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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.

 

Exhibit No.   Description
99.1   Press Release dated January 28, 2025, issued by Qualigen Therapeutics, Inc.
104   Cover Page Interactive Data File, formatting Inline Extensible Business Reporting Language (iXBRL).

 

 

 

 

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

 

 

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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