INTELLIGENT BIO SOLUTIONS INC.

Intelligent Bio Solutions Inc.

Overview

Intelligent Bio Solutions Inc. (INBS) develops and delivers rapid, non-invasive diagnostic and screening solutions. The company operates globally and focuses on fingerprint-sweat-based testing platforms intended to improve quality of life through innovative diagnostic technology.

Core products and platforms

Intelligent Fingerprinting Platform (IFP)

• Portable, fingerprint-sweat-based drug screening system.
• Components: single-use, tamper-evident fingerprint-sweat cartridge (collects ten samples in under one minute) and a handheld IFP Reader that provides on-screen results in under ten minutes.
• Detects drugs of abuse including opiates, cocaine, methamphetamine, benzodiazepines, cannabis, methadone, and buprenorphine.
• Confirmatory testing can be sent to third-party laboratories.
• Primary markets are outside the United States, with ongoing FDA 510(k) efforts in the U.S. for opiate/codeine detection.

Biosensor Platform (BPT)

• Licensed technology originally restricted to the APAC region via Life Science Biosensor Diagnostics Pty Ltd (LSBD).
• Consists of a printable modified organic thin-film transistor strip for multi-analyte biosensing.
• Development paused due to LSBD liquidation and reversion of IP to the University of Newcastle; final licensing terms are pending.
• COV2 products (SARS-CoV-2 related) were licensed under LSBD licenses; development is postponed for the same licensing reasons.

Other

• INBS holds a 50% equity interest in BiosensX (North America) Inc., which has a separate license related to glucose/diabetes management in the U.S., Mexico and Canada.

Intellectual property

• Multiple patent families cover fingerprint diagnostics, cartridge technology, readers, and associated workflows.
• Patent coverage includes the UK, Europe, Australia, Canada, Japan, the U.S., and other jurisdictions, with key families expiring roughly between 2033 and 2041+.
• LSBD liquidation has constrained licenses and IP related to the BPT and COV2 products, causing development delays while licensing negotiations with the University of Newcastle proceed.

Customers and market presence

• Customer base of over 502 small to medium-sized businesses.
• Primary market focus: United Kingdom, with distribution across Europe, APAC, MEA, and other regions.
• Ongoing expansion efforts into Australia, New Zealand, broader APAC, North America, and MEA.
• Distribution model: combination of direct sales in the UK and third-party distributors in Australia and other regions.
• Strategic partners and distribution collaborators include Bouygues UK, SMARTOX, Syrma Johari MedTech, Cliantha Research, CenExel Clinical Research, RASL (Australia), and the Vlepis alliance (Australia).

Manufacturing and operations

• UK manufacturing facility in Cambridge supporting cartridge fabrication and reader assembly.
• Manufacturing capacity up to 90,000 cartridges per month; current production about 12,000 cartridges per month with room to scale.
• IFP Reader manufacturing outsourced under a partnership with Syrma Johari MedTech Ltd.; first shipments occurred February 25, 2026.
• Quality systems: ISO 13485 and ISO 9001 compliance, UKAS accreditation, FDA site registration, and a QMSR framework aligned with the FDA’s quality system requirements effective February 2, 2026.

Regulatory and quality affairs

• IFP System designed to meet ISO 13485 and ISO 9001 standards, with UKAS-accredited labs and CE marking considerations for Europe.
• Ongoing engagement with the FDA for U.S. clearance via the 510(k) pathway for codeine/opiate detection; regulatory response cycles and data updates occurred during 2025–2026.
• APAC and other international markets rely on local distributors and their respective regulatory approvals.

Financial snapshot (year ended June 30, 2026, unless noted)

• Fiscal year 2025 net loss: $10,568,733.
• Fiscal year 2026 net loss: $12,430,975.
• Cash and cash equivalents: $3,992,312 as of June 30, 2026.
• The company reported that revenue from IFP product sales is not sufficient to cover operating costs.
• The independent auditor issued an explanatory paragraph about the company’s ability to continue as a going concern, reflecting the need for additional capital.
• Capital actions: 1-for-10 reverse stock split completed December 2025; Nasdaq confirmed compliance with the $1.00 bid price rule as of January 7, 2026.
• Public company status: ceased to qualify as an Emerging Growth Company as of June 30, 2026; remains a Smaller Reporting Company.

Principal risks

• Need for additional funding to continue operations.
• Dependence on third-party laboratories for confirmatory testing and on a limited number of single-source suppliers for key components.
• International regulatory and reimbursement challenges that could limit market adoption or coverage for IFP products.
• Uncertain and time-consuming regulatory approval processes in the U.S. and other regions.
• Intellectual property uncertainties and licensing negotiations stemming from LSBD liquidation and IP reversion.
• Cybersecurity and data privacy risks due to global operations and handling of patient data.
• Public company compliance costs and potential dilution from future fundraising.

Key strategic developments (selected milestones through 2025–2026)

• June 16, 2026: Initiation of an interference study to support FDA 510(k) submission for opiate/codeine detection (with CenExel Clinical Research).
• June 2, 2026: Start of a multi-site method comparison study for codeine with CenExel Clinical Research.
• April 20, 2026: Validation study to reduce analysis time for the IFP System.
• April 17, 2026: Completion of penetration testing for FDA submission; no major vulnerabilities identified.
• April 2, 2026: Initial clinical cut-off study for codeine detection completed (40 adults).
• March 26, 2026: European patent EP3752831 granted (fingerprint chemical analysis with fingerprint deposition volume).
• February 25, 2026: First shipment of IFP Readers under the Syrma Johari manufacturing partnership.
• February 24, 2026: Partnership with Bouygues UK for deployment across its UK operations.
• January 28, 2026: Commencement of clinical study program for FDA 510(k) submission (codeine detection) with Cliantha Research.
• January 2, 2026: Private placement closed for approximately $10.0 million (2,298,850 shares and associated warrants).

Availability of information

• INBS maintains investor information on its website and files periodic reports with the U.S. Securities and Exchange Commission (10-K, 10-Q, 8-K) available at sec.gov.

Summary

INBS develops non-invasive fingerprint-based diagnostic screening technologies led by the IFP Drug Screening System. The company is advancing regulatory clearances in the U.S. and expanding presence in the UK, Europe, APAC, and other regions while managing funding needs and IP licensing uncertainties related to LSBD liquidation. INBS serves a growing customer base (about 502 customers), maintains manufacturing in Cambridge, UK, and has a reader production arrangement with Syrma Johari. As of mid-2026, the company reported net losses of $12.4 million for fiscal 2026, cash of approximately $4.0 million, and a workforce of roughly 60 employees.