Tenax Therapeutics (TENX) investor relations material

Study progress and timelines

• LEVEL phase III trial enrollment target increased from 150 to 230, with completion expected in the first half of next year.

• Top-line results for LEVEL are anticipated in the second half of next year, following data cleaning and analysis.

• LEVEL 2 trial is planned to start this year, using the same 3 mg dose and similar design, but with a longer 26-week endpoint and global reach.

• Both LEVEL trials include open-label extensions up to 104 weeks, ensuring patient access until commercial availability.

Study design and methodology

• LEVEL uses a blinded sample size re-estimation (BSSR) to adjust for standard deviation, preserving 90% power.

• The six-minute walk test is the primary endpoint, with rigorous controls to minimize variability and placebo response.

• Inclusion/exclusion criteria are identical between LEVEL 1 and LEVEL 2, allowing for pooled analysis.

• LEVEL 2 will be larger, with more countries involved, but maintains the same patient population and statistical powering.

Rationale and clinical background

• Levosimendan acts as a potassium channel activator, reducing wedge pressure and improving exercise capacity in pH Group 2 HFpEF patients.

• A 25-meter difference in the six-minute walk test is considered a robust, clinically meaningful endpoint.

• Dose selection for oral levosimendan is based on prior studies, with 3 mg daily chosen for optimal efficacy and safety.

• The FDA recommended two pivotal trials to ensure sufficient safety data for a large target population.