Tenax Therapeutics (TENX) Q3 2026 earnings summary

Executive summary

• Phase 3 LEVEL missed its primary 6-minute walk distance and key secondary symptom-score endpoints overall; subgroup analyses showed exercise and biomarker benefits.

• Post hoc analyses informed an enrollment-enrichment amendment for LEVEL-2; enrollment is temporarily paused while sites implement narrower criteria.

Financial highlights

• Q3 operating expenses were $17.7M, up 5% YoY; net loss was $16.7M vs. $15.8M, and loss per share was $0.31 vs. $0.40.

• Q3 R&D was $12.1M vs. $10.3M, while SG&A was $5.7M vs. $6.5M; higher clinical and preclinical costs drove R&D growth, while lower stock-based compensation reduced SG&A.

• Nine-month operating expenses were $53.1M vs. $39.9M; net loss was $50.2M vs. $37.1M and loss per share was $1.01 vs. $0.96. R&D rose 65% to $36.5M; SG&A fell 7% to $16.6M.

Outlook and guidance

• Cash is expected to fund operations through FY2028 under the current plan, assuming the amended LEVEL-2 design and no additional trials; the outlook may change after FDA discussions.

• A Type C FDA meeting will address levosimendan’s development; a development update and LEVEL-2 design paper are expected in Q1 2027.

• LEVEL-2 enrollment is expected to resume as sites implement the amendment; SG&A is expected to rise as development advances toward potential commercialization.