What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-04-04 compared with 2022-03-21 · 323 added, 374 removed, 17 unchanged (98% of the section changed)

History and Overview

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.

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.

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.

Effective October 15, 2009,

we acquired Sunshine Biopharma, Inc.

in a transaction classified as a reverse acquisition.

About Sunshine Biopharma

are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including

oncology and antivirals.

In addition 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 49 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 drug.

In October 2012, we published

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

The 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.

In the first quarter of 2021, Sunshine Canada transitioned its focus

to the development and marketing of Science-Based Nutritional Supplements.

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 from Advanomics Corporation (now known as TRT Pharma Inc.), a related party, and terminated the License

We are continuing development of the Adva-27a anticancer drug covered by these patents.

In December 2018, the Company

launched its first Science-Based Nutritional Supplements product, Essential 9 ™ ,

an over-the-counter tablet comprised of the nine (9) essential amino acids that the human body cannot make.

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

On 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 49 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 ™

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

Effective April 6, 2020, we

completed another 20 to 1 reverse split of our 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 number of Common Shares authorized for issuance remained as previously

established at 3,000,000,000 shares.

On May 22, 2020, we filed

a provisional 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 main Coronavirus protease, Mpro, an enzyme that is essential for viral

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.

Effective October 6, 2020,

we entered into a Research Agreement with the University of Georgia Research Foundation, Inc.

(“UGARF”), 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 the Company’s Anti-Coronavirus lead compound, SBFM-PL4 (or derivatives

thereof) through various stages of preclinical development.

The agreement grants us an exclusive worldwide license for all of the intellectual

property developed during the term of the agreement, whether developed by UGA 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 2034.

On February 4, 2021, we entered

into an additional research agreement and an exclusive license agreement with the University of Georgia (“UGA”) for two Anti-Coronavirus

compounds which UGA had previously developed and patented.

This second research agreement provides for UGA to conduct mice studies on

the two UGA compounds licensed to us.

In December 2021, we were informed by the University of Georgia that preliminary results of the

mice study taking place indicated these two compounds have no significant effect on mice infected with SARS-CoV-2.

As a result, we no

longer plan to pursue the UGA License or further development of these two compounds.

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 2034.

The equivalent patent in the United States

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

On October 1, 2021, we filed

a patent application for a potential new treatment for neurodegenerative disorders.

The patent application contains experimental results

showing that certain mRNA molecules provide protective effects against oxidative stress in differentiated neuronal cells, a process that

mimics neuronal degeneration.

This new patent application has a priority date of October 1, 2021.

February 18, 2022 we entered into a research agreement with the Arizona Board of Regents on behalf of the University of Arizona (the “University

of Arizona”).

Pursuant to the research agreement, the University of Arizona agreed to use reasonable efforts 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, in consideration for certain milestone payments to be

made by the Company.

Under the agreement, the University of Arizona granted the Company 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.

Proprietary Drug Development Operations

SBFM-PL4 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 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 designed by Dr.

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 Coronavirus protease.

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 under the leadership of Dr.

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

We will proceed by conducting the in vitro studies followed by cell culture assays and assessment in Coronavirus infected mice before entering human clinical trials.

On February 18, 2022, we expanded our effort to identify new 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 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 have 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.

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:

Nervous System, Urology, Cardiovascular

Under Regulatory

Nervous System, Gastrointestinal

Under Regulatory

Nervous System, Cardiovascular, Metabolism

Under Regulatory

Cardiovascular, Urology, Endocrinology

Under Regulatory

Urology, Cardiovascular, Oncology, Anti-infectives

Under Regulatory

(Small Molecule)

(Pancreatic Cancer)

(Liver Cancer)

(Small Molecule)

Drugs in Development

Anticancer Compound

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).

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.

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.

Information on our website is not

part of this report.

We have been delayed in our

clinical development program due to lack of funding.

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

IND-Enabling Studies

Regulatory Filing (Fast-Track Status Anticipated)

Phase I Clinical Trials (Pancreatic Cancer Indication)

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

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.

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

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.

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 manufacture and market our new drug on our own.

The following, Figure 3, is a space-filling molecular model of our

Nutritional Supplements Operations

Sunshine Canada has recently

terminated its generic pharmaceuticals operations and shifted its focus to the development and marketing of science-based nutritional

In December 2018, we completed 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™

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

Figure 4 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 tablets.

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 Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol).

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.

Manufacturing

Our Essential 9™ nutritional

supplement is manufactured under contract by Inov Pharma Inc., an independent third party based in Montreal (Canada).

Inov Pharma Inc.

operates a GMP certified manufacturing facility and all of our nutritional supplements products are manufactured under such conditions.

We currently do not have any

pharmaceutical products on the market.

Research quantities of our drug candidates are currently manufactured at the University of Georgia,

Athens, GA (Anti-Coronavirus compounds) and WuXi App Tech (Adva-27a compound) in China.

Marketing and Sales

Our Essential 9™ nutritional

supplement is currently sold through Amazon only.

Company personnel and outside consultants develop and place ads on Google, YouTube and

Amazon, and the same team manages the Company’s account with Amazon.

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.

Similarly, we believe there is potentially a large market for our Anti-Coronavirus treatment currently under development

at the University of Georgia.

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 these drugs.

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.

If we do not consummate such a

transaction, and we receive required regulatory approvals, we will require significant capital in order to manufacture and market our

new drugs on our own.

Intellectual Property

We are the exclusive owner

of all worldwide rights pertaining to Adva-27a covered by PCT/FR2007/000697 and PCT/CA2014/000029.

The patent applications filed

under PCT/FR2007/000697 have been issued in the United States (US Patent Number 8,236,935), Europe, and Canada.

The patent applications

filed under PCT/CA2014/000029 have recently been issued in the United States (US Patent Number 10,272,065), and allowed in Europe, and

In 2018 we completed the development

of Essential 9™, our first nutritional supplement.

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

Sunshine Biopharma Inc.

to manufacture and sell the Essential 9™ product.

We are currently preparing the necessary documents for

registration of our Essential 9™ trademark in the United States.

In November 2019, we received

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

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 ™ .

On May 22, 2020, the Company

filed a provisional patent application in the United States for a new treatment for Coronavirus infections.

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

On April 30, 2021, the Company

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

All aspects of the clinical trials

in Canada will employ FDA standards at all levels.

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 within approximately the next twelve months.

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 whereby the Company was granted a first option to negotiate a royalty-bearing

commercial license for the underlying technology of the Research Project.

Encouraged by the results obtained to date, we submitted a

Notice of Option Exercise to the University of Arizona on September 13, 2022.

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.

The 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, and Canada.

May 22, 2020, we filed a provisional 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 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.

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

On October 1, 2021, we filed

a patent application for a potential new treatment for neurodegenerative disorders.

The patent application contains experimental results

showing that certain mRNA molecules provide protective effects against oxidative stress in differentiated neuronal cells, a process that

mimics neuronal degeneration.

This new patent application has a priority date of October 1, 2021.

Government Regulations

All of our business operations,

including our proprietary drug development operations, and nutritional supplements operations are subject to extensive and frequently

changing federal, state, provincial and local laws and regulations.

In the United States, the

Federal Government agency responsible for regulating drugs and nutritional supplements is the U.S.

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 ™ .

Manufacturing

generic drugs are manufactured by several different international partners under long-term contracts.

currently do not have any proprietary drugs on the market.

Research quantities of our proprietary drug candidates are currently manufactured

at the University of Arizona located in Tucson, Arizona (Anti-Coronavirus compounds), WuXi App Tech located in Hong Kong, China (Adva-27a

compound), and Arranta Bio MA LLC located in Watertown, Massachusetts (K1.1 mRNA).

OTC products are manufactured under contract by INOV Pharma Inc.

located in Montreal, Canada.

generic drugs are currently being sold across Canada.

All of our generic drug sales are conducted by Nora Pharma’s sales representatives

based in key Provinces across Canada.

In addition, a segment of our marketing team offers human resources and commercial assistance to

pharmacies and pharmacy owners by providing experienced pharmacists and technical assistant recruitment services as well as training

and education support.

OTC products are currently sold in the U.S.

and Canada through Amazon.com and Amazon.ca, respectively.

Our personnel together with

outside consultants develop and place ads on Google, YouTube, Amazon, and other media outlets.

The same team manages our

accounts with Amazon.

of our business operations, including our generic drugs, proprietary drugs, and OTC products operations, are subject to extensive and

frequently changing federal, state, provincial and local laws and regulations.

the United States, the Federal Government agency responsible for regulating prescription drugs and nonprescription OTC supplements is

Food and Drug Administration (“FDA”).

The Canadian counterpart to the FDA is Health Canada.

Though the FDA and Health Canada have generally similar requirements for drugs and

nutritional supplements to be approved or allowed to be marketed, approval in one jurisdiction does not automatically result in approval

in the other.

In Canada, drugs and nutritional supplements are authorized through the issuance by Health Canada of a Drug Identification

Number (DIN) for pharmaceutical products and a Natural Product Number (NPN) for nutritional supplements.

In the United States, the marketing

of nutritional supplements does not require prior approval from the FDA.

Though the FDA and Health

Canada have generally similar requirements for drugs and OTC supplements to be approved or allowed to be marketed, approval in one jurisdiction

does not automatically result in approval in the other.

In Canada, prescription drugs and nonprescription OTC supplements are authorized

through the issuance by Health Canada of a Drug Identification Number (DIN) for the former and a Natural Product Number (NPN) for the

In the United States, the marketing of OTC supplements does not require prior approval from the FDA, provided that the ingredients

are known to the FDA.

In both the U.S.

and Canada, the ingredients, manufacturing processes

and facilities for all drugs and supplements must meet the guidelines for Good Manufacturing Practices (“GMP”).

all drug manufacturers must perform a series of tests, both during and after production, to show that every drug or supplement batch made

meets the regulatory requirements for that product.

In connection with nutritional

supplements, the FDA regulates the formulation, manufacturing, packaging, storage, labeling, promotion, distribution and sale of such

products, while the Federal Trade Commission (“FTC”) regulates marketing and advertising claims.

In August 2007, a rule issued

by the FDA went into effect requiring companies that manufacture, package, label, distribute or hold nutritional supplements to meet certain

GMP requirements to ensure such products are of the quality specified and are properly packaged and labeled.

We are committed to meeting

or exceeding the standards set by the FDA and the FTC and we believe we are currently operating within both the FDA and FTC mandates.

In the area of drug development

where our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant regulations in the U.S.

in order to obtain

approval of the FDA to offer our products for sale.

The approximate procedure for obtaining FDA approval involves an initial filing

of an IND application following which the FDA would review and allow for the drug developer to proceed with Phase I clinical trials.

completion of Phase I, the results are filed with the FDA and a request is made to proceed to Phase II.

Similarly, following completion

of Phase II the data are filed with the FDA and a request is made to proceed to Phase III.

Following completion of Phase III, a new

drug application, or NDA is submitted and a request is made for marketing approval.

Depending on various issues and considerations, the

FDA could provide “emergency use authorization” or limited approval for “compassionate-use” if the drug treats

terminally ill patients with limited other treatment options available.

As of the date of the filing of this report, we have

not made any filings with the FDA or other regulatory bodies in other jurisdictions.

and Canada, the ingredients, manufacturing processes and facilities for all drugs and OTC supplements

must meet the guidelines for Good Manufacturing Practices (“GMP”).

Moreover, all drug manufacturers must perform a series

of tests, both during and after production, to show that every drug or supplement batch made meets the regulatory requirements for that

generic prescription medicines are produced following the same Good

Manufacturing Practices (GMP) guidelines as for brand-name drugs.

Prescription drugs dossiers are filed with Health Canada in order to

obtain a manufacturing Notice of Compliance (NOC) and a Drug Identification Number (DIN).

The same grant the applicant marketing authorization

In the case of Nora Pharma’s products, Nora Pharma secures cross-licenses from supply partners holding NOC’s and

in turn applies to Health Canada to obtain DIN’s issued in Nora Pharma’s name in order to commercialize in Canada.

the pan-Canadian Pharmaceutical Alliance (pCPA), an alliance of the provincial, territorial and federal governments that collaborates

on a range of public drug plan initiatives to increase and manage access to clinically effective and affordable drug treatments, determines

generic drugs pricing based on a percentage of the brand-name reference products.

the area of proprietary drug development where our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant

regulations in the U.S.

in order to obtain approval of the FDA to offer our products for sale.

The approximate procedure for obtaining

FDA approval involves an initial filing of an IND application following which the FDA would review and allow for the drug developer to

proceed with Phase I clinical trials.

Following completion of Phase I, the results are filed with the FDA and a request is made to proceed

Similarly, following completion of Phase II the data are filed with the FDA and a request is made to proceed to Phase III.

completion of Phase III, a new drug application, or NDA is submitted and a request is made for marketing approval.

Depending on various

issues and considerations, the FDA could provide “emergency use authorization” or limited approval for “compassionate-use”

if the drug treats terminally ill patients with limited other treatment options available.

As of the date of the filing of this report,

we have not made any filings with the FDA or other regulatory bodies in other jurisdictions.

We anticipate filing an initial IND application

for an anti-Covid-19 compound within approximately one year and filing an initial IND for our anti-cancer compound within approximately

We have however had discussions with clinicians and as a result we believe that the FDA and Health Canada are likely to

grant us a so-called “fast-track” process on the basis of the ongoing Covid-19 pandemic and the terminal nature of the cancer

type we are planning to treat.

We have however had discussions with clinicians and as a result we believe that the FDA and Health Canada are likely

to grant us a so-called “fast-track” process on the basis of the ongoing Covid-19 pandemic and the terminal nature of the

cancer type we are planning to treat.

There are no assurances this will occur.

As of the date of this report,

we have three employees, comprised of our management team.

Presently, most of our development and marketing activities are subcontracted

out to specialized service providers.

As our business activities expand, we anticipate that we will need additional employees in the areas

of accounting, regulatory affairs, marketing, sales and laboratory personnel.

Our Anti-Coronavirus drug

development project is in direct competition with over 34 companies in the U.S.

and abroad that are developing or that have developed

vaccine or treatment options for Covid-19.

Among the companies that have or are developing vaccines are Pfizer, Moderna, AstraZeneca,

and Johnson & Johnson.

connection with OTC supplements, the FDA regulates the formulation, manufacturing, packaging, storage, labeling, promotion, distribution,

and sale of such products, while the Federal Trade Commission (“FTC”) regulates marketing and advertising claims.

2007, a rule issued by the FDA went into effect requiring companies that manufacture, package, label, distribute or hold OTC supplements

to meet certain GMP requirements to ensure such products are of the quality specified and are properly packaged and labeled.

We are committed

to meeting or exceeding the standards set by the FDA and the FTC and we believe we are currently operating within both the FDA and FTC

of the date of this report we have a total of 46 employees, comprised of our management team and other corporate personnel and 37 employees

at Nora Pharma.

to deliver medicines that change patients’ lives.

Such ambitious goal is achieved through the relentless effort and dedication

of our talented workforce.

As of December 31, 2022, women compose approximately 48% of our workforce.

Going forward, we are committed

to maintaining fully balanced workforce that includes persons of diverse sexual orientation and ethnic backgrounds.

our proprietary drug development activities are subcontracted out to specialized service providers in the U.S.

consultants for various other activities including, marketing, accounting, and IT.

laws in Quebec provide for certain guaranteed minimum entitlements, including minimum wages, maternity leave, medical leave, employee

termination conditions, etc.

Moreover, the Province of Quebec has various language laws governing language use.

These laws require corporate

operations carried out in the Province of Quebec to be conducted to a large extent, and some cases entirely, in French.

We and our Canadian

subsidiaries operating in the Province of Quebec are fully compliant with these laws.

generic pharmaceuticals market is valued at approximately $7.2 billion CAD (approximately $5.3 billion USD).

Generic pharmaceutical

companies produce and deliver more than 70% of the prescribed medicines with high quality at affordable prices.

There are more than 35

active generic players in the market, of which, the top 3 hold approximately 50% share of the market.

Nora Pharma is relatively new in

this space but has demonstrated one of the fastest year-over-year sales increase amongst its peers.

Anti-Coronavirus drug development project is in direct competition with several companies in the U.S.

that have developed effective vaccines

or treatment options for Covid-19.

The companies focused on treatments include Pfizer, Merck, Gilead, Eli Lilly, and Regeneron.

To date, three

vaccines (Pfizer’s, Moderna’s, and Johnson & Johnson’s) and two (2) antibody treatments (Regeneron’s, and

Eli Lilly’s) have been approved by the FDA for emergency use, and Pfizer’s vaccine has received full FDA approval.

Remdesivir, an antiviral injectable, was approved by the FDA for treatment of Covid-19 in October 2020.

In addition, in December 2021,

Pfizer received Emergency Use Authorization (“EUA”), for its antiviral pill, Paxlovid, and, in the same month, the FDA granted

Merck EUA for its antiviral pill, Molnupiravir.

While the approved vaccines, pills and injectable treatments are effective, we believe

that additional treatment options such as the one we are developing could potentially form an important component of the range of anti-coronavirus

tools available to attending physicians.

In the area of anticancer

drug development, we compete with large publicly and privately held companies engaged in developing new cancer therapies.

There are numerous

other entities engaged in oncology therapeutics development that have greater resources, both financial and otherwise, than the resources

two leading vaccines (Pfizer’s, and Moderna’s) and two antibody treatments (Regeneron’s, and Eli Lilly’s) are

Gilead’s Remdesivir, an antiviral injectable, was approved by the FDA for treatment of Covid-19 in October 2020.

in December 2021, Pfizer received Emergency Use Authorization (“EUA”), for its antiviral pill, Paxlovid, and, in the same

month, the FDA granted Merck EUA for its antiviral pill, Molnupiravir.

While the approved vaccines, pills and injectable treatments are

effective, we believe that additional treatment options such as the one we are developing which targets a different part of the virus

could potentially form an important component of the range of anti-coronavirus treatment options available to attending physicians.

the area of anticancer drug development we compete with large publicly and privately held companies engaged in developing new cancer

There are numerous other entities engaged in oncology therapeutics development that have greater resources than the resources

presently available to us.

Nearly all major pharmaceutical companies including Merck, Amgen, Roche, Pfizer, Bristol-Myers Squibb

and Novartis, to name a few, have on-going anticancer drug development programs and some of the drugs they may develop could be in direct

Nearly all major pharmaceutical companies including Merck, Amgen, Roche, Pfizer, Bristol-Myers Squibb and

Novartis, to name a few, have on-going anticancer drug development programs and some of the drugs they may develop could be in direct

competition with our own.

1 unchanged sentence

that may be in competition with ours.

Similarly, our Essential 9™

and Essential Calcium-Vitamin D™ fall directly within a very crowded and highly competitive product sector.

As of the date of the

filing of this report, we believe Essential 9™ is the only Essential Amino Acid product that comprises all 9 essential amino acids

in tablet form.

We believe this may provide us with a competitive advantage, at least for the near future but there are no assurances

that this will occur.

our OTC products fall directly within a very crowded and highly competitive product sector.

As of the date of this report,

we believe Essential 9™ is the only Essential Amino Acid product that comprises all 9 essential amino acids in capsule form.

believe this may provide us with a competitive advantage, at least for the near future but there are no assurances that this will occur.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business