Tenax Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

Core Insights - Tenax Therapeutics has achieved its randomization target of 230 patients in the Phase 3 LEVEL study, with topline data expected in the third quarter of 2026 [2][6] - The company has initiated the global Phase 3 LEVEL-2 clinical trial and opened a long-term open-label extension study for patients to continue receiving the drug [1][2] Recent Corporate and Clinical Highlights - The screening period for the LEVEL study has closed, and randomization is anticipated to be completed by the end of March 2026 [2][6] - Tenax is focused on activating clinical sites globally for the LEVEL-2 study, which is expected to complete enrollment by the end of 2027 [2][6] - A virtual call with key opinion leaders was held in November 2025 to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF) [6] - In December 2025, a prespecified Blinded Sample Size Re-estimation (BSSR) demonstrated that the LEVEL study is powered at over 90% to detect a 25-meter change in 6-minute walk distance [6] Financial Results - As of December 31, 2025, Tenax reported cash and cash equivalents of $97.6 million, expected to fund operations through 2027 [4] - Research and development (R&D) expenses for Q4 2025 were $10.5 million, up from $4.6 million in Q4 2024, with total R&D expenses for the year at $32.7 million compared to $12.7 million in 2024 [5][7] - General and administrative (G&A) expenses for Q4 2025 were $5.9 million, compared to $2.7 million in Q4 2024, with total G&A expenses for the year at $23.7 million versus $6.8 million in 2024 [8] - The net loss for Q4 2025 was $15.5 million, compared to a net loss of $6.3 million in Q4 2024, with a total net loss for the year of $52.6 million compared to $17.6 million in 2024 [9][18]