INBS Intelligent Bio Solutions Inc

 

 

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 27, 2024

 

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, 41^st Street, 5^th 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 27, 2024, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) announcing the successful completion of in-clinic testing proposed to the FDA earlier this year in the Company’s clinical study plan. 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.

 

Item 9.01 Financial Statements and Exhibits.

 

No.		Description
99.1		Press release dated September 27, 2024
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 27, 2024
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro Sakiris
	Title:	Chief Financial Officer

 

 

 

 

 

Exhibit 99.1

 

Intelligent Bio Solutions Concludes In-Clinic Testing for Clinical Study Plan, Advancing Toward FDA 510(k) Submission.

 

New York, September 27, 2024 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful completion of in-clinic testing proposed to the FDA earlier this year in the Company’s clinical study plan. The clinical studies are a key element of the Company’s 510(k) submission, designed to demonstrate the accuracy and reliability of its sweat-based testing method.

 

The studies included a pharmacokinetic (PK) study, which aimed to demonstrate that the measurement of drugs in fingerprint sweat delivers results comparable or superior to other specimen matrices, such as blood, saliva and urine. In addition to the PK study, a method comparison and usability study was conducted to validate the accuracy of the Company’s fingerprint sweat drug screening method in the hands of intended users.

 

The clinical phase of the PK study concluded in June 2024, with all laboratory analyses completed and data currently under review. The method comparison and usability studies, carried out across three sites, involved 135 subjects who were randomly dosed with codeine and then tested using the Company’s drug screening system. The accuracy of the screening system results will be assessed relative to a traceable, laboratory-based reference method. “Executing these clinical studies required diligence and collaboration across multiple functions within Intelligent Bio Solutions and our CRO partners, CenExel and Cliantha,” said Daniel Brown, Head of Clinical Affairs at INBS.

 

“Completion of these in-clinic studies marks a significant achievement for our team and brings us closer to our goal of obtaining FDA 510(k) Notification clearance, said Harry Simeonidis, President and CEO at INBS. “The early feedback on results from these studies demonstrates the potential of our fingerprint-based testing method to provide a non-invasive, reliable alternative to traditional drug testing methods and address the needs of diverse sectors, including workplaces and government agencies.”

 

With the in-clinic testing phase now complete, INBS is preparing for the next steps in its FDA submission process. Achieving FDA clearance will enable the Company to market its product as a clinically validated tool, paving the way for adoption in the US and potentially transforming the landscape of drug screening. The Company expects clinical data analysis to be completed in the fourth calendar quarter of 2024 and to submit the 510(k) package during the same quarter.

 

About Intelligent 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 US include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.

 

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

 

 

Forward-Looking Statements:

 

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.   

 

Company Contact:

 

Intelligent Bio Solutions Inc.
info@ibs.inc
LinkedIn | Twitter

 

Investor & Media Contact:

 

Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com

 

 

 

 

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Trading Symbol	INBS
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