Tenax Therapeutics (TENX) Piper Sandler 37th Annual Healthcare Conference summary

Study progress and timelines

• Enrollment for the LEVEL phase III study is targeted to complete 230 subjects in the first half of next year, with top-line results expected in the second half of the year.

• The LEVEL study duration is 12 weeks, followed by a month each for data cleaning and statistical analysis.

• A blinded sample size re-estimation (BSSR) is built into the protocol, allowing for an increase in sample size if variability is higher than expected.

• LEVEL 2 is planned to start this year, with a longer 26-week endpoint and broader global participation.

• Both LEVEL and LEVEL 2 include open-label extensions up to 104 weeks for patient follow-up.

Study design and rationale

• The sample size was increased from 150 to 230 to enhance statistical power and reduce risk, supported by additional funding.

• The BSSR mechanism ensures 90% power is preserved by adjusting sample size only upward if needed.

• Both studies use identical inclusion/exclusion criteria, enabling pooled analysis and consistent patient populations.

• LEVEL 2 will be larger and more geographically diverse, with 15 countries expected to participate.

• The primary endpoint for both studies is the six-minute walk test, with a 25-meter treatment effect and 55-meter standard deviation powering the trials.

Drug mechanism and clinical rationale

• Levosimendan acts as a potassium channel activator, reducing venous constriction and lowering cardiac pressures.

• The drug targets PH Group 2 patients with HFpEF, aiming to reduce wedge pressure and improve exercise capacity.

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

• Previous phase II and HELP studies support the clinical rationale, with a 25-meter improvement considered meaningful.

• No other approved drug shares this mechanism of action, minimizing concerns about competing therapies.