tw0122
1 day ago
The Company submits this request for withdrawal as it does not intend to pursue, at this time, the public offering to which the Registration Statement relates. The Registration Statement has not been declared effective by the Commission and no securities have been issued or sold under the Registration Statement. Accordingly, withdrawal of the Registration Statement is consistent with the public interest and the protection of investors, as contemplated by paragraph (a) of Rule 477.
The Company requests that, in accordance with Rule 457(p) under the Securities Act, all fees paid to the Commission in connection with the filing of the Registration Statement be credited for future use.
Pursuant to Rule 477(b), the Company understands that this request for withdrawal of the Registration Statement will be deemed granted as of the date hereof unless the Company receives notice from the Commission within 15 days of the date hereof that such request will not be granted.
If you have any questions or require any further information, please contact the Company’s counsel, Goodwin Procter LLP, by calling Justin S. Platt, Esq. at (212) 459-7340.
Mr. Zen
6 months ago
NEWS:: Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced it has entered into a license agreement with Lee’s Pharmaceutical (HK) Limited (“Lee’s”) for the development and commercialization of Windtree’s product candidate istaroxime in Greater China, including for acute heart failure and cardiogenic shock. In addition to istaroxime, the agreement also licenses Windtree’s preclinical next-generation SERCA2a activators, known as dual mechanism SERCA2a activators, and rostafuroxin, a Phase 2 product candidate for hypertension associated with specific genotypes.
Mr. Zen
7 months ago
Windtree Therapeutics Announces the Start of Patient Dosing In Phase 2 SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that the Company recently enrolled the first subject in its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock. Study results are expected in mid-2024.
Building upon the positive SEISMiC study results, the Extension Study is expected to enroll up to 30 subjects with the objective to evaluate a longer dosing cycle of istaroxime, a novel first-in-class therapy that is designed to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure. The study of hospitalized patients with early cardiogenic shock (SCAI Stage B) due to acute heart failure (AHF) will evaluate two dose regimens of istaroxime compared to placebo. Subjects on istaroxime will receive infusions for up to 60 hours with one istaroxime group receiving a tapered decreasing dose over time and the second istaroxime group receiving a consistent lower dose. In the previous SEISMiC study in early cardiogenic shock, patients were infused with drug or placebo for 24 hours. We believe extending the dosing duration of istaroxime has the potential to provide additional benefit and, along with dose titration, is an important factor in determining the optimal dosing regimen to study in a potential Phase 3 trial. The Extension Study will also gather data to characterize the potential benefits of SERCA2a activation in these patients, advancing the Company’s clinical and regulatory position for potential Phase 3 readiness.
The Company is also progressing the start-up of a parallel study in more severe, SCAI Stage C cardiogenic shock patients. SCAI Stage C patients have low blood pressure and inadequate blood flow to vital organs. The istaroxime cardiogenic shock SCAI Stage C study is expected to enroll up to 20 subjects with SCAI Stage C cardiogenic shock due to AHF. Multiple physiologic measures associated with cardiac function, blood pressure and safety will be assessed. The Company is targeting data from this study in a similar timeframe as the SEISMiC Extension Study.
“The SEISMiC Extension Study builds upon the positive data from our three Phase 2 studies in acute heart failure and early cardiogenic shock and is expected to determine the best dosing regimen for our anticipated Phase 3 program in cardiogenic shock,” said Craig Fraser, Windtree's President and Chief Executive Officer. “Along with data from more severe, SCAI Stage C cardiogenic shock patients coming from a parallel study, program results in mid-2024 are expected to contribute to finalizing our strategy and design for Phase 3 clinical trials and our end of Phase 2 discussions with FDA.”
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 cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
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 lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Mr. Zen
8 months ago
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that the European Patent Office has granted Patent No. 3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates. The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline. The pure SERCA2a Activators are devoid of action on the Na+/K+ pump while activating SERCA2a. The new European patent, titled: “ANDROSTANE DERIVATIVES WITH ACTIVITY AS PURE OR PREDOMINANTLY PURE STIMULATORS OF SERCA2A FOR THE TREATMENT OF Heart Failure,” provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action. The other family of SERCA2a Activators is the dual mechanism of action (inhibition of the Na+/K+ pump and activation of SERCA2a) which the Company previously announced had received composition of matter patents from the European Patent Office and the U.S. Patent and Trademark Office.
The pure SERCA2a Activators have SERCA2a stimulatory activity, are intended to have oral and intravenous administration and would potentially be developed for use in the chronic out-patient heart failure market as well as the acute setting. In the U.S., approximately 6 million people (nearly 2% of the adult population) have heart failure and approximately half of these patients are expected to die within five years of diagnosis; and in the combined U.S., EU and Japan markets, there are more than 18 million patients suffering from heart failure. Heart failure is the leading cause of hospitalization in patients aged 65 years and older.
“SERCA2a activity is decreased in heart failure. Windtree believes activation of SERCA2a represents a potentially important advancement in heart failure treatment for patients,” said Craig Fraser, CEO of Windtree Therapeutics. “Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart’s main pumping chamber (left ventricle) becomes stiff and unable to fill properly. SERCA2a activation has the potential to be beneficial in this type of heart failure that accounts for nearly one-half of the chronic heart failure patients. Given the potential for oral (tablet) use, it could be utilized in both the chronic out-patient and hospital markets.”
About Pure SERCA2a Activators
These compounds activate SERCA2a without activity on the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Dual Mechanism SERCA2a Activators
Dual Mechanism SERCA2a Activators activate SERCA2a and inhibit the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing multiple 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 lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. Windtree’s pre-clinical heart failure platform includes follow-on, potentially oral, SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Mr. Zen
9 months ago
Windtree to Present at the Sidoti Micro Cap Conference on November 16th
November 08 2023 - 08:00AM
GlobeNewswire Inc.
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will present a corporate update at the Sidoti Micro Cap Conference on Thursday, November 16, 2023 at 1:45pm ET. Windtree management will also be participating in virtual 1x1 meetings with investors at the event on November 15 and 16.
The corporate update presentation can be viewed live by clicking on this link https://sidoti.zoom.us/webinar/register/WN_roHsRn17R5m0wQo8wOIKsQ or a recorded webcast may be accessed from the Events section of Windtree’s website at https://ir.windtreetx.com/events.
Mr. Zen
9 months ago
Windtree to Present at the ThinkEquity Conference on October 19th in New York City
October 12 2023 - 07:30AM
GlobeNewswire Inc.
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be presenting at the upcoming ThinkEquity Conference on Thursday, October 19, 2023 at 4:30pm ET. Windtree management will also be hosting 1x1 meetings with investors at the event.
The presentation will provide clinical development and business updates, including the Company’s progress on its lead product candidate istaroxime in cardiogenic shock.
Click here to register and attend the event: Click here.
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 cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
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 lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Contact Information:
Matt Epstein
mepstein@kendallir.com
Mr. Zen
10 months ago
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be participating in a panel discussion titled, “Cardiac Kids: Late-Stage Advancement for Cardiovascular Disorders,” at the Lytham Partners Fall 2023 Investor Conference on Tuesday, October 17, 2023 at 10:30am ET. Windtree management will also be participating in virtual 1x1 meetings with investors at the event.
The panel discussion will include Windtree’s progress on its lead pipeline candidate istaroxime for the treatment of cardiogenic shock. The panel can be accessed on the Company’s corporate website at: Events | Windtree Therapeutics, Inc (windtreetx.com).
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 cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
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 lead candidate, istaroxime, being developed as a first-in-class treatment for cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
Contact Information:
Matt Epstein
mepstein@kendallir.com
Mr. Zen
10 months ago
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that Craig Fraser, President and Chief Executive Officer, will be presenting at the upcoming Dawson James Small Cap Growth Conference on October 12, 2023 in Jupiter, FL.
The presentation will provide clinical development and business updates including Windtree’s progress on its lead product candidate istaroxime in cardiogenic shock.
Click here to register and attend the event: Click here
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 cardiac rhythm disturbances.
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