Study results finalized on schedule support FDA clearance and planned U.S. commercial launch

Company advances second phase of clinical program for 510(k) submission with method comparison, usability, and interference testing

Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions,  announced the successful completion of its initial clinical Cut-off Study supporting the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

The clinical Cut-off Study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March 2026. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate device, and confirmed findings through liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis.

INBS has now initiated the second phase of its clinical study program. This includes a multi-site Method Comparison and Usability Study. This study is designed to validate the system’s accuracy, usability, and workplace performance when operated by intended end users at several clinical sites. The Company expects to complete the Method Comparison and Usability Study by the end of June 2026. In parallel with the Method Comparison and Usability Study, the Company will be commencing an Interference Study, which will test the device in the presence of potentially interfering substances found in real-world settings. Completion of the Interference Study is anticipated by the end of July 2026.

"The U.S. drug screening market is a significant commercial opportunity for Intelligent Bio Solutions," said Harry Simeonidis, President and CEO at INBS, "The on-schedule completion of our Cut-off Study validates our clinical approach and keeps us firmly on track toward our FDA 510(k) submission and planned commercial launch."

The U.S. drug screening market represents a multi-billion-dollar annual opportunity. Major segments include workplace testing, criminal justice, pain management, and substance abuse treatment. The Company’s non-invasive fingerprint technology offers several advantages over traditional urine, oral fluid, and blood testing methods. Benefits include a detection window designed to identify current impairment rather than past use, rapid results, and the ability to conduct screening at any time and location.