Form 8-K

8-K — INTELLIGENT BIO SOLUTIONS INC.

Accession: 0001493152-26-026780

Filed: 2026-06-02

Period: 2026-06-02

CIK: 0001725430

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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): June 2, 2026

INTELLIGENT

BIO SOLUTIONS INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-39825

82-1512711

(State

Incorporation)

(Commission

File

Number)

(IRS

employer

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) 790-5756

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 ☒

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

7.01 Regulation FD Disclosure.

June 2, 2026, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) announcing

the initiation of a multi-site Method Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent

Fingerprinting Drug Screening System for the opiate codeine. 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.

The

information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed

to be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall

it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically

identified therein as being incorporated by reference.

Item

9.01 Financial Statements and Exhibits.

No.

Description

99.1

Press release dated June 2, 2026

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: June 2, 2026

INTELLIGENT

BIO SOLUTIONS INC.

By:

/s/

Spiro Sakiris

Name:

Spiro Sakiris

Title:

Chief Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Intelligent

Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Study

designed to validate accuracy and real-world workplace performance of the Intelligent Fingerprinting Drug Screening System

Company

expects to complete enrollment and data collection by the end of July, 2026

NEW

YORK, June 02, 2026 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical

technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the initiation of a multi-site Method

Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System

for the opiate codeine.

The

Company has partnered with nationwide clinical research site network, CenExel Clinical Research,

Inc., to perform the study, which will evaluate the accuracy of the Intelligent Fingerprinting Drug Screening System when operated

by intended end-users across multiple clinical sites. A total of 135 donor participants will be enrolled and randomized into dosing groups,

with demographics designed to reflect the diversity of the U.S. population. Fingerprint sweat specimens will be collected and analyzed

by nine operator participants representing typical workplace drug screening personnel. The study is designed to demonstrate the system’s

real-world performance when used by personnel who may not have specialized laboratory training.

User

performance evaluation is a key part of the Company’s FDA 510(k) submission. It is designed to show that typical users in occupational

health, HR, and workplace safety can operate the Intelligent Fingerprinting Drug Screening System accurately and effectively in real

pre-employment and workplace screening environments.

The

study will assess key performance metrics, including the system’s sensitivity, specificity, and overall accuracy. Results will

be independently confirmed via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”)

analysis, the gold standard method for drug detection confirmation.

“Demonstrating

that typical workplace personnel can operate our system accurately without specialized training will validate a core competitive advantage

- ease of use. This will strengthen our position in the workplace drug screening segment, where simplicity and reliability are key selection

criteria,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “While our technology is already sold and

used in markets outside of the United States, part of our FDA submission involves conducting a formal study to generate the clinical

evidence required to demonstrate its effectiveness within the U.S. regulatory framework.”

The

study will be conducted across multiple sites in accordance with ICH GCP (International Council for Harmonisation Good Clinical Practice)

Guidelines and national regulatory requirements, enhancing data robustness across diverse operating environments and user populations.

The

Company expects to complete enrollment and data collection by the end of July 2026. Results will be included in its FDA 510(k) submission

package. These results will appear alongside data from the previously announced clinical cut-off study which began in January 2026.

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: https://ibs.inc/

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, and involve risks and uncertainties.

Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s

ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and

collaborations, secure regulatory clearance or approvals, and timelines to enter the U.S. market, among others. Although Intelligent

Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual

results may differ materially from those expressed or implied by such 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,” and “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, including those described in Intelligent Bio Solutions’ public filings with the

U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release.

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.

info@ibs.inc

Investor &

Media Contact

Valter Pinto,

Managing Director

KCSA Strategic

Communications

PH: (212) 896-1254

INBS@kcsa.com

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