Inmune Bio, Inc. Q1 FY2025 earnings call

• Upcoming topline results from the MINDFuL Phase 2 trial in early Alzheimer’s disease expected mid-to-late June. - Biomarker profile from ADPD confirmed increased market opportunity for XPro in early AD, with over two-thirds of early AD patients eligible based on ApoE4 status. - INKmune program: Phase 1 dose escalation completed, well-tolerated in prostate cancer patients, Phase 2 enrollment ongoing. - CORDstrom program: On track for BLA filing in 2026 for RDEB, with FDA rare pediatric disease and orphan drug status. - Financials: Net loss attributable to common stockholders for Q1 2025 was approximately $9.7M, R&D expenses $7.6M, G&A expenses $2.3M, cash and cash equivalents $19.3M as of March 31, 2025.

No detailed breakdown of product segments with revenue contribution provided in the transcript.

• Topline data from the MINDFuL Phase 2 trial expected in June. - Aim for end of Phase 2 FDA meeting in Q4 2026 to design Phase 3 trial. - Complete enrollment in the Phase 2 portion of the INKmune trial this year with updates on immunologic and therapeutic responses. - Anticipate filing a BLA for CORDstrom in RDEB in H1 2026. - Initiate Phase 2 trial of XPro in treatment-resistant depression once NIH funding available.

Forward-looking statements involve risks and uncertainties as per SEC filings, where actual results may differ materially from forward-looking statements.

Q: Assuming positive readout in June, walk through next steps for the MINDFuL program, timeline for Phase 3 initiation.

A: RJ Tesi says they will defer design until after results and FDA meeting, aiming for end of Phase 2 FDA meeting in Q4 2026, with sites ready in Europe and US but no specific dates or sizes.

Q: With positive EMAC but equivocal CDR, how will investors react?

A: CJ Barnum states EMAC is the tool capturing cognitive changes, CDR is a blunt instrument, with correlations expected but CDR noisier.

Q: Status of CORDstrom 12-month open-label trial, enrollment aim, US sites.

A: Mark Lowdell says starting manufacturing with US-approved donors, submitting IND later this year, BLA submission with existing data, and follow-on trial in US next year.