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): March 25, 2025

INTELLIGENT

BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware	001-39825	82-1512711
(State<br><br> <br>of Incorporation)	(Commission<br><br> <br>File Number)	(IRS employer<br><br> <br>identification 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. ☐

Item 7.01 Regulation FD Disclosure.

On March 25, 2025, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) providing the Company’s shareholders with a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System. 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 March 25, 2025
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> March 25, 2025
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro<br> Sakiris
	Title:	Chief<br> Financial Officer

Exhibit99.1

IntelligentBio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch

NEWYORK, March 25, 2025 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided shareholders with a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System, which remains on track for launch in the U.S. in 2025 targeting its opiate test system for codeine, as validated in the Company’s Pharmacokinetic (PK) study.

On December 18, 2024, the Company announced the submission of 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, which the FDA classified as a 21 CFR 862.3650, Opiate Test System, a Class II device requiring submission of a 510(k) premarket notification. This submission marked a critical milestone in the Company’s efforts to enter the U.S. market with its drug testing system in 2025.

The Company’s 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the system’s 94.1% accuracy and a PK study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level. These findings highlight the system’s accuracy, reliability, and usability, demonstrating its capacity to meet the growing demand for efficient, non-invasive testing solutions in the U.S. market.

INBS’s 510(k) submission started the 90-day period within which the FDA is required to review and respond to 510(k) submissions. As expected, the FDA has reviewed and responded with questions by issuing an Additional Information (AI) request. When the FDA issues an AI request, the 90-day review clock is paused. The Company has reviewed the AI request and is in the process of responding so that the FDA can restart the review clock. As a result of this process, although the FDA is required to review and respond in 90 days, it is not uncommon for the FDA clearance process to take three to six months or longer if additional data is required. As INBS awaits FDA clearance, it continues to develop its plans to enter the multi-billion-dollar U.S. market in 2025 and pursue FDA clearance for additional drug classes on its panel. The Company’s full panel test is already widely adopted, with a presence in 19 countries and over 400 accounts globally.

“Thesubmission of our 510(k) premarket notification to the FDA marked a pivotal step in the journey to bring our Intelligent FingerprintDrug Screening System to the U.S. market,” said Harry Simeonidis, President and CEO at INBS. “ We appreciate the thoroughnessof the FDA’s process, which aligns with our expectations. As we await FDA clearance, we remain confident in the strength of ourdata, which demonstrates the accuracy, reliability, and usability of our technology. We are actively preparing for our planned U.S. launchin 2025, where we see significant opportunities to revolutionize drug screening with our non-invasive, rapid testing solution.”

AboutIntelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, 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, drug treatment organizations, and coroners.

For more information, visit: http://www.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, 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.

CompanyContact:

Intelligent Bio Solutions Inc.

info@ibs.inc

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Investor& Media Contact:

Valter Pinto, Managing Director

KCSA Strategic Communications

PH: (212) 896-1254

INBS@kcsa.com