Tenax Therapeutics (TENX) 2025 Conference March 10, 2025 03:40 PM ET Speaker0 So welcome everyone to our next session here. It's very much my pleasure to welcome two members of the leadership team of 10x. And I thought we'd actually kick off and assume that not everyone has read your bios. And maybe just very briefly, Chris, if you could just describe your background. And then you, Stuart, I thought that would take up most of the time. No, I'm just kidding. But I think it would be nice to set the stage, rig ...

Summary of Tenax Therapeutics (TENX) Conference Call Company Overview - **Company**: Tenax Therapeutics (TENX) - **Focus**: Development of therapies for pulmonary hypertension (PH), specifically targeting Group II PH with the drug Levisamendin [2][3] Core Points and Arguments - **Group II PH Opportunity**: - Group II PH patients represent 60-70% of the global PH population and currently have no approved therapies [8][9] - The primary therapeutic target for these patients is left atrial pressure, contrasting with Group I PH patients who have multiple approved treatments [8][10] - **Levisamendin Development**: - Levisamendin is being tested in a Phase III trial for Group II PH, with a new oral formulation developed [5][6] - The drug has a history of being approved in over 60 countries for acute decompensated heart failure but faced challenges in the U.S. due to differing FDA requirements [15][16] - The drug's unique mechanism focuses on reducing pulmonary capillary wedge pressure, a primary defect in Group II PH patients [12][16] - **Market Opportunity**: - There is a significant unmet medical need for effective treatments in the Group II PH space, with encouraging signals from physicians regarding the adoption of Levisamendin once approved [22][23] - The addressable market includes approximately 7.58 million Americans with heart failure, with a significant portion having PH [35] - **Phase II HELP Study Insights**: - The Phase II HELP study demonstrated a reduction in wedge pressure and improvements in six-minute walk distance, indicating potential efficacy [32][34] - The study's design included an open-label phase where patients showed willingness to continue treatment, suggesting perceived benefits [40] - **Regulatory Pathway**: - The current regulatory pathway does not require demonstration of mortality benefits, focusing instead on functional improvements [35][36] - A statistically significant improvement of 25 meters in the six-minute walk test is considered sufficient for regulatory approval [44][46] - **Competitive Landscape**: - There is potential overlap with other emerging HFpEF drugs (e.g., SGLT2 inhibitors, GLP-1s), but Tenax is taking precautions to minimize confounding effects in clinical trials [47][50] - The company is monitoring the use of these drugs among trial participants to ensure stable dosing [51][52] Additional Important Content - **Licensing and Rights**: - Tenax has secured worldwide rights for both oral and IV formulations of Levisamendin, enhancing its commercial potential [21][22] - **Physician Sentiment**: - Physicians expressed a willingness to prescribe Levisamendin based on any statistically significant improvement, highlighting the lack of current treatment options [38][56] - **Pricing Strategy**: - There is optimism regarding the drug's market reception and potential pricing power, with indications that initial estimates may have been conservative [56][57] This summary encapsulates the key points discussed during the Tenax Therapeutics conference call, focusing on the company's strategic direction, product development, market potential, and competitive landscape.