Exhibit 99.1

  

 

Windtree Therapeutics Reports Second Quarter 2020 Financial Results
and Provides Key Business Updates

 

WARRINGTON, PA – August 13, 2020Windtree Therapeutics, Inc. (NASDAQ: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today reported financial results for the second quarter ended June 30, 2020 and provided key business updates.

 

Key Business and Financial Updates

 

Completed an underwritten public offering of 3,172,413 units, offered at a price of $7.25 per unit, which included the full exercise of the underwriters’ over-allotment option. Each unit issued in the offering consisted of one share of common stock and one warrant to purchase one share of common stock at an exercise price of $7.975 per share. The gross proceeds to Windtree from this offering, including the over-allotment, were approximately $23 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In connection with the offering, Windtree’s common stock began trading on The Nasdaq Capital Market and began trading under the symbol “WINT” on May 20, 2020.

 

 

Presented a new subset analysis from a phase 2b study of istaroxime in patients hospitalized with acute heart failure at the American College of Cardiology 2020 virtual meeting. The new post-hoc analysis characterized the responses between Caucasian and Asian patients and showed the istaroxime dose of 0.5 µg/kg/min produced a similar response on E/e’, the primary study endpoint, and stroke volume index, an important measure of cardiac performance. The Company previously presented overall results of the study, where the primary endpoint demonstrated a significant improvement (p<0.05) in cardiac function at both istaroxime study doses.

 

 

Announced first patient enrolled in its AEROSURF Phase 2b Bridging Study in premature infants with respiratory distress syndrome (RDS). The Company also announced that all initial European trial sites are active and enrolling or able to enroll patients into its AEROSURF® Phase 2b bridging study in premature infants with respiratory distress syndrome (RDS). In addition, the Company announced that select patients in this study may be co-enrolled in an investigator-sponsored study, being run in parallel to the bridging study. The concomitant study will evaluate changes in cerebral electroencephalography (EEG) and cerebral oxygenation during surfactant administration. The bridging study is a multicenter, randomized, controlled study with masked treatment assignment in up to 90 premature infants 26 to 32 weeks gestational age receiving nasal continuous positive airway pressure for RDS. If successful, the bridging study is intended to complete the Phase 2 clinical program for AEROSURF and prepare the transition of clinical development to a Phase 3 program.

 

 

Announced the hiring of John Hamill as chief financial officer. Also, enhanced the team responsible for clinical execution with other new hires, including Dr. Pratap Paruchuru as executive director of clinical development, Catherine Kacprzycki as director of clinical operations and Tracy Rarick as head of operations and program management.

 

 

Hosted a business update call in June, highlighting the Company’s clinical programs in acute cardiovascular and pulmonary diseases.

 

“Windtree made considerable progress this quarter on both the business and clinical development fronts,” said Craig Fraser, president, and chief executive officer of Windtree. “We successfully completed a public offering and concurrently up-listed to The Nasdaq Capital Market, which provides us with the funding to support advancement of our lead clinical programs, and, we believe increases our market visibility as we move toward planned milestones with our multiple clinical and business development activities. We are focused on execution and look forward to an exciting second half of 2020 that we anticipate will include initiating the Phase 2b study in early cardiogenic shock in the third quarter, progressing toward a planned initial trial of our proprietary KL4 surfactant to impact key respiratory parameters in ventilated COVID-19 patients, and other development activity in line with our strategy.”

 

 

The following information was filed by Windtree Therapeutics Inc (WINT) on Friday, August 14, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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