Windtree Therapeutics Inc Stock Price, News & Analysis

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.

Windtree Therapeutics (NASDAQ: WINT) reported its Q2 2024 financial results and provided key business updates. The company expects to complete enrollment and report topline data for its Phase 2 SEISMiC Extension Study by Q3 2024 end. Windtree has begun enrollment in the Phase 2 SCAI Stage C cardiogenic shock study. In July 2024, the company closed two financial transactions for aggregate gross proceeds of $13.9 million. Windtree also entered a Common Stock Purchase Agreement with an equity line investor for up to $35 million. The company reported an operating loss of $11.5 million for Q2 2024, compared to $6.8 million in Q2 2023. As of June 30, 2024, Windtree had cash and cash equivalents of $1.8 million and current liabilities of $8.8 million, raising substantial doubt about its ability to continue as a going concern.

Windtree Therapeutics (NASDAQ: WINT) has announced significant changes to its board of directors, effective August 13, 2024. The company has appointed Saundra Pelletier and Jed Latkin as new independent directors, bringing extensive experience in public company leadership and the biotech industry. Pelletier, currently serving as Interim Chair and CEO of Evofem Biosciences, offers over 25 years of executive leadership experience. Latkin brings nearly three decades of financial and biotech expertise, including roles at ProPhase Labs and Navidea Biopharmaceuticals.

These appointments coincide with the resignations of Daniel Geffken and Leslie Williams from the board. Additionally, Mark Strobeck has been named Lead Independent Director. The company views these changes as strategic, particularly with upcoming Phase 2b clinical trial results and potential Phase 3 entry for its cardiovascular asset, istaroxime.