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. Announcement • 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. Announcement • 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. Announcement • 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. 