INmune Bio (INMB) Q3 2026 earnings summary

Executive summary

• Ebstrocel (CORDStrom) is the lead priority, advancing toward a UK MAA targeted for early February 2027; potential approval is anticipated in mid-2027, subject to agency review.

• XPro indication evaluation continues, but significant company-funded development is deferred until after Ebstrocel approval or until dedicated resources or a strategic partner are secured.

Financial highlights

• Q3 net loss was $4.7M versus $6.5M; R&D expense was $3.2M versus $4.9M, G&A was $1.8M versus $2.5M, and operating expenses were $5.0M versus $7.4M.

• 9M net loss was $11.4M versus $40.7M and operating expenses were $12.3M versus $42.0M; 2025 included a $16.5M XPro impairment.

• Cash and cash equivalents were $16.3M at September 30, 2026, versus $24.8M at December 31, 2025; 9M operating cash use was $10.0M versus $19.6M.

• Basic and diluted loss per share was $0.17 in Q3 versus $0.24; 9M loss per share was $0.42 versus $1.68.

Outlook and guidance

• Complete UK MAA submission is targeted for early February 2027; MHRA response is anticipated within three to six months, with potential approval in mid-2027, subject to validation, review and requests for information.

• A U.S. Type B meeting request is planned for early 2027; FDA feedback will inform BLA timing, with a mid-2027 submission target, followed by an EU application.

• Confirmatory Phase III trial is planned to open in Q1 2027 and run through mid-2028; initial trial batches are intended to validate commercial-scale manufacturing.

• Uniphar named-patient supply could enable earlier revenue in selected markets, subject to local implementation, physician requests, lawful supply and funding or reimbursement; no revenue forecast or first-sales date was announced.

• Current operating plan projects cash to fund operations through Q3 2027, including October financing proceeds.