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Submission: On May 31 via api from US — Scanned from DE
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Submission Tags: falconsandbox
Submission: On May 31 via api from US — Scanned from DE
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Skip to main navigation HEADER NAV * Company * Company Overview * Management * Board of Directors * Corporate Governance * Contact Us * Diversity, Inclusion and Innovation * Pipeline and Technology * Pipeline and Therapeutic Overview * Istaroxime * SERCA2a Activators * Lucinactant (KL4 surfactant) * AEROSURF® * Rostafuroxin * Expanded Access Policy * Business Development * Investors * Welcome * Financial Information * IR Snapshot * Annual Reports * Analyst Coverage * Financial Fundamentals * Stock Information * Stock Quote & Chart * Historic Price Lookup * Filings * SEC Filings * Ownership * Corporate Governance * Corporate Presentation * Events * Press Releases * Investor Alerts * Contact Us Select Page * Company * Company Overview * Management * Board of Directors * Corporate Governance * Contact Us * Diversity, Inclusion and Innovation * Pipeline and Technology * Pipeline and Therapeutic Overview * Istaroxime * SERCA2a Activators * Lucinactant (KL4 surfactant) * AEROSURF® * Rostafuroxin * Expanded Access Policy * Business Development * Investors * Welcome * Financial Information * IR Snapshot * Annual Reports * Analyst Coverage * Financial Fundamentals * Stock Information * Stock Quote & Chart * Historic Price Lookup * Filings * SEC Filings * Ownership * Corporate Governance * Corporate Presentation * Events * Press Releases * Investor Alerts * Contact Us WELCOME HEADER NAV * Welcome * Financial Information * IR Snapshot * Annual Reports * Analyst Coverage * Financial Fundamentals * Stock Information * Stock Quote & Chart * Historic Price Lookup * Filings * SEC Filings * Ownership * Corporate Governance * Corporate Presentation * Events * Press Releases * Investor Alerts TOOLKIT * Email Alerts * Print Page * Share * RSS Feeds * Contact IR * Search WELCOME Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with our lead candidate, istaroxime, being developed as a first in class treatment for cardiogenic shock and acute heart failure. Our Focus: Istaroxime in Cardiogenic Shock In May 2022, Windtree reported our positive Phase 2 study of istaroxime in early cardiogenic shock (SEISMiC study) results. The study’s positive primary endpoint and results have paved the way for our clinical development to potentially have istaroxime Phase 3 ready for cardiogenic shock in 2024. After these positive data results, Windtree has prioritized istaroxime in cardiogenic shock as our focus. We made this decision based upon the data and these drivers of opportunity and potential commercial value: * Currently available pharmacologic treatments for cardiogenic shock have poor outcomes and undesirable side effects * Lack of competition in development or in the market * Very high cost of cardiogenic shock care (~19.5 days1 in the hospital and > $200k cost2) which creates a big opportunity to demonstrate pharmacoeconomic benefits * Attractive valuation of commercial market potential versus time and cost of development Cardiogenic shock is a severe presentation of heart failure characterized by low blood pressure and inadequate blood flow to vital organs (hypoperfusion) accompanied by congestion and high filling pressures of the heart. Cardiogenic shock is an area of extreme unmet need with no satisfactory pharmacologic interventions to reverse the condition and available therapies have unwanted side effects such as arrythmias, decreasing blood pressure, renal dysfunction and increases in mortality. Cardiogenic shock has high mortality (approximately 30-40%) and substantial morbidity in survivors. There is potential for a relatively fast and less expensive development and regulatory pathway for istaroxime. Windtree’s Unique Approach with SERCA2a Activation Windtree’s heart failure platform includes follow-on preclinical SERCA2a Activator assets as well. Dual mechanism SERCA2a Activators: This class of drug candidates have a similar MOA to istaroxime. The first mechanism strengthens the contraction of the heart and the second mechanism promotes the relaxation of the heart’s ventricles so they can fill with more blood in between the heart beats. This group may be well suited for study in both the hospital inpatient area for acute HF where it could be administered as an IV and in the outpatient area as a potential oral pill formulation after a patient is released from the hospital. This group could be developed as a “fast follow on” to istaroxime in acute decompensated heart failure but offer the potential benefit of chronic dosing following patient hospital discharge. Pure SERCA2a Activators: This group’s mechanism of action focuses on the relaxation of the ventricles to fill more with blood in between heart beats. The group may be well suited for study in chronic heart failure as an outpatient in heart failure with preserved ejection fraction or HfpEF. This is an area highly underserved in CV disease. Also in its portfolio is rostafuroxin, a novel precision drug product targeting treatment resistant hypertensive patients with certain genetic profiles. AEROSURF and KL4 have been out-licensed globally to Lee’s Pharmaceutical (HK) and Zhoake Pharmaceutical. _______________________________________________________ 1 US Hospital Claims Data, 2022 2 Agency for Healthcare Research and Quality (AHRQ), 2018 RECENT NEWS May 7, 2024 Windtree Therapeutics Regains Compliance with Nasdaq WARRINGTON, Pa. , May 07, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it has received a Bid Price Apr 18, 2024 Windtree Therapeutics Announces Reverse Stock Split WARRINGTON, Pa. , April 18, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NASDAQ: WINT) (“Windtree” or the “Company”), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today announced that the Company’s Board of Directors has Apr 17, 2024 Windtree Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Key Business Updates WARRINGTON, Pa. , April 17, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the fourth quarter * Today * 3 mo. * 6 mo. * 1 year TODAY 3 MO. 6 MO. 1 YEAR NASDAQ: WINT $3.64 0 (0.00%) Volume: 461 Market Cap: $2.15 M Data Provided by Refinitiv. Minimum 15 minutes delayed. © Copyright 2024 Windtree Therapeutics, Inc