What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2024-04-08 compared with 2023-05-02 · 172 added, 400 removed, 145 unchanged (80% of the section changed)

are a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug

designation, while also commercializing diagnostics.

cancer therapeutics pipeline includes QN-302, RAS (formerly RAS-F) and QN-247.

lead oncology therapeutics program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription

inhibitor with strong binding affinity to G4s prevalent in cancer cells.

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).

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 Good Laboratory Practice (GLP) toxicology

RAS portfolio 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.

Preventing this binding could stop tumor growth, especially

in RAS-driven tumors such as pancreatic, colorectal and lung cancers.

investigational QN-247 compound binds nucleolin, a key multi-functional regulatory phosphoprotein that is overexpressed in cancer cells.

Such binding could inhibit the cancer cells’ proliferation.

The foundational aptamer of QN-247 is QN-165 (formerly referred to

as AS1411), which the Company has deprioritized as a drug candidate for treating COVID-19 and other viral-based infectious diseases.

addition to our oncology drug pipeline, we have an established diagnostics business.

revenue driver is our FastPack proprietary blood-based diagnostics platform which includes diagnostic instruments and test kits that

are sold commercially primarily in the United States, as well as certain European countries.

The FastPack System menu includes a rapid,

highly accurate immunoassay diagnostic testing system for cancer, men’s health, hormone function, and vitamin D status.

analyzers to our customers (physician offices, clinics and small hospitals) at low cost in order to increase sales volumes of higher-margin

May 26, 2022, we acquired a 52.8% interest in NanoSynex, Ltd.

(“NanoSynex”).

NanoSynex is a micro-biologics diagnostic company

domiciled in Israel.

NanoSynex’s technology is an Antimicrobial Susceptibility Testing (AST) 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.

See Part II, Item 7 “ Management’s Discussion and Analysis of Financial Condition and Results of Operations ”

for additional details.

of Reverse Recapitalization Transaction with Ritter Pharmaceuticals, Inc.

QN-302 is currently undergoing a Phase 1a clinical trial at START

Midwest in Grand Rapids, Michigan, and HonorHealth in Scottsdale, Arizona.

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.

May 22, 2020, we completed a “reverse recapitalization” transaction with Qualigen, Inc.

12 unchanged sentences

reverse recapitalization transaction.

Drug Pipeline and Diagnostic Products

lead drug compound QN-302 (formerly SOP1812) is being developed to target regulatory regions of cancer genes that down-regulate gene

expression in multiple cancer pathways for potential treatment of G4-targeted tumors ( e.g.

, pancreatic cancer).

The investigational

compounds within our RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS

and NRAS effector pathways.

Our anticancer drug candidate, QN-247 (formerly referred to as ALAN or AS1411-GNP) is aptamer-based and currently

in development to treat a variety of cancer types, including liquid and solid tumors.

deprioritized programs (and thus not featured in the chart above) include QN-165 (formerly referred to as AS1411), a drug candidate for

the potential broad-spectrum treatment of infectious diseases such as COVID-19, and our Selective Target Antigen Removal System (STARS),

a therapeutic device product concept, currently in discovery stage, designed to remove circulating tumor cells, viruses, inflammation

factors and immune checkpoints.

(formerly referred to as SOP1812)

exclusively in-licensed the global rights to the G4 selective transcription inhibitor platform from University College London

(“UCL”) in January 2022.

The licensed technology comprises lead compound QN-302 (formerly SOP1812) and back-up compounds

that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.

July 20, 2023, we sold our Qualigen, Inc.

subsidiary, which contained our former FastPack ® diagnostics business to Chembio

Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex, S.A.

Accordingly, our former FastPack ®

diagnostics business is reported as Discontinued Operations in this Annual Report.

aggregate net purchase price for Qualigen, Inc.

was $5.4 million in cash, of which $450,000 is being held in escrow to satisfy certain

Company indemnification obligations.

Any amounts remaining in the escrow that have not been offset or reserved for claims will be released

to us within five business days following January 20, 2025.

own a minority interest in NanoSynex, Ltd.

(“NanoSynex”), a privately-held microbiologics diagnostic company domiciled in

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 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%.

NanoSynex was deconsolidated from our financial statements as of July 20, 2023, and is reported

as Discontinued Operations in this Annual Report.

Our investment in NanoSynex will be accounted for in the future as an equity method

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 G-Quadruplex (G4) binding concept is derived from over 30 years in nucleic acid research,

including research on G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich repeats.

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.

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

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

3 unchanged sentences

could be efficacious in a variety of cancer types with a high prevalence of G4s.

cancer is the tenth most common cancer and third deadliest cancer in the United States and has one of the lowest rates of survival of

all cancer types, with 91% of those diagnosed dying from the disease and one in four dying within the first month of diagnosis.

The chemotherapy

drug Gemcitabine has been standard of care for patients with metastatic pancreatic cancer for more than 15 years.

Numerous clinical trials

have tested new drugs, either alone or in combination, with Gemcitabine.

We believe that QN-302 has the potential to demonstrate superior

efficacy and activity against pancreatic ductal adenocarcinoma (“PDAC”) compared to existing agents, with a distinct mechanism

of action and promising preclinical target profile.

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.

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, which represents 98% of pancreatic cancers.

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 has historically shown.

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.

preclinical in-vivo studies suggest activity in gemcitabine-resistant PDAC.

1 unchanged sentence

anti-tumor activity in three patient-derived PDAC xenograft models.

Early safety indicators suggest no significant adverse toxic effects at

proposed therapeutic doses in pancreatic cancer mouse in-vivo models.

Early safety indicators in pancreatic cancer mouse in-vivo models

suggest no significant adverse toxic effects at proposed therapeutic doses.

January 9, 2023, the U.S.

12 unchanged sentences

grants from the Office of Orphan Products Development that support clinical studies.

(formerly RAS-F)

July 2020, we entered into an exclusive worldwide license agreement with University of Louisville (“UofL”) for the intellectual

property covering the “RAS” family of pan RAS inhibitor small molecule drug candidates,

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.

will require additional cash resources to be able to continue and complete this Phase 1a clinical trial.

(formerly referred to as RAS or RAS-F)

July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville’s Research Foundation (“UofL”

or “ULRF”) 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 in-licensed the “RAS” compound family of drug candidates and 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 RAS inhibitor licensed products.

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

The license agreement with UofL for Pan-RAS was amended in March 2021 and June 2023.

is the most common oncogene in human cancer.

6 unchanged sentences

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.

March 2022 and October 2022, we signed amendments to our sponsored research agreement with UofL to extend our partnership.

amended agreement, the collaboration extends until the third quarter of 2023 and commits additional resources to support ongoing discovery

and preclinical efforts for the RAS platform.

(formerly referred to as ALAN or AS1411-GNP)

is an oligonucleotide-based drug candidate that is designed to treat different types of nucleolin-expressing cancers, including liquid and solid tumors.

inhibits nucleolin, a key multi-functional regulatory phosphoprotein that is overexpressed in cancer cells, and may thereby be able to inhibit

the cells’ proliferation.

QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (“AML”).

This novel technology may have several other potential applications, including enhancement of radiation therapy, enhancement of tumor

imaging, and delivery of other anti-cancer compounds directly to tumor cells.

QN-247 is an enhanced version of QN-165 (which in turn was formerly referred

to as AS1411), where the DNA oligonucleotide aptamer is conjugated.

A key component of QN-247, DNA oligonucleotide aptamer QN-165, has

been shown, primarily on a preclinical basis, to have the potential to target and destroy cancer cells.

This component has been administered

in Phase 1 and Phase 2 clinical trials to over 100 AML or renal cell carcinoma cancer patients and appears to be well tolerated with no

evidence of severe adverse events in such trials, with at least seven patients appearing to have clinical responses.

An in vivo efficacy study with

a triple negative breast cancer (TNBC) MDA-MB-231 xenograft mouse model was performed with 12 daily doses (1 mg/kg) of QN-247.

showed statistically significant reductions in mean tumor volumes for all QN-247 formulations compared to baseline and to vehicle control.

QN-247 formulations with higher oligonucleotide loading appeared to reduce tumor volumes more than lower oligonucleotide loading.

of adverse toxicity was observed.

entered into a sponsored research agreement with UofL in August 2018 which was subsequently amended in October 2020, pursuant to which

UofL performed various animal studies to assess antitumor efficacy and safety of different QN-247 compositions.

The sponsored research

agreement with UofL for QN-247 expired on August 31, 2022, and the license agreement with UofL for QN-247 was amended on January 9, 2023.

(formerly referred to as AS1411)

June 2020, we entered into an exclusive royalty-bearing license agreement with UofL for UofL’s intellectual property for the use

of QN-165 as a drug candidate for the treatment of COVID-19.

In September 2020 we and UofL jointly filed a U.S.

provisional patent application,

entitled “Methods of inhibiting or treating coronavirus infection, and methods for delivering an anti-nucleolin agent.” The

application was filed in conjunction with Drs.

Bates and Kenneth E.

Palmer from UofL, and covers methods for using QN-165 as

an antiviral drug candidate to prevent SARS-CoV-2 from entering the body through mucous membranes in the nose, mouth and eyes.

in the patent application, we believe that QN-165 could be administered by means of inhalers, nose spray or eye drops to individuals

who have recently come in contact with SARS-CoV-2, or are at high risk of contracting the virus.

believe that the mechanism by which QN-165 is believed to work, by blocking the ability of viruses to replicate in the body, may also

make the drug candidate effective against future mutations in COVID-19 as well as against other dangerous viruses including seasonal

Moreover, we believe that in addition to its proposed use as a therapeutic, QN-165 might be able to be used as a protective

defense or prophylaxis against COVID-19 and/or other viral-based diseases such as seasonal influenza.

July 13, 2021, we submitted an Investigational New Drug (“IND”) application with the FDA seeking approval to commence Phase

1b/2a clinical studies of QN-165 in hospitalized COVID-19 patients.

On August 11, 2021, the FDA informed us that additional preclinical

studies would be required for the IND application to be cleared to proceed into the clinic with QN-165.

We then decided to allocate our

resources to focus on our oncology pipeline, and deprioritized the development of QN-165 program.

Qualigen is seeking to out-license

QN-165 to a partner that has interest and expertise in antiviral development, such as dengue, influenza, RSV and other infectious diseases.

Due to its mechanism and in vivo potency, we believe that QN-165 could potentially be developed as a first-line treatment against emerging

viruses and biothreats.

FastPack System is a patent-protected rapid, onsite immunoassay testing system consisting of the FastPack Analyzer and the FastPack test

pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry.

Since the initial conception of the system,

we have developed successive versions of the analyzer and test pouch, known as “1.0,” “IP” and “PRO”,

and have expanded our assay menu to nine tests, including tests for prostate cancer, thyroid function, metabolic disorders, and research

applications.

We have sold FastPack products in the United States and overseas for over 20 years, and since inception, our sales of FastPack

products have exceeded $127 million.

We manufacture the FastPack products at our FDA and International Standards Organization (“ISO”)

certified Carlsbad, California facility.

As of April 2022 most FastPack sales are distributed through various distribution partners in

North America as well as in Europe (primarily Axon Labs in Germany and Switzerland).

We also sell direct to clinics and physician offices

located throughout North America.

July 2020, we submitted an official notification to the FDA to commence sales in the United States of our FastPack SARS-CoV-2 IgG test

for COVID-19 antibodies, which was designed for use with our new FastPack PRO.

The test was previously submitted to the FDA for Emergency

Use Authorization (“EUA”).

In April 2021, we withdrew this EUA.

During the nine months during which the EUA was with the

FDA, alternative tests and testing practices became widespread and we determined that there was no longer a viable business case for

scale-up of the test.

January 2022, we entered into a royalty-bearing license agreement with UCL, with respect to intellectual property and know-how covering

lead and backup compounds for our G4 selective transcription inhibitor program, QN-302.

are party to a royalty-bearing license agreement with UofL for the development of RAS and the QN-247 program.

in-license patents from DIAsource ImmunoAssays S.A.

and Future Diagnostics B.V., for reagents that are used in our FastPack Vitamin D

to April 2022, most of our FastPack sales were through our diagnostics distribution partner Sekisui Diagnostics, LLC (“Sekisui”)

pursuant to a distribution agreement.

The distribution agreement with Sekisui expired on March 31, 2022, at which time the activities

formerly provided by Sekisui reverted to us.

As of April 2022, most of our FastPack sales are through various distribution partners in

North America, including McKesson Medical-Surgical, Henry Schein Medical, Medline Industries and National Distribution & Contracting,

the largest distributors of physician office laboratory products in the United States.

Outside of the United States, we sell the FastPack

product line through a network of distributors in Europe (primarily Axon Labs in Germany and Switzerland).

We also continue to sell our

testosterone test kits directly to Low T Center, Inc.

(“Low T”), the largest men’s health group in the United States,

with 40 locations.

Low T was acquired by SynergenX in September 2022.

The combined company currently operates 64 locations.

sales to McKesson accounted for 48% of our total revenues and product sales to Low T accounted for 26% of our total revenues during the

fiscal year ended December 31, 2022.

The remaining revenue was comprised of product sales and warranties to other distributors and direct

sales accounts.

October 2020, we entered into an agreement with Yi Xin Zhen Duan Jishu (Suzhou) Ltd (“Yi Xin”), pursuant to which we granted

Yi Xin exclusive rights to manufacture and sell new generations of FastPack-based products as well as Yi Xin-manufactured versions of

our existing FastPack 1.0, IP and PRO product lines in China.

We are entitled to receive royalties on any such sales.

After May 1, 2022,

Yi Xin has the right to sell its new generations of FastPack-based diagnostic test systems throughout the world, other than to our then-current

FastPack customers;

and on a worldwide basis, except in the United States, Yi Xin also has the right to sell Yi Xin-manufactured versions

of our existing FastPack 1.0, IP and PRO product lines.

We are entitled to receive royalties on any of these sales.

After March 31, 2022,

Yi Xin has the right to buy Qualigen FastPack 1.0, IP and PRO products from us at distributor prices for resale in the United States,

again excluding resales toward our then-current FastPack customers.

Manufacturing

develop, manufacture and assemble our diagnostic products at our approximately 23,000 square feet facility in Carlsbad, California.

laboratory and manufacturing practices are governed by a series of internally published Standard Operating Procedures, in accordance

with FDA and ISO guidelines.

While we produce many of our own raw materials and sub-components for diagnostic products, we also purchase

certain materials from third-party suppliers such as Amcor, Enstrom, Gilson, Hi-Tech Products, Hamamatsu, Sigma Aldrich, Surmodics, 3M,

Thermo Fisher Scientific, and VWR International.

do not have in-house manufacturing capability for our therapeutics product candidates.

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.

also had a sponsored research agreement with UofL for Pan-RAS research;

that agreement expired in December 2023.

currently do not have the resources to advance our Pan-RAS program, and so we are seeking to out-license it.

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

ULRF license agreement, Pan-RAS Holdings.

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.

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 ULRF, as and when required.

if the contemplated closing had occurred, Pan-RAS Holdings would have 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.

would have owed certain amounts to ULRF under our in-license agreement from them, if, as and when we received any Non-Royalty Sublicensing

Income from Pan-RAS Holdings.

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.

have discontinued all of our efforts the following programs, and we do not plan to resume them:

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.

(formerly referred to as AS1411) – an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum

treatment of infectious diseases such as COVID-19.

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.

and Development

research and development of our drug candidates, we are leveraging the scientific and technical resources and laboratory facilities of

UofL and UCL, through technology licensing, sponsored research, and other consulting agreements, which are focused on aptamer technology

and applications.

We would engage contract research organizations (“CROs”) for any clinical trials of our drug candidates.

We intend to focus our internal research and development on oversight of these organizations and continuing support of the FastPack diagnostic

have obtained 17 FDA clearances/approvals and 28 CE Marks for our diagnostic products (FastPack analyzers, immunoassays, control kits,

calibration kits and verifications kits) to date.

We have not obtained FDA or other regulatory approval for any drug candidate.

Device Regulatory Clearances and Approvals

medical devices that we manufacture and market are subject to regulation by numerous worldwide regulatory bodies, including the FDA and

comparable international regulatory agencies.

These agencies require manufacturers of medical devices to comply with applicable laws

and regulations governing development, testing, manufacturing, labeling, marketing and distribution.

Medical devices are also generally

subject to varying levels of regulatory control based on the risk level of the device.

the United States, unless an exemption applies, before we can commercially distribute medical devices, we must obtain, depending on the

type of device, either premarket notification clearance or premarket approval (“PMA”) from the FDA.

The FDA classifies medical

devices into one of three classes.

Devices deemed to pose lower risks are placed in either class I or II, which typically requires the

manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device.

Some low-risk

devices are exempted from this requirement.

Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting

or implantable devices, or devices deemed not substantially equivalent to a previously cleared device, are placed in class III, generally

requiring PMA.

premarket notification process requires that a premarket notification (510(k)) be made to the FDA to demonstrate that a new device is

as safe and effective as, or substantially equivalent to, a legally marketed device (the “predicate” device).

is generally known as obtaining 510(k) clearance for a new device.

Under this process, applicants must submit performance data to establish

substantial equivalence.

In some instances, data from human clinical trials must also be submitted in support of a 510(k) premarket notification.

If so, these data must be collected in a manner that conforms to the applicable Investigational Device Exemption (“IDE”)

The FDA must issue a decision finding substantial equivalence before commercial distribution can occur.

Changes to cleared

devices that do not significantly affect the safety or effectiveness of the device can generally be made without additional 510(k) premarket

notifications;

otherwise, a new 510(k) is required.

PMA approval process requires the submission of a PMA application to the FDA to demonstrate that the new device is safe and effective

for its intended use.

This approval process applies to most Class III devices and generally requires clinical data to support the safety

and effectiveness of the device, obtained in adherence with IDE requirements.

The FDA will approve the PMA application if it finds that

there is a reasonable assurance that the device is safe and effective for its intended purpose and that the proposed manufacturing is

in compliance with the Quality System Regulation (“QSR”).

For novel technologies, the FDA may seek input from an advisory

panel of medical experts and seek their views on the safety, effectiveness and benefit-risk of the device.

The PMA process is generally

more detailed, lengthier and more expensive than the 510(k) process.

the European Union (“EU”), we are required to comply with the In-Vitro Diagnostic Regulation (“IVDR”), which

became effective May 2021, superseding existing Medical Device Directives.

Medical devices that have a valid EC Certificate to the prior

Directives (issued before May 2021) can continue to be sold until May 2025 or until the EC Certificate expires, whichever comes first,

providing there are no significant changes to the design or intended use.

The CE Mark, which is required to sell medical devices in the

EU is affixed following a Conformity Assessment and either approval from the appointed independent Notified Body or through self-certification

by the manufacturer.

The selected pathway to CE marking is based on device risk classification.

CE marking indicates conformity to the

applicable General Safety and Performance Requirements (“GSPRs”) for the IVDR.

The IVDR changes multiple aspects of the regulatory

framework for CE marking, such as increased clinical evidence requirements, changes to labeling, and new requirements, including Unique

Device Identification (“UDI”), and many new post-market reporting obligations.

IVDR also modifies and increases the compliance

requirements for the medical device industry and will continue to require significant investment to transition all products by May 2025.

The CE mark continues to be a prerequisite for successful registration in many other global geographies.

are also required to comply with the regulations of every other country where we commercialize products before we can launch or maintain

new products on the market.

FDA and other worldwide regulatory agencies and competent authorities actively monitor compliance to local laws and regulations through

review and inspection of design and manufacturing practices, record-keeping, reporting of adverse events, labeling and promotional practices.

The FDA can ban certain medical devices, detain or seize adulterated or misbranded medical devices, order recall or market withdrawal

of these devices and require notification of health professionals and others with regard to medical devices that present unreasonable

risks of substantial harm to the public health.

The FDA may also enjoin and restrain a company for certain violations of the Food, Drug

and Cosmetic Act (“FDCA”) and the Safe Medical Devices Act, pertaining to medical devices, or initiate action for criminal

prosecution of such violations.

Regulatory agencies and authorities in the countries where we do business can halt production in or distribution

within their respective country or otherwise take action in accordance with local laws and regulations.

International

sales of medical devices manufactured in the United States that are not approved by the FDA for use in the United States, or that are

banned or deviate from lawful performance standards, are subject to FDA export requirements.

Additionally, exported devices are subject

to the regulatory requirements of each country to which the device is exported.

Some countries do not have medical device regulations,

but in most foreign countries, medical devices are regulated.

Frequently, regulatory approval may first be obtained in a foreign country

prior to application in the United States due to differing regulatory requirements;

however, other countries, require approval in the

country of origin first.

Most countries outside of the United States require that product approvals be recertified on a regular basis.

The recertification process requires the evaluation of any device changes and any new regulations or standards relevant to the device

and, where needed, conduct appropriate testing to document continued compliance.

Where recertification applications are required, they

must be approved in order to continue selling our products in those countries.

Device Quality Assurance

are committed to providing high quality products to our customers and the patients they serve.

Our quality system starts with the initial

product specification and continues through the design of the product, component specification process and the manufacturing, sale and

servicing of the product.

Our quality system is intended to build in quality and process control and to utilize continuous improvement

concepts throughout the product life.

Our quality system is also designed to enable us to satisfy various international quality system

regulations, including those of the FDA with respect to products sold in the United States.

All of our medical device manufacturing facilities

and distribution centers are certified under the ISO 13485 quality system standard, established by the ISO for medical devices, which

includes requirements for an implemented quality system that applies to component quality, supplier control, product design and manufacturing

This certification can be obtained only after a complete audit of a company’s quality system by an independent outside

auditor, and maintenance of the certification requires that these facilities undergo periodic re-examination.

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.

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.

States—FDA Drug Approval Process

1 unchanged sentence

States and other countries.

In the United States, the FDA regulates drugs under the FDCA and its implementing regulations.

In the United States, the FDA regulates drugs under the Food, Drug and Cosmetics Act and its implementing

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;

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

by an independent institutional review board (“IRB”) or Ethics Committee (“EC”)

at each clinical trial site before each trial may be initiated;

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;

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;

with the FDA on the final labeling for the product and the design and implementation of any

required Risk Evaluation and Mitigation Strategy (“REMS”);

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).

laboratory tests, animal studies, and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice

(“GLP”) regulations;

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;

by an independent institutional review board (“IRB”) or Ethics Committee (“EC”) at each clinical trial site

before each trial may be initiated;

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;

to the FDA of a New Drug Application (“NDA”) and payment of user fees for FDA review of the NDA (unless a fee waiver

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;

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;

with the FDA on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation

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).

tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies.

17 unchanged sentences

for, among other things, informed consent and privacy of individually identifiable information.

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.

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

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning

larger and more expensive Phase 3 clinical trials.

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.

two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval

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.

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 prior to beginning larger and more

expensive Phase 3 clinical trials.

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.

Post-approval

51 unchanged sentences

FDA could also require, as a condition of NDA approval, post-marketing testing and surveillance to monitor the drug’s safety or

efficacy or impose other conditions, or a REMS that may include both special labeling and controls, known as Elements to Assure Safe

Use, on the distribution, prescribing, dispensing and use of a drug product.

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.

regarding the issued patents and pending patent applications, as of December 31, 2022, is as follows:

Patents and Trademarks

1.0, IP, and PRO

Europe, China, Japan

Europe, Canada, China, Japan, Korea

+ Gen-Probe (Joint)

Austrialia, Canada, China, Japan

1.0, IP, and PRO

efficacy or impose other conditions, or a Risk Evaluation and Mitigation Strategy that may include both special labeling and controls,

known as Elements to Assure Safe Use, on the distribution, prescribing, dispensing and use of a drug product.

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.

regarding our (in-licensed) issued patents and pending patent applications, as of December 31, 2023, 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.

College London (UCL)

2 unchanged sentences

Europe, Australia, Canada, China, Hong Kong, India, Israel, Japan, Korea, Mexico, Russia, South Africa

Europe, Canada, China, Hong Kong, Japan

* Anticipated

Capital Management

of March 31, 2023, we had 38 employees, 31 of whom were full-time employees.

None of our employees is represented by a labor union or

covered by a collective bargaining agreement.

Engagement, Benefits & Development.

We recognize that attracting, motivating and retaining talent at all levels is vital to our

continued success.

Our employees are a significant asset and we aim to create an equitable, inclusive and empowering environment in which

our employees can grow and advance their careers, with the overall goal of developing, retaining and expanding our workforce, as needed,

to support our current pipeline and future business goals.

By focusing on employee retention and engagement, we also improve our ability

to support our business and operations, our pipeline, and also protect the long-term interests of our shareholders.

We frequently benchmark

our compensation practices and benefits programs against those of comparable companies in our industry and in the geographic area where

we are located.

In our efforts to recruit and retain a diverse and exceptional workforce, we provide our employees with competitive cash

compensation, opportunities to own equity, and an employee benefit program that promotes well-being, including healthcare, a 401(k) Plan,

and paid time-off.

of March 25, 2024, we had 4 employees, all of whom were full-time.

None of our employees

is represented by a labor union or covered by a collective bargaining agreement.

& Inclusion .

Our success also depends on our ability to attract, engage and retain a diverse group of employees.

We value diversity

across our workforce and we will continue to focus on diversity and inclusion initiatives.

With respect to our employees overall, approximately

fifty percent (50%) are people of color and approximately forty-five percent (45%) are women.

We seek to have an inclusive and positive

culture that is centered on our shared corporate mission and values, and that is free from discrimination of any kind, including sexual

or other discriminatory harassment.

Our employees have multiple avenues available through which inappropriate behavior can be reported.

All reports of inappropriate behavior are promptly investigated with appropriate action taken to stop such behavior.

With respect to our employees overall, fifty percent (50%) are women and 0% are people of color.

Pharmaceuticals, Inc.

4 unchanged sentences

renamed Qualigen Therapeutics, Inc.

Qualisys Diagnostics, Inc.

was formed as a Minnesota corporation in 1996, reincorporated to become

a Delaware corporation in 1999, and then changed its name to Qualigen, Inc.

Qualigen, Inc.

is now a wholly-owned subsidiary

of the Company.

website address is www.qualigeninc.com .

We post links to our website to the following filings as soon as reasonably practicable

after they are electronically filed with or furnished to the SEC:

annual reports on Form 10-K, quarterly reports on Form 10-Q, current

reports on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements

and Qualigen, Inc.

became a wholly-owned subsidiary of the Company.

On July 20, 2023 we sold Qualigen

to ChemBio Diagnostics, Inc., an American subsidiary of French diagnostics provider Biosynex S.A.

website address is www.qlgntx.com .

We post links to our website to the following filings as soon as reasonably practicable after

they are electronically filed with or furnished to the SEC:

annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports

on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements

filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

4 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business