Na/K-ATPase inhibitors(Sodium/potassium-transporting ATPase inhibitors), SERCA2 activators(Sarcoplasmic/endoplasmic reticulum calcium ATPase 2 activators)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication

ShockShock, Cardiogenic

Inactive Indication

Acute decompensated heart failureHeart Failure

Originator Organization

Sigma-Tau BV

Active Organization

Windtree Therapeutics, Inc.

Inactive Organization

Debiopharm International SA

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

Sigma-Tau Industrie Farmaceutiche Riunite SpA

+ [1]

License Organization

Windtree Therapeutics, Inc.

ScinoPharm Taiwan Ltd.

Lee's Pharmaceutical Holdings Ltd.

+ [3]

Drug Highest PhasePhase 2

First Approval Date-

RegulationSpecial Review Project (China)

Structure/Sequence

Molecular FormulaC21H32N2O3

InChIKeyMPYLDWFDPHRTEG-IFVNMTGRSA-N

CAS Registry203737-93-3

Clinical Trials associated with Istaroxime

NCT05975021

/ RecruitingPhase 1/2

A Multicenter, Randomized, Placebo-Controlled, Parallel Group Trial on the Safety and Efficacy of Istaroxime for Cardiogenic Shock SCAI Stage C

The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices.
Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS.
Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

Start Date01 Jun 2024

Sponsor / Collaborator

Windtree Therapeutics, Inc.

NCT04325035

/ CompletedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

Start Date28 Sep 2020

Sponsor / Collaborator

Windtree Therapeutics, Inc.

[+1]

CTR20160151

/ CompletedPhase 2

Istaroxime治疗急性失代偿性心力衰竭的有效性和安全性临床研究——一项多中心、随机、双盲、安慰剂平行对照的临床研究

[Translation] Clinical study on the efficacy and safety of Istaroxime in the treatment of acute decompensated heart failure: a multicenter, randomized, double-blind, placebo-controlled clinical study

与安慰剂比较，24小时静脉输注2 种剂量(0.5 和1.0 μg/kg/min)Istaroxime 治疗急性失代偿性心力衰竭(ADHF)的意大利患者和中国患者，评价一种具有正性肌力和舒张活性并且可以改善心肌收缩--舒张循环的新型药物的安全性、耐受性和有效性。所有意大利患者与部分中国患者也将进Istaroxime 及其代谢物的的药代动力学研究。

[Translation]

Compared with placebo, 2 doses (0.5 and 1.0 μg/kg/min) of Istaroxime were infused intravenously for 24 hours in Italian and Chinese patients with acute decompensated heart failure (ADHF) to evaluate the safety, tolerability and efficacy of a new drug with positive inotropic and diastolic activity and can improve myocardial contraction-diastolic cycle. All Italian patients and some Chinese patients will also undergo a pharmacokinetic study of Istaroxime and its metabolites.

Start Date24 Nov 2016

Sponsor / Collaborator

Zhaoke Pharmaceutical (Hefei) Co., Ltd.

[+2]

100 Clinical Results associated with Istaroxime

100 Translational Medicine associated with Istaroxime

100 Patents (Medical) associated with Istaroxime

107

Literatures (Medical) associated with Istaroxime

01 Mar 2025·Cardiology in review

Istaroxime: A Novel Therapeutic Agent for Acute Heart Failure

Review

Author: Newbury, Danielle ; Frishman, William

Acute decompensated heart failure (ADHF) is a multifactorial process that is associated with high morbidity and mortality. Treatment with inotropes can rapidly improve hemodynamic status; however, their use has been associated with increased mortality and incidence of arrhythmias. Istaroxime is a first-in-class intravenous agent currently undergoing clinical trials for acute heart failure. It has the unique mechanism of action of both Na+/K+ ATPase inhibition and sarcoplasmic/endoplasmic reticulum Ca2+ ATPase 2a stimulation. Notably, its action on sarcoplasmic/endoplasmic reticulum Ca2+ ATPase 2a improves calcium handling, which is known to be abnormal in heart failure. Clinical trials have shown that istaroxime has beneficial hemodynamic effects; in particular, its ability to increase systolic blood pressure without causing significant increases in heart rate or clinically significant arrhythmias differentiates it from inotropes currently utilized for ADHF treatment, such as milrinone. While initial studies are encouraging, additional trials are needed to assess outcomes and to compare their performance to standard inotropes in patients hospitalized with ADHF. This article will review the relevant preclinical and clinical trials for istaroxime, as well as the relevant pharmacology.

01 Feb 2025·Clinical Implant Dentistry and Related Research

A Randomized Controlled Trial on the Timing of Soft Tissue Augmentation in Immediate Implant Placement: Soft Tissue Changes and Esthetic Outcome

Article

Author: Pitman, Jeremy ; Cosyn, Jan ; Van Hove, Pieter‐Jan ; De Bruyckere, Thomas ; Struys, Thibault ; Christiaens, Véronique

ABSTRACT:

Aim:

To assess the impact of the timing of soft tissue augmentation on soft tissue changes and esthetic outcome following single immediate implant placement (IIP) in the anterior maxilla.

Materials and Methods:

Patients with a failing tooth and intact buccal bone wall in the anterior maxilla (15–25) were enrolled in this RCT. Following single IIP and socket grafting, they were randomly allocated to the control group (immediate soft tissue augmentation performed in the same surgical procedure—ISTA) or the test group (delayed soft tissue augmentation performed 3 months later—DSTA). Implants were placed with a surgical guide and immediately restored with an implant‐supported provisional crown. Changes in soft tissue dimensions were assessed by a blinded clinician using superimposed STL files taken prior to surgery and at 1‐year follow‐up. The esthetic outcome was rated by a blinded clinician and the patient at 1‐year follow‐up. The study adhered to the STA‐COSM (Soft Tissue Augmentation—Core Outcome Set and Measurements for implant dentistry trials) guidelines.

Results:

Twenty patients were randomized to each group (control: 16 females, 4 males, mean age 57.6; test: 9 females, 11 males, mean age 54.2). The mean change in buccal soft tissue profile was −0.251 and 0.083 mm for ISTA and DSTA, respectively. The mean difference of −0.318 mm in favor of DSTA was not significant (95% CI: −0.860 to 0.224, p = 0.241). Median midfacial recession was −0.200 and − 0.350 mm for ISTA and DSTA, respectively. The median difference of 0.200 mm in favor of ISTA was not significant (95% CI: −0.210 to 0.700, p = 0.311). Mesial and distal papillary recession, Pink Esthetic Score and patients' esthetic satisfaction failed to demonstrate a significant difference between the groups.

Conclusion:

In patients with an intact buccal bone wall, the timing of soft tissue augmentation following IIP had no significant impact on soft tissue changes and esthetic outcome.Trial Registration:ClinicalTrials.gov: NCT05537545

01 Feb 2025·ESC Heart Failure

Safety and efficacy of up to 60 h of iv istaroxime in pre‐cardiogenic shock patients: Design of the SEISMiC trial

Article

Author: Gulati, Gaurav ; Mebazaa, Alexander ; Davison, Beth ; Zymliński, Robert ; Diaz, Maria Luz ; Pagnesi, Matteo ; Simonson, Steven ; Metra, Marco ; Guardia, Carlos ; Cotter, Gad ; Chioncel, Ovidiu ; Novosadova, Maria ; Gajewski, Piotr ; Simmons, Phillip ; Tycińska, Agnieszka ; Biegus, Jan ; Barros, Marianela ; Ponikowski, Piotr ; Filippatos, Gerasimos

Abstract:

Aims:

Cardiogenic shock (CS) is linked to high morbidity and mortality rates, posing a challenge for clinicians. Interventions to improve tissue perfusion and blood pressure are crucial to prevent further deterioration. Unfortunately, current inotropes, which act through adrenergic receptor stimulation, are associated with malignant arrhythmias and poorer outcomes. Due to its unique mechanism of action, istaroxime should improve haemodynamics without adrenergic overactivation. The SEISMiC study is designed to examine the safety and efficacy (haemodynamic effect) of istaroxime administrated in pre‐CS patients.

Methods and Results:

The SEISMiC study is a multinational, multicentre, randomized, double‐blind, placebo‐controlled safety and efficacy study with two parts (A and B). The study enrols patients hospitalized for decompensated heart failure (pre‐CS, not related to myocardial ischaemia) with persistent hypotension [systolic blood pressure (SBP) 70–100 mmHg for at least 2 h] and clinically confirmed congestion, NT‐proBNP ≥1400 pg/mL, and LVEF≤40%. Subjects must not have taken intravenous (iv) vasopressors, inotropes or digoxin in the past 6 h. Eligible patients are randomized to receive IV infusion of istaroxime (different doses and regimens in Parts A and B) or placebo for up to 60 h. Central haemodynamics, ECG Holter monitoring, cardiac ultrasound and biomarkers are recorded at predefined time points during the trial. The study's primary efficacy endpoint is the SBP area under the curve from baseline curve from baseline to 6 and 24 h in the combined SEISMiC Parts A and B population. Key secondary efficacy endpoints include haemodynamic, laboratory and clinical measures in SEISMiC B alone in the combined SEISMiC A and B studies.

Conclusions:

The study results will contribute to our understanding of the role of istaroxime in pre‐CS patients and potentially provide insight into the drug's haemodynamic effects and safety in this population.

News (Medical) associated with Istaroxime

06 May 2025

·www.globenewswire.com

Windtree Announces Istaroxime Exclusivity and Intellectual Property Potential Strategy for US

If istaroxime is granted the new chemical entity designation from FDA, it could provide 7.5 years of U.S. exclusivity and additionally the istaroxime U.S. issued method of use patent protects until 2039 for its planned initial indication in cardiogenic shockWARRINGTON, Pa., May 06, 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 it has received advice from intellectual property and FDA experts highlighting a U.S. strategy that can provide 7.5 years of U.S. exclusivity for istaroxime if it is approved by the FDA in cardiogenic shock. Specifically, as a never-before-approved active ingredient, istaroxime may receive New Chemical Entity (NCE) designation from the FDA. If the new drug application is approved with such a designation, istaroxime would be entitled to 5 years of data exclusivity, and a stay of FDA approval of any generic application equal to 7.5 years from the date of istaroxime’s FDA approval should any generic company challenge the patents that Windtree has obtained or is pursuing and if Windtree files a patent infringement lawsuit in response to such a challenge. Istaroxime also has a USPTO issued method of use patent providing protection until 2039 and a pending method of use patent providing protection until 2043. “We believe that the NCE exclusivity strategy is an attractive approach if istaroxime receives FDA approval in cardiogenic shock,” said Jed Latkin, Chief Executive Officer of Windtree. “It would be combined with our method of use patents for istaroxime in the U.S.” Mr. Latkin continued, “We continue our focused development and IP strategic planning for istaroxime in cardiogenic shock and our next milestone is a planned interim analysis of our Phase 2 cardiogenic shock SCAI Stage C study in Q3, 2025.” The istaroxime SCAI Stage C study (SEISMiC C) is a global trial including sites in the U.S. Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care, inotropes or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours and based on the patient’s condition, a withdrawal of the other therapies. The primary endpoint of the study is assessment of systolic blood pressure (SBP) profile over the first 6 hours of treatment. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to SCAI Stage D or E cardiogenic shock and need for mechanical cardiac support, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiologic measures (e.g., cardiac index) and length of stay in the intensive care unit and hospital. About IstaroximeIstaroxime 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 a biotechnology company focused on becoming a revenue generating biotech 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 StatementsThis press release contains statements related to the acquisition of the real estate property discussed above; rental revenue if such property is acquired; potential clinical effects of istaroxime; 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 Curtisecurtis@windtreetx.com

Phase 2

01 May 2025

·www.globenewswire.com

Windtree Announces Strategic Transaction to Drive Revenue Generation in Support of Ongoing Therapeutic Pipeline Development

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 entered an Assignment and Conditional Assumption Agreement with a seasoned real estate investment group pursuant to which it has gained the rights to purchase a 436 unit, multifamily residential property in Houston, Texas. The property is expected to contribute consistent rental revenue to the Company while it continues to develop its therapeutic pipeline. The planned acquisition would be effectuated through a separate wholly owned subsidiary division of the Company with the anticipated addition of certain new management. The acquisition is expected to be funded primarily from non-recourse secured mortgage financing, with the balance of the purchase price coming from proceeds of the issuance of preferred stock. The Company’s obligation to purchase the property is contingent upon the satisfactory completion of standard property due diligence and finalization of acceptable terms of the financing. The initial planned closing date is May 23, 2025, however, the Company has the option to extend the closing date for two periods of no greater than thirty days each. The Company’s new corporate strategy seeks to acquire assets that contribute revenue including the acquisition of small biotech companies with FDA approved products. Windtree will continue to develop its pipeline of unique drug candidates in the cardiovascular and oncology disease spaces. “Windtree is expected to become a revenue generating company and these additional assets are intended to diversity and stabilize the Company,” said Jed Latkin, Chief Executive Officer of Windtree. “By identifying opportunities to bring in stable revenue, we believe the Company can reduce its need for capital that could be dilutive to the stock price. We are actively looking at multiple acquisition candidates that could provide near term revenue and profits. We will continue in our mission to help patients in need with our existing unique drug candidates in cardiogenic shock, heart failure and cancer. We believe that this new approach will allow the Company to grow and limit future stockholder dilution.” About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue generating biotech 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 StatementsThis press release contains statements related to the acquisition of the real estate property discussed above; rental revenue if such property is acquired; potential clinical effects of istaroxime; 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 Curtisecurtis@windtreetx.com

AcquisitionPhase 2

15 Apr 2025

·www.globenewswire.com

Windtree Therapeutics Reports Year-End 2024 Financial Results and Provides Key Business Updates

WARRINGTON, Pa., April 15, 2025 (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 fiscal year ended December 31, 2024 and provided key business updates. “The year 2024 saw Windtree make great progress in many key areas including clinical development of our lead drug candidate istaroxime in cardiogenic shock, business development and the future strategy of the Company,” said Jed Latkin, CEO of Windtree. “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians express a high need for drug innovation. During the year, we announced positive results of our SEISMiC Extension Phase 2 istaroxime clinical study in early cardiogenic shock (SCAI Stage B) and also began our cardiogenic shock SEISMiC C (SCAI Stage C) Phase 2 study with an interim assessment planned for Q3 2025. In addition, we added a regional licensing partnership with Lee’s Pharmaceutical for greater China.for istaroxime, our preclinical dual mechanism SERCA2a activators and rostafuroxin. We are also continuing discussions with potential partners for our cardiovascular drug candidates.” Mr. Latkin further added, “Importantly, we also announced our new corporate strategy in early 2025 to become a revenue-generating biotech by using Company equity to acquire small biotech companies struggling to maximize the commercial potential of their FDA-approved products. We believe this could be a positive transformation and an opportunity to provide near-term value to our shareholders. As part of our strategy, we are actively evaluating revenue-generating opportunities across various sectors that align with our capabilities and strategic vision.” Mr. Latkin was appointed CEO in December of 2024. He has nearly three decades of financial and biotech experience including prior experience as the CEO of a public biotech company. Mr. Latkin served as the CEO of Navidea Biopharmaceuticals where he started as Chief Financial Officer and executed multiple deals and raised substantial funding. He has also served as CEO of Black Elk Energy Offshore in 2014 as part of Nagel Avenue Capital which he joined after ten years on Wall Street with a variety of investment banking organizations and funds, including ING, Morgan Stanley and Citigroup Securities. Most recently, Mr. Latkin served as the Chief Operating Officer and head of finance at ProPhase Labs, conducting deals and managing broad aspects of the business. Key Business Update Announced positive results from its Phase 2 SEISMiC Extension Study of istaroxime in the treatment of early cardiogenic shock in September 2024.Initiated enrollment in the global SEISMiC C trial evaluating istaroxime in SCAI Stage C cardiogenic shock—a more severely ill population than previously studied—building on positive SEISMiC A and B results; the placebo-controlled, double-blind study will assess istaroxime’s impact on systolic blood pressure and cardiac function alongside standard inotropic/vasopressor therapy, with a planned interim data review in Q3 2025 to inform Phase 3 readiness and regulatory discussions in early 2026.Launched a new corporate strategy to become a revenue generating biotech company through acquisitions of small companies and their FDA-approved products while continuing to progress the Company’s cardiovascular and oncology development pipeline.Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company will leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI.Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026.Completed istaroxime cardiogenic shock national phase filings of patent applications around the world, including in the U.S., Germany, France, Italy, Japan and China. These filings claimed priority to PCT/US2023/018998 entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock”. This application is currently pending before the United States Patent and Trademark Office (USPTO), Application no. 18/858,086. Filed a new PCT patent application for istaroxime and its derivatives targeting the prevention of acute myocardial arrhythmias—building on encouraging data from clinical trials in acute heart failure and early cardiogenic shock, as well as preclinical models showing enhanced efficacy of istaroxime metabolites in improving cardiac function and reducing ischemia-induced arrhythmias.Received a Notice of Allowance from the USPTO for a patent covering an intravenous istaroxime formulation for acute heart failure, and filed a related patent application in India targeting the prevention of life-threatening arrhythmias in heart failure patients—further strengthening the company’s global intellectual property portfolio. Completed national phase filings for the istaroxime patent titled “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGENIC SHOCK AND CARDIOGENIC SHOCK” (PCT/US2023/018998; U.S. Application No. 18/858,086) in key global markets including the U.S., Germany, France, Italy, Japan, and China—further strengthening international IP protection for its lead cardiovascular asset.Issued Japanese patent (No. 7603605, expiring 2040) for its novel aPKCi inhibitor platform targeting hedgehog pathway-dependent cancers—covering both topical and oral formulations, with potential applications in cancers such as basal cell carcinoma and small cell lung cancer, including use in combination therapies with HDAC inhibitors to enhance anti-cancer efficacy.Seeking to leverage positive Phase 2b results in early cardiogenic shock to secure non-dilutive funding through partnerships for istaroxime and next-generation oral SERCA2a activators outside Greater China; engaged New Growth Advisors to manage inbound interest and lead a broader out-licensing effort, while existing partner Lee’s Pharmaceuticals progresses toward a planned Phase 3 trial in acute heart failure in 1H 2025 under a deal worth up to $138 million in milestones plus royalties.Licensing partner Lee’s Pharmaceutical (HK) Ltd. is preparing to initiate a Phase 3 program for acute heart failure in Greater China, fully funding all development activities in the region; Windtree retains final protocol approval and is collaborating closely with Lee’s as it advances its global cardiogenic shock program in parallel. Select 2024 Year-End Financial Results Research and development (“R&D”) expenses were $16.3 million for the year ended December 31, 2024, compared to $8.3 million for the year ended December 31, 2023. The increase in research and development expenses is primarily due to (i) a $7.5 million charge related to acquired in-process R&D from the Varian asset purchase; and (ii) a $2.2 million increase in costs associated with the continued development of istaroxime, including the SEISMiC Extension study and start-up activities for the SEISMiC C study; partially offset by (iii) a $0.9 million reduction in royalty payments related to amendments to certain license agreements; (iv) a $0.6 million decrease in personnel costs due to headcount reductions; and (v) a $0.3 million decrease in non-cash stock-based compensation expense. General and administrative expenses for the year ended December 31, 2024 were $8.7 million, compared to $9.2 million for the year ended December 31, 2023. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.6 million in non-cash stock-based compensation expense; (ii) a decrease of $0.4 million in personnel costs due to headcount reductions; (iii) a decrease of $0.3 million in severance expense related to a former executive; and (iv) a decrease of $0.4 million in insurance costs; partially offset by (v) an increase of $1.2 million in professional fees, primarily related to increased legal fees and costs associated with the July 2024 private placements. For the year ended December 31, 2024, the Company reported a net loss of $1.8 million, compared to a net loss of $20.3 million for the year ended December 31, 2023. Net loss for the year ended December 31, 2024 includes a $14.4 million non-cash gain on debt extinguishment, a $10.5 million non-cash net gain related to the change in fair value of common stock warrant liability, and a non-cash loss on impairment of goodwill of $1.1 million. Net loss for the year ended December 31, 2023 includes a non-cash loss on impairment of goodwill of $3.1 million. The Company reported a net loss attributable to common stockholders of $5.5 million ($104.35 per basic share) for the year ended December 31, 2024, which includes a deemed dividend of $3.6 million on the Series C Preferred Stock. Net loss attributable to common stockholders was $20.3 million ($4,718.74 per basic share) for the year ended December 31, 2023. As of December 31, 2024, the Company reported cash and cash equivalents of $1.8 million. Subsequent to December 31, 2024, the Company (i) sold an additional 0.2 million shares of common stock under its equity line of credit purchase agreement for net proceeds of $1.5 million following mandatory redemption payments on our Series C preferred stock; (ii) received net proceeds of $0.3 million related to warrant exercises; and (iii) issued certain debt notes for aggregate net proceeds $0.5 million. As a result, the Company believes that it has sufficient resources available to fund its business operations through April 2025. Readers are referred to, and encouraged to read in its entirety, the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which will be filed with the Securities and Exchange Commission on April 15, 2025 and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations. About Windtree Therapeutics Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II 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 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: 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; 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 economic and social consequences of the COVID-19 pandemic and 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 Israel and Gaza, 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 Curtisecurtis@windtreetx.com WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIESConsolidated Balance Sheets (in thousands, except share and per share data) December 31,2024 December 31,2023 ASSETS Current assets: Cash and cash equivalents $1,779 $4,319 Prepaid expenses and other current assets 795 1,060 Total current assets 2,574 5,379 Property and equipment, net 111 183 Restricted cash 9 150 Operating lease right-of-use assets 1,051 1,444 Intangible assets 24,130 25,250 Total assets $27,875 $32,406 LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $1,879 $809 Accrued expenses 1,706 1,618 Operating lease liabilities - current portion 508 436 ELOC commitment note payable 328 - Derivative liability - ELOC commitment note 299 - Common stock warrant liability 305 - Loans payable - current portion 333 233 Other current liabilities 359 900 Total current liabilities 5,717 3,996 Operating lease liabilities - non-current portion 653 1,161 Restructured debt liability - contingent milestone payments - 15,000 Other liabilities 3,800 3,800 Deferred tax liabilities 4,528 5,058 Total liabilities 14,698 29,015 Mezzanine equity: Series C redeemable preferred stock, $0.001 par value; 18,820 and 0 shares authorized; 11,757 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively 3,181 - Series B redeemable preferred stock, $0.001 par value; 5,500 and 0 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Total mezzanine equity 3,181 - Stockholders’ equity: Preferred stock, $0.001 par value; 4,975,680 and 5,000,000 shares authorized; 0 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Common stock, $0.001 par value; 120,000,000 shares authorized; 256,397 and 6,664 shares issued and outstanding at December 31, 2024 and 2023, respectively - - Additional paid-in capital 859,660 851,268 Accumulated deficit (846,610) (844,823)Treasury stock (at cost); 1 share (3,054) (3,054)Total stockholders’ equity 9,996 3,391 Total liabilities, mezzanine equity & stockholders’ equity $27,875 $32,406 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except share and per share data) Year Ended December 31, 2024 2023 Expenses: Research and development $16,276 $8,341 General and administrative 8,743 9,198 Impairment of goodwill - 3,058 Impairment of intangible assets 1,120 - Total operating expenses 26,139 20,597 Operating loss (26,139) (20,597) Other (expense) income: Gain on debt extinguishment 14,437 - Change in fair value of common stock warrant liability 10,482 - Interest income 70 325 Interest expense (235) (50)Other (expense) income, net (408) 31 Total other income, net 24,346 306 Loss before income taxes (1,793) (20,291)Deferred income tax benefit 6 - Net loss $(1,787) $(20,291)Exchange of Series B preferred stock (79) - Deemed dividend on Series C preferred stock (3,621) - Net loss attributable to common stockholders $(5,487) $(20,291) Net loss per share attributable to common stockholders Basic and diluted $(104.35) $(4,718.84) Weighted average number of common shares outstanding Basic and diluted 52,583 4,300

Phase 2Clinical ResultExecutive ChangeFinancial StatementLicense out/in

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-	Istaroxime	-	DB06157

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Shock	Phase 2	United States	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Argentina	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Italy	Windtree Therapeutics, Inc.	28 Sep 2020
Shock	Phase 2	Poland	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	United States	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Argentina	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Italy	Windtree Therapeutics, Inc.	28 Sep 2020
Shock, Cardiogenic	Phase 2	Poland	Windtree Therapeutics, Inc.	28 Sep 2020
Acute decompensated heart failure	Phase 2	-	Debiopharm International SA	01 Jun 2009
Heart Failure	Phase 2	-	-	01 Aug 2006

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04325035 (SEISMiC, GlobeNewswire) Manual	Phase 2	Heart Failure	30	Istaroxime	axghjmwpyc(bmjindxfyy) = sedpvhnttg ldcpyvopil (qdigarczyu ) View more	Positive	30 Sep 2024
				Placebo	axghjmwpyc(bmjindxfyy) = naprdjtadw ldcpyvopil (qdigarczyu ) View more
Pubmed \| J Card Fail	Not Applicable	Shock, Cardiogenic	-	Istaroxime 1.0 µg/kg/min	hsjlmsaaeu(ofhtywsczn) = 5 serious adverse events in Ista-1.5 (4 of which were cardiac) but only 1 in Ista-1 ufejqteqgo (jcxjpmmbfe ) View more	Positive	01 Jul 2023
				Istaroxime 1.5 µg/kg/min
NCT02617446 (CTgov)	Phase 2	Acute decompensated heart failure	120	Istaroxime (Istaroxime 0.5 µg/kg/Min)	ireccopuzh(twxiynjjsy) = vuifpsjbib oqbrmuhuxs (hdufyzlzpn, unpoqilash - oufdiomyci) View more	-	24 May 2023
				Istaroxime (Istaroxime 1.0 µg/kg/Min)	ireccopuzh(twxiynjjsy) = nipourdtln oqbrmuhuxs (hdufyzlzpn, tlqgjaetlk - aalnpggwac) View more
NCT02772068 (Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a, Pubmed \| JACC Heart Fail)	Early Phase 1	Heart failure with normal ejection fraction	26	Istaroxime 0.5 mg/kg/min	kvmtiueiqn(kopgdeqtrj) = beyboxtdhr vzjlawhjpr (lystbbewaw ) View more	-	15 Mar 2023
				Placebo	kvmtiueiqn(kopgdeqtrj) = xzvwzcaatz vzjlawhjpr (lystbbewaw ) View more
NCT04325035 (SEISMiC, Pubmed) Manual	Phase 2	Heart Failure \| Shock	60	istaroxime	ngzosovucr(gfviclgasd) = bauewurmmg pfrzzgtfcw (lgfipdfbgw, 6.88) View more	Positive	22 Jul 2022
				Placebo	ngzosovucr(gfviclgasd) = uetlpvgqdr pfrzzgtfcw (lgfipdfbgw, 6.76) View more
NCT04325035 (SEISMiC, Biospace) Manual	Phase 2	Heart Failure \| Shock, Cardiogenic	60	Istaroxime	sztnjxtynm(uqwogyqota): P-Value = 0.017 View more	Positive	23 May 2022
				Placebo
NCT00616161 (HORIZON-HF, Pubmed \| J Am Coll Cardiol)	Phase 2	Heart Failure	120	Istaroxime	admpiwvhdy(jbgdcmxmeg) = avopjfktmi kqxfjzlpjf (atmmrwvvdo )	-	10 Jun 2008

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