INmune Bio (INMB) Q4 2024 earnings summary

Executive summary

• 2024 was a pivotal year, with 2025 expected to be transformational as phase II XPro AD02 data in early Alzheimer's is anticipated in June, focusing on neuroinflammation and using the novel EMACC endpoint.

• The AD02 trial enrolled 208 patients with neuroinflammation biomarkers, employing a precision medicine approach and the EMACC cognitive endpoint.

• CORDStrom showed favorable safety and efficacy in pediatric RDEB, earning FDA Rare Pediatric Disease and Orphan Drug Designations, with a BLA filing planned for early 2025.

• INKmune demonstrated safety and NK cell activation in mCRPC trials, completed phase I dose escalation, and advanced to phase II with expanded manufacturing.

• Raised $27.5M–$29.9M from securities offerings in 2024, repaid Silicon Valley Bank loan, and joined the Russell 3000® Index.

Financial highlights

• Net loss for 2024 was $42.1M, up from $30M in 2023; R&D expenses rose to $33.2M from $20.3M year-over-year.

• General and administrative expenses were $9.5M in 2024, nearly flat year-over-year.

• Cash and equivalents were $20.9M at year-end, with an additional $5.4M raised post-year-end.

• Cash runway expected through Q3 2025, not including potential warrant exercises or R&D rebates.

• Other income, net, was $0.6M in 2024 versus a net expense of $0.3M in 2023.

Outlook and guidance

• Top-line and secondary endpoint data from the phase II XPro AD02 trial expected in June 2025, with both EMACC and CDR endpoints released simultaneously.

• BLA filing for CORDStrom in RDEB planned for Q1 2025, with open-label extension trials ready to start in the UK and planned for the US.

• INKmune phase II enrollment for prostate cancer targeted by end of 2025, with interim data releases as available.

• Phase II XPro trial in treatment-resistant depression to begin enrollment pending NIH funding.

• Ongoing INKmune mCRPC trial data to be released in Q2/Q3 2025.