What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-06-30 compared with 2024-04-08 · 263 added, 140 removed, 177 unchanged (69% of the section changed)

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of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).

addition, on April 11, 2024, we entered into a Co-Development Agreement (the “Co-Development Agreement”) with Marizyme, Inc.

(“Marizyme”).

The Co-Development Agreement contemplated that we would invest an aggregate of $800,000 in Marizyme in April

2024 (the “Funding Payment”) and pay Marizyme a $200,000 Exclusivity Fee (Provided, that if the parties so agree the total

Funding Payment can be increased from time to time to up to a total of $1,500,000.) To date our Funding Payment investment has been $500,000,

and in July 2024 we have advanced an additional $1,250,000 pursuant to an 18% demand promissory note, and in August 2024 we amended the

Co-Development Agreement to increase the total Funding Payment to up to a total of $1,750,000.

The Funding Payment is designed to provide

financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult

patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts

used in coronary artery bypass grafting surgery.

In return for the Funding Payment we will receive quarterly a 33% payment in the nature

of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the

amount of the Funding Payment cash provided.

No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been

launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.

Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 (the “Exclusivity Period”) for purposes of proposing

and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business.

The Exclusivity Period

has ended, and we do not intend to expand the Exclusivity Period.

lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding

affinity to G4s prevalent in cancer cells (such as pancreatic cancer).

Such binding could, by stabilizing the G4s against DNA

“unwinding,” help inhibit cancer cell proliferation.

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

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

Such binding could, by stabilizing the G4s against DNA “unwinding,”

help inhibit cancer cell proliferation.

QN-302 is currently undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan,

and HonorHealth in Scottsdale, Arizona.

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.

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.

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.

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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.

Diagnostics, Inc.

(“Chembio”), an American subsidiary of French diagnostics provider Biosynex, S.A.

The aggregate net purchase

price for Qualigen, Inc.

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

obligations until January 20, 2025.

On June 4, 2024, the $450,000 escrow account was settled early and liquidated by mutual agreement

between us and Chembio.

In exchange for the early settlement, $350,000 was paid to the Company, and $100,000 was paid to Chembio.

settlement resulted in a $100,000 loss from discontinued operations in the second quarter of 2024.

Interest in NanoSynex

own a minority interest in NanoSynex, Ltd.

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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

Amendment”), pursuant to which we agreed to, in exchange for eliminating all future NanoSynex Funding Agreement obligations for

us to invest further cash in NanoSynex (except for obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000

on or before March 31, 2024), surrender 281,000 Series B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex

being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex;

in addition, we agreed to surrender

approximately $3.0 million of promissory notes which NanoSynex had issued to us under the Funding Agreement.

On November 22, 2023 we

further agreed to eliminate our obligations to lend NanoSynex $560,000 on or before November 30, 2023, and $670,000 on or before March

31, 2024, by instead surrendering shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex

voting equity from approximately 49.97% to 39.90%.

to Certificate of Designation of Series A-2 Preferred Stock

December 23, 2024, we filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of the Series A-2

Preferred Stock (the “Amended and Restated Certificate of Designation”) with the Secretary of State of Delaware, following

approval by the Board of Directors of the Company (“Board”) and by the holders of at least 67% of the outstanding shares

of Series A-2 Preferred Stock, par value $0.001 per share (the “Series A-2 Preferred Stock”).

The Amended and Restated Certificate

of Designation amends certain provisions of the Series A-2 Preferred Stock, specifically to prohibit any adjustment to the conversion

price unless approved by a majority of the shareholders entitled to vote in accordance with Nasdaq Rule 5635(d).

2024 Preferred Stock Offering

entered into a Securities Purchase Agreement (the “November Securities Purchase Agreement”) on November 18, 2024 with certain

institutional and accredited investors (the “Investors”).

Pursuant to the Securities Purchase Agreement, the Company agreed

to sell and issue shares of Qualigen’s newly designated Series A-2 Preferred Stock, par value $0.001 per share (the “Qualigen

Series A-2 Preferred Stock”), in a private placement transaction (the “November Private Placement”).

The closing of

the November Private Placement was on November 20, 2024.

We sold and issued to the Investors 5,100 shares of Qualigen Series A-2 Preferred

Stock at a purchase price of $1,000 per share, for an aggregate purchase price of $5.1 million.

share of Qualigen Series A-2 Preferred Stock was, at any time at the option of the holder, convertible into a number of shares of the

Company’s common stock equal to $1,000 shares divided by a conversion price initially equal to $3.64, subject to adjustment for

any stock splits, stock dividends and similar events and also subject to “ratchet” antidilution adjustment (subject to certain

customary exceptions), provided that any conversion of Qualigen Series A-2 Preferred Stock by a holder into shares of the Company’s

common stock would be prohibited if, as a result of such conversion, the holder, together with its affiliates and any other person or

entity whose beneficial ownership of the common stock would be aggregated with such holder’s for purposes of Section 13(d) of the

Securities Exchange Act of 1934, as amended, would beneficially own more than 4.99% of the total number of shares of the Company’s

common stock issued and outstanding after giving effect to such conversion.

Upon written notice to the Company, the holder could from

time to time increase or decrease such limitation to any other percentage not in excess of 9.99% specified in such notice.

of Qualigen Series A-2 Preferred Stock was entitled to a preference of $1,000 per share upon liquidation of the Company.

Without consent

of the holders of at least 67% of the Qualigen Series A-2 Preferred Stock, The Company could not amend its charter documents to materially

and adversely affect the rights of the Qualigen Series A-2 Preferred Stock, repurchase certain junior securities of the Company, pay

cash dividends on junior securities of us or (unless it is at arm’s-length and is approved by a majority of our disinterested directors)

enter into a material transaction with an affiliate of us.

Agreement with Chen

November 18, 2024, we entered into an Exchange Agreement (the “Exchange Agreement”) with Yi Hua Chen (“Chen”)

pursuant to which we issued 1,154 shares of our newly-designated Series A-2 Convertible Preferred Stock, par value $0.001 per share.

The shares of Series A-2 Preferred Stock was issued in exchange for the conversion of the $1,100,000 convertible notes issued on April

November 5, 2024, we implemented a 1-for-50 reverse stock split of the issued shares of its common stock (the “Reverse Stock Split”),

effective at 12:01 a.m.

Eastern time on November 5, 2024.

Our common stock began trading on a split-adjusted basis when the market opened

on Tuesday, November 5, 2024, and will continue to trade on The Nasdaq Capital Market under the symbol “QLGN.” The new CUSIP

number for the common stock is 74754R301.

Reverse Stock Split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the minimum

bid price requirement for continued listing on The Nasdaq Capital Market.

The Company’s stockholders authorized the Reverse Stock

Split at the Company’s annual meeting of stockholders held on October 25, 2024, with the final ratio subsequently determined by

a result of the Reverse Stock Split, every 50 shares of the Company’s pre-split common stock issued and outstanding were automatically

reclassified into one new share of the Company’s common stock.

This reduced the number of shares outstanding from 36,837,020 shares

to 736,431 shares as of November 5, 2024.

The number of authorized shares of the Company’s common stock will remain unchanged.

Stockholders who would otherwise be entitled to receive a fractional share will receive cash (without interest or deduction) in lieu

of such fractional shares, after aggregating all the fractional interests of such holder resulting from the Reverse Stock Split.

Proportionate

adjustments will be made to the exercise prices and the number of shares underlying the Company’s equity plans and grants thereunder,

as applicable.

The Reverse Stock Split will not affect the par value of the common stock.

All share numbers and exercise prices in this document have been adjusted

for the Reverse Stock Split.

Agency LLC Consulting Agreement

entered into a consulting agreement (the “IR Agency Consulting Agreement”) with IR Agency, LLC (“IR Agency”),

a provider of investor relations-related services on October 9, 2024.

Pursuant to the IR Agency Consulting Agreement, we have engaged

IR Agency, on a non-exclusive basis, to prepare marketing and advertising materials.

consideration for its performance under the IR Agency Consulting Agreement, we will pay IR Agency a fee of $800,000 upon the Company

raising $1.8 million or more in an equity financing over the thirty (30) days.

IR Agency is not a registered broker-dealer or investment

advisor and will not engage in any activities on behalf of us that would require it to be registered as a broker-dealer or investment

IR Agency Consulting Agreement will have a term of one (1) month and may be terminated by written notice, with or without cause, by us

the closing of the November 2024 Preferred Stock Offering, the Consulting Agreement (the “IR Agency Consulting Agreement”)

dated October 9, 2024, between the Company and IR Agency, LLC (“IR Agency”), a provider of investor relations services, became

Pursuant to the terms of the agreement, $800,000 of the proceeds has been paid to IR Agency for services to be rendered up until the third quarter of 2025.

2024 Public Offering

September 5, 2024, we entered into a placement agency agreement (the “September Placement Agent Agreement”) with

Univest Securities, LLC (“Univest”), to sell the September Shares (as defined below) to certain institutional investors that

were included in a public offering (the “September Offering”) of 294,481 shares of common stock (each a “September Share,” and collectively, the “September Shares”) at public offering price

of $6.50 per September Share and pre-funded warrants to purchase up to 239,455 shares at a price of $6.45 per share with an exercise

price of $0.05 per share (the “September Pre-Funded Warrants”).

The September Pre-Funded Warrants are exercisable upon issuance

and will remain exercisable until all the September Pre-Funded Warrants are exercised in full.

closing of the September Offering occurred on September 6, 2024, and the Company received aggregate gross proceeds of $3.47 million,

before payment of placement agent fees and expenses and other transaction costs.

At the closing of the September Offering, the Company

also issued to Univest, the exclusive placement agent in the September Offering, a warrant to purchase 16,018 Shares (the “September

Placement Agent Warrant”), pursuant to the September Placement Agent Agreement.

The September Placement Agent Warrant has a term

of five years commencing from the date of sales in the September Offering, is exercisable after 180 days after issuance, and has an exercise

price of $7.80 per share of common stock.

We paid Univest a cash fee equal to 3% of the gross proceeds received in the September

Offering and certain other amounts for reimbursement of expenses incurred by Univest in connection with the September Offering.

2024 Private Placement

February 26, 2024, we entered into a Securities Purchase Agreement (the “February Purchase Agreement”) with Alpha.

transactions contemplated by the February Purchase Agreement closed on February 27, 2024, at which time we delivered to Alpha a new

debenture and warrant, as described in this paragraph, and Alpha paid us a cash purchase price of $500,000 (less expenses).

to the February Purchase Agreement, we issued to Alpha an 8% Convertible Debenture (the “2024 Debenture”) in the

principal amount of $550,000.

The 2024 Debenture has a maturity date of December 31, 2024 and was convertible from time to time, at

Alpha’s option, into shares of common stock, at $6.50 per share, subject to adjustment as described in the 2024 Debenture.

2024 Debenture accrues interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity.

the terms of the February Purchase Agreement, we also issued to Alpha a 5-year common stock purchase warrant to purchase 18,001

shares of common stock at $13.00 per share.

We also granted to Alpha an option (the “Option”) that was exercisable until

July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of

$1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to a total of 36,001 additional

warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0 million in cash proceeds (less

expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).

Alpha assigned the Option to Chen in April 2024.

exclusively in-licensed the global rights to the G-Quadruplex (“G4”) selective transcription inhibitor platform from University

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

Early safety indicators in pancreatic cancer mouse in-vivo models

suggest no significant adverse toxic effects at proposed therapeutic doses.

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.

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(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 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.

July 2020 we entered into an exclusive worldwide in-license agreement with the University of Louisville Research Foundation, Inc.

for the intellectual property covering the “RAS” family of pan-RAS inhibitor small molecule drug candidates, which are believed

to work by blocking RAS mutations directly, thereby inhibiting tumor formation (especially in pancreatic, colorectal and lung cancers).

Pursuant to the license agreement, we will seek to identify and develop a lead drug candidate from the compound family and, upon commercialization,

will pay UofL royalties in the low-to-mid-single-digit percentages on net sales of Pan-RAS inhibitor licensed products.

The license agreement

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

is the most common oncogene in human cancer.

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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.

UofL license agreement, Pan-RAS Holdings.

Although the License and Sublicense Agreement called for a closing by March 16, 2024, the License

and Sublicense Agreement was in essence structured as a 30-day option in favor of Pan-RAS Holdings.

At the contemplated closing, Pan-RAS

Holdings would have paid us an upfront fee of $1,000,000 in cash.

In addition, Pan-RAS Holdings would have become responsible to pay

on our behalf our in-license royalty obligations to UofL, as and when required.

Finally, if the contemplated closing had occurred, Pan-RAS

Holdings would have been required to pay to us for our own account, on a semiannual basis, royalties equal to 1.0% of net sales of any

RAS products.

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

Sublicensing Income from Pan-RAS Holdings.

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.

have discontinued all of our efforts as to 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.

QN-165 (formerly referred to as AS1411)

– an oligonucleotide aptamer-based drug candidate for the potential broad-spectrum treatment of infectious diseases such as

Selective Target Antigen Removal System (STARS)

– a therapeutic blood-filtering device product concept, which would be designed to remove circulating tumor cells,

viruses, inflammation factors and immune checkpoints.

and Development

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steps required to be completed before a drug may be marketed in the United States include, among others:

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

preclinical laboratory tests, animal

studies, and formulation studies, all performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations;

submission to the FDA of an IND application for human

clinical testing, which must become effective before human clinical trials may begin and for which progress reports must be submitted

annually to the FDA;

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).

adequate and well-controlled

human clinical trials, conducted in accordance with applicable IND regulations, Good Clinical Practices (“GCP”), and

other clinical trial related regulations, to establish the safety and efficacy of the drug for each proposed indication to the FDA’s

satisfaction;

submission to the FDA of

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

satisfactory completion

of an FDA pre-approval inspection of one or more clinical trial site(s) at which the drug was studied in a clinical trial(s) and/or

of us as a clinical trial sponsor to assess compliance with GCP regulations;

satisfactory completion

of an FDA pre-approval inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance

with current GMPs regulations;

agreement with the FDA

on the final labeling for the product and the design and implementation of any required Risk Evaluation and Mitigation Strategy;

FDA review and approval

of the NDA, including satisfactory completion of an FDA advisory committee review, if applicable, based on a determination that the

drug is safe and effective for the proposed indication(s).

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

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an IND application, which must become effective before human clinical trials may begin.

An IND application will automatically become

effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct

of the trials as outlined in the IND application, and places the clinical trial(s) on a clinical hold.

In such a case, the IND application

sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed.

We cannot be certain that

submission of an IND application will result in the FDA allowing clinical trials to begin.

We cannot be certain that submission of an IND

application will result in the FDA allowing clinical trials to begin.

trials necessary for product approval are typically conducted in three sequential phases, but the phases may overlap or be combined.

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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 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

trials, sometimes referred to as Phase 4 clinical trials, may be conducted after receiving initial marketing approval.

These trials are

used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to

generate additional safety data regarding use of the product in a clinical setting.

In certain instances, the FDA may mandate the performance

of Phase 4 clinical trials as a condition of approval of an NDA or, in certain circumstances, post-approval.

Phase 1—Phase

1 clinical trials involve initial introduction of the study drug in a limited population of healthy human volunteers or patients

with the target disease or condition.

These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism

and distribution of the study drug in humans, evaluate the side effects associated with increasing doses, and, if possible, to gain

early evidence of effectiveness.

Phase 2—Phase 2 clinical

trials typically involve administration of the study drug to a limited patient population with a specified disease or condition to

evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase 2 clinical trials may be conducted to obtain information before beginning larger and more expensive Phase 3 clinical

Phase 3—Phase 3 clinical

trials typically involve administration of the study drug to an expanded patient population to further evaluate dosage, to provide

substantial evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical

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

FDA has various programs, including fast track designation, breakthrough therapy designation, priority review and accelerated approval,

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the manufacturing and production and testing facilities are in compliance with cGMP regulations.

The FDA also may audit the clinical

trial sponsor and one or more sites at which clinical trials have been conducted to determine compliance with GCPs and data integrity.

If the NDA and the manufacturing facilities are deemed acceptable by the FDA, it may issue an approval letter, and, if not, the Agency

may issue a Complete Response Letter (“CRL”).

An approval letter authorizes commercial marketing of the drug with specific

prescribing information for a specific indication(s).

A CRL indicates that the review cycle of the application is complete and the application

is not ready for approval.

A CRL may require additional clinical data and/or an additional pivotal Phase 3 clinical trial(s), and/or

other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.

such additional information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.

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 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.

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, 2024, is as follows (excluding patents

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issued patents and pending patent applications.

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

University College London (UCL)

U.S., Europe, Australia, Canada, China, Hong Kong,

India, Japan, Korea, Russia

University of Louisville

U.S., Europe, Australia, Canada, China, Hong Kong,

India, Israel, Japan, Korea, Mexico, Russia, South Africa

* Anticipated

Capital Management

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 .

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

of June 24, 2025, we had no employees.

Concern Qualification

working capital deficiency, stockholders’ equity deficit, and recurring losses from operations raise substantial doubt about our

ability to continue as a going concern.

As a result, our independent registered public accounting firm included an explanatory paragraph

in its report on our financial statements for the year ended December 31, 2024 with respect to this uncertainty.

Our ability to continue

as a going concern will require us to obtain additional funding.

Pharmaceuticals, Inc.

8 unchanged sentences

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”).

All such filings are available through our website free of charge.

However, the information contained on or accessed through our website

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 .

principal executive offices are located at 5857 Owens Avenue, Suite 300, Carlsbad, CA 92008.

Our telephone number is (760) 452-8111.

Our corporate website address is www.qlgntx.com .

Our website and the information contained on, or that can be accessed through,

our website will not be deemed to be incorporated by reference in, and are not considered part of, this Annual Report.

You should not

rely on our website or any such information in making your decision whether to purchase our securities.

make our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and, if applicable, amendments to

those reports, available on the investor relations portion of our website.

The reports are free of charge and are available as soon as

reasonably possible after they are filed with the SEC.

The SEC maintains a website at www.sec.gov that contains reports, proxy statements

and other information regarding SEC registrants, including Qualigen.

are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.

Smaller reporting companies may take advantage

of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.

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