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Item 1. Business

2025-04-01 compared with 2024-03-28 · 180 added, 174 removed, 161 unchanged (69% of the section changed)

About Sunshine Biopharma

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:

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

oncology and antivirals.

We have two wholly owned subsidiaries:

(i) Nora Pharma Inc.

(“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

(“Nora Pharma”), a Canadian

corporation, through which we currently have 70 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma

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

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.

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 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

development program which is comprised of (i) K1.1 mRNA, an LNP encapsulated mRNA targeted for liver cancer, and (ii) SBFM-PL4, a protease

inhibitor for treatment of SARS Coronavirus infections.

Commercial Operations

Our commercial operations are focused on the procurement

of rights to pharmaceutical products for sale, currently in Canada and ultimately around the world.

We seek to secure such rights through

various types of strategic arrangements, including:

· In-licensing

and Supply Agreements:

Nora Pharma acquires the rights to import, market, sell and distribute

the products in Canada by purchasing the drug dossiers from strategic partners.

then files the dossiers with Health Canada to obtain regulatory approval prior to marketing.

The approval process at Health Canada takes on average of 12 months.

The products are sold

under Nora Pharma label.

· Cross-licensing:

Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada

by receiving an authorization letter from pharmaceutical partners.

The partners’ products

are already approved in Canada but we are still required to obtain our own approval from

Health Canada, which takes on average 45-60 days.

The products are sold under Nora Pharma

· Distribution

Nora Pharma acquires the rights to market, sell and distribute the products

in Canada by signing a distribution agreement with pharmaceutical partners.

The partners’

products are already approved by Health Canada.

The products are sold under the partners’

Generic drugs are pharmaceutically equivalent

to the brand name drugs.

They contain identical medicinal ingredients in the same amounts as the brands.

Generic medications, however,

may have different non-medicinal ingredients than the brand name drugs, but the generic developer must show that these do not affect the

safety, efficacy, or quality of the drug compared to the brand.

When a generic drugs company wants to sell a generic drug in Canada, it

must file a generic drug submission with Health Canada.

The submission is called an Abbreviated New Drug Submission (ANDS).

The submission

is reviewed by scientists and health care experts at Health Products and Food Branch (HPFB) of Health Canada.

All generic drug submissions

go through the same process as the brand name drug submissions.

If the evaluation shows that the generic drug meets all regulatory requirements

(including patent and data protection considerations), Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification

Number (DIN) to the applicant.

The NOC and DIN signal the drug's official approval in Canada and permit the applicant to market the drug

Once a company obtains the NOC and DIN for a drug, then it begins the process with Pan-Canadian Pharmaceutical Alliance (pCPA)

in order to have the drug listed on the provincial and territorial formularies and federal government drug benefit plans.

We currently have the following

generic prescription drugs on the market in Canada:

Action/Indication/Therapeutic

Reference/Brand

Cardiovascular

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Central nervous system

Anti-inflammatory

Cardiovascular

Dapagliflozin

Antibacterial

Central nervous system

Antibacterial

Central nervous system

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Central nervous system

Antipsychotic

Central nervous system

Olanzapine ODT

Central nervous system

Cardiovascular

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Central nervous system

Progesterone*

Women's Health

Central nervous system

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Cardiovascular

Rizatriptan ODT

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Central nervous system

Cholelithiasis

Smoking cessation

Zoledronic Acid*

Central nervous system

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

through distribution agreements in which we act as distributor.

addition to the 70 drugs currently on the market, we have 64 additional drugs in our pipeline including 13 we anticipate launching

during the remainder of 2025.

These additional drugs will address various human health areas including cardiovascular, oncology,

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

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 ( Research and Markets ) and provide us with greater access to pharmacies as we become more of a go-to supplier for

every-day and specialty medicines.

Research and Development

The following table summarizes our proprietary

drugs in development:

Adva-27a (Small Molecule)

Oncology (Pancreatic Cancer)

Area/Indication

K1.1 (mRNA LNP)

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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.

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.

(Small Molecule)

(SARS Coronavirus)

K1.1 Anticancer mRNA

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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.

cells) showed that these mRNA molecules had little cytotoxic side effects.

These new mRNA molecules, bearing the laboratory name K1.1,

were adapted for delivery into patients using a lipid nanoparticle (LNP) technology similar to the one employed in the COVID-19 mRNA vaccines.

On April 20, 2022, we filed a provisional patent application in the United States covering our K1.1 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.

a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into specific lipid nanoparticles for use in

test animals including xenograft mice.

The initial results of our animal testing indicated that our K1.1 mRNA-LNP constructs were effective

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

We are currently seeking to confirm these results by conducting additional

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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.

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.

have since broadened our objective to include the development of a 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.

current lead compound was recently found to be active at sub micromolar concentrations against PLpro and exhibited antiviral

activity in SRAS-CoV-2 infected cells as well as in cells infected with several different variants of concern.

In addition, our

compound had favorable pharmacokinetics properties in rodent species and exhibited preferred drug accumulation in the lungs over

The compound was found to be orally active in a K18-human-ACE2 transgenic mouse model and to significantly reduce virus load

in the lungs of infected animals in a dose-dependent manner without gross toxicities.

In August 2024, we published

these and other research results related to this project in the Journal of Medicinal Chemistry ( J.

13681−13702 ).

A copy of this article is available on our website at:

www.sunshinebiopharma.com/scientific-publications.

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

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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

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.

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 various

media platforms and manage our accounts with Amazon.

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,

Our wholly owned subsidiary, Nora Pharma,

owns 200 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.

Nora Pharma also

owns the rights to sell 10 generic prescription drugs in Canada through distribution agreements with various international partners

under which Nora Pharma acts as distributor and receives a percentage of sales.

In addition, we own 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, (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,

Government Regulations

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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 compliance with 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.

In the area of proprietary drug development where

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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.

of the FDA to offer our products for sale when ready.

The 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.

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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

made any filings with the FDA or other regulatory bodies in other jurisdictions in connection with our proprietary drugs in development.

In respect of OTC supplements, the FDA regulates

the formulation, manufacturing, packaging, storage, labeling, promotion, distribution, and sale of such products, while the Federal Trade

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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 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.

Manufacturing

Our generic drugs are manufactured by our various

international partners (licensors or distribution partners) under long-term contracts.

We purchase finished goods from these partners

at varying costs.

currently do not have any proprietary drugs on the market.

Research quantities of our proprietary drug candidates are manufactured at

the University of Arizona located in Tucson, Arizona (Anti-Coronavirus compounds) and WuXi App Tech located in Hong Kong, China (K1.1

OTC products are manufactured under contract by INOV Pharma Inc.

located in Montreal, Canada.

generic drugs are currently being sold in Canada in the province of Quebec, and to a much lesser extent in the provinces of Ontario,

Alberta and British Columbia.

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

our marketing team provides human resources, commercial and technical assistance, as well as training and educational support to pharmacy

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 various media platforms and manage our accounts with Amazon.

to Research and Markets , the Canadian generic pharmaceuticals market was valued at approximately $9.7 billion USD in 2023 and

is expected to grow at a compound annual growth rate (CAGR) of 7.9%, reaching $19.2 billion USD by the end of 2032.

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 Canadian market, of which, the top 3 hold approximately 50% share of the total market.

Nora Pharma is relatively

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

Our Anti-Coronavirus drug development project is

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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.

Similarly, our OTC products compete 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.

of the date of this report we have a total of 52 employees.

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.

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 in some cases entirely,

We and our Canadian subsidiaries operating in the Province of Quebec are fully compliant with these laws.

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