INmune Bio's Q1 2025: Unpacking Contradictions in CORDStrom, EMACC, and Clinical Trial Strategies

CORDStrom regulatory strategy and timing, EMACC and CDR release timing, selectivity in patient enrollment and regulatory implications, clinical trial enrollment strategy and Phase III implications, CDR as a biomarker are the key contradictions discussed in INmune Bio's latest 2025Q1 earnings call.



MINDFuL Trial Update:
- INmune Bio is expecting topline cognitive data from its Phase 2 trial in patients with early Alzheimer's disease, MINDFuL, by mid-to-late June.
- The trial's primary goal is to assess the impact of neuroinflammation on Alzheimer's disease by targeting it properly.
- The trial's results will influence the company's strategic direction and potential market opportunities in early-stage Alzheimer's treatment.

Potential Market Opportunity Expansion:
- INmune Bio reported that more than two-thirds of early Alzheimer's disease patients could be eligible for XPro based on ApoE4 status alone, up from the previously estimated 40%.
- This expansion is attributed to new findings at the ADPD meeting and the targeted exclusion of ApoE4 homozygotes from lecanemab and donanemab treatments in Europe and the U.K.

Financial Performance Outlook:
- INmune Bio's net loss for the quarter ended March 31, 2025, was approximately $9.7 million, compared to approximately $11 million for the comparable period in 2024.
- Research and development expenses decreased to approximately $7.6 million, compared to $8.7 million in the previous year.
- The company has approximately $19.3 million in cash and cash equivalents, which is expected to be sufficient to fund operations through Q3 of 2025.

INKmune and CORDstrom Programs:
- The INKmune Phase 1 dose escalation cohorts completed without adverse events, and Phase 2 extension cohorts are ongoing.
- CORDstrom is being developed for a BLA filing in 2026 for treating recessive dystrophic epidermolysis bullosa, with positive data from an open-label trial in the U.K.
- The expected BLA submission for CORDstrom, along with the ongoing INKmune trial, showcases the company's progress in multiple therapeutic areas.