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Item 2. Management’s Discussion and Analysis

2022-05-06 compared with 2021-11-09 · 204 added, 416 removed, 37 unchanged (94% of the section changed)

DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion

should be read in conjunction with our consolidated financial statements and notes thereto included herein.

In connection with, and because

we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, we caution

readers regarding certain forward looking statements in the following discussion and elsewhere in this Report and in any other statement

made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission.

Forward looking statements are

statements not based on historical information and which relate to future operations, strategies, financial results or other developments.

Forward looking statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic

and competitive uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business

decisions, are subject to change.

These uncertainties and contingencies can affect actual results and could cause actual results to differ

materially from those expressed in any forward looking statements made by, or on our behalf.

We disclaim any obligation to update forward

looking statements.

We were incorporated in the

State of Colorado on August 31, 2006 under the name “Mountain West Business Solutions, Inc.” Until October 2009, our business

was to provide management consulting services to small and home-office based companies.

In October 2009, we acquired

Sunshine Biopharma, Inc., a Colorado corporation holding an exclusive license (the “License”) to a new anticancer drug bearing

the laboratory name, Adva-27a.

As a result of this transaction we changed our name to “Sunshine Biopharma, Inc.” and our officers

and directors resigned their positions with us and were replaced by Sunshine Biopharma, Inc.’s management at the time, including

our current CEO, Dr.

Slilaty, and our current CFO, Camille Sebaaly.

Our principal business became that of a pharmaceutical company

focusing on the development of our licensed Adva-27a anticancer compound.

In December 2015 we acquired all issued and pending patents

pertaining to our Adva-27a technology and terminated the License.

In October 2012, we published

the results of our initial preclinical studies of Adva-27a in the peer-reviewed journal, ANTICANCER RESEARCH.

The preclinical studies

were conducted in collaboration with Binghamton University, a State University of New York, and Ecole Polytechnique, Universite de Montreal.

The publication is entitled “Adva-27a, a Novel Podophyllotoxin Derivative Found to Be Effective Against Multidrug Resistant Human

Cancer Cells” [ANTICANCER RESEARCH Volume 32, Pages 4423-4432 (2012)].

In July 2014, we formed a

wholly owned Canadian subsidiary, Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), for the purposes of offering generic

pharmaceutical products in Canada and elsewhere around the world.

Sunshine Canada has recently transitioned its focus to the development

and marketing of Science-Based Nutritional Supplements.

In March 2018, we formed NOX

Pharmaceuticals, Inc., a wholly owned Colorado corporation, and assigned all of our interest in our Adva-27a anticancer compound to that

NOX Pharmaceuticals, Inc.’s mission is to research, develop and commercialize proprietary drugs including Adva-27a.

In December 2018, we completed

the development of our first Science-Based Nutritional Supplements product, Essential-9 tm .

This new supplement is an over-the-counter tablet comprised of the nine (9) amino acids which the human body cannot make.

Essential-9 tm

has been authorized for marketing by Health Canada under NPN 80089663.

On March 12, 2019, Essential-9 tm

became available for sale on Amazon.ca and shortly thereafter on Amazon.com.

Effective February 1, 2019,

we completed a 20 to 1 reverse split of our $0.001 par value Common Stock reducing the issued and outstanding shares of Common Stock from

1,713,046,242 to 85,652,400 (the “First Reverse Stock Split”).

The number of authorized shares of our $0.001 par value Common

Stock remained at 3,000,000,000 shares.

Effective April 6, 2020, we

completed another 20 to 1 reverse split of our $0.001 par value Common Stock, reducing the issued and outstanding shares of Common Stock

from 1,193,501,925 to 59,675,417 (the “Second Reverse Stock Split”).

The authorized capital of our Common Stock remained as

previously established at 3,000,000,000 shares.

Except in the paragraphs describing the reverse stock splits, all references in this Report

to our Common Stock as well as the price per share of Common Stock are presented on a post First and Second Reverse Stock Splits basis.

On May 22, 2020, we filed

a patent application in the United States for a new treatment for Coronavirus infections, including COVID-19.

Our patent application covers

composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease (Mpro), an enzyme that is essential

for viral replication.

The small molecules covered by the patent application were computer modelled and designed by Dr.

The patent application has a priority date of May 22, 2020.

On April 30, 2021, we filed a PCT application containing new research

results and extending coverage to include the Coronavirus Papain-Like protease, PLpro.

The priority date of May 22, 2020 has been maintained

in the newly filed PCT application.

On June 17, 2020, we filed

an amendment to our Articles of Incorporation (the “Amendment”) with the Secretary of State for the State of Colorado, to

eliminate the Series “A” Preferred Shares, consisting of Eight Hundred and Fifty Thousand (850,000) shares, par value $0.10

per share, and the designation thereof, such shares to be returned to the status of undesignated shares of Preferred Stock.

the Amendment increased the number of authorized Series “B” Preferred Shares from Five Hundred Thousand (500,000) to One Million

(1,000,000) shares.

Also on June 17, 2020, our

Board of Directors authorized the issuance of Five Hundred Thousand (500,000) shares of our Series “B” Preferred Stock in

Slilaty, our CEO and a director, in consideration for his development of a new treatment for Coronavirus infections,

including COVID-19.

The Series “B” Preferred Stock is non-convertible, non-redeemable, non-retractable and has a superior

liquidation value of $0.10 per share.

Each share of Series “B” Preferred Stock is entitled to 1,000 votes per share.

issuance brought the total number of Series “B” Preferred Stock held by Dr.

Slilaty to 1,000,000 shares.

On September 8, 2020, we executed

a financing agreement with RB Capital Partners, Inc., La Jolla, CA, who agreed to provide us with a minimum of $2 million in convertible

debt financing during the ensuing three to six month period pursuant to the terms and conditions included in relevant Promissory Notes

(the “Promissory Notes”).

The Promissory Notes bear interest at the rate of 5% per annum and have a maturity date of two years

from the date of issuance.

We have the right to pay off all or any part of the Promissory Notes at any time without penalty.

As of September 30, 2021, the total outstanding principal amounts of the Promissory Notes was $3,204,215.

Effective October 6, 2020,

we entered into a Research Agreement (the “Agreement”) with the University of Georgia Research Foundation, Inc.

representing the University of Georgia (“UGA”).

The purpose of the Agreement is to memorialize the terms of our working together

with UGA to conduct the necessary research and development to advance our Anti-Coronavirus lead compound, SBFM-PL4 (or derivatives thereof)

through various stages of preclinical development, animal studies and clinical trials for Coronavirus infections.

The Agreement grants

us an exclusive worldwide license for all of the intellectual property developed by UGA, whether alone or jointly with us.

On January 26, 2021, we received

a Notice of Allowances from the Canadian Intellectual Property Office for a new patent application covering Adva-27a.

The newly issued

patent contains new subject matter and extends the proprietary protection of Adva-27a in Canada until 2033.

On February 4, 2021, we entered

into an exclusive license agreement with the University of Georgia (“UGA”) for two Anti-Coronavirus compounds which UGA had

previously developed and patented.

In collaboration with UGA, we are currently advancing the development of these two compounds in parallel

with our own Anti-Coronavirus compound, SBFM-PL4.

On March 9, 2021, we received

a Notice of Allowance from the European Patent Office for a new patent application covering Adva-27a.

The newly issued patent contains

new subject matter and extends the proprietary protection of Adva-27a in Europe until 2033.

The equivalent patent in the United States

was issued in 2019 (US Patent Number 10,272,065).

Our principal place of business

is located at 6500 Trans-Canada Highway, 4th Floor, Pointe-Claire, Quebec, Canada H9R 0A5.

Our phone number is (514) 426-6161 and our

website address is www.sunshinebiopharma.com.

We have not been subject to

any bankruptcy, receivership or similar proceeding.

Plan of Operation

Despite the fact that we now

are generating revenues, we have elected to include a Plan of Operation to discuss our ongoing research and development activities relating

to our proprietary drug development operations, as well as our other business activities.

Drug Development Operations

Anti-Coronavirus Treatment

Viruses carry minimal genetic

information as they rely, for the most part, on host cellular machinery to multiply.

Coronavirus has a positive-sense RNA genome consisting

of approximately 30,000 nucleotides, a genome size that places it among the larger sized viruses.

A positive-sense RNA genome is effectively

a messenger RNA which allows the virus to express its genes immediately upon gaining entry into the host cell without the need for any

prior replication or transcription steps as is the case with negative-sense RNA or DNA viruses.

This is part of what makes Coronavirus

a highly aggressive pathogen.

Many of the causative agents of serious human diseases are positive-sense RNA viruses, including Hepatitis

C, Zeka, Polio, West Nile, Dengue, Cardiovirus, and many others.

Some positive-sense RNA viruses, such as the rhinoviruses that cause

the common cold, are less clinically serious but they are responsible for widespread morbidity on a yearly basis.

The initial genome expression

products of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, are two large polyproteins,

referred to as pp1a and pp1ab.

These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases (Mpro and PLpro)

to generate 16 different non-structural proteins essential for viral replication.

Mpro and PLpro represent an attractive anti-viral drug

development targets as they play a central role in the early stages of viral replication.

The crystal structure of Mpro shows the presence

of an active site Cysteine (Cys145) and a coordinated active site Histidine (His41), both of which are essential for the enzyme’s

proteolytic activity.

Similarly, PLpro, also a Cysteine Protease, has an active site Cysteine at position 112 and a Histidine at 273.

The following is a summary of the development to date of our Coronavirus Treatment project:

On May 22, 2020, we filed a patent application in the United States for a new treatment for Coronavirus infections.

Our patent application covers composition subject matter pertaining to small molecules for inhibition of the Coronavirus main protease (Mpro), an enzyme that is essential for viral replication.

The small molecules covered by the patent application were computer modelled and designed by Dr.

Slilaty, our CEO.

Management’s Discussion and Analysis

of Financial Condition and Results of Operations.

following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein.

discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the

Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

The statements regarding Sunshine

Biopharma, Inc.

contained in this Report that are not historical in nature, particularly those that utilize terminology such as “may,”

“will,” “should,” “likely,” “expects,” “anticipates,” “estimates,”

“believes” or “plans,” or comparable terminology, are forward-looking statements based on current expectations

and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed

in such forward-looking statements.

Important factors known to us that could cause such material differences are identified in this report

and in our annual report on Form 10-K for the year ended December 31, 2021.

We undertake no obligation to correct or update any forward-looking

statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.

advised, however, to consult any future disclosures we make on related subjects in future reports to the SEC .

We are a pharmaceutical and

nutritional supplement company focusing on the research and development of proprietary drugs including our anti-cancer compound Adva-27a,

and anti-coronavirus lead compound, SBFM-PL4.

In addition, we are engaged in the development of specific mRNA molecules for cancer therapy.

We also, through our wholly

owned Canadian subsidiary, Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), develop science-based nutritional supplements,

and currently sell one nutritional supplement product, Essential 9 tm .

Proprietary Drug Development Operations

SBFM-PL4 Anti-Coronavirus Treatment

The following is a summary

of the development to date of our coronavirus treatment project:

On May 22, 2020, we filed a patent application in the United States for a new treatment for

Coronavirus infections.

Our patent application covers composition subject matter pertaining to small molecules for inhibition of the

Coronavirus main protease (Mpro) and papain-like protease (PLpro).

Both enzymes are essential for viral replication.

addition to being involved in maturation of specific viral proteins, PLpro is responsible for suppression of the human immune system

making the virus more virulent.

The small molecules covered by the patent application were designed by Dr.

chief executive officer.

The patent application has a priority date of May 22, 2020.

In August 2020, we completed the synthesis of four different potential inhibitors of Coronavirus protease.

In August 2020, we completed the synthesis of four different potential inhibitors of PLpro.

These compounds are based on the technology described in our patent application filed on May 22, 2020.

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Pegan, Director of the Center for Drug Discovery and Interim Associate Head of Pharmaceutical and Biomedical Sciences.

In October 2020, we expanded our collaboration with Dr.

Scott Pegan group by entering into a research agreement with the University of Georgia to further develop our Anti-Coronavirus lead compound, SBFM-PL4.

On February 1, 2021, we entered into an exclusive license agreement with the University of Georgia for two Anti-Coronavirus compounds which the University of Georgia had previously developed and patented.

We are currently advancing the development of these two compounds in parallel with our SBFM-PL4 by conducting a transgenic mice study in collaboration with the University of Georgia.

The mice being used in the study have been genetically engineered to express the human angiotensin-converting enzyme 2 (hACE2) transmembrane protein in their lungs making them susceptible to lethal infection by SARS-CoV-2, the causative agent of COVID-19.

The SARSCoV-2 virus uses the hACE2 receptor to gain entry into human cells to replicate.

The goal of the study is to determine if our protease inhibitors will protect the hACE2-transgenic mice from disease progression and death following infection with SARS-CoV-2 virus.

Should these mice studies prove successful, we plan to submit the results to the FDA for authorization to conduct testing on actual COVID-19 patient volunteers in a Phase I clinical trial setting.

The implications of a COVID-19 treatment becoming available are vast.

This is particularly the case in view of the fact that some of the variants emerging around the world are more virulent and may escape neutralization by the current vaccines.

The next steps in our SBFM-PL4 drug development plan will involve

conducting in

vitro studies followed by cell culture assays and assessment in Coronavirus infected mice before entering human clinical

In February 2022, we expanded our search for additional PLpro inhibitors by entering into a research agreement with the University of Arizona.

Pursuant to the research agreement, the University of Arizona agreed to perform a research project focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, followed by efficacy testing in mice infected with SARS-CoV-2.

Under the research agreement, the University of Arizona granted us a first option to negotiate for a commercial, royalty-bearing license for all intellectual property invented or authored by University of Arizona personnel under the research project.

Adva-27a Anticancer Drug

Since inception, our proprietary

drug development activities has focused on the development of a small molecule called Adva-27a for the treatment of aggressive forms of

A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells including

Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH,

Volume 32, Pages 4423-4432, October 2012).

Sunshine Biopharma is direct owner of all issued and pending worldwide patents pertaining to

Adva-27a including U.S.

In the area of oncology, our

proprietary drug development activities have been focused on the development of a small molecule called Adva-27a for the treatment of

aggressive forms of cancer.

A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer

cells including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER

RESEARCH, Volume 32, Pages 4423-4432, October 2012).

Sunshine Biopharma is direct owner of all issued patents pertaining to Adva-27a including

Patents Number 8,236,935 and 10,272,065.

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Unlike Etoposide however, Adva-27a is able to penetrate and destroy Multidrug Resistant Cancer cells.

is the only compound known today that is capable of destroying Multidrug Resistant Cancer.

In addition, Adva-27a has been shown to have

distinct and more desirable biological and pharmacological properties compared to Etoposide.

In side-by-side studies using Multidrug Resistant

Breast Cancer cells and Etoposide as a reference, Adva-27a showed markedly greater cell killing activity (see Figure 2).

Our preclinical studies to

date have shown that:

Adva-27a is effective at killing different types of Multidrug Resistant cancer cells, including Pancreatic Cancer Cells (Panc-1), Breast Cancer Cells (MCF-7/MDR), Small-Cell Lung Cancer Cells (H69AR), and Uterine Sarcoma Cells (MES-SA/Dx5).

Adva-27a is unaffected by P-Glycoprotein, the enzyme responsible for making cancer cells resistant to anti-tumor drugs.

Adva-27a has excellent clearance time (half-life = 54 minutes) as indicated by human microsomes stability studies and pharmacokinetics data in rats.

Adva-27a clearance is independent of Cytochrome P450, a mechanism that is less likely to produce toxic intermediates.

Adva-27a is an excellent inhibitor of Topoisomerase II with an IC50 of only 13.7 micromolar (this number has recently been reduced to 1.44 micromolar as a result of resolving the two isomeric forms of Adva-27a).

Adva-27a has shown excellent pharmacokinetics profile as indicated by studies done in rats.

Adva-27a does not inhibit tubulin assembly.

These and other preclinical

data have been published in ANTICANCER RESEARCH, a peer-reviewed International Journal of Cancer Research and Treatment.

The publication

which is entitled “Adva-27a, a Novel Podophyllotoxin Derivative Found to Be Effective Against Multidrug Resistant Human Cancer Cells”

[ANTICANCER RESEARCH 32:

4423-4432 (2012)] is available on our website at www.sunshinebiopharma.com .

We have been delayed in our

clinical development program due to lack of funding.

See “Liquidity and Capital Resources” below for a discussion of our financing

requirements.

Our fund raising efforts are

continuing and as soon as adequate financing is in place we will continue our clinical development program of Adva-27a by conducting the

following next sequence of steps:

GMP Manufacturing of 2 kilogram for use in IND-Enabling Studies and Phase I Clinical Trials,

Adva-27a has been shown to have distinct and more desirable biological and pharmacological properties compared to Etoposide.

In side-by-side

studies using Multidrug Resistant Breast Cancer cells and Etoposide as a reference, Adva-27a showed markedly greater cell killing activity

(see Figure 2).

The next sequence of steps

in our Adva-27a development program include:

GMP Manufacturing of 2 kilograms for use in IND-Enabling Studies and Phase I Clinical Trials

IND-Enabling Studies

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Phase I Clinical Trials (Pancreatic Cancer indication)

Adva-27a’s initial indication

will be Pancreatic Cancer for which there are currently little or no treatment options available.

We are planning to conduct our clinical

trials at McGill University’s Jewish General Hospital in Montreal, Canada.

All aspects of the clinical trials in Canada will employ

FDA standards at all levels.

Adva-27a’s initial

indication will be pancreatic cancer for which there are currently little or no treatment options available.

We are planning to conduct

our clinical trials at McGill University’s Jewish General Hospital in Montreal, Canada.

All aspects of the clinical trials in Canada

will employ FDA standards at all levels.

According to the American

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Resistant Cancer, we believe Adva-27a can potentially treat all cancer types, particularly those in which Topoisomerase II has been amplified.

It is possible that upon successful completion of Phase I Clinical Trials we may receive one or more offers from large pharmaceutical

companies to buyout or license our drug.

However, there are no assurances that our Phase I Trials will be successful, or if successful,

that any pharmaceutical companies will make an acceptable offer to us.

In the event we do not consummate such a transaction, we will require

significant capital in order to manufacture and market our new drug on our own.

The following, Figure 3, is

a space-filling molecular model of our Adva-27a.

Generic Pharmaceuticals Operations

In July 2014, we formed a

wholly owned Canadian subsidiary, Sunshine Biopharma Canada Inc.

(“Sunshine Canada”) for the purposes of offering generic

pharmaceutical products in Canada and elsewhere around the world.

Due to unfavorable evolution of the generic drugs marketplace, Sunshine

Canada has recently terminated its Generic Pharmaceuticals Operations and shifted its focus to the development and marketing of Science-Based

Nutritional Supplements.

Science-Based Nutritional Supplements Operations

We believe that upon successful completion of Phase I Clinical Trials we may receive one or more offers from large pharmaceutical companies

to purchase or license our drug.

However, there are no assurances that our Phase I Trials will be successful, or if successful, that any

pharmaceutical companies will make an acceptable offer to us.

In the event we do not consummate such a transaction, we will require significant

capital in order to secure regulatory approval, manufacture and market our new drug on our own.

mRNA Molecules as Anti-Cancer Agents

In June 2021, we initiated

a new research project in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents.

The data collected

to date have shown that certain mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer

cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).

Other studies using non-transformed (normal)

human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects.

These new mRNA molecules are readily adaptable

for delivery into patients using the mRNA vaccine technology.

In April 2022, we filed a provisional patent application in the United States

covering the subject mRNA molecules.

We plan to commence mice xenograft studies within approximately the next twelve months.

Nutritional Supplements Operations

Our wholly owned Canadian

subsidiary, Sunshine Canada, focuses on the development and marketing of science-based nutritional supplements.

In December 2018, we completed

the development of Essential 9 ™ , the first in a line of essential micronutrients products

that we are planning to launch.

On December 14, 2018, Health Canada issued NPN 80089663 through which it authorized Sunshine Biopharma

to manufacture and sell the Essential 9™ product.

Our Essential 9™ nutritional supplement tablets contain a balanced

formula of the 9 Essential Amino Acids that the human body cannot make.

Essential Amino Acids are 9 out of the 20 amino acids required

for protein synthesis.

Proteins are involved in all body functions – From the musculature and immune system to hormones and neurotransmitters.

Like vitamins, Essential Amino Acids cannot be made by the human body and must be obtained through diet.

Deficiency in one or more of

the 9 Essential Amino Acids can lead to loss of muscle mass, fatigue, weight gain and reduced ability to build muscle mass in athletes.

Sunshine Biopharma’s Essential 9 ™ provides all 9 Essential Amino Acids in freeform

and in the proportions recommended by Health Canada.

Essential 9 ™ is currently available

on Amazon.com and Amazon.ca.

Figure 4 below shows our 60-Tablet Essential 9 ™ product.

the development of Essential 9 ™ .

On December 14, 2018, Health Canada issued

NPN 80089663 through which it authorized us to manufacture and sell the Essential 9™ product.

Our Essential 9™ nutritional

supplement tablets contain a balanced formula of the 9 Essential Amino Acids that the human body cannot make.

Essential Amino Acids are

9 out of the 20 amino acids required for protein synthesis.

Proteins are involved in all body functions – From the musculature and

immune system to hormones and neurotransmitters.

Like vitamins, Essential Amino Acids cannot be made by the human body and must be obtained

through diet.

Deficiency in one or more of the 9 Essential Amino Acids can lead to loss of muscle mass, fatigue, weight gain and reduced

ability to build muscle mass in athletes.

Our Essential 9™ provides all 9 Essential Amino Acids in freeform and in the proportions

recommended by Health Canada.

Essential 9™ is currently available on Amazon.com and Amazon.ca.

Figure 3 below shows our 60-Tablet

Essential 9™ product.

In November 2019, we received

Health Canada approval for another nutritional supplement, a new Calcium-Vitamin D tablet.

Health Canada issued NPN 80093432 through which

it authorized us to manufacture and sell the new Calcium-Vitamin D supplement under the brand name Essential Calcium-Vitamin D™.

Vitamin D is a group of steroid-like molecules responsible for increasing intestinal absorption of calcium, magnesium, and phosphate.

They are also involved in multiple other biological functions, including proper functioning of the immune system, promoting healthy growth

of bone, and reduction of inflammation.

The most important compounds in this group are ergocalciferol (Vitamin D2) and cholecalciferol

(Vitamin D3).

Sunshine Biopharma’s Essential Calcium-Vitamin D™ tablets contain both of these compounds as well as calcium

for optimum health benefits.

We are considering potentially launching this product in 2022.

We are also developing additional

nutritional supplement products.

We may launch additional nutritional supplement products within approximately 1-2 years.

Results of Operations

Comparison of results of operations for the

Nine Months ended September 30, 2021 and 2020

During the nine months ended

September 30, 2021, we generated revenues of $143,308 from the sale of products generated by our Science-Based Nutritional Supplements

Operations which we launched in March 2019.

The direct cost for generating these sales was $56,541 (39.5%).

We generated $43,397 in sales

revenues during the comparable period in 2020.

The direct cost for generating these sales was $15,384 (35.4%).

The decrease in our gross

margin during the nine months ended September 30, 2021, was due to the introduction of new products that have lower profitability margins.

General and administrative

expenses during the nine months ended September 30, 2021 was $2,247,270, compared to $261,569 during the nine months ended September 30,

2020, an increase of $1,985,701.

The reason for this relatively large increase was due to a general increase in our business activities

as funding for our drug development projects became available.

Specifically, all of our expense categories saw increases including executive

compensation which increased by $1,093,497 due to issuance of Common Stock to our Directors.

Similarly, our R&D expenditures increased

by $581,011 and our patenting fees by $14,571.

Our other expense categories, including accounting, consulting, legal and office expenses

together increased by a total of $297,591.

We incurred $10,709,843 in

losses arising from debt conversion during the nine months ended September 30, 2021, compared to $1,416,313 in losses from debt conversion

during the similar period in 2020.

This large increase was due to more costly convertible debt financing that we took on in order to fund

our R&D activities.

The other contributing factor is related to recent volatility in our stock price.

We also incurred $292,191 in

interest expense during the nine months ended September 30, 2021, compared to $62,669 in interest expense during the similar period in

The increase was a result of the aforementioned more costly debt financing we took on.

As a result, we incurred a

net loss of $13,103,563 ($0.03 per share) during the nine month period ended September 30, 2021, compared to a net loss of $1,700,298

($0.01 per share) during the nine month period ended September 30, 2020.

Comparison of Results of Operations for the Three Months Ended September

30, 2021 and 2020

three months ended March 31, 2022 and 2021

During the three months ended

September 30, 2021, we generated $50,376 in revenues, compared to $17,150 in revenues for the same three month period in 2020, an increase

The increase is attributable to an enhanced advertising campaign we initiated in 2021.

All of these revenues were generated

from our new Science-Based Nutritional Supplements Operations which we launched in March 2019.

The direct cost for generating these revenues

was $19,506 (38.7%) for the period ended September 30, 2021, compared to $6,340 (37.0%) for the same period in 2020.

Our gross profit

increased to $30,870 for the period ended September 30, 2021, compared to a gross profit of $10,810 for the same period in 2020.

March 31, 20212, we generated $122,645 in revenues, compared to $40,058 for the three months ended March 31, 2021, an increase of $82,587.

The increase is attributable to a slightly widened advertising program.

All of these revenues were generated from our science-based nutritional

supplements operations.

The direct cost for generating these revenues was $59,845 for the three months ended March 31, 2022 (48.8%), compared

to $18,520 (46.2%) for the three months ended March 31, 2021.

The increase in the cost of goods sold in 2022 is due to increased manufacturing

Our gross profit increased to $62,800 for the three months ended March 31, 2022, compared to a gross profit of $21,538 for the same

period in 2021.

General and administrative

expenses during the three month period ended September 30, 2021 were $527,120, compared to general and administrative expenses of $78,098

incurred during the three month period ended September 30, 2020, an increase of $449,031.

Nearly all categories of our general and administrative

expenses saw an increase during the three month period ended September 30, 2021, compared to the same period in 2020.

Specifically, the

increases included R&D expenditures by $222,465, consulting fees by $16,775, office expenses by $38,993, and legal fees by $50,028.

These increases were due to expansion of our drug development and nutritional supplements operations.

Overall, we incurred a loss of $496,259

from our operations in the three month period ended September 30, 2021, compared to a loss of $67,288 in the similar period of 2020.

expenses during the three month period ended March 31, 2022 were $1,286,164 compared to $1,297,184 during the three month period ended

March 31, 2021, a decrease of $10,420.

Overall, we incurred a loss of $1,223,364 from our operations in the three month period ended March

31, 2022, compared to a loss from operations of $1,275,646 in the similar period of 2021.

In addition, we incurred $12,864

in interest expense during the three months ended September 30, 2021, compared to $22,094 in interest expense during the similar period

We also incurred $3,504,000 in losses arising from debt conversion during the three months ended September 30, 2021, compared

to $608,899 in losses from debt conversion during the similar period in 2020.

These increases were due to increased, more costly borrowings

to fund our expanded drug development and nutritional supplements operations.

As a result, we incurred a

net loss of $4,039,383 ($0.01 per share) for the three month period ended September 30, 2021, compared to a net loss of $698,595 ($0.00

per share) during the three month period ended September 30, 2020.

in interest expense during the three months ended March 31, 2022, compared to $49,711 in interest expense during the similar period in

We incurred no losses related to debt conversion during the three months ended March 31, 2022, compared to $4,910,786 in losses

arising from debt conversion during the three months ended March 31, 2021.

This was due to the fact that all of our outstanding debt was

paid during the quarter ended March 31, 2022 prior to the occurrence of any debt conversion events.

As a result, we incurred

a net loss of $1,236,234 for the three month period ended March 31, 2022, compared to a net loss of $6,185,126 for the three month period

ended March 31, 2021.

Liquidity and Capital Resources

As of September 30, 2021, we had cash and cash equivalents

As of March 31, 2022, we had cash or cash equivalents

of $13,177,625.

As discussed in Note 2 to

the consolidated financial statements included in this Report for going concern, we have incurred significant continuing losses in 2021

Our total accumulated deficits as of September 30, 2021 and December 31, 2020 were $33.3 million and $20.2 million, respectively.

Our ability to continue operating is highly dependent upon continued funding from the debt and/or equity markets.

Our historical and ongoing

dependence on proceeds from debt and/or equity issuances to fund operating expenses could raise substantial doubt about our ability to

continue as a going concern.

On June 25, 2021, the Company entered into an engagement agreement with Aegis Capital Corp.

pursuant to which we engaged Aegis to act as lead underwriter in connection with a proposed public offering (the “Offering”)

of approximately $10 million of common stock and warrants by the Company.

The Offering is contingent on satisfaction of various conditions,

including Aegis’s due diligence examination of the Company, Nasdaq approval of the listing of the Company’s Common Stock,

and successful completion of a reverse stock split.

If successful, of which there can be no assurance, we believe that this financing

will fully mitigate the afore expressed doubt about our ability to continue as a going concern.

The consolidated financial statements

included in this Report have been prepared assuming that we will continue as a going concern and, accordingly, do not include any adjustments

relating to any going concern uncertainty.

Net cash used in operating

activities was $1,517,015 during the nine month period ended September 30, 2021, compared to $233,627 for the nine month period ended

September 30, 2020.

We anticipate that overhead costs and other expenses will increase in the future as we move forward with our Proprietary

Drug Development activities and our Science-Based Nutritional Supplements operations discussed above.

activities was $1,304,208 during the three months ended March 31, 2022, compared to $297,355 during the three month period ended March

The increase was a result of increased business activities including expenses related to the two financing transactions

completed during the quarter ended March 31, 2022.

Cash flows provided by financing

activities were $2,928,339 for the nine month periods ended September 30, 2021, compared to $683,643 during the nine months ended September

Cash flows used in investing activities were $-0- for both, the nine month period ended September 30, 2021 and the same nine

month period ended in 2020.

During the nine month period

ended September 30, 2021, we issued a total of 103,673,969 shares of our Common Stock valued at $11,981,072 for the conversion of outstanding

notes payable, reducing debt by $1,233,028 and interest payable by $38,201 and generating a loss on conversion of $10,709,843.

During the nine months ended

September 30, 2020, we issued a total of 269,099,306 shares of our Common Stock valued at $1,831,816 for the conversion of outstanding

notes payable, reducing the debt by $373,269 and interest payable by $42,233 and generating a loss on conversion of $1,416,314.

During the nine months ended

September 30, 2021, we did not sell any of our capital stock for cash;

however we entered into the following new debt arrangements:

On January 12, 2021, we received monies in exchange for a Note

Payable having a Face Value of $150,000 with interest accruing at 5% is due January 12, 2023.

The Note is convertible after 180 days

from issuance into Common Stock at a price equal to $0.30 per share.

On January 27, 2021, we received monies in exchange for a Note

Payable having a Face Value of $300,000 with interest accruing at 5% is due January 27, 2023.

The Note is convertible after 180 days

from issuance into Common Stock at a price equal to $0.50 per share.

On February 12, 2021, we received monies in exchange for a

Note Payable having a Face Value of $700,000 with interest accruing at 5% is due February 12, 2023.

The Note is convertible after 180

days from issuance into Common Stock at a price equal to $0.60 per share.

On April 5, 2021, we received monies in exchange for a Note

Payable having a Face Value of $330,000 with interest accruing at 10% is due January 5, 2022.

The Note is convertible after 180 days

from issuance into Common Stock at a price 35% below market value.

On April 20, 2021, we received monies in exchange for a Note

Payable having a Face Value of $500,000 with interest accruing at 5% is due February April 20, 2023.

The Note is convertible after 180

days from issuance into Common Stock at a price equal to $0.30 per share.

· On July 6, 2021, we received monies in exchange

for a Note Payable having a Face Value of $900,000 with interest accruing at 5% is due July 6, 2023.

The Note is convertible after 180

days from issuance into Common Stock at a price equal to $0.30 per share.

· On August 18, 2021, we received monies in exchange

for a Note Payable having a Face Value of $500,000 with interest accruing at 5% is due August 18, 2023.

The Note is convertible after

180 days from issuance into Common Stock at a price equal to $0.30 per share.

On September 8, 2020, we executed

a financing agreement with RB Capital Partners, Inc., La Jolla, CA, who agreed to provide us with a minimum of $2 million in convertible

debt financing during the ensuing three to six month period pursuant to the terms and conditions included in relevant Promissory Notes

(the “Promissory Notes”).

The Promissory Notes bear interest at the rate of 5% per annum and have a maturity date of two years

from the date of issuance.

We have the right to pay off all or any part of the Promissory Notes at any time without penalty.

As of September

30,, 2021, the total outstanding principal amounts of the Promissory Notes was $3,204,215.

We are not generating adequate

revenues from our operations to fully implement our business plan as set forth herein.

As a result, our future success will depend on

the future availability of financing, among other things.

Such financing will be required to enable us to actualize our Drug Development

program and further develop our Science-Based Nutritional Supplements operation.

We intend to raise funds through private placements of

our Common Stock and/or debt financing.

We estimate that we will require approximately $10 million (approximately $9 million for our Proprietary

Drug Development projects and $1 million for our Science-Based Nutritional Supplements operations) to fully implement our business plan

in the future and there are no assurances that we will be able to raise this capital.

Our inability to obtain sufficient funds from external

sources when needed will have a material adverse effect on our plan of operation, results of operations and financial condition.

On June 25, 2021, the Company

entered into an engagement agreement with Aegis Capital Corp.

(“Aegis”), pursuant to which we engaged Aegis to act as lead

underwriter in connection with a proposed public offering (the “Offering”) of approximately $10 million of common stock and

warrants by the Company.

The Offering is contingent on satisfaction of various conditions, including Aegis’s due diligence examination

of the Company, Nasdaq approval of the listing of the Company’s Common Stock, and successful completion of a reverse stock split.

While there are no assurances that this financing will successfully close, we believe that this financing, if successfully completed,

will provide us with adequate working capital for the near term.

Our cost of operations is

expected to increase as we continue to move forward with implementation of our business plan.

We do not have sufficient funds to cover

the anticipated increase in the relevant expenses.

We need to raise additional capital in order to continue our existing operations and

finance our expansion plans for the next year.

If we are successful in raising additional funds, we expect our operations and business

efforts to continue and expand.

There are no assurances this will occur.

On October 13, 2021, the holder

of a Note Payable dated April 5, 2021 elected to convert a total of $330,000 in principal and $16,500 in accrued interest into 5,250,000

shares of our Common Stock leaving a principal balance of $-0-.

Balance Sheet Arrangements

activities were $12,437,673 for the three months ended March 31, 2022, compared to $1,102,000 for the three month periods ended March

The increase was a result of the two financing transactions completed on February 17 and March 14, 2022.

Cash flows used in investing

activities were $0 for the three months ended March 31, 2022, compared to $0 for the three month period ended March 31, 2021.

are not generating adequate revenues from our operations to fully implement our business plan as set forth herein.

On February 17, 2022,

we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in an underwritten public offering.

On March 14, 2022, we received net proceeds of approximately $6.8 million from the sale of common stock and warrants in a private placement.

On April 28, 2022, we received net proceeds of approximately $16.8 million from the sale of common stock and warrants in a private

We believe our existing cash will be sufficient to fund our operations, including general and administrative expenses, expanded

research and development activities, and nutritional supplement business, for the next 24 months.

There is no assurance our estimates

will be accurate.

We have no committed sources of capital and we anticipate that we will need to raise additional capital in the future,

including for further research and development activities and possibly clinical trials.

Additional capital may not be available on terms

acceptable to us, or at all.

Critical Accounting

Policies and Estimates

Critical Accounting

discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been

prepared in accordance with accounting principles generally accepted in the United States.

The preparation of these financial statements

requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure

of contingent assets and liabilities.

On an on-going basis, we evaluate our estimates based on historical experience and on various other

assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about

the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ

from these estimates under different assumptions or conditions.

For a detailed list of significant

accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2021, including our financial statements

and notes thereto included therein as filed with the SEC on March 21, 2022,

Adopted Accounting Standards

February 2020, the FASB issued ASU 2020-02, Financial Instruments-Credit Losses (Topic 326) and Leases (Topic 842) - Amendments

to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No.

119 and Update to SEC Section on Effective Date Related to Accounting

Standards Update No.

2016-02, Leases (Topic 842) which amends the effective date of the original pronouncement for smaller reporting

ASU 2016-13 and its amendments will be effective for the Company for interim and annual periods in fiscal years beginning after

December 15, 2022.

The Company believes the adoption will modify the way the Company analyzes financial instruments, but it does not anticipate

a material impact on results of operations.

The Company is in the process of determining the effects adoption will have on its consolidated

financial statements.

August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40) , (“ASU 2020-06”).

ASU 2020-06 simplifies

the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and

contracts on an entity’s own equity.

The ASU2020-06 amendments are effective for fiscal years beginning after December 15, 2023,

and interim periods within those fiscal years.

Early adoption is permitted, but no earlier than fiscal years beginning after

December 15, 2020, including interim periods within those fiscal years.

The Company is evaluating the impact of this guidance on its

unaudited consolidated financial statements.

Off Balance-Sheet Arrangements

Quantitative and Qualitative Disclosures

1 unchanged sentence

We are a smaller reporting

company and are not required to provide the information under this item pursuant to Regulation S-K.

company and are not required to provide the information under this item.

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-Q

Item 2. Management’s Discussion and Analysis