−Removed: MANAGEMENT’S DISCUSSION AND ANALYSIS
−Removed: OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: The following discussion should be read in
−Removed: conjunction with our consolidated financial statements and notes thereto included herein.
−Removed: This discussion includes forward-looking
−Removed: statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the
−Removed: Securities Exchange Act of 1934, as amended, or the Exchange Act.
−Removed: The statements regarding Sunshine Biopharma Inc.
−Removed: contained in this Report
−Removed: that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,”
−Removed: “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,”
−Removed: or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and
−Removed: uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements.
−Removed: 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
−Removed: the year ended December 31, 2024.
−Removed: We undertake no obligation to correct or update any forward-looking statements, whether as a result
−Removed: of new information, future events or otherwise, except as may be required under applicable law.
−Removed: You are advised, however, to consult any
−Removed: future disclosures we make on related subjects in future reports we file with the SEC .
−Removed: About Sunshine Biopharma
−Removed: We are a pharmaceutical company offering and researching
−Removed: life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals.
+Added: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
+Added: following discussion should be read in conjunction with our consolidated financial statements and notes thereto included herein.
+Added: discussion includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the
+Added: Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act.
+Added: The statements regarding Sunshine
+Added: Biopharma Inc.
+Added: contained in this Report that are not historical in nature, particularly those that utilize terminology such as “may,”
+Added: “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,”
+Added: “believes” or “plans,” or comparable terminology, are forward-looking statements based on current expectations
+Added: and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed
+Added: in such forward-looking statements.
+Added: Important factors known to us that could cause such material differences are identified in this report
+Added: and in our annual report on Form 10-K for the year ended December 31, 2025.
+Added: We undertake no obligation to correct or update any forward-looking
+Added: statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.
+Added: advised, however, to consult any future disclosures we make on related subjects in future reports we file with the SEC .
+Added: Sunshine Biopharma
+Added: are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology
+Added: and antivirals.
We have two wholly owned subsidiaries:
(i) Nora Pharma Inc.
−Removed: (“Nora Pharma”), a Canadian corporation, through which we currently have 76 generic prescription drugs
−Removed: on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.
−Removed: (“Sunshine Canada”), a Canadian corporation through which
−Removed: we develop and sell OTC supplements.
−Removed: In addition, we are conducting a proprietary drug
−Removed: development program which is comprised of (i) K1.1 mRNA, an LNP encapsulated mRNA targeted for liver cancer, and (ii) SBFM-PL4, a protease
−Removed: inhibitor for treatment of SARS Coronavirus infections.
−Removed: Commercial Operations
−Removed: Our commercial operations are focused on the procurement
−Removed: of rights to generic pharmaceutical products for sale, currently in Canada and ultimately around the world.
−Removed: We seek to secure such rights
−Removed: through various types of strategic arrangements, including:
−Removed: In-licensing and Supply Agreements:
−Removed: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by purchasing the drug dossiers from strategic partners.
+Added: (“Nora Pharma”), a Canadian corporation, through
+Added: which we currently have 60 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc.
+Added: Canada”), a Canadian corporation through which we develop and sell OTC supplements.
+Added: addition, we are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an LNP encapsulated mRNA targeted
+Added: for liver cancer, and (ii) SBFM-PL4, a protease inhibitor for treatment of SARS Coronavirus infections.
+Added: commercial operations are focused on the procurement of rights to generic pharmaceutical products for sale, currently in Canada and ultimately
+Added: around the world.
+Added: We seek to secure such rights through various types of strategic arrangements, including:
+Added: In-licensing and Supply
+Added: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by purchasing the drug
+Added: dossiers from strategic partners.
Nora Pharma then files the dossiers with Health Canada to obtain regulatory approval prior to marketing.
2 unchanged sentences
Cross-licensing:
−Removed: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by receiving an authorization letter from pharmaceutical partners.
−Removed: 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.
+Added: Nora Pharma acquires the rights to import, market, sell and distribute the products in Canada by receiving an authorization letter
+Added: from pharmaceutical partners.
+Added: The partners’ products are already approved in Canada but we are still required to obtain our
+Added: own approval from Health Canada, which takes on average 45-60 days.
The products are sold under Nora Pharma label.
−Removed: Distribution Agreements:
−Removed: Nora Pharma acquires the rights to market, sell and distribute the products in Canada by signing a distribution agreement with pharmaceutical partners.
+Added: Nora Pharma acquires the rights to market, sell and distribute the products in Canada by signing distribution
+Added: agreements with various pharmaceutical partners.
The partners’ products are already approved by Health Canada.
−Removed: The products are sold under the partners’ label.
−Removed: Generic drugs are pharmaceutically equivalent
−Removed: to the brand name drugs.
−Removed: They contain identical medicinal ingredients in the same amounts as the brands.
−Removed: Generic medications may have
−Removed: different non-medicinal ingredients than the brand name drugs, but the generic developer must show that these do not affect the safety,
−Removed: efficacy, or quality of the drug compared to the brand.
−Removed: When a generic drug company wants to sell a generic drug in Canada, it must file
−Removed: a generic drug submission with Health Canada.
−Removed: The submission is called an Abbreviated New Drug Submission (ANDS).
−Removed: The submission is reviewed
−Removed: by scientists and health care experts at Health Products and Food Branch (HPFB) of Health Canada.
−Removed: All generic drug submissions go through
−Removed: the same process as the brand name drug submissions.
−Removed: If the evaluation shows that the generic drug meets all regulatory requirements (including
−Removed: patent and data protection considerations), Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN)
−Removed: to the applicant.
−Removed: The NOC and DIN signal the drug's official approval in Canada and permit the applicant to market the drug in Canada.
−Removed: Once a company obtains the NOC and DIN for a drug, then it begins the process with Pan-Canadian Pharmaceutical Alliance (pCPA) in order
−Removed: to have the drug listed on the provincial and territorial formularies and federal government drug benefit plans.
−Removed: We currently have the following generic prescription
−Removed: drugs on the market in Canada:
−Removed: Therapeutic Area
+Added: are sold under the partners’ label.
+Added: drugs are pharmaceutically equivalent to the brand name drugs.
+Added: They contain identical medicinal ingredients in the same amounts as the
+Added: Generic medications, however, may have different non-medicinal ingredients than the brand name drugs, but the generic developer
+Added: must show that these do not affect the safety, efficacy, or quality of the drug compared to the brand.
+Added: When a generic drugs company wants
+Added: to sell a generic drug in Canada, it must file a generic drug submission with Health Canada.
+Added: The submission is called an Abbreviated
+Added: New Drug Submission (ANDS).
+Added: The submission is reviewed by scientists and health care experts at Health Products and Food Branch (HPFB)
+Added: of Health Canada.
+Added: All generic drug submissions go through the same process as the brand name drug submissions.
+Added: If the evaluation shows
+Added: that the generic drug meets all regulatory requirements (including patent and data protection considerations), Health Canada will issue
+Added: a Notice of Compliance (NOC) and a Drug Identification Number (DIN) to the applicant.
+Added: The NOC and DIN signal the drug's official approval
+Added: in Canada and permit the applicant to market the drug in Canada.
+Added: Once a company obtains the NOC and DIN for a drug, then it begins the
+Added: process with Pan-Canadian Pharmaceutical Alliance (pCPA) to have the drug listed on the provincial and territorial formularies
+Added: and federal government drug benefit plans.
+Added: currently have the following generic prescription drugs on the market in Canada:
Cardiovascular
8 unchanged sentences
Central nervous system
−Removed: Anti-inflammatory
Cardiovascular
Dapagliflozin
−Removed: Antibacterial
−Removed: Gynecologic pathology
−Removed: Central nervous system
−Removed: Docusate Sodium
−Removed: Gastroenterology
−Removed: Gastroenterology
+Added: Gastrointestinal
Central nervous system
1 unchanged sentence
Central nervous system
−Removed: Cardiovascular
−Removed: Therapeutic Area
+Added: Central nervous system
Cardiovascular
2 unchanged sentences
Hydroxychloroquine
−Removed: Central nervous system
Levetiracetam
11 unchanged sentences
Central nervous system
−Removed: Pegfilgrastim (Niopeg®)
Cardiovascular
1 unchanged sentence
Central nervous system
−Removed: Progesterone*
Women's Health
−Removed: Women's Health
Central nervous system
2 unchanged sentences
Cardiovascular
−Removed: Cardiovascular
Rizatriptan ODT
2 unchanged sentences
Central nervous system
−Removed: Sitagliptin-Metformin*
Cardiovascular
5 unchanged sentences
Smoking cessation
−Removed: Zoledronic Acid*
Central nervous system
−Removed: Central nervous system
−Removed: Sold through distribution agreements in which we act as distributor
−Removed: In addition to the 76 drugs currently on the market, we have 12 additional
−Removed: drugs in our pipeline which we anticipate launching in 2026.
−Removed: These additional drugs will address various human health areas including
−Removed: cardiovascular, oncology, gastroenterology, central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.
−Removed: We believe the addition of these products to our
−Removed: existing portfolio will strengthen our presence in the Canadian $9.7 billion a year generic drug market ( Research and Markets )
+Added: Central nervous
+Added: Our distribution agreements were terminated effective December 31, 2025, reducing the drugs we have on the market from 71 to
+Added: addition to the 60 drugs currently on the market, we have 22 additional drugs in our pipeline including 12 we anticipate launching during
+Added: the remainder of 2026.
+Added: These additional drugs will address various human health areas including cardiovascular, oncology, gastroenterology,
+Added: central nervous system, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.
+Added: We believe the addition of these
+Added: products to our existing portfolio will strengthen our presence in the Canadian $11.2 billion a year generic drug market ( IMARC Group )
and provide us with greater access to pharmacies as we become more of a go-to supplier for every-day and specialty medicines.
−Removed: Research and Development
−Removed: The following table summarizes our proprietary
−Removed: drugs in development:
−Removed: Drug Candidate
−Removed: Therapeutic Area/Indication
−Removed: Development Stage
+Added: and Development
+Added: following table summarizes our proprietary drugs in development:
+Added: Area/Indication
K1.1 (mRNA LNP)
1 unchanged sentence
Animal Testing
−Removed: SBFM-PL4 (Small Molecule)
−Removed: Antiviral (SARS Coronavirus Infection)
−Removed: Animal Testing
−Removed: K1.1 Anticancer mRNA
−Removed: In June 2021, we initiated a new research project
−Removed: in which we set out to determine if certain mRNA molecules can be used as anti-cancer agents.
−Removed: The data collected to date have shown that
−Removed: a selected group of mRNA molecules are capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR),
−Removed: ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
−Removed: Studies using non-transformed (normal) human cells (HMEC
−Removed: cells) showed that these mRNA molecules had little cytotoxic side effects.
−Removed: These new mRNA molecules, bearing the laboratory name K1.1,
−Removed: were adapted for delivery into patients using a lipid nanoparticle (LNP) technology similar to the one employed in the COVID-19 mRNA vaccines.
−Removed: On April 20, 2022, we filed a provisional patent application in the United States covering our K1.1 mRNA molecules.
−Removed: In November 2022, we concluded an agreement with
−Removed: a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules into specific lipid nanoparticles for use in
−Removed: test animals including xenograft mice.
−Removed: The initial results of our animal testing indicated that our K1.1 mRNA-LNP constructs were effective
−Removed: at reducing the size of liver cancer tumors in xenograft mice.
−Removed: We are currently seeking to confirm these results by conducting additional
−Removed: xenograft experiments on a broader scale and in more detailed dose-response studies.
−Removed: SBFM-PL4 SARS Coronavirus Treatment
−Removed: The initial genome expression products following
−Removed: infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins, referred to as pp1a and pp1ab.
−Removed: These two polyproteins
−Removed: are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and PLpro, to generate 16 different non-structural proteins
−Removed: essential for viral replication.
−Removed: Mpro and PLpro represent attractive anti-viral drug development targets as they play a central role in
−Removed: the early stages of viral replication.
−Removed: PLpro is of particular interest as a therapeutic target in that, in addition to processing essential
−Removed: viral proteins, it is also responsible for suppression of the human immune system making the virus more life-threatening.
−Removed: PLpro is present
−Removed: only in Betacoronaviruses, the subgroup of Coronaviruses represented by the highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
−Removed: Our Anti-Coronavirus research effort has been
−Removed: focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a patent application in the United States covering composition
−Removed: subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.
−Removed: In February 2022, we expanded our PLpro inhibitors
−Removed: research effort by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on
−Removed: determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors,
−Removed: to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research Project”).
−Removed: Under the agreement, the University
−Removed: of Arizona granted us a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University
−Removed: of Arizona under the Research Project.
−Removed: In addition, we and the University of Arizona have entered into an option agreement (the “Option
−Removed: Agreement”) whereby we were granted a first option to negotiate a royalty-bearing commercial license for the underlying technology
−Removed: of the Research Project.
−Removed: On September 13, 2022, we exercised our options, and on February 24, 2023, we entered into an exclusive worldwide
−Removed: license agreement with the University of Arizona for all of the technology related to the Research Project.
−Removed: We have since broadened our objective to include
−Removed: the development of a first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially SARS-CoV and MERS-CoV infection in patients who
−Removed: could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions and possible rebound infections and other
−Removed: side effects.
−Removed: Our current lead compound was recently found
−Removed: to be active at sub micromolar concentrations against PLpro and exhibited antiviral activity in SRAS-CoV-2 infected cells as well as
−Removed: in cells infected with several different variants of concern.
−Removed: In addition, our compound had favorable pharmacokinetics properties in
−Removed: rodent species and exhibited preferred drug accumulation in the lungs over plasma.
−Removed: The compound was found to be orally active in a
−Removed: K18-human-ACE2 transgenic mouse model and to significantly reduce virus load in the lungs of infected animals in a dose-dependent
−Removed: manner without gross toxicities.
−Removed: In August 2024, we published these and other research results related to this project in the
−Removed: Journal of Medicinal Chemistry ( J.
+Added: (Small Molecule)
+Added: (SARS Coronavirus Infections)
+Added: Anticancer mRNA
+Added: 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
+Added: The data collected to date have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro
+Added: including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2).
+Added: Studies using non-transformed (normal) human cells (HMEC cells) showed that these mRNA molecules had little cytotoxic side effects.
+Added: new mRNA molecules, bearing the laboratory name K1.1, were adapted for delivery into patients using a lipid nanoparticle (LNP) technology
+Added: similar to the one employed in the COVID-19 mRNA vaccines.
+Added: On April 20, 2022, we filed a provisional patent application in the United
+Added: States covering our K1.1 mRNA molecules.
+Added: The patent application was converted into a PCT Application on October 18, 2024 and published
+Added: by the United States Patent and Trademark Office (“USPTO”) on September 4, 2025.
+Added: November 2022, we concluded an agreement with a specialized commercial partner for the purposes of formulating our K1.1 mRNA molecules
+Added: into specific lipid nanoparticles for use in test animals including xenograft mice.
+Added: The initial results of our animal testing indicated
+Added: that our K1.1 mRNA-LNP constructs were effective at reducing the size of liver cancer tumors in xenograft mice.
+Added: We are currently seeking
+Added: to confirm these results by conducting additional xenograft experiments on a broader scale and in more detailed dose-response studies.
+Added: SARS Coronavirus Treatment
+Added: initial genome expression products following infection by Betacoronavirus, the causative agent of COVID-19, are two large polyproteins,
+Added: referred to as pp1a and pp1ab.
+Added: These two polyproteins are cleaved at 15 specific sites by two virus encoded proteases, called Mpro and
+Added: PLpro, to generate 16 different non-structural proteins essential for viral replication.
+Added: Mpro and PLpro represent attractive anti-viral
+Added: drug development targets as they play a central role in the early stages of viral replication.
+Added: PLpro is of particular interest as a therapeutic
+Added: target in that, in addition to processing essential viral proteins, it is also responsible for suppression of the human immune system
+Added: making the virus more life-threatening.
+Added: PLpro is present only in Betacoronaviruses, the subgroup of Coronaviruses represented by the
+Added: highly pathogenic SARS-CoV, MERS-CoV, and SARS-CoV-2.
+Added: Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a provisional patent
+Added: application in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus
+Added: PLpro as well as Mpro.
+Added: Our provisional patent application, entitled Inhibitors of Coronavirus Protease , was converted into a PCT
+Added: patent application on April 30, 2021.
+Added: On December 23, 2025, we received a Notice of Allowance from the USPTO for our PCT patent application.
+Added: On May 7, 2026, we received an Issue Notification from the USPTO indicating
+Added: that the patent will be issued on May 12, 2026.
+Added: In addition, the Issue Notification confirms that the patent is eligible for an extension
+Added: of 706 days and will therefore expire on April 6, 2043.
+Added: February 2022, we expanded our PLpro inhibitors research effort by entering into a research agreement with the University of Arizona
+Added: for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of
+Added: three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the “Research
+Added: Under the agreement, the University of Arizona granted us a first option to negotiate a commercial, royalty-bearing
+Added: license for all intellectual property developed by University of Arizona under the Research Project.
+Added: In addition, we and the University
+Added: of Arizona have entered into an option agreement (the “Option Agreement”) whereby we were granted a first option to negotiate
+Added: a royalty-bearing commercial license for the underlying technology of the Research Project.
+Added: On September 13, 2022, we exercised our options,
+Added: and on February 24, 2023, we entered into an exclusive worldwide license agreement with the University of Arizona for all of the technology
+Added: related to the Research Project.
+Added: have since broadened our objective to include the development of a first-in-class PLpro inhibitor to treat SARS-CoV2 and potentially
+Added: SARS-CoV and MERS-CoV infection in patients who could not use Paxlovid, Molnupiravir, or Remdesivir, due to concerns about drug interactions
+Added: and possible rebound infections and other side effects.
+Added: current lead compound has been found to be active at sub micromolar concentrations against PLpro and exhibited antiviral activity in
+Added: SRAS-CoV-2 infected cells as well as in cells infected with several different variants of concern.
+Added: In addition, our compound had favorable
+Added: pharmacokinetics properties in rodent species and exhibited preferred drug accumulation in the lungs over plasma.
+Added: The compound was found
+Added: to be orally active in a K18-human-ACE2 transgenic mouse model and to significantly reduce virus load in the lungs of infected animals
+Added: in a dose-dependent manner without gross toxicities.
+Added: In August 2024, we published these and other research results related to this project
+Added: in the Journal of Medicinal Chemistry ( J.
2024, 67, 13681−13702 ).
1 unchanged sentence
www.sunshinebiopharma.com/scientific-publications.
−Removed: A new manuscript describing the latest research results on our lead compound
−Removed: is currently in preparation.
−Removed: Intellectual Property
−Removed: On May 22, 2020, we filed a provisional patent
−Removed: application in the United States for a new treatment for Coronavirus infections.
−Removed: Our patent application covers composition subject matter
−Removed: pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication.
−Removed: The patent application has a priority date of May 22, 2020.
−Removed: On April 30, 2021, we filed a PCT application containing new research results
−Removed: and extending coverage to include the Coronavirus Papain-Like protease, PLpro.
−Removed: The priority date of May 22, 2020 has been maintained in
−Removed: the newly filed PCT application.
−Removed: On April 20, 2022, we filed a provisional patent
−Removed: application in the United States covering mRNA molecules capable of destroying cancer cells in vitro.
−Removed: The patent application contains
−Removed: composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules.
−Removed: Effective February 24, 2023, we became the exclusive,
−Removed: worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease,
−Removed: Our wholly owned subsidiary, Nora Pharma,
−Removed: owns over 200 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.
−Removed: These DIN’s were
−Removed: secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products.
−Removed: Nora Pharma also
−Removed: owns the rights to sell 10 generic prescription drugs in Canada through distribution agreements with various international partners
−Removed: under which Nora Pharma acts as distributor and receives a percentage of sales.
−Removed: In addition, we own four (4) NPN’s issued
−Removed: by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell our in-house developed OTC product, Essential•9™,
−Removed: (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product, Calcium-Vitamin D, (iii) NPN 80125047 which authorizes
−Removed: us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436 which authorizes us to manufacture and sell the OTC product,
−Removed: Results of Operations
−Removed: Comparison of results of operations for
−Removed: the three months ended September 30, 2025 and 2024
−Removed: During the three months ended September 30, 2025,
−Removed: we generated $9,417,179 in sales, compared to $8,435,178 for the three months ended September 30, 2024, an increase of $982,001, or 11.6%.
−Removed: The direct cost for generating these sales was $6,343,639 (67.4%) for the three months ended September 30, 2025, compared to $5,569,027
−Removed: (66.0%) for the three months ended September 30, 2024, an increase of 1.4% due to increased cost of finished products.
−Removed: Our gross profit
−Removed: for the three months ended September 30, 2025 was $3,073,540, compared to $2,866,151 for the three months ended September 30, 2024, an
−Removed: increase of $207,389.
−Removed: General and administrative expenses during the
−Removed: three-month period ended September 30, 2025, were $4,160,153, compared to $3,972,504 during the three-month period ended September 30,
−Removed: 2024, an increase of $187,649.
−Removed: The expense categories that saw an increase were impairment of intangible assets ($554,650) resulting from
−Removed: the determination that certain product licenses could not be commercialized, accounting fees ($10,641), legal fees ($74,698), and office
−Removed: expenses ($84,327).
−Removed: These were offset by a decrease in consulting fees ($316,029), marketing expenses ($47,528), and salaries ($260,678).
−Removed: Overall, we incurred a loss of $1,086,613 from our operations for the three months ended September 30, 2025, compared to a loss of $1,106,353
−Removed: from our operations in the three-month period ended September 30, 2024, largely unchanged.
−Removed: We had interest income of $75,352 during the three
−Removed: months ended September 30, 2025, compared to interest income of $108,614 during the three months ended September 30, 2024, as a result
−Removed: of changes in interest rates.
−Removed: As a result of the foregoing, we incurred a net loss of $883,820 ($0.19 per
−Removed: share) for the three months ended September 30, 2025, compared to a net loss of $1,197,803 ($0.94 per share) for the three-month period
−Removed: ended September 30, 2024, a 24.0% decrease.
−Removed: Comparison of results of operations for
−Removed: the nine months ended September 30, 2025 and 2024
−Removed: During the nine months ended September 30, 2025,
−Removed: we generated revenues of $27,728,750, compared to revenue of $25,279,291 for the nine months ended September 30, 2024, an increase of
−Removed: $2,449,459, or 9.7%.
−Removed: The increase is attributable to enhanced marketing efforts in 2025.
−Removed: The direct cost for generating these revenues
−Removed: was $18,501,918 for the nine months ended September 30, 2025 (66.7%), compared to $17,702,546 (70.0%) for the nine months ended September
−Removed: The decrease in the cost of goods sold in 2025 was due to the procurement of better cost of finished products.
−Removed: Our gross profit
−Removed: increased by $1,650,087 from $7,576,745 for the nine months ended September 30, 2024, to $9,226,832 for the same period in 2025.
−Removed: General and administrative expenses during the
−Removed: nine-month period ended September 30, 2025, were $13,663,850, compared to $11,351,144 during the nine-month period ended September 30,
−Removed: 2024, an increase of $2,312,706.
−Removed: The significant increase was primarily attributable to a $1,616,459 impairment of intangible assets resulting
−Removed: from the determination that certain product licenses could not be commercialized.
−Removed: The other expense categories which contributed to this
−Removed: increase were consulting fees which increased by $684,536 due to fees paid in connection with warrant exercises, marketing fees which
−Removed: increased by $98,120, office expenses which increased by $143,174, and salaries which increased by $223,556 due to new hiring.
−Removed: These increases
−Removed: were offset to some extent by a decrease in accounting fees by $60,389, legal fees by $278,542, and R&D by $253,823.
−Removed: Overall, we incurred
−Removed: a loss of $4,437,018 from our operations in the nine-month period ended September 30, 2025, compared to a loss from operations of $3,774,399
−Removed: in the similar period of 2024.
−Removed: We had interest income of $223,434 during the
−Removed: nine months ended September 30, 2025, compared to interest income of $396,698 during the nine months ended September 30, 2024.
−Removed: was a result of having less cash on hand.
−Removed: As a result of the foregoing, we incurred a
−Removed: net loss of $3,834,425 ($0.98 per share) for the nine-month period ended September 30, 2025, compared to a net loss of $2,975,904
−Removed: ($13,61 per share) for the nine-month period ended September 30, 2024.
−Removed: Liquidity and Capital Resources
−Removed: of September 30, 2025, we had cash and cash equivalents of $9,306,438.
−Removed: cash used in operating activities was $3,715,067 during the nine months ended September 30, 2025, compared to $9,119,519 during the nine-month
−Removed: period ended September 30, 2024.
−Removed: The decrease was a result of reduced cash required for the operations of Nora Pharma.
−Removed: flows used in investing activities were $786,097 for the nine months ended September 30, 2025, compared to $1,881,543 for the nine months
−Removed: ended September 30, 2024.
−Removed: The decrease was the result of less cash needed for the Nora Pharma operations.
−Removed: flows provided by financing activities were $4,023,908 during the nine months ended September 30, 2025, compared to $7,323,370 during
−Removed: the nine months ended September 30, 2024.
−Removed: The decrease was primarily as a result of a smaller financing event completed during the nine
−Removed: months ended September 30, 2025, compared to an offering yielding net proceeds of $8,522,411 completed during the nine months ended September
−Removed: October 14, 2025, we announced that our Board of Directors had allocated $5 million of our cash on hand for investment in Bitcoin.
−Removed: further consideration and in light of recent volatility in Bitcoin, we determined that we will not proceed with this investment.
−Removed: are currently generating revenue of approximately $9.4 million per quarter and incurring a quarterly deficit of approximately $1.0 million.
−Removed: In addition to increasing sales and streamlining operations to reduce expenses, we are currently focusing our attention on lowering our
−Removed: cost of goods sold from our current level of approximately 67% to approximately 60%.
−Removed: We believe these measures could bring us to breakeven
−Removed: and make us less dependent on the capital markets for financing, although there can be no assurances that we will be successful in achieving
−Removed: these reductions.
−Removed: We believe our existing cash on hand together with cash we generate from sales will be sufficient to fund our operations
−Removed: for the next 24 months.
+Added: Additional research results on our lead compound have recently been submitted
+Added: for publication in the Journal of Medicinal Chemistry and the research article has been peer-reviewed and is currently in press.
+Added: May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
+Added: application, entitled Inhibitors of Coronavirus Protease , covers composition subject matter pertaining to small molecules for
+Added: inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication.
+Added: The patent application has a priority
+Added: date of May 22, 2020.
+Added: On April 30, 2021, we filed a PCT application containing new research results and extending coverage to include
+Added: the Coronavirus Papain-Like protease, PLpro.
+Added: The priority date of May 22, 2020 has been maintained in the newly filed PCT application.
+Added: On December 23, 2025, we received a Notice of Allowance from the USPTO for our PCT patent application.
+Added: On May 7, 2026, we received an Issue Notification from the USPTO indicating
+Added: that the patent will be issued on May 12, 2026.
+Added: In addition, the Issue Notification confirms that the patent is eligible for an extension
+Added: of 706 days and will therefore expire on April 6, 2043.
+Added: April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells
+Added: The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant
+Added: mRNA molecules.
+Added: The patent application was converted into a PCT Application on October 18, 2024 and published by the USPTO on
+Added: September 4, 2025.
+Added: February 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules
+Added: which inhibit the Coronavirus protease, PLpro.
+Added: wholly owned subsidiary, Nora Pharma, owns 200 DIN’s issued by Health Canada for prescription drugs currently on the market in
+Added: These DIN’s were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical
+Added: Nora Pharma also owns the rights to sell 10 generic prescription drugs in Canada through distribution agreements with various
+Added: international partners under which Nora Pharma acts as distributor and receives a percentage of sales.
+Added: addition, we own four (4) NPN’s issued by Health Canada including (i) NPN 80089663 which authorizes us to manufacture and sell
+Added: our in-house developed OTC product, Essential•9™, (ii) NPN 80093432 which authorizes us to manufacture and sell the OTC product,
+Added: Calcium-Vitamin D, (iii) NPN 80125047 which authorizes us to manufacture and sell the OTC product, L-Citrulline, and (iv) NPN 80127436
+Added: which authorizes us to manufacture and sell the OTC product, Taurine.
+Added: September 30, 2025, we received official trademark registration from the United States Patent and Trademark Office (Registration No.
+Added: 7,963,385) for “Sunshine Biopharma Inc.” and Design.
+Added: April 15, 2026, we received official trademark registration from the Canadian Intellectual Property Office of Canadian trademark registration
+Added: (Registration No.
+Added: LMC/TMA 1,402,862) for “Sunshine Biopharma Inc.” and Design.
+Added: of Operations
+Added: of results of operations for the three months ended March 31, 2026 and 2025
+Added: the three months ended March 31, 2026, we generated $8,088,765 in sales, compared to $8,901,341 for the three months ended March 31,
+Added: 2025, a decrease of $812,576 (9.1%).
+Added: The decrease is largely a result of termination of our distribution agreements effective December
+Added: The direct cost for generating these sales was $5,907,775 (73.0%) for the three months ended March 31, 2026, compared to $6,170,915
+Added: (69.3%) for the three months ended March 31, 2025.
+Added: Our gross profit for the three months ended March 31, 2026 was $2,180,990 (27.0%),
+Added: compared to $2,730,426 (30.7%) for the three months ended March 31, 2025, a decrease of $549,436.
+Added: and administrative expenses during the three-month period ended March 31, 2026 were $3,576,587, compared to $4,026,176 during the
+Added: three-month period ended March 31, 2025, a decrease of $449,589.
+Added: The decrease was the net result of decreases in certain expense
+Added: categories against modest increases in others.
+Added: For example, while there was an increase in legal fees by $61,877 and salaries by
+Added: $183,038, there was a decrease in accounting fees by $117,950, consulting fees by $222,139, marketing expenses by $148,138, office
+Added: expenses by $54,270, and R&D by $183,038.
+Added: Overall, we incurred a loss of $1,395,597 from our operations for the three months
+Added: ended March 31, 2026, compared to a loss of $1,295,750 from our operations in the three-month period ended March 31,
+Added: We had interest income of $48,426 during the three months ended March 31, 2026, compared to interest income of $75,367 during
+Added: the three months ended March 31, 2025, as a result of having less cash on hand.
+Added: addition, we had a one-time payment of $103,320 in the three months ended March 31, 2026 which we did not have in the three months ended
+Added: March 31, 2025.
+Added: This amount was allocated to us as part of a settlement of a class-action lawsuit against BF Borgers CPA PC, our previous
+Added: auditor whom we terminated in May 2024.
+Added: a result, we incurred a net loss of $1,243,869 ($0.25 per share) for the three months ended March 31, 2026, compared to a net loss of
+Added: $1,179,771 ($0.44 per share) for the three-month period ended March 31, 2025.
+Added: and Capital Resources
+Added: 31, 2026, we had cash and cash equivalents of $6,913,013.
+Added: Net cash used in operating activities was $2,072,100
+Added: during the three months ended March 31, 2026, compared to $1,695,002 during the three-month period ended March 31, 2025.
+Added: was largely a result of an increase in Nora Pharma’s accounts receivable.
+Added: Cash flows used in investing activities were $104,518
+Added: for the three months ended March 31, 2026, compared to $212,017 for the three months ended March 31, 2025.
+Added: The decrease was the result
+Added: of fewer purchases of equipment and intangible assets (drug licenses) by Nora Pharma.
+Added: Cash flows provided by financing activities were
+Added: $0 during the three months ended March 31, 2026, compared to $355,297 during the three months ended March 31, 2025.
+Added: The decrease was a
+Added: result of no warrant exercises taking place during the three months ended March 31, 2026, compared to $355,297 in warrant exercises during
+Added: the three months ended March 31, 2025.
+Added: We are currently generating revenue of approximately
+Added: $8 million per quarter and incurring a quarterly deficit of approximately $1.2 million.
+Added: Our attention is currently focused on increasing
+Added: sales and streamlining operations to reduce expenses.
+Added: We believe these measures could bring us to breakeven and make us less dependent
+Added: on the capital markets for financing.
+Added: Our existing cash on hand together with cash we generate from sales will be sufficient to fund
+Added: our operations for the next 17 months.
There is no assurance our estimates will be accurate.
−Removed: We have no committed sources of capital and we anticipate
−Removed: that we will need to raise additional capital in the future, including for further research and development activities and possibly clinical
−Removed: trials, as well as expansion of our generic pharmaceutical operations.
−Removed: Additional capital may not be available on terms acceptable to
−Removed: us, or at all.
−Removed: Critical Accounting Estimates
−Removed: The discussion and analysis of our financial condition
−Removed: and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally
−Removed: accepted in the United States.
−Removed: The preparation of these financial statements requires us to make estimates and judgments that affect the
−Removed: amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
−Removed: On an on-going basis,
−Removed: we evaluate our estimates based on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
−Removed: the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
−Removed: from other sources.
−Removed: Actual results may differ from these estimates under different assumptions or conditions.
−Removed: For a detailed list of significant accounting
−Removed: policies, please see our annual report on Form 10-K for the fiscal year ended December 31, 2024, including our financial statements and
−Removed: notes thereto included therein as filed with the SEC on April 1, 2025.
−Removed: Recently Adopted Accounting Standards
−Removed: We have adopted all new accounting standards impacting
−Removed: Off Balance-Sheet Arrangements
−Removed: We have not entered into any off-balance sheet
−Removed: arrangements.
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES
−Removed: ABOUT MARKET RISK
−Removed: We are a smaller reporting company and are not
−Removed: required to provide the information under this item.
+Added: We have no committed sources of capital
+Added: and we anticipate that we will need to raise additional capital in the future for expansion of our generic pharmaceuticals sales operations
+Added: and further research and development.
+Added: Additional capital may not be available on terms acceptable to us, or at all.
+Added: Accounting Estimates
+Added: discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been
+Added: prepared in accordance with accounting principles generally accepted in the United States.
+Added: The preparation of these financial statements
+Added: requires us to make estimates and judgments that affect the amounts of assets, liabilities, revenues and expenses, and related disclosure
+Added: of contingent assets and liabilities.
+Added: On an on-going basis, we evaluate our estimates based on historical experience and on various other
+Added: assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about
+Added: the carrying values of assets and liabilities that are not readily apparent from other sources.
+Added: Actual results may differ from these
+Added: estimates under different assumptions or conditions.
+Added: a detailed list of significant accounting policies, please see our annual report on Form 10-K for the fiscal year ended December 31,
+Added: 2025, including our financial statements and notes thereto included therein as filed with the SEC on April 3, 2026.
+Added: Adopted Accounting Standards
+Added: have adopted all new accounting standards impacting operations.
+Added: Balance-Sheet Arrangements
+Added: have not entered into any off-balance sheet arrangements.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: 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.