Financial Overview of Windtree Therapeutics

Windtree Therapeutics is a biotechnology company focused on advancing innovative therapies for critical conditions and diseases. The company’s portfolio includes several product candidates in various stages of development, with its lead candidate istaroxime in Phase 2 trials for acute heart failure and cardiogenic shock.

In 2024, Windtree reported a net loss of $1.8 million, a significant improvement from the $20.3 million net loss in 2023. This was driven by several key factors:

Revenue Generation Strategy Shift In January 2025, Windtree launched a new corporate strategy to become a revenue-generating biotech company through the acquisition of small companies with FDA-approved products. The company believes there is an opportunity to acquire and commercialize products from smaller biotechs that struggle to maximize their potential. Windtree plans to use equity to acquire these subsidiaries and leverage its management team’s commercialization expertise.

Istaroxime Development Progress Windtree’s lead product candidate istaroxime demonstrated positive results in Phase 2 trials for acute heart failure and cardiogenic shock. The company initiated a Phase 2 global study (SEISMiC) to evaluate istaroxime for the treatment of early cardiogenic shock, which showed the drug rapidly and significantly increased blood pressure while improving cardiac function. Windtree also initiated a follow-up SEISMiC Extension study and a study in more severe cardiogenic shock (SEISMiC C). These studies are expected to drive increased R&D spending going forward as the istaroxime program advances.

Acquisition of Varian Assets In April 2024, Windtree acquired the assets of Varian Biopharmaceuticals, including a novel aPKCi inhibitor with potential applications in oncology. This acquisition resulted in a $7.5 million charge for acquired in-process R&D, contributing to the increase in R&D expenses in 2024.

Debt Restructuring and Warrant Revaluation Windtree recognized a $14.4 million non-cash gain on debt extinguishment related to the termination of certain milestone payment obligations. Additionally, the company recorded a $10.5 million gain from the change in fair value of its common stock warrant liability. These one-time items significantly improved the company’s 2024 net loss.

Operational Cost Reductions Windtree was able to reduce its general and administrative expenses by $0.5 million in 2024 through lower personnel costs, stock-based compensation, and insurance expenses. However, R&D expenses increased by $7.9 million, primarily due to the Varian asset acquisition and increased spending on the istaroxime clinical program.

Liquidity and Capital Resources As of December 31, 2024, Windtree had $1.8 million in cash and cash equivalents and $5.7 million in current liabilities. The company believes it has sufficient resources to fund operations through April 2025. However, Windtree will require additional capital to continue advancing its development programs, particularly the istaroxime studies. The company is pursuing various financing options, including public/private securities offerings, convertible debt, and potential strategic partnerships or transactions.

Risks and Uncertainties Windtree’s ability to execute its business plan is subject to significant risks and uncertainties, including:

• Ability to secure adequate financing to fund ongoing operations and development programs
• Successful completion of clinical trials and regulatory approval for its product candidates
• Potential delisting from the Nasdaq exchange due to failure to maintain listing requirements
• Dilution to existing shareholders from future equity issuances
• Potential antitakeover implications from the company’s reverse stock splits
• Volatility in the company’s stock price

Overall, Windtree made progress in 2024 by advancing its istaroxime program, acquiring promising new assets, and improving its financial position through debt restructuring. However, the company continues to face significant challenges in funding its operations and development activities. Successful execution of its new revenue-generating strategy through strategic acquisitions could help provide a more sustainable financial foundation, but Windtree will need to secure additional capital in the near-term to continue advancing its clinical pipeline.