What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2024-04-08 compared with 2023-05-02 · 435 added, 689 removed, 236 unchanged (83% of the section changed)

14 unchanged sentences

business strategy is high-risk

are focusing our resources and efforts primarily on development of therapeutic product candidates, which requires extensive cash needs

for research and development activities.

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

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.

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).

are focusing our resources and efforts on development of drug product candidates, which requires extensive cash needs for research and

development activities.

This is a high-risk strategy because there is no assurance that that our cash resources will be adequate to develop

our product candidates, that our product candidates will ever be proven to be safe and effective or that any products will ever become

commercially viable.

This makes our stock an unsuitable investment for many investors.

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

have suffered recurring losses from operations, and we are now essentially a non-revenue company.

We will need capital to maintain our

operations and to support our intended development of our therapeutics business.

Future financings will be necessary in order for us

to survive as a going concern and to properly execute our strategic plan.

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

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

To the extent that we seek to raise additional funds by issuing equity or equity-linked securities, our stockholders may (as has already

occurred several times) 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.

we may consider alternative approaches such as licensing, joint venture, or partnership arrangements to provide short term or long term

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, a related party and the holder of our 8% Senior Convertible Debenture

and of our 8% Convertible Debenture (together, the “Debentures”), and/or trigger certain adjustments to the conversion prices

of the Debentures or to the exercise prices of warrants held by Alpha and/or by other persons.

See Part II, Item 7 “ Management’s

Discussion and Analysis of Financial Condition and Results of Operations ” for additional details regarding the Debentures.

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

ability to make payments to Alpha of principal or interest on the Debentures or to make any potential

prepayments for the Debentures, to the extent applicable, depends on our future performance, which is subject to economic, financial,

competitive and other factors beyond our control.

Our cash resources currently on hand, plus any anticipated near-term cash flow from

operations or dispositions, would not be sufficient to service our indebtedness and/or to make necessary expenditures.

December 2022, we entered into a Securities Purchase Agreement with Alpha and in exchange for $3,000,000 in cash (less $50,000 for expense

reimbursement) issued to Alpha our 8% Senior Convertible Debenture with an original face amount of $3,300,000 due on December 22, 2025

(the “2022 Debenture”), plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through June 22, 2028) at $1.65

Commencing 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 2022 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 2022

Debenture (the “Monthly Redemption Amount”).

The Monthly Redemption Amount must be paid in cash;

provided that after the

first two monthly redemptions, we may (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived)

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 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the

2022 Debenture) for the five consecutive trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption

2022 Debenture accrues interest at the rate of 8% per annum, which began 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.

provided that the Equity Conditions

have been satisfied.

has waived the Equity Conditions for certain Monthly Redemption Amounts, but Alpha is not required to continue such waivers beyond May

For the foreseeable future, we do not expect to be able to satisfy the Equity Conditions;

as a result, where there is no waiver

of the Equity Conditions we would not have the opportunity to make 2022 Debenture payments in the form of stock rather than in the form

of cash, even for types of payments for which payment in the form of stock would have been allowed.

2022 Debenture is convertible into our common stock at any time at the holder’s option;

the conversion price was originally $1.32

but pursuant to a Securities Purchase Agreement amendment in December 2023 it was reduced to $0.73 and then in February 2024 it was adjusted

downward to $0.26 per share by virtue of the operation of a “ratchet” antidilution provision.

(The exercise price of the

warrants issued with the 2022 Debenture was originally $1.65 but pursuant to a Securities Purchase Agreement amendment in December 2023

it was reduced to $0.73 and then in February 2024 it was adjusted downward to $0.26 per share by virtue of the operation of a “ratchet”

antidilution provision.)

than the Monthly Redemption Amounts, the 2022 Debenture does not call for scheduled payments of principal before the scheduled maturity

the 2022 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to their conversion price

and exercise price.

the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

61 days’ notice to the Company.

granted Alpha resale registration rights for the common shares underlying the 2022 Debenture and the accompanying warrants.

December 2023 amendment of the 2022 Debenture conversion price (and the accompanying warrants’ exercise price) to be $0.73 per

share resulted in the 2022 Debenture’s then current $1,528,922 principal amount thereof becoming convertible into 2,094,414 shares

of Company common stock (as opposed to the 1,158,274 shares into which such outstanding principal amount was convertible pre-adjustment).

Also, the December 2023 amendment triggered a “ratchet” antidilution adjustment in the Company’s outstanding “exploding”

“Series C Warrants,” resulting in such Series C Warrants becoming exercisable for 455,623 common shares (at an exercise price

of $0.73 per share), as opposed to the 251,971 common shares into which such outstanding Series C Warrants would have been exercisable

(at $1.32 per share) pre-adjustment.

Finally, the $0.73 price triggered a “ratchet” antidilution adjustment in the exercise

price of other outstanding Company common stock warrants, including 7,048 warrants held by Alpha and 67,620 warrants held by other persons,

which were previously exercisable at $1.32 per share.

February 2024, we entered into a Securities Purchase Agreement with Alpha and in exchange for $500,000 in cash (less $25,000 for expense

reimbursement) issued to Alpha an 8% Convertible Debenture with a face amount of $550,000 due on December 31, 2024 (the “2024 Debenture”),

plus 900,016 5-year common stock warrants exercisable at $0.26 per share.

In addition, per this Securities Purchase Agreement Alpha obtained

an option to purchase 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 1,800,032 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).

This option is valid through July 1, 2024.

2024 Debenture has a maturity date of December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option,

into shares of our common stock, at $0.6111 per share.

The 2024 Debenture does not call for scheduled

payments of principal or interest before the scheduled maturity date.

Interest on the 2024 Debenture accrues on its outstanding

principal balance at the rate of 8% per annum.

the 2024 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to the Conversion Price and

Exercise Price.

the 2024 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon

61 days’ notice to the Company.

granted Alpha “piggyback” registration rights for the common shares underlying the 2024 Debenture and the accompanying warrants.

$0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in the

2022 Debenture, resulting in the then current $1,198,922 principal amount thereof becoming convertible into 4,611,238 shares of Company

common stock (as opposed to the 1,642,359 shares into which such outstanding principal amount were convertible pre-adjustment).

the $0.26 exercise price of the warrants issued with the 2024 Debenture triggered a “ratchet” antidilution adjustment in

the Company’s outstanding “exploding” “Series C Warrants,” resulting in such Series C Warrants becoming

exercisable for 1,279,261 common shares (at an exercise price of $0.26 per share), as opposed to the 455,623 common shares into which

such outstanding Series C Warrants would have been exercisable (at $0.73 per share) pre-adjustment.

Finally, the $0.26 exercise price

of the Warrant would trigger a “ratchet” antidilution adjustment in the exercise price of other outstanding Company common

stock warrants, including 2,507,048 warrants held by Alpha and 67,620 warrants held by other persons, all of which were previously exercisable

at $0.73 per share.

we continue to lack cash resources sufficient

to service our indebtedness, 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

2 unchanged sentences

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

our business, financial condition and operating results or even put us out of business.

Related to Our Product 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.

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

Although we have begun Phase 1a clinical trials for QN-302, we might

be unable to obtain further regulatory approval for QN-302 or any other drug candidate.

We may never obtain marketing approval for any

of our drug candidates.

are still early in our Pan-RAS development efforts and have not yet sought approval for, or begun enrollment, in any clinical trials

evaluating Pan-RAS.

There can be no assurance that any of our drug product candidates will achieve success in their clinical trials or

obtain regulatory approval.

ability to generate revenues from our drug product candidates will depend on the successful development and eventual commercialization

of such drug candidates.

1 unchanged sentence

completion of preclinical studies and clinical trials;

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

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 results;

demonstration

of safety, efficacy and acceptable risk-benefit profiles of our products to the satisfaction

of the FDA and foreign regulatory agencies;

and related terms of marketing approvals from applicable regulatory authorities, including

the completion of any required post-marketing studies or trials;

and maintaining patent, trade secret and other intellectual property protection and regulatory

exclusivity for our products;

of safety, efficacy and acceptable risk-benefit profiles of our products to the satisfaction of the FDA and foreign regulatory agencies;

and related terms of marketing approvals from applicable regulatory authorities, including the completion of any required post-marketing

studies or trials;

and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity for our products;

and implementing marketing and reimbursement strategies;

● establishing

sales, marketing and distribution capabilities and launching commercial sales of our products,

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

sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone

or in collaboration with others;

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

● effectively

competing with other therapies;

and maintaining third-party payor coverage and adequate reimbursement;

● maintaining

a continued acceptable safety profile of the products following approval.

4 unchanged sentences

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.

business could be harmed if results of the clinical trials of QN-302, Pan-RAS or 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.

be unable to complete, the development and commercialization of our drug product candidates.

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

10 unchanged sentences

candidates, including:

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

conduct a clinical trial at a prospective trial site;

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial

contracts or clinical trial protocols with prospective trial sites;

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

for clinical trial participants from investigational and approved therapies may make it more

difficult to enroll patients in our clinical trials;

third-party contractors may fail to meet their contractual obligations to us in a timely

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

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;

may not be able to obtain enough capital to begin clinical trials ort to complete any already-begun clinical trials, or to complete

any necessary preclinical studies;

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

may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols

with prospective trial sites;

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;

for clinical trial participants from investigational and approved therapies may make it more difficult to enroll patients in our

clinical trials;

third-party contractors may fail to meet their contractual obligations to us in a timely manner, or at all, or may fail to comply

with regulatory requirements;

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

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 trials.

product development costs will increase if we experience delays in preclinical studies or clinical trials or in obtaining marketing approvals.

6 unchanged sentences

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.

delays in the commencement or completion, or termination or suspension, of our current clinical trial or 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, 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

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

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

clinical studies to demonstrate safety and efficacy.

8 unchanged sentences

trials can be delayed for a number of reasons, including delays related to:

FDA disagreeing as to the design or implementation of our clinical trials or with our recommended

dose for any of our pipeline programs;

ability to pay for the costs and expenses for the clinical trials;

FDA disagreeing as to the design or implementation of our clinical trials or with our recommended dose for any of our pipeline programs;

FDA authorization to commence a trial or reaching a consensus with the FDA on trial design;

approval from one or more IRBs/ECs;

refusing to approve, suspending or terminating the trial at an investigational site, precluding

enrollment of additional subjects, or withdrawing their approval of the trial;

refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects,

or withdrawing their approval of the trial;

to clinical trial protocol;

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

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

post-treatment follow-up;

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 post-treatment follow-up;

choosing an alternative treatment, or participating in competing clinical trials;

2 unchanged sentences

of serious adverse events in trials of the same class of agents conducted by other companies;

or being required to use clinical end points that require prolonged periods of clinical observation

or analysis of the resulting data;

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

down due to violations of cGMP, regulations or other applicable requirements, or infections

or being required to use clinical end points that require prolonged periods of clinical observation or analysis of the resulting

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 down due to violations of cGMP, regulations or other applicable requirements, or infections

or cross-contaminations in the manufacturing process;

of stability of our clinical trial material or any quality issues that arise with the clinical

trial material;

of stability of our clinical trial material or any quality issues that arise with the clinical trial material;

changes to our manufacturing process that may be necessary or desired;

or our third-party contractors, not performing data collection or analysis in a timely or

accurate manner or improperly disclosing data prematurely or otherwise in violation of a

clinical trial protocol;

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA

or other government or regulatory authorities for violations of regulatory requirements,

in which case we may need to find a substitute contractor, and we may not be able to use

or our third-party contractors, not performing data collection or analysis in a timely or accurate manner or improperly disclosing

data prematurely or otherwise in violation of a clinical trial protocol;

third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities

for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use

some or all of the data produced by such contractors in support of our marketing applications.

14 unchanged sentences

In addition, some of our competitors

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

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

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

3 unchanged sentences

one or more clinical trials altogether.

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.

Undesirable side effects caused by our products could result in the delay, suspension or termination of clinical trials by us or the

FDA for a number of reasons.

side effects or other safety risks associated with our drug 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 current and planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected

characteristics.

Undesirable side effects caused by our products could result in the delay, suspension or termination of clinical trials

by us or the FDA for a number of reasons.

if our products are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect

11 unchanged sentences

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

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

approvals for any 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, 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

product candidate in the United States until we obtain approval from the FDA of the NDA for that product.

An NDA must be supported by

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

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

several years.

The FDA also has substantial discretion in the approval process.

The number and types of preclinical studies and clinical

trials that will be required for NDA or PMA approval varies depending on the product candidate, the disease or the condition that the

product candidate is designed to treat and the regulations applicable to any particular product candidate.

Despite the time and expense

associated with preclinical studies and clinical trials, failure can occur at any stage.

The results of preclinical and any 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

criteria and failure to demonstrate favorable safety or efficacy traits, and failure in clinical trials can occur at any stage.

in the pharmaceutical and device industry frequently suffer setbacks in the advancement of clinical trials due to lack of efficacy or

adverse safety profiles, notwithstanding promising results in earlier trials.

Based upon negative or inconclusive results, we may decide,

or regulators may require us, to conduct additional clinical trials or preclinical studies.

In addition, data obtained from clinical

trials are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may further

delay, limit or prevent regulatory approval.

if we are able to commercialize any drug candidates, the products may become subject to unfavorable pricing regulations, third-party

reimbursement practices or healthcare reform initiatives, which would harm our business.

regulations that govern marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country.

Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause

delays in obtaining approvals.

Some countries require approval of the sale price of a drug before it can be marketed.

In many countries,

the pricing review period begins after marketing or product licensing approval is granted.

To obtain reimbursement or pricing approval

in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our drug candidate to other

available therapies.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control

even after initial approval is granted.

As a result, we might obtain marketing approval for a drug candidate in a particular country,

but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, and negatively

impact the revenues, if any, we are able to generate from the sale of the product in that country.

Adverse pricing limitations may hinder

our ability to recoup our investment in one or more drug candidates, even if such drug candidates obtain regulatory approval.

ability to commercialize any drug candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement

for these products and related treatments will be available from third-party payors, including government healthcare programs, private

health insurers and other organizations.

Third-party payors decide which medications they will pay for and establish reimbursement levels.

A primary trend in the U.S.

healthcare industry and elsewhere has been cost containment.

Third-party payors have attempted to control

costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly, third-party payors are requiring

that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.

Coverage and reimbursement may not be available for any product that we commercialize and, even if these are available, the level of

reimbursement may not be satisfactory.

Reimbursement may affect the demand for, or the price of, any drug candidate for which we obtain

regulatory approval.

Obtaining and maintaining coverage and adequate reimbursement for our products may be difficult.

We may be required

to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies.

If coverage and adequate reimbursement are not available or reimbursement is available only to limited levels, we may not be able to

successfully commercialize any drug candidate for which we obtain regulatory approval.

may also be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than

the purposes for which the drug is approved by the FDA or similar regulatory authorities outside of the United States.

Moreover, eligibility

for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers our costs, including

research, development, intellectual property, manufacture, sale and distribution expenses.

Interim reimbursement levels for new drugs,

if applicable, may also not be sufficient to cover our costs and may not be made permanent.

Reimbursement rates may vary according to

the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs

and may be incorporated into existing payments for other services.

Net prices for drugs may be reduced by mandatory discounts or rebates

required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of

drugs from countries where they may be sold at lower prices than in the United States.

Third-party payors often rely upon Medicare coverage

policy and payment limitations in setting their own reimbursement policies, but also have their own methods and approval process apart

from Medicare determinations.

expect that the Affordable Care Act, as well as other healthcare reform measures that may be adopted in the future, may continue to result

in more rigorous coverage criteria and in additional downward pressure on the price that providers receive for any approved therapeutics

products of ours.

This would adversely affect the prices we receive and could also adversely affect providers’ willingness to prescribe

our therapeutics products, if any.

may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates.

authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as “orphan

drugs.” Under the Orphan Drug Act of 1983, as amended, the FDA may designate a drug candidate as an orphan drug if it is intended

to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United

States, or if the disease or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation

that the cost of developing and making a drug product available in the United States for the type of disease or condition will be recovered

from sales of the product.

drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax

advantages and user-fee waivers.

Additionally, if a product that has orphan designation subsequently receives the first FDA approval

for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity.

This means that the

FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except

in certain circumstances, including proving clinical superiority ( i.e ., another product is safer, more effective or makes a major

contribution to patient care) to the product with orphan exclusivity.

Competitors, however, may receive approval of different products

for the indication for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication

than that for which the orphan product has exclusivity.

In addition, exclusive marketing rights in the United States may be limited if

we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the

request for designation was materially defective.

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.

possible activities relating to drug product candidates such as ours are subject to extensive regulation.

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, 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.

are dependent on third parties to conduct our planned preclinical studies and clinical trials of our drug product candidates.

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 on UofL for preclinical studies related to Pan-RAS, and we expect to rely heavily

on CROs and sponsored academic researchers for any further preclinical studies.

As to any clinical trials, we expect to rely on CROs,

sponsored academic researchers, clinical investigators and/or 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.

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

resources to our development activities or perform as contractually required.

If any of these third parties fail to meet expected deadlines,

adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate their engagements

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

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

or impossible.

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 and/or other third parties on which we rely will devote adequate time

and resources to our development activities or perform as contractually required.

If any of these third parties fail to meet expected

deadlines, adhere to our clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate

their engagements with us, the timelines for our development programs may be extended or delayed or our development activities may be

suspended or terminated.

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 or impossible.

these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct clinical trials in accordance

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

for our drug product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our products.

Manufacturing

6 unchanged sentences

rely, and expect to continue to rely, on third parties for the manufacture of our products for preclinical and any clinical testing,

as well as for commercial manufacture if any of our product candidates obtain regulatory approval.

This reliance on third parties increases

the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or quality, which

could delay, prevent or impair our development or commercialization efforts.

as well as for future commercial manufacture if any of our product candidates obtain regulatory approval.

This reliance on third parties

increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost or

quality, which could delay, prevent or impair our development or commercialization efforts.

may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms.

2 unchanged sentences

on the third-party for regulatory, compliance and quality assurance;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated

to our business or operations, including the bankruptcy of the manufacturer or supplier or

the issuance of an FDA Form 483 notice or warning letter;

of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including

the bankruptcy of the manufacturer or supplier or the issuance of an FDA Form 483 notice or warning letter;

possible breach of the manufacturing agreement by the third-party;

possible termination or nonrenewal of the agreement by the third-party at a time that is

costly or inconvenient for us.

possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us.

do not have manufacturing agreements in place for any of our current drug candidates.

4 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, RAS or QN-247.

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

If those collaborations are

not successful, we may not be able to capitalize on the market potential of these products.

Even if they are successful, they may result

in a limitation of our upside potential.

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

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

which is in early-stage development.

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

will need to seek and enter into out-licenses or collaborations with third parties for the development and commercialization of our products,

resulting in a limitation of our upside potential.

expect that we will need third-party out-licensees or collaborators for the development and commercialization of our products.

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

9 unchanged sentences

these arrangements.

collaboration will necessarily result in a sharing of economics with the collaborator, which might otherwise have been captured by us

if any of our product candidates receives regulatory approval, we may fail to achieve the degree of market acceptance by physicians,

patients, third-party payors and others in the medical community necessary for commercial success.

any of our product candidates receives regulatory approval, we may nonetheless fail to gain sufficient market acceptance by physicians,

patients, third-party payors and others in the medical community.

For example, current cancer treatments, such as existing targeted therapies,

chemotherapy, and radiation therapy, are well established in the medical community, and doctors may continue to rely on these treatments.

If our product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may

not become profitable.

The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number

of factors, including:

efficacy and potential advantages compared to alternative treatments;

prevalence and severity of any side effects, in particular compared to alternative treatments;

● limitations

or warnings contained in the labeling approved for our product candidates by the FDA;

size of the target patient population;

willingness of the target patient population to try new therapies and of physicians to prescribe

these therapies;

ability to offer our products for sale at competitive prices;

convenience and ease of administration compared to alternative treatments;

strength of marketing and distribution support;

for our product candidates and competing products and treatments;

existence of distribution and/or use restrictions, such as through a Risk Evaluation and

Mitigation Strategy;

availability of third-party payor coverage and adequate reimbursement and the willingness

of patients to pay for our products in the absence of such coverage and adequate reimbursement;

timing of any marketing approval in relation to other product approvals;

from patient advocacy groups;

restrictions on the use of our products together with other medications.

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

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

and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals

and marketing and selling approved products than we do.

Mergers and acquisitions in the pharmaceutical and biotechnology industries may

result in even more resources being concentrated among a smaller number of our competitors.

Smaller and other early-stage companies may

also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

third parties compete with us in recruiting and retaining qualified scientific, management and sales and marketing personnel, establishing

clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary

for, our programs.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective,

have fewer or less severe side effects, are approved for broader indications or patient populations, are more convenient or are less

expensive than any products that we may develop.

Our competitors also may obtain FDA or other marketing approval for their products more

rapidly than any approval we may obtain, which could result in our competitors establishing a strong market position before we are able

to enter the market.

In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking

to encourage the use of generic products.

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

out-license or collaboration will necessarily result in a sharing of economics with the out licensee or collaborator, which might otherwise

have been captured by us directly.

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.

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

7 unchanged sentences

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.

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

and enforced in a manner consistent with the best interests of our business.

depending on the terms of any 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 and enforced in a manner consistent with the best interests of

our business.

cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents, whether any issued patents will

1 unchanged sentence

from commercializing competing technologies and product candidates.

We have not filed patent applications in every jurisdiction, and

some filings are only pending in the United States.

patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain

so until issued, we cannot be certain that we were the first to file or invent (before March 16, 2013) the invention disclosed in any

patent application related to our product candidates or technology.

Our licensors have not filed patent applications in every jurisdiction,

and some filings are only pending in the United States.

because the issuance of a patent, although presumptive, is not conclusive as to its inventorship, scope, validity or enforceability,

our patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad.

Such challenges

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 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

time from our scientists and management, even if the eventual outcome is favorable to us.

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

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

our licensors’ patents or pending patent applications may be challenged in the courts or patent offices in the United States and

Such challenges may result in loss of exclusivity or in the 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 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 time from our scientists and management, even if the eventual outcome is favorable to us.

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

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

if the 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 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.

the amount of time required for the development, testing and regulatory review of drug candidates, patents protecting such candidates

might expire before or shortly after such candidates are commercialized.

In such an event (and if we are unable to obtain patent term

extension or the term of any such extension is less than we request), our competitors and other third parties may be able to obtain approval

of competing products following patent expiration and take advantage of our investment in development and clinical trials by referencing

our clinical and preclinical data and launch their product earlier than might otherwise be the case.

Generic competition usually results

in serious price erosion for the original drug brand.

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

other third parties may be able to circumvent our licensors’ patents by developing similar or alternative products or technologies

in a non-infringing manner.

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 licensors’

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 licensors’ patents invalid or unenforceable, or that our competitors are competing in a non-infringing

Thus, even if we have in-licensed 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 in-licensed patents may be inadequate to protect our competitive position on our products.

the amount of time required for the development, testing and regulatory review of drug candidates, our in-licensed patents protecting

such candidates might expire before or shortly after such candidates are commercialized.

In such an event (and if we are unable to obtain

patent term extension or the term of any such extension is less than we request), our competitors and other third parties may be able

to obtain approval of competing products following patent expiration and take advantage of our investment in development and clinical

trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case.

Generic competition

usually results in serious price erosion for the original drug brand.

Related to Employee Matters, 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, 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.

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

Financial Officer.

In addition, the rest of our team has been sharply reduced due to rightsizing, voluntary departures and the disposition

of our Qualigen, Inc.

diagnostics-products subsidiary – we currently have only two other employees.

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

6 unchanged sentences

opportunities for career advancement.

Any or all of these competing factors may limit our ability to continue to attract and retain high

quality personnel, which could negatively affect our ability to successfully develop and commercialize our product candidates and to

grow our business and operations as currently contemplated.

expect that we will need to expand our development and regulatory capabilities as our product candidates progress through the clinic,

or additional product candidates are developed;

if any products are approved, we would have to implement sales, marketing and distribution

capabilities, and as a result, we may encounter difficulties in managing growth, which could disrupt our operations.

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,

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.

Any or all of these competing factors (as well as our own limited resources) may limit our ability

to attract and retain high quality personnel, which could negatively affect our ability to successfully develop and commercialize our

product candidates and to grow our business and operations as currently contemplated.

will need to rebuild our development and regulatory teams.

to rightsizing, voluntary departures and the disposition of Qualigen, Inc.

and our former FastPack®products business, we currently

have only four employees .

Although we outsource many drug development functions and may choose to continue to do so in the future, we expect that (resources allowing)

to recruit and retain more employees in all areas, and particularly in the areas of clinical development, clinical operations, and regulatory

affairs (and maybe, longer-term, in areas such as manufacturing, sales, marketing and distribution).

We will also need to implement and

improve our managerial, operational and financial systems, and obtain stage-appropriate facilities.

We do not currently have the cash

resources needed for any of the above.

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, 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.

and consultants to provide certain services, including assuming substantial responsibilities for the conduct of our clinical trials.

We cannot assure that the services of such third-party contract research organizations 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.

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.

4 unchanged sentences

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:

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

These transactions may entail

numerous operational and financial risks, including:

to unknown liabilities;

of business and diversion of management’s time and attention in order to develop acquired

products, drug candidates or technologies;

of business and diversion of management’s time and attention in order to develop acquired products, drug candidates or technologies;

of substantial debt or dilutive issuances of equity securities to pay for acquisitions;

than expected acquisition and integration costs;

● write-downs

of assets or impairment charges;

amortization expenses;

and cost in combining the operations, systems and personnel of any acquired businesses with

our operations, systems and personnel;

of relationships with key suppliers or customers of any acquired businesses due to changes

in management and ownership;

and cost in combining the operations, systems and personnel of any acquired businesses with our operations, systems and personnel;

of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership;

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:

minority-interest investment in NanoSynex is illiquid and has many risks associated with it.

investment in NanoSynex has been reduced to a 39% equity interest and 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;

as to the availability to NanoSynex of the cash resources it needs to execute its plans;

technological

inability, now that we are no longer a majority shareholder of NanoSynex, to control or veto NanoSynex’s decisions;

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;

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

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;

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

them difficult to predict or understand.

addition, NanoSynex is a privately-held company and its shares are illiquid, which means that we could not readily obtain cash in exchange

for some or all of our equity interest.

We no longer hold any NanoSynex debt instruments.

reported financial condition may fluctuate significantly from quarter to quarter and year to year, which makes them difficult to predict

or understand.

expect our financial condition and results of operations to fluctuate from quarter to quarter and year to year due to a variety of factors,

many of which are beyond our control.

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.

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

indications of future financial status or 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, 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.

of December 31, 2023 there were 398,924 stock options outstanding under our equity incentive plans, 3,081,717 outstanding warrants, and

1,943,729 shares issuable upon voluntary conversion of principal amount of the 2022 Debenture issued to Alpha.

(At December 31, 2023,

such principal amount was $1,418,922) Due to antidilution adjustments occurring as a result of the 2024 Debenture transaction in February

2024, the outstanding principal balance of the 2022 Debenture (which at March 25, 2024 was $1,088,922) is now convertible upon voluntary

conversions into 4,188,162 shares;

and in addition the 2024 Debenture’s principal amount is convertible upon voluntary conversions

into 900,016 shares, and the warrants issued with the 2024 Debenture are exercisable for 900,016 shares.

2022 and 2024 Debentures issued to Alpha are convertible, at any time, and from time to time, at Alpha’s option, into shares of

our common stock, subject to the terms and conditions described in the Debentures.

Currently the conversion price for such optional conversions

is $0.26 per share for the 2022 Debenture and $0.6111 per share for the 2024 Debenture.

Furthermore, subject to certain terms and conditions

described in the 2022 Debenture, we may elect to pay all or a portion of the Monthly Redemption Amount and/or interest required by the

2022 Debenture in shares of our common stock.

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

amounts owed under the Debentures 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.

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

information, and otherwise to support our business and process.

In the future, our systems may prove inadequate to our business needs

and necessary upgrades may not operate as designed, which could result in excessive costs or disruptions in portions of our business.

utilize information technology systems to transmit and store information, including sensitive personal information and proprietary or

confidential information, and otherwise to support our business and process.

In the future, our systems may prove inadequate to our business

needs and necessary upgrades may not operate as designed, which could result in excessive costs or disruptions in portions of our business.

In particular, any disruptions, delays or deficiencies from our enterprise resource planning systems could adversely affect our ability

to, among other matters, process orders, procure supplies, manufacture and ship products, track inventory, provide services and customer

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

to, among other matters, process orders, procure supplies, manufacture and ship products, send invoices and track payments, fulfill contractual

obligations or otherwise operate our business.

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

15 unchanged sentences

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.

conditions, disruptions in the financial markets, or inflation could adversely impact our business.

In addition, the global macroeconomic

environment has been and may continue to be negatively affected by, among other things, instability in global economic markets, increased

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 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.

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.

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

plans may not adequately protect us from a serious disaster.

are located in southern California, and are subject to risks posed by natural disasters, including wildfires, earthquakes and severe

weather that may interfere with our operations.

Extreme weather events and other natural disasters could severely disrupt our operations,

and have a material adverse effect on our business, results of operations, financial condition and prospects.

If a natural disaster,

power outage or other event occurred that prevented Qualigen from using all or a significant portion of our headquarters, that damaged

critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted

operations, it may be difficult or, in certain cases, impossible for Qualigen to continue our business for a substantial period of time.

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

are located in southern California and are subject to risks posed by natural disasters, including wildfires, earthquakes and severe weather

that may interfere with our operations.

Extreme weather events and other natural disasters could severely disrupt our operations, and

have a material adverse effect on our business, results of operations, financial condition and prospects.

If a natural disaster, power

outage or other event occurred that damaged critical infrastructure, such as the facilities of our third-party clinical sites or contract

manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business

for a substantial period of time.

Any disaster recovery and business continuity plans we have in place may prove inadequate in the event

of a serious disaster or similar event.

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.

internal controls, particularly those related to financial reporting, 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.

In addition, investors relying

1 unchanged sentence

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

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.

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.

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 the material weakness identified in connection with the 2021 audit had not been fully remediated

and 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 the 2022 Annual Report.

connection with the audit of our financial statements as of and for the year ended December 31, 2023, our management identified material weaknesses in our internal control over financial reporting related to limited accounting

personnel and resources resulting in lack of segregation of duties, and to the fact that we have not designed and implemented effective Information Technology General Controls related

to access controls to financing accounting systems.

intend to continue to take steps to enhance our internal controls, including implementing additional internal procedures and utilizing

well-established external consulting resources with experience and expertise in U.S.

GAAP and public company accounting and reporting

requirements.

we are unable to remediate the material weaknesses and achieve and maintain effective internal control over financial reporting and effective

disclosure controls, our business could be adversely affected.

right to use our “shelf” Form S-3 registration statement is sharply limited.

filed a Form S-3 “shelf” registration statement with the SEC for the issuance of up to $150,000,000 of securities, and the

SEC declared the registration statement effective on August 5, 2022.

However, due to the “baby shelf” rules adopted by the

SEC, the maximum amount of securities we can sell under this registration is now limited to one-third of our public float.

public float is very modest (e.g., $2.9 million at December 31, 2023), the maximum amount we could sell using this registration statement

was under $1.0 million at that time.

Therefore, the registration statement no longer constitutes an important tool for accessing the

public markets to satisfy our needs for capital.

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

4 unchanged sentences

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 delay in filing the 2022 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 had no immediate effect on the listing or trading of our common stock on the

Nasdaq Capital Market.

On May 2, 2023, the Company filed the Form 10-K with the SEC and was subsequently notified by Nasdaq on May 4,

2023 that it had regained compliance with Nasdaq’s listing rule 5250(c)(1) as a result thereof and that the matter was closed.

November 20, 2023, we received a letter (the “Bid Price Deficiency Notice”) from The Nasdaq Stock Market (“Nasdaq”)

notifying the Company that, because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business

days, it no longer complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market.

Nasdaq Listing

Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”),

and Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for

a period of 30 consecutive business days.

Bid Price Deficiency Notice has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market.

Pursuant to Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has been provided an initial compliance period of 180 calendar days, or

until May 20, 2024 to regain compliance with the Minimum Bid Price Requirement.

During the compliance period, the Company’s shares

of common stock will continue to be listed and traded on The Nasdaq Capital Market.

To regain compliance, the closing bid price of the

Company’s common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar

day grace period.

the event the Company is not in compliance with the Minimum Bid Price Requirement by May 20, 2024, the Company may be afforded a second

180 calendar day grace period.

Company intends to actively monitor the bid price for its common stock between now and May 20, 2024 and will consider available options

to regain compliance with the Minimum Bid Price Requirement.

November 21, 2023, the Company also received a letter (the “Equity Deficiency Letter”) from Nasdaq notifying the Company

that, based on the Company’s stockholders’ deficit of ($1,640,552) as of September 30, 2023, as reported in the Company’s

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, it is no longer in compliance with the minimum stockholders’

equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1), which requires listed companies

to maintain stockholders’ equity of at least $2.5 million (the “Minimum Stockholders’ Equity Requirement”), or

the alternative criteria of $35 million market value of listed securities or $500,000 in net income from continuing operations in the

most recent fiscal year or two or the last three fiscal years—which alternatives, as noted in the Equity Deficiency Letter, the

Company does not meet.

The Company was given until January 5, 2024 to provide Nasdaq with a specific plan (the “Compliance Plan”)

to achieve and sustain compliance with the Minimum Stockholders’ Equity Requirement or its alternatives.

If the Company’s

Compliance Plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Equity Deficiency Letter for

the Company to evidence compliance.

Company submitted a Compliance Plan to Nasdaq on January 5, 2024 to regain compliance with the Nasdaq Listing Rules.

The Compliance Plan

was accepted by Nasdaq and the Company was granted an extension of up to 180 calendar days from

the date of the Equity Deficiency Letter (i.e., until May 20, 2024) for the Company to evidence compliance.

If the Company does

not regain compliance within the requisite time period, or if the Company fails to satisfy another Nasdaq requirement for continued listing,

Nasdaq could provide notice that the Company’s securities will become subject to delisting, which delisting determination the Company

has the right to appeal.

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

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.

Mine Safety Disclosures.

our Nasdaq other listing would seriously harm us, by undermining our ability to raise capital and decreasing our attractiveness to possible

merger partners.

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