Presentation will be the interim data from the Phase 2 study of istaroxime in SEISMiC C - Cardiogenic Shock SCAI Stage C

Cardiogenic shock SCAI Stage C has an in hospital mortality rate of 20-30%

Istaroxime interim data was consistent with the profile seen in previous studies gives Windtree confidence to move forward with a global Phase 3 study

WARRINGTON, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, announced that istaroxime was chosen for a presentation entitled, “Safety and Efficacy of intravenous administration of istaroxime for 48 hours in patients with SCAI Stage C cardiogenic shock due to heart failure” at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025.

Acute decompensated heart failure and cardiogenic shock have had very little drug innovation in decades. The Company believes istaroxime has a profile that offers potential benefits to patients with low blood pressure due to heart failure. Istaroxime improves cardiac function and can increase blood pressure without increasing heart rate. Also, istaroxime tends to preserve measures of renal function and contributes to resolution of congestion and fluid overload that often accompanies heart failure. Importantly, it does not appear to increase clinically significant arrythmias. The istaroxime cardiogenic shock SCAI Stage C interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies.

“We are very pleased with the interim results of the SEISMiC C study,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe istaroxime can be an important drug innovation for acute decompensated heart failure and cardiogenic shock patients because the istaroxime studies have promising results and this is a condition with a large unmet need and has been underserved for decades.”

About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners.

Forward Looking Statements
The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact Information:
Eric Curtis
[email protected]