Istaroxime

Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to low blood flow These data provide the Company confidence to move forward with a global Phase 3 trial WARRINGTON, Pa., Aug. 05, 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, has performed a planned interim analysis of the SEISMiC C Phase 2 study data evaluating istaroxime in SCAI Stage C cardiogenic shock which showed istaroxime had a similar profile to that seen in previous studies despite a greater severity of illness and being used in addition to currently available inotropes and vasopressors. The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors in patients with more severe cardiogenic shock (SCAI stage C) than has been studied previously. The study follows the results of the SEISMIC B study where istaroxime was shown to improve blood pressure and hemodynamic variables such as cardiac output (the amount of blood pumped by the heart per minute), reduced filling pressures in the heart and improved signs of organ perfusion such as mixed venous oxygenation in patients with milder cardiogenic shock (SCAI stage B). This data is contributing to a very unique profile of istaroxime in acute decompensated heart failure across severity of illness. Inotropes and vasopressors agents are given to many patients in intensive care units in the USA every year and the results of the SEISMIC program may suggest potential advantages to istaroxime over existing therapies in efficacy and possibly safety. The SESIMIC C study was designed to assess the effects of istaroxime in patients with SCAI Stage C cardiogenic shock (i.e., more severe cardiogenic shock than patients enrolled in previous acute heart failure and cardiogenic shock studies in the past). Many patients in SESIMIC C were treated at the time of enrollment with vasopressors or inotropes and hence the SESIMIC C study is testing for the first time the safety and efficacy of istaroxime in more severe cardiogenic shock when istaroxime treatment is combined with other therapies for cardiogenic shock. The interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrhythmias 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. “The results of the SEISMIC C interim analysis are exciting,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe these data will be instrumental in moving istaroxime to a global Phase 3 program in heart failure and cardiogenic shock. Steve Simonson, Chief Medical Officer added, “The interim data are consistent with the previous clinical study results seen in patients with AHF and less severe forms of cardiogenic shock. These data are encouraging for the potential of istaroxime to be effective across the spectrum of cardiogenic shock due to AHF with or without other inotropic or vasopressor drugs.” About IstaroximeIstaroxime 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 StatementsThe 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 Curtisecurtis@windtreetx.com

1.3 million patients are hospitalized annually in the U.S. from acute heart failure and it is the #1 cause of hospitalization in patients >65 years old If istaroxime is approved in the US for acute heart failure, this patent would provide protection to 2039 WARRINGTON, Pa., July 02, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries is pleased to announce that the United States Patent and Trademark Office has issued an istaroxime patent for the United States - application number 18/150,870 directed to “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF ACUTE HEART FAILURE.” Acute heart failure, or AHF, impacts millions of patients globally and istaroxime has previously completed two positive Phase 2 AHF studies and two positive early cardiogenic shock studies caused by acute heart failure. “We are pleased to strengthen our intellectual property for istaroxime with this patent for the United States,” said Jed Latkin, CEO of Windtree. “Istaroxime is approaching Phase 3 readiness in cardiogenic shock and acute heart failure. If istaroxime is approved in AHF, this patent would provide protection until 2039. We believe the profile of istaroxime is differentiated from currently available drugs and drug treatment innovation is desired for patients.” About IstaroximeIstaroxime 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 focused on becoming a revenue generating company in a multitude of growing industries to drive toward overall profitability. Forward Looking StatementsThe 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 Company’s risks and uncertainties associated with the success and advancement of its product candidates; the Company’s ability to manage costs and execute on its operational and budget plans; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to regulatory requirements; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the impacts of political unrest, including as a result of geopolitical tension, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites. 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 Curtisecurtis@windtreetx.com