Lexaria Releases Additional Results from its Successful Phase 1b Study GLP-1-H24-4

Rhea-AI Summary

Lexaria (NASDAQ:LEXX) published additional final results from its Phase 1b 12-week study GLP-1-H24-4 (126 subjects) comparing four DehydraTECH (DHT) arms to a Rybelsus® control.

Primary endpoint met: DHT test articles showed good safety and tolerability with reductions in total and GI adverse events versus Rybelsus®. Notable secondary/exploratory findings include body-composition differences, sustained plasma CBD and tirzepatide detectability, and meaningful blood pressure reductions in the DHT-CBD arm.

Positive

• Primary endpoint met: safety/tolerability improved versus Rybelsus®
• GI adverse events reduced versus Rybelsus® (clear reduction reported)
• DHT-CBD arm blood pressure −4.6/−4.0 mmHg (systolic/diastolic) at week 4
• Plasma CBD quantifiable through week 16 in DHT-CBD arms
• 126 participants enrolled in GLP-1-H24-4

Negative

• DHT-semaglutide fat mass change −1.08 kg vs Rybelsus® −3.55 kg at week 12
• DHT-semaglutide lean mass loss −0.41 kg vs Rybelsus® −1.72 kg at week 12
• Plasma semaglutide not quantifiable by LCMS in DHT arms due to assay recovery issues
• Plasma tirzepatide quantifiable only through week 12 (Cmax at week 8)

Key Figures

Study participants 126 volunteers/patients GLP-1-H24-4 overweight, obese, pre-diabetic and/or type-2 diabetic

DHT-semaglutide fat loss −1.08 kg Numerical LSM reduction in fat mass at week 12

Rybelsus fat loss −3.55 kg Numerical LSM reduction in fat mass at week 12

DHT-CBD BP change −4.6 / −4.0 mmHg Week 4 mean systolic/diastolic change in DHT-CBD arm

DHT-CBD BP follow-up −2.6 / −3.0 mmHg Week 16 follow-up mean systolic/diastolic change

Lean mass loss DHT −0.41 kg Numerical LSM lean mass change at week 12 (DHT-semaglutide)

Lean mass loss Rybelsus −1.72 kg Numerical LSM lean mass change at week 12 (Rybelsus control)

Study report size >7,000 pages Final and complete GLP-1-H24-4 Study report length

Market Reality Check

$0.6170 Last Close

Volume Volume 756,027 is below the 20-day average of 1,450,396, indicating subdued trading interest relative to typical activity. low

Technical Shares at $0.56 are trading below the 200-day MA of $1.06 and remain 76.95% under the 52-week high.

Peers on Argus 1 Up

LEXX gained 5.48% while close peers were mixed: ASBP up 0.65%, NRXS up 7.97%, but CING, CRIS and PMN down between about 1.89% and 3.09%, suggesting a stock-specific reaction to the new Phase 1b data.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 23	Clinical trial update	Positive	-8.0%	Phase 1b GLP-1-H24-4 met primary safety endpoint with fewer adverse events.
Dec 16	Equity financing	Negative	-5.6%	Closed $3.5M registered direct offering with concurrent warrant issuance.
Dec 15	Equity financing	Negative	-33.6%	Announced $3.5M registered direct offering and private placement of warrants.
Nov 18	Equity financing	Negative	+4.0%	Entered agreement for $4.0M registered direct and private placement financing.
Nov 12	Partnership update	Positive	+1.8%	Extended Material Transfer Agreement with pharma partner through Apr 30, 2026.

Pattern Detected

Recent capital raises have generally led to negative price reactions, while positive clinical or partnership updates have produced mixed outcomes, with notable divergences where favorable trial results coincided with share price declines.

Recent Company History

Over the last few months, Lexaria has combined clinical progress with repeated equity financings. On Dec 23, 2025, the company reported that GLP-1-H24-4 met its primary safety and tolerability endpoint with reduced adverse events versus Rybelsus, yet the stock fell 8.01%. Multiple registered direct offerings in mid-December and earlier in November raised capital but triggered sharp declines. In contrast, the Nov 12, 2025 MTA extension with a pharmaceutical partner saw a modest positive reaction, showing that partnership news has been better received than dilution events.

Market Pulse Summary

This announcement expands on GLP-1-H24-4 by highlighting body composition, blood pressure and quality-of-life measures across DehydraTECH-based arms versus Rybelsus®. The data complement the prior primary endpoint success, showing comparable metabolic effects and intriguing blood pressure signals for DHT-CBD. Recent history also includes multiple registered direct offerings and an extended Material Transfer Agreement through April 30, 2026, so investors may track how partners respond to the full dataset and how future financings intersect with ongoing clinical work.

Key Terms

semaglutide medical

"While both DHT-semaglutide and Rybelsus® reduced body weight during the Study..."

Semaglutide is a medication originally developed to help manage blood sugar levels in people with diabetes, but it also promotes weight loss. It works by mimicking a natural hormone that helps control appetite and insulin release. For investors, its potential to influence healthcare and weight management markets makes it a significant product in the pharmaceutical industry.

tirzepatide medical

"In the DHT-tirzepatide arm, plasma tirzepatide concentrations were quantifiable only..."

Tirzepatide is a prescription medicine that helps lower blood sugar and reduce appetite by activating two hormones that regulate insulin and hunger; think of it as a two-in-one switch that calms the body’s sugar spikes and decreases cravings. Investors watch it because regulatory approvals, clinical results, pricing and patient demand determine sales potential and competitive impact on companies in diabetes and obesity treatment markets.

cannabidiol medical

"it was noteworthy that the DHT-cannabidiol ("DHT-CBD") arm achieved meaningful..."

Cannabidiol (CBD) is a natural compound found in cannabis and hemp plants that does not produce a “high.” Investors watch CBD because it is the active ingredient in many health, wellness, and consumer products, and its value depends on shifting rules, clinical evidence, product approvals, and consumer demand—much like a key ingredient in a popular food or drug that determines shelf placement, pricing, and sales potential.

dual-energy, x-ray absorptiometry medical

"using the dual-energy, X-ray absorptiometry / Bioelectrical Impedance Analysis methodology..."

A medical imaging test that uses two different X‑ray energy levels to measure bone density and body composition, giving a precise picture of how much mineral is in bones and how fat and lean tissue are distributed. Investors care because the test drives demand for diagnostic devices, supports drug and device approval or reimbursement decisions, and is a key tool in evaluating treatments for bone and metabolic diseases—think of it as a very accurate scale and scanner for the body’s internal makeup.

bioelectrical impedance analysis medical

"dual-energy, X-ray absorptiometry / Bioelectrical Impedance Analysis methodology, at week 12..."

A noninvasive method that estimates body composition by sending a tiny, harmless electrical signal through the body and measuring how easily it passes; tissues with more water (like muscle) conduct electricity better than fatty tissue, so the device uses that difference to estimate fat, muscle and hydration. Investors care because the accuracy, regulatory approval and consumer trust in these devices affect sales and adoption of scales, wearables and medical tools—essentially the product’s market value and growth potential.

liquid chromatography mass spectrometry technical

"using a validated liquid chromatography mass spectrometry ("LCMS") assay..."

Liquid chromatography–mass spectrometry is a lab technique that first separates a mixture into its individual chemical components (like sorting letters into piles) and then measures and identifies those components (like scanning and weighing each letter). Investors care because it is a key tool for confirming drug composition, detecting impurities, measuring biomarkers and ensuring product quality and regulatory compliance, so its use or improvement can materially affect R&D progress, safety and market clearance.

enzyme-linked immunosorbent assay medical

"a separately performed, enzyme-linked immunosorbent assay ("ELISA") upon a subset..."

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.

AI-generated analysis. Not financial advice.

KELOWNA, BC / ACCESS Newswire / December 30, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following additional secondary and exploratory endpoint final results update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study" or the "Lexaria Study"), recently completed in Australia, focusing on 4 DehydraTECH™ ("DHT") study arms relative to the Rybelsus® control study arm.

"We are pleased to report additional data from our first Phase 1b clinical study," stated Richard Christopher, CEO of Lexaria. "It adds to a growing dataset which showcases the many potential benefits of our platform technology - DehydraTECH."

"At our stage of development, clinical data is of paramount importance to us," continued Mr. Christopher. "Lexaria's "follow the science" approach and the positive results from this Study are already guiding our 2026 R&D plans as well as our business development initiatives. We are expecting exciting developments in 2026 and beyond."

Secondary Efficacy Parameters
At week 16, rough parity was reached between the DHT arms and the Rybelsus® control as there were no statistically significant treatment differences observed in terms of the numerical least squares means ("LSM") changes from baseline in the secondary efficacy parameters of mean fasting glucose, cholesterol, and low density lipoprotein ("LDL") cholesterol specifically (nominal p-values were >0.05).

Body Composition
While both DHT-semaglutide and Rybelsus® reduced body weight during the Study, it was noteworthy that upon a separate body composition analysis performed in the Study using the dual-energy, X-ray absorptiometry / Bioelectrical Impedance Analysis methodology, at week 12, the DHT‑semaglutide arm showed a modest numerical LSM reduction in fat mass of −1.08 kg and in total mass of −1.40 kg, accompanied by minimal reduction in lean mass of −0.41 kg. In contrast, the Rybelsus® control arm achieved greater LSM reductions in fat mass of −3.55 kg and in total mass of −5.36 kg, but also had a notably higher reduction in lean mass of −1.72 kg. This finding is considered intriguing as it possibly points to proportionally lower lean mass to fat mass bodyweight reduction potential being achievable with DHT-semaglutide (37.96% as compared to 48.45% for Rybelsus®).

Blood Pressure Analyses
While blood pressure analysis was not formally an efficacy endpoint of the Study, it was noteworthy that the DHT-cannabidiol ("DHT-CBD") arm achieved meaningful reductions in blood pressure. This is of special interest since the Study participants were not generally hypertensive (i.e., hypertension was not a recruitment requirement in this Study).

At week 4, a mean change of −4.6 mmHg in systolic blood pressure and −4.0 mmHg in diastolic blood pressure was evidenced in the DHT-CBD arm. Blood pressure reductions were also evident in this arm following completion of treatment at the week 16 follow up point (4 weeks after cessation of treatment) with a mean change of −2.6 mmHg in systolic blood pressure and −3.0 mmHg in diastolic blood pressure reported.

These findings are very encouraging relative to Lexaria's separate program interests in pursuing development of DHT-CBD for the treatment of hypertensive patients. Lexaria has earlier received FDA clearance to conduct a Phase 1b study to investigate this phenomenon more thoroughly.

Pharmacokinetic Exploratory Analyses
Blood plasma level analyses of CBD, semaglutide and tirzepatide were performed for all patients as applicable using a validated liquid chromatography mass spectrometry ("LCMS") assay. In the DHT‑CBD alone and DHT‑CBD with DHT‑semaglutide arms, plasma CBD concentrations were quantifiable through week 16. In the DHT-tirzepatide arm, plasma tirzepatide concentrations were quantifiable only through week 12, with the maximum plasma concentrations observed at week 8. Plasma semaglutide concentrations were not quantifiable in the DHT-semaglutide and DHT-CBD with DHT-semaglutide arms. This was believed to be due to unforeseen LCMS assay issues affecting blood plasma recovery and detection for DHT-delivered semaglutide, not applicable to the Rybelsus® delivered semaglutide. However, preliminary testing using a separately performed, enzyme-linked immunosorbent assay ("ELISA") upon a subset of patient blood plasma samples from these DHT arms did detect clearly recoverable/measurable semaglutide levels. Based on this, additional testing is in process on the full complement of patient blood plasma samples from these arms.

Short Form 36 Health Survey
The short form 36 health survey ("SF-36") is a widely administered questionnaire designed to allow persons to self-report their perceived health status assessing health-related quality of life parameters across eight domains (i.e., physical/role functioning, bodily pain, general health, vitality, mental health, social functioning). In this Study, participants were asked to complete the SF-36 upon the completion of dosing. Those participants in the Rybelsus® control Study arm reported modest mean improvements ranging from 2.39 to 4.35 points or no changes (neither worsening nor improving); whereas those participants receiving the DHT-semaglutide arm reported mean improvements of >5 points in the physical components and >3 points in the mental components.

It is not known specifically why the DHT-semaglutide participants self-reported better SF-36 survey results than the Rybelsus®-only participants, but it may be at least in part linked to the reduction in adverse events ("AE's"), as noted in our December 23, 2025 press release.

Overall Conclusions and Next Steps
As previously announced, study GLP-1-H24-4 met its primary endpoint objectives showing good safety and tolerability of all DHT test articles with clear reductions in total and gastrointestinal ("GI")-specific AEs relative to the Rybelsus® control arm. The Study demonstrated positive findings across numerous parameters with comparability, and in some instances, superiority to the Rybelsus® control arm.

Shareholders and interested parties should note that the final and complete Study report is in excess of 7,000 pages long. When Lexaria communicates that a great deal of information must be reviewed prior to this public dissemination or via partner review, the enormity of this data set should always be considered.

Based on the findings from this Study, Lexaria considers the DHT-semaglutide test article to be most worthy of continued investigation for the therapeutic indication studied. However, it would seem most prudent for any such work to include the salcaprozate sodium ("SNAC") ingredient chemistry present in Lexaria's DHT-semaglutide formulations originally tested in its previous human clinical studies GLP-1-H24-1 and GLP-1-H24-2, (Human Pilot Studies #1 and #2), but not included in the current Study. These previous human clinical studies evidenced the strongest DHT-semaglutide efficacy performance superior to the Rybelsus® control used therein, while also maintaining improvements in safety and tolerability relatively speaking with the DHT-semaglutide formulation studied.

Moving forward, Lexaria intends to consider its options to perform prospective follow on human clinical testing with a DHT + SNAC + semaglutide composition compared to Rybelsus® accordingly, to expand and build upon the learnings in aggregate from studies GLP-1-H24-1, GLP-1-H24-2 and GLP-1-H24-4. Details will be provided on this if/when Lexaria formalizes plans to perform such a study.

In parallel, now that public release of final results from study GLP-1-H24-4 has occurred, Lexaria is taking steps to proceed with relaying the dataset to the pharmaceutical company ("PharmaCo") that Lexaria has a Material Transfer Agreement ("MTA") in place with. As previously announced, this MTA was recently extended through April 30, 2026 to accommodate time needed for PharmaCo's receipt and review of this dataset, after which time further information will be provided.

Lexaria remains hopeful that achievement of its primary endpoint in the current Study, with DHT evidencing superior safety and tolerability and a significant reduction in GI side effects especially relative to Rybelsus®, will be considered attractive and compelling to PharmaCo in its deliberations about potential next steps in its relationship with Lexaria. This would be consistent with the pharmaceutical industry's strong appetite in the related therapeutic sectors for improvements in unwanted side effects as Lexaria previously reported.

Lexaria was pleased to have recently raised additional capital through financings intended to allow it to fund prospective new development opportunities through the entirety of calendar 2026; the details of which are in the process of being finalized and will be forthcoming in due course. Deployment of these funds may include, but not be limited to, progressing its prospective further human clinical testing upon DHT + SNAC + semaglutide as noted above, as well as supporting other complementary research and development program work in the Glucagon-Like Peptide-1 ("GLP-1") sector.

About the Study
Study GLP-1-H24-4 investigated 126 overweight, obese, pre-diabetic and/or type-2 diabetic human volunteers/patients. The primary endpoint in this study was to assess impacts upon safety and tolerability based on the incidence of treatment emergent adverse events. This Study initially included 3 DHT arms testing DHT-CBD, DHT-semaglutide and a combination of DHT-CBD with DHT-semaglutide. Performance across these three initial study arms was monitored compared to commercially available Rybelsus® as the Study positive control group. Of note, the DHT-semaglutide composition evaluated used pure semaglutide processed without inclusion of the SNAC ingredient found in the Rybelsus® composition differing, therefore, from the DHT-semaglutide composition previously tested by Lexaria in its studies GLP-1-H24-1 and GLP-1-H24-2 that used reformulated commercially available SNAC-inclusive Rybelsus® as the semaglutide active substance input. In addition, this Study was expanded after initiation to incorporate an orally delivered DHT-tirzepatide arm to assess safety, tolerability and effectiveness in an effort to potentially advance the findings discovered with Lexaria's previous DHT-tirzepatide human pilot study GLP-1-H24-3. Of note, however, the DHT-tirzepatide composition evaluated in study GLP-1-H24-4 used pure tirzepatide as the active substance input instead of reformulated commercially available Zepbound® differing, therefore, compared to the composition utilized in study GLP-1-H24-3.

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 over 50 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 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, 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 did Lexaria announce about its Phase 1b GLP-1-H24-4 study for LEXX on December 30, 2025?

Lexaria reported final secondary and exploratory results from GLP-1-H24-4 (126 subjects), confirming safety/tolerability and reduced GI adverse events for DHT arms versus Rybelsus®.

How did DHT-CBD affect blood pressure in Lexaria's GLP-1-H24-4 study (LEXX)?

The DHT-CBD arm showed mean reductions of −4.6 mmHg systolic and −4.0 mmHg diastolic at week 4, with sustained reductions at week 16.

What were the body-composition results for DHT-semaglutide versus Rybelsus® in the LEXX study?

At week 12, DHT-semaglutide LSM changes: fat −1.08 kg, total −1.40 kg, lean −0.41 kg; Rybelsus®: fat −3.55 kg, total −5.36 kg, lean −1.72 kg.

Were semaglutide and tirzepatide measurable in Lexaria's GLP-1-H24-4 pharmacokinetic analyses?

Plasma tirzepatide was quantifiable through week 12 (Cmax at week 8); semaglutide was not quantifiable by LCMS in DHT arms due to assay recovery issues but was detected by ELISA in a subset.

What are Lexaria's next steps after the GLP-1-H24-4 results for LEXX?

Lexaria plans to pursue follow-up work, considering DHT + SNAC + semaglutide formulations and sharing the dataset with its PharmaCo under an extended MTA through April 30, 2026.