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Pipeline(2)

PIPELINE

Pipeline Overview

Windtree is focused on developing novel treatments for respiratory critical care patients using its proprietary synthetic KL4 surfactant and aerosol delivery technologies, beginning with the treatment of RDS in premature infants. Windtree believes that its aerosolized KL4 surfactant, alone or in combination with other pharmaceutical compounds, has the potential to be developed to address a range of serious respiratory conditions and may be an effective intervention for such conditions as acute lung injury (ALI), including influenza-induced ALI, acute radiation exposure to the lung (acute radiation pneumonitis and delayed lung injury), and chemical-induced ALI. Windtree has participated in a number of U.S. Government agency-funded studies with noted research institutions to evaluate the utility of using KL4 surfactant to address the foregoing indications, and expects to seek additional funding in the future through U.S. Government programs or otherwise to further study and potentially establish proof of concept to support further development of these product candidates.

The following chart depicts Windtree’s current pipeline programs:

WINDTREE_PIPELINE_CHART(FINAL)

The preclinical development activities listed above have been or are being funded by grants issued by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to study influenza (contract HHSN272201500027C) and radiation (award number R44AI102308) induced lung injury, and by the NIH Office of the Director and the Countermeasures Against Chemical Threats (CounterACT) program to study chemical-induced lung injury. The foregoing content concerning these initiatives is solely the responsibility of Windtree Therapeutics and does not necessarily represent the official views of the NIH.

 

In addition, Windtree believes that there may be an opportunity to apply its KL4 surfactant and drug delivery platform to improve the treatment of a number of conditions, including, potentially, chronic rhinosinusitis, complications of certain major surgeries, mechanical ventilator-induced lung injury (often referred to as VILI), pneumonia, diseases involving mucociliary clearance disorders, such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). Windtree is assessing these potential product candidates to prioritize and establish a longer range development strategy.

 

Windtree’s development strategy is supported by a broad technology platform that includes pharmaceutical patents for lyophilized KL4 surfactant that extend to 2033 and medical device patents supporting the further development of the aerosol delivery system (ADS) that extend to at least 2031.  In addition, Windtree holds the following orphan drug designations granted by the FDA: KL4 surfactant for the treatment of RDS in premature infants, KL4 surfactant for the prevention and treatment of bronchopulmonary dysplasia (BPD) in premature infants, KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in adults, and KL4 surfactant for the treatment of CF. The European Medicines Agency (EMA) has granted Windtree Orphan Medicinal Product designation for KL4 surfactant for the prevention of RDS in premature infants of less than 32 weeks gestational age, KL4 surfactant for the treatment of RDS in premature infants of less than 37 weeks gestational age, KL4 surfactant for the treatment of ALI (which in this circumstance encompasses ARDS), and KL4 surfactant for the treatment of CF.