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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): August 1, 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, 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
142
West, 57th Street, 11th
Floor, New
York, NY
10019
(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
August 1, 2024, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) announcing
that CenExel, a nationwide clinical research site network, will perform a method comparison clinical study as part of the Company’s
FDA 510(k) 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.
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:
August 1, 2024 |
|
|
|
INTELLIGENT BIO SOLUTIONS INC. |
|
|
|
|
By:
|
/s/
Spiro Sakiris |
|
Name:
|
Spiro
Sakiris |
|
Title: |
Chief
Financial Officer |
Exhibit 99.1
Intelligent
Bio Solutions Partners with CenExel to Conduct Clinical Study as Part of FDA 510(k) Pathway
NEW
YORK, August 1, 2024 – Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”),
a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with CenExel,
a nationwide clinical research site network, to perform a method comparison clinical study as part of the Company’s FDA 510(k)
clinical study plan.
The
Company’s method comparison study will recruit 135 healthy adult subjects across three sites under an IRB-approved protocol and
compare the results of fingerprint sweat opiate screening tests to the results from a validated, traceable liquid chromatography mass
spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.
Harry
Simeonidis, President and CEO of Intelligent Bio Solutions, commented, “We are pleased to announce our partnership with CenExel
and the initiation of the method comparison study, marking the final phase in our clinical study plan. Over the past two months, we have
made substantial progress and are steadily getting closer to filing our 510(k) submission with the FDA. We remain on track for our planned
submission to the FDA in the fourth quarter of this calendar year. I commend our dedicated team and clinical study partners for their
immense effort and commitment to ensuring the smooth execution of our clinical study plan.” Stuart Goldblatt, Chief Executive Officer
at CenExel, stated, “CenExel is excited to commence this clinical trial to test this innovative device with the potential to provide
rapid and non-invasive testing for opiates.”
The
Company recently completed the in-clinic portion of a pharmacokinetic (PK) study on opiates in human fingerprint sweat. Through the method
comparison study, the Company intends to demonstrate that the Intelligent Fingerprinting Drug Screening System, which comprises
the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader, performs accurately in the hands of intended
users to detect the presence of opiates. The Company plans to commence the method comparison study in August 2024.
About
CenExel
CenExel
provides unparalleled medical and scientific support in the design and execution of clinical trials. CenExel’s therapeutic area
focus, attention to detail, and auxiliary services assure quality, reliable results and help it to consistently achieve and exceed patient
recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted
in a vast depth of experience and insight for the Principal Investigators and research staff in each facility. The CenExel Centers of
Excellence deliver the engagement, expertise, and results to ensure clients achieve their clinical research goals.
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 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. Additionally,
the Company’s biosensor platform has the potential to test for various indications, ranging from immunological conditions to communicable
diseases. The Company’s current customer segments 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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Intelligent Bio Solutions (NASDAQ:INBS)
過去 株価チャート
から 8 2024 まで 9 2024
Intelligent Bio Solutions (NASDAQ:INBS)
過去 株価チャート
から 9 2023 まで 9 2024