Tenax Therapeutics, Inc. (TENX) Guggenheim Healthcare Innovation Conference (Transcript)

Summary of Tenax Therapeutics Conference Call Company Overview - Company: Tenax Therapeutics, Inc. (NASDAQ:TENX) - Focus: Pulmonary hypertension, specifically targeting group 2 pulmonary hypertension (PH-HFpEF) with oral levosimendan - Market Capitalization: Clarified to be between $200 million to $250 million, contrary to initial confusion of $15 million [1] Financial Position - Cash Position: As of September, Tenax had $98 million, funding operations through 2027 based on current projections [2] - Recent Fundraising: Raised $100 million in August [2] Clinical Development - Phase 3 Trials: Currently conducting a Phase 3 trial (LEVEL) for oral levosimendan in group 2 PH, with 52 sites initiated and plans to enroll 152 subjects by mid-next year [2] - Market Opportunity: Estimated prevalence of group 2 PH in the US is between 2.2 to 3.7 million patients by 2030, with an addressable market of $6 billion to $7.5 billion from 2030 to 2040 [2] Drug Mechanism and Efficacy - Levosimendan: Previously authorized in 60 countries as an IV formulation for acutely decompensated heart failure; Tenax is transitioning to an oral formulation [3] - Clinical Results: In the Phase 2 HELP study, levosimendan showed improvements in hemodynamic measures and a 29-meter increase in the six-minute walk test, a significant clinical endpoint [12] - Mechanism of Action: Acts as a potassium channel activator, providing vasodilatory effects on venous beds, which is crucial for treating PH-HFpEF [3][14] Trial Design and Endpoints - Primary Endpoint: Six-minute walk test, with a target improvement of 10 to 15 meters considered beneficial [19] - Secondary Endpoints: Include KCCQ questionnaire and clinical events, with the first trial lasting 12 weeks and a second planned for six months [15][20] Safety and Tolerability - Safety Profile: No significant adverse events reported during the trials; patients transitioned from IV to oral formulation without complications [18] - Patient Retention: High retention rates in the study, indicating patient satisfaction and drug efficacy [18] Intellectual Property - Patents: Developed four patents in the last two and a half years, with protections extending to 2040 and potential for additional exclusivity until 2042 [22][23] Future Outlook - Next Steps: Plans to accelerate the timeline for New Drug Application (NDA) based on funding secured through 2027, with no need to wait for top-line data from the first trial [20] - Potential for Dosing Improvements: Exploration of transitioning from three times a day dosing to once daily in the future [21] Conclusion - Tenax Therapeutics is positioned to make significant advancements in the treatment of pulmonary hypertension with its oral levosimendan, backed by strong clinical data and a solid financial foundation. The company is focused on expanding its market presence and improving patient outcomes in a largely underserved patient population.