Tenax Therapeutics Announces Prespecified Blinded Sample Size Re-Estimation Of LEVEL Demonstrated Trial Is Powered At Well Over 90% To Detect 25 Meter Change In 6MWD, Primary Endpoint

Planned Review of Standard Deviation Demonstrates No Need to Increase Size of Ongoing LEVEL Study

LEVEL On Track to Complete Enrollment in First Half of 2026; Topline Data Expected in Second Half of 2026

Global Phase 3 LEVEL-2 Study Initiated; Company Estimates Completion of Enrollment by End of 2027

CHAPEL HILL, N.C., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (NASDAQ:TENX) ("Tenax" or "Tenax Therapeutics" or the "Company"), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, announced today that the prespecified Blinded Sample Size Re-estimation (BSSR) of LEVEL demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint. Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026.