INmune Bio Inc.

INmune Bio Inc. is a clinical-stage biotechnology company dedicated to developing novel immunotherapies that reprogram the innate immune system to combat debilitating diseases such as cancer and Alzheimer's disease. The company's core mission is centered on a patient-centric, pioneering scientific approach to address unmet medical needs by modulating the body's natural defense mechanisms. Headquartered in Boca Raton, Florida, INmune Bio was incorporated in 2015.

INmune Bio's pipeline is built upon three distinct product platforms: CORDStrom, XPro (DN-TNF), and INKmune. The CORDStrom platform utilizes proprietary human umbilical cord-derived mesenchymal stromal/stem cells (hucMSCs) and recently completed a blinded randomized trial for recessive dystrophic epidermolysis bullosa. The XPro platform, featuring XPro1595 (also known as pegipanermin or INB03), is a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product designed to selectively neutralize soluble TNF, a key driver of inflammation and immune dysfunction, with a primary focus on neuroinflammation in Alzheimer's disease. The INKmune platform is a cell-based medicine engineered to prime a patient's natural killer (NK) cells to eliminate minimal residual disease in various cancers, currently undergoing trials for metastatic castration-resistant prostate cancer.

In recent developments, David J. Moss was appointed CEO in August 2025, succeeding co-founder RJ Tesi, signaling a strategic refocusing on core therapeutic areas. The company has achieved FDA alignment on an integrated Phase 2b/3 registrational pathway for XPro1595 in early Alzheimer's disease, utilizing a biomarker-enriched design to target patients with neuroinflammation. Additionally, preclinical data for INB03 (XPro1595) has shown promise in overcoming resistance and reducing metastases in HER2-positive breast cancer models, and regulatory filings for CORDStrom are anticipated by mid-2026. As a publicly traded entity on the NASDAQ Capital Market under the ticker INMB, INmune Bio's operational model is heavily centered on research and development and clinical trial progression.