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Windtree Therapeutics Announces Istaroxime Presentation at European Society of Cardiology Heart Failure Conference

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Windtree Therapeutics (NASDAQ: WINT) announced the presentation of istaroxime data from their SEISMiC Extension Phase 2b study at the European Society of Cardiology Heart Failure 2025 Conference in Belgrade. The presentation, focusing on the safety and efficacy of intravenous istaroxime for pre-cardiogenic shock patients over 60-hour periods, will be delivered by Dr. Jan Biegus from Wroclaw Medical University. Dr. Steve Simonson, Windtree's CMO, highlighted the positive study results as crucial for advancing istaroxime to Phase 3 trials. The company believes istaroxime's unique profile distinguishes it from existing therapies for treating cardiogenic shock, a condition associated with high mortality, morbidity, and healthcare costs.
Windtree Therapeutics (NASDAQ: WINT) ha annunciato la presentazione dei dati su istaroxime provenienti dallo studio SEISMiC Extension Fase 2b durante la conferenza della European Society of Cardiology Heart Failure 2025 a Belgrado. La presentazione, che si concentrerà sulla sicurezza e l'efficacia dell'istaroxime somministrato per via endovenosa in pazienti con shock pre-cardiogeno per un periodo di 60 ore, sarà tenuta dal Dr. Jan Biegus dell'Università Medica di Wroclaw. Il Dr. Steve Simonson, CMO di Windtree, ha sottolineato che i risultati positivi dello studio sono fondamentali per il passaggio dell'istaroxime alla Fase 3 dei trial clinici. L'azienda ritiene che il profilo unico di istaroxime lo distingua dalle terapie attualmente disponibili per il trattamento dello shock cardiogenico, una condizione caratterizzata da elevata mortalità, morbilità e costi sanitari.
Windtree Therapeutics (NASDAQ: WINT) anunció la presentación de datos sobre istaroxima del estudio SEISMiC Extension Fase 2b en la Conferencia de Insuficiencia Cardíaca 2025 de la Sociedad Europea de Cardiología en Belgrado. La presentación, que se centrará en la seguridad y eficacia de la administración intravenosa de istaroxima en pacientes con pre-shock cardiogénico durante un período de 60 horas, será realizada por el Dr. Jan Biegus de la Universidad Médica de Wroclaw. El Dr. Steve Simonson, director médico de Windtree, destacó que los resultados positivos del estudio son clave para avanzar con istaroxima a los ensayos de Fase 3. La compañía considera que el perfil único de istaroxima lo diferencia de las terapias existentes para tratar el shock cardiogénico, una condición asociada con alta mortalidad, morbilidad y costos sanitarios.
Windtree Therapeutics(NASDAQ: WINT)는 SEISMiC Extension 2b상 연구에서 얻은 이스타록심 데이터가 2025년 베오그라드에서 개최되는 유럽심장학회 심부전 컨퍼런스에서 발표될 예정임을 발표했습니다. 이번 발표는 60시간 동안 정맥 주사로 투여된 이스타록심의 안전성과 효능에 대해 다룰 예정이며, 브로츠와프 의과대학의 Jan Biegus 박사가 발표를 맡습니다. Windtree의 최고의학책임자(CMO)인 Steve Simonson 박사는 이번 연구 결과가 이스타록심을 3상 임상시험으로 진전시키는 데 중요한 역할을 한다고 강조했습니다. 회사는 이스타록심의 독특한 특성이 높은 사망률, 이환율 및 의료비용과 관련된 심인성 쇼크 치료를 위한 기존 치료법과 차별화된다고 보고 있습니다.
Windtree Therapeutics (NASDAQ : WINT) a annoncé la présentation des données sur l'istaroxime issues de leur étude SEISMiC Extension Phase 2b lors de la conférence European Society of Cardiology Heart Failure 2025 à Belgrade. Cette présentation, axée sur la sécurité et l'efficacité de l'istaroxime administré par voie intraveineuse chez des patients en état de choc pré-cardiogénique sur une période de 60 heures, sera réalisée par le Dr Jan Biegus de l'Université médicale de Wroclaw. Le Dr Steve Simonson, directeur médical de Windtree, a souligné que les résultats positifs de l'étude sont essentiels pour faire progresser l'istaroxime vers les essais de phase 3. L'entreprise estime que le profil unique de l'istaroxime le distingue des thérapies existantes pour le traitement du choc cardiogénique, une pathologie associée à une mortalité, une morbidité et des coûts de santé élevés.
Windtree Therapeutics (NASDAQ: WINT) gab bekannt, dass Daten zu Istaroxim aus ihrer SEISMiC Extension Phase 2b-Studie auf der European Society of Cardiology Heart Failure 2025 Konferenz in Belgrad präsentiert werden. Die Präsentation, die sich auf die Sicherheit und Wirksamkeit von intravenösem Istaroxim bei Patienten mit prä-kardiogenem Schock über einen Zeitraum von 60 Stunden konzentriert, wird von Dr. Jan Biegus von der Medizinischen Universität Wroclaw gehalten. Dr. Steve Simonson, Chief Medical Officer von Windtree, betonte, dass die positiven Studienergebnisse entscheidend sind, um Istaroxim in die Phase-3-Studien zu bringen. Das Unternehmen ist der Ansicht, dass das einzigartige Profil von Istaroxim es von bestehenden Therapien zur Behandlung des kardiogenen Schocks unterscheidet, einer Erkrankung, die mit hoher Sterblichkeit, Morbidität und Gesundheitskosten verbunden ist.
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Cardiogenic shock is a medically urgent condition and drug treatment innovation is desired by providers who treat the condition

WARRINGTON, Pa., May 19, 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, today announced istaroxime data from the early cardiogenic shock SEISMiC Extension Phase 2b study will be presented today at the European Society of Cardiology Heart Failure 2025 Conference in Belgrade, Serbia.

The istaroxime data will be presented by Jan Biegus MD, Institute of Heart Diseases, Wroclaw Medical University, Wrocław, Poland. The presentation is entitled, “Safety and Efficacy of up to 60 Hours of Intravenous Istaroxime for Patients with Pre-Cardiogenic Shock: the SEISMiC Trial.”

“The positive results from the SEISMiC Extension Study are important data to help us advance istaroxime toward Phase 3 for cardiogenic shock,” said Dr. Steve Simonson, Chief Medical Officer and Senior Vice President of Windtree Therapeutics. “We believe that istaroxime is differentiating itself from currently available therapies to support the acutely failing heart. The unique profile of istaroxime is well-suited to potentially be a new important treatment for cardiogenic shock which has high mortality, morbidity and cost of care.”

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 significantly improves 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 biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.

Forward Looking Statements
This press release contains statements related to the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 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 could lose its deposit on the real estate property discussed above; the Company may fail to acquire such real estate property; the Company’s ability to acquire revenue generating subsidiaries; the market’s reaction to potential acquisitions by the Company; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; 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 rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; 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, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Middle East, 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, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. 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


FAQ

What is the purpose of Windtree's istaroxime presentation at ESC Heart Failure 2025?

The presentation will share data from the SEISMiC Extension Phase 2b study, focusing on istaroxime's safety and efficacy in treating pre-cardiogenic shock patients over 60-hour periods.

Who will present WINT's istaroxime data at the ESC Heart Failure Conference?

Dr. Jan Biegus from the Institute of Heart Diseases, Wroclaw Medical University, Poland, will present the istaroxime data.

What is the current development stage of Windtree's istaroxime?

Istaroxime has completed Phase 2b studies and is preparing to advance to Phase 3 trials for cardiogenic shock treatment.

What condition does Windtree's istaroxime target?

Istaroxime targets cardiogenic shock, a medically urgent condition with high mortality, morbidity, and healthcare costs.
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