WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) recently announced its financial results for the second quarter ending June 30, 2024, along with significant business updates. The company has made notable progress with its lead asset, istaroxime, which is being developed for the treatment of cardiogenic shock.
Chairman and CEO Craig Fraser commented, “The second quarter of 2024 was marked with significant progress with our lead asset, istaroxime in development for the treatment of cardiogenic shock. We expect the istaroxime Phase 2 SEISMiC Extension study to complete enrollment in the next few weeks and we plan to report topline data by the end of the third quarter of 2024. We are also supporting our regional partner, Lee’s Pharmaceutical, in their planned istaroxime Phase 3 program in acute heart failure.”
Windtree has taken steps to ensure it has sufficient capital for operational needs. The company completed financial transactions in July 2024, raising approximately $13.9 million. This includes $4.4 million in new funding and a $9.5 million payment through the cancellation of outstanding senior notes and shares of Series B Convertible Preferred Stock. Additionally, Windtree entered into a Common Stock Purchase Agreement, giving the company the right to sell up to $35 million in newly issued shares, providing further financial flexibility.
Fraser added, “With trial execution and active operations comes the need for capital and we successfully completed transactions providing resources for our near-term needs as well as secured an equity line of credit to potentially support future requirements.”
The company also welcomed two new independent directors, Saundra Pelletier and Jed Latkin, to its board. Their appointments bring valuable public company and executive leadership experience to Windtree, particularly in drug development, business development, licensing, and commercialization.
Fraser stated, “Looking to the next several months, besides the important data read out on the istaroxime SEISMiC Extension Study, based on available resources, we plan to accelerate enrollments in the istaroxime SCAI Stage C cardiogenic shock study as well as provide guidance on our strategy and planned activities with our oncology preclinical aPKCi inhibitor assets. Finally, we are excited about our two new independent board directors, Saundra Pelletier and Jed Latkin, who have joined our Board at a pivotal time and we look forward to their contributions to the next phase of our progress.”
Key Business Updates:
- Istaroxime Development: Windtree expects to complete enrollment and report topline data for its Phase 2 SEISMiC Extension Study by the end of the third quarter in 2024. The company has also begun enrollment for the Phase 2 SCAI Stage C cardiogenic shock study and continues to expand global study sites.
- Financial Transactions: The company raised $13.9 million through two transactions in July 2024. It also entered into a Common Stock Purchase Agreement, potentially enabling the sale of up to $35 million in newly issued shares.
- Board Changes: Jed Latkin and Saundra Pelletier joined Windtree’s board, bringing significant experience in drug development and business strategy.
Financial Performance:
For the second quarter of 2024, Windtree reported an operating loss of $11.5 million, compared to $6.8 million in the same period in 2023. This includes $7.5 million of non-cash R&D expenses related to the Varian asset acquisition. Research and development expenses increased to $9.9 million from $1.8 million a year earlier, primarily due to the Varian acquisition and ongoing clinical trials.
General and administrative expenses decreased to $1.6 million from $2.4 million in the second quarter of 2023, reflecting lower professional fees, personnel costs, stock-based compensation, and insurance costs.
The company reported a net loss of $12.0 million ($20.91 per basic share) for the second quarter of 2024, compared to a net loss of $6.6 million ($29.47 per basic share) for the same period in 2023. As of June 30, 2024, Windtree had cash and cash equivalents of $1.8 million and current liabilities of $8.8 million, raising concerns about its ability to continue as a going concern.
These financial updates and key business developments highlight Windtree Therapeutics’ ongoing efforts and strategic initiatives as it navigates the challenges and opportunities in advancing its pipeline and securing necessary funding.
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