INMB · INmune Bio, Inc.

The FDA Fast Track designation for XPro™ (pegipanermin), INmune Bio's first-in-class selective soluble TNF inhibitor, marks a pivotal advancement for the company's Alzheimer's disease program. This status facilitates expedited development and review for a therapy targeting neuroinflammation, recognized as an early driver of cognitive decline where no approved treatments exist. XPro™ neutralizes soluble TNF while preserving protective transmembrane TNF functions, positioning it to address disease progression in patients with inflammatory biomarkers. CEO David Moss highlighted this as a transformative milestone, enabling closer FDA collaboration to efficiently advance toward patients. The upcoming Phase 2b/3 seamless adaptive trial will enroll biologically confirmed early AD patients with inflammation markers, using EMACC and plasma pTau217 for Phase 2b decisions and CDR-SB for Phase 3 outcomes. This precision-medicine approach, supported by prior Phase 2 MINDFuL data and End-of-Phase 2 FDA alignment, enhances the potential for a registrational program. With 7.4 million Americans aged 65+ living with Alzheimer's dementia and 15 million with MCI per the 2026 Alzheimer's Association report, the early symptomatic window offers a critical intervention opportunity, amplifying the investor significance of this regulatory recognition.