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Dec 31, 2023
Intensity Therapeutics Q4 2023 Earnings Report
Announced full year 2023 financial results and provided a corporate update.
Key Takeaways
Intensity Therapeutics reported its full year 2023 financial results, highlighting the advancement of its lead drug candidate, INT230-6, into late-stage clinical programs and a year-end cash position of $14.8 million expected to fund operations through Q1 2025.
INT230-6 advances into late-stage clinical programs in sarcoma and breast cancer.
Received Study May Proceed letter from the FDA for Phase 3 protocol in soft tissue sarcoma.
Year-end cash and investments of $14.8 million expected to fund operations through the end of Q1 ’25.
Plans to initiate Phase 3 sarcoma study in mid-2024.
Forward Guidance
Intensity Therapeutics anticipates initiating a Phase 3 study in metastatic soft tissue sarcoma subtypes and a Phase 2/3 program in presurgical breast cancer in mid-2024.
Positive Outlook
- Initiate INVINCIBLE-3 Study in certain metastatic soft tissue sarcoma subtypes.
- The Company plans to enroll 333 patients with an endpoint of overall survival.
- The study will compare INT230-6 as a monotherapy treatment to the three current SOC drugs in 2nd and 3rd line soft tissue sarcoma subtypes.
- Initiate the Phase 2/3 program in presurgical breast cancer with the start of INVINCIBLE-4, a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC (immune-chemotherapy) compared to the SOC alone.
- The endpoint for this portion of the study is the change in the pathological complete response rate for the combination.
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