Expert Financial Analysis and Reporting

Key Points: The phase 2b trial failed, but there was an encouraging signal of activity. The failure was related to clogging of a cartridge used in the medical device used to deliver Aerosurf which affected some patients in the 50 minute dose cohort. In patients unaffected by this problem, results were positive and if they […]

Introduction This report discusses a new licensing deal with Lee’s Pharmaceutical and alerts investors to two upcoming catalysts for the stock. In July, the critical results from the phase 2b trial of Aerosurf will be published. Before then in June, results from the phase 2a trial in babies of the 26 to 28 weeks will […]

Investment Thesis Windtree is facing the ultimate of binary events when it releases topline results in July for its critical phase 2b proof of concept trial of Aerosurf in premature babies with RDS syndrome. It is on track to run out of cash in July if it does not receive some type of cash infusion. […]

Purpose of this Report I last summarized my stock recommendations in a September 12, 2016 report. There has been little change in my thinking or my recommendations since then on most stocks in my universe, but I did issue a Buy on Bristol-Myers Squibb and a sell on Juno Therapeutics. You may want to revisit […]

Overview Windtree held a conference call on October 25 to update investors on the status of the phase 2a trial of Aerosurf and to discuss a trial that investigated the distribution of Aerosurf in the lungs of non-human primates. Management has consistently underestimated the time that it will take to complete the phase 2a trial. […]

Investment Thesis The current market valuation of Windtree is only $16 million. This seems extremely low for a Company that is close to having phase 2b data for its key drug Aerosurf. With success in phase 2b, Aerosurf, which potentially has blockbuster commercial potential, will be ready for a phase 3 trial. This key asset […]

Investment Overview The Stock Market Has Written off Aerosurf The current stock market valuation for Discovery Laboratories of $13 million (8 million shares times $1.60) assigns virtually zero probability for Aerosurf being successfully developed and commercialized. Stocks selling at such a micro-cap market valuation are usually dismissed out of hand by investors as there is […]

Upcoming Key Events There are two very important events in the next year. The first is reporting of results in a phase 2a trial of Aerosurf in younger babies of 26 to 28 weeks gestational age (GA). The key objective is to show safety. Encouraging results from this trial have already been reported for older […]

Introduction This report discusses the results of Discovery Laboratory’s first in human, phase 2a trial of Aerosurf. In writing this report, I am assuming that the reader has an in-depth understanding of Aerosurf and its disease target. If you are new to the Company, I would strongly urge you to read my in-depth article of […]

Key Points Phase 2 trials are enrolling rapidly. Topline results from a trial involving babies of 29 to 34 weeks gestational age should be available in 4Q, 2015. There will be 16 babies on Aerosurf plus nCPAP and 16 babies on nCPAP alone. Topline results from a second trial involving babies of 26 to 28 […]