Intelligent Bio Solutions Inc（INBS）のニュースとイベントINBSIntelligent Bio Solutions Inc

Intelligent Bio Solutions Submits Drug Screening System to FDA

Intelligent Bio Solutions announced the submission of its 510 premarket notification to the FDA, seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The submission represents the culmination of data from a structured, multi-study clinical program that the company has executed throughout 2026, targeting entry into the multi-billion-dollar U.S. drug screening market.

Intelligent Bio Solutions Enters Agreement to Issue 2,036,659 Shares

Intelligent Bio Solutions announced that it has entered into a securities purchase agreement with a single existing institutional investor to issue, in a private placement priced at-the-market under Nasdaq rules, 2,036,659 shares of common stock (or Series M pre-funded warrants in lieu thereof), Series N-1 warrants to purchase up to an aggregate of 2,036,659 shares of common stock, and Series N-2 warrants to purchase up to an aggregate of 2,036,659 shares of common stock, at a combined purchase price of $2.455 per share of common stock (or Series M pre-funded warrant) and associated Series N-1 warrants and Series N-2 warrants, for expected gross proceeds to INBS of approximately $5.0 million, before deducting placement agent fees and other offering expenses payable by the Company. Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the private placement.

Intelligent Bio Solutions Completes Drug Screening Study

Intelligent Bio Solutions announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several studies underpinning the company's FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. All clinical data collection across the company's FDA 510(k) clinical study program is now complete. The study was conducted across three independent U.S. clinical sites over three weeks in partnership with CenExel Clinical Research. A total of 135 participants were enrolled. The company now moves into analysis, compilation, and finalization of its 510(k) submission package, targeting submission in the second half of 2026, ahead of planned entry into the multi-billion-dollar U.S. market.