Windtree Therapeutics Reports $1.8 Million Net Loss for Fiscal Year 2024

Windtree Therapeutics, Inc. reported a net loss of $1.8 million for the fiscal year ended December 31, 2024, compared to a net loss of $20.3 million in 2023. The 2024 net loss included a $14.4 million non-cash gain on debt extinguishment, a $10.5 million change in fair value of common stock warrant liability, $7.5 million in R&D expense related to the Varian asset acquisition, and a $1.1 million loss on impairment of intangible assets. The 2023 net loss included a $3.1 million loss on impairment of goodwill. Research and development expenses increased by $7.9 million to $16.3 million in 2024, primarily due to the Varian acquisition and increased spending on the istaroxime cardiogenic shock program. General and administrative expenses decreased by $455,000 to $8.7 million.

The company's cash and cash equivalents totaled $1.8 million at the end of 2024, with current liabilities of $5.7 million. Subsequent to the end of the fiscal year, Windtree raised additional capital through equity sales, warrant conversions, and the issuance of senior secured notes and promissory notes, bringing its total resources to a level the company believes sufficient to fund operations through April 2025. However, the company acknowledges that its current cash position and losses raise substantial doubt about its ability to continue as a going concern without securing further financing. The company plans to pursue additional funding through various avenues, including public or private securities offerings and strategic partnerships.

In April 2024, Windtree acquired Varian Biopharmaceuticals' assets related to an aPKCi inhibitor, expanding its oncology pipeline. The company also announced positive topline results from its Phase 2b SEISMiC Extension Study for istaroxime in cardiogenic shock in September 2024 and initiated a Phase 2 study in more severe cardiogenic shock (SEISMiC C Study). Windtree also entered into a license agreement with Lee's Pharmaceutical (HK) Ltd. in January 2024 for the development and commercialization of istaroxime, rostafuroxin, and SERCA2a activators in Greater China. The company's new corporate strategy, launched in January 2025, focuses on generating revenue through acquisitions of small companies with FDA-approved products.

As of April 15, 2025, Windtree had 14 full-time employees, 11 of whom were based in the U.S. The company's lead product candidate, istaroxime, is in Phase 2 clinical trials for both cardiogenic shock and acute heart failure. The company also has preclinical programs for SERCA2a activators and an aPKCi inhibitor. Windtree's licensing agreements include partnerships with Lee's Pharmaceutical (HK) Ltd. for istaroxime and KL4 surfactant in Greater China, and Philip Morris for aerosol delivery system technology.

Windtree's outlook remains uncertain, contingent upon securing additional funding to support its ongoing operations and clinical development programs. The company's ability to achieve profitability and successfully commercialize its product candidates depends on several factors, including the successful completion of clinical trials, regulatory approvals, market acceptance, and securing adequate reimbursement from third-party payers. The company's financial statements include an explanatory paragraph raising substantial doubt about its ability to continue as a going concern.