What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-05-10 compared with 2022-11-07 · 340 added, 268 removed, 6 unchanged (99% of the section changed)

Management’s 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.

This 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.

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.

You are advised, however, to consult any

future disclosures we make on related subjects in future reports to the SEC .

We are a pharmaceutical company

focusing on the research and development of proprietary drugs including our anticancer compound Adva-27a, our anticancer K1.1 mRNA molecules,

and anti-coronavirus lead compound, SBFM-PL4.

In addition, we develop science-based

nutritional supplements through our wholly owned Canadian subsidiary, Sunshine Biopharma Canada Inc.

(“Sunshine Canada”),

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

On October 20, 2022, we completed the acquisition of Nora Pharma Inc.

(“Nora Pharma”), a Canadian generic pharmaceuticals company.

Based in the greater Montreal area, Nora Pharma has 36 employees

and operates in a 15,000 square foot facility certified by Health Canada.

Nora Pharma currently offers over 50 pharmaceutical products,

including generic prescription drugs, over-the-counter products and biosimilars.

Nora Pharma sales were $10.7 million for its fiscal year

ended June 30, 2022 and its net income for this period was $0.3 million (USD).

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.

In 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

Slilaty, our 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 PLpro.

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

In September 2020, we completed the screening of our four compounds and subsequently identified a lead Anti-Coronavirus drug candidate (SBFM-PL4).

The screening which pinpointed the lead compound was performed at the University of Georgia, College of Pharmacy.

The next steps in our SBFM-PL4 drug development plan will involve conducting additional in vitro studies followed by cell culture assays and assessment in Coronavirus infected mice before entering human clinical trials.

In February 2022, we expanded our search for additional PLpro inhibitors by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”).

Under the agreement, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of Arizona personnel under the Research Project.

In addition, the Company and the University of Arizona entered into an Option Agreement whereby the Company was granted a first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project.

Intending to move forward with the technology, we submitted a Notice of Option Exercise to the University of Arizona on September 13, 2022.

Adva-27a Anticancer Compound

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

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 U.S.

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

Adva-27a is a GEM-difluorinated

C-glycoside derivative of Podophyllotoxin (see Figure 1).

Another derivative of Podophyllotoxin called Etoposide is currently on the market

and is used to treat various types of cancer including leukemia, lymphoma, testicular cancer, lung cancer, brain cancer, prostate cancer,

bladder cancer, colon cancer, ovarian cancer, liver cancer and several other forms of cancer.

Etoposide is one of the most widely used

anticancer drugs.

Adva-27a and Etoposide are similar in that they both attack the same target in cancer cells, namely the DNA unwinding

enzyme, Topoisomerase II.

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

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 includes:

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

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 .

Sunshine Biopharma

Sunshine Biopharma Inc.

is a pharmaceutical company

offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals.

to our own drug development operations, we operate three wholly owned subsidiaries, including (i) Nora Pharma Inc.

(“Nora Pharma”),

a Canadian corporation with a portfolio consisting of 50 prescription drugs on the market in Canada and 28 additional drugs scheduled

to be launched in 2023 and 2024, (ii) Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), a Canadian corporation which develops

and sells OTC supplements, and (iii) NOX Pharmaceuticals, Inc., a Colorado corporation which is inactive and is scheduled to be dissolved

later this year.

were incorporated in the State of Colorado on August 31, 2006 and on October 15, 2009 we acquired Sunshine Biopharma, Inc.

in a transaction

classified as a reverse acquisition.

Sunshine Biopharma, Inc.

was holding an exclusive license to a new anticancer drug bearing the laboratory

name, Adva-27a (the “License Agreement”).

Upon completion of the reverse acquisition transaction, we changed our name to

Sunshine Biopharma, Inc.

and began operating as a pharmaceutical company focusing on the development of the licensed Adva-27a anticancer

In December 2015, we acquired all worldwide issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697

and PCT/CA2014/000029 for the Adva-27a anticancer compound and terminated the License Agreement.

early 2020, we initiated a new R&D project focused on the development of a treatment for COVID-19 and on May 22, 2020, we filed a

provisional patent application in the United States for the new coronavirus treatment.

The patent application covers composition subject

matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro.

On April 30, 2021, we filed a PCT application

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

June 2021, we initiated another R&D project in which we set out to determine if certain mRNA molecules can be used as anticancer

The data obtained for mRNA molecules bearing the laboratory name K1.1 became the subject of a new patent application filed in

October 20, 2022, we acquired Nora Pharma Inc.

(“Nora Pharma”), a Canadian generic pharmaceuticals company based in the greater

Montreal area.

Nora Pharma has 37 employees and operates in a 15,000 square foot facility certified by Health Canada.

Nora Pharma currently

offers 50 generic prescription drugs and 11 nonprescription OTC products.

Nora Pharma sales were $10.7 million USD during its fiscal

year ended June 30, 2022.

The consolidated financial statements contained in this report include the results of operations of Nora Pharma

from October 20, 2022 through December 31, 2022.

on the Market

a result of the acquisition of Nora Pharma we now have the following generic prescription drugs on the market in Canada:

Action/Indication

Cardiovascular

Antibacterial

Candesartan HCTZ

Anti-inflammatory

Ciprofloxacin

Central nervous system

Cardiovascular

Central nervous system

Cardiovascular

Central nervous system

Hydroxychloroquine

Central nervous system

Levetiracetam

Central nervous system

Olanzapine ODT

Central nervous system

Cardiovascular

Olmesartan HCTZ

Cardiovascular

Olmetec Plus®

Central nervous system

Cardiovascular

Central nervous system

Quetiapine XR

Central nervous system

Cardiovascular

Rizatriptan ODT

Central nervous system

Cardiovascular

Central nervous system

Cardiovascular

Telmisartan HCTZ

Cardiovascular

Micardis Plus®

Tramadol Acetaminophen

Central nervous system

addition, we have the following nonprescription OTC products on the market in Canada and partially in the U.S.:

Essential 9 ™

Essential Amino Acids capsules (761 mg)

L-Arginine capsules (500

L-Carnitine capsules (667

Extreme-Mass ™

Weight Gain powder

Whey Protein powder

Branched-Chain Amino Acids

capsules (600 mg)

L-Creatine Monohydrate powder

Nora B12-1000

Vitamin B-12 tablets (Cyanocobalamine,

Calcium Carbonate tablets

Nora Cal-D 400

Calcium Carbonate (500 mg)

+ Vitamin D (400 IU) tablets

Nora Cal-D 1000

Calcium Carbonate (500 mg)

+ Vitamin D (1,000 IU) tablets

Vitamin D tablets (Calciferol

Senna Alexandrina tablets

Nora Sennosides

Senna Alexandrina tablets

Acetylsalicylic Acid tablets

NRA-Docusate Sodium

Docusate Sodium capsules

Potassium Chloride tablets

in Development

following table summarizes our generic and proprietary drugs in development:

Group A (4 Products)

Central Nervous System, Urology,

Cardiovascular

Under Regulatory Review

Group B (3 Products)

Central Nervous System, Gastrointestinal

Under Regulatory Review

Group C (1 Product)

Under Regulatory Review

Group D (8 Products)

Central Nervous System, Cardiovascular,

Under Regulatory Review

Group E (5 Products)

Cardiovascular, Urology,

Endocrinology

Under Regulatory Review

Group F (6 Products)

Urology, Cardiovascular,

Oncology, Anti-infectives

Under Regulatory Review

Adva-27a (Small Molecule)

Oncology (Pancreatic Cancer)

IND-Enabling Studies

Regulatory Filing (Fast-Track status anticipated)

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.

K1.1 (mRNA LNP)

Oncology (Liver Cancer)

Animal Testing

SBFM-PL4 (Small Molecule)

Antiviral (COVID-19)

Animal Testing

Drugs in Development

Anticancer Drug

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).

We are the direct owner of all patents pertaining

to Adva-27a including U.S.

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

is a GEM-difluorinated C-glycoside derivative of Podophyllotoxin.

Another derivative of Podophyllotoxin called Etoposide is currently

on the market and is used to treat various types of cancer including leukemia, lymphoma, testicular cancer, lung cancer, brain cancer,

prostate cancer, bladder cancer, colon cancer, ovarian cancer, liver cancer and several other forms of cancer.

Etoposide is one of the

most widely used anticancer drugs.

Adva-27a and Etoposide are similar in that they both attack the same target in cancer cells, namely

the DNA unwinding enzyme, Topoisomerase II.

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

In addition, Adva-27a has been shown to have distinct and more desirable biological and pharmacological properties compared to

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 1).

February 2023, we signed a research agreement with the Jewish General Hospital (“JGH”), to complete the IND-enabling studies.

The JGH has also agreed to negotiate with us the terms for Phase I Clinical Trials.

Adva-27a’s initial indication will be pancreatic

cancer for which there are currently little or no treatment options available.

All aspects of the clinical trials in Canada will employ

FDA standards at all levels.

According to the American Cancer

Society, nearly 1.5 million new cases of cancer are diagnosed in the U.S.

While particularly effective against Multidrug Resistant

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

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.

K1.1 Anti-cancer mRNA

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 a selected group of 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, bearing the

laboratory name K1.1, 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 are currently in discussion with several potential partners

for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (K1.1::LNP).

Using the K1.1::LNP formulations, 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 our first nutritional supplement product which we named Essential 9 ™ .

On December 14, 2018, Health Canada issued NPN 80089663 through which it authorized us to manufacture and sell the Essential 9™

Our Essential 9™ nutritional supplement product was originally launched as a tablet and has now been reformatted into vegan

Our Essential 9 tm capsules 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.

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 reformatted 60-Capsule 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 2023.

Results of Operations

Comparison of results of operations for the

three months ended September 30, 2022 and 2021

During the three months ended

September 30, 2022, we generated revenues of $132,808, compared to revenue of $50,376 for the three months ended September 30, 2021.

increase is attributable to increased marketing efforts.

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

The direct cost for generating these revenues was $65,783 for the three months ended September 30, 2022 (49.5%), compared

to $19,506 (38.7%) for the three months ended September 30, 2021.

The increase in cost of sales in 2022 is due to increases in manufacturing

Our gross profit increased to $67,025 for the three months ended September 30, 2022, compared to a gross profit of $30,870 for the

same period in 2021.

General and administrative expenses

during the three month period ended September 30, 2022 were $1,785,005 compared to $527,129 during the three month period ended September

30, 2021, an increase of $1,257,876.

Overall, we incurred a loss of $1,717,980 from our operations in the three month period ended September

30, 2022, compared to a loss from operations of $496,259 in the similar period of 2021.

In addition, we had interest income of $260,938, interest expense of

$2, and debt forgiveness of $0, during the three months ended September 30, 2022, compared to interest income of $0, interest expense

of $46,849, and debt forgiveness of $7,688, during the three months ended September 30, 2021.

This was primarily due to the transitioning

of our financing from convertible debt to equity.

We incurred no losses related to debt conversion during the three months ended September

30, 2022, compared to $3,504,000 in losses arising from debt conversion during the three months ended September 30, 2021.

This was also

due to the transitioning of our financing from convertible debt to equity.

As a result, we incurred a net

loss of $1,457,019 for the three month period ended September 30, 2022, compared to a net loss of $4,039,383 for the three month period

ended September 30, 2021.

Comparison of results of operations for the

nine months ended September 30, 2022 and 2021

During the nine months ended September

30, 2022, we generated revenues of $405,760, compared to revenue of $143,308 for the nine months ended September 30, 2021.

is attributable to increased marketing efforts.

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

The direct cost for generating these revenues was $200,311 for the nine months ended September 30, 2022 (49.4%), compared to $56,541 (39.5%)

for the nine months ended September 30, 2021.

The increase in cost of sales in 2022 is due to increases in manufacturing cost.

profit increased to $205,449 for the nine months ended September 30, 2022, compared to a gross profit of $86,767 for the same period in

General and administrative expenses

during the nine month period ended September 30, 2022 were $3,842,589 compared to $2,247,270 during the nine month period ended September

30, 2021, an increase of $1,595,319.

Overall, we incurred a loss of $3,637,140 from our operations in the nine month period ended September

30, 2022, compared to a loss from operations of $2,160,503 in the similar period of 2021.

In addition, we had interest

income of $406,984, interest expense of $12,866, and debt forgiveness of $10,852 during the nine months ended September 30, 2022, compared

to interest income of $0, interest expense of $292,188, and debt forgiveness of $58,940 during the nine months ended September 30, 2021.

This was primarily due to the transitioning of our financing from convertible debt to equity.

We incurred no losses related to debt conversion

during the nine months ended September 30, 2022, compared to $10,709,843 in losses arising from debt conversion during the nine months

ended September 30, 2021.

This was also due to the transitioning of our financing from convertible debt to equity.

As a result, we incurred a net

loss of $3,232,125 for the nine month period ended September 30, 2022, compared to a net loss of $13,103,563 for the nine month period

ended September 30, 2021.

Liquidity and Capital Resources

As of September 30, 2022, we had cash and cash equivalents

of $40,555,931.

Net cash used in operating activities

was $3,001,746 during the nine months ended September 30, 2022, compared to $1,517,015 during the nine month period ended September 30,

The increase was a result of increased marketing and R&D activities as well as increases in professional fees related to becoming

a Nasdaq listed company.

Cash flows provided by financing

activities were $41,561,363 for the nine months ended September 30, 2022, compared to $2,928,339 for the nine month period ended September

The increase was a result of three financing events completed in February, March and April 2022, as well as warrant exercises.

Cash flows used in investing activities

were $0 for the nine months ended September 30, 2022 and September 30, 2021.

We 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 placement.

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.

Anticancer mRNA

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

The data collected to date have shown that a selected group of 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).

Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic effects.

new mRNA molecules, bearing the laboratory name K1.1, 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 recently concluded

an agreement with a specialized partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles, ready for use

to conduct studies in xenograft mice.

We anticipate commencing such studies later this year.

COVID-19 Treatment

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

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

PLpro is of particular

interest as a therapeutic target in that, in addition to processing viral proteins, it is also responsible for suppression of the human

immune system making the virus more life-threatening.

COVID-19 research effort has been focused on developing an inhibitor of PLpro, the viral enzyme that mediates suppression of the human

immune system.

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

patent application covers composition subject matter pertaining to small molecules for inhibition of the Coronavirus main protease (Mpro)

and papain-like protease (PLpro).

February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona

for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of

three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research

Under the agreement, the University of Arizona granted the Company a first option to negotiate a commercial, royalty-bearing

license for all intellectual property developed by University of Arizona personnel under the Research Project.

In addition, the Company

and the University of Arizona entered into an option agreement (the “Option Agreement”) whereby the Company was granted a

first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project.

On September 13,

2022, we exercised our option under the Option Agreement and on February 24, 2023, we entered into an exclusive worldwide license agreement

with the University of Arizona for all of the technology related to the Research Project.

are the sole owner of all worldwide rights pertaining to Adva-27a.

These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029.

patent applications filed under these two PCT's have been issued in the United States (US Patent Number 8,236,935 and 10,272,065), Europe,

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

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 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.

priority date of May 22, 2020 has been maintained in the newly filed PCT application.

April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells

The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant

mRNA molecules.

recently acquired wholly owned subsidiary, Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently

on the market in Canada.

These DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic

pharmaceutical products.

addition, we are the owner of two NPN’s issued by Health Canada:

NPN 80089663 authorizes us to manufacture and sell our in-house

developed OTC product, Essential 9™, and NPN 80093432 authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D

under the brand name Essential Calcium-Vitamin D ™ .

of Operations

of results of operations for the three months ended March 31, 2023 and 2022

the three months ended March 31, 2023, we generated $4,894,053 in sales, compared to $122,645 for the three months

ended March 31, 2022, an increase of $4,771,408.

The increase is attributable to sales generated by our recently acquired wholly owned

subsidiary, Nora Pharma.

The direct cost for generating these sales was $3,065,931 (62.6%) for the three months ended March 31, 2023,

compared to $59,845 for the three months ended March 31, 2022 (48.8%).

The increase in the cost of goods sold in 2023 is due to the cost

of manufacturing of the generic prescription drugs sold by Nora Pharma.

Our gross profit grew to $1,828,122 for the three months ended

March 31, 2023, compared to $62,800 for the three months ended March 31, 2022.

General and administrative expenses during the three month period ended March

31, 2023 were $3,657,103, compared to $1,286,164 during the three month period ended March 31, 2022, an increase of $2,370,939.

This increase

was the result of increased overhead associated with being a Nasdaq listed company and expenses related to Nora Pharma operations.

Specifically,

we incurred increased costs in accounting ($95,951), consulting ($126,117), office costs ($199,953), research and development ($71,273),

salaries ($1,739,257) and taxes ($63,718).

Overall, we incurred a loss of $1,828,981 from our operations for the three months ended March

31, 2023, compared to a loss of $1,223,364 from our operations in the three month period ended March 31, 2022.

addition, we had net interest income of approximately $172,821 during the three months ended March 31, 2023, compared to a net interest

expense of approximately $12,870 during the three months ended March 31, 2022, as a result of interest earned on the cash on hand.

a result, we incurred a net loss of $1,702,430 for the three months ended March 31, 2023, compared to a net loss of $1,236,234 for the

three month period ended March 31, 2022.

and Capital Resources

31, 2023, we had cash or cash equivalents of $19,294,218.

Net cash used in operating activities was $1,850,106

during the three months ended March 31, 2023, compared to $1,304,208 during the three month period ended March 31, 2022.

was a result of the addition of Nora Pharma’s operations.

Cash flows used in investing activities were $146,303

for the three months ended March 31, 2023, compared to $0 for the three months ended March 31, 2022.

The increase was the result of cash

invested in Nora Pharma.

Cash flows used in financing activities were $(538,299)

for the three months ended March 31, 2023, compared to $12,437,673 provided by financing activities for the three months ended March 31,

The decrease was primarily as a result of no offerings made during the three months ended March 31, 2023 compared to two offerings

completed in February and March 2022, and due to our purchase of $506,822 in common stock under Rule 10B-14 in the first quarter of 2023

period compared to $0 during the same period in 2022.

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 placement.

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

and development activities, and OTC supplements 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, as well as expansion of our generic pharmaceutical operations arising from the Nora Pharma acquisition.

Additional capital may not be available on terms acceptable to us, or at all.

Critical Accounting Policies and Estimates

Critical Accounting Estimates

The 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,

Recently Adopted Accounting Standards

In 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.

Management estimates that we will need additional capital in the amount of approximately

$30 million to fully implement our business plan, including funding for further research and development activities and possibly clinical

trials, as well as expansion of our generic pharmaceuticals operations arising from the Nora Pharma acquisition.

Additional capital may

not be available on terms acceptable to us, or at all.

Currently, we do not have any firm committed arrangements for financing and

can provide no assurance that we will be able to obtain financing when required.

No assurance can be given that we will obtain access

to capital markets in the future or that financing, adequate to satisfy the cash requirements of implementing our business will be available

on acceptable terms.

Our inability to obtain acceptable financing could have an adverse effect upon the results of our operations and

financial condition.

Accounting Estimates

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.

a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31,

2022, including our financial statements and notes thereto included therein as filed with the SEC on April 4, 2023.

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

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

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

In 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

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

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

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.

The Company is evaluating the impact of this guidance on its unaudited consolidated financial statements.

Off Balance-Sheet Arrangements

Quantitative and Qualitative Disclosures

About Market Risk.

We are a smaller reporting company

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

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

Balance-Sheet Arrangements

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

are a smaller reporting 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