INmune Bio, Inc. Q3 FY2025 earnings call

• David Moss introduced the call, noting transition since July as CEO, focusing on next stage of platform drug programs. • Mark Lowdell provided updates on CORDStrom, including progress towards UK and US regulatory filings, data analysis from MissionEB trial showing improvements in disease activity scores, and INKmune Phase II trial completion with primary endpoint met. • CJ Barnum updated on XPro, including submission of Phase II MINDFuL trial manuscript, ongoing analysis of neuroimaging endpoints, and focus on addressing unmet need in Alzheimer's with XPro. • Cory Ellspermann presented financial results, noting expense reductions and cash position. • Upcoming milestones include MAA filing in UK mid-2026, BLA filing in US post-UK, XPro FDA feedback in Q1 2026, and Q4 2025 imaging data for XPro.

Net loss attributable to common stockholders for Q3 2025 was approximately $6.5 million, compared to ~$12.1 million in the comparable period of 2024. Research and development expenses totaled ~$4.9 million in Q3 2025, down from ~$10.1 million in 2024. General and administrative expenses were ~$2.5 million in Q3 2025, vs ~$2.2 million in 2024. As of September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million, and expects to fund operations into Q4 2026.

• For CORDStrom: Expect to file MAA in UK mid-2026, BLA in US a few months after UK filing, with FDA feedback expected mid-2027 or later. • For XPro: Anticipate Q4 2025 MRI data from MINDFuL trial, FDA feedback on accelerated pathway in Q1 2026, and Phase II meeting minutes in Q1 2026.

• Forward-looking statements involve risks and uncertainties, including actual results differing from forward-looking statements. • Uncertainties in clinical trial outcomes, regulatory approvals, and ability to meet development milestones.

Q: On XPro, what are the biggest questions/discussion topics for the end of Phase II meeting with FDA, and why the delay in the meeting?

A: David Moss and CJ Barnum discussed questions around regulatory alignment, enrichment biomarkers, safety database, and need for data to align for registration trial. Delay due to not having enough data in time for end-of-Q4 meeting.

Q: Sticking with XPro on partnership conversations, color on progress and INKmune's future?

A: David Moss and Mark Lowdell mentioned top-level partnership discussions ongoing, waiting for regulatory feedback and data, and INKmune's potential with Phase II data and opportunities for further development.

Q: Feedback from European regulators on CORDStrom MAA filing, uniqueness of cytokine-based activation, and mechanistic questions?

A: Mark Lowdell discussed UK MHRA interactions, cytokine-based activation targeting inflammation in RDEB, and CORDStrom's platform tailoring for different diseases.

Q: Treatment paradigm for RDEB in UK, data on systemic effect of CORDStrom, and cash runway?

A: Mark Lowdell and David Moss discussed RDEB treatment paradigm, systemic effect data being audited, and cash runway expected to fund operations into Q4 2026 with key milestones ahead.