Tenax Therapeutics (TENX) Guggenheim SMID Cap Biotech Conference summary

Leadership and organizational updates

• Doug Randall was promoted to Chief Business Officer, reflecting leadership changes.

Clinical development and scientific rationale

• Levosimendan was identified as a potential therapy for Group 2 PH due to its wedge-pressure lowering effect, addressing a major unmet need.

• Phase II studies showed promising reductions in pulmonary capillary wedge pressure, leading to confidence in advancing to phase III with a novel oral formulation.

• Group 2 PH patients have no approved therapies, unlike Group 1, and are defined by elevated wedge pressure, especially during exercise.

• Levosimendan targets both pulmonary capillary wedge pressure and central venous pressure, differentiating it from prior failed therapies.

Regulatory and market landscape

• Levosimendan is approved in over 60 countries for acute heart failure but not in the U.S. due to FDA's mortality endpoint requirements.

• Novel use in PH-HFpEF led to three granted patents, with further intellectual property expected.

• Licensing agreements evolved to provide worldwide rights for both IV and oral formulations in PH-HFpEF.