Tenax Therapeutics (NasdaqCM:TENX) FY Conference Transcript

Summary of Tenax Therapeutics FY Conference Call Company Overview - Company: Tenax Therapeutics (NasdaqCM:TENX) - Event: 37th Annual Healthcare Conference - Date: December 04, 2025 Key Points Industry and Company Focus - Tenax Therapeutics is focused on developing treatments for pulmonary hypertension, specifically targeting Group 2 patients with heart failure and preserved ejection fraction (HFpEF) [1][19]. Phase III LEVEL Study - The Phase III LEVEL study is on track to read out in the second half of 2026, with a goal to enroll 230 subjects by the first half of 2026 [1][3]. - The sample size was increased from 150 to 230 based on investor support and funding, which is expected to de-risk the study and maintain a 90% power in statistical calculations [5][6]. Study Design and Methodology - The LEVEL study is a 12-week trial, followed by a month for data cleaning and statistical analysis [4]. - An adaptive element called BSSR (Blinded Sample Size Reassessment) allows for adjustments based on interim data analysis once two-thirds of subjects have completed treatment [7][8]. - The study will utilize a six-minute walk test as a primary endpoint, with a clinically meaningful difference set at 25 meters [26]. Mechanism of Action - Levosimendan, the drug under investigation, works through calcium sensitization and potassium channel activation, which helps regulate venous circulation and improve exercise capacity in patients [24][25]. Clinical Data and Efficacy - The Phase II trial was the only successful trial to date, and the company is confident in achieving a treatment effect of 25 meters based on previous data [26][30]. - The six-minute walk test has been established as a valid cardiovascular endpoint, and measures are in place to control placebo responses [31][32]. Future Studies - LEVEL 2 study is planned to be a larger, 26-week trial involving multiple countries, with the same inclusion and exclusion criteria as LEVEL 1 [38][39]. - The FDA has indicated that both studies will provide sufficient safety data for approval [37]. Open-Label Extension (OLE) - Both LEVEL studies will include an open-label extension of up to 104 weeks, ensuring continuity of care for participants [51]. Investor Sentiment - The management expressed optimism about the upcoming year, highlighting the potential catalysts from the ongoing studies [52]. Additional Insights - The company is focused on maintaining a robust study design to ensure the validity of results, particularly in controlling variables that could affect the six-minute walk test outcomes [32][33]. - There is a strategic plan to avoid enrollment cannibalization between LEVEL 1 and LEVEL 2 by introducing new sites for LEVEL 2 [46]. This summary encapsulates the critical aspects of Tenax Therapeutics' conference call, focusing on the company's ongoing studies, drug mechanism, and future plans in the context of the pulmonary hypertension market.