INmune Bio Inc. Common stock 2026 Q2 Earnings Call

Thank you for joining INmune Bio's second quarter conference call. The second quarter and the weeks that followed were defined by execution across both of our late-stage platforms. I will begin with the investor perspective on the progress we have made. I will then turn the call over to Dr. Mark Lowdell, our Chief Scientific Officer and the inventor of CORDStrom, to discuss Ebstrocel and the CORDStrom platform in greater detail. Cory Ellspermann will review our financial results, and I will return to discuss the milestones ahead before we open the call for questions. For Ebstrocel, we secured formal MHRA alignment, received approval of the pediatric investigation plan, completed a commercial manufacturing milestone, and strengthened our long-term supply chain. Together, these achievements materially reduced regulatory and operational risk ahead of our planned U.K. marketing authorization application.

We now expect to submit Ebstrocel MAA to the MHRA by the end of Q3 or early Q4 2026. The application will seek conditional marketing authorization in RDEB and is supported by written MHRA alignment across the CMC, non-clinical, and clinical evidence packages. The agency also recognized the MissionEB data as demonstrating clinical, meaningful, symptomatic benefits, particularly in pain and pruritus. After submitting the MAA in the U.K., we plan to submit the MAA to the EMA in early 2027, along with a BLA in the U.S. seeking conditional approval. Manufacturing readiness has advanced in parallel. We successfully processed the first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult facility in Stevenage and transferred the MSC isolation stage used to manufacture master cell banks into the intended commercial facility.

Combined with our expanded Anthony Nolan agreement, this gives us a scalable supply foundation designed to support U.K., E.U., and U.S. filings and future commercial supply. We also advanced the CORDStrom platform patent application into the U.S. national phase and established a working Scientific Advisory Board of international recognized MSC and RDEB experts. The SAB will help strengthen Ebstrocel's late-stage development package and prioritize additional disease-specific applications of the CORDStrom platform. XPro also reached important milestones this quarter. The FDA granted Fast Track designation for early Alzheimer's disease, and the phase II MINDFuL study showed a statistically significant treatment effect on white matter myelin MRI biomarkers in the full modified intent-to-treat population. The treatment difference was P 0.0028 with a Cohen's d effect size of 0.46. In the biomarker-enriched population, the effect size increased further to 0.59.

Expanded analysis presented at AAIC showed concordant treatment-related effects across independent white matter and cortical gray matter measures at week 24. These data, together with our successful end-of-phase II alignment with the FDA and publication of the MINDFuL results in npj Dementia, strengthen the clinical and regulatory foundation of the phase IIb/III program. The peer-reviewed report shows directionally consistent benefit across clinical and biomarker endpoints in the pre-specified inflammation-rich subgroup with no amyloid-related imaging abnormalities observed. Recent TBI, traumatic brain injury, and oncology data also support broader platform optionality. Although our clinical priority remains Alzheimer's disease, we continue to evaluate strategic partnership opportunities that could accelerate the program while preserving meaningful value for INmune shareholders while we focus all of our attention and resources on getting Ebstrocel to the RDEB patients who are in great need.

With that, I will turn the call over to Dr. Mark Lowdell to discuss CORDStrom program in greater detail.

Mark? Thank you, David. I want to focus on three key areas in the road to bringing Ebstrocel to the market that have been materially de-risked since our last call.

First, the regulatory package to manufacturing and supply chain and the broader CORDStrom platform from which Ebstrocel is the first product to market. First, the MHRA's official minutes from our May 12th pre-MAA scientific advice meeting confirmed their alignment across every question that we submitted, covering CMC, non-clinical, and clinical matters. This is important because it gives us a defined path for the planned conditional marketing authorization application, rather than requiring us to infer what the agency might expect. Second, the MHRA approved the Ebstrocel pediatric investigation plan in less than three months.

The pediatric strategy incorporates the planned open-label phase III confirmatory study. The agency's feedback recognized the MissionEB phase II data as demonstrating clinically meaningful improvement in symptoms that matter to patients, mostly pain and pruritus or itch. The feedback also supports evaluating Ebstrocel as a chronic or intermittent supportive therapy in RDEB. Third, we completed a key commercial manufacturing milestone at the Cell and Gene Therapy Catapult and the Manufacturing Innovation Centre in Stevenage for Ebstrocel and for subsequent cell drugs from the CORDStrom platform. The first commercial compliant cord tissues have been processed successfully. The MSC isolation stage for manufacture of the master cell banks was transferred into the facility intended to support registration and subsequently future commercial supply.

Our expanded agreement with the Anthony Nolan Cord Blood Bank secures long-term access to qualified umbilical cord tissue for the platform for use in the U.K., the EU, and the U.S. This matters because the CORDStrom platform was designed to solve two persistent challenges that we've seen in MSC therapy over the past years, donor variability and manufacturing inconsistency. Our proprietary donor screening, pooling, and expansion processes are intended to produce an off-the-shelf, scalable, batch-to-batch consistent cell medicine, and that is what we have shown the MHRA. The recent manufacturing work brings the initial master cell bank production stage into the commercial-ready manufacturing supply chain. We've also strengthened the platform from which the Ebstrocel lead program is derived. The CORDStrom patent application entered the U.S. national phase following a favorable international written opinion, and if granted, could provide broad protection into at least 2045.

In addition, our newly formed scientific advisory board brings together major leaders in MSC clinical translation, potency assessment, manufacturing, rare pediatric skin disease, and additional therapeutic areas that we can focus on. This is a working advisory board with defined priorities including phase III design, translational biomarker identification, potency and release assays, and selection of these additional indications. Taken together, these achievements give us greater confidence that the scientific, clinical, regulatory, and manufacturing components required for a successful filing are now converging. Our immediate objective is to submit the U.K. MAA by the end of Q3 or early Q4 this year, followed by the planned European and U.S. submissions, while preparing the platform for future indications. I'll now turn the call over to Cory for a review of our financial results.

Cory? Thank you, Mark. I'll provide a brief overview of our financial results for the second quarter.

Net loss attributable to common stockholders for the quarter ended June 30th, 2026, was approximately $1.3 million, compared to approximately $24.5 million for the quarter ended June 30th, 2025. The prior period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets. Research and development expenses totaled the benefit of approximately $0.8 million for the quarter ended June 30th, 2026, compared to approximately $5.8 million of expense for the quarter ended June 30th, 2025. The research and development benefit during the 2026 period was primarily due to the recognition of additional Australian research and development rebate. General and administrative expenses were approximately $2.3 million for each of the quarters ended June 30th, 2026, and June 30th, 2025.