Windtree Therapeutics Inc (WINT)

[Purchaser]

The waiting game (Release Nov. 12):

In October 2015, we announced that we have completed enrollment in an AEROSURF phase 2a clinical expansion study in 32 premature infants 29 to 34 week gestational age who are receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in higher (60 and 90 minutes) doses compared to nCPAP alone. We expect to release top line results of this study in mid-November. We also have begun enrollment for a phase 2a clinical study in 32 premature infants 26 to 28 week gestational age receiving nCPAP for RDS, primarily to evaluate safety and tolerability of aerosolized KL4 surfactant administered in two escalating (30 and 45 minutes) doses, with potential repeat doses, compared to nCPAP alone. We anticipate releasing top-line results of this study in the first quarter of 2016. As with the initial phase 2a study, in both follow-on studies we are assessing performance of the CAG in the NICU and available physiological data for indications that aerosolized KL4 surfactant is being delivered to the lungs.

For those of you not familiar with the general activity of DSCO here is from the 10-Q released Nov. 5th:

With the knowledge that we gain from developing AEROSURF for the treatment of RDS in premature infants, we believe that we may be able to develop our proprietary aerosolized KL4 surfactant and drug delivery technologies potentially to address serious critical care respiratory conditions affecting pediatric and adult patient populations.

While we remain focused on RDS, we have explored, primarily in collaborations with research organizations and universities to assess potential application of our KL4 surfactant in studies funded in part through various U.S. Government-sponsored programs, including grants in support of our AEROSURF clinical program and biodefense-related initiatives that encourage private sector development of medical countermeasures against chemical, biological, radiological, nuclear terrorism threat agents and pandemic influenza, and provide a mechanism for federal acquisition of such countermeasures.

We expect that we may have opportunities in the future to participate in similar programs. If funding is available, we would likely seek to explore potential opportunities to address such respiratory conditions as acute lung injury (ALI), including acute radiation exposure to the lung (acute pneumonitis and delayed lung injury), chemical-induced ALI, and influenza-induced ALI, where there are no currently approved therapies other than supportive respiratory care.

In addition, if funding is available, we would consider opportunities to apply KL4 surfactant therapies to treat conditions such as chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, and diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis. We believe that our proprietary aerosolized KL4 surfactant and drug delivery technologies potentially could support a pipeline of KL4 surfactant products that could address significant unmet medical needs and represent significant market opportunities