8-K
INTELLIGENT BIO SOLUTIONS INC. (INBS)
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): August 6, 2025
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**, 41^st^Street** , 5thFloor
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 August 6, 2025, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) announcing the submission of its Additional Information (“AI”) response to the United States Food and Drug Administration (“FDA”) as part of its ongoing 510(k) clearance process for planned entry to U.S. market later this year. 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.
Item8.01. Other Events.
On August 6, 2025, the Company, announced the submission of its Additional Information (“AI”) response to the FDA as part of its ongoing 510(k) clearance process.
Item9.01 Financial Statements and Exhibits.
| No. | Description |
|---|---|
| 99.1 | Press release dated August 6, 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> August 6, 2025 | ||
|---|---|---|
| INTELLIGENT BIO SOLUTIONS INC. | ||
| By: | /s/ Spiro Sakiris | |
| Name: | Spiro<br> Sakiris | |
| Title: | Chief<br> Financial Officer |
Exhibit 99.1
IntelligentBio Solutions Strengthens FDA 510(k) Package with New Cybersecurity and Performance Data Ahead of Planned U.S. Market Launch
FDAresponse expected within six weeks; Company remains focused on 2025 U.S. expansion
NEWYORK, August 06, 2025 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the submission of its Additional Information (“AI”) response to the United States Food and Drug Administration (“FDA”) as part of its ongoing 510(k) clearance process for planned entry to the U.S. market later this year. The response includes new positive data that strengthens the Company’s 510(k) submission and further validates the security and performance of its innovative fingerprint sweat-based drug screening technology.
The Company’s updated submission incorporates data from intensive cybersecurity testing, including penetration and electromagnetic compatibility testing. These efforts have reinforced the system’s resilience across varied environments and supported targeted updates to further strengthen platform integrity and dependability. An extraordinary 10,000 hours were dedicated to the collection of new data for the submission, which included 23 detailed test reports and more than 100 supporting attachments, totaling over 1900 pages, along with over 7800 lines of data collected throughout the process.
“Weare both pleased and proud to submit our recent findings to the FDA, said Peter Passaris, Vice President of Product Development at IntelligentBio Solutions. “The quality, depth, and regulatory alignment of our current submission represents a significant advancement. Ourteam has shown aptitude and diligence at the highest level throughout the information request period, and we are confident in the updatedpackage we’re submitting.”
INBS has also reaffirmed the accuracy of its technology using advanced quantification methods, including human eccrine sweat testing. An Ultra-Micro Balance scale, an extremely sensitive measuring device, confirmed the system’s capability to detect and analyze minute sweat volumes found in a single fingerprint.
“SecuringFDA clearance has been a top priority as we look to bring our fingerprint sweat-based solution to more markets, particularly those withsignificant commercial potential, such as the multi-billion-dollar U.S. market,” said Harry Simeonidis, President and CEO at IntelligentBio Solutions. “The data we have gathered reflects the outstanding work of our R&D team, whose technical expertise has strengthenedthe case for our technology’s accuracy and reliability.”
INBS continues to advance its U.S. expansion strategy, prioritizing FDA clearance for its opiate test system for codeine and U.S. market entry in 2025. The Company’s non-invasive drug screening technology is used across more than 450 accounts in 24 countries, supporting workplace, law enforcement and justice sectors. With 18 global distribution partners and growing awareness and adoption, INBS is steadily expanding its international presence. Entry into the multi-billion-dollar U.S. market will open significant opportunities for the Company as it pursues its global expansion plans. The Company expects a response from the FDA within six weeks.
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 US 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, 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