Tenax Therapeutics (TENX) Leerink’s Global Healthcare Conference 2025 summary

Leadership and expertise

• CEO and CMO bring decades of clinical trial and cardiovascular drug development experience, with deep backgrounds in both industry and academia.

• CMO has extensive FDA advisory experience and a long-standing focus on pulmonary hypertension and heart failure.

Clinical development updates

• Phase 3 LEVEL trial enrollment target increased from 152 to 230 subjects, with completion expected by year-end.

• LEVEL-2, a second required phase 3 trial, will begin enrollment this year, aiming for global participation.

• Over 95% patient adherence and low dropout rates observed in the LEVEL trial and its open-label extension.

Market opportunity and product positioning

• Oral levosimendan targets PH-HFpEF, a subset of Group 2 PH, with a U.S. prevalence of 2.2–3.7 million.

• Addressable market estimated at $6–10 billion, with no approved therapies currently available.

• Oral formulation offers advantages over IV, including ease of use and steady-state drug levels.