Form 8-K - Current report

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): November 7, 2023

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 $.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 November 7, 2023, Qualigen Therapeutics, Inc. (the “Company”) issued a press release announcing that the first patient in the Phase 1a clinical trial of QN-302 had been dosed for the treatment of advanced or metastatic solid tumors. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item 7.01 (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall the information in this Item 7.01 (including Exhibit 99.1 attached hereto) be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

On November 7, 2023, the Company announced that the first patient in the Phase 1a clinical trial of QN-302 had been dosed for the treatment of advanced or metastatic solid tumors.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description

99.1		Press Release, dated November 7, 2023, issued by Qualigen Therapeutics, Inc.

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.

	QUALIGEN THERAPEUTICS, INC.

Date: November 7, 2023	By:	/s/ Michael S. Poirier
		Michael S. Poirier, Chief Executive Officer

Exhibit 99.1

Qualigen Therapeutics Announces First Patient Dosed in the Phase 1a Clinical Trial of QN-302 for Treatment of Advanced or Metastatic Solid Tumors

CARLSBAD, Calif., Nov. 7^th, 2023 (GLOBE NEWSWIRE) – Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that the first patient in the Phase 1a clinical trial has been dosed with QN-302, a potential first-in-class, investigational G-Quadruplex (G4)-selective transcription inhibitor designed for the treatment of advanced or metastatic solid tumors. The first clinical site is located at START Midwest in Grand Rapids, Michigan.

QN-302 works by selectively stabilizing G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes, and may potentially offer a tumor-agnostic clinical approach to treatment. It was invented and developed by Dr. Stephen Neidle’s team at the University College London and exclusively licensed by Qualigen in January 2022. Qualigen received Orphan Drug Designation for the intended treatment of pancreatic cancer in January and clearance from the US FDA to initiate a Phase 1 clinical trial in July of this year.

“G-quadruplexes are prevalent in a number of difficult-to-treat tumor types, including pancreatic cancer,” said Sreenivasa Chandana, M.D., PhD. Director of GI/GU medical oncology research at Cancer and Hematology Centers of Western Michigan in Grand Rapids, and an investigator for the QN-302 Phase 1a clinical trial at START Midwest. “QN-302 is a potentially tumor-agnostic approach that may offer a once weekly treatment option for patients with advanced disease with a unique mechanism of action to improve patient outcomes. We are excited to participate in the first-in-human clinical trial of QN-302 to explore this potential new treatment modality.”

The QN-302 Phase 1 clinical trial is multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study. The exact number of patients to be enrolled will depend on the observed safety profile, which will determine the number of patients per dose level, as well as the number of dose escalations required to meet the Maximum Tolerated Dose (MTD). Once the MTD has been established in dose escalation, dose expansion will begin.

“The initiation of the QN-302 Phase 1a clinical trial represents a significant milestone for Qualigen and further progress toward our goal to offer patients new treatment options for devastating diseases, such as pancreatic cancer and other advanced solid tumors,” commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer. “We are grateful for the support of our CRO, TD2, as well as study sites, investigators, and patients and families who are all working together to explore the potential of QN-302 as a novel treatment for G4-prevalent tumors. We look forward to continuing these close partnerships as we enroll additional patients in our Phase 1a study.”

The QN-302 Phase 1a clinical trial will be conducted at up to four leading clinics and medical centers in the United States. In addition to the first site at START Midwest in Grand Rapids, Michigan, we expect to activate additional sites in Q4 this year. Qualigen anticipates providing an update on safety and preliminary efficacy of the Phase 1a study in the first half of 2024. For more information on QN-302 or the Phase 1a clinical trial, please visit our QN-302 clinical trial website on ClinicalTrials.gov.

About QN-302

QN-302 is a small molecule G4-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer, prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and may potentially offer a tumor-agnostic clinical approach to treatment. Orphan Drug Designation was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer. The Company anticipates, subject to the Company securing additional funding, the dosing of at least 24 patients in the Phase 1a trial can be completed by the end of 2024, funded in part by proceeds received by the divestiture of the Company’s diagnostics business in July 2023.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. The investigational compounds within Qualigen’s family of Pan-RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.

Forward-Looking Statements

This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. These statements include those related to the Company’s prospects and strategy for development of its therapeutic drug candidates, including the anticipated timeline for the Company’s Phase 1 clinical trial and enrolling and dosing of patients, and the activation of additional clinical trial sites, the sharing of initial data. Actual events or results may differ materially from the Company’s expectations. There can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, Pan-RAS and QN-247); that preclinical development of the Company’s drugs (including Pan-RAS and QN-247) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that preclinical study results the Company observed in animals will be borne out in human patients; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company’s owned and in-licensed patent applications; that such patents, if any, and the Company’s currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn additional sufficient working capital to complete the development, testing and launch of the Company’s prospective therapeutic products (including QN-302, Pan-RAS and QN-247). The Company’s stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fail to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company’s business can be found in the Company’s prior filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, all of which are available at www.sec.gov.

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.

For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.

Contact:

Investor Relations
ir@qlgntx.com.

Source: Qualigen Therapeutics, Inc.

Cover	Nov. 07, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 07, 2023
Entity File Number	001-37428
Entity Registrant Name	Qualigen Therapeutics, Inc.
Entity Central Index Key	0001460702
Entity Tax Identification Number	26-3474527
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	5857 Owens Avenue
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Carlsbad
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92008
City Area Code	(760)
Local Phone Number	452-8111
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $.001 per share
Trading Symbol	QLGN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false