Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, announces it has entered into a binding term sheet with Lee's Pharmaceutical Holdings (HK) Ltd pursuant to which Lee's will provide project financing for the continued development of the Company's lead acute pulmonary product candidate, AEROSURF® for the treatment of preterm infants with respiratory distress syndrome. The financing will fund the AEROSURF phase 2b bridge study which, if successful, is intended to transition the product into a phase 3 ready clinical product development.
"Our Company has a great partnership with Lee's and this arrangement is designed to fund the AEROSURF bridge study both globally and in China and ensures the strength of expertise in the KL4 franchise can be applied to our clinical pursuits," stated Craig Fraser, CEO of Windtree. "This non-dilutive financing from Lee's also enables us to focus our cash on opportunities in our istaroxime cardiovascular clinical programs – namely the cardiogenic shock clinical study as well as study start up activities for the next acute heart failure phase 2b trial."
The Term Sheet provides, among other things, that in connection with the continued development of AEROSURF, Lee's will make non-refundable payments to the Company during the period from April 1, 2020 through September 1, 2020. The parties have agreed that they will negotiate in good faith the terms of a definitive agreement prior to September 30, 2020, which will also set forth additional semi-annual non-refundable payments to fund the continued development of AEROSURF subsequent to September 30, 2020. The Company has agreed to repay 125% of the amounts funded by Lee's for the development of AEROSURF out of proceeds received from all revenue amounts and payments received by the Company for any sale, divestiture, license or other development and/or commercialization of the KL4 surfactant /AEROSURF patent portfolio with certain exclusions. The Term Sheet also provides that Lee's and the Company will amend certain existing royalty provisions of the License, Development and Commercialization Agreement between the Company and Lee's dated as of June 12, 2017.
Readers are referred to and encouraged to read the Form 8-K filed with the Securities and Exchange Commission on March 23, 2020 for further details regarding this transaction.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is a clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has three lead clinical development programs spanning respiratory and cardiovascular disease states, including istaroxime, a novel, dual-acting agent being developed to improve cardiac function in patients with acute heart failure and cardiogenic shock; AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company's proprietary synthetic, peptide-containing surfactant noninvasively to premature infants with respiratory distress syndrome (RDS); and rostafuroxin, a novel precision drug product being developed to target hypertensive patients with certain genetic profiles in the important group of patients with resistant hypertension. Windtree also has multiple pre-clinical programs, including potential heart failure therapies delivered orally that are based on SERCA2a mechanism of action.
For more information, please visit the Company's website at www.windtreetx.com.
