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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): January 28, 2025
Qualigen
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-37428 |
|
26-3474527 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
5857
Owens Avenue, Suite 300, Carlsbad, California 92008
(Address
of principal executive offices) (Zip Code)
(760)
452-8111
(Registrant’s
telephone number, including area code)
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 |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
QLGN |
|
The
Nasdaq Capital Market of 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 (§230.405 of this
chapter) or Rule 12b-2 of the Exchange Act (§240.12b-2 of this chapter).
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
January 28, 2025, Qualigen Therapeutics, Inc. issued a press release announcing that the Company will participate in the next funding
round for NanoSynex. A copy of the press release is attached to this report as Exhibit 99.1.
The
information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 7.01 and shall
not be deemed to be “filed” for the purpose of Section 18 of the Exchange Act or otherwise subject to the liabilities of
that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing. This Item 7.01 of this
Current Report on Form 8-K will not be deemed an admission as the materiality of any information in this Item 7.01 that is required to
be disclosed solely by Regulation FD.
Item
9.01 Financial Statement and Exhibits
(d)
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.
|
QUALIGEN
THERAPEUTICS, INC. |
|
|
|
Date:
January 28, 2025 |
By: |
/s/
Kevin Richardson II |
|
|
Kevin
Richardson II, Interim Chief Executive Officer |
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1460702/000149315225003982/ex99-1_001.jpg)
Qualigen
to participate in next funding round for NanoSynex
Market
size expected to reach $4.7 billion in 2027
CARLSBAD,
Calif., January 28, 2025 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN)
(the “Company”)announced today they will be the first investors participating in the 2025 bridge round of funding for NanoSynex.
NanoSynex will be raising up to $500,000.
“We
are very excited to participate and be the first investors to commit in this round of funding for NanoSynex. The technology they are
developing will help the world of Antimicrobial Susceptibility Testing (AST) by reducing the time required for tests in half, offering
more robust diagnostics, which will lead to better use and not over use of the wrong antibiotics for patients globally. The Minimum Viable
Product (MVP) System has numerous competitive advantages to existing tests and is priced competitively with those slower and less robust
products.”, stated Kevin Richardson II, CEO of Qualigen. NanoSynex plans to be approved for the EU market in 2027 and US in 2028.
The market size globally is expected to reach $4.7 billion by 2027. The US market alone is expected to reach $1.6 billion. NaoSynex also
has a strong pipeline of other indications and verticals they can pursue with this technology. NanoSynex also has 4 patents protecting
the technology.
Diane
Abensur, CEO of NanoSynex, stated, “We are thrilled to have Qualigen’s involvement in being the first to commit to this bridge
round funding. It will allow us to jump start our product development of our MVP system for AST, generation 2.0 . The need for our product
and the lives we can help save by getting more timely and accurate robust diagnostics will help NanoSynex grow dramatically.”
About
NanoSynex
NanoSynex
is a MedTech company, based in Israel, that aims at providing new solutions to improve testing quality and reduce healthcare costs by
speeding up diagnostic processes.
Today,
NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology
is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth.
This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the
Technion Institute of Technology – Biomedical Engineering Faculty.
NanoSynex’s
team is composed of passionate, dedicated business executives, top-notch biomedical engineers and microbiologist team members and supported
by a network of experts, including strategic alliances with future distributors, that know how to bring this revolutionary product to
the market.
https://nanosynex.com/
About
Qualigen Therapeutics, Inc.
For
more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.
Forward-Looking
Statements
This
news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. The Company may in some cases use terms such as “predicts,”
“believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “likely,” “will,”
“should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements.
The Company’s forward-looking statements are based on current beliefs and expectations of its management team that involve risks,
potential changes in circumstances, assumptions, and uncertainties, including statements regarding the timing of the offering. Any or
all of the forward-looking statements may turn out to be wrong or be affected by assumptions the Company makes that later turn out to
be incorrect, or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties
including risks related to the Company’s ability to regain compliance with Nasdaq’s continued listing requirements, including
the Company’s ability to file its Form 10-Q for the period ended September 30, 2024, or otherwise in the future, or otherwise maintain
compliance with any other listing requirement of The Nasdaq Capital Market, the potential de-listing of the Company’s shares from
The Nasdaq Capital Market due to its failure to comply with the Nasdaq’s continued listing requirement, or its alternatives, or
otherwise in the future, and the other risks set forth in the Company’s filings with the Securities and Exchange Commission, including
in its Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could
be materially different from those expressed in or implied by the Company’s forward-looking statements. You are cautioned not to
place undue reliance on these forward-looking statements, which are made only as of the date of this news release. The Company disclaims
any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law.
This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Investor
Relations
ir@qlgntx.com.
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