Core Insights - Intelligent Bio Solutions Inc. (INBS) is progressing towards FDA 510(k) clearance for its Intelligent Fingerprinting Drug Screening System, specifically for opiate codeine, with an anticipated timeline for clearance in the second half of 2026 [2][3] - The company is initiating clinical studies to gather additional data to support its 510(k) submission, with studies expected to conclude in the first half of 2026 [3][4] - INBS's drug testing technology has been adopted by over 450 accounts across 24 countries, indicating a strong global presence and demand for its solutions [4] Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, aiming to revolutionize portable testing through fingerprint sweat analysis [5] - The Intelligent Fingerprinting Drug Screening System screens for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, providing results in under ten minutes [5] - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport, logistics, mining, drug treatment organizations, and coroners [5]

Core Viewpoint - Intelligent Bio Solutions Inc. is progressing through the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System, which is a novel non-invasive testing solution [1][2][3]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA in December 2024, and received an Additional Information request in February 2025, which included over 70 items to address [2]. - INBS responded to the FDA's questions and submitted additional information in August 2025, but the FDA has requested further information, necessitating a resubmission of the 510(k) notification [3][4]. - The device is unique as there are no comparable sweat-based products currently on the market, requiring extensive validation to demonstrate its performance [3]. Company Strategy and Market Position - The company is consulting with specialized FDA consultants to evaluate the FDA's questions and plans to provide an investor update within ten days regarding the timeline for FDA clearance [4]. - The CEO expressed confidence in the technology and emphasized the company's commitment to bringing the solution to the U.S. market while continuing to grow its international business [5]. - INBS is developing partnerships and driving sales growth outside the U.S., targeting sectors such as construction, manufacturing, transport, and drug treatment organizations [6]. Product Overview - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive drug testing through fingerprint sweat analysis, screening for drugs commonly found in workplaces [6]. - The system offers quick sample collection and results in under ten minutes, making it a valuable tool for safety-critical industries [6].

Core Insights - Intelligent Bio Solutions Inc. achieved record monthly cartridge sales in July 2025, with 519 boxes shipped, translating to over 12,500 cartridges and a 60% year-on-year growth [1][2]. Group 1: Business Model and Revenue Growth - Cartridges are a high-margin consumable in the Company's fingerprint sweat-based drug testing system, forming the basis of its razor/razor blade business model, which is experiencing growth due to new large contracts and an expanding global installed base [2][3]. - The Company secured a significant multi-site, high-volume contract in the transportation sector, which has increased ongoing demand for consumables [2]. - There is a growing pipeline of opportunities, with an increasing number of bids and tenders for large-scale deployments, indicating a robust demand for the Company's products [2]. Group 2: Management Insights - The President and CEO of Intelligent Bio Solutions highlighted that the record cartridge sales reflect the strength of the business model and the momentum from major contract wins, suggesting continued growth in cartridge demand and reliable revenue streams [3]. - The Company aims to leverage its installed base to drive recurring sales of cartridges while planning for U.S. market expansion beyond forensic use in the second half of 2025 [3]. Group 3: Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat [4]. - The technology is designed to be hygienic and cost-effective, screening for drugs commonly found in the workplace, with quick sample collection and results [4]. - Current customer segments outside the U.S. include construction, manufacturing, transport, mining, and drug treatment organizations, indicating a diverse market presence [4].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number 001-39825 Intelligent Bio Solutions Inc. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of i ...

Core Insights - Intelligent Bio Solutions Inc. reported a 16% year-on-year and quarter-on-quarter revenue growth in the fourth quarter of fiscal 2025, driven by increased demand for drug testing cartridges [1][5][7] - The company is focused on securing FDA 510(k) clearance for its opiate test system, which will allow for broader use beyond forensic settings in the U.S. market [4][6] - Fiscal 2025 was characterized by operational streamlining, higher-margin cartridge sales, and an expanding international customer base exceeding 450 accounts across 24 countries [2][3][11] Financial Performance - Revenue for the fiscal fourth quarter reached $843,884, up from $727,824 in the same quarter of the previous year, reflecting a 16% increase [7] - Total revenue for fiscal 2025 was $3,052,532, a slight decrease from $3,111,781 in fiscal 2024 [17] - The company reported a net loss of $10,568,733 for fiscal 2025, compared to a net loss of $10,156,759 in fiscal 2024 [17] Operational Highlights - The company secured 115 new accounts in fiscal 2025, contributing to a total of over 450 active customer accounts [11] - Revenue from cartridge sales increased by 24% year-on-year in the fourth quarter and 14% year-on-year for the full fiscal year [7] - The company implemented measures to improve gross margins and reduce net loss, including product enhancements and manufacturing improvements [8] Regulatory and Market Expansion - The company is actively working on its regulatory strategy to secure FDA clearance, which includes engaging with regulatory consultants and refining clinical study designs [4][6] - Efforts to expand into international markets are ongoing, with active scoping in Canada, Indonesia, and the Philippines [6] - The company aims to expand its commercial presence in the U.S. market, which is the largest drug screening market globally [3][4]

Company Overview - Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions [3] - The company aims to revolutionize portable testing through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat [3] - The system is designed to be hygienic and cost-effective, screening for recent drug use including opiates, cocaine, methamphetamine, and cannabis [3] Technology and Applications - The Intelligent Fingerprinting Drug Screening System allows for sample collection in seconds and provides results in under ten minutes [3] - This technology is particularly valuable for employers in safety-critical industries, enhancing workplace safety [3] - Current customer segments outside the US include construction, manufacturing, engineering, transport and logistics, mining, drug treatment organizations, and coroners [3] Upcoming Events - The management team will participate in the Sidoti Micro-Cap Virtual Conference on August 20-21, 2025 [1] - A presentation is scheduled for August 21, 2025, at 9:15 a.m. Eastern Time [2] - Interested parties can register for the conference through a provided link and schedule one-on-one meetings with the management team [2]

[FORM 8-K General Information](index=1&type=section&id=FORM%208-K%20General%20Information) This section provides an overview of the Form 8-K filing, including general information about the registrant and the filing's purpose [Filing Details and Registrant Information](index=1&type=section&id=Filing%20Details%20and%20Registrant%20Information) This section provides the general filing information for the Form 8-K, including the registrant's details, incorporation state, and securities registration information - The report date is August 7, 2025, filed by Intelligent Bio Solutions Inc., incorporated in Delaware[1](index=1&type=chunk) Registered Securities Information | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :----------------------- | :---------------- | :---------------------------------------- | | Common Stock, $0.01 par value | INBS | The Nasdaq Stock Market LLC | - The registrant, Intelligent Bio Solutions Inc., is an emerging growth company[2](index=2&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section details the preliminary, unaudited financial results for the fiscal fourth quarter [Preliminary Revenue Announcement](index=2&type=section&id=Preliminary%20Revenue%20Announcement) Intelligent Bio Solutions Inc. announced preliminary, unaudited revenue results for the fiscal fourth quarter ended June 30, 2025, via a press release furnished as Exhibit 99.1 - On August 7, 2025, Intelligent Bio Solutions Inc. issued a press release announcing preliminary, unaudited revenue results for the fiscal fourth quarter ended June 30, 2025[3](index=3&type=chunk) - The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K[3](index=3&type=chunk) - The information in this report, including the exhibit, is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, nor subject to liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933[4](index=4&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists all financial statements and exhibits included in the Form 8-K filing [Exhibits Filed](index=2&type=section&id=Exhibits%20Filed) This section lists the exhibits accompanying the Form 8-K filing, which include the press release and the interactive data file List of Exhibits | No. | Description | | :-- | :------------------------------------ | | 99.1 | Press release dated August 7, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [SIGNATURES](index=3&type=section&id=SIGNATURES) This section contains the official signatures confirming the authenticity and submission of the report [Report Sign-off](index=3&type=section&id=Report%20Sign-off) The report was duly signed on behalf of Intelligent Bio Solutions Inc. by its Chief Financial Officer - The report was signed on August 7, 2025[8](index=8&type=chunk) - Spiro Sakiris, Chief Financial Officer, signed the report on behalf of Intelligent Bio Solutions Inc[8](index=8&type=chunk)

Core Viewpoint - Intelligent Bio Solutions Inc. is focused on obtaining FDA clearance for its innovative fingerprint sweat-based drug screening technology, with a response expected within six weeks, aiming for U.S. market entry in 2025 [1][4]. Company Developments - The company submitted an Additional Information response to the FDA, which includes new positive data that enhances its 510(k) submission and validates the technology's security and performance [1][4]. - The updated submission involved extensive cybersecurity testing, dedicating 10,000 hours to data collection, resulting in 23 detailed test reports and over 1,900 pages of documentation [2][4]. - The technology has been reaffirmed for accuracy using advanced quantification methods, confirming its capability to detect minute sweat volumes from a single fingerprint [3][4]. Market Strategy - Securing FDA clearance is a top priority for the company as it seeks to enter the multi-billion-dollar U.S. market, which presents significant commercial opportunities [4]. - The company's non-invasive drug screening technology is already in use across more than 450 accounts in 24 countries, with a growing international presence supported by 18 global distribution partners [4][5]. - The technology is designed for rapid testing, providing results in under ten minutes, making it suitable for safety-critical industries such as construction, manufacturing, and law enforcement [5].

Core Insights - Intelligent Bio Solutions Inc. (INBS) has secured a significant contract with a major public transport operator in London, covering 14 operational sites and employing over 4,400 staff [1] - The deployment of INBS's Intelligent Fingerprinting Drug Screening System will take place across a bus network that serves over one million passengers daily, utilizing more than 1,400 low-emission vehicles [2] - The CEO of INBS highlighted the advantages of their technology, including rapid drug testing, reduced financial loss from wait times, and improved workforce efficiency [3] Company Overview - INBS specializes in intelligent, rapid, non-invasive testing solutions, with a focus on drug screening through fingerprint sweat analysis [5] - The company's drug testing technology is currently used by over 450 accounts in 24 countries, with plans for expansion in Europe, the Middle East, Africa, Asia Pacific, and the U.S. [4] - INBS aims to secure regulatory clearance from the U.S. FDA to enter the U.S. market in 2025 [4]

Core Viewpoint - Intelligent Bio Solutions Inc. has announced an agreement to exercise existing warrants to raise approximately $3.8 million, which will be used to fund the completion of its 510k filing with the U.S. FDA for its Fingerprint Drug Screening System [1][3][5]. Group 1: Financial Details - The company will exercise existing warrants to purchase up to 2,023,228 shares at a reduced price of $1.90 per share [1]. - The gross proceeds from this transaction are expected to be around $3.8 million before deducting fees and expenses [3]. - The transaction is anticipated to close on or about July 28, 2025, subject to customary closing conditions [5]. Group 2: Warrant and Share Details - Current warrant holders will receive new Inducement Warrants to purchase up to 4,046,456 shares at the same reduced exercise price of $1.90 per share, with a term of 5.5 years [4]. - In lieu of a complete exercise of the Existing Warrants, some holders will prepay $1.89 of the reduced exercise price and receive an amended warrant with an exercise price of $0.01 per share [4]. Group 3: Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, particularly its Fingerprint Drug Screening System [8]. - The system is designed to screen for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, and aims to serve safety-critical industries [8].