What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-05-02 compared with 2022-03-31 · 487 added, 340 removed, 438 unchanged (65% of the section changed)

12 unchanged sentences

“Cautionary Note Regarding Forward-Looking Statements.”

Related to Our Therapeutics and Diagnostics Pipeline

Related to Our Business Generally

business strategy is high-risk

2 unchanged sentences

This is a high-risk strategy because there is no assurance that our products will ever become

commercially viable (commercial risk), that we will prevent other companies from depriving us of market share and profit margins by selling

products based on our inventions and developments (legal risk), that we will successfully manage a company in a new area of business

and on a different scale than we have operated in the past (operational risk), that our product candidates will be able to achieve the

desired therapeutic results (scientific risk), or that our cash resources will be adequate to develop our product candidates until we

become profitable, if ever (financial risk).

This may make our stock an unsuitable investment for many investors.

do not currently have enough working capital to execute fully our strategic plan .

commercially viable, that we will prevent other companies from depriving us of market share and profit margins by selling products based

on our inventions and developments, that we will successfully manage a company in a new area of business and on a different scale than

we have operated in the past, that our product candidates will be able to achieve the desired therapeutic results, or that our cash resources

will be adequate to develop our product candidates until we become profitable, if ever.

This may make our stock an unsuitable investment

for many investors.

do not currently have enough working capital to fully execute our strategic plan .

have suffered recurring losses from operations, and we will need capital to support our intended development of our therapeutics business.

We believe that future financings will be necessary in order for us to properly execute our strategic plan.

There can be no assurance

that such future financings will be able to be obtained (or, if they can be obtained, that they can be obtained on desirable terms).

However, there can be no

assurance that such future financings will be available to us (or, if they are, that they can be consummated on desirable terms).

may, in the short and long-term, seek to raise capital through the issuance of equity securities or through other financing sources.

To the extent that we seek to raise additional funds by issuing equity securities, our stockholders may experience significant dilution.

Any debt financing, if available, may include financial and other covenants that could restrict our use of the proceeds from such financing

or impose other business and financial restrictions on us.

In addition, we may consider alternative approaches such as licensing, joint

venture, or partnership arrangements to provide long term capital.

Additional funding may not be available to us on acceptable terms,

To the extent that we seek to raise additional funds by issuing equity securities, our stockholders may experience significant

Any debt financing, if available, may include financial and other covenants that could restrict our use of the proceeds

from such financing or impose other business and financial restrictions on us.

In addition, we may consider alternative approaches

such as licensing, joint venture, or partnership arrangements to provide long term capital.

Additional funding may not be available

to us on acceptable terms, or at all.

In addition, any future financing (depending on the terms and conditions) may be subject to

the approval of Alpha Capital Anstalt (“Alpha”), a related party and the holder of our 8% Senior Convertible Debenture

(the “Debenture”), and/or trigger certain adjustments to the Debenture or warrants held by Alpha.

See Part II, Item 7

“ Management’s Discussion and Analysis of Financial Condition and Results of Operations ” for additional

details regarding the Debenture.

our debt will require a significant amount of cash, and we may not have sufficient cash flow from our business to pay this debt.

ability to make payments to Alpha of principal or interest on our indebtedness or to make any potential prepayments for the Debenture,

to the extent applicable, depends on our future performance, which is subject to economic, financial, competitive and other factors beyond

If the assumptions underlying our cash flow guidance are incorrect, our business may not continue to generate cash flow

from operations in the future sufficient to service our indebtedness and make necessary capital expenditures.

June 1, 2023 and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption

of the Debenture (each such date, a “Monthly Redemption Date”), we must redeem $110,000 plus accrued but unpaid interest,

liquidated damages and any amounts then owing under the Debenture (the “Monthly Redemption Amount”).

The Monthly Redemption

Amount must be paid in cash;

provided that after the first two monthly redemptions, we may elect to pay all or a portion of a Monthly

Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i) the then applicable conversion

price of the Debenture and (ii) 85% of the average of the VWAPs (as defined in the Debenture) for the five consecutive trading days ending

on the trading day that is immediately prior to the applicable Monthly Redemption Date.

We may also redeem some or all of the then outstanding

principal amount of the Debenture at any time for cash in an amount equal to 105% of the then outstanding principal amount of the Debenture

being redeemed plus accrued but unpaid interest, liquidated damages and any amounts then owing under the Debenture.

These monthly redemption

and optional redemptions are subject to the satisfaction of the Equity Conditions (as defined in the Debenture), which include a condition

that we have obtained stockholder approval for such share issuances.

Debenture accrues interest at the rate of 8% per annum, which begins accruing on December 1, 2023, and will be payable on a quarterly

Interest may be paid in cash or shares of common stock or a combination thereof at our option;

provided that interest may only

be paid in shares if the Equity Conditions have been satisfied, including the stockholder approval condition as described above.

we are unable to obtain stockholder approval for the issuance of shares of common stock under the Debenture, we will required to make

any required payments to Alpha in cash.

If we are unable to generate cash flow sufficient to service our indebtedness and make necessary

capital expenditures, we may be required to adopt one or more alternatives, such as selling assets, restructuring debt or issuing additional

equity, equity-linked or debt instruments on terms that may be onerous or highly dilutive.

Our ability to refinance our indebtedness

will depend on the capital markets and our financial condition at such time.

If we are unable to engage in any of these activities or

engage in these activities on desirable terms, we may be unable to meet our debt obligations, which would materially and adversely impact

our business, financial condition and operating results.

Related to Our Therapeutics and Diagnostics Pipeline

product candidates are still in the early stages of development.

We have not begun clinical trials or obtained regulatory approval for

any drug candidate or STARS.

We may never obtain approval for any of our drug candidates or STARS.

are still early in our development efforts and have not yet begun enrollment in any clinical trials evaluating QN-302, QN-247, RAS-F

There can be no assurance that QN-302, QN-247, RAS-F or STARS will achieve success in their clinical trials or obtain regulatory

ability to generate revenues from drug candidates or STARS will depend on the successful development and eventual commercialization of

QN-302, QN-247, RAS-F or STARS.

any drug candidate.

We may never obtain approval for any of our drug candidates.

are still early in our development efforts and have not yet begun enrollment in any clinical trials evaluating QN-302, RAS, or QN-247.

There can be no assurance that QN-302, RAS, and/or QN-247 will achieve success in their clinical trials or obtain regulatory approval.

ability to generate revenues from QN-302, RAS, and/or QN-247 will depend on the successful development and eventual commercialization

of such drug candidates.

The success of these products will depend on several factors, including the following:

completion of preclinical studies and clinical trials;

of an IND or IDE application by the FDA or other clinical trial or similar applications from

foreign regulatory authorities for our future clinical trials for our pipeline;

of an IND application by the FDA or other clinical trial or similar applications from foreign

regulatory authorities for our future clinical trials for our pipeline;

and successful enrollment of patients in, and completion of, clinical trials with favorable

10 unchanged sentences

if and when approved, whether alone or in collaboration with others;

of our drugs or STARS, if and when approved, by patients, the medical community and third-party

of our drugs, if and when approved, by patients, the medical community and third-party payors;

● effectively

3 unchanged sentences

a continued acceptable safety profile of the products following approval.

of these factors are beyond our control, and it is possible that none of our drug candidates or STARS will ever obtain regulatory approval

even if we expend substantial time and resources seeking such approval.

If we do not achieve one or more of these factors in a timely

manner or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates or STARS.

For example, our business could be harmed if results of the clinical trials of QN-302, QN-247, RAS-F, any other drug candidates or STARS

vary adversely from our expectations.

and device development involves a lengthy and expensive process.

We may incur additional costs or experience delays in completing, or

ultimately be unable to complete, the development and commercialization of QN-302, QN-247, RAS-F or STARS.

drug candidates fail, and taking a medical device from concept through clinical trials and regulatory approval is not easy or guaranteed.

We are unable to predict when or if our drug candidates or STARS, our therapeutic medical device concept, will prove effective or safe

in humans or will obtain marketing approval.

Before obtaining marketing approval from regulatory authorities for the sale of these products,

we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of these products

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to

A failure of one or more clinical trials can occur at any stage of testing.

The outcome of preclinical testing and early

clinical trials may not be predictive of the success of later clinical trials, and interim or preliminary results of a clinical trial

do not necessarily predict final results.

of these factors are beyond our control, and it is possible that none of our drug candidates will ever obtain regulatory approval even

if we expend substantial time and resources seeking such approval.

If we do not achieve one or more of these factors in a timely manner

or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates.

For example, our

business could be harmed if results of the clinical trials of QN-302, RAS, QN-247, any other drug candidates vary adversely from our

expectations.

development involves a lengthy and expensive process.

We may incur additional costs or experience delays in completing, or ultimately

be unable to complete, the development and commercialization of QN-302, RAS, and/or QN-247.

drug candidates fail, and taking a drug candidate from concept through clinical trials and regulatory approval is not easy or guaranteed.

We are unable to predict when or if our drug candidates, will prove effective or safe in humans or will obtain marketing approval.

obtaining marketing approval from regulatory authorities for the sale of these products, we must complete preclinical development and

then conduct extensive clinical trials to demonstrate the safety and efficacy of these products for humans.

Clinical testing is expensive,

difficult to design and implement, can take many years to complete and is uncertain as to the outcome.

A failure of one or more clinical

trials can occur at any stage of testing.

The outcome of preclinical testing and early clinical trials may not be predictive of the success

of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results.

may experience numerous unforeseen events that could delay or prevent our ability to obtain marketing approval or commercialize our drug

candidates or STARS, including:

candidates, including:

or IRBs or ECs may not authorize us or our investigators to commence a clinical trial or

2 unchanged sentences

contracts or clinical trial protocols with prospective trial sites;

trials for our drug candidates and STARS may produce negative or inconclusive results, and

we may decide, or regulators may require us, to conduct additional clinical trials, delay

clinical trials or abandon product development programs;

number of patients required for clinical trials for our drug candidates and STARS may be

larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate,

participants may drop out of these clinical trials at a higher rate than we anticipate or

the duration of these clinical trials may be longer than we anticipate;

trials for our drug candidates may produce negative or inconclusive results, and we may decide,

or regulators may require us, to conduct additional clinical trials, delay clinical trials

or abandon product development programs;

number of patients required for clinical trials for our drug candidates may be larger than

we anticipate, enrollment in these clinical trials may be slower than we anticipate, participants

may drop out of these clinical trials at a higher rate than we anticipate or the duration

of these clinical trials may be longer than we anticipate;

● competition

3 unchanged sentences

manner, or at all, or may fail to comply with regulatory requirements;

may have to suspend or terminate clinical trials for our drug candidates or STARS for various

reasons, including a finding that the participants are being exposed to unacceptable health

drug candidates or STARS may have undesirable or unexpected side effects or other unexpected

characteristics, causing us or our investigators, regulators or IRBs/ECs to suspend or terminate

cost of clinical trials for our drug candidates and STARS may be greater than we anticipate;

supply or quality of our drug candidates, STARS or other materials necessary to conduct clinical

may have to suspend or terminate clinical trials for our drug candidates for various reasons,

including a finding that the participants are being exposed to unacceptable health risks;

drug candidates may have undesirable or unexpected side effects or other unexpected characteristics,

causing us or our investigators, regulators or IRBs/ECs to suspend or terminate the trials;

cost of clinical trials for our drug candidates may be greater than we anticipate;

supply or quality of our drug candidates, or other materials necessary to conduct clinical

trials may be insufficient or inadequate and result in delays or suspension of our clinical

5 unchanged sentences

preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our

drug candidates or STARS or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize

our drug candidates or STARS.

drug candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize

our drug candidates.

delays in the commencement or completion, or termination or suspension, of our future clinical trials, if any, could result in increased

costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.

we can initiate clinical trials of a drug candidate or STARS, we must submit the results of preclinical studies to the FDA along with

other information as part of an IND or IDE application or similar regulatory filing, and the FDA (or corresponding foreign regulatory

body) must approve the application.

We have not yet submitted our IND application for QN-302 for pancreatic cancer) and we remain in

a development stage with respect to STARS and any subsequent IDE.

We cannot guarantee the timing for submitting the IND application for

QN-302, and we do not know when this IND application (or any other IND or IDE application) would be approved, if ever.

obtaining marketing approval from the FDA for the sale of QN-302, QN-247, RAS-F, any other drug candidate or STARS, we must conduct extensive

we can initiate clinical trials of a drug candidate, we must submit the results of preclinical studies to the FDA along with other information

as part of an IND or IDE application or similar regulatory filing, and the FDA (or corresponding foreign regulatory body) must approve

the application.

We have not yet submitted our IND application for QN-302 for pancreatic cancer.

While we expect to submit the IND application

during the first half of 2023, we cannot guarantee the timing for submitting the IND application for QN-302, and we do not know when

this IND application (or any other IND application) would be approved, if ever.

obtaining marketing approval from the FDA for the sale of QN-302, RAS, QN-247, or any other future drug candidate, we must conduct extensive

clinical studies to demonstrate safety and efficacy.

Clinical testing is expensive, time consuming and uncertain as to outcome.

may require us to conduct additional preclinical studies for any drug candidate or STARS before it allows us to initiate clinical trials

under any IND or IDE, which may lead to additional delays and increase the costs of our preclinical development programs.

may require us to conduct additional preclinical studies for any drug candidate before it allows us to initiate clinical trials under

any IND application, which may lead to additional delays and increase the costs of our preclinical development programs.

delays in the commencement or completion of our ongoing, planned or future clinical trials could significantly increase our costs, slow

12 unchanged sentences

sites deviating from trial protocol or dropping out of a trial;

to manufacture or obtain sufficient quantities of drug candidate, STARS or, if applicable,

combination therapies for use in clinical trials;

to manufacture or obtain sufficient quantities of drug candidate, or, if applicable, combination

therapies for use in clinical trials;

failing to enroll or remain in our trial at the rate we expect, or failing to return for

6 unchanged sentences

or analysis of the resulting data;

facility manufacturing our drug candidates, STARS or any of their components, including without

facility manufacturing our drug candidates, or any of their components, including without

limitation, our own facilities being ordered by the FDA to temporarily or permanently shut

21 unchanged sentences

or successful completion of a clinical trial.

we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory

we experience delays or difficulties enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory

approval could be delayed or prevented.

2 unchanged sentences

In addition, some of our competitors

may have ongoing clinical trials for products that would treat the same patients as QN-302, QN-247, RAS-F or STARS, and patients who

would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ products.

introduction of new drugs or devices to the marketplace may have an effect on the number of patients available or timing of the availability

of the patients.

may have ongoing clinical trials for products that would treat the same patients as QN-302, RAS or QN-247, and patients who would otherwise

be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ products.

In addition, introduction

of new drugs or devices to the marketplace may have an effect on the number of patients available or timing of the availability of the

inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon

one or more clinical trials altogether.

side effects or other safety risks associated with QN-302, QN-247, RAS-F or STARS product candidates could delay or preclude approval,

cause us to suspend or discontinue any clinical trials or abandon further development, limit the commercial profile of an approved label,

or result in significant negative consequences following regulatory approval, if any.

side effects or other safety risks associated with QN-302, RAS, and/or QN-247 product candidates could delay or preclude approval, cause

us to suspend or discontinue any clinical trials or abandon further development, limit the commercial profile of an approved label, or

result in significant negative consequences following regulatory approval, if any.

of our planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

9 unchanged sentences

In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

is possible that as we test our drug candidates and STARS in larger, longer and more extensive clinical trials, including with different

dosing regimens, or as the use of our drug candidates and STARS becomes more widespread following any regulatory approval, illnesses,

injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went

undetected in previous trials, will be reported by patients.

is possible that as we test our drug candidates in larger, longer and more extensive clinical trials, including with different dosing

regimens, or as the use of our drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts

and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous

trials, will be reported by patients.

development and commercialization of pharmaceutical and device products are subject to extensive regulation, and we may not obtain regulatory

approvals for QN-302, QN-247, RAS-F, STARS or any other product candidates, on a timely basis or at all.

approvals for QN-302, RAS, QN-247 or any other product candidates, on a timely basis or at all.

clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing,

distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other

possible activities relating to QN-302, QN-247, RAS-F and STARS, as well as any other product candidate that we may develop in the future,

are subject to extensive regulation.

possible activities relating to QN-302, RAS and QN-247, as well as any other product candidate that we may develop in the future, are

subject to extensive regulation.

approval of drugs in the United States requires the submission of an NDA to the FDA and we are not permitted to market any pharmaceutical

2 unchanged sentences

extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing and controls.

current anticipated regulatory pathway for STARS in the United States will require the submission of a PMA to the FDA to demonstrate

that the device is safe and effective for its intended use.

This approval process generally requires clinical data to support the safety

and effectiveness of the device.

approval of an NDA or PMA is not guaranteed, and the review and approval process is an expensive and uncertain process that may take

7 unchanged sentences

The results of preclinical and any clinical

trials of QN-302, QN-247, RAS-F, STARS or any other product candidate may not be predictive of the results of our later-stage clinical

trials of QN-302, RAS or QN-247 or any other future product candidate may not be predictive of the results of our later-stage clinical

trial failure may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, patient enrollment

86 unchanged sentences

request for designation was materially defective.

intend to seek orphan drug designation in the United States for QN-302, QN-247, and/or RAS-F for one or more indications, such as

pancreatic cancer, AML and pediatric neuroblastoma.

Orphan drug status does not ensure that we will receive marketing exclusivity in

a particular market, and there is no assurance that any application for orphan drug designation will be granted.

designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the

regulatory review or approval process.

have received orphan drug designation in the United States for QN-302 for

the indication of pancreatic cancer.

Following having data that supports other rare cancer indications, we intend to seek orphan drug

designation in the United States for QN-302 for additional indications, and will also seek orphan drug designations for RAS for one or

more indications.

Orphan drug status does not ensure that we will receive marketing exclusivity in a particular market, and there is no

assurance that any application for orphan drug designation will be granted.

Orphan drug designation neither shortens the development time

or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

rely, and intend to continue to rely, on third parties to conduct our preclinical studies and clinical trials and perform some of our

3 unchanged sentences

costs or we may be unable to obtain regulatory approval.

are dependent on third parties to conduct our planned preclinical studies and clinical trials of QN-302, QN-247, RAS-F and STARS.

timing of the initiation and completion of these trials will therefore be partially controlled by such third parties and may result in

delays to our development programs.

We have relied heavily, and expect to continue to rely, on UofL for preclinical studies related to

QN-247 and RAS-F, and we expect to rely heavily on contract research organizations (“CROs”) and sponsored academic researchers

for preclinical studies related to QN-302.

As to any clinical trials, we expect to rely on CROs, sponsored academic researchers, clinical

investigators and consultants to play a significant role in the conduct of these trials and the subsequent collection and analysis of

are dependent on third parties to conduct our planned preclinical studies and clinical trials of QN-302, RAS and QN-247.

The timing of

the initiation and completion of these trials will therefore be partially controlled by such third parties and may result in delays to

our development programs.

We have relied heavily, and expect to continue to rely, on UofL for preclinical studies related to RAS, and

we expect to rely heavily on CROs and sponsored academic researchers for preclinical studies related to QN-302.

As to any clinical trials,

we expect to rely on CROs, sponsored academic researchers, clinical investigators and consultants to play a significant role in the conduct

of these trials and the subsequent collection and analysis of data.

However, we will not be able to control all aspects of their activities.

Nevertheless, we are responsible for ensuring that each

clinical trial is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, including GCP,

requirements, and our reliance on the CROs and other third parties does not relieve us of our regulatory responsibilities.

Nevertheless, we are responsible for ensuring that each clinical trial is conducted in accordance with the applicable protocol and legal,

regulatory and scientific standards, including GCP, requirements, and our reliance on the CROs and other third parties does not relieve

us of our regulatory responsibilities.

is no guarantee that any such CROs, clinical trial investigators or other third parties on which we rely will devote adequate time and

3 unchanged sentences

with us, the timelines for our development programs may be extended or delayed or our development activities may be suspended or terminated.

If a Qualigen clinical trial site terminates for any reason, we may experience the loss of follow-up information on subjects enrolled

If one of our clinical trial site terminates for any reason, we may experience the loss of follow-up information on subjects enrolled

in such clinical trial unless we are able to transfer those subjects to another qualified clinical trial site, which may be difficult

2 unchanged sentences

with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals

for QN-302, QN-247, RAS-F or STARS and will not be able to, or may be delayed in our efforts to, successfully commercialize our products.

for QN-302, RAS and/or QN-247 and will not be able to, or may be delayed in our efforts to, successfully commercialize our products.

Manufacturing

26 unchanged sentences

performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval.

not currently have arrangements in place for redundant supply or a second source for bulk drug substance for QN-302, QN-247 or RAS-F.

not currently have arrangements in place for redundant supply or a second source for bulk drug substance for QN-302, RAS or QN-247.

may enter into collaborations with third parties for the development and commercialization of our products.

4 unchanged sentences

may in the future seek third-party collaborators for the development and commercialization of some of our products on a selected basis.

Our likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national

pharmaceutical companies and biotechnology companies.

For example, we expect that we will require partners to continue the development of QN-247

which is in early-stage development.

likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical

companies and biotechnology companies.

We face significant competition in seeking appropriate collaborators.

to reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s

resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a

number of factors.

Our ability to reach a definitive

agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise,

the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

we do enter into any such arrangements with any third parties, we will likely have limited control over the amount and timing of resources

33 unchanged sentences

face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully

development and commercialization of pharmaceutical and device therapeutics products is highly competitive.

We face competition from

major pharmaceutical and device companies, specialty pharmaceutical and device companies and biotechnology companies worldwide.

are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development

of products for the treatment of the disease indications for which we are developing our product candidates and other platform technologies

that may be effective in developing therapeutics.

Some of these competitive products, therapies and technologies are based on scientific

approaches that are similar to our approach, and others are based on entirely different approaches.

Potential competitors also include

academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection

and establish collaborative arrangements for research, development, manufacturing and commercialization.

expect that our oncology drug product candidates and our STARS system will face competition from traditional small or large molecule

drugs that target specific cancers that are FDA-approved and marketed for the indications that we are pursuing, in addition to off-label

use of current therapeutics and therapeutics in development;

and from other drugs using targeted approaches to direct payloads to cancerous

tumors, as well as newer approaches, such as immuno-oncology, which attempts to harness the patient’s own immune system to fight

cancer itself.

development and commercialization of pharmaceutical products is highly competitive.

We face competition from major pharmaceutical companies,

specialty pharmaceutical and and biotechnology companies worldwide.

There are a number of large pharmaceutical and biotechnology companies

that currently market and sell products or are pursuing the development of products for the treatment of the disease indications for

which we are developing our product candidates that may be effective in developing therapeutics.

Some of these competitive products,

therapies are based on scientific approaches that are similar to our approach, and others are based on entirely different approaches.

Potential competitors also include academic institutions, government agencies and other public and private research organizations that

conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

expect that our oncology drug product candidates will face competition from traditional small or large molecule drugs that target specific

cancers that are FDA-approved and marketed for the indications that we are pursuing, in addition to off-label use of current therapeutics

and therapeutics in development;

and from other drugs using targeted approaches to direct payloads to cancerous tumors, as well as newer

approaches, such as immuno-oncology, which attempts to harness the patient’s own immune system to fight cancer itself.

of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources

16 unchanged sentences

to encourage the use of generic products.

The key competitive factors affecting the success of QN-302, QN-247, RAS-F and STARS are likely

to be efficacy, safety, scope and limitations of marketing approval, and availability of reimbursement.

we are unable to obtain and maintain sufficient patent protection for our therapeutic product candidates and platform technologies, or

if the scope of the patent protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize

The key competitive factors affecting the success of QN-302, RAS, QN-247 are likely to be efficacy,

safety, scope and limitations of marketing approval, and availability of reimbursement.

maintain our cash at financial institutions, often in balances that exceed federally insured limits.

maintain our cash at financial institutions, often in balances that exceed federally insured limits.We maintain the majority of our cash

and cash equivalents in accounts at banking institutions in the United States that we believe are of high quality.

Cash held in these

accounts often exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits.

If such banking institutions were

to fail, we could lose all or a portion of amounts held in excess of such insurance limitations.

The FDIC recently took control of two

such banking institutions, Silicon Valley Bank (“SVB”) on March 10, 2023 and Signature Bank (“Signature Bank”)

on March 12, 2023.

While we did not have an account at either of these two banks, in the event of failure of any of the financial institutions

where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely

manner or at all.

Any inability to access or delay in accessing these funds could adversely affect our business and financial position.

Related to Our Diagnostics Business

may face challenges distributing our FastPack System.

distribution agreement with Sekisui for our FastPack System expired on March 31, 2022.

We have and will continue to incur costs re-establishing

and maintaining a direct sales force, and we may also face logistical issues and relationship issues with customers during the transition

In addition, there is the risk that the direct sales force assembled and used by us will not be as efficient and effective as

Sekisui’s distribution efforts.

may provide inadequate training to our sales force and/or fail to increase our sales and marketing capabilities.

rely on our direct sales force to sell our FastPack System in targeted geographic regions, territories and distribution channels, and

any failure to maintain our direct sales force could harm our business.

The members of our direct sales force are specifically trained

to market and sell our FastPack System and they possess technical expertise, which we believe is critical in driving the awareness and

adoption of our product.

The members of our sales force are at-will employees.

The loss of these personnel to competitors, or otherwise,

could materially harm our business.

If we are unable to retain our direct sales force personnel or replace them with individuals of comparable

expertise and qualifications, or if we are unable to successfully instill such expertise in replacement personnel, our product sales,

revenues and results of operations could be materially harmed.

and recruiting qualified sales and marketing professionals and training them on our FastPack System, on applicable federal and state

laws and regulations and on our internal policies and procedures requires significant time, expense and attention.

It can take several

months or more before a sales representative is fully trained and productive.

Our sales force may subject us to higher fixed costs than

those of companies with competing products that can utilize independent third parties, placing us at a competitive disadvantage.

business may be harmed if our efforts to expand and train our sales force do not generate a corresponding increase in product sales and

revenue, and our higher fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our products.

Any failure to hire, develop and retain talented sales personnel, to achieve desired productivity levels in a reasonable period of time

or timely reduce fixed costs, could have material adverse effect on our business, financial condition and results of operations.

diagnostic products face heavy competition.

FastPack System is a mature technology and faces heavy competition from manufacturers of more complex immunoassay systems designed primarily

for central laboratory use, but that also are sold to physician offices.

Many of our competitors have substantially greater financial,

technical, research and other resources and capabilities.

We also face competition from companies that have developed or are developing

newer blood testing systems for use in physician offices.

The FastPack system may not continue to be competitive in light of future technological

developments by others.

diagnostic products are disadvantaged by reduced Medicare reimbursement and third-party payer pricing.

noted above, a primary trend in the U.S.

healthcare industry and elsewhere is cost containment.

Third-party payors have attempted to

control costs by limiting coverage and the amount of reimbursement for particular medical devices, especially mature ones such as ours.

Decreases in Medicare and private-insurer reimbursement for diagnostic tests such as ours in recent years are a negative factor in our

attempts to maintain and grow our diagnostics business.

This factor constrains the price that we can charge to providers for our diagnostic

Moreover, if adequate reimbursement is not available or reimbursement is available only to limited levels, some physician offices,

clinics and small hospitals may choose not to offer (or to discontinue offering) some or all of our diagnostic products.

Xin may not meet expectations in its China/overseas FastPack business.

Xin is a new and untested company and there is no assurance that its financial and other capabilities will enable it to succeed in commercializing

FastPack-based diagnostic products.

We will receive royalties from Yi Xin if and only if Yi Xin achieves sales of FastPack-based diagnostic

Related to our Intellectual Property

we are unable to obtain and maintain sufficient patent protection for our therapeutic product candidates and diagnostic technologies,

or if the scope of the patent protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize

products similar or identical to ours, and our ability to commercialize our product candidates successfully may be adversely affected.

commercial success depends significantly on our ability to protect our proprietary (and exclusively in-licensed) technologies that we

believe are important to our business, including pursuing, obtaining and maintaining patent protection in the United States and other

countries intended to cover the composition of matter of our product candidates, for example, QN-302, QN-247, RAS-F and STARS, the methods

of use, related technologies, and other inventions that are important to our business.

In addition to patent protection, we also rely

on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

If we do not adequately pursue, obtain, maintain, protect or enforce our intellectual property, third parties, including our competitors

and/or collaborators, may be able to erode or negate any competitive advantage we may have, which could harm our business and ability

to achieve profitability.

protect our proprietary position, we file patent applications in the United States and abroad related to our product candidates, their

methods of manufacture and use.

commercial success depends significantly on our ability to protect our proprietary (and exclusively in-licensed) product candidates or

technologies that we believe are important to our business, including pursuing, obtaining and maintaining patent protection in the United

States and other countries intended to cover the composition of matter of our product candidates, the methods of use, related technologies,

and other inventions that are important to our business.

In addition to patent protection, we also rely on trade secrets to protect aspects

of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

If we do not adequately pursue,

obtain, maintain, protect or enforce our intellectual property, third parties, including our competitors and/or collaborators, may be

able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.

protect our proprietary position, we file patent applications in the United States and abroad related to our product candidates and technologies,

their methods of manufacture and use.

The patent application and approval process is expensive, time-consuming and complex.

We may not be able

to prepare, file, prosecute and maintain all necessary or desirable patent applications at a reasonable cost or in a timely manner or

in all jurisdictions.

It is also possible that we will fail to identify patentable aspects of our research and development output before

it is too late to obtain patent protection.

Moreover, depending on the terms of any future license agreements to which we may become

a party, we may not have the right to control the preparation, filing, and prosecution of patent applications, or to maintain or defend

the patents, covering technology licensed from third parties.

be able to prepare, file, prosecute and maintain all necessary or desirable patent applications at a reasonable cost or in a timely manner

or in all jurisdictions.

It is also possible that we will fail to identify patentable aspects of our research and development output

before it is too late to obtain patent protection.

Moreover, depending on the terms of any future license agreements to which we may

become a party, we may not have the right to control the preparation, filing, and prosecution of patent applications, or to maintain

or defend the patents, covering technology licensed from third parties.

Therefore, these patents and patent applications may not be prosecuted

12 unchanged sentences

may result in loss of exclusivity or in our patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which

could limit our ability to stop others from using or commercializing similar or identical technology and products or limit the duration

of the patent protection of our technology and products.

could limit our ability to stop others from using or commercializing similar or identical products and technologies or limit the duration

of the patent protection of our products and technologies.

Such challenges also may result in substantial cost and require significant

1 unchanged sentence

and our licensors’ pending and future patent applications may not result in patents being issued that protect our product candidates

in whole or in part, or that effectively prevent others from commercializing competitive products.

Even if our patent applications issue

as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties

from competing with us or otherwise provide us with any competitive advantage.

Our competitors and other third parties may be able to

circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.

and technologies, in whole or in part, or that effectively prevent others from commercializing competitive products and technologies.

Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent

competitors or other third parties from competing with us or otherwise provide us with any competitive advantage.

Our competitors and

other third parties may also seek approval to market their own products similar to or otherwise competitive with our products.

Alternatively,

our competitors or other third parties may seek to market generic versions of any approved products by submitting abbreviated NDAs to

the FDA during which process they may claim that patents owned by us are invalid, unenforceable or not infringed.

In these circumstances,

we may need to defend or assert our patents, or both, including by filing lawsuits alleging patent infringement.

In any of these types

of proceedings, a court or other agency with jurisdiction may find our patents invalid or unenforceable, or that our competitors are

competing in a non-infringing manner.

Thus, even if we have valid and enforceable patents, these patents still may not provide protection

against competing products or processes sufficient to achieve our business objectives.

other third parties may be able to circumvent our patents by developing similar or alternative products or technologies in a non-infringing

Our competitors and other third parties may also seek approval to market their own products and technologies similar to or otherwise

competitive with our products and technologies.

Alternatively, our competitors or other third parties may seek to market generic versions

of any approved products by submitting abbreviated NDAs to the FDA during which process they may claim that patents owned by us are invalid,

unenforceable or not infringed.

In these circumstances, we may need to defend or assert our patents, or both, including by filing lawsuits

alleging patent infringement.

In any of these types of proceedings, a court or other agency with jurisdiction may find our patents invalid

or unenforceable, or that our competitors are competing in a non-infringing manner.

Thus, even if we have valid and enforceable patents,

these patents still may not provide protection against competing products or processes sufficient to achieve our business objectives.

term of our patents may be inadequate to protect our competitive position on our products.

7 unchanged sentences

in serious price erosion for the original drug brand.

Related to Our Diagnostics Business

may face challenges distributing our diagnostic products after our distribution agreement with Sekisui expires.

currently rely on our diagnostics distribution partner Sekisui for most of our FastPack® distribution worldwide, pursuant to the

terms of our distribution agreement with Sekisui.

We maintain direct distribution for certain house accounts, including Low T.

distribution agreement with Sekisui expires on March 31, 2022.

We will incur costs re-establishing and maintaining a direct sales force,

and we may also face logistical issues and relationship issues with customers during the transition period.

In addition, there is the

risk that the direct sales force assembled and used by us will not be as efficient and effective as Sekisui’s distribution efforts.

diagnostic products face heavy competition.

FastPack system is a mature technology and faces heavy competition from manufacturers of more complex immunoassay systems designed primarily

for central laboratory use, but that also are sold to physician offices.

Many of our competitors have substantially greater financial,

technical, research and other resources and capabilities.

We also face competition from companies that have developed or are developing

newer blood testing systems for use in physician offices.

The FastPack system may not continue to be competitive in light of future technological

developments by others.

diagnostic products are disadvantaged by reduced Medicare reimbursement and third-party payer pricing.

noted above, a primary trend in the U.S.

healthcare industry and elsewhere is cost containment.

Third-party payors have attempted to

control costs by limiting coverage and the amount of reimbursement for particular medical devices, especially mature ones such as ours.

Decreases in Medicare and private-insurer reimbursement for diagnostic tests such as ours in recent years are a negative factor in our

attempts to maintain and grow our diagnostics business.

This factor constrains the price that we can charge to providers for our diagnostic

Moreover, if adequate reimbursement is not available or reimbursement is available only to limited levels, some physician offices,

clinics and small hospitals may choose not to offer (or to discontinue offering) some or all of our diagnostic products.

During the Transition

Period, Low T discontinued our Total PSA test for this reason.

Xin may not meet expectations in its China/overseas business.

have largely ceded our overseas diagnostics business to Yi Xin.

Yi Xin is a new and untested company and there is no assurance that its

financial and other capabilities will enable it to succeed in commercializing FastPack-based diagnostic products.

We would receive royalties

from Yi Xin if and only if Yi Xin achieves sales of FastPack-based diagnostic products.

Related to Employee Matters, Managing Growth, Potential Dilution, Stock Price Variability and Other Risks Related to Our Business

future success depends on our ability to retain key employees and to attract, retain and motivate qualified personnel.

are highly dependent on Michael Poirier, our Chief Executive Officer and Chairman, Christopher Lotz, our Chief Financial Officer and

Vice President of Finance, Amy Broidrick, our President and Chief Strategy Officer, Dr.

Wajdi Abdul-Ahad, our Chief Scientific Officer

and Vice President of Research & Development, Shishir Sinha, our Chief Operating Officer, and Dr.

Tariq Arshad, MD, our Chief Medical

Officer, as well as other members of scientific, operations and corporate development teams.

are highly dependent on Michael Poirier, our Chief Executive Officer and Chairman, as well as other members of our management, scientific,

operations and corporate development teams.

previously disclosed, in January 2023, as part of certain cost-cutting measures, we approved a temporary 20% reduction to the base salaries

of all executive officers of the Company, effective immediately.

As part of these cost-cutting measures, we terminated the employment

of certain employees, including our former Chief Operating Officer and former Vice President and Chief Scientific Officer.

These cost-cutting

measures could make us vulnerable to attrition among our current senior management team and other key employees, and may make it difficult

for us to hire additional senior managers and other key employees.

ability to compete depends upon our ability to attract, retain and motivate highly skilled and experienced personnel with scientific,

14 unchanged sentences

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

Although we outsource many drug development functions and may choose to continue to do so in the future, we expect to experience growth

in the number of employees and the scope of our operations, particularly in the areas of clinical development, clinical operations, manufacturing,

and regulatory affairs as we progress QN-302, QN-247, RAS-F and STARS through the clinic and develop additional product candidates.

addition, in anticipation of the expiration of our distribution agreement with Sekisui on March 31, 2022, we are currently recruiting

direct sales personnel.

If any of our therapeutics product candidates receives regulatory approval, we would potentially need to expand

into sales, marketing and distribution.

To manage anticipated future growth, we must continue to implement and improve our managerial,

operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel.

be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

The expansion of our

operations may lead to significant costs and may divert management and business development resources.

Although we outsource many drug development functions and

may choose to continue to do so in the future, we expect to experience growth in the number of employees and the scope of our operations,

particularly in the areas of clinical development, clinical operations, manufacturing, and regulatory affairs as we progress QN-302,

RAS and QN-247 through the clinic and develop additional product candidates.

If any of our therapeutics product candidates receives regulatory

approval, we may need to expand into sales, marketing and distribution.

To manage anticipated future growth, we must continue to implement

and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified

We may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

The expansion of our operations may lead to significant costs and may divert management and business development resources.

currently rely, and for the foreseeable future will continue to rely, in substantial part, on certain third-party contract research organizations,

sponsored academic researchers, advisors and consultants to provide certain services, including assuming substantial responsibilities

for the conduct of our clinical trials and the manufacture of QN-302, QN-247, RAS-F, STARS or any of our other current or future product

We cannot assure that the services of such third-party contract research organizations, sponsored academic researchers, advisors

and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements.

if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by our vendors

or consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain

regulatory approval of QN-302, QN-247, RAS-F, STARS or any of our other current or future product candidates or otherwise advance our

We cannot assure that we will be able to properly manage our existing vendors or consultants or find other competent outside

vendors and consultants on economically reasonable terms, or at all.

for the conduct of our clinical trials and the manufacture of QN-302, RAS and QN-247 or any future product candidates.

We cannot assure

that the services of such third-party contract research organizations, sponsored academic researchers, advisors and consultants will

continue to be available to us on a timely basis when needed, or that we can find qualified replacements.

In addition, if we are unable

to effectively manage our outsourced activities or if the quality or accuracy of the services provided by our vendors or consultants

is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory

approval of QN-302, RAS and/or QN-247 or any of future product candidates or otherwise advance our business.

We cannot assure that we

will be able to properly manage our existing vendors or consultants or find other competent outside vendors and consultants on economically

reasonable terms, or at all.

may engage in strategic transactions that could impact liquidity, increase expenses and present significant distractions to management.

1 unchanged sentence

of products, drug candidates or technologies.

Additional potential transactions that we may consider include a variety of different business

arrangements, including spin-offs, in-licensing, strategic partnerships, joint ventures, restructurings, divestitures, business combinations

and investments.

Any such transaction may require us to incur non-recurring or other charges, may increase near term or long-term expenditures

and may pose significant integration challenges or disrupt management or business, which could adversely affect our operations and financial

For example, these transactions may entail numerous operational and financial risks, including:

Potential transactions that we may consider include a variety of different business arrangements,

including spin-offs, in-licensing, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments.

Any such transaction may require us to incur non-recurring or other charges, may increase near term or long-term expenditures and may

pose significant integration challenges or disrupt management or business, which could adversely affect our operations and financial results.

For example, as a result of annual goodwill impairment testing, we recognized a $4.2 million non-cash goodwill impairment charge

in the valuation of our business acquisition of Nanosynex for the year ended December 31, 2022.

These trans actions

may entail numerous operational and financial risks, including:

to unknown liabilities;

11 unchanged sentences

to retain key employees of any acquired businesses.

investment in NanoSynex, our majority owned indirect subsidiary, has a number of risks associated with it.

investment in NanoSynex, our majority owned indirect subsidiary domiciled in Israel, has a number of risks associated with it, including,

among others, the following:

history of operating losses, with no assurance of future revenues or operating profits;

associated with the development of medical devices and NanoSynex’s ability to obtain

the necessary regulatory approvals for the development and commercialization of its antimicrobial

susceptibility test platform;

limited manufacturing, marketing, distribution and sales capabilities;

● competition

from both public and private companies and academic collaborators, many of which have significantly

greater experience and financial resources;

by life sciences research and diagnostic communities is not assured;

development of its antimicrobial susceptibility test platform is not assured;

inability to manufacture, market or sell its proposed products if it is unsuccessful in entering

into strategic alliances or joint ventures with third parties;

related to the political, economic and military conditions in Israel.

addition, as a condition to our acquisition of NanoSynex, we agreed to provide NanoSynex with up to $10.4 million of future funding in

the form of promissory notes to us based on NanoSynex’s achievement of certain future development milestones and subject to other

terms and conditions described in the funding agreement.

See Part II, Item 7 “ Management’s Discussion and Analysis of

Financial Condition and Results of Operations ” for additional details.

If we are unable to make these payments, if and when

required, and if NanoSynex is unable to find alternative sources of funding, NanoSynex’s operations may be negatively impacted,

which would ultimately have a negative impact on us.

reported financial condition and results of operations may fluctuate significantly from quarter to quarter and year to year, which makes

2 unchanged sentences

many of which are beyond our control.

In particular, the warrant liabilities from our issued “exploding warrants” (and change

in the fair value of warrant liabilities, over a reporting period) results in distortions and sharp variability in reported periodic

Accordingly, you should not blindly rely upon the results of any quarterly or annual periods as indications of future operating

Other investors may, however, attach undue significance to reported results which are heavily influenced by such distortions

and variability, which in turn could cause our stock price to rise or fall despite there being no corresponding change in our prospects

or position as a practical matter.

In particular, the warrant liabilities (and change in the fair value of warrant liabilities, over

a reporting period) may result in distortions and sharp variability in reported periodic results.

Accordingly, you should not blindly

rely upon the results of any quarterly or annual periods as indications of future operating performance.

Other investors may, however,

attach undue significance to reported results which are heavily influenced by such distortions and variability, which in turn could cause

our stock price to rise or fall despite there being no corresponding change in our prospects or position as a practical matter.

have a substantial amount of derivative securities outstanding.

of December 31, 2021 there were 4,841,856 stock options outstanding under our equity incentive plans for service providers.

as of December 31, 2021, we had 9,821,399 outstanding warrants, of which 5,469,994 were held by Alpha Capital Anstalt.

Outstanding stock

options, warrants and preferred stock can potentially result in dilution to the holders of existing outstanding common stock.

of December 31, 2022 there were 608,012 stock options outstanding under our equity incentive plans.

and 4,575,617 outstanding warrants.

addition, the Debenture issued to Alpha in December 2022 is convertible, at any time, and from time to time, at Alpha’s option,

into shares of our common stock, subject to our receipt of the necessary stockholder approvals and other terms and conditions described

in the Debenture.

Furthermore, subject to our receipt of the necessary stockholder approvals and other terms and conditions described

in the Debenture, we may elect to pay all or a portion of the Monthly Redemption Amount and/or interest required by the Debenture in

shares of our common stock.

issuance of shares upon the exercise or conversion of outstanding stock options, warrants and the Debenture (or our election to pay amounts

owed under the Debenture in shares of our common stock) could result in significant dilution to the holders of our existing outstanding

common stock.

rely significantly upon information technology, and any failure, inadequacy, interruption or security lapse of that technology, including

1 unchanged sentence

development programs.

could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of

information maintained in the information systems and networks of our company.

Outside parties may attempt to penetrate our systems or

those of our partners or fraudulently induce our employees or employees of our partners to disclose sensitive information to gain access

Like other companies, we may experience threats to our data and systems, including malicious codes and computer viruses,

cyber-attacks or other system failures.

Any system failure, accident or security breach that causes interruptions in our operations,

for us or our partners, could result in a material disruption of our product development programs and business operations, in addition

to possibly requiring substantial expenditures of resources to remedy.

For example, the loss of clinical trial data from completed clinical

trials could result in delays in our regulatory approval efforts and we could incur significant increases in costs to recover or reproduce

The risk o f cyber incidents could also be increased by cyberwarfare in connection

with the ongoing conflict between Russia and Ukraine, including potential proliferation of malware from the conflict into systems unrelated

to the conflict.

To the extent that any disruption or security breach results in a loss of, or damage to, our data or applications, or

inappropriate public disclosure of confidential or proprietary information, we may incur liabilities and the further development of our

product candidates may be delayed.

number and complexity of these security threats continue to increase over time.

If a breach of our security systems or that of our partners

occurs, the market perception of the effectiveness of our security measures could be harmed, we could lose business and our reputation

and credibility could be damaged.

We could be required to expend significant amounts of money and other resources to repair or replace

information systems or networks.

Although we develop and maintain systems and controls designed to prevent these events from occurring,

and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly

and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become more sophisticated.

Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely.

has and may continue to adversely affect our business and prospects.

has had, and may continue to have, adverse impacts on the U.S.

and world economy, health care systems, personnel availability,

supply chains, social and political assumptions, and capital markets.

Those impacts may be especially serious for smaller companies

such as Qualigen.

We could also be impacted by other pandemics, epidemics, or infectious diseases.

Our sales of diagnostic products

fell significantly during 2020 (and net loss increased significantly), as deferral of patients’ non-emergency visits to physician

offices, clinics and small hospitals sharply reduced demand for FastPack tests.

In 2021 we experienced some recovery in demand, but this

phenomenon ma y

continue to some extent for the duration of the pandemic, although its degree will probably vary depending on progress toward suppressing

the pandemic, lockdowns and similar responses, and personal and societal behavior changes arising from psychological factors.

We continue to evaluate the extent to which COVID-19 may impact our business and operations and adjust risk mitigation planning and

business continuity activities as needed.

in our IT and storage systems, including as a result of cyber-security breaches, could significantly disrupt our business or force us

to expend excessive costs.

utilize complex IT systems to transmit and store information, including sensitive personal information and proprietary or confidential

5 unchanged sentences

support, send invoices and track payments, fulfill contractual obligations or otherwise operate our business.

IT and storage systems are potentially vulnerable to physical or electronic break-ins, ransomware attacks, computer viruses and similar

disruptive problems.

Sustained or repeated system failures that interrupt our ability to generate, maintain or access data could result

in a material disruption in our operations.

could also be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss

of information maintained in the information systems and networks of our company.

Outside parties may attempt to penetrate our systems

or those of our partners or fraudulently induce our employees or employees of our partners to disclose sensitive information to gain

access to our data.

Like other companies, we may experience threats to our data and systems, including malicious codes and computer viruses,

cyber-attacks or other system failures.

Furthermore, a security breach could be facilitated by ineffective protection measures, employee

3 unchanged sentences

to continue to protect against potential security breaches or to remediate problems caused by such attacks or any breach of our safeguards.

In addition, a data security breach or ransomware attack could distract management or other key personnel from performing their primary

operational duties.

If such a breach leads to disclosure of consumer, customer, supplier, partner or employee information (including

personally identifiable information or protected health information), it could harm our reputation, compel us to comply with disparate

state and foreign breach notification laws and otherwise subject us to liability under laws that protect personal data, resulting in

increased costs or loss of revenue.

The costs of maintaining adequate protection against such threats are significant and are expected

to continue to increase in the future and may be material to our financial statements.

Any system failure, accident or security breach that causes interruptions in our operations, for us or our partners, could result in

a material disruption of our product development programs and business operations, in addition to possibly requiring substantial expenditures

of resources to remedy.

For example, the loss of clinical trial data from completed clinical trials could result in delays in our regulatory

approval efforts and we could incur significant increases in costs to recover or reproduce the data.

The risk of cyber incidents could

also be increased by cyberwarfare in connection with the ongoing war in Ukraine, including potential proliferation of malware from the

conflict into systems unrelated to the conflict.

To the extent that any disruption or security breach results in a loss of, or damage

to, our data or applications, or inappropriate public disclosure of confidential or proprietary information, we may incur liabilities

and the further development of our product candidates may be delayed.

number and complexity of these security threats continue to increase over time.

The costs of maintaining adequate protection against

such threats are significant and are expected to continue to increase in the future and may be material to our financial statements.

If a breach of our security systems or that of our partners occurs, the market perception of the effectiveness of our security measures

could be harmed, we could lose business and our reputation and credibility could be damaged.

We could be required to expend significant

amounts of money and other resources to repair or replace information systems or networks.

We may also be required to comply with disparate

state and foreign breach notification laws and otherwise subject to liability under laws that protect personal data, resulting in increased

costs or loss of revenue.

In addition, a data security breach or ransomware attack could distract management or other key personnel from

performing their primary operational duties.

Although we develop and maintain systems and controls designed to prevent these events from

occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes

is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become more sophisticated.

Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely.

business, financial condition, results of operations and growth have been adversely impacted by the effects of the COVID-19 pandemic

and may be adversely impacted by COVID-19 or another pandemic, epidemic or infectious disease outbreak in the future.

COVID-19 pandemic and related governmental and business responses had and may again have an adverse effect on the markets we derive project

opportunities from, our customers, and our operations.

The extent to which the COVID-19 pandemic could again impact us will depend on

numerous evolving factors and future developments that are uncertain and that we are not able to predict at this time, including:

timing, extent, trajectory and duration of the pandemic;

the emergence of new variants;

the development, availability, distribution and

effectiveness of vaccines and treatments;

the imposition of protective public safety measures;

and the impact of the pandemic on the

global economy and demand for our products and services.

Although the COVID-19 pandemic has subsided, we could again experience adverse

impacts to our business as a result of any related economic recession that occurred or may occur in the future from COVID-19 or other

similar global pandemics.

global conditions, including economic uncertainty, may negatively impact our financial results.

3 unchanged sentences

trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability

in the geopolitical environment as a result of the conflict between Russia and Ukraine, the withdrawal of the United Kingdom from the

European Union, and other political tensions, and foreign governmental debt concerns.

Such challenges have caused, and may continue to

cause, uncertainty and instability in local economies and in global financial markets, which may adversely affect our business.

in the geopolitical environment as a result of the war in Ukraine, the withdrawal of the United Kingdom from the European Union, and

other political tensions, and foreign governmental debt concerns.

Such challenges have caused, and may continue to cause, uncertainty

and instability in local economies and in global financial markets, which may adversely affect our business.

or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery

9 unchanged sentences

Any disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar

we are unable to remediate the material weakness in our internal controls over financial reporting or if additional material weaknesses

are discovered in our internal accounting procedures, the accuracy and timing of our financial reporting may be adversely affected, which

may adversely affect investor confidence in us and, as a result, the value of our common stock.

In connection with the audit

of our 2021 consolidated financial statements, our management and independent registered public accounting firm noted a material weakness

in our controls as discussed in Part 9.A.

A material weakness is a deficiency or combination of deficiencies in internal control

over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial

statements will not be prevented or detected on a timely basis.

Any failure to develop or

maintain effective internal controls over financial reporting or difficulties encountered in implementing or improving our internal controls

over financial reporting could harm our operating results and prevent us from meeting our reporting obligations.

Moreover, effective

internal controls, particularly those related to revenue recognition, are necessary for us to produce reliable financial reports.

we cannot provide reliable financial reports, our business and operating results could be harmed, investors could lose confidence in

our reported financial information, and the trading price of our common stock could drop significantly.

failure to develop or maintain effective internal controls over financial reporting or difficulties encountered in implementing or improving

our internal controls over financial reporting could harm our operating results and prevent us from meeting our reporting obligations.

effective internal controls, particularly those related to financial reporting, are necessary for us to produce reliable financial reports.

If we cannot provide reliable financial reports, our business and operating results could be harmed, investors could lose confidence

in our reported financial information, and the trading price of our common stock could drop significantly.

In addition, investors relying

1 unchanged sentence

SEC or other regulatory authorities or to stockholder class action securities litigation.

We cannot assure you that measures being taken in order to remediate the material weakness described above will

fully remediate such material weakness.

We also cannot assure you that we have identified all of our existing control deficiencies or

that we will not in the future have additional material weaknesses.

addition, discovery and disclosure of a material weakness, by definition, could have a material adverse impact on our financial

As previously described in our annual report on Form 10-K for the year ended December 31, 2021, in connection with the

audit of our financial statements as of and for the year ended December 31, 2021 (the “2021 audit”), our management identified a material weakness in our internal control over financial reporting related to the lack of

accounting department resources and/or policies and procedures to ensure recording and disclosure of items in compliance with U.S.

This material weakness resulted in adjustments to our warrant valuations in connection with the 2021 audit.

In response to the

material weakness, we took a number of remediation steps to enhance our internal controls, including implementing

additional procedures and utilizing external consulting resources with experience and expertise in U.S.

GAAP and public company

accounting and reporting requirements to assist management with its accounting and reporting of complex and/or non-recurring

transactions and related disclosures.

However, in connection with the audit of our financial statements as of and for the year ended

December 31, 2022 (the “2022 audit”), our management determined that that the material weakness identified in connection

with the 2021 audit has not been fully remediated and has resulted in adjustments to the accounting treatment related to

convertible debt, the business combination and goodwill impairment during the 2022 audit, which resulted in the late filing of this

Annual Report (see Item 9A.

Controls and Procedures).

If we are unable to remediate the material weakness and achieve and maintain

effective internal control over financial reporting and effective disclosure controls, our business could be adversely affected.

customers and/or suppliers may choose not to do business with us and the price of our common stock could be adversely impacted.

in turn, negatively affect our ability to access equity capital markets.

failure to be current in our filings with the SEC could pose significant risks to our business, which could materially and adversely

affect our financial condition and results of operations.

are required, as a public reporting company, to provide investors on a regular basis with periodic reports that contain important financial

and business information, including annual reports on Form 10-K and other periodic reports.

Periodic reports help investors to make informed

investment decisions about the purchase or sale of a reporting company’s securities.

Our inability to timely file periodic reports

with the SEC could have an adverse impact on our ability to, among other things, (i) raise funds in the public markets and (ii) attract

and retain key employees, which could materially and adversely affect our financial condition and results of operations.

the late filing of our Annual Report has also adversely affected our eligibility to use our Form S-3 registration statement.

Form requires, among other things, that the issuer be current in its reports under the Exchange Act for at least 12 months.

of our being unable to use Form S-3, we will have to meet more demanding requirements to register our securities, so it will be more

difficult for us to effect public offering transactions, and our range of available financing alternatives could be narrowed.

failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.

we fail to satisfy the continued listing requirements of Nasdaq, Nasdaq may take steps to delist our common stock.

Such a delisting would

likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when

you wish to do so.

April 20, 2023, we received a notification letter from the Listing Qualifications Department of Nasdaq indicating that, as a result of

our delay in filing this Annual Report, we were not in compliance with the timely filing requirements for continued listing under Nasdaq

Listing Rule 5250(c)(1).

The notification letter has no immediate effect on the listing or trading of our common stock on the Nasdaq

Capital Market.

The notification letter states that, under Nasdaq rules, we have 60 calendar days, or until June 20, 2023, to submit

a plan to regain compliance with Nasdaq’s continued listing requirements.

Alternatively, we may also regain compliance with Nasdaq’s

continued listing requirements at any time before June 20, 2023, by filing this Annual Report with the SEC, as well as any subsequent

periodic financial reports that may become due, and continuing to comply with Nasdaq’s other continued listing requirements.

expect that the filing of this Annual Report will be sufficient to avoid the delisting of our common stock.

have in the past been in noncompliance with other Nasdaq continued listing rules.

For example, on November 23, 2022, we effected a 1-for-10

reverse stock split of our outstanding common stock to cure our noncompliance, for a period of more than 30 consecutive business days,

with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid

price of $1.00 per share.

we are unable to maintain compliance with Nasdaq’s continued listing requirements.

In the event of a delisting, we would take action

to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us

would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent

our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s other

listing requirements.

Unresolved Staff Comments.

currently lease an approximately 23,000 square feet all-purpose facility in Carlsbad, California, where we conduct all our operations.

Our wholly-owned subsidiary Qualigen, Inc.

currently leases an all-purpose facility in Carlsbad, California.

Our partially owned subsidiary NanoSynex currently leases an R&D facility in Ness Ziona, Israel.

Legal Proceedings.

information set forth in “Litigation and Other Legal Proceedings” in Note 9 to the Consolidated Financial Statements included

in this Annual Report is incorporated herein by reference.

Mine Safety Disclosures.

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 1A. Risk Factors