INmune Bio, Inc. Q2 FY2025 earnings call

Management Statement and Operational Highlights

• XPro: Phase II MINDFuL trial data supports XPro's potential in Alzheimer's patients with high inflammation. Purpose of Phase II is to inform Phase III design. Exploring strategic partnerships for XPro.
• CORDStrom: Focus on preparing marketing authorization application (MAA) for U.K. and biologics license application (BLA) for U.S. by mid-2026. Umbilical cord-derived MSC product can be tailored for various indications.
• INKmune: Phase I/II near completion, data shows safety and NK cell benefits. Plan to move to trial in less advanced patient group.
• Leadership: Acknowledged RJ Tesi's retirement, David Moss as new CEO. Cory Ellspermann appointed Interim CFO.

Segment Performance

• XPro: Phase II MINDFuL trial data confirmed Alzheimer's patients with 2 or more inflammation biomarkers are optimal. Though not meeting primary endpoint overall, it showed benefits in high-inflammation subgroup with effect sizes comparable to approved Alzheimer's therapies. Revenue contribution not specified as a percentage.
• CORDStrom: Preparing for U.K. and U.S. approvals by mid-2026, with umbilical cord-derived MSC product tailorable for different indications (e.g., RDEB, osteoarthritis). Potential for PRV if approved in U.S.
• INKmune: Phase I/II near completion, safe with immunologic benefits, best for targeting minimal residual disease. Trials closed for recruitment, planning trial in less advanced patient group.

Guidance

• XPro: Expect end of Phase II meeting with FDA in Q4 2025. Preparing briefing book and manuscript for MINDFuL trial.
• CORDStrom: Aim to file MAA and BLA by mid-2026. Potential PRV if approved in U.S. through Give Kids a Chance Act.
• INKmune: Plan trial in less advanced patient group to optimize INKmune's potential.

Risks

• Forward-looking statements involve risks of actual results differing from projections. Regulatory risks in trials and approvals. Uncertainties in strategic partnerships for drug development.

Question and Answer

Q: Specific date for XPro end of Phase II meeting with the FDA?

A: Not set yet; preparing briefing book and manuscript, expected in Q4 2025.

Q: Atmosphere at AAIC for XPro?

A: Positive feedback, interest in neuropsychiatric benefits (NPI) and absence of ARIA, indicating strong safety profile.

Q: Status of partnerships for XPro?

A: Looking for partner to finance registration trial, likely to occur post-end of Phase II meeting with FDA.

Q: Biomarkers in XPro trial, refinements for EMACC?

A: EMACC performed as expected in high-inflammation subgroup; FDA feedback on EMACC is positive as it captured change in the right patient population.

Q: CORDStrom BLA preparation details?

A: Statistical analysis plan improved for better data analysis; open-label post-BLA trial planned, but results may not be included in BLA package initially