INmune Bio Raises $27.5M, Targets Mid-Summer UK MAA Filing for CORDStrom Therapy
INmune Bio secured $27.5 million net proceeds from selling 4.3 million shares and received a A$5.2 million (US$3.6 million) R&D rebate, extending cash runway through Q1 2027. It plans a mid-summer UK MAA filing for CORDStrom™ and Q4 2026 FDA BLA submission, with FDA-aligned Phase 2b/3 path for XPro™.
1. 2025 Financial Results
INmune Bio generated net cash proceeds of $27.5 million in 2025 by selling 4,304,707 shares and received A$5.2 million (US$3.6 million) in Australian R&D rebates in January 2026, resulting in cash on hand sufficient to fund operations through Q1 2027.
2. CORDStrom™ Regulatory Milestones
The company submitted a pre-MAA package to the UK’s MHRA in February and will hold a face-to-face meeting in mid-May, remaining on track to file its Marketing Authorization Application for CORDStrom™ in recessive dystrophic epidermolysis bullosa by mid-summer 2026, followed by EMA and FDA BLA filings in Q4 2026.
3. XPro™ Development Pathway
XPro™ presented new Phase 2 imaging data at the Clinical Trials on Alzheimer’s Disease conference and secured FDA alignment for an adaptive Phase 2b/3 registrational pathway in early Alzheimer’s, leveraging biomarker-enriched patient selection validated by the Phase 2 MINDFuL trial.
4. Strategic Outlook and Manufacturing
INmune Bio completed three commercial pilot-scale manufacturing runs at its Stevenage facility, meeting all release criteria to support near-term commercialization, and plans to capitalize on the Rare Pediatric Disease Priority Review Voucher program through 2029 to non-dilutively fund further development.