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Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for critical cardiovascular disorders, today announced that the Company entered an Exchange and Termination Agreement with affiliates of Deerfield Management Company (collectively, "Deerfield") pursuant to which Deerfield has agreed to terminate its rights under the Company's 2017 Exchange and Termination Agreement to receive up to $15,000,000 in development and commercial milestone payments associated with AEROSURF®, an acute pulmonary drug/device combination intended to treat premature infants with respiratory distress syndrome. Windtree out-licensed global rights to AEROSURF® in 2022.
"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, the Company agreed to issue to Deerfield 608,272 shares of the Company's common stock and to pay Deerfield a $100,000 cash payment upon execution of the agreement. In addition, the Company agreed to pay Deerfield an additional $100,000 on the earlier of (i) January 24, 2025 or (ii) the Company receiving a specified amount of gross proceeds from debt or equity financings occurring on or after the agreement date.
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Lyophilized Lucinactant and AEROSURF®
Lyophilized lucinactant is an investigational synthetic peptide (KL4 surfactant) containing drug product that is being developed to improve the management of RDS in premature infants who may not have fully developed natural lung surfactant and may require surfactant therapy to sustain life. AEROSURF® (lucinactant for inhalation) is a drug/device combination designed to deliver aerosolized KL4 surfactant noninvasively using our proprietary ADS technology and potentially may meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation. The KL4 and AEROSURF® program was globally out-licensed to Lee's Pharmaceutical and Zhaoke Pharmaceutical in 2022.
Posted In: WINT
