Exhibit 99.1

 

 

 

Windtree Therapeutics Reports Fourth Quarter 2016 Financial Results and Provides Key Business Updates

 

Company Continues to Advance Phase 2 Program and is On-Track for Mid-Year Phase 2b Results

 

WARRINGTON, PA – March 31, 2017 –

Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today reported financial results for the fourth quarter ended December 31, 2016 and provided key business updates.

 

Key Business and Financial Updates

 

 

Enrollment in the AEROSURF® phase 2b clinical trial in up to 240 premature infants 28 to 32 week gestational age for respiratory distress syndrome (RDS) is progressing and the Company reaffirms its plan to announce top-line results from this study in mid-year 2017.

 

 

Enrollment in the third dose group of the AEROSURF phase 2a clinical trial in 48 premature infants 26 to 28 week gestational age for RDS is progressing. This study is designed to evaluate safety and tolerability of AEROSURF. Due to a lower number of premature infants who are eligible for enrollment in this age range, enrollment has required additional time and the Company now expects to complete enrollment and announce top-line results in mid-second quarter of 2017.

 

 

The Company previously reported positive results from two NIH funded preclinical studies evaluating (i) KL4 surfactant as a possible countermeasure to mitigate acute and chronic/late-phase radiation induced lung injury; and, (ii) as a potential medical intervention to reduce morbidity and mortality associated with both seasonal and pandemic influenza pneumonia.

 

 

As of December 31, 2016, the Company had cash and cash equivalents of $5.6 million. In February 2017, the Company completed a private placement offering of 7,049 Series A Convertible Preferred Stock units for net proceeds of approximately $10.5 million, including $1.6 million of non-cash consideration in the form of a reduction in amounts due for current development services that otherwise would have become payable in cash in the first and second quarters of 2017.

 

 

The Company anticipates that, before any additional financings, its currently existing cash resources are sufficient to fund its operations through the planned completion of the AEROSURF phase 2b clinical trial and announcement of results in mid-year 2017.

 

“The fourth quarter of 2016 was one of meaningful progress for Windtree and our AEROSURF phase 2 program,” commented Craig Fraser, President and Chief Executive Officer. “The expansion of our phase 2b clinical trial to select sites in Europe and Latin America resulted in an increased rate of patient screening and enrollments. We have enrolled patients from all regions and active sites and are on track with previously stated guidance to release top-line data by mid-year 2017. In addition, with the successful completion of the $10.5 million private placement in February, we have met our previously stated goal of securing the additional capital necessary to adequately fund our operations through announcement of top line phase 2b data.”

 

Select Financial Results for the Fourth Quarter ended December 31, 2016

 

For the quarter ended December 31, 2016, the Company reported an operating loss of $6.4 million, compared to $9.8 million for the fourth quarter of 2015.

 

 

The following information was filed by Windtree Therapeutics Inc (WINT) on Friday, March 31, 2017 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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