Windtree Therapeutics, Inc. - WINT STOCK NEWS

Windtree Therapeutics, Inc. (WINT) announced the issuance of U.S. Patent No. 10,874,818 for its aerosol delivery system (ADS) related to the AEROSURF device. This patent, effective until 2039, enhances their IP portfolio in aerosolized pulmonary surfactants. The redesigned ADS features improved ergonomics and reduced treatment interruptions, potentially improving clinical outcomes for patients with respiratory distress syndrome. CEO Craig Fraser expressed confidence in the company's ongoing efforts to strengthen its intellectual property across its product lines, including istaroxime for acute heart failure.

Windtree Therapeutics (NasdaqCM: WINT) announced the appointment of Dr. Evan Loh, Ms. Leslie Williams, and Dr. Rob Scott to its Board of Directors, following a board composition analysis to meet the company’s evolving needs. The new members bring extensive experience in drug development and commercialization. Former directors John Leone, Joseph Mahady, and Brian Schreiber will retire, leaving a seven-member board. CEO Craig Fraser expressed optimism about the new appointments aligning with Windtree’s late-stage trials for istaroxime and lucinactant, enhancing strategic growth.

Windtree Therapeutics, a biotechnology company focused on acute cardiovascular and pulmonary disorders, has appointed Dr. Joseph Soffer as Executive Director of Clinical Development. This appointment aims to bolster efforts in the istaroxime program, targeting acute heart failure. Dr. Soffer brings over 30 years of experience, previously serving as a Senior Medical Director at GlaxoSmithKline. In connection with his role, he has been granted a stock option to purchase 100,000 shares at a closing price determined on January 29, 2021.

Windtree Therapeutics, Inc. (NasdaqCM: WINT) has initiated its Phase 2 clinical trial, dosing the first patient with lucinactant for adult acute lung injury related to COVID-19 and ARDS. This synthetic KL4 surfactant aims to improve respiratory function and reduce mechanical ventilation time. The trial will enroll up to 20 patients at multiple U.S. sites, evaluating physiological changes and tolerability. With rising COVID-19 cases and a lack of approved ARDS therapies, the study is critical for developing effective treatments for severe respiratory conditions.

Windtree Therapeutics (WINT) reported a net loss of $9.0 million for Q3 2020, with an operating loss of $8.7 million. Research and development expenses rose slightly to $3.9 million, while general and administrative expenses increased to $4.8 million, partly due to severance costs. The company announced the dosing of the first patient in a Phase 2 clinical trial of istaroxime for cardiogenic shock and received FDA acceptance for a Phase 2 trial of KL4 surfactant in COVID-19 patients. Cash and cash equivalents stand at $22.4 million, sufficient for operations through at least the next 12 months.

Windtree Therapeutics (NasdaqCM: WINT) has initiated its Phase 2 study of istaroxime for treating early cardiogenic shock, having dosed the first patient. This dual-action therapy aims to enhance heart function and blood pressure in critically ill patients. The study, involving 60 patients, will evaluate blood pressure changes and overall safety. Positive previous results in acute heart failure and regulatory precedents could accelerate istaroxime's development. The CEO highlighted the therapy's potential to address unmet needs in cardiogenic shock.

Windtree Therapeutics has announced that the FDA accepted its IND application for a Phase 2 clinical trial of KL4 surfactant. This study will focus on treating COVID-19 associated lung injury and ARDS in patients requiring mechanical ventilation. The trial will assess dosing, tolerability, and changes in gas exchange. It will involve up to 20 patients from multiple U.S. sites. If successful, further studies may evaluate clinical outcomes and explore aerosol delivery methods. This follows the company's established expertise in acute respiratory conditions.

Windtree Therapeutics (NasdaqCM: WINT) announced that CEO Craig Frasier will present at the H.C. Wainwright 22nd Annual Global Investment Conference, scheduled for September 14-16, 2020. The presentation is set for September 14 at 5:00 p.m. EDT. Interested parties can access a live audio webcast on the company's website, with a replay available for 30 days. Windtree focuses on developing treatments for acute cardiovascular and pulmonary disorders, including istaroxime for heart failure and AEROSURF® for respiratory distress in infants.

Windtree Therapeutics (NASDAQ: WINT) announced Q2 2020 results, reporting a net loss of $9.6 million, or $0.63 per share, compared to a loss of $6.4 million in Q2 2019. The company completed a public offering generating approximately $23 million, enhancing its capital to support clinical programs. Key developments include the enrollment of the first patient in the AEROSURF Phase 2b study for respiratory distress syndrome and a new subset analysis of istaroxime presented at a major cardiology conference. Cash reserves stand at $31.5 million, expected to last for at least a year.