What changed in Sunshine Biopharma Inc.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of Sunshine Biopharma Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+123 added−111 removedSource: 10-K (2026-04-03) vs 10-K (2025-04-01)
Top changes in Sunshine Biopharma Inc.'s 2025 10-K
123 paragraphs added · 111 removed · 84 edited across 6 sections
- Item 1A. Risk Factors+52 / −60 · 40 edited
- Item 1. Business+37 / −27 · 27 edited
- Item 7. Management's Discussion & Analysis+15 / −12 · 7 edited
- Item 5. Market for Registrant's Common Equity+11 / −4 · 4 edited
- Item 1C. Cybersecurity+7 / −7 · 5 edited
Item 1. Business
Business — how the company describes what it does
27 edited+10 added−0 removed39 unchanged
Item 1. Business
Business — how the company describes what it does
27 edited+10 added−0 removed39 unchanged
2024 filing
2025 filing
Biggest changeOn 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.
Biggest changeFull patents are typically issued by the USPTO 4 to 8 weeks following the issuance of the Notice of Allowance and payment of the issue fees. On April 20, 2022, we filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro.
Nora Pharma is relatively new in this space but has demonstrated one of the fastest year-over-year sales growth amongst its peers. 6 Our Anti-Coronavirus drug development project is in direct competition with several companies in the U.S. that have developed effective vaccines or treatment options for COVID-19. The companies focused on treatments include Pfizer, Merck, Gilead, Eli Lilly, and Regeneron.
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 in direct competition with several companies in the U.S. that have developed effective vaccines or treatment options for COVID-19. The companies focused on treatments include Pfizer, Merck, Gilead, Eli Lilly, and Regeneron.
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.
Generic medications 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.
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.
Our Anti-Coronavirus research effort has been focused on developing an inhibitor of PLpro and, on May 22, 2020, we filed a provisional patent application in the United States covering composition subject matter pertaining to small molecules for inhibition of the Coronavirus PLpro as well as Mpro.
While the approved vaccines, pills and injectable treatments are effective, we believe that additional treatment options such as the one we are developing which targets a different part of the virus could potentially form an important component of the range of anti-coronavirus treatment options available to attending physicians.
While the approved vaccines, pills and injectable treatments are effective, we believe that additional treatment options such as the one we are developing which targets a different part of the virus could potentially form an important component of the range of anti-coronavirus treatment options available to physicians.
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.
Our patent application, entitled Inhibitors of Coronavirus Protease , 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.
(“Nora Pharma”), a Canadian corporation, through which we currently have 70 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells OTC supplements.
(“Nora Pharma”), a Canadian corporation, through which we currently have 71 generic prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. (“Sunshine Canada”), a Canadian corporation which develops and sells OTC supplements.
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. 1 We currently have the following generic prescription drugs on the market in Canada: Drug Action/Indication/Therapeutic Area Reference/Brand Abiraterone* Oncology Zytiga® Alendronate Osteoporosis Fosamax® Amlodipine Cardiovascular Norvasc® Apixaban Cardiovascular Eliquis® Aripiprazole Antipsychotic Abilify® Atorvastatin Cardiovascular Lipitor® Azithromycin Antibacterial Zithromax® Betahistine Vertigo Serc® Bilastine Allergy Blexten® Candesartan Hypertension Atacand® Candesartan HCTZ Hypertension Atacand Plus® Celecoxib Anti-inflammatory Celebrex® Cetirizine Allergy Reactine® Ciprofloxacin Antibiotic Cipro® Citalopram Central nervous system Celexa® Clindamycin Antibiotic Dalacin® Clobetasol* Anti-inflammatory Clobex® Clopidogrel Cardiovascular Plavix® Dapagliflozin Diabetes Forxiga® Daptomycin* Antibacterial Cubicin® Dasatinib* Oncology Sprycel® Donepezil Central nervous system Aricept® Duloxetine Central nervous system Cymbalta® Dutasteride Urology Avodart® Ertapenem* Antibacterial Invanz® Escitalopram Central nervous system Cipralex® Everolimus* Oncology Afinitor® Ezetimibe Cardiovascular Ezetrol® Finasteride Urology Proscar® Flecainide Cardiovascular Tambocor® Fluconazole Antifungal Diflucan® Fluoxetine Central nervous system Prozac® Hanzema®* Dermatology Toctino® Hydroxychloroquine Antimalarial Plaquenil® Lacosamide Central nervous system Vimpat® Letrozole Oncology Femara® Levetiracetam Central nervous system Keppra® Lurasidone Antipsychotic Latuda® Metformin Diabetes Glucophage® Mirtazapine Central nervous system Remeron® Montelukast Allergy Singulair® Olanzapine Central nervous system Zyprexa® Olanzapine ODT Central nervous system Zyprexa® Olmesartan Cardiovascular Olmetec® Olmesartan HCTZ Cardiovascular Olmetec Plus® Pantoprazole Gastroenterology Pantoloc® Paroxetine Central nervous system Paxil® Perindopril Cardiovascular Coversyl® Pravastatin Cardiovascular Pravachol® 2 Pregabalin Central nervous system Lyrica® Progesterone* Women's Health Prometrium® Prucalopride Women's Health Resotran® Quetiapine Central nervous system Seroquel® Quetiapine XR Central nervous system Seroquel XR® Ramipril Cardiovascular Altace® Rivaroxaban* Cardiovascular Xarelto® Rizatriptan ODT Central nervous system Maxalt® ODT Rosuvastatin Cardiovascular Crestor® Sertraline Central nervous system Zoloft® Sildenafil Urology Viagra® Tadalafil Urology Cialis® Telmisartan Cardiovascular Micardis® Telmisartan HCTZ Cardiovascular Micardis Plus® Topiramate Anticonvulsant Topamax® Tramadol Acetaminophen Central nervous system Tramacet® Ursodiol Cholelithiasis Urso® Varenicline Smoking cessation Champix® Zoledronic Acid* Osteoporosis Aclasta® Zolmitriptan Central nervous system Zomig® Zopiclone Central nervous system Imovane® *Sold through distribution agreements in which we act as distributor.
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. 1 We currently have the following generic prescription drugs on the market in Canada: Drug Therapeutic Area Brand Abiraterone* Oncology Zytiga® Alendronate Osteoporosis Fosamax® Amlodipine Cardiovascular Norvasc® Apixaban Cardiovascular Eliquis® Aripiprazole Antipsychotic Abilify® Atorvastatin Cardiovascular Lipitor® Azithromycin Antibacterial Zithromax® Betahistine Vertigo Serc® Bilastine Allergy Blexten® Candesartan Hypertension Atacand® Candesartan HCTZ Hypertension Atacand Plus® Celecoxib Anti-inflammatory Celebrex® Cetirizine Allergy Reactine® Ciprofloxacin Antibiotic Cipro® Citalopram Central nervous system Celexa® Clindamycin Antibiotic Dalacin® Clobetasol* Anti-inflammatory Clobex® Clopidogrel Cardiovascular Plavix® Dapagliflozin Diabetes Forxiga® Daptomycin* Antibacterial Cubicin® Dasatinib* Oncology Sprycel® Docusate Gastroenterology Colace® Donepezil Central nervous system Aricept® Doxycycline Antibacterial Vibramycin® Duloxetine Central nervous system Cymbalta® Dutasteride Urology Avodart® Ertapenem* Antibacterial Invanz® Escitalopram Central nervous system Cipralex® Everolimus* Oncology Afinitor® Ezetimibe Cardiovascular Ezetrol® Finasteride Urology Proscar® Fluconazole Antifungal Diflucan® Fluoxetine Central nervous system Prozac® Gabapentin Central nervous system Neurontin® Hanzema®* Dermatology Toctino® Hydroxychloroquine Antimalarial Plaquenil® Letrozole Oncology Femara® Levetiracetam Central nervous system Keppra® Lurasidone Antipsychotic Latuda® Metformin Diabetes Glucophage® Mirtazapine Central nervous system Remeron® Montelukast Allergy Singulair® Olanzapine Central nervous system Zyprexa® Olanzapine ODT Central nervous system Zyprexa® Olmesartan Cardiovascular Olmetec® Olmesartan HCTZ Cardiovascular Olmetec Plus® Pantoprazole Gastroenterology Pantoloc® Paroxetine Central nervous system Paxil® Pegfilgrastim Oncology Neulasta® Perindopril Cardiovascular Coversyl® Pravastatin Cardiovascular Pravachol® 2 Pregabalin Central nervous system Lyrica® Progesterone* Women's Health Prometrium® Prucalopride Women's Health Resotran® Quetiapine Central nervous system Seroquel® Quetiapine XR Central nervous system Seroquel XR® Ramipril Cardiovascular Altace® Rivaroxaban* Cardiovascular Xarelto® Rizatriptan ODT Central nervous system Maxalt® ODT Rosuvastatin Cardiovascular Crestor® Sertraline Central nervous system Zoloft® Sildenafil Urology Viagra® Tadalafil Urology Cialis® Telmisartan Cardiovascular Micardis® Telmisartan HCTZ Cardiovascular Micardis Plus® Topiramate Anticonvulsant Topamax® Ursodiol Cholelithiasis Urso® Varenicline Smoking cessation Champix® Zoledronic Acid* Osteoporosis Aclasta® Zolmitriptan Central nervous system Zomig® Zopiclone Central nervous system Imovane® *Sold through distribution agreements in which we act as distributor.
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.
Our current lead compound has been 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.
In the area of anticancer drug development, we compete with large publicly and privately held companies engaged in developing new cancer therapies. There are numerous other entities engaged in oncology therapeutics development that have greater resources than the resources presently available to us.
In the area of anticancer drug development, we compete with large publicly and privately held companies engaged in developing new cancer therapies. There are numerous other entities engaged in oncology therapeutics development that have greater resources than us.
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.
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 the products in Canada under the Nora Pharma label.
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.
In addition to the 71 drugs currently on the market, we have 22 additional drugs in our pipeline including 12 we anticipate launching during the remainder of 2026. 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.
We believe the addition of these products to our existing portfolio will strengthen our presence in the Canadian $10.4 billion a year generic drugs 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.
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.
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. 7
Marketing and Sales Our 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 OTC products are manufactured under contract by INOV Pharma Inc. located in Montreal, Canada. Marketing and Sales Our 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.
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. Workforce As of the date of this report we have a total of 52 employees.
As of the date of this report, we believe Essential•9™ is the only Essential Amino Acid supplement that comprises all 9 essential amino acids in capsule form. Workforce As of the date of this report, we have a total of 50 employees, all of whom are full-time.
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 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 December 23, 2025, we received a Notice of Allowance from the USPTO for our PCT patent application.
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.
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.
Our generic prescription medicines are produced 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 Canada.
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.
We 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 mRNA). Our OTC products are manufactured under contract by INOV Pharma Inc. located in Montreal, Canada.
At present, approximately 75% of the drugs in our products portfolio are manufactured by three (3) suppliers overseas. We 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 mRNA).
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. Labor laws in Quebec provide for certain guaranteed minimum entitlements, including minimum wages, maternity leave, medical leave, employee termination conditions, and other similar benefits.
Presently, our proprietary drug development activities are subcontracted out to specialized service providers in the U.S., Canada and overseas. We also use consultants and outside professionals for various other activities including marketing, accounting, and IT.
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. 5 In the area of proprietary drug development where our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant regulations in the U.S. in order to obtain approval of the FDA to offer our products for sale when ready.
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 price of the brand-name reference products.
In both the U.S. and Canada, the ingredients, manufacturing processes and facilities for all drugs and OTC supplements must meet the guidelines for Good Manufacturing Practices (“GMP”). Moreover, all drug manufacturers must perform a series of tests, both during and after production, to show that every drug or supplement batch made meets the regulatory requirements for that product.
Moreover, all drug manufacturers must perform a series of tests, both during and after production, to show that every drug or supplement batch made meets the regulatory requirements for that product. 5 Our generic prescription medicines are produced in compliance with GMP guidelines as for brand-name drugs.
Chem. 2024, 67, 13681−13702 ). A copy of this article is available on our website at: www.sunshinebiopharma.com/scientific-publications. 4 Intellectual Property On May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
Chem. 2024, 67, 13681−13702 ). A copy of this article is available on our website at: www.sunshinebiopharma.com/scientific-publications.
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 200 DIN’s issued by Health Canada for prescription drugs currently on the market in Canada.
The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules. Effective February 24, 2023, we became the exclusive, worldwide licensee of the University of Arizona for three (3) patents related to small molecules which inhibit the Coronavirus protease, PLpro.
Competition According 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.
Our personnel, together with outside consultants develop and place ads on various media platforms and manage our Amazon.ca account. 6 Competition According to IMARC Group , the Canadian generic pharmaceuticals market was valued at approximately $10.4 billion USD in 2024 and is expected to grow to $19.7 billion USD by 2033.
A segment of our marketing team provides human resources, commercial and technical assistance, as well as training and educational 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.
A segment of our marketing team provides human resources, commercial and technical assistance, as well as training and educational support to pharmacy owners. We believe these pharmacy support activities, which we provide mostly free of charge, enhance our visibility in the marketplace and bolster our sales efforts.
Added
Our provisional patent application, entitled Inhibitors of Coronavirus Protease , was converted into a PCT patent application on April 30, 2021. On December 23, 2025, we received a Notice of Allowance from the USPTO for our PCT patent application.
Added
Full patents are typically issued by the USPTO 4 to 8 weeks following the issuance of the Notice of Allowance and payment of the issue fees.
Added
Additional research results on our lead compound have recently been submitted for publication in the Journal of Medicinal Chemistry and the research article has been peer-reviewed and is currently in press. 4 Intellectual Property On May 22, 2020, we filed a provisional patent application in the United States for a new treatment for Coronavirus infections.
Added
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.
Added
On September 30, 2025, we received official trademark registration from the United States Patent and Trademark Office (Registration No. 7,963,385) for “Sunshine Biopharma Inc.” and Design. On November 10, 2025, we received confirmation of from the Canadian Intellectual Property Office of Canadian trademark registration (Registration No. TMA1,056,964 and TMA1,056,969) for “Sunshine Biopharma Inc.” and Design.
Added
In both the U.S. and Canada, the ingredients, manufacturing processes and facilities for all drugs and OTC supplements must meet the guidelines for Good Manufacturing Practices (“GMP”).
Added
In the area of proprietary drug development where our Anti-Coronavirus and Anti-Cancer compounds fall, we will be subject to significant regulations in the U.S. in order to obtain approval of the FDA to offer our products for sale.
Added
Our OTC products are sold in Canada exclusively through the Amazon marketplace, and until the third quarter of 2025, were also sold in the United States exclusively through the Amazon marketplace. In Q3 2025, we discontinued our Amazon sales operations in the United States. We rely on Amazon’s infrastructure for order processing, fulfillment, and customer service.
Added
Prior to our discontinuation of sales operations in the United States, revenue from OTC product sales was derived approximately 10% from the United States and 90% from Canada.
Added
Labor laws in the Province of 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 in the workplace.
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
40 edited+12 added−20 removed60 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
40 edited+12 added−20 removed60 unchanged
2024 filing
2025 filing
Biggest changeEven if we obtain required US and foreign regulatory approvals, as applicable, factors that may inhibit our efforts to commercialize our pharmaceutical product candidates without strategic partners or licensees include: · difficulty recruiting and retaining adequate numbers of effective sales and marketing personnel; · the inability of sales personnel to obtain access to, or persuade adequate numbers of, physicians to prescribe our products; · the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage against companies with broader product lines; and · unforeseen costs associated with creating an independent sales and marketing organization. 11 Even if we successfully develop and obtain approval for our proprietary drug product candidates, our business will not be profitable if such products do not achieve and maintain market acceptance Even if our proprietary drug product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of our approved product candidates by physicians, healthcare professionals, patients and third-party payors, and our resulting profitability and growth, will depend on a number of factors, including: · our ability to provide acceptable evidence of safety and efficacy; · relative convenience and ease of administration; · the prevalence and severity of any adverse side effects; · the availability of alternative treatments; · the details of FDA labeling requirements, including the scope of approved indications and any safety warnings; · pricing and cost effectiveness; · the effectiveness of our or our collaborators' sales and marketing strategy; · our ability to obtain sufficient third-party insurance coverage or reimbursement; and · our ability to have the product listed on insurance company formularies.
Biggest changeEven if we successfully develop and obtain approval for our proprietary drug product candidates, our business will not be profitable if such products do not achieve and maintain market acceptance Even if our proprietary drug product candidates are approved for commercial sale by the FDA or other regulatory authorities, the degree of market acceptance of our approved product candidates by physicians, healthcare professionals, patients and third-party payors, and our resulting profitability and growth, will depend on a number of factors, including: · Our ability to provide acceptable evidence of safety and efficacy; · Relative convenience and ease of administration; · The prevalence and severity of any adverse side effects; · The availability of alternative treatments; · The details of FDA labeling requirements, including the scope of approved indications and any safety warnings; · Pricing and cost effectiveness; · The effectiveness of our or our collaborators' sales and marketing strategy; · Our ability to obtain sufficient third-party insurance coverage or reimbursement; and · Our ability to have the product listed on insurance company formularies. 12 If our proprietary drug product candidates achieve market acceptance, we may not maintain that market acceptance over time if new products or technologies are introduced that are received more favorably or are more cost effective.
In addition, an unfavorable outcome in any such litigation could have a material adverse effect on our business, results of operations and cash flows. If we are unable to attract and retain qualified scientific, technical, and key management personnel, or if our key executive, Dr. Steve N.
In addition, an unfavorable outcome in any such litigation could have a material adverse effect on our business, results of operations and cash flows. 10 If we are unable to attract and retain qualified scientific, technical, and key management personnel, or if our key executive, Dr. Steve N.
Slilaty would result in a significant negative impact on our ability to implement our business plan. The loss of Dr. Slilaty will also significantly delay or prevent the achievement of our business objectives.
Slilaty would result in a significant negative impact on our ability to implement our business plan. The loss of Dr. Slilaty would also significantly delay or prevent the achievement of our business objectives.
The occurrence of these or any other operational problems, including the improper installation or operation of equipment, terrorism, pandemics (including COVID-19), natural or other disasters, intentional acts of violence, and the need to comply with the requirements or directives of governmental agencies, including the FDA and Health Canada may have a material adverse effect on our business, financial condition and results of operations.
The occurrence of these or any other operational problems, including the improper installation or operation of equipment, terrorism, pandemics, natural or other disasters, intentional acts of violence, and the need to comply with the requirements or directives of governmental agencies, including the FDA and Health Canada may have a material adverse effect on our business, financial condition and results of operations.
The failure of our service providers and suppliers to supply quality services and materials in sufficient quantities, at a favorable price, and in a timely fashion could adversely affect the results of our operations Our outside manufacturers buy raw materials from a limited number of suppliers.
The failure of our suppliers to supply quality materials in sufficient quantities, at a favorable price, and in a timely fashion could adversely affect the results of our operations Our outside manufacturers buy raw materials from a limited number of suppliers.
Increasing cost pricing pressures on raw materials and other products occurred throughout fiscal 2023 as a result of limited supplies of various ingredients, the effects of higher labor and transportation costs, and the impact of Covid-19. We expect these upward pressures to continue through fiscal 2024.
Increasing cost pricing pressures on raw materials and other products occurred throughout fiscal 2024 and 2025 as a result of limited supplies of various ingredients, and the effects of higher labor and transportation costs. We expect these upward pressures to continue through fiscal 2026.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: · we were the first to make the inventions covered by each of our pending patent applications; · we were the first to file patent applications for these inventions; · others will not independently develop similar or alternative technologies or duplicate any of our technologies; · any patents issued to us or our collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages, or will not be challenged by third parties; · our pending patent applications will result in issued patents; · we will develop additional proprietary technologies that are patentable; · the patents of others will not have a negative effect on our ability to do business; or · our issued patents will have sufficient useful life remaining for commercial viability of our product candidate. 13 If we cannot maintain the confidentiality of our technology and other confidential information in connection with our collaborations, then our ability to receive patent protection or protect our proprietary information will be impaired.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: · We were the first to make the inventions covered by each of our pending patent applications; · We were the first to file patent applications for these inventions; · Others will not independently develop similar or alternative technologies or duplicate any of our technologies; · Any patents issued to us or our collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages, or will not be challenged by third parties; · Our pending patent applications will result in issued patents; · We will develop additional proprietary technologies that are patentable; · The patents of others will not have a negative effect on our ability to do business; or · Our issued patents will have sufficient useful life remaining for commercial viability of our product candidate.
In addition, as of the date of filing of this report, we had 12,226,549 Series B Warrants issued and outstanding, each exercisable to purchase one share of our common stock at an exercise price of $2.79 per warrant.. The issuance of additional securities in the future will dilute the percentage ownership of our current stockholders. ITEM 1B.
In addition, as of the date of filing of this report, we had 15,227,962 Series B Warrants issued and outstanding, each exercisable to purchase one share of our common stock at an exercise price of $2.07 per warrant. The issuance of additional securities in the future will dilute the percentage ownership of our current stockholders. 17 ITEM 1B.
Since 2022, as the global economy has recovered from the impact of the COVID-19 pandemic, it has also been experiencing additional macroeconomic pressures such as rising inflation and disruptions to the global supply chain, in part resulting from the ongoing conflict between Russia and Ukraine.
Since 2022, as the global economy has recovered from the impact of the COVID-19 pandemic, it has also been experiencing additional macroeconomic pressures such as rising inflation and disruptions to the global supply chain, in part resulting from ongoing conflicts and tariff escalations.
Our business, financial condition, results of operations and prospects could be materially and adversely affected by these risks. Risks Related to Our Business We have incurred losses and may never achieve profitability We have an accumulated deficit of $69,084,565 as of December 31, 2024.
Our business, financial condition, results of operations and prospects could be materially and adversely affected by these risks. Risks Related to Our Business We have incurred losses and may never achieve profitability We have an accumulated deficit of $75,015,126 as of December 31, 2025.
The price and daily trading volume of our common stock have been very volatile and may continue to be so, and any significant trading volume in our common stock may not be maintained.
The price and daily trading volume of our common stock have been very volatile and may continue to be so, and any significant trading volume in our common stock may not be maintained. These factors may have an adverse impact on the trading and price of our common stock.
Although we believe we could establish alternate manufacturers and sources for most of our raw materials, any delay in locating and establishing relationships with other sources could result in shortages of products we manufacture from such raw materials, with a resulting loss of sales and customers. 14 A shortage of raw materials or an unexpected interruption of supply could also result in higher prices for those materials.
Although we believe we could establish alternate manufacturers and sources for most of our raw materials, any delay in locating and establishing relationships with other sources could result in shortages of products we manufacture from such raw materials, with a resulting loss of sales and customers.
A delisting of our common stock and our inability to list on another national securities market could negatively impact us by: (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use certain registration statements to offer and sell freely tradeable securities, thereby limiting our ability to access the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.
A delisting of our common stock and our inability to list on another national securities market could negatively impact us by: (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) limiting our ability to use certain registration statements to offer and sell freely tradeable securities, thereby limiting our ability to access the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees. 16 We do not intend to pay dividends on our common stock for the foreseeable future We have paid no dividends on our common stock to date and we do not anticipate paying any dividends to holders of our common stock in the foreseeable future.
Because our proprietary drug product candidates and our development and collaboration efforts depend on our intellectual property rights, adverse events affecting our intellectual property rights will harm our ability to commercialize products Our success will depend to a large degree on our own and our licensors’ ability to obtain and defend patents for each party's respective technologies and the compounds and other products, if any, resulting from the application of such technologies.
Any approved drugs resulting from our research and development efforts, or from our joint efforts with our existing or future collaborative partners, might not be able to compete successfully with our competitors' existing or future products. 13 Because our proprietary drug product candidates and our development and collaboration efforts depend on our intellectual property rights, adverse events affecting our intellectual property rights will harm our ability to commercialize products Our success will depend to a large degree on our own and our licensors’ ability to obtain and defend patents for each party's respective technologies and the compounds and other products, if any, resulting from the application of such technologies.
A successful product liability claim, or series of claims brought against us would decrease our cash reserves and could cause our stock price to fall significantly. 10 We face regulation and risks related to hazardous materials and environmental laws, violations of which may subject us to claims for damages or fines that could materially affect our business, cash flow, financial condition and results of operations Our research and development activities involve the use of controlled and/or hazardous materials and chemicals.
We face regulation and risks related to hazardous materials and environmental laws, violations of which may subject us to claims for damages or fines that could materially affect our business, cash flow, financial condition and results of operations Our research and development activities involve the use of controlled and/or hazardous materials and chemicals.
To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidates or grant licenses on terms that are not favorable to us. 9 We may be sued or become a party to litigation, which could require significant management time and attention and result in significant legal expenses and may result in an unfavorable outcome which could have a material adverse effect on our business, financial condition, results of operations and cash flow We may be forced to incur costs and expenses in connection with defending ourselves with respect to litigation and the payment of any settlement or judgment in connection therewith if there is an unfavorable outcome.
We may be sued or become a party to litigation, which could require significant management time and attention and result in significant legal expenses and may result in an unfavorable outcome which could have a material adverse effect on our business, financial condition, results of operations and cash flow We may be forced to incur costs and expenses in connection with defending ourselves with respect to litigation and the payment of any settlement or judgment in connection therewith if there is an unfavorable outcome.
Such manufacturing operations, and those of their suppliers, are subject to power failures, blackouts, border shutdowns, telecommunications failures, computer viruses, cybersecurity vulnerabilities, human error, breakdown, failure or substandard performance.
As a result, we are dependent on the uninterrupted and efficient operation of these facilities. Such manufacturing operations, and those of their suppliers, are subject to power failures, blackouts, border shutdowns, telecommunications failures, computer viruses, cybersecurity vulnerabilities, human error, breakdown, failure or substandard performance.
These actions may increase the costs and risks of our efforts to introduce generic products and may delay or prevent such introductions altogether. 8 We may experience delays in launching our new generic products If we cannot execute timely launches of new products, we may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and accelerated generics approvals for competing products.
We may experience delays in launching our new generic products If we cannot execute timely launches of new products, we may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and approvals for competing products.
Our business, financial condition and results of operations could be adversely affected if any of our products or any similar products distributed by other companies are alleged to be or are proved to be harmful to consumers or to have unanticipated and unwanted health consequences.
Our business, financial condition and results of operations could be adversely affected if any of our products or any similar products distributed by other companies are alleged to be or are proved to be harmful to consumers or to have unanticipated and unwanted health consequences. 15 Our manufacturing and third-party fulfillment activities are subject to certain risks Our products are manufactured at third party manufacturing facilities in Canada and overseas.
The Company’s securities may be delisted from Nasdaq at that time. We may be unable to maintain compliance with Nasdaq listing requirements. If we are unable to maintain compliance with Nasdaq listing requirements, we could be subject to suspension and delisting proceedings.
If we are unable to maintain compliance with Nasdaq listing requirements, we could be subject to suspension and delisting proceedings.
Investors should take note of the fact that a lack of a dividend can further affect the market value of our common stock and could significantly affect the value of any investment in our Company. 16 Our articles of incorporation allow for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock Our board of directors has the authority to fix and determine the relative rights and preferences of preferred stock.
Our articles of incorporation allow for our board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock Our board of directors has the authority to fix and determine the relative rights and preferences of preferred stock.
The implementation of our business plan may result in a period of rapid growth that will impose a significant burden on our current administrative and operational resources Our ability to effectively manage our growth will require us to substantially expand the capabilities of our administrative and operational resources by attracting, training, managing, and retaining additional qualified personnel, including additional members of management, technicians, and others.
Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. 14 The implementation of our business plan may result in a period of rapid growth that will impose a significant burden on our current administrative and operational resources Our ability to effectively manage our growth will require us to substantially expand the capabilities of our administrative and operational resources by attracting, training, managing, and retaining additional qualified personnel, including additional members of management, technicians, and others.
We incurred a net loss of $5,178,907 for the year ended December 31, 2024, and a net loss of $4,506,044 for the year ended December 31, 2023. We may never achieve profitability.
We incurred a net loss of $5,975,352 for the year ended December 31, 2025, and a net loss of $5,134,116 for the year ended December 31, 2024. We may never achieve profitability.
Any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on our business, financial condition, and results of operations.
Pricing pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between the pharmaceutical industry and the federal government. Any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on our business, financial condition, and results of operations.
We have experienced increases in various raw material costs, transportation costs and the cost of petroleum-based raw materials and packaging supplies used in our business.
A shortage of raw materials or an unexpected interruption of supply could also result in higher prices for those materials. We have experienced increases in various raw material costs, transportation costs and the cost of petroleum-based raw materials and packaging supplies used in our business.
These adverse market forces would have a direct impact on our ability to achieve our sales projections. · A significant portion of Nora Pharma’s revenues are derived from relatively few key customers, and any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on Nora Pharma’s business, financial condition, and results of operations. · If Nora Pharma encounters difficulties in executing launches of new products, it may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and accelerated generics approvals for competitors.
These adverse market forces would have a direct impact on our ability to achieve our sales projections. 8 · If Nora Pharma encounters difficulties in executing launches of new products, it may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and increasing generics approvals for competitors.
Sales of our generic products may be adversely affected by the drug regulatory environment in Canada Currently we sell our generic drugs only in Canada. Our net sales may be affected by fluctuations in the buying patterns of our customers resulting from government lead pricing pressures and other factors.
Our net sales may be affected by fluctuations in the buying patterns of our customers resulting from government lead pricing pressures and other factors. Our generic sales in Canada are done via retail pharmacies, pharmacy channels, distributors, and wholesalers.
Our most advanced product candidate, K1.1 mRNA and our potential Covid-19 treatment in development may never be approved for commercial sale. We have not made any filings to date with the FDA or other regulatory bodies in other jurisdictions. The time required to attain product sales and profitability is expensive, lengthy and highly uncertain.
We have not made any filings to date with the FDA or other regulatory bodies in other jurisdictions. The time required to attain product sales and profitability is expensive, lengthy and highly uncertain. If we fail to obtain required regulatory approvals for our pharmaceutical product candidates our business will be materially harmed.
If we are unable to establish sales and marketing capabilities for our pharmaceutical product candidates or enter into agreements with third parties to sell and market any such products we may develop, we may be unable to generate revenues from our non-generic pharmaceutical business We do not currently have product sales and marketing capabilities for our non-generic pharmaceutical operations.
The failure of collaborators or third-party manufacturers to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our business. 11 If we are unable to establish sales and marketing capabilities for our pharmaceutical product candidates or enter into agreements with third parties to sell and market any such products we may develop, we may be unable to generate revenues from our non-generic pharmaceutical business We do not currently have product sales and marketing capabilities for our non-generic pharmaceutical operations.
Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation. Failure or delays in executing launches of new generic products could have a material adverse effect on our business, financial condition, and results of operations.
Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.
Brand companies may seek to delay introduction of generic equivalents through a variety of commercial and regulatory tactics.
Brand companies may seek to delay introduction of generic equivalents through a variety of commercial and regulatory tactics. These actions may increase the costs and risks of our efforts to introduce generic products and may delay or prevent such introductions altogether.
If our proprietary drug product candidates achieve market acceptance, we may not maintain that market acceptance over time if new products or technologies are introduced that are received more favorably or are more cost effective. Complications may also arise, such as development of new know-how or new medical or therapeutic capabilities by other parties that render our product obsolete.
Complications may also arise, such as development of new know-how or new medical or therapeutic capabilities by other parties that render our product obsolete.
Any such disruptions could have a material adverse impact on our business and our results of operation and financial condition. 7 Other risks associated with our generic pharmaceutical business include: · Current macroeconomic conditions are becoming increasingly less stable due to the war in Ukraine, and tensions in the Middle and Far East.
Other risks associated with our generic pharmaceutical business include: · Current macroeconomic conditions are becoming increasingly less stable due to ongoing war in Ukraine, and the Middle East, and threats of war in various other areas around the world including South America, Greenland, and the Far East.
Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation. Failure or delays to execute launches of new generic products could have a material adverse effect on Nora Pharma’s business and its ability to realize projected sales.
Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.
These factors may have an adverse impact on the trading and price of our common stock. 15 If we are unable to continue to meet the listing requirements of Nasdaq, our common stock will be delisted Our common stock currently trades on Nasdaq, where it is subject to various listing requirements.
If we are unable to continue to meet the listing requirements of Nasdaq, our common stock will be delisted Our common stock currently trades on Nasdaq, where it is subject to various listing requirements, including Nasdaq Rule 5500(a)(2), which requires that our common stock maintain a minimum bid price of at least $1.00 to maintain its listing on Nasdaq (the “Bid Price Rule”).
We may not receive required regulatory approval for any of our non-generic pharmaceutical product candidates We have not received approval for any of our proprietary (non-generic) drug development operations product candidates from the FDA. Any compounds we discover or in-license will require extensive and costly development, preclinical testing and clinical trials prior to seeking regulatory approval for commercial sales.
Any compounds we discover or in-license will require extensive and costly development, preclinical testing and clinical trials prior to seeking regulatory approval for commercial sales. Our most advanced product candidate, K1.1 mRNA and our potential Covid-19 treatment in development may never be approved for commercial sale.
In addition, some of the technology we have developed or licensed relies on inventions developed using U.S. and other governments’ resources.
If we cannot maintain the confidentiality of our technology and other confidential information in connection with our collaborations, then our ability to receive patent protection or protect our proprietary information will be impaired. In addition, some of the technology we have licensed relies on inventions developed using U.S. government resources.
On occasion, juries have awarded large judgments in class action lawsuits based on drugs that had unanticipated side effects.
On occasion, juries have awarded large judgments in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim, or series of claims brought against us would decrease our cash reserves and could cause our stock price to fall significantly.
A significant or prolonged economic downturn could have a material adverse effect on our results of operations A significant or prolonged economic downturn may adversely affect the disposable income of many consumers and may lower demand for some of our products. Any decline in economic conditions could negatively impact our business.
These risks, individually or in the aggregate, could have a material adverse effect on our business, financial condition, and results of operations.
In addition, courts outside the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
In addition, courts outside the United States may be less willing to protect trade secrets.
Removed
Our generic sales in Canada are done via retail pharmacies, pharmacy channels, distributors, and wholesalers. Pricing pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between the pharmaceutical industry and the federal government.
Added
Any such disruptions could have a material adverse impact on our business and our results of operation and financial condition.
Removed
If we fail to obtain required regulatory approvals for our pharmaceutical product candidates our business will be materially harmed.
Added
Failure or delays to execute launches of new generic products could have a material adverse effect on Nora Pharma’s business and its ability to realize projected sales. · Nora Pharma’s sales of generic pharmaceutical products in Canada are heavily dependent on federal and provincial reimbursement frameworks, which determine pricing, formulary inclusion, and allowable markups.
Removed
Our product candidates require precise, high-quality manufacturing. The failure of collaborators or third-party manufacturers to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our business.
Added
Any changes to these government-controlled reimbursement policies, whether through cost-containment measures, reference pricing adjustments, or formulary restrictions, could adversely affect Nora Pharma’s revenues in this market. Sales of our generic products may be adversely affected by the drug regulatory environment in Canada Currently we sell our generic drugs only in Canada.
Removed
The future clinical testing of our proprietary drug product candidates could be delayed, resulting in increased costs to us and a delay in our ability to generate revenues Our proprietary drug product candidates will require additional preclinical testing and extensive clinical trials prior to submission of a regulatory application for commercial sales.
Added
Failure or delays in executing launches of new generic products could have a material adverse effect on our business, financial condition, and results of operations. 9 We may not receive required regulatory approval for any of our non-generic pharmaceutical product candidates We have not received approval for any of our proprietary (non-generic) drug development operations product candidates from the FDA or any other regulatory bodies in other jurisdictions.
Removed
We do not know whether clinical trials will begin on time, if at all. Delays in the commencement of clinical testing could significantly increase our product development costs and delay product commercialization.
Added
To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidates or grant licenses on terms that are not favorable to us.
Removed
In addition, many of the factors that may cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory approval of a product candidate. Each of these results would adversely affect our ability to generate revenues.
Added
Even if we obtain required U.S. and foreign regulatory approvals, as applicable, factors that may inhibit our efforts to commercialize our pharmaceutical product candidates without strategic partners or licensees include: · Difficulty recruiting and retaining adequate numbers of effective sales and marketing personnel; · The inability of sales personnel to obtain access to, or persuade adequate numbers of, physicians to prescribe our products; · The lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage against companies with broader product lines; and · Unforeseen costs associated with creating an independent sales and marketing organization.
Removed
The commencement of clinical trials can be delayed for a variety of reasons, including delays in: · demonstrating sufficient safety to obtain regulatory approval to commence a clinical trial; · reaching agreement on acceptable terms with prospective research organizations and trial sites; · manufacturing sufficient quantities of a product candidate; · obtaining institutional review board approvals to conduct clinical trials at prospective sites; and · procuring adequate financing to fund the work. 12 In addition, the commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease, and the eligibility criteria for the clinical trial.
Added
We are dependent on a concentrated base of finished goods suppliers, which increases our risk of product interruption Approximately 75% of the drugs in our products portfolio are manufactured by three (3) suppliers overseas. Reliance on a limited number of third-party suppliers for finished products exposes us to material operational, regulatory, and financial risks.
Removed
If we are unable to enroll a sufficient number of evaluable patients, the clinical trials for our product candidates could be delayed until sufficient numbers are achieved.
Added
Because these suppliers are responsible for manufacturing, packaging, and releasing finished pharmaceuticals under stringent regulatory requirements, any disruption in their operations can directly affect our ability to maintain continuous product supply.
Removed
Any approved drugs resulting from our research and development efforts, or from our joint efforts with our existing or future collaborative partners, might not be able to compete successfully with our competitors' existing or future products.
Added
Disruptions may arise from GMP non-compliance, regulatory inspection findings, quality system failures, contamination events, batch deviations, or shortages of critical components such as active pharmaceutical ingredients, excipients, or specialized packaging. Regulatory actions, including FDA Form 483 observations, warning letters, import alerts, or license suspensions can halt production or delay batch release.
Removed
A significant decline in consumer demand, even if only due in part to general economic conditions could have a material adverse effect on our revenues and profit margins.
Added
Our common stock has recently traded at prices slightly above the $1.00 Nasdaq required minimum bid price requirement.
Removed
Our manufacturing and third-party fulfillment activities are subject to certain risks Our products are manufactured at third party manufacturing facilities in Canada and overseas. As a result, we are dependent on the uninterrupted and efficient operation of these facilities.
Added
In addition, though we have obtained stockholder approval to authorize the board of directors to implement a reverse stock split in its discretion, in a ratio of up to 1-for-10, there is no assurance that, even if we implement a reverse split, we will be able to maintain compliance with the Bid Price Rule or other applicable requirements for continued listing on Nasdaq.
Removed
On February 28, 2024, we received a notification letter from Nasdaq advising that Nasdaq’s staff had determined that as of February 27, 2024, our common stock had a closing bid price of $0.10 or less for ten consecutive trading days and accordingly, we were subject to the provisions contemplated under Listing Rule 5810(c)(3)(A)(iii).
Added
Investors should take note of the fact that a lack of a dividend can further affect the market value of our common stock and could significantly affect the value of any investment in our Company.
Removed
Accordingly, Nasdaq determined to remove our securities from listing and registration on Nasdaq, subject to the procedures set forth in the Nasdaq Listing Rule 5800 Series which provides us with the opportunity to appeal this determination.
Removed
On June 7, 2024, we received a notification letter from Nasdaq, that based on further review of our public filings with the Securities and Exchange Commission and supporting materials submitted to Nasdaq, its staff determined to delist our securities pursuant to its discretionary authority under Listing Rule 5101.
Removed
Specifically, as set forth in the letter, Nasdaq’s staff determined that the “alternative cashless exercise” provision of the Series A Warrants the Company issued on February 15, 2024, raised public interest and investor protection concerns because the issuance of Series A Warrants resulted in substantial dilution for the stockholders of the Company to date and could cause potential future dilution.
Removed
Accordingly, as set forth in the letter, this matter served as an additional basis for delisting the Company’s securities from The Nasdaq Stock Market. The letter served as a formal notification that the Nasdaq Hearings Panel (the “Panel”) would consider this matter in their decision regarding our continued listing on The Nasdaq Capital Market.
Removed
On September 9, 2024, we received a letter from Nasdaq confirming that we had regained compliance with the bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”), as required by the Panel’s decision dated June 28, 2024. The letter further stated that the Company will be subject to a Mandatory Panel Monitor for a period of one year.
Removed
If, within that one-year monitoring period, the Nasdaq Listing Qualifications staff (“Nasdaq Staff”) finds the Company again out of compliance with the Bid Price Rule, the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3).
Removed
Instead, the Nasdaq Staff will issue a Delist Determination Letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C).
Removed
We do not intend to pay dividends on our common stock for the foreseeable future We have paid no dividends on our common stock to date and we do not anticipate paying any dividends to holders of our common stock in the foreseeable future.
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
5 edited+2 added−2 removed1 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
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2024 filing
2025 filing
Biggest changeWe collaborate with external cybersecurity experts and law enforcement agencies to enhance our incident response capabilities. 17 Employee Training and Awareness We provide ongoing cybersecurity training and awareness programs for all employees to promote a culture of security. Our training programs cover topics such as phishing prevention, secure data handling, and recognizing potential cyber threats.
Biggest changeIncident Response and Recovery We have a robust incident response plan in place to quickly detect, respond to, and recover from cybersecurity incidents. We collaborate with external cybersecurity experts and law enforcement agencies to enhance our incident response capabilities. Employee Training and Awareness We provide ongoing cybersecurity training and awareness programs for all employees to promote a culture of security.
Third-Party Risk Management We assess the cybersecurity practices of our third-party vendors and partners to ensure they meet our security standards. Our contracts with third parties include provisions for cybersecurity requirements and incident reporting.
Our training programs cover topics such as phishing prevention, secure data handling, and recognizing potential cyber threats. Third-Party Risk Management We assess the cybersecurity practices of our third-party vendors and partners to ensure they meet our security standards. Our contracts with third parties include provisions for cybersecurity requirements and incident reporting.
Our risk management framework is aligned with industry standards such as the NIST Cybersecurity Framework (CSF) and ISO 27001. We continuously monitor and update our cybersecurity measures to address emerging threats and ensure the protection of our assets. Cybersecurity Governance Our management oversees our cybersecurity risk management efforts.
We continuously monitor and update our cybersecurity measures to address emerging threats and ensure the protection of our assets. Cybersecurity Governance Our management oversees our cybersecurity risk management efforts. Our senior management team is actively involved in cybersecurity policies, procedures and strategy development.
ITEM 1C. CYBERSECURITY Our Company recognizes the critical importance of cybersecurity in protecting our sensitive data, intellectual property, and the personal information of our employees and partners. We have implemented a comprehensive cybersecurity risk management program that includes the following key components: Risk Assessment and Management We conduct regular risk assessments to identify and evaluate potential cybersecurity threats and vulnerabilities.
ITEM 1C. CYBERSECURITY Risk Our Company recognizes the critical importance of cybersecurity in protecting our sensitive data, intellectual property, and the personal information of our employees and partners.
Investments in Cybersecurity We continuously invest in advanced cybersecurity technologies, including threat detection and prevention systems, encryption, and secure access controls. Our cybersecurity is part of our overall budget which is reviewed and approved by our board of directors to ensure adequate resources are allocated to protect our assets.
Our cybersecurity is part of our overall budget which is reviewed and approved by our board of directors to ensure adequate resources are allocated to protect our assets. 18 Cybersecurity Incidents During the past fiscal year, we experienced no cybersecurity incidents .
Removed
Our senior management team is actively involved in cybersecurity policies, procedures and strategy development. Incident Response and Recovery We have a robust incident response plan in place to quickly detect, respond to, and recover from cybersecurity incidents.
Added
We have implemented a comprehensive cybersecurity risk management program that includes the following key components: Risk Assessment and Management We conduct regular risk assessments to identify and evaluate potential cybersecurity threats and vulnerabilities. Our risk management framework is aligned with industry standards such as the NIST Cybersecurity Framework (CSF) and ISO 27001.
Removed
Cybersecurity Incidents During the past fiscal year, we experienced no cybersecurity incidents.
Added
Investments in Cybersecurity We continuously invest in advanced cybersecurity technologies, including threat detection and prevention systems, encryption, and secure access controls.
Item 2. Properties
Properties — owned and leased real estate
1 edited+0 added−0 removed3 unchanged
Item 2. Properties
Properties — owned and leased real estate
1 edited+0 added−0 removed3 unchanged
2024 filing
2025 filing
Biggest changeThis site is composed of 18,500 square feet of warehouse space and 5,000 square feet of executive office space. The facility houses all administrative, marketing, quality control, regulatory affairs, and other operations personal, as well as a Health Canada licensed warehouse space. We pay a monthly rent of $27,250 CAD (approximately $19,900 USD), including taxes.
Biggest changeThis site is composed of 18,500 square feet of warehouse space and 5,000 square feet of executive office space. The facility houses all administrative, marketing, quality control, regulatory affairs, and other operations personnel, as well as a Health Canada licensed warehouse space. We pay a monthly rent of $27,250 CAD (approximately $19,900 USD), including taxes.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
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Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
4 edited+7 added−0 removed0 unchanged
2024 filing
2025 filing
Biggest changeDividend Policy We have not paid any dividends since our incorporation and do not anticipate paying any dividends in the foreseeable future. At present, our policy is to retain earnings, if any, to develop and market our products. Our payment of dividends in the future will depend upon, among other factors, our earnings, capital requirements, and operating financial conditions.
Biggest changeAt present, our policy is to retain earnings, if any, to develop and market our products. Our payment of dividends in the future will depend upon, among other factors, our earnings, capital requirements, and operating financial conditions. Repurchases of Equity Securities We did not repurchase any shares of our common stock during the three months ended December 31, 2025.
We also have tradeable warrants exercisable to purchase shares of our common stock listed on the Nasdaq Capital Market under the symbol “SBFMW.” As of April 1, 2025, we had 482 tradeable warrants outstanding exercisable at $220.00 per warrant.
As of April 2, 2026, we had 4,905,945 shares of our common stock issued and outstanding. We also have tradeable warrants exercisable to purchase shares of our common stock listed on the Nasdaq Capital Market under the symbol “SBFMW.” As of April 2, 2026, we had 482 tradeable warrants outstanding exercisable at $220.00 per warrant.
As of April 1, 2025, there were approximately 149 holders of record of our common stock, not including those holding their shares in “street name.” Equity Compensation Plan Information The following table sets forth information regarding our equity compensation plans as of December 31, 2024: Plan Category Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans Equity compensation plans approved by security holders* – – 1,661 Equity compensation plans not approved by security holders – – – *Represents our 2023 Equity Incentive Plan.
We currently do not have a Rule 10b5-1 plan or other repurchase arrangements in place. 20 Equity Compensation Plan Information The following table sets forth information regarding our equity compensation plans as of December 31, 2025: Plan Category Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights Weighted-Average Exercise Price of Outstanding Options, Warrants and Rights Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans Equity compensation plans approved by security holders* – – 683,000 Equity compensation plans not approved by security holders – – – *Represents our 2023 Equity Incentive Plan as amended on December 11, 2025 at the Company’s 2025 Annual General Meeting of the shareholders.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our common stock is listed on the Nasdaq Capital Market under the symbol “SBFM”. As of April 1, 2025, we had a total of 2,707,541 shares of our common stock issued and outstanding.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES In this section, we provide information about the market for our common equity, the number of holders of our common stock, our dividend practices, and our repurchases of equity securities.
Added
In addition, we provide disclosures regarding our equity compensation plans and our policies and practices for granting stock options and stock appreciation rights, including awards made in close proximity to the release of material nonpublic information, as required under recently adopted SEC rules. Market Information Our common stock is listed on the Nasdaq Capital Market under the symbol “SBFM”.
Added
Holders As of April 2, 2026, there were approximately 117 holders of record of our common stock. The total number of beneficial owners exceeds holders of record due to Street-Name holdings. Dividend Policy We have not paid any dividends since our incorporation and do not anticipate paying any dividends in the foreseeable future.
Added
Option and SAR Grant Timing in Relation to MNPI Releases We have established policies and practices governing the timing and administration of equity awards, including stock options and stock appreciation rights (“SARs”).
Added
We may grant equity awards pursuant to our 2023 Equity Incentive Plan, as approved by the Compensation Committee, the Board of Directors at regularly scheduled meetings or by unanimous written consent.
Added
We do not coordinate the timing of option or SAR grants with the release of material non-public information (“MNPI”), nor do we time the public disclosure of MNPI for the purpose of affecting the value of executive compensation. We have not granted any such awards to date.
Added
We have not granted stock options or SARs to any executive officer in periods proximate to the release of MNPI, as defined in Item 402(x) of Regulation S-K. Accordingly, no tabular disclosure under Item 402(x)(2) is required for the fiscal years ended December 31, 2024 and 2025.
Added
If we were to grant options or SARs in such circumstances in the future, we would provide the required tabular disclosure in accordance with SEC rules.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
7 edited+8 added−5 removed9 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
7 edited+8 added−5 removed9 unchanged
2024 filing
2025 filing
Biggest changeThe decrease was due to reduced interest rates and less cash on hand in 2024. As a result, we incurred a net loss of $5,134,116 for the year ended December 31, 2024, compared to a net loss of $4,506,044 for the year ended December 31, 2023.
Biggest changeAs a result of the foregoing, we incurred a net loss of $5,975,352 for the year ended December 31, 2025, compared to a net loss of $5,134,116 for the year ended December 31, 2024. Liquidity and Capital Resources As of December 31, 2025, we had cash and cash equivalents of $9,123,308.
Actual results may differ from these estimates under different assumptions or conditions. Leases We follow the guidance in ASC 842 “ Accounting for Leases ,” as amended, which requires us to evaluate the lease agreements we enter into to determine whether they represent operating or capital leases at the inception of the lease.
Actual results may differ from these estimates under different assumptions or conditions. Leases We follow the guidance in ASC 842 – Accounting for Leases , as amended, which requires us to evaluate the lease agreements we enter into to determine whether they represent operating or capital leases at the inception of the lease.
We 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 pharmaceutical operations. Additional capital may not be available on terms acceptable to us, or at all.
There is no assurance our estimates will be accurate. We have no committed sources of capital and we anticipate that we will need to raise additional capital in the future to expand our generic pharmaceutical operations. Additional capital may not be available on terms acceptable to us, or at all.
Results of Operations Comparison of Results of Operations for the fiscal years ended December 31, 2024 and 2023 During our fiscal year ended December 31, 2024, we generated revenues of $34,874,283, compared to revenues of $24,092,787 in 2023.
Results of Operations Comparison of Results of Operations for the fiscal years ended December 31, 2025 and 2024 During our fiscal year ended December 31, 2025, we generated revenues of $36,305,891, compared to revenues of $34,874,283 in 2024, an increase of approximately $1.4 million.
Cash flows used in investing activities were $2,320,847 during the year ended December 31, 2024, compared to $656,150 during our fiscal year ended December 31, 2023. The reason for the increase was due to the acquisition of intangible assets and equipment for Nora Pharma operations.
Cash flows used in investing activities were $836,306 during the year ended December 31, 2025, compared to $1,979,313 during our fiscal year ended December 31, 2024. The decrease of approximately $1.7 million was due to reduced acquisition of intangible assets and purchase of equipment for Nora Pharma’s operations.
We received net proceeds of approximately $4.1 million from the private placement. On February 11, 2024, we redeemed all of the April Warrants and all of the May Investor Warrants for an aggregate purchase price of $3,139,651.
During the fiscal years ended December 31, 2024 and 2025, we received aggregate proceeds of $6,478,624 in connection with warrant exercises. On February 11, 2024, we redeemed certain warrants we issued on May 16, 2023, and April 28, 2022 for an aggregate purchase price of $3,139,651.
The cost of sales in 2024 and 2023 for generating these revenues was $24,204,489 (69.4%) and $15,753,616 (65.4%), respectively. The 4% increase in the cost of sales in 2024 was due to higher professional allowances incurred on the sale of products outside the Province of Quebec. In the Province of Quebec, professional allowances are capped by government regulations.
The 3.2% decrease in the cost of sales in 2025 was largely due to lower professional allowances incurred on the sale of products outside the Province of Quebec. In the Province of Quebec professional allowances are set by government regulations. We also had lower wholesalers’ fees and discounts in 2025.
Removed
The increase of approximately $10.8 million was the result of expansion of Nora Pharma sales efforts in the Province of Quebec as well as entry into the Provinces of Ontario, Alberta and British Columbia. Another contributing factor was the increased number of products offered by Nora Pharma, which increased by 5 during 2024.
Added
The increase was the result of expansion of Nora Pharma sales efforts in the Provinces of Quebec, Ontario, Alberta, and British Columbia. The cost of sales in 2025 and 2024 for generating these revenues was $24,050,214 (66.2%) and $24,204,489 (69.4%), respectively.
Removed
General and administrative (“G&A”) expenses for our fiscal year ended December 31, 2024, were $16,481,915, compared to $13,124,470 during our fiscal year ended December 31, 2023, an increase of $3,357,445. This relatively modest increase occurred in connection with Nora Pharma’s expansion of sales operations. We had interest income of $496,003 in 2024, compared to interest income of $811,974 in 2023.
Added
General and administrative (“G&A”) expenses for our fiscal year ended December 31, 2025, were $18,482,706, compared to $16,481,915 during our fiscal year ended December 31, 2024, an increase of $2,000,791. The increase in the year ended December 31, 2025 is primarily attributable to a non-cash charge of $1,748,247 related to the impairment of intangible assets.
Removed
Liquidity and Capital Resources As of December 31, 2024, we had cash and cash equivalents of $9,686,529. During the fiscal years ended December 31, 2023 and 2024, we received aggregate proceeds of $3,558,812 in connection with warrant exercises. On May 16, 2023, we completed a private placement of common stock and warrants for gross proceeds of approximately $5 million.
Added
In January 2026, we implemented initiatives to reduce our general and administrative expenses and better align our cost structure with the Company’s objective of achieving profitability in the near term. Based on our current plans, we expect these initiatives to reduce expenses by approximately $2 million to $3 million in 2026.
Removed
Net cash flows provided by financing activities were $9,289,507 in 2024, compared to $3,425,587 in 2023. The increase was primarily due to a larger financing event in 2024 than in 2023 and the exercise of more warrants in 2024 than in 2023. Net cash used in operations was $12,531,180 in 2024, compared to $8,775,111 in 2023.
Added
However, there can be no assurance that we will realize these anticipated reductions. We had interest income of $280,901 in 2025, compared to interest income of $496,003 in 2024. The decrease was due to reduced interest rates and less cash on hand in 2025.
Removed
The increase was due to expansion of Nora Pharma’s operations and increase in inventory. 20 We believe our existing cash will be sufficient to fund our pharmaceuticals sales operations and research and development activities for the next 24 months. There is no assurance our estimates will be accurate.
Added
On April 2, 2025, the Company issued 660,000 shares of common stock upon the exercise of 660,000 Series B Warrants and received $1,840,014 in net proceeds.
Added
On April 3, 2025, the Company issued an aggregate of 1,188,404 shares of common stock in connection with a registered direct offering and received $1,828,596 in net proceeds. 22 On October 16, 2025, the Company issued 350,000 shares of common stock upon the exercise of 350,000 Series B Warrants and received net proceeds of $724,500.
Added
Net cash used in operations was $5,331,073 in 2025, compared to $12,524,779 in 2024. The substantial decrease was due to more streamlined Nora Pharma operations and a significant decrease in the rate of inventory growth.
Added
Net cash flows provided by financing activities were $4,748,408 in 2025, compared to $8,941,572 in 2024. The decrease was due to a smaller financing event in 2025 as well as the exercise of fewer warrants. We believe our existing cash will be sufficient to fund our operations for the next 18 months.