Gelteq Announces Positive Preclinical Results Showing Increased Medicinal Cannabinoid Absorption Using Its Oral Gel Delivery Platform

Gelteq (GELS) announced positive preclinical results on Jan 13, 2026 showing its oral gel delivery platform increased cannabidiol (CBD) absorption versus an FDA-approved oil product.

Rhea-AI Summary

Gelteq (GELS) announced positive preclinical results on Jan 13, 2026 showing its oral gel delivery platform increased cannabidiol (CBD) absorption versus an FDA-approved oil product. Gelteq reported a greater than 22% increase in bioavailability and a higher peak exposure despite using a lower CBD concentration. The company says the platform enables precise, pre-measured dosing, faster uptake, and a non-invasive alternative to vaping.

Gelteq highlighted the Special Access Scheme (SAS) as a potential expedited pathway to earlier patient access in Australia and a stepping stone for global commercial partnerships and licensing opportunities.

Positive

• Bioavailability +22% versus an FDA-approved oil
• Higher peak exposure despite lower CBD concentration
• Potential expedited market entry via SAS in Australia enabling earlier patient access

Negative

• Data are preclinical and preliminary, not human clinical efficacy results

Argus Jan 13 session

+6.44% close to close Open Argus

Details

News Market Reaction – GELS

In the Jan 13 session, GELS gained 6.44%, reflecting a notable positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with pas...

Analysis

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with past patterns where favorable preclinical data and commercial updates often preceded gains, including moves of up to 20.39%. The cannabinoid-specific bioavailability lift of more than 22% reinforces the platform story. However, persistent operating losses of about AUD $6.6M in FY 2025 and reliance on external partners highlight financing and execution risks that could limit durability.

Key Figures

CBD bioavailability increase: >22% Minimum annual order commitments: USD $1.3 million Minimum expected revenue: USD $1.3 million +5 more

CBD bioavailability increase

>22%

Preclinical oral gel vs FDA-approved oil-based CBD product

Minimum annual order commitments

USD $1.3 million

China-focused sales agreement cited Dec 16, 2025

Minimum expected revenue

USD $1.3 million

Three-year Shenzhen Mana Health agreement term

Bioavailability increase (first hour)

300%

Preclinical oil-soluble drug study vs FDA-approved reference

Overall absorption increase

>20%

24-hour absorption vs FDA-approved reference product

Systemic exposure increase (AUC)

38–45%

Preclinical study vs leading marketed antihistamine

Net loss FY 2025

AUD $6,645,453

Year ended June 30, 2025 (Form 20-F)

Net loss FY 2024

AUD $3,546,195

Year ended June 30, 2024 (Form 20-F)

Historical Context

5 past events · Latest: Dec 16

5 events

1. Dec 16

   Sports partnership

   24h Move

   +0.1%

   Partnership with Hong Kong Flag Football and Asia commercial traction.

2. Dec 09

   China sales deal

   24h Move

   -0.9%

   Three-year China sales agreement with minimum order volumes.

3. Dec 05

   Preclinical platform data

   24h Move

   +5.8%

   Preclinical data showing improved delivery of oil-soluble drugs.

4. Dec 02

   Investor conference

   24h Move

   +3.9%

   CEO presentation on growth strategy and upcoming catalysts.

5. Nov 24

   Preclinical bioavailability

   24h Move

   +20.4%

   Preclinical AUC and Cmax improvements versus marketed antihistamine.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

bioavailability, special access scheme, therapeutic goods administration, preclinical, +4 more

8 terms

bioavailability medical

"enhances the absorption and bioavailability of cannabidiol (“CBD”)"

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.

special access scheme regulatory

"via the Special Access Scheme (“SAS”) which could position Gelteq"

A special access scheme is a regulated program that lets doctors obtain and use medicines, devices or treatments that are not yet fully approved for the general market for individual patients with unmet medical needs. For investors, it matters because such access can provide early real‑world use and safety data, possible limited revenue, and a market signal of demand — like allowing select customers to test‑drive a product before its full launch, while also carrying regulatory and reputational risks.

therapeutic goods administration regulatory

"without the products undergoing the full Therapeutic Goods Administration (“TGA”) approval process"

The Therapeutic Goods Administration is the Australian government agency that assesses and regulates medicines, medical devices, vaccines and other health products for safety, quality and effectiveness before they can be marketed. For investors, a TGA decision is like a building inspector’s sign-off: approval opens access to the Australian market and can unlock sales and valuation, while delays, restrictions or safety warnings can limit revenue, force product changes or raise compliance and legal costs.

preclinical medical

"announced positive results from a recently completed preclinical study"

Preclinical describes the stage of drug or medical-product development when researchers test a candidate in the lab and in animals to see if it is safe, reaches intended targets, and shows basic effectiveness before any human trials begin. For investors, preclinical status signals an early, higher‑risk opportunity where positive lab results can increase value but significant work, time, and regulatory hurdles remain — like proofing a prototype in a workshop before road testing.

pharmacokinetic medical

"announced positive preclinical pharmacokinetic results on Nov 24, 2025"

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.

systemic exposure medical

"showing its proprietary gel formulation produced a 38–45% increase in systemic exposure (AUC)"

Systemic exposure refers to the level of risk that an individual or organization faces from potential problems within the entire financial system. It is like the amount of water in a boat that could be affected if the boat’s hull develops a leak; the more exposed, the greater the potential impact from widespread issues. Understanding systemic exposure helps investors gauge how vulnerable they might be to large-scale financial disruptions.

cmax medical

"plus markedly higher Cmax and a comparable Tmax"

Cmax is the highest concentration of a drug measured in the bloodstream after a dose, like the peak of a wave after a stone is dropped into water. It matters to investors because that peak helps regulators and doctors judge safety and likely effectiveness, informs dosing schedules, and is used to compare formulations or generics—data that can affect a drug’s approval, marketability, and commercial value.

tmax medical

"plus markedly higher Cmax and a comparable Tmax"

tmax is the time after a drug is taken when its level in the blood reaches its highest point. Investors care because it shows how quickly a medicine begins to act and can influence dosing convenience, side effects and market appeal — similar to how quickly coffee kicks in affects whether someone likes it and uses it regularly.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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MELBOURNE, Australia, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Gelteq Limited (“Gelteq” or the “Company”), a clinical and science-based developer of advanced gel-based oral delivery systems, today announced positive results from a recently completed preclinical study which evaluated medicinal cannabinoids delivery through the Company’s proprietary oral gel platform. The findings demonstrate that Gelteq’s platform significantly enhances the absorption and bioavailability of cannabidiol (“CBD”) compared to an existing FDA approved oil-based product. The preliminary results reinforces our platform’s potential to change how medicinal cannabis is delivered and experienced by patients.

Despite having a much lower concentration of CBD, Gelteq’s formulation achieved greater than 22% increase in bioavailability along with a higher peak exposure. As such, the results demonstrate that our oral gel platform enhances the delivery of lipophilic cannabinoid molecules and delivers more efficient uptake in the body. These results create a clear pathway for a potential expedited market launch of new medicinal cannabis products in Australia via the Special Access Scheme (“SAS”) which could position Gelteq for efficient entry into additional global markets. The SAS is an Australian Government program that allows authorised healthcare practitioners to prescribe medicinal cannabis products to patients without the products undergoing the full Therapeutic Goods Administration (“TGA”) approval process. As a resault, the SAS could potentially grant our oral gel platform earlier patient access and a faster pathway to market.

A Major Advancement for Medicinal Cannabis Patients

These results represent a meaningful step forward for patients who rely on medicinal cannabis, extracts or cannabinoids for therapeutic outcomes. Traditional products such as CBD oils and vapes often present challenges which include variable dosing, slow onset, inconsistent absorption, unpleasant taste, and inhalation-related risks. Gelteq’s oral gel platform overcomes these limitations by offering a safer, predictable and more convenient alternative.

As Gelteq’s oral gel platform improves bioavailability, patients may achieve therapeutic effects with lower doses which could reduce exposure to unnecessary excipients or cannabinoids. The oral gel format enables pre-measured and precise dosing with no use of droppers and no reliance on food timing which enables treatment consistentency and greater convenience.

Importantly, the gel also provides a non-invasive alternative to vaping which is expected to alleviate concerns around respiratory irritation or long-term inhalation safety. The ease of administration also makes the gel well-suited for patient groups that traditionally struggle with oils or capsules such as paediatric, geriatric, and palliative-care populations.

A Potential Commercial Breakthrough for Gelteq in the Global Medicinal Cannabis Sector

We believe the preliminary results could open the door to significant global commercial opportunities. Medicinal cannabis is one of the fastest-growing therapeutic markets worldwide¹ and product differentiation is increasingly driven by delivery innovation. With the ability to enhance absorption, simplify dosing, and improve patient experience, Gelteq’s oral gel platform could enable cannabis producers to improve their offerings beyond conventional oils, vapes or tinctures.

Importantly, the study’s outcome means that Gelteq could directly partner with medicinal cannabis companies without the need for additional studies for this product format. This could accelerate potential licensing, white-label manufacturing, and co-development opportunities across a range of cannabinoid-based products which includes CBD, THC, balanced ratios, minor cannabinoids, and even combination cannabinoid–nutraceutical formulations.

The Australian government’s SAS program could also enable Gelteq to bring products to market more rapidly which could generate early revenues and establish a viable product to support broader international expansion.

Positioning Gelteq as a Leader in Advanced Oral Delivery Solutions

The improved bioavailability of medicinally relevant cannabinoids as delivered by our oral gel platform further validates Gelteq’s position in advanced oral-delivery technologies. By enabling a simpler and more effective cannabinoid administration, our oral gel platform aims to support the next generation of medicinal cannabis products designed around patient needs and meet modern clinical expectations.

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

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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.

1. Business Research Insights. (2025). Medicinal Cannabis Market Size, Share, Growth, and Industry Analysis, by Type (Tetrahydrocannabinol (THC) and Cannabidiol (CBD)), by Application (pain, arthritis, neurological disease and other), and Regional Forecast to 2035.
   

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Gelteq (GELS) announce on Jan 13, 2026 about CBD absorption?

Gelteq reported preclinical data showing its oral gel produced a greater than 22% increase in CBD bioavailability versus an FDA-approved oil.

How could Gelteq's Jan 2026 results affect time to market for GELS products in Australia?

The company said the Special Access Scheme (SAS) could enable earlier patient access and a faster pathway to market in Australia.

Does Gelteq's oral gel use higher CBD doses to achieve better exposure?

No; Gelteq reported higher peak exposure despite a much lower concentration of CBD in its formulation.

Are Gelteq's Jan 2026 findings clinical proof of efficacy for GELS products?

No; the announcement describes preclinical, preliminary results, not completed human clinical trials.

What commercial opportunities did Gelteq cite after the Jan 13, 2026 results for GELS?

Gelteq highlighted potential licensing, white-label manufacturing, and co-development opportunities with medicinal cannabis companies.