INmune Bio, Inc. Q1 FY2026 earnings call

RJ Tesse discussed upcoming top-line results from the Mindful phase two trial in early Alzheimer's disease expected mid to late June. He mentioned the market opportunity for EXPRO in early AD has increased to nearly 70% of early AD patients based on APOE4 status. The safety profile of EXPRO in the mindful trial is excellent. Mark Liddell provided updates on IncMUNE's CarePC trial in prostate cancer, including completed Phase I dose escalation, well-tolerated drug, and ongoing Phase II recruitment. He also updated on Cordstrom's progress towards a BLA filing in 2026 for RDEB, including data from the UK trial and manufacturing plans. David Moss reviewed financial results, noting a loss of approximately $9.7 million, R&D expenses of $7.6 million, G&A expenses of $2.3 million, cash and cash equivalents of $19.3 million as of March 31, 2025, and upcoming milestones like top-line cognitive data from Mindful in June, end of Phase II meeting with FDA in Q4 2026, enrollment completion in INCBUNE trial this year, BLA filing for Cordstrom in H1 2026, and initiation of Phase II trial for Expro in treatment-resistant depression once NIH funding is available.

Anticipates top-line cognitive data from Mindful phase two trial in early Alzheimer's disease in mid to late June. Plans end of Phase II meeting with FDA in Q4 2026 to agree on Phase III trial design. Expect to complete enrollment in Phase II portion of INCBUNE trial this year. Anticipates filing BLA for Cordstrom in RDEB in H1 2026. Will initiate Phase II trial of Expro in treatment-resistant depression once NIH funding is made available.

Q: Assuming positive readout in June, walk through exact next steps for Alzheimer's program, timeline for Phase III initiation, and metrics on sites and patients enrolled.

A: RJ Tesse said goal is to have end of phase two meeting with FDA in Q4 2026, then move to getting sites open and patients enrolled. Goal is to as quickly as possible get to FDA for end of phase two meeting.

Q: With positive readout in June, how investors react to scenario of hitting on EMAC but CDR equivocal, and APOE4 homozygotes in trial?

A: CJ Barnum said EMAC is tool capturing cognitive changes in early AD, CDR is more blunt instrument. RJ Tesse said APOE4 homozygotes are about 15% in some trials.

Q: For Cordstrom, on track to initiate 12-month open-label trial mid year, enrollment aim and U.S. sites?

A: Mark Liddell said starting manufacturing program of new batch using US approved cord donors, expecting to submit IND later this year, planning BLA submission with data from double blind placebo controlled crossover trial, and running follow on trial in US next year.

Q: Description of regulatory space for RDEV treatments and Abiona's approval for gene therapy for RDEV?

A: Mark Liddell said synthetic skin gene modified product is good but only for open wounds on skin, requires surgical intervention. Cordstrom is systemic therapy for systemic disease in RDEB patients, sees role in treating systemic disease as well as skin lesions