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Item 2. Management’s Discussion and Analysis

2025-05-15 compared with 2024-11-05 · 249 added, 293 removed, 61 unchanged (90% of the section changed)

DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following

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

This discussion

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

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

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

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

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

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

in such forward-looking statements.

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

and in our annual report on Form 10-K for the year ended December 31, 2023.

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

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

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

MANAGEMENT’S DISCUSSION AND ANALYSIS

OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction

with our consolidated financial statements and notes thereto included herein.

This discussion includes forward-looking statements

within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities

Exchange Act of 1934, as amended, or the Exchange Act.

The statements regarding Sunshine Biopharma Inc.

contained in this Report that

are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,”

“likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,”

or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and

uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.

factors known to us that could cause such material differences are identified in this report and in our annual report on Form 10-K for

the year ended December 31, 2024.

We undertake no obligation to correct or update any forward-looking statements, whether as a result

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

You are advised, however, to consult any

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

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.

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 63 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.

(“Sunshine Canada”), a

Canadian corporation which develops and sells nonprescription over-the-counter (“OTC”) products.

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, a

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”

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 Agreement”).

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

began operating as a pharmaceutical company.

In December 2015,

we acquired all 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 recently 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 inhibitors for 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.

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, a Canadian generic pharmaceuticals company based in the greater Montreal area.

Nora Pharma has 46

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

Nora Pharma currently has 63 generic

prescription drugs on the market in Canada and is planning to launch 32 additional generic prescription drugs in the remainder of

2024 and 2025.

Products on the Market

Through Nora Pharma we currently have

the following generic prescription drugs on the market in Canada:

Action/Indication

(“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 through which we develop

and sell OTC supplements.

In addition, we are conducting a proprietary drug 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 generic pharmaceutical products for sale, currently in Canada and ultimately around the world.

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.

Nora Pharma 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 label.

Distribution Agreements:

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’ label.

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 in Canada.

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

6 unchanged sentences

Anti-inflammatory

Ciprofloxacin

Central nervous system

Anti-inflammatory

Cardiovascular

6 unchanged sentences

Cardiovascular

Action/Indication/Therapeutic Area

Reference/Brand

Cardiovascular

4 unchanged sentences

Central nervous system

Antipsychotic

Central nervous system

Olanzapine ODT

Central nervous system

Cardiovascular

9 unchanged sentences

Women's Health

Central nervous system

12 unchanged sentences

Anticonvulsant

Acetaminophen

nervous system

Tramadol Acetaminophen

Central nervous system

Cholelithiasis

Smoking cessation

1 unchanged sentence

Central nervous system

*Sold through distribution agreements

addition to the 63 drugs currently on the market, we have 32 additional

drugs scheduled to be launched in Q4 2024 and in 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.

new drugs to be launched in 2024 is NIOPEG®, a biosimilar of NEULASTA®.

Like NEULASTA®, NIOPEG® is a long-acting form

of recombinant human granulocyte colony-stimulating factor (filgrastim).

It is indicated to decrease the incidence of infection in patients

with non-myeloid malignancies receiving anti-neoplastic therapy.

Nora Pharma received Health Canada marketing approval for NIOPEG®

on April 17, 2024.

NIOPEG® is anticipated to be on the market in Canada in Q4 2024.

We believe the addition

of these new 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.

Drugs in Development

The following table summarizes our proprietary

drugs in development:

Adva-27a (Small Molecule)

Oncology (Pancreatic Cancer)

Central nervous

* Sold through distribution agreements in

which we act as distributor.

In 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.

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 ( 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:

Area/Indication

K1.1 (mRNA LNP)

1 unchanged sentence

Animal Testing

SBFM-PL4 (Small Molecule)

Antiviral (SARS Coronavirus)

Animal Testing

* See “ Adva-27a Anticancer

Compound ” below

Adva-27a Anticancer

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 U.S.

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 test results of the Adva-27a

molecule were not favorable.

After conclusion of an internal review of the laboratory results on November 2, 2023, we provided notice

to JGH of termination of the Research Agreement.

We have 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

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.

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

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

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.

(Small Molecule)

(SARS Coronavirus)

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 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 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

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 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

Our 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 plasma.

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.

2024, 67, 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 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 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.

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.

DIN’s 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.

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.

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,

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,

Results of Operations

of results of operations for the three months ended September 30, 2024 and 2023

the three months ended September 30, 2024, we generated $8,435,178 in sales, compared to $5,957,668 for the three months ended September

30, 2023, an increase of $2,477,510, or 42%.

The increase is attributable to expanded marketing and sales efforts by our wholly owned

subsidiary, Nora Pharma.

The direct cost for generating these sales was $5,569,027 (66%) for the three months ended September 30, 2024,

compared to $3,967,412 (67%) for

the three months ended September 30, 2023.

Our gross profit grew to $2,866,151 for the three months ended September 30, 2024, compared

to $1,990,256 for the three months ended September 30, 2023.

General and administrative

expenses during the three-month period ended September 30, 2024, were $3,972,504, compared to $2,769,730 during the three-month period

ended September 30, 2023, an increase of $1,202,774.

The increase was due to increases in accounting fees ($68,422), consulting ($253,251),

marketing ($40,848), and salaries ($949,473).

The increase in salaries was due to the hiring of two (2) new employees and a bonus paid

to the CEO of the Company.

The only expense category that saw a decrease was R&D, which was reduced by $111,650.

Overall, we incurred

a loss of $1,106,353 from our operations for the three months ended September 30, 2024, compared to a loss of $779,474 from our operations

in the three-month period ended September 30, 2023.

In addition, we

had interest income of $108,614 during the three months ended September 30, 2024, compared to net interest income of $168,904 during

the three months ended September 30, 2023, as a result of less interest earned on cash on hand.

As a result, we

incurred a net loss of $1,197,803 ($0.94 per share) for the three months ended September 30, 2024, compared to a net loss of $651,482

($50.72 per share) for the three-month period ended September 30, 2023.

Comparison of results

of operations for the nine months ended September 30, 2024 and 2023

During the nine

months ended September 30, 2024, we generated revenues of $25,279,291, compared to revenue of $16,412,586 for the nine months ended September

Comparison of results of operations

for the three months ended March 31, 2025 and 2024

the three months ended March 31, 2025, we generated $8,901,341 in sales, compared to $7,541,046 for the three months ended March 31,

2024, an increase of $1,360,295, or 18.0%.

The increase is attributable to expanded marketing and sales efforts by our wholly owned

subsidiary, Nora Pharma.

The direct cost for generating these revenues was $17,702,546 for the nine months ended September 30, 2024 (70%),

compared to $10,641,461 (65%) for the nine months ended September 30, 2023.

The increase in the cost of sales in the nine-month

period of 2024 is related to greater retailer allowances offered to gain access to new regional markets.

Our gross profit increased to

$7,576,745 for the nine months ended September 30, 2024, compared to a gross profit of $5,771,125 for the same period in 2023.

General and administrative

expenses during the nine-month period ended September 30, 2024, were $11,351,144, compared to $9,369,203 during the nine-month period

ended September 30, 2023, an increase of $1,981,941.

The increase was a result of increases in accounting ($263,791), legal ($170,871),

marketing ($234,129), office costs ($781,912), and salaries ($838,937).

The two expense categories that saw a decrease were consulting

($169,369), and R&D ($254,872).

Overall, we incurred a loss of $3,774,399 from our operations in the nine-month period ended September

30, 2024, compared to a loss from operations of $3,598,078 in the similar period of 2023.

In addition, we

had interest income of $396,453 during the nine months ended September 30, 2024, compared to interest income of $517,163 during the nine

months ended September 30, 2023.

The decrease was due to the Company having less cash on hand.

As a result, we

incurred a net loss of $2,975,904 ($13.61 per share) for the nine-month period ended September 30, 2024, compared to a net loss of $3,256,020

($265.71 per share) for the nine-month period ended September 30, 2023.

Liquidity and Capital

As of September

30, 2024, we had cash and cash equivalents of $12,206,655.

Net cash used in

operating activities was $9,123,898 during the nine months ended September 30, 2024, compared to $6,085,435 during the nine-month period

ended September 30, 2023.

The increase was a result of increased business activities by Nora Pharma.

Cash flows used

in investing activities were $1,789,312 for the nine months ended September 30, 2024, compared to $386,920 for the nine months ended

September 30, 2023.

The increase was the result of cash invested in Nora Pharma to finance increase in inventory and expansion of operations

and product line.

Cash flows provided

by financing activities were $7,235,518 during the nine months ended September 30, 2024, compared to $3,456,106 during the nine months

ended September 30, 2023.

The increase was primarily a result of the approximately $10 million financing event completed in February

2024, compared to an approximately $5 million financing event completed in May 2023.

We are not generating

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

We believe our existing cash on hand

will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24 months.

is no assurance our estimates will be accurate.

We currently have no committed sources of capital and we anticipate that we will need

to raise additional capital in the future, including for further research and development activities and possibly clinical trials, as

well as expansion of our generic pharmaceuticals operations.

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

Critical Accounting

The discussion and

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

with accounting principles generally accepted in the United States.

The preparation of these financial statements requires us to make

estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets

and liabilities.

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

we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values

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

Actual results may differ from these estimates under different

assumptions or conditions.

For a detailed list

of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2023, including

our financial statements and notes thereto included therein as filed with the SEC on March 28, 2024.

Recently Adopted Accounting

We have adopted all new accounting standards impacting operations.

Off Balance-Sheet

AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are a smaller reporting company and

are not required to provide the information under this item.

The increase is attributable to new product launches and expanded marketing and sales efforts.

The direct cost for generating these sales was $6,170,915 (69.3%) for the three months ended March 31, 2025, compared to $5,186,709 (68.8%)

for the three months ended March 31, 2024, largely unchanged.

Our gross profit for the three months ended March 31, 2025 was $2,730,426,

compared to $2,354,337 for the three months ended March 31, 2024, an increase of $376,089.

and administrative expenses during the three-month period ended March 31, 2025, were $4,026,176, compared to $3,704,926 during the three-month

period ended March 31, 2024, an increase of $321,250.

This relatively small increase was the net result of increases and decreases in

specific expense categories.

For example, while consulting fees increased by $317,886 and marketing expenses increased by $200,315, there

was a decrease in accounting fees of $58,247 and legal fees of $194,799.

Overall, we incurred a loss of $1,295,750 from our operations

for the three months ended March 31, 2025, compared to a loss of $1,350,589 from our operations in the three-month period ended March

In addition, we had interest income of $75,367 during the three

months ended March 31, 2025, compared to interest income of $144,089 during the three months ended March 31, 2024, as a result of having

less cash on hand.

As a result, we incurred a net loss of $1,179,771

($0.44 per share) for the three months ended March 31, 2025, compared to a net loss of $1,283,801 ($2.00 per share) for the three-month

period ended March 31, 2024.

Liquidity and Capital Resources

As of March 31, 2025, we had cash and cash equivalents of $8,124,610.

cash used in operating activities was $1,713,835 during the three months ended March 31,

2025, compared to $3,185,158 during the three-month period ended March 31, 2024.

was a result of reduced cash required for the operations of Nora Pharma.

flows used in investing activities were $176,024 for the three months ended March 31, 2025, compared to $668,736 for the three months

ended March 31, 2024.

The decrease was the result of less cash invested in Nora Pharma.

flows provided by financing activities were $338,137 during the three months ended March 31, 2025, compared to $5,398,149 during the

three months ended March 31, 2024.

The decrease was primarily as a result of no financing events completed during the three months ended

March 31, 2025, compared to an offering yielding net proceeds of $8,522,411 completed during the three months ended March 31, 2024.

are currently generating revenue of approximately $8.9 million per quarter and incurring a quarterly deficit of approximately $1.2 million.

In addition to increasing sales and streamlining operations to reduce expenses, we are currently focusing our attention on lowering our

cost of goods sold from our current level of approximately 70% to possibly 60%.

We believe these measures could bring us to breakeven

and make us less dependent on the capital markets for financing.

We believe our existing cash on hand together with cash we generate

from sales will be sufficient to fund our operations for the next 24 months.

There is no assurance our estimates will be accurate.

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

research and development activities and possibly clinical trials, as well as expansion of our generic pharmaceuticals operations.

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

Critical Accounting Estimates

The discussion and analysis of our financial condition

and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally

accepted in the United States.

The preparation of these financial statements requires us to make estimates and judgments that affect the

amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.

On an on-going basis,

we evaluate our estimates based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,

the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent

from other sources.

Actual results may differ from these estimates under different assumptions or conditions.

For a detailed list of significant accounting policies,

please see our annual report on Form 10-K for the fiscal year ended December 31, 2024, including our financial statements and notes thereto

included therein as filed with the SEC on April 1, 2025.

Recently Adopted Accounting Standards

We have adopted all new accounting standards impacting

Off Balance-Sheet Arrangements

We have not entered into any off-balance sheet arrangements.

QUANTITATIVE AND QUALITATIVE DISCLOSURES

ABOUT MARKET RISK

We are a smaller reporting company and are not required

to provide the information under this item.

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis