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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, 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.) |
2042
Corte Del Nogal, Carlsbad, California 92011
(Address
of principal executive offices) (Zip Code)
(760)
918-9165
(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
August 1, 2023, Qualigen Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug
Administration has cleared the Company’s investigational new drug (IND) application for QN-302. 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
August 1, 2023, the Company announced that the FDA has cleared the Company’s investigational new drug (IND) application for QN-302,
allowing the Company to commence its Phase 1 clinical trial.
Item
9.01. Financial Statements 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:
August 1, 2023 |
By:
|
/s/ Michael S. Poirier |
|
|
Michael
S. Poirier, Chief Executive Officer |
Exhibit
99.1
Qualigen
Therapeutics Announces US FDA IND Clearance to Initiate Phase 1 Clinical Trial of QN-302 for Treatment of Advanced or Metastatic Solid
Tumors
Investigational
New Drug (IND) clearance transitions Qualigen Therapeutics from preclinical to clinical-stage company and demonstrates leadership in
G4-targeting therapies for areas of high unmet need in oncology
CARLSBAD,
Calif., August 1st, 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 U.S. Food and Drug Administration (FDA) has cleared the Company’s IND application for QN-302, a potential best-in-class
small molecule G-Quadruplex (G4)-selective transcription inhibitor. Based on this clearance, the Company plans to initiate the Phase
1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors.
Michael
Poirier, Qualigen’s Chairman and CEO, commented, “This is a pivotal milestone for our therapeutics pipeline as it transitions
us into a clinical-stage company. The IND clearance for QN-302 brings us closer to our objective of developing best in class treatments
that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumors. Our clinical team has worked
diligently to prepare for this milestone and is now dedicated to start enrolling patients, anticipated to take place in the second half
of 2023.”
The
proposed Phase 1 trial is a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic study with dose expansion
to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors that have not responded to
or have recurred following treatment with available therapies. The Company anticipates the dosing of at least 24 patients in the Phase
1 trial can be completed in 2024, funded in part by proceeds received by the divestiture of the Company’s diagnostics business
in July 2023.
About
QN-302
QN-302
is a small molecule G-Quadruplex (G4)-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing
solid tumors, such as pancreatic cancer (PDAC), 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 potentially offering a tumor-agnostic
clinical approach to treatment. Orphan Drug Designation (ODD) was granted by the FDA in January of this year for QN-302 for the intended
indication of pancreatic cancer.
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 initiating the Company’s Phase 1 clinical trial and
dosing of patients. Actual events or results may differ 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 QN-302, Pan-RAS and QN-247, and the deprioritized infectious-disease drug candidate QN-165) 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 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 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, and QN-165). 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.qualigeninc.com.
Contact:
Investor
Relations
760-530-6487
ir@qualigeninc.com
Source:
Qualigen Therapeutics, Inc.
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Qualigen Therapeutics (NASDAQ:QLGN)
過去 株価チャート
から 8 2024 まで 9 2024
Qualigen Therapeutics (NASDAQ:QLGN)
過去 株価チャート
から 9 2023 まで 9 2024