Windtree Therapeutics Inc Stock Price, News & Analysis

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.

Windtree Therapeutics (NASDAQ: WINT) has completed national phase patent filings for its istaroxime formulation across major global markets, including the United States, Germany, France, Italy, Japan, and China. The patent, numbered PCT/US2023/018998 and application No. 18/858,086, is titled 'ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF PRE-CARDIOGEN1C SHOCK AND CARDIOGENIC SHOCK'. This strategic move aims to strengthen the company's intellectual property position for istaroxime in treating cardiogenic shock patients.