8-K - INBS - Equibles

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): January 28, 2026

INTELLIGENT

BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

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

135West, 41st Street, 5th Floor

NewYork, 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> 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<br> of each class	Trading<br> Symbol(s)	Name<br> of each exchange on which registered
Common<br> Stock, $0.01 par value	INBS	The<br> 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. ☐

Item7.01 Regulation FD Disclosure.

On January 28, 2026, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) announcing the commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. 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.

Item9.01 Financial Statements and Exhibits.

No.	Description
99.1	Press Release, dated January 28, 2026
104	Cover<br> 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:<br> January 28, 2026
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro<br> Sakiris
	Title:	Chief<br> Financial Officer

Exhibit99.1

IntelligentBio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S.Market

Clinicalstudies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market

Companyanticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package

NEWYORK, January 28, 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 commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

As part of its clinical study program, the Company has again partnered with Cliantha Research, a leading clinical research organization, leveraging its extensive regulatory and clinical trial expertise.

The first clinical study will assess codeine detection cut-off levels in 40 adults at a single site. The study will utilize the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, together forming the Company’s non-invasive Intelligent Fingerprinting Drug Screening System. Participants will receive controlled doses of codeine, with sample collection and analysis conducted to establish and verify optimal detection cut-off levels. The study design includes direct comparisons with a predicate FDA-cleared device to support the 510(k) regulatory pathway. Results will be corroborated via a liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. This clinical approach is designed to support both the Company’s U.S. regulatory pathway and commercial strategy to enter the U.S. market beyond the Forensic Use Only category.

The U.S. drug screening market represents a substantial commercial opportunity, generating several billions of dollars annually across workplace testing, criminal justice applications, pain management, and substance abuse treatment settings. The Company’s non-invasive fingerprint-based technology offers significant advantages over traditional urine, oral fluid, and blood testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs.

“ObtainingFDA clearance for the U.S. market is a major opportunity for Intelligent Bio Solutions,” said Harry Simeonidis, President and CEOat Intelligent Bio Solutions. “The U.S. drug screening market is the largest and most sophisticated in the world, and our IntelligentFingerprinting technology is uniquely positioned to address unmet needs across multiple high-value segments, including workplace testing,clinical settings, and law enforcement applications. Initiating our clinical studies marks a pivotal moment for our company and the customerswe aim to serve. This milestone reflects years of rigorous scientific development and dedicationfrom our team. It will further demonstrate the proven performance of our technology, with over 500,000 tests already sold and used outsidethe U.S. We look forward to completing these trials and compiling the results as part of our overall FDA submission.”

Cliantha has initiated subject recruiting and screening, with the first testing cohort scheduled to begin on January 28, 2026, and full data analysis anticipated by the end of March 2026. The Company plans to incorporate this clinical data into its new FDA 510(k) submission package.

AboutIntelligent 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-LookingStatements

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, and secure regulatory clearance or 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, 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.

CompanyContact

Intelligent Bio Solutions Inc.

info@ibs.inc

Investor& Media Contact

Valter Pinto, Managing Director

KCSA Strategic Communications

PH: (212) 896-1254

INBS@kcsa.com