Gelteq Initiates Preclinical Trial for Innovative Drug Delivery Technology

Gelteq Limited, a company based in Melbourne, Australia, has announced the commencement of a preclinical animal trial aimed at evaluating its proprietary technology designed to enhance the delivery of oily and poorly soluble drugs. This initiative is being conducted in collaboration with the Monash University Institute of Pharmaceutical Science, a prominent institution in the field of pharmaceutical research and development.

“The effective oral delivery of oily and poorly soluble drugs is one of the most significant challenges facing drug development and commercialization today,” stated Nathan Givoni, the CEO of Gelteq. He emphasized that over 40% of drugs currently on the market, along with up to 90% of new drug candidates, encounter issues related to low solubility and inconsistent bioavailability. These challenges often lead to the need for higher doses, increased risk of side effects, and variable outcomes for patients.

Gelteq aims to utilize its formulation expertise to fully exploit the potential of these challenging drug types, reviving previously shelved molecules and creating enhanced value for partners within the global pharmaceutical sector.

Each year, pharmaceutical companies allocate over USD $4 billion to developing technologies that improve the delivery of oily and poorly soluble drugs. This includes advancements in solubility-enhancing excipients, lipid-based formulations, and lipid nanoparticles, all of which are projected to experience substantial growth through the year 2030.

However, there are growing concerns regarding the impact of emulsifiers used in lipid-based drug delivery systems on gut microbiota, which can adversely affect gastrointestinal health. Thus, reducing dependence on such additives is crucial for ensuring safer and more effective delivery methods for oily and poorly soluble drugs.

If Gelteq successfully demonstrates its capabilities in this preclinical trial, the company plans to offer commercial solutions to potential clients, which may include:

  • Pipeline salvage, aimed at reviving drug candidates that were previously abandoned due to solubility and bioavailability concerns.
  • Lifecycle extension, which involves reformulating existing medications to provide renewed patent protection and market exclusivity.
  • Improved adherence, potentially allowing for smaller active pharmaceutical ingredient doses and reduced dependence on food for efficacy, which could lead to fewer side effects and more consistent patient outcomes.

“This preclinical trial is a crucial step in demonstrating Gelteq”s ability to address a major and unmet need within the pharmaceutical industry,” Mr. Givoni added.

About Gelteq Ltd.

Based in Melbourne, Australia, Gelteq (NASDAQ: GELS) is committed to developing and commercializing gel-based oral delivery solutions for a variety of applications, including prescription drugs, nutraceuticals, pet care, and sports nutrition. The company”s proprietary formulation technology aims to tackle challenges associated with traditional drug delivery, such as taste masking, difficulties in swallowing, and precision dosing. For additional information, please visit www.gelteq.com.

Gelteq Contact:

Investor Relations

Matt Kreps, Darrow Associates IR

+1-214-597-8200

[email protected]

Forward-Looking Statements

This press release contains “forward-looking statements,” as defined by the Private Securities Litigation Reform Act of 1995. These statements, except for those based on historical facts, are subject to risks, uncertainties, and other factors that may cause actual results to differ significantly from those anticipated. For comprehensive details on these risks and uncertainties, please refer to Gelteq”s filings with the U.S. Securities and Exchange Commission (“SEC”), including its Annual Report on Form 20-F filed on November 15, 2024, and its Registration Statement on Form F-1 initially filed with the SEC on July 1, 2025. Gelteq is not obligated to update any forward-looking statements following the date of this release.