Inmune Bio outlines 2026 regulatory milestones and cash runway through Q4 2026

Earnings Call Insights: INmune Bio (INMB) Q3 2025

Management View

• David Moss, President, CEO, Treasurer, Secretary & Director, stated the company has transitioned its focus after concluding the Alzheimer's trial in June and is now advancing its platform drug programs toward key development milestones. Moss said, "CORDStrom is our most advanced program as we are now in the process of preparing for submission for marketing approval to the regulatory bodies in both the U.K. and the U.S." He highlighted CORDStrom's potential as "one of the first systemic treatments for RDEB" and described ongoing work on platform expansion into other indications and possible genetic modifications for cancer.
• Moss provided updates on the XPro platform, noting management is "actively pursuing an accelerated regulatory pathway and preparing for our end of Phase II meeting with the FDA." He emphasized that defining the next steps for XPro is a top priority and important for future funding and partnership discussions.
• Moss referenced the completion of the Phase II trial of INKmune in prostate cancer, with the primary endpoint and 2 of 3 secondary endpoints met.
• Dr. Mark Lowdell, Chief Scientific Officer & Chief Manufacturing Officer, reported CORDStrom is now in CGMP manufacturing space and technology transfer was completed, putting the company "on track to be ready for U.K. filing at the end of Q2 next year." Lowdell also discussed ongoing statistical data analysis for the MissionEB trial and progress in INKmune's development.
• Dr. CJ Barnum, Head of Neuroscience, outlined four priorities for XPro: regulatory alignment, accelerated approval, publishing insights from Phase II MINDFuL trial, and advancing partnership discussions. Barnum stated, "The findings demonstrate that longer treatment durations with XPro are associated with greater improvements in neuropsychiatric symptoms and biomarkers, including pTau217 and GFAP."
• Cory Ellspermann, Interim CFO, said, "Net loss attributable to common stockholders for the quarter ended September 30, 2025, was approximately $6.5 million compared with approximately $12.1 million for the comparable period in 2024." Ellspermann added, "At September 30, 2025, the company had cash and cash equivalents of approximately $27.7 million... sufficient to fund our operations into Q4 2026."

Outlook

• Moss stated, "For our CORDStrom program, we have a number of significant events in front of us. In Q4, we'll present additional data from the trial. In mid-'26, we expect to file a marketing authorization application in the U.K. A few months after... we expect to file a BLA, biologics licensing application with the FDA. We'd expect to hear back from the FDA sometime by the middle of '27 or later."
• Moss indicated that for XPro, further MRI data from the MINDFuL trial is expected in Q4, and feedback from the FDA on accelerated pathway and end of Phase II meeting minutes are anticipated in Q1 2026.

Financial Results

• Ellspermann reported, "Research and development expenses totaled approximately $4.9 million for the quarter ended September 30, 2025, compared with approximately $10.1 million for the comparable period in 2024. General and administrative expenses were approximately $2.5 million for the quarter ended September 30, 2025, compared with approximately $2.2 million for the comparable period in 2024."
• Ellspermann stated the company's cash position at $27.7 million as of September 30, 2025, with a runway into Q4 2026.

Q&A

• Denis Reznik, Raymond James Ltd., asked about the timeline for the end of Phase II FDA meeting for XPro and reasons for any delay. Moss responded the delay was due to not having "enough of the data in time to really get it to the FDA," but "we're very close."
• Reznik asked about partnership discussions for XPro and INKmune's future. Moss said, "Before we really have aggressive partnering discussions... they want to see what the regulatory feedback and alignment looks like" and more data. Lowdell added, "I'm always very keen to talk to potential partners and others that would want to invest in or buy the asset."
• Jason McCarthy, Maxim Group, inquired about regulatory feedback for CORDStrom's MAA filing. Lowdell replied, "We are waiting for our scientific meeting with the MHRA... I'm expecting early next month to submit the data to the agency for a scientific advice meeting." He also noted the aim to file the MAA by Q2 next year.
• McCarthy also asked about CORDStrom's mechanism and platform potential. Lowdell described the unique donor selection and pooling process, making CORDStrom "a platform for multiple different indications."
• An unknown analyst (Matt for Jim Molloy, AGP) questioned CORDStrom's place in the U.K. treatment paradigm. Lowdell confirmed there is demand, with no RDEB-specific treatment reimbursed by NHS, and emphasized cost competitiveness and systemic benefit.
• The same analyst asked about cash runway. Moss stated, "Our cash runway, as we've reported in the quarter is really to the end of next year in Q4."

Sentiment Analysis

• Analysts focused on regulatory timelines, partnership prospects, and clarity on data, with a neutral tone and some slight skepticism regarding timing and partnerships.
• Management maintained a confident tone in prepared remarks and Q&A, emphasizing readiness, progress, and the strength of ongoing data, but showed minor defensiveness regarding regulatory timing: "we're being relatively conservative saying in Q1" (Moss).
• Compared to the previous quarter, management’s confidence remains steady but with more specific references to regulatory steps and manufacturing progress. Analysts' tone has not significantly shifted, remaining focused on practical next steps and key data.

Quarter-over-Quarter Comparison

• Guidance on regulatory filings remains consistent, with both quarters targeting mid-2026 for CORDStrom filings in the U.K. and U.S., and a focus on completing the end of Phase II meeting for XPro.
• Strategic focus has shifted from discussing the broader platform potential and partnership hopes to more concrete details about manufacturing, regulatory submissions, and cash runway.
• Management’s tone in the current quarter is slightly more detailed on operational execution, with continued confidence in the company’s pipeline and milestones.
• Analysts’ focus continues to be on regulatory clarity, partnerships, and cash, with similar themes as last quarter.
• Key metric changes include reduced net loss and lower R&D expenses in Q3 2025 vs. Q2 2025, and a confirmed cash runway into Q4 2026.

Risks and Concerns

• Management discussed the ongoing need for regulatory feedback and successful data analysis for CORDStrom’s MAA and BLA filings.
• There is recognition of the importance of securing partnerships to support late-stage development, particularly for XPro and INKmune.
• Moss acknowledged the risk of not having data ready for regulatory meetings as scheduled, which could impact timelines.
• Analysts raised concerns about potential delays, clarity on regulatory pathways, and the need for more data to drive partnerships.

Final Takeaway

INmune Bio’s management conveyed optimism about upcoming regulatory milestones, with CORDStrom approaching marketing applications in the U.K. and U.S. and XPro moving toward an end of Phase II meeting and potential accelerated pathway with the FDA. The company highlighted operational progress, notably in manufacturing readiness and data analysis, and reported a strengthened cash position supporting operations into Q4 2026. Ongoing partnership discussions remain dependent on further regulatory clarity and data readouts, with multiple clinical and regulatory milestones anticipated through 2026.

Read the full Earnings Call Transcript