What changed in this filing

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Item 1A. Risk Factors

2022-03-31 compared with 2020-03-31 · 776 added, 1405 removed, 2 unchanged (100% of the section changed)

operate in a dynamic and rapidly changing business environment that involves multiple risks and substantial uncertainty.

The following

discussion addresses risks and uncertainties that could cause, or contribute to causing, actual results to differ from expectations

in material ways.

In evaluating our business, investors should pay particular attention to the risks and uncertainties described

below and in other sections of this Annual Report and in our subsequent filings with the SEC.

These risks and uncertainties, or

other events that we do not currently anticipate or that we currently deem immaterial also may affect our results of operations,

cash flows and financial condition.

The trading price of our common stock could also decline due to any of these risks, and you

could lose all or part of your investment.

The following information should be read in conjunction with Part II, Item 7, “Management’s

Discussion and Analysis of Financial Condition and Results of Operations”

and the financial statements and related notes

included in Part II, Item 8, “Financial Statements and Supplementary Data”

of this Annual Report.

Related to the Merger

to complete the merger may result in our having to paying a termination fee to Qualigen and could significantly harm the market

price of our common stock and negatively affect our future business and operations of each company.

the merger is not completed and the Merger Agreement is terminated under certain circumstances, we may be required to pay Qualigen

a termination fee of $100,000.

Even if a termination fee is not payable in connection with a termination of the Merger Agreement,

we will have incurred significant fees and expenses, most of which must be paid whether or not the merger is completed.

if the merger is not completed, it could significantly harm the market price of our common stock and will likely result our being

involuntarily delisted from Nasdaq.

See section entitled “

Risk Factors–Our failure to meet the continued listing

requirements of Nasdaq could result in a delisting of our common stock and the termination of the Merger Agreement by Qualigen .”

addition, if the Merger Agreement is terminated and our board of directors determines to seek another business combination,

there can be no assurance that we will be able to find a partner and close an alternative transaction on terms that are as favorable

or more favorable than the terms set forth in the Merger Agreement.

See the section entitled “

Risk Factors—If the

merger is not completed, we may be unsuccessful in completing an alternative transaction on terms that are as favorable as the

terms of the merger with Qualigen, or at all, and we may otherwise be unable to continue to operate our business.

directors may decide to pursue a dissolution and liquidation.

In such an event, the amount of cash available for distribution

to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved

for commitments and contingent liabilities.

issuance of our common stock to Qualigen stockholders pursuant to the Merger Agreement and the resulting change in control resulting

from the merger must be approved by our stockholders (pursuant to Nasdaq rules) along with certain other matters, and the Merger

Agreement and transactions contemplated thereby must be approved by the Qualigen’s stockholders.

Failure to obtain these

approvals would prevent the closing of the merger.

the merger can be completed, the stockholders of each of Ritter and Qualigen must approve the merger.

Failure to obtain the required

stockholder approvals may result in a material delay in, or the abandonment of, the merger.

Any delay in completing the merger

may materially adversely affect the timing and benefits that are expected to be achieved from the merger and could result in our

being involuntarily delisted from Nasdaq.

Risk Factors–Our failure to meet the continued listing requirements

of Nasdaq could result in a delisting of our common stock and the termination of the Merger Agreement by Qualigen .”

merger may be completed even though certain events occur prior to the closing that materially and adversely affect Ritter

Merger Agreement provides that either Ritter or Qualigen can refuse to complete the merger if there is a material adverse change

affecting the other party between January 15, 2020, the date of the Merger Agreement, and the closing.

However, certain

types of changes do not permit either party to refuse to complete the merger, even if such change could be said to have a material

adverse effect on Ritter or Qualigen, including:

business or economic conditions affecting the industries in which Qualigen or Ritter, as applicable, operates, except to the

extent they disproportionately affect Ritter or Qualigen, taken as a whole, relative to other similarly situated companies

in the industries in which Ritter and Qualigen operate;

acts of war, armed hostilities or terrorism, except to the extent they disproportionately affect Ritter or Qualigen, taken

as a whole, relative to other similarly situated companies in the industries in which Ritter and Qualigen operate;

changes in financial, banking or securities markets, except to the extent they disproportionately affect Ritter or Qualigen,

taken as a whole, relative to other similarly situated companies in the industries in which Ritter and Qualigen operate;

respect to Ritter, any change in the stock price or trading volume of Ritter common stock (it being understood, however, that

any underlying effect that may have caused or contributed to such change may be taken into account in determining whether

a material adverse effect has occurred, unless such effects are otherwise excepted from causing a material adverse effect

under the Merger Agreement);

to meet internal or analysts’

expectations or projections or the results of operations;

respect to Ritter, any clinical trial programs or studies, including any adverse data, event or outcome arising out of or

related to any such programs or studies;

change in, or any compliance with or action taken for the purpose of complying with, any applicable laws or generally accepted

accounting principles in the United States (“GAAP”, or interpretations thereof;

effect resulting from the announcement or pendency of the Merger Agreement, merger or any related transactions;

respect to Ritter, continued losses from operations or decreases in its cash balances;

effect resulting from the taking of any action by Ritter or Qualigen specifically required to be taken by the Merger Agreement;

adverse changes occur and we still complete the merger, the market price of the combined company’s common stock may suffer.

This in turn may reduce the value of the merger to the stockholders of Ritter, Qualigen or both.

Some of our officers and directors

have interests in the merger that are different from those of our stockholders and that may influence them to support or approve

the merger without regard to the interests of our stockholders.

of our officers and directors participate in arrangements that provide them with interests in the merger that are different from

the interests of our stockholders.

example, we have entered into executive severance and change of control agreements with our executive officers that will result

in the receipt by such executive officers of cash severance payments, vesting of equity awards and other benefits in the event

of a covered termination of employment of each executive officer’s employment in connection with a change of control of

The CVR Agreement provides

that our legacy executives, if any, who assisted a particular Legacy Monetization on behalf of Parent, will be entitled to

receive a cash bonus, in an amount equal in the aggregate to 30% of the net proceeds of such Legacy Monetization (a “Success

Bonus”) which shall be allocated among the Legacy Executives in accordance with, during the Consultant Term, the sole, good-faith

discretion of the Consultant or, after expiration or termination of the Consultant Term, the sole, good-faith discretion of the

CVR Holders’

Representative.

interests, among others, may influence our officers and directors to support or approve the merger.

market price of our common stock following the merger may decline as a result of the merger.

market price of our common stock may decline as a result of the merger for a number of reasons, including if:

react negatively to the prospects of the combined company’s product candidates, business and financial condition following

effect of the merger on the combined company’s business and prospects is not consistent with the expectations of financial

or industry analysts;

combined company does not achieve the perceived benefits of the merger as rapidly or to the extent anticipated by financial

or industry analysts.

Capital Anstalt will own a large percentage of

the combined company, which may dissuade others from investing in Ritter.

The Investor may also have different interests than

other stockholders of the combined company following the merger.

Alpha Capital Anstalt (the “Investor’) is expected to

own securities representing in excess of 25% of the fully-diluted outstanding securities of Ritter as of immediately after the

Although the derivative securities of Ritter owned after the merger by the Investor will be subject to a 9.9% “blocker”

provision (meaning that they will not be convertible or exercisable to the extent that conversion or exercise results in the Investor

owning, following the conversion or exercise, more than 9.9% of Ritter common stock), the Investor’s ownership may have an

impact on the future willingness of other persons to invest in Ritter.

The Investor may have different interests and goals than

other stockholders, and its sales of our common stock could depress our stock market price.

securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of,

the combined company following the Closing as compared to their current ownership and voting interest in our company.

the proposed merger is completed, our current securityholders will own a smaller percentage of the combined company than their

current ownership in Ritter prior to the merger.

Applying the current estimate of the exchange ratio, the pre-merger Ritter securityholders

are expected to own approximately 7.5% of the combined company, on a fully diluted basis, Accordingly, the issuance of shares

of our common stock to Qualigen stockholders in the merger will reduce significantly the relative voting power of each share of

common stock held by our current stockholders.

Consequently, our stockholders as a group will have less influence over the management

and policies of the combined company after the merger than prior to the merger.

stockholders may not realize a benefit from the merger commensurate with the ownership dilution they will experience in connection

with the merger.

the combined company is unable to realize the strategic and financial benefits currently anticipated from the merger, our stockholders

will have experienced substantial dilution of their ownership interests without receiving the expected commensurate benefit, or

only receiving part of the commensurate benefit to the extent the combined company is able to realize only part of the expected

strategic and financial benefits currently anticipated from the merger.

combined company will need to raise additional capital by issuing securities or debt or through licensing or other strategic arrangements,

which may cause dilution to the combined company’s stockholders or restrict the combined company’s operations or impact

its proprietary rights.

combined company may be required to raise additional funds sooner than currently planned.

If either or both of Ritter or Qualigen

hold less cash at the time of the Closing than the parties currently expect, the combined company will need to raise additional

capital sooner than expected.

Additional financing may not be available to the combined company when it needs it or may not be

available on favorable terms.

To the extent that the combined company raises additional capital by issuing equity securities,

such an issuance may cause significant dilution to the combined company’s stockholders’

ownership and the terms of

any new equity securities may have preferences over the combined company’s common stock.

Any debt financing the combined

company enters into may involve covenants that restrict its operations.

These restrictive covenants may include limitations on

additional borrowing and specific restrictions on the use of the combined company’s assets, as well as prohibitions on its

ability to create liens, pay dividends, redeem its stock or make investments.

In addition, if the combined company raises additional

funds through licensing, partnering or other strategic arrangements, it may be necessary to relinquish rights to some of the combined

company’s technologies or product candidates and proprietary rights, or grant licenses on terms that are not favorable to

the combined company.

the pendency of the merger, we may not be able to enter into a business combination with another party at a favorable price

because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

in the Merger Agreement impede our ability to make acquisitions, subject to certain exceptions relating to fiduciary duties, or

to complete other transactions that would endanger the listing of our common stock on Nasdaq.

As a result, if the merger is not

completed, we may be at a disadvantage to our competitors during such period.

In addition, while the Merger Agreement is in effect,

we are generally prohibited from soliciting, initiating, encouraging or entering into certain extraordinary transactions, such

as a merger, sale of assets, or other business combination with any third-party that would endanger the listing of our common

stock on Nasdaq, subject to certain exceptions relating to fiduciary duties.

Any such transactions could be favorable to our stockholders.

provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals to us, including

proposals that may be superior to the arrangements contemplated by the Merger Agreement.

terms of the Merger Agreement prohibit us from soliciting alternative takeover proposals or cooperating with persons making unsolicited

takeover proposals, except in limited circumstances when our board of directors determines in good faith that an unsolicited alternative

takeover proposal is or is reasonably likely to lead to a superior takeover proposal and that failure to cooperate with the proponent

of the proposal would be reasonably likely to be inconsistent with our board of director’s fiduciary duties.

Any such transactions

could be favorable to our stockholders.

the conditions to the merger are not met, or the Merger Agreement is terminated pursuant to the conditions set forth in the Merger

Agreement, the merger will not occur and it is likely that we will be involuntarily delisted from Nasdaq.

can be no assurances that the necessary stockholder approvals will be obtained to complete the merger.

Failure to obtain stockholder

approval may result in a material delay in, or the abandonment of, the merger.

Even if the merger is approved by Ritter stockholders

and Qualigen stockholders, certain other specified conditions set forth in the Merger Agreement must be satisfied or waived to

complete the merger.

The Merger Agreement may also be terminated by the parties in certain circumstances, including, without limitation,

by Qualigen if we fail to maintain our listing on Nasdaq.

We cannot assure you that all of the conditions will be satisfied or

waived, or that the Merger Agreement will not be terminated prior to the closing.

If the conditions are not satisfied or waived,

or the Merger Agreement is terminated, the merger will not occur or will be delayed, and we may lose some or all of the intended

benefits of the merger.

If the merger is not consummated, it is also likely that we will be involuntarily delisted from Nasdaq.

Risk Factors–Our failure to meet the continued listing requirements of Nasdaq could result in a delisting

of our common stock and the termination of the Merger Agreement by Qualigen .”

relating to the merger could require us to incur significant costs and suffer management distraction, and could delay or

enjoin the merger.

could be subject to demands or litigation related to the merger,

whether or not the merger is consummated.

Such actions may create uncertainty relating to the merger, or delay or enjoin the merger,

result in substantial costs to us and divert management time and resources.

Related to the Proposed Reverse Stock Split

proposed reverse stock split may not increase the combined company’s stock price over the long-term.

of the proposals to be voted on at the special meeting to vote on the merger, is a proposal to approve a reverse stock split of

our outstanding common stock immediately prior to the merger.

One of the purposes of the proposed reverse stock split is to increase

the per-share market price of our common stock in order to comply with the continued listing requirements of Nasdaq.

be assured, however, that the proposed reverse stock split will accomplish this objective for any meaningful period of time.

it is expected that the reduction in the number of our outstanding shares will proportionally increase the market price of our

common stock, it cannot be assured that the proposed reverse stock split will increase the market price of our common stock by

a multiple of the proposed reverse stock split ratio, or result in any permanent or sustained increase in the market price of

our common stock, which is dependent upon many factors, including the combined company’s business and financial performance,

general market conditions and prospects for future success.

Thus, while the stock price of the combined company might meet the

continued listing requirements of Nasdaq, it cannot be assured that it will continue to do so.

proposed reverse stock split may decrease the liquidity of the combined company’s common stock.

our board of directors believes that the anticipated increase in the market price of the combined company’s common stock

could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could

also be adversely affected by the reduced number of shares outstanding after the proposed reverse stock split.

The reduction in

the number of outstanding shares may lead to reduced trading and a smaller number of market makers for our common stock.

proposed reverse stock split may lead to a decrease in the combined company’s overall market capitalization.

the market price of the combined company’s common stock decline after the proposed reverse stock split, the percentage decline

may be greater, due to the smaller number of shares outstanding, than it would have been prior to the proposed reverse stock split.

A reverse stock split may be viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s

overall market capitalization.

If the per share market price does not increase in proportion to the proposed reverse stock split

ratio, then the value of the combined company, as measured by its stock capitalization, will be reduced.

In some cases, the per-share

stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly,

it cannot be assured that the total market value of the combined company’s common stock will remain the same after the proposed

reverse stock split is effected, or that the proposed reverse stock split will not have an adverse effect on the stock price of

our common stock due to the reduced number of shares outstanding after the proposed reverse stock split.

Related to Our Financial Condition and Our Need for Additional Financing, and Additional Risks Related to the Merger

is no assurance that the merger will be completed in a timely manner or at all.

If the merger is not completed, our business

could suffer materially and our stock price could decline, and we will likely be involuntarily delisted from Nasdaq.

closing of the merger is subject to the satisfaction or waiver of a number of closing conditions, as described above, including

the required approvals by Ritter stockholders and Qualigen stockholders and other customary closing conditions.

See the risk factors

above titled, “

The issuance of our common stock to Qualigen stockholders pursuant to the Merger Agreement and the resulting

change in control from the merger (pursuant to Nasdaq rules) along with certain other matters must be approved by our stockholders,

and the Merger Agreement and transactions contemplated thereby must be approved by the Qualigen stockholders.

Failure to obtain

these approvals would prevent the closing of the merger.

If the conditions are not satisfied or waived, the merger

may be materially delayed or abandoned.

If the merger is not consummated, our ongoing business may be adversely affected and,

without realizing any of the benefits of having consummated the merger, we will be subject to a number of risks, including the

have incurred and expect to continue to incur significant expenses related to the merger even if the merger is not consummated;

could be obligated to pay Qualigen a termination fee of

$100,000 under certain circumstances set forth in the Merger Agreement;

market price of our common stock may decline to the extent that the current market price reflects a market assumption

that the merger will be completed;

relating to the merger have required and will continue to require substantial commitments of time and resources by our

remaining management and employees, which could otherwise have been devoted to other opportunities that may have been

beneficial to us.

also could be subject to litigation related to any failure to consummate the merger or to perform our obligations under the Merger

If the merger is not completed, these risks may materialize and may adversely affect our business, financial condition

and the market price of our common stock.

If the merger is not consummated, it is also likely that we will be involuntarily delisted

Risk Factors–Our failure to meet the continued listing requirements of Nasdaq could result in

a delisting of our common stock and the termination of the Merger Agreement by Qualigen .”

the merger is not completed, we may be unsuccessful in completing an alternative transaction on terms that are as favorable as

the terms of the merger with Qualigen, or at all, and we may otherwise be unable to continue to operate our business.

of directors may decide to pursue a dissolution and liquidation.

In such an event, the amount of cash available for distribution

to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved

for commitments and contingent liabilities.

assets currently consist primarily of cash, cash equivalents and short-term investments, our RP-G28 assets, our listing on the

Nasdaq Capital Market and the Merger Agreement with Qualigen.

While we have entered into the Merger Agreement with Qualigen, the

closing of the merger may be delayed or may not occur at all and there can be no assurance that the merger will deliver the anticipated

benefits we expect or enhance stockholder value.

If we are unable to consummate the merger, our board of directors may elect to

pursue an alternative strategy, one of which may be a strategic transaction similar to the merger.

If the merger is not consummated,

it is likely that we will be involuntarily delisted from Nasdaq, which may make it more difficult for us to complete an alternative

Attempting to complete an alternative transaction like the merger will be costly and time consuming, and we can make

no assurances that such an alternative transaction would occur at all.

the merger is not consummated, our board of directors may elect to continue our operations to determine if we can identify a path

forward for RP-G28.

We may seek to recommence the development and commercialization of RP-G28 as a prescription drug (which may

require the filing of a new IND), or explore its potential development as an OTC product or dietary supplement for the consumer

healthcare industry.

However, our existing capital resources will not be adequate to enable us to conduct and complete any additional

clinical trials that would be required to obtain the necessary regulatory approvals to commercialize RP-G28.

We would need significant

additional funding to initiate and complete any additional clinical trials of RP-G28 and to otherwise further the development

of our RP-G28 program.

the merger is not completed and we are unable to raise sufficient additional funds for the continued development of RP-G28, whether

through potential collaborative, partnering or other strategic arrangements or otherwise, or if we otherwise determine to discontinue

the development of our RP-G28 program, we will likely determine to cease operations.

our board of directors pursues a dissolution and liquidation, the amount of cash available for distribution to our stockholders

will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution

will be reduced as we continue to fund our operations.

In addition, if our board of directors were to approve and recommend, and

our stockholders were to approve, a dissolution and liquidation, we would be required under Delaware corporate law to pay our

outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions

in liquidation to our stockholders.

Our commitments and contingent liabilities may include severance obligations, regulatory and

clinical obligations, and certain fees and expenses related to the merger.

As a result of this requirement, a portion of our assets

may need to be reserved pending the resolution of such obligations.

In addition, we may be subject to litigation or other claims

related to a dissolution and liquidation.

If a dissolution and liquidation were pursued, our board of directors, in consultation

with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve.

our stockholders could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding

issuance of shares of our common stock to Qualigen stockholders in the merger will substantially dilute the voting power

of our current stockholders.

the merger is completed, pre-merger Ritter securityholders are expected to own approximately 7.5% of the combined company, on

a fully-diluted basis.

Accordingly, the issuance of shares of our common stock to Qualigen stockholders in the merger will reduce

significantly the relative voting power of each share of common stock held by our current stockholders.

Consequently, our stockholders

as a group will have significantly less influence over the management and policies of the combined company after the merger than

prior to the merger.

These estimates are based on the anticipated exchange ratio and are subject to adjustment as provided in

the Merger Agreement.

stockholders may not receive any payment on the CVRs and the CVRs may otherwise expire valueless.

right of our stockholders to receive any future payment for or derive any value from the CVRs will be contingent solely upon our

ability to monetize all or any part of our current business or all or any part of our intellectual property or technology through

a Legacy Monetization within the time periods specified in the CVR Agreement and the consideration received being greater than

the amounts permitted to be retained or deducted by us (including the success bonus contemplated by the CVR Agreement) under the

CVR Agreement.

There is currently no third-party sale or transaction involving RP-G28 planned or contemplated and there is no

guarantee that we will be able to find a buyer or strategic partner for these assets, particularly in light of our failed Liberatus

Phase 3 clinical trial.

If a Legacy Monetization is not achieved within the time periods specified in the CVR Agreement or the

consideration received is not greater than the amounts permitted to be retained or deducted by us, no payments will be made under

the CVR Agreement, and the CVRs will expire valueless.

Qualigen has agreed to commit up to $350,000 to support our pursuit of

a Legacy Monetization, subject to reductions.

the Effective Time, neither Ritter nor Qualigen will have any obligation to develop RP-G28, or to expend any effort or resources

to divest or otherwise monetize RP-G28.

If the up to $350,000 (or any such reduced amount) is insufficient to fund the expenses

incurred in connection with a Legacy Monetization, neither Ritter nor Qualigen will have any obligation to provide further funding.

the CVRs will be unsecured obligations of the combined company and all payments under the CVRs, all other obligations under the

CVR Agreement and the CVRs and any rights or claims relating thereto will be subordinated in right of payment to the prior payment

in full of all current or future senior obligations of the combined company.

tax treatment of the CVRs is uncertain.

There is no authority directly on point addressing the U.S.

federal income tax treatment

of contingent value rights with characteristics similar to the CVRs.

Therefore, it is possible that the issuance of the CVRs may

be treated as a distribution of equity with respect to our stock, as an “open transaction,”

or as a “debt instrument”

federal income tax purposes, and such questions are inherently factual in nature.

have incurred losses since inception, and we anticipate that we will continue to incur losses for the foreseeable future.

net losses were $10.1 million for the year ended December 31, 2019.

As of December 31, 2019, we had an accumulated deficit of

$80.3 million.

These losses, among other things, have had and will continue to have an adverse effect on our stockholders’

equity and working capital.

We expect to continue to incur significant expenses and increased operating losses for the foreseeable

have financed our operations primarily through the issuance and sale of common stock and warrants in public and private offerings,

and have devoted substantially all of our financial resources and efforts on research and development, including clinical development

However, in September 2019 we announced that our Liberatus Phase 3 clinical trial

of RP-G28 for LI failed to demonstrate statistical significance in its pre-specified primary and secondary endpoints.

failure of the Liberatus Phase 3 clinical trial to achieve its endpoints has significantly depressed our stock price and has severely

harmed our ability to raise additional capital and to secure potential collaborative, partnering or other strategic arrangements

for its RP-G28 assets, and consequently, our prospects to continue as a going concern have been severely diminished.

become and remain profitable, we must develop and eventually commercialize a product with market potential, which would require

us to raise additional capital.

Currently, we have no ongoing collaborations for the development and commercialization of RP-G28

or any other product candidate and have limited sources of revenue.

If the merger is not completed and we are unable to raise

sufficient additional funds for the continued development of our RP-G28 program, whether through potential collaborative, partnering

or other strategic arrangements or otherwise, or if we otherwise determine to discontinue the development of our RP-G28 program,

we will likely determine to cease operations.

if we are able to raise additional funds to permit the continued development of RP-G28 or another product candidate, if we and/or

any potential collaborators are unable to develop and commercialize RP-G28 or another product candidate, if development is further

delayed or is eliminated, or if sales revenue from any product upon receiving marketing approval, if ever, is insufficient, we

may never become profitable and it will not be successful.

are substantially dependent on our remaining employees to facilitate the consummation of the merger.

of the date of this Annual Report, we have only five full-time employees.

Our ability to successfully complete the merger depends

in large part on our ability to retain our remaining personnel.

Despite our efforts to retain these employees, one or more may

terminate their employment with us on short notice.

The loss of the services of these employees could potentially harm our ability

to consummate the merger, to run our day-to-day business operations, and to continue to fulfill our reporting obligations as a

public company.

pendency of the merger could have an adverse effect on the trading price of our common stock and our business, financial condition

and prospects.

pendency of the merger could disrupt our business in many ways, including:

attention of our remaining management and employees may be directed toward the completion of the merger and related

matters and may be diverted from our day-to-day business operations;

parties may seek to terminate or renegotiate their relationships with us as a result of the merger, whether pursuant

to the terms of their existing agreements with us or otherwise.

occurrence of these events or others resulting from the proposed merger could adversely affect the trading price of our

common stock or harm its business, financial condition and prospects.

Related to Regulatory Approval Status of RP-G28 and Ongoing Regulatory Requirements if the Merger is not Completed

business has been entirely dependent on the success of RP-G28, our only product candidate.

The failure of RP-G28 to demonstrate

statistical significance in its pre-specified primary and secondary endpoints in our Liberatus Phase 3 clinical trial has severely

diminished our prospects to continue as a going concern.

If the merger is not completed, we may seek to recommence the development

and commercialization of RP-G28 as either a prescription drug (which may require the filing of a new IND), or explore its potential

development as an OTC product or a dietary supplement for the consumer healthcare industry, which would, in any case, require

significant additional funding.

If we are unable to obtain funding for and to advance the development of RP-G28, we would likely

be required to cease operations.

Even if we are able to obtain funding for and to advance the development of RP-G28 (as either

a prescription drug, OTC product or dietary supplement), we may never receive marketing approval for, or successfully commercialize,

RP-G28 for any indication.

currently have only one product candidate, RP-G28, previously in clinical development as a prescription drug, and our business

has depended on RP-G28’s successful clinical development, regulatory approval and commercialization.

In September 2019,

we announced that our Liberatus Phase 3 clinical trial of RP-G28 for lactose intolerance failed to demonstrate statistical significance

in its primary and secondary endpoints.

failure of the Liberatus trial to achieve its primary and secondary endpoints has significantly depressed our stock price and

has severely harmed our ability to raise additional capital and to secure potential collaborative, partnering or other strategic

arrangements for our RP-G28 assets, and consequently, our prospects to continue as a going concern have been severely diminished.

the Effective Time, neither Ritter nor Qualigen will have any obligation to continue the development of RP-G28, or to expend

any funds or efforts with respect to RP-G28.

Pursuant to the terms of the CVR Agreement, Qualigen has agreed to commit up to $350,000

(subject to possible reduction pursuant to the terms of the Merger Agreement) to support our continued pursuit of a Legacy

Monetization.

If the up to $350,000 (or any such reduced amount) is insufficient to fund the expenses incurred in connection with

a Legacy Monetization, however, neither Ritter nor Qualigen will have any obligation to provide further funding.

if we were to obtain the additional funding necessary to advance the development of RP-G28 (as a prescription drug, OTC

product or dietary supplement), including through a strategic partnership, the process for obtaining regulatory approval

or completing the regulatory process necessary to commercialize RP-G28 could be extensive and lengthy.

There can be no guarantee

that we would ever obtain the regulatory approvals or the regulatory hurdles necessary to commercialize RP-G28 in these

commercialize RP-G28 as a prescription drug or OTC product,

we will need to demonstrate to the FDA the safety and efficacy of RP-G28 for its intended use.

Additional clinical testing

is expensive, time consuming and uncertain as to outcome.

OTC drugs must generally either receive premarket approval by the FDA

through the NDA process or conform to a “monograph”

for a particular drug category, as established by the FDA’s

OTC Drug Review.

These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective,

and not misbranded.

Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs

is finalized as a regulation.

However, once the FDA has made a final determination on the status of an OTC drug category, such

products must either be the subject of an approved NDA or comply with the appropriate monograph for an OTC drug.

can be given that RP-G28 may be sold as an OTC drug product under and NDA or under the FDA’s OTC monograph product regulations.

Of the large number of drugs in development in the United States, only a small percentage of drugs successfully complete the FDA

regulatory process and are commercialized.

Accordingly, even if we are able to complete development of RP-G28, we

cannot assure you that RP-G28 will ever be commercialized.

the merger is not completed, we may also seek to explore the development and commercialization of RP-G28 as a dietary supplement.

A dietary supplement is a product taken by mouth that contains a “dietary ingredient”

intended to supplement the diet.

The “dietary ingredients”

in these products may include:

vitamins, minerals, herbs or other botanicals, amino acids,

and substances such as enzymes, organ tissues, glandulars, and metabolites.

Dietary supplements can also be extracts or concentrates,

and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders.

Whatever their form may be,

the Dietary Supplement Health and Education Act (“DSHEA”) places dietary supplements in a special category under the

general umbrella of “foods,”

not drugs, and requires that every supplement be labeled a dietary supplement.

created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA, a firm is responsible for

determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about

them are substantiated by adequate evidence to show that they are not false or misleading.

This means that dietary supplements

do not need approval from the FDA before they are marketed.

Except in the case of a new dietary ingredient, where pre-market review

for safety data and other information is required by law, a firm does not have to provide the FDA with the evidence it relies

on to substantiate safety or effectiveness before or after it markets its products.

is a >95% purified GOS, product derived from a commercially available GOS food ingredient, which is designated as “generally

recognized as safe”

(“GRAS”) by the FDA.

In 2016, the FDA published an updated draft guidance, which is intended,

among other things, to help manufacturers and distributors of dietary supplement products determine when they are required to

file with the FDA a New Dietary Ingredient (“NDI”), notification with respect to a dietary supplement product.

this draft guidance, the FDA highlighted the necessity for marketers of dietary supplements to submit NDI notifications as an

important preventive control to ensure that consumers are not exposed to potential unnecessary public health risks in the form

of new ingredients with unknown safety profiles.

Ritter cannot provide any assurance that if it decided to pursue RP-G28 as a

dietary supplement, it would not be required to submit an NDI notification.

If the FDA were to conclude that we should

have filed an NDI notification, then we could be subject to enforcement actions by the FDA.

Such enforcement actions could

include product seizures and injunctive relief being granted against us, any of which would harm its business.

or more stringent regulations of dietary supplements and other products have been considered from time to time.

In recent years,

there has been increased pressure in the United States and other markets to increase regulation of dietary supplements.

New regulations,

or new interpretations of those regulations, could impose additional restrictions, including requiring reformulation of some products

to meet new standards, recalls or discontinuance of some products not able to be reformulated, additional record-keeping requirements,

increased documentation of the properties of some products, additional or different labeling, additional scientific substantiation,

additional adverse event reporting, or other new requirements.

may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require it to be

taken off the market, require us to include safety warnings or otherwise limit sales.

the merger is not completed and we elect to recommence the development and commercialization of RP-G28 as a prescription

drug (which may require the filing of a new IND) or explore its potential development as an OTC product or a dietary supplement

for the consumer healthcare industry, and we are able to obtain the necessary funding for such development, the detection

of any undesirable side effects could delay or prevent marketing approval or commercialization.

Alternatively, if we are

able to identify and secure a Legacy Monetization for RP-G28, and undesirable side effects of RP-G28 are later identified, we

could face seller liability.

were no notable differences observed between placebo-treated subjects and RP-G28-treated subjects in the Phase 3 clinical trial.

However, unforeseen side effects from RP-G28 could arise at any time during clinical development or, if approved, after RP-G28

has been marketed.

Any undesirable or unacceptable side effects associated with RP-G28 could interrupt, delay or halt clinical

trials, and result in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities, and could

impact our ability to attract potential third-party collaborators, or could result in our facing seller liability

in the event RP-G28 is sold to another party.

if we receive regulatory approval for RP-G28, we may still face future development and regulatory difficulties.

if approved (as either a prescription drug or OTC product) or launched as a dietary supplement, will be subject to ongoing regulatory

requirements for labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market

In addition, products, manufacturers and manufacturers’

facilities are required to comply with extensive FDA

and EMA requirements and requirements of other similar agencies, including ensuring

that quality control and manufacturing procedures conform to applicable current good manufacturing practice (“cGMPs”),

whether governing drugs or dietary supplements.

Accordingly, we and others with whom we works must continue to expend time, money

and effort in all areas of regulatory compliance, including manufacturing, production and quality control.

We will also be required

to report certain adverse reactions and production problems, if any, to the FDA and EMA and other similar agencies and to comply

with certain requirements concerning advertising and promotion for its products.

Promotional communications with respect to prescription

drugs are subject to a variety of legal and regulatory restrictions by the FDA and must be consistent with the information in

the product’s approved label.

Accordingly, we may not promote its approved products, if any, for indications or uses for

which they are not approved.

Similarly, the U.S.

Federal Trade Commission (the “FTC”) exercises jurisdiction over

the advertising of OTC product and dietary supplements and has instituted numerous enforcement actions against OTC product and

supplement companies for failure to have adequate substantiation for claims made in advertising or for the use of false or misleading

advertising claims.

Our failure to comply with applicable regulations could result in substantial monetary penalties, which could

have a material adverse effect on our financial condition or results of operations.

a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or

frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling

of a product, it may impose restrictions on that product or us, including requiring withdrawal of the product from the

If RP-G28, or any product candidate we develop in the future, fails to comply with applicable regulatory requirements,

a regulatory agency may:

warning letters;

modifications to promotional materials or require us to provide corrective information to healthcare practitioners;

us or our potential future collaborators to enter into a consent decree or permanent injunction, which can include

imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for

noncompliance;

other administrative or judicial civil or criminal penalties;

investment in our common stock involves risks.

You should carefully consider the risks described below, together with all of the other

information included in this Annual Report, as well as in our other filings with the SEC, in evaluating our business.

If any of the following

risks actually occur, our business, financial condition, operating results and future prospects could be materially and adversely affected.

In that case, the trading price of our common stock may decline and you might lose all or part of your investment.

The risks described

below, which are the risks we judge (rightly or wrongly) to be the most significant to investors, are not the only ones we face.

risks that we currently do not judge to be among the “most significant” may also impair our business, financial condition,

operating results and prospects.

statements below are forward-looking statements.

For additional information, see the section of this Annual Report under the caption

“Cautionary Note Regarding Forward-Looking Statements.”

Related to Our Therapeutics and Diagnostics Pipeline

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

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

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

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

become profitable, if ever (financial risk).

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

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

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

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

There can be no assurance

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

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

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

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

or impose other business and financial restrictions on us.

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

venture, or partnership arrangements to provide long term capital.

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

product candidates are still in the early stages of development.

We have not begun clinical trials or obtained regulatory approval for

any drug candidate or STARS.

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

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

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

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

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

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

completion of preclinical studies and clinical trials;

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

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

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

● 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;

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;

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

● 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.

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

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

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

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

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

vary adversely from our expectations.

and device development involves a lengthy and expensive process.

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

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

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

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

in humans or will obtain marketing approval.

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

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

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

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

The outcome of preclinical testing and early

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

do not necessarily predict final results.

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

candidates or STARS, 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 and STARS may produce negative or inconclusive results, and

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

clinical trials or abandon product development programs;

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

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

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

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

● 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 or STARS for various

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

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

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

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

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

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

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

We do not know whether any of our planned preclinical studies or clinical trials will begin on a timely basis or at all, will need to

be restructured or will be completed on schedule, or at all.

For example, the FDA may place a partial or full clinical hold on any of

our clinical trials for a variety of reasons.

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

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

our drug candidates or STARS.

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

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

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

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

body) must approve the application.

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

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

We cannot guarantee the timing for submitting the IND application for

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

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

clinical studies to demonstrate safety and efficacy.

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

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

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

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

down our development and approval process and jeopardize our ability to commence product sales and generate revenues.

We do not know

whether our planned trials will begin on time or at all, or be completed on schedule, if at all.

The commencement and completion of clinical

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;

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;

to clinical trial protocol;

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

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

combination therapies for use in clinical trials;

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;

of adequate funding to continue the clinical trial;

experiencing severe or unexpected drug-related adverse effects;

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, STARS 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;

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

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

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs/ECs of the institutions in which such trials

are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA.

Such authorities may impose such a suspension or

termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or

our clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical

hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using the product under investigation,

changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes.

Amendments may require us to resubmit our clinical trial protocols to IRBs/ECs for reexamination, which may impact the costs, timing

or successful completion of a clinical trial.

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

approval could be delayed or prevented.

may not be able to initiate or continue our ongoing or planned clinical trials for our products if we are unable to identify and enroll

a sufficient number of eligible patients to participate in these trials as required by the FDA.

In addition, some of our competitors

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

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

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

of the patients.

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

one or more clinical trials altogether.

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

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

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

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.

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

to abandon or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics

are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for our

products, if approved.

We may also be required to modify our study plans based on findings in our clinical trials.

Many drug candidates

that initially showed promise in early stage testing have later been found to cause side effects that prevented further development.

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

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

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

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

undetected in previous trials, will be reported by patients.

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

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

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

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

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

are subject to extensive regulation.

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.

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

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

This approval process generally requires clinical data to support the safety

and effectiveness of the device.

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

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, QN-247, RAS-F, STARS or any other 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.

to approve pending applications or supplements to approved applications filed by us or our potential future

collaborators;

restrictions on operations, including costly new manufacturing requirements;

seize and/or condemn and destroy products.

we market products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws,

we may be subject to civil or criminal penalties.

addition to FDA and FTC restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare

laws, commonly referred to as “fraud and abuse”

laws, have been applied in recent years to restrict certain marketing

practices in the pharmaceutical and supplement industry.

Other jurisdictions such as Europe have similar laws.

These laws include

false claims and anti-kickback statutes.

If we market our products and our products are paid for by governmental programs, it

is possible that some of our business activities could be subject to challenge under one or more of these laws.

false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the

federal government or knowingly making, or causing to be made, a false statement to get a false claim paid.

The federal healthcare

program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving

remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare

item or service covered by Medicare, Medicaid or other federally financed healthcare programs.

This statute has been interpreted

to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers or formulary managers

on the other.

Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities

from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce

prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

states also have statutes or regulations similar to the federal anti-kickback law and federal false claims laws, which apply to

items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the payor.

Administrative,

civil and criminal sanctions may be imposed under these federal and state laws.

the past few years, a number of pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety

of promotional and marketing activities, such as:

providing free trips, free goods, sham consulting fees and grants and other

monetary benefits to prescribers;

reporting inflated average wholesale prices that were then used by federal programs to set reimbursement

engaging in off-label promotion;

and submitting inflated best price information to the Medicaid Rebate Program to reduce

liability for Medicaid rebates.

Related to Dependence on Third Parties

collaborative arrangements that we establish in the future may not be successful or we may otherwise not realize the anticipated

benefits from these collaborations.

In addition, any future collaborative arrangements may place the development and commercialization

of our product candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable

the merger with Qualigen is not completed, we may continue to seek partnering, collaborative or similar strategic arrangements

with third parties to develop and commercialize RP-G28 either as a prescription drug or OTC product or as a dietary supplement,

but we may be unsuccessful in locating a third-party collaborator to develop and market RP-G28.

If we are able to locate a third-party

collaborator, the collaboration may not be successful or we may otherwise not realize the anticipated benefits from such collaboration.

on collaborative arrangements subjects us to a number of risks, including:

may not be able to control the

amount and timing of resources that our potential collaborators may devote to RP-G28;

collaborations may experience financial difficulties or changes in business focus;

may be required to relinquish important rights such as

marketing and distribution rights;

a collaborator fail to develop or commercialize RP-G28, we may not receive any future milestone payments and will not

receive any royalties for RP-G28;

combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s

willingness or ability to complete its obligations under any arrangement;

certain circumstances, a collaborator could move forward with a competing product candidate developed either independently

or in collaboration with others, including our competitors;

collaborative

arrangements are often terminated or allowed to expire, which could delay the development and may increase the cost of developing

delay or disruption in the manufacture and supply of any product may negatively impact our operations.

do not intend to manufacture any product that is offered for sale.

We currently have an agreement with RSM, our contract manufacturer,

for the production of Improved GOS, the active pharmaceutical ingredient in RP-G28, and the formulation of sufficient quantities

of Improved GOS for the clinical and nonclinical studies that we believe we will need to conduct prior to seeking regulatory approval

for RP-G28 if we decide to pursue the development of RP-G28.

However, we do not have agreements for commercial supplies of RP-G28

and we may not be able to reach agreement with RSM or any other contract manufacturer for sufficient supplies to commercialize

RP-G28 if it is approved or any other product candidate we may develop in the future.

on third-party manufacturers entails risks, to which we would not be subject if it manufactured its products itself, including:

possibility that we are unable to enter into a manufacturing agreement with third parties to manufacture RP-G28 or

any other product candidate we may develop in the future;

possible breach of the manufacturing agreements by third parties because of factors beyond our control;

possible termination or nonrenewal of manufacturing agreements by the third parties before we are able to arrange for

a qualified replacement third-party manufacturer.

of these factors could cause the delay of approval or commercialization of RP-G28 or any other product candidate we may develop

in the future (in the event the merger is not completed), or cause us to incur higher costs.

Furthermore, if RP-G28 or another

product candidate is approved and contract manufacturers fail to deliver the required commercial quantities of finished product

on a timely basis and at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable

of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would

likely be unable to meet demand for our product and could lose potential revenue.

It may take several years to establish an alternative

source of supply for RP-G28 or any other product candidate and to have any such new source approved by the government agencies

that regulate our products.

In the event we do need to identify alternative manufacturing partners, we may have to secure licenses

to manufacturing and/or purification technologies, including third-party patent licenses, to allow us to manufacture RP-G28 or

any other product candidate that is suitable for the late-stage regulatory review process and/or adequate to manufacture commercial

quantities for such product candidate.

have historically depended on third-party contractors for a substantial portion of our operations and may not be able to control

our work as effectively as if we performed these functions itself.

the merger is not completed and we elect to continue the clinical development of RP-G28 (as either a prescription drug, OTC product

or dietary supplement) we will continue to outsource substantial portions of our operations to third-party service providers,

including the conduct of preclinical studies and clinical trials, collection and analysis of data, and manufacturing.

Our agreements

with third-party service providers and contract research organizations (“CROs”) are on a study-by-study and project-by-project

Typically, we may terminate the agreements with notice and would be responsible for the supplier’s previously incurred

In addition, any CRO that we retain will be subject to the FDA’s and EMA’s regulatory requirements and similar

standards outside of the United States and Europe and we do not have control over compliance with these regulations by these providers.

Consequently, if these providers do not adhere to applicable governing practices and standards, the development and commercialization

of our product candidates could be delayed or stopped, which could severely harm our business and financial condition.

we have relied on third parties, our internal capacity to perform these functions is limited to management oversight.

these functions involves the risk that third parties may not perform to our standards, may not produce results in a timely manner

or may fail to perform at all.

Although we have not experienced any significant difficulties with its third-party contractors,

it is possible that we could experience difficulties in the future.

In addition, the use of third-party service providers requires

us to disclose its proprietary information to these parties, which could increase the risk that this information will be misappropriated.

There are a limited number of third-party service providers that specialize or have the expertise required to achieve its business

Identifying, qualifying and managing performance of third-party service providers can be difficult, time consuming

and cause delays in our development programs.

We currently have a small number of employees, which limits the internal resources

we have available to identify and monitor third-party service providers.

To the extent we are unable to identify, retain and successfully

manage the performance of third-party service providers in the future, our business may be adversely affected, and we may be subject

to the imposition of civil or criminal penalties if their conduct of clinical trials violates applicable law.

Reimbursement

decisions by third-party payors may have an adverse effect on pricing and market acceptance.

If there is not sufficient reimbursement

for RP-G28, it is less likely that it will be widely used.

the event we are able to obtain the additional funding necessary to advance the clinical development of RP-G28, and RP-G28 is

ultimately approved for sale by the applicable regulatory authorities, market acceptance and sales of RP-G28 will depend on reimbursement

policies and may be affected by, among other things, future healthcare reform measures.

Government authorities and third-party

payors, such as private health insurers and health maintenance organizations, decide which drugs they will cover and establish

payment levels.

We cannot be certain that reimbursement will be available for RP-G28.

Also, we cannot be certain that reimbursement

policies will not reduce the demand for, or the price paid for, our products.

If reimbursement is not available or is available

on a limited basis, we may not be able to successfully commercialize RP-G28.

the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the “MMA”), changed

the way Medicare covers and pays for pharmaceutical products.

The legislation established Medicare Part D, which expanded Medicare

coverage for outpatient prescription drug purchases by the elderly but provided authority for limiting the number of drugs that

will be covered in any therapeutic class.

The MMA also introduced a new reimbursement methodology based on average sales prices

for physician-administered drugs.

Any negotiated prices for our products covered by a Part D prescription drug plan would

likely be lower than the prices it might otherwise obtain in the United States.

Moreover, while the MMA applies only to drug

benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their

own payment rates.

Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental

United States and several other jurisdictions are considering, or have already enacted, a number of legislative and regulatory

proposals to change the healthcare system in ways that could affect our ability to sell its products profitably.

policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare

systems with the stated goals of containing healthcare costs, improving quality and/or expanding access to healthcare.

United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by

major legislative initiatives.

If RP-G28 is ultimately approved for sale by the applicable regulatory authorities, we expect

that it would experience pricing pressures in connection with the sale of RP-G28, due to the trend toward managed healthcare,

the increasing influence of health maintenance organizations and additional legislative proposals.

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010

(collectively, the “ACA”), enacted in March 2010, is a sweeping law intended to broaden access to health insurance,

reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements

for healthcare and health insurance industries, impose new taxes and fees on health industry and impose additional health policy

With regard to pharmaceutical products, among other things, the ACA is expected to expand and increase industry rebates

for drugs covered under Medicaid programs and make changes to the coverage requirements under Medicare Part D program.

it is too early to determine the full effect of the ACA, the law appears likely to continue the pressure on pharmaceutical pricing,

especially under the Medicare program, and may also increase our regulatory burdens and operating costs.

Since its enactment,

there have been judicial and Congressional challenges to certain aspects of the ACA.

Congress and President Trump have expressed

their intentions to repeal and replace the ACA.

President Trump issued an Executive Order and both chambers of Congress passed

bills, all with the goal of fulfilling their intentions.

However, to date, the Executive Order has had limited effect and the

Congressional activities have not resulted in the passage of a law.

If a law is enacted, many if not all of the provisions of

the ACA may no longer apply to prescription drugs.

Related to the Commercialization of RP-G28 or Any Other Product Candidate Developed by Us in the Future in the Event the

Merger is not Completed

product approved for sale by the applicable regulatory authorities, or launched as an OTC product without the need for regulatory

approval, may not achieve broad market acceptance among physicians, patients and healthcare payors, and as a result our

revenues generated from sales of any such product may be limited.

commercial success of any product we launch will depend upon its acceptance among the medical community, including physicians,

health care payors and patients.

The degree of market acceptance of a product will depend on a number of factors, including:

or warnings contained in our product candidates’

labeling, including FDA-approved labeling;

in the standard of care or availability of alternative therapies at similar or lower costs for the targeted indications for

such product candidates;

in the approved clinical indications or intended use for such product;

clinical safety and efficacy compared to other products;

of significant adverse side effects;

marketing and distribution support;

of reimbursement from managed care plans and other third-party payors;

of market introduction and perceived effectiveness of competitive products;

degree of cost-effectiveness;

of alternative therapies at similar or lower cost, including generics and OTC products;

extent to which a product candidate is approved for inclusion on formularies of hospitals and managed care organizations;

a product candidate is designated under physician treatment guidelines for the treatment of or reduction of symptoms associated

with the indications for which we have received regulatory approval;

publicity about a product candidate or favorable publicity about competitive products;

and ease of administration of a product candidate;

product liability claims.

RP-G28 or any other product candidate we develop is approved by the applicable regulatory authorities (or launched without

the need for regulatory approval), but does not achieve an adequate level of acceptance by physicians, patients, the medical community

and healthcare payors, sufficient revenue may not be generated from its sales and we may not become or remain profitable.

In addition, efforts to educate the medical community and third-party payors on the benefits of any product candidate may require

significant resources and may never be successful.

OTC drug business is subject to significant competitive pressures.

the merger is not completed, we may continue to seek partnering, collaborative or similar strategic arrangements with third parties

to develop and commercialize RP-G28 as an OTC product.

The OTC healthcare product industry, however, is highly competitive.

participants in this industry have substantially greater capital resources, technical staffs, facilities, marketing resources,

product development, and distribution experience than we do.

We believe that our ability to compete in the OTC healthcare product

industry will depend on a number of factors, including product quality and price, availability, speed to market, consumer marketing,

reliability, credit terms, brand name recognition, delivery time and post-sale service and support.

However, our failure to appropriately

and timely respond to consumer preferences and demand for new products could significantly harm its business, financial condition

and results of operations.

Furthermore, unfavorable publicity or consumer perception of products we develop and commercialize

could have a material adverse effect on our business and operations.

There can be no assurance that we would be able to compete

successfully in this highly competitive OTC industry.

If we are unable to compete effectively, our earnings would be significantly

negatively impacted.

have no internal sales, distribution and/or marketing capabilities and we would have to invest significant resources to develop

those capabilities or enter into acceptable third-party sales and marketing arrangements in the event the merger is not completed

and we decide to continue operations.

have no internal sales, distribution and/or marketing capabilities

at this time.

To develop these capabilities, we would need to invest significant amounts of financial and management resources,

some of which may need to be committed prior to any confirmation that a particular product candidate will be approved.

could also face a number of additional risks, including:

or our third-party sales collaborators may not be able

to attract and build an effective marketing or sales force;

cost of securing or establishing a marketing or sales force may exceed the revenues generated by the product candidate;

direct sales and marketing efforts may not be successful.

may have limited or no control over the sales, marketing and distribution activities of third parties.

Its future revenues could

depend heavily on the success of the efforts of third parties.

Relating to Our Intellectual Property if the Merger is not Completed

our patent position does not adequately protect our product candidates, others could compete against us more directly, which would

harm our business, possibly materially.

commercial success will depend in part on obtaining, maintaining and enforcing patent protection and on developing, preserving

and enforcing current trade secret protection.

In particular, it will depend in part on our ability to obtain, maintain and enforce

patents, especially those directed to methods of using our products and those directed to the methods used to develop and manufacture

our products, as well as successfully defending these patents against third-party challenges.

Our ability to stop third parties

from making, using, selling, offering to sell or importing our products depends on the extent to which we have rights under valid

and enforceable patents (and/or trade secrets) that cover these activities.

We cannot be sure that patents will be granted with

respect to any of its pending patent applications or with respect to any patent applications it files in the future, nor can we

be sure that any of its existing patents or any patents that may be granted to it in the future will withstand subsequent challenges

to their validity, enforceability, and/or patentability, or if they will be commercially useful in protecting our product candidates,

discovery programs and processes.

Furthermore, we cannot be sure that our existing patents and patent applications will embrace

(or “claim”) the particular uses for RP-G28 or any other product candidate that may be approved by the FDA.

Our inability

to protect our patents, would also likely impact our ability to attract potential third-party collaborators.

patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions

for which important legal principles remain unresolved.

consistent policy regarding the patentability and/or validity of patent claims related to pharmaceutical patents has emerged,

to date, in the United States or in most jurisdictions outside of the United States.

Changes in either the patent laws (be they

substantive or procedural) or in the interpretations of patent laws in the United States and other countries may diminish the

value of our intellectual property.

Accordingly, we cannot predict the breadth of any claims that will issue or will be enforceable

in the patents that have or may be issued from the patents and applications we currently own or may in the future own or license

from third parties.

Further, if any patents we obtain, or to which we obtain licenses, are deemed invalid, unpatentable and unenforceable,

our ability to commercialize or license our technology could be adversely affected.

the future others may file patent applications directed to products, uses for products, and manufacturing techniques and related

technologies that are similar, identical or competitive to our or important to our business.

We cannot be certain that any patent

or patent application owned by a third-party will not have priority over patent applications filed or in-licensed by us in the

future, or that we or our licensors will not be involved in interference, opposition, inter partes review or invalidity proceedings

patent offices or courts.

degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection

and may not adequately protect its rights or permit us to gain or keep its competitive advantage.

may be able to develop a platform similar to, or better than, ours in a way that does not infringe our patents;

may be able to make compounds that are similar to our product candidates but that do not infringe our patents;

may be able to manufacture compounds that are similar or identical to our product candidates using processes that do not infringe

our method of making patents;

may obtain regulatory approval for uses of compounds, similar or identical to our product, that do not infringe our pharmaceutical

composition patents or our method of use patents;

may not be able to obtain licenses for patents that are essential to the process of making the product;

might not have been the first to make the inventions claimed in its issued patents and pending patent applications;

might not have been the first to file patent applications for these inventions;

may independently develop similar or alternative technologies or duplicate any of our technologies;

patents that we obtain may not provide us with any competitive advantages;

may not develop additional proprietary technologies that are patentable;

patents of others may have an adverse effect on our business.

directed to pharmaceutical compositions containing RP-G28 or methods of using RP-G28 expire in 2030 if the appropriate maintenance

fee renewal, annuity, or other government fees are paid, unless a patent term extension based on regulatory delay is obtained.

We expect that expiration in 2030 of some of its pharmaceutical composition and method-of-use patents directed to RP-G28 and its

use in treating lactose intolerance will have a limited impact on its ability to protect its intellectual property in the United

States, where we have additional issued patents directed to such compositions and uses that extend until 2030.

In other countries,

our issued patents and pending patent applications directed to compositions containing or methods of using RP-G28 for treating

other indications, if issued, would expire in 2030.

If we decide to pursue the continued development of RP-G28, including with

a strategic partner, we will attempt to mitigate the effect of patent expiration by seeking data exclusivity, or the foreign equivalent

thereof, in conjunction with product approval, as well as by filing additional patent applications covering improvements in its

intellectual property.

expect that the other patent applications for the RP-G28 portfolio, if issued, and if the appropriate maintenance, renewal, annuity

or other governmental fees are paid, would expire in 2030.

We own pending applications in the United States, Europe, and certain

other countries directed to uses of RP-G28 to treat a variety of disorders, including lactose intolerance.

Patent protection,

to the extent these patents issue, would be expected to extend to 2030, unless a patent term extension based on regulatory delay

to the patent laws of a country, or the decisions of a patent examiner in a country, or our own filing strategies, we may not

obtain patents directed to all of its product candidates or methods involving these candidates in the parent patent application.

We could pursue divisional patent applications or continuation patent applications in the United States and other countries to

obtain claims directed to inventions that were disclosed but not claimed in the parent patent application.

also may rely on trade secrets to protect its technology, especially where we do not believe patent protection is appropriate

However, trade secrets are difficult to protect.

Although we use reasonable efforts to protect our trade secrets,

its employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully

disclose our information to competitors.

Enforcing a claim that a third-party illegally obtained and is using any of our trade

secrets is expensive and time consuming, and the outcome is unpredictable.

In addition, courts outside the United States are sometimes

less willing to protect trade secrets.

Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

patents are not directed to RP-G28 as a composition of matter.

we own certain patents and patent applications with claims directed to specific pharmaceutical compositions and methods of using

RP-G28 to treat LI, we do not have patents directed to RP-G28 as a composition of matter in the United States or elsewhere.

a result, we may be limited in our ability to list our patents in the FDA’s Orange Book if our product or the use of our

product, consistent with its FDA-approved label, would not fall within the scope of our patent claims.

Also, our competitors may

be able to offer and sell products so long as these competitors do not infringe any other patents that we (or third parties) hold,

including patents with claims directed to the manufacture of RP-G28, pharmaceutical compositions containing RP-G28, and/or method

of using RP-G28.

In general, pharmaceutical composition patents and method of use patents are more difficult to enforce than composition

of matter patents because, for example, of the risks that FDA may approve alternative uses of the subject compounds not covered

by the method of use patents, and others may engage in off-label sale or use of the subject compounds.

Physicians are permitted

to prescribe an approved product for uses that are not described in the product’s labeling.

Although off-label prescriptions

may infringe our method of use patents, the practice is common across medical specialties and such infringement is difficult to

prevent or prosecute.

FDA approval of uses that are not covered by our patents would limit its ability to generate revenue from

the sale of RP-G28, if approved, for commercial sale.

Off-label sales would limit our ability to generate revenue from the sale

of RP-G28, if approved for commercial sale.

Any of these factors could impact our ability to attract potential third-party collaborators.

may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property

we choose to go to court to stop another party from using the inventions claimed in any patents we obtain, that individual or

company may seek a post grant review (including inter partes review) of our patents, and has the right to ask the court to rule

that such patents are invalid or should not be enforced against that third-party.

These lawsuits and administrative proceedings

are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we

were successful in stopping the infringement of such patents.

In addition, there is a risk that the court or administrative body

will decide that such patents are not valid or unpatentable and that we do not have the right to stop the other party from using

the inventions.

There is also the risk that, even if the validity/patentability of such patents is upheld, the court will refuse

to stop the other party on the ground that such other party’s activities do not infringe our patents.

In addition, the U.S.

Supreme Court and the Court of Appeals for the Federal Circuit have articulated and/or modified certain tests used by the U.S.

Patent and Trademark Office (the “USPTO”), in assessing patentability and by the courts in assessing validity and

claim scope, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood that others

may succeed in challenging any patents we obtain or license.

may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop it

from commercializing or increase the costs of commercializing our product candidates.

success will depend in part on our ability to operate without infringing the proprietary rights of third parties.

We cannot guarantee

that our products, methods of manufacture, or uses of RP-G28 (or any future product candidate), will not infringe third-party

Furthermore, a third-party may claim that we or our manufacturing or commercialization collaborators are using inventions

covered by the third-party’s patent rights and may go to court to stop us from engaging in our normal operations and activities,

including making or selling its product candidates.

These lawsuits are costly and could affect our results of operations and divert

the attention of managerial and scientific personnel.

There is a risk that a court would decide that we or our commercialization

collaborators are infringing the third-party’s patents and would order us or our collaborators to stop the activities covered

by the patents.

In that event, we or our commercialization collaborators may not have a viable way around the patent and may need

to halt commercialization of the relevant product.

In addition, there is a risk that a court will order us or our collaborators

to pay the other party damages for having violated the other party’s patents.

In the future, we may agree to indemnify our

commercial collaborators against certain intellectual property infringement claims brought by third parties.

The pharmaceutical

and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including

Ritter, which patents cover various types of products or methods of use.

The scope of coverage of a patent is subject to interpretation

by the courts, and the interpretation is not always uniform.

we are sued for patent infringement, the patentee would need to demonstrate, by a preponderance of the evidence that our products

or methods infringe the patent claims of the relevant patent, and we would need to demonstrate either that we do not infringe

or, by clear and convincing evidence, that the patent claims are invalid;

we may not be able to do this.

Proving invalidity is

For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome

the presumption of validity enjoyed by issued patents.

Even if we are successful in these proceedings, we may incur substantial

costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect

If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, which may not be

available, defend an infringement action or challenge the validity or enforceability of the patents in court.

Patent litigation

is costly and time consuming.

We may not have sufficient resources to bring these actions to a successful conclusion.

if we do not obtain a license, develop or obtain non-infringing technology, otherwise fail to defend an infringement action successfully

or have a court hold that any patent we infringe is invalid or unenforceable, we may incur substantial monetary damages, encounter

significant delays in bringing its product candidates to market and may be precluded from manufacturing or selling its product

cannot be certain that others have not filed patent applications for technology claimed in its pending applications, or that we

were the first to invent the technology, because:

patent applications in the United States may be maintained in secrecy until the patents are issued;

applications in the United States are typically not published until at least 18 months after the earliest asserted priority

in the scientific literature often lag behind actual discoveries.

competitors may have filed, and may in the future file, patent applications directed to technology similar to ours.

Any such patent

application may have priority over our patent applications, which could further require us to obtain rights to issued patents

directed to such technologies.

If another party has filed a U.S.

patent application on inventions similar to ours, we may have

to participate in an interference proceeding declared by the USPTO to determine priority of invention in the United States.

costs of these proceedings could be substantial, and it is possible that such efforts would be unsuccessful if, unbeknownst to

us, the other party had independently arrived at the same or similar invention prior to our own invention, resulting in a loss

patent position with respect to such inventions.

Other countries have similar laws that permit secrecy of patent applications,

and other parties may be entitled to priority over our applications in such jurisdictions.

of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have

substantially greater resources.

In addition, any uncertainties resulting from the initiation and continuation of any litigation

could have a material adverse effect on our ability to raise the funds necessary to continue its operations or to attract potential

third-party collaborators.

and maintaining our patent portfolio depends on compliance with various procedural, document submission, fee payment and other

requirements imposed by governmental patent agencies, and our patents could be deemed abandoned or eliminated for non-compliance

with these requirements.

maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to

be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime

of the patents and/or applications.

We employ an outside firm to pay fees due to non-U.S.

patent agencies and this outside firm

has systems in place to ensure compliance on payment of fees.

The USPTO and various non-U.S.

governmental patent agencies require

compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured

by payment of a late fee or by other means in accordance with the applicable rules.

However, there are situations in which noncompliance

can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights

in the relevant jurisdiction.

In such an event, our competitors might be able to enter the market and this circumstance would

have a material adverse effect on our business.

Furthermore, our inability to protect its patents, would also likely impact its

ability to attract potential third-party collaborators.

may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology

and products could be significantly diminished.

is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology

or pharmaceutical companies, including competitors or potential competitors.

We may be subject to claims that these employees,

or that we, have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against these claims.

Even if we were successful in defending against these claims, litigation

could result in substantial costs and be a distraction to management.

have relied on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is

appropriate or obtainable.

However, trade secrets are difficult to protect.

We have also relied in part on confidentiality agreements

with our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade

secrets and other proprietary information.

These agreements may not effectively prevent disclosure of confidential information

and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.

In addition, others

may independently discover our trade secrets and proprietary information.

For example, the FDA, as part of its Transparency Initiative,

is currently considering whether to make additional information publicly available on a routine basis, including information that

we may consider to be trade secrets or other proprietary information, and it is not clear at the present time how the FDA’s

disclosure policies may change in the future, if at all.

Costly and time-consuming litigation could be necessary to enforce and

determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect

our competitive business position.

to secure trademark registrations could adversely affect our business.

have not developed a trademark for our RP-G28 product.

Hence, we do not currently own any actual or potential trademark rights

associated with our RP-G28 product.

If we seek to register any trademarks in the future, our trademark applications may not be

allowed for registration or our registered trademarks may not be maintained or enforced.

During trademark registration proceedings,

we may receive rejections.

Although we would be given an opportunity to respond to those rejections, we may be unable to overcome

such rejections.

In addition, in the USPTO and in comparable agencies in many other jurisdictions, third parties are given an

opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.

Opposition or cancellation proceedings

may be filed against our trademarks, and our trademarks may not survive such proceedings.

If we do not secure registrations for

our trademarks, we may encounter more difficulty in enforcing them against third parties than we otherwise would.

Relating to Our Business and Strategy if the Merger is not Completed

the merger is not completed and we decide to continue our operations and the development of RP-G28 as either a prescription drug,

OTC product or dietary supplement, we will face competition from other biotechnology and pharmaceutical companies and our operating

results will suffer if we fail to compete effectively.

we know of no other drug candidates in advanced clinical trials for treating lactose intolerance, the biotechnology and pharmaceutical

industries are intensely competitive and subject to rapid and significant technological change.

If the merger is not completed

and we decide to continue our operations and the development of RP-G28 as either a prescription drug, OTC product or dietary supplement,

we would have potential competitors in the United States, Europe and other jurisdictions, including major multinational pharmaceutical

companies, established biotechnology companies, specialty pharmaceutical and generic drug companies and universities and other

research institutions.

Many of these potential competitors have greater financial and other resources, such as larger research

and development staff and more experienced marketing and manufacturing organizations.

Large pharmaceutical companies, in particular,

have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical

These companies also have significantly greater research, sales and marketing capabilities and collaborative arrangements

in our target markets with leading companies and research institutions.

Established pharmaceutical companies may also invest heavily

to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates

that we develop obsolete.

a result of all of these factors, these potential competitors may succeed in obtaining patent protection and/or FDA approval or

discovering, developing and commercializing drugs for the diseases that we would target before we do.

Smaller or early-stage companies

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

Some of the pharmaceutical and biotechnology companies we could compete with include microbiome-based development companies:

Genome, Inc., Seres Health, Inc., Enterome SA, Vedanta Biosciences, Inc., and Rebiotix Inc.

In addition, many universities and

private and public research institutes may become active in our target disease areas.

These potential competitors may succeed

in developing, acquiring or licensing on an exclusive basis, technologies and drug products that are more effective or less costly,

which could render our products obsolete and noncompetitive.

believe that our ability to successfully compete will depend on, among other things:

ability to commercialize and market any product candidates

approved for sale;

efficacy, safety and reliability of any product candidates approved for sale;

price of any product candidates approved for sale;

levels of reimbursement under private and governmental health insurance plans, including Medicare;

ability to protect intellectual property rights related

to any product candidates approved for sale;

ability to manufacture and sell commercial quantities

of any product candidates approved for sale to the market;

of any product candidates approved for sale by physicians and other health care providers.

our competitors market products that are more effective, safer or less expensive, or that reach the market sooner than any of

our product candidate approved for sale, we may not achieve commercial success.

In addition, the biopharmaceutical industry is

characterized by rapid technological change.

Because our research approach integrates many technologies, it may be difficult for

us to stay abreast of the rapid changes in each technology.

If we fail to stay at the forefront of technological change, we may

be unable to compete effectively.

Technological advances or products developed by our competitors may render our technologies

or product candidates obsolete, less competitive or not economical.

the merger is not completed and we are able to raise the additional funds necessary to pursue the continued development of RP-G28

(either as a prescription drug, OTC product or dietary supplement), we will need to expand our operations and increase the size

of its company, and we may experience difficulties in managing growth.

the merger is not completed and we are able to raise the additional funds necessary to pursue the continued development of RP-G28

(either as a prescription drug, OTC product or dietary supplement), we will need to increase its product development, scientific

and administrative headcount to manage the development and commercialization of our product candidates.

If we are unable to successfully

manage this growth and increased complexity of operations, our business may be adversely affected.

may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants.

we are not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience

constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital

and its ability to implement our business strategy.

There is also a risk that other obligations could distract our officers and

employees from its business, which could have negative impact on our ability to effectuate its business plans.

to hire and retain consultants from a limited pool is intense.

Further, because these advisors are not our employees, they may

have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us, and typically

they will not enter into non-compete agreements with us.

If a conflict of interest arises between their work for us and their

work for another entity, we may lose their services.

In addition, our advisors may have arrangements with other companies to assist

those companies in developing products or technologies that may compete with ours.

the merger is not completed and we decide to pursue the development of RP-G28 as either a prescription drug, OTC product or dietary

supplement, we may face product liability exposure, and if successful claims are brought against us, we may incur substantial

liability for a product candidate and may have to limit its commercialization.

use of our product candidates in clinical trials and the sale of any products for which we may obtain marketing approval expose

us to the risk of product liability claims.

Product liability claims may be brought against us or our potential future collaborators

by participants enrolled in its clinical trials, patients, health care providers or others using, administering or selling its

If we cannot successfully defend ourselves against any such claims, we would incur substantial liabilities.

of merit or eventual outcome, product liability claims may result in:

of clinical trial participants;

of clinical trial sites or entire trial programs;

of related litigation;

monetary awards to patients or other claimants;

demand for our product candidates and loss of revenues;

of our business reputation;

of management and scientific resources from our business operations;

inability to commercialize our product candidates.

have product liability insurance coverage for our clinical trials in the United States and in selected other jurisdictions where

we intends to conduct clinical trials at levels we believe are sufficient and consistent with industry standards for companies

at our stage of development.

However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for

any expenses or losses we may suffer.

Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we

may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due

to product liability.

We intend to expand our insurance coverage for products to include the sale of any commercial products for

which we obtain marketing approval, but we may be unable to obtain commercially reasonable product liability insurance for any

products approved for marketing.

Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated

side effects.

A successful product liability claim or series of claims brought against us, particularly if judgments exceed our

insurance coverage, could decrease our cash resources and adversely affect our business.

insurance policies are expensive and only protect

it from some business risks, which will leave us exposed to significant uninsured liabilities.

do not carry insurance for all categories of risk that our business may encounter.

Some of the policies we currently maintain

include general liability ($2.0 million coverage), employment practices liability, workers’

compensation, and directors’

and officers’

insurance at levels we believe are typical for a company in our industry and at our stage of development.

We currently carry clinical trial liability insurance for our clinical trials at levels we believe are sufficient and consistent

with industry standards for companies at our stage of development.

We do not know, however, if we will be able to maintain insurance

with adequate levels of coverage.

Any significant uninsured liability may require us to pay substantial amounts, which would adversely

affect our financial position and results of operations.

Relating to Our Capital Stock

active trading market for our common stock may not develop or be sustained.

active trading market in our common stock may not develop or, if developed, may not be sustained.

The lack of an active market

may impair your ability to sell your shares at the time you wish to sell them or at a price that you consider reasonable.

lack of an active market may also reduce the fair market value of our common stock.

An inactive market may also impair our ability

to raise capital to continue to fund operations by selling shares and may impair our ability to acquire other companies or technologies

by using our shares as consideration.

share price has been and may continue to be volatile, which could subject us to securities class action litigation and prevent

our stockholders from being able to sell their shares at or above their purchase price.

market price of shares of Ritter common stock could be subject to wide fluctuations in response to many risk factors listed in

this section, and others beyond Ritter’s control, including:

ability to consummate

the transactions contemplated by the Merger Agreement, including the merger;

ability to raise

sufficient additional funds necessary for the continued development of RP-G28 (as a prescription

drug, OTC product or dietary supplement), in the event we decide

to continue development of RP-G28, whether through potential collaborative, partnering

or other strategic arrangements or otherwise, and the terms and timing of any future

collaborative, licensing or other strategic arrangements that we may establish;

ability to realize

any value from the sale of its RP-G28 assets, in the event we decide to sell or

license RP-G28 to a third-party;

ability to maintain

our listing on the Nasdaq Capital Market;

of clinical trials of our competitors’

actions with respect to our products or Ritter’s competitors’

or anticipated fluctuations in our financial condition and operating results;

or anticipated changes in our growth rate relative to our competitors;

or anticipated fluctuations in our competitors’

operating results or changes

in their growth rate;

from existing products or new products that may emerge;

announcements

by us, our potential future collaborators or its competitors of significant acquisitions,

strategic collaborations, joint ventures, or capital commitments;

of new or updated research or reports by securities analysts;

in the valuation of companies perceived by investors to be comparable to us;

trading volume levels of our shares;

or departures of key management or scientific personnel;

or other developments related to proprietary rights, including patents, litigation matters

and our ability to obtain patent protection for our technologies;

or expectation of additional financing efforts;

of our common stock by us, our insiders or our other stockholders;

conditions for biopharmaceutical stocks in general;

economic and market conditions.

the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market

prices of equity securities of many companies.

These fluctuations often have been unrelated or disproportionate to the operating

performance of those companies.

These broad market and industry fluctuations, as well as general economic, political and market

conditions such as recessions, interest rate changes or international currency fluctuations, may negatively impact the market

price of shares of our common stock.

In addition, such fluctuations could subject us to securities class action

litigation, which could result in substantial costs and divert our management’s attention from other business concerns,

which could seriously harm our business.

securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business,

our share price and trading volume could decline.

trading market for our common stock will depend on the research and reports that securities or industry analysts publish about

us or our business.

We do not have any control over these analysts.

There can be no assurance that analysts will cover us or provide

favorable coverage.

If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our

share price would likely decline.

If one or more of these analysts cease coverage of us or fail to regularly publish reports on

us, we could lose visibility in the financial markets, which could cause its share price or trading volume to decline.

sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline,

even if our business is doing well.

by our stockholders of a substantial number of shares of our common stock in the public market could occur in the future.

sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could

reduce the market price of our common stock.

may sell up to approximately $8.0 million of our shares of common stock under our at-the-market (“ATM Agreement”)

sales agreement with A.G.P./Alliance Global Partners (“AGP”).

The sale of a substantial number of shares of our common

stock pursuant to the ATM Agreement, or anticipation of such sales, could cause the trading price of our common stock to decline

or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might

otherwise desire.

However, we may terminate the financing arrangement at any time at our discretion without any penalty or cost

of options or warrants or conversion of convertible securities may have a dilutive effect on your percentage ownership and may

result in a dilution of your voting power and an increase in the number of shares of common stock eligible for future resale in

the public market, which may negatively impact the trading price of our shares of common stock.

exercise or conversion of some or all of our outstanding options, warrants, or convertible securities (or, after the merger, the

issuance of equity awards under the Ritter 2020 Plan) could result in significant dilution in the percentage ownership interest

of our stockholders and in a significant dilution of voting rights and earnings per share.

Additionally,

the issuance of shares of our common stock upon exercise of stock options outstanding under our stock incentive plans will further

dilute our stockholders’

voting interests.

To the extent options and/or warrants and/or conversion rights are exercised,

additional shares of common stock will be issued, and such issuance will dilute stockholders.

are an “emerging growth company”

and will be able to avail itself of reduced disclosure requirements applicable to emerging growth companies, which could make

our common stock less attractive to investors.

are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act (the “JOBS Act”),

and rely on certain exemptions from various reporting requirements that are applicable to other public companies that are not

“emerging growth companies”

including not being required to comply with the auditor attestation requirements of Section

404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and

proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder

approval of any golden parachute payments not previously approved.

We cannot predict if investors will find our common stock less

attractive because we may rely on these exemptions.

If some investors find our common stock less attractive as a result, there

may be a less active trading market for our common stock and our stock price may be more volatile.

(and the combined company following the merger) may take advantage of these reporting exemptions until we are no longer an “emerging

growth company.”

We will remain an emerging growth company until December 31, 2020, the last day of the fiscal year following

the fifth anniversary of the date we completed our initial public offering, after which time the combined company will no longer

be entitled to rely on the exemptions available to emerging growth companies.

failure to meet the continued listing requirements

of Nasdaq could result in a delisting of our common stock and the termination of the Merger Agreement by Qualigen.

August 19, 2019, we received a written notice from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5550(b)(1),

as our stockholders’

equity, as reported in our Quarterly Report on Form 10-Q for the period ended June 30, 2019, was below

$2.5 million, which is the minimum stockholders’

equity required for compliance with Rule 5550(b)(1).

As of August 19, 2019,

we also did not satisfy the conditions for the alternative market value of listed securities standard for continued listing or

the net income standard for continued listing.

were given until October 3, 2019 to submit a plan to regain compliance, which, if accepted by Nasdaq, could have resulted in us

being granted an extension of up to 180 calendar days from the date of the original notice of noncompliance, or until February

15, 2020, to demonstrate compliance with Nasdaq Listing Rule 5550(b)(1).

October 28, 2019, we received a second written notice from Nasdaq indicating that, because the closing bid price for our common

stock had been below $1.00 per share for 30 consecutive business days, we no longer complied 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.

We were given until April 27, 2020, to regain compliance with the Minimum Bid Price Requirement.

To regain compliance, the closing

bid price of our common stock would need to meet or exceed $1.00 per share for a minimum of 10 consecutive business days during

the 180-calendar day grace period.

November 21, 2019, we received a letter from the Listing Qualifications Department of Nasdaq, notifying us that Nasdaq had determined

to delist our common stock pursuant to Nasdaq’s discretionary authority under Listing Rule 5101, based on our failure to

comply with the above described continued listing requirements and its belief that we do not have any current operating business.

The letter stated that, unless we appealed Nasdaq’s determination and requested a hearing on the matter by the applicable

deadline, trading of our common stock on the Nasdaq Capital Market would be suspended at the opening of business on December 3,

2019 and a Form 25-NSE would be filed with the SEC.

appealed Nasdaq’s determination and a hearing was held on January 16, 2020, at which we submitted our compliance plan to

The plan identified the Merger Agreement as a “change of control”

transaction under Nasdaq Rule 5110(a) and

indicated that upon filing the Registration Statement, we would file a Change of Control Application with Nasdaq via the Nasdaq

Listing Center.

The compliance plan also formally requested, on behalf of Ritter, and its proposed partner, Qualigen, that an

exception through May 19, 2020 to complete the merger and provide evidence of compliance with all applicable requirements for

Initial Listing on the Nasdaq Capital Market be made, which request has been granted by Nasdaq.

terms of the Merger Agreement provide that the Merger Agreement may be terminated by Qualigen if we fail to maintain our listing

If our common stock is delisted, we would expect our common stock to be traded in the OTC market, which could adversely

affect the liquidity of our common stock.

Additionally, we could face significant material adverse consequences, including:

limited availability of market quotations for our common stock;

decreased ability to issue additional securities and a concomitant substantial impairment

in our ability to obtain sufficient additional capital to fund its operations

and to continue as a going concern;

liquidity for our stockholders;

loss of confidence by employees and potential future partners or collaborators;

and loss of institutional investor interest

and fewer business development opportunities.

in our corporate charter documents and under Delaware law could make an acquisition of Ritter, which may be beneficial to our

stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

in our Certificate of Incorporation and our Bylaws may discourage, delay or prevent a merger, acquisition or other change in control

that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares.

These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock,

thereby depressing the market price of our common stock.

In addition, because our board of directors is responsible for appointing

the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove

our current management by making it more difficult for stockholders to replace members of our board of directors.

things, these provisions provide that:

authorized number of directors can be changed only by resolution of our board of directors;

Bylaws may be amended

or repealed by our board of directors or our stockholders;

may not call special meetings of the stockholders or fill vacancies on the board of directors;

board of directors is authorized to issue, without stockholder approval, preferred stock,

the rights of which will be determined at the discretion of the board of directors and

that, if issued, could operate as a “poison pill”

to dilute the stock ownership

of a potential hostile acquirer to prevent an acquisition that our board of directors

does not approve;

stockholders do not have cumulative voting rights, and therefore our stockholders holding

a majority of the shares of common stock outstanding will be able to elect all of our

stockholders must comply with advance notice provisions to bring business before or nominate

directors for election at a stockholder meeting.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL, which prohibits a person

who owns in excess of 15% of our outstanding voting stock from merging or combining with Ritter for a period of three years after

the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or

combination is approved in a prescribed manner.

for indemnification by our directors and officers may reduce our available funds to satisfy successful stockholder claims against

us and may reduce the amount of money available to us.

permitted by Section 102(b)(7) of the DGCL, our Certificate of Incorporation limits the liability of our directors to the fullest

extent permitted by law.

In addition, as permitted by Section 145 of the DGCL, our Certificate of Incorporation and our Bylaws

provide that we shall indemnify, to the fullest extent authorized by the DGCL, each person who is involved in any litigation or

other proceeding because such person is or was a director or officer of Ritter or is or was serving as an officer or director

of another entity at our request, against all expense, loss or liability reasonably incurred or suffered in connection therewith.

Our Certificate of Incorporation provides that the right to indemnification includes the right to be paid expenses incurred in

defending any proceeding in advance of its final disposition, provided, however, that such advance payment will only be made upon

delivery to us of an undertaking, by or on behalf of the director or officer, to repay all amounts so advanced if it is ultimately

determined that such director is not entitled to indemnification.

If we do not pay a proper claim for indemnification in full

within 60 days after we receive a written claim for such indemnification, except in the case of a claim for an advancement of

expenses, in which case such period is 20 days, our Certificate of Incorporation and our Bylaws authorize the claimant to bring

an action against us and prescribe what constitutes a defense to such action.

145 of the DGCL permits a corporation to indemnify any director or officer of the corporation against expenses (including attorney’s

fees), judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with any action, suit or

proceeding brought by reason of the fact that such person is or was a director or officer of the corporation, if such person acted

in good faith and in a manner that he reasonably believed to be in, or not opposed to, the best interests of the corporation,

and, with respect to any criminal action or proceeding, if he or she had no reason to believe his or her conduct was unlawful.

In a derivative action, ( i.e.

, one brought by or on behalf of the corporation), indemnification may be provided only for

expenses actually and reasonably incurred by any director or officer in connection with the defense or settlement of such an action

or suit if such person acted in good faith and in a manner that he or she reasonably believed to be in, or not opposed to, the

best interests of the corporation, except that no indemnification shall be provided if such person shall have been adjudged to

be liable to the corporation, unless and only to the extent that the court in which the action or suit was brought shall determine

that the defendant is fairly and reasonably entitled to indemnity for such expenses despite such adjudication of liability.

rights conferred in our Certificate of Incorporation and Bylaws are not exclusive, and we are authorized to enter into indemnification

agreements with our directors, officers, employees and agents and to obtain insurance to indemnify such persons.

We have entered

into indemnification agreements with each of our officers and directors.

above limitations on liability and our indemnification obligations limit the personal liability of our directors and officers

for monetary damages for breach of their fiduciary duty as directors by shifting the burden of such losses and expenses to us.

Although we plan to increase the coverage under our directors’

and officers’

liability insurance, certain liabilities

or expenses covered by our indemnification obligations may not be covered by such insurance or the coverage limitation amounts

may be exceeded.

As a result, we may need to use a significant amount of our funds to satisfy our indemnification obligations,

which could severely harm our business and financial condition and limit the funds available to stockholders who may choose to

bring a claim against us.

the merger will result in an ownership change under Section 382 of the Code for Ritter, our pre-merger net operating loss carryforwards

and certain other tax attributes will be subject to limitation or elimination.

The net operating loss carryforwards and certain

other tax attributes of Qualigen and of the combined company may also be subject to limitations as a result of ownership changes.

a corporation undergoes an “ownership change”

within the meaning of Section 382 of the Code, the corporation’s

net operating loss carryforwards and certain other tax attributes arising before the ownership change are subject to limitations

on use after the ownership change.

In general, an ownership change occurs if there is a cumulative change in the corporation’s

equity ownership by certain stockholders that exceed 50 percentage points by value over a rolling three-year period.

Similar rules

may apply under applicable state income tax laws.

While we have not performed a detailed analysis of limitations on the use of

our existing net operating loss carry forwards and certain other tax attributes arising before the ownership change, the merger

will result in an ownership change for Ritter and, accordingly, our net operating loss carryforwards and certain other tax attributes

will be subject to limitation and possibly elimination after the merger.

The merger may, if part of a cumulative change in Qualigen’s

equity ownership by certain stockholders that exceeds 50 percentage points by value over a rolling three-year period, limit Qualigen’s

net operating loss carryforwards and certain other tax attributes.

Additional ownership changes in the future could result in

additional limitations on Ritter’s, Qualigen’s and the combined company’s net operating loss carryforwards and

certain other tax attributes.

Consequently, even if the combined company achieves profitability, it may not be able to utilize

a material portion of Ritter’s, Qualigen’s or the combined company’s net operating loss carryforwards and certain

other tax attributes, which could have a material adverse effect on cash flow and results of operations.

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.

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

pancreatic cancer, AML and pediatric neuroblastoma.

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

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

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

regulatory review or approval process.

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

research and preclinical studies.

If these third parties do not satisfactorily carry out their contractual duties, fail to comply with

applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased

costs or we may be unable to obtain regulatory approval.

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

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

delays to our development programs.

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

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

for preclinical studies related to QN-302.

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

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

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

Manufacturing

pharmaceutical products is complex and subject to product loss for a variety of reasons.

We contract with third parties for the manufacture

of our product candidates for preclinical testing and clinical trials and expect to continue to do so for commercialization.

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.

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.

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

Even if we are able to establish

agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

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;

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.

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

We acquire many key materials on a purchase order

As a result, we do not have long-term committed arrangements with respect to our product candidates and other materials.

obtain regulatory approval for any of our product candidates, we will need to establish an agreement for commercial manufacture with

a third-party.

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

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

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.

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

pharmaceutical companies and biotechnology companies.

We face significant competition in seeking appropriate collaborators.

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

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

number of factors.

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

that such collaborators dedicate to the development or commercialization of our products.

Our ability to generate revenues from these

arrangements will depend on our collaborators’ abilities and efforts to successfully perform the functions assigned to them in

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 and device therapeutics products is highly competitive.

We face competition from

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

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

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

that may be effective in developing therapeutics.

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

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

Potential competitors also include

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

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

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

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

use of current therapeutics and therapeutics in development;

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

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

cancer itself.

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, QN-247, RAS-F and STARS are likely

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

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

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

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

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

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

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

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

In addition to patent protection, we also rely

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

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

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

to achieve profitability.

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

methods of manufacture and use.

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

We may not be able

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

in all jurisdictions.

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

it is too late to obtain patent protection.

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

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

the patents, covering technology licensed from third parties.

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

be found invalid and unenforceable or will be threatened by third parties or whether any issued patents will effectively prevent others

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.

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 technology and products or limit the duration

of the patent protection of our technology and products.

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,

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

Even if our patent applications issue

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

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

Our competitors and other third parties may be able to

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

Our competitors and

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

Alternatively,

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

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

In these circumstances,

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

In any of these types

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

competing in a non-infringing manner.

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

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

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 Our Diagnostics Business

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

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

terms of our distribution agreement with Sekisui.

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

distribution agreement with Sekisui expires on March 31, 2022.

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

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

In addition, there is the

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

diagnostic products face heavy competition.

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

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

Many of our competitors have substantially greater financial,

technical, research and other resources and capabilities.

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

newer blood testing systems for use in physician offices.

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

developments by others.

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

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

healthcare industry and elsewhere is cost containment.

Third-party payors have attempted to

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

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

attempts to maintain and grow our diagnostics business.

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

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

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

During the Transition

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

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

have largely ceded our overseas diagnostics business to Yi Xin.

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

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

We would receive royalties

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

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

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

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

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

Wajdi Abdul-Ahad, our Chief Scientific Officer

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

Tariq Arshad, MD, our Chief Medical

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

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

clinical, regulatory, manufacturing and management skills and experience.

We may not be able to attract or retain qualified personnel

in the future.

Many of the companies against which we compete have greater financial and other resources, different risk profiles and

a longer history in the industry than we do.

Our competitors may provide higher compensation, more diverse opportunities and/or better

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 25, 2022 , we had 46 employees, 39 of whom were full-time employees.

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

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

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

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

direct sales personnel.

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

into sales, marketing and distribution.

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

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

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

The expansion of our

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

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

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

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

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

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

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

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

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

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

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

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

time to time, we may consider strategic transactions, such as acquisitions of companies, businesses or assets and out-licensing or in-licensing

of products, drug candidates or technologies.

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

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

and investments.

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

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

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

to unknown liabilities;

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;

to retain key employees of any acquired businesses.

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.

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 from our issued “exploding warrants” (and change

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

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

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

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

or position as a practical matter.

have a substantial amount of derivative securities outstanding.

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

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

Outstanding stock

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

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

any cyber security incidents, could harm our ability to operate our business effectively and result in a material disruption of our product

development programs.

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

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

Outside parties may attempt to penetrate our systems or

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

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

cyber-attacks or other system failures.

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

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

to possibly requiring substantial expenditures of resources to remedy.

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

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

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

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

to the conflict.

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

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

product candidates may be delayed.

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

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

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

and credibility could be damaged.

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

information systems or networks.

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

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

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

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

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

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

and world economy, health care systems, personnel availability,

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

Those impacts may be especially serious for smaller companies

such as Qualigen.

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

Our sales of diagnostic products

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

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

In 2021 we experienced some recovery in demand, but this

phenomenon ma y

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

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

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

business continuity activities as needed.

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

to expend excessive costs.

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

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.

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

disruptive problems.

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

in a material disruption in our operations.

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

errors or omissions, and malfeasance.

Despite our efforts to protect against cyber-attacks and security breaches, hackers and other cyber

criminals are using increasingly sophisticated and constantly evolving techniques, and we may need to expend substantial additional resources

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

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

operational duties.

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

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

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

increased costs or loss of revenue.

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

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

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 conflict between Russia and Ukraine, the withdrawal of the United Kingdom from the

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

Such challenges have caused, and may continue to

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

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

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

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

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

In connection with the audit

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

in our controls as discussed in Part 9.A.

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

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

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

Any failure to develop or

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

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

Moreover, effective

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

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

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

In addition, investors relying

upon this misinformation could make an uninformed investment decision, and we could be subject to sanctions or investigations by the

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

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

fully remediate such material weakness.

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

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

Unresolved Staff Comments.

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

Legal Proceedings.

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

in this Annual Report is incorporated herein by reference.

Mine Safety Disclosures.

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

What changed 10-K

Item 1A. Risk Factors