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 to host Feb 26 webinar on new CORDStrom Phase III data for RDEB
Webinar on February 26, 2026 at 1:00 PM ET to present new MissionEB Phase III data for CORDStrom in RDEB.
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 amends 1.35M April 2024 warrants; exercise price cut to $1.95, term extended to June 2026
Exercise price of 1,348,315 outstanding April 2024 warrants reduced to $1.95 per share.
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.
INmune Bio terminates $75M ATM sales agreement with RBC and BTIG effective Dec 19, 2025
Company notified RBC and BTIG of termination on Dec 5 and Dec 9, 2025; effective Dec 19.
INmune Bio extends poison pill rights agreement to December 31, 2026
Amendment No. 5 to Rights Agreement dated Dec 5, 2025 extends expiration to Dec 31, 2026.
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 corrects CEO/CFO base salaries and CEO option grant in employment agreements
CEO David Moss base salary corrected to $454,000 per annum; option grant corrected to 750,000 shares.
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 to host Q3 2025 results conference call on October 30, 2025
Company will report Q3 2025 financial results and provide corporate update on October 30, 2025 at 4:30 PM ET.
INmune Bio CEO to present at Maxim Growth Summit on RDEB panel
CEO David Moss will participate in a Dermatologic Rare Disease Panel at the Maxim Growth Summit on Oct 22, 2025.
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 shareholders approve share increase to 6.5M; XPro shows amyloid reduction post-TBI
Stockholders approved Amended 2021 Stock Incentive Plan, increasing shares from 4M to 6.5M; permits accelerated vesting on change of control.
INmune Bio to present at RBC Capital Markets Global Healthcare Conference on May 20-21
Fireside chat and 1-on-1 virtual meetings on May 20-21, 2025, at InterContinental Barclay NY.
INmune Bio Q1 net loss narrows to $9.7M; Alzheimer's Phase 2 data expected late June
Net loss $9.7M ($0.42 per share) vs $11.0M YoY; R&D expenses down to $7.6M from $8.7M.
INmune Bio dismisses Marcum as auditor, engages CBIZ CPAs due to acquisition
Dismissed Marcum LLP on May 7, 2025, following acquisition of its attest business by CBIZ CPAs P.C.
INmune Bio schedules Q1 2025 earnings call for May 8; no results released yet
Press release dated May 5, 2025 announces conference call on May 8, 2025 at 4:30 p.m. ET.
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 presents MINDFuL Phase II baseline data at AD/PD 2025; topline results due June 2025
Poster details baseline demographics of 208 patients (44% MCI, 56% mild AD) enrolled in MINDFuL Phase II trial of XPro1595.
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 to host Q4 2024 conference call on March 27
Conference call scheduled for March 27, 2025, at 4:30 p.m. ET to discuss Q4 2024 results and corporate update.
Preliminary phase I/II results for INKmune in metastatic castration-resistant prostate cancer highlighted in new investor deck.
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.
First patient treated in Phase II portion of Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC) at West LA VA Medical Center.
Rights Agreement amended to extend expiration to December 30, 2025.
Total of 208 patients enrolled, exceeding target; 56% mild AD and 44% MCI.
INmune Bio releases new investor presentation; no financial updates in filing
Company furnished a slide deck for use in investor presentations (Exhibit 99.1).
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 to host Nov 7 webinar on EMACC cognitive tool for Alzheimer's trials
Webinar on Nov 7, 2024 at 1 PM ET, titled "Why EMACC is the Optimal Tool for Measuring Cognitive Change in Early Alzheimer's Trials."
INmune Bio announces Cell Reports publication showing XPro1595 promotes remyelination
Publication in Cell Reports demonstrates XPro1595 converts microglia from demyelinating to remyelinating cell.
INmune Bio schedules Q3 2024 earnings call for Oct 31 at 4:30pm EDT
Press release issued Oct 24, 2024 announcing conference call date.
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