TNX-103 (oral levosimendan) - (LEVEL)

August 10, 2026: Tenax Therapeutics (NASDAQ: TENX) reported topline Phase 3 LEVEL results for TNX-103 (oral levosimendan) in pulmonary hypertension associated with HFpEF (PH-HFpEF). The registrational trial (NCT05983250; n=241) did not meet the primary endpoint of change in 6-minute walk distance at Week 12 versus placebo (LS mean difference 3.5 meters; p=0.63) or the key secondary endpoint of KCCQ total symptom score (difference 0.1 points).

Prespecified analyses showed stronger effects in sicker patients: among those with baseline 6MWD below the median of 333 meters, TNX-103 improved 6MWD by 26.3 meters versus placebo (95% CI 6.0, 46.7; nominal p=0.0112); in patients age 71+ the treatment difference was 27.1 meters, and 37.6 meters in the oldest tertile (>74 years). Exploratory overall-population analyses showed a 49% reduction in NT-proBNP versus placebo (95% CI 0.43, 0.60; nominal p<0.0001) and a 3.5 mmHg reduction in RVSP (95% CI -6.01, -1.10; nominal p=0.0045).

TNX-103 was generally safe and well tolerated; serious adverse events were balanced (10.8% vs 10.7%). Tenax plans to request an FDA Type C meeting and seek EMA scientific consultation on revising the registrational path. Full LEVEL data will be presented at ESC Congress 2026 (August 28-31).