Tenax Therapeutics Reports Phase 3 LEVEL Trial Of TNX‑103 In PH‑HFpEF; Study Did Not Meet Primary Or Key Secondary Endpoints

TNX-103 did not meet statistical significance on the primary endpoint of improvement in 6-minute walk distance versus placebo

In prespecified exploratory analyses in the overall trial population, treatment with TNX-103 resulted in a 49% greater reduction in NT-proBNP compared to placebo (nominal p<0.0001) and a reduction of 3.5 mmHg in right ventricular systolic pressure compared to placebo (nominal p=0.0045)

In a prespecified analysis, patients with a baseline 6-minute walk distance below the trial median of 333 meters showed a 26.3-meter improvement compared to placebo (95% CI 6.0, 46.7; nominal p=0.0112)

Company to hold conference call and webcast today at 8:00 a.m. ET

CHAPEL HILL, N.C., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (NASDAQ:TENX) ("Tenax" or "Tenax Therapeutics" or the "Company") today announced topline results from the Phase 3 LEVEL clinical trial evaluating TNX-103 (oral levosimendan) in patients with PH-HFpEF. LEVEL did not meet its primary endpoint of improvement in the 6-minute walk distance versus placebo, or the key secondary endpoint of improvement in Kansas City Cardiomyopathy Questionnaire total symptom score. Prespecified subgroup analyses identified a substantial beneficial treatment effect in patients with greater disease burden, supported by clinically meaningful changes in predefined cardiac biomarker and pulmonary hemodynamic measures across the overall trial population. TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events balanced across treatment arms. Based on the results of the LEVEL trial, Tenax intends to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss revisions to the ongoing registrational development of TNX-103 for the treatment of PH-HFpEF.