimer's, did not meet cognitive endpoints in phase II but received FDA Fast Track and a clear registration path for phase II-B/III.

• XPro program is on hold while CORDStrom advances regulatory submissions.

• CORDStrom (Ebstrocel) targets recessive dystrophic EB, with UK approval expected Q2 next year and US/EU submissions in Q1.

• Priority review voucher from US approval will help fund further Alzheimer's trials.

Clinical data and patient impact

• Ebstrocel is the first systemic treatment for RDEB, addressing both external and internal symptoms.

• Top patient complaints are itch and pain, not wounds; Ebstrocel reduces itch, pain, and inflammation, improving quality of life.

• Largest blinded, randomized RDEB trial showed significant itch reduction at three and six months, with later improvements in skin integrity.

• Patient-reported outcomes highlighted improved daily activities, less pain, and better school attendance.

• No serious adverse events reported after over 200 administrations.

Regulatory and manufacturing progress

• Conditional approval framework in UK/EU and accelerated pathway in US are being pursued.

• Open label phase III trial will expand age range to 0–18 years due to demonstrated safety.

• Mechanism of action is well-matched to clinical endpoints, with clear biomarker changes in treated patients.

• Manufacturing process ensures batch consistency and scalability, solving previous MSC heterogeneity issues.

• All clinical and CMC issues identified by regulators are addressable; BLA and MAA submissions planned for Q1 next year.