Progress in the ReSPECT-LM Trial
The trial reached an agreement with the FDA to proceed under a multiple dose escalation protocol, with doses up to 44 millicuries found to be safe and well tolerated. Further data from Cohorts 1 through 4 showed a 53% reduction in circulating tumor cells on average at day 28 post-treatment, and a median overall survival of 12 months compared to a historical consensus of 4 months.
Expansion of Clinical Trial Sites
Added Ohio State University and North Shore Hospital to support Phase II enrollment and potentially a pivotal trial, with Phase II completion expected by mid-2025.
Financial Strength and Grant Support
The company received $4.4 million in grant revenue year-to-date, with expectations of $6 million to $7 million in 2024. They have significant grant support from CPRIT and the Department of Defense, totaling approximately $27 million including committed grant revenue.