Monitor MHRA response to pre-MAA package (expected 3-6 months) and FDA Type B meeting request for BLA pathway clarity. The Uniphar agreement provides a capital-efficient commercialization path but named-patient revenue is uncertain until pricing and reimbursement are secured.
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Executive Summary
INmune Bio filed an 8-K announcing two key Ebstrocel (CORDStrom) milestones: submission of a pre-MAA package to the UK MHRA with a full MAA targeted for February 2027 and potential UK approval in mid-2027, and a Master Services Agreement with Uniphar for international named-patient access and commercialization. The filing also includes an investor presentation highlighting Phase 2 data for Ebstrocel in RDEB and XPro1595 in Alzheimer's disease.
Key Facts
- Pre-MAA package submitted to UK MHRA on October 20, 2026; full MAA targeted for early February 2027.
- Potential UK approval in mid-2027, accelerated by approximately six weeks vs. prior timeline.
- U.S. BLA planned for Q2 2027, subject to FDA Type B meeting feedback.
- Master Services Agreement signed with Uniphar for named-patient access in selected European and MENA markets.
- Ebstrocel holds U.S. Orphan Drug and Rare Pediatric Disease designations.
- Phase 2 Mission EB trial showed 27.5% itch reduction at month 6 in RDEB-Severe patients; primary safety endpoint met.
- XPro1595 Phase 2b/3 adaptive trial design aligned with FDA; Fast Track granted Q2 2026.
- Investor presentation details CORDStrom and XPro1595 platforms, regulatory milestones, and commercial strategy.
Financial Impact
No financial figures provided; potential revenue from Ebstrocel commercialization if approved in UK and/or US in 2027.
Risk Factors
- Regulatory approval not assured; MHRA, FDA, or EMA may require additional data or deny applications.
- Phase 2 Mission EB trial failed primary endpoint (EBDASI score at 3 months); reliance on secondary endpoints and qualitative data.
- XPro1595 Phase 2b/3 trial in Alzheimer's disease carries high clinical and regulatory risk.
- Company requires substantial additional funding to continue operations and commercialization efforts.
- Named-patient access revenue is contingent on country-specific statements of work and local approvals.
Investment Themes
Documents Analyzed
This report is based on 7 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-111207 |
| Document: ea0309223-8k_inmune.htm | 0001213900-26-111207 |
| Document: ea030922301ex99-1.htm | 0001213900-26-111207 |
| Document: ea030922301ex99-2.htm | 0001213900-26-111207 |
| Document: 0001213900-26-111207-index-headers.html | 0001213900-26-111207 |
| Document: 0001213900-26-111207-index.html | 0001213900-26-111207 |
| Document: 0001213900-26-111207.txt | 0001213900-26-111207 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 5d ago | 8-K | $1.61 | awaiting T+60 | — | $1.43 (−11.18%) |
Sep 16, 2026 5w ago | 3 | $2.18 | awaiting T+60 | — | $1.43 (−34.40%) |
Jul 9, 2026 15w ago | Press Release | $1.79 $1.93 | ▲ +7.82% | ▲ +6.19% | $1.43 (−20.11%) |
Jul 1, 2026 16w ago | 8-K | $1.68 | awaiting T+60 | — | $1.43 (+14.88%) |
Jun 23, 2026 17w ago | 8-K | $1.35 | awaiting T+60 | — | $1.43 (+5.93%) |
Jun 17, 2026 18w ago | 8-K | $1.45 | awaiting T+60 | — | $1.43 (−1.38%) |
Jun 2, 2026 20w ago | 8-K | $1.32 $2.40 | ▲ +81.82% | ▲ +79.32% | $1.43 (+8.33%) |
May 7, 2026 24w ago | Press Release | $1.43 $1.91 | ▲ +33.57% | ▲ +28.73% | $1.43 (−0.00%) |
May 5, 2026 24w ago | 8-K | $1.52 $1.75 | ▲ +15.13% | ▲ +13.07% | $1.43 (−5.92%) |
Apr 30, 2026 25w ago | Press Release | $1.43 | awaiting T+60 | — | $1.43 (−0.00%) |
US Market Status
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