Annuncio • 7h
Gelteq Limited Commences Clinical Trial For Antiparasitic Drug Candidate Powered By Gelteq Technology Gelteq Limited commenced its first clinical trial for an antiparasitic drug candidate powered by Gelteq technology, marking a significant milestone as the Company expands into the veterinary pharmaceutical sector. The clinical trial seeks to support Gelteq’s planned FDA regulatory pathway for animal use, with the Company targeting a potential application later in 2026. Commencement of the clinical trial builds on Gelteq’s prior announcement regarding the FDA’s acceptance of its suitability petition, representing a key step in progressing the antiparasitic drug candidate powered by Gelteq technology toward regulatory approval. The trial is expected to generate critical data to support the safety, efficacy, and formulation performance of Gelteq technology in an animal health setting. With the clinical trial now underway, Gelteq intends to generate data that will support both regulatory progression and future commercial opportunities within the veterinary sector. The global animal health market is estimated to exceed USD 78 billion in 2026, with antiparasitic treatments representing a significant segment driven by increasing pet ownership and ongoing demand for parasite prevention and control. As Gelteq advances this program toward potential regulatory approval, the Company believes it is strategically positioned to participate in a large and growing market segment, where improved delivery formats may offer meaningful advantages in compliance and dosing. With Gelteq’s recent financing, the Company believes it is well positioned with sufficient capital to execute on its dual-track strategy of advancing pharmaceutical programs for long-term value while continuing to drive near-term revenue through its commercial nutraceutical portfolio. New Risk • Apr 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 31% per year over the past 5 years. Revenue is less than US$1m (AU$413k revenue, or US$285k). Market cap is less than US$10m (US$7.27m market cap). Board Change • Feb 03
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. No highly experienced directors. 1 independent director (2 non-independent directors). Independent Non-Executive Director Philip Dalidakis was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Annuncio • Jan 13
Gelteq Limited Announces Positive Preclinical Results Showing Increased Medicinal Cannabinoid Absorption Using Its Oral Gel Delivery Platform Gelteq Limited 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 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 company's 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 the company's oral gel platform earlier patient access and a faster pathway to market. 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. company'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 dosing 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 consistent 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. The preliminary results could open the door to significant global commercial opportunities. Medicinal cannabis is one of the fastest-growing therapeutic markets worldwide 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 platforms 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 company's oral gel platform further validates company's position in advanced oral-delivery technologies. By enabling a simpler and more effective cannabinoid administration, company's oral gel platform aims to support the next generation of medicinal cannabis products designed around patient needs and meet modern clinical expectations. Annuncio • Dec 05
Gelteq Limited Preclinical Study Demonstrates Enhanced Oral Delivery of Oil-Soluble and Poorly Soluble Drugs Using Its Gel-Based Platform Gelteq Limited 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% 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 gelbase, but the overall absorption was also improved. Over 24 hours, the absorption was improved by more than 20% 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 intestinal. 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 poorlyuble drugs. With more than 40% of approved drugs and up to 90% of developmental candidates affected by poor soluble and bioavailability, the industry continues to invest billions of dollars 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. Annuncio • Nov 25
Gelteq Limited Announces Positive Preclinical Results Demonstrating Enhanced Bioavailability Using Its Proprietary Gel-Based Drug Delivery Platform Gelteq Limited announced positive preclinical results showing its proprietary gel formulation achieved substantially higher bioavailability than a leading on-market reference antihistamine product. In a comparative pharmacokinetic study, Gelteq's formulation demonstrated a 38-45% increase in systemic exposure and absorption (AUC) and markedly higher peak concentrations (Cmax), while maintaining a comparable time to peak plasma concentration (Tmax). The results of the study show Gelteq's gel-based delivery technology can significantly enhance oral bioavailability of the drug, in addition to the broad benefits of the technology in solving drug delivery, swallowing and patient compliance issues. Importantly, the findings extend beyond the specific antihistamine evaluated in the study. Because the test compound is water-soluble, the demonstrated bioavailability improvement provides a strong foundation for applying Gelteq's platform across a range of other water-soluble drug classes, significantly broadening the Company's commercial scope. The Company anticipates using these results to further pursue an FDA approval pathway for an antihistamine product and to increase engagement with potential pharmaceutical partners interested in next-generation drug delivery formats. Annuncio • Nov 04
Gelteq Limited announced delayed 20-F filing On 11/03/2025, Gelteq Limited announced that they will be unable to file their next 20-F by the deadline required by the SEC. Annuncio • Oct 24
Gelteq Announces Commencement of Preclinical Trial Targeting Oil Soluble Drug Market with Novel Delivery Platform Gelteq Limited announced it has started a preclinical animal trial evaluating its proprietary formulation technology for oily and poorly soluble drugs. Gelteq will conduct the study with Monash University Institute of Pharmaceutical Science, a recognised leader in pharmaceutical development and contract research. Pharmaceutical companies invest more than USD 4 billion annually in technologies to improve delivery of oily and poorly soluble drugs, including solubility-enhancement excipients, lipid-based formulations and lipid nanoparticles with strong projected growth through 2030. However, there are increasing concerns that emulsifiers in lipid-based drug delivery can disrupt the gut microbiota and compromise gastrointestinal health so it is important to reduce reliance on such additives to enable safer and more effective delivery of oily or poorly soluble drugs. Should Gelteq be able to demonstrate through the trial its ability to work successfully with oily or poorly soluble drugs, Gelteq would seek to assist potential clients with a portfolio of oily and poorly soluble drugs via the following commercial options: Pipeline salvage - reviving promising drug molecules previously abandoned due to solubility and bioavailability issues. Lifecycle extension - reformulating existing drugs to provide new patent protection and exclusivity. Improved adherence - the potential to reduce API dose size and food-effect dependence, which has the potential for fewer side effects and more consistent patient outcomes. Annuncio • Sep 08
Gelteq Limited Announces Commencement of Preclinical Trial for Novel Gel-Based Antihistamine Formulation Targeting Allergy Market Gelteq Limited announced plans to commence a preclinical bioequivalence study in September 2025 to evaluate its novel gel-based formulation of a widely used allergy treatment. The study will be conducted by Adgyl Lifesciences (a partner of Eurofins Advinus), a leader in preclinical contract research services. If preclinical results are successful, Gelteq anticipates advancing to human clinical trials targeting U.S. Food and Drug Administration (FDA) approval via the 505(b)(2) regulatory pathway. Allergic conditions affect over 50 million people annually in the United States alone. The global allergy market was valued at approximately $9 billion in 2023 growing at a 6% CAGR, projected to reach over USD 12 billion by 2028. Demand spans paediatric, adult, and increasingly, animal health (3), reflecting the diverse applications for antihistamine therapies. Gelteq's proprietary gel formulations aim to address key limitations of traditional tablets and syrups, including palatability challenges for children, swallowing difficulties for elderly patients, and precise dosing needs in veterinary medicine. New Risk • Sep 05
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.27m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings have declined by 31% per year over the past 5 years. Revenue is less than US$1m (AU$378k revenue, or US$248k). Market cap is less than US$10m (US$9.27m market cap). Board Change • Jul 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Independent Non-Executive Director Philip Dalidakis was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. New Risk • Jun 03
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (65% average weekly change). Earnings have declined by 33% per year over the past 5 years. Revenue is less than US$1m (AU$143k revenue, or US$93k). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Market cap is less than US$100m (US$14.2m market cap). New Risk • Mar 20
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.84m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 33% per year over the past 5 years. Revenue is less than US$1m (AU$143k revenue, or US$90k). Market cap is less than US$10m (US$9.84m market cap). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). Annuncio • Mar 15
Gelteq Limited announced that it expects to receive $12 million in funding from Lincoln Park Capital, LLC Gelteq Limited announced a private placement of ordinary shares for the gross proceeds of $12,000,000 on March 13, 2025. Annuncio • Jan 24
Gelteq Appoints Matthew Jones as Head of Sports Performance Gelteq Limited announced the appointment of Matthew Jones as Head of Sports Performance. He will oversee the growth, outreach, and customer strategy of Gelteq’s sports vertical. Mr. Jones is a leading internationally-experienced sports dietitian who currently works as Head of Nutrition with the United Arab Emirates Football Association and as a consultant to the Boston Celtics in the National Basketball Association. He has more than 12 years of applied experience in elite sports, having worked in international football, the English Premier League, the Women’s Super League, and NCAA Division I sports. Jones holds a Master’s Degree in Nutrition Science from University of Chester and is registered with the British Dietetic Association, Sport Nutrition Register. Annuncio • Dec 19
Gelteq Limited Appoints Paul Wynne as Chief Scientific Officer Gelteq Limited announced the appointment of Dr. Paul Wynne as its Chief Scientific Officer. Dr. Wynne will oversee the product and formulation strategies and the growth of Gelteq’s scientific team and various business verticals. He will assist with Gelteq’s intellectual property portfolio, academic partnerships, gel formulations, and distribution channels, and will work closely with manufacturing and supply side partners. Dr. Wynne has over 35 years of experience in the disciplines of analytical chemistry, the design and manufacture of advanced materials, drug metabolism, pharmaceutical formulation, drug delivery and forensic toxicology. Prior to joining Gelteq, he was the Manager of the Medicines Manufacturing Innovation Centre at Monash University in Melbourne for eight years, which works to strengthen the pharmaceutical and allied manufacturing sector in Australia for domestic and International clients. Monash University is ranked #2 in the world in pharmacy and pharmaceutical science by the QS World University Rankings by Subject 2024: Pharmacy & Pharmacology. Dr. Wynne is also the author of over 80 peer reviewed papers, book chapters, and patents, and more than 120 lectures, presentations and industry technical articles. He holds a Bachelor of Applied Science (Applied Chemistry), Master of Applied Science (Organic Photochemistry), and a Doctor of Philosophy (Chemistry and Toxicology) from RMIT University. Annuncio • Dec 18
Gelteq Limited Receives FDA Approval of its Suitability Petition for New Animal Drug Gelteq Limited announced that the U.S. Food and Drug Administration (FDA) has approved its suitability petition for a new animal drug under development. The new animal drug leverages Gelteq’s ingestible gel platform designed for nutrient and drug delivery. A suitability petition is a request by a drug sponsor to submit an abbreviated new animal drug application (ANADA) for a proposed innovative new animal drug that differs from a previously FDA approved generic animal drug. Gelteq has proposed changing the reference drug from a pill form into an oral gel form. These changes could be considered through the suitability petition, as defined under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FDA found that the proposed changes did not require Gelteq to conduct further investigations to show the safety and effectiveness of the innovative new animal drug for its intended uses. Therefore, the FDA approved the petition under section 512(n)(3)(C) of the FD&C Act which foregoes the safety and effectiveness studies and helps reduce the timeframe to reach potential approval of the new animal drug. This approval of the suitability petition, however, does not guarantee approval of the ANADA for Gelteq’s proposed generic new animal drug. Annuncio • Nov 13
Gelteq Limited Appoints Adam Bendell as President of U.S. Operations Gelteq Limited announced that it has expanded its operations in the United States with the appointment of Adam Bendell as President of U.S. Operations. Adam is an accomplished corporate strategist with nearly a decade of experience driving growth and transformational change for global companies, retail brands, and government organizations. He brings a deep understanding of the entire retail value chain, having worked on integrated brand, product, marketing, sales/distribution, and operations strategies for brands of various sizes from early-stage ventures to established global names including Deloitte Consulting, Calvin Klein, Tommy Hilfiger, and Cole Haan. Annuncio • Nov 01
Gelteq Limited announced delayed 20-F filing On 10/31/2024, Gelteq Limited announced that they will be unable to file their next 20-F by the deadline required by the SEC. Annuncio • Oct 23
Gelteq Limited has completed an IPO in the amount of $5.2 million. Gelteq Limited has completed an IPO in the amount of $5.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,300,000
Price\Range: $4
Discount Per Security: $0.28
Transaction Features: Sponsor Backed Offering