What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-05-02 compared with 2022-03-31 · 307 added, 351 removed, 238 unchanged (73% 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.

Our cancer therapeutics pipeline includes QN-302, QN-247 and RAS-F.

investigational QN-302 compound is a small molecule G4 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.

QN-247 is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer;

the nanoparticle

conjugate technology is similar to the core nanoparticle coating technology used in our blood-testing diagnostic products.

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.

RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules

for preventing 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.

Although we have no ongoing development efforts

for STARS, a DNA/RNA-based therapeutic device product concept for removing precisely targeted tumor-produced and viral compounds

from circulating blood, we are currently identifying strategic partnering opportunities.

FastPack System diagnostic instruments and test kits are sold commercially primarily in the United States, as well as certain European

The FastPack System menu includes a rapid, highly accurate immunoassay diagnostic testing system for cancer, men’s health,

hormone function, and vitamin D status.

We provide analyzers to our customers (physician offices, clinics and small hospitals)

at low cost in order to increase sales volumes of higher-margin test kits.

We currently use our diagnostics distribution partner

Sekisui Diagnostics, LLC (“Sekisui”) for most FastPack distribution worldwide pursuant to a distribution agreement, but maintain

direct distribution for certain house accounts, including selling our total testosterone test kits to Low T Center, Inc.

T”), the largest men’s health group in the United States, with 40 locations.

The distribution agreement with Sekisui will

expire on March 31, 2022, at which time the services currently provided by Sekisui will revert to us and we will recognize 100% of the

revenue from the sales of our FastPack diagnostic instruments and test kits.

We have licensed and technology-transferred our FastPack

System technology to Yi Xin Zhen Duan Jishu (Suzhou) Ltd.

for the China diagnostics market.

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.

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.

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commenced trading on Nasdaq, on a post-reverse-stock-split adjusted basis, under the ticker symbol “QLGN” on May 26, 2020.

are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc.

had focused before the reverse

recapitalization transaction.

Product Candidates

and Diagnostics Pipeline

We are no longer pursuing the gastrointestinal disease treatment business on which Ritter Pharmaceuticals, Inc.

had focused before the

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.

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.

Our RAS-F portfolio is designed to suppress the interaction of endogenous RAS with

c-RAF, upstream of the KRAS, HRAS and NRAS effector pathways.

Selective Target Antigen Removal System (STARS) is a therapeutic device product concept, currently in discovery stage, designed to remove

circulating tumor cells, viruses, inflammation factors and immune checkpoints.

deprioritized, non-core drug candidate QN-165 (formerly referred to as AS1411, thus not featured in the chart above) is a drug candidate

for the potential broad-spectrum treatment of infectious diseases such as COVID-19.

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.

Stephen Neidle and his group at UCL, the G4 binding concept is derived from over 30 years in nucleic acid research, including

that of G4s, which are higher order DNA and RNA structures formed by sequences containing guanine-rich repeats.

G4s are overrepresented

in telomeres 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.

small molecules such as QN-302 and backup compounds target the regulatory regions of those cancer genes which have a high prevalence

of enriched G4s in a process that can be predicted by bioinformatics.

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 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.

This has been supported by in-vitro

and in-vivo studies that have shown that G4 stabilization by QN-302 results in inhibition of target gene expression and cessation of

cell growth in a variety of G4 prevalent cancers, including pancreatic ductal adenocarcinoma (“PDAC”) which represents 98%

of pancreatic cancers.

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

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.

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.

Their prevalence is therefore significantly greater in cancer cells compared to normal human

small molecules such as QN-302 and backup compounds target the regulatory regions of cancer genes, which have a high prevalence of enriched

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.

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.

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

efficacy and activity against PDAC compared to existing agents, with a distinct mechanism of action and preclinical target profile.

vitro studies show QN-302 potently inhibits the growth of several PDAC cell lines at low nM concentrations.

Likewise, QN-302 shows longer

survival duration in a KPC genetic mouse model for pancreatic cancer than gemcitabine has historically shown.

Additional preclinical

studies suggest activity in gemcitabine resistant PDAC.

Data from therapy studies on three patient-derived PDAC xenografts indicated

that QN-302 had significant anti-tumor activity in PDAC.

Early safety indicators suggest no adverse toxic effects at proposed therapeutic

doses in pancreatic cancer in-vivo models.

plan to seek to obtain Orphan Drug status for QN-302 for one or more indications, such as PDAC.

Orphan Drug status, if obtained, would

be expected to confer advantages that may include faster regulatory review and increased market protection.

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

of action and promising preclinical target profile.

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.

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 suggest no significant adverse toxic effects at

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

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.

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.

(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,

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.

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.

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 aptamer-based drug candidate that is designed to treat different types of cancer, including liquid and solid tumors.

QN-247 inhibits

nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells;

QN-247 may thereby be able to inhibit the

cells’ proliferation.

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”).

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

key component of this drug candidate, DNA 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 side effects, with at least seven patients

appearing to have long-lasting clinical responses where their cancers disappeared or shrank substantially.

(QN-165 may also be useful

against infectious diseases – see below.)

is an enhanced version of QN-165 (which in turn was formerly referred to as AS1411) where the DNA aptamer is attached to a gold nanoparticle.

a Qualigen-sponsored University of Louisville (“UofL”) in-vitro preclinical study involving tumor-associated macrophages,

QN-247 was shown to have stronger anti-cancer activity than QN-165 alone did.

Tumor-associated macrophages are a class of immune cells

present in high numbers around solid tumors and affect most aspects of tumor cell biology;

they drive pathological phenomena including

tumor cell proliferation, tumor angiogenesis, invasion and metastasis, immunosuppression, and drug resistance.

In most cancers, the tumor-associated

macrophages have an M2 phenotype, which may inhibit the anti-tumor effects of immune checkpoint inhibitor drugs, such as Merck’s

Keytruda (pembrolizumab).

We believe that converting these M2 macrophages to the M1 phenotype could enhance the activity of these immune

checkpoint inhibitors.

In the UofL study, QN-247 increased the conversion of M2 macrophages to the M1 phenotype, while also reducing

the overall proliferation of macrophages.

UofL in-vitro preclinical study with triple negative breast cancer cells (MDA-MB-231) indicated that QN-247, in combination with radiation

therapy, resulted in reduced tumor cell colony size ( i.e ., resulted in increased tumor cell necrosis) compared to radiation alone.

plan to seek to obtain Orphan Drug status for QN-247 for one or more indications, such as pancreatic cancer, AML and pediatric neuroblastoma.

Orphan Drug status, if obtained, would be expected to confer advantages that may include faster regulatory review and increased market

In October 2020,

we entered into an amended sponsored research agreement with UofL to advance development of our QN-247 drug candidate.

The work being

performed under the original sponsored research agreement, entered into in August 2018, comprises animal studies to assess antitumor

efficacy and safety of different QN-247 compositions designed to treat pediatric and adult AML.

Under the amended sponsored research

agreement, UofL is performing preclinical studies on AML and on additional indications including glioblastoma, a malignant brain cancer

that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately

85% of the 1.6 million global lung cancer cases each year.

Additionally, we and UofL will study how QN-247 may inhibit metastasis

of cancer cells as a potential adjuvant therapy.

July 2020, we entered into an exclusive worldwide license agreement with UofL for the intellectual property covering the “RAS-F”

family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates, which would work by blocking RAS mutations

directly and thereby inhibiting tumor formation (especially in pancreatic, colorectal and lung cancers).

Pursuant to the license agreement,

we in-licensed the “RAS-F” 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 protein-protein interaction inhibitor licensed products.

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 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.

There is currently no FDA-approved direct RAS protein inhibitor

Drugs that target signaling downstream of RAS are available;

however, such drugs have shown disappointing clinical activity

because RAS is a “hub” that activates multiple effectors, so drugs that block a single pathway downstream do not account

for the many other activated pathways.

March 2022, we signed an amendment to our active sponsored research agreement with UofL to extend our partnership.

Under the revised

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

preclinical efforts for the RAS-F platform.

FastPack diagnostic system and related core technologies are now the basis for potential blood-filtering therapeutic applications for

the treatment of cancer and infectious disease.

Our Selective Target Antigen Removal System (“STARS”) therapeutic

device concept is intended to utilize core expertise in advanced reagents and coatings to remove disease associated agents, including

viruses and tumor-produced compounds, directly from a patient’s blood.

The key components of STARS, membranes coated with target

capture reagents, will utilize several proprietary processes developed and used in the FastPack product lines.

Proprietary STARS cartridges

are expected to be designed for use with conventional dialysis or hemofiltration machines to remove immune checkpoints, metastatic cells

and inflammation factors from cancer patients’ bloodstreams.

We believe STARS may also be able to be developed to treat infectious

diseases, by removing circulating viruses sufficiently to facilitate patient stabilization and recovery.

we have no ongoing development efforts for STARS, we are currently identifying strategic partnering opportunities.

August 2020, the United States Patent and Trademark Office issued to us patent No.

10,744,258 entitled “Devices and Methods for

On-Line Whole Blood Treatment” regarding our STARS technology.

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)

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

In September 2020 we and UofL jointly filed a United States 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.

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

As stated 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.

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

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

July 13, 2021, we filed an Investigational New Drug (“IND”) application with the U.S.

Food and Drug Administration (“FDA”)

to seek approval to commence Phase 1b/2a clinical studies with QN-165 in hospitalized COVID-19 patients.

On August 11, 2021,

the FDA informed us that additional preclinical studies would be required in order for such application to be cleared.

There can be no

assurance when (if ever) the FDA would clear this IND application or any other IND application we may file.

We have decided to deprioritize

the QN-165 program as our therapeutics strategy is focused on oncology.

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

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certified Carlsbad, California facility.

We maintain direct distribution for certain house accounts, including Low T, but pursuant to

a distribution agreement, our diagnostics distribution partner Sekisui holds most FastPack distribution rights until March 31, 2022,

after which time we will resume full commercial responsibility.

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”).

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.

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

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.

have entered into a royalty-bearing license agreement for key components of QN-247 from UofL and we have commissioned sponsored research

from UofL’s development teams in order to optimize and prepare QN-247 for human trials.

A separate team at UofL, funded by us under

a sponsored research agreement, is developing RAS-F.

We have an active royalty-bearing license agreement for the RAS-F program as well.

2016, we entered into an agreement with Sekisui, whereby Sekisui distributes our diagnostic product line worldwide.

As described above,

this distribution agreement will expire on March 31, 2022.

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

had exclusive rights to the core QN-165 aptamer from Advanced Cancer Therapeutics, LLC;

this agreement terminated on March 1, 2022.

currently sell our FastPack diagnostic product line primarily through our distribution partner Sekisui under a distribution agreement

whereby Sekisui receives a portion of sales revenue.

In the United States, Sekisui commercializes the FastPack product line through its

own direct sales force and distribution agreements with 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, Sekisui commercializes the FastPack product line through a network of distributors in Europe, Asia, Middle East, and North

Our distribution agreement with Sekisui will expire on March 31, 2022, at which time the

services currently provided by Sekisui will revert to us and we will recognize 100% of the revenue from the sales of our FastPack diagnostic

instruments and test kits.

Once the distribution agreement expires, we do not expect any interruption to our diagnostics sales and marketing

engine as we will continue to leverage established partnerships with our various distributors in both the United States and abroad.

addition, among our other direct sales accounts, we currently sell FastPack products directly to Low T.

Sales to Sekisui accounted for

62% of our total revenues during the fiscal year ended December 31, 2021, and sales to Low T accounted for 22% of our total revenues

during this period.

The remaining revenue was comprised of warranties and product sales to our other direct sales accounts as well as

license revenues.

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

obtained 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 would be entitled to receive royalties on any such sales.

After May 1, 2022, Yi Xin will have 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 will also have the right

to sell Yi Xin-manufactured versions of our existing FastPack 1.0, IP and PRO product lines.

We would be entitled to receive royalties

on any of these sales, as well.

After March 31, 2022, Yi Xin will have 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.

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

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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 Thermo Fisher Scientific, Equitech-Bio, Surmodics, OYC Americas, Amcor, 3M, VWR,

Gilson, Impact Project Management, Enstrom, Hi-Tech Products, and Hamamatsu.

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.

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

and applications in the cancer and infectious disease fields.

We would engage contract research organizations for any clinical trials

of our drug candidates.

We intend to focus our internal research and development on continuing support of the FastPack diagnostic line.

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,

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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.

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

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

the European Union (“EU”), we are required to comply with the Medical Device Regulation (“MDR” or “EU

MDR”), which became effective May 2021, superseding existing Medical Device Directives.

Medical devices that have a

valid CE Certificate to the prior Directives (issued before May 2021) can continue to be sold until May 2024 or until the CE 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 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.

marking indicates conformity to the applicable General Safety and Performance Requirements (“GSPRs”) for the MDR.

changes multiple aspects of the regulatory framework for CE marking, such as increased clinical evidence requirements, changes to labelling,

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

also modifies and increases the compliance requirements for the medical device industry and will continue to require significant investment

over the next few years to transition all products by May 2024.

The CE mark continues to be a prerequisite for successful registration

in many other global geographies.

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.

Regulatory requirements are becoming more stringent, with the China National Medical Product Administration

(“NMPA”) recently increasing the regulatory requirements to market and maintain products in China, and the introduction of

such regulatory requirements in many countries in the Middle East and Southeast Asia that previously did not have medical device regulations,

or had minimal regulations.

As a result of the United Kingdom’s departure from the EU, we also expect a U.K.

to be implemented beginning July 2023, with requirements to sell in the U.K.

already in place including appointment of a U.K.

Person and device registration with The Medicines and Healthcare products Regulatory Agency (“MHRA”).

In addition, other

EU countries continue to impose significant local registration requirements despite the implementation of MDR.

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

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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,

such as China, for example, 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.

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

We 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 operations.

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.

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.

States—FDA Drug Approval Process

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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);

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

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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”);

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

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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

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.

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.

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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.

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

From time to time, we anticipate applying for such programs where we believe we meet the applicable FDA criteria.

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

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.

results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the

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the product reaches the market.

currently maintain a portfolio of 147 issued, allowed, in-licensed or pending patents, patent applications and provisional patent applications

covering various aspects of our products and product candidates in the United States, Canada, Mexico, Europe, Japan, China, Korea, Israel,

South Africa, and Australia.

In addition, we have seven issued and 28 pending trademark registrations in the United States pertaining

to our diagnostics and therapeutics businesses.

There are currently no contested proceedings or third party claims against any Qualigen

intellectual property.

our diagnostics patent portfolio, we hold two issued patents covering FastPack 1.0, IP and PRO and 23 issued patents covering FastPack

In addition, we in-licensed one issued patent covering our Vitamin D assay from DIAsource ImmunoAssays S.A..

We also, with Gen-Probe

Incorporated, hold 24 issued joint patents covering FastPack Molecular, an inactive product program.

Last, we hold five issued patents

and 10 patents-pending covering our development-stage STARS theranostic system.

our therapeutics patent portfolio, we have 43 issued and 11 patents-pending, including patent applications, covering the QN-247 program

set to expire 2032-2038.

In addition, we have two patent applications covering the QN-165 program and 15 pending patents covering the

All 71 patents, pending patents and applications covering QN-247, QN-165, and RAS are in-licensed from ULRF.

exclusively in-licensed 11 patents, two of which are issued, from UCL covering our QN-302 program and set to expire 2030-2033.

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

College London (UCL)

Europe, Australia, Canada, China, Hong Kong, India, Japan, Korea, Russia

of Louisville (ULRF)

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.

None of our employees is represented by a labor union or

covered by a collective bargaining agreement.

Engagement, Benefits & Development.

We believe that our future success is dependent upon our ability to recruit, hire and retain

exceptional employees.

We frequently benchmark our compensation practices and benefits programs

against those of comparable industries and in the geographic area where our facility is located.

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 with matching contributions, and paid time-off.

success of our business is fundamentally connected to the well-being, health and safety of our employees.

In an effort to protect the

health and safety of our employees, we took proactive action from the earliest signs of the COVID-19 outbreak, which included implementing

social distancing policies at our facilities, facilitating remote working arrangements and imposing employee travel restrictions.

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.

& Inclusion .

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

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.

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.

Pharmaceuticals, Inc.

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does not constitute part of this Annual Report, and references to our website address in this Annual Report are inactive textual references

All such reports are also available free of charge via EDGAR through the SEC website at www.sec.gov .

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