Lexaria's Registered GLP-1 Study #4 begins dosing

Lexaria Bioscience Corp , a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's proprietary DehydraTECH technology improves the safety and effectiveness of existing GLP-1 drugs.

"Achieving the first patient, first dose Study milestone is a critical achievement," said John Docherty, President and Chief Scientific Officer of Lexaria Bioscience Corp. "The world's first 12-week human study evaluating DehydraTECH-processed GLP-1 drugs, in addition to DehydraTECH-CBD, in pre-diabetics or diabetic patients is underway. Potential benefits of reduced side-effects and improved efficacy could be evidenced."

The Study arms are as follows:

• Arm 1 - DehydraTECH-CBD capsules

• Arm 2 - DehydraTECH-semaglutide capsules

• Arm 3 - DehydraTECH-semaglutide combined with DehydraTECH-CBD capsules

• Arm 4 - Rybelsus tablets (positive control)

• Arm 5 - DehydraTECH-tirzepatide capsules (potential additional arm with offset start date)

Quality control release testing of the clinical test articles has now been completed. The Study is planned to be conducted using seven clinical investigational sites in Australia as a registrational Phase 1b study within Australian clinical regulatory authority regulations. The Study, upon completion, is expected to be regarded as the equivalent of a Phase 1b registrational study by the U.S. Food and Drug Administration ("FDA").

The Study is planned to commence with 20 overweight, obese, pre- or type 2 diabetic patients for each of Study arms 1-4, with the potential DehydraTECH-tirzepatide Study arm 5 to be added at a later date if supported by positive results from Lexaria's separate ongoing study GLP-1-H24-3. All drugs will be administered daily by oral tablet or capsule - there are no drug injections involved in this Study.

In its first-ever GLP-1 study in humans reported in January, 2024, Lexaria discovered that DehydraTECH processing of Rybelsus-branded semaglutide, after a single dose, improved blood sugar control and reached higher levels of semaglutide measured in blood, than did Rybelsus itself. Also, in rodent study work reported in October, 2024, Lexaria was pleased to see comparable performance of DehydraTECH-semaglutide without SNAC to DehydraTECH-processed Rybelsus formulations including SNAC; which Lexaria previously reported may be due to DehydraTECH preserving similar molecular properties in the gut for ingested semaglutide which has been shown to be integral to SNAC-enabled semaglutide gut absorption.