WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced its financial results for the third quarter ending September 30, 2024, alongside significant business updates. The company achieved progress in its clinical programs and financial strategies and outlined plans to accelerate its pipeline activities.
A major milestone for the quarter was the positive topline results from the Phase 2b SEISMiC B clinical study. Istaroxime, the company’s lead drug candidate, demonstrated improvements in cardiac function and blood pressure in patients with early cardiogenic shock. The study met its primary goal of significantly improving systolic blood pressure over six hours, sustained improvements over 96 hours, and positive impacts on kidney function and overall heart performance. Additionally, the therapy was well-tolerated, with a favorable safety profile.
“The third quarter of 2024 was marked with significant progress,” said Craig Fraser, Chairman and CEO of Windtree. “With trial execution and active operations comes the need for capital, and we successfully completed transactions providing resources for our near-term needs as well as secured an equity line of credit to potentially support future requirements.”
The company also completed two private placements in July 2024, raising $13.9 million combined. These proceeds included $4.4 million in new funding and $9.5 million through the cancellation of outstanding senior notes and other agreements. Windtree entered a Common Stock Purchase Agreement, giving it the right to sell up to $35 million in shares, providing additional flexibility for future financial needs.
Looking ahead, Windtree plans to speed up patient enrollment in its global SEISMiC C study of istaroxime for SCAI Stage C cardiogenic shock. Interim data from this Phase 2b study are expected in early Q2 2025. The company is also exploring business development opportunities to form partnerships and secure non-dilutive funding for its cardiovascular platform.
Other updates included the expansion of Windtree’s patent portfolio, with new patents issued for istaroxime formulations in regions such as the United States, Europe, Japan, and China. These patents strengthen the company’s position in the treatment of heart failure and acute cardiac conditions.
From a financial standpoint, Windtree reported an operating loss of $4.7 million for Q3 2024, level with the same period last year. Research and development expenses totaled $2 million, focused primarily on the SEISMiC Extension trial of istaroxime. Cash and equivalents stood at $2.3 million as of September 30, 2024, with the company expecting sufficient resources to fund operations through January 2025.
On the Nasdaq front, Windtree resolved a compliance issue related to the timely filing of its Q3 Form 10-Q. Following the filing on November 26, 2024, Nasdaq confirmed the company’s compliance, closing the matter.
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