INmune Bio (NASDAQ:INMB) outlined plans to file for conditional approval of its Ebstrocel cell therapy in the United Kingdom by the end of the third quarter or early in the fourth quarter of 2026, while reporting a narrower second-quarter net loss and cash runway into the second quarter of 2027.
Chief Executive Officer David Moss said the company’s second quarter and subsequent weeks were marked by regulatory, manufacturing and supply-chain progress for Ebstrocel, its lead product candidate from the CORDStrom platform. Ebstrocel is being developed for recessive dystrophic epidermolysis bullosa, or RDEB, a severe inherited skin disorder.
Ebstrocel Regulatory and Manufacturing Progress
Chief Scientific Officer Mark Lowdell said official MHRA meeting minutes from a May 12 pre-application scientific-advice meeting confirmed the agency’s alignment on each question submitted by the company. The MHRA also approved Ebstrocel’s pediatric investigation plan in less than three months, according to Lowdell.
Management said the agency recognized Phase II MissionEB data as demonstrating clinically meaningful symptomatic benefits, particularly for pain and pruritus, or itch. Moss said the company plans to use itch and pain as primary endpoints in its regulatory strategy, noting that persistent itching can contribute to wound formation and delayed healing among RDEB patients.
Following the planned U.K. filing, INmune Bio expects to submit an application to the European Medicines Agency in early 2027 and a U.S. Biologics License Application seeking conditional approval in the first quarter of 2027.
The company also reported progress toward commercial-scale production. It processed its first commercial-ready umbilical cord tissue at the Cell and Gene Therapy Catapult facility in Stevenage, England, and transferred the mesenchymal stromal cell isolation stage used to produce master cell banks to the intended commercial manufacturing site.
INmune Bio expanded its agreement with the Anthony Nolan Cord Blood Bank, which management said provides long-term access to qualified umbilical cord tissue for prospective supply in the U.K., European Union and U.S. Lowdell said the CORDStrom platform is designed to address donor variability and manufacturing inconsistency through donor screening, pooling and expansion processes.
The company’s CORDStrom patent application entered the U.S. national phase following what Lowdell described as a favorable international written opinion. If granted, the patent could provide protection through at least 2045, he said. INmune Bio also established a scientific advisory board to support Phase III trial design, biomarkers, potency and release assays, and potential additional indications for the platform.
Confirmatory Trial and Potential U.K. Launch
During the question-and-answer session, Moss said the planned open-label Phase III Ebstrocel study is the same safety and confirmatory study that the company had previously discussed. It is expected to enroll roughly 40 to 45 patients, including approximately 33 patients who have already been identified, primarily from the original trial.
Management expects enrollment of one to two patients per week. The study is expected to run for 18 months and involve three treatment sessions, with two infusions given about 10 days apart during each session. Moss said the company expects data around the middle of 2028.
Regarding a potential U.K. commercial rollout, Moss said Ebstrocel was studied at two leading U.K. children’s hospitals that treat a substantial portion of RDEB patients. He said investigators at those centers are familiar with administering the therapy and its clinical results. Moss said he expects the company could reach about 100 U.K. patients within two years of an approval, including trial participants and additional patients.
Moss estimated that the U.K. has roughly 800 patients with epidermolysis bullosa overall, while 10% to 15% of the broader EB population has the more severe RDEB form. He said the U.S. and Europe each have approximately 2,000 to 3,000 RDEB patients.
On pricing, Moss said INmune Bio expects annual pricing in the range of 400,000 pounds to 500,000 pounds per child in the U.K. The company plans to begin pricing discussions after filing its MHRA application. He said U.K. hospitals may have the ability to fund treatments while reimbursement and pricing negotiations are underway.
XPro Alzheimer’s Program Advances
INmune Bio also highlighted progress for XPro, its program for early Alzheimer’s disease. The FDA granted XPro Fast Track designation, while 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, management said.
Moss reported a p-value of 0.0028 and a Cohen’s d effect size of 0.46 in the full population, increasing to 0.59 in a biomarker-enriched population. The company presented additional analyses at the Alzheimer’s Association International Conference that it said showed consistent treatment-related effects across independent white-matter and cortical gray-matter measures at week 24.
Management said published MINDFuL results showed directionally consistent benefits across clinical and biomarker endpoints in a pre-specified inflammation-rich subgroup, with no amyloid-related imaging abnormalities observed. While Alzheimer’s remains the clinical priority for XPro, Moss said the company is evaluating partnership opportunities as it concentrates resources on Ebstrocel.
Financial Results and Cash Position
For the quarter ended June 30, INmune Bio reported a net loss attributable to common stockholders of approximately $1.3 million, compared with a net loss of approximately $24.5 million in the year-earlier quarter. The 2025 period included a $16.5 million impairment charge related to acquired in-process research and development intangible assets.
Research and development produced a benefit of approximately $0.8 million in the 2026 quarter, compared with $5.8 million in expense a year earlier, primarily due to recognition of an additional Australian research and development rebate. General and administrative expenses were approximately $2.3 million in both periods.
The company had approximately $18.4 million in cash and cash equivalents as of June 30 and subsequently received about $4.2 million from an Australian R&D tax rebate. CFO Cory Ellspermann said existing resources are expected to fund operations into the second quarter of 2027. He estimated ongoing cash burn at approximately $1 million to $1.5 million per month, excluding the unusually high level of R&D rebates received during the prior six months.
About INmune Bio (NASDAQ:INMB)
INmune Bio, Inc is a clinical-stage immunology company based in San Diego, California, focused on harnessing the innate immune system to combat a range of serious diseases. The company’s research and development efforts concentrate on modulating cellular pathways to restore and enhance the body’s natural defenses, particularly in oncology and neurodegenerative conditions.
The company’s lead therapeutic candidate, XPro1595 (also referred to as INB03), is a proprietary selective inhibitor of soluble tumor necrosis factor (TNF) designed to reduce chronic inflammation without impairing membrane-bound TNF functions.
