Lexaria Announces Positive Final Results From Human Pilot Study #5

Rhea-AI Summary

Lexaria (NASDAQ:LEXX) announced final results from Human Pilot Study #5 comparing oral DehydraTECH-liraglutide (DHT-LIR) capsules to injected Saxenda® (SAX-LIR) liraglutide. The Study met its primary safety and tolerability endpoint, reporting a 22.7% reduction in adverse events with DHT-LIR, including 67% less nausea and 31% fewer GI adverse events.

Pharmacokinetic blood quantitation faced assay background noise challenges, limiting PK conclusions to exploratory ELISA signal visualizations that showed broadly similar temporal patterns between treatments. Lexaria is exploring a 505(b)(2) regulatory pathway and potential collaborations to develop an oral liraglutide product.

Positive

• Adverse events reduced by 22.7% with DHT-LIR
• Nausea reduced by 67% versus injected liraglutide
• Gastrointestinal adverse events reduced by 31%
• Functional comparability observed in exploratory PK signal patterns

Negative

• PK blood quantitation limited by ELISA background signal noise
• Very short treatment period of 1 week per arm
• Small study size (approximately 10 per arm) limits statistical power

Key Figures

AE reduction: 22.7% Nausea reduction: 67% GI AE reduction: 31% +5 more

8 metrics

AE reduction 22.7% Reduction in adverse events for DHT-liraglutide vs Saxenda in Pilot Study #5

Nausea reduction 67% Reduction in nausea AEs for DHT-liraglutide vs Saxenda in Study #5

GI AE reduction 31% Reduction in gastrointestinal adverse events for DHT-liraglutide vs Saxenda

Weight loss incidence 9 of 10 subjects Participants experiencing weight loss in each arm over 1-week treatment

Treatment duration 1 week Duration of each treatment period in Human Pilot Study #5

SNAC acquisition value $1.8 billion Novo Nordisk acquisition cost of SNAC delivery technology for Rybelsus

Price change -5.35% LEXX 24-hour move prior to/around publication of this news

Market cap $19,058,806 Equity value based on latest pre-news market data

Market Reality Check

Price: $0.0012 Vol: Volume 356,009 is 1.73x t...

high vol

$0.0012 Last Close

Volume Volume 356,009 is 1.73x the 20-day average of 205,574, indicating elevated trading interest before/around this release. high

Technical Shares at $0.7248 trade below the 200-day MA of $0.96 and sit 62.07% under the 52-week high of $1.911, though still 57.57% above the 52-week low of $0.46.

Peers on Argus

LEXX declined 5.35% while nearby biotech peers showed mixed moves: ASBP (-3.73%)...

1 Up

LEXX declined 5.35% while nearby biotech peers showed mixed moves: ASBP (-3.73%), CING (-0.79%), CRIS (+5.49%), PMN (+0.71%), NRXS (+2.59%). Momentum scanners only flagged XCUR (+6.86%) on the upside, supporting this as a stock‑specific move rather than a coordinated sector rotation.

Historical Context

5 past events · Latest: Jan 22 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 22	Patent grants	Positive	+2.1%	Six additional patents granted, bringing portfolio to 60 worldwide.
Jan 12	Strategic update	Positive	+3.2%	CEO annual letter highlighting GLP‑1 data, IP growth and 2025 financing.
Dec 30	Clinical data update	Positive	-2.9%	Additional positive Phase 1b GLP‑1 study results versus Rybelsus control.
Dec 23	Phase 1b results	Positive	-8.0%	Primary endpoint met in GLP‑1-H24-4 with reduced adverse events.
Dec 16	Equity offering	Negative	-5.6%	Registered direct financing of 2,661,600 shares plus warrants for $3.5M.

Pattern Detected

Recent GLP‑1/DehydraTECH milestones and patent wins often read positively but have produced mixed price reactions, with some clinically positive updates followed by declines while financing news has also pressured shares.

Recent Company History

Over the past few months, LEXX reported multiple DehydraTECH GLP‑1 milestones and financings. On Dec 16, 2025, a $3.5M registered direct offering coincided with a -5.62% move. Positive Phase 1b GLP‑1 results on Dec 23 and further data on Dec 30 saw reactions of -8.01% and -2.89%, respectively, despite safety/tolerability wins. By contrast, a CEO annual letter on Jan 12, 2026 and six new patents on Jan 22 were followed by modest gains, suggesting the market has rewarded IP and strategic updates more consistently than detailed clinical data.

Market Pulse Summary

This announcement reinforces Lexaria’s GLP‑1 strategy, showing oral DehydraTECH‑liraglutide achieved...

Analysis

This announcement reinforces Lexaria’s GLP‑1 strategy, showing oral DehydraTECH‑liraglutide achieved the primary safety and tolerability endpoint with a 22.7% reduction in adverse events and notably less nausea. The study supports functional comparability to injected Saxenda, which could be relevant for a 505(b)(2) pathway. Against a backdrop of recent financings and going‑concern disclosures, future updates on partnering, dose optimization and regulatory engagement will be key metrics to monitor.

Key Terms

glp-1, pharmacokinetic, elisa, enzyme-linked immunosorbent assay, +3 more

7 terms

glp-1 medical

"Novo Nordisk, which also sells an oral tablet form of the blockbuster GLP-1 drug"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

pharmacokinetic medical

"determine the precise pharmacokinetic ("PK") blood liraglutide quantitation"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

elisa medical

"two different manufactured brands of commercially available ELISA (enzyme-linked"

A laboratory test that detects specific proteins or antibodies in a sample by producing a measurable color or signal, similar to how a home pregnancy test shows a line when it finds a target substance. Investors care because ELISA results help determine whether a medical product works, meets regulatory standards, or can be manufactured reliably — factors that affect a company’s revenue potential, approval timelines, and risk profile.

enzyme-linked immunosorbent assay medical

"commercially available ELISA (enzyme-linked immunosorbent assay) test kits"

An enzyme-linked immunosorbent assay (ELISA) is a laboratory test that uses a chemical “tag” to detect and measure specific proteins, antibodies or other molecules in blood or other samples. Like a smoke detector that signals a specific threat, ELISAs tell researchers and companies whether a biological target is present and how much, information that matters for diagnosing disease, validating treatments, ensuring product quality and supporting regulatory approval.

albumin medical

"bind with, and have poor separation from, albumin, a naturally occurring protein"

Albumin is the most common protein in blood, made by the liver; it acts like a sponge that helps keep fluid in blood vessels and like a delivery truck that carries hormones, fats and many drugs around the body. Investors watch albumin levels because low or high values signal liver, kidney or nutritional problems, affect how medicines bind and are dosed, and can influence clinical trial outcomes, hospital costs and demand for related diagnostics or therapies.

505(b)(2) new drug application regulatory

"allowing for an expedited FDA regulatory development pathway known as a 505(b)(2) new drug application"

A 505(b)(2) new drug application is an FDA regulatory pathway that lets a company rely partly on existing data about a previously approved drug or published studies while adding new information about changes like a new formulation, dose, route, or combination. For investors it speeds development and reduces cost and risk compared with entirely new drugs, like remodeling a proven recipe rather than inventing one from scratch, potentially shortening time to market and revenue.

salcaprozate sodium medical

"Of note, the salcaprozate sodium ("SNAC") delivery technology that Novo Nordisk acquired"

Salcaprozate sodium is a pharmaceutical absorption enhancer — a small, water‑soluble compound added to oral drug formulations to help large, normally injected molecules cross the stomach lining into the bloodstream. Like a temporary key that opens a door without changing the lock, it can turn injectable medicines into convenient pills, which can expand patient use, simplify manufacturing and distribution, and materially affect a drug’s market potential and licensing or royalty value to investors.

AI-generated analysis. Not financial advice.

Company Further Examining the Pursuit of the World's First Oral Liraglutide Product

KELOWNA, BC / ACCESS Newswire / February 5, 2026 / Lexaria Bioscience Corp. (NASDAQ:LEXX), (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce final results from Human Pilot Study #5 (GLP-1-H25-5) (the "Study"), which compared oral DehydraTECH-liraglutide ("DHT-LIR") capsules to injected Saxenda^® branded liraglutide ("SAX-LIR").

"We are extremely pleased with the results of Human Pilot Study #5," stated Richard Christopher, CEO of Lexaria. "In addition to achieving the Study's primary safety and tolerability endpoint, we also demonstrated that oral DehydraTECH-liraglutide functioned comparably to traditionally injected liraglutide, consistent with our regulatory development pathway objectives," continued Mr. Christopher. "We now have compiled compelling evidence to further support examining the pursuit of the world's first oral liraglutide product."

The primary results from this Study were issued on June 11, 2025, at which time Lexaria reported a 22.7% reduction in adverse events ("AEs") with DHT-LIR as compared to the SAX-LIR, with a particular emphasis on a 67% reduction in nausea and a 31% reduction in overall gastrointestinal AEs. The differences in measurements of blood glucose, insulin and body weight across most time points were not statistically significantly different, with remarkable similarity in many areas and slight differences in others. Weight loss was experienced by 9 out of 10 people in each Study arm and slightly higher in the Saxenda^® Study arm; though weight loss was not a primary goal of this Study with the very short treatment period of only 1 week with each treatment. Evaluating the safety and tolerability of the oral DHT-LIR capsules relative to injected SAX-LIR was the primary endpoint of this Study. This objective was successfully met with clear signs of improved safety and tolerability performance by the DHT-LIR.

Since mid-2025, Lexaria and its third-party bioanalytical service providers have invested considerable time and expertise in attempting to determine the precise pharmacokinetic ("PK") blood liraglutide quantitation and profiling results from the Study. This included the use of two different manufactured brands of commercially available ELISA (enzyme-linked immunosorbent assay) test kits. Throughout the course of this bioanalytical work, challenges were encountered with background signal noise detection, which complicated our ability to accurately capture blood liraglutide measurements in both the SAX-LIR and DHT-LIR study samples. The background signal noise is believed to be attributable to the fact that liraglutide and other peptide drugs are commonly known to bind with, and have poor separation from, albumin, a naturally occurring protein present in human blood plasma.

In light of this issue, the PK testing from the Study was limited to exploratory visualization of the raw ELISA signals which, nonetheless, over time demonstrated broadly similar temporal patterns between the DHT-LIR and the SAX-LIR. The visualization of the similar signal patterns of the two treatments is consistent with the instances of functional comparability otherwise demonstrated in the Study, pursuant to Lexaria's regulatory development pathway objectives. Lexaria considers this to be particularly noteworthy given the fact that the DHT-LIR dose quantity studied was conservatively low (see "About the Study", below) for this initial human investigation, relative to that of the SAX-LIR, with room for possibly increasing the dose if necessary in potential future studies.

The two most important strategic objectives of this Study were:

1. To discover whether the DehydraTECH processing of liraglutide would work sufficiently enough to potentially allow for an oral version of the drug to be compared to the current injection-only delivery method; and

2. To demonstrate that oral DHT-LIR could produce comparable functional results to the injected version, allowing for an expedited FDA regulatory development pathway known as a 505(b)(2) new drug application (the "505(b)(2) Pathway") that is available when an alternate version of a drug (e.g., the dosage form change from injection to oral administration as tested within this Study) retains certain similar performance characteristics as an earlier-approved version of that same drug.

In both these respects, the results from this Study have shown tremendous promise while also evidencing tolerability advantages from a user appeal perspective.

Saxenda® is owned by Novo Nordisk, which also sells an oral tablet form of the blockbuster GLP-1 drug semaglutide under the brand name Rybelsus^®. Of note, the salcaprozate sodium ("SNAC") delivery technology that Novo Nordisk acquired for $1.8 billion utilized within the Rybelsus^® tablet was found by other researchers to be unfavorable for co-formulation of an oral version of liraglutide. Liraglutide went off patent in 2024 and is now offered in a generic injectable format by Teva Pharmaceuticals and others.

For these reasons, Lexaria is excited about the possibility of establishing DehydraTECH-liraglutide as a brand-new oral liraglutide-dosing alternative to Saxenda^® and the other generic versions of injected liraglutide. Lexaria feels this is an unmet market need which DehydraTECH may empower.

Lexaria has had, and intends to continue, discussions with pharmaceutical companies regarding the possibility of collaborating in pursuing a 505(b)(2) Pathway to enable commercialization of an oral DHT-LIR product. Further details on prospective next steps in development of the DHT-LIR product candidate will be provided when available in due course.

About the Study

Study GLP-1-H25-5 was a pilot, cross-over investigation in 10 overweight (average weight 73 Kg; average body mass index 26.81) volunteers. SAX-LIR injection was administered daily at its commercially available starting dose of 0.6 mg for 7 days with a follow-up evaluation at day 8, compared to oral DHT-LIR (45 mg), also administered daily for 7 days with an identical day 8 evaluation. All drug administrations were performed after an overnight fast. Oral administration was accomplished with a 50 mL glass of water. Blood draws were performed upon the subjects at baseline (pre-dose) and multiple 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 of the Study and, finally, on day 8 without any dosing. Subjects were allowed to consume standardized meals/snacks over the 12 hours post-dosing on the first treatment day at predetermined time intervals. Subjects were allowed to resume their normal diet following fasted dosing on the subsequent treatment days.

The DHT-LIR 45 mg dose equated to a 75-fold multiple of the 0.6 mg SAX-LIR dose exposure tested. This dosing multiple was selected conservatively relative to the 98- to 196-fold dosing multiple currently used with Novo Nordisk's Rybelsus^®-branded semaglutide, whereby a 14 mg Rybelsus^® daily dose is considered to be bioequivalent to a 0.5-1.0 mg once-weekly dose of its Ozempic^®- or Wegovy^®-branded semaglutide injectable products. Accordingly, Lexaria notes that there is arguably room to further titrate the DHT-LIR oral dose upwards in prospective future studies in an effort to most closely match the effectiveness of the injectable regimen consistent with its 505(b)(2) Pathway strategy.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH^™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 60 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

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," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the intended use of proceeds from the offering and relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, market and other conditions, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext. 202

SOURCE: Lexaria Bioscience Corp.

View the original press release on ACCESS Newswire

FAQ

What were the main safety results of Lexaria's Human Pilot Study #5 (LEXX) on February 5, 2026?

DHT-LIR met the primary safety and tolerability endpoint showing a 22.7% reduction in adverse events. According to the company, reductions included 67% less nausea and 31% fewer GI adverse events versus injected Saxenda.

Did Lexaria (LEXX) show that oral DehydraTECH-liraglutide works like injected liraglutide?

Yes, the Study demonstrated functional comparability in many measures between oral DHT-LIR and injected SAX-LIR. According to the company, exploratory ELISA signal patterns were broadly similar across treatments despite PK assay limits.

Why were pharmacokinetic (PK) blood measurements limited in Lexaria's LEXX Study #5?

PK quantitation was complicated by background signal noise in ELISA assays, affecting accurate liraglutide measurement. According to the company, albumin binding of peptide drugs likely contributed to poor separation and elevated assay background.

How did body weight change in Lexaria's Human Pilot Study #5 (LEXX)?

Weight loss occurred in 9 of 10 participants in each study arm, with slightly higher loss in the Saxenda arm. According to the company, the one-week dosing period was short and weight loss was not a primary Study goal.

What regulatory pathway is Lexaria (LEXX) considering for oral DHT-LIR development?

Lexaria is exploring a 505(b)(2) new drug application pathway to leverage comparability with an approved product. According to the company, demonstrating similar performance could enable an expedited regulatory route.

What are Lexaria's next steps after the Human Pilot Study #5 (LEXX)?

Lexaria plans further examination and discussions with pharmaceutical partners about development and commercialization of oral DHT-LIR. According to the company, additional development details and potential collaborations will be provided when available.