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Windtree Therapeutics, Inc. (NASDAQ: WINT) is a pioneering biotechnology company specializing in the development of innovative therapies for critical cardiovascular and respiratory conditions. The company's advanced research and proprietary technologies aim to address significant unmet medical needs, offering hope to patients and their families.
At the core of Windtree's portfolio is its KL4 surfactant technology, a synthetic, peptide-containing surfactant structurally similar to human pulmonary surfactant. This technology is being developed for noninvasive administration via aerosolization, with a primary focus on treating Respiratory Distress Syndrome (RDS) in premature infants. The potential of this technology extends to various other respiratory diseases, promising new therapeutic avenues where few or no approved treatments exist.
In the cardiovascular domain, Windtree is advancing istaroxime, a Phase 2 candidate exhibiting unique dual mechanisms that enhance both systolic and diastolic cardiac functions. Istaroxime targets acute heart failure and cardiogenic shock, conditions with high mortality and limited treatment options. Recent collaborations, including a significant license agreement with Lee's Pharmaceutical, aim to develop and commercialize istaroxime in Greater China, reflecting its global potential.
Windtree is also exploring preclinical SERCA2a activators for heart failure, aiming to develop both intravenous and oral formulations to treat acute and chronic heart failure, respectively. Additionally, the company is advancing rostafuroxin, targeting hypertension in patients with specific genetic markers, and a preclinical atypical protein kinase C iota (aPKCi) inhibitor, for potential oncology applications.
Financially, Windtree's strategic licensing and partnerships, such as the recent agreement with Deerfield Management to retire a $15 million liability, have strengthened its balance sheet. The company is strategically positioned to advance its late-stage clinical programs while optimizing its financial resources to support ongoing and future endeavors.
Windtree's commitment to scientific innovation and strategic collaborations is poised to transform treatment paradigms in cardiovascular and respiratory care, with a robust pipeline that holds significant promise for the future.
Windtree Therapeutics (NASDAQ: WINT) has secured a new Japanese patent (No. 7603605) for its oncology pipeline, specifically for inhibitors of atypical protein kinase C (aPKCi) in treating hedgehog pathway-dependent cancers. The patent will expire in 2040.
The company's aPKCi inhibitor platform represents a novel, high-potency drug candidate targeting various cancers, including basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, and small cell lung cancer. The platform features both topical and oral formulations, developed in collaboration with Cancer Research UK and academic research centers. The patent claims also cover combination therapies using hedgehog pathway inhibitors with HDAC inhibitors for enhanced anti-cancer efficacy.
Windtree Therapeutics has announced the appointment of Leanne Kelly to its Board of Directors. Ms. Kelly, who will serve as an independent director and chair of the audit committee, brings over 20 years of public company executive experience. She is currently the Chief Financial Officer at GRI Bio and has previously held significant roles at Vallon Pharmaceuticals, OptiNose, Flower Orthopedics, Iroko Pharmaceuticals, and Genaera Ms. Kelly holds a degree in business economics with a concentration in accounting from Lehigh University and is a licensed CPA (inactive) in Pennsylvania.
Windtree's CEO, Jed Latkin, expressed excitement about Ms. Kelly's addition, highlighting her expertise as a valuable asset to the board. This appointment aligns with Windtree's new corporate strategy aimed at transforming into a revenue-generating biotechnology company. The strategy involves using company equity to acquire small biotech firms with FDA-approved products that have yet to realize their full commercial potential.
Windtree Therapeutics (WINT) has announced a new corporate strategy aimed at becoming a revenue-generating biotech company through all-stock acquisitions of small companies with FDA-approved products. The company plans to operate as a parent company, acquiring strategic subsidiaries while continuing to advance its cardiovascular and oncology development pipeline.
The strategy targets small biotech companies that struggle to maximize their commercialization potential. Windtree's management team, with commercialization expertise across multiple therapeutic areas in both large pharmaceutical and small biotech companies, aims to leverage synergies and optimize commercial performance across future subsidiaries. The number of acquisitions will depend on the valuation and growth potential of target companies.
Windtree Therapeutics (WINT) announced that Dr. Alexandre Mebazaa, a leading expert in cardiogenic shock, presented data from the Phase 2b SEISMiC B study of istaroxime at the Cardiovascular Clinical Trials Conference in Washington, DC. Istaroxime, a first-in-class investigational therapy for early cardiogenic shock due to heart failure, has shown positive results in four Phase 2 trials. The drug demonstrated ability to rapidly increase blood pressure and improve cardiac output without increasing heart rate, while maintaining renal function and showing a favorable safety profile. The company plans to advance istaroxime to Phase 3 trials in cardiogenic shock treatment.
Windtree Therapeutics has filed a new PCT patent application for istaroxime derivatives aimed at preventing or reducing the risk of acute myocardial arrhythmia. The filing builds on data from animal model testing and human clinical trials for acute heart failure (AHF) and early cardiogenic shock (ECS), including a positive Phase 2b study in ECS patients. Istaroxime has demonstrated beneficial effects in rat studies with ischemia-reperfusion induced arrhythmias, showing potential as a therapeutic for improving cardiac function in patients with ischemia. The drug has shown no increase in clinically significant cardiac arrhythmias in Phase 2 trials, potentially due to its SERCA2a activation, differentiating it from current treatments. The company believes these unique aspects justify intellectual property protection.
Windtree Therapeutics (NASDAQ: WINT) has partnered with New Growth Advisors (NGA) to explore strategic opportunities for its cardiovascular portfolio, including potential out-licensing or asset sale. The company aims to capitalize on positive Phase 2 results for istaroxime in cardiogenic shock and acute heart failure.
NGA, which has advised on transactions worth nearly $400 million in 2023-2024, will manage current interest and lead an expanded out-licensing process. Windtree already has a licensing agreement with Lee's Pharmaceuticals for Greater China territory, potentially worth up to $138 million in milestones plus royalties. Lee's plans to initiate Phase 3 trials in acute heart failure in their licensed territory in first half 2025.
Windtree Therapeutics (WINT) reported Q3 2024 financial results and key updates. The company announced positive Phase 2b results for istaroxime in early cardiogenic shock, showing significant improvements in cardiac function and blood pressure. The company completed two private placements for $13.9 million and secured a $35 million equity line agreement. Q3 operating loss was $4.7 million with cash and equivalents of $2.3 million as of September 30, 2024. The company expects current funding to support operations through January 2025.
Windtree Therapeutics (NASDAQ: WINT) announced a leadership transition as CEO Craig Fraser plans to retire effective December 1, 2024, after nearly nine years of service. Fraser will remain as Board Chairman while Jed Latkin, a current director, will assume the CEO position. During Fraser's tenure since 2016, the company achieved several milestones including clinical studies, Nasdaq uplisting, and various transactions. Latkin brings nearly three decades of financial and biotech experience, including previous CEO roles at Navidea Biopharmaceuticals and Black Elk Energy Offshore, with extensive experience in dealmaking and fund raising.
Windtree Therapeutics (WINT) has announced the issuance of an istaroxime patent in Hong Kong, valid until 2039. The patent covers formulations and methods of use for istaroxime in acute heart failure (AHF) treatment. This development supports the company's licensing agreement with Lee's Pharmaceutical, which is planning Phase 3 trials in Greater China. Lee's will fund all regional development, with Windtree maintaining protocol authority. The agreement could yield up to $138 million in milestones plus double-digit royalties for Windtree. Istaroxime, studied in four positive Phase 2 trials, is designed to improve heart function while maintaining renal function.
Windtree Therapeutics (WINT) has initiated enrollment in the SEISMiC C trial for SCAI Stage C cardiogenic shock, following positive results from SEISMiC A and B trials. The study evaluates istaroxime in more severely ill patients who require inotropic or vasopressor drugs. The global, placebo-controlled trial will assess istaroxime's effectiveness when added to standard care, with primary focus on systolic blood pressure profile over 6 hours. A data review is planned for late Q1/early Q2 2025. Previous trials showed istaroxime improved blood pressure, cardiac and renal function without increased arrhythmia risks.