Sunshine Biopharma Inc.

Company overview

• Sunshine Biopharma is a pharmaceutical company focused on life-saving medicines across multiple therapeutic areas, including oncology and antivirals.
• Corporate structure:
  • Nora Pharma Inc. (Canada): wholly owned subsidiary through which the company currently has 71 generic prescription drugs on the Canadian market.
  • Sunshine Biopharma Canada Inc. (Canada): wholly owned subsidiary that develops and sells OTC (non-prescription) supplements.

Headquarters and principal operations

• Principal place of business: Fort Lauderdale, Florida, USA.
• Nora Pharma operates a 23,500 sq ft facility in Varennes, Quebec (lease through January 2030 with a five-year extension option; includes an 18,500 sq ft warehouse and 5,000 sq ft office; licensed Health Canada warehouse).

Commercial operations and go-to-market model

• Focus: acquisition of rights to pharmaceutical products for sale in Canada, with potential global reach.
• Business models in Canada:
  • In-licensing and supply agreements: Nora Pharma imports, markets, sells, and distributes products in Canada by purchasing drug dossiers and filing with Health Canada for regulatory approval (approximately 12-month cycle), then markets under the Nora Pharma label.
  • Cross-licensing: Nora Pharma receives authorization letters from partners whose products are already Health Canada approved; Nora Pharma obtains its own Health Canada approval (approximately 45–60 days) and markets under the Nora Pharma label.
  • Distribution agreements: Nora Pharma distributes partner products that are sold under the partner’s label.
• Regulatory pathway: Health Canada approval yields a Drug Identification Number (DIN) for prescription drugs; Notice of Compliance (NOC) and DIN support market access; pCPA (Pan-Canadian Pharmaceutical Alliance) determines listing on provincial and federal drug plans.
• U.S. and international channels:
  • OTC products sold in Canada via Amazon.ca.
  • OTC sales in the U.S. via Amazon were discontinued in Q3 2025.

Product portfolio and pipeline

• Current portfolio (Canada):
  • 71 generic prescription drugs on the market across therapeutic areas including oncology, cardiovascular, anti-infective, CNS, GI, dermatology, and urology.
  • Example molecules/categories: abiraterone, alendronate, amlodipine, apixaban, aripiprazole, atorvastatin, azithromycin, candesartan, ciprofloxacin, doxycycline, esomeprazole, fluconazole, gabapentin, letrozole, metformin, pravastatin, sertraline, sildenafil, tadalafil, rosuvastatin, zolmitriptan, and others.
  • Nora Pharma owns 200 Health Canada DINs for prescription drugs (acquired via in-licenses and cross-licenses) and distributes 10 additional generic drugs under distribution agreements.
• OTC products:
  • Four Natural Product Numbers (NPNs) for in-house OTC items: Essential•9, Calcium–Vitamin D, L-Citrulline, Taurine.
• Pipeline:
  • 22 additional drug candidates in development, including 12 anticipated launches in the remainder of 2026.
  • Targeted therapeutic areas: cardiovascular, oncology, gastroenterology, CNS, diabetes, urology, endocrinology, anti-infective, and anti-inflammatory.

Proprietary drug development and IP

• K1.1 mRNA: LNP-encapsulated mRNA targeting liver cancer. In vitro data show cytotoxic effects on certain cancer cells with limited toxicity to normal cells; preclinical xenograft studies show tumor reduction in mouse liver cancer models.
• SBFM-PL4: Small-molecule PLpro/Mpro inhibitors with activity against SARS-CoV-2 and related coronaviruses; IP includes provisional and PCT filings and a Notice of Allowance from the USPTO dated December 23, 2025.
• University of Arizona license (Feb 2023): exclusive worldwide license for technology related to the PLpro inhibitors and associated research; first-option and related option agreements are in place.
• Patents and IP timeline:
  • May 22, 2020: US provisional for coronavirus protease inhibitors (Mpro).
  • April 30, 2021: PCT filing extending coverage to PLpro.
  • April 20, 2022: US provisional for mRNA cancer-destroying molecules (K1.1).
  • December 23, 2025: Notice of Allowance from USPTO for the PCT application related to the protease inhibitors.
• Ownership of regulatory assets:
  • Nora Pharma owns 200 Health Canada DINs and 4 NPNs for in-house OTC products.
• Trademarks: U.S. and Canadian trademark registrations for “Sunshine Biopharma Inc.” and design (U.S. 7,963,385; Canada TMA1,056,964 and TMA1,056,969).

Regulatory environment and manufacturing

• Regulatory focus:
  • Canada: Health Canada approvals for DINs and NPNs; pCPA formulary listings for public reimbursement.
  • U.S.: FDA pathways for non-generic candidates (IND → Phase I/II/III → NDA); potential EUA or compassionate use pathways may apply for certain programs. OTC supplements are regulated with GMP requirements and FTC advertising oversight.
• Manufacturing:
  • Generics: production primarily by three overseas suppliers (approximately 75% of products).
  • Non-generic/proprietary candidates: preclinical and early-stage manufacturing at the University of Arizona (K1.1) and WuXi AppTec (K1.1 mRNA) in Hong Kong.
  • OTC products: manufactured by INOV Pharma Inc. (Montreal, Canada).
• Quality and compliance: GMP adherence for generics and OTC products; Health Canada and FDA guidelines apply to development programs and manufacturing facilities.

Marketing, sales, and customers

• Canada is the primary market for generic products; sales channels include retail pharmacies, distributors, and wholesalers. Nora Pharma’s sales team provides training and education to pharmacy owners.
• OTC products are marketed in Canada via Amazon.ca.
• U.S. OTC sales via Amazon were discontinued in Q3 2025.

Workforce, facilities, and operations

• Employees: 50 full-time staff.
• Primary Canadian facility: Nora Pharma’s Varennes headquarters/warehouse (23,500 sq ft; lease expires January 2030; monthly rent CAD 27,250). The facility includes warehousing and office space and is licensed for Health Canada storage.
• Corporate headquarters: Fort Lauderdale, Florida.

Financial highlights (year ended December 31, 2025)

• Accumulated deficit: $75,015,126.
• Net loss for 2025: $5,975,352.
• Net loss for 2024: $5,134,116.
• Revenues are primarily from generic product sales in Canada.
• The company expects to need additional funding to support operations and product development.

Legal and risk snapshot

• Listed on Nasdaq; risks include stock price volatility and potential delisting if listing requirements are not maintained.
• No revenues from non-generic products currently; the company relies substantially on funding from securities.
• Operational risks include reliance on a small number of foreign suppliers and manufacturing partners.
• Proprietary programs are at preclinical stages; development success is uncertain and costs can be substantial.

Bottom line

Sunshine Biopharma operates through Nora Pharma and Sunshine Biopharma Canada Inc., focusing on acquiring and commercializing generics in Canada and selling OTC supplements. The company lists 71 generics on the Canadian market, holds 200 DINs and four NPNs, and has a pipeline of 22 additional drug candidates (including 12 planned launches in 2026). Proprietary programs include K1.1 mRNA for liver cancer and SBFM-PL4 antiviral inhibitors, supported by licensing and patent activity. The company maintains a 50-person workforce, a leased facility in Varennes, Quebec, and a corporate office in Fort Lauderdale, with ongoing preclinical development and reported accumulated deficits and net losses through 2025.