Tenax Therapeutics (TENX) Leerink Global Healthcare Conference 2026 summary

Key clinical trial updates

• LEVEL trial achieved target enrollment of 230 PH-HFpEF patients ahead of schedule, with randomization to conclude in March and results expected in Q3.

• High patient retention and capsule consumption rates observed, with over 90% entering open-label extension, indicating strong tolerability and perceived benefit.

• LEVEL trial population is less sick than HELP, targeting a broader, more representative PH-HFpEF group, with inclusion criteria based on hemodynamic measures from HELP.

• Sample size reassessment showed lower-than-expected standard deviation, increasing trial power to above 90%.

• Patient anecdotes suggest improved quality of life, with many reporting the ability to resume daily activities previously limited by their condition.

Mechanism of action and clinical rationale

• Oral levosimendan targets splanchnic circulation, reducing pulmonary and right atrial pressures, as demonstrated in both device and pharmacologic studies.

• HELP phase II trial confirmed hemodynamic effects and improved patient function, supporting the mechanism of action.

• Enrichment strategy in LEVEL focuses on patients with elevated pressures likely to benefit, based on prior HELP responders.

• Approximately 80% of HFpEF patients may have pulmonary hypertension, suggesting a large potential treatment population.

Global trial expansion and regulatory outlook

• LEVEL-2 global trial will double subject numbers, extend treatment to 26 weeks, and expand to at least 10 European countries plus Korea and Taiwan.

• Enrollment in LEVEL-2 expected to be faster in some regions, leveraging established use of levosimendan in acute heart failure care.

• Positive LEVEL results anticipated to catalyze LEVEL-2 enrollment.

• Regulatory discussions ongoing regarding potential for single pivotal trial approval, but current plan is to run both LEVEL and LEVEL-2 to meet safety data requirements.

• Company is well-funded, with cash runway extending 18 months past data, and is scaling workforce and infrastructure for global operations.