INMB News & Events

INmune Bio announced that it received the official minutes from its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA. The minutes confirm regulatory alignment on the Company's proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer's Disease. "The outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595," said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. "The FDA's feedback on our enrichment-led design, primary endpoint, and integrated Phase 2b/3 structure validates our scientific and clinical strategy and provides a clearly defined regulatory path to advancing XPro1595 into a registration-intent program in early Alzheimer's disease."

INmune Bio has formally submitted its pre-submission package for CORDStrom with the United Kingdom's Medicines and Healthcare Products Regulatory Agency. This early engagement step is designed to solicit targeted scientific, regulatory, and procedural feedback, streamlining the full Marketing Authorization Application process and potentially shortening time to market for what could become the first systemic therapy for this devastating "butterfly skin" disease. INmune Bio has completed three commercial pilot-scale manufacturing runs at the state-of-the-art CGT Catapult facility, each demonstrating consistent product characteristics that met predefined release criteria. These manufacturing results confirm readiness for commercial supply. The Company anticipates filing a full Marketing Authorization Application with MHRA following receipt of pre-submission feedback, currently targeted for mid-summer 2026, with subsequent EU and U.S. regulatory submissions to follow in Q4, 2026, subject to regulatory alignment and manufacturing readiness.

INmune Bio presented a letter to investors from David Moss, CEO, which read in part, "As we reflect on 2025, I want to thank you for your continued support of INmune Bio. This past year marked an important period of execution, discipline, and focus as we advanced our mission to develop innovative therapies that address serious neuroinflammatory and immunologic diseases with high unmet needs. 2025 was a pivotal year for our company, highlighted by compelling clinical learnings from XPro(TM) in our Phase 2 Alzheimer's disease trial and significant progress advancing CORDStrom in Recessive Dystrophic Epidermolysis Bullosa. Our focus on harnessing the innate immune system to address conditions with large unmet need and meaningful market potential continues to drive us forward...Financially, we exit 2025 well positioned for continued execution. In June we closed on a private placement, and we expect to receive a research and development rebate from Australia, bolstering our cash position. As of September 30, 2025, our cash and cash equivalents stood at approximately $27.7 million. These resources, combined with disciplined expense management, provide us with sufficient funds to last through year-end 2026, enabling us to achieve key milestones. INmune Bio was founded on the belief that targeted immunomodulation can meaningfully change the course of devastating diseases. We remain at the forefront of biotechnology with two industry-leading assets: CORDStrom, a mesenchymal stromal cell platform engineered specifically for therapeutic use from inception, and XPro, a premier approach for treating complex neuroinflammatory conditions within the central nervous system. While challenges remain, we are encouraged by the progress we have made and the opportunities ahead. We are committed to transparent communication, thoughtful decision-making, and the creation of long-term shareholder value. Most importantly, our primary mission remains improving the lives of patients and their families."

INmune Bio announces a recently published overview of future applications and research areas for mesenchymal stromal cell therapies, such as INmune's CORDStrom platform. The article, titled, "Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions," was published in the peer-reviewed journal Cytotherapy. The article was the result of an invitation-only working party of basic, clinical and translational scientists working on MSCs and available on Cytotherapy's website, reviews the current knowledge-base and critical gaps in order to formulate experimental questions designed to enhance development of MSC therapies such as the CORDStrom platform. These topics included systemic delivery of MSCs, local and/or depot-delivery, and in vivo persistence.