Tenax Therapeutics (NasdaqCM:TENX) 2026 Conference Transcript

Tenax Therapeutics Conference Call Summary Company Overview - Company: Tenax Therapeutics (NasdaqCM:TENX) - Focus: Development of levosimendan for heart failure patients with pulmonary hypertension (PH-HFpEF) [4][3] Key Points and Arguments Clinical Trials and Development - Phase 3 Trial: Initiated a global Phase 3 trial of levosimendan in heart failure patients with PH, with a recruitment period expected to last two years [4][5] - First Trial: Nearing completion of recruitment for a Phase 2 trial in the US and Canada, targeting 230 randomized subjects, with data expected in the second half of the year [4][5] - Unique Aspects of LEVEL Study: The LEVEL study tested invasive hemodynamics under exercise conditions, which is unprecedented in this patient population [23][25] Market Opportunity - Market Size: Estimated multi-billion dollar commercial opportunity, with over 2 million patients in the US and a similar number in Europe suffering from PH-HFpEF, and no approved therapies available [14][12] - Intellectual Property: Strong IP position for levosimendan in treating PH-HFpEF enhances commercial potential [14][12] Drug Mechanism and Efficacy - Mechanism of Action: Levosimendan acts as a vasodilator, reducing preload in patients, which is crucial for those with elevated wedge pressure [8][11] - Clinical Outcomes: In the Phase 2 trial, patients showed a 29-meter improvement in the six-minute walk test and significant reductions in wedge pressure without changes in cardiac output [11][11] Patient Recruitment and Study Design - Patient Cohorts: The trial is recruiting a broad cohort, including both Cpc-PH and Ipc-PH phenotypes, which allows for a larger patient population [17][19] - Study Duration: The upcoming trial will last 26 weeks, compared to 12 weeks for the previous study, allowing for more comprehensive data collection [61][63] Safety and Compliance - Open-Label Extension (OLE): Patients transitioning from IV to oral levosimendan showed high acceptance, with 18 out of 19 agreeing to switch to the oral formulation [35][39] - Patient Feedback: Positive anecdotal feedback from patients regarding the oral formulation, with improvements noted in KCCQ scores and BNP levels [45][41] Competitive Landscape - Differentiation: Tenax's product profile is distinct from competitors, with demonstrated improvements in six-minute walk distance and exercise hemodynamics, and an oral therapy option compared to subcutaneous alternatives [110][112] - Market Position: The company believes it has a strong competitive edge due to its broader patient recruitment strategy and unique drug delivery method [112][110] Additional Important Information - Regulatory Considerations: The FDA values symptom-addressing data, which could support approval based on KCCQ improvements, although the primary endpoint remains the six-minute walk test [29][32] - Adaptive Trial Design: The company implemented a blinded sample size reassessment to ensure adequate power for detecting meaningful changes in the primary endpoint [64][66] This summary encapsulates the critical insights from the Tenax Therapeutics conference call, highlighting the company's strategic direction, market potential, and clinical development efforts.