Tenax Therapeutics (TENX) investor relations material

Key data insights and trial results

• The primary endpoint was not met, but substantial biological effects and clinically meaningful improvements were observed, especially in sicker patients with lower baseline 6MWD, including a placebo-adjusted difference of +26.3 meters at 12 weeks (p=0.0112).

• Significant reductions in NT-proBNP (49% vs placebo, p<0.0001) and pulmonary artery pressures were observed, with improvements in both left and right ventricular function, supporting the drug’s bi-ventricular mechanism.

• Placebo effects were pronounced in healthier patients, who had less room for improvement, but no evidence of harm or clinical worsening was found in any group.

• Exploratory and multivariate analyses confirmed that baseline health status, especially Six-Minute Walk distance, NT-proBNP, and age, are strong predictors of treatment effect, with older and sicker patients deriving the greatest benefit.

• Safety profile was acceptable, with higher rates of treatment-related adverse events (mainly headache, palpitations, hypotension) but balanced rates of serious adverse events and clinical worsening between arms.

Lessons learned and protocol adjustments

• Enrolling patients with higher baseline 6MWD diluted the treatment effect; future trials will exclude these healthier patients to better capture drug efficacy.

• The cutoff for baseline Six-Minute Walk will be lowered in LEVEL-2, with protocol changes to ensure sicker, more representative patients are enrolled.

• Investigators will refine patient assessment procedures to avoid enrolling unusually healthy individuals, especially those able to perform strenuous tests.

• Safety data showed no increase in adverse events among sicker patients, supporting the plan to focus on this group in future studies.

• Feedback from key opinion leaders at ESC was positive, with strong interest in the biological effects and NT-proBNP reductions.

Strategic implications and next steps

• LEVEL-2 trial design will reflect these insights, with updates on timing, size, and budget forthcoming; enrollment may be more challenging but is expected to improve with broader international participation.

• The company is not planning major protocol changes, but will stop enrolling patients with high baseline walk distances.

• Regulatory strategy, including FDA interactions, will remain confidential, but no concerns have been raised about the enrichment approach.

• The focus remains on demonstrating efficacy in sicker patients, with the expectation that this will yield more robust and clinically meaningful results.

• Updates on LEVEL-2 and further data releases are anticipated as the trial progresses, with further publications and presentations planned through 2027.