Core Insights - Intelligent Bio Solutions Inc. has initiated a clinical study program to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, aimed at detecting the opiate codeine [1][5] - The U.S. drug screening market presents a significant commercial opportunity, generating several billion dollars annually across various sectors [4] Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, with a focus on fingerprint-based drug screening technology [6] - The Intelligent Fingerprinting Drug Screening System is designed to be hygienic, cost-effective, and capable of providing results in under ten minutes, making it suitable for safety-critical industries [6] Clinical Study Details - The first clinical study will involve 40 adults and will assess codeine detection cut-off levels using the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader [3] - The study will compare results with an FDA-cleared device and will utilize liquid chromatography-tandem mass spectrometry (LC-MS/MS) for corroboration [3] Market Potential - The U.S. drug screening market is the largest globally, with applications in workplace testing, criminal justice, pain management, and substance abuse treatment [4] - The company's technology offers advantages over traditional testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs [4] Strategic Partnerships - The company has partnered with Cliantha Research, a clinical research organization, to leverage its expertise in regulatory and clinical trials [2] - Subject recruiting and screening for the clinical study have already begun, with the first testing cohort starting on January 28, 2026 [5]

Core Insights - Intelligent Bio Solutions Inc. reported a 20% sequential quarterly revenue growth and a 91% year-over-year gross profit growth for the fiscal third quarter ended March 31, 2025 [1][10] - The company achieved a significant increase in recurring higher-margin cartridge sales, which now account for 58% of total sales for the nine months ended March 31, 2025 [1][13] - The active customer base grew to over 450 accounts, with 35 new accounts added during the quarter, indicating strong customer acquisition and expansion efforts [2][8] Financial Performance - Revenue for the three months ended March 31, 2025, increased by $121,373, or 20%, to $728,867 compared to $607,494 for the previous quarter [10][13] - Gross profit for the same period rose by $162,879, or 91%, to $341,368 from $178,489 year-over-year [10][13] - Total revenue for the nine months ended March 31, 2025, was $2.21 million, a decrease from $2.38 million for the same period in 2024 [10][13] Business Strategy and Growth - The company is advancing its international growth strategy with initiatives such as expanded access in key European markets and multilingual upgrades to its drug screening system [3][4] - A focus on growing cartridge adoption is strengthening the business fundamentals, contributing to margin improvement and operational efficiency [4][8] - The company launched localized websites in multiple languages and activated multi-channel advertising campaigns targeting safety-critical industries [8][9] Regulatory and Product Development - The company granted a patent in the U.S. for the Intelligent Fingerprinting Drug Screening Cartridge, marking its sixth U.S. patent [13] - Continued regulatory scoping in Canada, Indonesia, and the Philippines supports the long-term expansion strategy [13]