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WARRINGTON, Pa. - Windtree Therapeutics, Inc. (NASDAQ:WINT), a clinical-stage biotech company with a market capitalization of $2.17 million, announced Monday that its Phase 2 study of istaroxime for early cardiogenic shock has been published in the Journal of Heart and Lung Transplantation. According to InvestingPro data, the company faces significant financial challenges with negative EBITDA of $24.12 million in the last twelve months.
The SEISMiC B study demonstrated that istaroxime significantly increased blood pressure during the first six hours of treatment, with effects persisting for 60 hours. Patients also showed improved cardiac output and decreased pulmonary capillary wedge pressure without increased heart rate or significant arrhythmias, while maintaining renal function.
An accompanying editorial described istaroxime as "a potential new approach to heart failure-cardiogenic shock in which the next frontier is not just survival, but earlier and smarter stabilization."
Istaroxime has completed four Phase 2 studies, including two in early cardiogenic shock. The company is currently conducting the SEISMiC C trial for more severe SCAI Stage C cardiogenic shock, with interim data expected in July.
"We are having discussions with multiple potential partners for our cardiovascular pipeline," said Jed Latkin, Chief Executive Officer of Windtree. The cardiogenic shock market was valued at $1.25 billion in 2020, according to the company’s statement. InvestingPro analysis shows the stock has faced significant headwinds, with a 99.62% decline over the past year. InvestingPro subscribers have access to 14 additional key insights about WINT’s financial health and market position.
Istaroxime is a dual-mechanism therapy designed to improve both systolic and diastolic cardiac function through inhibition of Na+/K+-ATPase and activation of the SERCA2a calcium pump.
The company is also in the final stages of protocol design for a Phase 3 study in acute heart failure for the China market, which will be fully funded by a regional license partner. InvestingPro data reveals the company’s current ratio of 0.25 indicates potential liquidity challenges, highlighting the importance of successful partnerships and funding arrangements.
This article is based on a press release from Windtree Therapeutics.
In other recent news, Windtree Therapeutics Inc. has entered into a binding letter of intent to acquire Titan Environmental Solutions Inc. for $35 million in preferred stock, with additional notes totaling $1.75 million. This acquisition includes a 60-day exclusivity period for Titan and a potential $8 million breakup fee if the deal falls through. Separately, Windtree has received a $7 million offer for its preclinical oncology aPKCi inhibitor platform, which includes potential milestone payments and royalties. The company is also exploring the acceptance of cryptocurrency payments, aligning with digital commerce trends. Windtree is seeking extended U.S. market exclusivity for its cardiac drug istaroxime, pending FDA approval, which could secure 7.5 years of exclusivity. Additionally, the company announced the resignation of board member Craig Fraser, reducing the board’s size to four members. These developments reflect Windtree’s strategic efforts to enhance shareholder value and diversify its operations.
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