Windtree Therapeutics (WINT) Investor Day 2024 summary

Strategic Focus and Business Development

• Prioritizing cardiogenic shock as lead indication due to faster, less costly regulatory pathway and high unmet need, with acute heart failure pursued in partnership.

• Cardiogenic shock market estimated at $1.25 billion globally, with $1 billion in US and Europe.

• Recent $139 million regional license deal with double-digit royalty potential and ongoing business development for non-dilutive funding.

• Active global and regional licensing deals in place, with ongoing discussions for additional cardiovascular asset licenses and co-promotion rights in the US.

• Lean operational model focused on capital efficiency and value-generating clinical development.

Clinical Development and Pipeline

• Lead asset istaroxime is a novel dual-mechanism IV agent for hospitalized patients with cardiogenic shock and acute heart failure, in Phase 2b for both indications.

• SEISMiC Phase 2b studies demonstrated rapid, significant, and sustained increases in systolic blood pressure, improved cardiac output, and reduced pulmonary capillary wedge pressure.

• Istaroxime improved renal function, organ perfusion, and facilitated transition to goal-directed medical therapy, with favorable safety and fewer serious adverse events than placebo.

• Ongoing study in more severe SCAI Stage C cardiogenic shock patients, with data expected in late Q1 2025.

• Next-generation oral SERCA2a activators in preclinical development, targeting both acute and chronic heart failure.

Market Opportunity and Physician Feedback

• No effective therapies currently available for cardiogenic shock; existing treatments have significant side effects and are used as rescue medications.

• 99% of surveyed US cardiologists see high need for drug innovation in cardiogenic shock; 84% likely to use istaroxime as first-line therapy.

• No other drugs in development for cardiogenic shock, reinforcing the unique market position.

• Focus on heart failure patients with low blood pressure and diuretic resistance, addressing populations with greatest unmet need.