TH104 - Opioid Overdose Prophylaxis - TH104 is a first-in-class buccal film delivery of nalmefene for military use and is NDA fileable[6, 84] - The FDA has confirmed that no additional clinical trials will be required prior to NDA submission for TH104 for its initial indication[7] - Current naloxone autoinjector provides approximately 2-hour protection versus 7-hour fentanyl exposure, necessitating frequent re-dosing[17] - Government acquired 788,000 Kaléo autoinjector units, indicating growing demand for synthetic opioid countermeasures[46] - At 24-hours, Groups A & B in Phase 1 Chronic Liver Disease (CLD) Study had mean declines of 30.7% & 35.2%, respectively in pruritus scores[106] TH023 - Oral Anti-TNFα for Autoimmune Diseases - TH023 is an oral anti-TNFα monoclonal antibody targeting autoimmune diseases and is Phase 1-ready[6, 84] - The oral anti-TNFα market opportunity has the potential to disrupt the $50B+ global autoimmune biologics market[6, 84] - The existing market size generated annually by TNFα inhibitors (e.g., Humira, Remicade) is approximately $47B[58] Strategic & Financial - The company anticipates a clear pathway to NDA submission for TH104 within 12 months of CMC initiation[34] - The global PBC treatment market is valued at approximately $2.5B and is expected to grow[96]
Tharimmune (THAR) Earnings Call Presentation