Windtree Therapeutics, Inc. - WINT STOCK NEWS

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.

Windtree Therapeutics (NasdaqCM: WINT), a biotechnology company focusing on innovative therapies for critical conditions, has announced its participation in the ThinkEquity Conference on October 30th. Craig Fraser, Chairman and CEO, will present a corporate update at 12:30pm ET and participate in one-on-one meetings with investors.

The presentation will cover:

• Recent positive topline data results from the Phase 2b SEISMiC Extension Study
• Updates on the company's lead drug candidate, istaroxime, for heart failure associated early cardiogenic shock
• Company strategy and planned milestones

This event provides an opportunity for Windtree to showcase its progress in developing therapies for critical conditions and diseases to potential investors and industry professionals.

Windtree Therapeutics (NasdaqCM: WINT) has announced the issuance of a new patent for istaroxime in Japan. The patent, titled 'Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF),' covers intravenous administration of istaroxime with increased infusion times, alone or combined with other AHF treatments. This method aims to improve heart failure treatment and diastolic relaxation compared to conventional protocols.

The patent (No. 7560134) was registered on September 24, 2024, and will expire in 2039. Istaroxime, Windtree's novel first-in-class investigational therapy, has shown positive results in four Phase 2 trials for acute heart failure and early cardiogenic shock. The company views this patent issuance as an important step in expanding and strengthening its cardiovascular platform patent estate in key markets.

Windtree Therapeutics (NASDAQ: WINT) announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in heart failure patients with early cardiogenic shock. The study met its primary endpoint, significantly improving systolic blood pressure over six hours compared to placebo. Key findings include:

- Improved cardiac output by ~15% in the istaroxime group
- Reduced pulmonary capillary wedge pressure
- Enhanced mixed venous oxygen saturation
- Improved renal function
- Decreased NYHA heart failure classification severity
- Reduced incidence of worsening heart failure as a serious adverse event

The safety profile was generally consistent with previous istaroxime trials, with no increase in clinically significant arrhythmias compared to placebo. These results support istaroxime's potential as a novel therapy for early cardiogenic shock and acute heart failure.

Windtree Therapeutics (NasdaqCM: WINT) has announced a virtual Investor Day Presentation scheduled for October 1 at 3pm ET. The event will showcase new positive topline results from the Phase 2b SEISMiC Extension Study of istaroxime in early cardiogenic shock. Windtree will discuss the istaroxime cardiogenic shock opportunity, company strategy, and planned near-term milestones.

Joining the management team will be Dr. Alexandre Mebazaa, a global expert in cardiogenic shock and heart failure. The presentation will be followed by a Q&A session. Istaroxime, Windtree's novel first-in-class therapy, is designed to improve heart function and blood pressure while maintaining or improving renal function. It has shown positive results in four Phase 2 trials for acute heart failure and early cardiogenic shock.

Windtree Therapeutics (NasdaqCM: WINT) announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in early cardiogenic shock. The study met its primary endpoint, significantly improving systolic blood pressure over six hours compared to placebo. Significant benefits were also observed in many secondary endpoints.

The study evaluated two different dose regimens of istaroxime against placebo, with infusions lasting up to 60 hours. It focused on improving low blood pressure and heart function in SCAI Stage B cardiogenic shock patients. The safety profile was favorable and consistent with previous clinical trials.

Detailed results will be presented at the Heart Failure Society of America Meeting on September 30, 2024. Windtree plans to issue a press release with more detailed results and conduct an investor call following the presentation.

Windtree Therapeutics (NASDAQ: WINT) has completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime for early cardiogenic shock caused by heart failure. The study aims to extend positive results from a previous Phase 2 trial, evaluating istaroxime's ability to improve heart function and blood pressure. The trial includes longer dosing duration and dose tapering, with topline data expected in late September 2024.

Istaroxime is a novel first-in-class therapy that has shown promise in three Phase 2 trials for acute heart failure. The global cardiogenic shock market is estimated at $1.25 billion annually. The study, conducted in the U.S., Europe, and Latin America, focuses on dose optimization and further characterization of istaroxime's SERCA2a mechanism in early cardiogenic shock patients.