Form 8-K

8-K — INTELLIGENT BIO SOLUTIONS INC.

Accession: 0001493152-26-037206

Filed: 2026-08-11

Period: 2026-08-11

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): August 11, 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.

August 11, 2026, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”)

announcing the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of

several studies underpinning the Company’s FDA 510(k) submission for U.S. market clearance for detection of 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 August 11, 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:

August 11, 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 Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

All

clinical data collection across the Company’s FDA 510(k) clinical study program is complete; FDA submission on track for second

half of 2026

NEW

YORK, August 11, 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 completion of its multi-site

Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several studies underpinning the Company’s

FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. All clinical data collection across the Company’s

FDA 510(k) clinical study program is now complete.

Following

ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines, the study was conducted across three independent

U.S. clinical sites over three weeks in partnership with CenExel Clinical Research, Inc. A total of 135 participants were enrolled, with

the study population structured to represent the demographic diversity of the U.S. population. The screening process was administered

by nine operator participants representing typical workplace drug screening personnel. Data analysis is currently underway, with all

specimens to be independently verified via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis.

The

Method Comparison Study was 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 the field. The study evaluated this by measuring sensitivity, specificity,

and accuracy in pre-employment and workplace screening environments, making it one of the most operationally relevant components of the

Company’s FDA 510(k) submission.

“Completing

this final study on schedule is the milestone the entire program has been building toward. It amounts to a substantial body of work and

clinical evidence,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “We are now firmly in the final

stretch of data analysis and assembly of our FDA 510(k) submission package, and we remain focused on bringing our technology to the U.S.

market.”

The

completion of data collection in this final study concludes a structured, multi-study clinical program designed to address safety, accuracy,

usability, specificity, and precision requirements. The Company now moves into analysis, compilation, and finalization of its 510(k)

submission package, targeting submission in the second half of 2026, ahead of planned entry into the multi-billion-dollar U.S. market.

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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