FDA 510(k) timeline update from Intelligent Bio Solutions (NASDAQ: INBS)

Rhea-AI Filing Summary

Intelligent Bio Solutions Inc. furnished a current report describing a press release about its regulatory plans. On September 26, 2025, the company announced an update to the timeline for its anticipated FDA 510(k) clearance for using its Intelligent Fingerprinting Drug Screening System to test for the opiate codeine. The press release with further details is attached as an exhibit to the report and is treated as furnished, not filed, under securities law.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): September 26, 2025

INTELLIGENT BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware		001-39825		82-1512711
(State of 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) 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 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 ☒

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 September 26, 2025, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) announcing an update on the timeline for anticipated FDA 510(k) clearance for the use 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 September 26, 2025.
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: September 26, 2025
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro Sakiris
	Title:	Chief Financial Officer

FAQ

What did Intelligent Bio Solutions (INBS) report in this 8-K?

The company reported that it issued a press release updating the timeline for anticipated FDA 510(k) clearance of its Intelligent Fingerprinting Drug Screening System for codeine.

Which product is mentioned in the INBS 8-K filing?

The filing references the company’s Intelligent Fingerprinting Drug Screening System, specifically for screening the opiate codeine.

What regulatory pathway is discussed for INBS in this document?

The document discusses anticipated FDA 510(k) clearance related to the company’s drug screening system for codeine.

How did Intelligent Bio Solutions communicate the FDA timeline update?

The company communicated the update through a press release dated September 26, 2025, which is furnished as Exhibit 99.1.

Is the INBS press release considered filed or furnished with the SEC?

The press release is furnished, not filed, meaning it is not automatically incorporated into other Securities Act or Exchange Act filings unless specifically referenced.

Who signed the Intelligent Bio Solutions 8-K related to the FDA timeline update?

The report was signed on behalf of the company by Spiro Sakiris, Chief Financial Officer.