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MELBOURNE - Gelteq Limited (NASDAQ:GELS), a micro-cap pharmaceutical company with a market capitalization of $10.8 million, announced plans to commence a preclinical bioequivalence study this month to evaluate its gel-based formulation of a widely used antihistamine for allergy treatment. The company’s stock has declined over 67% in the past year, according to InvestingPro data.
The study, conducted by Adgyl Lifesciences, will assess the potential of Gelteq’s proprietary gel technology to deliver an established antihistamine in a new format. If preclinical results prove successful, the company intends to advance to human clinical trials targeting U.S. Food and Drug Administration approval via the 505(b)(2) regulatory pathway.
"Our gel-based delivery platform is expected to transform traditional pharmaceutical products currently available on the market, especially where patient compliance and dosage control are critical," said Nathan Givoni, CEO of Gelteq. While the company maintains a healthy gross profit margin of 54%, InvestingPro analysis indicates challenges with cash burn and short-term obligations exceeding liquid assets.
The company aims to address limitations of traditional tablets and syrups, including palatability challenges for children, swallowing difficulties for elderly patients, and precise dosing needs in veterinary medicine.
According to the press release, allergic conditions affect over 50 million people annually in the United States. The global antihistamine market was valued at approximately $9 billion in 2023 with a 6% compound annual growth rate, projected to reach over $12 billion by 2028.
Gelteq, headquartered in Melbourne, Australia, specializes in developing gel-based oral delivery solutions for prescription drugs, nutraceuticals, pet care, sports nutrition, and other applications.
The company’s announcement comes as part of its strategy to capture value in the allergy market by offering alternative delivery methods for established medications. With an EBITDA of -$1.44 million in the last twelve months, Gelteq faces significant financial hurdles. InvestingPro subscribers can access 8 additional key insights about Gelteq’s financial health and market position, helping investors make more informed decisions.
In other recent news, Gelteq Limited has announced several strategic partnerships to enhance its manufacturing and distribution capabilities. Gelteq has entered into a memorandum of understanding with IDT Australia to establish a dedicated manufacturing facility for its gel-based delivery solutions. This facility will support the scale-up and commercialization of Gelteq’s proprietary gel-based oral delivery platform across various markets globally. Additionally, Gelteq has partnered with Healthy Extracts Inc. to manage logistics and distribution in North America. This agreement designates Healthy Extracts as the exclusive partner for storage, shipping, and fulfillment of Gelteq’s product lines in the United States and Canada. Gelteq’s CEO, Nathan Givoni, expressed confidence that the partnership with Healthy Extracts will expedite product delivery and improve customer reach in North America. These developments reflect Gelteq’s ongoing efforts to expand its market presence and enhance operational efficiency.
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