Form 8-K

8-K — INTELLIGENT BIO SOLUTIONS INC.

Accession: 0001493152-26-034428

Filed: 2026-07-23

Period: 2026-07-23

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): July 23, 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.

July 23, 2026, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) announcing

that it has addressed all the cybersecurity and software-related review items for its upcoming FDA 510(k) submission. 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 July 23, 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:

July 23, 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 Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry

Company

has addressed final review items from penetration testing and finalized cybersecurity and software documentation

510(k)

package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S. drug screening market

NEW

YORK, July 23, 2026 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical

technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it has addressed all the cybersecurity

and software-related review items for its upcoming FDA 510(k) submission. This follows the Company’s recent completion of independent

third-party penetration testing and confirms that all review items have now been resolved. The Company is on track to submit its 510(k)

notification in calendar H2 2026.

Following

the April 2026 announcement that penetration testing identified no major vulnerabilities, INBS has now completed the full remediation

cycle. All cybersecurity review items have been addressed, with 100% of medium-risk vulnerabilities remediated and low-risk vulnerabilities

reduced from 11 to 2. The remaining items are supported by a comprehensive risk-based justification confirming that there is no impact

on device safety, effectiveness, or performance. In parallel, all 19 software bill of materials (SBOM) vulnerabilities have been fully

resolved, with documentation and system configuration aligned with FDA guidance. Independent third-party verification confirmed there

were no remaining issues. Together, these outcomes materially reduce regulatory risk and further strengthen the Company’s 510(k)

package ahead of its planned calendar H2 2026 filing.

“This

is a meaningful de-risking event for INBS and an important milestone in our progression toward planned U.S. market entry. Having completed

the independent penetration study, we have now resolved all cybersecurity and software-related issues,” said Harry Simeonidis,

President and CEO at Intelligent Bio Solutions. “We believe we are in a strong position as we advance through the remaining

stages of the FDA review process and move toward our planned 510(k) submission in the second half of 2026.”

The

Company’s 510(k) package targets codeine detection as the initial indication. Clearance is expected to open opportunities for the

Company in the U.S. market beyond Forensic Use Only settings. The U.S. drug screening market represents a multi-billion-dollar annual

opportunity spanning workplace testing, criminal justice, pain management, law enforcement, and substance abuse treatment. With its manufacturing

partnership with Syrma Johari MedTech expected to deliver annual production cost savings of more than 40% and an expected annual gross

margin improvement of approximately 20 percentage points, INBS is building the operational and financial infrastructure to support a

scalable U.S. commercial launch following FDA clearance.

The

Intelligent Fingerprinting Drug Screening System collects fingerprint sweat samples in seconds and delivers results in under ten minutes.

The process is non-invasive, hygienic, and occurs at the point of collection. This innovative technology is designed to detect recent

drug use up to 16-24 hours before testing, and in other countries, is being used to screen for opiates, cocaine, methamphetamine, and

cannabis. The System is already commercially deployed outside the U.S. across workplace, law enforcement, and government settings.

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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