Windtree Therapeutics Inc Stock Price, News & Analysis

Windtree Therapeutics (NASDAQ:WINT) has achieved its target enrollment of 20 patients for the interim analysis of its Phase 2 SEISMiC C study, evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study represents the third trial in the company's istaroxime cardiogenic shock development program, following two previously successful Phase 2 studies in SCAI Stage B patients.

The SEISMiC C trial is a global, placebo-controlled, double-blinded study conducted across the U.S., Europe, and Latin America. The study evaluates istaroxime in combination with standard care treatments, including inotropes and vasopressors. The primary endpoint focuses on systolic blood pressure profile during the first six hours of treatment.

The interim analysis will primarily assess preliminary safety, tolerability, and efficacy signals to determine appropriate sizing for the remainder of the trial. The company notes that a statistically significant efficacy signal is not expected at this interim stage. The data from this study will be crucial for Phase 3 readiness and upcoming FDA discussions.

Windtree Therapeutics (NASDAQ:WINT) has secured a contract with a Chinese pharmaceutical manufacturer to produce PHEXXI, Evofem's hormone-free contraceptive gel, at significantly reduced costs. The manufacturing agreement is expected to cut PHEXXI production costs by over 50% by the end of 2026.

The technology transfer process has begun, with early-stage manufacturing scheduled to start later in 2025. This arrangement, stemming from Windtree's March 2025 License and Supply Agreement with Evofem, is anticipated to generate revenue for Windtree starting in 2026. PHEXXI has shown four consecutive years of net sales growth, with plans for international expansion beginning with a marketing approval submission in the UAE.

Windtree Therapeutics (WINT) announced the publication of positive Phase 2 SEISMiC B study results for istaroxime in the Journal of Heart and Lung Transplantation. The study demonstrated significant efficacy in treating early cardiogenic shock, with istaroxime increasing blood pressure over 6 hours and maintaining effects for 60 hours. Key benefits included improved cardiac output, decreased pulmonary capillary wedge pressure, no increase in heart rate, no significant arrhythmias, and preserved renal function. The company is in partnership discussions to fund remaining clinical development, targeting the $1.25 billion cardiogenic shock market. Windtree plans to release interim data from the SEISMiC C trial in July and is finalizing Phase 3 protocol design for acute heart failure indication in China with a regional partner.

Windtree Therapeutics (WINT) has received a non-binding letter of intent to sell its preclinical oncology aPKCi inhibitor platform. The deal includes a $7.0 million upfront payment in cash or freely tradable stock, potential milestone payments up to $130 million, and high single-digit royalties that could reach $1.5 billion over the drug's lifetime. The agreement also includes options to acquire Windtree's cardiovascular drug candidates and its manufacturing agreement with Evofem Biosciences. The company has 21 days to close the oncology portion of the transaction. This move aligns with Windtree's new corporate strategy to focus on revenue-generating opportunities while reducing cash burn.

Windtree Therapeutics (WINT) has announced a transformative acquisition of Titan Environmental Services, marking its entry into the $85 billion US waste management market. The deal involves issuing preferred shares and securing debt financing, with Titan becoming a subsidiary renamed as Windtree Environmental Services. The acquisition is expected to generate $12 million in revenue over the next 12 months and includes an $8 million breakup fee protection. The company plans to retain Titan's management team and pursue a roll-up strategy in the fragmented waste management industry. This move represents a strategic shift for Windtree, which is actively seeking to divest or partner its pharmaceutical assets to reduce costs and increase profitability. The transaction is anticipated to close in Q3 2025.

Aditxt (ADTX) has appointed Evofem Biosciences CEO Saundra Pelletier to its Board of Directors. Pelletier brings over three decades of pharmaceutical industry experience, specializing in women's health. During her 10-year leadership at Evofem, she successfully led the company's public market transition and oversaw the approval of PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an antibiotic for bacterial infections. Her appointment aligns with Aditxt's strategy to expand into women's health monitoring, prevention, and treatment. Pelletier's extensive background includes roles at Woman Care Global and G.D. Searle, and she currently serves on multiple boards including Windtree Therapeutics.

Windtree Therapeutics (WINT) announced its Board of Directors has approved the development of a cryptocurrency policy that will enable the company to accept cryptocurrency payments and hold them as strategic assets. The biotechnology company, which is transitioning to become revenue-generating, is in discussions with several Bitcoin-focused groups regarding payment options and treasury strategy. CEO Jed Latkin indicated that the policy development is aligned with digital commerce trends and will be completed in the near term. The initiative is part of Windtree's broader corporate strategy to generate revenue while maintaining its focus on innovative therapies for critical conditions.

Windtree Therapeutics (WINT) has announced that interim analysis results for its istaroxime SEISMiC SCAI Stage C Phase 2 study in cardiogenic shock are targeted for July 2025. The global trial, conducted across the U.S., Europe, and Latin America, is evaluating istaroxime as an addition to standard care treatments. The study is placebo-controlled and double-blinded, with the primary endpoint focusing on systolic blood pressure profile during the first six hours of treatment. The trial will assess various metrics including cardiac function, vasopressor-inotrope score, progression prevention to more severe stages, and patient recovery indicators. This study follows two previously completed positive Phase 2 studies in SCAI Stage B cardiogenic shock and represents a crucial step toward advancing to Phase 3 trials.

Windtree Therapeutics (NASDAQ: WINT) announced the presentation of istaroxime data from their SEISMiC Extension Phase 2b study at the European Society of Cardiology Heart Failure 2025 Conference in Belgrade. The presentation, focusing on the safety and efficacy of intravenous istaroxime for pre-cardiogenic shock patients over 60-hour periods, will be delivered by Dr. Jan Biegus from Wroclaw Medical University. Dr. Steve Simonson, Windtree's CMO, highlighted the positive study results as crucial for advancing istaroxime to Phase 3 trials. The company believes istaroxime's unique profile distinguishes it from existing therapies for treating cardiogenic shock, a condition associated with high mortality, morbidity, and healthcare costs.