Gelteq Preclinical Study Demonstrates Enhanced Oral Delivery of Oil-Soluble and Poorly Soluble Drugs Using Its Gel-Based Platform

Rhea-AI Summary

Gelteq (ASX:GELS) reported preclinical results showing its proprietary gel platform improved oral delivery of oil-soluble and poorly soluble drugs.

Key findings: a 300% increase in bioavailability within the first hour versus an existing FDA‑approved reference product and >20% higher overall absorption over 24 hours. Studies showed uniform small‑intestinal distribution, controlled GI transit, targeted release, effective absorption, and full clearance of API and gel material.

The company says the platform may reduce emulsifier needs, enhance bioavailability, and help reformulate challenging molecules across multiple therapeutic areas.

Positive

• 300% first‑hour bioavailability increase versus FDA reference
• > 20% higher overall absorption over 24 hours versus FDA reference
• Uniform intestinal distribution supporting broader mucosal absorption
• Full clearance of API and gel material observed in GI transit study

Negative

• Results are preclinical, not yet demonstrated in human clinical trials

Key Figures

Early bioavailability gain 300% increase Bioavailability across the first hour vs FDA-approved reference product

24-hour absorption gain More than 20% improvement Overall 24-hour absorption vs FDA-approved reference product

First-hour window First 1 hour Critical period for rapid onset of action in preclinical study

Extended window 24 hours Evaluation period for overall absorption improvement

Approved drugs affected More than 40% Share of approved drugs with poor solubility and bioavailability

Development candidates affected Up to 90% Share of developmental candidates with poor solubility and bioavailability

Market Reality Check

$1.03 Last Close

Volume Volume 45,349 is far below the 20-day average of 3,029,172 (relative volume 0.01). low

Technical Price at $1.03, trading below the 200-day MA of $1.46 and 81.27% under the 52-week high.

Peers on Argus

While GELS was down 4.63%, several peers such as FLGC, TXMD, AYTU, and IMCC showed gains between 3.04% and 4.43%, with only TLPH down 2.67%, indicating a stock-specific move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Investor conference	Positive	+3.9%	Announcement of virtual investor summit presentation and upcoming catalysts discussion.
Nov 24	Preclinical data update	Positive	+20.4%	Positive preclinical PK data showing increased exposure for a water-soluble antihistamine.
Oct 23	Trial commencement	Positive	+23.0%	Start of preclinical animal trial for oily and poorly soluble drugs with Monash University.
Oct 09	Partnership agreement	Positive	+6.3%	Product development and profit share agreement with Melbourne Health for HAMSB products.
Sep 12	Commercial launch	Positive	+6.7%	U.S. launch of nutraceutical products via Healthy Extracts partnership, marking commercialization.

Pattern Detected

Recent fundamentally positive news has often aligned with strong positive price reactions.

Recent Company History

This announcement adds further preclinical validation for Gelteq’s gel-based oral delivery platform, now showing benefits for oil-soluble and poorly soluble drugs. Earlier news in September 2025 highlighted initial U.S. commercialization in nutraceuticals, followed by an October agreement with Melbourne Health for a bowel polyp program. On October 23, 2025, Gelteq began a preclinical trial in oily drugs, and on November 24, 2025 reported positive pharmacokinetic results for a water-soluble antihistamine. A December 2, 2025 investor conference appearance supports ongoing outreach, even as the current price sits well below the 52-week high.

Market Pulse Summary

This announcement adds preclinical evidence that Gelteq’s gel platform improves oral delivery of oil-soluble and poorly soluble drugs, with a reported 300% first-hour bioavailability increase and over 20% better 24-hour absorption versus an approved product. It complements earlier data in water-soluble antihistamines and ongoing commercial and partnership activity. Investors may track further preclinical and clinical milestones, business development traction, and disclosures in filings like the 20-F, which has highlighted ongoing losses and funding needs.

Key Terms

bioavailability medical

"with a 300 percent increase in bioavailability across the first hour."

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

API medical

"clearance of both the active pharmaceutical ingredients (API) and the gel"

An API, or Application Programming Interface, is a set of rules that allows different software programs to communicate and work together smoothly, much like a waiter translating your order into the kitchen and then bringing your meal back. For investors, APIs are important because they enable real-time access to financial data, trading systems, and other digital services, making it easier to make informed decisions quickly and efficiently.

AI-generated analysis. Not financial advice.

MELBOURNE, Australia, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq” or the “Company”), a clinical and science-based developer of advanced gel-based oral delivery systems, today announced preclinical findings demonstrating the effectiveness, flexibility, and safety profile of its proprietary gel platform. The results address a major challenge in pharmaceutical development and demonstrate that Gelteq’s technology can enhance the oral delivery of oil-soluble and poorly soluble drugs.

Across two complementary preclinical studies, the results showed a more rapid absorption of an oil soluble compound in Gelteq’s gel base compared to an existing FDA approved reference product, with a 300 percent increase in bioavailability across the first hour. High bioavailability in the first hour is critical for rapid onset of action.

Further results demonstrated that the oil soluble compound wasn’t just more rapidly absorbed in Gelteq’s gel base, but the overall absorption was also improved. Over 24 hours, the absorption was improved by more than 20 percent overall compared to an existing FDA approved reference product. These findings further illustrate that Gelteq’s gel matrix can support the delivery of lipophilic compounds whilst moderating the need for high levels of emulsifiers.

The study results also demonstrate that Gelteq’s platform enables controlled movement through the digestive system, targeted release, and effective absorption while maintaining full clearance of both the active pharmaceutical ingredients (API) and the gel material itself.

The GI transit evaluation demonstrated that the gel disperses the active ingredient uniformly along the small intestine. This extended distribution behaviour supports improved absorption through both mucoadhesive interactions and the presentation of the drug across a larger intestinal surface area.

The studies also showed that the gel can be formulated to allow efficient transit and rapid early absorption of the API. The gel’s structural matrix dispersed and cleared effectively to the large intestine, reinforcing the platform’s safety and compatibility with oral administration.

These combined findings highlight Gelteq’s potential to provide a new and more versatile alternative to existing oral delivery approaches for oil-soluble and poorly soluble drugs.

With more than 40 percent of approved drugs and up to 90 percent of developmental candidates affected by poor solubility and bioavailability, the industry continues to invest billions of dollars¹ annually in new technologies to overcome these issues. Gelteq’s platform offers a streamlined solution that may reduce developmental burdens, enhance bioavailability, and open pathways to revive previously shelved or challenging molecules.

Therapeutic areas most likely to benefit from Gelteq’s gel-based delivery system include neurology, inflammation and pain management, hormonal therapies, cardiovascular medicine, nutraceuticals, weight management, oncology and veterinary health - categories where lipid-based or poorly soluble APIs are common and where improved absorption could meaningfully enhance clinical performance.

By enabling more consistent absorption, targeted delivery, reduced excipient reliance, and strong safety characteristics, the gel-based delivery system positions Gelteq as a valuable development partner for pharmaceutical and nutraceutical companies seeking to reformulate existing assets or address complex formulation challenges in their pipelines.

About Gelteq Ltd.

Headquartered in Melbourne, Australia, Gelteq (NASDAQ: GELS) is a biotechnology company that has developed a novel drug delivery platform in an ingestible gel form. Gelteq specializes in the formulation, development and manufacturing of gel products for licensed partners across pharmaceutical, consumer health and animal health markets. The proprietary formulation technology aims to address challenges associated with conventional drug and nutrient delivery by enhancing bioavailability, improving patient compliance, and enabling precise dosing. For more information, visit www.gelteq.com.

Gelteq Contact:
Investor Relations
Matt Kreps, Darrow Associates IR
+1-214-597-8200
mkreps@darrowir.com

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained herein are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied in such statements. For a discussion of these risks and uncertainties, refer to Gelteq’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F filed on November 17, 2025. Gelteq undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.

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¹ Solubility Enhancement Excipients Market Size 2025-2032

FAQ

What did Gelteq (GELS) announce on December 5, 2025 about its gel platform?

Gelteq announced preclinical studies showing a 300% increase in first‑hour bioavailability and >20% higher 24‑hour absorption versus an FDA‑approved reference product.

How much did Gelteq's gel increase early absorption in the preclinical study for GELS?

The gel base produced a 300% increase in bioavailability across the first hour versus the reference product.

Does Gelteq (GELS) show full clearance of the gel material in studies?

Yes; studies reported the gel matrix dispersed and cleared effectively, with full clearance of both the API and gel material.

What clinical stages are Gelteq's (GELS) results currently in?

The results are from preclinical studies and have not yet been demonstrated in human clinical trials.

Which drug types could benefit from Gelteq's GELS gel‑based delivery system?

Therapeutic areas listed include neurology, inflammation and pain, hormonal therapies, cardiovascular medicine, nutraceuticals, weight management, oncology and veterinary health.

How might Gelteq's (GELS) platform affect formulation needs for lipid‑based APIs?

The company reported the gel can support lipophilic delivery while moderating the need for high levels of emulsifiers.