Inmune Bio, Inc. Q4 FY2024 earnings call

• Alzheimer's Program: ADO2 Phase 2 trial targeting neuroinflammation in early AD, using EMACC as primary endpoint, with top-line data expected in June 2025. Focus on precision medicine with patient selection using biomarkers.
• Prostate Cancer Program: Completed Phase 1 dose escalation, moving to Phase 2 with enrollment of additional patients in middle and high dose cohorts, expecting trial completion by end of 2025 and data release as available.
• RDEB Program: CORDStrom is an allogeneic umbilical cord-derived mesenchymal stem cell therapy for RDEB, aiming for BLA filing in Q1 2025, with open label trial to gather more data on persistence and delivery.

No detailed breakdown of financial performance by product segments with revenue contribution percentages provided in the transcript. Key programs mentioned include XPro for Alzheimer's, INmune for prostate cancer, and CORDStrom for RDEB, but no financial segment performance data with revenue contributions are detailed.

• Expect top-line data from ADO2 Phase 2 trial in Alzheimer's in June 2025.
• INmune prostate cancer trial expected to complete enrollment by end of 2025 with data released as available.
• CORDStrom aims to file BLA in Q1 2025.

General risks associated with clinical trial outcomes, regulatory approvals, and uncertainties in drug development as mentioned in forward-looking statements.

Q: Regarding the RDEB program, is the 12-month open label trial required for filing and differences in FDA vs UK approval?

A: Mark Lowdell states they have access to trial data, spoke to FDA about BLA eligibility, and MHRA will review CMC data; open label trial to gather more data on persistence and delivery.

Q: On EXPAREL Phase 2 trial, dropout rates, EMACC acceptance, and TRD program enrichment?

A: Christopher Barnum says dropout rates are less than expected, mostly elderly-related; EMACC follows FDA playbook but FDA's stance is unknown; TRD program uses similar but different enrichment based on disease specifics.

Q: On EXPAREL Phase 2 trial dropouts, Phase III timeline, and CORDStrom commercialization?

A: Christopher Barnum says dropouts are not due to drug efficacy/safety; Phase III timeline depends on FDA discussion; CORDStrom likely to seek partner for commercialization once regulatory filing is near.

Q: On RDEB program CMC and filing timeline, and PRV program renewal?

A: Mark Lowdell says CMC work ongoing, expecting data ready by end of Q1 2025; PRV program likely extended as it provides benefit with no cost to government.