Tenax Therapeutics (NasdaqCM:TENX) FY Conference December 02, 2025 04:15 PM ET Company ParticipantsChris Giordano - President and CEOStuart Rich - CMOModeratorNext up, we have Chris Giordano and Stuart Rich from Tenax Therapeutics. I'm going to turn it right over to you guys for an introduction of the company, where things stand today. Then we'll come back for some questions.Chris GiordanoGreat, great. Hi, I'm Chris Giordano. Thanks for attending. We're currently enrolling in a U.S. and Canadian phase III t ...

Tenax 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.