Windtree Therapeutics Reports First Quarter 2017 Financial Results And Provides Key Business Updates

WARRINGTON, Pa., May 15, 2017 /PRNewswire/ -- Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today reported financial results for the first quarter ended March 31, 2017 and provided key business updates.

Windtree Therapeutics, Inc. - Striving to deliver hope for a lifetime

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 according to previous guidance and the Company expects to announce top-line results from this study in July 2017.
  • The Company previously reported the successful completion of the second and final planned AEROSURF 2b clinical trial interim safety review; the independent Data Safety Monitoring Board (DSMB) recommended continuing the trial without modification.
  • 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 and the Company now expects to complete enrollment and announce top-line results by July 2017.
  • In February 2017, the Company completed a private placement offering of convertible preferred stock units which generated 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.
  • As of March 31, 2017, the Company had cash and cash equivalents of $8.0 million and the Company anticipates that 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 top-line results.
  • Effective May 5, 2017, the Company’s common stock shares began trading on the OTCQB® Market (OTCQB) under the symbol “WINT.”

“The first quarter of 2017 was marked with significant progress for Windtree. As a result of expanding our phase 2b clinical program across 50 sites globally, we experienced an increasing rate of patient screening and enrollment. This achievement, along with clearing the final interim safety review, has us well positioned to deliver top-line data in July 2017,” commented Craig Fraser, President and Chief Executive Officer. “The first quarter also saw Windtree successfully complete a private placement in February to fund our operations through announcement of top line phase 2b data in July 2017. We are looking forward to completing the phase 2b enrollment and sharing the top-line results with the medical and investor communities in approximately two months.”

Select Financial Results for the First Quarter ended March 31, 2017

For the quarter ended March 31, 2017, the Company reported an operating loss of $8.1 million, compared to $13.9 million for the first quarter of 2016.

Grant revenue for the first quarter of 2017 was $0.2 million compared to $0.1 million for the first quarter of 2016. Grant revenue for 2017 and 2016 primarily represents funds received and expended under Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH) to study the Company’s aerosolized KL4 surfactant as (i) a medical countermeasure to mitigate acute and chronic/late-phase radiation-induced lung injury; and, (ii) to provide support for the AEROSURF phase 2b clinical trial in premature infants 28 to 32 week gestational age with RDS.

Research and development expenses were $6.4 million for the first quarter of 2017, compared to $10.4 million for the first quarter of 2016. The decrease was due to (i) reductions in AEROSURF phase 2 clinical development program costs including decreases in clinical trial site start-up costs and production of aerosol delivery systems; and (ii) cost reduction measures initiated in the second quarter of 2016.

General and administrative expenses for the first quarter of 2017 were $1.9 million, compared to $3.7 million for the first quarter of 2016. The decrease was primarily due to (i) cost reduction measures initiated in the second quarter of 2016; and (ii) a $1.2 million severance charge during the first quarter of 2016 associated with the termination of our former CEO.

Interest expense for the first quarter of 2017 and 2016 was $0.6 million.

The Company reported a net loss of $8.7 million for the quarter ended March 31, 2017, compared to a net loss of $13.9 million for the comparable period in 2016.

In addition, in the first quarter of 2017, the Company reported a $3.6 million one-time, non-cash deemed dividend on preferred stock, resulting in a net loss attributable to common shareholders of $12.3 million ($1.37 per basic share) on 9.0 million weighted-average common shares outstanding for the quarter ended March 31, 2017, compared to a net loss of $13.9 million ($1.70 per basic share) on 8.2 million weighted average common shares outstanding for the comparable period in 2016.

As of March 31, 2017, the Company had cash and cash equivalents of $8.0 million. Net operating cash outflows before financing activities for the first quarter of 2017 were $7.4 million. In February 2017, the Company completed a private placement offering of 7,049 Series A Convertible Preferred Stock units at a purchase price per unit of $1,495 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. Each unit consists of one share of Series A Convertible Preferred Stock, which is convertible into 1,000 shares of the Company’s common stock at a conversion price of $1.37 per share, and 1,000 Series A-1 seven-year warrants to purchase one share of the Company’s common stock at an exercise price of $1.37. In addition, for the first quarter, we completed registered offerings under our at-the-market equity sales program resulting in net proceeds to us of $1.0 million.

Based on current projections and development timelines, the Company anticipates that it has sufficient cash to support its operations through the planned completion of the AEROSURF phase 2b clinical trial and the release of top line results, which is expected in July 2017.

In addition, as of March 31, 2017, the Company reported current liabilities of $24.8 million (including $12.5 million of long-term debt, current portion) and long-term debt of $12.5 million. The current portion of long-term debt is due in February 2018, and may be deferred one year if certain conditions are satisfied. The non-current portion of long-term debt is due in February 2019.

Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 which includes discussion about the Company’s business plans and operations, financial condition and results of operations.

About AEROSURF®
Windtree’s lead product candidate is AEROSURF®, a novel, investigational drug/device combination product that combines the Company’s proprietary KL4 surfactant and aerosolization technologies. AEROSURF is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS). Enrollment is ongoing in a phase 2b clinical trial in up to 240 premature infants 28 to 32-week gestational age receiving nasal continuous positive airway pressure (nCPAP) for RDS, comparing AEROSURF to infants receiving nCPAP alone. The phase 2b trial is a global trial with clinical sites in North America, Europe and Latin America.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel surfactant therapies for respiratory diseases and other potential applications. Windtree’s proprietary technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant and novel drug-delivery technologies being developed to enable noninvasive administration of aerosolized KL4 surfactant. Windtree is focused initially on improving the management of respiratory distress syndrome (RDS) in premature infants and believes that its proprietary technology may make it possible, over time, to develop a pipeline of KL4 surfactant product candidates to address a variety of respiratory diseases for which there are few or no approved therapies.

For more information, please visit the Company’s website at www.windtreetx.com.

To read full press release, please click here.

MORE ON THIS TOPIC