A Pre-IND meeting offers open communication between applicants and the FDA, enabling the applicants to receive information regarding the preparation of an IND application and guidance for the clinical studies of the Company’s ExoPTEN drug. The FDA provided clear and valuable guidance on the chemistry manufacturing and controls and agreed that our proposed ExoPTEN release testing strategy would be expected to adequately control for safety of the ExoPTEN product for use in the planned first-in-human clinical trial. The FDA’s response to the Company indicated that the planned toxicity study strategy is acceptable under FDA guidelines and large-scale animal studies will not be required. Based on the FDA’s feedback, the Company plans to submit an IND application regarding the development of ExoPTEN by Q4, 2024, and expects to initiate Phase 1/2 human clinical studies in 2025.