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Windtree Announces Issuance of Istaroxime Patent for the United States for Acute Heart Failure
Globenewswire· 2025-07-02 13:00
Core Insights - Istaroxime is a first-in-class dual-mechanism therapy aimed at treating acute heart failure (AHF) and has shown positive results in Phase 2 studies [3] - The United States Patent and Trademark Office has granted a patent for istaroxime, which will provide protection until 2039 if approved for AHF [1][2] - Windtree Therapeutics is focused on becoming a revenue-generating company across multiple growing industries [4] Company Overview - Windtree Therapeutics, Inc. is a diversified company with a focus on revenue generation and profitability in various industries [4] - The company is advancing istaroxime towards Phase 3 readiness for cardiogenic shock and AHF [2] Product Details - Istaroxime improves both systolic and diastolic cardiac function, increasing myocardial contractility and facilitating myocardial relaxation [3] - Clinical data indicates that istaroxime can significantly enhance cardiac function and blood pressure without raising heart rate or causing significant cardiac rhythm disturbances [3]
Windtree Announces Istaroxime Phase 2 Cardiogenic Shock Study Hits Enrollment Target for Planned Interim Analysis
Globenewswire· 2025-06-30 13:00
The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may be receiving standard of care with inotropes and vasopressors SCAI Stage C is a sicker patient population than early cardiogenic shock and has high mortality despite currently used drug treatments WARRINGTON, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a diversified company focused on revenu ...
Windtree Announces Plan for Cryptocurrency Treasury Policy
Globenewswire· 2025-06-03 20:05
Core Viewpoint - Windtree Therapeutics, Inc. plans to implement a cryptocurrency policy to accept cryptocurrency as a payment option and hold it as an asset, aligning with digital commerce trends [1][2][3] Company Strategy - The company is focused on becoming a revenue-generating entity while advancing innovative therapies for critical conditions and diseases [4] - Windtree is in discussions with groups specializing in Bitcoin and other cryptocurrencies to develop a treasury strategy [3] Cryptocurrency Policy - The cryptocurrency policy aims to allow the company to accept cryptocurrency payments and hold them long-term as a strategic asset [2][3] - The Board of Directors supports the development of this cryptocurrency policy, which is expected to be completed soon [3] Product Portfolio - Windtree's product candidates include istaroxime, a Phase 2 candidate for acute heart failure, and preclinical SERCA2a activators and precision aPKCi inhibitors for oncology applications [4]
Windtree Therapeutics Announces Istaroxime Cardiogenic Shock SCAI Stage C Phase 2 Study Planned Interim Analysis Results Targeted for July 2025
Globenewswire· 2025-05-22 12:16
Core Insights - Windtree Therapeutics is advancing its istaroxime cardiogenic shock program with the SEISMiC C Study, targeting interim analysis results for July 2025 [1][2][3] - Istaroxime is a first-in-class dual-mechanism therapy aimed at improving cardiac function in patients with cardiogenic shock [4] Company Overview - Windtree Therapeutics focuses on developing innovative therapies for critical conditions and aims to become a revenue-generating company [5] - The company's product portfolio includes istaroxime, which is in Phase 2 trials for acute heart failure and cardiogenic shock, as well as preclinical candidates for heart failure and oncology applications [5] Study Details - The SEISMiC C Study is a global, placebo-controlled, double-blinded trial assessing the efficacy of istaroxime in addition to standard care [2] - The primary endpoint is the systolic blood pressure profile over the first six hours, with additional measurements including cardiac function and treatment failure rates [2] Clinical Significance - Interim data from the SEISMiC C Study will provide insights into istaroxime's physiological impact and safety profile in more severely ill patients [3] - Previous Phase 2 studies have shown that istaroxime can significantly improve cardiac function and blood pressure without increasing heart rate or causing significant rhythm disturbances [4]
Windtree Therapeutics Reports First Quarter 2025 Financial Results and Provides Key Business Updates
Globenewswire· 2025-05-16 12:00
WARRINGTON, Pa., May 16, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates. “The first quarter of 2025 was marked with significant progress. We announced our new corporate strategy to become a reve ...
Windtree Therapeutics Announces Presentation of Preclinical Data on Istaroxime and a Selective SERCA2a Activator at the European Society of Cardiology Heart Failure Conference May 17, 2025
Globenewswire· 2025-05-12 12:00
Core Insights - Windtree Therapeutics, Inc. announced data on istaroxime and a selective SERCA2a activator demonstrating a reduction in arrhythmias in an animal study presented at the European Society of Cardiology Heart Failure Conference [1][2] - The study focused on the activation of SERCA2a to reduce calcium-dependent arrhythmias in a rat model induced by ischemia-reperfusion, identifying a potential mechanism for decreased arrhythmias [2] Company Overview - Windtree Therapeutics is a biotechnology company aiming to generate revenue and advance innovative therapies for critical conditions, with a focus on istaroxime, a Phase 2 candidate for acute heart failure and cardiogenic shock [6] - The company is also developing preclinical SERCA2a activators and precision aPKCi inhibitors for oncology applications, alongside a licensing business model with existing partnership out-licenses [6] Product Details - Istaroxime is a first-in-class dual-mechanism therapy that enhances both systolic and diastolic cardiac function, improving myocardial contractility and facilitating myocardial relaxation through SERCA2a activation [4] - Previous Phase 2 studies indicated that intravenous istaroxime significantly improves cardiac function and blood pressure without increasing heart rate or cardiac rhythm disturbances [4] Research and Development - The current research includes evaluating preclinical product candidates for heart failure, focusing on both oral and intravenous SERCA2a activators [5]
Windtree Announces Istaroxime Exclusivity and Intellectual Property Potential Strategy for US
Globenewswire· 2025-05-06 12:18
Core Insights - Windtree Therapeutics is advancing istaroxime, a potential treatment for cardiogenic shock, which may receive New Chemical Entity designation from the FDA, providing 7.5 years of U.S. exclusivity if approved [1][3] - Istaroxime has existing patents protecting its method of use until 2039 and a pending patent extending protection until 2043 [2] - The company is focused on the development of istaroxime, with an interim analysis of its Phase 2 study planned for Q3 2025 [3] Company Overview - Windtree Therapeutics is a biotechnology company aiming to generate revenue through innovative therapies for critical conditions, with istaroxime being a key candidate in its portfolio [5] - Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function, showing significant improvements in cardiac function and blood pressure in Phase 2 studies [4]
Windtree Announces Strategic Transaction to Drive Revenue Generation in Support of Ongoing Therapeutic Pipeline Development
Globenewswire· 2025-05-01 12:30
Initial transaction provides the right to buy the target asset which may provide consistent revenue to Windtree while it continues to develop its biotech pipeline drug candidatesWARRINGTON, Pa., May 01, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entere ...
Windtree Therapeutics Reports Year-End 2024 Financial Results and Provides Key Business Updates
Globenewswire· 2025-04-15 12:00
Core Insights - Windtree Therapeutics, Inc. reported significant advancements in clinical development and business strategy for 2024, particularly focusing on its lead drug candidate, istaroxime, for treating cardiogenic shock [2][3] Business Development - The company announced positive results from the Phase 2 SEISMiC Extension Study of istaroxime in September 2024 and initiated the global SEISMiC C trial for more severely ill patients, with an interim assessment planned for Q3 2025 [3] - A new corporate strategy was launched to become a revenue-generating biotech through acquisitions of small companies with FDA-approved products, aiming to provide near-term value to shareholders [2][3] - Windtree entered a licensing partnership with Lee's Pharmaceutical for istaroxime and other drug candidates, enhancing its market reach in Greater China [2][3] Financial Performance - For the fiscal year ended December 31, 2024, research and development expenses increased to $16.3 million from $8.3 million in 2023, primarily due to a $7.5 million charge related to acquired in-process R&D [5] - General and administrative expenses decreased to $8.7 million from $9.2 million in 2023, attributed to reductions in stock-based compensation and personnel costs [6] - The company reported a net loss of $1.8 million for 2024, a significant improvement from a net loss of $20.3 million in 2023, influenced by non-cash gains on debt extinguishment and changes in fair value of common stock warrant liability [7][8] Intellectual Property and Regulatory Compliance - Windtree completed national phase filings for istaroxime patent applications in key markets, including the U.S., Germany, and China, strengthening its global intellectual property portfolio [9] - The company regained compliance with Nasdaq listing requirements, ensuring continued listing on the exchange [3] Cash Position - As of December 31, 2024, Windtree reported cash and cash equivalents of $1.8 million, with subsequent sales of common stock and warrant exercises providing additional liquidity [10]