INmune Bio's Q4 2024: Navigating Contradictions in Alzheimer's Trials, CORDStrom Strategy, and Regulatory Timelines

These are the key contradictions discussed in INmune Bio's latest 2024Q4 earnings call, specifically including: Alzheimer's trial design and patient selection, CORDStrom commercialization strategy, EXPAREL trial endpoints and EMACC acceptance, and timeline for CORDStrom's BLA:



Clinical Program and Data Release:
- INmune Bio's ADO2 Alzheimer's trial stands out, with top-line data expected in June 2025, following 208 patient enrollment across eight countries, after screening nearly 800 patients.
- The trial selects patients with biomarkers of inflammation and uses EMACC as the primary endpoint, aiming to halt cognitive decline rather than just slow it.

Financial Performance and Funding:
- The company raised $29.9 million in 2024 from a common stock and warrant offering, with approximately $30 million potentially available through warrant exercises.
- Cash and cash equivalents at year-end were $20.9 million, with an additional $5.4 million raised post-year-end via an ATM offering, enough to fund operations through Q3 2025.

CORDStrom Program and BLA Filing:
- INmune Bio is preparing for a BLA filing for CORDStrom, a systemic disease-modifying therapy for epidermolysis bullosa, in Q1 2026, following a successful trial in the UK.
- The filing is supported by compelling data and includes orphan drug and rare pediatric disease designations, addressing a significant unmet clinical need in pediatric patients.

Cell Therapy Platform Shift:
- The company completed the pivot of its INmune NK cell targeting platform to solid tumors, with the CaRe PC trial in metastatic prostate cancer showing progress.
- Dosing is ongoing, with plans to complete in 2025, aiming to expand the platform's applicability in treating cancers with underlying inflammation.