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MELBOURNE, Australia, June 17, 2026 (GLOBE NEWSWIRE) -- Gelteq Limited (NASDAQ: GELS) ("Gelteq" or the "Company"), a biotechnology company developing a proprietary gel-based delivery platform for pharmaceutical, animal health and consumer health applications, today provided a corporate update on recent clinical and commercial milestones toward broader pharmaceutical adoption.

Highlights

Over the first half of 2026, Gelteq has commenced veterinary and pharmaceutical development programs, expanded its delivery platform, and advanced toward future clinical milestones including:

• Human clinical trial planning completed and the clinical trial is expected to commence next quarter (beginning July 1, 2026), which is anticipated to advance Gelteq’s pharmaceutical program toward a potential FDA regulatory pathway;
• Veterinary clinical trial commenced for an antiparasitic drug candidate, supporting a planned FDA application targeted for later in 2026 in a global animal health market estimated to exceed US$78 billion¹;
• Preclinical diabetes study commenced, expanding the pharmaceutical pipeline into a major chronic-disease category;
• Development underway in our research facilities to incorporate peptides and peptide-based therapeutics into stable oral formulations, spanning compounds traditionally delivered by injection and an emerging generation of therapies in development;
• Signed a strategic debt financing of up to US$3.5 million with an institutional investor to advance our clinical programs and accelerate commercialization;
• Veterinary palatability trials with Kemin Industries completed, demonstrating strong canine acceptance and confirming Gelteq’s ability to mask bitter functional ingredients;
• Commercial product manufactured for a new customer in the East Asian region, demonstrating Gelteq's ability to formulate, manufacture and deliver at commercial scale;
• Center of Excellence established in Guangdong Province, China, providing strategic access to one of the world’s fastest-growing pharmaceutical ecosystems; and
• Continued expansion of the active pharmaceutical ingredient (“API”) pipeline across multiple therapeutic categories.
  
  

"Our objective is to establish Gelteq^® technology as a scalable delivery platform capable of supporting a broad range of active ingredients across pharmaceutical, animal health and consumer health applications while generating near-term revenue from commercial products," said Nathan Givoni, Chief Executive Officer of Gelteq. "The milestones achieved so far this year reflect continued execution against that vision and positions Gelteq for the next phase of development."

Progressing the Pharmaceutical Pipeline

Gelteq believes the largest long-term opportunity for its delivery platform resides within pharmaceutical applications.

The Company recently commenced a preclinical study evaluating a diabetes medication powered by Gelteq^® technology, which is expected to advance its pharmaceutical pipeline and broader regulatory strategy.

The study is expected to generate data relating to formulation performance, dosing and delivery to inform future clinical development and regulatory planning. Diabetes represents one of the largest and fastest-growing chronic-disease categories worldwide, and the Company believes a gel-based oral delivery format could offer meaningful advantages in dosing and patient compliance.

We believe the program further demonstrates the applicability of Gelteq’s delivery platform across multiple therapeutic categories.

Expanding the API Pipeline and Oral Delivery Opportunities

In parallel with its clinical development activities, Gelteq continues to expand its API pipeline and evaluate new therapeutic opportunities where its delivery platform may provide meaningful advantages.

A key area involves the evaluation of compounds for incorporation into stable oral formulations powered by Gelteq^® technology. This includes peptide-based therapeutics and complex biologics traditionally administered via injection, as well as an emerging generation of peptides and biologics in development that are not yet established in either oral or injectable form.

Demand for patient-friendly oral alternatives continues to grow, driven both by the rapid global uptake of injectable peptide therapeutics and by rising interest in novel compounds being developed specifically for oral administration.

The Company believes success in this area could meaningfully expand the application of Gelteq^® technology across categories where patient compliance, ease of administration and therapeutic performance are important considerations.

Advancing Animal Health Opportunities

Gelteq has also achieved important milestones within its expanding animal health initiatives.

Building on previously announced animal studies, Gelteq successfully completed palatability trials conducted in collaboration with Kemin Industries. The trials evaluated a range of formulations, including products containing naturally bitter compounds, demonstrating strong canine acceptance while confirming the ability of Gelteq^® technology to effectively mask bitter functional ingredients without compromising palatability.

The Company also commenced its first veterinary clinical trial, evaluating an antiparasitic drug candidate powered by Gelteq^® technology. Building on the FDA’s prior acceptance of Gelteq’s suitability petition, the trial is expected to generate data on safety, efficacy and formulation performance in an animal health setting, with a planned FDA application targeted for later in 2026.

With a global animal health market estimated to exceed US$78 billion in 2026 and antiparasitic treatments representing a significant segment¹, Gelteq believes the combination of positive palatability data, previous animal study outcomes and ongoing clinical evaluation strengthens the commercial and development potential of the platform.

Together, these programs broaden the range of APIs and formulations with the potential to be incorporated into products powered by Gelteq^® technology while supporting ongoing discussions with prospective strategic partners.

Commercialization and Validation

Gelteq successfully manufactured a commercial product for a new customer in the East Asian region, with delivery expected within the coming weeks.

While the commercialization activity represents an important operational and commercial milestone, the Company views this as validation of Gelteq's ability to formulate, manufacture and deliver new commercial products for new clients, a capability the Company intends to continue scaling.

Early commercial revenue can also support the near-term, revenue-generating side of the Company's dual-track strategy, complementing its longer-horizon pharmaceutical development programs.

Expanding Operational Capacity and Strategic Reach

Alongside product and clinical development activities, Gelteq has continued to strengthen the operational foundations required to support long-term growth.

The Company recently expanded its global footprint through the establishment of a Center of Excellence in Guangdong Province, China. The hub is expected to accelerate product development and commercialization timelines, expand formulation and testing capabilities, and increase capacity to advance multiple programs simultaneously.

The presence also positions Gelteq within one of the world’s most active biopharmaceutical markets, where cross-border out-licensing transactions originating from China were estimated at nearly US$60 billion in deal value in the first quarter of 2026 alone, opening potential partnership and licensing pathways across Asia².

On May 7, 2026, Gelteq signed a strategic debt financing of up to US$3.5 million with an institutional investor to advance its clinical programs and accelerate commercialization. Under the debt financing, the investor initially funded US$1 million to the Company upon closing in consideration for an issuance of a convertible promissory note to such investor. Upon the Company’s receipt of shareholder approval of the debt financing arrangement, the investor has agreed to fund a further US$2.5 million under similar terms. The Company will hold a shareholder meeting to vote on the debt financing on June 18, 2026. The financing does not require repayments for at least for six months from the initial closing which preserves operational flexibility during the next phase of commercialization. (For further information on the debt financing arrangements, please refer to the Form 6-K filed with the Securities and Exchange Commission on May 26, 2026.)

Together, these initiatives position Gelteq to pursue growth opportunities from a position of strength while continuing to advance its delivery platform and development pipeline.

Upcoming Milestones and Growth Initiatives

As Gelteq enters the next phase of growth, management remains focused on executing several key development objectives. Gelteq’s anticipated near-term milestones are summarized below.

Anticipated Upcoming Milestones

Program	Anticipated Milestone	Expected Timing*
Veterinary (antiparasitic) program	Clinical trial data; planned FDA application	Clinical trial results expected in July 2026; planned FDA application targeted later in 2026
Human pharmaceutical program	Commencement of first human clinical trial	Next quarter (beginning July 1, 2026)
Preclinical diabetes study	Preclinical trial completed	Results expected in July 2026
Commercial (Asia)	Commercial product manufactured and delivered	Commercial product delivery expected in June 2026
Financing	Shareholder approval for remaining US$2.5M tranche	Shareholders meeting to be held on June 18, 2026

*Timing of anticipated milestones is subject to a range of factors, including trial outcomes, regulatory processes and shareholder approval, and may change.

We believe positive outcomes from these programs would further validate the versatility of Gelteq^® technology and support the advancement of additional API opportunities currently under evaluation.

The Company is also planning to commence a human clinical trial in the next quarter (beginning July 1, 2026) as its first clinical program in humans which could be a significant milestone in advancing Gelteq^® technology. The Company believes the human trial has the potential to generate data supporting the continued development of the platform and to inform the Company’s broader regulatory strategy.

Beyond these near-term milestones, Gelteq intends to continue expanding its API pipeline and advance research programs focused on enabling oral delivery across a broad range of APIs, including compounds traditionally administered through injection. These initiatives are intended to broaden the potential commercial applications of Gelteq^® technology and support future pharmaceutical partnership opportunities.

Positioned for Continued Growth

Gelteq believes the progress achieved so far during 2026 has established a strong foundation for future growth. Supported by advancing pharmaceutical programs, expanding platform capabilities, growing strategic relationships, commercial validation activities and a strengthened financial position, the Company remains focused on executing its strategy of building Gelteq^® technology into a leading delivery platform.

"We believe the progress achieved over the past several months highlights the growing breadth of opportunities for Gelteq^® technology," added Givoni. "From advancing pharmaceutical development programs and expanding our API pipeline, to generating commercial validation and strengthening our operational capabilities, we continue to build the scientific, clinical and commercial foundations necessary to support long-term growth. We remain focused on execution and excited about the opportunities ahead."

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^® technology, a propriety delivery technology, is designed to improve how active ingredients are formulated, stabilized and absorbed by the body. Gelteq specializes in research and development, product creation and manufacturing for partners across pharmaceutical, consumer health and animal health markets. Gelteq^® 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.

¹ Fortune Business Insights. (2025). Animal health market size, share & industry analysis. Report ID: FBI102371
² PharmCube. (2026). NextPharma / NextBiopharm Database: China Cross-Border Biopharma Out-Licensing Transactions Tracker.