Tenax Therapeutics (TENX) Corporate presentation summary

Disease overview and unmet need

• Pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFPEF) is the most common form of PH, affecting a large and growing patient population with significant unmet need and no approved therapies to date.

• By 2030, an estimated 2.2–3.7 million PH-HFPEF patients are projected in the US alone.

• Over 80% of HFpEF patients are estimated to have pulmonary hypertension, highlighting the scale of the problem.

Mechanism of disease and rationale for therapy

• PH-HFPEF is characterized by excessive venous return, elevated pulmonary capillary wedge pressure (PCWP), and right atrial pressure, leading to pulmonary congestion and vascular remodeling.

• Chronic constriction of the splanchnic circulation and maladaptive blood volume shifts contribute to disease progression.

• Targeting venous blood volume and splanchnic vascular tone is a novel therapeutic approach, as prior attempts to target pulmonary vascular resistance have been ineffective.

Levosimendan: mechanism and clinical data

• Levosimendan is a first-in-class K-ATP channel activator and calcium sensitizer, uniquely suited to reduce venous blood volume and pulmonary pressures while improving right ventricular function.

• Phase 2 HELP study demonstrated safety and efficacy, with significant improvements in PCWP, exercise capacity (6MWD), and biomarkers (NT-proBNP).

• Oral levosimendan (TNX-103) showed comparable safety and efficacy to IV formulation, with sustained improvements in exercise capacity and patient-reported outcomes.