Windtree Therapeutics (WINT) Investor Update summary

Strategic Focus and Market Opportunity

• Prioritizing cardiogenic shock due to high unmet need, favorable regulatory pathway, and faster, less costly development compared to acute heart failure.

• Cardiogenic shock market estimated at $1.25 billion globally, with $1 billion in US and Europe, representing a significant opportunity due to high mortality and limited competition.

• 99% of surveyed cardiologists see high need for drug innovation; 84% would likely use istaroxime for early cardiogenic shock.

• No other drugs in development for cardiogenic shock; current therapies have significant side effects and are considered rescue options.

• Active global and regional licensing deals in place, with ongoing discussions for additional cardiovascular asset licenses and non-dilutive funding.

Clinical Development, Trial Results, and Efficacy

• Istaroxime demonstrated rapid, significant, and sustained increases in systolic blood pressure in SEISMIC phase II studies, meeting primary endpoints at multiple time points.

• Statistically significant improvements in cardiac output, pulmonary capillary wedge pressure, and organ perfusion observed, with cardiac output increasing by approximately 15% during infusion.

• Renal function (eGFR) improved and maintained over time, reaching statistical significance at 48 hours, with effective diuresis and weight reduction.

• More patients transitioned to goal-directed medical therapy, with significant improvement in NYHA heart failure class at 24, 48, and 72 hours.

• Istaroxime is a first-in-class dual-mechanism therapy targeting both systolic and diastolic cardiac function, with no increase in heart rate or arrhythmias.

Safety and Adverse Events

• Istaroxime showed a favorable safety profile, with serious adverse events less frequent than placebo (as low as 5.3% vs 18.2%), and no increase in clinically significant arrhythmias.

• Most common adverse events included infusion site pain/inflammation, gastrointestinal symptoms, nausea, vomiting, and headache.

• Treatment-emergent adverse events were more common with istaroxime (up to 78.9% vs 45.5%), but serious events were infrequent.