Tenax Therapeutics (TENX) investor relations material

Clinical development progress

• Initiated a global Phase III trial for levosimendan in PH-HFpEF, with a two-year recruitment period and enrollment completion expected in the first half of this year; data anticipated in the second half.

• LEVEL study demonstrated significant improvements in six-minute walk distance and reductions in wedge pressure, central venous pressure, and mean pulmonary arterial pressure under exercise conditions.

• Transition from IV to oral levosimendan in the open-label extension showed high patient acceptance, sustained therapy, and improvements in KCCQ, BNP, and six-minute walk test.

• Phase III trials are enrolling similar patient populations globally, with extended treatment duration (26 weeks) and increased sample size to ensure robust safety and efficacy data.

• Blinded sample size reassessment confirmed strong statistical power for detecting clinically meaningful changes in primary endpoints.

Market opportunity and competitive landscape

• PH-HFpEF represents a multi-billion dollar commercial opportunity, with over 2 million patients in the US and a similar number in Europe, and no approved therapies currently available.

• The trial targets a broad patient cohort, including both Cpc-PH and Ipc-PH phenotypes, expanding the addressable market.

• Levosimendan's oral formulation and demonstrated clinical benefits differentiate it from competitors, which often target smaller populations and use less convenient delivery methods.

• Strong intellectual property position supports a significant commercial runway.

Study design, endpoints, and patient experience

• Primary endpoint is improvement in six-minute walk distance, with KCCQ and clinical worsening events as key secondary endpoints.

• High compliance rates observed with TID dosing in clinical trials, attributed to the severity of symptoms and patient motivation.

• Open-label extension provides valuable safety and patient experience data, with over 95% of eligible patients opting in.

• No differences in endpoint hierarchy between LEVEL-1 and LEVEL-2 trials.

• Ongoing market research and physician feedback indicate strong potential for real-world adherence and uptake.