Highest-materiality recent filing
INmune Bio reports statistically significant white matter MRI biomarker in Phase 2 Alzheimer's trial
XPro1595 showed significant myelin improvement vs placebo in full mITT (p=0.0028, d=0.46, n=200).
FDA grants Fast Track designation to INmune Bio's XPro for early Alzheimer's disease
Fast Track covers XPro for early Alzheimer's disease (MCI due to AD and mild AD dementia).
AN granted exclusive license to use donor materials; INmune Bio added as party with joint liability for royalty payments.
CORDStrom Phase 3 shows improvements in itch, pain, and skin scores in RDEB; MAA submission expected Q3 2026 for UK.
INmune Bio receives FDA alignment to advance XPro1595 to registrational study in Alzheimer's
FDA End-of-Phase 2 meeting yielded alignment to proceed with registrational study in biomarker-enriched early Alzheimer's patients.
INmune Bio advances CORDStrom in UK, secures FDA alignment for XPro1595 Alzheimer's program
Submitted CORDStrom pre-submission package to UK MHRA for RDEB; targets full MAA filing mid-summer 2026.
INmune Bio updates on CORDStrom RDEB timing and XPro Alzheimer's Phase 2 results
CORDStrom commercial pilot runs completed; MAA to UK MHRA planned mid-2026; BLA to FDA targeted end of 2026.
INmune Bio enters $65M ATM equity distribution agreement with A.G.P.
Up to $65M of common stock may be sold from time to time through A.G.P. as sales agent.
New PerpPD+ MRI imaging from Phase 2 MINDFuL trial shows trend toward slowed cortical disarray progression in early AD patients with high neuroinflammation (ADi).
INmune Bio enters new employment agreements with CEO, CFO, and CSO
CEO David Moss: $500,000 base salary, 50% bonus target, option for 800,000 shares.
Shareholders approve option repricing to $1.50; CTAD presentations set for Dec 1-4
Special meeting approves repricing of up to 5,511,000 outstanding stock options for employees, execs, and directors to $1.50 per share.
INmune Bio: CORDStrom MAA mid-2026, XPro Phase 3 in 2027; $30M cash as of Oct 14
CORDStrom Phase 2 in RDEB improves itch/pain; MAA to UK MHRA mid-2026, BLA in US late-2026.
INmune Bio Q3 net loss $6.5M; appoints new CEO, CFO; INKmune trial meets primary endpoint
Net loss narrowed to $6.5M from $12.1M YoY; R&D spend cut to $4.9M; cash $27.7M.
INmune Bio submits Phase 2 MINDFuL manuscript; highlights subgroup benefit and no ARIA
Phase 2 MINDFuL trial of XPro1595 missed primary endpoint overall but showed positive trends in ADi subgroup with high inflammatory burden.
INmune Bio posts $24.5M net loss, CEO replaced; INKmune trial meets endpoints
Net loss $24.5M in Q2 2025 vs $9.7M in Q2 2024; includes $16.5M impairment of in-process R&D intangibles.
INmune Bio to publish video with additional Phase 2 XPro trial findings after AAIC
Video detailing additional MINDFuL Phase 2 findings of XPro (soluble TNF inhibitor) to be published July 31 at 4 PM ET.
INmune Bio Phase 2 XPro trial misses primary endpoint; positive subpopulation data at AAIC
Primary endpoint not met in mITT group; 208 early-AD participants with inflammation biomarkers.
Primary cognitive endpoint EMACC not met in mITT (n=200); predefined subgroup with ≥2 inflammation biomarkers (n=100) showed cognitive benefit (effect size 0.27).
INmune Bio raises ~$19M in registered direct offering of 3M shares at $6.30/sh
Offering of 3,000,000 common shares at $6.30/share to two healthcare-focused institutional investors.
INmune Bio to announce top line Phase 2 MINDFuL Alzheimer's data on June 30
Conference call scheduled for June 30, 2025 at 8:00 AM ET to present top line Phase 2 MINDFuL results.
INmune Bio receives favorable USPTO patentability opinion for CORDStrom platform
USPTO, as International Search Authority, issued favorable opinion on all claims of PCT/US25/17028 on April 8, 2025.
INmune Bio partners with CGT Catapult to scale CORDStrom manufacturing for commercial readiness
Partnership with Cell and Gene Therapy Catapult aims to establish large-scale commercial manufacturing for cell therapy platforms.
INmune Bio presents MINDFul Phase 2 baseline data; top-line results expected June 2025
Poster at AD/PD conference details demographics: mean age 72.5 years, 69.2% APOE ε4 carriers.
INmune Bio FY2024 net loss $42.1M; AD02 top-line data expected June 2025
Net loss $42.1M vs $30.0M in FY2023; R&D expenses rose to $33.2M from $20.3M.
INmune Bio completes Phase I dose cohort for INKmune in mCRPC, opens Phase II
Third and highest dose cohort of Phase I completed; no safety issues found.
INmune Bio details CORDStrom regulatory path for RDEB; Phase 2 data shows itch reduction
CORDStrom Phase 2 in 30 RDEB patients met endpoints on itch and skin scores; well tolerated with no related AEs.
INmune Bio licenses MissionEB data, plans BLA for CORDStrom in pediatric RDEB
Plans to submit BLA in 2025 for CORDStrom to treat pediatric RDEB, supported by positive Phase 2 MissionEB data in 30 patients.
Total of 208 patients enrolled, exceeding target; 56% mild AD and 44% MCI.
INmune Bio Q3 net loss $12.1M; Phase 2 Alzheimer's trial fully enrolled; top-line data Q2 2025
Net loss $12.1M vs $8.6M Q3 2023; R&D expenses $10.1M (up from $6.0M).
INmune Bio announces Cell Reports publication showing XPro1595 promotes remyelination
Publication in Cell Reports demonstrates XPro1595 converts microglia from demyelinating to remyelinating cell.
On July 5, 2024, Edgardo Baracchini informed INmune Bio Inc. (the “Company”) of his resignation from the board of directors of the Company (the “Board”), effective immediately.
Max materiality 0.85 · Median 0.60 · Most common event other_material