Tenax Therapeutics (NasdaqCM:TENX) FY Conference Transcript

Tenax Therapeutics FY Conference Summary Company Overview - Company: Tenax Therapeutics (NasdaqCM:TENX) - Focus: Development of treatments for pulmonary hypertension with heart failure preserved ejection fraction (PH-HFpEF) Clinical Trials and Development - Current Trials: Enrolling in a U.S. and Canadian phase 3 trial for PH-HFpEF since March 2024, targeting 230 subjects in the first half of 2026 with data expected in the second half of 2026 [2][42] - Upcoming Trials: Anticipation of a second phase 3 trial with a longer endpoint of 26 weeks and a global reach across approximately 15 countries [2] Market Potential - Patient Population: Estimated 2.2 to 3.7 million U.S. patients suffering from PH-HFpEF, characterized by significant symptoms affecting daily life [4] - Market Size: Addressable market estimated at $20 billion, highlighting a high unmet need with zero available drugs for this condition [40] Mechanism of Action - Drug Mechanism: The drug targets elevated wedge pressure rather than pulmonary artery pressure, which is a common failure point in previous trials for PH-HFpEF [8] - Physiological Rationale: The drug aims to reduce splenic blood volume overload, which is linked to improved hemodynamic responses and better six-minute walk test outcomes [10][11] Clinical Data Insights - Previous Trials: Past trials have shown that the drug can lower wedge pressure, correlating with improved six-minute walk distances, although not in a direct linear relationship [17] - BNP Reduction: A 23% reduction in BNP levels was observed during the transition from IV to oral levosimendan, indicating a significant effect on heart failure patients [18] Study Design and Expectations - Control Arm Expectations: The control group is expected to show no significant change in six-minute walk distance over time, with all benefits anticipated in the active treatment group [26] - Sample Size Reassessment: A blinded reassessment of sample size will occur after 150 subjects are randomized, with the potential to increase the trial size to ensure 90% power [30] Financial Position - Funding: The company is funded through the end of 2027, having raised $100 million over a year ago and an additional $25 million in March [42][43] - Cash Runway: The company expects to have more than 12 months of funding post-top line data for the LEVEL trial [42] Future Milestones - Key Milestones: Announcement of the last patient randomized and the start of the second trial are critical upcoming events, with significant data expected in the second half of 2026 [42]