PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Unaudited financial statements for March 31, 2025, show decreased assets and equity, a narrowed quarterly net loss, but a widened nine-month net loss, alongside significant liquidity and going concern issues [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$9.58 million** from **$13.78 million**, primarily due to reduced cash, while shareholders' equity fell to **$4.94 million** from **$8.18 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 | June 30, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $2,807,112 | $6,304,098 | | Total current assets | $5,107,331 | $8,534,243 | | Total assets | $9,584,527 | $13,778,863 | | Total current liabilities | $4,564,385 | $5,450,733 | | Total liabilities | $4,640,761 | $5,595,672 | | Total shareholders' equity | $4,943,766 | $8,183,191 | [Condensed Consolidated Statements of Operations and Other Comprehensive Income (Loss)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Other%20Comprehensive%20Income%20(Loss)) For Q3 FY2025, revenue decreased, but gross profit and net loss improved, while the nine-month period saw a slight revenue decline and a widened net loss Statement of Operations Highlights (Unaudited) | Metric | Q3 FY2025 (3 months) | Q3 FY2024 (3 months) | YTD FY2025 (9 months) | YTD FY2024 (9 months) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $728,867 | $823,800 | $2,208,648 | $2,383,957 | | Gross Profit | $341,368 | $178,489 | $911,282 | $610,068 | | Loss from Operations | ($2,553,248) | ($2,953,735) | ($7,542,991) | ($7,471,457) | | Net Loss Attributable to INBS | ($2,543,526) | ($2,977,667) | ($7,478,629) | ($7,372,512) | | Net Loss Per Share | ($0.44) | ($1.43) | ($1.59) | ($6.64) | [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Shareholders' equity decreased from **$8.18 million** to **$4.94 million** due to a **$7.48 million** net loss, partially offset by capital raised from stock issuances - Total shareholders' equity decreased from **$8,183,191** on June 30, 2024, to **$4,943,766** on March 31, 2025[14](index=14&type=chunk)[15](index=15&type=chunk) - The decrease in equity was primarily due to a cumulative net loss of **$7,478,629** for the nine months ended March 31, 2025, offset by proceeds from stock issuances[14](index=14&type=chunk)[15](index=15&type=chunk)[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended March 31, 2025, cash used in operations increased, financing cash decreased significantly, resulting in a **$3.50 million** net cash decrease and an ending balance of **$2.81 million** Cash Flow Highlights (Unaudited, Nine Months Ended March 31) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,467,356) | ($6,627,555) | | Net cash used in investing activities | ($23,321) | ($54,118) | | Net cash provided by financing activities | $3,995,808 | $14,555,243 | | Net (decrease) increase in cash | ($3,496,986) | $7,860,279 | | Cash and cash equivalents, end of period | $2,807,112 | $9,397,523 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's medical technology business, significant liquidity issues, and substantial doubt about its going concern ability, highlighting its two operating segments and recent capital raising efforts - The company is a medical technology firm focused on rapid, non-invasive testing solutions[23](index=23&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern due to insufficient cash to fund operations for the next 12 months. The company will need to raise additional funds[28](index=28&type=chunk)[29](index=29&type=chunk) - The company operates through two segments: Intelligent Fingerprinting Products (IFPG), which accounted for **100% of revenue**, and the development-stage Biosensor Platform Technology (BPT)[49](index=49&type=chunk)[51](index=51&type=chunk) - Subsequent to March 31, 2025, the company raised an additional **$135,351** through its ATM offering and issued **4,892** shares upon cashless warrant exercises[73](index=73&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased quarterly revenue, significantly improved gross profit margin due to sales mix and efficiency, stable operating expenses, and increased nine-month development costs, while emphasizing ongoing liquidity challenges and going concern doubts despite recent capital raises [Highlights of Achievements](index=22&type=section&id=Highlights%20of%20Achievements) Key achievements include securing a sixth U.S. patent, expanding European and Middle Eastern market presence, integrating Arabic into the screening system, and adding **35** new customer accounts, totaling over **450** across **24** countries - Granted a new U.S. patent for its Intelligent Fingerprinting Drug Screening Cartridge, its **sixth** patent[83](index=83&type=chunk) - Expanded access to its drug testing in Spain and Andorra and strengthened its European and Middle Eastern foothold through new partnerships[83](index=83&type=chunk) - Secured **35** new customer accounts during the quarter, reaching a total of over **450** active accounts in **24** countries[83](index=83&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Q3 2025 revenue decreased, but gross profit margin significantly improved due to sales mix and lower production costs, while nine-month development expenses increased due to FDA clinical study costs, leading to a narrowed quarterly net loss Revenue by Product (IFPG Segment) | Product | Q3 2025 (3 months) | Q3 2024 (3 months) | YTD 2025 (9 months) | YTD 2024 (9 months) | | :--- | :--- | :--- | :--- | :--- | | Cartridges | $442,029 | $448,868 | $1,278,840 | $1,159,876 | | Readers | $165,801 | $227,361 | $520,374 | $752,052 | | Other sales | $121,037 | $147,571 | $409,434 | $472,029 | | **Total Revenue** | **$728,867** | **$823,800** | **$2,208,648** | **$2,383,957** | Gross Profit Margin Analysis | Metric | Q3 2025 (3 months) | Q3 2024 (3 months) | YTD 2025 (9 months) | YTD 2024 (9 months) | | :--- | :--- | :--- | :--- | :--- | | Gross Profit | $341,368 | $178,489 | $911,282 | $610,068 | | Gross Profit Margin | 46.84% | 21.67% | 41.26% | 25.59% | - The increase in gross profit margin is attributed to a higher proportion of revenue from high-margin cartridges and enhanced production capacity leading to reduced direct labor and overhead costs[93](index=93&type=chunk) - Development and regulatory approval expenses increased by **$890,335** for the nine months ended March 31, 2025, primarily due to costs associated with the FDA 510(k) clinical study plan[104](index=104&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company's cash and working capital are insufficient to fund operations for the next twelve months, raising substantial doubt about its going concern ability, despite recent capital raises of approximately **$1.49 million** from an ATM offering and **$2.65 million** from a public offering - As of March 31, 2025, the company had **$2,807,112** in cash and cash equivalents and **$542,946** in working capital[121](index=121&type=chunk) - The company raised approximately **$1.49 million** (net) through its ATM Agreement between September 2024 and March 2025[122](index=122&type=chunk) - A February 2025 public offering raised approximately **$2.65 million** (net)[123](index=123&type=chunk) - Management believes there is a material risk that current cash is insufficient to fund operations for the next twelve months, raising substantial doubt about the company's ability to continue as a going concern[124](index=124&type=chunk)[148](index=148&type=chunk) [Controls and Procedures](index=31&type=section&id=Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025, due to a material weakness in internal control over financial reporting, with an ongoing remediation plan to address deficiencies - Management concluded that disclosure controls and procedures were ineffective as of March 31, 2025[135](index=135&type=chunk) - A material weakness was identified relating to the control environment, risk assessment, control activities, and monitoring, including limited accounting personnel and a lack of formally documented procedures[137](index=137&type=chunk) - The ongoing remediation plan includes adding accounting personnel, enhancing controls for complex accounting, engaging experts, and implementing a new accounting system[138](index=138&type=chunk)[139](index=139&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently engaged in any material legal proceedings[146](index=146&type=chunk) [Item 1A. Risk Factors](index=33&type=page&id=Item%201A.%20Risk%20Factors) The company faces material risks including the need for additional capital, a **$2.28 million** grant refund liability due to unmet milestones, and development delays for its Biosensor Platform Technology (BPT) due to intellectual property licensing issues - The company needs to raise additional capital to continue operations, and there is substantial doubt about its ability to continue as a going concern. Failure to secure funding could force it to cease or scale back operations[148](index=148&type=chunk)[149](index=149&type=chunk) - The company failed to meet milestones for an Australian government grant and will be required to refund a portion of the funds. The liability for this refund is recorded as **$2,278,681** as of March 31, 2025[150](index=150&type=chunk) - Development of the Biosensor Platform Technology (BPT) is postponed due to the liquidation of the licensor, LSBD. The company faces risks of extended delays or unfavorable terms in renegotiating the IP license with the University of Newcastle[151](index=151&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any unregistered securities during the period, other than those previously disclosed in Form 8-K filings - No unregistered securities were sold during the period, other than those previously reported on Form 8-K[155](index=155&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including the Underwriting Agreement, officer certifications, and Inline XBRL data files - Exhibits filed include the Underwriting Agreement dated February 20, 2025, certifications by the CEO and CFO, and XBRL financial data[159](index=159&type=chunk)

Core Insights - Intelligent Bio Solutions Inc. reported a 20% sequential quarterly revenue growth and a 91% year-over-year gross profit growth for the fiscal third quarter ended March 31, 2025 [1][10] - The company achieved a significant increase in recurring higher-margin cartridge sales, which now account for 58% of total sales for the nine months ended March 31, 2025 [1][13] - The active customer base grew to over 450 accounts, with 35 new accounts added during the quarter, indicating strong customer acquisition and expansion efforts [2][8] Financial Performance - Revenue for the three months ended March 31, 2025, increased by $121,373, or 20%, to $728,867 compared to $607,494 for the previous quarter [10][13] - Gross profit for the same period rose by $162,879, or 91%, to $341,368 from $178,489 year-over-year [10][13] - Total revenue for the nine months ended March 31, 2025, was $2.21 million, a decrease from $2.38 million for the same period in 2024 [10][13] Business Strategy and Growth - The company is advancing its international growth strategy with initiatives such as expanded access in key European markets and multilingual upgrades to its drug screening system [3][4] - A focus on growing cartridge adoption is strengthening the business fundamentals, contributing to margin improvement and operational efficiency [4][8] - The company launched localized websites in multiple languages and activated multi-channel advertising campaigns targeting safety-critical industries [8][9] Regulatory and Product Development - The company granted a patent in the U.S. for the Intelligent Fingerprinting Drug Screening Cartridge, marking its sixth U.S. patent [13] - Continued regulatory scoping in Canada, Indonesia, and the Philippines supports the long-term expansion strategy [13]

Arabic, Italian, and Spanish-language websites unlock commercial access to regions representing over 1.4 billion people "This is not just a translation project; it's a commercial growth engine," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "By localizing our online presence and sales infrastructure to make it ready for use by customers across the globe, we are building scalable access to high-potential markets. These initiatives are the foundation for strengthening distributor rela ...

Company expands Intelligent Fingerprinting Drug Screening System multilingual capabilities to meet growing demand across Latin American Spanish-speaking markets Latin American drug screening market projected to reach USD 1.1 billion by 2030 Expansion is part of major multilingual Drug Screening System upgrade, targeting over 4 billion potential users worldwide NEW YORK, April 22, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (NASDAQ:INBS) ("INBS" or the "Company"), a medical technology company del ...

Core Viewpoint - Intelligent Bio Solutions Inc. has integrated Arabic as the second international language into its Intelligent Fingerprinting Drug Screening System, enhancing accessibility for Arabic-speaking organizations and reinforcing its presence in the Middle East [1][2][4]. Company Developments - The integration of Arabic follows the company's expansion plans in the Middle East through a partnership with Ivy Diagnostics, targeting a market where Arabic is spoken by approximately 450 million people [2][4]. - The addition of Arabic is expected to improve usability for organizations in safety-critical industries, law enforcement, and drug rehabilitation, aligning with the growing global demand for innovative drug testing solutions [2][3]. Market Potential - The workplace drug testing market in Saudi Arabia is projected to reach $64.5 million by 2030, indicating significant growth opportunities for the company in the region [3]. - The integration of Arabic will facilitate the incorporation of the company's technology into existing safety protocols, enhancing workplace safety standards [3]. Strategic Growth - The integration of Arabic is a key milestone in the company's broader international growth strategy, which includes scaling operations across North and South America, Europe, Asia Pacific, and the Middle East [4]. - The company aims to expand its presence in 19 countries and has made strategic milestones, including a recent FDA 510(k) submission and plans to enter the multi-billion dollar U.S. market in 2025 [4].

NEW YORK, March 28, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (NASDAQ:INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its participation as a gold sponsor at the 2025 National Drug and Alcohol Screening Association (NDASA) Conference and Trade Show, taking place from April 1 – 4 in Jacksonville, Florida. Daniel Brown, Head of Clinical Affairs at Intelligent Bio Solutions, will present at the Internation ...

Company Overview - Intelligent Bio Solutions Inc. (INBS) has secured a key patent in the United States for its Intelligent Fingerprinting Drug Screening Cartridge, marking its sixth active patent in the U.S. [1][4] - The company aims to enhance its competitive edge and accelerate the commercialization of its technology as it approaches market launch [2][4]. Market Position and Financials - INBS currently has a market capitalization of $11.9 billion and anticipates an earnings growth of 80.4% in 2025 [5]. - Following the patent announcement, INBS shares fell by 5.1%, closing at $1.67, with a 6-month decline of 8.2%, compared to the industry's 13.2% decline [3]. Product and Technology - The Intelligent Fingerprinting Drug Screening Cartridge is a non-invasive drug testing solution that detects drug metabolites through fingerprint sweat analysis, offering rapid and hygienic screening [9][10]. - The cartridge collects a small sweat sample and provides results in minutes, eliminating the need for invasive sample collection and reducing contamination risks [10]. Intellectual Property and Competitive Advantage - INBS has developed a robust intellectual property portfolio, with six active U.S. patents covering various aspects of its drug screening technology [6][8]. - The strengthened IP protection reduces imitation risks and reinforces investor confidence in the company's long-term growth potential [4]. Industry Prospects - The global drug screening market was valued at $7.7 billion in 2023 and is projected to grow at a CAGR of 16.6%, reaching $19.5 billion by 2029, positioning INBS to capitalize on this growth with its patented technology [11].

Company Overview - Intelligent Bio Solutions Inc. (INBS) is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [6] - The company aims to revolutionize portable testing via fingerprint sweat analysis, which is designed to be hygienic and cost-effective, screening for recent drug use in workplace settings [6] Market Opportunity - The Spanish drug testing market is projected to reach $448 million by 2030, driven by increasing drug abuse prevention efforts, growing acceptance of drug screening for safety, and rising illicit drug use [4] - Major Spanish accounts currently require 1,000 drug testing cartridges per month, indicating a strong demand for INBS' technology [3] Strategic Partnerships - INBS has expanded its access to fingerprint drug testing in Spain and Andorra through a collaboration with Detecto, a division of MTB Distribuciones Tecnologicas SL, which is a leading provider of drug testing solutions in the region [1][2] - Detecto has successfully integrated INBS' solution into existing security protocols for major clients, including Metro Barcelona and a large mine operated by Rio Tinto, enhancing workplace safety [3] Product Acceptance - The fingerprint drug testing system has been well received due to its non-invasive nature, ease of collection, and increased acceptance among workers, along with reduced maintenance costs due to yearly calibration [3] - Detecto is broadening its focus to include law enforcement and rehabilitation sectors, as well as engaging with the maritime industry, indicating strong growth potential in various sectors [4] Industry Focus - Detecto provides consulting services regarding substance abuse in the workplace, emphasizing worker safety and well-being, particularly in high-risk sectors [5] - The company offers training and information on new drugs and technologies, positioning itself as a key player in the prevention and treatment of addictive behaviors in Spain [5]

Core Viewpoint - Intelligent Bio Solutions Inc. has been granted its sixth U.S. patent, enhancing its intellectual property portfolio and competitive position as it prepares to enter the multi-billion dollar U.S. drug screening market in 2025 [1][3]. Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions, particularly through its Intelligent Fingerprinting Drug Screening System [4]. - The company aims to revolutionize portable testing via fingerprint sweat analysis, which is designed to be hygienic and cost-effective [4]. Patent Details - The newly granted U.S. Patent No. 12259385 pertains to the proprietary lateral flow test strip within the Drug Screening Cartridge, ensuring protection for all current and future products developed by the company [2]. - This patent is fundamental to the company's testing system, which utilizes lateral flow technology to detect drugs in fingerprint sweat [2]. Market Position and Strategy - The U.S. market is identified as a key focus for the company, with plans to enter this market in 2025, supported by the recent FDA 510(k) submission in December 2024 [3]. - The Intelligent Fingerprinting Drug Testing Solution addresses the growing demand for drug testing in safety-sensitive industries, providing a non-invasive alternative that supports employee well-being and compliance [3]. Target Industries - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport and logistics, drug treatment organizations, and coroners [4].

Core Viewpoint - Intelligent Bio Solutions Inc. is progressing towards the FDA clearance for its Intelligent Fingerprint Drug Screening System, aiming for a U.S. market launch in 2025, specifically targeting opiate testing for codeine [1][2][5]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA on December 18, 2024, marking a significant milestone for entering the U.S. market [2]. - The FDA classified the system as a Class II device, requiring a 510(k) submission, which initiated a 90-day review period [2][4]. - The FDA has issued an Additional Information (AI) request, pausing the review clock, and the company is currently addressing this request [4]. Performance Data - The 510(k) submission included performance data showing a 94.1% accuracy rate and validation studies indicating that fingerprint sweat is a reliable sample matrix for drug detection [3]. - The pharmacokinetic (PK) study results align closely with blood data, demonstrating the system's reliability and usability [3]. Market Potential - The company is preparing for a significant entry into the multi-billion-dollar U.S. market in 2025 and is also pursuing FDA clearance for additional drug classes [4]. - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive testing, with results available in under ten minutes, making it suitable for safety-critical industries [6]. Global Presence - The company's full panel test is already adopted in 19 countries with over 400 accounts globally, indicating a strong international presence [4].