Tenax Therapeutics (NASDAQ: TENX) reported a net loss of $52.6 million for 2025 and a cash balance of $97.6 million as of December 31 2025, reflecting the company’s continued investment in its lead candidate, levosimendan (TNX‑103). The loss is driven by a sharp rise in research and development expense to $32.7 million, up from $12.7 million in 2024, and a jump in general and administrative costs to $23.7 million, compared with $6.8 million the previous year. These increases are largely attributable to accelerated spending associated with the ongoing Phase 3 LEVEL trial and the launch of the global LEVEL‑2 study, as well as higher stock‑based compensation and professional fees that have expanded the G&A budget.
Tenax’s clinical program has reached a key de‑risking milestone: the Phase 3 LEVEL study has achieved its randomization target of 230 patients and closed its screening period. The company also confirmed the initiation of the global LEVEL‑2 Phase 3 trial and opened a long‑term open‑label extension to provide continued access to TNX‑103 and gather additional safety data. These developments position the company to potentially deliver the first‑in‑class therapy for pulmonary hypertension with preserved ejection fraction (PH‑HFpEF), a condition with no approved treatments.
"We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study. As we strive to make significant progress executing on our registrational LEVEL program, achievement of this important milestone demonstrates our team's commitment to rapidly advancing TNX‑103," said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. "The screening period for LEVEL has closed. Patients already screening will have the opportunity to qualify for randomization, which we anticipate finishing this month. We expect to share initial results from LEVEL in the third quarter of 2026."
"In parallel, we remain focused on activating clinical sites around the world to advance the global LEVEL‑2 study, which we continue to anticipate will complete enrollment by the end of 2027. With a continued focus on execution, we aim to rapidly advance the development of TNX‑103, a novel and potential first‑in‑class therapy for patients with PH‑HFpEF who have no approved treatment options for their debilitating disease."
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