TARA-002 in Lymphatic Malformations (LMs) - LMs represent a significant pediatric rare disease opportunity with no currently approved therapies[8] - TARA-002 has the potential to treat macrocystic and mixed cystic LMs, which most often are present in the head and neck region[11] - The incidence of LMs is approximately 1,400-1,800 cases per year, with a prevalence of approximately 20,000 patients seeking treatment[14] - Macrocystic LMs account for approximately 47%, microcystic LMs for approximately 21%, and mixed LMs for approximately 32% of cases[14] STARBORN-1 Interim Data - In the STARBORN-1 trial, TARA-002 demonstrated clinical success in 80% of patients that completed treatment[30] - Among evaluable patients in STARBORN-1, TARA-002 showed a 100% clinical success rate at 8-weeks post-treatment[30] - In evaluable patients, 83% with macrocystic LMs, 100% with mixed-cystic LMs and 100% with Ranula achieved complete or substantial response[35] - In the STARBORN-1 trial, 66.7% of patients experienced any grade TEAEs, with 8.3% experiencing Grade 3 TEAEs and no Grade 4/5 TEAEs[39] OK-432 Data Review - OK-432, the predecessor compound to TARA-002, has shown strong safety and efficacy results in over 500 U S pediatric LMs patients in a University of Iowa-led study[18] - OK-432 demonstrated a 69% clinical success rate in the immediate treatment group 6 months after enrollment[46] - OK-432 showed an 84% clinical success rate in patients with macrocystic lesion types[46]