Windtree Announces Issuance of Istaroxime Patent for the United States for Acute Heart Failure

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 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 focused on becoming a revenue generating company in a multitude of growing industries to drive toward overall profitability.

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 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 Curtis
ecurtis@windtreetx.com

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