INmune Bio (INMB) Q2 2026 earnings summary

Executive summary

• Achieved key regulatory and operational milestones for Ebstrocel/CORDStrom, including MHRA alignment, pediatric plan approval, and commercial manufacturing readiness, reducing risk ahead of U.K. MAA submission and with EU and U.S. filings planned.

• XPro program received FDA Fast Track for early Alzheimer's and showed significant phase II biomarker results, supporting further registrational strategy and partnership opportunities.

• Focus remains on disciplined execution, capital preservation, and building commercial capabilities for upcoming regulatory submissions and launches.

• Named a founding member of the American Biotech Innovation Alliance, strengthening industry leadership.

• Substantial doubt exists about the ability to continue as a going concern due to recurring losses and projected insufficient liquidity.

Financial highlights

• Net loss for Q2 2026 was $1.3 million, a significant improvement from $24.5 million in Q2 2025, mainly due to lower R&D expenses and absence of impairment charges.

• R&D expenses were a benefit of $0.8 million in Q2 2026 due to Australian R&D rebate, compared to $5.8 million expense in Q2 2025.

• General and administrative expenses remained stable at $2.3 million year-over-year.

• Cash and equivalents stood at $18.4 million as of June 30, 2026, with an additional $4.2 million received post-quarter from R&D tax rebate.

• Cash runway expected to fund operations into Q2 2027, but substantial doubt remains about long-term liquidity.

Outlook and guidance

• Ebstrocel/CORDStrom MAA submission to MHRA expected by end of Q3 or early Q4 2026, with EMA and FDA filings planned for early 2027.

• Open-label phase III confirmatory trial for Ebstrocel to enroll 40-45 patients, run for 18 months, with data expected mid-2028.

• Anticipated U.K. approval could lead to 100 patients treated within two years of launch.

• Ongoing evaluation of financing strategies, including equity, debt, partnerships, and government funding.

• Registrational Phase 2b/3 protocol for XPro in early Alzheimer's to be submitted to FDA in Q4 2026.