Windtree Therapeutics Q2 2024 Financial Results and Business Updates

Windtree Therapeutics, Inc., a biotechnology company specializing in innovative therapies for critical conditions, reported its financial results for the second quarter ending June 30, 2024, and provided significant business updates. The company, which trades on the Nasdaq under the symbol WINT, made substantial progress in its lead project, istaroxime, which is in development for the treatment of cardiogenic shock.

Craig Fraser, Chairman and CEO of Windtree, noted that the second quarter was marked by significant advancements, particularly with the istaroxime Phase 2 SEISMiC Extension study, which is nearing the completion of its enrollment phase. The company anticipates reporting topline data by the end of the third quarter of 2024. Additionally, Windtree is supporting Lee’s Pharmaceutical in their planned Phase 3 program for istaroxime in acute heart failure.

Fraser highlighted the company's successful capital-raising efforts, which included completing transactions that provided near-term resources and securing an equity line of credit to potentially support future needs. Looking ahead, Windtree plans to accelerate enrollments in the istaroxime SCAI Stage C cardiogenic shock study and provide guidance on its strategy for oncology preclinical aPKCi inhibitor assets. The addition of two new independent board directors, Saundra Pelletier and Jed Latkin, is also expected to bring valuable public company and executive leadership experience to the company.

Key business updates from Windtree include the expected completion of enrollment and reporting of topline data for the Phase 2 SEISMiC Extension Study by the end of the third quarter. The company has also begun enrollment in the Phase 2 SCAI Stage C cardiogenic shock study and is expanding global study sites. In July 2024, Windtree closed two financial transactions, which included securing approximately $13.9 million in gross proceeds. This funding comprised around $4.4 million in new funding and a $9.5 million payment through the cancellation of certain senior notes and shares of Series B Convertible Preferred Stock. Furthermore, Windtree entered into a Common Stock Purchase Agreement with an equity line investor, giving the company the right to sell up to $35 million in newly issued shares.

On the financial front, Windtree reported an operating loss of $11.5 million for the second quarter of 2024, up from a $6.8 million loss in the same period in 2023. This increase is largely attributed to $7.5 million in non-cash R&D expenses related to the Varian asset acquisition. Research and development expenses rose to $9.9 million, compared to $1.8 million the previous year, primarily due to the costs associated with the Varian acquisition and the ongoing SEISMiC Extension trial. General and administrative expenses decreased to $1.6 million from $2.4 million in the second quarter of 2023, reflecting reductions in professional fees, personnel costs, stock-based compensation, and insurance costs.

Windtree reported a net loss of $12.0 million for the second quarter of 2024, compared to a net loss of $6.6 million for the same period in 2023. As of June 30, 2024, the company had cash and cash equivalents totaling $1.8 million, with current liabilities amounting to $8.8 million. The company acknowledged that it does not have sufficient cash and cash equivalents to support its operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern.

Windtree Therapeutics focuses on advancing therapies for critical conditions, with a portfolio that includes istaroxime for acute heart failure and cardiogenic shock, preclinical SERCA2a activators for heart failure, and preclinical precision aPKCi inhibitors for oncology applications. The company also operates a licensing business model with current partnership out-licenses in place.