Lexaria Bioscience provides update on IND application process for HYPER-H23-1

Lexaria Bioscience is providing this update on the status of the Company’s anticipated submission of an Investigational New Drug application with the U.S. Food and Drug Administration for its planned U.S. Phase 1b Hypertension Clinical Trial designated as HYPER-H23-1. As previously reported, work that was mostly under Lexaria’s control such as batch manufacturing of DehydraTECH-processed cannabidiol and placebo materials necessary for the IND application filing was completed earlier this year, followed by analytical release and ongoing stability testing.In parallel, compilation of the large set of documentation necessary for inclusion in the IND filing has been progressing on time by the Company and its service providers. However, work that is outside of Lexaria’s control, namely the provision of required documentation by one of Lexaria’s material suppliers related to their analytical and stability testing of their material, has been delayed. Accordingly, Lexaria is not in a position to submit the IND package to the FDA for their review and consideration until these delays have been cured by the supplier. Lexaria is in communication with its material supplier to provide their required information as soon as possible but, as at the current date, we have not received the results nor an estimated time of receipt for same. Lexaria continues to finalize the IND application so that the Company is in a position to file with the FDA as soon as possible following receipt of the outstanding information and will provide updated details regarding the status of its IND application filing as they become available.