Tenax Therapeutics (NasdaqCM:TENX) FY Conference Transcript

Tenax Therapeutics Conference Call Summary Company Overview - Company: Tenax Therapeutics (NasdaqCM:TENX) - Focus: Development of Levosimendan for the treatment of pulmonary hypertension with preserved ejection fraction (PH-HFpEF) [2][3] Industry Context - Market Size: Estimated prevalence of PH-HFpEF in the U.S. is about 2 million patients, with an additional 2 million in Europe, indicating a significant market opportunity [12][13] - Unmet Need: No approved therapies for PH-HFpEF exist, and some existing treatments have been harmful, highlighting a substantial unmet medical need [12][13] Core Points and Arguments - Drug Development: - Levosimendan is currently in phase three trials, with the first trial ongoing and a second trial expected to start soon [2][25] - The drug has been approved in over 60 countries for IV use but has not been previously studied for HFpEF in the U.S. [6][7] - Tenax's approach involves treating volume overload rather than directly targeting left ventricular compliance, which has been a common failure point in past drug developments [4][5] - Trial Design: - The phase two HELP trial demonstrated significant improvements in hemodynamics, specifically in wedge pressure and central venous pressure, without affecting contractility [15][16] - The primary endpoint for the phase three trials is the six-minute walk distance, which is a recognized endpoint for approval in pulmonary hypertension [17][27] - Licensing and Rights: - Tenax has secured a worldwide license for Levosimendan, allowing for various formulations, including oral and modified oral forms [9] - Patient Transition: - Transition from IV to oral formulation has shown positive outcomes, with patients reporting improved symptoms and walking distances [20][24] Additional Important Insights - Regulatory Pathway: The use of six-minute walk as an endpoint is seen as a straightforward regulatory path for approval, especially given the lack of existing effective therapies [17][27] - Market Research: Feedback from key opinion leaders (KOLs) indicates that the three-times-a-day dosing of the oral formulation is not seen as a barrier to patient compliance due to the significant symptom relief it provides [32][33] - Future Opportunities: There are plans for lifecycle management, including potential dosing changes to improve market penetration and patient adherence [33][34] Financial Position - Cash Runway: As of the last reported quarter, Tenax had over $100 million in cash, which is expected to support ongoing research and development efforts [35]