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WARRINGTON, Pa. - Windtree Therapeutics, Inc. (NASDAQ:WINT), a micro-cap biotech company with a market capitalization of $1.65 million, announced Monday it has reached the planned enrollment of 20 patients for the interim analysis in its Phase 2 SEISMiC C study of istaroxime in SCAI Stage C cardiogenic shock patients. According to InvestingPro data, the company faces significant financial challenges with negative EBITDA of $24.12 million in the last twelve months.
The SEISMiC C study is the third trial in the company’s istaroxime cardiogenic shock development program and focuses on more severely ill patients than the company’s previous two positive Phase 2 studies, which examined SCAI Stage B patients. InvestingPro analysis reveals the company’s current ratio of 0.25, indicating potential challenges in meeting short-term obligations while pursuing clinical development.
This global, placebo-controlled, double-blinded trial is evaluating istaroxime when added to current standard of care treatments, including inotropes or vasopressors. The study’s primary endpoint measures systolic blood pressure profile over the first six hours of treatment.
According to the company, the interim analysis will primarily assess preliminary safety and tolerability in this setting, along with early efficacy signals to determine appropriate sizing for the remainder of the trial. Windtree noted that a statistically significant efficacy signal is not anticipated at this interim stage.
"As we make progress toward Phase 3 readiness for istaroxime, we believe the profile of istaroxime is being differentiated from currently available drugs used for this condition," said Steve Simonson, Chief Medical Officer of Windtree, in the press release.
The company indicated that data from this study will be valuable for Phase 3 preparation and for its planned end of Phase 2 meeting with the FDA.
Istaroxime is described as a first-in-class 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 information in this article is based on a company press release. Despite recent clinical progress, InvestingPro identifies several key financial challenges for Windtree, with 12 additional exclusive insights available to subscribers, including detailed analysis of the company’s cash burn rate and profitability outlook.
In other recent news, Windtree Therapeutics has reported positive results from its Phase 2 study of istaroxime for early cardiogenic shock. The study, published in the Journal of Heart and Lung Transplantation, showed significant improvements in blood pressure and cardiac output without adverse effects on heart rate. Additionally, Windtree is conducting a Phase 3 study in acute heart failure for the China market, fully funded by a regional partner. In a strategic move, Windtree plans to acquire Titan Environmental Solutions for $35 million in preferred stock, along with purchasing notes totaling $1.75 million. The acquisition agreement includes a 60-day exclusivity period and an $8 million breakup fee if the deal falls through.
Moreover, Windtree has received a $7 million offer to sell its preclinical oncology aPKCi inhibitor platform, with potential milestone payments and royalties. The company is also exploring the acceptance of cryptocurrency payments as part of its revenue diversification strategy. Lastly, Windtree aims to secure 7.5 years of U.S. market exclusivity for istaroxime, pending FDA approval, by seeking New Chemical Entity designation.
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