INmune Bio, Inc. Q3 2026 Earnings Recap

INmune Bio shares fell 15.0% after earnings, with investors likely focused on the long path to potential approval and the company’s still-conditional U.S. timeline. The company remains on track for a UK application in early February 2027, but U.S. submission is targeted only for mid-2027 and depends on feedback from a planned FDA interaction.

Key Takeaways

• Management is targeting potential UK approval by mid-2027, following the planned early-February 2027 marketing authorization application.
• A U.S. application is targeted for mid-2027, subject to feedback on the company’s planned FDA interaction; INmune is prioritizing the U.S. application ahead of an EMA submission.
• Management says nearly all patients from the trial are waiting to enroll in a confirmation trial, with additional patients also seeking treatment.
• The Uniphar agreement provides a framework to pursue named-patient access in selected European, Middle Eastern, and North African markets, where local rules permit.
• Management cited progress in manufacturing and regulatory preparation, but said the final approval decision rests with regulators.