Lexaria Announces Positive Final Results from Human Pilot Study #5

(TheNewswire)

Company further examining thepursuit of the world’s first oral liraglutide product

Kelowna, British Columbia –February 5, 2026 – TheNewswire - Lexaria Bioscience Corp.(Nasdaq: LEXX), (the “Company” or “Lexaria”), a globalinnovator in drug delivery platforms is pleased to announce finalresults from Human Pilot Study #5 (GLP-1-H25-5) (the “Study”)which compared oral  DehydraTECH-liraglutide (“DHT-LIR”) capsulesto injected Saxenda® branded liraglutide (“SAX-LIR”).

“We are extremely pleased with the results of HumanPilot Study #5,” stated Richard Christopher, CEO of Lexaria. “Inaddition to achieving the Study’s primary safety and tolerabilityendpoint, we also demonstrated that oral DehydraTECH-liraglutidefunctioned comparably to traditionally injected liraglutide,consistent with our regulatory development pathway objectives,”continued Mr. Christopher. “We now have compiled compelling evidenceto further support examining the pursuit of the world’s first oralliraglutide product.”

The primary results from this Study were issued on June 11,2025, at which time Lexaria reporteda 22.7% reduction in adverse events (“AEs”) with DHT-LIR ascompared to the SAX-LIR, with a particular emphasis on a 67% reductionin nausea and a 31% reduction in overall gastrointestinalAEs. The differences inmeasurements of blood glucose, insulin and body weight across mosttime points were not statistically significantly different, withremarkable similarity in many areas and slight differences in others.Weight loss was experienced by 9 out of 10 people in each Study armand slightly higher in the Saxenda® Study arm; though weight loss wasnot a primary goal of this Study with the very short treatment periodof only 1 week with each treatment. Evaluating the safety andtolerability of the oral DHT-LIR capsules relative to injected SAX-LIRwas the primary endpoint of this Study.  This objective wassuccessfully met with clear signs of improved safety and tolerabilityperformance by the DHT-LIR.

Since mid-2025, Lexaria and its third-partybioanalytical service providers have invested considerable time andexpertise in attempting to determine the precise pharmacokinetic(“PK”) blood liraglutide quantitation and profiling results fromthe Study.  This included the use of two different manufacturedbrands of commercially available ELISA (enzyme-linked immunosorbentassay) test kits. Throughout the course of this bioanalytical work,challenges were encountered with background signal noise detectionwhich complicated our ability to accurately capture blood liraglutidemeasurements in both the SAX-LIR and DHT-LIR study samples.  Thebackground signal noise is believed to be attributable to the factthat liraglutide and other peptide drugs are commonly known to bindwith, and have poor separation from, albumin; a naturally occurringprotein present in human blood plasma.

In light of this issue, the PK testing from the Studywas limited to exploratory visualization of the raw ELISA signalswhich, nonetheless, over time demonstrated broadly similar temporalpatterns between the DHT-LIR and the SAX-LIR.  The visualization ofthe similar signal patterns of the two treatments is consistent withthe instances of functional comparability otherwise demonstrated inthe Study, pursuant to Lexaria’s regulatory development pathwayobjectives.  Lexaria considers this to be particularly noteworthygiven the fact that the DHT-LIR dose quantitystudied was conservatively low (see “About the Study”, below), forthis initial human investigation, relative to that of the SAX-LIR,with room for possibly increasing the dose if necessary, in potentialfuture studies.  

The two most important strategic objectives of thisStudy were:

1 – To discover whether the DehydraTECH processing ofliraglutide would work sufficiently enough to potentially allow for anoral version of the drug to be compared to the current injection-onlydelivery method; and

2 – To demonstrate that oral DHT-LIR could producecomparable functional results to the injected version, allowing for anexpedited FDA regulatory development pathway known asa 505(b)(2) new drug application (the“505(b)(2) Pathway”) that is available when an alternate versionof a drug (e.g., the dosage form change from injection to oraladministration as tested within this Study) retains certain similarperformance characteristics as an earlier-approved version of thatsame drug.

In both these respects, the results from this Studyhave shown tremendous promise, while also evidencing tolerabilityadvantages from a user appeal perspective.

Saxenda® is owned by Novo Nordisk, who also sells anoral tablet form of the blockbuster GLP-1 drug semaglutide under thebrand name Rybelsus®. Of note, the salcaprozate sodium (“SNAC”)delivery technology that Novo Nordisk acquired for $1.8 billionutilized within the Rybelsus® tablet was foundby other researchers to be unfavorable for co-formulation of an oralversion of liraglutide.  Liraglutide wentoff patent in 2024 and is now offered in a generic injectable formatby Teva Pharmaceuticals and others.  

For these reasons, Lexaria is excited about thepossibility of establishing DehydraTECH-liraglutide as a brand neworal liraglutide-dosing alternative to Saxenda® and the other genericversions of injected liraglutide. Lexaria feels this is an unmetmarket need which DehydraTECH may empower.

Lexaria has had, and intends to continue, discussionswith pharmaceutical companies regarding the possibility ofcollaborating in pursuing a 505(b)(2) Pathway to enablecommercialization of an oral DHT-LIR product.  Further details onprospective next steps in development of the DHT-LIR product candidatewill be provided when available in due course.

About the Study

Study GLP-1-H25-5 was a pilot, cross-over investigationin 10 overweight (average weight 73 Kg, average body mass index 26.81)volunteers. SAX-LIR injection was administered daily at itscommercially available starting dose of 0.6 mg for 7 days with afollow-up evaluation at day 8, compared to oral DHT-LIR (45 mg) alsoadministered daily for 7 days with an identical day 8 evaluation. Alldrug administrations were performed after an overnight fast. Oraladministration was accomplished with a 50 mL glass of water. Blooddraws were performed upon the subjects at baseline (pre-dose) andmultiple time points over the first 12 hours of day 1 of the Study,followed by daily draws 30-minutes post-dosing on each of days 2-7 ofthe Study and, finally, on day 8 without anydosing. Subjects were allowed to consume standardized meals/snacksover the 12 hours post-dosing on the first treatment day atpredetermined time intervals. Subjects were allowed to resume theirnormal diet following fasted dosing on the subsequent treatmentdays.

The DHT-LIR 45 mg dose equated to a 75-fold multiple ofthe 0.6 mg SAX-LIR dose exposure tested. This dosing multiple wasselected conservatively relative to the 98 to 196-fold dosing multiplecurrently used with Novo Nordisk’s Rybelsus® brandedsemaglutide, whereby a 14 mgRybelsus® daily dose is considered to be bioequivalent to a 0.5-1.0mg once-weekly dose of their Ozempic® or Wegovy® branded semaglutideinjectable products. Accordingly,Lexaria notes that there is arguably room to further titrate theDHT-LIR oral dose upwards in prospective future studies, in an effortto most closely match the effectiveness of the injectable regimenconsistent with its 505(b)(2) Pathway strategy.

About Lexaria Bioscience Corp. &DehydraTECH

DehydraTECH™ is Lexaria’s patented drug deliveryformulation and processing platform technology which improves the waya wide variety of drugs enter the bloodstream, always through oraldelivery. DehydraTECH has repeatedly evidenced the ability to increasebio-absorption, reduce side-effects, and deliver some drugs moreeffectively across the blood brain barrier. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 60 patents granted and additional patentspending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS

This press release includes forward-looking statements.Statements as such term is defined under applicable securities laws.These statements may be identified by words such as “anticipate,”“if,” “believe,” “plan,” “estimate,” “expect,”“intend,” “may,” “could,” “should,” “will,” andother similar expressions. Such forward-looking statements in thispress release include, but are not limited to, statements by theCompany relating to the intended use of proceeds from the offering andrelating to the Company’s ability to carry out research initiatives,receive regulatory approvals or grants or experience positive effectsor results from any research or study. Such forward-looking statementsare estimates reflecting the Company’s best judgment based uponcurrent information and involve a number of risks and uncertainties,and there can be no assurance that the Company will actually achievethe plans, intentions, or expectations disclosed in theseforward-looking statements. As such, you should not place unduereliance on these forward-looking statements. Factors which couldcause actual results to differ materially from those estimated by theCompany include, but are not limited to, market and other conditions,government regulation and regulatory approvals, managing andmaintaining growth, the effect of adverse publicity, litigation,competition, scientific discovery, the patent application and approvalprocess, potential adverse effects arising from the testing or use ofproducts utilizing the DehydraTECH technology, the Company’s abilityto maintain existing collaborations and realize the benefits thereof,delays or cancellations of planned R&D that could occur related topandemics or for other reasons, and other factors which may beidentified from time to time in the Company’s public announcementsand periodic filings with the US Securities and Exchange Commission onEDGAR. The Company provides links to third-party websites only as acourtesy to readers and disclaims any responsibility for thethoroughness, accuracy or timeliness of information at third-partywebsites. There is no assurance that any of Lexaria’s postulateduses, benefits, or advantages for the patented and patent-pendingtechnology will in fact be realized in any manner or in any part. Nostatement herein has been evaluated by the Food and DrugAdministration (FDA). Lexaria-associated products are not intended todiagnose, treat, cure or prevent any disease. Any forward-lookingstatements contained in this release speak only as of the date hereof,and the Company expressly disclaims any obligation to update anyforward-looking statements or links to third-party websites containedherein, whether as a result of any new information, future events,changed circumstances or otherwise, except as otherwise required bylaw.

INVESTOR CONTACT:

George Jurcic – Head of InvestorRelations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

Copyright (c) 2026 TheNewswire - All rights reserved.