This segment focuses on the research and development of novel therapeutics for neurological conditions, specifically acute ischemic stroke (AIS). The primary focus is on DM199, a recombinant human tissue kallikrein-1 protein, which is currently in Phase 2/3 clinical trials (REMEDY2) for the treatment of AIS. Research and development activities include clinical trial management, data analysis, and regulatory submissions. The technology platform centers around the use of kallikrein-1 to reduce ischemia and improve outcomes in stroke patients. The patient impact is significant, as effective treatments for AIS can dramatically improve patient survival and reduce long-term disability. Market positioning involves targeting a significant unmet medical need with a potentially first-in-class therapy. Future opportunities include expanding the application of DM199 to other neurological conditions. Regulatory aspects involve navigating FDA approval processes and ensuring compliance with clinical trial regulations. Partnerships and collaborations may be sought to accelerate clinical development and commercialization.

This segment is dedicated to the development of treatments for kidney diseases, with a primary focus on chronic kidney disease (CKD) caused by Type I or Type II diabetes. The lead candidate, DM199, is in Phase 2 clinical trials (REDUX) for this indication. Research and development activities include clinical trial design, patient recruitment, and data analysis to assess the efficacy and safety of DM199. The technology platform utilizes recombinant human tissue kallikrein-1 protein to address the underlying pathophysiology of CKD. The therapeutic area focuses on improving kidney function and slowing the progression of the disease, thereby improving patient outcomes and quality of life. Market positioning involves addressing a significant unmet need in the treatment of diabetic CKD. Future opportunities include expanding the use of DM199 to other kidney-related conditions. Regulatory aspects involve obtaining necessary approvals from regulatory bodies. Partnerships and collaborations may be pursued to enhance clinical development and commercialization efforts.