Windtree Therapeutics and Intensity Therapeutics have recently announced significant advancements in their respective clinical development programs, alongside updates on their financial positions. Windtree is focused on cardiovascular therapies, while Intensity is advancing intratumoral cancer treatments.
Windtree's Istaroxime Shows Promise in Cardiogenic Shock
Windtree Therapeutics, Inc. (NasdaqCM: WINT) reported positive topline results from its Phase 2b SEISMiC study of istaroxime in heart failure patients experiencing early cardiogenic shock. The study demonstrated statistically significant improvements in systolic blood pressure (SBP) over six hours, meeting its primary endpoint. Improvements were sustained through 96 hours of measurement. The trial also showed improvements in cardiac output, filling pressures, and kidney function, along with a favorable safety profile.
"The third quarter of 2024 was marked with significant progress... There have been four positive Phase 2 studies with over 300 patients treated with istaroxime resulting in a consistent, unique and attractive drug profile across a wide range of severities," said Craig Fraser, Chairman and CEO of Windtree.
Building on these results, Windtree has initiated the SEISMiC C study, a Phase 2b trial of istaroxime in SCAI Stage C cardiogenic shock, with an interim data readout planned for early Q2 2025. The company is also pursuing business development activities to secure additional licenses and partnerships for its cardiovascular platform.
Intensity Therapeutics Advances INT230-6 in Sarcoma and Breast Cancer
Intensity Therapeutics, Inc. (Nasdaq: INTS) is making strides in oncology with its lead candidate, INT230-6. The company announced the first patients were dosed in the INVINCIBLE-3 Study, a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to standard of care in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. The primary endpoint in the INVINCIBLE-3 Study is overall survival.
Additionally, Intensity Therapeutics has initiated the INVINCIBLE-4 Study, a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the pathological complete response rate in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France.
"This has been an excellent quarter of regulatory success in multiple countries... We remain committed to exploring our new treatment that causes immunological cell death in severe diseases such as soft tissue sarcoma and triple-negative breast cancer," said Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics.
Financial Updates
Windtree reported an operating loss of $4.7 million for the third quarter of 2024, comparable to the same period in 2023. Research and development expenses were $2.0 million, primarily related to the SEISMiC Extension trial. As of September 30, 2024, the company had $2.3 million in cash and cash equivalents, with sufficient resources to fund operations through January 2025.
Intensity Therapeutics reported research and development expenses of $2.2 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023. Net loss for the quarter was $3.5 million. As of September 30, 2024, cash and cash equivalents totaled $2.8 million, expected to fund operations into the first quarter of 2025.
