WARRINGTON, PA / ACCESSWIRE / January 26, 2024 / Windtree Therapeutics (NASDAQ: WINT) announced an agreement with affiliates of biopharma investor Deerfield Management Company to fully retire a $15 million contingent liability associated with Windtree's Aerosurf®, a drug and device combination treatment for premature infants with respiratory distress syndrome.

No Significant Debt On The Balance Sheet And Increased Shareholder Equity Ahead Of Windtree's Anticipated Later-Stage Clinical Trials

"We appreciate the support of Deerfield in our efforts to strengthen our financial position with the completion of this transaction and the expected elimination the $15 million contingent liability. As a result, we believe we have meaningfully strengthened and simplified our balance sheet," said Craig Fraser, Windtree's President and Chief Executive Officer. "In addition, our lead asset, istaroxime, is progressing in two ongoing clinical trials in cardiogenic shock and we recently announced a new regional license with Lee's Pharmaceuticals intended to initiate Phase 3 work in acute heart failure and potentially provide non-dilutive revenue. Along with significantly cutting our cash burn rate since the second half of 2022, I believe we have strengthened the company through recent transactions such as this one. We look forward to keeping our shareholders updated on our progress."

In exchange for Deerfield terminating its rights to receive any milestone payments, Windtree agreed to issue Deerfield 608,272 shares of its common stock and to pay Deerfield a $100,000 cash payment upon execution of the agreement. In addition, Windtree agreed to pay Deerfield an additional $100,000 on the earlier of (i) January 24, 2025, or (ii) Windtree receiving a specified amount of gross proceeds from debt or equity financings occurring on or after the agreement date.

Windtree's public filings can be viewed on its corporate website www.windtreetx.com.

Windtree Targeting Phase 3 Readiness In Cardiogenic Shock

Windtree reports that a recently completed positive phase 2 study on istaroxime as a treatment for early cardiogenic shock demonstrated improvement in both blood pressure and cardiac function, which are in a critically low state and result in high morbidity and mortality in cardiogenic shock. There is likely a high unmet need in the potential market for istaroxime because market research shows doctors have a high desire for drug innovation to treat cardiogenic shock. Adding to the positive story for Windtree, there are no other known drugs in development for cardiogenic shock and the regulatory approval pathway may provide requirements that cost less and are able to be completed faster than typical cardiovascular phase 3 programs.

If approved for cardiogenic shock, istaroxime's efficacy and safety profile could make it a standard treatment to improve both blood pressure and heart function. Windtree is in the process of starting a small extension study following the positive phase 2 data for dose optimization and also has begun start-up activity in a second small phase 2 study with cardiogenic shock patients one stage more severe called SCAI Stage C. These two small studies are expected to move the cardiogenic shock development program for istaroxime to phase 3 readiness in 2024.

"Windtree is highly engaged with two global cardiogenic studies as well as business development activity. We look forward to sharing our progress and especially our data and milestones over the next few quarters," Fraser said in a statement.

Featured photo by Wance Paleri on Unsplash.

Contact:

Matt Epstein
mepstein@kendallir.com

SOURCE: Windtree