Item 1. Business
ITEM
1. BUSINESS
Overview
We
are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists
of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).
In
addition, on April 11, 2024, we entered into a Co-Development Agreement (the “Co-Development Agreement”) with Marizyme, Inc.
(“Marizyme”). The Co-Development Agreement contemplated that we would invest an aggregate of $800,000 in Marizyme in April
2024 (the “Funding Payment”) and pay Marizyme a $200,000 Exclusivity Fee (Provided, that if the parties so agree the total
Funding Payment can be increased from time to time to up to a total of $1,500,000.) To date our Funding Payment investment has been $500,000,
and in July 2024 we have advanced an additional $1,250,000 pursuant to an 18% demand promissory note, and in August 2024 we amended the
Co-Development Agreement to increase the total Funding Payment to up to a total of $1,750,000. The Funding Payment is designed to provide
financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult
patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts
used in coronary artery bypass grafting surgery. In return for the Funding Payment we will receive quarterly a 33% payment in the nature
of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the
amount of the Funding Payment cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been
launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.
The
Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 (the “Exclusivity Period”) for purposes of proposing
and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Exclusivity Period
has ended, and we do not intend to expand the Exclusivity Period.
Our
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA “unwinding,”
help inhibit cancer cell proliferation. QN-302 is currently undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan,
and HonorHealth in Scottsdale, Arizona.
Our
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
small molecules believed to inhibit or block mutated RAS genes’ proteins from binding 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. The investigational compounds
within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS
effector pathways.
On
May 22, 2020, we completed a “reverse recapitalization” transaction with Qualigen, Inc. (not to be confused with the Company);
pursuant to which our merger subsidiary merged with and into Qualigen, Inc. with Qualigen, Inc. surviving as a wholly owned subsidiary
of the Company. The Company, which had previously been known as Ritter Pharmaceuticals, Inc., was renamed Qualigen Therapeutics, Inc.,
and the former stockholders of Qualigen, Inc. acquired, via the recapitalization, a substantial majority of the shares of the Company.
Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,”
commenced trading on Nasdaq, on a post-reverse-stock-split adjusted basis, under the ticker symbol “QLGN” on May 26, 2020.
We are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc. had focused before the
reverse recapitalization transaction.
On
July 20, 2023, we sold our Qualigen, Inc. subsidiary, which contained our former FastPack ® diagnostics business to Chembio
Diagnostics, Inc. (“Chembio”), an American subsidiary of French diagnostics provider Biosynex, S.A. The aggregate net purchase
price for Qualigen, Inc. was $5.4 million in cash, of which $450,000 was being held in escrow to satisfy certain of our indemnification
obligations until January 20, 2025. On June 4, 2024, the $450,000 escrow account was settled early and liquidated by mutual agreement
between us and Chembio. In exchange for the early settlement, $350,000 was paid to the Company, and $100,000 was paid to Chembio. This
settlement resulted in a $100,000 loss from discontinued operations in the second quarter of 2024.
Minority
Interest in NanoSynex
We
own a minority interest in NanoSynex, Ltd. (“NanoSynex”), a privately-held microbiologics diagnostic company domiciled in
Israel. NanoSynex’s technology is for Antimicrobial Susceptibility Testing that aims to enable better targeting of antibiotics
for their most suitable uses to ultimately result in faster and more efficacious treatment, hence reducing hospitals’ mortality
and morbidity rates. On May 26, 2022, we acquired a 52.8% interest in NanoSynex from our related party Alpha Capital Anstalt (“Alpha”)
and NanoSynex, and entered into a Master Agreement for the Operational and Technological Funding of NanoSynex with NanoSynex (the “NanoSynex
Funding Agreement”). On July 20, 2023, we entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), pursuant to which we agreed to, in exchange for eliminating all future NanoSynex Funding Agreement obligations for
us to invest further cash in NanoSynex (except for obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000
on or before March 31, 2024), surrender 281,000 Series B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex
being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex; in addition, we agreed to surrender
approximately $3.0 million of promissory notes which NanoSynex had issued to us under the Funding Agreement. On November 22, 2023 we
further agreed to eliminate our obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before March
31, 2024, by instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex
voting equity from approximately 49.97% to 39.90%.
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Recent
Development
Amendment
to Certificate of Designation of Series A-2 Preferred Stock
On
December 23, 2024, we filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series A-2
Preferred Stock (the “Amended and Restated Certificate of Designation”) with the Secretary of State of Delaware, following
approval by the Board of Directors of the Company (“Board”) and by the holders of at least 67% of the outstanding shares
of Series A-2 Preferred Stock, par value $0.001 per share (the “Series A-2 Preferred Stock”). The Amended and Restated Certificate
of Designation amends certain provisions of the Series A-2 Preferred Stock, specifically to prohibit any adjustment to the conversion
price unless approved by a majority of the shareholders entitled to vote in accordance with Nasdaq Rule 5635(d).
November
2024 Preferred Stock Offering
We
entered into a Securities Purchase Agreement (the “November Securities Purchase Agreement”) on November 18, 2024 with certain
institutional and accredited investors (the “Investors”). Pursuant to the Securities Purchase Agreement, the Company agreed
to sell and issue shares of Qualigen’s newly designated Series A-2 Preferred Stock, par value $0.001 per share (the “Qualigen
Series A-2 Preferred Stock”), in a private placement transaction (the “November Private Placement”). The closing of
the November Private Placement was on November 20, 2024. We sold and issued to the Investors 5,100 shares of Qualigen Series A-2 Preferred
Stock at a purchase price of $1,000 per share, for an aggregate purchase price of $5.1 million.
Each
share of Qualigen Series A-2 Preferred Stock was, at any time at the option of the holder, convertible into a number of shares of the
Company’s common stock equal to $1,000 shares divided by a conversion price initially equal to $3.64, subject to adjustment for
any stock splits, stock dividends and similar events and also subject to “ratchet” antidilution adjustment (subject to certain
customary exceptions), provided that any conversion of Qualigen Series A-2 Preferred Stock by a holder into shares of the Company’s
common stock would be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or
entity whose beneficial ownership of the common stock would be aggregated with such holder’s for purposes of Section 13(d) of the
Securities Exchange Act of 1934, as amended, would beneficially own more than 4.99% of the total number of shares of the Company’s
common stock issued and outstanding after giving effect to such conversion. Upon written notice to the Company, the holder could from
time to time increase or decrease such limitation to any other percentage not in excess of 9.99% specified in such notice. Each share
of Qualigen Series A-2 Preferred Stock was entitled to a preference of $1,000 per share upon liquidation of the Company. Without consent
of the holders of at least 67% of the Qualigen Series A-2 Preferred Stock, The Company could not amend its charter documents to materially
and adversely affect the rights of the Qualigen Series A-2 Preferred Stock, repurchase certain junior securities of the Company, pay
cash dividends on junior securities of us or (unless it is at arm’s-length and is approved by a majority of our disinterested directors)
enter into a material transaction with an affiliate of us.
Exchange
Agreement with Chen
On
November 18, 2024, we entered into an Exchange Agreement (the “Exchange Agreement”) with Yi Hua Chen (“Chen”)
pursuant to which we issued 1,154 shares of our newly-designated Series A-2 Convertible Preferred Stock, par value $0.001 per share.
The shares of Series A-2 Preferred Stock was issued in exchange for the conversion of the $1,100,000 convertible notes issued on April
12, 2024.
Reverse
Stock Split
On
November 5, 2024, we implemented a 1-for-50 reverse stock split of the issued shares of its common stock (the “Reverse Stock Split”),
effective at 12:01 a.m. Eastern time on November 5, 2024. Our common stock began trading on a split-adjusted basis when the market opened
on Tuesday, November 5, 2024, and will continue to trade on The Nasdaq Capital Market under the symbol “QLGN.” The new CUSIP
number for the common stock is 74754R301.
The
Reverse Stock Split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the minimum
bid price requirement for continued listing on The Nasdaq Capital Market. The Company’s stockholders authorized the Reverse Stock
Split at the Company’s annual meeting of stockholders held on October 25, 2024, with the final ratio subsequently determined by
the Board.
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As
a result of the Reverse Stock Split, every 50 shares of the Company’s pre-split common stock issued and outstanding were automatically
reclassified into one new share of the Company’s common stock. This reduced the number of shares outstanding from 36,837,020 shares
to 736,431 shares as of November 5, 2024. The number of authorized shares of the Company’s common stock will remain unchanged.
Stockholders who would otherwise be entitled to receive a fractional share will receive cash (without interest or deduction) in lieu
of such fractional shares, after aggregating all the fractional interests of such holder resulting from the Reverse Stock Split. Proportionate
adjustments will be made to the exercise prices and the number of shares underlying the Company’s equity plans and grants thereunder,
as applicable. The Reverse Stock Split will not affect the par value of the common stock.
All share numbers and exercise prices in this document have been adjusted
for the Reverse Stock Split.
IR
Agency LLC Consulting Agreement
We
entered into a consulting agreement (the “IR Agency Consulting Agreement”) with IR Agency, LLC (“IR Agency”),
a provider of investor relations-related services on October 9, 2024. Pursuant to the IR Agency Consulting Agreement, we have engaged
IR Agency, on a non-exclusive basis, to prepare marketing and advertising materials.
As
consideration for its performance under the IR Agency Consulting Agreement, we will pay IR Agency a fee of $800,000 upon the Company
raising $1.8 million or more in an equity financing over the thirty (30) days. IR Agency is not a registered broker-dealer or investment
advisor and will not engage in any activities on behalf of us that would require it to be registered as a broker-dealer or investment
advisor.
The
IR Agency Consulting Agreement will have a term of one (1) month and may be terminated by written notice, with or without cause, by us
at any time.
Upon
the closing of the November 2024 Preferred Stock Offering, the Consulting Agreement (the “IR Agency Consulting Agreement”)
dated October 9, 2024, between the Company and IR Agency, LLC (“IR Agency”), a provider of investor relations services, became
effective. Pursuant to the terms of the agreement, $800,000 of the proceeds has been paid to IR Agency for services to be rendered up until the third quarter of 2025.
September
2024 Public Offering
On
September 5, 2024, we entered into a placement agency agreement (the “September Placement Agent Agreement”) with
Univest Securities, LLC (“Univest”), to sell the September Shares (as defined below) to certain institutional investors that
were included in a public offering (the “September Offering”) of 294,481 shares of common stock (each a “September Share,” and collectively, the “September Shares”) at public offering price
of $6.50 per September Share and pre-funded warrants to purchase up to 239,455 shares at a price of $6.45 per share with an exercise
price of $0.05 per share (the “September Pre-Funded Warrants”). The September Pre-Funded Warrants are exercisable upon issuance
and will remain exercisable until all the September Pre-Funded Warrants are exercised in full.
The
closing of the September Offering occurred on September 6, 2024, and the Company received aggregate gross proceeds of $3.47 million,
before payment of placement agent fees and expenses and other transaction costs. At the closing of the September Offering, the Company
also issued to Univest, the exclusive placement agent in the September Offering, a warrant to purchase 16,018 Shares (the “September
Placement Agent Warrant”), pursuant to the September Placement Agent Agreement. The September Placement Agent Warrant has a term
of five years commencing from the date of sales in the September Offering, is exercisable after 180 days after issuance, and has an exercise
price of $7.80 per share of common stock. We paid Univest a cash fee equal to 3% of the gross proceeds received in the September
Offering and certain other amounts for reimbursement of expenses incurred by Univest in connection with the September Offering.
February
2024 Private Placement
On
February 26, 2024, we entered into a Securities Purchase Agreement (the “February Purchase Agreement”) with Alpha. The
transactions contemplated by the February Purchase Agreement closed on February 27, 2024, at which time we delivered to Alpha a new
debenture and warrant, as described in this paragraph, and Alpha paid us a cash purchase price of $500,000 (less expenses). Pursuant
to the February Purchase Agreement, we issued to Alpha an 8% Convertible Debenture (the “2024 Debenture”) in the
principal amount of $550,000. The 2024 Debenture has a maturity date of December 31, 2024 and was convertible from time to time, at
Alpha’s option, into shares of common stock, at $6.50 per share, subject to adjustment as described in the 2024 Debenture. The
2024 Debenture accrues interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity. Pursuant to
the terms of the February Purchase Agreement, we also issued to Alpha a 5-year common stock purchase warrant to purchase 18,001
shares of common stock at $13.00 per share. We also granted to Alpha an option (the “Option”) that was exercisable until
July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of
$1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 36,001 additional
warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less
expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants). Alpha assigned the Option to Chen in April 2024.
6
Product
Pipeline
QN-302
We
exclusively in-licensed the global rights to the G-Quadruplex (“G4”) selective transcription inhibitor platform from University
College London (“UCL”) in January 2022. The licensed technology comprises lead compound QN-302 (formerly known as SOP1812)
and back-up compounds that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.
Developed by Dr. Stephen Neidle and his group at UCL, the G4 binding concept is derived from nucleic acid research conducted over more
than over 30 years, including research on G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich
repeats. G4s are overrepresented in telomeres (a region of repetitive DNA sequences at the end of a chromosome) as well as promoter sequences
and untranslated regions of many oncogenes. Their prevalence is therefore significantly greater in cancer cells compared to normal human
cells.
G4-selective
small molecules such as QN-302 and backup compounds target the regulatory regions of cancer genes, which have a high prevalence of enriched
G4s. Stable G4-QN-302 complexes can be impediments to replication, transcription or translation of those cancer genes containing G4s,
and the drugs’ binding to G4s are believed to stabilize the G4s against possible “unwinding.” G4 binders like QN-302
could be efficacious in a variety of cancer types with a high prevalence of G4s.
We
believe that QN-302 has the potential to demonstrate superior efficacy and activity against pancreatic ductal adenocarcinoma (“PDAC”),
which represents 98% of pancreatic cancers. Pancreatic cancer is the tenth most common cancer in men and the seventh most common in women,
but it is the fourth leading cause of cancer deaths in men and the third leading cause in women; it accounts for about 3% of all cancers
in the United States but is responsible for about 8% of all cancer-related deaths. It has one of the lowest rates of survival of all
cancer types.
In-vitro
and in-vivo studies have shown that G4 stabilization by QN-302 resulted in inhibition of target gene expression and cessation
of cell growth in various cancers, including PDAC. In in-vitro studies, QN-302 was potent in inhibiting the growth of several
PDAC cell lines at low nanomolar concentrations. Similarly, in in-vivo studies, QN-302 showed a longer survival duration in a
KPC genetic mouse model for pancreatic cancer than gemcitabine (the current standard of care for PDAC) has historically shown. Additional
preclinical in-vivo studies suggest activity in gemcitabine-resistant PDAC. Data further demonstrated that QN-302 had significant
anti-tumor activity in three patient-derived PDAC xenograft models. Early safety indicators in pancreatic cancer mouse in-vivo
models suggest no significant adverse toxic effects at proposed therapeutic doses.
On
January 9, 2023, the U.S. Food and Drug Administration (“FDA”) granted Orphan Drug Designation (“ODD”) to QN-302
for the indication of pancreatic cancer. ODD provides advantages to pharmaceutical companies that are developing investigational drugs
or biological products that show promise in treating rare diseases or conditions that affect fewer than 200,000 people in the United
States, including seven-year marketing exclusivity and eligibility to receive regulatory support and guidance from the FDA in the design
of an overall drug development plan.
There
are also economic advantages to receiving ODD, including a 25% federal tax credit for expenses incurred in conducting clinical research
on the orphan designated product within the United States. Tax credits may be applied to the prior year or applied to up to 20 years
of future taxes. ODD recipients may also have their Prescription Drug User Fee Act (PDUFA) application fees waived, a potential savings
of around $3.2 million (as of fiscal year 2023) for applications requiring covered clinical data, and may qualify to compete for research
grants from the Office of Orphan Products Development that support clinical studies.
On
August 1, 2023 we announced that the FDA had cleared our investigational new drug (“IND”) application for QN-302, and on
November 1, 2023 the first patient in our Phase 1a clinical trial for QN-302 was dosed at START Midwest in Grand Rapids, Michigan.
We
will require additional cash resources to be able to continue and complete this Phase 1a clinical trial.
Pan-RAS
(formerly referred to as RAS or RAS-F)
In
July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville Research Foundation, Inc. (“UofL”)
for the intellectual property covering the “RAS” family of pan-RAS inhibitor small molecule drug candidates, which are believed
to work by blocking RAS mutations directly, thereby inhibiting tumor formation (especially in pancreatic, colorectal and lung cancers).
Pursuant to the license agreement, we will seek to identify and develop a lead drug candidate from the compound family and, upon commercialization,
will pay UofL royalties in the low-to-mid-single-digit percentages on net sales of Pan-RAS inhibitor licensed products. The license agreement
with UofL for Pan-RAS was amended in March 2021 and June 2023.
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RAS
is the most common oncogene in human cancer. Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are
present in about one-fourth to one-third of all cancers. For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas,
52% of colon cancers, and 32% of lung adenocarcinomas. For these three cancer types, cancers with mutant KRAS are diagnosed in more than
170,000 people each year in the United States and cause more than 120,000 deaths. Drugs that target signaling downstream of RAS are available;
however, such drugs have shown disappointing clinical durability because RAS is a “hub” that activates multiple effectors,
so drugs that block a single pathway downstream may not account for the many other activated pathways.
We
also had a sponsored research agreement with UofL for Pan-RAS research; that agreement expired in December 2023.
On
February 15, 2024, we entered into a License and Sublicense Agreement with Pan-RAS Holdings, Inc., a New York corporation (“Pan-RAS
Holdings”), which contemplated an exclusive out-license of our Pan-RAS drug development program, including our rights under the
UofL license agreement, Pan-RAS Holdings. Although the License and Sublicense Agreement called for a closing by March 16, 2024, the License
and Sublicense Agreement was in essence structured as a 30-day option in favor of Pan-RAS Holdings. At the contemplated closing, Pan-RAS
Holdings would have paid us an upfront fee of $1,000,000 in cash. In addition, Pan-RAS Holdings would have become responsible to pay
on our behalf our in-license royalty obligations to UofL, as and when required. Finally, if the contemplated closing had occurred, Pan-RAS
Holdings would have been required to pay to us for our own account, on a semiannual basis, royalties equal to 1.0% of net sales of any
RAS products. We would have owed certain amounts to UofL under our in-license agreement from them, if, as and when we received any Non-Royalty
Sublicensing Income from Pan-RAS Holdings.
Pan-RAS
Holdings did not effectuate the closing by March 16, 2024, and we and they voluntarily terminated the License and Sublicense Agreement
effective as of March 16, 2024.
Previous
Programs
We
have discontinued all of our efforts as to the following programs, and we do not plan to resume them:
1.
QN-247 (formerly referred
to as ALAN or AS1411-GNP) – an oligonucleotide aptamer-based, nucleolin-inhibiting anticancer drug candidate, consisting
of QN-165 conjugated with gold nanoparticles.
2.
QN-165 (formerly referred to as AS1411)
– an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum treatment of infectious diseases such as
COVID-19.
3.
Selective Target Antigen Removal System (STARS)
– a therapeutic blood-filtering device product concept, which would be designed to remove circulating tumor cells,
viruses, inflammation factors and immune checkpoints.
Research
and Development
For
research and development of our drug candidates, we have historically leveraged the scientific and technical resources and laboratory
facilities of UofL and UCL, through technology licensing, sponsored research, and other consulting agreements. We have engaged contract
research organizations (“CROs”) and clinical sites for the Phase 1a clinical trial of QN-302. We intend to focus our internal
research and development on oversight of these CROs. We currently have no internal research and development facilities.
Regulatory
Matters
We
have obtained FDA clearance/approval for our QN-302 Phase 1a clinical trial. We have not obtained FDA or other regulatory approval for
any other drug candidate.
United
States—FDA Drug Approval Process
The
research, development, testing, and manufacture of product candidates are extensively regulated by governmental authorities in the United
States and other countries. In the United States, the FDA regulates drugs under the Food, Drug and Cosmetics Act and its implementing
regulations.
The
steps required to be completed before a drug may be marketed in the United States include, among others:
●
preclinical laboratory tests, animal
studies, and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations;
●
submission to the FDA of an IND application for human
clinical testing, which must become effective before human clinical trials may begin and for which progress reports must be submitted
annually to the FDA;
8
●
approval by
an independent institutional review board (“IRB”) or Ethics Committee (“EC”) at each clinical trial site
before each trial may be initiated;
●
adequate and well-controlled
human clinical trials, conducted in accordance with applicable IND regulations, Good Clinical Practices (“GCP”), and
other clinical trial related regulations, to establish the safety and efficacy of the drug for each proposed indication to the FDA’s
satisfaction;
●
submission to the FDA of
a New Drug Application (“NDA”) and payment of user fees for FDA review of the NDA (unless a fee waiver applies);
●
satisfactory completion
of an FDA pre-approval inspection of one or more clinical trial site(s) at which the drug was studied in a clinical trial(s) and/or
of us as a clinical trial sponsor to assess compliance with GCP regulations;
●
satisfactory completion
of an FDA pre-approval inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance
with current GMPs regulations;
●
agreement with the FDA
on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation Strategy;
and
●
FDA review and approval
of the NDA, including satisfactory completion of an FDA advisory committee review, if applicable, based on a determination that the
drug is safe and effective for the proposed indication(s).
Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies. The conduct of the preclinical
tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations.
The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of
an IND application, which must become effective before human clinical trials may begin. We cannot be certain that submission of an IND
application will result in the FDA allowing clinical trials to begin.
Clinical
trials necessary for product approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
The study protocol and informed consent information for study subjects in clinical trials must also be approved by an IRB for each institution
where the trials will be conducted, and each IRB must monitor the study until completion. Study subjects must provide informed consent
and sign an informed consent form before participating in a clinical trial. Clinical testing also must satisfy the extensive GCP regulations
for, among other things, informed consent and privacy of individually identifiable information.
●
Phase 1—Phase
1 clinical trials involve initial introduction of the study drug in a limited population of healthy human volunteers or patients
with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism
and distribution of the study drug in humans, evaluate the side effects associated with increasing doses, and, if possible, to gain
early evidence of effectiveness.
●
Phase 2—Phase 2 clinical
trials typically involve administration of the study drug to a limited patient population with a specified disease or condition to
evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.
Multiple Phase 2 clinical trials may be conducted to obtain information before beginning larger and more expensive Phase 3 clinical
trials.
●
Phase 3—Phase 3 clinical
trials typically involve administration of the study drug to an expanded patient population to further evaluate dosage, to provide
substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical
trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the study drug and to provide an adequate
basis for product approval. Generally, adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval
of an NDA.
The
FDA has various programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval,
which are intended to expedite or simplify the process for the development, and the FDA’s review of drugs ( e.g., approving
an NDA on the basis of surrogate endpoints subject to post-approval trials). Generally, drugs that may be eligible for one or more of
these programs are those intended to treat serious or life-threatening diseases or conditions, those with the potential to address unmet
medical needs for those disease or conditions, and/or those that provide a meaningful benefit over existing treatments. For example,
a sponsor may be granted FDA designation of a drug candidate as a “breakthrough therapy” if the drug candidate is intended,
alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as breakthrough therapy,
the FDA will take actions to help expedite the development and review of such drug. Moreover, if a sponsor submits an NDA for a product
intended to treat certain rare pediatric or tropical diseases or for use as a medical countermeasure for a material threat, and that
meets other eligibility criteria, upon approval such sponsor may be granted a priority review voucher that can be used for a subsequent
NDA. From time to time, we anticipate applying for such programs where we believe we meet the applicable FDA criteria. A company cannot
be sure that any of its drugs will qualify for any of these programs, or even if a drug does qualify, that the review time will be reduced.
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The
results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the
manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval to market the product for
one or more proposed indications. The testing and approval process requires substantial time, effort and financial resources. Unless
the applicant qualifies for an exemption, the filing of an NDA typically must be accompanied by a substantial “user fee”
payment to the FDA. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety
and efficacy of the product in the proposed patient population to the satisfaction of the FDA. After an NDA is accepted for filing, the
FDA substantively reviews the application and may deem it to be inadequate, and companies cannot be sure that any approval will be granted
on a timely basis, if at all. The FDA may also refer the application to an appropriate advisory committee, typically a panel of clinicians,
for review, evaluation and a recommendation as to whether the application should be approved, but is not bound by the recommendations
of the advisory committee.
Before
approving an NDA, the FDA usually will inspect the facility or the facilities at which the drug is manufactured and determine whether
the manufacturing and production and testing facilities are in compliance with cGMP regulations. Once issued, the FDA may withdraw product
approval if, among other things, ongoing regulatory requirements are not met, certain defects exist in the NDA, or safety or efficacy
problems occur after the product reaches the market.
Intellectual
Property
Information
regarding our (in-licensed) issued patents and pending patent applications, as of December 31, 2024, is as follows (excluding patents
and pending patent applications which pertain to programs which we have discontinued). As of that date we did not have any directly-owned
issued patents and pending patent applications.
Subject
Matter
Issued
Pending
Geographic
Scope
Patent
Term
In-Licensed
Patents
University College London (UCL)
QN-302
3
10
U.S., Europe, Australia, Canada, China, Hong Kong,
India, Japan, Korea, Russia
2030-2040
University of Louisville
Pan-RAS
0
12
U.S., Europe, Australia, Canada, China, Hong Kong,
India, Israel, Japan, Korea, Mexico, Russia, South Africa
2039*
TOTAL
3
22
* Anticipated
patent term
Human
Capital Management
As
of June 24, 2025, we had no employees.
Going
Concern Qualification
Our
working capital deficiency, stockholders’ equity deficit, and recurring losses from operations raise substantial doubt about our
ability to continue as a going concern. As a result, our independent registered public accounting firm included an explanatory paragraph
in its report on our financial statements for the year ended December 31, 2024 with respect to this uncertainty. Our ability to continue
as a going concern will require us to obtain additional funding.
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Corporate
Information
Ritter
Pharmaceuticals, Inc. (our predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural
Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc. On May
22, 2020, upon completing the “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc. was
renamed Qualigen Therapeutics, Inc. and Qualigen, Inc. became a wholly-owned subsidiary of the Company. On July 20, 2023 we sold Qualigen,
Inc. to Chembio Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex S.A.
Our
principal executive offices are located at 5857 Owens Avenue, Suite 300, Carlsbad, CA 92008. Our telephone number is (760) 452-8111.
Our corporate website address is www.qlgntx.com . Our website and the information contained on, or that can be accessed through,
our website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report. You should not
rely on our website or any such information in making your decision whether to purchase our securities.
We
make our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and, if applicable, amendments to
those reports, available on the investor relations portion of our website. The reports are free of charge and are available as soon as
reasonably possible after they are filed with the SEC. The SEC maintains a website at www.sec.gov that contains reports, proxy statements
and other information regarding SEC registrants, including Qualigen.
We
are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage
of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
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