Windtree Therapeutics Announces KL4 Surfactant and AEROSURF Global License Agreement

Windtree Therapeutics, Inc. announced it has entered into a global licensing agreement with Lee’s Pharmaceutical (HK) Limited, (Lee’s) and its affiliate Zhaoke Pharmaceutical (Hefei) Co. Ltd., (Zhaoke) for the development and commercialization of Windtree’s acute pulmonary pipeline treatments KL4 surfactant and drug/device combination, AEROSURF, for the treatment of preterm infants with respiratory distress syndrome (RDS) and other potential applications. RDS often occurs in preterm infants when the lung is not fully developed with natural lung surfactant and may require surfactant therapy to sustain life.

“We are excited to announce this global licensing transaction for our KL4 surfactant platform given the value it can provide to the Company, its shareholders and critically ill patients,” said Craig Fraser, President and Chief Executive Officer of Windtree. “The out-licensing of the KL4 platform supports our portfolio prioritization and increases non-dilutive resources to progressing istaroxime on the significant opportunity in the major markets of cardiogenic shock and heart failure where recent positive data has created what we believe could be a relatively fast and less expensive developmental pathway in cardiogenic shock. Given the clinical potential of KL4 surfactant and AEROSURF to help preterm infants with RDS, we desired a partner who was capable of fully assuming execution of the platform and could build value. Over the past few years, we have worked with the Lee’s and Zhaoke’s teams as they invested significantly in building manufacturing, analytical and clinical capabilities to move the KL4 platform into late-stage development. This transaction strengthens Windtree’s resources for its core programs and delivers significant potential value to its shareholders on assets we were no longer progressing ourselves.”

Under terms of the global license agreement, Lee’s and Zhaoke will receive a global license to develop and commercialize Surfaxin^®, lyophilized lucinactant and AEROSURF for any potential indications and applications. Lee’s and Zhaoke will be responsible for funding all development, intellectual property, manufacturing, and commercialization activities and provide developmental, regulatory and eventual commercial sales milestones for Windtree of up to $78.9 million plus potential double-digit royalties. Windtree had previously granted a regional license to Lee’s and Zhaoke for KL4 and AEROSURF for the territory of Greater China for which Windtree received an upfront payment, and this new agreement expands that territory globally. With the execution of this agreement, Windtree will no longer have ongoing maintenance and operating costs for the KL4 platform.