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-Company closes approximately $5.47 million in equity financing in 2Q/3Q25
-TH104 potentially fills a critical National Security Need against Weaponized Fentanyl
-TH023 may fulfill the promise of delivering a safe and effective oral antibody medication against inflammation
-Company Strengthens Operational Leadership, Corporate Governance and Accounting
-Received positive feedback on New Drug Application submission via the 505(b)(2) pathway
-Company leveraging existing human pharmacokinetic data with TH104
-Advancing CMC plan to meet requirements of a New Drug Application
FDA Provides Positive Feedback to Company Regarding TH104 Phase 2 Program
Company Incorporating FDA Feedback into Phase 2 Protocol
Company Believes it is On-track to Initiate Phase 2 Trial
Pharmacokinetic profile of oral transmucosal delivery of TH104 was comparable to intravenous delivery of reference drug
Positive safety/tolerability achieved with TH104 reporting a mild side-effect profile
Planning for Phase 2 trial for moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) is ongoing and on track to initiate in 2024
- Obtained rights from Washington University to develop and incorporate human HER2 directed antibodies
- Complements early pipeline of novel tunable "Knob domain" antibodies for HER2 & HER3