Windtree Therapeutics WINT made an announcement on a groundbreaking agreement with affiliates of biopharma investor Deerfield Management Company, signaling a complete retirement of a $15 million contingent liability linked to Windtree’s Aerosurf®- a drug and device combination treatment expressly designed for premature infants struggling with respiratory distress syndrome. This strategic move comes as Windtree gears up for later-stage clinical trials, capitalizing on a positive trajectory and solid financial footing, influencing both, its balance sheet and stakeholder equity positively.
Debt-Free with a Solid Financial Base for Anticipated Clinical Trials
The company’s CEO, Craig Fraser, expressed gratitude towards the support from Deerfield. “We appreciate the support of Deerfield in our efforts to strengthen our financial position with the completion of this transaction,” said Fraser. “As a result, we believe we have meaningfully strengthened and simplified our balance sheet.” Fraser also highlighted the company’s progress with its lead asset, istaroxime, in two ongoing clinical trials in cardiogenic shock and a new regional license with Lee’s Pharmaceuticals intended to initiate Phase 3 work in acute heart failure. Additionally, Windtree has streamlined its cash burn rate since the second half of 2022, fortifying the organization through recent transactions like this one. Fraser assured shareholders of upcoming updates on the company’s progress.
In exchange for 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. Further, Windtree committed to another $100,000 payment, due either on January 24, 2025, or upon reaching a specified amount of gross proceeds from debt or equity financings occurring after the agreement date.
Advancing towards Phase 3 Readiness in Cardiogenic Shock
In recent reports, Windtree highlighted a positive phase 2 study on istaroxime, showcasing promising results as a treatment for early cardiogenic shock. This study demonstrated improvements in blood pressure and cardiac function, pivotal in addressing the high morbidity and mortality associated with cardiogenic shock. The potential market for istaroxime appears promising due to a high demand from the medical community for innovative treatments in this space. Moreover, istaroxime stands unchallenged by any other known drugs in development for cardiogenic shock, offering favorable regulatory approval pathways that are cost-effective and quicker than traditional cardiovascular phase 3 programs.
If approved for cardiogenic shock, istaroxime is poised to become a standard treatment, enhancing both blood pressure and heart function. Windtree is now advancing into a small extension study following the positive phase 2 data, primarily focused on dose optimization, in addition to commencing start-up activities for a second small phase 2 study involving cardiogenic shock patients in an even more severe condition, termed SCAI Stage C. These key initiatives are projected to propel the cardiogenic shock development program for istaroxime to phase 3 readiness in 2024.
Fraser, commented, “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.”
Featured photo by Wance Paleri on Unsplash.
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