What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-04-04 · 277 added, 282 removed, 58 unchanged (91% of the section changed)

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

We are a pharmaceutical company offering and researching

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

We operate two wholly owned subsidiaries:

(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

(“Nora Pharma”), a Canadian corporation with a portfolio consisting of 52 prescription drugs on the market

in Canada, and (ii) Sunshine Biopharma Canada Inc.

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

In addition, we are conducting a proprietary drug

development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus

infections, and (iii) Adva-27a for pancreatic cancer.

Development of the latter has been paused pending further analysis of unfavorable

in vitro results obtained in the second half of 2023.

See “Drugs in Development,” below.

We 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.

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

held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the “License

Upon completion of the reverse acquisition transaction, we changed our name to Sunshine Biopharma, Inc.

operating as a pharmaceutical company focusing on the development of the licensed Adva-27a anticancer drug.

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.

Development of Adva-27a has been paused pending further analysis

of unexpected in vitro results obtained in the latter part of 2023.

See “Drugs in Development,” below.

In 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.

In June 2021, we initiated another R&D project

in which we set out to determine if certain mRNA molecules can be used as anticancer agents.

The data obtained for mRNA molecules bearing

the laboratory name K1.1 became the subject of a new patent application filed in April 2022.

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:

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

Nora Pharma has 44 employees

and operates in a 23,500 square foot facility certified by Health Canada.

Nora Pharma currently has 52 generic prescription drugs on the market in Canada.

Products on the Market

Through Nora Pharma we currently have the

following generic prescription drugs on the market in Canada:

Action/Indication

1 unchanged sentence

Cardiovascular

Antipsychotic

Cardiovascular

1 unchanged sentence

Candesartan HCTZ

Atacand Plus®

Anti-inflammatory

2 unchanged sentences

Cardiovascular

Dapagliflozin

Central nervous system

9 unchanged sentences

Central nervous system

Olanzapine ODT

Central nervous system

Cardiovascular

2 unchanged sentences

Olmetec Plus®

Gastroenterology

Central nervous system

14 unchanged sentences

Micardis Plus®

Anticonvulsant

Tramadol Acetaminophen

2 unchanged sentences

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:

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)

In addition to the 52 drugs currently on the market,

we have 32 additional drugs scheduled to be launched in 2024 and 2025.

These new drugs will address various human health areas including

cardiovascular, oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.

We believe the addition of these products to our

existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide us with greater access

to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.

Products in Development

The following table summarizes our proprietary

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.

Adva-27a (Small Molecule)

Oncology (Pancreatic Cancer)

K1.1 (mRNA LNP)

Oncology (Liver Cancer)

Animal Testing

SBFM-PL4 (Small Molecule)

Antiviral (SARS Coronavirus)

Animal Testing

*See “Adva-27a Anticancer Compound,”

Adva-27a Anticancer Compound

Adva-27a is a small molecule designed 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

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

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.

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.

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 ™ .

In December 2022, we entered into a research agreement

with the Jewish General Hospital (“JGH”), to conduct the IND-enabling studies of Adva-27a (the “Research Agreement”).

In August 2023, we were informed by the JGH that the laboratory results on testing of the Adva-27a molecule were not favorable.

conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice to JGH of termination of the Research

We have now paused the IND-enabling studies of Adva-27a pending a review of the results and the possibility of chemical modification

of the compound to address the suboptimal performance of the molecule in certain studies.

K1.1 Anticancer 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).

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.

In November 2022, we concluded an agreement with

a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into lipid nanoparticles (“LNP”)

for use to conduct xenograft mice studies.

The initial results of our xenograft mice studies indicate that our K1.1 mRNA-LNP is effective

at reducing the size of liver cancer xenograft tumors in mice.

We are currently seeking to confirm these results by conducting additional

xenograft experiments on a broader scale and in more detailed dose-response studies.

SBFM-PL4 SARS Coronavirus Treatment

The initial genome expression products following

infection by Betacoronavirus, 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, called 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 essential

viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening.

PLpro is present

only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.

Our Anti-Coronavirus research effort has been focused

on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition subject

matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.

In 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 Project”).

Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing license for all

intellectual property developed by University of Arizona under the Research Project.

In addition, we and the University of Arizona

have entered into an option agreement (the “Option Agreement”) whereby we were 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

options, 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.

We have recently broadened our objective to include

the development of an injectable drug candidate of first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV

infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible ‘rebound’

infections and other side effects.

Intellectual Property

We are the sole owner of all rights pertaining

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 under US Patent Number 8,236,935 and 10,272,065.

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 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 April 20, 2022, we filed a provisional patent

application in the United States covering mRNA molecules capable of destroying cancer cells in vitro.

The patent application contains

composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.

Effective February 24, 2023, we became the

exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the

Coronavirus protease, PLpro.

Our wholly owned subsidiary,

Nora Pharma, owns 152 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.

were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.

In addition, we are the owner of four (4) NPN’s

issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential

9™, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential

Calcium-Vitamin D ™ , (iii) NPN 80125047 which authorizes us to manufacture

and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product, Taurine.

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.

Our generic drugs are manufactured by several different

international partners under long-term contracts.

We 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).

Our 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.

Marketing and Sales

Our generic drugs are currently being sold across

All of our generic drug sales are conducted by Nora Pharma’s sales representatives based in key Provinces across Canada.

A segment of our marketing team provides human resources, commercial and technical assistance, as well as training and education support

to pharmacy owners.

Our 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

Our personnel, together with outside consultants develop and place ads on various

media platforms and manage our accounts with Amazon.

Government Regulations

All 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.

In the United States, the Federal Government agency

responsible for regulating prescription drugs and nonprescription OTC supplements is the U.S.

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 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.

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

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 latter.

In the United States, OTC supplements are

required to be registered with the FDA prior to marketing.

In both the U.S.

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.

There are no assurances this will occur.

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.

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 product.

Our 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 Canada.

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.

In 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.

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 or no 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.

In 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.

In August 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 mandates.

As of the date of this report we have a total

of 44 employees.

Women compose approximately 57% of our workforce.

Going forward, we are committed to maintaining fully balanced workforce that includes persons of diverse sexual orientation and ethnic

Presently, our proprietary drug development activities

are subcontracted out to specialized service providers in the U.S., Canada and overseas.

We also use consultants for various other activities

including marketing, accounting, and IT.

Labors laws in Quebec provide for certain guaranteed

minimum entitlements, including minimum wages, maternity leave, medical leave, employee termination conditions, and other similar benefits.

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.

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

competition with our own.

In addition, a number of smaller companies are working in the area of cancer therapy and could develop drugs

that may be in competition with ours.

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.

These laws require corporate operations carried out

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

We and our Canadian subsidiaries operating

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

The Canadian generic pharmaceuticals market

was valued at approximately $9.7 billion USD in 2023.

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 a 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.

Our 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.

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

Today two leading vaccines (Pfizer’s, and

Moderna’s) and two antibody treatments (Regeneron’s, and Eli Lilly’s) are in use.

Gilead’s 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 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.

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 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 competition with our own.

In addition, a number of

smaller companies are working in the area of cancer therapy and could develop drugs that may be in competition with ours.

Similarly, 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.

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.

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