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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 17, 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
8.01 Other Events.
On September 17, 2025, Intelligent Bio Solutions
Inc. (the “Company”), issued a press release (the “Press Release”) providing an update on the FDA 510(k) clearance
process for its Intelligent Fingerprinting Drug Screening System. The Press Release announced that the FDA has requested new additional
information about the Intelligent Fingerprinting Drug Screening System that requires the Company to resubmit a new 510(k)
notification. The FDA’s requests were made in a letter dated September 12, 2025. The Company expects to have an investor update
in the next ten days outlining an updated timeline for FDA clearance.
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.
Item
9.01 Financial Statements and Exhibits.
| No. |
|
Description |
| 99.1 |
|
Press Release, dated September 17, 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 17, 2025 |
|
|
| |
INTELLIGENT
BIO SOLUTIONS INC. |
| |
|
|
| |
By:
|
/s/
Spiro Sakiris |
| |
Name:
|
Spiro
Sakiris |
| |
Title: |
Chief
Financial Officer |
