What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2022-03-31 compared with 2020-03-31 · 587 added, 1022 removed, 2 unchanged (100% of the section changed)

were formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC.

Since our inception,

we have focused on the development of therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases.

Our only product candidate, RP-G28, is an orally administered, high purity galacto-oligosaccharide (“GOS”), for the

treatment of lactose intolerance (“LI”), a condition that affects millions of people worldwide.

RP-G28 is designed

to selectively stimulate the growth of lactose-metabolizing bacteria in the colon, thereby effectively adapting the gut microbiome

to assist in digesting lactose (the sugar found in milk) that reaches the large intestine.

first prototype LI product, Lactagen ™

an alternative LI treatment method with a mechanism of action similar to RP-G28.

In 2004, clinical testing was conducted with

Lactagen, which included a 61-subject double-blind placebo controlled clinical trial.

The results were published in the Federation

of American Societies for Experimental Biology in May 2005.

early 2008, we initiated a prescription drug development program by developing RP-G28, an improved, second-generation version

of Lactagen, based on the belief that if we were successful in gaining approval from the U.S.

Food and Drug Administration

(“FDA”), we would be able to make stronger claims of both efficacy and safety, garner more medical community support

and reach a wider market in the effort to treat LI.

November 2010, we were awarded a grant from the United States government’s Health Care Bill program, the Qualifying

Therapeutic Discovery Project, to help fund the development of RP-G28.

This grant program provides support for innovative

projects that are determined by the U.S.

Department of Health and Human Services to have reasonable potential to result in new

therapies that treat areas of unmet medical need and/or prevent, detect or treat chronic or acute diseases and conditions.

November 2011, we completed a Phase 2a clinical trial of RP-G28.

Positive trends were seen when the entire per protocol

study population was analyzed, including some statistically significant subgroup.

The combined data demonstrated proof of concept

and suggested that RP-G28 administration produced a positive therapeutic effect.

RP-G28 was also well tolerated with no significant

study-drug related adverse effects.

October 2016, we completed a Phase 2b multi-center, randomized, double-blind, placebo-controlled, parallel group trial

Topline results of the trial were announced in March 2017.

Results showed a clinically meaningful benefit to subjects

in the reduction of LI symptoms across a variety of outcome measures.

The majority of analyses showed positive outcome measures

and the robustness of the data point to a clear drug effect.

Treatment patients not only reported meaningful reduced symptoms,

but also 30 days after taking the treatment, patients reported adequate relief from LI symptoms and satisfaction with the results

of the treatment, with RP-G28 preventing or treating their LI symptoms.

Greater milk and dairy product consumption was also reported

August 2017, we held an End-of-Phase 2 meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products.

purpose of the meeting was to obtain the FDA’s feedback on our Phase 3 program.

We reached general consensus with the FDA

on certain elements of our Phase 3 program and clear guidance and recommendations on many necessary components of our Phase 3

including the clinical, non-clinical, and chemistry, manufacturing and controls (“CMC”) requirements needed

to support a new drug application (“NDA”) submission.

June 2018, we initiated the first pivotal Phase 3 clinical trial of RP-G28.

Called “Liberatus”, this study

was to determine the efficacy, safety and tolerability of RP-G28 to treat LI when compared to placebo.

The study was a multicenter,

randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States.

Trial enrollment exceeded expectations,

concluding with approximately 557 subjects randomized.

More than 30 U.S.

sites participated in the study.

The protocol design

included a 2-week screening period that included one week of study drug administration, a randomized 30-day study drug treatment

period and a 90-day “real world experience”

period to assess study drug response and durability of effect after treatment

as patients consumed their normal diets including dairy products.

The primary endpoint of the study was the mean change in LI

symptom composite score 30-days post-treatment compared to baseline.

Secondary endpoints were to examine the safety, tolerability

and meaningfulness of treatment benefit with RP-G28 and the durability of effect of treatment with RP-G28 on reduction of LI symptoms

after real-world lactose exposure.

The study utilized the prior validated symptom assessment measure and patient questionnaires

to capture relevant outcomes.

In addition, risk-based data review was used to monitor and assess potential protocol deviations

and site quality indicators.

completed enrollment of our Liberatus Phase 3 clinical trial of RP-G28 in March 2019 and last patient visit in July 2019.

2019, we announced that our Phase 3 clinical trial of RP-G28 for LI failed to demonstrate statistical significance in its pre-specified

primary and secondary endpoints.

On October 7, 2019,

we announced publicly that we had engaged A.G.P./Alliance Global Partners (“AGP”) as a financial advisor to explore

and evaluate potential strategic alternatives, as we continued to analyze the results of the trial to better understand the data

and clinical outcome to assess a path forward for RP-G28.

All further development efforts for RP-G28 have been suspended, until

such time as we determine a path forward.

January 15, 2020, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Qualigen, pursuant

to which a wholly-owned subsidiary of Ritter (the “Merger Sub”) will merge with and into Qualigen, with Qualigen surviving

as a wholly-owned subsidiary of Ritter Pharmaceuticals, Inc.

(“Ritter”)

the merger is consummated, the combined company does not intend to continue the clinical development of RP-G28.

Pursuant to the

terms of the Merger Agreement, at the Effective Time, Ritter, John Beck, as the initial CVR Holders’

Representative, and

Andrew Ritter, in his capacity as a consultant to Ritter, will enter into the CVR Agreement, pursuant to which, each Ritter Stockholder

of record as of immediately prior to the Effective Time (after giving effect to the exercise of any outstanding Ritter stock options

or warrants and the conversion of any outstanding Ritter preferred stock, but not to be adjusted for any reverse split to be effected

in connection with the merger) will receive one CVR for each share of Ritter capital stock held by such stockholder, entitling

the holder to receive the net proceeds, if any, from a Legacy Monetization that is entered into during the period beginning on

the date the Merger Agreement was signed and ending on the third anniversary of the closing date of the Merger.

Under the CVR

Agreement, the combined company agreed to commit up to $350,000 (subject to reduction pursuant to the terms of the Merger Agreement)

for certain expenses to be incurred by Ritter in pursuing and closing any Legacy Monetization.

The CVRs will not be transferable

by the CVR Holders, except in certain limited circumstances, will not be certificated or evidenced by any instrument, will not

accrue interest and will not be registered with the SEC or listed for trading on any exchange.

The CVRs will terminate on the

CVR Termination Date.

No payments with respect to the CVRs will be payable in respect of any Legacy Monetization proceeds actually

received after the CVR Termination Date by Ritter.

From and after the CVR Termination Date, any further proceeds received by Ritter

arising from any Legacy Monetization will be retained by Ritter and will not be distributed to the CVR Holders.

may not be successful in completing the merger.

If the merger is not completed, we may seek to pursue the development and commercialization

of RP-G28 as either a prescription drug, OTC product or dietary supplement for the consumer healthcare industry, which would,

in any case, require significant additional funding.

If we are unable to obtain funding for the development of RP-G28, whether

through potential collaborative, partnering or other strategic arrangements or otherwise, we will likely be required to cease

Risk Factors—Our business has been entirely dependent on the success of RP-G28, its only product

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 a prescription drug (which may require

the filing of a new investigational new drug (“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.”

Gut Microbiome

human gut is a relatively under-explored ecosystem providing an opportunity for using dietary intervention strategies to reduce

the impact of digestive disorders and gastrointestinal disease.

The human body carries about 100 trillion microorganisms in the

intestines, which is 10 times greater than the number of cells in the human body.

This microbial population is responsible for

a number of beneficial activities such as fermentation, strengthening the immune system, preventing growth of pathogenic bacteria,

providing nutrients, and providing hormones.

The increasing knowledge of how these microbial populations impact human health provides

opportunities for novel therapies to treat an assortment of diseases such as neurological disease, cardiovascular disease, obesity,

irritable bowel syndrome, inflammatory bowel disease, colon cancer, allergies, autism and depression.

Intolerance (LI)

is a common condition attributed to the absence or insufficient levels of the naturally-occurring enzyme lactase in the body.

Lactase is needed to properly digest lactose, a complex sugar found in milk, milk-containing foods and other dairy products.

have suggested that LI is a widespread condition affecting over one billion people worldwide and over 40 million people in the

United States (or 15% of the U.S.

population), with an estimated nine million of those individuals demonstrating moderate to severe

Current annual spending on OTC LI aids in the United States has been estimated at approximately $2.45 billion.

these options are limited and there is no long-term treatment available.

many common gastrointestinal conditions, such as irritable bowel syndrome, inflammatory bowel diseases, gastroesophageal reflux

disease, or dyspepsia (among many others), LI symptoms can be completely abated by avoiding dietary lactose.

In this regard, LI

is an avoidance condition, similar to celiac sprue, food intolerances, or various environmental allergies.

However, dairy avoidance

may lead to inadequate calcium and vitamin D intake, which can predispose individuals to decreased bone accrual, osteoporosis,

hypertension, rickets, osteomalacia, and possibly certain cancers.

Although supplements and calcium-rich foods are available,

the 2010 National Institutes of Health conference on LI highlighted the long-term consequences of dairy avoidance demonstrating

both the importance of treating the condition and the need to find improved solutions for patients.

is often diagnosed by evaluating an individual’s clinical history, which reveals a relationship between lactose ingestion

and onset of symptoms.

Hydrogen breath tests, milk challenges and short-term dairy avoidance dieting may also be utilized to diagnose

Further tests can be conducted to rule out other digestive diseases or conditions, including stool examination to document

the presence of a parasite, blood tests to determine the presence of celiac disease, and intestinal biopsies to determine mucosal

problems leading to malabsorption, such as inflammatory bowel disease or ulcerative colitis.

evidence indicates that LI is a major factor in limiting calcium intake in the diet of individuals who are lactose intolerant.

Several studies have shown that LI patients had an average calcium intake of only 300-388 mg/day, significantly less than the

1000-1200 mg/day adult dietary recommended levels.

the 2010 National Institute of Health (“NIH”) Consensus Development Conference:

LI and Health, the NIH highlighted

numerous health risks tied to reduced calcium intake in those suffering from LI such as:

osteoporosis;

hypertension;

Adequate calcium intake is essential to reducing the risks of osteoporosis and hypertension .

In addition, chronic

calcium depletion has been linked to increased arterial blood pressure, thereby establishing a relationship between hypertension

and low calcium intake .

Moreover, there is evidence of a correlation between calcium intake and both colon and breast cancer .

is a novel, highly-purified GOS, which is synthesized enzymatically.

The product was being developed for the treatment of LI,

to be taken orally (a powder solution mixed in water) for 30 consecutive days.

The proposed mechanism of action of RP-G28 is to

selectively increase the intestinal growth and colonization of strains of bacteria that preferentially metabolize lactose to compensate

for a patient’s intrinsic inability to digest lactose.

Once this colonization of beneficial bacteria has occurred, it is

hypothesized that patients will continue to tolerate lactose so long as they maintain their beneficial microflora balance.

Galacto-oligosaccharides

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.

GOS refers to a group of compounds containing β-linkages of 1

to 6 galactose units with a single glucose on the compound’s terminal end and are found at low levels in human milk.

is purified to a pharmaceutical grade by minimizing residual glucose, lactose, galactose and other impurities.

Further processing

includes ultra-filtration, nano-filtration, decolorization, deionization, and concentration to yield GOS 95 syrup, which is the

starting material for RP-G28.

products resist hydrolysis, or chemical breakdown, by salivary and intestinal enzymes of the upper digestive system because of

the configuration of their glycosidic bonds and thus reach the colon virtually intact.

The undigested GOS enhances the growth

of beneficial, lactose-metabolizing colonic bacteria that already exist in the subject’s digestive track, including multiple

species and strains of bifidobacteria and lactobacilli.

Once colonies of these bacteria have increased, continued lactose exposure

should maintain tolerability of lactose without further exposure to RP-G28 so long as the beneficial microflora balance is maintained.

formal nonclinical studies evaluating the safety of RP-G28 have not been performed, other commercially available GOS products

have been successfully evaluated in acute and repeat-dose general toxicology studies, reproductive toxicology studies, juvenile

toxicology studies, genetic toxicology studies and in long-term safety studies.

studies of GOS products were reviewed as part of the safety evaluation to support the IND for RP-G28.

These include studies in

adults (including pregnant women and geriatrics), children, infants and newborns (preterm and full term).

The safety of GOS products

in humans has been evaluated in 1,316 adults at doses of 2.5 to 20 g/day for up to 12 months, and in 1,125 children > 1 year

of age at doses of 2.0 to 12 g/day for up to 1 year.

Overall, no safety concerns attributable to the consumption of GOS were reported.

Where side effects were observed, they were typically mild and limited to increased flatulence, abdominal discomfort, and changes

in stool consistency and frequency;

however, effects were not consistently observed in all studies.

Similar observations of increased

flatulence have been reported following the consumption fructo-oligosaccharides (FOS) (15 g/day) over a 7-day period (Alles, 1996),

and this symptom represents a localized effect that is expected in association with the consumption of indigestible fiber in large

There were no reports of events in other System Organ Class suggestive of systemic toxicity.

significance of a higher purity GOS, namely RP-G28, was highlighted in a 2010 study by Klaenhammer.

The in-vitro study concluded

that RP-G28 promoted growth of lactobacilli and bifidobacteria but did not promote multiple strains of E.

In contrast, lower

purity GOS stimulated both bifidobacteria as well as the strains of E.

coli evaluated.

As seen below in Figure 1, NCK 430 (E.

coli) grew in the presence of low purity GOS (GOS 2).

Alternatively, the higher purity GOS (RP-G28/GOS 1) did not promote the

is understood to resist hydrolysis, or chemical breakdown, by salivary and intestinal enzymes of the upper digestive system because

of the configuration of their glycosidic bonds and thus reach the colon virtually intact.

The product is then broken down intracellularly

by galactosidases, and eventually β-galactosidase hydrolyzes the terminal lactose generating a new nutrition supply for lactose

digesting bacteria strains.

This leads to selective alterations in the composition and activity of the microbiome favoring the

growth of lactose-metabolizing bacteria, including species of Bifidobacteria and Lactobacilli (30).

In our Phase 2a Clinical

Trial (G28-001), shifts in the fecal microbiome in 82% of participants on treatment and increases in relative abundance of both

Bifidobacteria and Lactobacilli were reported.

RP-G28 had a bifidogenic effect in 90% of responders, which included species Bifidobacterium

longum, Bifidobacterium adolenscentis, Bifidobacterium catenulatum, Bifidobacterium breve, and Bifidobacterium dentium (30).

understood mechanism of action is that by increasing lactose-metabolizing bacteria, less undigested lactose is fermented, and

thus reduces gas production and related LI symptoms.

Data correlating bacterial taxa and symptom metadata support this proposed

In the Phase 2a study, microbiome changes correlated with clinical outcomes of improved lactose tolerance in which

an increase in Bifidobacterium was associated with decreased pain and cramping outcomes.

Medical Needs

is a challenging condition to manage.

According to a market research study conducted by Objective Insights in April 2012, approximately

60% of lactose intolerant sufferers reported experiencing symptoms daily, or bi-weekly.

Not only can symptoms be painful and embarrassing,

they can also dramatically affect one’s quality of life, social activities, and health.

Currently there are few reliable,

or effective, treatments available that provide consistent or satisfactory relief.

there is no approved prescription treatment for LI.

Most persons with LI attempt to avoid ingestion of milk and dairy products

while others substitute non-lactose-containing foods in their diet.

However, complete avoidance of lactose-containing foods is

difficult to achieve (especially for those with moderate to severe symptoms) and can lead to significant long-term morbidity ( i.e.

dietary deficiencies of calcium and vitamin D).

generally recommend the following treatments for the management of LI:

(1) dairy avoidance;

(2) lactase supplements;

(3) probiotics/dietary

and (4) dairy substitutes/lactose free products.

Despite educating their patients on all viable treatment options,

physicians generally tend to advise their patients to refrain from consuming any dairy products whatsoever.

However, in a 2008

survey conducted by Engage Health, 47% of LI sufferers reported that this method was not effective (largely due to hidden dairy

products in ingredients), and only 30% of LI sufferers reported lactase supplements as being effective in managing their LI .

A 2019 survey conducted by Cadence Communications and Research found that while these treatment options can be effective for

mildly symptomatic patients, up to 50% of moderate to severe patients continue to experience symptoms after treatment, according

to physicians.

Further, while probiotics/dietary supplements have been demonstrated to aid and support one’s digestive system,

helping break down general foods consumed, they don’t directly help with LI.

The 2008 survey by Engage Health suggests that

the majority of LI patients are dissatisfied with current treatment options.

Unsatisfied with Current Management Options

Prevalence and Awareness

prevalence continues to increase in both the developed and developing world.

It has been estimated that gastroenterologists see

approximately 15 new patients with LI each month.

Education and awareness have increased, and diets in both the developed and

developing world have changed greatly over the past decade to include more dairy-based goods.

As the populace is growing older,

the prevalence of LI also increases because more people tend to develop LI later in life.

Increased education and diagnosis is

making more people aware of their allergies and digestive conditions.

Physicians may compound the growth of LI prevalence and

its associated disorders by recommending individuals avoid dairy products, a practice which, in and of itself, may increase severity

of the intolerance.

and Regulatory

C Meeting with the FDA

February 2013, we held a Type C meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products.

purpose of the meeting was to obtain the FDA’s feedback on the planned Phase 2 program and Phase 3 programs, inform the

FDA of our ongoing development plans, gain feedback on relevant clinical trial design and end points related to patient

meaningful benefits, and to inform the FDA of the status of our product characterization

Application/Phase 1

IND for RP-G28 was activated initially to support a Phase 2a safety, tolerability and efficacy study in lactose intolerant patients.

Standard Phase 1 single and repeat dose safety and tolerability studies in healthy volunteers were not needed because other GOS

products that contain similar GOS constituents are generally regarded as safe and therefore supported the safety of RP-G28 in

The IND was inactivated on February 21, 2020, as a result of our determination not to proceed with the clinical

development of RP-G28 in light of the anticipated merger.

2018, a Phase 1 study was conducted to understand the potential for systemic absorption of RP-G28 and any impact the presence

of food may have on the pharmacokinetic profile of RP-G28.

Additional Phase 1 studies may be required prior to any filing of an

NDA based on the results of future in-vitro studies and discussions with the FDA.

2a Clinical Trial

November 2011, we completed a double-blinded, randomized, multi-center, placebo-controlled Phase 2a clinical trial to validate

the efficacy, safety and tolerability of RP-G28 compared to placebo.

We evaluated RP-G28 in 62 patients with LI over a

treatment period of 35 consecutive days.

Post-treatment, subjects reintroduced dairy into their diets and were followed for an

additional 30 days to evaluate lactose digestion, as measured by hydrogen production and symptom improvements.

The primary endpoints

included tracking patients’

gastrointestinal symptoms via a patient-reported symptom assessment instrument (a Likert Scale,

measuring individual symptoms of flatulence, bloating, cramping, abdominal pain and diarrhea, on a scale of 0 (none) to 10 (worst))

at baseline, day 36 and day 66;

as well as the measurement of hydrogen gas levels in their breath following a 25-gram lactose

trends were seen when the entire per protocol study population was analyzed, including some statistically significant subgroup

Although there were few primary and secondary efficacy endpoints with statistically significant results, which we

believe were due to the small cohort size, the combined data suggest that RP-G28 administration produced a positive therapeutic

RP-G28 was also well tolerated with no significant study-drug related adverse effects.

clinical results of our Phase 2a study were published in Nutrition Journal in a manuscript entitled “

lactose digestion and symptoms of LI with a novel galacto-oligosaccharide (RP-G28):

a randomized, double-blind clinical trial .”

The microbiome results were published in the Proceedings of the National Academy of Science in a manuscript entitled “Impact

of short-chain galacto-oligosaccharides on the gut microbiome of lactose-intolerant individuals.”

2b Clinical Trial

March 2016, we began enrollment in a multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 2b

clinical trial to validate the efficacy, safety and tolerability of two dosing regimens of RP-G28 compared to a placebo in 368

patients with moderate to severe LI.

hundred and forty-seven (247) patients received RP-G28 while 121 patients received placebo.

Twenty-four (24) patients were discontinued

prematurely from the study and 344 (91.2%) completed the study.

trial assessed patients with LI symptoms as measured on a Likert scale after a lactose challenge.

Entry criteria in the Phase

2b trial included a hydrogen breath test to validate lactase deficiency.

The Phase 2b trial design included a screening period,

a 30-day course treatment period, and a 30-day post-treatment “real world”

observation period during which subjects

were followed while lactose containing food products were re-introduced into their diets.

The study was designed to escalate the

dose beyond the 15 gm/day dose level evaluated in the Phase 2a study.

Study subjects abstained from lactose containing food products

and were then randomized evenly (1:1:1) to receive one of two doses of RP-G28 or placebo for 30 days.

primary endpoint for the Phase 2b clinical trial was a LI symptom composite score response at day 31.

A response was based on

change from baseline (Day -7, visit 1) to end of treatment period at day 31 (visit 5), combined average of four maximum symptom

scores taken over 0.5, 1, 2, 3, 4, and 5 hours for each symptom (abdominal pain, cramping, bloating, and gas movement) after a

lactose challenge test.

A response was defined as a 4-point or greater decrease from baseline or a composite score of zero at

The Phase 2b trial further required the collection of fecal samples from patients enrolled to evaluate the baseline and

changes to the patient’s microbiome that correlate to symptom reduction and lactose tolerance.

held a Type C meeting with the FDA in March 2017, to discuss our development plans and Phase 2b clinical trial.

The focus of the

meeting was to obtain the FDA’s feedback on our Phase 2b clinical trial, including our Statistical Analysis Plan (“SAP”),

prior to unblinding any data.

results of the Phase 2b clinical trial were announced in March 2017.

Due to inconsistent data results from one study site, the

data from this site was excluded from the primary analysis population (Efficacy Subset mITT, n=296).

After excluding the data

from the one anomalous study site, results showed a clinically meaningful benefit to subjects in the reduction of LI symptoms

across a variety of outcome measures.

The majority of analyses showed positive outcome measures and the robustness of the data

point to a clear drug effect.

Treatment patients not only reported meaningful reduced symptoms, but also 30-days after taking

the treatment, patients reported adequate relief from LI symptoms and satisfaction with the results of the treatment, with RP-G28

preventing or treating their LI symptoms.

Greater milk and dairy product consumption was also reported by patients.

the Efficacy Subset mITT Analysis group, the primary endpoint met statistical significance, (39.7% of the pooled dosing group

compared to 25.8% of the placebo group responded (p=0.0159)).

Because the primary analysis was statistically significant, the

primary endpoint comparison between the high dose group and the placebo group was then tested and also met statistical significance

(38.1% of the high dose group, compared to 25.8% of the placebo group responded (p=0.0294)).

The comparison between the low dose

group and the placebo group further met statistical significance (p=0.0434).

the entire study population (mITT population), including patients from the excluded study site, taking at least one dose of drug

(n=368), the comparison between the pooled treatment groups and the placebo group narrowly missed statistical significance (p=0.0618),

(40.1% of the pooled treatment group responded compared to 31.4% of the placebo group).

Both low dose and high dose group arms

demonstrated a higher proportion of responders than the placebo group.

the Efficacy Subset Per-protocol population (Efficacy Subset PP), significant and meaningful symptom improvement was consistently

seen across key individual LI symptoms by patients reporting a ≥4-point improvement from baseline (proportion of subjects on

treatment that reported improvement in severity of each symptom).

Of the treatment patients, 56.1% reported significant improvement

in abdominal pain compared to 45.7% in the placebo group (p=0.1046).

Of the treatment patients, 54.5% reported statistically significant

improvement in cramping compared to 40.2% in the placebo group (p=0.0257).

Of the treatment patients, 55% reported statistically

significant improvement in bloating compared to 41.3% in the placebo group (p=0.0282).

Finally, 44.4% of treatment patients reported

significant improvement in gas movement compared to 32.6% in the placebo group (p=0.0599).

See Figure 4 below.

a more stringent assessment, many patients reported that they experienced complete elimination of LI symptoms, scoring a 0 out

of 10 on a Likert pain scale post-treatment (Efficacy Subset PP).

Of the treatment patients, 37.0% reported complete elimination

of abdominal pain compared to 21.7% in the placebo group (p=0.0144).

Of the treatment patients, 34.9% reported complete elimination

of cramping compared to 16.3% in the placebo group (p=0.0020).

Of the treatment patients, 29.6% reported complete elimination

of bloating compared to 16.3% in the placebo group (p=0.015).

Of the treatment patients, 16.4% reported complete elimination of

gas movement compared to 2.2% in the placebo group (p=0.0005).

Symptoms of abdominal pain, cramping, bloating and gas movement

were then combined into a composite endpoint representing the key symptoms of LI.

Of the treatment patients, 13% experienced complete

elimination of LI symptoms compared to 2% in the placebo group (p=0.004).

See Figure 5 below.

global patient-reported assessments (Efficacy Subset PP) on multiple aspects of their symptom severity and treatment benefit experience

30 days after treatment and adding dairy and milk products back into their diets, 81.9% of treatment patients reported no or mild

LI symptoms compared to 63.7% in the placebo group (p=0.0013).

Of the treatment patients, 66.3% reported being very or extremely

satisfied with RP-G28 preventing or treating their LI symptoms compared to 51.6% in the placebo group (p=0.0302).

the treatment patients, 83.2% reported adequate relief from LI symptoms compared to 72.5% in the placebo group (p=0.042).

treatment patients, 39.7% reported much or very much improvement in their LI symptoms compared to 25.3% in the placebo group (p=0.0343).

See Figure 6 below.

a real-world milk intake assessment was conducted on treatment and placebo group patients (Efficacy Subset PP).

At baseline, LI

patients reported consuming 0.2 cups/d of milk.

After RP-G28, treatment patients increased their milk consumption to 1.5 cups/d

of milk, consuming 1.3 cups/d more of milk (p=0.0084), 39% more milk consumed per day than placebo patients reported consuming

(See Figure 7 below).

We believe this is significant because the USDA recommends healthy individuals to consume 1.5 cups/d

Overall, 62% of treatment patients consumed ≥1 cups/d of milk after being treated (p=0.0095).

The increase in milk

consumption is meaningful for dairy avoiders because it reflects increased lactose tolerance and may lead to more dietary calcium

intake post-treatment as milk contains a higher percentage of one’s daily intake of calcium.

serious adverse events related to treatment were reported and the number of adverse events reported was similar between treatment

and placebo groups.

2 Meeting with the FDA

August 2017, we held an End-of-Phase 2 meeting with the FDA’s Division of Gastroenterology and Inborn Errors Products.

purpose of the meeting was to obtain the FDA’s feedback on our planned Phase 3 program.

We reached general consensus with

the FDA on certain elements of our Phase 3 program and received clear guidance and recommendations on many necessary components

of our Phase 3 program;

including the clinical, non-clinical, and CMC requirements needed to support an NDA.

We incorporated much

of this guidance into our Phase 3 program.

the established safety profile of GOS in humans and the lack of significant safety concerns with RP-G28 administered to subjects

in the Phase 2a and Phase 2b clinical trials, it was agreed with the FDA that no additional non-clinical safety studies would

be required to support continued evaluation of RP-G28 in the Phase 3 program.

The FDA also agreed that no rat fertility, rat peri-post

natal reproductive toxicity, genotoxicity or, importantly, rodent carcinogenicity studies would be needed for the NDA submission.

FDA recommended that we continue to evaluate females of child-bearing potential who are willing to use appropriate contraception

throughout the duration of any study.

ICH-compliant embryo-fetal development toxicology studies of RP-G28 in the rat and rabbit

may be needed to support an NDA submission.

Additional general toxicity studies may also need to be conducted for an NDA submission.

requirement for additional in-vitro fertility, peri-post natal reproductive toxicity, genotoxicity or carcinogenicity studies

may be reassessed by the FDA in the future based on subsequent events or changes in the agency’s NDA submission requirements.

3 Clinical Trial (“Liberatus”)

June 2018, we began enrollment in the first pivotal Phase 3 clinical trial of RP-G28, known as Liberatus.

The purpose of

this study was to determine the efficacy, safety and tolerability of RP-G28 to treat LI when compared to placebo.

The study was

a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States.

design included a two-week screening period that included one week of study drug administration, a randomized 30-day study drug

treatment period and a 90-day “real world experience”

period to assess study drug response and durability of effect

after treatment, as patients consume their normal diets including dairy products.

There was a second randomized, 30-day, study

drug treatment period to assess safety and efficacy of a repeat round of therapy.

The primary endpoint of the study was the mean

change in LI symptom composite score 30-days post-treatment compared to baseline.

Secondary endpoints were to examine the safety,

tolerability and meaningfulness of treatment benefit with RP-G28 and the durability of effect of treatment with RP-G28 on reduction

of LI symptoms after real-world lactose exposure.

The study utilized the prior validated symptom assessment measure and patient

questionnaires to capture relevant outcomes.

In addition, risk-based data review was used to monitor and assess potential protocol

deviations and site quality indicators.

March 2019, we announced that we had completed, ahead of schedule, enrollment in Liberatus.

Trial enrollment exceeded

expectations, concluding with approximately 557 subjects randomized.

More than 30 U.S.

sites participated in the study.

site enrolled more than 10.2% of the total population, and 43% of sites enrolled at least 15 subjects.

Demographics, even though

blinded, indicated a broad population distribution with gender balance and ethnic diversity.

No safety signals were reported,

which was consistent with the well-tolerated safety and tolerability profile seen in earlier clinical studies.

September 12, 2019, we announced publicly that its Liberatus Phase 3 clinical trial of RP-G28 in LI had failed to demonstrate

statistical significance in its pre-specified primary and secondary endpoints.

Top-line data from the 557-subject Phase 3 clinical

trial indicated that RP-G-28 provided significant symptom improvements in patients;

however, there was no, or little difference

compared to the placebo.

In the primary endpoint, measuring LI symptom reduction at day 61 (30 days post-treatment) compared to

baseline, the treatment group reported a 3.159 mean reduction compared to a reported 3.420 mean reduction in the placebo group

(p-value, one-sided = 0.106).

In addition, RP-G28 missed its first secondary endpoint of responders with a meaningful treatment

36.2% of treatment group compared to 34.1% of placebo group (p-value, one-sided = 0.284).

The remaining secondary endpoints

also missed statistical significance with treatment and placebo groups generally reporting similar results to each other.

was generally well-tolerated, with placebo and treatment groups reporting similar safety profiles.

In light of these results,

we also announced that we planned to continue in the near term to analyze the results of the trial to better understand

the data and clinical outcomes to assess a path forward, and publicly announced that our board of directors was conducting

a review of a range of strategic alternatives.

inactivated the IND for RP-G28 on February 21, 2020, as a

result of our determination not to proceed with the clinical development of RP-G28 in light of the anticipated merger.

are a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan

Drug designation, while also commercializing diagnostics.

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

investigational QN-302 compound is a small molecule G4 selective transcription inhibitor with strong binding affinity to G4s prevalent

in cancer cells.

Such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation.

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

the nanoparticle

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

The foundational

aptamer of QN-247 is QN-165 (formerly referred to as AS1411), which the Company has deprioritized as a drug candidate for treating

COVID-19 and other viral-based infectious diseases.

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

for preventing mutated RAS genes’ proteins from binding to their effector proteins;

preventing this binding could stop tumor growth,

especially in RAS-driven tumors such as pancreatic, colorectal and lung cancers.

Although we have no ongoing development efforts

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

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

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

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

hormone function, and vitamin D status.

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

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

We currently use our diagnostics distribution partner

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

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

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

The distribution agreement with Sekisui will

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

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

We have licensed and technology-transferred our FastPack

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

for the China diagnostics market.

of Reverse Recapitalization Transaction with Ritter Pharmaceuticals, Inc.

May 22, 2020, we completed a “reverse recapitalization” transaction with Qualigen, Inc.

(not to be confused with the Company);

pursuant to which our merger subsidiary merged with and into Qualigen, Inc.

with Qualigen, Inc.

surviving as a wholly owned subsidiary

of the Company.

The Company, which had previously been known as Ritter Pharmaceuticals, Inc., was renamed Qualigen Therapeutics, Inc.,

and the former stockholders of Qualigen, Inc.

acquired, via the recapitalization, a substantial majority of the shares of the Company.

Ritter/Qualigen Therapeutics common stock, which was previously traded on the Nasdaq Capital Market under the ticker symbol “RTTR,”

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

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

had focused before the reverse

recapitalization transaction.

Product Candidates

and Diagnostics Pipeline

lead drug compound QN-302 (formerly SOP1812) is being developed to target regulatory regions of cancer genes that down-regulate gene

expression in multiple cancer pathways.

Our anticancer

drug candidate, QN-247 (formerly referred to as ALAN or AS1411-GNP) is aptamer-based and currently in development to treat a variety

of cancer types, including liquid and solid tumors.

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

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

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

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

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

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

(formerly referred to as SOP1812)

exclusively in-licensed the global rights to the G4 selective transcription inhibitor platform from University College London (“UCL”)

in January 2022.

The licensed technology comprises lead compound QN-302 (formerly SOP1812) and

back-up compounds that target regulatory regions of cancer genes that down-regulate gene expression in multiple cancer pathways.

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

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

G4s are overrepresented

in telomeres as well as promoter sequences and untranslated regions of many oncogenes.

Their prevalence is therefore significantly greater

in cancer cells compared to normal human cells.

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

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

Stable G4-QN-302 complexes can be impediments to replication, transcription

or translation of those cancer genes containing G4s, and the drugs’ binding to G4s stabilize the G4s against possible “unwinding.”

G4 binders like QN-302 could be efficacious in a variety of cancer types with a high prevalence of G4s.

This has been supported by in-vitro

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

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

of pancreatic cancers.

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

all cancer types, with 98% of those diagnosed dying from the disease and one in four dying within the first month of diagnosis.

The chemotherapy

drug gemcitabine has been standard of care for patients with metastatic pancreatic cancer for more than 15 years.

Numerous clinical trials

have tested new drugs, either alone or in combination, with gemcitabine.

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

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

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

Likewise, QN-302 shows longer

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

Additional preclinical

studies suggest activity in gemcitabine resistant PDAC.

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

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

Early safety indicators suggest no adverse toxic effects at proposed therapeutic

doses in pancreatic cancer in-vivo models.

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

Orphan Drug status, if obtained, would

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

(formerly referred to as ALAN or AS1411-GNP)

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

QN-247 inhibits

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

QN-247 may thereby be able to inhibit the

cells’ proliferation.

QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (“AML”).

This novel technology may have several other potential applications, including enhancement of radiation therapy, enhancement of tumor

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

key component of this drug candidate, DNA aptamer QN-165, has been shown, primarily on a preclinical basis, to have the potential to

target and destroy cancer cells.

This component has been administered in Phase 1 and Phase 2 clinical trials to over 100 AML or renal

cell carcinoma cancer patients and appears to be well tolerated with no evidence of severe side effects, with at least seven patients

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

(QN-165 may also be useful

against infectious diseases – see below.)

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

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

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

Tumor-associated macrophages are a class of immune cells

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

they drive pathological phenomena including

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

In most cancers, the tumor-associated

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

Keytruda (pembrolizumab).

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

checkpoint inhibitors.

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

the overall proliferation of macrophages.

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

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

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

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

In October 2020,

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

The work being

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

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

Under the amended sponsored research

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

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

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

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

of cancer cells as a potential adjuvant therapy.

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

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

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

Pursuant to the license agreement,

we in-licensed the “RAS-F” compound family of drug candidates and will seek to identify and develop a lead drug candidate

from the compound family and, upon commercialization, will pay UofL royalties in the low-to-mid-single-digit percentages on net sales

of RAS protein-protein interaction inhibitor licensed products.

is the most common oncogene in human cancer.

Activating mutations in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS) are

present in about one-fourth of all cancers.

For example, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas, 52% of colon

cancers, and 32% of lung adenocarcinomas.

For these three cancer types, cancers with mutant KRAS are diagnosed in more than 170,000 people

each year in the United States and cause more than 120,000 deaths.

There is currently no FDA-approved direct RAS protein inhibitor

Drugs that target signaling downstream of RAS are available;

however, such drugs have shown disappointing clinical activity

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

for the many other activated pathways.

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

Under the revised

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

preclinical efforts for the RAS-F platform.

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

the treatment of cancer and infectious disease.

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

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

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

The key components of STARS, membranes coated with target

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

Proprietary STARS cartridges

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

and inflammation factors from cancer patients’ bloodstreams.

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

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

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

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

10,744,258 entitled “Devices and Methods for

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

(formerly referred to as AS1411)

June 2020, we entered into an exclusive royalty-bearing license agreement with UofL for UofL’s intellectual property for the use

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

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

patent application, entitled “Methods of inhibiting or treating coronavirus infection, and methods for delivering an anti-nucleolin

agent.” The application was filed in conjunction with Drs.

Bates and Kenneth E.

Palmer from UofL, and covers methods for

using QN-165 as an antiviral drug candidate to prevent SARS-CoV-2 from entering the body through mucous membranes in the nose, mouth

As stated in the patent application, we believe that QN-165 could be administered by means of inhalers, nose spray or eye drops

to individuals who have recently come in contact with SARS-CoV-2, or are at high risk of contracting the virus.

believe that the mechanism by which QN-165 is believed to work, by blocking the ability of viruses to replicate in the body, may also

make the drug candidate effective against future mutations in COVID-19 as well as against other dangerous viruses including seasonal

Moreover, we believe that in addition to its proposed use as a therapeutic, QN-165 might be able to be used as a protective

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

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

Food and Drug Administration (“FDA”)

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

On August 11, 2021,

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

There can be no

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

We have decided to deprioritize

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

FastPack System is a patent-protected rapid, onsite immunoassay testing system consisting of the FastPack Analyzer and the FastPack test

pouch, a single-use, disposable, foil packet which includes the FastPack reagent chemistry.

Since the initial conception of the system,

we have developed successive versions of the analyzer and test pouch, known as “1.0,” “IP” and “PRO”,

and have expanded our assay menu to nine tests, including tests for prostate cancer, thyroid function, metabolic disorders, and research

applications.

We have sold FastPack products in the United States and overseas for over 20 years, and since inception, our sales of FastPack

products have exceeded $120 million.

We manufacture the FastPack products at our FDA and International Standards Organization (“ISO”)

certified Carlsbad, California facility.

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

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

after which time we will resume full commercial responsibility.

July 2020, we submitted an official notification to the FDA to commence sales in the United States of our FastPack SARS-CoV-2

IgG test for COVID-19 antibodies, which was designed for use with our new FastPack PRO.

The test was previously submitted to the FDA

for Emergency Use Authorization (“EUA”).

In April 2021, we withdrew this EUA.

During the nine months during which the EUA

was with the FDA, alternative tests and testing practices became widespread and we determined that there was no longer

a viable business case for scale-up of the test.

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

lead and backup compounds for our G4 selective transcription inhibitor program, QN-302.

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

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

A separate team at UofL, funded by us under

a sponsored research agreement, is developing RAS-F.

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

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

As described above,

this distribution agreement will expire on March 31, 2022.

in-license patents from DIAsource ImmunoAssays S.A.

and Future Diagnostics B.V., for reagents that are used in our FastPack Vitamin D

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

this agreement terminated on March 1, 2022.

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

whereby Sekisui receives a portion of sales revenue.

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

own direct sales force and distribution agreements with McKesson Medical-Surgical, Henry Schein Medical, Medline Industries and National

Distribution & Contracting, the largest distributors of physician office laboratory products in the United States.

Outside of the

United States, Sekisui commercializes the FastPack product line through a network of distributors in Europe, Asia, Middle East, and North

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

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

instruments and test kits.

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

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

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

Sales to Sekisui accounted for

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

during this period.

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

license revenues.

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

obtained exclusive rights to manufacture and sell new generations of FastPack-based products as well as Yi Xin-manufactured versions

of our existing FastPack 1.0, IP and PRO product lines in China.

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

After May 1, 2022, Yi Xin will have the right to sell its new generations of FastPack-based diagnostic test systems throughout the world,

other than to our then-current FastPack customers;

and on a worldwide basis, except in the United States, Yi Xin will also have the right

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

We would be entitled to receive royalties

on any of these sales, as well.

After March 31, 2022, Yi Xin will have the right to buy Qualigen FastPack 1.0, IP and PRO products from

us at distributor prices for resale in the United States, again excluding resales toward our then-current FastPack customers.

Manufacturing

do not own or operate manufacturing facilities.

an exclusive worldwide agreement (the “Supply Agreement”) with Ricerche Sperimentali Montale SpA (“RSM”)

pursuant to which RSM manufactures a higher purity form of GOS (referred to as “Improved GOS”) in connection with

our clinical and nonclinical studies.

RSM has also agreed that it will not, except as necessary for RSM to perform its

obligations under the Supply Agreement, market or sell Improved GOS, or any galacto-oligosaccharides that are of greater purity

to any third-party.

to the terms of the Supply Agreement, as amended on July 24, 2015, we purchased the exclusive worldwide assignment of all right,

title and interest to the Improved GOS (the “Improved GOS IP”) on July 30, 2015 for $800,000.

We also issued 100,000

shares of our common stock to RSM pursuant to a stock purchase agreement.

the terms of the Supply Agreement, as amended, if we fail to make any future option payment required under the terms of the Supply

Agreement, we may be required to return the Improved GOS IP to RSM.

The terms of the Supply Agreement, as amended, require us

to pay RSM $400,000 within 10 days following FDA approval of a new drug application for the first product owned or controlled

by us using Improved GOS as its active pharmaceutical ingredient.

Commercialization

have not established a commercial organization or distribution capabilities.

If the merger is not completed and RP-G28 is ultimately

approved by the necessary regulatory authorities, our plan would be to evaluate a possible partnership to commercialize RP-G28

for the treatment of LI in patients in the United States and/or Europe.

Outside of the United States and Europe, subject to obtaining

necessary marketing approvals, we would likely seek to commercialize RP-G28 through distribution or other collaboration arrangements

for patients suffering from LI.

biopharmaceutical industry is characterized by intense competition and rapid innovation.

Although we are unaware of any drug candidate,

other than RP-G28, that is in advanced clinical trials for treating LI, other biopharmaceutical companies may be able to develop

compounds or drugs that are able to achieve similar or better results.

Our potential competitors, if the merger is not completed

and we elect to continue the development of RP-G28, would include major multinational pharmaceutical companies, established biotechnology

companies, specialty pharmaceutical companies and universities and other research institutions.

Some of the pharmaceutical and

biotechnology companies we expect we would compete with include publicly-traded microbiome-based development companies such as

Synlogic, Inc., Seres Therapeutics, Inc., Evelo Biosciences, Inc.

and Synthetic Biologics, Inc.

Smaller or early-stage companies

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

We would also compete with providers of a wide variety of lactase supplements (the most widely used supplement in the United States

being Lactaid ®

), probiotic/dietary supplements, and lactose-free and dairy-free products.

We believe that the key

competitive factors that would affect the development and commercial success of any approved product candidates are efficacy,

safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.

have sought patent protection in the United States and internationally for uses of RP-G28 and our discovery programs, and any

other inventions to which we have rights, where available and when appropriate.

Our policy has been to pursue, maintain and defend

patent rights, whether developed internally or licensed from third parties, and to protect the technology, inventions and improvements

that are commercially important to the development of its business.

We have also relied on trade secrets that may be important

to the development of our business.

We do not have composition of matter patent protection in the United States for RP-G28, which

may result in competitors being able to offer and sell products so long as these competitors do not infringe any other patents

that we hold, including patents directed to oral dosage forms containing RP-G28, methods of manufacturing purified RP-G28, or

methods of using RP-G28.

and Proprietary Rights Covering RP-G28

intellectual property portfolio directed to RP-G28 contains

more than 15 issued patents relating to RP-G28 dosage forms, or to uses of RP-G28.

That portfolio also includes at least ten other

related, pending patent applications in the United States and worldwide.

We also own a patent family-including claims generally

directed to processes for producing an improved form of galacto-oligosaccharides (GOS) mixtures (higher purity);

this family includes

issued patents in United States (not expiring until 2030), Europe (validated in Germany, France, the Netherlands, Great Britain,

Ireland, and Switzerland, not expiring until 2030), Italy (not expiring until 2029), and China, India, Japan, and Korea (not expiring

until 2030), as well as applications pending in the United States and other jurisdictions.

This portfolio includes patents and

proprietary rights related to:

8,486,668, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to methods for treating LI comprising administering, for a predetermined number of days, a high

purity galacto-oligosaccharides (GOS) pharmaceutical composition, and wherein the administration leads to a persistent decrease

in at least one symptom of LI;

8,492,124, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to methods for treating LI comprising administering, for a predetermined number of days, a controlled

release pharmaceutical composition that contains galacto-oligosaccharides (GOS), but does not contain a probiotic;

8,785,160, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to methods for treating LI comprising administering a hydrogen breath test, diagnosing LI based

upon the hydrogen breath test, and administering a high purity galacto-oligosaccharides (GOS) pharmaceutical composition;

9,200,303, which has a current expiry date of August 6, 2030 (subject to the payment of maintenance fees), includes

claims generally directed to the processes for producing ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions

by utilizing sequential microbiological purifications;

9,370,532, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to methods for preventing or reducing diarrhea associated with LI, and methods for the reduction

of severity of diarrhea associated with LI, comprising administering a high purity galacto-oligosaccharides (GOS) having 1-10%

by weight pentasaccharides and at least a 45% by weight trisaccharides;

9,579,340, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to an oral dosage form comprising a GOS composition having 95% or more galacto-oligosaccharides

(GOS) by weight and less than 5% digestible saccharides by weight, and having 45% by weight trisaccharides;

9,775,860, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to methods of improving gastrointestinal health, including heartburn, stomach upset, bloating, diarrhea,

constipation, or gas by administering a composition having 95% or more GOS by weight and less than 5% digestible saccharides

by weight, and having at least 45% by weight trisaccharides;

9,592,248, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to an oral dosage form having one or more dosing units, each having 0.1 to 10 g of a liquid GOS

composition in a gelatin capsule, where the GOS composition has at least about 95% GOS by weight, less than about 5% digestible

saccharides by weight, and at least 45% by weight trisaccharides;

9,808,481, which has a current expiry date of February 17, 2030 (subject to payment of maintenance fees), includes

claims generally directed to a GOS composition having at least 95% by weight GOS and 5% or less by weight digestible saccharides,

and having about 5-25% pentasaccharides;

2400839, validated in six European countries (Germany, Spain, the Netherlands, Great Britain, Italy, and France,

which has a current expiry date of August 6, 2030 (subject to payment of annuities), includes claims generally directed to

the use of a high purity galacto-oligosaccharides (GOS) to treat LI;

Kingdom Patent No.

GB2480042, which has a current expiry date of February 16, 2030 (subject to payment of annuities), includes

claims generally directed to a solid oral unit-dosage form of a high purity galacto-oligosaccharides (GOS);

2010218439, which has a current expiry date of February 16, 2030 (subject to payment of annuities), includes claims

generally directed to a solid oral unit-dosage form of a high purity galacto-oligosaccharides (GOS);

214806, which has a current expiry date of February 16, 2030 (subject to payment of annuities), includes claims

generally directed to the use of a high purity galacto-oligosaccharides (GOS) to treat LI;

1-2011-501682, which has a current expiry date of February 16, 2030 (subject to payment of annuities), includes

claims generally directed to a solid oral unit-dosage form of a high purity galacto-oligosaccharides (GOS);

CA2752800, which has a current expiry date of February 16, 2030 (subject to payment of annuities), includes claims

generally directed to the daily use of GOS compositions to increase lactose tolerance or to treat LI;

JP6105680, which has a current expiry date of August 6, 2030 (subject to payment of annuities), includes claims

generally directed to the production of ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing

sequential microbiological purifications;

EP 2,462,234, validated in six European countries, including Germany, Great Britain, and France, which has a current

expiry date of August 6, 2030 (subject to payment of annuities), includes claims generally directed to the processes for producing

preparing ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing sequential microbiological purifications;

IT 1,395,068, which has a current expiry date of August 7, 2029 (subject to the payment of annuities), includes

claims generally directed to the production of ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing

sequential microbiological purifications;

ZL 201080035013.2, which has a current expiry date of August 6, 2030 (subject to payment of annuities), includes

claims generally directed to the production of ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing

sequential microbiological purifications;

303745, which has a current expiry date of August 6, 2030 (subject to payment of annuities), includes claims generally

directed to the production of ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing sequential

microbiological purifications;

10-1776164, which has a current expiry date of August 6, 2030 (subject to payment of annuities), includes claims

generally directed to the production of ultra-pure galacto-oligosaccharides (GOS) pharmaceutical compositions by utilizing

sequential microbiological purifications.

also have patent applications still pending in the

United States, Europe, Japan and other jurisdictions, and, if they issue as patents, will not expire until at least 2030, and

include claims generally directed to (i) oral dosage forms of a higher purity galacto-oligosaccharides (GOS), (ii) use of galacto-oligosaccharides

(GOS) for treating LI, (iii) methods of preventing or reducing certain symptoms of LI using galacto-oligosaccharides (GOS) dosage

forms, (iv) methods of improving gastrointestinal health using galacto-oligosaccharides (GOS) dosage forms and (v) methods for

assessing efficacy of an oligosaccharide mixture in improving gastrointestinal health by measuring a change in at least one abdominal

addition to patents, we have relied on trade secrets and know-how to develop and maintain our competitive position.

Trade secrets

and know-how can be difficult to protect.

We have sought to protect our proprietary processes, in part, by confidentiality agreements

and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners.

These agreements are designed to protect our proprietary information.

We have also sought to preserve the integrity and confidentiality

of its data, trade secrets and know-how by maintaining physical security of its premises and physical and electronic security

of its information technology systems.

Regulation and Product Approval

Governmental authorities

in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the

research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and

export and import of products.

Any product candidate must be approved by the FDA through the NDA process before it may be legally

marketed in the United States and by the European Medicines Agency (“EMA”) through the Marketing Authorization

Application (“MAA”) process before it may be legally marketed in Europe.

Product candidates are subject to similar

requirements in other countries prior to marketing in those countries.

The process of obtaining regulatory approvals and the subsequent

compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time

and financial resources.

States Government Regulation

Approval Processes

the United States, the FDA regulates drugs under the FDCA and implemented regulations.

Failure to comply with the applicable FDA

requirements at any time during the product development process or approval process, or after approval, may subject an applicant

to administrative or judicial sanctions, any of which could have a material adverse effect on us.

These sanctions could include:

to approve pending applications;

of an approval;

of a clinical hold;

seizures and/or condemnation and destruction;

or partial suspension of production or distribution;

fines, disgorgement, or civil or criminal penalties.

process required by the FDA before a drug may be marketed in the United States generally involves the following:

of nonclinical laboratory tests, animal studies and formulation studies conducted according to Good Laboratory Practices (“GLPs”)

or other applicable regulations;

to the FDA of an IND, which must become effective before human clinical trials may begin;

of adequate and well-controlled human clinical trials according to GCPs, to establish the safety and efficacy of the proposed

drug for its intended use;

to the FDA of a marketing application such as an NDA;

completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance

with cGMPs to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength,

quality and purity;

review and approval of the marketing application.

a pharmaceutical candidate is identified for development, it enters the preclinical or nonclinical testing stage.

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

A sponsor of an

IND must submit the results of the nonclinical tests, together with manufacturing information and analytical data, to the FDA

as part of the IND.

Some nonclinical testing may continue even after the IND is submitted.

In addition to including the results

of the nonclinical studies, the IND will also include a clinical protocol detailing, among other things, the objectives of the

clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the first phase

lends itself to an efficacy determination.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the

FDA, within the 30-day time period, notifies the sponsor of a clinical hold.

In such a case, the IND sponsor and the FDA must

resolve any outstanding concerns before clinical trials can begin.

A clinical hold may occur at any time during the life of an

IND, and may affect one or more specific studies or all studies conducted under the IND.

clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCPs.

be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject selection and exclusion

criteria and the safety and effectiveness criteria to be evaluated.

Each protocol must be submitted to the FDA as an amendment

to the IND, and progress reports detailing the status of the clinical trials must be submitted to the FDA annually in the IND

Annual Report.

Sponsors must also report to the FDA, within required timelines, serious and unexpected adverse reactions, any

clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigation

brochure, or any findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to

An IRB at each institution participating in the clinical trial must review and approve the protocol before a clinical

trial commences at that institution and must also approve the information regarding the trial and the consent form that must be

provided to each research subject or the subject’s legal representative, monitor the study until completed and otherwise

comply with IRB regulations.

clinical trials are typically conducted in three sequential phases that may overlap or be combined:

The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism,

distribution and elimination.

In the case of some products for severe or life-threatening diseases, such as cancer, especially

when the product may be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often

conducted in patients.

Clinical trials are performed on a limited patient population intended to identify possible adverse effects and safety

risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance

and optimal dosage.

Although there are no statutory or regulatory definitions for Phase 2a and Phase 2b, Phase 2a is commonly

used to describe a Phase 2 clinical trial designed to evaluate efficacy, adverse effects and safety risks and Phase 2b is

commonly used to describe a subsequent Phase 2 clinical trial that also evaluates dosage tolerance and optimal dosage.

Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population

at geographically dispersed clinical study sites.

These studies are intended to establish the overall risk-benefit ratio of

the product and provide an adequate basis for product labeling.

clinical trials are inherently uncertain and Phase 1, Phase 2 and Phase 3 testing may not be successfully completed.

the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research subjects

or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical

trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the

drug has been associated with unexpected serious harm to patients.

the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points.

These points may be prior

to the submission of an IND, at the end of Phase 2 and before an NDA is submitted.

Meetings with the FDA may be granted at other

times during the development program when requested.

with clinical trials, sponsors usually complete additional animal safety studies and also develop additional information about

the chemistry and physical characteristics of the drug and finalize a process for manufacturing commercial quantities of the product

in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the

drug and the manufacturer must develop methods for testing the identity, strength, quality, purity and potency of the drug.

Additionally,

appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate

does not undergo unacceptable deterioration over its proposed shelf-life.

results of product development, nonclinical studies and clinical trials, along with descriptions of the manufacturing process,

analytical tests and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part

of an NDA requesting approval to market the product.

The submission of an NDA is subject to the payment of user fees, but a waiver

of such fees may be obtained under specified circumstances.

The FDA has 60 days from its receipt of an NDA to determine whether

the application will be accepted for filing based on the agency’s threshold determination of whether it is sufficiently

complete to permit substantive review.

It may request additional information rather than accept an NDA for filing.

In this event,

the NDA must be resubmitted with the additional information.

The resubmitted application also is subject to review before the

FDA accepts it for filing.

the submission is accepted for filing, the FDA begins an in-depth review.

NDAs receive either standard or priority review.

representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review.

refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data.

Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.

reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its

manufacturing is cGMP-compliant.

The FDA may refer the NDA to an advisory committee for review and recommendation as to whether

the application should be approved and under what conditions.

The FDA is not bound by the recommendation of an advisory committee,

but it generally follows such recommendations.

Before approving an NDA, the FDA will inspect the facility or facilities where

the product is manufactured and tested.

Term Restoration and Marketing Exclusivity

upon the timing, duration and specifics of any FDA marketing approval of RP-G28, one of our U.S.

patents may be eligible

for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the

Hatch-Waxman Act.

The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost

during product development and the FDA regulatory review process.

However, patent term restoration cannot extend the remaining

term of a patent beyond a total of 14 years from the product’s approval date.

The patent term restoration period is generally

one-half the time between the effective date of an IND, and the submission date of an NDA, plus the time between the submission

date of an NDA and the approval of that application.

Only one patent applicable to an approved drug is eligible for the extension

and the application for extension must be made prior to expiration of the patent.

The United States Patent and Trademark Office,

in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.

apply for restorations of patent term for some of its currently owned or licensed patents to add patent life beyond their current

expiration date, depending on the expected length of clinical trials and other factors involved in the submission of the relevant

exclusivity provisions under the FDCA also can delay the submission or the approval of certain applications.

The FDCA provides

a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an

NDA for a new chemical entity.

A drug is a new chemical entity if the FDA has not previously approved any other new drug containing

the same active moiety, which is the molecule or ion responsible for the action of the drug substance.

During the exclusivity

period, the FDA may not accept for review an abbreviated new drug application (“ANDA”), or a 505(b)(2) NDA submitted

by another company for another version of such drug where the applicant does not own or have a legal right of reference to all

the data required for approval.

However, an application may be submitted after four years if it contains a certification of patent

invalidity or non-infringement.

The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement

to an approved NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the

applicant are deemed by the FDA to be essential to the approval of the application, for example, for new indications, dosages

or strengths of an existing drug.

This three-year exclusivity covers only the conditions associated with the new clinical investigations

and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent.

Five-year and three-year exclusivity

will not delay the submission or approval of a full NDA;

however, an applicant submitting a full NDA would be required to conduct

or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to

demonstrate safety and effectiveness.

Exclusivity and Pediatric Use

the Best Pharmaceuticals for Children Act (“BPCA”), certain drugs may obtain an additional six months of exclusivity,

if the sponsor submits information requested in writing by the FDA (a Written Request) relating to the use of the active moiety

of the drug in children.

The FDA may not issue a Written Request for studies on unapproved or approved indications or where it

determines that information relating to the use of a drug in a pediatric population, or part of the pediatric population, may

not produce health benefits in that population.

have not received a Written Request for such pediatric studies,

although we could ask the FDA to issue a Written Request for such studies in the future.

To receive the six-month pediatric

market exclusivity, we would have to receive a Written Request from the FDA, conduct the requested studies in accordance

with a written agreement with the FDA or, if there is no written agreement, in accordance with commonly accepted scientific principles,

and submit reports of the studies.

A Written Request may include studies for indications that are not currently in the labeling

if the FDA determines that such information will benefit the public health.

The FDA will accept the reports upon its determination

that the studies were conducted in accordance with and are responsive to the original Written Request or commonly accepted scientific

principles, as appropriate, and that the reports comply with the FDA’s filing requirements.

addition, the Pediatric Research Equity Act (“PREA”) requires all applications (or supplements to an application)

submitted under section 505 of the FDCA (21 U.S.C.

§355) for a new active ingredient, new indication, new dosage form, new

dosing regimen or new route of administration to contain a pediatric assessment unless the applicant has obtained a waiver or

It also authorizes the FDA to require holders of approved NDAs for marketed drugs to conduct pediatric studies under

certain circumstances.

In general, PREA applies only to those drugs developed for diseases and/or conditions that occur in both

the adult and pediatric populations.

Products intended for pediatric-specific indications will be subject to the requirements

of PREA only if they are initially developed for a subset of the relevant pediatric population.

part of the Food and Drug Administration Safety and Innovation Act, Congress reauthorized both BPCA and PREA, which were slated

to expire on September 30, 2012, and made both laws permanent.

the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition,

defined as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient

population greater than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of

developing and making available the drug or biologic in the United States will be recovered from sales in the United States for

that drug or biologic.

a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for

the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA

may not approve any other applications, including a full NDA, to market the same product for the same indication for seven years,

except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if the

FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities

of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated.

exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same

drug or biologic for a different disease or condition.

Among the other benefits of orphan drug designation are tax credits for

certain research and a waiver of the NDA application user fee.

designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication

for which it received orphan designation.

Orphan drug exclusive marketing rights in the United States also may be lost if the

FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient

quantities of the product to meet the needs of patients with the rare disease or condition.

the merger is not completed and we elect to continue the development of RP-G28, we may

explore orphan drug designation for RP-G28 for any orphan indication in which there is a medically plausible basis for treatment

of the indication through colonic adaptation of gut bacteria.

develop, manufacture and assemble our diagnostic products at our approximately 23,000 square feet facility in Carlsbad, California.

laboratory and manufacturing practices are governed by a series of internally published Standard Operating Procedures, in accordance

with FDA and ISO guidelines.

While we produce many of our own raw materials and sub-components for diagnostic products, we also purchase

certain materials from third-party suppliers such as Thermo Fisher Scientific, Equitech-Bio, Surmodics, OYC Americas, Amcor, 3M, VWR,

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

do not have in-house manufacturing capability for our therapeutics product candidates.

and Development

research and development of our drug candidates, we are leveraging the scientific and technical resources and laboratory facilities of

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

and applications in the cancer and infectious disease fields.

We would engage contract research organizations for any clinical trials

of our drug candidates.

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

have obtained 17 FDA clearances/approvals and 28 CE Marks for our diagnostic products (FastPack analyzers, immunoassays, control kits,

calibration kits and verifications kits) to date.

We have not obtained FDA or other regulatory approval for any drug candidate.

Device Regulatory Clearances and Approvals

medical devices that we manufacture and market are subject to regulation by numerous worldwide regulatory bodies, including the FDA and

comparable international regulatory agencies.

These agencies require manufacturers of medical devices to comply with applicable laws

and regulations governing development, testing, manufacturing, labeling, marketing and distribution.

Medical devices are also generally

subject to varying levels of regulatory control based on the risk level of the device.

the United States, unless an exemption applies, before we can commercially distribute medical devices, we must obtain, depending

on the type of device, either premarket notification clearance or premarket approval (“PMA”) from the FDA.

The FDA classifies

medical devices into one of three classes.

Devices deemed to pose lower risks are placed in either class I or II, which typically requires

the manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device.

Some low-risk

devices are exempted from this requirement.

Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting

or implantable devices, or devices deemed not substantially equivalent to a previously cleared device, are placed in class III, generally

requiring PMA.

premarket notification process requires that a premarket notification (510(k)) be made to the FDA to demonstrate that a new device is

as safe and effective as, or substantially equivalent to, a legally marketed device (the “predicate” device).

is generally known as obtaining 510(k) clearance for a new device.

Under this process, applicants must submit performance data to establish

substantial equivalence.

In some instances, data from human clinical trials must also be submitted in support of a 510(k) premarket notification.

If so, these data must be collected in a manner that conforms to the applicable Investigational Device Exemption (“IDE”)

The FDA must issue a decision finding substantial equivalence before commercial distribution can occur.

Changes to cleared

devices that do not significantly affect the safety or effectiveness of the device can generally be made without additional 510(k) premarket

notifications;

otherwise, a new 510(k) is required.

PMA approval process requires the submission of a PMA application to the FDA to demonstrate that the new device is safe and effective

for its intended use.

This approval process applies to most Class III devices and generally requires clinical data to support the safety

and effectiveness of the device, obtained in adherence with IDE requirements.

The FDA will approve the PMA application if it finds that

there is a reasonable assurance that the device is safe and effective for its intended purpose and that the proposed manufacturing is

in compliance with the Quality System Regulation (“QSR”).

For novel technologies, the FDA may seek input from an advisory

panel of medical experts and seek their views on the safety, effectiveness and benefit-risk of the device.

The PMA process is generally

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

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

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

Medical devices that have a

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

expires, whichever comes first, providing there are no significant changes to the design or intended use.

The CE Mark, which is required

to sell medical devices in the EU is affixed following a Conformity Assessment and either approval from the appointed independent Notified

Body or through self-certification by the manufacturer.

The selected pathway to CE marking is based on device risk classification.

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

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

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

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

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

The CE mark continues to be a prerequisite for successful registration

in many other global geographies.

are also required to comply with the regulations of every other country where we commercialize products before we can launch or maintain

new products on the market.

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

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

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

or had minimal regulations.

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

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

already in place including appointment of a U.K.

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

In addition, other

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

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

review and inspection of design and manufacturing practices, record-keeping, reporting of adverse events, labeling and promotional practices.

The FDA can ban certain medical devices, detain or seize adulterated or misbranded medical devices, order recall or market withdrawal

of these devices and require notification of health professionals and others with regard to medical devices that present unreasonable

risks of substantial harm to the public health.

The FDA may also enjoin and restrain a company for certain violations of the Food, Drug

and Cosmetic Act (“FDCA”) and the Safe Medical Devices Act, pertaining to medical devices, or initiate action for criminal

prosecution of such violations.

Regulatory agencies and authorities in the countries where we do business can halt production in or distribution

within their respective country or otherwise take action in accordance with local laws and regulations.

International

sales of medical devices manufactured in the United States that are not approved by the FDA for use in the United States,

or that are banned or deviate from lawful performance standards, are subject to FDA export requirements.

Additionally, exported devices

are subject to the regulatory requirements of each country to which the device is exported.

Some countries do not have medical device

regulations, but in most foreign countries, medical devices are regulated.

Frequently, regulatory approval may first be obtained in a

foreign country prior to application in the United States due to differing regulatory requirements;

however, other countries,

such as China, for example, require approval in the country of origin first.

Most countries outside of the United States require

that product approvals be recertified on a regular basis.

The recertification process requires the evaluation of any device changes and

any new regulations or standards relevant to the device and, where needed, conduct appropriate testing to document continued compliance.

Where recertification applications are required, they must be approved in order to continue selling our products in those countries.

Device Quality Assurance

We are committed to providing

high quality products to our customers and the patients they serve.

Our quality system starts with the initial product specification

and continues through the design of the product, component specification process and the manufacturing, sale and servicing of the product.

Our quality system is intended to build in quality and process control and to utilize continuous improvement concepts throughout the

product life.

Our quality system is also designed to enable us to satisfy various international quality system regulations, including

those of the FDA with respect to products sold in the United States.

All of our medical device manufacturing facilities and distribution

centers are certified under the ISO 13485 quality system standard, established by the ISO for medical devices, which includes requirements

for an implemented quality system that applies to component quality, supplier control, product design and manufacturing operations.

certification can be obtained only after a complete audit of a company’s quality system by an independent outside auditor, and

maintenance of the certification requires that these facilities undergo periodic re-examination.

States—FDA Drug Approval Process

research, development, testing, and manufacture of product candidates are extensively regulated by governmental authorities in the United

States and other countries.

In the United States, the FDA regulates drugs under the FDCA and its implementing regulations.

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

● preclinical

laboratory tests, animal studies, and formulation studies, all performed in accordance with

the FDA’s Good Laboratory Practice (“GLP”) regulations;

to the FDA of an IND application for human clinical testing, which must become effective

before human clinical trials may begin and for which progress reports must be submitted annually

by an independent institutional review board (“IRB”) or Ethics Committee (“EC”)

at each clinical trial site before each trial may be initiated;

and well-controlled human clinical trials, conducted in accordance with applicable IND regulations,

Good Clinical Practices (“GCP”), and other clinical trial related regulations,

to establish the safety and efficacy of the drug for each proposed indication to the

FDA’s satisfaction;

to the FDA of a New Drug Application (“NDA”) and payment of user fees

for FDA review of the NDA (unless a fee waiver applies);

● satisfactory

completion of an FDA pre-approval inspection of one or more clinical trial site(s) at which

the drug was studied in a clinical trial(s) and/or of us as a clinical trial sponsor to assess

compliance with GCP regulations;

● satisfactory

completion of an FDA pre-approval inspection of the manufacturing facility or facilities

at which the drug is produced to assess compliance with current GMPs regulations;

with the FDA on the final labeling for the product and the design and implementation

of any required Risk Evaluation and Mitigation Strategy (“REMS”);

review and approval of the NDA, including satisfactory completion of an FDA advisory committee

review, if applicable, based on a determination that the drug is safe and effective for the

proposed indication(s).

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

The conduct of the preclinical

tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations.

The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of

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

An IND application will automatically become

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

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

In such a case, the IND application

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

We cannot be certain that

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

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

The study protocol and informed consent information for study subjects in clinical trials must also be approved by an IRB for each institution

where the trials will be conducted, and each IRB must monitor the study until completion.

Study subjects must provide informed consent

and sign an informed consent form before participating in a clinical trial.

Clinical testing also must satisfy the extensive GCP regulations

for, among other things, informed consent and privacy of individually identifiable information.

1—Phase 1 clinical trials involve initial introduction of the study drug in a limited

population of healthy human volunteers or patients with the target disease or condition.

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

and distribution of the study drug in humans, evaluate the side effects associated with increasing

doses, and, if possible, to gain early evidence of effectiveness.

2—Phase 2 clinical trials typically involve administration of the study drug to a limited

patient population with a specified disease or condition to evaluate the preliminary efficacy,

optimal dosages and dosing schedule and to identify possible adverse side effects and safety

Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning

larger and more expensive Phase 3 clinical trials.

3—Phase 3 clinical trials typically involve administration of the study drug to an

expanded patient population to further evaluate dosage, to provide substantial evidence of

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

clinical trial sites.

These clinical trials are intended to establish the overall risk/benefit

ratio of the study drug and to provide an adequate basis for product approval.

two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval

Post-approval

an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements is not maintained or if problems

occur after the product reaches the market.

Later discovery of previously unknown problems with a product may result in restrictions

on the product or even complete withdrawal of the product from the market.

After approval, some types of changes to the approved

product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review

and approval.

In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products that

have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of

these post-marketing programs.

drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA,

including, among other things:

record-keeping

requirements;

of adverse experiences with the drug;

the FDA with updated safety and efficacy information;

sampling and distribution requirements;

the FDA and gaining its approval of specified manufacturing or labeling changes;

with FDA promotion and advertising requirements.

manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their

establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and some

state agencies for compliance with cGMP and other laws.

have relied on third parties for the production of clinical

and commercial quantities of our products.

Future FDA and state inspections could identify compliance issues at the facilities

of our contract manufacturers that could disrupt production or distribution or require substantial resources to correct.

time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions

governing the approval, manufacturing and marketing of products regulated by the FDA.

In addition, FDA regulations and guidance

are often revised or reinterpreted by the agency in ways that may significantly affect a business and its products.

It is impossible

to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact

of such changes, if any, may be.

Outside of the United States

addition to regulations in the United States, we are subject to regulations of other countries governing clinical trials and commercial

sales and distribution of its products.

Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable

regulatory authorities of countries outside of the United States before we can commence clinical trials in such countries and

approval of the regulators of such countries or economic areas, such as the EU, before we may market products in those countries

The approval process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement

vary greatly from place to place, and the time may be longer or shorter than that required for FDA approval.

EU regulatory systems, a company may submit marketing authorization applications either under a centralized or decentralized procedure.

The centralized procedure, which is compulsory for medicines produced by biotechnology or those medicines intended to treat AIDS,

cancer, neurodegenerative disorders or diabetes and optional for those medicines which are highly innovative, provides for the

grant of a single marketing authorization that is valid for all EU member states.

The decentralized procedure provides for mutual

recognition of national approval decisions.

Under this procedure, the holder of a national marketing authorization may submit

an application to the remaining member states.

Within 90 days of receiving the applications and assessments report, each member

state must decide whether to recognize approval.

If a member state does not recognize the marketing authorization, the disputed

points are eventually referred to the European Commission, whose decision is binding on all member states.

Reimbursement

RP-G28 or any other future product candidate is approved by regulatory authorities, sales of such product will depend, in part,

on the extent to which the costs of such products will be covered by third-party payors, such as government health programs, commercial

insurance and managed healthcare organizations.

These third-party payors are increasingly challenging the prices charged for medical

products and services.

Additionally, the containment of healthcare costs has become a priority of federal and state governments

and the prices of drugs have been a focus in this effort.

government, state legislatures and foreign governments have

shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement

and requirements for substitution of generic products.

Adoption of price controls and cost-containment measures, and adoption

of more restrictive policies in jurisdictions with existing controls and measures, could further limit net revenue and results.

If these third-party payors do not consider our products to be cost-effective compared to other therapies, they may not

cover our products after approved as a benefit under their plans or, if they do, the level of payment may not be sufficient

to allow us to sell our products on a profitable basis.

MMA imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries.

Under Part D,

Medicare beneficiaries may enroll in prescription drug plans offered by private entities which will provide coverage of outpatient

prescription drugs.

Part D plans include both stand-alone prescription drug benefit plans and prescription drug coverage as a

supplement to Medicare Advantage plans.

Unlike Medicare Part A and B, Part D coverage is not standardized.

Part D prescription

drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary

that identifies which drugs it will cover and at what tier or level.

However, Part D prescription drug formularies must include

drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category

Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.

Government payment for some of the costs of prescription drugs may increase demand for any of our products that receive marketing

However, any negotiated prices for our products covered by a Part D prescription drug plan would likely be lower than

the prices we might otherwise obtain.

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 payors.

American Recovery and Reinvestment Act of 2009 provides funding for the federal government to compare the effectiveness of different

treatments for the same illness.

A plan for the research will be developed by the Department of Health and Human Services, the

Agency for Healthcare Research and Quality and the National Institutes for Health, and periodic reports on the status of the research

and related expenditures will be made to Congress.

Although the results of the comparative effectiveness studies are not intended

to mandate coverage policies for public or private payors, it is not clear what effect, if any, the research will have on the

sales of any product, if any such product or the condition that it is intended to treat is the subject of a study.

possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect

the sales of Ritter’s product candidates.

If third-party payors do not consider our products to be cost-effective

compared to other available therapies, they may not cover Ritter’s products as a benefit under their plans or, if they do,

the level of payment may not be sufficient to allow Ritter to sell its products on a profitable basis.

The 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, substantially changed the way healthcare is financed by both government health

plans and private insurers.

The ACA was designed to expand coverage for the uninsured while at the same time containing overall

healthcare costs.

With regard to pharmaceutical products, among other things, the ACA expanded and increased industry rebates

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

broader paradigm shift caused by the ACA towards performance-based reimbursement, and the launch of several value-based purchasing

initiatives, have also placed demands on the pharmaceutical industry to offer products with proven real-world outcomes data and

a favorable economic profile.

Ritter cannot predict the full impact of the ACA on pharmaceutical companies, as many of the ACA

reforms require the promulgation of detailed regulations implementing the statutory provisions, which has not yet occurred.

January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent, or loosen certain

requirements mandated by the ACA.

Concurrently, Congress has considered legislation that would repeal or repeal and replace all

or part of the ACA.

While Congress has not passed repeal legislation, the Tax Cuts and Jobs Act of 2017 includes a provision repealing,

effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain

qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”.

may consider other legislation to repeal or replace elements of the ACA, all of which adds to the uncertainty of the legislative

changes enacted as part of the ACA.

addition, in some non-U.S.

jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements governing drug pricing vary widely from country to country.

For example, the EU provides options for its member

states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and

to control the prices of medicinal products for human use.

A member state may approve a specific price for the medicinal product

or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product

on the market.

Historically, products launched in the EU do not follow price structures of the United States and generally tend

to be significantly lower.

As of March 25, 2020,

we had five employees, all of whom were full time employees.

None of our employees are represented by a labor union or subject

to a collective bargaining agreement.

were formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural Sciences, LLC.

2008, we converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc.

completed our initial public offering in June 2015.

Our common stock is currently traded on the Nasdaq Capital Market under the

trading symbol “RTTR”.

file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy and information statements

and amendments to reports filed or furnished pursuant to Sections 13(a), 14 and 15(d) of the Securities Exchange Act of 1934,

as amended, with the SEC.

The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements

and other information regarding Ritter Pharmaceuticals, Inc.

and other companies that file materials with the SEC electronically.

As soon as practicable after filing with the SEC, Ritter also makes copies of its reports on Form 10-K, Forms 10-Q and Forms 8-K

available to the public, free of charge, through the investor relations tab on its web site, http://www.ritterpharmaceuticals.com/investors.

currently lease approximately 2,780 square feet of office

space located at 1880 Century Park East, Suite 1000, Los Angeles, California 90067 for our headquarters.

time to time, we may be involved in various claims and legal proceedings relating to claims arising out of our operations.

are not currently a party to any legal proceeding that, in the opinion of its management, is likely to have a material adverse

effect on our business.

Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs,

diversion of management resources and other factors.

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

These trials are

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

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

In certain instances, the FDA may mandate the performance

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

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

which are intended to expedite or simplify the process for the development, and the FDA’s review of drugs ( e.g.,

approving an NDA on the basis of surrogate endpoints subject to post-approval trials).

Generally, drugs that may be eligible for one

or more of these programs are those intended to treat serious or life-threatening diseases or conditions, those with the potential to

address unmet medical needs for those disease or conditions, and/or those that provide a meaningful benefit over existing treatments.

For example, a sponsor may be granted FDA designation of a drug candidate as a “breakthrough therapy” if the drug candidate

is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary

clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant

endpoints, such as substantial treatment effects observed early in clinical development.

If a drug is designated as breakthrough therapy,

the FDA will take actions to help expedite the development and review of such drug.

Moreover, if a sponsor submits an NDA for

a product intended to treat certain rare pediatric or tropical diseases or for use as a medical countermeasure for a material threat,

and that meets other eligibility criteria, upon approval such sponsor may be granted a priority review voucher that can be used for a

subsequent NDA.

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

cannot be sure that any of its drugs will qualify for any of these programs, or even if a drug does qualify, that the review time will

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

manufacture and composition of the drug, are submitted to the FDA in the form of an NDA requesting approval to market the product for

one or more proposed indications.

The testing and approval process requires substantial time, effort and financial resources.

the applicant qualifies for an exemption, the filing of an NDA typically must be accompanied by a substantial “user fee”

payment to the FDA.

To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety

and efficacy of the product in the proposed patient population to the satisfaction of the FDA.

After an NDA is accepted for filing, the

FDA substantively reviews the application and may deem it to be inadequate, and companies cannot be sure that any approval will be granted

on a timely basis, if at all.

The FDA may also refer the application to an appropriate advisory committee, typically a panel of clinicians,

for review, evaluation and a recommendation as to whether the application should be approved, but is not bound by the recommendations

of the advisory committee.

approving an NDA, the FDA usually will inspect the facility or the facilities at which the drug is manufactured and determine whether

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

The FDA also may audit the clinical

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

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

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

An approval letter authorizes commercial marketing of the drug with specific

prescribing information for a specific indication(s).

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

is not ready for approval.

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

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

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

FDA could also require, as a condition of NDA approval, post-marketing testing and surveillance to monitor the drug’s safety or

efficacy or impose other conditions, or a REMS that may include both special labeling and controls, known as Elements to Assure Safe

Use, on the distribution, prescribing, dispensing and use of a drug product.

Once issued, the FDA may withdraw product approval if, among

other things, ongoing regulatory requirements are not met, certain defects exist in the NDA, or safety or efficacy problems occur after

the product reaches the market.

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

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

South Africa, and Australia.

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

to our diagnostics and therapeutics businesses.

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

intellectual property.

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

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

We also, with Gen-Probe

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

Last, we hold five issued patents

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

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

set to expire 2032-2038.

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

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

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

Capital Management

of March 25, 2022, we had 46 employees, 39 of whom were full-time employees.

None of our employees is represented

by a labor union or covered by a collective bargaining agreement.

Engagement, Benefits & Development.

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

exceptional employees.

We frequently benchmark our compensation practices and benefits programs

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

We provide our employees with

competitive cash compensation, opportunities to own equity, and an employee benefit program that promotes well-being, including healthcare,

a 401(k) Plan with matching contributions, and paid time-off.

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

In an effort to protect the

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

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

& Inclusion .

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

seek to have an inclusive and positive culture that is centered on our shared corporate mission and values, and that is free

from discrimination of any kind, including sexual or other discriminatory harassment.

Our employees have multiple avenues available through

which inappropriate behavior can be reported.

All reports of inappropriate behavior are promptly investigated with appropriate action

taken to stop such behavior.

Pharmaceuticals, Inc.

(our predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the name Ritter Natural

Sciences, LLC.

In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals, Inc.

22, 2020, upon completing the “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals, Inc.

renamed Qualigen Therapeutics, Inc.

Qualisys Diagnostics, Inc.

was formed as a Minnesota corporation in 1996, reincorporated to become

a Delaware corporation in 1999, and then changed its name to Qualigen, Inc.

Qualigen, Inc.

is now a wholly-owned subsidiary

of the Company.

website address is www.qualigeninc.com .

We post links to our website to the following filings as soon as reasonably practicable

after they are electronically filed with or furnished to the SEC:

annual reports on Form 10-K, quarterly reports on Form 10-Q, current

reports on Form 8-K, proxy statements, information statements, beneficial ownership reports and any amendments to those reports or statements

filed or furnished pursuant to Sections 13(a), 14 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

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

However, the information contained on or accessed through our website

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

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business