Analyst Summary
- Lixte Biotechnology Holdings, Inc. amended the Clinical Trial Agreement with Grupo Español de Investigación en Sarcomas (GEIS) effective March 11, 2025.
- The amendment relieves Lixte of the financial obligation of approximately $3,095,000 to support the randomized Phase 2 portion of the clinical trial.
- The clinical trial is studying the safety and efficacy of LB-100, Lixte’s lead compound, in combination with doxorubicin for advanced soft tissue sarcomas.
- The Phase 1b portion of the study completed recruitment during the quarter ended September 30, 2024, and initial data on toxicity and preliminary efficacy is expected during the quarter ending December 31, 2025.
- The original Clinical Trial Agreement was filed on August 6, 2019, and the study commenced during the quarter ended June 30, 2023, with an expected completion date of December 31, 2026.