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].

Core Insights - Intelligent Bio Solutions Inc. has successfully collected new data that reinforces the security and performance of its Intelligent Fingerprinting Drug Screening System, which is crucial for its FDA 510(k) submission [2][5] - The company has engaged in constructive dialogue with the FDA and plans to submit findings along with new data in August [3][5] - The technology utilizes advanced quantification techniques to measure trace sweat volumes, confirming its ability to detect minute levels of sweat in a single fingerprint [4][5] Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [6] - The system screens for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, and is designed for safety-critical industries [6] - The company currently supports over 450 accounts across 24 countries and is expanding its global reach through 18 distribution partners [5][6] Regulatory and Technical Developments - The company has completed rigorous cybersecurity testing to validate the resilience of its system, confirming its strength in secure and varied operating environments [3] - The R&D team has invested over 6,000 hours into testing, data aggregation, analysis, and technical reporting to enhance the quality of the FDA submission [5] - The technology is capable of measuring down to 0.0000001 grams, which is approximately 10 million times lighter than a U.S. one-dollar bill, showcasing its precision [4]

Company Overview - Intelligent Bio Solutions Inc. (INBS) is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions [6] - The company aims to revolutionize portable testing through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat for drug use [6] Partnership and Product Expansion - INBS announced a global distribution agreement with SMARTOX® to introduce the SmarTest Patch drug detection product to international markets outside the U.S. and Canada [1][2] - The SmarTest Patch enhances INBS's product portfolio by providing continuous sweat-based drug detection over an extended period, targeting sectors such as justice and rehabilitation [2][3] Market Potential - The global drug testing market is projected to grow significantly, reaching approximately $18.6 billion by 2030, presenting new opportunities for INBS [2] - The partnership with SMARTOX supports INBS's international growth strategy and introduces an additional revenue stream aligned with its broader expansion goals [2] Regulatory Strategy - INBS is prioritizing securing FDA clearance for its fingerprint sweat-based drug testing technology for use beyond forensic settings as part of its U.S. expansion strategy [4] - The company is actively engaging with regulatory consultants and stakeholders to bring its innovative solution to market in the U.S. [4] Current Operations - INBS currently serves over 450 active accounts in 24 countries, providing non-invasive drug testing solutions across health, justice, and workplace sectors [3]

Core Insights - Intelligent Bio Solutions Inc. has introduced the SmarTest® Patch, a non-invasive drug testing solution that detects substances through sweat over a 7 to 10-day period [1][2] - The SmarTest Patch complements the existing Intelligent Fingerprinting Drug Testing Solution, enhancing the company's product portfolio in non-invasive testing technologies [1][2] Product Features - The SmarTest Patch is discreet, water-resistant, and tamper-evident, designed to continuously collect sweat for drug detection [2] - It can detect a wide range of substances, including cocaine, opiates, methamphetamines, marijuana, and fentanyl [2] - The differing detection windows of the SmarTest Patch and the Intelligent Fingerprinting Drug Screening System allow the company to meet varied customer requirements [2][3] Market Opportunities - The introduction of the SmarTest Patch opens new opportunities in markets requiring longer detection windows, particularly in justice and rehabilitation settings [3] - The product enhances the company's commercial edge by providing customers with more adaptable tools for both short and long-term detection needs [3] Company Background - Intelligent Bio Solutions Inc. focuses on delivering rapid, non-invasive testing solutions and aims to revolutionize portable testing through fingerprint sweat analysis [5] - The company targets various customer segments outside the U.S., including construction, manufacturing, transport, and drug treatment organizations [5] Partner Information - SMARTOX, the developer of the SmarTest Patch, is a U.S.-based provider of drug and alcohol testing products and services, committed to advanced technology and exceptional results [4] - SMARTOX is actively expanding its presence in forensic testing markets through investments and pilot programs [4]

Core Insights - Intelligent Bio Solutions Inc. (INBS) is set to present its Pharmacokinetic (PK) study data at the ADLM 2025 Clinical Lab Expo, showcasing the effectiveness of its Intelligent Fingerprinting Drug Screening System for non-invasive drug testing [2][4]. Group 1: Study Findings - The PK study demonstrated that fingerprint sweat can accurately reflect the rate and extent of codeine found in blood and saliva, indicating its reliability for drug detection [3]. - Statistical comparisons at a 95% confidence level confirmed that fingerprint sweat serves as a dependable sample matrix for drug screening [3]. Group 2: Event Participation - Daniel Brown, Head of Clinical Affairs at INBS, will represent the company at the ADLM event, engaging with attendees and presenting the study's methodology and findings [4]. - ADLM 2025 is a significant global exposition for laboratory medicine, featuring over 300 expert speakers and more than 250 educational sessions [5]. Group 3: Company Overview - INBS's Drug Screening System is designed for accurate and efficient testing across various sectors, including construction, transportation, and manufacturing, with over 450 accounts in 24 countries [7]. - The Intelligent Fingerprinting Drug Screening System aims to revolutionize portable testing through rapid sample collection and results, making it a valuable tool for safety-critical industries [8].