# EDGAR Filing Document

**Accession Number:** 0001725430
**File Stem:** 0001493152-25-013836
**Filing Date:** 2025-9
**Character Count:** 11120
**Document Hash:** 8e0782b3d3a27093d5bca79b04c6bce8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-013836.hdr.sgml**: 20250917

**ACCESSION NUMBER**: 0001493152-25-013836

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250917

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250917

**DATE AS OF CHANGE**: 20250917

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** INTELLIGENT BIO SOLUTIONS INC.
- **CENTRAL INDEX KEY:** 0001725430
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 821512711
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39825
- **FILM NUMBER:** 251318853

**BUSINESS ADDRESS:**
- **STREET 1:** 135 W 41ST ST,
- **STREET 2:** FLOOR 5
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10036
- **BUSINESS PHONE:** 646-790-5756

**MAIL ADDRESS:**
- **STREET 1:** 135 W 41ST ST,
- **STREET 2:** FLOOR 5
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10036

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** GBS Inc.
- **DATE OF NAME CHANGE:** 20190919

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Glucose Biosensor Systems (Greater China) Holdings, Inc.
- **DATE OF NAME CHANGE:** 20171214

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of**

**the Securities Exchange Act of 1934**

Date of Report (Date of Earliest Event Reported): **September 17, 2025**

**INTELLIGENT BIO SOLUTIONS INC.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-39825** | **82-1512711** |
| (State of<br> Incorporation) | (Commission<br> File Number) | (IRS employer<br> identification no.) |

---

**135 West, 41st Street, 5th Floor**

**New York, NY 10036**

(Address of principal executive offices, including zip code)

Registrant's telephone number, including area code: **(646) 828-8258**

**N/A**

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| 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 |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 8.01 Other Events.**

On September 17, 2025, Intelligent Bio Solutions Inc. (the "Company"), issued a press release (the "Press Release") providing an update on the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. The Press Release announced that the FDA has requested new additional information about the Intelligent Fingerprinting Drug Screening System that requires the Company to resubmit a new 510(k) notification. The FDA's requests were made in a letter dated September 12, 2025. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The foregoing disclosure is qualified in its entirety by the full text of the Press Release.

**Item 9.01 Financial Statements and Exhibits.**

---

| | |
|:---|:---|
| **No.** | **Description** |
| 99.1 | [Press Release, dated September 17, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
| Date: September 17, 2025 |  |  |
|  | **INTELLIGENT BIO SOLUTIONS INC.** | **INTELLIGENT BIO SOLUTIONS INC.** |
|  | By: | */s/ Spiro Sakiris* |
|  | Name: | Spiro Sakiris |
|  | Title: | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Intelligent Bio Solutions Provides Update on FDA 510(k) Clearance Process for Intelligent Fingerprinting Drug Screening System**

**NEW YORK, September 17, 2025** – Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System.

In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA's questions and submitted additional information in August 2025.

The FDA appeared to be satisfied with the majority of responses to the items and has responded with a request for new additional information that requires the Company to resubmit a new 510(k) notification. As a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, the Company's Intelligent Fingerprinting Drug Screening System requires extensive supporting information to validate its performance. The practical feedback received from the FDA is not uncommon for breakthrough technologies.

INBS is in the process of evaluating the FDA's questions and is currently in consultation with its specialized FDA consultants. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance.

*"The FDA's feedback provides constructive clarity on the additional information it requires to advance our application,"* said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. *"We are confident in the capabilities of our technology, and we remain fully committed to bringing our innovative solution to the U.S. market. We will work to respond to the FDA's additional questions to support validation of our device, in order to resubmit our 510(k) Notification as soon as possible. The progress we have made so far in terms of additional data collected to substantiate the strength of our product throughout this process places us in a strong position as we work toward clearance. Importantly, our international business continues to grow, enabling us to maintain commercial progress globally while pursuing U.S. clearance outside of the Forensic Use Only market."*

The Company continues to advance its commercial activities outside the U.S., developing new partnerships and driving sales growth while pursuing further international market penetration.

**About Intelligent Bio Solutions Inc.** 

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company's current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.

For more information, visit <u>https://ibs.inc/</u>

**Forward-Looking Statements** 

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

**Company Contact**

Intelligent Bio Solutions Inc.

<u>info@ibs.inc</u>

LinkedIn \| Twitter

**Investor & Media Contact**

Valter Pinto, Managing Director

KCSA Strategic Communications

PH: (212) 896-1254

<u>INBS@kcsa.com</u>