INmune Bio Inc

INmune Bio announced plans to submit a UK marketing authorization application for Ebstracel in RDEB by the end of the third quarter or early fourth quarter of 2026, supported by formal MHRA alignment on clinical and manufacturing evidence. The company also reported that its XPro Alzheimer’s candidate received FDA Fast Track designation and showed a statistically significant treatment effect on white matter myelin MRI biomarkers in the Phase 2 MINDFUL trial, with a p-value of 0.0028 and a Cohen’s effect size of 0.46 in the intent-to-treat population. For the second quarter, net loss attributable to common stockholders was $1.3 million, compared to $24.5 million in the prior-year period which included a $16.5 million impairment charge, while R&D expenses reflected a benefit of $800,000 due to Australian rebates. Cash and cash equivalents stood at $18.4 million as of June 30, 2026, with an additional $4.2 million received post-quarter from an Australian tax rebate, and management expects the cash runway to extend into the second quarter of 2027. The company guided for a monthly burn rate of $1 million to $1.5 million and highlighted that the Priority Review Voucher associated with Ebstracel’s rare pediatric disease designation could be worth $102 million to $110 million, with recent secondary market transactions reaching $150 million to $200 million.

INmune Bio Inc. has received research and development cash rebates totaling approximately $4.6 million from government programs in Australia and the United Kingdom. The company received about $4.2 million from Australia on July 30, 2026, and approximately $0.4 million from the UK during June 2026. After adjusting second-quarter operating cash flows to exclude the UK rebate, the combined proceeds exceeded the company's net cash used in operating activities during the quarter. CEO David Moss said the non-dilutive cash strengthens the balance sheet and extends the cash runway as INmune Bio advances its CORDStrom therapy toward regulatory filings.

INmune Bio has submitted its CORDStrom™ platform patent application into the U.S. national phase before the USPTO, advancing a key element of its global intellectual property strategy. The filing follows a favorable Written Opinion received during the international phase of the corresponding PCT application, which validated the novelty and inventiveness of the underlying asset. The application covers the company's lead program Ebstrocel for epidermolysis bullosa as well as next-generation engineered modalities, with protection projected to extend into at least 2045 if granted. INmune Bio also expects to pursue corresponding patent applications in the United Kingdom, Europe, Asia, Latin America, and other major markets.