Windtree Enters into Agreement with Lee's Pharmaceutical for Non-Dilutive Funding of the Continued Development of AEROSURF®

WARRINGTON, Pa., March 31, 2020 /PRNewswire/ -- 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 (the "Term Sheet") with Lee's Pharmaceutical Holdings (HK) Ltd ("Lee's") 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 ("RDS").  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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include: the Company's ability to continue as a going concern,  the success and advancement of the  clinical development programs for istaroxime and AEROSURF®; the Company's ability to secure significant additional capital as and when needed, the ability to access the debt or equity markets, risks related to Windtree's  development programs,; risks related to technology transfers to contract manufacturers and manufacturing development activities, delays encountered by Windtree, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with Windtree on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of Windtree's product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to Windtree's efforts to maintain and protect the patents and licenses related to its products.  These and other risks are described in the Company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

For more information, please visit the Company's website at www.windtreetx.com.

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SOURCE Windtree Therapeutics, Inc.