Tenax Therapeutics (TENX) investor relations material

Company overview and market opportunity

• Focused on Phase III development of an oral formulation for group two pulmonary hypertension (PH) patients with ejection fraction >40%.

• Drug has a 25-year history and is approved in 60 countries for other indications.

• U.S. heart failure population projected to grow from 6.7M in 2020 to 8.5M by 2030.

• Addressable market for the target indication estimated at $10B, with no approved therapies currently.

• Disease is progressive, debilitating, and often fatal, highlighting significant unmet need.

Scientific rationale and clinical development

• Drug lowers elevated wedge pressure in heart failure patients, a key mechanism for symptom relief.

• Phase II HELP trial demonstrated significant reduction in pulmonary wedge and right atrial pressures during exercise.

• Mechanism of action attributed to reduction in preload and blood volume, not contractility.

• Transition from IV to oral formulation was successful, supporting further development.

• Legacy data and mechanistic studies provided confidence in safety and efficacy.

Phase III program design and progress

• Ongoing Phase III trial (LEVEL) enrolling 230 subjects, with a 12-week primary endpoint focused on six-minute walk distance.

• LEVEL 2 trial to start this year, expanding to 15+ countries and a 26-week endpoint.

• Blinded sample size reassessment planned after 150 subjects complete treatment; FDA-approved cap on enrollment.

• No new safety signals observed; high participation in open-label extension.

• Enrollment for LEVEL expected to complete in the first half of next year.