Welcome to our dedicated page for INTELLIGENT BIO SOLUTIONS SEC filings (Ticker: INBS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Intelligent Bio Solutions Inc. filings document a medical technology issuer commercializing rapid, non-invasive fingerprint sweat drug screening and reporting through periodic material-event disclosures. Recent 8-Ks cover operating results, preliminary revenue information, Regulation FD presentations, clinical study program updates tied to the Intelligent Fingerprinting Drug Screening System, and manufacturing disclosures for readers and lateral-flow test strips.
The filing record also includes capital-structure and governance subjects, including common stock issued through warrant exercises and an at-the-market offering agreement, restricted stock awards under the 2019 Long Term Incentive Plan and Australian Sub-Plan, and Nasdaq Capital Market bid-price compliance notices. These disclosures frame the company's product commercialization, regulatory pathway, equity compensation, share count and listing-status matters.
Intelligent Bio Solutions Inc. received an amended passive ownership report from Armistice Capital, LLC and Steven Boyd. The reporting persons disclose beneficial ownership of 141,397 shares of common stock, representing 5.91% of the class. All 141,397 shares are reported with shared voting and shared dispositive power, with no sole voting or dispositive authority. Armistice Capital is investment manager to Armistice Capital Master Fund Ltd., the direct holder of the shares, and may be deemed to beneficially own these securities. Steven Boyd, as managing member of Armistice Capital, may also be deemed to beneficially own the same shares. The Master Fund has the right to receive dividends or sale proceeds on the reported securities.
Intelligent Bio Solutions Inc. reported completing its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) program for U.S. clearance to detect the opiate codeine. All clinical data collection across the FDA 510(k) clinical study program is now finished. The study, conducted under ICH GCP guidelines at three independent U.S. clinical sites over three weeks with 135 participants and nine operator participants, is intended to demonstrate that typical workplace users can operate the system accurately by measuring sensitivity, specificity, and accuracy. The company is analyzing data and assembling its 510(k) submission package, targeting submission in the second half of 2026 ahead of planned entry into the U.S. market.
Intelligent Bio Solutions Inc. reported completion of a Usability Study for its Intelligent Fingerprinting Drug Screening System, supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. The study, run with CenExel Clinical Research, followed FDA guidance and ICH GCP standards.
The study evaluated how easily workplace operators can be trained to use the system; 15 operators with no specialist laboratory background successfully participated, reinforcing that the system can be administered by non-specialists. This Usability Study is part of a broader 510(k) program that also includes cut-off, method comparison, interference, precision and penetration testing. The company states it remains on track to submit its 510(k) package in calendar H2 2026 as it moves toward planned entry into the multi-billion-dollar U.S. drug screening market.
Intelligent Bio Solutions Inc. reported completion of an Interference Study for its Intelligent Fingerprinting Drug Screening System, a key element supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine.
The study, conducted with CenExel Clinical Research, Inc. under FDA guidance and ICH GCP standards, tested whether everyday substances such as hand creams, alcohol-based products, oils, dirt, and water affect test accuracy. Data analysis is underway, with independent verification via LC-MS/MS. The Interference Study forms part of a broader program including clinical cut-off, method comparison, precision, and penetration testing, and the company states it remains on track to submit its 510(k) package in calendar H2 2026 as it works toward entry into the multi-billion-dollar U.S. drug screening market.
Intelligent Bio Solutions Inc. reported that its total outstanding common stock was 3,018,188 shares as of the close of business on July 31, 2026. This updated share count reflects sales under an At The Market Offering Agreement, exercises of previously issued warrants, and issuances of restricted shares under an investor relations and corporate development advisory agreement.
Intelligent Bio Solutions Inc. reports that it has addressed all cybersecurity and software-related review items for its planned FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. This follows independent third-party penetration testing, with 100% of medium-risk vulnerabilities remediated and low-risk items reduced from 11 to 2, supported by risk-based justifications that remaining issues do not affect device safety, effectiveness, or performance.
The company has also fully resolved all 19 software bill of materials (SBOM) vulnerabilities, aligning documentation and system configuration with FDA guidance and obtaining independent verification that no issues remain. Management states these steps materially reduce regulatory risk and strengthen its 510(k) package, which is on track for submission in calendar H2 2026, initially targeting codeine detection in a multi-billion-dollar U.S. drug screening market. A manufacturing partnership with Syrma Johari MedTech is expected to deliver more than 40% annual production cost savings and approximately 20 percentage-point gross margin improvement to support a scalable U.S. launch following potential FDA clearance.
Intelligent Bio Solutions Inc. reported completing extensive precision testing to support its planned FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.
The precision program covered more than 1,600 tests across three production runs and three independent sites, demonstrating repeatable, reproducible performance suited to workplace and other drug screening environments. These data, together with penetration testing and prior Cut-off, Method Comparison, and Interference Studies, form a comprehensive package addressing safety, accuracy, usability, specificity, security, and precision. The company describes the U.S. drug screening market as a multi‑billion‑dollar annual opportunity and highlights rapid, non‑invasive fingerprint testing with results in under ten minutes.
Intelligent Bio Solutions Inc. filed a current report describing a new Interference Study to support its FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. The company has partnered with CenExel Clinical Research to run the study with 75 healthy adult participants under undosed and dosed conditions while handling common substances that might affect results.
The study is designed to show the system maintains specificity for codeine and avoids false positives or negatives, with samples confirmed by LC‑MS/MS analysis. It will run alongside a Method Comparison Study and follows a Cut-off Study that began in January 2026. Intelligent Bio Solutions expects to finish the Interference Study by mid‑July 2026 and include the data in its FDA 510(k) submission package.
Intelligent Bio Solutions Inc. is starting a multi-site Method Comparison Study to support an FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for the opiate codeine. The company is working with CenExel Clinical Research to test the system’s accuracy when used by typical workplace screening staff.
The study will enroll 135 donor participants and use nine operator participants to mirror real-world employment and safety-sensitive settings. Key metrics such as sensitivity, specificity, and overall accuracy will be confirmed using LC-MS/MS, and enrollment and data collection are expected to finish by the end of July 2026, with results included in the company’s 510(k) package.
INTELLIGENT BIO SOLUTIONS INC. ownership disclosure: Armistice Capital, LLC and Steven Boyd report beneficial ownership of 163,571 shares of Common Stock, representing 9.99% of the class. The filing states Armistice Capital exercises shared voting and dispositive power over these shares under an Investment Management Agreement.
The report is a joint Schedule 13G filing executed by Steven Boyd on 05/15/2026 and identifies Armistice Capital Master Fund Ltd. as the direct holder while the Master Fund disclaims direct beneficial ownership due to the Investment Management Agreement.