TNX-103 (oral levosimendan) - (LEVEL)

July 2, 2026: Tenax Therapeutics, Inc. (NASDAQ: TENX) said results from its registrational Phase 3 LEVEL trial (NCT05983250) of TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) will be presented as a Late-Breaking Clinical Science session at ESC Congress 2026 (Aug. 28–31, 2026; Munich). The company expects to report topline LEVEL data in August 2026 and is proceeding toward planned database lock and statistical analysis; an abstract was submitted in anticipation of having results in time for ESC.

Presentation: “Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial,” presented by Prof. Sanjiv Shah (Northwestern University) on Saturday, Aug. 29, 2026 (11:15–11:30 CEST).

Trial status: Enrollment of >230 patients was completed in March 2026. Tenax noted that a prespecified blinded sample size re-estimation in December 2025 indicated the trial is powered at well over 90% to detect a 25-meter change in 6-minute walk distance (6MWD), the primary endpoint.