HTIC, Inc. is proud to announce a significant milestone in its therapeutic pipeline. The company recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its first-in-class humanized monoclonal antibody designed to address NETosis-mediated immune dysregulation in human disease. On November 19, 2025, HTIC received the FDA’s “safe to proceed” notification, clearing the way for the launch of clinical trials.

Our Phase 1/2a studies will evaluate the safety, tolerability, and preliminary efficacy of the antibody in healthy volunteers and in patients with sepsis-induced mild-to-moderate ARDS. These clinical studies will begin in the coming weeks, supported by funding from the VA Catalyst Program.

This milestone represents a significant achievement for our translational and commercialization team across UVA, the University of Michigan, Virginia Commonwealth University, and our CDMO partners.