Windtree Therapeutics Inc Stock Price, News & Analysis

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.

Windtree Therapeutics (NasdaqCM: WINT) announced the strategic expansion of its clinical development team, appointing Dr. Pratap Paruchuru as executive director, Catherine Kacprzycki as director of clinical operations, and Tracy Rarick as head of operations. These hires aim to strengthen efforts in developing interventions for acute cardiovascular and pulmonary disorders, focusing on the istaroxime program. Dr. Paruchuru brings extensive experience from Novartis and GSK, while Kacprzycki and Rarick add valuable leadership from top firms. The company is fostering growth amid increasing clinical trials.

Windtree Therapeutics (NasdaqCM: WINT) appointed John Hamill as Senior Vice President and Chief Financial Officer, effective July 20, 2020. Mr. Hamill brings over 30 years of financial leadership experience in the pharmaceutical and biopharmaceutical sectors. He has a strong track record in financial operations and has successfully led IPOs and capital raises. The Board granted him a stock option for 211,000 shares, vesting over three years. Hamill replaces former CFO John Tattory, who is leaving for other opportunities. This leadership change aims to drive business initiatives and enhance shareholder value.

Windtree Therapeutics (NasdaqCM: WINT) announced the activation of all initial European trial sites for its AEROSURF Phase 2b bridging study for premature infants with respiratory distress syndrome (RDS). This milestone enables patient enrollment and may lead to expanded site locations in the EU and U.S. The study aims to validate AEROSURF technology by evaluating its non-invasive surfactant delivery system against standard care. The study also includes a parallel investigation into cerebral physiology, potentially highlighting additional benefits of non-invasive treatment.