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Tenax Therapeutics (TENX) investor relations material

Tenax Therapeutics Cantor Global Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Cantor Global Healthcare Conference 2025 summary4 Sep, 2025

Company overview and market opportunity

  • Focused on Phase III development of an oral formulation for group two pulmonary hypertension (PH) patients with ejection fraction >40%.

  • Drug has a 25-year history and is approved in 60 countries for other indications.

  • U.S. heart failure population projected to grow from 6.7M in 2020 to 8.5M by 2030.

  • Addressable market for the target indication estimated at $10B, with no approved therapies currently.

  • Disease is progressive, debilitating, and often fatal, highlighting significant unmet need.

Scientific rationale and clinical development

  • Drug lowers elevated wedge pressure in heart failure patients, a key mechanism for symptom relief.

  • Phase II HELP trial demonstrated significant reduction in pulmonary wedge and right atrial pressures during exercise.

  • Mechanism of action attributed to reduction in preload and blood volume, not contractility.

  • Transition from IV to oral formulation was successful, supporting further development.

  • Legacy data and mechanistic studies provided confidence in safety and efficacy.

Phase III program design and progress

  • Ongoing Phase III trial (LEVEL) enrolling 230 subjects, with a 12-week primary endpoint focused on six-minute walk distance.

  • LEVEL 2 trial to start this year, expanding to 15+ countries and a 26-week endpoint.

  • Blinded sample size reassessment planned after 150 subjects complete treatment; FDA-approved cap on enrollment.

  • No new safety signals observed; high participation in open-label extension.

  • Enrollment for LEVEL expected to complete in the first half of next year.

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Next Tenax Therapeutics earnings date

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Q3 202512 Nov, 2025
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Frequently asked questions

Tenax Therapeutics Inc is a U.S.-based pharmaceutical company engaged in the development of therapies for cardiovascular and pulmonary diseases. The company focuses on late-stage clinical development and regulatory advancement of drug candidates aimed at addressing unmet medical needs in rare conditions. It operates within the biotechnology sector and collaborates with research institutions and clinical networks. The company is headquartered in Chapel Hill, North Carolina, and its shares are listed on the NASDAQ.

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