Tenax Therapeutics(US:TENX)2025-11-13 22:30Tenax Therapeutics Conference Call Summary Company Overview - Company: Tenax Therapeutics (NasdaqCM:TENX) - Focus: Development of TNX-103, an oral formulation of levosimendan for treating pulmonary hypertension with heart failure preserved ejection fraction (PH-HFpEF) [2][3] Key Industry Insights - Market Need: There is a significant unmet need for effective treatments for PH-HFpEF, as no drugs are currently approved for this condition [2] - Research Landscape: Tenax is not alone in this space; other investigational strategies are being evaluated for PH-HFpEF, highlighting the growing interest in this area [2] Core Development Program - Current Studies: - TNX-103 is in late-stage development, specifically in the phase 3 LEVEL study, with top-line data expected in the second half of 2026 [2] - LEVEL II, a global phase 3 study, is set to initiate this year [2] - Unique Mechanism: Tenax's approach targets a different physiological mechanism compared to other drugs in development, focusing on venous blood volume and its impact on heart function [3][5] Scientific Discussion Points - Volume Overload: Excessive blood volume in the heart and lungs is a critical issue in patients with PH-HFpEF, leading to symptoms and hospitalizations [5][6] - Physiological Mechanism: The discussion highlighted the importance of understanding the physiological changes in patients with PH-HFpEF, particularly the role of splenic blood volume and its impact on heart function [8][9] - Proof of Concept: Data from mechanical preload-reducing devices and nerve block studies support the hypothesis that reducing blood volume can lead to hemodynamic improvements without negatively impacting cardiac output [17][19] Clinical Trial Insights - Phase 2 HELP Study: Demonstrated that levosimendan significantly reduces wedge pressure during exercise, with 85% of patients responding positively [20][29] - Transition to Oral Formulation: Patients transitioning from IV to oral levosimendan reported improved symptoms and exercise capacity, indicating the potential for better outcomes with chronic oral administration [32][39] Comparison with Other Treatments - Pulmonary Vasodilators: The call discussed the limitations of existing pulmonary vasodilators in treating HFpEF, emphasizing that many trials have failed due to the complexity of the disease and the body's compensatory mechanisms [50][52] - Relaxin Trials: The outcomes of trials involving Relaxin analogs were discussed, highlighting the challenges faced in achieving positive results in HFpEF patients [60][61] Regulatory and Patent Considerations - FDA Filing: The potential for accelerated approval is contingent on the magnitude of benefit observed in the LEVEL trial, with a robust safety database being a critical requirement [67][68] - Patent Protection: Tenax holds multiple method of use patents for levosimendan, which are considered strong and extend to various formulations and combinations [69][70] Additional Insights - Patient Experience: Feedback from patients involved in the HELP and LEVEL studies indicates significant improvements in their quality of life and functional capacity [73] - Future Directions: The company is focused on ensuring that the transition from IV to oral formulations maintains efficacy and safety, with ongoing studies to support this [74] This summary encapsulates the key points discussed during the Tenax Therapeutics conference call, providing insights into the company's development programs, industry context, and future directions.