other material
confidence high
sentiment positive
materiality 0.75
Tenax raises $25M, expands Phase 3 LEVEL study to 230 patients, adds LEVEL-2 trial
TENAX THERAPEUTICS, INC.
- Private placement with RTW Investments grossed ~$25M; issued 378K shares + pre-funded warrants for 3.76M shares at $6.04/$6.03.
- FDA accepted amendment to expand LEVEL study from 152 to 230 patients, increasing statistical power to >95%; enrollment expected by end of 2025.
- FDA agreed to initiate second global Phase 3 LEVEL-2 study; first patient expected in 2025; primary endpoint 6MWD at 26 weeks.
- Blinded LEVEL data shows >95% patients remain on therapy, no safety signals; topline data expected mid-2026.
- Proceeds extend cash runway through end of 2027, funding Phase 3 trials and operations.