Windtree Therapeutics, Inc. - WINT STOCK NEWS

Windtree Therapeutics (WINT) reported its fourth-quarter and full-year 2021 financial results, highlighting significant progress in clinical trials, particularly the completion of enrollment in the istaroxime phase 2 study for early cardiogenic shock. The company faced a net loss of $13.1 million in Q4 2021, up from $7.5 million in Q4 2020, and a full-year net loss of $67.6 million, compared to $32.6 million a year prior. Cash resources were $22.3 million as of December 31, 2021, expected to last into Q1 2023, supporting ongoing clinical development and patent protections into 2039.

Windtree Therapeutics announced positive results from its Phase 2 study of lucinactant (KL4 surfactant) for treating critically ill patients with severe COVID-19 associated acute respiratory distress syndrome (ARDS). The trial demonstrated that lucinactant was generally safe and well tolerated for intratracheal administration. Key findings included easier administration compared to previous formulations, stable or improved oxygenation in patients, and support for further development of this treatment approach, indicating potential for addressing ARDS from COVID-19 and other causes.

Windtree Therapeutics (NasdaqCM: WINT) has completed enrollment for its phase 2 study of istaroxime targeting early cardiogenic shock due to heart failure. The randomized, double-blind, placebo-controlled trial enrolled 60 patients, with 30 receiving istaroxime. Primary outcomes focus on systolic blood pressure (SBP) over 6 hours, with topline data expected in April 2022. Cardiogenic shock represents a critical need for new treatments, as current options have severe side effects. With a potential market value of $1.25 billion, istaroxime may address a significant gap in therapy.

Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that CEO Craig Fraser will present a corporate overview at the Oppenheimer 32nd Annual Healthcare Conference on March 15 at 1:20 p.m. ET. The presentation aims to highlight Windtree's advancements in treatments for acute cardiovascular and pulmonary disorders, primarily focusing on their lead candidate, istaroxime, for acute heart failure. Investors can view the live webcast and subsequent replay on the company's investor page.

Windtree Therapeutics (WINT) has completed enrollment in its Phase 2 study of lucinactant for COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS). The trial involves 20 patients and aims to assess the safety and tolerability of lucinactant delivered via an endotracheal tube. Results are expected in Q1 2022. Lucinactant, designed to mimic human surfactant, may alleviate surfactant deficiency caused by COVID-19, potentially improving lung function. The company is also developing treatments for acute cardiovascular conditions.

Windtree Therapeutics announced the issuance of U.S. Patent No. 11197869, covering the intravenous delivery of istaroxime for treating acute heart failure, protecting its intellectual property until late 2039. This patent allows for longer infusion durations, enhancing outcomes related to diastolic function. Istaroxime, a dual mechanism therapy, has shown significant improvements in cardiac function and has received FDA Fast Track designation. Windtree plans to expand its intellectual property around istaroxime as it approaches crucial clinical study results in 2022.

Windtree Therapeutics is advancing its study on istaroxime for early cardiogenic shock patients, highlighting the urgent need for new treatments; inpatient mortality rates reached 30% in 2020 for this condition. The company aims to complete its phase 2 study, evaluating istaroxime's effectiveness to improve blood pressure and cardiac function without severe side effects. Results are expected in Q1 2022, aiming for regulatory discussions to expedite development.

Windtree Therapeutics, Inc. (NasdaqCM: WINT) reported its Q3 2021 financial results, highlighting ongoing clinical advancements for istaroxime as a treatment for early cardiogenic shock. The company posted an operating loss of $8.1 million, a slight improvement from $8.7 million in Q3 2020. R&D expenses increased to $4.7 million, reflecting the development of istaroxime. Windtree raised $3.2 million in October 2021, bringing cash reserves to $24.5 million, expected to sustain operations for the next year. Topline data for istaroxime is anticipated in Q1 2022.

Windtree Therapeutics (NasdaqCM: WINT) announced a Notice of Allowance for a new patent by the USPTO, which will protect the istaroxime formulation until late 2039. This patent covers longer infusion durations aimed at improving treatment outcomes for acute heart failure. Following successful Phase 2 studies showing enhanced cardiac function, Windtree plans to initiate a new study in mid-2022 targeting patients with normal to low blood pressure. The ongoing development of istaroxime continues to position Windtree for future clinical advancement.