INmune Bio Earnings Call Transcripts
Fiscal Year 2026
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Q1 2026 saw reduced net loss and R&D expenses, with $21.4M in cash supporting operations into 2027. Regulatory and manufacturing milestones for CORDStrom are progressing, while XPro advances with new imaging data and partnership exploration.
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Mission EB phase III trial showed CORDStrom, a pooled umbilical cord-derived cell therapy, significantly reduced itch and pain, improved wound healing, and was safe in children with RDEB. Sustained benefits were observed at six months, with the greatest impact in severe cases. Regulatory submissions are planned for 2024.
Fiscal Year 2025
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Advanced CORDStrom for RDEB towards regulatory filings, completed phase II trials for XPro in Alzheimer's and INKmune in prostate cancer, and raised $27.5M in equity. Cash runway extends through Q1 2027, with key regulatory milestones expected in 2026–2027.
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Q3 2025 saw reduced net loss and R&D spend, with CORDStrom advancing toward UK and US filings for RDEB, XPro showing promise in Alzheimer's, and INKmune meeting key endpoints in prostate cancer. Cash runway extends into Q4 2026.
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Q2 2025 saw a CEO transition, a $24.5M net loss driven by a $16.5M XPro impairment, and progress on XPro, CORDStrom, and INKmune clinical programs. XPro showed efficacy in a key Alzheimer's subgroup, with strategic partnerships expected post-FDA meeting.
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XPro was safe and showed cognitive benefit in early Alzheimer's patients with two or more inflammation biomarkers, though the primary endpoint was not met in the broader population. Effect sizes were comparable to leading therapies, and the company plans to advance to phase III pending FDA discussions.
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Phase 2 Alzheimer's trial results are expected in June, with XPro showing strong safety and expanded eligibility. Cordstrom advances toward a 2026 BLA for RDEB, supported by orphan status and regulatory momentum.
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A randomized, placebo-controlled trial in pediatric RDEB showed CORDStrom MSC therapy significantly reduced itch and improved skin and pain scores, especially in younger and intermediate patients, with no serious safety concerns. FDA recognized itch as a valid endpoint for approval.
Fiscal Year 2024
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2024 saw major clinical and financial progress, with phase II XPro AD02 Alzheimer's data expected in June 2025 and a BLA filing for CORDStrom in RDEB planned for early 2025. Cash runway extends through Q3 2025, and strong insider participation underscores confidence.
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Enrollment completed in the phase II Alzheimer's trial and INKmune prostate cancer trial advanced to high-dose cohorts, both showing strong safety and operational progress. $13M was raised, with cash sufficient into Q3 2025, and key data readouts expected in 2025.
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Steady clinical progress in Alzheimer's and oncology programs, with new data supporting XPro's mechanism and INKmune's safety. Raised $14.5M, ending Q2 with $31.1M cash, and joined the Russell 3000 Index. Key data readouts and trial milestones expected in late 2024.